|
The Netherlands
|
| | | | |
Not Applicable
|
|
|
(State or other jurisdiction of
incorporation or organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer
Identification Number) |
|
|
Richard D. Truesdell, Jr.
Leo Borchardt Davis Polk & Wardwell LLP 450 Lexington Avenue New York, New York 10017 +1 (212) 450-4000 |
| |
Paul van der Bijl
NautaDutilh N.V. Beethovenstraat 400 1082 PR Amsterdam The Netherlands +31 (20) 717-1000 |
| |
Nathan Ajiashvili
Oliver Seiler Latham & Watkins LLP 885 Third Avenue New York, New York 10022 +1 (212) 906-1200 |
|
CALCULATION OF REGISTRATION FEE
|
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Title of each class of securities to be registered
|
| |
Proposed maximum aggregate offering price(1)
|
| |
Amount of registration fee(2)
|
| ||||||
Common shares, par value €0.12 per share
|
| | | $ | 100,000,000 | | | | | $ | 12,980 | | |
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| | | | F-1 | | |
| Issuer | | | CureVac B.V., to be converted into and renamed CureVac N.V. prior to the closing of this offering. | |
|
Common shares offered
|
| | We are offering common shares. | |
|
Underwriters’ option to purchase additional common shares
|
| |
We have granted the underwriters the right to purchase up to an additional common shares from us within 30 days of the date of this prospectus. |
|
| Concurrent Private Placement | | | Mr. Dietmar Hopp, has agreed, concurrently with, and subject to, the completion of this offering, to purchase from us a certain number of common shares with an aggregate value of €100 million at the initial public offering price per share. This purchase will be made by Mr. Hopp pursuant to the concurrent private placement. The closing of this offering is not conditioned upon the closing of the concurrent private placement. | |
|
Common shares to be outstanding after this offering
|
| |
common shares ( common shares if the underwriters’ option to purchase additional common shares is exercised in full) assuming that we issue and sell common shares to Mr. Hopp in the concurrent private placement. |
|
|
Voting rights
|
| | Our common shares have one vote per share. | |
| Listing | | | We have applied to list our common shares on The Nasdaq Global Market, or Nasdaq, under the symbol “CVAC.” | |
|
Use of proceeds
|
| | We estimate that the net proceeds to us from the offering will be (i) approximately $ ($ if the underwriters’ option to purchase additional common shares is exercised in full), assuming an initial public offering price of $ per common share, which is the midpoint of the price range set forth on the cover page of this prospectus; and (ii) additional net proceeds of €100 million from the concurrent private placement. We currently intend to use the net proceeds from the offering and the concurrent private placement, together with cash and cash equivalents on hand as follows: (i) to advance our lead oncology program, CV8102, through the completion of the Phase 2 clinical trial; (ii) to advance our lead vaccine program, CV7202, through the completion of the Phase 2 clinical trial; (iii) to fund clinical development of our mRNA vaccine program against SARS-CoV-2 through the completion of the Phase 2 clinical trial; (iv) to advance the development of our other preclinical and clinical programs; (v) to invest in further development of our mRNA technology platform; (vi) to fund the expansion of our manufacturing capabilities; and (vii) the remainder for working capital and general corporate purposes. See “Use of Proceeds.” | |
|
Dividend policy
|
| | We have never paid or declared any cash dividends on our common shares and we do not anticipate paying any cash dividends on our common shares in the foreseeable future. We intend to retain all available funds and any future | |
| | | | earnings to fund the development and expansion of our business. As of the completion of our corporate reorganization, under Dutch law, we may only pay dividends to the extent our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-in and called-up share capital plus the reserves required to be maintained by Dutch law or by our articles of association and (if it concerns a distribution of profits) after adoption of the annual accounts by the general meeting from which it appears that such dividend distribution is allowed. Subject to such restrictions, any future determination to pay dividends will be at the discretion of our management board with the approval of our supervisory board and will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors our management board and supervisory board deem relevant. | |
|
Lock-up agreements
|
| | We have agreed with the underwriters, subject to certain exceptions, not to offer, sell or dispose of any shares of our share capital or securities convertible into or exchangeable or exercisable for any shares of our share capital during the 180-day period following the date of this prospectus. Our managing directors and our supervisory directors, as well as substantially all of our existing shareholders, have agreed to substantially similar lock-up provisions, subject to certain exceptions. | |
|
Risk factors
|
| | See “Risk Factors” and the other information included in this prospectus for a discussion of factors you should consider before deciding to invest in our common shares. | |
|
Directed share program
|
| | At our request, the underwriters have reserved up to common shares, or % of common shares to be offered by this prospectus for sale, at the initial public offering price, through a directed share program. Common shares purchased through the directed share program will not be subject to a lock-up restriction, except in the case of common shares purchased by any of our directors or officers. We do not know if any of these potential investors will choose to purchase all or any portion of the allocated shares, but the number of common shares available for sale to the general public will be reduced to the extent these individuals or entities purchase such reserved common shares. Any reserved common shares that are not so purchased will be offered by the underwriters to the general public on the same basis as the other common shares offered by this prospectus. | |
| | |
For the Years Ended
December 31, |
| |
For the Three-
Months Ended March 31, |
| ||||||||||||||||||
| | |
2018
|
| |
2019
|
| |
2019
|
| |
2020
|
| ||||||||||||
(in thousands of euros, except per share amounts)
|
| | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data:
|
| | | | | | | | | | | | | | | ||||||||||
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | | | | | 3,156 | | | | | | 3,119 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | | | | | (7,558) | | | | | | (5,475) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | | | | | (198) | | | | | | (330) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | | | | | (10,862) | | | | | | (10,902) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | | | | | (6,887) | | | | | | (11,495) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | | | | | 732 | | | | | | 1,995 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | | | | | (108) | | | | | | (127) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | | | | | (21,725) | | | | | | (23,216) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | | | | | 649 | | | | | | 1,041 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | | | | | (90) | | | | | | (1,719) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | | | | | (21,166) | | | | | | (23,894) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | | | | | (142) | | | | | | 44 | | |
Net loss for the year
|
| | | | (71,241) | | | | | | (99,873) | | | | | | (21,308) | | | | | | (23,850) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | | | | | 36 | | | | | | 48 | | |
Total comprehensive loss for the year
|
| | | | (71,175) | | | | | | (99,841) | | | | | | (21,272) | | | | | | (23,802) | | |
|
| | |
As of March 31, 2020
|
| |||||||||
| | |
Actual
|
| |
Pro
Forma(1) |
| |
Pro Forma
As Adjusted(2)(3) |
| |||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Statement of Financial Position Data: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | | 43,474 | | | |
|
| |
|
|
Total assets
|
| | | | 155,656 | | | | | | | | |
Total liabilities
|
| | | | 199,313 | | | | | | | | |
Total equity
|
| | | | (43,657) | | | | | | | | |
| | |
March 31, 2020
|
| |||||||||||||||
| | |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted(1) |
| |||||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||||||||
Cash and cash equivalents
|
| | | | 43,474 | | | | | | | | | | | | | ||
Convertible loans
|
| | | | 67,078 | | | | | | | | | | | | | | |
Equity(2): | | | | | | | | | | | | | | | | | | | |
Issued capital
|
| | | | 743 | | | | | | | | | | | | | | |
Capital reserve
|
| | | | 495,327 | | | | | | | | | | | | | | |
Accumulated deficit
|
| | | | (539,797) | | | | | | | | | | | | | | |
Other comprehensive income
|
| | | | 70 | | | | | | | | | | | | | | |
Total shareholders’ equity
|
| | | | (43,657) | | | | | | | | | | | | | | |
Total capitalization
|
| | | | 23,241 | | | | | | | | | | | | | | |
| | |
$
|
| |
€
|
| ||||||
Assumed initial public offering price per common share
|
| | | | | | | | | | | ||
Pro forma net tangible book value per common share at March 31, 2020 after giving
effect to (i) the consummation of the 2020 Private Investment, (ii) the consummation of the concurrent private placement to Mr. Hopp of €100 million of our common shares at a price per share equal to the public offering price in this public offering, (iii) the repayment in full of the Convertible Loans with Mr. Dietmar Hopp and (iv) our corporate reorganization |
| | | | | | | | | | | | |
Increase in net tangible book value per common share attributable to new investors
|
| | | | | | | | | | | | |
Pro forma as adjusted net tangible book value per common share at March 31, 2020 after giving effect to the corporate reorganization and the offering
|
| | | | | | | | | | | | |
Dilution per common share to new investors
|
| | | | | | | | | | | | |
Percentage of dilution per common share to new investors
|
| | | | | | | | | | | | |
| | |
For the Years Ended
December 31, |
| |
For the Three
Months Ended March 31, |
| ||||||||||||||||||
(in thousands of euros, except per share amounts)
|
| |
2018
|
| |
2019
|
| |
2019
|
| |
2020
|
| ||||||||||||
| | | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data: | | | | | | | | | | | | | | | | ||||||||||
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | | | | | 3,156 | | | | | | 3,119 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | | | | | (7,558) | | | | | | (5,475) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | | | | | (198) | | | | | | (330) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | | | | | (10,862) | | | | | | (10,902) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | | | | | (6,887) | | | | | | (11,495) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | | | | | 732 | | | | | | 1,995 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | | | | | (108) | | | | | | (127) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | | | | | (21,725) | | | | | | (23,216) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | | | | | 649 | | | | | | 1,041 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | | | | | (90) | | | | | | (1,719) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | | | | | (21,166) | | | | | | (23,894) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | | | | | (142) | | | | | | 44 | | |
Net loss for the year
|
| | | | (71,241) | | | | | | (99,873) | | | | | | (21,308) | | | | | | (23,850) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | | | | | 36 | | | | | | 48 | | |
Total comprehensive loss for the year
|
| | | | (71,175) | | | | | | (99,841) | | | | | | (21,272) | | | | | | (23,802) | | |
Net loss per share (basic and diluted)
|
| | | | (98.05) | | | | | | (137.45) | | | | | | (29.32) | | | | | | (32.48) | | |
|
| | |
As of December 31,
|
| |
As of March 31,
|
| ||||||||||||
| | |
2018
|
| |
2019
|
| |
2020
|
| |||||||||
(in thousands of euros)
|
| | | | |
(unaudited)
|
| ||||||||||||
Statement of Financial Position Data: | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | | 21,380 | | | | | | 30,684 | | | | | | 43,474 | | |
Total assets
|
| | | | 125,659 | | | | | | 130,620 | | | | | | 155,656 | | |
Total liabilities
|
| | | | 93,576 | | | | | | 173,422 | | | | | | 199,313 | | |
Total equity
|
| | | | 32,083 | | | | | | (42,802) | | | | | | (43,657) | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
(in thousands of EUR, except per share data)
|
| |
2019
|
| |
2020
|
| ||||||
| | |
(unaudited)
|
| |||||||||
Statement of Operations and Comprehensive Income (Loss) Data: | | | | | | | | | | | | | |
Revenue
|
| | | | 3,156 | | | | | | 3,119 | | |
Cost of sales
|
| | | | (7,558) | | | | | | (5,475) | | |
Selling and distribution expenses
|
| | | | (198) | | | | | | (330) | | |
Research and development expenses
|
| | | | (10,862) | | | | | | (10,902) | | |
General and administrative expenses
|
| | | | (6,887) | | | | | | (11,495) | | |
Other operating income
|
| | | | 732 | | | | | | 1,995 | | |
Other operating expenses
|
| | | | (108) | | | | | | (127) | | |
Operating loss
|
| | | | (21,725) | | | | | | (23,216) | | |
Finance income
|
| | | | 649 | | | | | | 1,041 | | |
Finance expenses
|
| | | | (90) | | | | | | (1,719) | | |
Loss before income tax
|
| | | | (21,166) | | | | | | (23,894) | | |
Income tax benefit (expense)
|
| | | | (142) | | | | | | 44 | | |
Net loss for the year
|
| | | | (21,308) | | | | | | (23,850) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 36 | | | | | | 48 | | |
Total comprehensive loss for the year
|
| | | | (21,272) | | | | | | (23,802) | | |
Net loss per share (basic and diluted)
|
| | | | (29.32) | | | | | | (32.48) | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (2,488) | | | | | | (2,821) | | |
Materials
|
| | | | (2,928) | | | | | | (1,550) | | |
Third-party services
|
| | | | (1,489) | | | | | | (675) | | |
Maintenance and lease
|
| | | | (206) | | | | | | (159) | | |
Amortization and depreciation
|
| | | | (401) | | | | | | (246) | | |
Other
|
| | | | (46) | | | | | | (24) | | |
Total | | | | | (7,558) | | | | | | (5,475) | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (79) | | | | | | (240) | | |
Maintenance and lease costs
|
| | | | (88) | | | | | | — | | |
Amortization and depreciation
|
| | | | (19) | | | | | | (41) | | |
Other
|
| | | | (12) | | | | | | (49) | | |
Total | | | | | (198) | | | | | | (330) | | |
|
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Materials
|
| | | | (963) | | | | | | (1,165) | | |
Personnel
|
| | | | (3,251) | | | | | | (3,686) | | |
Amortization and depreciation
|
| | | | (129) | | | | | | (351) | | |
Patents and fees to register a legal right
|
| | | | (1,202) | | | | | | (823) | | |
Third-party services
|
| | | | (5,094) | | | | | | (4,263) | | |
Maintenance and lease
|
| | | | (111) | | | | | | (454) | | |
Other
|
| | | | (112) | | | | | | (160) | | |
Total | | | | | (10,862) | | | | | | (10,902) | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Key Programs (CV8102, CV7202 and SARS-CoV-2) | | | | | | | | | | | | | |
CV8102
|
| | | | 1,125 | | | | | | 1,425 | | |
CV7202
|
| | | | 527 | | | | | | 898 | | |
SARS-CoV-2
|
| | | | — | | | | | | 396 | | |
Other Research and Development Programs
|
| | | | 3,535 | | | | | | 2,836 | | |
Unallocated costs(1)
|
| | | | 5,675 | | | | | | 5,347 | | |
Total | | | | | 10,862 | | | | | | 10,902 | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Personnel
|
| | | | (3,936) | | | | | | (7,055) | | |
Maintenance and lease costs
|
| | | | (990) | | | | | | (1,333) | | |
Third-party services
|
| | | | (571) | | | | | | (1,420) | | |
Legal and other professional services
|
| | | | (154) | | | | | | (427) | | |
Amortization and depreciation
|
| | | | (426) | | | | | | (418) | | |
Other
|
| | | | (810) | | | | | | (842) | | |
Total | | | | | (6,887) | | | | | | (11,495) | | |
| | |
For the Years Ended
December 31, |
| |||||||||
(in thousands of EUR, except per share data)
|
| |
2018
|
| |
2019
|
| ||||||
Statement of Operations and Comprehensive Income (Loss) Data: | | | | | | | | | | | | | |
Revenue
|
| | | | 12,871 | | | | | | 17,416 | | |
Cost of sales
|
| | | | (17,744) | | | | | | (27,983) | | |
Selling and distribution expenses
|
| | | | (1,085) | | | | | | (1,755) | | |
Research and development expenses
|
| | | | (41,722) | | | | | | (43,242) | | |
General and administrative expenses
|
| | | | (25,289) | | | | | | (48,969) | | |
Other operating income
|
| | | | 808 | | | | | | 5,587 | | |
Other operating expenses
|
| | | | (663) | | | | | | (552) | | |
Operating loss
|
| | | | (72,824) | | | | | | (99,498) | | |
Finance income
|
| | | | 1,968 | | | | | | 833 | | |
Finance expenses
|
| | | | (275) | | | | | | (1,460) | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Income tax benefit (expense)
|
| | | | (110) | | | | | | 252 | | |
Net loss for the year
|
| | | | (71,241) | | | | | | (99,873) | | |
Other comprehensive income/loss: | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | 66 | | | | | | 32 | | |
Total comprehensive loss for the year
|
| | | | (71,175) | | | | | | (99,841) | | |
Net loss per share (basic and diluted)
|
| | | | (98.05) | | | | | | (137.45) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (7,703) | | | | | | (9,855) | | |
Materials
|
| | | | (4,941) | | | | | | (7,542) | | |
Third-party services
|
| | | | (2,340) | | | | | | (7,268) | | |
Maintenance and lease
|
| | | | (1,758) | | | | | | (1,060) | | |
Amortization and depreciation
|
| | | | (893) | | | | | | (2,038) | | |
Other
|
| | | | (109) | | | | | | (220) | | |
Total | | | | | (17,744) | | | | | | (27,983) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (581) | | | | | | (1,263) | | |
Maintenance and lease costs
|
| | | | (300) | | | | | | (167) | | |
Amortization and depreciation
|
| | | | (95) | | | | | | (81) | | |
Other
|
| | | | (109) | | | | | | (243) | | |
Total | | | | | (1,085) | | | | | | (1,755) | | |
| | |
For the years ended December 31,
|
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Materials
|
| | | | (5,867) | | | | | | (4,015) | | |
Personnel
|
| | | | (7,565) | | | | | | (14,385) | | |
Amortization and depreciation
|
| | | | (1,143) | | | | | | (474) | | |
Patents and fees to register a legal right
|
| | | | (4,847) | | | | | | (4,551) | | |
Third-party services
|
| | | | (19,921) | | | | | | (18,626) | | |
Maintenance and lease
|
| | | | (1,156) | | | | | | (670) | | |
Other
|
| | | | (1,223) | | | | | | (521) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
|
| | |
For the years ended December 31,
|
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Key Programs (CV8102 and CV7202) | | | | | | | | | | | | | |
CV8102
|
| | | | (1,525) | | | | | | (4,511) | | |
CV7202
|
| | | | (1,987) | | | | | | (2,236) | | |
Other Research and Development Programs
|
| | | | (14,047) | | | | | | (14,271) | | |
Unallocated costs(1)
|
| | | | (24,163) | | | | | | (22,224) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Personnel
|
| | | | (10,084) | | | | | | (31,645) | | |
Maintenance and lease costs
|
| | | | (3,239) | | | | | | (4,604) | | |
Third-party services
|
| | | | (4,006) | | | | | | (5,970) | | |
Legal and other professional services
|
| | | | (4,078) | | | | | | (2,110) | | |
Amortization and depreciation
|
| | | | (1,635) | | | | | | (2,182) | | |
Other
|
| | | | (2,247) | | | | | | (2,458) | | |
Total | | | | | (25,289) | | | | | | (48,969) | | |
| | |
For the Three Months Ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
(in thousands of euros)
(unaudited) |
| |||||||||
Net cash flow from (used in): | | | | | | | | | | | | | |
Operating activities
|
| | | | (22,630) | | | | | | (2,680) | | |
Investing activities
|
| | | | 16,723 | | | | | | (3,319) | | |
Financing activities
|
| | | | (279) | | | | | | 18,742 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | 36 | | | | | | 47 | | |
Overall cash inflow (outflow)
|
| | | | 15,260 | | | | | | 43,474 | | |
| | |
For the years ended
December 31, |
| |||||||||
| | |
2018
|
| |
2019
|
| ||||||
| | |
(in thousands of euros)
|
| |||||||||
Net cash flow from (used in): | | | | | | | | | | | | | |
Operating activities
|
| | | | (74,110) | | | | | | (86,963) | | |
Investing activities
|
| | | | (4,264) | | | | | | 28,181 | | |
Financing activities
|
| | | | (112) | | | | | | 67,979 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | 213 | | | | | | 107 | | |
Overall cash inflow (outflow)
|
| | | | (78,273) | | | | | | 9,304 | | |
| | |
Payment Due by Period
|
| |||||||||||||||||||||||||||||||||||||||
| | |
Total
|
| |
2020
|
| |
2021
|
| |
2022
|
| |
2023
|
| |
2024
|
| |
Thereafter
|
| |||||||||||||||||||||
| | |
(in thousands of Euros)
|
| |||||||||||||||||||||||||||||||||||||||
Convertible loans
|
| | | | (83,940)(1) | | | | | | — | | | | | | — | | | | | | (83,940) | | | | | | — | | | | | | — | | | | | | — | | |
Lease liabilities
|
| | | | (17,121) | | | | | | (2,843) | | | | | | (2,298) | | | | | | (2,298) | | | | | | (2,298) | | | | | | (2,298) | | | | | | (5,086) | | |
Total
|
| | | | (101,061) | | | | | | (2,843) | | | | | | (2,298) | | | | | | (86,238) | | | | | | (2,298) | | | | | | (2,298) | | | | | | (5,086) | | |
Patients with a least one event, n (%)
|
| |
Stratum 1
(n=16) |
| |
Stratum 2
(n=8) |
| |
Stratum 3
(n=2) |
| |
Overall
(n=26) |
| ||||||||||||
TEAE
|
| | | | 16 (100.0) | | | | | | 8 (100.0) | | | | | | 2 (100.0) | | | | | | 26 (100.0) | | |
BI1361849- and/or radiation-related AE
|
| | | | 16 (100.0) | | | | | | 8 (100.0) | | | | | | 2 (100.0) | | | | | | 26 (100.0) | | |
TEAE related to BI1361849
|
| | | | 15 (93.8) | | | | | | 8 (100.0) | | | | | | 2 (100.0) | | | | | | 26 (96.2) | | |
TEAE related to radiation
|
| | | | 4 (25.0) | | | | | | 1 (12.5) | | | | | | 0 (50.0) | | | | | | 5 (19.2) | | |
Serious TEAE
|
| | | | 7 (43.8) | | | | | | 3 (37.5) | | | | | | 1 (50.0) | | | | | | 11 (42.3) | | |
Serious BI1361849- and/or radiation-related AE
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
Related to BI1361849
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Related to radiation
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
TEAE toxicity grade ≥ 3a
|
| | | | 9 (56.3) | | | | | | 4 (50.0) | | | | | | 2 (100.0) | | | | | | 15 (57.7) | | |
BI1361849- and/or radiation-related AE toxicity grade ≥ 3a
|
| | | | 2 (12.5) | | | | | | 1 (12.5) | | | | | | 1 (50.0) | | | | | | 4 (15.4) | | |
Related to BI1361849
|
| | | | 1 (6.3) | | | | | | 1 (12.5) | | | | | | 1 (50.0) | | | | | | 3 (11.5) | | |
Related to radiation
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
Serious BI1361849- and/or radiation-related AE toxicity grade ≥ 3a
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
Related to BI1361849
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Related to radiation
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
TEAE leading to discontinuation
|
| | | | 4 (25.0) | | | | | | 0 | | | | | | 0 | | | | | | 4 (15.4) | | |
TEAE toxicity grade ≥ 3 leading to discontinuation
|
| | | | 2 (12.5) | | | | | | 0 | | | | | | 0 | | | | | | 2 (7.7) | | |
TEAE leading to interruption/dose modification
|
| | | | 4 (25.0) | | | | | | 0 | | | | | | 0 | | | | | | 4 (15.4) | | |
TEAE leading to death
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
Parameter
|
| |
Patients with response, n (%) [95% confidence interval]
|
| |||||||||||||||||||||
| | |
Stratum 1
(n=16) |
| |
Stratum 2
(n=8) |
| |
Stratum 3
(n=2) |
| |
Overall
(n=26) |
| ||||||||||||
Response (CR + PR) rate
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
| | | | | [0.2-30.2] | | | | | | [0.0-36.9] | | | | | | [0.0-84.2] | | | | | | [0.1-19.6] | | |
Best overall response
|
| | | | | | | | | | | | | | | | | | | | | | | | |
CR
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | | | | | 0 | | |
| | | | | [0.0-20.6] | | | | | | [0.0-36.9] | | | | | | [0.0-84.2] | | | | | | [0.0-13.2] | | |
PR
|
| | | | 1 (6.3) | | | | | | 0 | | | | | | 0 | | | | | | 1 (3.8) | | |
| | | | | [0.2-30.2] | | | | | | [0.0-36.9] | | | | | | [0.0-84.2] | | | | | | [0.1-19.6] | | |
SD
|
| | | | 8 (50.0) | | | | | | 3 (37.5) | | | | | | 1 (50.0) | | | | | | 12 (46.2) | | |
| | | | | [24.7-75.3] | | | | | | [8.5-75.5] | | | | | | [1.3-98.7] | | | | | | [26.6-66.6] | | |
PD
|
| | | | 7 (43.8) | | | | | | 4 (50.0) | | | | | | 1(50.0) | | | | | | 12 (46.2) | | |
| | | | | [19.8-70.1] | | | | | | [15.7-84.3] | | | | | | [1.3-98.7] | | | | | | [26.6-66.6] | | |
NE
|
| | | | 0 | | | | | | 1 (12.5) | | | | | | 0 | | | | | | 1 (3.8) | | |
| | | | | [0.0-20.6] | | | | | | [0.3-52.7] | | | | | | [0.0-84.2] | | | | | | [0.1-19.6] | | |
|
|
| |
|
|
Location
|
| |
Area
(Approximate Sq. Feet) |
| |||
Germany: | | | | | | | |
Tübingen
|
| | | | 189,000 | | |
Frankfurt am Main
|
| | | | 8,600 | | |
Total
|
| | | | 197,600 | | |
United States: | | | | | | | |
Boston
|
| | | | 12,900 | | |
Total
|
| | | | 12,900 | | |
Total
|
| | | | 210,500 | | |
|
Name(1)
|
| |
Age
|
| |
Term Served
|
| |
Year in
which Term Expires |
| |
Position
|
|
| Franz-Werner Haas, LLD, LLM | | |
50
|
| |
6/2020 – Present
|
| |
2022
|
| | Chief Executive Officer | |
| Florian von der Mülbe, Ph.D., MBA | | |
48
|
| |
9/2015 – Present
|
| |
2023
|
| | Chief Production Officer | |
| Mariola Fotin-Mleczek, Ph.D. | | |
53
|
| |
9/2015 – Present
|
| |
2023
|
| | Chief Technology Officer | |
| Pierre Kemula, B.Sc. | | |
46
|
| |
11/2016 – Present
|
| |
2021
|
| | Chief Financial Officer | |
| Bernd Winterhalter, MD, Ph.D.(2) | | |
61
|
| |
6/2018 – Present
|
| |
Not
Defined |
| | Chief Development Officer (Interim) | |
| Igor Splawski, Ph.D., MSc | | |
52
|
| |
7/2020 – Present
|
| |
2023
|
| | Chief Scientific Officer | |
|
Name
|
| |
Age
|
| |
Term Served
|
| |
Year in
which Term Expires |
| |
Functions
|
|
| Baron Jean Stéphenne, MSc, MBA | | |
70
|
| |
8/2015 – Present
|
| |
2024
|
| | Chairman and Supervisory Director | |
| Ralf Clemens, MD, Ph.D. | | |
68
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
| Mathias Hothum, Ph.D. | | |
53
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
| Hans Christoph Tanner, Ph.D. | | |
69
|
| |
8/2015 – Present
|
| |
2024
|
| | Supervisory Director | |
| Friedrich von Bohlen und Halbach, Ph.D. | | |
58
|
| |
8/2015 – Present
|
| |
2022
|
| | Vice Chairman and Supervisory Director | |
| Timothy M. Wright, MD | | |
64
|
| |
6/2019 – Present
|
| |
2022
|
| | Supervisory Director | |
| Craig A. Tooman, MBA | | |
54
|
| |
6/2019 – Present
|
| |
2022
|
| | Supervisory Director | |
Name
|
| |
Fixed
Compensation (€) |
| |
Attendance
Fees (€) |
| |
Total
Compensation (€) |
| |||||||||
Baron Jean Stéphenne
|
| | | | 82,500 | | | | | | | | | | | | 82,500 | | |
Ralf Clemens
|
| | | | 55,000 | | | | | | 27,500 | | | | | | 82,500 | | |
Mathias Hothum
|
| | | | 55,000 | | | | | | | | | | | | 55,000 | | |
Hans Cristoph Tanner
|
| | | | 55,000 | | | | | | 27,500 | | | | | | 82,500 | | |
Friedrich von Bohlen und Halbach
|
| | | | 55,000 | | | | | | | | | | | | 55,000 | | |
Ingmar Hoerr(1)
|
| | | | 110,000 | | | | | | | | | | | | 110,000 | | |
Timothy M. Wright
|
| | | | 21,389 | | | | | | | | | | | | 21,388 | | |
Craig A. Tooman
|
| | | | 21,389 | | | | | | | | | | | | 21,388 | | |
Name
|
| |
Number
of Shares |
| |
Percentage
of Shares Outstanding |
| |
Voting
Rights |
| |||||||||
Baron Jean Stéphenne
|
| | | | — | | | | | | — | | | | | | — | | |
Ralf Clemens
|
| | | | — | | | | | | — | | | | | | — | | |
Mathias Hothum
|
| | | | — | | | | | | — | | | | | | — | | |
Hans Cristoph Tanner
|
| | | | 1,414 | | | | | | 0.20% | | | | |
|
(2)
|
| |
Friedrich von Bohlen und Halbach
|
| | | | 1,818 | | | | | | 0.24% | | | | |
|
(3)
|
| |
Ingmar Hoerr(1)
|
| | | | 8,485 | | | | | | 1.14% | | | | |
|
(4)
|
| |
Timothy M. Wright
|
| | | | — | | | | | | — | | | | | | — | | |
Craig A. Tooman
|
| | | | — | | | | | | — | | | | | | — | | |
Name
|
| |
Number of
Options |
| |
Title
|
| |
Amount of
Securities (€) |
| |
Exercise
Price (€) |
| |
Purchase
Price (€) |
| |
Expiration
Date |
| |||||||||||||||
Baron Jean Stéphenne
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ralf Clemens
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Mathias Hothum
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Hans Cristoph Tanner
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Friedrich von Bohlen und Halbach
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ingmar Hoerr(1)
|
| | | | 2,776 | | | |
Share Option Awards
|
| | | | 2,776 | | | | | | 1.00 | | | | | | 2,776 | | | | | | 12/31/2021 | | |
Timothy M. Wright
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Craig A. Tooman
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Name*
|
| |
Salary
(€) |
| |
Bonus
(€)(3) |
| |
All Other
Compensation(4) (€) |
| |
Total
Compensation (€) |
| ||||||||||||
Daniel L. Menichella(1)(2)
|
| | | | 508,455(3) | | | | | | 206,250 | | | | | | 37,098 | | | | | | 751,803 | | |
Florian von der Mülbe
|
| | | | 250,000 | | | | | | 84,375 | | | | | | 25,634 | | | | | | 360,009 | | |
Mariola Fotin-Mleczek
|
| | | | 210,000 | | | | | | 70,875 | | | | | | 12,977 | | | | | | 293,852 | | |
Franz-Werner Haas
|
| | | | 247,000 | | | | | | 111,150 | | | | | | 25,442 | | | | | | 383,592 | | |
Pierre Kemula(5)
|
| | | | 250,000 | | | | | | 84,375 | | | | | | 146,103 | | | | | | 480,478 | | |
Bernd Winterhalter(6)
|
| | | | — | | | | | | — | | | | | | 333,601 | | | | | | 333,601 | | |
Dimitris Voliotis(7)(2)
|
| | | | 425,208 | | | | | | 168,760 | | | | | | — | | | | | | 593,958 | | |
Ulrike Gnad-Vogt(8)
|
| | | | 187,500 | | | | | | 63,281 | | | | | | 9,732 | | | | | | 260,513 | | |
Name*
|
| |
Number of
Shares |
| |
Percentage of
Shares Outstanding |
| |
Voting
Rights |
| |||||||||
Daniel L. Menichella(1)
|
| | | | — | | | | | | — | | | | | | — | | |
Florian von der Mülbe
|
| | | | 6,162(2) | | | | | | 0.83% | | | | |
|
(3)
|
| |
Mariola Fotin-Mleczek
|
| | | | — | | | | | | — | | | | | | — | | |
Franz-Werner Haas
|
| | | | — | | | | | | — | | | | | | — | | |
Pierre Kemula
|
| | | | — | | | | | | — | | | | | | — | | |
Bernd Winterhalter(4)
|
| | | | — | | | | | | — | | | | | | — | | |
Dimitris Voliotis
|
| | | | — | | | | | | — | | | | | | — | | |
Ulrike Gnad-Vogt
|
| | | | — | | | | | | — | | | | | | — | | |
Name*
|
| |
Number of
Options |
| |
Title
|
| |
Amount of
Securities (€) |
| |
Exercise
Price (€) |
| |
Purchase
Price (€) |
| |
Expiration
Date |
| |||||||||||||||
Daniel Menichella(1)
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Florian von der Mülbe
|
| | | | 2,017 | | | |
Share Option Awards
|
| | | | 2,017 | | | | | | 1.00 | | | | | | 2,017 | | | | | | 12/31/2021 | | |
Mariola Fotin-Mleczek
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Franz-Werner Haas
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Pierre Kemula
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Bernd Winterhalter(2)
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Dimitris Voliotis
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Ulrike Gnad-Vogt
|
| | | | — | | | |
—
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Name
|
| |
Program
|
| |
VS
Points Granted |
| |
Max
Vested Points |
| |
Start of
Vesting Period (Only for New Participants) |
| |
Grant date
(Date of Allocation Letter) |
| |
Vesting
Period |
| |
VSOP
Plan |
| |
Valid
until |
| ||||||||||||
Florian von der Mülbe
|
| |
VS
|
| | | | 778 | | | | | | 778 | | | | | | | | | 01.01.2009 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mülbe
|
| |
VS
|
| | | | 3,486 | | | | | | 3,486 | | | | | | | | | 01.01.2011 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mülbe
|
| |
VS
|
| | | | 736 | | | | | | 736 | | | | | | | | | 01.01.2013 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mülbe
|
| |
VS
|
| | | | 1,522 | | | | | | 1,522 | | | | | | | | | 01.01.2015 | | | |
12
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Florian von der Mülbe
|
| |
VS
|
| | | | 6,100 | | | | | | 6,100 | | | | | | | | | 11.12.2015 | | | |
12
|
| |
Prior VSOP IPO only
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| |
VS
|
| | | | 316 | | | | | | 316 | | | | | | | | | 01.01.2009 | | | |
60
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2013 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2014 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2015 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Mariola Fotin-Mleczek
|
| |
VS
|
| | | | 2,327 | | | | | | 2,327 | | | | | | | | | 01.01.2015 | | | |
12
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| |
VS
|
| | | | 682 | | | | | | 682 | | | | | | | | | 01.07.2011 | | | |
60
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2013 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2014 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Ulrike Gnad-Vogt
|
| |
VS
|
| | | | 250 | | | | | | 250 | | | | | | | | | 01.01.2015 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Name
|
| |
Program
|
| |
VS
Points Granted |
| |
Max
Vested Points |
| |
Start of
Vesting Period (Only for New Participants) |
| |
Grant date
(Date of Allocation Letter) |
| |
Vesting
Period |
| |
VSOP
Plan |
| |
Valid
until |
| |||||||||||||||
Ulrike Gnad-Vogt
|
| |
VS
|
| | | | 1,961 | | | | | | 1,961 | | | | | | | | | | | | 01.01.2015 | | | |
12
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| |
VS
|
| | | | 1,400 | | | | | | 1,400 | | | | | | | | | | | | 01.06.2012 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| |
VS
|
| | | | 3,600 | | | | | | 3,600 | | | | | | | | | | | | 01.01.2013 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Franz-Werner Haas
|
| |
VS
|
| | | | 1,522 | | | | | | 1,522 | | | | | | | | | | | | 01.01.2015 | | | |
12
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Pierre Kemula
|
| |
VS
|
| | | | 5,000 | | | | | | 5,000 | | | | | | 01.10.2016 | | | | | | 18.04.2019 | | | |
36
|
| |
Prior VSOP
|
| | | | 31.12.2025 | | |
Daniel Menichella*
|
| |
*
|
| | | | 29,053 | | | | | | 29,053 | | | | | | 08.01.2017 | | | | | | 14.10.2019 | | | |
48
|
| |
*
|
| | | | 08.01.2027 | | |
| | |
Shares beneficially
owned prior to the corporate reorganization and the Offering(1) |
| |
Common shares beneficially
owned after giving effect to the corporate reorganization and the Offering |
| ||||||||||||||||||
| | | | | | | | | | | |
No exercise
of underwriter’s option |
| |
Full exercise
of underwriter’s option |
| |||||||||
Shareholder
|
| |
Number
|
| |
Percentage
|
| |
Number
|
| |
Percentage
|
| |
Percentage
|
| |||||||||
5% Shareholders: | | | | | | | | | | | | | | | | | | | | | | | | | |
Dievini Hopp BioTech holding
GmbH & Co. KG |
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Mr. Dietmar Hopp
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Kreditanstalt für Wiederaufbau(2)
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Glaxo Group Limited
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
| | |
Shares beneficially
owned prior to the corporate reorganization and the Offering(1) |
| |
Common shares beneficially
owned after giving effect to the corporate reorganization and the Offering |
| ||||||||||||||||||
| | | | | | | | | | | |
No exercise
of underwriter’s option |
| |
Full exercise
of underwriter’s option |
| |||||||||
Shareholder
|
| |
Number
|
| |
Percentage
|
| |
Number
|
| |
Percentage
|
| |
Percentage
|
| |||||||||
Managing Directors: | | | | | | | | | | | | | | | | | | | | | | | | | |
Florian von der Mülbe, Ph.D., MBA
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Mariola Fotin-Mleczek, Ph.D.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Franz-Werner Haas, LLD, LLM
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Pierre Kemula, B.Sc.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Supervisory Directors: | | | | | | | | | | | | | | | | | | | | | | | | | |
Ralf Clemens, MD, Ph.D.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Mathias Hothum, Ph.D.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Baron Jean Stéphenne, MSc, MBA
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Hans Cristoph Tanner, Ph.D.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Friedrich von Bohlen und Halbach, Ph.D.
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Timothy M. Wright, MD
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Craig A. Tooman, MBA
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
All Managing Directors and Supervisory Directors as a Group:
|
| | | | | | | % | | | | | | | | | % | | | | | | % | | |
Underwriter
|
| |
Number
of Shares |
| |||
BofA Securities, Inc.
|
| | | | | | |
Jefferies LLC
|
| | | | | | |
Credit Suisse Securities (USA) LLC
|
| | | | | | |
Kempen & Co U.S.A., Inc
|
| | | | | | |
Total
|
| | | | | |
| | |
Per Share
|
| |
Without Option
|
| |
With Option
|
| |||||||||
Public offering price
|
| | | $ | | | | | $ | | | | | $ | | | |||
Underwriting discount
|
| | | $ | | | | | $ | | | | | $ | | | |||
Proceeds, before expenses, to us
|
| | | $ | | | | | $ | | | | | $ | | | |
Expenses
|
| |
Amount
|
| |||
U.S. Securities and Exchange Commission registration fee
|
| | | $ | 12,980 | | |
Nasdaq listing fee
|
| | | $ | 25,000 | | |
FINRA filing fee
|
| | | | * | | |
Printing and engraving expenses
|
| | | $ | 250,000 | | |
Legal fees and expenses
|
| | | | * | | |
Accounting fees and expenses
|
| | | | * | | |
Miscellaneous costs
|
| | | | * | | |
Total
|
| | | | * | | |
| | | | | F-2 | | | |
| | | | | F-3 | | | |
| | | | | F-4 | | | |
| | | | | F-5 | | | |
| | | | | F-6 | | |
| | | | | F-15 | | | |
| | | | | F-16 | | | |
| | | | | F-17 | | | |
| | | | | F-18 | | | |
| | | | | F-19 | | | |
| | | | | F-20 | | |
| | | | | | | | |
Three months ended March 31,
|
| |||||||||
| | |
Note
|
| |
2019
|
| |
2020
|
| |||||||||
(in thousands of EUR, except per share data)
|
| | | | | | | |
(unaudited)
|
| |||||||||
Revenue
|
| | | | | | | | | | 3,156 | | | | | | 3,119 | | |
Cost of sales
|
| | | | 3.2 | | | | | | (7,558) | | | | | | (5,475) | | |
Selling and distribution expenses
|
| | | | 3.3 | | | | | | (198) | | | | | | (330) | | |
Research and development expenses
|
| | | | 3.4 | | | | | | (10,862) | | | | | | (10,902) | | |
General and administrative expenses
|
| | | | 3.5 | | | | | | (6,887) | | | | | | (11,495) | | |
Other operating income
|
| | | | 3.6 | | | | | | 732 | | | | | | 1,995 | | |
Other operating expenses
|
| | | | | | | | | | (108) | | | | | | (127) | | |
Operating loss
|
| | | | | | | | | | (21,725) | | | | | | (23,216) | | |
Finance income
|
| | | | | | | | | | 649 | | | | | | 1,041 | | |
Finance expenses
|
| | | | | | | | | | (90) | | | | | | (1,719) | | |
Loss before income tax
|
| | | | | | | | | | (21,166) | | | | | | (23,894) | | |
Income tax benefit / (expense)
|
| | | | | | | | | | (142) | | | | | | 44 | | |
Net loss for the period
|
| | | | | | | | | | (21,308) | | | | | | (23,850) | | |
Other comprehensive income:
|
| | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss
|
| | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | | | | | | | 36 | | | | | | 48 | | |
Total comprehensive loss for the period
|
| | | | | | | | | | (21,272) | | | | | | (23,802) | | |
Net loss per share (basic and diluted)
|
| | | | | | | | | | (29.32) | | | | | | (32.48) | | |
| | | | | | | | |
As at
|
| |||||||||
| | |
Note
|
| |
December 31,
2019 |
| |
March 31,
2020 |
| |||||||||
(in thousands of EUR)
|
| | | | | | | | | | | | | |
(unaudited)
|
| |||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets
|
| | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | | | | | | | 5,698 | | | | | | 6,120 | | |
Property, plant and equipment
|
| | | | 6.1 | | | | | | 48,075 | | | | | | 50,356 | | |
Right-of-use assets
|
| | | | 8 | | | | | | 13,611 | | | | | | 36,876 | | |
Other assets
|
| | | | 6.2 | | | | | | 6,061 | | | | | | 2,027 | | |
Deferred tax assets
|
| | | | | | | | | | — | | | | | | 169 | | |
Total non-current assets
|
| | | | | | | | | | 73,445 | | | | | | 95,548 | | |
Current assets
|
| | | | | | | | | | | | | | | | | | |
Inventories
|
| | | | 9 | | | | | | 6,197 | | | | | | 5,425 | | |
Trade receivables
|
| | | | 3 | | | | | | 15,690 | | | | | | 2,410 | | |
Contract assets
|
| | | | 3 | | | | | | 1,463 | | | | | | 2,422 | | |
Other financial assets
|
| | | | 10 | | | | | | 1,458 | | | | | | 1,418 | | |
Prepaid expenses and other assets
|
| | | | 7 | | | | | | 1,683 | | | | | | 4,959 | | |
Cash and cash equivalents
|
| | | | | | | | | | 30,684 | | | | | | 43,474 | | |
Total current assets
|
| | | | | | | | | | 57,175 | | | | | | 60,108 | | |
Total assets
|
| | | | | | | | | | 130,620 | | | | | | 155,656 | | |
Equity and liabilities
|
| | | | | | | | | | | | | | | | | | |
Equity | | | | | | | | | | | | | | | | | | | |
Issued capital
|
| | | | 4 | | | | | | 727 | | | | | | 743 | | |
Capital reserve
|
| | | | 4, 5 | | | | | | 472,396 | | | | | | 495,327 | | |
Accumulated deficit
|
| | | | | | | | | | (515,947) | | | | | | (539,797) | | |
Other comprehensive income
|
| | | | | | | | | | 22 | | | | | | 70 | | |
Total equity
|
| | | | | | | | | | (42,802) | | | | | | (43,657) | | |
Non-current liabilities
|
| | | | | | | | | | | | | | | | | | |
Convertible loans
|
| | | | 11 | | | | | | 65,018 | | | | | | 67,078 | | |
Lease liabilities
|
| | | | 8 | | | | | | 12,126 | | | | | | 29,320 | | |
Contract liabilities
|
| | | | 3 | | | | | | 66,040 | | | | | | 64,002 | | |
Deferred tax liabilities
|
| | | | | | | | | | 1,623 | | | | | | 1,636 | | |
Other liabilities
|
| | | | | | | | | | 529 | | | | | | 784 | | |
Total non-current liabilities
|
| | | | | | | | | | 145,336 | | | | | | 162,820 | | |
Current liabilities
|
| | | | | | | | | | | | | | | | | | |
Lease liabilities
|
| | | | 8 | | | | | | 2,004 | | | | | | 3,088 | | |
Trade and other payables
|
| | | | | | | | | | 6,475 | | | | | | 6,078 | | |
Other liabilities
|
| | | | 3.6 | | | | | | 12,015 | | | | | | 19,453 | | |
Income taxes payable
|
| | | | 12 | | | | | | 111 | | | | | | 226 | | |
Contract liabilities
|
| | | | 3 | | | | | | 7,481 | | | | | | 7,648 | | |
Total current liabilities
|
| | | | | | | | | | 28,086 | | | | | | 36,493 | | |
Total liabilities
|
| | | | | | | | | | 173,422 | | | | | | 199,313 | | |
Total equity and liabilities
|
| | | | | | | | | | 130,620 | | | | | | 155,656 | | |
(in thousands of EUR)
|
| |
Issued
capital |
| |
Capital
reserve |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total equity
|
| |||||||||||||||
Balance as of January 1, 2020
|
| | | | 727 | | | | | | 472,396 | | | | | | (515,947) | | | | | | 22 | | | | | | (42,802) | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (23,850) | | | | | | — | | | | | | (23,850) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 48 | | | | | | 48 | | |
Total comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | (23,850) | | | | | | 48 | | | | | | (23,802) | | |
Share-based payment expense
|
| | | | — | | | | | | 2,947 | | | | | | — | | | | | | — | | | | | | 2,947 | | |
Issuance of share capital
|
| | | | 16 | | | | | | 19,984 | | | | | | — | | | | | | — | | | | | | 20,000 | | |
Balance as of March 31, 2020 (unaudited)
|
| | | | 743 | | | | | | 495,327 | | | | | | (539,797) | | | | | | 70 | | | | | | (43,657) | | |
|
(in thousands of EUR)
|
| |
Issued
capital |
| |
Capital
reserve |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total equity
|
|
Balance as of January 1, 2019
|
| |
727
|
| |
447,440
|
| |
(416,074)
|
| |
(10)
|
| |
32,083
|
|
Net loss
|
| |
—
|
| |
—
|
| |
(21,308)
|
| |
—
|
| |
(21,308)
|
|
Other comprehensive income (loss)
|
| |
—
|
| |
—
|
| |
—
|
| |
36
|
| |
36
|
|
Total comprehensive income (loss)
|
| |
—
|
| |
—
|
| |
(21,308)
|
| |
36
|
| |
(21,272)
|
|
Balance as of March 31, 2019 (unaudited)
|
| |
727
|
| |
447,440
|
| |
(437,382)
|
| |
26
|
| |
10,811
|
|
| | |
For the three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
(in thousands of EUR)
|
| |
(unaudited)
|
| |||||||||
Operating activities
|
| | | | | | | | | | | | |
Loss before income tax
|
| | |
|
(21,308)
|
| | | |
|
(23,850)
|
| |
Adjustments to reconcile loss before tax to net cash flows
|
| | | | | | | | | | | | |
Finance income
|
| | | | (649) | | | | | | (1,041) | | |
Finance expense
|
| | | | 90 | | | | | | 1,719 | | |
Depreciation and amortization
|
| | | | 1,561 | | | | | | 1,831 | | |
Share-based payment expense
|
| | | | — | | | | | | 2,947 | | |
Working capital changes
|
| | | | | | | | | | | | |
Decrease / (increase) in trade receivables and contract assets
|
| | | | 3,476 | | | | | | 13,201 | | |
Decrease / (increase) in inventory
|
| | | | (1,401) | | | | | | 772 | | |
Decrease / (increase) in other assets
|
| | | | 129 | | | | | | (3,357) | | |
Receipts from grants from government agencies and similar bodies
|
| | | | 3,477 | | | | | | 11,717 | | |
(Decrease) / increase in trade and other payables and contract liabilities
|
| | | | (8,208) | | | | | | (6,430) | | |
(Decrease) / Increase in other current financial and other liabilities
|
| | | | 417 | | | | | | 99 | | |
Interest paid
|
| | | | (214) | | | | | | (288) | | |
Net cash flow used in operating activities
|
| | | | (22,630) | | | | | | (2,680) | | |
Investing activities
|
| | | | | | | | | | | | |
Purchase of property, plant and equipment
|
| | | | (1,956) | | | | | | (4,490) | | |
Purchase of intangible assets
|
| | | | (290) | | | | | | (776) | | |
Proceeds from asset-related grants
|
| | | | — | | | | | | 1,907 | | |
Proceeds from sale of other financial assets
|
| | | | 18,971 | | | | | | 40 | | |
Net cash flow provided by (used in) investing activities
|
| | | | 16,723 | | | | | | (3,319) | | |
Financing activities
|
| | | | | | | | | | | | |
Equity-related transaction costs
|
| | | | — | | | | | | (626) | | |
Payments on lease obligations
|
| | | | (279) | | | | | | (632) | | |
Proceeds from issuance of share capital
|
| | | | — | | | | | | 20,000 | | |
Net cash flow provided by (used in) financing activities
|
| | | | (279) | | | | | | 18,742 | | |
Currency translation gains (losses) on cash and cash equivalents
|
| | | | 36 | | | | | | 47 | | |
Increase (decrease) in cash and cash equivalents
|
| | | | (6,156) | | | | | | 12,743 | | |
Cash and cash equivalents, beginning of period
|
| | | | 21,380 | | | | | | 30,684 | | |
Cash and cash equivalents, end of period
|
| | | | 15,260 | | | | | | 43,474 | | |
| | |
Three Months ended
March 31, |
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
United States | | | | | | | | | | | | | |
Eli Lilly and Company
|
| | | | 2,592 | | | | | | 1,993 | | |
Germany | | | | | | | | | | | | | |
Boehringer Ingelheim
|
| | | | 467 | | | | | | 482 | | |
Switzerland | | | | | | | | | | | | | |
CRISPR
|
| | | | 97 | | | | | | 78 | | |
Netherlands | | | | | | | | | | | | | |
Genmab
|
| | | | — | | | | | | 566 | | |
Total | | | | | 3,156 | | | | | | 3,119 | | |
| | |
Upfront payments
|
| |
Upfront payments
included in contract liabilities at March 31, 2019 |
| |
Upfront payments
included in contract liabilities at March 31, 2020 |
| |
Revenue recognized
from upfront payments |
| |||||||||||||||
| | |
March 31, 2020
|
| |
March 31, 2019
|
| |
March 31, 2020
|
| ||||||||||||||||||
Customer
|
| |
(in thousands)
|
| |
(EUR k)
|
| |
(EUR k)
|
| |
(EUR k)
|
| |||||||||||||||
Eli Lilly and Company
|
| | USD 50,000 (EUR 42,200) * | | | | | 37,492 | | | | | | 33,975 | | | | | | 879 | | | | | | 879 | | |
CRISPR
|
| | USD 3,000 (EUR 2,524) * | | | | | 2,091 | | | | | | 1,782 | | | | | | 77 | | | | | | 77 | | |
Boehringer Ingelheim
|
| | EUR 30,000 | | | | | 17,312 | | | | | | 15,403 | | | | | | 509 | | | | | | 467 | | |
Genmab
|
| | USD 10,000 (EUR 8,937) * | | | | | — | | | | | | 8,490 | | | | | | — | | | | | | 447 | | |
Total | | | | | | | | 56,895 | | | | | | 59,650 | | | | | | 1,465 | | | | | | 1,870 | | |
| | |
December 31,
2019 |
| |
March 31,
2020 |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Trade receivables
|
| | | | 15,690 | | | | | | 2,410 | | |
Contract assets
|
| | | | 1,463 | | | | | | 2,422 | | |
Contract liabilities
|
| | | | 73,521 | | | | | | 71,650 | | |
| | |
Three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (2,488) | | | | | | (2,821) | | |
Materials
|
| | | | (2,928) | | | | | | (1,550) | | |
Third-party services
|
| | | | (1,489) | | | | | | (675) | | |
Maintenance and lease
|
| | | | (206) | | | | | | (159) | | |
Amortization and depreciation
|
| | | | (401) | | | | | | (246) | | |
Other
|
| | | | (46) | | | | | | (24) | | |
Total | | | | | (7,558) | | | | | | (5,475) | | |
| | |
Three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (79) | | | | | | (240) | | |
Maintenance and lease
|
| | | | (88) | | | | | | — | | |
Amortization and depreciation
|
| | | | (19) | | | | | | (41) | | |
Other
|
| | | | (12) | | | | | | (49) | | |
Total | | | | | (198) | | | | | | (330) | | |
| | |
Three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Materials
|
| | | | (963) | | | | | | (1,165) | | |
Personnel
|
| | | | (3,251) | | | | | | (3,686) | | |
Amortization and depreciation
|
| | | | (129) | | | | | | (351) | | |
Patents and fees to register a legal right
|
| | | | (1,202) | | | | | | (823) | | |
Third-party services
|
| | | | (5,094) | | | | | | (4,263) | | |
Maintenance and lease
|
| | | | (111) | | | | | | (454) | | |
Other
|
| | | | (112) | | | | | | (160) | | |
Total | | | | | (10,862) | | | | | | (10,902) | | |
|
| | |
Three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (3,936) | | | | | | (7,055) | | |
Maintenance and lease
|
| | | | (990) | | | | | | (1,333) | | |
Third-party services
|
| | | | (571) | | | | | | (1,420) | | |
Legal and other professional services
|
| | | | (154) | | | | | | (427) | | |
Amortization and depreciation
|
| | | | (426) | | | | | | (418) | | |
Other
|
| | | | (810) | | | | | | (842) | | |
Total | | | | | (6,887) | | | | | | (11,495) | | |
| | |
Three months ended March 31,
|
| |||||||||
| | |
2019
|
| |
2020
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Grants and other cost reimbursements from government agencies and similar bodies
|
| | | | 531 | | | | | | 1,623 | | |
Other
|
| | | | 201 | | | | | | 372 | | |
Total | | | | | 732 | | | | | | 1,995 | | |
Series
|
| |
Shares as of
December 31, 2019 |
| |
Shares as of
March 31, 2020 |
| ||||||
A
|
| | | | 23,400 | | | | | | 23,400 | | |
B
|
| | | | 688,692 | | | | | | 705,037 | | |
C
|
| | | | 14,500 | | | | | | 14,500 | | |
Total | | | | | 726,592 | | | | | | 742,937 | | |
|
/s/ Dr. Elia Napolitano
Wirtschaftsprüfer (German Public Auditor) |
| |
/s/ Steffen Maurer
Wirtschaftsprüfer (German Public Auditor) |
|
| | | | | | | | |
Years ended December 31,
|
| |||||||||
(in thousands of EUR, except per share data)
|
| |
Note
|
| |
2018
|
| |
2019
|
| |||||||||
Revenue
|
| | | | 3.1 | | | | | | 12,871 | | | | | | 17,416 | | |
Cost of sales
|
| | | | 3.2 | | | | | | (17,744) | | | | | | (27,983) | | |
Selling and distribution expenses
|
| | | | 3.3 | | | | | | (1,085) | | | | | | (1,755) | | |
Research and development expenses
|
| | | | 3.4 | | | | | | (41,722) | | | | | | (43,242) | | |
General and administrative expenses
|
| | | | 3.5 | | | | | | (25,289) | | | | | | (48,969) | | |
Other operating income
|
| | | | 3.6 | | | | | | 808 | | | | | | 5,587 | | |
Other operating expenses
|
| | | | 3.7 | | | | | | (663) | | | | | | (552) | | |
Operating loss
|
| | | | | | | | | | (72,824) | | | | | | (99,498) | | |
Finance income
|
| | | | | | | | | | 1,968 | | | | | | 833 | | |
Finance expenses
|
| | | | | | | | | | (275) | | | | | | (1,460) | | |
Loss before income tax
|
| | | | | | | | | | (71,131) | | | | | | (100,125) | | |
Income tax benefit / (expense)
|
| | | | 14 | | | | | | (110) | | | | | | 252 | | |
Net loss for the year
|
| | | | | | | | | | (71,241) | | | | | | (99,873) | | |
Other comprehensive income | | | | | | | | | | | | | | | | | | | |
Items that may be subsequently reclassified to profit or loss | | | | | | | | | | | | | | | | | | | |
Foreign currency adjustments
|
| | | | | | | | | | 66 | | | | | | 32 | | |
Total comprehensive loss for the year
|
| | | | | | | | | | (71,175) | | | | | | (99,841) | | |
Net loss per share (basic and diluted)
|
| | | | | | | | | | (98.05) | | | | | | (137.45) | | |
| | | | | | | | |
December 31,
|
| |||||||||
(in thousands of EUR)
|
| |
Note
|
| |
2018
|
| |
2019
|
| |||||||||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 4 | | | | | | 6,213 | | | | | | 5,698 | | |
Property, plant and equipment
|
| | | | 4 | | | | | | 40,472 | | | | | | 48,075 | | |
Other assets
|
| | | | 4 | | | | | | 5,771 | | | | | | 6,061 | | |
Right-of-use assets
|
| | | | 2 | | | | | | — | | | | | | 13,611 | | |
Deferred tax assets
|
| | | | 14 | | | | | | 133 | | | | | | — | | |
Total non-current assets
|
| | | | | | | | | | 52,589 | | | | | | 73,445 | | |
Current assets | | | | | | | | | | | | | | | | | | | |
Inventories
|
| | | | 5 | | | | | | 2,951 | | | | | | 6,197 | | |
Trade receivables
|
| | | | 3 | | | | | | 5,476 | | | | | | 15,690 | | |
Contract assets
|
| | | | 3 | | | | | | 1,382 | | | | | | 1,463 | | |
Other financial assets
|
| | | | 6 | | | | | | 39,253 | | | | | | 1,458 | | |
Prepaid expenses and other assets
|
| | | | 7 | | | | | | 2,628 | | | | | | 1,683 | | |
Cash and cash equivalents
|
| | | | | | | | | | 21,380 | | | | | | 30,684 | | |
Total current assets
|
| | | | | | | | | | 73,070 | | | | | | 57,175 | | |
Total assets
|
| | | | | | | | | | 125,659 | | | | | | 130,620 | | |
Equity and liabilities | | | | | | | | | | | | | | | | | | | |
Equity | | | | | | | | | | | | | | | | | | | |
Issued capital
|
| | | | | | | | | | 727 | | | | | | 727 | | |
Capital reserve
|
| | | | | | | | | | 447,440 | | | | | | 472,396 | | |
Accumulated deficit
|
| | | | | | | | | | (416,074) | | | | | | (515,947) | | |
Other comprehensive income
|
| | | | | | | | | | (10) | | | | | | 22 | | |
Total equity
|
| | | | 8 | | | | | | 32,083 | | | | | | (42,802) | | |
Non-current liabilities | | | | | | | | | | | | | | | | | | | |
Convertible loans
|
| | | | 12 | | | | | | — | | | | | | 65,018 | | |
Lease liabilities
|
| | | | 2 | | | | | | — | | | | | | 12,126 | | |
Contract liabilities
|
| | | | 3 | | | | | | 64,583 | | | | | | 66,040 | | |
Deferred tax liabilities
|
| | | | 13 | | | | | | — | | | | | | 1,623 | | |
Other liabilities
|
| | | | | | | | | | 863 | | | | | | 529 | | |
Total non-current liabilities
|
| | | | | | | | | | 65,446 | | | | | | 145,336 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Other financial liabilities
|
| | | | | | | | | | 77 | | | | | | — | | |
Lease liabilities
|
| | | | 2 | | | | | | — | | | | | | 2,004 | | |
Trade and other payables
|
| | | | 11 | | | | | | 10,913 | | | | | | 6,475 | | |
Other liabilities
|
| | | | 12 | | | | | | 11,146 | | | | | | 12,015 | | |
Income Taxes payable
|
| | | | 13 | | | | | | 217 | | | | | | 111 | | |
Contract liabilities
|
| | | | 3 | | | | | | 5,777 | | | | | | 7,481 | | |
Total current liabilities
|
| | | | | | | | | | 28,130 | | | | | | 28,086 | | |
Total liabilities
|
| | | | | | | | | | 93,576 | | | | | | 173,422 | | |
Total equity and liabilities
|
| | | | | | | | | | 125,659 | | | | | | 130,620 | | |
(in thousands of EUR)
|
| |
Issued
capital |
| |
Capital
reserve |
| |
Accumulated
deficit |
| |
Currency
translation reserve |
| |
Total equity
|
| |||||||||||||||
Balance as of January 1, 2018
|
| | | | 727 | | | | | | 447,438 | | | | | | (345,320) | | | | | | (76) | | | | | | 102,769 | | |
Effects from the first-time adoption of IFRS 9
|
| | | | — | | | | | | — | | | | | | (183) | | | | | | — | | | | | | (183) | | |
Effects from the first-time adoption of IFRS 15
|
| | | | — | | | | | | — | | | | | | 670 | | | | | | — | | | | | | 670 | | |
Adjusted balance as of January 1, 2018
|
| | | | 727 | | | | | | 447,438 | | | | | | (344,833) | | | | | | (76) | | | | | | 103,256 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (71,241) | | | | | | — | | | | | | (71,241) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 66 | | | | | | 66 | | |
Total comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | (71,241) | | | | | | 66 | | | | | | (71,175) | | |
Expenses from share-based payment plan
|
| | | | — | | | | | | 2 | | | | | | — | | | | | | — | | | | | | 2 | | |
Balance as of December 31, 2018
|
| | | | 727 | | | | | | 447,440 | | | | | | (416,074) | | | | | | (10) | | | | | | 32,083 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | (99,873) | | | | | | — | | | | | | (99,873) | | |
Other comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | — | | | | | | 32 | | | | | | 32 | | |
Total comprehensive income (loss)
|
| | | | — | | | | | | — | | | | | | (99,873) | | | | | | 32 | | | | | | (99,841) | | |
Equity component of convertible loans
|
| | | | — | | | | | | 7,604 | | | | | | — | | | | | | — | | | | | | 7,604 | | |
Deferred taxes on convertible loans
|
| | | | — | | | | | | (2,212) | | | | | | — | | | | | | — | | | | | | (2,212) | | |
Expenses from share-based payment plan
|
| | | | — | | | | | | 19,564 | | | | | | — | | | | | | — | | | | | | 19,564 | | |
Balance as of December 31, 2019
|
| | | | 727 | | | | | | 472,396 | | | | | | (515,947) | | | | | | 22 | | | | | | (42,802) | | |
| | |
Years ended December 31,
|
| |||||||||
(in thousands of EUR)
|
| |
2018
|
| |
2019
|
| ||||||
Operating activities | | | | | | | | | | | | | |
Loss before income tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Adjustments to reconcile loss before tax to net cash flows | | | | | | | | | | | | | |
Finance income
|
| | | | (1,968) | | | | | | (833) | | |
Finance expense
|
| | | | 275 | | | | | | 1,460 | | |
Depreciation and amortization
|
| | | | 3,781 | | | | | | 7,164 | | |
Loss on disposal of fixed assets
|
| | | | 52 | | | | | | 241 | | |
Share-based payment expense
|
| | | | (4,248) | | | | | | 19,564 | | |
Working capital changes | | | | | | | | | | | | | |
Decrease / (increase) in trade receivables and contract assets
|
| | | | (5,595) | | | | | | (10,117) | | |
Decrease / (increase) in inventory
|
| | | | 878 | | | | | | (3,246) | | |
Decrease / (increase) in other assets
|
| | | | (6,106) | | | | | | 630 | | |
Receipts from grants from government agencies and similar bodies
|
| | | | 214 | | | | | | 9,304 | | |
(Decrease) / increase in trade and other payables and contract liabilities
|
| | | | 9,402 | | | | | | (9,584) | | |
(Decrease) / Increase in other current financial and other liabilities
|
| | | | 336 | | | | | | (334) | | |
Income taxes paid
|
| | | | (26) | | | | | | (345) | | |
Interest received
|
| | | | 15 | | | | | | 81 | | |
Interest paid
|
| | | | 11 | | | | | | (824) | | |
Net cash flow (used in) operating activities
|
| | | | (74,110) | | | | | | (86,963) | | |
Investing activities | | | | | | | | | | | | | |
Purchase of property, plant and equipment
|
| | | | (9,406) | | | | | | (11,172) | | |
Purchase of intangible assets
|
| | | | (5,317) | | | | | | (1,052) | | |
Proceeds from asset-related grants
|
| | | | — | | | | | | 2,325 | | |
Proceeds from other financial assets
|
| | | | 10,459 | | | | | | 38,080 | | |
Net cash flow from (used in) investing activities
|
| | | | (4,264) | | | | | | 28,181 | | |
Financing activities | | | | | | | | | | | | | |
Payments on lease obligation
|
| | | | (112) | | | | | | (1,910) | | |
Proceeds from the convertible loans
|
| | | | — | | | | | | 69,889 | | |
Net cash flow from (used in) financing activities
|
| | | | (112) | | | | | | 67,979 | | |
Net increase (decrease) in cash and cash equivalents
|
| | | | (78,486) | | | | | | 9,197 | | |
Effect of currency translation gains on cash and cash equivalents
|
| | | | 213 | | | | | | 107 | | |
Cash and cash equivalents, beginning of period
|
| | | | 99,653 | | | | | | 21,380 | | |
Cash and cash equivalents, end of period
|
| | | | 21,380 | | | | | | 30,684 | | |
|
Software and Licenses
|
| |
3 to 8 years
|
|
|
Buildings:
|
| |
1 to 10 years
|
|
|
Technical equipment and machines:
|
| |
3 to 14 years
|
|
|
Other equipment, furniture and fixtures:
|
| |
3 to 14 years
|
|
| | |
EUR k
|
| |||
Existing commitments as at December 31, 2018 | | | | | | | |
Operating lease commitments
|
| | | | 48,008 | | |
Minimum lease payments (notional amount) on finance lease liabilities
|
| | | | 78 | | |
Relief option for short-term leases
|
| | | | (110) | | |
Leases with commencement date after January 1, 2019 in the amounts included above as existing commitments as at December 31, 2018
|
| | | | (28,557) | | |
Other
|
| | | | 123 | | |
Gross lease liabilities as at January 1, 2019
|
| | | | 19,542 | | |
Effect of discounting
|
| | | | (3,655) | | |
Lease liabilities as at January 1, 2019
|
| | | | 15,887 | | |
Present value of finance lease liabilities as at December 31, 2018
|
| | | | (77) | | |
Lease liabilities upon initial application of IFRS 16 as at January 1, 2019
|
| | | | 15,810 | | |
Weighted average incremental borrowing rate as at January 1, 2019
|
| | | | 5.64% | | |
|
Land and Buildings:
|
| |
1 to 15 years
|
|
|
Vehicles:
|
| |
3 to 4 years
|
|
|
Other equipment:
|
| |
2 to 5 years
|
|
| | |
Right-of-use assets
|
| |||||||||||||||||||||
| | |
Land and
Buildings |
| |
Vehicles
|
| |
Other
equipment |
| |
Total
|
| ||||||||||||
| | |
EURk
|
| |
EURk
|
| |
EURk
|
| |
EURk
|
| ||||||||||||
As at January 1, 2019
|
| | | | 15,536 | | | | | | 132 | | | | | | 239 | | | | | | 15,907 | | |
Additions
|
| | | | 82 | | | | | | 59 | | | | | | 13 | | | | | | 154 | | |
Depreciation expense
|
| | | | (2,322) | | | | | | (65) | | | | | | (142) | | | | | | (2,529) | | |
Foreign currency translation
|
| | | | 79 | | | | | | — | | | | | | — | | | | | | 79 | | |
As at December 31, 2019
|
| | | | 13,375 | | | | | | 126 | | | | | | 110 | | | | | | 13,611 | | |
| | |
EUR k
|
| |||
As at January 1, 2019
|
| | |
|
15,887
|
| |
Additions
|
| | | | 153 | | |
Accretion of interest
|
| | | | 824 | | |
Payments
|
| | | | (2,812) | | |
Foreign currency translation
|
| | | | 78 | | |
As at December 31, 2019
|
| | | | 14,130 | | |
Current
|
| | | | 2,004 | | |
Non-current
|
| | | | 12,126 | | |
| | |
EUR k
|
| |||
Depreciation expense of right-of-use assets
|
| | | | (2,529) | | |
Interest expense on lease liabilities
|
| | | | (824) | | |
Expense relating to short-term leases (included in cost of sales)
|
| | | | (167) | | |
Expense relating to leases of low-value assets (included in administrative expenses)
|
| | | | (94) | | |
Total amount recognized in profit or loss
|
| | | | (3,614) | | |
| | |
December 31,
2018 |
| |
December 31,
2019 |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
United States | | | | | | | | | | | | | |
Eli Lilly and Company
|
| | | | 8,927 | | | | | | 14,319 | | |
Germany | | | | | | | | | | | | | |
Boehringer Ingelheim
|
| | | | 3,337 | | | | | | 2,474 | | |
Others
|
| | | | 5 | | | | | | 104 | | |
Switzerland | | | | | | | | | | | | | |
CRISPR
|
| | | | 602 | | | | | | 519 | | |
Total
|
| | | | 12,871 | | | | | | 17,416 | | |
Customer
|
| |
Upfront payments
received or receivable at December 31, 2019 (in thousands) |
| |
Upfront payments
included in contract liabilities at December 31, 2019 (in EUR k) |
| |
Revenue recognized
from upfront payments (in EUR k) |
| ||||||||||||
|
2018
|
| |
2019
|
| |||||||||||||||||
Eli Lilly and Company
|
| |
USD 50,000 (EUR 42,200)
|
| | | | 34,854 | | | | | | 3,516 | | | | | | 3,516 | | |
CRISPR
|
| | USD 3,000 (EUR 2,524) | | | | | 1,859 | | | | | | 310 | | | | | | 310 | | |
Boehringer Ingelheim
|
| | EUR 30,000 | | | | | 15,870 | | | | | | 2,035 | | | | | | 1,951 | | |
Genmab
|
| | USD 10,000 (EUR 8,937) | | | | | 8,937 | | | | | | — | | | | | | — | | |
Total | | | | | 61,520 | | | | | | 5,861 | | | | | | 5,777 | | |
| | |
January 1,
2018 |
| |
December 31,
2018 |
| |
December 31,
2019 |
| |||||||||
| | |
EUR k
|
| |
EUR k
|
| |
EUR k
|
| |||||||||
Trade receivables
|
| | | | 463 | | | | | | 5,476 | | | | | | 15,690 | | |
Contract assets
|
| | | | — | | | | | | 1,382 | | | | | | 1,463 | | |
Contract liabilities
|
| | | | 69,220 | | | | | | 70,360 | | | | | | 73,521 | | |
| | |
Year ended
|
| |||||||||
| | |
2018
EUR k |
| |
2019
EUR k |
| ||||||
Within one year
|
| | | | 5,777 | | | | | | 7,481 | | |
More than one year
|
| | | | 64,583 | | | | | | 66,040 | | |
Total | | | | | 70,360 | | | | | | 73,521 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (7,703) | | | | | | (9,855) | | |
Materials
|
| | | | (4,941) | | | | | | (7,542) | | |
Third-party services
|
| | | | (2,340) | | | | | | (7,268) | | |
Maintenance and lease
|
| | | | (1,758) | | | | | | (1,060) | | |
Amortization and depreciation
|
| | | | (893) | | | | | | (2,038) | | |
Other
|
| | | | (109) | | | | | | (220) | | |
Total
|
| | | | (17,744) | | | | | | (27,983) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (581) | | | | | | (1,263) | | |
Maintenance and lease costs
|
| | | | (300) | | | | | | (167) | | |
Amortization and depreciation
|
| | | | (95) | | | | | | (81) | | |
Other
|
| | | | (109) | | | | | | (243) | | |
Total | | | | | (1,085) | | | | | | (1,755) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Materials
|
| | | | (5,867) | | | | | | (4,015) | | |
Personnel
|
| | | | (7,565) | | | | | | (14,385) | | |
Amortization and depreciation
|
| | | | (1,143) | | | | | | (474) | | |
Patents and fees to register a legal right
|
| | | | (4,847) | | | | | | (4,551) | | |
Third-party services
|
| | | | (19,921) | | | | | | (18,626) | | |
Maintenance and lease
|
| | | | (1,156) | | | | | | (670) | | |
Other
|
| | | | (1,223) | | | | | | (521) | | |
Total | | | | | (41,722) | | | | | | (43,242) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Personnel
|
| | | | (10,084) | | | | | | (31,645) | | |
Maintenance and lease costs
|
| | | | (3,239) | | | | | | (4,604) | | |
Third-party services
|
| | | | (4,006) | | | | | | (5,970) | | |
Legal and other professional services
|
| | | | (4,078) | | | | | | (2,110) | | |
Amortization and depreciation
|
| | | | (1,635) | | | | | | (2,182) | | |
Other
|
| | | | (2,247) | | | | | | (2,458) | | |
Total | | | | | (25,289) | | | | | | (48,969) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Grants and other cost reimbursements from government agencies and similar bodies
|
| | | | 808 | | | | | | 5,385 | | |
Other
|
| | | | — | | | | | | 202 | | |
Total
|
| | | | 808 | | | | | | 5,587 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Renumeration of supervisory board
|
| | | | (343) | | | | | | (521) | | |
Other
|
| | | | (320) | | | | | | (30) | | |
Total
|
| | | | (663) | | | | | | (552) | | |
(in thousands of EUR)
|
| |
Software and
licenses |
| |
Advance
payments |
| |
Total
|
| |||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 3,402 | | | | | | 235 | | | | | | 3,638 | | |
Additions
|
| | | | 5,314 | | | | | | 2 | | | | | | 5,317 | | |
As of December 31, 2018
|
| | | | 8,717 | | | | | | 238 | | | | | | 8,954 | | |
Cumulative amortization and impairment charges | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,545 | | | | | | — | | | | | | 1,545 | | |
Amortization
|
| | | | 1,197 | | | | | | — | | | | | | 1,197 | | |
As of December 31, 2018
|
| | | | 2,742 | | | | | | — | | | | | | 2,742 | | |
|
(in thousands of EUR)
|
| |
Software and
licenses |
| |
Advance
payments |
| |
Total
|
| |||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 8,717 | | | | | | 238 | | | | | | 8,954 | | |
Additions
|
| | | | 738 | | | | | | 44 | | | | | | 782 | | |
Disposals
|
| | | | (6) | | | | | | — | | | | | | (6) | | |
As of December 31, 2019
|
| | | | 9,449 | | | | | | 282 | | | | | | 9,731 | | |
Cumulative amortization and impairment charges | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 2,742 | | | | | | — | | | | | | 2,742 | | |
Amortization
|
| | | | 1,295 | | | | | | — | | | | | | 1,295 | | |
Disposals
|
| | | | (4) | | | | | | — | | | | | | (4) | | |
As of December 31, 2019
|
| | | | 4,033 | | | | | | — | | | | | | 4,033 | | |
Carrying amount | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,858 | | | | | | 235 | | | | | | 2,093 | | |
As of December 31, 2018
|
| | | | 5,975 | | | | | | 238 | | | | | | 6,213 | | |
As of December 31, 2019
|
| | | | 5,416 | | | | | | 282 | | | | | | 5,698 | | |
(in thousands of EUR)
|
| |
Buildings
|
| |
Technical
equipment and machines |
| |
Other
equipment, furniture and fixtures |
| |
Assets
under construction |
| |
Total
|
| |||||||||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 5,398 | | | | | | 12,230 | | | | | | 4,665 | | | | | | 27,103 | | | | | | 49,397 | | |
Additions
|
| | | | 490 | | | | | | 953 | | | | | | 719 | | | | | | 7,244 | | | | | | 9,406 | | |
Disposals
|
| | | | — | | | | | | (150) | | | | | | (157) | | | | | | — | | | | | | (307) | | |
Reclassifications
|
| | | | — | | | | | | 1,303 | | | | | | 19 | | | | | | (1,323) | | | | | | — | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | — | | | | | | 1 | | | | | | 1 | | |
As of December 31, 2018
|
| | | | 5,888 | | | | | | 14,336 | | | | | | 5,247 | | | | | | 33,025 | | | | | | 58,497 | | |
Cumulative depreciation and impairment charges | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 1,337 | | | | | | 4,610 | | | | | | 2,654 | | | | | | 7,120 | | | | | | 15,721 | | |
Depreciation
|
| | | | 371 | | | | | | 1,299 | | | | | | 890 | | | | | | — | | | | | | 2,559 | | |
Disposals
|
| | | | — | | | | | | (99) | | | | | | (157) | | | | | | — | | | | | | (255) | | |
As of December 31, 2018
|
| | | | 1,708 | | | | | | 5,810 | | | | | | 3,387 | | | | | | 7,120 | | | | | | 18,025 | | |
|
(in thousands of EUR)
|
| |
Buildings
|
| |
Technical
equipment and machines |
| |
Other
equipment, furniture and fixtures |
| |
Assets
under construction |
| |
Total
|
| |||||||||||||||
Acquisition costs | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 5,888 | | | | | | 14,336 | | | | | | 5,247 | | | | | | 33,025 | | | | | | 58,497 | | |
Additions
|
| | | | 854 | | | | | | 2,152 | | | | | | 712 | | | | | | 7,435 | | | | | | 11,152 | | |
Disposals
|
| | | | (65) | | | | | | (319) | | | | | | (248) | | | | | | — | | | | | | (632) | | |
Reclassifications
|
| | | | 167 | | | | | | 883 | | | | | | 187 | | | | | | (1,237) | | | | | | — | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | 3 | | | | | | 4 | | | | | | 6 | | |
As of December 31, 2019
|
| | | | 6,844 | | | | | | 17,051 | | | | | | 5,902 | | | | | | 39,226 | | | | | | 69,023 | | |
Cumulative depreciation and impairment charges | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 1,708 | | | | | | 5,810 | | | | | | 3,388 | | | | | | 7,120 | | | | | | 18,026 | | |
Depreciation
|
| | | | 779 | | | | | | 1,637 | | | | | | 899 | | | | | | — | | | | | | 3,315 | | |
Disposals
|
| | | | (37) | | | | | | (190) | | | | | | (164) | | | | | | — | | | | | | (392) | | |
Currency translation
|
| | | | — | | | | | | — | | | | | | 1 | | | | | | — | | | | | | 1 | | |
As of December 31, 2019
|
| | | | 2,449 | | | | | | 7,257 | | | | | | 4,123 | | | | | | 7,120 | | | | | | 20,949 | | |
Carrying amount | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2018
|
| | | | 4,061 | | | | | | 7,621 | | | | | | 2,011 | | | | | | 19,982 | | | | | | 33,675 | | |
As of December 31, 2018
|
| | | | 4,181 | | | | | | 8,526 | | | | | | 1,860 | | | | | | 25,904 | | | | | | 40,472 | | |
As of December 31, 2019
|
| | | | 4,395 | | | | | | 9,795 | | | | | | 1,779 | | | | | | 32,105 | | | | | | 48,075 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Raw materials
|
| | | | 2,742 | | | | | | 6,177 | | |
Finished goods
|
| | | | — | | | | | | 14 | | |
Other
|
| | | | 209 | | | | | | 6 | | |
Total
|
| | | | 2,951 | | | | | | 6,197 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term investments
|
| | | | 39,024 | | | | | | 430 | | |
Other
|
| | | | 229 | | | | | | 1,028 | | |
Total | | | | | 39,253 | | | | | | 1,458 | | |
|
Series
|
| |
Shares
|
| |||
A
|
| | | | 23,400 | | |
B
|
| | | | 688,692 | | |
C
|
| | | | 14,500 | | |
Total
|
| | | | 726,592 | | |
| | |
2018
|
| |
2019
|
| ||||||
Outstanding at the beginning of the period
|
| | | | 59,908 | | | | | | 49,899 | | |
Granted during the period
|
| | | | — | | | | | | 5,000 | | |
Expired during the period
|
| | | | (10,009) | | | | | | — | | |
Outstanding at the end of the period
|
| | | | 49,899 | | | | | | 54,899 | | |
Thereof vested (and expensed)
|
| | | | 49,899 | | | | | | 54,899 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Research and development expenses
|
| | | | 4,229 | | | | | | — | | |
General and administrative expenses
|
| | | | 21 | | | | | | (6,074) | | |
Total | | | | | 4,250 | | | | | | (6,074) | | |
|
Weighted average fair value
|
| | | | EUR 505.48 | | |
|
Weighted average share price
|
| | | | EUR1,223.16 | | |
|
Exercise price (USD 825.77)
|
| | | | EUR 750.99 | | |
|
Expected volatility (%)
|
| | | | 50.0% | | |
|
Expected life (years)
|
| | | | 1.16 | | |
|
Risk-free interest rate (%)
|
| | | | 1.77% | | |
|
Outstanding at the beginning of the period
|
| | | | — | | |
|
Granted during the period
|
| | | | 5,600 | | |
|
Outstanding at the end of the period
|
| | | | 5,600 | | |
|
Thereof vested
|
| | | | 1,318 | | |
|
Thereof expensed
|
| | | | 2,137 | | |
| | |
2019
|
| |||
| | |
EUR k
|
| |||
Research and development expenses
|
| | | | (258) | | |
Selling and distribution expenses
|
| | | | (743) | | |
General and administrative expenses
|
| | | | (79) | | |
Total | | | | | (1,080) | | |
|
Weighted average fair value
|
| | EUR 514.93 | |
|
Weighted average share price
|
| | EUR 1,223.16 | |
|
Exercise price (USD 1,101.03)
|
| | EUR 998.38 | |
|
Expected volatility (%)
|
| | 50.0% | |
|
Expected life (years)
|
| | 4.77 | |
|
Risk-free interest rate(%)
|
| | 1.71% | |
|
Outstanding at the beginning of the period
|
| | | | — | | |
|
Granted during the period
|
| | | | 29,053 | | |
|
Outstanding at the end of the period
|
| | | | 29,053 | | |
|
Thereof vested
|
| | | | 21,184 | | |
|
Thereof expensed
|
| | | | 24,099 | | |
| | |
2019
|
| |||
| | |
EUR k
|
| |||
General and administrative expenses
|
| | | | (12,409) | | |
Total | | | | | (12,409) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Trade payables
|
| | | | (9,029) | | | | | | (5,331) | | |
License fees payable
|
| | | | (501) | | | | | | (537) | | |
Miscellaneous liabilities
|
| | | | (1,383) | | | | | | (607) | | |
Total | | | | | (10,913) | | | | | | (6,475) | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Accrued bonuses
|
| | | | 1,903 | | | | | | 2,477 | | |
Accrued vacation
|
| | | | 682 | | | | | | 780 | | |
Outstanding invoices
|
| | | | 6,812 | | | | | | 3,478 | | |
Professional fees
|
| | | | 292 | | | | | | 578 | | |
Grants from government agencies and similar bodies
|
| | | | 1,186 | | | | | | 4,148 | | |
Other
|
| | | | 271 | | | | | | 554 | | |
Total | | | | | 11,146 | | | | | | 12,015 | | |
| | |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Loss before tax
|
| | | | (71,131) | | | | | | (100,125) | | |
Expected tax benefit (based on statutory tax rate of 29.13% in 2019 and 2018)
|
| | | | 20,744 | | | | | | 29,162 | | |
Adjustments in respect of current income tax of previous years
|
| | | | 42 | | | | | | — | | |
Effects from differences between Group and local tax rates
|
| | | | 10 | | | | | | 8 | | |
Effects resulting from non-recognition of tax loss carryforwards
|
| | | | (22,428) | | | | | | (22,836) | | |
Effects resulting from non-recognition of DTA/DTL
|
| | | | — | | | | | | — | | |
First-time-recognition of tax loss carryforwards
|
| | | | 430 | | | | | | — | | |
Non-deductible expenses for tax purposes
|
| | | | | | | | | | | | |
− Effects from non-deductible share-based-payments
|
| | | | 1,209 | | | | | | (5,698) | | |
− Effects from (additions/ deductions) for local trade taxes
|
| | | | (65) | | | | | | (191) | | |
− Other non-deductible expenses
|
| | | | (53) | | | | | | (78) | | |
Other effects
|
| | | | — | | | | | | (114) | | |
Effective tax benefit/ (expense)
|
| | | | (110) | | | | | | 252 | | |
Tax loss carryforwards
|
| |
2018
|
| |
2019
|
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Unused tax losses for corporate income tax
|
| | | | 330,753 | | | | | | 407,434 | | |
Unused tax losses for trade tax
|
| | | | 329,210 | | | | | | 405,123 | | |
2019
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total
EURk |
| |||||||||||||||
Convertible loans
|
| | | | — | | | | | | — | | | | | | (83,940) | | | | | | — | | | | | | (83,940) | | |
Lease liabilities (Note 2)
|
| | | | (732) | | | | | | (1,985) | | | | | | (9,192) | | | | | | (5,086) | | | | | | (16,995) | | |
Other liabilities
|
| | | | — | | | | | | (12,015) | | | | | | (362) | | | | | | (167) | | | | | | (12,544) | | |
Trade and other payables
|
| | | | (5,938) | | | | | | (537) | | | | | | — | | | | | | — | | | | | | (6,475) | | |
Total | | | | | (6,670) | | | | | | (14,537) | | | | | | (93,494) | | | | | | (5,253) | | | | | | (119,954) | | |
|
2018
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total EURk
|
| |||||||||||||||
Finance lease liabilities
|
| | | | (29) | | | | | | (48) | | | | | | — | | | | | | — | | | | | | (77) | | |
Other liabilities
|
| | | | — | | | | | | (11,146) | | | | | | (688) | | | | | | (175) | | | | | | (12,009) | | |
Trade and other payables
|
| | | | (10,378) | | | | | | (535) | | | | | | — | | | | | | — | | | | | | (10,913) | | |
Total | | | | | (10,407) | | | | | | (11,729) | | | | | | (688) | | | | | | (175) | | | | | | (22,999) | | |
2018
|
| |
less than
3 months EURk |
| |
3 to 12 months
EURk |
| |
1 to 5 years
EURk |
| |
> 5 years
EURk |
| |
Total EURk
|
| |||||||||||||||
Operating lease commitments
|
| | | | — | | | | | | (84) | | | | | | (91) | | | | | | — | | | | | | (175) | | |
Rental agreements
|
| | | | (683) | | | | | | (2,576) | | | | | | (21,160) | | | | | | (23,589) | | | | | | (48,008) | | |
Total | | | | | (683) | | | | | | (2,660) | | | | | | (21,251) | | | | | | (23,589) | | | | | | (48,183) | | |
| | |
2019
(in thousands) |
| |||
Cash and cash equivalents
|
| |
22,608 EUR
|
| |
25,398 USD
|
|
Trade and other receivables
|
| |
9,458 EUR
|
| |
10,585 USD
|
|
Other receivables
|
| |
105 EUR
|
| |
93 GBP
|
|
| | |
84 EUR
|
| |
92 CHF
|
|
| | |
81 EUR
|
| |
91 USD
|
|
Monetary assets in foreign currency
|
| |
32,336 EUR
|
| | | |
Trade and other payables
|
| |
505 EUR
|
| |
567 USD
|
|
| | |
219 EUR
|
| |
186 GBP
|
|
| | |
10 EUR
|
| |
11 CHF
|
|
Monetary liabilities in foreign currency
|
| |
734 EUR
|
| | | |
| | |
2018
(in thousands) |
| |||
Cash and cash equivalents
|
| |
16,941 EUR
|
| |
19,398 USD
|
|
Trade and other receivables
|
| |
2,059 EUR
|
| |
3,374 USD
|
|
Monetary assets in foreign currency
|
| |
19,000 EUR
|
| |
22,772 USD
|
|
Trade and other payables
|
| |
8,002 EUR
|
| |
9,162 USD
|
|
| | |
132 EUR
|
| |
118 GBP
|
|
| | |
46 EUR
|
| |
51 CHF
|
|
Monetary liabilities in Foreign Currency
|
| |
8,180 EUR
|
| | | |
| 2018 (1 EUR= 1.1450 USD) | | | 2019 (1 EUR = 1.1234 USD) | |
| EUR 10,544k from USD 13,090k | | | EUR 30,656k from USD 34,400k | |
in thousands of EUR
|
| |
January 1,
2019 |
| |
Cash
flows |
| |
Reclassification
|
| |
New
leases |
| |
Accrued
interest |
| |
Foreign
Exchange Movements |
| |
December 31,
2019 |
| |||||||||||||||||||||
Convertible loans
|
| | | | — | | | | | | 69,889 | | | | | | (7,604) | | | | | | — | | | | | | 2,733 | | | | | | — | | | | | | 65,018 | | |
Lease liabilities
|
| | | | 15,810 | | | | | | (1,910) | | | | | | — | | | | | | 153 | | | | | | — | | | | | | 77 | | | | | | 14,130 | | |
Total liabilities from financing
activities |
| | | | 15,810 | | | | | | 67,979 | | | | | | (7,604) | | | | | | 153 | | | | | | 2,733 | | | | | | 77 | | | | | | 79,148 | | |
|
in thousands of EUR
|
| |
January 1,
2018 |
| |
Changes from
financing cash flows |
| |
December 31,
2018 |
| |||||||||
Lease liabilities
|
| | | | 188 | | | | | | (112) | | | | | | 77 | | |
Total liabilities from financing activities
|
| | | | 188 | | | | | | (112) | | | | | | 77 | | |
Remuneration of key management in 2019
|
| |
Management
Board |
| |
Supervisory
Board |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term benefits
|
| | | | 3,166 | | | | | | 521 | | |
Share-based payments
|
| | | | 18,483 | | | | | | — | | |
Total | | | | | 21,649 | | | | | | 521 | | |
Remuneration of key management in 2018
|
| |
Management
Board |
| |
Supervisory
Board |
| ||||||
| | |
EUR k
|
| |
EUR k
|
| ||||||
Short-term benefits
|
| | | | 2,195 | | | | | | 343 | | |
Total | | | | | 2,195 | | | | | | 343 | | |
| | 99.10 | | | | Consent of Pierre Kemula, as Management Board nominee** | |
| | 99.11 | | | | Consent of Igor Splawski, as Management Board nominee** | |
| CureVac B.V. | | |||
| By: | | | /s/ Franz-Werner Haas, LLD, LLM | |
| Name: | | | Franz-Werner Haas, LLD, LLM | |
| Title: | | | Chief Executive Officer | |
| By: | | | /s/ Pierre Kemula, B.Sc. | |
| Name: | | | Pierre Kemula, B.Sc. | |
| Title: | | | Chief Financial Officer | |
| | | | CureVac Inc. | |
| | | |
/s/ Franz-Werner Haas
Name: Franz-Werner Haas
Title: Member of Board of Directors |
|
Exhibit 3.1
This
is a translation into English of the official Dutch version of the articles of association of a
public company with limited
liability under Dutch law. Definitions included in Article 1
below appear in the English alphabetical order, but will appear
in the Dutch
alphabetical order in the official Dutch version. In the event of a conflict between the
English and Dutch
texts, the Dutch text shall prevail.
ARTICLES OF ASSOCIATION
CUREVAC N.V.
DEFINITIONS AND INTERPRETATION
Article | 1 |
1.1 | In these articles of association the following definitions shall apply: |
Affiliate | Any Person controlling, controlled by, or under common control with another Person, with "control" meaning directly or indirectly owning or controlling at least fifty percent (50%) of such company's voting stock, or possessing the decisive power, whether directly or indirectly, to direct or cause the direction of such company's management and policies and includes in case of KfW also the Federal Republic of Germany and its special estates (Sondervermögen), corporate bodies (Körperschaften), institutions (Anstalten) as well as their respective Affiliates (in relation to KfW, "KfW Affiliates"). |
Article | An article of these articles of association. |
CEO | The Company's chief executive officer. |
Chairman | The chairman of the Supervisory Board. |
Change of Control |
The occurrence of any one or more of the following events with respect to dievini, as determined by the Supervisory Board:
a. the direct or indirect change in ownership or control of dievini effected through one transaction, or a series of related transactions within a twelve-month period, as a result of which any Person or group of Persons acting in concert, directly or indirectly acquires (i) beneficial ownership of more than half of the share capital or interests of dievini and/or (ii) the ability to cast more than half of the voting rights in the shareholders' meeting (or equivalent body) of dievini;
b. the consummation of a merger, demerger or business combination of dievini with another Person, unless such transaction results in the shares and voting interests in dievini outstanding immediately prior to the consummation of such transaction continuing to represent (either by remaining outstanding or by being converted into, or exchanged for, voting securities of the surviving or acquiring Person or a parent thereof) at least half of the voting rights in the shareholders' meeting (or equivalent body) of such surviving or acquiring Person or parent outstanding immediately after the consummation of such transaction; or
c. the consummation of any sale, lease, exchange or other transfer to any Person or group of Persons acting in concert, in one transaction or a series of related transactions within a twelve-month period, of all or substantially all of the business of dievini,
in each case unless the Person entering into the transaction concerned is an Affiliate or an Ultimate Beneficiary of dievini. |
Class Meeting | The meeting formed by the Persons with Meeting Rights with respect to shares of a certain class. |
Company | The company to which these articles of association pertain. |
CureVac AG | CureVac AG, registered with the Commercial Register of the Local Court in Stuttgart under HRB 754041, or its legal successors. |
DCC | The Dutch Civil Code. |
dievini | dievini Hopp BioTech holding GmbH & Co. KG, registered with the Commercial Register of the Local Court in Mannheim under HRA 700792, or its legal successors or permitted assigns under the SHA. |
dievini Nominee | A member of the Supervisory Board appointed upon nomination by dievini pursuant to Articles 22.2 and 22.3. |
Euribor | The Euribor rate (or a European reference rate that has replaced the Euribor rate) published by Thomson Reuters or another institution chosen by the Management Board, for loans with a maturity of three, six, nine or twelve months, whichever had the highest mathematical average over the financial year (or the relevant part thereof) in respect of which the relevant distribution is made, but in any event no less than zero percent. |
General Meeting | The Company's general meeting. |
Group Company | An entity or partnership which is organisationally connected with the Company in an economic unit within the meaning of Section 2:24b DCC. |
Indemnified Officer | A current or former Managing Director or Supervisory Director or such other current or former officer or employee of the Company or its Group Companies as designated by the Management Board, subject to approval by the Supervisory Board. |
Initial Approval Period | The period during which the SHA has not expired or otherwise terminated in accordance with its terms, as determined by the Supervisory Board. |
Initial Nomination Period |
The following respective periods:
a. with respect to nomination rights of dievini under these articles of association, the period from [effective date of these articles of association] until the earlier of:
i. dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) no longer holding ordinary shares representing at least ten percent (10%) of the Company's issued share capital; or
ii. the occurrence of a Change of Control;
b. with respect to nomination rights of KfW under these articles of association, the period from [effective date of these articles of association] until KfW nor any of the KfW Affiliates (individually or together with any other KfW Affiliates) no longer holds ordinary shares representing at least ten percent (10%) of the Company's issued share capital,
in each case as determined by the Supervisory Board.
|
Initial Period |
The period from [effective date of these articles of association] until the earlier of:
a. dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) no longer holding shares representing at least twenty-five percent (25%) of the Company's issued share capital; or
b. the occurrence of a Change of Control,
in each case as determined by the Supervisory Board.
|
KfW | KfW, a public law institution (Anstalt des öffentlichen Rechts) under German law, having its seat in Frankfurt am Main, Germany, or its legal successors or permitted assigns under the SHA. |
KfW Nominee | A member of the Supervisory Board appointed upon nomination by KfW pursuant to Articles 22.2 and 22.3. |
Management Board | The Company's management board. |
Management Board Rules | The internal rules applicable to the Management Board, as drawn up by the Management Board. |
Managing Director | A member of the Management Board. |
Meeting Rights | With respect to the Company, the rights attributed by law to the holders of depository receipts issued for shares with a company's cooperation, including the right to attend and address a General Meeting. |
Nomination Concert |
Any shareholder or group of shareholders acting in concert representing at least twenty percent (20%) of the Company's issued share capital, in each case excluding:
a. dievini and its Affiliates and Ultimate Beneficiaries during the Initial Nomination Period for dievini; and
b. KfW and its Affiliates during the Initial Nomination Period for KfW.
|
Person | A natural person, partnership, company, corporation, association with or without legal personality (rechtspersoonlijkheid), cooperative, mutual insurance society, foundation or any other entity or body which operates externally as an independent unit or organization, including state or governmental institutions, departments and agencies and other entities under public law.
|
Person with Meeting Rights | A shareholder, a usufructuary or pledgee with voting rights or a holder of depository receipts for shares issued with the Company's cooperation. |
Preferred Distribution |
A distribution on the preferred shares for an amount equal to the Preferred Interest Rate calculated over the aggregate amount paid up on those preferred shares, whereby:
a. any amount paid up on those preferred shares (including as a result of an issue of preferred shares) during the financial year (or the relevant part thereof) in respect of which the distribution is made shall only be taken into account proportionate to the number of days that elapsed during that financial year (or the relevant part thereof) after the payment was made on those preferred shares;
b. any reduction of the aggregate amount paid up on preferred shares during the financial year (or the relevant part thereof) in respect of which the distribution is made shall be taken into account proportionate to the number of days that elapsed during that financial year (or the relevant part thereof) until such reduction was effected; and
c. if the distribution is made in respect of part of a financial year, the amount of the distribution shall be proportionate to the number of days that elapsed during that part of the financial year.
|
Preferred Interest Rate | The mathematical average, calculated over the financial year (or the relevant part thereof) in respect of which a distribution is made on preferred shares, of the relevant Euribor interest rate, plus a margin not exceeding five hundred basis points (500bps) to be determined by the Management Board each time when, or before, preferred shares are issued without preferred shares already forming part of the Company's issued share capital. |
Record Date | The date of registration for a General Meeting as provided by law. |
SHA | The Shareholders' Agreement originally entered into between KfW, dievini and Mr. Dietmar Hopp and dated the sixteenth day of June two thousand and twenty, as amended from time to time. |
Simple Majority | More than half of the votes cast. |
Subsidiary | A subsidiary within the meaning of Section 2:24a DCC. |
Supervisory Board | The Company's supervisory board. |
Supervisory Board Rules | The internal rules applicable to the Supervisory Board, as drawn up by the Supervisory Board. |
Supervisory Director | A member of the Supervisory Board. |
Ultimate Beneficiary |
Each Person who is:
a. an ultimate beneficiary of dievini, determined as of [effective date of these articles of association];
b. a member of the immediate family of an ultimate beneficiary referred to under paragraph a. above, with "immediate family" meaning any family member by blood, marriage or adoption, not more remote than the first cousin;
c. an Affiliate of an ultimate beneficiary referred to under paragraph a. above; or
d. an Affiliate of a member of the immediate family of an ultimate beneficiary referred to under paragraph b. above. |
Vice-Chairman | The vice-chairman of the Supervisory Board. |
1.2 | Unless the context requires otherwise, references to "shares" or "shareholders" without further specification are to shares in the Company's capital, irrespective of their class, or to the holders thereof, respectively. |
1.3 | References to statutory provisions are to those provisions as they are in force from time to time. |
1.4 | Terms that are defined in the singular have a corresponding meaning in the plural. |
1.5 | Words denoting a gender include each other gender. |
1.6 | Except as otherwise required by law, the terms "written" and "in writing" include the use of electronic means of communication. |
NAME AND SEAT
Article | 2 |
2.1 | The Company's name is CureVac N.V. |
2.2 | The Company has its corporate seat in Amsterdam. |
OBJECTS
Article | 3 |
The Company's objects are:
a. | to incorporate, to participate in, to finance, to hold any other interest in and to conduct the management or supervision of other entities, companies and partnerships in the area of pharmaceuticals and related products; |
b. | to acquire, to manage, to invest, to exploit, to encumber and to dispose of assets and liabilities; |
c. | to furnish guarantees, to provide security, to warrant performance in any other way and to assume liability, whether jointly and severally or otherwise, in respect of obligations of Group Companies or other parties; and |
d. | to do anything which, in the widest sense, is connected with or may be conducive to the objects described above. |
SHARES - AUTHORISED SHARE CAPITAL AND DEPOSITORY RECEIPTS
Article | 4 |
4.1 | The Company's authorised share capital amounts to [amount] euro (EUR [amount]). |
4.2 | The authorised share capital is divided into: |
a. | [number] ([number]) ordinary shares; and |
b. | [number] ([number]) preferred shares, |
each having a nominal value of twelve eurocents (EUR 0.12).
4.3 | Until the expiration of the later of (i) the Initial Period or (ii) the Initial Approval Period, the preferred shares cannot be issued and shall not be part of the Company's issued share capital. |
4.4 | The Management Board may resolve that one or more shares are divided into such number of fractional shares as may be determined by the Management Board. Unless specified differently, the provisions of these articles of association concerning shares and shareholders apply mutatis mutandis to fractional shares and the holders thereof, respectively. |
4.5 | The Company may cooperate with the issue of depository receipts for shares in its capital. |
SHARES - FORM OF SHARES AND SHARE REGISTER
Article 5
5.1 | All shares are registered shares. The Company may issue share certificates for registered shares in such form as may be approved by the Management Board. Each Managing Director is authorised to sign any such share certificate on behalf of the Company. |
5.2 | Shares shall be numbered consecutively, starting from 1 for each class of shares. |
5.3 | The Management Board shall keep a register setting out the names and addresses of all shareholders and all holders of a usufruct or pledge in respect of shares. The register shall also set out any other particulars that must be included in the register pursuant to applicable law. Part of the register may be kept outside the Netherlands to comply with applicable local law or pursuant to stock exchange rules. |
5.4 | Shareholders, usufructuaries and pledgees shall provide the Management Board with the necessary particulars in a timely fashion. Any consequences of not, or incorrectly, notifying such particulars shall be borne by the party concerned. |
5.5 | All notifications may be sent to shareholders, usufructuaries and pledgees at their respective addresses as set out in the register. |
SHARES - ISSUE
Article 6
6.1 | Subject to Article 4.3, the Company can only issue shares pursuant to a resolution of the General Meeting or of another body authorised by the General Meeting for this purpose for a specified period not exceeding five years. When granting such authorisation, the number of shares that may be issued must be specified. The authorisation may be extended, in each case for a period not exceeding five years. Unless stipulated differently when granting the authorisation, the authorisation cannot be revoked. For as long as and to the extent that another body has been authorised to resolve to issue shares, the General Meeting shall not have this authority. |
6.2 | In order for a resolution of the General Meeting on an issuance or an authorisation as referred to in Article 6.1 to be valid, a prior or simultaneous approval shall be required from each Class Meeting of shares whose rights are prejudiced by the issuance. |
6.3 | The preceding provisions of this Article 6 apply mutatis mutandis to the granting of rights to subscribe for shares, but do not apply in respect of issuing shares to a party exercising a previously acquired right to subscribe for shares. |
6.4 | The Company may not subscribe for shares in its own capital. |
SHARES - PRE-EMPTION RIGHTS
Article 7
7.1 | Upon an issue of shares, each holder of ordinary shares shall have a pre-emption right in proportion to the aggregate nominal value of his ordinary shares. No pre-emption rights are attached to preferred shares. |
7.2 | In deviation of Article 7.1, holders of ordinary shares do not have pre-emption rights in respect of: |
a. | preferred shares; |
b. | shares issued against non-cash contribution; or |
c. | shares issued to employees of the Company or of a Group Company. |
7.3 | The Company shall announce an issue with pre-emption rights and the period during which those rights can be exercised in accordance with applicable law. |
7.4 | Pre-emption rights may be exercised for a period of at least two weeks after the date of announcement in accordance with applicable law. |
7.5 | Pre-emption rights may be limited or excluded by a resolution of the General Meeting or of the body authorised as referred to in Article 6.1, if that body was authorised by the General Meeting for this purpose for a specified period not exceeding five years. The authorisation may be extended, in each case for a period not exceeding five years. Unless stipulated differently when granting the authorisation, the authorisation cannot be revoked. For as long as and to the extent that another body has been authorised to resolve to limit or exclude pre-emption rights, the General Meeting shall not have this authority. |
7.6 | A resolution of the General Meeting to limit or exclude pre-emption rights, or to grant an authorisation as referred to in Article 7.5, shall require a majority of at least two thirds of the votes cast if less than half of the issued share capital is represented at the General Meeting. |
7.7 | The preceding provisions of this Article 7 apply mutatis mutandis to the granting of rights to subscribe for shares, but do not apply in respect of issuing shares to a party exercising a previously acquired right to subscribe for shares. |
SHARES - PAYMENT
Article 8
8.1 | Without prejudice to Section 2:80(2) DCC, the nominal value of a share and, if the share is subscribed for at a higher price, the difference between these amounts must be paid up upon subscription for that share. However, it may be stipulated that part of the nominal value of a preferred share, not exceeding three quarters thereof, need not be paid up until the Company has called for payment. The Company shall observe a reasonable notice period of at least one month with respect to any such call for payment. |
8.2 | Shares must be paid up in cash, except to the extent that payment by means of a contribution in another form has been agreed. |
8.3 | Payment in a currency other than the euro can only be made with the Company's consent. Where such a payment is made, the payment obligation is satisfied for the amount in euro for which the paid amount can be freely exchanged. Without prejudice to the last sentence of Section 2:80a(3) DCC, the date of the payment determines the exchange rate. |
SHARES - FINANCIAL ASSISTANCE
Article 9
9.1 | The Company may not provide security, give a price guarantee, warrant performance in any other way or commit itself jointly and severally or otherwise with or for others with a view to the subscription for or acquisition of shares or depository receipts for shares in its capital by others. This prohibition applies equally to Subsidiaries of the Company. |
9.2 | The Company and its Subsidiaries may not provide loans with a view to the subscription for or acquisition of shares or depository receipts for shares in the Company's capital by others, unless the Management Board resolves to do so and Section 2:98c DCC is observed. |
9.3 | The preceding provisions of this Article 9 do not apply if shares or depository receipts for shares are subscribed for or acquired by or for employees of the Company or of a Group Company. |
SHARES - ACQUISITION OF OWN SHARES
Article 10
10.1 | The acquisition by the Company of shares in its own capital which have not been fully paid up shall be null and void. |
10.2 | The Company may only acquire fully paid up shares in its own capital for no consideration or if and to the extent that the General Meeting has authorised the Management Board for this purpose and all other relevant statutory requirements of Section 2:98 DCC are observed. |
10.3 | An authorisation as referred to in Article 10.2 remains valid for no longer than eighteen months. When granting such authorisation, the General Meeting shall determine the number of shares that may be acquired, how they may be acquired and within which range the acquisition price must be. An authorisation shall not be required for the Company to acquire ordinary shares in its own capital in order to transfer them to employees of the Company or of a Group Company pursuant to an arrangement applicable to them, provided that these ordinary shares are included on the price list of a stock exchange. |
10.4 | Without prejudice to Articles 10.1 through 10.3, the Company may acquire shares in its own capital for cash consideration or for consideration satisfied in the form of assets. In the case of a consideration being satisfied in the form of assets, the value thereof, as determined by the Management Board, must be within the range stipulated by the General Meeting as referred to in Article 10.3. |
10.5 | The previous provisions of this Article 10 do not apply to shares acquired by the Company under universal title of succession. |
10.6 | In this Article 10, references to shares include depository receipts for shares. |
SHARES - REDUCTION OF ISSUED SHARE CAPITAL
Article | 11 |
11.1 | The General Meeting can resolve to reduce the Company's issued share capital by cancelling shares or by reducing the nominal value of shares by virtue of an amendment to these articles of association. The resolution must designate the shares to which the resolution relates and it must provide for the implementation of the resolution. |
11.2 | A resolution to cancel shares can only relate to: |
a. | shares held by the Company itself or in respect of which the Company holds the depository receipts; and |
b. | all preferred shares, with repayment of the amounts paid up in respect thereof and provided that, to the extent allowed under Articles 35.1 and 35.2, a distribution is made on those preferred shares, in proportion to the amounts paid up on those preferred shares, immediately prior to such cancellation becoming effective, for an aggregate amount of: |
i. | the total of all Preferred Distributions (or parts thereof) in relation to financial years prior to the financial year in which the cancellation occurs, to the extent that these should have been distributed but have not yet been distributed as described in Article 37.1; and |
ii. | the Preferred Distribution calculated in respect of the part of the financial year in which the cancellation occurs, for the number of days that have elapsed during such part of the financial year. |
11.3 | A resolution to reduce the Company's issued share capital, shall require a prior or simultaneous approval from each Class Meeting of shares whose rights are prejudiced. However, if such a resolution relates to preferred shares, such resolution shall always require the prior or simultaneous approval of the Class Meeting concerned. |
11.4 | A resolution of the General Meeting to reduce the Company's issued share capital shall require a majority of at least two thirds of the votes cast if less than half of the issued share capital is represented at the General Meeting. The previous sentence applies mutatis mutandis to a resolution as referred to in Article 11.3. |
SHARES - ISSUE AND TRANSFER REQUIREMENTS
Article 12
12.1 | Except as otherwise provided or allowed by applicable law, the issue or transfer of a share shall require a deed to that effect and, in the case of a transfer and unless the Company itself is a party to the transaction, acknowledgement of the transfer by the Company. |
12.2 | The acknowledgement shall be set out in the deed or shall be made in such other manner as prescribed by law. |
12.3 | For as long as any ordinary shares are admitted to trading on the New York Stock Exchange, the NASDAQ Stock Market or on any other regulated stock exchange operating in the United States of America, the laws of the State of New York shall apply to the property law aspects of the ordinary shares reflected in the register administered by the relevant transfer agent, without prejudice to the applicable provisions of Chapters 4 and 5 of Title 10 of Book 10 DCC. |
SHARES - USUFRUCT AND PLEDGE
Article 13
13.1 | Shares can be encumbered with a usufruct or pledge. The creation of a pledge on preferred shares shall require the prior approval of the Management Board. |
13.2 | The voting rights attached to a share which is subject to a usufruct or pledge vest in the shareholder concerned. |
13.3 | In deviation of Article 13.2: |
a. | the holder of a usufruct or pledge on ordinary shares shall have the voting rights attached thereto if this was provided when the usufruct or pledge was created; and |
b. | the holder of a usufruct or pledge on preferred shares shall have the voting rights attached thereto if this was provided when the usufruct or pledge was created and this was approved by the Management Board. |
13.4 | Usufructuaries and pledgees without voting rights shall not have Meeting Rights. Shareholders without voting rights as a result of a usufruct or pledge shall have Meeting Rights. |
SHARES - TRANSFER RESTRICTIONS
Article 14
14.1 | A transfer of preferred shares shall require the prior approval of the Management Board. A shareholder wishing to transfer preferred shares must first request the Management Board to grant such approval. A transfer of ordinary shares is not subject to transfer restrictions under these articles of association. |
14.2 | A transfer of the preferred shares to which the request for approval relates must take place within three months after the approval of the Management Board has been granted or is deemed to have been granted pursuant to Article 14.3. |
14.3 | The approval of the Management Board shall be deemed to have been granted: |
a. | if no resolution granting or denying the approval has been passed by the Management Board within three months after the Company has received the request for approval; or |
b. | if the Management Board, when denying the approval, does not notify the requesting shareholder of the identity of one or more interested parties willing to purchase the relevant preferred shares. |
14.4 | If the Management Board denies the approval and notifies the requesting shareholder of the identity of one or more interested parties, the requesting shareholder shall notify the Management Board within two weeks after having received such notice whether: |
a. | he withdraws his request for approval, in which case the requesting shareholder cannot transfer the relevant preferred shares; or |
b. | he accepts the interested party(ies), in which case the requesting shareholder shall promptly enter into negotiations with the interested party(ies) regarding the price to be paid for the relevant preferred shares. |
If the requesting shareholder does not notify the Management Board of his choice in a timely fashion, he shall be deemed to have withdrawn his request for approval, in which case he cannot transfer the relevant preferred shares.
14.5 | If an agreement is reached in the negotiations referred to in Article 14.4 paragraph b. within two weeks after the end of the period referred to in Article 14.4, the relevant preferred shares shall be transferred for the agreed price within three months after such agreement having been reached. If no agreement is reached in these negotiations in a timely fashion: |
a. | the requesting shareholder shall promptly notify the Management Board thereof; and |
b. | the price to be paid for the relevant preferred shares shall be equal to the value thereof, as determined by one or more independent experts to be appointed by the requesting shareholder and the interested party(ies) by mutual agreement. |
14.6 | If no agreement is reached on the appointment of the independent expert(s) as referred to in Article 14.5 paragraph b. within two weeks after the end of the period referred to in Article 14.5: |
a. | the requesting shareholder shall promptly notify the Management Board thereof; and |
b. | the requesting shareholder shall promptly request the president of the district court in whose district the Company has its corporate seat to appoint three independent experts to determine the value of the relevant preferred shares. |
14.7 | If and when the value of the relevant preferred shares has been determined by the independent expert(s), irrespective of whether he/they was/were appointed by mutual agreement or by the president of the relevant district court, the requesting shareholder shall promptly notify the Management Board of the value so determined. The Management Board shall then promptly inform the interested party(ies) of such value, following which the/each interested party may withdraw from the sale procedure by giving notice thereof to the Management Board within two weeks. |
14.8 | If any interested party withdraws from the sale procedure in accordance with Article 14.7, the Management Board: |
a. | shall promptly inform the requesting shareholder and the other interested party(ies), if any, thereof; and |
b. | shall give the opportunity to the/each other interested party, if any, to declare to the Management Board and the requesting shareholder, within two weeks, his willingness to acquire the preferred shares having become available as a result of the withdrawal, for the price determined by the independent expert(s) (with the Management Board being entitled to determine the allocation of such preferred shares among any such willing interested party(ies) at its absolute discretion). |
14.9 | If it becomes apparent to the Management Board that all relevant preferred shares can be transferred to one or more interested parties for the price determined by the independent expert(s), the Management Board shall promptly notify the requesting shareholder and such interested party(ies) thereof. Within three months after sending such notice the relevant preferred shares shall be transferred. |
14.10 | If it becomes apparent to the Management Board that not all relevant preferred shares can be transferred to one or more interested parties for the price determined by the independent expert(s): |
a. | the Management Board shall promptly notify the requesting shareholder thereof; and |
b. | the requesting shareholder shall be free to transfer all relevant preferred shares, provided that the transfer takes place within three months after having received the notice referred to in paragraph a. |
14.11 | The Company may only be an interested party under this Article 14 with the consent of the requesting shareholder. |
14.12 | All notices given pursuant to this Article 14 shall be provided in writing. |
14.13 | The preceding provisions of this Article 14 do not apply: |
a. | to the extent that a shareholder is under a statutory obligation to transfer preferred shares to a previous holder thereof; |
b. | if it concerns a transfer in connection with an enforcement of a pledge pursuant to Section 3:248 DCC in conjunction with Section 3:250 or 3:251 DCC; or |
c. | if it concerns a transfer to the Company, except in the case that the Company acts as an interested party pursuant to Article 14.11. |
14.14 | This Article 14 applies mutatis mutandis in case of a transfer of rights to subscribe for preferred shares. |
MANAGEMENT BOARD - COMPOSITION
Article 15
15.1 | The Company has a Management Board consisting of one or more Managing Directors, provided that, during the Initial Period, the Management Board shall consist of up to six (6) Managing Directors. The Management Board shall be composed of individuals. |
15.2 | The Supervisory Board shall determine the number of Managing Directors. |
15.3 | The Supervisory Board shall elect a Managing Director to be the CEO. The Supervisory Board may dismiss the CEO, provided that the Managing Director so dismissed shall subsequently continue his term of office as a Managing Director without having the title of CEO. |
15.4 | If a Managing Director is absent or incapacitated, he may be replaced temporarily by a person whom the Management Board has designated for that purpose and, until then, the other Managing Director(s) shall be charged with the management of the Company. If all Managing Directors are absent or incapacitated, the management of the Company shall be attributed to the Supervisory Board. The person(s) charged with the management of the Company in this manner, may designate one or more persons to be charged with the management of the Company instead of, or together with, such person(s). |
15.5 | A Managing Director shall be considered to be unable to act within the meaning of Article 15.4: |
a. | during the existence of a vacancy on the Management Board, including as a result of: |
i. | his death; |
ii. | his dismissal by the General Meeting, other than at the proposal of the Supervisory Board; or |
iii. | his voluntary resignation before his term of office has expired; |
iv. | not being reappointed by the General Meeting, notwithstanding a (binding) nomination to that effect by the Supervisory Board, |
provided that the Supervisory Board may always decide to decrease the number of Managing Directors such that a vacancy no longer exists; or
b. | during his suspension; |
c. | in a period during which the Company has not been able to contact him (including as a result of illness), provided that such period lasted longer than five consecutive days (or such other period as determined by the Supervisory Board on the basis of the facts and circumstances at hand); or |
d. | in connection with and during the deliberations and decision-making of the Management Board on matters in relation to which he has declared to have, or in relation to which the Supervisory Board has established that he has, a conflict of interests as described in Article 18.6. |
MANAGEMENT BOARD - APPOINTMENT, SUSPENSION AND DISMISSAL
Article 16
16.1 | The General Meeting shall appoint the Managing Directors and may at any time suspend or dismiss any Managing Director. In addition, the Supervisory Board may at any time suspend a Managing Director. A suspension by the Supervisory Board can at any time be lifted by the General Meeting. |
16.2 | The General Meeting can only appoint Managing Directors upon a nomination by the Supervisory Board. The General Meeting may at any time resolve to render such nomination to be non-binding by a Simple Majority representing at least one third of the issued share capital. If a nomination is rendered non-binding, a new nomination shall be made by the Supervisory Board. If the nomination comprises one candidate for a vacancy, a resolution concerning the nomination shall result in the appointment of the candidate, unless the nomination is rendered non-binding. A second meeting as referred to in Section 2:120(3) DCC cannot be convened. |
16.3 | At a General Meeting, a resolution to appoint a Managing Director can only be passed in respect of candidates whose names are stated for that purpose in the agenda of that General Meeting or the explanatory notes thereto. |
16.4 | A resolution of the General Meeting to suspend or dismiss a Managing Director shall require a majority of at least two thirds of the votes cast representing more than half of the issued share capital, unless the resolution is passed at the proposal of the Supervisory Board. A second meeting as referred to in Section 2:120(3) DCC cannot be convened. |
16.5 | If a Managing Director is suspended and the General Meeting does not resolve to dismiss him within three months from the date of such suspension, the suspension shall lapse. |
MANAGEMENT BOARD - DUTIES AND ORGANISATION
Article 17
17.1 | The Management Board is charged with the management of the Company, subject to the restrictions contained in these articles of association. In performing their duties, Managing Directors shall be guided by the interests of the Company and of the business connected with it. |
17.2 | The Management Board shall draw up Management Board Rules concerning its organisation, decision-making and other internal matters, with due observance of these articles of association. In performing their duties, the Managing Directors shall act in compliance with the Management Board Rules. |
17.3 | The Management Board may perform the legal acts referred to in Section 2:94(1) DCC without the prior approval of the General Meeting. |
MANAGEMENT BOARD - DECISION-MAKING
Article 18
18.1 | Without prejudice to Article 18.5, each Managing Director may cast one vote in the decision-making of the Management Board. |
18.2 | A Managing Director can be represented by another Managing Director holding a written proxy for the purpose of the deliberations and the decision-making of the Management Board. |
18.3 | Resolutions of the Management Board shall be passed, irrespective of whether this occurs at a meeting or otherwise, by Simple Majority unless the Management Board Rules provide differently. |
18.4 | Invalid votes, blank votes and abstentions shall not be counted as votes cast. Managing Directors who casted an invalid or blank vote or who abstained from voting shall be taken into account when determining the number of Managing Directors who are present or represented at a meeting of the Management Board. |
18.5 | Where there is a tie in any vote of the Management Board, the CEO shall have a casting vote, provided that there are at least three Managing Directors in office. Otherwise, the relevant resolution shall not have been passed. |
18.6 | A Managing Director shall not participate in the deliberations and decision-making of the Management Board on a matter in relation to which he has a direct or indirect personal interest which conflicts with the interests of the Company and of the business connected with it. If, as a result thereof, no resolution can be passed by the Management Board, the resolution shall be passed by the Supervisory Board. |
18.7 | Meetings of the Management Board can be held through audio-communication facilities, unless a Managing Director objects thereto. |
18.8 | Resolutions of the Management Board may, instead of at a meeting, be passed in writing, provided that all Managing Directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 18.1 through 18.6 apply mutatis mutandis. |
18.9 | The approval of the Supervisory Board is required for resolutions of the Management Board concerning the following matters: |
a. | the making of a proposal to the General Meeting concerning: |
i. | the issue of shares or the granting of rights to subscribe for shares; |
ii. | the limitation or exclusion of pre-emption rights; |
iii. | the designation or granting of an authorisation as referred to in Articles 6.1, 7.5 and 10.2, respectively; |
iv. | the reduction of the Company's issued share capital; |
v. | the making of a distribution from the Company's profits or reserves; |
vi. | the determination that all or part of a distribution, instead of being made in cash, shall be made in the form of shares in the Company's capital or in the form of assets; |
vii. | the amendment of these articles of association; |
viii. | the entering into of a merger or demerger; |
ix. | the instruction of the Management Board to apply for the Company's bankruptcy; and |
x. | the Company's dissolution; |
b. | the issue of shares or the granting of rights to subscribe for shares (except in connection with the ordinary operation of the Company's equity incentive plans); |
c. | the limitation or exclusion of pre-emption rights (except in connection with the ordinary operation of the Company's equity incentive plans); |
d. | calling for a payment as referred to in Article 8.1; |
e. | the establishment of new activities of the Company or its direct or indirect Subsidiaries in the areas of research, development, production and administration and/or the approval to establish activities of CureVac AG or its Subsidiaries in these areas, in each case in a state outside the European Union; |
f. | the acquisition of shares by the Company in its own capital (except in connection with the ordinary operation of the Company's equity incentive plans), including the determination of the value of a non-cash consideration for such an acquisition as referred to in Article 10.4; |
g. | the granting of an approval for the creation of a pledge as referred to in Article 13.1; |
h. | the granting of an approval for a transfer as referred to in Article 14.1; |
i. | the temporary replacement of a Managing Director who is absent or incapacitated as referred to in Article 15.4; |
j. | the drawing up or amendment of the Management Board Rules; |
k. | the performance of the legal acts described in Article 17.3 and 18.10; |
l. | the charging of amounts to be paid up on shares against the Company's reserves as described in Article 36.4; |
m. | the making of an interim distribution; |
n. | designating a current or former officer or employee of the Company or its Group Companies, who is not a current or former Managing Director or Supervisory Director, as an Indemnified Officer; |
o. | the stipulation of additional terms, conditions and restrictions in relation to the indemnification referred to in Article 26.1; and |
p. | such other resolutions of the Management Board as the Supervisory Board shall have specified in a resolution to that effect and notified to the Management Board. |
18.10 | The approval of the General Meeting is required for resolutions of the Management Board concerning a material change to the identity or the character of the Company or the business, including in any event: |
a. | transferring the business or materially all of the business to a third party; |
b. | entering into or terminating a long-lasting alliance of the Company or of a Subsidiary of the Company either with another entity or company, or as a fully liable partner of a limited partnership or general partnership, if this alliance or termination is of significant importance for the Company; and |
c. | acquiring or disposing of an interest in the capital of a company by the Company or by a Subsidiary of the Company with a value of at least one third of the value of the assets, according to the balance sheet with explanatory notes or, if the Company prepares a consolidated balance sheet, according to the consolidated balance sheet with explanatory notes in the Company's most recently adopted annual accounts. |
18.11 | In addition, during the Initial Approval Period, the approval of the General Meeting and the Supervisory Board is required for resolutions of the Management Board concerning: |
a. | the transfer of the tax domicile of the Company and/or the approval of the transfer of the corporate or administrative seat of CureVac AG; |
b. | the relocation of activities of the Company or its direct or indirect Subsidiaries in the areas of research, development, production and administration and/or the approval to relocate activities of CureVac AG or its Subsidiaries in these areas, including the relocation of such activities to Subsidiaries of the Company and CureVac AG, in each case in or to a state outside the European Union and in each case except to the extent that the Supervisory Board considers such activities – in particular in the area of the development of vaccines – not to be material for the protection of the health of the population of the European Union; |
c. | the cessation of activities (including by way of disposal, demerger or similar transactions) of the Company, CureVac AG and/or their respective Subsidiaries in the areas of research, development, production and administration, in each case except to the extent that the Supervisory Board considers such activities – in particular in the area of the development of vaccines – not to be material for the protection of the health of the population of the European Union; |
d. | the entering into by the Company or any of its Subsidiaries of mergers, demergers and similar reorganisations and the entering into by the Company or any of its Subsidiaries of acquisitions of businesses or participations, in each case except to the extent that the Supervisory Board considers such transactions not to be material; |
e. | any amendment to the articles of association of CureVac AG which would result in one or more of the matters listed in this Article 18.11 no longer requiring a resolution of the Management Board subject to the approval of the General Meeting and the Supervisory Board; and |
f. | the exercise of voting rights on shares or other voting interests held by the Company, directly or indirectly, in CureVac AG approving, directing or causing any one or more of the matters listed in this Article 18.11. |
18.12 | The absence of the approval of the Supervisory Board or the General Meeting of a resolution as referred to in Articles 18.9 through 18.11, respectively, shall result in the relevant resolution being null and void pursuant to Section 2:14(1) DCC but shall not affect the powers of representation of the Management Board or of the Managing Directors. |
MANAGEMENT BOARD - COMPENSATION
Article 19
19.1 | The General Meeting shall determine the Company's policy concerning the compensation of the Management Board with due observance of the relevant statutory requirements. |
19.2 | The compensation of Managing Directors shall be determined by the Supervisory Board with due observance of the policy referred to in Article 19.1. |
19.3 | The Supervisory Board shall submit proposals concerning compensation arrangements for the Management Board in the form of shares or rights to subscribe for shares to the General Meeting for approval. This proposal must at least include the number of shares or rights to subscribe for shares that may be awarded to the Management Board and which criteria apply for such awards or changes thereto. The absence of the approval of the General Meeting shall not affect the powers of representation of the Management Board or of the Managing Directors. |
MANAGEMENT BOARD - REPRESENTATION
Article 20
20.1 | The Management Board is entitled to represent the Company. |
20.2 | The power to represent the Company also vests in the CEO individually, as well as in any other two Managing Directors acting jointly. |
20.3 | The Company may also be represented by the holder of a power of attorney to that effect. If the Company grants a power of attorney to an individual, the Management Board may grant an appropriate title to such person. |
SUPERVISORY BOARD - COMPOSITION
Article 21
21.1 | The Company has a Supervisory Board consisting of three or more Supervisory Directors provided that, during either Initial Nomination Period, the Supervisory Board shall consist of up to eight (8) Supervisory Directors. The Supervisory Board shall be composed of individuals. |
21.2 | Subject to the first sentence of Article 21.1, the Supervisory Board shall determine the number of Supervisory Directors, which shall be no less than the number of Supervisory Directors as are necessary in order to allow dievini and KfW to exercise their respective nomination rights under Articles 22.2 and 22.3 during their respective Initial Nomination Period. |
21.3 | The Supervisory Board shall elect a Supervisory Director to be the Chairman and another Supervisory Director to be the Vice-Chairman. The Supervisory Board may dismiss the Chairman and/or the Vice-Chairman, provided that the Supervisory Director so dismissed shall subsequently continue his term of office as a Supervisory Director without having the title of Chairman or Vice-Chairman, as applicable. |
21.4 | Where a Supervisory Director is no longer in office or is unable to act, he may be replaced temporarily by a person whom the Supervisory Board has designated for that purpose and, until then, the other Supervisory Director(s) shall be charged with the supervision of the Company. Where a Supervisory Director who has been appointed upon a nomination by dievini or KfW pursuant to Articles 22.2 and 22.3 is no longer in office or is unable to act, he may only be temporarily replaced by a person designated for such purposes by dievini or KfW, as applicable. The replacement becomes effective and the Supervisory Director so designated shall immediately have all rights, responsibilities, tasks and duties of a Supervisory Director (including any voting rights and specific rights awarded to the Supervisory Director he is replacing at the Supervisory Board) and (in relation to dievini to the fullest extent permitted by applicable law and at all times subject to KfW’s right to designate a Supervisory Director in accordance with this Article 21.4) shall become a full member of the Supervisory Board with the rights of a KfW Nominee or dievini Nominee , as the case may be, as soon as a written designation to that effect has been received by the Chairman or the Vice-Chairman. Article 22.10 shall apply. Where all Supervisory Directors are no longer in office or are unable to act, the supervision of the Company shall be attributed to: |
a. | the former Supervisory Director who most recently ceased to hold office as the Chairman, provided that he is willing and able to accept that position; |
b. | during the Initial Nomination Period for dievini, a person designated for such purpose by dievini, unless the former Supervisory Director referred to in this Article 21.4 under a. above was appointed upon a nomination by dievini pursuant to Articles 22.2 and 22.3 and he is willing and able to accept the position; and |
c. | during the Initial Nomination Period for KfW, a person designated for such purpose by KfW, unless the former Supervisory Director referred to in this Article 21.4 under a. above was appointed upon a nomination by KfW pursuant to Articles 22.2 and 22.3 and he is willing and able to accept the position, |
which persons jointly may designate one or more other persons to be charged with the supervision of the Company (instead of, or together with, the former Supervisory Director and/or persons designated by dievini and KfW in accordance with this full sentence). The persons charged with the supervision of the Company pursuant to the previous sentence shall cease to hold that position when the General Meeting has appointed one or more persons as Supervisory Director(s) with due observance of Articles 22.2 and 22.3. Article 15.5 applies mutatis mutandis.
SUPERVISORY BOARD - APPOINTMENT, SUSPENSION AND DISMISSAL
Article | 22 |
22.1 | The General Meeting shall appoint the Supervisory Directors and may at any time suspend or dismiss any Supervisory Director in accordance with this Article 22. |
22.2 | The General Meeting can only appoint a Supervisory Director upon a nomination by: |
a. | the Supervisory Board; |
b. | dievini in accordance with Article 22.3 paragraph a., during the Initial Nomination Period for dievini; |
c. | KfW in accordance with Article 22.3 paragraph b. during the Initial Nomination Period for KfW; or |
d. | any Nomination Concert in accordance with Article 22.4. |
As soon as reasonably practicable upon such nomination being made, the Supervisory Board shall convene a General Meeting for purposes of appointing such nominee to the Supervisory Board. The General Meeting may at any time resolve to render such nomination to be non-binding by a Simple Majority representing at least one third of the issued share capital. If a nomination is rendered non-binding, a new nomination shall be made by the Supervisory Board, the relevant Nomination Concert or, during the respective Initial Nomination Periods, dievini or KfW, as applicable. A second meeting as referred to in Section 2:120(3) DCC cannot be convened.
22.3 | During the respective Initial Nomination Periods for dievini (as regards paragraph a. below) or KfW (as regards paragraph b. below): |
a. | dievini may nominate the following number of Supervisory Directors pursuant to Article 22.2: |
i. | if dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) hold shares representing at least seventy percent (70%) of the Company's issued share capital: four (4) Supervisory Directors; |
ii. | if dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) hold shares representing at least fifty percent (50%), but less than seventy percent (70%), of the Company's issued share capital: three (3) Supervisory Directors; |
iii. | if dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) hold shares representing at least thirty percent (30%), but less than fifty percent (50%), of the Company's issued share capital: two (2) Supervisory Directors; |
iv. | if dievini and its Affiliates and Ultimate Beneficiaries (individually or collectively) hold shares representing at least ten percent (10%), but less than thirty percent (30%), of the Company's issued share capital: one (1) Supervisory Director; and |
b. | KfW may nominate one (1) Supervisory Director pursuant to Article 22.2. |
In the event where a Supervisory Director has been designated by dievini as temporary replacement in accordance with Article 21.4, such Supervisory Director shall be automatically dismissed from the moment where a dievini Nominee is appointed pursuant to Articles 22.2 and 22.3. The previous sentence applies mutatis mutandis with respect to KfW.
22.4 | Any Nomination Concert may nominate one (1) Supervisory Director for each twenty percent (20%) of the issued share capital represented by that Nomination Concert pursuant to Article 22.2. Such nominee must be independent from the Nomination Concert and the Company under the standards applicable to the Company under the Dutch Corporate Governance Code and United States securities laws and stock exchange rules. |
22.5 | The Company may from time to time request supporting information and/or documents demonstrating the shareholding of dievini, together with its Affiliates and Ultimate Beneficiaries, KfW and any Nomination Concert for purposes of determining to which extent they have nomination rights pursuant to Articles 22.2 through 22.4. Upon the Company having made such a request, dievini, KfW or the relevant Nomination Concert, as applicable, shall promptly comply with such request to the extent permitted by applicable law. |
22.6 | If a Supervisory Director who was nominated by dievini, KfW or a Nomination Concert pursuant to Articles 22.2 through 22.4, as applicable, ceases to be a Supervisory Director before the expiry of his or her term of appointment, dievini, KfW or the relevant Nomination Concert, as applicable, shall as soon as reasonable possible nominate a successor (if, at that time, dievini, KfW or the Nomination Concert, as applicable, still has nomination rights under Articles 22.2 through 22.4, as applicable, at that time) and the Supervisory Board shall subsequently and promptly convene a General Meeting for purposes of appointing such nominee to the Supervisory Board. |
22.7 | Upon the making of a nomination for the appointment of a Supervisory Director, the following information shall be provided with respect to the candidate: |
a. | his age and profession; |
b. | the aggregate nominal value of the shares held by him in the Company's capital; |
c. | his present and past positions, to the extent that these are relevant for the performance of the tasks of a Supervisory Director; |
d. | the names of any entities of which he is already a supervisory director or a non-executive director; if these include entities that form part of the same group, a specification of the group's name shall suffice; and |
e. | if it concerns the nomination of a Supervisory Director pursuant to Article 22.4, all relevant information to establish that such nominee is independent as described in Article 22.4. |
The nomination must be supported by reasons. In the case of a reappointment, the manner in which the candidate has fulfilled his duties as a Supervisory Director shall be taken into account.
22.8 | At a General Meeting, a resolution to appoint a Supervisory Director can only be passed in respect of candidates whose names are stated for that purpose in the agenda of that General Meeting or the explanatory notes thereto. |
22.9 | If and when dievini, KfW or a Nomination Concert nominates an individual in accordance with Article 22.3 or Article 22.4, the Company and/or the Supervisory Board shall, upon request of the relevant nominator, procure that the Supervisory Board invites such nominee for its meetings and any of its committee meetings, where applicable, as an observer without voting rights until such individual has been appointed as member of the Supervisory Board, provided that such individual agrees with the Company to be bound by customary confidentiality with respect to any information received by that individual as an observer. |
22.10 | If, for whatever reason, there is no dievini Nominee or no KfW Nominee in office during the Initial Nomination Period for dievini or KfW, as relevant, and a decision needs to be taken with respect to any matter referred to in Articles 6.12 and 6.13 of the Supervisory Board Rules, then the Supervisory Board shall not take any such decision until the replacement Supervisory Director of dievini or KfW, respectively, has validly become a full member of the Supervisory Board following his designation, unless dievini or KfW, as the case may be, has failed to notify the designation to the Chairman within four weeks after Chairman has notified dievini or KfW, as the case may be, in writing of the absence of the nominee. dievini or KfW, as the case may, shall notify the designation of the replacement Supervisory Director of dievini or KfW, respectively, to the Chairman as soon as reasonably and practicably possible but in any event within the four-week period as referred to in the previous sentence. |
This Article 22.10 can only be amended by the General Meeting with the affirmative vote of (i) during the Initial Nomination Period for dievini, dievini and (ii) during the Initial Nomination Period for KfW, KfW, and Articles 6.12, 6.13 and 6.19 of the Supervisory Board Rules can only be amended by the Supervisory Board with the affirmative vote of (i) during the Initial Nomination Period for dievini, at least one dievini Nominee and (ii) during the Initial Nomination Period for KfW, the KfW Nominee.
22.11 | A resolution of the General Meeting to suspend or dismiss a Supervisory Director shall require a majority of at least two thirds of the votes cast representing more than half of the issued share capital, unless the resolution is passed (i) at the proposal of the Supervisory Board, (ii) during the Initial Nomination Period for dievini, at the proposal of dievini (in respect of a dievini Nominee) or (iii) during the Initial Nomination Period for KfW, at the proposal of KfW (in respect of the KfW Nominee). A second meeting as referred to in Section 2:120(3) DCC cannot be convened. |
22.12 | If a Supervisory Director is suspended and the General Meeting does not resolve to dismiss him within three months from the date of such suspension, the suspension shall lapse. |
SUPERVISORY BOARD - DUTIES AND ORGANISATION
Article 23
23.1 | The Supervisory Board is charged with the supervision of the policy of the Management Board and the general course of affairs of the Company and of the business connected with it. The Supervisory Board shall provide the Management Board with advice. In performing their duties, Supervisory Directors shall be guided by the interests of the Company and of the business connected with it. |
23.2 | The Management Board shall provide the Supervisory Board with the information necessary for the performance of its tasks in a timely fashion. At least once a year, the Management Board shall inform the Supervisory Board in writing of the main features of the strategic policy, the general and financial risks and the administration and control system of the Company. |
23.3 | The Supervisory Board shall draw up Supervisory Board Rules concerning its organisation, decision-making and other internal matters, with due observance of these articles of association. In performing their duties, the Supervisory Directors shall act in compliance with the Supervisory Board Rules. |
23.4 | The Supervisory Board shall establish the committees which the Company is required to have and otherwise such committees as are deemed to be appropriate by the Supervisory Board. The Supervisory Board shall draw up (and/or include in the Supervisory Board Rules) rules concerning the organisation, decision-making and other internal matters of its committees. |
SUPERVISORY BOARD - DECISION-MAKING
Article 24
24.1 | Without prejudice to Article 24.5, each Supervisory Director may cast one vote in the decision-making of the Supervisory Board. |
24.2 | A Supervisory Director can be represented by another Supervisory Director holding a written proxy for the purpose of the deliberations and the decision-making of the Supervisory Board. |
24.3 | Resolutions of the Supervisory Board shall be passed, irrespective of whether this occurs at a meeting or otherwise, by Simple Majority unless the Supervisory Board Rules provide differently. |
24.4 | Invalid votes, blank votes and abstentions shall not be counted as votes cast. Supervisory Directors who casted an invalid or blank vote or who abstained from voting shall be taken into account when determining the number of Supervisory Directors who are present or represented at a meeting of the Supervisory Board. |
24.5 | Where there is a tie in any vote of the Supervisory Board, the Chairman shall have a casting vote, provided that there are at least three Supervisory Directors in office. Otherwise, the relevant resolution shall not have been passed. |
24.6 | A Supervisory Director shall not participate in the deliberations and decision-making of the Supervisory Board on a matter in relation to which he has a direct or indirect personal interest which conflicts with the interests of the Company and of the business connected with it. If, as a result thereof, no resolution can be passed by the Supervisory Board, the resolution may nevertheless be passed by the Supervisory Board as if none of the Supervisory Directors has a conflict of interests as described in the previous sentence. |
24.7 | Meetings of the Supervisory Board can be held through audio-communication facilities, unless a Supervisory Director objects thereto. |
24.8 | Resolutions of the Supervisory Board may, instead of at a meeting, be passed in writing, provided that all Supervisory Directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 24.1 through 24.6 apply mutatis mutandis. |
SUPERVISORY BOARD - COMPENSATION
Article 25
The General Meeting may grant a compensation to the Supervisory Directors.
INDEMNITY
Article | 26 |
26.1 | The Company shall indemnify and hold harmless each of its Indemnified Officers against: |
a. | any financial losses or damages incurred by such Indemnified Officer; and |
b. | any expense reasonably paid or incurred by such Indemnified Officer in connection with any threatened, pending or completed suit, claim, action or legal proceedings of a civil, criminal, administrative or other nature, formal or informal, in which he becomes involved, |
to the extent this relates to his current or former position with the Company and/or a Group Company and in each case to the extent permitted by applicable law.
26.2 | No indemnification shall be given to an Indemnified Officer: |
a. | if a competent court or arbitral tribunal has established, without having (or no longer having) the possibility for appeal, that the acts or omissions of such Indemnified Officer that led to the financial losses, damages, expenses, suit, claim, action or legal proceedings as described in Article 26.1 are of an unlawful nature (including acts or omissions which are considered to constitute malice, gross negligence, intentional recklessness and/or serious culpability attributable to such Indemnified Officer); |
b. | to the extent that his financial losses, damages and expenses are covered under insurance and the relevant insurer has settled, or has provided reimbursement for, these financial losses, damages and expenses (or has irrevocably undertaken to do so); |
c. | in relation to proceedings brought by such Indemnified Officer against the Company, except for proceedings brought to enforce indemnification to which he is entitled pursuant to these articles of association, pursuant to an agreement between such Indemnified Officer and the Company which has been approved by the Management Board or pursuant to insurance taken out by the Company for the benefit of such Indemnified Officer; or |
d. | for any financial losses, damages or expenses incurred in connection with a settlement of any proceedings effected without the Company's prior consent. |
26.3 | The Management Board may stipulate additional terms, conditions and restrictions in relation to the indemnification referred to in Article 26.1. |
GENERAL MEETING - CONVENING AND HOLDING MEETINGS
Article 27
27.1 | Annually, at least one General Meeting shall be held. This annual General Meeting shall be held within six months after the end of the Company's financial year. |
27.2 | A General Meeting shall also be held: |
a. | within three months after the Management Board has considered it to be likely that the Company's equity has decreased to an amount equal to or lower than half of its paid up and called up capital, in order to discuss the measures to be taken if so required; and |
b. | whenever the Management Board or the Supervisory Board so decides. |
27.3 | General Meetings must be held in the place where the Company has its corporate seat or in Arnhem, Assen, The Hague, Haarlem, 's-Hertogenbosch, Groningen, Leeuwarden, Lelystad, Maastricht, Middelburg, Rotterdam, Schiphol (Haarlemmermeer), Utrecht or Zwolle. |
27.4 | If the Management Board and the Supervisory Board have failed to ensure that a General Meeting as referred to in Articles 27.1 or 27.2 paragraph a. is held, each Person with Meeting Rights may be authorised by the court in preliminary relief proceedings to do so. |
27.5 | One or more Persons with Meeting Rights who collectively represent at least the part of the Company's issued share capital prescribed by law for this purpose may request the Management Board and the Supervisory Board in writing to convene a General Meeting, setting out in detail the matters to be discussed. If neither the Management Board nor the Supervisory Board (each in that case being equally authorised for this purpose) has taken the steps necessary to ensure that the General Meeting could be held within the relevant statutory period after the request, the requesting Person(s) with Meeting Rights may be authorised, at his/their request, by the court in preliminary relief proceedings to convene a General Meeting. |
27.6 | Any matter of which the discussion has been requested in writing by one or more Persons with Meeting Rights who, individually or collectively, represent at least the part of the Company's issued share capital prescribed by law for this purpose shall be included in the convening notice or announced in the same manner, if the Company has received the substantiated request or a proposal for a resolution no later than on the sixtieth day prior to that of the General Meeting. |
27.7 | Persons with Meeting Rights who wish to exercise their rights as described in Articles 27.5 and 27.6 must first consult the Management Board. If the intended exercise of such rights might result in a change to the Company's strategy, including by dismissing one or more Managing Directors or Supervisory Directors, the Management Board must be given the opportunity to invoke a reasonable period to respond to such intention with due observance of the applicable provisions of Dutch law and the Dutch Corporate Governance Code. The Person(s) with Meeting Rights concerned must respect any such response period stipulated by the Management Board. This Article 27.7 does not prejudice any rights which the Company or the Management Board and the Supervisory Board may have under Dutch law with regard to invoking a similar period or deliberation time. |
27.8 | A General Meeting must be convened with due observance of the relevant statutory minimum convening period. |
27.9 | All Persons with Meeting Rights must be convened for the General Meeting in accordance with applicable law. The shareholders may be convened for the General Meeting by means of convening letters sent to the addresses of those shareholders in accordance with Article 5.5. The previous sentence does not prejudice the possibility of sending a convening notice by electronic means in accordance with Section 2:113(4) DCC. |
GENERAL MEETING - PROCEDURAL RULES
Article 28
28.1 | The General Meeting shall be chaired by one of the following individuals, taking into account the following order of priority: |
a. | by the Chairman, if there is a Chairman and he is present at the General Meeting; |
b. | by the Vice-Chairman, if there is a Vice-Chairman and he is present at the General Meeting; |
c. | by another Supervisory Director who is chosen by the Supervisory Directors present at the General Meeting from their midst; |
d. | by the CEO, if there is a CEO and he is present at the General Meeting; |
e. | by another Managing Director who is chosen by the Managing Directors present at the General Meeting from their midst; or |
f. | by another person appointed by the General Meeting. |
The person who should chair the General Meeting pursuant to paragraphs a. through f. may appoint another person to chair the General Meeting instead of him.
28.2 | The chairman of the General Meeting shall appoint another person present at the General Meeting to act as secretary and to minute the proceedings at the General Meeting. The minutes of a General Meeting shall be adopted by the chairman of that General Meeting or by the Management Board. Where an official report of the proceedings is drawn up by a civil law notary, no minutes need to be prepared. Every Managing Director and Supervisory Director may instruct a civil law notary to draw up such an official report at the Company's expense. |
28.3 | The chairman of the General Meeting shall decide on the admittance to the General Meeting of persons other than: |
a. | the persons who have Meeting Rights at that General Meeting, or their proxyholders; and |
b. | those who have a statutory right to attend that General Meeting on other grounds. |
28.4 | The holder of a written proxy from a Person with Meeting Rights who is entitled to attend a General Meeting shall only be admitted to that General Meeting if the proxy is determined to be acceptable by the chairman of that General Meeting. |
28.5 | The Company may direct that any person, before being admitted to a General Meeting, identify himself by means of a valid passport or driver's license and/or should be submitted to such security arrangements as the Company may consider to be appropriate under the given circumstances. Persons who do not comply with these requirements may be refused entry to the General Meeting. |
28.6 | The chairman of the General Meeting has the right to eject any person from the General Meeting if he considers that person to disrupt the orderly proceedings at the General Meeting. |
28.7 | The General Meeting may be conducted in a language other than the Dutch language, if so determined by the chairman of the General Meeting. |
28.8 | The chairman of the General Meeting may limit the amount of time that persons present at the General Meeting are allowed to take in addressing the General Meeting and the number of questions they are allowed to raise, with a view to safeguarding the orderly proceedings at the General Meeting. The chairman of the General Meeting may also adjourn the meeting if he considers that this shall safeguard the orderly proceedings at the General Meeting. |
GENERAL MEETING - EXERCISE OF MEETING AND VOTING RIGHTS
Article | 29 |
29.1 | Each Person with Meeting Rights has the right to attend, address and, if applicable, vote at General Meetings, whether in person or represented by the holder of a written proxy. Holders of fractional shares together constituting the nominal value of a share of the relevant class shall exercise these rights collectively, whether through one of them or through the holder of a written proxy. |
29.2 | The Management Board may decide that each Person with Meeting Rights is entitled, whether in person or represented by the holder of a written proxy, to participate in, address and, if applicable, vote at the General Meeting by electronic means of communication. For the purpose of applying the preceding sentence it must be possible, by electronic means of communication, for the Person with Meeting Rights to be identified, to observe in real time the proceedings at the General Meeting and, if applicable, to vote. The Management Board may impose conditions on the use of the electronic means of communication, provided that these conditions are reasonable and necessary for the identification of the Person with Meeting Rights and the reliability and security of the communication. Such conditions must be announced in the convening notice. |
29.3 | The Management Board can also decide that votes cast through electronic means of communication or by means of a letter prior to the General Meeting are considered to be votes that are cast during the General Meeting. These votes shall not be cast prior to the Record Date. |
29.4 | For the purpose of Articles 29.1 through 29.3, those who have voting rights and/or Meeting Rights on the Record Date and are recorded as such in a register designated by the Management Board shall be considered to have those rights, irrespective of whoever is entitled to the shares or depository receipts at the time of the General Meeting. Unless Dutch law requires otherwise, the Management Board is free to determine, when convening a General Meeting, (i) whether the previous sentence applies and (ii) that the Record Date is applied with respect to shares of a specific class only. |
29.5 | Each Person with Meeting Rights must notify the Company in writing of his identity and his intention to attend the General Meeting. This notice must be received by the Company ultimately on the seventh day prior to the General Meeting, unless indicated otherwise when such General Meeting is convened. Persons with Meeting Rights that have not complied with this requirement may be refused entry to the General Meeting. When a General Meeting is convened the Management Board may stipulate not to apply the previous provisions of this Article 29.5 in respect of the exercise of Meeting Rights and/or voting rights attached to preferred shares at such General Meeting. |
GENERAL MEETING - DECISION-MAKING
Article 30
30.1 | Each share, irrespective of which class it concerns, shall give the right to cast one vote at the General Meeting. Fractional shares of a certain class, if any, collectively constituting the nominal value of a share of that class shall be considered to be equivalent to such a share. |
30.2 | No vote can be cast at a General Meeting in respect of a share belonging to the Company or a Subsidiary of the Company or in respect of a share for which any of them holds the depository receipts. Usufructuaries and pledgees of shares belonging to the Company or its Subsidiaries are not, however, precluded from exercising their voting rights if the usufruct or pledge was created before the relevant share belonged to the Company or a Subsidiary of the Company. Neither the Company nor a Subsidiary of the Company can vote shares in respect of which it holds a usufruct or a pledge. |
30.3 | Unless a greater majority is required by law or by these articles of association, all resolutions of the General Meeting shall be passed by Simple Majority. If applicable law requires a greater majority for resolutions of the General Meeting and allows the articles of association to provide for a lower majority, those resolutions shall be passed with the lowest possible majority, except if these articles of association explicitly provide otherwise. |
30.4 | Invalid votes, blank votes and abstentions shall not be counted as votes cast. Shares in respect of which an invalid or blank vote has been cast and shares in respect of which an abstention has been made shall be taken into account when determining the part of the issued share capital that is represented at a General Meeting. |
30.5 | Where there is a tie in any vote of the General Meeting, the relevant resolution shall not have been passed. |
30.6 | The chairman of the General Meeting shall decide on the method of voting and the voting procedure at the General Meeting. |
30.7 | The determination during the General Meeting made by the chairman of that General Meeting with regard to the results of a vote shall be decisive. If the accuracy of the chairman's determination is contested immediately after it has been made, a new vote shall take place if the majority of the General Meeting so requires or, where the original vote did not take place by response to a roll call or in writing, if any party with voting rights who is present so requires. The legal consequences of the original vote shall lapse as a result of the new vote. |
30.8 | The Management Board shall keep a record of the resolutions passed. The record shall be available at the Company's office for inspection by Persons with Meeting Rights. Each of them shall, upon request, be provided with a copy of or extract from the record, at no more than the cost price. |
30.9 | Shareholders may pass resolutions outside a meeting, unless the Company has cooperated with the issuance of depository receipts for shares in its capital. Such resolutions can only be passed by a unanimous vote of all shareholders with voting rights. The votes shall be cast in writing and may be cast through electronic means. |
30.10 | The Managing Directors and Supervisory Directors shall, in that capacity, have an advisory vote at the General Meetings. |
GENERAL MEETING - SPECIAL RESOLUTIONS
Article 31
31.1 | The following resolutions can only be passed by the General Meeting at the proposal of the Management Board: |
a. | the issue of shares or the granting of rights to subscribe for shares; |
b. | the limitation or exclusion of pre-emption rights; |
c. | the designation or granting of an authorisation as referred to in Articles 6.1, 7.5 and 10.2, respectively; |
d. | the reduction of the Company's issued share capital; |
e. | the making of a distribution on the ordinary shares from the Company's profits or reserves; |
f. | the making of a distribution in the form of shares in the Company's capital or in the form of assets, instead of in cash; |
g. | the amendment of these articles of association; |
h. | the entering into of a merger or demerger; |
i. | the instruction of the Management Board to apply for the Company's bankruptcy; and |
j. | the Company's dissolution. |
31.2 | A matter which has been included in the convening notice or announced in the same manner by or at the request of one or more Persons with Meeting Rights pursuant to Articles 27.5 and/or 27.6 shall not be considered to have been proposed by the Management Board for purposes of Article 31.1, unless the Management Board has expressly indicated that it supports the discussion of such matter in the agenda of the General Meeting concerned or in the explanatory notes thereto. |
CLASS MEETINGS
Article 32
32.1 | A Class Meeting shall be held whenever a resolution of that Class Meeting is required by Dutch law or under these articles of association and otherwise whenever the Management Board or the Supervisory Board so decides. |
32.2 | Without prejudice to Article 32.1, for Class Meetings of ordinary shares, the provisions concerning the convening of, drawing up of the agenda for, holding of and decision-making by the General Meeting apply mutatis mutandis. |
32.3 | For Class Meetings of preferred shares, the following shall apply: |
a. | Articles 27.3, 27.9, 28.3, 30.1, 30.2 through 30.10 apply mutatis mutandis; |
b. | a Class Meeting must be convened no later than on the eighth day prior to that of the meeting; |
c. | a Class Meeting shall appoint its own chairman; and |
d. | where the rules laid down by these articles of association in relation to the convening, location of or drawing up of the agenda for a Class Meeting have not been complied with, legally valid resolutions may still be passed by that Class Meeting by a unanimous vote at a meeting at which all shares of the relevant class are represented. |
REPORTING - FINANCIAL YEAR, ANNUAL ACCOUNTS AND MANAGEMENT REPORT
Article | 33 |
33.1 | The Company's financial year shall coincide with the calendar year. |
33.2 | Annually, within the relevant statutory period, the Management Board shall prepare the annual accounts and the management report and deposit them at the Company's office for inspection by the shareholders. |
33.3 | The annual accounts shall be signed by the Managing Directors and the Supervisory Directors. If any of their signatures is missing, this shall be mentioned, stating the reasons. |
33.4 | The Company shall ensure that the annual accounts, the management report and the particulars to be added pursuant to Section 2:392(1) DCC shall be available at its offices as from the convening of the General Meeting at which they are to be discussed. The Persons with Meeting Rights are entitled to inspect such documents at that location and to obtain a copy at no cost. |
33.5 | The annual accounts shall be adopted by the General Meeting. |
REPORTING - AUDIT
Article 34
34.1 | The General Meeting shall instruct an external auditor as referred to in Section 2:393 DCC to audit the annual accounts. Where the General Meeting fails to do so, the Supervisory Board shall be authorised to do so. |
34.2 | The instruction may be revoked by the General Meeting and by the body that has granted the instruction. The instruction can only be revoked for well-founded reasons; a difference of opinion regarding the reporting or auditing methods shall not constitute such a reason. |
DISTRIBUTIONS - GENERAL
Article | 35 |
35.1 | A distribution can only be made to the extent that the Company's equity exceeds the amount of the paid up and called up part of its capital plus the reserves which must be maintained by law. |
35.2 | The Management Board may resolve to make interim distributions, provided that it appears from interim accounts to be prepared in accordance with Section 2:105(4) DCC that the requirement referred to in Article 35.1 has been met and, if it concerns an interim distribution of profits, taking into account the order of priority described in Article 37.1. |
35.3 | No entitlement to distributions is attached to preferred shares, other than as described in Articles 11.2, 37.1 and 38.3. |
35.4 | Distributions shall be made in proportion to the aggregate nominal value of the shares . In deviation of the previous sentence, distributions on preferred shares (or to the former holders of preferred shares) shall be made in proportion to the amounts paid up (or formerly paid up) on those preferred shares. |
35.5 | The parties entitled to a distribution shall be the relevant shareholders, usufructuaries and pledgees, as the case may be, at a date to be determined by the Management Board for that purpose. This date shall not be earlier than the date on which the distribution was announced. |
35.6 | The General Meeting may resolve, subject to Article 31, that all or part of a distribution, instead of being made in cash, shall be made in the form of shares in the Company's capital or in the form of the Company's assets. |
35.7 | A distribution shall be payable on such date and, if it concerns a distribution in cash, in such currency or currencies as determined by the Management Board. If it concerns a distribution in the form of the Company's assets, the Management Board shall determine the value attributed to such distribution for purposes of recording the distribution in the Company's accounts with due observance of applicable law (including the applicable accounting principles). |
35.8 | A claim for payment of a distribution shall lapse after five years have expired after the distribution became payable. |
35.9 | For the purpose of calculating the amount or allocation of any distribution, shares held by the Company in its own capital shall not be taken into account. No distribution shall be made to the Company in respect of shares held by it in its own capital. |
DISTRIBUTIONS - RESERVES
Article | 36 |
36.1 | All reserves maintained by the Company shall be attached exclusively to the ordinary shares. |
36.2 | Subject to Article 31, the General Meeting is authorised to resolve to make a distribution from the Company's reserves. |
36.3 | Without prejudice to Articles 36.4 and 37.2, distributions from a reserve shall be made exclusively on the ordinary shares. |
36.4 | The Management Board may resolve to charge amounts to be paid up on shares against the Company's reserves, irrespective of whether those shares are issued to existing shareholders. |
DISTRIBUTIONS - PROFITS
Article | 37 |
37.1 | Subject to Article 35.1, the profits shown in the Company's annual accounts in respect of a financial year shall be appropriated as follows, and in the following order of priority: |
a. | to the extent that any preferred shares have been cancelled without the distribution described in Article 11.2 paragraph b. having been paid in full and without any such deficit subsequently having been paid in full as described in this Article 37.1 or Article 37.2, an amount equal to any such (remaining) deficit shall be distributed to those who held those preferred shares at the moment of such cancellation becoming effective; |
b. | to the extent that any Preferred Distribution (or part thereof) in relation to previous financial years has not yet been paid in full as described in this Article 37.1 or Article 37.2, an amount equal to any such (remaining) deficit shall be distributed on the preferred shares; |
c. | the Preferred Distribution shall be distributed on the preferred shares in respect of the financial year to which the annual accounts pertain; |
d. | the Management Board shall determine which part of the remaining profits shall be added to the Company's reserves; and |
e. | subject Article 31, the remaining profits shall be at the disposal of the General Meeting for distribution on the ordinary shares. |
37.2 | To the extent that the distributions described in Article 37.1 paragraphs a. through c. (or any part thereof) cannot be paid out of the profits shown in the annual accounts, any such deficit shall be distributed from the Company's reserves, subject to Articles 35.1 and 35.2. |
37.3 | Subject to Article 35.1, a distribution of profits shall be made after the adoption of the annual accounts that show that such distribution is allowed. |
DISSOLUTION AND LIQUIDATION
Article | 38 |
38.1 | In the event of the Company being dissolved, the liquidation shall be effected by the Management Board under the supervision of the Supervisory Board, unless the General Meeting decides otherwise. |
38.2 | To the extent possible, these articles of association shall remain in effect during the liquidation. |
38.3 | To the extent that any assets remain after payment of all of the Company's debts, those assets shall be distributed as follows, and in the following order of priority: |
a. | the amounts paid up on the preferred shares shall be repaid on such preferred shares; |
b. | to the extent that any preferred shares have been cancelled without the distribution described in Article 11.2 paragraph b. having been paid in full and without any such deficit subsequently having been paid in full as described in Articles 37.1 and 37.2, an amount equal to any such (remaining) deficit shall be distributed to those who held those preferred shares at the moment of such cancellation becoming effective; |
c. | to the extent that any Preferred Distribution (or part thereof) in relation to financial years prior to the financial year in which the distribution referred to in paragraph a. occurs has not yet been paid in full as described in Articles 37.1 and 37.2, an amount equal to any such (remaining) deficit shall be distributed on the preferred shares; |
d. | the Preferred Distribution shall be paid on the preferred shares calculated in respect of the part of the financial year in which the distribution referred to in paragraph a. is made, for the number of days that have already elapsed during such part of the financial year; and |
e. | any remaining assets shall be distributed to the holders of ordinary shares. |
38.4 | After the Company has ceased to exist, its books, records and other information carriers shall be kept for the period prescribed by law by the person designated for that purpose in the resolution of the General Meeting to dissolve the Company. Where the General Meeting has not designated such a person, the liquidators shall do so. |
TRANSITIONAL PROVISIONS
Article | 39 |
39.1 | Upon the Company's issued share capital increasing to an amount of at least [amount] euro (EUR [amount]): |
a. | the Company's authorised share capital described in Article 4.1 shall immediately and automatically increase to an amount of [amount] euro (EUR [amount]); and |
b. | the composition of the authorised share capital described in Article 4.2 shall immediately and automatically be adjusted, such that the authorised share capital shall be divided into: |
i. | [number] ([number]) ordinary shares; and |
ii. | [number] ([number]) preferred shares, |
each having a nominal value of twelve eurocents (EUR 0.12).
This Article 39.1 shall lapse and shall no longer form part of these articles of association at the moment immediately after the increase of the Company's issued share capital as described in the first sentence of this Article 39.1 shall have become effective.
39.2 | The Company's first financial year ends on the thirty-first day of December two thousand and twenty. |
39.3 | This entire Article 39 shall lapse and shall no longer form part of these articles of association on the first day of the Company's second financial year. |
Exhibit 3.2
MANAGEMENT BOARD RULES
CUREVAC N.V.
INTRODUCTION
Article | 1 |
1.1 | These rules govern the organisation, decision-making and other internal matters of the Management Board. In performing their duties, the Managing Directors shall comply with these rules. |
1.2 | These rules shall be posted on the Website. |
DEFINITIONS AND INTERPRETATION
Article | 2 |
2.1 | In these rules the following definitions shall apply: |
Affiliate | An Affiliate (Gelieerde Partij) as defined in the Articles of Association. | |
Article | An article of these rules. | |
Articles of Association | The Company's articles of association. | |
Board Meeting | A meeting of the Management Board. | |
CEO | The Company's chief executive officer. | |
CFO | The Company's chief financial officer. | |
Company | CureVac N.V. | |
Conflict of Interests | A direct or indirect personal interest which conflicts with the interests of the Company and of the business connected with it. | |
Diversity Policy | The Company's diversity policy. | |
External Auditor | The external auditor or audit firm within the meaning of Section 2:393 of the Dutch Civil Code, engaged or to be engaged to examine the Company's annual accounts and management report, or the Company's independent outside audit firm for purposes of U.S. laws and regulation (including applicable NASDAQ and/or SEC requirements), as the context may require. | |
Family Member | A Managing Director's spouse, registered partner or other life companion, foster child or any relative or in-law up to the second degree. | |
General Meeting | The Company's general meeting. |
Group | The Company and all its Subsidiaries. | |
Initial Approval Period | The Initial Approval Period (Initiële Goedkeuringsperiode) as defined in the Articles of Association. | |
Initial Nomination Period | The Initial Nomination Period (Initiële Nominatieperiode) as defined in the Articles of Association. | |
Initial Period | The Initial Period (Initiële Periode) as defined in the Articles of Association. | |
Management Board | The Company's management board. | |
Managing Director | A member of the Management Board. | |
NASDAQ | The NASDAQ Stock Market. | |
Protective Foundation | A foundation under Dutch law whose objective it would be to promote and protect the interests of the Company, the business connected with it and its stakeholders from time to time, and repressing possible influences which could threaten the strategy, continuity, independence and/or identity of the Company or the business connected with it to such an extent that this could be considered to be damaging to the aforementioned interests. | |
SEC | The U.S. Securities and Exchange Commission. | |
Simple Majority | More than half of the votes cast. | |
Subsidiary | A subsidiary within the meaning of Section 2:24a DCC. | |
Supervisory Board | The Company's supervisory board. | |
Website | The Company's website. |
2.2 | References to statutory provisions are to those provisions as they are in force from time to time. |
2.3 | Terms that are defined in the singular have a corresponding meaning in the plural. |
2.4 | Words denoting a gender include each other gender. |
2.5 | Except as otherwise required by law, the terms "written" and "in writing" include the use of electronic means of communication. |
COMPOSITION
Article | 3 |
3.1 | The Management Board consists of one or more Managing Directors, provided that, during the Initial Period, the Management Board shall consist of up to seven Managing Directors. |
3.2 | The composition of the Management Board shall be determined taking into consideration the principles laid down in the Diversity Policy and in paragraph 1 of Annex B to these rules. |
3.3 | The Managing Directors shall be appointed, suspended and dismissed in accordance with the Articles of Association, these rules and applicable law. |
3.4 | A person may be appointed as Managing Director for a term of up to four years, without limitation on the number of consecutive terms which a Managing Director may serve. |
3.5 | The Supervisory Board shall elect a Managing Director to be the CEO. The Supervisory Board may dismiss the CEO, provided that the Managing Director so dismissed shall subsequently continue his term of office as a Managing Director without having the title of CEO. |
3.6 | The Management Board shall elect a Managing Director to be the CFO. The Management Board may dismiss the CFO, provided that the Managing Director so dismissed shall subsequently continue his term of office as a Managing Director without having the title of CFO. |
3.7 | A Managing Director shall retire in the event of inadequate performance, structural incompatibility of interests, and in other instances where early retirement of the Managing Director is considered necessary by the Supervisory Board. |
3.8 | The acceptance by a Managing Director of a position as supervisory director or non-executive director with another company or entity shall be subject to the approval of the Supervisory Board. A Managing Director shall notify the Supervisory Board in advance of any other position he wishes to pursue. |
DUTIES AND ORGANISATION
Article | 4 |
4.1 | The Management Board is charged with the management of the Company, subject to the restrictions contained in the Articles of Association and these rules. In performing their duties, Managing Directors shall be guided by the interests of the Company and of the business connected with it. In doing so, the Management Board shall focus on long-term value creation for the Company and its business and take into account the relevant stakeholder interests. |
4.2 | The tasks and duties of the Management Board include the following matters: |
a. | setting the Company's management agenda; |
b. | enhancing the Group's performance; |
c. | developing a general strategy and taking into account risks connected to the Group's business activities; |
d. | determining and pursuing operational and financial objectives; |
e. | structuring and managing internal business control systems; |
f. | overseeing the Group's financial reporting processes; |
g. | ensuring the Group's compliance with applicable laws and regulations; |
h. | ensuring compliance with and maintaining the Group's corporate governance structure; |
i. | ensuring publication by the Company of any information required by applicable laws and regulations; |
j. | preparing the Company's annual report, the annual budget and significant capital expenditures; and |
k. | monitoring corporate social responsibility issues. |
4.3 | The Management Board shall provide the Supervisory Board with the information necessary for the performance of its tasks in a timely fashion. At least once a year, the Management Board shall inform the Supervisory Board in writing of the main features of the strategic policy, the general and financial risks and the administration and control system of the Company. |
4.4 | Without limiting the generality of Article 4.3, the Management Board shall furnish to the Supervisory Board: |
a. | immediately after receipt of the Company's audit report from the External Auditor with respect to the Company's annual financial statements as of the end of each financial year, those audited financial statements and the related audited statements of income, stockholders' equity and cash flows for the financial year then ended, prepared in accordance with the applicable accounting principles and certified by the External Auditor and the consolidated financial statements of the Company and its Subsidiaries to the extent legally required, together with the respective audit report(s); |
b. | no later than thirty (30) days prior to the start of each financial year, an annual operating plan for the Company and its Subsidiaries in respect of such financial year that shall include: |
i. | monthly projections of profit and loss including a cash flow forecast and a balance sheet projection for such financial year; |
ii. | a business plan for the Company and its Subsidiaries relating to the succeeding financial year setting forth in reasonable detail a development plan, financial plan and investment plan, budgeted and projected figures and other information; and |
iii. | forecasts for the next succeeding financial year; |
c. | within thirty (30) days after each quarter in each financial year, unaudited quarterly financial statements of the Company and its Subsidiaries as of the end of such quarter and the related unaudited statements of income, stockholders' equity and cash flows for such quarter, prepared in accordance with the applicable accounting principles; |
d. | promptly following the first six months of each financial year, an update to the annual operating plan including the matters set forth in paragraph b. above, showing the differences from the annual operating plan as initially approved and the actual results; and |
e. | without unreasonable delay a prompt notice of: |
i. | any material adverse event relating to the Company and its Subsidiaries; and |
ii. | any lawsuit, claim, proceeding or investigation pending or, to the knowledge of the Management Board, threatened, or any judgment, order or decree involving the Company or its Subsidiaries that would reasonably be expected to have a material adverse effect on the Company or any of its Subsidiaries. |
4.5 | The CFO shall regularly report to the CEO and discuss the performance of his tasks and duties with the CEO, in each case subject to supervision by the Supervisory Board. |
4.6 | All Managing Directors shall follow an induction programme geared to their role, covering general financial, social and legal affairs, financial reporting by the Company, specific aspects that are unique to the Company and its business, the Company's corporate culture, the Company's relationship with employees and the responsibilities of a Managing Director under applicable law. |
4.7 | The Management Board shall ensure that internal procedures are established and maintained which safeguard that relevant information is or becomes known to the Management Board and the Supervisory Board in a timely fashion. |
4.8 | The chairman of the Supervisory Board is the main contact of the Supervisory Board regarding the performance of the Managing Directors. |
4.9 | At least annually, the Management Board shall evaluate its own functioning and the functioning of the individual Managing Directors, shall discuss the conclusions of such evaluations, and shall identify aspects where the Managing Directors require further training or education. During such evaluation, Managing Directors should be able to express their views confidentially. |
4.10 | Each Managing Director must treat all information and documentation obtained in connection with his or her position as Managing Director with the utmost discretion, integrity and confidentiality. |
DECISION-MAKING
Article | 5 |
5.1 | The Management Board shall meet as often as any Managing Director deems necessary or appropriate. |
5.2 | At least twice per calendar year, as part of the Company's strategy, the Management Board shall discuss the Company's long-term strategy with the Supervisory Board. As part of those discussions, the Management Board and the Supervisory Board shall consider whether it would be in the best interests of the Company and its business to cause the incorporation of a Protective Foundation and to grant a customary right to subscribe for preferred shares in the Company's capital to such Protective Foundation (which right would in any event not be exercisable until after the expiration of the later of (i) the Initial Period or (ii) the Initial Approval Period). |
5.3 | A Board Meeting may be convened by, or at the request of, any Managing Director by means of a written notice sent to all Managing Directors. Notice of a Board Meeting shall include the date, time, place and agenda for that Board Meeting. Board Meetings can be held through audio-communication facilities. Managing Directors attending the Board Meeting through audio-communication are considered present at the Board Meeting. |
5.4 | All Managing Directors shall be given reasonable notice of at least five days for all Board Meetings, unless a shorter notice is required to avoid a delay which could reasonably be expected to have an adverse effect on the Company and/or the business connected with it. |
5.5 | If a Board Meeting has not been duly convened, resolutions may nevertheless be passed at that Board Meeting if all Managing Directors not present or represented at that Board Meeting have waived compliance with the convening formalities in writing. |
5.6 | The Managing Director convening a Board Meeting sets the agenda for that Board Meeting. Other Managing Directors may submit agenda items to the Managing Director convening the Board Meeting. |
5.7 | All Board Meetings shall be chaired by the CEO or, in his absence, by another Managing Director designated by the Managing Directors present at the relevant Board Meeting. The chairman of the Board Meeting shall appoint a secretary to prepare the minutes of the proceedings at such Board Meeting. The secretary does not necessarily need to be a Managing Director. |
5.8 | Minutes of the proceedings at a Board Meeting shall be sufficient evidence thereof and of the observance (or waiver) of all necessary formalities, provided that such minutes are certified by a Managing Director. |
5.9 | Resolutions of a Board Meeting can also be evidenced by a statement signed by the chairman and the secretary of that Board Meeting. |
5.10 | Without prejudice to Article 5.13, each Managing Director may cast one vote in the decision-making of the Management Board. Invalid votes, blank votes and abstentions shall not be counted as votes cast. |
5.11 | A Managing Director can be represented by another Managing Director holding a written proxy for the purpose of the deliberations and the decision-making of the Management Board. |
5.12 | Resolutions of the Management Board shall be passed, irrespective of whether this occurs at a Board Meeting or otherwise, by Simple Majority, unless these rules provide differently. The Management Board shall require the approval of the Supervisory Board for the matters listed in Annex A to these rules. The Management Board shall require the approval of the General Meeting for the matters set out in the Articles of Association, in particular in articles 18.10 and 18.11 of the Articles of Association. |
5.13 | Where there is a tie in any vote of the Management Board, the CEO shall have a casting vote, provided that there are at least three Managing Directors in office. Otherwise, the relevant resolution shall not have been passed. |
5.14 | Resolutions of the Management Board may, instead of at a Board Meeting, be passed in writing, provided that all Managing Directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 5.10 through 5.13 apply mutatis mutandis. |
5.15 | The Management Board shall observe and abide by the rules described in Annex B to these rules in order to preserve the Company's tax residency in Germany. |
5.16 | The Management Board may require that officers and external advisers attend Board Meetings. In particular, the Management Board shall request the External Auditor to attend the Board Meeting where the External Auditor's audit report regarding the Company's financial statements is discussed. |
CONFLICT OF INTERESTS
Article | 6 |
6.1 | A Managing Director shall promptly report any actual or potential Conflict of Interests in a transaction that is of material significance to the Company and/or such Managing Director to the chairman of the Supervisory Board and to the other Managing Directors, providing all relevant information relating to such transaction, including the involvement of any Family Member. |
6.2 | The determination whether a Managing Director has a Conflict of Interests shall primarily be the responsibility of that Managing Director. However, in case of debate, that determination shall be made by the Supervisory Board without the Managing Director concerned being present. |
6.3 | A Managing Director shall not participate in the deliberations and decision-making of the Management Board on a matter in relation to which he has a Conflict of Interests. If, as a result thereof, no resolution can be passed by the Management Board, the resolution shall be passed by the Supervisory Board. |
6.4 | Transactions in respect of which a Managing Director has a Conflict of Interests shall be agreed on arms' length terms. Any such transactions where the Conflict of Interests is of material significance to the Company and/or to the Managing Director concerned shall be subject to the approval of the Supervisory Board. |
6.5 | In order to avoid potential Conflicts of Interests, or the appearance thereof, Managing Directors shall not: |
a. | enter into competition with the Company; |
b. | demand or accept substantial gifts from the Company for themselves or for their respective Family Members; |
c. | provide unjustified advantages to third parties to the detriment of the Company; |
d. | take advantage of business opportunities to which the Company would be entitled for themselves or for their respective Family Members. |
6.6 | The Company shall not grant its Managing Directors or their respective Family Members any personal loans, guarantees or similar financial arrangements. |
OWNERSHIP OF AND TRADING IN FINANCIAL INSTRUMENTS
Article | 7 |
The Managing Directors shall be subject to the Company's insider trading policy. In addition, each Managing Director shall practice great reticence:
a. | when trading in shares or other financial instruments issued by another listed company, if this could reasonably create the appearance of such Managing Director violating applicable insider trading and/or market manipulation prohibitions; and |
b. | when trading in shares or other financial instruments issued by another listed company which is a direct competitor of the Company. |
AMENDMENTS AND DEVIATIONS
Article | 8 |
Pursuant to a resolution to that effect, the Management Board may, with the approval of the Supervisory Board, amend or supplement these rules and allow temporary deviations from these rules, subject to ongoing compliance with NASDAQ requirements, SEC rules and applicable law generally.
GOVERNING LAW AND JURISDICTION
Article | 9 |
These rules shall be governed by and shall be construed in accordance with the laws of the Netherlands. Any dispute arising in connection with these rules shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands.
Annex A – Matters Requiring Supervisory Board Approval
The Management Board will require the approval of the Supervisory Board for (i) the matters described in article 18.9 and, during the Initial Approval Period, article 18.11 of the Articles of Association and (ii) any of the following resolutions, to the extent these concern the Company or any of its Subsidiaries or participations (deelnemingen):
a. | the matters which require the approval of the Supervisory Board as listed in these rules and/or in the Company's articles of association; |
b. | entering into Related Person transactions (as defined in the Company's related person transaction policy, as approved by the Supervisory Board from time to time) and in any event including transactions representing a transaction value greater than EUR 100,000.00 (determined per transaction, with related transactions concluded within one year being considered to constitute the same transaction) (or such higher threshold as determined by the Supervisory Board and notified to the Management Board in writing) between the Company or a Subsidiary on the one hand and a shareholder of the Company or an Affiliate of a shareholder of the Company on the other hand; |
c. | incurring debt in an amount greater than EUR 250,000.00 (determined per transaction, with related transactions concluded within one year being considered to constitute the same transaction) (or such higher threshold as determined by the Supervisory Board and notified to the Management Board in writing); |
d. | declaring or proposing dividends and other distributions or entering into repurchase or redemption transactions of equity securities, other than, in the case of repurchase or redemption of equity securities, in connection with the ordinary operation of the Company's equity incentive plans; |
e. | any acquisition, sale, divestiture or similar M&A transaction representing a transaction value greater than EUR 250,000.00 (determined per transaction, with related transactions concluded within one year being considered to constitute the same transaction) (or such higher threshold as determined by the Supervisory Board and notified to the Management Board in writing); |
f. | entry into any material joint venture or other strategic partnership representing a transaction value greater than EUR 200,000.00 (determined per transaction, with related transactions concluded within one year being considered to constitute the same transaction) (or such higher threshold as determined by the Supervisory Board and notified to the Management Board in writing); |
g. | the taking up of new lines of business or termination or significant limitation of existing lines of business, in either case of the Group, CureVac AG or its Subsidiaries |
h. | proposing or making any amendment to the Company's articles of association or other internal policies; |
i. | the adoption, amendment or termination of any equity incentive plan of the Company; |
j. | proposing or effecting a liquidation, dissolution, restructuring, recapitalization, reorganization or similar transaction; |
k. | making material proposals for resolutions by the General Meeting, as listed in the Company's articles of association; |
l. | the issuance or sale of shares or equity securities of the Company or any of its Subsidiaries, except in connection with the ordinary operation of the Company's equity incentive plans; |
m. | the acquisition, disposal and encumbrance of intellectual property rights and acquisition and granting of licences and sublicenses, if the interest or value of such intellectual property rights, licences or sublicenses exceeds an amount of EUR 200,000.00 (or such higher amount as determined by the Supervisory Board and notified to the Management Board in writing); |
n. | taking any action towards the incorporation of a Protective Foundation and to grant a customary right to subscribe for preferred shares in the Company's capital to such Protective Foundation (which right would in any event not be exercisable until after the expiration of the later of (i) the Initial Period or (ii) the Initial Approval Period); |
o. | such other resolutions of the Management Board as the Supervisory Board shall have specified in a resolution to that effect and notified to the Management Board; |
p. | to appoint or dismiss the senior internal auditor; |
q. | to approve the audit plan drawn up by the internal audit function; |
r. | the approval of and changes to the Company’s annual budget; |
s. | the assumption of new branches of operations and cessation of existing activities; |
t. | the establishment of branches, establishments and subsidiaries outside of Germany and the Netherlands; |
u. | the hiring, appointment and dismissal of personnel with a gross annual salary of EUR 150,000.00 and the terms concerning such hiring, appointment and dismissal; |
v. | the determination of compensation in the form of shares or rights to subscribe for shares to personnel and related issuance of securities under an employee incentive plan of the Company; and |
w. | any transaction entered into or legal act performed by the Company which is outside the ordinary course of business. |
Annex B – Rules for Preserving German Tax Residency
1. | The majority of all members of the Management Board shall be resident in Germany. |
2. | All Board Meetings must be held in Germany. |
3. | If a Board Meeting is held using audio-communication facilities, the majority of the Managing Directors attending such Board Meeting (in person or through audio-communication facilities) must be located in Germany, and none of the Managing Directors attending such Board Meeting (in person or through audio-communication facilities) may be located in the Netherlands, for the duration of such Board Meeting. |
4. | A written resolution of the Management Board may be passed, subject to Article 5.14, provided that the majority of the Managing Directors casting a vote in respect of such resolution are located in Germany, and none of the Managing Directors are located in the Netherlands, at the time of casting their vote. |
5. | To the extent reasonably practicable, actions performed by Managing Directors in relation to the Company shall generally be performed in Germany. |
6. | The rules described in this Annex B may only be deviated from on a case-by-case basis in order to avoid or mitigate a delay in the deliberations and/or decision-making of the Management Board which the Management Board reasonably believes to be contrary to the interests of the Company and its business. |
Exhibit 3.3
SUPERVISORY BOARD RULES
CUREVAC N.V.
INTRODUCTION
Article | 1 |
1.1 | These rules govern the organisation, decision-making and other internal matters of the Supervisory Board. In performing their duties, the Supervisory Directors shall comply with these rules. |
1.2 | These rules shall be posted on the Website. |
DEFINITIONS AND INTERPRETATION
Article | 2 |
2.1 | In these rules the following definitions shall apply: |
20% Shareholder Nominee | Any Supervisory Director who has been appointed pursuant to a binding nomination made by a Nomination Concert. | |
Affiliate | An Affiliate (Aangeslotene) as defined in the Articles of Association. | |
Article | An article of these rules. | |
Articles of Association | The Company's articles of association. | |
Audit Committee | The Company's audit committee. | |
CEO | The Company's chief executive officer. | |
Chairman | The chairman of the Supervisory Board. | |
Change of Control | A Change of Control (Wijziging van Zeggenschap) as defined in the Articles of Association. | |
Committee | The Audit Committee, the Compensation Committee and the Nomination and Corporate Governance Committee (excluding, for the avoidance of doubt, the Special Committee). | |
Committee Charter | The charter of the relevant Committee. | |
Company | CureVac N.V. | |
Company Secretary | The Company's company secretary. | |
Compensation Committee | The Company's compensation committee. | |
Conflict of Interests | A direct or indirect personal interest which conflicts with the interests of the Company and of the business connected with it. |
CureVac AG | CureVac AG, registered with the Commercial Register of the Local Court in Stuttgart under HRB 754041, or its legal successors. | |
dievini | dievini Hopp BioTech holding GmbH & Co. KG, registered with the Commercial Register of the Local Court in Mannheim under HRA 700792, or its legal successors or permitted assigns under the SHA. | |
dievini Nominee | Any Supervisory Director who has been appointed pursuant to a binding nomination made by dievini. | |
Diversity Policy | The Company's diversity policy. | |
External Auditor | The auditor or audit firm within the meaning of Section 2:393 of the Dutch Civil Code, engaged to audit the Company's annual accounts and management report, or the Company's independent outside audit firm for purposes of U.S. laws and regulation (including applicable NASDAQ and/or SEC requirements), as the context may require. | |
Family Member | A Supervisory Director's spouse, registered partner or other life companion, foster child or any relative or in-law up to the second degree. | |
General Meeting | The Company's general meeting. | |
KfW | KfW, a public law institution (Anstalt des öffentlichen Rechts) under German law, having its seat in Frankfurt am Main, Germany, or its legal successors or permitted assigns under the SHA. | |
KfW Nominee | The Supervisory Director who has been appointed pursuant to a binding nomination made by KfW. | |
Initial Approval Period | The Initial Approval Period (Initiële Goedkeuringsperiode) as defined in the Articles of Association. | |
Initial Nomination Period | The Initial Nomination Period (Initiële Nominatieperiode) as defined in the Articles of Association. | |
Initial Period | The Initial Period (Initiële Periode) as defined in the Articles of Association. | |
Internal Controls | The Company's internal risk management and control systems, including its disclosure controls and procedures and internal control over financial reporting. | |
Management Board | The Company's management board. | |
Managing Director | A member of the Management Board. | |
NASDAQ | The NASDAQ Stock Market. |
Nomination and Corporate Governance Committee | The Company's nomination and corporate governance committee. | |
Nomination Concert | A Nomination Concert (Nominatie Groep) as defined in the Articles of Association. | |
Profile | The Company's profile for the size, composition and independence of the Supervisory Board. | |
Protective Foundation | A foundation under Dutch law whose objective it would be to promote and protect the interests of the Company, the business connected with it and its stakeholders from time to time, and repressing possible influences which could threaten the strategy, continuity, independence and/or identity of the Company or the business connected with it to such an extent that this could be considered to be damaging to the aforementioned interests. | |
SEC | The United States Securities and Exchange Commission. | |
SHA | The Shareholders' Agreement originally entered into between KfW, dievini and Mr. Dietmar Hopp and dated the sixteenth day of June two thousand and twenty, as amended from time to time. | |
Simple Majority | More than half of the votes cast. | |
Special Committee | A special committee of the Supervisory Board established under and in accordance with these rules and the Articles of Association for the purpose of approval of certain capital measures. | |
Subsidiary | A subsidiary within the meaning of Section 2:24a DCC. | |
Supervisory Board | The Company's supervisory board. | |
Supervisory Board Meeting | A meeting of the Supervisory Board. | |
Supervisory Director | A member of the Supervisory Board. | |
Vice-Chairman | The vice-chairman of the Supervisory Board. | |
Website | The Company's website. |
2.2 | References to statutory provisions are to those provisions as they are in force from time to time. |
2.3 | Terms that are defined in the singular have a corresponding meaning in the plural. |
2.4 | Words denoting a gender include each other gender. |
2.5 | Except as otherwise required by law, the terms "written" and "in writing" include the use of electronic means of communication. |
COMPOSITION
Article | 3 |
3.1 | The Supervisory Board consists of up to eight Supervisory Directors. |
3.2 | The size, composition and independence of the Supervisory Board shall be determined taking into consideration the principles laid down in the Diversity Policy and the Profile, each of which shall be adopted by the Supervisory Board taking into account the nature of the Company's business and the tasks, duties and competences of the Supervisory Board. |
3.3 | The Supervisory Directors shall be appointed, suspended and dismissed in accordance with the Articles of Association, these rules and applicable law always observing the nomination and designation rights set out in the Articles of Association. |
3.4 | A person may be appointed as Supervisory Director for a maximum of two consecutive terms of up to four years each and, subsequently, for a maximum of two consecutive terms of up to two years each. |
3.5 | The Supervisory Board shall elect a Supervisory Director to be the Chairman and another Supervisory Director to be the Vice-Chairman. The Supervisory Board may dismiss the Chairman or the Vice-Chairman, provided that the Supervisory Director so dismissed shall subsequently continue his term of office as a Supervisory Director without having the title of Chairman or Vice-Chairman, as the case may be. |
3.6 | A Supervisory Director shall promptly resign: |
a. | in the event of inadequate performance, structural incompatibility of interests on the part of such Supervisory Director, and in other instances where early retirement of such Supervisory Director is considered necessary by the Supervisory Board; |
b. | in respect of all dievini Nominees, upon expiry of the Initial Nomination Period for dievini; |
c. | in respect of the KfW Nominee, upon expiry of the Initial Nomination Period for KfW; or |
d. | in respect of a 20% Shareholder Nominee, upon: |
i. | the shareholder(s) on the basis of whose nomination such 20% Shareholder Nominee was appointed no longer constituting a Nomination Concert; or |
ii. | such 20% Shareholder Nominee no longer being independent from the relevant Nomination Concert and/or the Company under the standards applicable to the Company under the Dutch Corporate Governance Code and United States securities laws and stock exchange rules. |
In addition and without prejudice to the previous provisions of this Article 3.6, if at any time during the Initial Nomination Period for dievini, dievini is entitled to nominate less Supervisory Directors pursuant to its nomination rights under the Articles of Association than the number of dievini Nominees in office at that time, the excess number of dievini Nominee(s) shall promptly resign. In such instance, the Supervisory Board shall select the dievini Nominee(s) who must resign if the dievini Nominees, amongst themselves, do not reach agreement promptly as to who should resign (and the dievini Nominees shall, in such case, be deemed to have a Conflict of Interests in such decision).
3.7 | The Supervisory Board shall ensure that: |
a. | the Company has a sound plan in place for the succession of Managing Directors and Supervisory Directors which is aimed at retaining the appropriate balance in the requisite expertise, experience and diversity on the Management Board and the Supervisory Board; and |
b. | a retirement schedule is prepared in order to avoid, as much as possible and practicable, Supervisory Directors retiring simultaneously. |
3.8 | A Supervisory Director shall notify the Supervisory Board in advance of any other position he wishes to pursue. |
DUTIES AND ORGANISATION
Article | 4 |
4.1 | The Supervisory Board is charged with the supervision of the policy of the Management Board and the general course of affairs of the Company and of the business connected with it. The Supervisory Board shall provide the Management Board with advice. In performing their duties, Supervisory Directors shall be guided by the interests of the Company and of the business connected with it. In doing so, the Supervisory Board shall focus on long-term value creation for the Company and its business and take into account the relevant stakeholder interests. |
4.2 | At least twice per calendar year, as part of the Company's strategy, the Management Board shall discuss the Company's long-term strategy with the Supervisory Board in particular with regard to business operations and/or the management of the Company or its Subsidiaries, including but not limited to (i) taking up new lines of business, (ii) the termination or significant limitation of existing business lines and (iii) any significant transactions between the Company on the one hand and a shareholder or a shareholder's Affiliate on the other hand, which require the approval of the Supervisory Board. As part of those discussions, the Management Board and the Supervisory Board shall consider whether it would be in the best interests of the Company and its business to cause the incorporation of a Protective Foundation and to grant a customary right to subscribe for preferred shares in the Company's capital to such Protective Foundation (which right would in any event not be exercisable until after the expiration of the later of (i) the Initial Period or (ii) the Initial Approval Period). |
4.3 | The Supervisory Board may obtain information from officers and external advisers of the Company in order to perform their duties, and the Company shall facilitate this. |
4.4 | All Supervisory Directors shall follow an induction programme geared to their role, covering general financial, social and legal affairs, financial reporting by the Company, specific aspects that are unique to the Company and its business, the Company's corporate culture, the Company's relationship with employees and the responsibilities of a Supervisory Director under applicable law. |
4.5 | The tasks and duties of the Supervisory Board include the supervision of the following matters: |
a. | the Company's strategy, the implementation thereof and the principal risks associated with it; |
b. | the review by the Management Board of the effectiveness of the design and operation of the Internal Controls, including: |
i. | identified material weaknesses or significant deficiencies in the Internal Controls; and |
ii. | material changes made to, and any material improvements planned for, the Internal Controls; |
c. | the functioning of, and the developments in, the relationship with the External Auditor; |
d. | the establishment and implementation of the internal procedures by the Management Board; |
e. | the Company's corporate culture and values; |
f. | the amount, level and structure of compensation packages through review of proposals, reports and recommendations of the Compensation Committee |
g. | the findings and observations of the Management Board relating to the effectiveness of, and compliance with, the Company's internal policies, including its code of business conduct and ethics; |
h. | monitoring the operation of the Company's procedure for reporting actual or suspected misconduct or irregularities, the initiation of appropriate and independent investigations into signs of misconduct or irregularities, and, if an instance of misconduct or an irregularity has been discovered, adequate follow-up of recommendations for remedial actions; |
i. | the Company's relations with shareholders; and |
j. | deciding on matters proposed or recommended by the Committees pursuant to their respective Committee Charters. |
4.6 | At least annually, the Supervisory Board shall evaluate - outside the presence of the Managing Directors - its own functioning, the functioning of the Management Board, the functioning of the Committees and the functioning of the individual Managing Directors and Supervisory Directors, shall discuss the conclusions of such evaluations, and shall identify aspects where the Supervisory Directors require further training or education. During such evaluation, Supervisory Directors should be able to express their views confidentially. When performing their evaluations, the Supervisory Directors shall at least consider: |
a. | the mutual interaction among the Management Board and the Supervisory Board; |
b. | the mutual interaction among the Supervisory Directors; |
c. | lessons learned from recent events; and |
d. | the desired profile, composition, competency and expertise of the Supervisory Board. |
4.7 | Each Supervisory Director must treat all information and documentation obtained in connection with his position as Supervisory Director with the utmost discretion, integrity and confidentiality. |
CHAIRMAN, VICE-CHAIRMAN AND COMPANY SECRETARY
Article | 5 |
5.1 | The Chairman, in regular consultation with the CEO, shall ensure that: |
a. | the Supervisory Board has proper contact with the Management Board, the Company's employee representatives (if any) and the General Meeting; |
b. | the Supervisory Board elects a Vice-Chairman; |
c. | there is sufficient time for deliberation and decision-making by the Supervisory Board; |
d. | the Supervisory Directors receive all information that is necessary for the proper performance of their duties in a timely fashion; |
e. | the Supervisory Board and the Committees function properly; |
f. | the functioning of individual Managing Directors and Supervisory Directors is reviewed at least annually; |
g. | the Supervisory Directors and Managing Directors follow their induction programme, as well as their education or training programme (if and when relevant); |
h. | the Management Board performs activities in respect of corporate culture; |
i. | the Supervisory Board is responsive to signs of misconduct or irregularities from the Company's business and ensures that any material misconduct and irregularities, or suspicions thereof, are reported to the Supervisory Board without delay; |
j. | the General Meeting proceeds in an orderly and efficient manner; |
k. | effective communication with the Company's shareholders is assured; and |
l. | the Supervisory Board shall be involved closely, and at an early stage, in any acquisition, merger or takeover process involving the Company. |
5.2 | If the Chairman is absent or incapacitated, he may be replaced temporarily by the Vice-Chairman. |
5.3 | The Chairman shall act on behalf of the Supervisory Board as the primary contact for Managing Directors, Supervisory Directors and shareholders regarding the functioning of Managing Directors and Supervisory Directors, except for the Chairman himself. The Vice-Chairman shall fulfil such role regarding the functioning of the Chairman. |
5.4 | The Chairman shall consult regularly with the CEO. |
5.5 | The Supervisory Board may be supported by the Company Secretary. The Company Secretary may be appointed and dismissed by the Management Board, subject to the prior approval of the Supervisory Board. |
DECISION-MAKING
Article | 6 |
6.1 | The Supervisory Board shall meet as often as any Supervisory Director deems necessary or appropriate, but no less than annually and as a rule at least once per calendar quarter. |
6.2 | Supervisory Directors are expected to attend Supervisory Board Meetings and the meetings of the Committees of which they are members. If a Supervisory Director is frequently absent at such meetings, he shall be held accountable by the Supervisory Board. |
6.3 | A Supervisory Board Meeting may be convened by, or at the request of, any Supervisory Director by means of a written notice sent to all Supervisory Directors. Notice of a Supervisory Board Meeting shall include the date, time, place and agenda for that Supervisory Board Meeting. Supervisory Board Meetings can be held through audio-communication facilities. Supervisory Directors attending the Supervisory Board Meeting through audio communication are considered present at the Supervisory Board Meeting. |
6.4 | All Supervisory Directors shall be given reasonable notice of at least five days for all Supervisory Board Meetings, unless a shorter notice is required to avoid a delay which could reasonably be expected to have an adverse effect on the Company and/or the business connected with it. |
6.5 | If a Supervisory Board Meeting has not been duly convened, resolutions may nevertheless be passed at that Supervisory Board Meeting if all Supervisory Directors not present or represented at that Supervisory Board Meeting have waived compliance with the convening formalities in writing. |
6.6 | The Supervisory Director convening a Supervisory Board Meeting shall set the agenda for that Supervisory Board Meeting. Other Supervisory Directors may submit agenda items to the Supervisory Director convening the Supervisory Board Meeting. |
6.7 | All Supervisory Board Meetings shall be chaired by the Chairman or, in his absence, by the Vice-Chairman or, in his absence, by another Supervisory Director designated by the Supervisory Directors present at the relevant Supervisory Board Meeting. The chairman of the Supervisory Board Meeting shall appoint a secretary to prepare the minutes of the proceedings at such Supervisory Board Meeting. The secretary does not necessarily need to be a Supervisory Director. |
6.8 | Minutes of the proceedings at a Supervisory Board Meeting shall be sufficient evidence thereof and of the observance (or waiver) of all necessary formalities, provided that such minutes are certified by a Supervisory Director. Resolutions of a Supervisory Board Meeting can also be evidenced by a statement signed by the chairman and the secretary of that Supervisory Board Meeting. |
6.9 | Without prejudice to Article 6.14, each Supervisory Director may cast one vote in the decision-making of the Supervisory Board. Invalid votes, blank votes and abstentions shall not be counted as votes cast. |
6.10 | A Supervisory Director can be represented by another Supervisory Director holding a written proxy for the purpose of the deliberations and the decision-making of the Supervisory Board. |
6.11 | Resolutions of the Supervisory Board shall be passed, irrespective of whether this occurs at a Supervisory Board Meeting or otherwise, by Simple Majority, unless these rules provide differently. |
6.12 | A resolution of the Supervisory Board to approve a resolution of the Management Board to exclude or limit pre-emption rights (except in connection with the ordinary operation of the Company's equity incentive plans) or to implement an issuance of shares in the Company's capital against non-cash contribution (under article 7.2 paragraph b. of the Articles of Association) shall require the approval of the Special Committee with the affirmative vote of (i) during the Initial Nomination Period for dievini, the dievini Nominee who is a member of the Special Committee and (ii) during the Initial Nomination Period for KfW, the KfW Nominee. In this respect, the Supervisory Board shall sufficiently in advance involve the Special Committee in the deliberations and decision-making concerning the matters referred to in the previous sentence. |
6.13 | The following resolutions of the Supervisory Board shall require the affirmative vote of (i) during the Initial Nomination Period for dievini, at least one dievini Nominee and (ii) during the Initial Nomination Period for KfW, the KfW Nominee: |
a. | amendments of or supplements to these rules and allowing temporary deviations from these rules; |
b. | issuance of shares in case the Supervisory Board is authorised by the General Meeting for this purpose in accordance with Article 6.1 of the Articles of Association or needs to approve a resolution to issue shares by the Management Board; |
c. | the determination of whether a Change of Control has occurred; |
d. | the determination of whether the Initial Period has expired; |
e. | the determination of whether an Initial Nomination Period has expired; |
f. | the determination of whether the Initial Approval Period has expired; and |
g. | during the Initial Approval Period, the approval of a resolution of the Management Board concerning: |
i. | any proposal to the General Meeting of any amendment to the text or purport of articles 18.9, 18.11, 21.2, 22.1 through 22.5 and/or 22.8 of the Articles of Association, or the definitions used in those articles; |
ii. | any amendment to the text or purport of the internal rules of the Management Board; |
iii. | any of the matters described in article 18.11 of the Articles of Association and make decisions on materiality under Article 18.11 paragraphs b, c and d of the Articles of Association. |
6.14 | Resolutions of the Supervisory Board on any of the matters described in Article 18.9(e) of the Articles of Association shall not be taken, during the Initial Approval Period, if collectively, (i) at least one dievini Nominee and (ii) the KfW Nominee vote against a matter as aforementioned. |
6.15 | Where there is a tie in any vote of the Supervisory Board, the Chairman shall have a casting vote, provided that there are at least three Supervisory Directors in office. Otherwise, the relevant resolution shall not have been passed. |
6.16 | Resolutions of the Supervisory Board may, instead of at a Supervisory Board Meeting, be passed in writing, provided that all Supervisory Directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 6.9 through 6.15 apply mutatis mutandis. |
6.17 | The Supervisory Board may require that officers and external advisers attend Supervisory Board Meetings. In particular, the Supervisory Board shall request the External Auditor to attend the Supervisory Board Meeting where the External Auditor's audit report regarding the Company's financial statements is discussed. |
6.18 | If and when dievini, KfW or a Nomination Concert nominates an individual for appointment as a Supervisory Director in accordance with the Articles of Association, such individual shall, upon request of the relevant nominator, have the right to attend any meeting of the Supervisory Board and any of its Committee meetings, where applicable, as an observer without voting rights until such individual has been appointed as member of the Supervisory Board, provided that such individual agrees with the Company to be bound by customary confidentiality with respect to any information received by that individual as an observer. |
6.19 | If, for whatever reason, there is no dievini Nominee and/or no KfW Nominee in office at the Supervisory Board or as member of the Special Committee, as the case may be, during the Initial Nomination Period for dievini or KfW, as relevant, and a decision needs to be taken with respect to any matter referred to in Articles 6.12 and 6.13, then the Supervisory Board shall request dievini or KfW, as applicable, to designate a temporary replacement under article 21.4 of the Articles of Association and, if such temporary replacement is not designated within a period of four weeks, shall, as soon as reasonably practicable, convene a General Meeting and submit such matter to the General Meeting for the decision. In case a temporary replacement is designated by dievini or KfW, as applicable, in accordance with the first full sentence of this Article 6.18 and article 21.4 of the Articles of Association, such person will for the purpose of Articles 6.12 and 6.13 be deemed to be the dievini Nominee or KfW Nominee, as applicable. |
CONFLICT OF INTERESTS
Article | 7 |
7.1 | A Supervisory Director shall promptly report any actual or potential Conflict of Interests in a transaction that is of material significance to the Company and/or such Supervisory Director to the other Supervisory Directors, providing all relevant information relating to such transaction, including the involvement of any Family Member. |
7.2 | The determination whether a Supervisory Director has a Conflict of Interests shall primarily be the responsibility of that Supervisory Director. However, in case of debate, that determination shall be made by the Supervisory Board without the Supervisory Director concerned being present. |
7.3 | A Supervisory Director shall not participate in the deliberations and decision-making of the Supervisory Board on a matter in relation to which he has a Conflict of Interests. If, as a result thereof, no resolution can be passed by the Supervisory Board, the resolution may nevertheless be passed by the Supervisory Board as if none of the Supervisory Directors has a Conflict of Interests. |
7.4 | Transactions in respect of which a Supervisory Director has a Conflict of Interests shall be agreed on arms' length terms. Any such transactions where the Conflict of Interests is of material significance to the Company and/or to the Supervisory Director concerned shall be subject to the approval of the Supervisory Board. |
7.5 | In order to avoid potential Conflicts of Interests, or the appearance thereof, Supervisory Directors shall not: |
a. | enter into competition with the Company; |
b. | demand or accept substantial gifts from the Company for themselves or for their respective Family Members; |
c. | provide unjustified advantages to third parties to the detriment of the Company; |
d. | take advantage of business opportunities to which the Company would be entitled for themselves or for their respective Family Members. |
7.6 | The Company shall not grant its Supervisory Directors or their respective Family Members any personal loans, guarantees or similar financial arrangements. |
7.7 | The Supervisory Board shall deal with any actual or potential Conflict of Interest in a transaction that is of material significance to the Company and/or a Managing Director in accordance with the provisions included in the Management Board Rules. |
OWNERSHIP OF AND TRADING IN FINANCIAL INSTRUMENTS
Article | 8 |
8.1 | The Supervisory Directors shall be subject to the Company's insider trading policy. In addition, each Supervisory Director shall practice great reticence: |
a. | when trading in shares or other financial instruments issued by another listed company, if this could reasonably create the appearance of such Supervisory Director violating applicable insider trading and/or market manipulation prohibitions; and |
b. | when trading in shares or other financial instruments issued by another listed company which is a direct competitor of the Company. |
8.2 | Any shares in the Company's capital held by a Supervisory Director are expected to be long-term investments. |
COMMITTEES
Article | 9 |
9.1 | The Supervisory Board has established the Audit Committee, the Compensation Committee and the Nomination and the Corporate Governance Committee and the Special Committee and may establish such other committees as deemed necessary or appropriate by the Supervisory Board. |
9.2 | The Special Committee shall be established for the purposes described in these rules, inter alia, to approve certain capital measures. The Special Committee consists of: |
a. | during the Initial Nomination Period for dievini, one dievini Nominee (selected by the Supervisory Board in case there is more than one dievini Nominee); |
b. | during the Initial Nomination Period for KfW, the KfW Nominee; and |
c. | as long as the Supervisory Board comprises at least one 20% Shareholder Nominee, one 20% Shareholder Nominee (selected by the Supervisory Board in case there is more than one 20% Shareholder Nominee). |
9.3 | Each Committee shall be subject to this Article 9 and its respective Committee Charter. |
9.4 | Unless the relevant Committee Charter provides differently, Article 6 applies mutatis mutandis to the decision-making of each Committee, provided that references to the Chairman should be interpreted as being references to the chairman of the relevant Committee. |
9.5 | The Supervisory Board shall regularly review and discuss the reports received from the respective Committees. |
9.6 | For the avoidance of doubt, Articles 9.3 through 9.5 do not apply to the Special Committee. The tasks, duties, organization and decision-making of the Special Committee is governed exclusively by these rules, to the extent they refer to the Special Committee. |
AMENDMENTS AND DEVIATIONS
Article | 10 |
Pursuant to a resolution to that effect, subject to Article 6.13, the Supervisory Board may amend or supplement these rules and allow temporary deviations from these rules, subject to ongoing compliance with NASDAQ requirements, SEC rules and applicable law generally.
GOVERNING LAW AND JURISDICTION
Article | 11 |
These rules shall be governed by and shall be construed in accordance with the laws of the Netherlands. Any dispute arising in connection with these rules shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands.
Exhibit 3.5
(1) | CureVac AG |
(2) dievini Hopp BioTech holding GmbH & Co. KG
(3) Bill & Melinda Gates Foundation
(4) Dr. Ingmar Hoerr
(5) Dr. Florian von der Mülbe
(6) Dr. Wolfgang Klein
(7) Prof. Dr. Hans-Georg Rammensee
(8) Prof. Dr. Günther Jung
(9) Prof. Dr. Friedrich von Bohlen und Halbach
(10) Dr. Hans Christoph Tanner
(11) Scottish Mortgage Investment Trust plc
(12) Vanguard World Fund
(13) Vanguard Variable Insurance Funds
(14) Jupiter Partners LP
(15) Harborside Creek Ltd
(16) Vico Holdings Ltd
(17) ELMA Investments Ltd
(18) Chartwave Limited
(19) Chelt Trading Limited
(20) | Landeskreditbank Baden-Württemberg – Förderbank – |
(21) | LBBW Asset Management Investmentgesellschaft mbH acting on behalf of the fund “LBBW AM-VA-Aktien Global Value/Total Return (EFA) Segment 1" |
(22) | Lilly Global Nederland Holdings B.V. |
(23) | Genmab A/S |
(24) | KfW |
(25) | Glaxo Group Limited |
(26) | Qatar Holding LLC |
(27) | FCP Biotech Holding GmbH |
(28) | CureVac B.V. |
Investment and Shareholders’ Agreement | ||
between
1. | CureVac AG, with registered offices in Tübingen, registered with the commercial register of the Stuttgart local court under HRB 754041, Friedrich-Miescher-Straße 15, 72076 Tübingen (“Corporation”), |
2. | dievini Hopp BioTech holding GmbH & Co. KG, with registered offices in Walldorf, Johann-Jakob-Astor-Str. 57, 69190 Walldorf (“dievini”), |
3. | Bill & Melinda Gates Foundation, 500 5th Ave N., Seattle, WA 98109 (“BMGF”), |
4. | Dr. Ingmar Hoerr, |
5. | Dr. Florian von der Mülbe, (also referred to below as “Managing Shareholder”), |
6. | Dr. Wolfgang Klein, |
7. | Prof. Dr. Hans-Georg Rammensee, |
8. | Prof. Dr. Günther Jung, |
9. | Prof. Dr. Friedrich von Bohlen und Halbach, |
10. | Dr. Hans Christoph Tanner, |
11. | Scottish Mortgage Investment Trust plc, a trust incorporated under the laws of Scotland acting through Baillie Gifford & Co, its agent with address Calton Square, 1 Greenside Row, Edinburgh, EH1 3AN (“SMI”), |
12. | Vanguard World Fund, a Delaware statutory trust on behalf of its series of shares known as the Vanguard International Growth Fund, acting through Baillie Gifford Overseas Limited, its agent, with address Calton Square, 1 Greenside Row, Edinburgh, EH1 3AN (“Vanguard 1”), |
13. | Vanguard Variable Insurance Funds, a Delaware statutory trust on behalf of its series of shares known as the International Portfolio, acting through Baillie Gifford Overseas Limited, its agent, with address Calton Square, 1 Greenside Row, Edinburgh, EH1 3AN (“Vanguard 2”), |
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14. | Jupiter Partners LP, a Canadian limited partnership with address 199, Bay Street, Suite no. 4000, Toronto (Ontario), M5L 1A9, Canada, (“Jupiter”), |
15. | Harborside Creek Ltd., a Bahamian limited partnership with address One Montague Place, East Bay Street, P.O. Box, N-4906 Nassau, The Bahamas (“Harborside”), |
16. | Vico Holdings Ltd., a Cayman Islands limited liability company with address at P.O. Box 10741, 3rd Floor – Cayman Corporate Centre, 27 Hospital Rd, George Town, Grand Cayman, Cayman Islands KY1-1007 (“Vico”), |
17. | ELMA Investments Ltd., a Cayman Islands limited liability company with address at P.O. Box 10741, 3rd Floor – Cayman Corporate Centre, 27 Hospital Rd, George Town, Grand Cayman, Cayman Islands KY1-1007 (“ELMA”), |
18. | Chartwave Limited, a British Virgin Islands limited liability company with address Trident Chambers, P.O. Box 146, Road Town, Tortola, British Virgin Islands (“Chartwave”), |
19. | Chelt Trading Limited, a British Virgin Islands company with address at c/o Overseas Management, Company Trust (BVI) Ltd, Palm Chambers 3, P.O. Box 3152, Road Town, Tortola, British Virgin Islands (“Chelt Trading”), |
(SMI, Vanguard 1, Vanguard 2, Jupiter, Harborside, ELMA, Vico, Chartwave and Chelt Trading also referred to together below as “Series B Investors 2015” or each a “Series B Investor 2015”),
20. | Landeskreditbank Baden-Württemberg – Förderbank – a German independent public law institution (Anstalt des öffentlichen Rechts) with address Schlossplatz 10, 76131 Karlsruhe, Germany (“L-Bank”), |
21. | LBBW Asset Management Investmentgesellschaft mbH, a German AIF management company pursuant to the meaning given in the German Capital Investment Code (Kapitalanlagegesetzbuch - “KAGB”), acting on behalf of the fund “LBBW AM-VA-Aktien Global Value/Total Return (EFA) Segment 1" (the “Fund”), with address Fritz-Elsas-Straße 31, 70174 Stuttgart, Germany (“LBBW AM”), |
(L-Bank and LBBW AM also referred to below as “Series B Investors 2016” and each a “Series B Investor 2016”),
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22. | Lilly Global Nederland Holdings B.V., a Dutch limited liability company with address at Papendorpseweg 83, 3528 BJ, Utrecht, Netherlands (“Lilly” or “Series B Investor 2017”), |
23. | Genmab A/S, CVR. no. 2102 3884, a Danish corporation, having a place of business at Kalvebod Brygge 43, DK-1560 Copenhagen (“Genmab” or “Series B Investor 2019”), |
24. | KfW, a German independent public law institution (Anstalt des öffentlichen Rechts) with address Palmengartenstrasse 5-9, 60325 Frankfurt am Main, Germany (“KfW”), |
25. | Glaxo Group Limited, an English limited liability corporation with address at 980 Great West Road, TW8 9GS Brentford, Middlesex, United Kingdom (“GSK”), |
26. | Qatar Holding LLC, a company established pursuant to the regulations of the Qatar Financial Centre and licensed by the Qatar Financial Centre Authority with registration number 00004, with its address at Ooredoo Tower (Building 14), Al Dafna Street (Street 801), Al Dafna (Zone 61), Doha, Qatar (“QIA”), |
27. | FCP Biotech Holding GmbH, a German limited iability company with address Freihamer Straße 2, D-82166 Gräfelfing, Germany (“FCP”), |
28. | CureVac B.V., a Dutch limited liability company with business address at Friedrich-Miescher-Straße 15, D-72076 Tübingen, Germany, which is intended to be converted to a public limited liability company (naamloze vennootschap) under Dutch law under the name of CureVac N.V. (CureVac B.V. and CureVac N.V., as the case may be, hereinafter referred to as “CureVac NL”); |
- | parties 24 - 27 as well as parties 14 through 19 and 21, relative to their respectively subsctribed Series B Investors 2020 Shares, also referred to as “Series B Investors 2020” or collectively with the Series B Investor 2019, the Series B Investor 2017, the Series B Investors 2016 and the Series B Investors 2015, as “Investors” or each an “Investor” - |
- | parties 2 - 10 are also referred to below as “Existing Shareholders 2015”; the Existing Shareholders 2015 together with parties 11 - 23 also collectively referred to as “Existing Shareholders” - |
- | parties 4 - 8 are also referred to below as “Founders” - |
- | parties 1 - 28 are also referred to as the “Parties” or each as a “Party” - |
- | parties 2 - 27 are also collectively referred to as “Shareholders” or each as a “Shareholder”. |
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List of Annexes
Annex 2.1(a) | Series B Investors 2020 Shares |
Annex 2.1(d) | Articles of Association of the Corporation |
Annex 2.4 | Sample Written Declaration (Zeichnungsschein) |
Annex 5.2(d) | Agreements with Present/Former Employees regarding participation in Results of the Corporation |
Annex 5.2(e) | Convertible Loan |
Annex 5.2(g) | List of Certain Joint Venture Agreements |
Annex 5.3(d) | List of Real Estate |
Annex 5.3(f) | List of Material Contracts |
Annex 5.4 | Litigation |
Annex 5.7(a) | List of Registered Corporation-Owned IPR |
Annex 5.7(b) | List of Commercial License Agreements |
Annex 5.7(d) | List of Legal Actions against Corporation-Owned IPR |
Annex 5.7(e) | List of Commercial License Agreements (Licensed-In IPR) |
Annex 9 | BMGF Global Access Agreement |
Annex 13.7(g) | Management Board Rules of Procedure |
Annex 21.4 | Sample Calculations on Liquidation Preference |
Annex 27.1 | Sample Written Declaration of Acceptance |
Annex 30.1(g) | List of Companies entitled to Confidential Information by Contract |
Schedule 1 | Form of PFIC Statement |
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Preamble:
(A) | The Corporation develops and protects a technology which renders messenger RNA (mRNA) therapeutically usable. The technology has been tested on animal subjects and in clinical experiments for medically relevant therapeutic application in humans. This method and the data generated form the basis of the commercial objective of the Corporation which primarily consists of developing and licensing suitable product candidates to pharmaceutical companies, in particular in the field of vaccination against the Corona-Sars 2 virus and vaccination against other infectious diseases as well as cancer therapy (the “Object of Business”). |
(B) | A substantial success factor for the further development of the Corporation, in particular the further economic development, is the sufficient scale production of mRNA to achieve competitive prices. It is therefore required not only to modify the Corporation’s current production process to a production process which is focused on a higher output but also to complement the production unit with a second production site that has the ability to ensure commercial supply to the market. |
(C) | BMGF is committed to accelerating the development of lifesaving and low-cost vaccines and drugs to reduce the burden of disease in low-income and lower middle-income countries (such countries on The World Bank list (http://www.worldbank.org/data/countryclass/classgroups.htm) at the date of its becoming a Shareholder the “Access Countries”) in furtherance of its mission to help all people lead healthy, productive lives. In furtherance of its mission BMGF has provided the Corporation with the BMGF Funds (as defined below). Beyond the corporate relationship, BMGF and the Corporation intend to cooperate increasingly in joint projects in the future to further BMGF's charitable mission. The full particulars of that cooperation between the Corporation and BMGF are laid down in a separate global access commitments agreement (“Global Access Agreement”). |
(D) | The Investors are committed to accelerate the development of CureVac’s technology platform and related products. |
(E) | The Series B Investors 2015 provided to the Corporation altogether EUR 98,745,814.44 (in words: ninety eight million seven hundred forty five thousand eight hundred fourteen Euros and forty four Eurocents) on the basis of an investment and shareholders’ agreement dated 2 October 2015; the Series B Investors 2016 provided to the Corporation altogether EUR 26,497,909.00 (in words: twenty-six million four hundred ninety-seven thousand nine hundred nine Euros) on the basis of an amended investment and shareholders’ agreement dated 14 October 2016. The Series B Investor 2017 provided to the Corporation equity in an aggregate amount of EUR 45,000,000.00 (in words: forty five million Euros), on the basis of an amended investment and shareholders’ agreement dated 13 October 2017. The Series B Investor 2019 provided to the Corporation cash equity in an overall amount of EUR 20,000,000.00 (in words: twenty million Euros), on the basis of an amended investment and shareholders’ agreement dated 18 December 2019. |
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(F) | The Series B Investors 2020 intend to invest in the Corporation an aggregate amount of up to EUR 559,279,809.00 (“Series B Investors 2020 Overall Contribution”), subject to the provisions of this Agreement. |
(G) | KfW intends to invest EUR 299,998,809.00 against the issuance of 224,466 Series B Shares. |
(H) | GSK intends to invest EUR 149,999,404.50 against the issuance of 112,233 Series B Shares. |
(I) | QIA intends to invest EUR 59,999,494.50 against the issuance of 44,893 Series B Shares. |
(J) | FCP intends to invest EUR 19,999,386.00 against the issuance of 14,964 Series B Shares. |
(K) | Jupiter intends to invest EUR 1,762,843.50 against the issuance of 1,319 Series B Shares. |
(L) | Harborside intends to invest EUR 1,762,843.50 against the issuance of 1,319 Series B Shares. |
(M) | Vico intends to invest EUR 4,999,846.50 against the issuance of 3,741 Series B Shares. |
(N) | ELMA intends to invest EUR 9,999,693.00 against the issuance of 7,482 Series B Shares. |
(O) | Chartwave intends to invest EUR 4,999,846.50 against the issuance of 3,741 Series B Shares. |
(P) | Chelt Trading intends to invest EUR 1,758,834.00 against the issuance of 1,316 Series B Shares. |
(Q) | LBBW AM intends to invest EUR 3,998,808.00 against the issuance of 2,992 Series B Shares. |
(R) | In preparation of the proposed IPO, the Shareholders intend to contribute all their Shares in the Corporation to CureVac NL (“NL Contribution”) leading to CureVac NL becoming the sole shareholder of the Corporation and the Shareholders becoming the sole shareholders of CureVac NL holding proportionally the same interests in CureVac NL as in the Corporation. The Parties agree that, upon effectiveness of the NL Contribution, this Agreement shall apply to CureVac NL, to the greatest extent legally permitted (i) prior to and until the date of the first listing in the event of an IPO and (ii) as per the date of first listing in the event of an IPO, with limited content as set forth in this Agreement, in each case as provided in lit. (i) and (ii) above, in the same manner as it applies to the Corporation. |
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Now therefore, the Parties agree as follows:
Definitions
Whereas certain terms have been defined throughout this Agreement (as defined in Section 1.6), the following terms shall have the definitions set forth below:
“Accession Agreement” shall have the meaning given to it in Section 27.1.
“Affiliate”, except as otherwise defined herein, means any individual person or legal entities who or which are affiliated enterprises (verbundene Unternehmen) within the meaning of §§ 15 et seq. AktG and includes in case of KfW also the Federal Republic of Germany and its special estates (Sondervermögen), corporate bodies (Körperschaften), institutions (Anstalten) as well as their respective Affiliates (“KfW Affiliates”).
“AktG” means the German Stock Corporation Act (Aktiengesetz).
“Applicable Fund Laws” means (i) the United States Investment Company Act of 1940 (the “Investment Company Act”), and regulations promulgated thereunder, and (ii) all other statutes, enactments, acts of legislature or parliament, ordinances, rules, by-laws, regulations, notifications, guidelines, policies, directions, directives, rulings and orders of any government, statutory authority, tribunal, arbitration body, board, court whether in the United States or any other jurisdiction applicable to the operations of the Mutual Fund Investors.
“Articles” means the Articles of Association (Satzung) of the Corporation in the respective applicable version.
“Articles NL” means the Articles of Association (statuten) of CureVac NL in the respective applicable version.
“Banking Day” means every day on which it is customary for banks in Frankfurt am Main to be open.
“Baillie Gifford & Co” means Baillie Gifford & Co, a Scottish partnership with its principal place of business at Calton Square, 1 Greenside Row, Edinburgh, EH1 3AN, the United Kingdom.
“Baillie Gifford Entities” means any of Baillie Gifford & Co, the Baillie Gifford Funds, and each of their respective Affiliates from time to time.
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“Baillie Gifford Funds” means, collectively and acting severally (and not jointly), SMI, Vanguard 1 and Vanguard 2, and, in each case, their successors in title from time to time following a transfer conducted pursuant to the terms of this Agreement (including, but not limited to, any transfer made pursuant to Sections 17.3 or 17.5(d)).
“BGB” means the German Civil Code (Bürgerliches Gesetzbuch).
“BMGF Tranche I Series B Shares” means 23,321 Series B Shares (originally with serial no. 21 through 23,341) acquired by BMGF under the amendment to the investment and shareholders’ agreement dated February 13, 2015 (deed-roll no. 27/2015 of the notary Dr. Jochen Scheel in Frankfurt).
“Change in Control” means as defined in Section 10.8.
“Competitor” means any person, legal entity or its respective Affiliates (including subsidiaries) who (i) conduct a business that is substantially similar to and/or in competition with the Corporation’s Object of Business (including the commercialisation of products developed), as amended, from time to time (whether at the date of this Agreement or subsequently) or (ii) is invested as a shareholder in a competing business as set forth in lit. (i) above. In any event, KfW and KfW Affiliates as well as GSK and any Affiliates of GSK as well as QIA and the Affiliates of QIA shall not be considered as Competitors.
“dievini Tranche II Series B Shares” means 21,777 Series B Shares (originally with serial no. 23,379 through 45,155) in the Corporation acquired by dievini under the amendment to the investment and shareholders’ agreement dated February 13, 2015, as of July 15, 2015 (deed-roll no. 128/2015 of the notary Dr. Jochen Scheel in Frankfurt) respectively, the corresponding number of Shares in CureVac NL issued to dievini in place of such Series B Shares in the Corporation.
“Encumbrances” means all pledges, charges, liens or security interests having similar effect, mortgages, pre-emption rights, rights of first refusal, options, sell or buy-out rights or similar, except for the rights to sell/purchase and to assign/transfer 1/3 of the dievini Tranche II Series B Shares held by dievini from dievini to BMGF as set forth in the notarial transfer agreement between dievini and BMGF (deed no. 129/2015 of the notary Dr. Jochen Scheel, Frankfurt am Main) dated 15 July 2015 and labelled as Permitted Transfer pursuant to Section 17.5(c) herein.
“Exit Shareholder” means as defined in Section 20.1.
“HGB” means German Commercial Code (Handelsgesetzbuch).
“IP Rights” means as defined in Section 25.1.
“Knowledge of” or other derivations of “know” with respect to a Party means the knowledge of a person which such person obtained after diligent inquiry or could have obtained had he made due inquiry with the care and diligence of a prudent businessman within the meaning of § 93 par. 1 AktG of the individuals and representatives in charge of the respective subject matters unless stated in this Agreement that actual knowledge is relevant in the specific context.
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“Licensed-in IPR” means intellectual property rights owned by a third party (including software) which the Corporation has been licensed to use from such third party.
“Major Shareholder” means as defined in Section 22.6.
“Management Board” means as defined in Section 12.1 in conjunction with Section 12.3.
“Managing Shareholder” means Dr. Florian von der Mülbe.
“Material Adverse Change” means any change, circumstance or event that occur or become known which – individually or in connection with other changes, circumstances or events – have a material adverse effect on the net assets, financial condition or results of operation, business operations or business prospects of the Corporation or cause such effects to be expected.
“Mutual Fund Investors” means Baillie Gifford & Co and the Baillie Gifford Funds.
“NL Contribution” means as defined in Section 1.3.
“Platform Technology” means the Corporation’s technology for development of prophylactic and therapeutic mRNA vaccines and drugs against infectious diseases and vaccine adjuvants, comprised of long, non-coding RNA molecules and formulation/delivery technology necessary to develop the mRNA vaccines and drugs. For the avoidance of doubt the intent of the Parties is that development activities will include the full process from pre-clinical development to delivery.
“Recognized Stock Exchange” means any regulated market in the European Union within the meaning of Article 4, paragraph 1, point 14 of Directive 2004/39/EC, the London Stock Exchange, the New York Stock Exchange, NASDAQ or Hong Kong Stock Exchange.
“Registration Statement” means a registration statement or registration statements of the Corporation and/or the entity into which the shares in the Corporation have been contributed filed with the SEC under the US Securities Act of 1933 covering shares beneficially owned by a Major Shareholder.
“Resolutions” means as defined in Section 2.1.
“Sale Shares” means as defined in Section 17.2.
“Shareholder” means any of the parties under nos. 2 - 27.
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“SEC” means the US Securities and Exchange Commission.
“Shares” means any no-par value shares (nennwertlose Stückaktien) in the Corporation issued by the Corporation from time to time as well as any shares in CureVac NL issued by CureVac NL (regardless of its legal form) from time to time.
“Subsidiary” means any and all companies controlled by the Corporation from time to time, whether at the date of this Agreement or subsequently, with “control” meaning directly or indirectly owning or controlling at least 50% of such companies’ voting stock, or possessing the power to direct or to cause the direction of such companies’ management and policies.
“Supervisory Board” means as defined in Section 13.1 in conjunction with Section 13.13.
“Tag Along Shareholder” means as defined in Section 18.
“Third Party” means any person other than any Shareholder in the Corporation or the Corporation or other than any person which directly or indirectly controls or is controlled by any Shareholder or its Affiliates.
I. Investment
1. | Current Investment Ratios in the Corporation |
1.1 | The Corporation is registered with the commercial register of the Stuttgart local court under HRB 754041. As set forth in Section 1.3 below, its registered share capital (Grundkapital) amounts to EUR 742,937.00 and is divided into a total number of 742,937 Shares, of which 23,400 Shares are Series A Shares (as defined below), 705,037 Shares are Series B Shares (as defined below), and 14,500 Shares are Series C Shares (as defined below). The registered share capital has been fully contributed and has neither directly nor indirectly been paid back. |
1.2 | CureVac B.V. is registered with the commercial register of the Chamber of Commerce (Kamer van Koophandel) under no. 77798031. Its registered share capital amounts to EUR 0.12 and is divided into one (1) share. The sole shareholder of CureVac B.V. as of the date of this Agreement is Dr. Franz-Werner Haas. The registered share capital has been fully contributed and has neither directly nor indirectly been paid back. |
1.3 | The Parties agree that, upon effectiveness of the NL Contribution, this Agreement shall apply to CureVac NL in the same manner as it applies to the Corporation to the greatest extent legally permitted. |
1.4 | The Founders and other Existing Shareholders 2015 have same-level shares without special rights (“Series A Shares”). dievini and BMGF as well as Prof. Dr. Günther Jung and Prof. Dr. Hans-Georg Rammensee likewise hold Series A Shares as well as shares with special rights, which were also granted to the Series B Investors 2015, the Series B Investors 2016, the Series B Investor 2017 and the Series B Investor 2019, as the case may be, by means of the investment agreement dated 15 December 2005 and the investment and shareholders’ agreement dated 13 February 2015 as amended (i) by the amendment to the investment and shareholders’ agreement dated 15 July 2015, (ii) by the investment and shareholders’ agreement dated 2 October 2015, (iii) by the investment and shareholders’ agreement dated 14 October 2016, (iv) by the investment and shareholders’ agreement dated 13 October 2017 and (v) by the investment and shareholders’ agreement dated 18 December 2019 (collectively the “Investment and Shareholders’ Agreement”) (“Series B Shares”). Furthermore, the Managing Shareholder and the Party under no. 4 hold “Series C Shares” with preferential liquidation rights. Upon consummation of the measures set forth in Sections 2 and 3 below, the Series B Investors 2020 Shares (as defined below) issued for the benefit of the Series B Investors 2020 shall also be Series B Shares with all rights attached thereto under this Agreement and the Articles. |
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1.5 | Since registration of the last capital increase on 18 February 2020 and accession of the Series B Investor 2019 to the Corporation the Existing Shareholders were invested in the Corporation’s registered share capital as follows: |
Shareholder | Number of Shares | Series of Shares | Nominal (in EUR) | |||||
dievini Hopp BioTech holding GmbH & Co. KG | 585,537 | B | 585,537 | |||||
dievini Hopp BioTech holding GmbH & Co. KG | 13,926 | A | 13,926 | |||||
Dr. Ingmar Hörr | 8,400 | C | 8,400 | |||||
Dr. Ingmar Hörr | 85 | A | 85 | |||||
Dr. Florian von der Mülbe | 6,100 | C | 6,100 | |||||
Dr. Florian von der Mülbe | 62 | A | 62 | |||||
Dr. Wolfgang Klein | 1,919 | A | 1,919 | |||||
Prof. Dr. Friedrich von Bohlen und Halbach | 1,818 | A | 1,818 | |||||
Dr. Hans Christoph Tanner | 1,414 | A | 1,414 | |||||
Prof. Dr. Hans-Georg Rammensee | 40 | B | 40 |
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Shareholder | Number of Shares | Series of Shares | Nominal (in EUR) | |||||
Prof. Dr. Hans-Georg Rammensee | 1,415 | A | 1,415 | |||||
Prof. Dr. Günther Jung | 50 | B | 50 | |||||
Prof. Dr. Günther Jung | 2,526 | A | 2,526 | |||||
Bill & Melinda Gates Foundation | 23,321 | B | 23,321 | |||||
Bill & Melinda Gates Foundation | 235 | A | 235 | |||||
SMI | 11,710 | B | 11,710 | |||||
Vanguard 1 | 12,600 | B | 12,600 | |||||
Vanguard 2 | 1,452 | B | 1,452 | |||||
Jupiter | 2,927 | B | 2,927 | |||||
Harborside | 5,855 | B | 5,855 | |||||
Vico | 4,684 | B | 4,684 | |||||
ELMA | 2,342 | B | 2,342 | |||||
Chartwave | 2,342 | B | 2,342 | |||||
Chelt Trading | 2,342 | B | 2,342 | |||||
L-Bank | 5,855 | B | 5,855 | |||||
LBBW AM | 6,557 | B | 6,557 | |||||
Lilly | 21,078 | B | 21,078 | |||||
Genmab A/S | 16,345 | B | 16,345 | |||||
742,937 |
1.6 | With this investment and shareholders’ agreement (this “Agreement”), the Parties intend to set forth their mutual rights and duties and to supplement the provisions contained in the Articles. |
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2. | Series B Capital Increase 2020, Subscription for Shares with Preferential Rights |
2.1 | For the purpose of admitting the Series B Investors 2020 as shareholders into the Corporation (as further set out in Section 2.3), immediately following this Agreement becomes legally effective, waiving all form and notice provisions with regard to holding a shareholders’ meeting (Hauptversammlung) and with regard to the passing of shareholders’ resolutions, the Existing Shareholders will hold a shareholders’ meeting of the Corporation and unanimously pass the following notarized (notariell beurkundet) resolution as well as separate notarized resolutions for each of the Series A Shares, Series B Shares and Series C Shares (collectively, the “Resolutions”): |
(a) | In return for cash contributions, the current share capital of the Corporation of EUR 742,937.00 (the “Current Share Capital”) shall be increased by the issuance of 418,466 new no-par value shares (nennwertlose Stückaktien) (the “Series B Investors 2020 Shares” and such capital increase, the “Series B Capital Increase 2020”). On the basis of a pre-money valuation of the Corporation of EUR 1.000,000,000.00 (in words: one billion Euros) (“Series B 2020 Valuation”) the number of Series B Investors 2020 Shares to be issued and the resulting Series B Investors 2020 Overall Contribution will be calculated based on the agreed share price for a Share of EUR 1,336.50 (in words: one thousand three hundred thirty six Euros fifty Eurocents) (the “Share Price”).. Accordingly, the number of Series B Investors 2020 Shares issued to the Series B Investors 2020 will be calculated by dividing the amount of EUR 559,279,809.00 (in words: [five hundred fifty nine million two hundred seventy nine thousand eight hundred and nine] Euros) by the Share Price amounting to 418,466 Series B Investors 2020 Shares. The numbers of shares (Stückzahlen) of the Series B Investors 2020 Shares to be acquired by each Series B Investor 2020 is set out in Annex 2.1(a). |
(b) | The Series B Investors 2020 Shares shall carry the right to dividends from the beginning of the financial year in which the Series B Capital Increase 2020 is registered with the commercial register and shall carry all preferential and other rights associated with Series B Shares. |
(c) | Each Series B Investors 2020 Share shall be issued for a nominal amount of EUR 1.00 (the “Issue Amount” (Ausgabebetrag)). |
(d) | The articles of association of the Corporation shall be restated in accordance with Annex 2.1(d). |
2.2 | With regard to the Series B Capital Increase 2020, the Existing Shareholders hereby waive their statutory and contractual subscription rights. The Series B Investors 2020 shall be admitted to subscribe for the Series B Investors 2020 Shares as set out in Annex 2.1(a). |
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2.3 | The Corporation shall provide each Series B Investor 2020 with copies of the Resolutions without undue delay (unverzüglich). |
2.4 | The Series B Investors 2020 each undertake to the Existing Shareholders, but not to the Corporation which shall not have any claim in its own right to this undertaking (kein Vertrag zugunsten Dritter) pursuant to § 328 BGB, without undue delay after the receipt from the Corporation of copies of the Resolutions, (i) to subscribe by written declaration (Zeichnungsschein) as attached hereto as Annex 2.4 for all (and not portions) of their respective Series B Investors 2020 Shares set out in Annex 2.1(a) and (ii) to send to the Corporation two (2) originals of their respective signed written declaration (Zeichnungsschein). |
2.5 | Within 5 (five) Banking Days after subscribing for the Series B Investors 2020 Shares, each Series B Investor 2020 shall pay the respective Issue Amount for its Series B Investors 2020 Shares in cash by bank transfer free of bank charges to the following account of the Corporation (the “Corporation Bank Account”): |
Bank: Deutsche Bank AG, Stuttgart
Account Holder: CureVac AG
IBAN: DE96 6407 0085 0034 6361 00
BIC: DEUTDESS640
The Corporation shall confirm without undue delay to each Series B Investor 2020 and to the Existing Shareholders in written form (Textform) in accordance with § 126b BGB the receipt of each and every Issue Amount payment by the respective Series B Investor 2020.
2.6 | The Corporation warrants that the Corporation Bank Account is a separate account which does not show a negative balance and will not be debited until the registration of the Series B Capital Increase 2020 with the Corporation’s commercial register. |
2.7 | The Corporation is obliged to submit to the commercial register the application for the registration of the Resolutions together with the application of the execution (Durchführung) on the Series B Capital Increase 2020 (including the respective amendments to the Articles reflecting the Series B Capital Increase 2020) without undue delay, but not later than two (2) Banking Days after the complete Issue Amount has been received in accordance with Section 2.5 above. In connection with this, also in circumstances where interim orders (Zwischenverfügungen) are issued, without undue delay the Parties shall take all necessary actions and make all necessary statements so that the above Series B Capital Increase 2020 is entered into the commercial register of the Corporation. The Parties undertake (also in the sense of an obligation binding them to exercise their voting rights in a prescribed manner) to take all necessary steps and make all necessary declarations which are required in order to wholly implement all of the provisions in this Section without delay in accordance with its spirit and purpose. The Corporation shall confirm the registration of the Series B Capital Increase 2020, and shall provide a copy of the respective registration notice of the commercial register, without undue delay to the Series B Investors 2020 and to the Existing Shareholders in written form (Textform) in accordance with § 126b BGB. |
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2.8 | Upon registration of the Series B Capital Increase 2020 the Shares in the Corporation will be held as follows: |
Shareholder | Number of Shares | Series of Shares |
Nominal Amount (in EUR) |
dievini Hopp BioTech holding GmbH & Co. KG |
585,537 | B | 585,537 |
dievini Hopp BioTech holding GmbH & Co. KG |
13,926 | A | 13,926 |
Dr. Ingmar Hörr | 8,400 | C | 8,400 |
Dr. Ingmar Hörr | 85 | A | 85 |
Dr. Florian von der Mülbe | 6,100 | C | 6,100 |
Dr. Florian von der Mülbe | 62 | A | 62 |
Dr. Wolfgang Klein | 1,919 | A | 1,919 |
Prof. Dr. Friedrich von Bohlen und Halbach | 1,818 | A | 1,818 |
Dr. Hans Christoph Tanner | 1,414 | A | 1,414 |
Prof. Dr. Hans-Georg Rammensee | 40 | B | 40 |
Prof. Dr. Hans-Georg Rammensee | 1,415 | A | 1,415 |
Prof. Dr. Günther Jung | 50 | B | 50 |
Prof. Dr. Günther Jung | 2,526 | A | 2,526 |
Bill & Melinda Gates Foundation | 23,321 | B | 23,321 |
Bill & Melinda Gates Foundation | 235 | A | 235 |
SMI | 11,710 | B | 11,710 |
Vanguard 1 | 12,600 | B | 12,600 |
Vanguard 2 | 1,452 | B | 1,452 |
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Shareholder | Number of Shares | Series of Shares |
Nominal Amount (in EUR) |
Jupiter | 2,927 | B | 2,927 |
Jupiter (Series B Investors 2020 Shares) |
1,319 | B | 1,319 |
Harborside | 5,855 | B | 5,855 |
Harborside (Series B Investors 2020 Shares) | 1,319 | B | 1,319 |
Vico | 4,684 | B | 4,684 |
Vico (Series B Investors 2020 Shares) |
3,741 | B | 3,741 |
ELMA | 2,342 | B | 2,342 |
ELMA (Series B Investors 2020 Shares) |
7,482 | B | 7,482 |
Chartwave | 2,342 | B | 2,342 |
Chartwave (Series B Investors 2020 Shares) |
3,741 | B | 3,741 |
Chelt Trading | 2,342 | B | 2,342 |
Chelt Trading (Series B Investors 2020 Shares) |
1,316 | B | 1,316 |
L-Bank | 5,855 | B | 5,855 |
LBBW AM | 6,557 | B | 6,557 |
LBBW AM (Series B Investors 2020 Shares) |
2,992 | B | 2,992 |
Lilly | 21,078 | B | 21,078 |
Genmab A/S | 16,345 | B | 16,345 |
KfW (Series B Investors 2020 Shares) |
224,466 | B | 224,466 |
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Shareholder | Number of Shares | Series of Shares |
Nominal Amount (in EUR) |
GSK (Series B Investors 2020 Shares) |
112,233 | B | 112,233 |
QIA (Series B Investors 2020 Shares) |
44,893 | B | 44,893 |
FCP (Series B Investors 2020 Shares) |
14,964 | B | 14,964 |
1,161,403 |
The Corporation shall without undue delay, but not later than within two (2) Banking Days after the Series B Capital Increase 2020 has been registered with the commercial register, update the Corporation’s share register (Aktienregister) duly reflecting the shareholding of the Series B Investors 2020 Shares by the Series B Investors 2020 and shall provide a respective copy of this updated share register to the Series B Investors 2020 and to the Existing Shareholders.
3. | Capital Reserves Payment |
3.1 | In addition to the payment of the Issue Amount for each Series B Investor 2020 Share, the Series B Investors 2020 undertake vis-à-vis each other and to the Existing Shareholders, but not to the Corporation, which shall not have any claim in its own right to receive this amount (kein Vertrag zugunsten Dritter) pursuant to § 328 BGB, to make an additional payment in the amount of EUR 558,861,343.00 (in words: five hundred fifty eight million eight hundred sixty one thousand three hundred forty three Euros) into the free capital reserve of the Corporation pursuant to § 272 para. 2 no. 4 HGB (the “Series B Capital Reserves Payments 2020”) as follows: |
Series B Investor 2020 | Series B Capital Reserves Payment 2020 |
KfW | EUR 299,774,343.00 |
GSK | EUR 149,887,171.50 |
QIA | EUR 59,954,601.50 |
FCP | EUR 19,984,422.00 |
Jupiter | EUR 1,761,524.50 |
Harborside | EUR 1,761,524.50 |
Vico | EUR 4,996,105.50 |
ELMA | EUR 9,992,211.00 |
Chartwave | EUR 4,996,105.50 |
Chelt Trading | EUR 1,757,518.00 |
LBBW AM | EUR 3,995,816.00 |
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3.2 | The Series B Capital Reserves Payments 2020 shall be due for payment to the Corporation Bank Account within fifteen (15) Banking Days after the registration of the Series B Capital Increase 2020 with the Corporation’s commercial register and notification thereof by the Corporation to the respective Series B Investor 2020 in written form (Textform) in accordance with § 126b BGB as set out in Section 2.7 above. The Corporation shall without undue delay (unverzüglich) confirm to each Series B Investor 2020 and to the Existing Shareholders in written form (Textform) in accordance with § 126b BGB the receipt of each and every Series B Capital Reserves Payment 2020 by the respective Series B Investors 2020. |
3.3 | Under the condition precedent (aufschiebende Bedingung) that a Series B Investor 2020 has not paid its Series B Capital Reserves Payment 2020 in accordance with the provisions set forth in Sections 3.1 and/or 3.2 above (in such case, the “Breaching Series B Investor 2020”), such Breaching Series B Investor 2020 hereby declares to transfer and assign its Series B Investors 2020 Shares to a community by undivided shares (Bruchteilsgemeinschaft) of the Existing Shareholders in proportion to their respective shareholding in the Corporation for this purpose disregarding the shareholdings of the Breaching Series B Investor 2020 as follows: |
Existing Shareholder | Shareholding in the Corporation |
dievini Hopp BioTech holding GmbH & Co. KG | 80.68% |
Dr. Ingmar Hörr | 1.14% |
Dr. Florian von der Mülbe | 0.83% |
Dr. Wolfgang Klein | 0.26% |
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Existing Shareholder | Shareholding in the Corporation |
Prof. Dr. Friedrich von Bohlen und Halbach | 0.24% |
Dr. Hans Christoph Tanner | 0.19% |
Prof. Dr. Hans-Georg Rammensee | 0.20% |
Prof. Dr. Günther Jung | 0.35% |
Bill & Melinda Gates Foundation | 3.17% |
SMI | 1.58% |
Vanguard 1 | 1.70% |
Vanguard 2 | 0.20% |
Jupiter | 0.39% |
Harborside | 0.79% |
Vico | 0.62% |
ELMA | 0.32% |
Chartwave | 0.32% |
Chelt Trading | 0.32% |
L-Bank | 0.79% |
LBBW AM | 0.88% |
Lilly | 2.84% |
Genmab A/S | 2.20% |
~ 100% |
(the “Existing Shareholders’ Community”) provided, however, that the shareholdings set forth above for dievini and BMGF, respectively, shall be adjusted to reflect the shareholdings of those two Shareholders if, either prior to or after the occurrence of the above condition, BMGF has received from dievini 1/3 of the dievini Tranche II Series B Shares pursuant to Section 17.5(c) below. Each of the Existing Shareholders hereby declares acceptance of such transfer and assignment. The Breaching Series B Investor 2020 is not entitled to any compensation whatsoever from the Existing Shareholders in case of such transfer and assignment.
3.4 | If the Breaching Series B Investor 2020 within ten (10) Banking Days after the condition precedent set forth in Section 3.3 above has been fulfilled |
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(a) | pays its respective Series B Capital Reserves Payment 2020 to the Corporation Bank Account, the Existing Shareholders are obliged to (re-) transfer and (re-) assign their respective portions in the Existing Shareholders’ Community equaling such Series B Investors 2020 Shares to the Breaching Series B Investor 2020 without undue delay. |
(b) | does not pay its respective Series B Capital Reserves Payment 2020 to the Corporation Bank Account in its entirety, the Existing Shareholders are obliged to transfer and assign such pro rata portions in the Existing Shareholders’ Community equaling with such Series B Investors Shares 2020 individually to the non-breaching Series B Investors in relation to the respective non-breaching Series B Investors 2020 shareholdings in the Corporation. If (at all) required, the Existing Shareholders and the non-breaching Series B Investors 2020 agree to consider a surplus settlement (Spitzenausgleich) in the course of such transfer. |
3.5 | Regardless of the transfer and assignment applicable in accordance with Sections 3.3 and/or 3.4 above, the respective Breaching Series B Investor 2020 shall bear any and all reasonable costs, fees and expenses (including, for the avoidance of doubt, all reasonable costs, fees and expenses incurred by each Existing Shareholder) in connection with such (re-) transfers and (re-) assignments of Series B Shares of the Breaching Series B Investor 2020. Any transfer and assignment set forth in Sections 3.3 or 3.4 above is deemed a Permitted Transfer in accordance with Section 17.1 below. |
4. | Legal Title Warranties |
By means of independent guarantees which apply regardless of fault (selbständige und verschuldensunabhängige Garantieversprechen) pursuant to § 311 para. 1 BGB and exclusively regarding the Shares each of them holds before the Series B Capital Increase 2020, the Existing Shareholders (the “Title Guarantors”), and (i) for Section 4.2 the Parties 1 and 5 only, and (ii) for Section 4.6, dievini only, each warrant vis-à-vis each of the Series B Investors 2020 that the statements set forth in Sections 4.1 to 4.6 below are correct at the time of the signing of this Agreement and of the time of the registration of the Series B Capital Increase 2020 with the commercial register of the Corporation. The Parties are in agreement that the warranties in this Section 4 do not constitute warranties as to the quality of the object (Beschaffenheit der Sache) within the meaning of §§ 443 and 444 BGB and that the provisions set forth in § 442 BGB and § 377 HGB shall not apply, neither directly nor by analogy.
4.1 | The statements in Preamble (E), Sections 1.1, 1.4 and 1.5 in relation to the Corporation and the Existing Shareholders’ shareholdings are true, complete and correct. The respective Shares have been validly issued to the respective Existing Shareholder; the respective original capital contributions (Grundkapitaleinlagen) have been paid up in full by and have not been returned – neither directly nor indirectly – to the respective Existing Shareholder. The respective Existing Shareholder does not have any liabilities in respect of repayments of capital. |
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4.2 | The statements in Section 1.2 in relation to CureVac B.V. are true, complete and correct. The respective shares have been validly issued to Dr. Franz-Werner Haas; the respective original capital contributions (Grundkapitaleinlagen) have been paid up in full by and have not been returned – neither directly nor indirectly – to Dr. Franz- Werner Haas. Dr. Franz-Werner Haas does not have any liabilities in respect of repayments of capital. |
4.3 | With regard to their respective Shares, each relevant Existing Shareholder has full power and authority to enter into and perform this Agreement and this Agreement constitutes valid and binding obligations of the respective Existing Shareholder in accordance with the terms herein. |
4.4 | Except for the shares held by Dr. Ingmar Hoerr pledged to Privatbank Berlin the respective Existing Shareholder is the sole and unrestricted owner of the Shares set forth in the row with his name in Section 1.5 above. Except for the shares held by Dr. Ingmar Hoerr pledged to Privatbank Berlin the respective Shares held by such Existing Shareholder are free of rights of third parties of whatever kind (in particular rights of lien, pledge or other Encumbrance, trusteeships, sub-participations, silent partners’ holdings, rights of first refusal, purchase rights, options, earn-outs etc.), and no rights exist to the granting of such rights or to the transfer of shares in the Corporation, however, always subject to the provisions set forth in this Agreement. Except as disclosed in this Agreement there are no obligations with regard to the Shares and no option agreements in relation to the acquisition of Shares. |
4.5 | Except for the shares held by Dr. Ingmar Hoerr pledged to Privatbank Berlin and except as disclosed in this Agreement each Existing Shareholder is not, nor has he/it committed to become, a party to any agreement binding him/it for the time after conclusion of this Agreement in any way to dispose of or encumber his/its respective Shares in the Corporation in any circumstance, or exercise the rights arising from such Shares in any way, except to another Shareholder or as provided for in the Articles and in this Agreement. |
4.6 | No tax-detrimental direct or indirect changes of ownership in the Shares of the Corporation or its subsidiaries with respect to Shares held by dievini have occurred until the date hereof. |
5. | Business Warranties |
5.1 | By means of independent guarantees which apply regardless of fault (selbständige und verschuldensunabhängige Garantieversprechen) pursuant to § 311 para. 1 BGB, the Managing Shareholder hereby warrants vis-à-vis each Series B Investor 2020 that the following statements are true, complete and correct at the time of the signing of this Agreement and - except as provided below and subject to changes in the ordinary course of business - of the time of the registration of the Series B Capital Increase 2020 with the commercial register of the Corporation. The Parties are in agreement that the warranties in this Section 5 do not constitute warranties as to the quality of the object (Beschaffenheit der Sache) within the meaning of §§ 443 and 444 BGB and that the provisions set forth in § 442 BGB and § 377 HGB shall not apply, neither directly nor by analogy. |
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5.2 | Corporate status |
(a) | The Corporation is a stock corporation (Aktiengesellschaft, AG), lawfully established pursuant to the statutory law of the Federal Republic of Germany and exists in accordance with applicable law. The current excerpt of the Corporation’s commercial register with the local court of Stuttgart for registration number HRB 754041 dated 15 July 2020 reflects fully and accurately all of the Corporation’s corporate details, which require registration, and no corporate measures requiring registration have been taken or occurred, which are not duly reflected therein. |
(b) | Aside from 100% of the share capital in (i) CureVac Inc., a Subsidiary to the Corporation, incorporated under the laws of Delaware/USA and having its registered offices in Boston (Massachusetts/USA) and (ii) CureVac Real Estate GmbH, a Subsidiary to the Corporation, incorporated under the laws of Germany, having its registered offices in Tübingen (Germany) and registered with the commercial register at the local court in Stuttgart under HRB 757523, the Corporation does not hold, neither directly nor indirectly, (or through an escrow agent (Treuhänder)) any shares, partnership interests, memberships or equity interests (including silent partnerships and sub-participations) in other companies or enterprises, and it is not obligated to acquire such shares, partnership interests, memberships or equity interests. The agreements of the Corporation with its subsidiaries have been entered into and carried out at arm’s length. The split-off (Ausgliederung) into CureVac Real Estate GmbH has, to the Knowledge of the Managing Shareholder, been effected as set out in the corresponding binding tax ruling. To the Knowledge of the Managing Shareholder, insofar all relevant filing and holding terms (Melde- und Haltefristen) have been observed. |
(c) | The financing of the Corporation on the basis of this Agreement does not trigger any payment obligations of the Corporation which are not provided for in this Agreement. |
(d) | With the exception of the VESOP (as defined below), potential future stock option programs and the rights defined in Section 5.2(e), there are no silent partnerships, loans with profit participation or other types of participations in the results of the Corporation, in particular there are also no agreements between the Corporation on the one hand and (i) to the extent not disclosed in Annex 5.2(d), present and/or former employees or (ii) the Existing Shareholders or (iii) persons/companies closely associated with Existing Shareholders on the other hand regarding participation in turn-over or profits or liquidation proceeds, or earn-out agreements. |
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(e) | With the exception of (i) existing option rights of Dr. Ingmar Hoerr and Dr. Florian von der Mülbe vis-à-vis the Corporation under option agreement dated 25 July 2012 (public deed of the notary Marius Meier in Basel, Switzerland), option agreement dated 17 February 2009 (deed-roll no. Notariat IX Mannheim 312/2009 of the notary director Dr. Rainer Preusche), as well as of the former managing director Dr. Wolfgang Klein vis-à-vis the Corporation under option agreement dated 17 February 2009 (deed-roll no. Notariat IX Mannheim 312/2009 of the notary director Dr. Rainer Preusche) and option agreement dated 25 July 2012 (public deed of the notary Marius Meier in Basel, Switzerland, not numbered) to acquire Shares in the Corporation in the nominal amount of altogether EUR 5,282.00 for a purchase price of EUR 1.00 per Share, and (ii) the convertible loan with Mr. Dietmar Hopp dated 24 October 2019 and the amendment agreement on the convertible loan with Dietmar Hopp dated 25 June 2020 disclosed in Annex 5.2.(e) no convertible bonds, option rights or similar rights exist which impose an obligation on the Corporation to issue new shares, transfer existing Shares or to grant voting rights to any third party. |
(f) | The Corporation is not a party to any enterprise agreement (Unternehmensverträge) within the meaning of §§ 291, 292 AktG. |
(g) | Except for the agreements listed in Annex 5.2(g), the Corporation is not a party to a joint venture agreement, where it is under any obligation to make equity related co-funding or equity contribution payments or otherwise relating to a partnership or form of equity participation. |
(h) | Except for the current service contract with the Managing Shareholder, the advisory agreement between the Party under no. 4 and the Corporation dated June 20, 2018, the advisory service agreement between the Corporation, Universitätsklinikum Tübingen and Prof. Dr. Georg Rammensee dated 15 February 2008 and the Global Access Agreement between the Corporation and BMGF effective 13 February 2015, the Definitive Agreement (#3) and Project Collaboration Plan for Nanoparticle Strategies for Next Generation Vaccine candidates for RSV/hMPV effective 18 March 2015, the Framework Agreement between BMGF and CureVac effective 11 December 2013, the Definitive Agreement and Project Collaboration Plan for Assessment of RNA Vaccine Technology for Non-live Rotavirus Vaccines in Pre-clinical Models effective 15 May 2014, the Definitive Agreement (#2) and Project Collaboration Plan for Testing the Nearest Neighbor Approach to active Vaccination for HIV-1 bNAbs effective 1 April 2014, the Grant Agreement (Investment ID OPP1160582) for Messenger RNA vaccine candidates for diseases with a disproportionate negative impact on smallholder farmers and their families effective 17 November 2016, the Grant Agreement (Investment ID OPP1179263) for Malaria vaccine candidates based on novel antigen-encoding mRNA effective 27 November 2017 and the Grant Agreement (Investment ID OPP1181063) for Universal Influenza vaccine based on novel antigen-encoding mRNA effective 27 November 2017, the Collaboration and License Agreement between the Corporation and Genmab B.V. effective 19 December 2019 as well as the Termination Agreement between the Corporation and Eli Lilly effective 26 June 2020 by which (i) the License and Collaboration Agreement between the Corporation and Eli Lilly, effective 13 October 2017, (ii) the Early Clinical Phase Supply Agreement between the Corporation and Eli Lilly effective 5 July 2018 and (iii) the Quality Agreement between the Corporation and Eli Lilly, effective 29 June 2018 have been terminated, there are no further contracts or legal transactions between the Corporation on the one hand and an Existing Shareholder, a relative of an Existing Shareholder within the meaning of § 138 par. 1 German Insolvency Act (Insolvenzordnung – “InsO”) (“Relative”) or an Affiliate of an Existing Shareholder on the other hand except material transfer agreements (i.e. agreements dealing with the supply of substances and physical materials) and confidentiality agreements that have, respectively, been each concluded in the ordinary course of business and at arm’s length. |
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5.3 | Financial Statements, Contracts |
(a) | The annual financial statements as per 31 December 2019 (the “Financial Statements”) have been formally approved by the Corporation’s supervisory board (Aufsichtsrat) and were prepared in accordance with the applicable accounting rules and, in particular, the generally accepted principles of accounting (Grundsätze ordnungsmäßiger Buchführung - GOB) consistent with past practice regarding their formal organization and measurement (unter Wahrung formeller under materieller Bilanzkontinuität). Specifically, all accounting and valuation principles, methods and rules were retained and all options to capitalize or to include items on the liabilities side (Aktivierungs- und Passivierungswahlrechte) were consistently applied. |
(b) | The Financial Statements present a true and fair view of the liabilities, net assets (Vermögenslage), financial condition (Finanzlage) and results of operation (Ertragslage) of the Corporation. |
(c) | With the exception of retentions of title and security rights customary in the ordinary course of business, the Corporation is entitled to the full and unencumbered ownership of its current economic assets, free of all third party rights, in particular security rights, rights of lien, encumbrances, restrictions on alienation and restrictions on the ownership position. |
(d) | Except as listed in or attached as Annex 5.3(d), the Corporation and its Affiliates do not own any real estate and the use of the property rented by the Corporation does not infringe any applicable legal provisions. |
(e) | Apart from usual wear and tear, the Corporation’s items of property are serviceable for their respective current period of use. |
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(f) | All Material Contracts of the Corporation are listed in or attached as Annex 5.3(f). “Material Contracts” are (i) those contracts relating to the financing of the Corporation with equity capital or loan capital and (ii) contracts existing on the date hereof which establish current or future obligations of the Corporation of more than EUR 1,500,000.00 in value with the exception of general indemnifications (allgemeine Ersatzpflichten) agreed upon in licensing or service agreements in the ordinary course of business. To the Knowledge of the Managing Shareholder, as of the day hereof, (i) there are no reasons in the sphere of the Corporation preventing the Corporation from fulfilling its obligations under the Development and Option Agreement with Acuitas Therapeutics Inc. (“Acuitas”) or the Framework Agreement with CEPI, and (ii) there are no facts in the sphere of the Corporation or information from the contractual partners indicating a premature termination of the respective agreement by Acuitas or CEPI. |
(g) | Since the balance sheet date of the Financial Statements, the Corporation and its business have been managed with the care of a diligent businessman (Sorgfalt eines ordentlichen Geschäftmannes) and in all material respects in the same manner as prior to the balance sheet date of the Financial Statements. To the Knowledge of the Managing Shareholder, since the balance sheet date of the Financial Statements no business transaction outside the ordinary course of business and no Material Adverse Change has occurred. |
(h) | To the Knowledge of the Managing Shareholder there was and as at the time of the signing of this Agreement there is no Charitability Default. The Corporation has not been informed that a Charitability Default has occurred nor that it has not complied with and fulfilled all of its other obligations under and in connection with the Global Access Commitments (incl. the Global Access Agreement). To the Knowledge of the Managing Shareholder there are no specific facts and circumstances based on which a Charitability Default is likely to occur. The Corporation has undertook and still undertakes its best efforts to prevent the occurrence of a Charitability Default. |
5.4 | Litigation |
To the Knowledge of the Managing Shareholder and except as set forth in Annex 5.4 as of the date of this Agreement the Corporation is not a party to court proceedings, where a notification of such court proceedings has been received by the Corporation, including such pending in front of an administrative court, and proceedings have neither been threatened nor are - to the Knowledge of the Managing Shareholder - to be expected on the basis of specific circumstances.
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5.5 | Solvency |
Irrespective of the negative equity reflected in the balance sheet as of 31 December 2019 the Corporation is neither over-indebted (überschuldet) nor unable, or threatened to become unable, to pay its debts when due (zahlungsunfähig) within the meaning of §§ 16 through 19 InsO, and there is no reason or legal obligation to apply for insolvency proceedings in accordance with the provisions set out in the InsO.
5.6 | Compliance |
To the Knowledge of the Managing Shareholder, in the past the business operations of the Corporation have been conducted in accordance with the authorizations and permissions granted to it as well as complying with applicable statutory law and are currently so conducted at the date of this Agreement.
5.7 | Intellectual Property |
(a) | Annex 5.7(a) contains a true, complete and accurate list of the Registered Corporation-Owned IPR and any related disclosures. “Registered Corporation-Owned IPR” means registered patents, registered utility models, registered trademarks and service marks, registered designs, domain names (including any application for any of the same) owned by the Corporation anywhere in the world. “Corporation-Owned IPR” means (i) the Registered Corporation-Owned IPR and (ii) all other (non-registered) intellectual property rights of any kind which are used by the Corporation under and in connection with its Object of Business (in particular copyrights and Know-How). “Know-How” means, know how, formulas, recipes, trade secrets, technical data, production, testing and quality control of the past and present products and technology of the Corporation. |
(b) | To the actual Knowledge of the Managing Shareholder, the Corporation owns and has a legal and valid right to use all Corporation-Owned IPR. Annex 5.7(b) contains a list of all commercial license agreements under which the Corporation has granted commercial rights to third parties to use Corporation-Owned IPR. All such agreements are in force, valid and at arm’s length, unless otherwise provided for in the Annex 5.7(b). No Corporation-Owned IPR is held by any Shareholders, their respective Affiliates or members of the Supervisory Board or the Management Board of the Corporation. |
(c) | To the Knowledge of the Managing Shareholder, all material Know-How necessary for the Corporation’s business as it is currently conducted has been reasonably documented (either physically or digitally) in such way that the Corporation still has or will have access to such Know-How even if the original knowledge bearer of the relevant Know-How permanently has left or will leave the Corporation. |
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(d) | To the Knowledge of the Managing Shareholder, except for the action listed in Annex 5.7(d) no action is pending in any court or national or international patent, trademark or other intellectual property office challenging the validity, enforceability or the Corporation’s ownership of any Corporation-Owned IPR. To the Knowledge of the Managing Shareholder all maintenance, renewal and other official fees due in respect of the Registered Corporation-Owned IPR have been paid and other mandatory formalities have been complied with to avoid expiration. The Corporation-Owned IPR are free and clear of all liens and of any royalty or commission rights of third parties. To the Knowledge of the Managing Shareholder, there are no claims pending or threatened in writing that a third party has infringed any Corporation-Owned IPR. |
(e) | To the Knowledge of the Managing Shareholder, there are no claims pending with regard to any Licensed-In IPR nor are – to the Knowledge of the Managing Shareholder – claims threatened in writing with regard to any Licensed-In IPR. To the actual Knowledge of the Managing Shareholder the Licensed-In IPR necessary for the conduct of the Corporation’s business as it is currently conducted are validly licensed. Annex 5.7(e) contains a complete and accurate list of all license agreements under which the Corporation is licensed to use Licensed-In IPR. |
(f) | To the Knowledge of the Managing Shareholder, (i) the Corporation-Owned IPR and the Licensed-In IPR are sufficient and adequate and freely available for the Corporation to perform after the date of this Agreement in the same way that it did before that date and (ii), as per the date of this Agreement, the Corporation is in a position to expand its Corporation-Owned IPR in a manner required to pursue its Object of Business after the date of this Agreement. |
(g) | All inventions of current and former employees, members of the Management Board or of the Supervisory Board of the Corporation which were made in the course of and in relation to their employment with, or service for, the Corporation were assumed by the Corporation (in particular, in accordance with the German Law on Employee Inventions (Arbeitnehmererfindungsgesetz)) in such a way that the employee or the member of the Management Board or of the Supervisory Board, as the case may be, can neither exploit nor prevent the Corporation from exploiting or enjoying the use of such invention. |
(h) | The hardware, software, communication systems, networks and other information technology used by the Corporation (the “IT Systems”) are owned by the Corporation or are licensed, leased or supplied under customary and valid third party contracts (the “Third Party IT Contracts”).To the Knowledge of the Managing Shareholder, neither the Corporation nor any other parties to the Third Party IT Contracts are in material default of the terms of any of the Third Party IT Contracts and there are no existing disputes under any such Third Party IT Contracts. During the twelve (12) months before the date of this Agreement the IT Systems were not subject to any failure and/or data loss with negative effects on the business of the Corporation nor are there any defects which could lead to such failure or data loss. The Corporation has not received any written notice alleging that it has failed to comply with any applicable data protection laws in relation to the operation of the business of the Corporation. |
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5.8 | Tax |
To the Knowledge of the Managing Shareholder, (i) all tax and other returns and reports required to be filed by or on behalf of the Corporation and its Subsidiaries have been filed with the appropriate authorities in all jurisdictions in which such tax and other reports and returns are required to be filed, and (ii) all such tax and other returns and reports were, at the time of such filing, in material compliance with all laws and rules applicable thereto. To the Knowledge of the Managing Shareholder, all taxes that have become due and payable by the Corporation and its Subsidiaries have been fully and timely paid or fully provided for.
6. | Legal consequences of breach of warranty |
6.1 | If and to the extent that |
(i) | one of the legal title warranties given pursuant to Section 4 above proves to be incorrect, not fulfilled or not complied with, by means of restitution in kind (Naturalrestitution), the Title Guarantor who has breached the legal warranty shall, and / or |
(ii) | one of the business warranties given pursuant to Section 5 above proves to be incorrect, incomplete, not fulfilled or not complied with, by means of restitution in kind (Naturalrestitution), the Managing Shareholder shall, |
put each of the Series B Investors 2020 in the position they would have been in if the respective warranty had been properly fulfilled or complied with or had been correct by creating the conditions corresponding to the warranty. If restitution in kind is not possible or does not take place within two (2) weeks after receipt of the corresponding written request from any of the Series B Investors 2020, each of the Series B Investors 2020 may instead demand monetary damages pursuant to §§ 249 et seq. BGB to be payable to the respective Series B Investor 2020 or, at their choice, to the Corporation in such amount as is necessary to reinstate the Series B Investors 2020 or the Corporation in such position as they would have been in had the respective warranty been (i) properly fulfilled or complied with or (ii) correct. Neither the Title Guarantors nor the Managing Shareholder shall be liable, and the Series B Investors 2020 shall not be entitled to bring any claims under or in connection with this Section 6, to the extent that the facts giving rise to the respective claim (anspruchsbegründende Tatsachen) of the respective warranty that has been breached have been truly and fairly and in a reasonably specific manner disclosed in the Corporation’s data room dedicated to the Series B Investors 2020 as of 15 July 2020, midnight (CET).
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6.2 | Liability Cap |
(a) | The liability of the Title Guarantors is, in the case of BMGF, limited to the lesser of (i) the BMGF Funds (as defined below in Section 8 below) or (ii) to the aggregate amount of the Series B Investors 2020 investment (Issue Amount multiplied with the number of Series B Investors 2020 Shares plus Series B Capital Reserves Payment 2020), and in the case of the other Title Guarantors limited to the lesser of (i) the sum of the respective Existing Shareholders investment (i.e., issue amount and capital reserves payments as set forth in the respective investment and shareholders’ agreement) or (ii) to the amount of the aggregate Series B Investors 2020 investment (Issue Amount multiplied with the number of Series B Investors 2020 Shares plus Series B Capital Reserves Payment 2020) (the “Liability Cap”). |
(b) | The Managing Shareholder’s liability to (as the case may be) the Series B Investors 2015, the Series B Investors 2016, the Series B Investor 2017, the Series B Investor 2019 and the Series B Investors 2020 for any and all breaches of business warranties set out in the investment and shareholders’ agreement dated 2 October 2015, the investment and shareholders’ agreement dated 14 October 2016, the investment and shareholders’ agreement dated 13 October 2017, the investment and shareholders’ agreement dated 18 December 2019 as well as pursuant to Section 5 of this Agreement is limited to a maximum liability sum (Haftungshöchstgrenze) of EUR 250,000.00 (in words: two hundred fifty thousand Euros) in aggregate. As per the date of this Agreement, neither a Series B Investor 2015 nor a Series B Investor 2016, nor the Series B Investor 2017 or the Series B Investor 2019 has raised any claims vis-à-vis the Managing Shareholder as a consequence of a (potential) breach of business warranties under the investment and shareholders’ agreement dated 2 October 2015, the investment and shareholders’ agreement dated 14 October 2016, the investment and shareholders’ agreement dated 13 October 2017 and/or the investment and shareholders’ agreement dated 18 December 2019. |
(c) | The Liability Cap and the limitation of liability set forth in Section 6.2(b) shall not apply in cases of fraudulent misrepresentation and gross negligence. |
6.3 | Claims arising from a breach of the warranties given in this Agreement may only be enforced against the relevant guarantor if the total damage resulting from such specific breach exceeds a threshold (Freigrenze) of EUR 100,000.00 (in words: one hundred thousand Euros), but if it does exceed that figure, then it may be enforced in the full amount and not simply the excess above EUR 100,000.00 (in words: one hundred thousand Euros). |
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6.4 | Claims arising from the warranties pursuant to Sections 4 and 5 above shall become time-barred within twenty-four (24) months after registration of the Series B Capital Increase 2020 in the commercial register of the Corporation. |
7. | Undertakings |
7.1 | Any Shareholder shall be entitled to receive any information which has been provided by the Corporation or CureVac NL to any of the other Shareholders, and the Corporation or CureVac NL shall provide any such information automatically to the respective other Shareholders at the same time. |
7.2 | The Corporation and CureVac NL shall reasonably cooperate with any Shareholder to provide such Shareholder with such information as requested by such Shareholder as permitted by law and applicable stock exchange rules to complete such Shareholder’s audit of its holdings in the Corporation or CureVac NL within one hundred and twenty (120) days after the end of each fiscal year. |
7.3 | No later than sixty (60) days following the end of each taxable year of the Corporation, the Corporation shall provide details of the Corporation’s capitalization and shareholders as of the end of the last day of such taxable year to each of the Mutual Fund Investors. In addition, the Corporation shall provide each of the Mutual Fund Investors with access to such other Corporation information as may be necessary (i) for each of the Mutual Fund Investors to determine the status of the Corporation or any of the Corporation’s Affiliates as a “controlled foreign corporation” (“CFC”) as defined in the U.S. Internal Revenue Code of 1986, as amended (or any successor thereto) (the “Code”) and (ii) to determine whether each of the Mutual Fund Investors or their respective Affiliates is required to report its pro rata portion of the Corporation’s Subpart F Income on its United States federal income tax return, or to allow each of the Mutual Fund Investors or their respective Affiliates to otherwise comply with applicable United States federal income tax laws. The Corporation and the Existing Shareholders shall not, without the written consent of each of the Mutual Fund Investors issue or transfer stock in the Corporation to any investor if, following such issuance or transfer the Corporation, in the determination of counsel or accountants for any of the Mutual Fund Investors, (such opinion also to be addressed to the Corporation), would be a CFC. For the purposes of this Section 7.3, the term “Affiliates”, with respect to any Mutual Fund Investor, shall include but not be limited to any person that receives, whether directly or indirectly, investment management or investment advisory services from such Mutual Fund Investor, or any of such party’s respective Affiliates. |
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7.4 | In connection with a “Qualified Electing Fund” election made by any of the Mutual Fund Investors, (being, for the purposes of this Section 7.4, the “PFIC Investors” and “PFIC” a “passive foreign investment company” within the meaning of Section 1297 of the Code) pursuant to Section 1295 of the Code or a “Protective Statement” filed by any of the PFIC Investors pursuant to U.S. Treasury Regulation Section 1.1295-3, as amended (or any successor thereto), with respect to the Corporation or any Subsidiary, the Corporation shall provide annual financial information regarding the Corporation and any such Subsidiary to each of the PFIC Investors in the form attached as Schedule 1 (which shall be signed by an officer of the Corporation or such Subsidiary, as applicable) as soon as reasonably practicable following the end of each taxable year of any of the PFIC Investors (but in no event later than ninety (90) days following the end of each such taxable year), and shall provide each of the PFIC Investors with such other information regarding the Corporation and any Subsidiary as may be required for purposes of filing U.S. federal income tax returns in connection with such “Qualified Electing Fund” election or “Protective Statement”; provided that the reasonable expenses incurred by the Corporation in connection with the foregoing information obligations shall be borne by each of the PFIC Investors pro rata based on the relative ownership of such Parties. Each of the PFIC Investors, or their respective direct or indirect beneficial owners, as applicable, who has made a “Qualified Electing Fund” election must include in its gross income for a particular taxable year its pro rata share of the Corporation’s earnings and profits pursuant to Section 1293 of the United States Internal Code of 1986, as amended (or any successor thereto). To the extent in compliance with German stock corporation law, and further provided that the provisions in Section 10.5 and 16 of this Agreement shall prevail, the Corporation agrees to declare and pay a dividend distribution to such of the PFIC Investors (no later than sixty (60) days following the end of such PFIC Investor’s taxable year or, if later, sixty (60) days after the Corporation is informed by such Party, that such Party or its Affiliate has been required to recognize such an income inclusion) in an amount equal to 50% (fifty percent) of the amount that would be so included by such PFIC Investor, if such PFIC Investor were a “United States person” as such term is defined in Section 7701(a)(30) of the U.S. Internal Revenue Code and had such PFIC Investor made a valid and timely “Qualified Electing Fund” election that was applicable to such taxable year. In the event any dividend is paid pursuant to this Section 7.4, a like dividend shall be paid to all other Shareholders. |
7.5 | Notwithstanding any statutory or contractual information rights set forth herein, the Corporation shall furnish to the Mutual Fund Investors such other information as is reasonably requested: |
(a) | by such Mutual Fund Investor to value the Corporation’s securities for purposes of such Mutual Fund Investor’s valuation, disclosure or reporting obligations under Applicable Fund Law; |
(b) | to value the Corporation’s securities for purposes of such Mutual Fund Investor’s valuation, disclosure or reporting obligations (if any) under the Investment Company Act (as amended) and regulations promulgated thereunder. |
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For the avoidance of doubt, and in addition to any information rights that a Mutual Fund Investor may have pursuant to the terms of this agreement (including but not limited to those rights set out in Sections 7.1 and 7.2 above), the Corporation agrees to provide to a Mutual Fund Investor the information set out in Sections 15.1(a), 15.1(b) and 15.1(c) below (in each case on the same timetable as set out in the applicable Section).
7.6 | In the event that any of the Corporation’s Affiliates is determined by counsel or accountants for each of the Mutual Fund Investors to be subject to the reporting requirements of either or both of Sections 6038 and 6038B of the Code, the Corporation agrees, upon a request from such Party, to provide such information to such Party as may be necessary to fulfill such Party’s obligations thereunder. |
The Corporation shall not, and the Corporation shall to the extent legally practicable cause any Affiliate under its control and shall use its best efforts to cause each of their respective directors, officers, board (supervisory and management) members, employees, independent contractors, representatives or agents not to, make, directly or indirectly, any payment or promise to pay, or gift or promise to give or authorize such a promise or gift, of any money or anything of value, directly or indirectly, to: (a) any “foreign official” (as such term is defined in the United States Foreign Corrupt Practices Act (the “FCPA”)) for the purpose of influencing any official act or decision of such official or inducing him or her to use his or her influence to affect any act or decision of a governmental authority; or (b) any “foreign political party” or official thereof or “candidate for foreign political office” (as defined in the FCPA) for the purpose of influencing any official act or decision of such party, official or candidate or inducing such party, official or candidate to use his, her or its influence to affect any act or decision of a foreign governmental authority, in the case of both (a) and (b) above in order to assist the Corporation or any of its Affiliates to obtain or retain business for, or direct business to the Corporation or any of its Affiliates, as applicable. The Corporation shall to the extent legally practicable ensure that none of its Affiliates under its control and shall use its best efforts to ensure that none of their respective directors, officers, board (supervisory and management) members, employees, independent contractors, representatives or agents shall make any bribe, rebate, payoff, influence payment, kickback or other unlawful payment of funds or received or retained any funds in violation of any law, rule or regulation. The Corporation further represents that it shall, and shall to the extent legally practicable cause each of its Affiliates under its control to, maintain systems of internal controls (including, but not limited to, accounting systems, purchasing systems and billing systems) to ensure compliance with the FCPA or any other applicable anti-bribery or anti-corruption law.
7.7 | Without limitation to any statutory information rights and any other information rights granted under this Agreement, the Corporation and CureVac NL, as the case may be, shall provide to KfW to the extent not prohibited by any mandatory law and applicable stock exchange rules (a) the information set out in Sections 15.1(a), 15.1(b) and 15.1(c) below (in each case on the same timetable as set out in the applicable Section) and (b) the information reasonably requested by KfW for the management and controlling of KfW’s shareholding in the Corporation or CureVac NL in order for KfW or any other of the institutions listed in the following sentence to comply with their respective obligations. In addition, the member of the Supervisory Board designated (nominiert) by KfW shall, to the extent not prohibited by any mandatory law and applicable stock exchange rules, be entitled to pass on, and discuss any information received in his or her capacity as a member of the Supervisory Board with (i) KfW, (ii) the federal ministry responsible for the supervision of the participation (currently the Federal Ministry for Economy and Energy (Bundesministerium für Wirtschaft und Energie)), (iii) the German Federal Ministry of Finances (Bundesministerium der Finanzen) and the (iv) Federal Audit Office (Bundesrechnungshof), in order for each of the foregoing to comply with their respective obligations mandatory by law or statute. The right of passing on and discussing information shall not apply to confidential information and business, operational and other secrets of the Corporation (or CureVac NL, as the case may be), if and to the extent such information is not necessarily required by any person listed in (i) to (iv) for compliance as further described in the previous sentence. Section 30.1, in particular the exemptions in Section 30.1 second sentence, shall apply accordingly. Within the scope of mandatory law or statute governing the Federal Audit Office and applicable stock exchange rules, the Federal Audit Office shall have its own audit right and the Corporation and CureVac NL shall enable the Federal Audit Office to carry out such audit and fully cooperate with the Federal Audit Office. |
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7.8 | Without limitation to any statutory information rights and in addition to any information rights that GSK and/or BMGF may have pursuant to the terms of this Agreement, the Corporation and CureVac NL, as the case may be, shall provide to GSK and to BMGF at their request and to the extent not prohibited by any mandatory law and applicable stock exchange rules, the information set out in Sections 15.1(a),15.1(b) and 15.1(c) below (in each case on the same timetable as set out in the applicable Section). |
7.9 | The Corporation and CureVac NL shall reasonably cooperate with each Shareholder to provide each such Shareholder in a timely manner with such information (including ad hoc information on the qualified Corporation’s financing and qualified M&A opportunities or information which is mandatory for tax purposes) as permitted by mandatory law and applicable stock exchange rules and required by the respective Investor to comply with its (or its Affiliates) statutory and regulatory obligations (including financial accounting requirements) or to fulfil information requests made by governmental authorities. Section 7.5 Sentence 2 shall apply to each Series B Investor 2016, the Series B Investor 2017, the Series B Investor 2019 and each Series B Investor 2020 accordingly. |
7.10 | Withholding tax on dividends (including constructive/deemed and other dividends) and on interest under and in connection with arrangements or contracts (such as sale and purchase agreements, swap agreements, loan agreements, rental agreements) entered into or existing before and until the consummation of the IPO or in connection with their implementation, amendment, unwinding or termination whether or not these occur before or after the IPO (i) which is paid by the Corporation or CureVac NL and (ii) which was not properly withheld by the Corporation or CureVac NL and (iii) which is creditable (anrechenbar) by, or reimbursable to, the Existing Shareholders or their respective Affiliates or related persons, shall be procured by the relevant Existing Shareholder to be reimbursed to the Corporation or CureVac NL (whichever paid the withholding tax) immediately after the respective Existing Shareholder, its Affiliate or related person has received the credit or reimbursement. Each Existing Shareholder has to use best efforts in order for the respective Existing Shareholder, its Affiliates or related persons, as the case may be, to obtain a credit or reimbursement. Related persons in the aforementioned sense are at least all direct or (calculated by multiplication of the respective shareholding quotas at each shareholding level) indirect shareholders of the Corporation holding at least 15 per cent of the direct and/or indirect shareholding. |
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For the purpose of this Section 7.10, BMGF’s compliance as an Existing Shareholder shall be voluntary.
III. Use of Funds, Cooperation between Corporation and BMGF
8. | Use of Funds |
The Parties agree that the Corporation shall use the proceeds from
(a) | BMGF’s payment into the Corporation’s capital reserves related to the BMGF Tranche I Series B Shares as well as an amount of USD 12,000,000.00 (in words: twelve million US-Dollars) from dievini’s payment into the Corporation’s capital reserves related to dievini Tranche II Series B Shares (the “BMGF Funds”) exclusively (i) to finance the new facility to be used inter alia to manufacture vaccines and drugs in support of BMGF’s Charitable Purpose (as defined in the Global Access Agreement), and/or (ii) for the continued development of the Corporation’s Platform Technology and use of the Platform Technology to advance vaccine and drug candidates in support of BMGF’s Charitable Purpose; |
(b) | Series B Investors 2020 to fund (i) the development of its proprietary pipeline, including earlier stage assets currently in preclinical development, (ii) research and development activities to expand its mRNA platform technology, in particular with respect to a vaccine fighting the COVID-19 pandemic and other infectious diseases and (iii) manufacturing capacities for mRNA-based drug product candidates and products. |
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9. | Global Access Commitments |
The Parties hereby acknowledge that the Corporation undertakes to support BMGF in its pursuit of its Charitable Purpose. The Parties agree that BMGF and the Corporation have entered into the Global Access Commitments set forth in the Global Access Agreement in the form as attached hereto as Annex 9 (the “Global Access Commitments”) and undertake vis-à-vis BMGF to BMGF (also in the sense of an obligation binding them to exercise their voting rights in a prescribed manner, if required) to take all necessary steps and action and make all necessary declarations which are required in order to cause the Corporation to wholly implement the obligations of the Corporation according to the Global Access Agreement. For the avoidance of doubt, this Section 9 does not require the other Shareholders to make any additional capital contributions or other payments or to incur any liability or assume any obligations beyond those in this Section 9.
10. | BMGF’S Right of Withdrawal |
10.1 | The Corporation and, as the case may be, CureVac NL, is required, to the extent permitted by § 71 AktG and any other statutory provision applicable in this context, at the request of BMGF to either |
(a) | acquire all Shares of the Corporation held by BMGF or its Affiliates as of the date of this Agreement including any securities issued as replacement of such Shares through a conversion or exchange or as the result of a dividend, share split, split-up, or other distribution with respect to such Shares (the “BMGF Shares” or “BMGF’s Shares”) at a purchase price equal to the greater of (x) the Fair Market Value (as defined below) times the number of BMGF Shares, or (y) the aggregate amount of the capital reserves made for the BMGF Shares (whether by BMGF or any other person) and the nominal amount of the BMGF Shares plus 0.5% p.a. interest on such amount from the time of the respective investment until the date of the purchase of the Shares (the “Minimum Purchase Price”) and/or |
(b) | facilitate the purchase of all Shares held by BMGF or its Affiliates by a third party at a price per Share no less than the Minimum Purchase Price in a transaction that complies with applicable law, |
if the Corporation commits a Charitability Default (as defined below) and the Charitability Default is not cured (the “Uncured Charitability Default”) within ninety (90) days after the Corporation receives notification of the Charitability Default from BMGF; the period of ninety (90) days shall be extended up to one hundred twenty (120) days if at the end of the period of ninety (90) days the Corporation demonstrates to BMGF that despite the Corporation’s reasonable best efforts to cure the Charitability Default during the initial cure period of ninety (90) days, additional time to cure the Charitability Default is necessary and that such cure is possible within an additional thirty (30) days. The Corporation and, as the case may be, CureVac NL, will use their reasonable and diligent efforts to fulfill its obligations under Section 10.1 as soon as reasonably practicable in the event of an Uncured Charitability Default.
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“Charitability Default” means any event in which the Corporation or, as the case may be, CureVac NL:
(i) | commits a material breach of the Global Access Commitments; |
(ii) | uses BMGF funds for purposes other than those set forth in Section 8 of this Agreement or uses BMGF funds in violation of Section 15 of the Global Access Agreement; or |
(iii) | fails to comply with the U.S. tax code-related obligations set forth in Sections 9, 11 and 13 of the Global Access Agreement. |
10.2 | In case of an Uncured Charitability Default and in case the obligation according to Section 10.1 cannot be fulfilled within four (4) months after the Uncured Charitability Default occurred, BMGF shall be entitled to sell and transfer its Shares to any Third Party chosen by BMGF. For the avoidance of doubt, any transfer of BMGF Shares in exercise of the withdrawal right pursuant to this Section 10 shall be a Permitted Transfer as defined in Section 17.1. The limitations set forth in Sections 17 and 18 below shall not apply to such sale and transfer, whereas, however, Section 19 below shall apply. |
10.3 | If the Corporation or, as the case may be, CureVac NL, is unable to redeem all of BMGF’s Shares because it is prohibited from doing so under applicable law, and the Corporation or, as the case may be, CureVac NL, is not able to provide the sales right pursuant to Section 10.1(b), then the Corporation or, as the case may be, CureVac NL, shall acquire as many of BMGF’s Shares as is legally permissible and continuously use its best efforts to effect the withdrawal right, consistent with applicable law, until such time as BMGF and its Affiliates no longer hold any Shares. Upon the transfer of any shares by BMGF to any one or more transferees that are tax-exempt organizations as described in section 501(c)(3) of the Code, BMGF may assign to any such transferee all of its rights attached to such Shares. |
10.4 | After execution of the investment and shareholders’ agreement dated 2 October 2015, the Shareholders (excluding the Series B Investors 2015) held an extraordinary shareholders’ meeting of the Corporation (Vollversammlung) waiving all statutory provisions and provisions of the Articles as to holding and convening a shareholders meeting and, in this shareholders’ meeting, have passed an unanimous shareholders’ resolution pursuant to § 71 para. 1 no. 8 AktG authorizing the Corporation for a period of five years to acquire all Shares held by BMGF or its Affiliates pursuant to Section 10.1(a) or as many of BMGF’s Shares as is legally permissible pursuant to Section 10.3 each for the Minimum Purchase Price. For the avoidance of doubt, the Shareholders hereby undertake not to pass any subsequent shareholders’ resolution resulting in a revocation of the authorization of the Corporation to acquire the Shares of BMGF according to Sections 10.1(a) or 10.3. The Shareholders hereby further undertake to pass a resolution renewing the authorization of the Corporation to acquire the Shares of BMGF according to Section 10.1(a) or 10.3 upon request of BMGF any time before or after the expiry of the authorization period. Correspondingly, after the NL Contribution, the Shareholders hereby also undertake vis-à-vis BMGF to resolve on and renew the authorization of CureVac NL to acquire BMGF Shares as required and permissible under Dutch corporate law. |
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10.5 | During the period when the Corporation or, as the case may be, CureVac NL, is unable to perform its obligation to redeem or find a purchaser of all of BMGF’s Shares, the Corporation or, as the case may be, CureVac NL, shall not pay dividends on any of its share capital, redeem the Shares of any other Shareholder of the Corporation or, as the case may be, CureVac NL, (other than repurchases at cost of Shares of the share capital from employees, officers, directors, consultants or other persons performing services for the Corporation or any Affiliate pursuant to agreements under which the Corporation has the option to repurchase such Shares upon the occurrence of the termination of employment or service) or otherwise make any other distribution to any other Shareholder of the Corporation in respect of the share capital held by such Shareholders. |
10.6 | The Corporation or, as the case may be, CureVac NL, shall pay all fees and expenses incident to the performance of or compliance with this Section 10 by the Corporation. |
10.7 | If BMGF’s Shares are sold or redeemed due to an Uncured Charitability Default, commencing upon the date of such sale or redemption, BMGF or its Affiliates will have a twelve (12) month look-back right by which, in the event of (i) a Change in Control (as defined below) that results in cash proceeds, or (ii) upon the closing of a firmly underwritten public offering of Shares of the Corporation or, as the case may be, CureVac NL, representing a per share valuation for the Corporation or, as the case may be, CureVac NL, in excess of 200% of the valuation used for the sale or redemption of BMGF’s Shares, BMGF will receive compensation equal to the excess of what it would have received in such transaction if it still held the Shares at the time of such Change in Control or public offering over what it actually received in the sale or redemption of the Shares had the Uncured Charitability Default not occurred. |
10.8 | For purposes of this Agreement, “Change in Control” means |
(a) | the acquisition after the date of this Agreement, directly or indirectly, by any person or group of the beneficial ownership of securities of the Corporation possessing more than 50% of the total combined voting power of all outstanding voting securities of the Corporation; |
(b) | a merger, consolidation or other similar transaction involving the Corporation, except for a transaction in which the Shareholders (or their respective Affiliates) of the outstanding voting securities of the Corporation immediately prior to such merger, consolidation or other transaction hold, in the aggregate, securities possessing more than 50% of the total combined voting power of all outstanding voting securities of the surviving entity immediately after such merger, consolidation or other transaction; or |
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(c) | the sale, transfer, license or other disposition (in one transaction or a series of related transactions) of all or substantially all of the assets of the Corporation to any person or group. |
10.9 | “Fair Market Value” of a Share means (i) if the Shares are Freely Tradable (as defined below), the closing price of a Share on the primary securities exchange on which the Shares trade on the most recent day such exchange was open for trading prior to the closing date of the purchase under this Section 10 and (ii) if the Shares are not Freely Tradable, the then current fair market value per share of the Shares as determined by an auditor mutually agreed upon by the Corporation or, as the case may be, CureVac NL, and BMGF (which agreement will not be unreasonably withheld) as an independent appraiser (Sachverständiger) with binding effect on the Parties. The appraiser shall value the Shares in accordance with the acknowledged valuation principles for company appraisals set forth by the Institut der Wirtschaftsprüfer e. V. in Düsseldorf (IDW-S1) and is required to record the results of his/her examination in a written report unless the Parties waive this requirement. If the Corporation or, as the case may be, CureVac NL, and BMGF cannot agree on the person of the appraiser within 10 Banking Days upon the written proposal of one of the Parties to the other, then the appraiser shall be appointed by the Chamber of Auditors at the request of one party. “Freely Tradable” means that the Shares are listed on a Recognized Stock Exchange and are not subject to restrictions from trading under applicable laws or the rules of such Recognized Stock Exchange and the Corporation is current in its filings with applicable securities regulatory agencies. |
10.10 | For the avoidance of doubt it is understood by the Parties that the validity of the Global Access Agreement and any project agreed on in connection with the Global Access Commitments shall continue regardless of a sale of BMGF's Shares pursuant to this Section 10 and BMGF shall continue to be entitled to enforce its rights under the Global Access Agreement and in relation to any agreed projects. Further for the avoidance of doubt, an exercise by BMGF of its rights under this Section 10 will cause BMGF to cease having any further obligations under this Agreement at such time as it no longer holds any Shares, except for the confidentiality obligations pursuant to Section 30, and Section 31.5 shall not apply. |
10.11 | The Corporation or, as the case may be, CureVac NL, will inform the Shareholders holding Series B Shares (the “Series B Shareholders”) without undue delay (unverzüglich) of (i) any notification of a Charitability Default from BMGF set forth in Section 10.1 above and the measures the Corporation has taken and/or will take to cure such Charitability Default within the time period set forth in Section 10.1 above and (ii) any Uncured Charitability Default set forth in Section 10.1 above. |
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10.12 | For the avoidance of doubt, the Shareholders shall not be liable for any payment BMGF is or could be entitled to receive from the Corporation under this Section 10. |
11. | ANti-Dilution and Downround Protection |
11.1 | In the event that subsequent to the Series B 2020 Capital Increase additional increases of the Corporation’s or CureVac NL’s registered share capital will be implemented, all Shareholders shall have the right to subscribe to new Shares, as the case may be, resulting from each new capital increase under the same terms and conditions under which the new Shares are issued and to such extent as is necessary to preserve the shareholding of the respective Shareholder in the Corporation or in CureVac NL prior to such new capital increase. If not all Shareholders exercise their respective subscription rights in a new capital increase that would lead to a third party acquiring control over the Corporation or CureVac NL, the Corporation or CureVac NL, will inform the other Shareholders who did exercise their respective subscription rights without undue delay by written notice about the number of Shares for which subscription rights have not been exercised and the respective Shareholders may acquire the remaining new Shares within ten (10) Banking Days after receipt of the written notice given by the Corporation or CureVac NL. If the Shareholders collectively express interest in acquiring more shares than the number of shares for which the subscription rights have not been exercised, they shall receive shares each on a pro-rata basis calculated by reference to their respective percentage holdings of Shares prior to the capital increase. |
11.2 | If within a period of 24 months after the registration of the Series B 2020 Capital Increase (“Exercise Period”) a financing of the Corporation or CureVac NL takes place based on a price per share less than the Share Price (such financing a “Down Round”) each Series B Investor 2020 is entitled to subscribe for as many new Shares to be issued at par value to the respective Series B Investor 2020 in the context of the Down Round as are required to ensure that the respective Series B Investor 2020 is put in the position as though the Series B 2020 Capital Increase had taken place at the lower per share price used in the Down Round (“Down Round Right”). Each Series B Investor 2020 may exercise the Down Round Right only once but, however, it is in the sole discretion of each of the Series B Investors 2020 either to exercise the Down Round Right at the time of and in the context of (i) the first Down Round or (ii) any later Down Round within the Exercise Period. The Parties undertake to take all necessary actions to facilitate the exercise of the Down Round Right. |
IV. Corporate Governance
12. | Management Board |
12.1 | The Corporation shall have a management board (the “Management Board” (Vorstand)), which shall have the powers and responsibilities specified herein and in the Articles. The Management Board is responsible for the management of the Corporation. |
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12.2 | The members of the Management Board of the Corporation (collectively, the “Directors”) (Vorstandsmitglieder) shall be appointed and removed by the Supervisory Board if not otherwise determined in the Articles. |
12.3 | Upon the NL Contribution becoming effective, Section 12.1 shall apply to any management board established at CureVac NL accordingly and members of the management board established at CureVac NL shall be appointed by the general meeting of shareholders of CureVac NL on the basis of a binding nomination by the supervisory board of CureVac NL. References to the “Management Board” throughout this Agreement shall also include such management board of CureVac NL. |
13. | Supervisory Board |
13.1 | The Corporation has a supervisory board (Aufsichtsrat) which consists of eight members (the “Supervisory Board”). |
13.2 | BMGF has the right to nominate (entsenden) (i) by written declaration to the other Shareholders a member of the Supervisory Board of the Corporation (and to remove such member of the Supervisory Board at its sole discretion) and (ii) a member of the Supervisory Board of CureVac NL, if the IPO of the Corporation or CureVac NL, as the case may be, at NASDAQ has not occurred on or before 30 September 2020. All Shareholders shall use their respective shareholders’ and other rights and influence to ensure that this nomination right will be implemented in all corporate and other documents and agreements including the Articles NL. Furthermore, the Parties shall to the extent legally permissible ensure that any established advisory board or any other comparable panel of a Subsidiary or Affiliate of the Corporation shall also give BMGF the right upon its discretion to include a member to be nominated (entsenden) in accordance with this Section 13.2. |
13.3 | KfW has the right to designate (nominieren) by written declaration to dievini (with a copy to the other Shareholders and the Corporation) one member of the Supervisory Board (and to prompt the recall of such member of the Supervisory Board at its sole discretion) as long as KfW’s shareholding in the share capital of the Corporation or CureVac NL is at least 10%. Furthermore, the Parties shall to the extent legally permissible ensure that any established advisory board or any other comparable panel of a Subsidiary or Affiliate of the Corporation shall also give KfW the right upon its discretion to include a member to be designated (nominieren) in accordance with this Section 13.3. If the IPO of the Corporation or CureVac NL, as the case may be, at NASDAQ has not occurred on or before 30 September 2020, this right shall be converted into a nomination right (Entsendungsrecht) and shall be re-converted back into a mere designation right (Nominierungsrecht) if and as soon as no other Shareholder has a nomination right (Entsendungsrecht). All Shareholders shall use their respective shareholders’ and other rights and influence to ensure that this nomination right will be implemented in all corporate and other documents and agreements including the Articles and Articles NL. |
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13.4 | The remaining members of the Supervisory Board shall be elected by the shareholders’ meeting by simple voting majority. |
13.5 | The Shareholders have the mutual understanding that Lilly, to the extent legally permissible, can be represented by a non-voting observer (“Observer”) in the Supervisory Board. The Observer shall be duly invited to attend and speak at meetings of the Supervisory Board. The Observer shall be suspended from attending the respective Board meetings regarding any discussions on agenda items/topics might cause a conflict of interest in relation on the part of Lilly and/or its Affiliates (e.g. esp. regarding the Corporation’s business activities and/or transactions with third parties); the threatening of such prohibitive conflict of interest shall be interpreted strictly and, already in case of substantiated doubt, shall lead to a suspension of the Observer on such agenda item/topic. Such Observer needs to be either a qualified employee or an external industry expert, in each case as designated by Lilly, and be bound to strict confidentiality obligations. |
13.6 | GSK shall have the right to be represented by an Observer in the Supervisory Board on the same terms and conditions as set out for Lilly in Section 13.5 (the “GSK Observer Option”), however, subject to the fulfillment of the following cumulative conditions: |
(a) | The IPO of Corporation or CureVac NL, as the case may be, at NASDAQ has not occurred on or before 30 September 2020; |
(b) | the respectively competent merger control authorities have cleared the exercise of the GSK Observer Option under the applicable merger control laws or have declared that the exercise of the GSK Observer Option is not subject to applicable merger control; and |
(c) | GSK has declared in writing vis-à-vis the Corporation or CureVac NL that it intends to exercise the GSK Observer Option. |
The Corporation undertakes to provide reasonable support to GSK in relation to the proceedings before the competent merger control authorities and to provide any information reasonably required for the filing in due time.
13.7 | The Parties agree that the Supervisory Board shall have the powers and responsibilities specified by applicable law, in the Articles and herein, namely for |
(a) | the appointment and removal of Directors; |
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(b) | the conclusion of service agreements with the Directors, including the terms of their compensation; |
(c) | the supervising and advising of the Directors; |
(d) | the adoption of the financial statement (Jahresabschluss) of the Corporation; |
(e) | the adoption of the annual budget of the Corporation; |
(f) | approvals of the matters relating to the Corporation’s virtual participation plan as set out further in Section 23; |
(g) | the adoption of rules of procedure for the Directors which contain inter alia transactions, which have significant impact on the business operations and/or the management of the Corporation, including but not limited to, taking up new lines of business and the termination or significant limitation of existing business lines or any significant transactions (Rechtsgeschäfte) between the Corporation on the one hand and on the other hand a Shareholder or a Shareholder’s Affiliate, which require the approval of the Supervisory Board; the Parties shall procure that as soon as reasonably possible after the registration of the Series B Capital Increase 2020 the Supervisory Board will adopt new rules of procedure for the Directors substantially in the form of Annex 13.7(g); |
(h) | the approval of other business transactions that, in terms of their financial volume, term, subject matter, or otherwise go beyond the usual scope of the Corporation’s transactions; and |
(i) | the approval of any envisaged Share transfers directly or indirectly to a Competitor or to an Affiliate of a Competitor. |
13.8 | By a simple majority, the Supervisory Board shall elect from amongst its members a chairperson and a vice-chair. If the office of a member of the Supervisory Board terminates before the expiry of its respective term specified in the Articles, the Shareholder that had nominated (entsandt) the original member shall without undue delay nominate (entsenden) a substitute member. If such nomination (Entsendung) has not occurred within two (2) weeks of a respective written request by Shareholders that hold in the aggregate 10% or more of the registered share capital of the Corporation, the substitute member shall be determined by shareholders’ resolution which is to be adopted with a simple majority of the votes cast. |
13.9 | The following persons currently serve as members of the Supervisory Board: |
(a) | Baron Jean Stéphenne |
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(b) | Prof. Dr. Friedrich von Bohlen und Halbach |
(c) | Dr. Mathias Hothum |
(d) | Dr. Ralf Clemens |
(e) | Dr. Hans Christoph Tanner |
(f) | Dr. Timothy M. Wright |
(g) | Craig A. Tooman |
13.10 | The Supervisory Board will meet a minimum of four (4) times a year, at meetings no less than once per calendar quarter. The Supervisory Board shall decide with simple voting majority. In case of a tie, the chairperson shall have the casting vote. |
13.11 | The members of the Supervisory Board shall receive remuneration for their service which amount is for every full fiscal year to be determined by a shareholders’ resolution. Furthermore, the members of the Supervisory Board shall receive reimbursement from the Corporation for their reasonable and documented expenses (in particular reasonable travel costs) incurred for the purposes of participating in meetings of the Supervisory Board as well as for participating in other meetings which are held at the request of the Supervisory Board. |
13.12 | The Supervisory Board may adopt a resolution, in particular by establishing rules of procedure for the Management Board to make certain additional actions of the Management Board contingent on such a reservation of approval by the Supervisory Board. |
13.13 | Upon the NL Contribution becoming effective, Section 13.1, Section 13.2, Section 13.3, Sections 13.5 through 13.8 and Sections 13.10 through 13.12 shall also apply accordingly to any supervisory board established at CureVac NL to the greatest extent legally permitted. References to “Supervisory Board” throughout this Agreement shall also include such supervisory board of CureVac NL. |
13.14 | The Shareholders shall procure that a supervisory board established at CureVac NL shall establish a special committee comprising, in any case, representatives of dievini and KfW (as long as dievini and KfW have designation rights). Such committee shall have the competence to decide on capital measures excluding subscription rights of the Shareholders as well as granting and exclusion of subscription rights whereby such measures shall not be taken without consent of dievini’s and KfW’s representatives (as long as dievini and KfW have designation rights). |
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14. | Shareholders’ Resolutions |
14.1 | Shareholders’ resolutions of the Corporation and of CureVac NL shall be passed by the respective Shareholders’ meeting in accordance with the provisions of the respective articles of association, the applicable laws and this Agreement. |
14.2 | Notwithstanding any applicable mandatory legal requirements, which must be met in any event in order to adopt the following fundamental measures, the Parties agree that any of the following measures will require the consent of dievini, BMGF and each of the Investors in order to be valid and effective: |
(a) | any steps taken or measures towards dissolving, liquidating or winding up the Corporation or CureVac NL, or cessation of all or a substantial part of the business of the Corporation or CureVac NL; |
(b) | any amendment to the rights, preferences or privileges of the Series B Shares; and |
(c) | any amendment to the Articles or Articles NL to the extent that any substantial rights of dievini, BMGF, and/or a Series B Investors as Shareholders are likely to be unfairly prejudiced, with “substantial” meaning a negative impact on the valuation of the respective Shareholder’s stake in the Corporation or CureVac NL. |
14.3 | The Parties agree that the restrictions in Section 14.2(c) shall not apply to any changes in the share capital structure of the Corporation or CureVac NL (e.g. a dilution of the respective Shareholder’s stake in the Corporation or CureVac NL in the course of subsequent financing rounds) observing Section 11 and/or an IPO that has been approved pursuant to the terms of Section 22.1. |
15. | Information Rights, Financial and Investment Planning |
15.1 | Notwithstanding any statutory information rights, the Corporation and CureVac NL shall furnish to the Supervisory Board: |
(a) | Immediately after receipt of the audit report, an audited financial statement (Jahresabschluss) of the Corporation and of CureVac NL as of the end of each fiscal year and the related audited statements of income, stockholders’ equity and cash flows for the fiscal year then ended, prepared in accordance with German (or Dutch in the case of CureVac NL) generally accepted accounting principles and certified by a firm of independent public accountants selected by the Management Board with approval of the Supervisory Board and a consolidated financial statement of the Corporation and/or CureVac NL to the extent legally required, together with the respective audit report(s); |
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(b) | not later than thirty (30) days prior to the start of each fiscal year, an annual operating plan for the Corporation and CureVac NL in respect of such fiscal year that shall include (i) monthly projections of profit and loss including a cash flow forecast and a balance sheet projection for such fiscal year, (ii) a business plan for the Corporation and CureVac NL relating to the succeeding fiscal year setting forth in reasonable detail a development plan, financial and investment plan, budgeted and projected figures and other information, and (iii) forecasts for the next succeeding fiscal year. The Supervisory Board will approve the planning by a simple majority; |
(c) | within thirty (30) days after each quarter in each fiscal year unaudited quarterly financial statements of the Corporation and CureVac NL as of the end of such quarter and the related unaudited statements of income, stockholders’ equity and cash flows for such quarter, prepared in accordance with German (or in the case of CureVac NL, Dutch) generally accepted accounting principles; |
(d) | at least by the middle of the year in each fiscal year an update to the annual operating plan including the matters set forth in Section 15.1(b) above showing the differences from the Corporation’s or CureVac NL’s annual operating plan as initially approved and the Corporation’s and CureVac NL’s actual results; and |
(e) | without unreasonable delay a prompt notice of (i) any material adverse event relating to the Corporation or to CureVac NL and (ii) any lawsuit, claim, proceeding or investigation pending or, to the knowledge of the Corporation or CureVac NL, threatened, or any judgment, order or decree involving the Corporation that would reasonably be expected to have a material adverse effect on the Corporation or on CureVac NL. |
16. | Profit Distribution, Retirement of Shares |
The Shareholders agree not to pass resolutions for distributions (Ausschüttungen) or dividends or any redemption (Einziehung) of Shares of the Corporation without the approval of BMGF at its discretion as long as the BMGF Funds that have been invested in the Corporation have not yet been used by the Corporation in accordance with the requirements of Section 8(a).
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V. Disposal of Shares
17. | Limit of Transferability |
17.1 | The sale (including by the way of share swap, contribution and merger), transfer, assignment, pledging, or any Encumbrance of Shares (as applicable) is deemed a “Share Transfer”. For the purposes of this Section 17, all Share Transfers set out in lit. (a) through (c) of Section 17.3 below shall be designated as “Permitted Transfers”. Notwithstanding any provision to the contrary in this Agreement, the Parties agree that no Shareholder may enter into or consummate, directly or indirectly, a Share Transfer to a Competitor or to an Affiliate of a Competitor without the prior written consent of the Supervisory Board of the Corporation or CureVac NL. |
17.2 | Other than in the case of a Permitted Transfer, a Shareholder who intends to transfer a part or all of his present or future Shares (the “Sale Shares”) with or without consideration (the “Selling Shareholder”) shall inform the Corporation or CureVac NL, respectively, and the remaining Shareholders (the “Remaining Shareholders”) by written notice (Schriftform) in accordance with § 126 BGB sent by courier letter via a highly reputed courier service (e.g. (but not limited to) DHL or FedEx) only (the “Registered Letter”) (collectively, the “Transfer Notice”). The Transfer Notice of the Selling Shareholder shall reflect, as far as possible, the following information: |
(a) | Name/company and address/registered office of the Selling Shareholder; |
(b) | Nominal amount and class (Series A, Series B, or Series C) of the Sale Shares as well as name/company and address/registered office of the prospective buyer; |
(c) | Purchase price and/or other consideration for the intended sale/transaction; |
(d) | Due date of the purchase price and/or other consideration; |
(e) | Representations and warranties undertaken by the Selling Shareholder. |
In the case of a Permitted Transfer (other than a Permitted Transfer made pursuant to Section 17.3(a) below in which case this Section 17.2(a) through 17.2(e) shall fully apply), the Shareholder who intends to make the Permitted Transfer shall inform the Corporation or CureVac NL, respectively, and the Remaining Shareholders by written notice (Schriftform) in accordance with § 126 BGB sent by Registered Letter (the “Permitted Transfer Notice”); such Selling Shareholder’s obligation in relation to the Remaining Shareholders is deemed to be complied with if the Registered Letters are dispatched to the addresses of the respective Remaining Shareholders set forth in this Agreement or – as the case may be – to such Remaining Shareholders’ new addresses as provided to the Selling Shareholder by Registered Letter. The Permitted Transfer Notice of the Selling Shareholder shall reflect the information set out in Sections 17.2(a) and 17.2(b) above.
17.3 | Other than as set out in this Section 17.3, a Share Transfer requires the Corporation’s or CureVac NL’s approval (by consent of the Management Board based on a Shareholders’ resolution in their discretion with a 100% majority of the votes cast) in order to be valid. The following Permitted Transfers shall not be subject to the restriction set out in phrase 1 of this Section 17.3, in each case provided that the relevant transferee executes an Accession Agreement to this Agreement (save if the relevant transferee is a Shareholder) and that such Share Transfer is otherwise made in accordance with the terms of this Agreement: |
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(a) | a Share Transfer where the Drag Along Right and any subsequent prerequisites set forth in Section 20 in relation to a Trade Sale have been properly observed as well as the Right of First Refusal (Section 19) and/or any Tag Along Right and any subsequent prerequisites set forth in Section 18 have been observed properly; it being understood that those shares transferred within the scope of the Share Transfer according to the aforementioned sentence pursuant to the Tag Along Right (Section 18), the Right of First Refusal (Section 19) and the Drag Along Right (Section 20) shall as well be permitted hereunder, |
(b) | a Share Transfer made pursuant to Section 17.5 and |
(c) | a Share Transfer by a Shareholder to an Affiliate, provided that such Affiliate remains an Affiliate of the original holder of the transferred Shares or other interests at all times while the restriction set forth in this Section remains effective. The Shareholders undertake to procure that the transferred Shares are re-transferred from the transferee to the original holder of the transferred Shares, if and when the transferee ceases to be an Affiliate of the original holder of the Shares. For the purposes of transfers to Affiliates pursuant to this Section 17.3(c), the Parties agree that each of the Baillie Gifford Entities and Baillie Gifford & Co (including its Affiliates), and any fund, company or corporate entity (such entities being professional financial investors comparable to the Investors listed as parties 11 through 13 hereto at the date of this Agreement) on whose behalf Baillie Gifford & Co (or any one of its Affiliates) manages funds (and, for the avoidance of doubt, does not solely provide investment advice or comparable services without managing funds), shall be deemed to be Affiliates of each other including (but not limited to) in cases where in the reasonable judgment of the relevant Baillie Gifford Entity a transfer pursuant to Section 17.5(d) is required to comply with the Investment Company Act, as amended, and regulations promulgated thereunder. |
17.4 | The provisions of Sections 17.1 and 17.3 apply accordingly to the granting of trusteeships, sub-interests, the establishment of silent companies and other encumbrances as well as the granting of rights favoring Third Parties to the Shares. |
17.5 | With respect to intra-group transfers of Shares, the Parties agree that Section 18 and Section 19 shall not apply to any transfers by dievini, BMGF, or any of the Investors (whether such transaction is with or without consideration) to any of their respective Affiliates (including those specified in Section 17.3(c) above, if applicable), or any beneficiary or any trust or any account or arrangement managed by dievini, BMGF, or any of the Investors (as applicable) or any entity of which the beneficiaries are the same group of people or entities as set out below, provided in each case, that the respective transferee has joined this Agreement in legal succession to the respective transferor, unless at that point in time the transferee will already be a party hereto. In particular, |
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(a) | dievini may at any time transfer all its Shares in whole or in part to a third party who is either a Relative or a member of the family of Mr. Dietmar Hopp, Walldorf, (the “Hopp Family”) or an entity, in which any member of the Hopp Family, or a Relative to a member of the Hopp Family or dievini (including its shareholders, their Relatives and the management board of dievini and, for the avoidance of doubt, the dievini management board members Prof. Dr. Christof Hettich and Dr. Friedrich von Bohlen also as private individuals) directly or indirectly has a decisive (bestimmend) influence on the third party or directly or indirectly has a decisive (bestimmend) interest in the third party; dievini will notify the Corporation or CureVac NL of any such assignment, including the identity of the assignee, in a timely manner. For the avoidance of doubt, if dievini transfers its Shares as permitted by this Section, all of dievini’s rights associated with such shares will also be transferred. |
(b) | BMGF may at any time transfer its Shares in whole or in part to a third party who is (i) a successor charitable organization of BMGF that is a tax-exempt organization as described in section 501(c)(3) of the Code, or (ii) a tax-exempt organization as described in section 501(c)(3) of the Code controlled by one or more trustees of BMGF. BMGF will notify the Corporation or CureVac NL of any such assignment, including the identity of the assignee, in a timely manner. For the avoidance of doubt, if BMGF transfers its Shares as permitted by this Section, all of BMGF’s rights associated with such shares will also be transferred. |
(c) | dievini may at any time transfer 1/3 of the dievini Tranche II Series B Shares to BMGF. |
(d) | Notwithstanding any provision to the contrary set forth in this Agreement, if any Mutual Fund Investor or its transferee is required by the Investment Company Act (including the rules and regulations promulgated thereunder) or the constitutive documents governing the transferring fund to dispose of some or all of their Shares, Section 18 shall not apply to such disposition. |
(e) | Jupiter and/or Harborside may at any time transfer all of their respective Shares in whole or in part to a third party who is either a Relative or a member of the family of Mr. José Coppel and Mr. Augustín Coppel, (the “Coppel Family”) or an entity, in which any member of the Coppel Family, or a Relative to a member of the Coppel Family or Jupiter and/or Harborside (including its shareholders, their Relatives and the management board of Jupiter and/or Harborside) directly or indirectly has a decisive (bestimmend) influence on the third party or directly or indirectly has a decisive (bestimmend) interest in the third party; Jupiter and/or Harborside, as the case may be, will notify the Corporation or CureVac NL of any such assignment, including the identity of the assignee, in a timely manner. For the avoidance of doubt, if Jupiter and/or Harborside transfers their respective Shares as permitted by this Section, all of Jupiter’s and/or Harborside’s rights respectively associated with such shares will also be transferred. |
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(f) | Chartwave may at any time transfer all its Shares in whole or in part to a third party, provided such third party is a party in which Chartwave has directly or indirectly a decisive (bestimmend) influence or a decisive (bestimmend) interest; Chartwave will notify the Corporation or CureVac NL of any such assignment, including the identity of the assignee, in a timely manner. For the avoidance of doubt, if Chartwave transfers its Shares as permitted by this Section, all of Chartwave’s rights associated with such shares will also be transferred. |
(g) | Each Series B Investor 2016, Series B Investor 2017, the Series B Investor 2019 and each Series B Investor 2020 may at any time transfer all its Shares in whole or in part to an Affiliate (however, for the purpose of this Section only, Baden-Württembergische Versorgungsanstalt für Ärzte, Zahnärzte und Tierärzte, Tübingen, the ultimate beneficial owner of the Fund, is deemed to be an Affiliate in relation to the Series B Investor 2016 and the Series B Investor 2020 LBBW AM) of the respective Series B Investor 2016, the Series B Investor 2017, the Series B Investor 2019 and the respective Series B Investor 2020 and / or a minority participation of the respective Series B Investor 2016, the Series B Investor 2017,the Series B Investor 2019 or the respective Series B Investor 2020, in which the respective Series B Investor 2016, the Series B Investor 2017, the Series B Investor 2019 or the respective Series B Investor 2020 directly has a decisive (bestimmend) influence, provided such Affiliate or such minority participation of the respective Series B Investor 2016, the Series B Investor 2017, the Series B Investor 2019 or the respective Series B Investor 2020 remains an Affiliate or minority participation as qualified above of the respective Series B Investor 2016, the Series B Investor 2017, the Series B Investor 2019 or the respective Series B Investor 2020 at all times while the restriction set forth in Section 17.3 remains effective. |
(h) | Vico may at any time transfer all its Shares in whole or in part to ELMA and vice versa. |
17.6 | The Parties agree that Section 18 and Section 19 shall not apply to any transfers of a Founder to an entity which is directly controlled (100%) by such transferring Founder, provided such entity joins this Agreement in legal succession to the particular Founder without said Founder’s personal obligations being affected thereby. However, each transferring Founder shall be each individually obliged to secure that the respective transferred Shares will have to be retransferred to the transferring Founder if the receiving entity is not an entity directly controlled by such Founder any more or if the shares in the receiving entity are pledged or encumbered. |
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17.7 | Each Shareholder acknowledges and agrees that the Shares have not been registered under the United States Securities Act (“Securities Act”). Accordingly, each Shareholder agrees that it, its Affiliates and any person acting on its behalf, will not offer, sell or otherwise transfer Shares within the United States except (i) pursuant to registration under, or (ii) pursuant to an exemption from, or in a transaction not subject to, the registration requirement of the Securities Act; for the purposes of this Section 17.7, the term “Affiliate” shall have the meaning set forth in Rule 405 under the Securities Act. |
17.8 | For the avoidance of doubt, to the extent that the approval for any Permitted Transfers pursuant to Sections 17.3(a) through 17.3(c) is required under either statute or the Articles, the Corporation or CureVac NL, respectively, (by consent of the Management Board) shall approve such Permitted Transfer, and shall take any additional actions as may be necessary to give effect to such Permitted Transfer. In such case, to the extent legally permissible, the Shareholders shall use all reasonable efforts to procure that the Corporation or CureVac NL, respectively, (by its Management Board) approves such Permitted Transfer; should the Corporation or CureVac NL refuse to grant its approval, the Shareholders undertake to hold an extraordinary shareholders’ meeting of the Corporation or CureVac NL waiving all statutory provisions and provisions of the Articles or Articles NL as to holding and convening a shareholders’ meeting without undue delay and, in this shareholders’ meeting, to pass an unanimous shareholders’ resolution prompting the Corporation or CureVac NL to grant the approval for the respective Permitted Transfer. |
18. | Tag Along Right |
In case one or several Shareholders together holding at least 50% of the Shares (in each case a “Tag Along Shareholder”) serve a Transfer Notice on the Remaining Shareholders about an intended transfer of Sale Shares to a Third Party (not qualifying as an intra-group transfer pursuant to Section 17.5) such that it or they would collectively – or, in the case of dievini, it would together with the Shares held by KfW – subsequently hold less than 45% of the Shares in the Corporation or CureVac NL, then such Tag Along Shareholder(s) shall ensure that the Remaining Shareholders shall have the right to sell along, transfer and/or swap their Shares in the Corporation or CureVac NL on the same economical terms – save for Section 21 if the prerequisites are met – agreed between the Tag Along Shareholder and the respective buyer to the respective Third Party buyer (the “Tag Along Right”). As part of the Tag Along Right the Tag Along Shareholder shall offer the Shares of which the co-sale is demanded (the “Co-Sale Shares”) to the respective Third Party buyer in addition to the Sale Shares. If, in addition to the Sale Shares, the respective Third Party buyer is not prepared to also acquire the Co-Sale Shares, at the request of the Shareholders having exercised their Tag Along Rights, the Tag Along Shareholder shall procure that the Sale Shares and the Co-Sale Shares are sold in proportion to the shareholding of the Tag Along Shareholder and the Shareholders having exercised their Tag Along Rights. The Tag Along Right shall be exercised by the relevant Shareholder by written notice (Schriftform) in accordance with § 126 BGB sent by Registered Letter to the Tag Along Shareholder within three (3) weeks after receipt of the Transfer Notice (as defined above) by the respective Shareholder. Section 19 shall remain unaffected.
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19. | Right of First Refusal |
19.1 | Each of the Investors, dievini and BMGF shall be entitled to purchase all of the Sale Shares on the same terms and conditions as stated in the Transfer Notice to have been negotiated between the Selling Shareholder and any Third Party as set forth in Section 17 (the “Right of First Refusal”) (Vorkaufsrecht) as set forth below. The Selling Shareholder who wished to transfer his Shares and who has negotiated with a Third Party a sale and transfer agreement shall send the purchase agreement to the Investors, to dievini and to BMGF. The Investors, dievini and BMGF may exercise their respective Right of First Refusal within three (3) weeks after receipt of the purchase agreement by written declaration. After such three (3) week period, the Selling Shareholder who wishes to transfer his Shares shall inform each Investor, dievini and BMGF whether the other Investors, dievini and BMGF exercised their respective Right of First Refusal. If not all Investors, dievini and BMGF exercised their respective Right of First Refusal, the Investors, dievini or BMGF who did exercise their respective Right of First Refusal may acquire the remaining Sale Shares within ten (10) Banking Days after receipt of the notice. In case that more than one Investor, dievini or BMGF intends to exercise his Right of First Refusal, each of the Investors, dievini and BMGF shall have the right to purchase the Sale Shares on a pro-rata basis, calculated by reference to their respective percentage holdings of Shares as per the date of the Transfer Notice. Should no Investor, dievini or BMGF exercise the Right of First Refusal within the aforementioned three (3) week time period, the Right of First Refusal is deemed not to be exercised. |
19.2 | The Right of First Refusal shall be exercised by written notice (Schriftform) in accordance with § 126 BGB sent by Registered Letter to the Selling Shareholder at its address as shown in the books of the Corporation. The Registered Letter shall be deemed to be received not later than five (5) Banking Days after the date on which it is mailed in case the acceptance is refused by the Selling Shareholder. The transfer restrictions set forth in Sections 17 and 18 shall remain unaffected by the provisions of this Section 19 (including the Right of First Refusal). |
19.3 | In case of a share swap the relevant consideration shall be the fair market value of the swapped Shares. For listed companies, the consideration corresponds to the share price on the day of the mailing of the Transfer Notice according to Section 17.1; for non-listed companies, the fair market value shall be determined by an auditor appointed unanimously by the Shareholders (if the Shareholders cannot agree on an auditor within fourteen (14) Banking Days, on request of either Shareholder the auditor shall be nominated by the Institut der Wirtschaftsprüfer e.V. in Düsseldorf). The same shall apply in case of any other consideration. |
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19.4 | In case that the procedures as set forth in Section 19.1 (Right of First Refusal) have been observed properly by the Selling Shareholder, and the Investors, and/or dievini and/or BMGF did not purchase all of the Sale Shares by way of the Right of First Refusal, the Selling Shareholder may within the following six (6) months freely dispose of such Shares that have not been purchased on conditions no less favorable for the Selling Shareholder than those outlined in the Transfer Notice. Section 17.3(a) through 17.3(c) above remain unaffected. |
19.5 | The rights of the Investors, of dievini and of BMGF under this Section 19 shall be exercisable among those of the Investors, dievini and BMGF electing to exercise any of such rights in proportion to their respective shareholdings at that time. |
19.6 | For the avoidance of doubt, the Right of First Refusal shall not apply to any Share Transfer in accordance with Section 10.1 above. |
19.7 | The Right of First Refusal shall apply mutatis mutandis to any proposed issuance of treasury shares (eigene Aktien) by the Corporation or CureVac NL to a Shareholder or to a Third Party unless resolved otherwise by the respective Shareholders’ meeting. |
20. | Trade Sale / Asset Deal / Drag along Right |
20.1 | In the event a buyer which is a bona fide Third Party, unrelated to the Shareholders, (i) intends to purchase (including by way of a share swap, contribution or merger) all or substantially all of the Shares (i.e., covering at least 85% of the Shares in the Corporation or CureVac NL) (the “Trade Sale”), or (ii) intends to enter into an Asset Deal or any measure pursuant to the German Transformation Act (Umwandlungsgesetz) in relation to the Corporation or respective applicable provisions under the Dutch law in relation to CureVac NL (the “Measure”) (the Trade Sale, the Asset Deal and the Measure each and collectively the “Exit-Transaction”), upon the written request (Schriftform) in accordance with § 126 BGB of the shareholder(s) holding (collectively) at least 85% of the Shares in the Corporation or CureVac NL, as the case may be, and intending to trigger the Exit-Transaction (together the “Exit Shareholder”) (or an Exit Shareholder’s Affiliate or a person or entity that falls under the definition set out in Section 17.5 that has taken over in each case the majority of the Exit Shareholder’s Shares) sent by Registered Letter to all Shareholders they shall be obliged to sell and transfer, swap or convert (e.g., mergers) on a pro-rata basis (relative ownership in the Corporation’s or CureVac NL’s share capital) and on the same economical terms (including accepting in-kind contribution) – save for Section 21 if the prerequisites are met – their shares to the bona fide Third Party, unrelated to the Shareholders, (the “Drag Along Right”) and/or to take up all other measures required to effect such Exit-Transaction. |
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20.2 | For purposes of Section 20.1 with respect to the Exit Shareholder, a bona fide Third Party, unrelated to the Shareholders, shall mean anybody not being a permitted transferee as set out in Section 17.5. |
20.3 | For the avoidance of doubt, the Shareholders agree that in the event of a Trade Sale pursuant to this provision, Section 19 (Right of First Refusal etc.) shall not apply. However, if one or more Shareholders - with the exception of the Exit Shareholder - or the Corporation or CureVac NL receive an offer by a bona fide Third Party, unrelated to the Shareholders, to enter into an Exit Transaction, the relevant Shareholder(s) and/or the Corporation or CureVac NL, as appropriate, shall as soon as practicable inform the Supervisory Board of the Corporation or CureVac NL (as the case may be) of the respective entity by written notice (Schriftform) in accordance with § 126 BGB sent by Registered Letter of such offer. The written notice provided to the Supervisory Board shall include the information according to Sections 17.2(a) and 17.2(c). The Supervisory Board will have twenty-five (25) Banking Days after it has been notified to discuss the offer by the bona fide Third Party, unrelated to the Shareholders, it being understood that before the expiry of this twenty-five (25) Banking Days period the Shareholders shall not enter into definitive agreements regarding the Exit Transaction. All Parties shall keep all information received in connection with the bona fide Third Party, unrelated to the Shareholders, offer and any counteroffer confidential. Section 30 shall apply mutatis mutandis. |
20.4 | The Remaining Shareholders may prevent the exercising of the Drag Along Right by the Exit Shareholder pursuant to Section 20.1 by declaring with written notice (Schriftform) in accordance with § 126 BGB within eight (8) weeks from receipt of the written request by the Exit Shareholder, which must include the buyer and the terms and conditions of the intended Exit Transaction sent by Registered Letter to the Exit Shareholder, that they either themselves and/or one or more of their Affiliate(s) and/or one or more other bona fide Third Party(ies), unrelated to the Shareholders, intend(s) to acquire the Shares from the Exit Shareholder which the Exit Shareholder intends to sell to a bona fide Third Party as described above, on the same terms and conditions that are offered by such bona fide Third Party, unrelated to the Shareholders, and by submitting sufficient proof of credit-worthiness. In so far as the acquisition is made in this case by one or more other bona fide Third Part(y)(ies), unrelated to the Shareholders, the Remaining Shareholders are liable as absolute guarantors, or provide other or additional forms of security as the Exit Shareholder may reasonably require, on a pro-rata basis for the fulfilment of the purchase price obligation of such other bona fide Third Party(ies), unrelated to the Shareholders, named by them. In order to enable the Remaining Shareholders to exercise the right under this Section 20.4, the Exit Shareholder will notify the other Shareholders, while upholding the justified confidentiality interests of a potential buyer, as early as possible about such negotiations for which the Exit Shareholder wants to trigger its Drag Along Right according to Section 20.1. |
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VI. Special Rights of Shareholders
21. | Allocation of Exit Proceeds |
21.1 | The following terms shall have the meaning ascribed to them as follows: |
(a) | “Total Investment” shall mean the sum of all contributions (including – if any - the conversion of shareholders’ (convertible) loans and respective interest accrued thereon) by a Shareholder and their legal successors in the equity (Eigenkapital within the meaning of § 272 HGB) of the Corporation (i.e., contributions in the stated capital including any premium (Agio) and/or other payments in the capital reserves of the Corporation according inter alia to § 272 para. 2 HGB) to the Corporation up to the Exit Event in connection with the issuance of the Series B Shares. In case a Shareholder has purchased and acquired existing Shares from another Shareholder, all contributions made in the equity with respect to such Shares shall no longer be attributed to the selling Shareholder and instead attributed to the acquiring Shareholder. |
(b) | “Exit Event” shall mean any of the following events, and “Exit Proceeds” shall mean the distributable proceeds derived from: |
(i) | A sale of more than 70% of the share capital of the Corporation to a Third Party (excluding those persons defined in Sections 17.5(a), and 17.5(b) as well as 17.5 (e) to 17.5(g)) as part of a share deal in a single transaction or a series of related transactions (including after exercising the Drag Along Right according to Section 20); |
(ii) | A sale of the total or a predominant part (minimum 70% of the market value) of the Corporation’s tangible and intangible assets (Wirtschaftsgüter) (calculated at fair market value) to a Third Party (excluding any person defined in Sections 17.5(a) and 17.5(b)) as part of an asset deal or a plurality of successive asset deals (“Asset Deal”), provided that in the event of successive transactions, the asset ratios at the time of the first individual transaction are to be used for calculating the definitive total rate of the above 70% threshold and then to add in relation thereof the rates of the following individual transactions for the assets existing at that time. To the extent that the Shareholders collect funds which derive from such individual transactions based on profit distributions by the Corporation, which do not take place by claiming the liquidation preferences, they are not required to provide them again to service the liquidation preferences; |
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(iii) | A share swap, contribution of shares or the assets of the Corporation, a merger or another act of conversion as part of the Conversion Act (Umwandlungsgesetz) with a Third Party (excluding any person defined in Sections 17.5(a) and 17.5(b) as well as in Sections 17.5(e) to 17.5(g)) under the condition that the Shareholders of the Corporation hold less than 50% of the voting rights in the new company as a result of such a transaction, provided that the so derived Exit Proceeds shall to the extent possible be distributed by transferring (if applicable after completion of the transaction between the former shareholders) shares that they have received as consideration for the Shares in the Corporation. If a transfer of such new company shares is not possible (for example, because they are subject to transfer restrictions), such shares which would be transferred pursuant to the previous sentence to the parties entitled to such Exit Proceeds are to be held on behalf of the parties entitled to them in trust (i.e., by disbursing the revenue from the relevant shares or their sale, but without impairing the other shareholder rights, in particular the voting right) by the parties obligated to distribute Exit Proceeds. Settling the Exit Proceeds in cash is not required in this case. The Investors, dievini and BMGF, however, may elect to cooperate in the fulfilment of the Series C Liquidation Preference (as defined below) by transferring shares or by holding in trust the relevant shares or by payment of a corresponding amount in cash. The exchange ratio definitive for the transaction itself will apply to the evaluation of the shares and accordingly the calculation of the Exit Proceeds as well as the shares to be assigned in consequence thereof; or |
(iv) | the liquidation of the Corporation. |
21.2 | In case of an Exit Event, subject to Section 21.5 the Shareholders hereby agree that the Exit Proceeds shall be allocated as follows: |
(a) | The Series B Shareholders will first receive from the Exit Proceeds 100% of their respective Total Investment (“Series B Liquidation Preference”), provided that in the case of an Exit Event pursuant to Section 21.1(b)(i) or economically similar cases in terms of Section 21.1(b)(iii), the Exit Proceeds to be distributed hereunder shall be reduced according to the percentage at which the Shares of the Corporation are not sold in the relevant Exit Event. If the Exit Proceeds are insufficient to completely satisfy the rights of the Series B Shareholders under the Series B Liquidation Preference, the Exit Proceeds will be distributed to the Series B Shareholders pro rata based on the proportion their Total Investment for the Series B Shares bears to the aggregate Total Investment for the Series B Shares in the Corporation. For the avoidance of doubt, the distribution in proportion to the Total Investment only applies to the Series B Liquidation Preference, but not to further proceeds to be distributed to all Shareholders according to their percentage of ownership upon the payment of all liquidation preferences as set out in the following lit. (b). |
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(b) | The remaining amount of the Exit Proceeds will be distributed among the Shareholders (including the Series B Shareholders) in proportion to their percentage of ownership in the Corporation as at the time of an Exit Event subject to the following Section 21.3. |
(c) | For the avoidance of doubt, a Series B Shareholder shall benefit from the Series B Liquidation Preference as set forth in Section 21.2(a) only if and to the extent such Series B Shareholder has (co-)sold its Series B Shares in an Exit Event. |
21.3 | The preferential rights of Series C Shares grant the following “Series C Liquidation Preference”, provided that in the case of an Exit Event pursuant to Section 21.1(b)(i) or economically similar cases in terms of Section 21.1(b)(iii), the key values of the following thresholds of EUR 223 million, EUR 780 million, and EUR [1,000 million] will be reduced by the percentage at which the shares of the Corporation are not sold in the context of the transaction(s) triggering the relevant Series C Liquidation Preference: |
(a) | If the Exit Proceeds are less than or equal to EUR 223 million, then the portion of Exit Proceeds which accrues to the owners of the Series C Shares after completion of the Series B Liquidation Preference from the Exit Proceeds shall be: | |
(Exit Proceeds - Series B Liquidation Preference) x percentage of ownership. |
(b) | If the Exit Proceeds exceed EUR 223 million, then the portion of Exit Proceeds which accrues to the owners of the Series C Shares after completion of the Series B Liquidation Preference from the Exit Proceeds exceeding EUR 223 million and up to (and including) EUR 780 million will be multiplied by a factor of 1.5 (“C.1 Liquidation Preference”), i.e., |
(EUR 223 million - Series B Liquidation Preference) x percentage of ownership
+ (Exit Proceeds - EUR 223 million) x percentage of ownership x 1.5
(c) | If the Exit Proceeds exceed EUR 780 million, then – in addition to the C.1 Liquidation Preference – the portion of Exit Proceeds which accrues to the owners of the Series C Shares after completion of the Series B Liquidation Preference from the Exit Proceeds exceeding EUR 780 million and up to (and including) EUR 1,000 million will be multiplied by a factor of 2 (“C.2 Liquidation Preference”), i.e., |
(EUR 223 million - Series B Liquidation Preference) x percentage of ownership
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+ EUR 557 million x percentage of ownership x 1.5
+ (Exit Proceeds - EUR 780 million) x percentage ownership x 2.
(d) | If the Exit Proceeds exceed EUR 1,000 million, then – in addition to the C.1 and C.2 Liquidation Preferences – the portion of Exit Proceeds which accrues to the owners of the Series C Shares after completion of the Series B Liquidation Preference from the Exit Proceeds exceeding EUR 1,000 million will be multiplied by a factor of 3 (“C.3 Liquidation Preference”), i.e., |
(EUR 223 million - Series B Liquidation Preference) x percentage of ownership
+ EUR 557 million x percentage of ownership x 1.5
+ EUR 220 million x percentage of ownership x 2
+ (Exit Proceeds - EUR 1,000 million) x percentage of ownership x 3.
(e) | To the extent that the Series C Liquidation Preference exceeds the amount to which the owners of Series C Shares would be entitled after complete satisfaction of the Series B Liquidation Preference without the Series C Liquidation Preference, the participation in Exit Proceeds by the owners of Series B Shares remaining after completion of the Series B Liquidation Preference will be reduced by this amount. |
(f) | The Corporation and the owners of the Series B Shares agree in each case to provide to the owners of the Series C Shares all necessary information required to present and calculate the Series C Liquidation Preference. Section 21.2(c) applies accordingly. |
21.4 | Examples of the complete distribution of various proceeds amounts are attached in Annex 21.4 to explain the above liquidation preferences. |
21.5 | If in an Exit Event a Shareholder does not (co-) sell all his Shares held in the Corporation as at that time but only a portion thereof, the Exit Proceeds to be distributed to such Shareholder under this Section 21 shall be reduced proportionately. |
22. | Initial Public Offering (IPO) and subsequent Measures |
22.1 | Upon request of a majority of the votes attaching to the Series B Shares, the Shareholders agree to use their collective best efforts to cause the Corporation or CureVac NL to effect an Initial Public Offering (the “IPO”) at a Recognized Stock Exchange. |
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22.2 | The terms of any such IPO (including the appointment of an internationally recognized investment bank to effect such an IPO) shall be determined by the Management Board, subject to the prior approval of the majority of all Shareholders. Each Shareholder agrees to take all such actions which are available to it in its capacity as a Shareholder to facilitate such IPO (including, but not limited to, voting with its Shares in favour of any proposal by the Management Board in connection with such IPO). For the avoidance of doubt, it is agreed that none of the Series B Shareholders shall be obliged to make any additional capital and/or other financial contributions and/or incur any liability (however, for the avoidance of doubt, not excluding a Major Shareholder’s Potential IPO Liability, as the case may be) for the purpose of an IPO. The Corporation and CureVac NL agree, subject to any restrictions imposed by any applicable law, to pay all the fees and expenses incurred in connection with any such IPO (it being understood that the Corporation shall not be liable for the payment of any underwriting commissions or discounts in connection with any such IPO with respect to Shares sold therein by or on behalf of any Shareholder). If the intended IPO is not completed (no first listing), the Parties hereto undertake to ensure that all steps and measures shall be implemented and consummated required to revise the Articles or Articles NL, as the case may be, formally and contentwise to put them essentially into a state they had in their material substance been (subject to legal and factual practicability) in at the date on which the Shareholders have resolved upon the kick-off of the IPO process in accordance with Section 22.1. |
22.3 | Each Shareholder shall be obliged to comply with all regulations, conditions and restrictions applicable to the stock exchange and the exchange segment concerned and take all measures required in order to procure and not block or prevent a listing of the Corporation’s or CureVac NL’s shares. |
22.4 | In the event that the stock exchange listing requires a restructuring of the Corporation (e.g., the transfer of the Shares to a foreign holding company, in particular in CureVac NL, in return for the issue of shares in that company), |
(a) | then all Shareholders and the Corporation are upon request of the relevant Investor, of dievini or of BMGF obliged to approve any such restructuring measures and to make all other declarations necessary for this purpose and to support all transactions to effect such restructuring, provided that the Shareholders shall not be obliged to make any additional capital or other financial contributions. In case a Shareholder will incur unreasonable tax disadvantages or other unreasonable liability as a consequence of the envisaged restructuring measure, the Shareholders shall discuss in good faith to find another way to implement the envisaged restructuring. |
(b) | the Parties agree that any Shares of the Corporation to be transferred to a foreign holding company, in particular into CureVac NL, shall be transferred on basis of their respective tax book value (Buchwert). In the context, the Parties also agree that the foreign holding company, in particular CureVac NL, shall file an application for continuation of tax book value (Antrag auf Buchwertfortführung acc. to Sec. 21 par. 1 second and third sentences German Tax Conversion Act - UmwStG) regarding the Shares of the Corporation to be transferred as set out above with the respectively competent tax authorities within four (4) months after the date of this Agreement at the latest. Furthermore, CureVac NL shall inform all other Parties as soon as the application has been filed. |
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22.5 | In particular the Management Board shall be obliged to subject themselves to and comply with all lock-up and corporate governance provisions which are required under the terms for the particular stock market listing procedure, the admission for trading on a specific stock exchange and/or on the specific market segment or by the underwriting agent in connection with the IPO, and upon request of any Shareholder the Management Board shall report on these provisions to the Shareholders. |
22.6 | Taking into account the potential exposure of any Shareholder holding at least 10% of any class of the Corporation’s and/or CureVac NL’s shares (each a “Major Shareholder”; with respect to KfW as long as qualifying as a Major Shareholder for purposes of this definition also including the Federal Republic of Germany (“Bund”)) in the event of an IPO at an US-stock exchange due to the size of each Major Shareholder’s investment, the following provisions for the benefit of each Major Shareholder shall apply: |
(a) | The Corporation and/or CureVac NL, as applicable, shall, and the Shareholders shall cause the Corporation and/or CureVac NL to, inform any Major Shareholder with respect to any IPO process (or subsequent SEC-registered offering process) and shall give any Major Shareholder access to the draft IPO documentation (or draft documentation in relation to any subsequent SEC-registered offering) including any additional notifications to the US Securities and Exchange Commission (“SEC”) (collectively, the “IPO Documentation”), if and to the extent this is reasonably requested by a Major Shareholder to evaluate its potential liability exposure arising from such Major Shareholder being a “control person” under applicable US securities-laws and related regulations (in each case, the “Major Shareholder’s Potential IPO Liability”). |
(b) | The Corporation and/or CureVac NL, as applicable, shall, and the Shareholders shall cause the Corporation and/or CureVac NL to, discuss and take into account any Major Shareholder’s input to the IPO Documentation if and to the extent such input is (i) in a Major Shareholder’s opinion directly related to the respective Major Shareholder’s Potential IPO Liability and (ii) furnished within two (2) business days after such IPO Documentation has been provided to the respective Major Shareholder (it being understood that any IPO Documentation provided to a Major Shareholder after 6 p.m. (CET) shall be deemed to have been delivered on the following business day) (the “Reaction Time Limit”) provided, however, that if CureVac NL is required by US securities law to make such filing within a time that is shorter than the Recation Time Limit, CureVac NL shall deliver such documents to the Major Shareholders with a written notice of the specific deadline that the Major Shareholders’ input is required in order for CureVac NL to comply with the US securities law. |
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(c) | The Corporation and/or CureVac NL, as applicable, shall, and the Shareholders shall cause the Corporation and/or CureVac NL to, provide, upon reasonable request of a Major Shareholder, such Major Shareholder with access to due diligence related documents to be provided relative to the IPO Documentation’s preparation and discuss with the Major Shareholder due diligence related questions, if and to the extent this is reasonably required by the Major Shareholder in its opinion to evaluate its respective Major Shareholder’s Potential IPO Liability. |
(d) | With respect to the IPO Documentation, an identification of a Major Shareholder by name or the mention of any agreements in which the Major Shareholder is participating shall be subject to such Controlling Shareholder’s prior consent (not to be unreasonably withheld). If a Major Shareholder does not communicate its decision to the Corporation or CureVac NL within the Reaction Time Limit, such Major Shareholder’s consent is deemed to have been granted. |
(e) | Upon its respective written request, any Major Shareholder shall be added to the prospectus liability insurance as amended by the Corporation in connection with the IPO, in any case, restricted to any Major Shareholder’s Potential IPO Liability (the “Major Shareholders’ Insured Risk”) as a named insured and the costs for such Major Shareholders’ Insured Risk shall be ultimately borne by the respective Major Shareholder. |
(f) | Section 30.1 shall apply accordingly. |
22.7 | In addition to the rights set out in Section 22.6 above, in the event of any future sale (after the IPO) by a Major Shareholder of all or part of the Shares held by it, any such Major Shareholder shall be provided with reasonable access to the management of the Corporation and CureVac NL for the purpose of due diligence by banks or potential investors, to the extent legally permitted. Section 30.1 shall apply accordingly. |
22.8 | Following the IPO and for as long as a Major Shareholder could be viewed as a “control person” within the meaning of applicable US securities laws, the Corporation or CureVac NL shall, if requested by a Major Shareholder, give such Major Shareholder access to drafts of SEC filings in connection with SEC reporting requirements, to the extent legally permitted and if and to the extent this is reasonably required by such Major Shareholder in its opinion to evaluate such Major Shareholder’s potential liability exposure under applicable US laws and regulations. The Corporation or CureVac NL shall, upon reasonable request of a Major Shareholder, discuss and take into account such Major Shareholder’s input to such SEC filings if and to the extent such input is in such Major Shareholder’s opinion (i) directly related to its potential liability in connection with such filings and (ii) furnished within the Reaction Time Limit. |
22.9 | Prior to the IPO, the Corporation and/or CureVac NL shall enter into a registration rights agreement with any Major Shareholder pursuant to which the respective Major Shareholder shall, until 90 days after such time as that Major Shareholder or any of its Affiliates own less than 10% of any class of the Corporation’s or CureVac NL’s Shares, be granted by the Corporation or CureVac NL, as the case may be, customary registration rights for the resale of the respective Shares held by a Major Shareholder or any of its Affiliates pursuant to an effective registration statement. Such registration rights shall include, subject to customary conditions and exceptions, among other things: |
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(a) | three (3) demands for registration on an SEC Form F-1 or S-1, as applicable, which demands may be exercised upon the earlier to occur of (i) two years after the date hereof and (ii) six months after the IPO is consummated; |
(b) | an unlimited number of demands by the respective Major Shareholder for registration on Form F-3 or S-3 (but up to three (3) such demands during any twelve (12) month period), as applicable, if the Corporation or CureVac NL is eligible to use such form for a registration statement; |
(c) | piggyback registration rights to participate pro rata in any registration statement filed by the Corporation or CureVac NL for itself or another holder, other than a registration statement in connection with the IPO; |
(d) | an undertaking by the Corporation and/or CureVac NL to use its reasonable best efforts to effect the registration so as to have the Registration Statement declared effective by the SEC and qualify the shares under any blue sky laws and bear all costs related thereto (other than any direct selling commission with respect to any shares placed in a sale pursuant to such registration); |
(e) | in connection with such registration rights, for the Corporation and/or CureVac NL to take all actions reasonably necessary or advisable to facilitate the disposition of Shares by the respective Major Shareholder and its Affiliates, including causing appropriate officers and employees to be available for meetings with prospective investors in presentations, meetings and road shows and |
(f) | customary indemnification by the Corporation and CureVac NL in favour of the respective Major Shareholder and its Affiliates with respect to any liabilities arising under securities laws for the sale of Shares and a reciprocal indemnity from the respective Major Shareholder to the Corporation or CureVac, as the case may be, with respect to the respective Major Shareholder’s provision of information in respect of any such registration statement (i) identifying the respective Major Shareholder, (ii) the respective Major Shareholder’s title to the Shares being registered and (iii) the respective Major Shareholder’s intended method of distribution, provided that in each of (i)-(iii) the aggregate amount of the liability of the respective Major Shareholder and its Affiliates in connection with such indemnity shall not exceed its and their net proceeds from sale. |
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VII. Employees and Management
23. | Participation Plan for Employees and Members of the Management Board |
23.1 | The Corporation has a virtual participation plan for members of the Management Board and other key employees (the “VESOP”) for a total of up to 60,175 participation rights corresponding (the “VESOP Total”) with 10% of the share capital of the Corporation as of 01 February 2015 in the amount of altogether EUR 601,750. Currently under the VESOP 60.175 virtual shares (Beteiligungspunkte) are issued. |
23.2 | The Parties are in agreement that other than mentioned above in Section 23.1 no further virtual shares and/or additional virtual option rights shall be issued under the VESOP. |
23.3 | The Parties further agree inter partes that economically any claims of any beneficiary under the VESOP of whatever kind (a “VESOP Entitlement”) shall be borne exclusively out of the shareholdings of the Existing Shareholders 2015 as set forth in this Section 23, as follows: |
(a) | the economic burden of any VESOP Entitlement shall be borne exclusively by the Existing Shareholders 2015; |
(b) | the Investors shall at no time be liable for any costs or expenses associated with or resulting from any VESOP Entitlement; |
(c) | the Existing Shareholders 2015 shall exercise all their voting rights and other direct or indirect powers of control in respect of the Corporation to ensure that the respective shareholdings of the Investors are not diluted by any VESOP Entitlement and |
(d) | the Existing Shareholders 2015, the Corporation and CureVac NL take the common view that any amounts paid or shares provided to the Corporation or CureVac NL in settlement of their respective obligations hereunder shall be considered as a tax neutral contribution (neutrale Einlage) on the level of the Corporation and CureVac NL. The Existing Shareholders 2015, the Corporation and CureVac NL shall be obliged to observe this approach when preparing their respective individual tax returns and – if challenged by the respectively competent tax authorities – shall defend this approach until a final and binding assessment (formell und materiell bestandskräftige Entscheidung) has been received provided that, however, only if and to the extent the filing and perpetuation of such remedies are commercially reasonable. The Existing Shareholders 2015 shall not deduct any amounts paid or shares provided under this Section 23.3 from any tax base unless such deduction does not infringe the tax neutral treatment at the level of the Cor-poration and CureVac NL as stipulated in sentence 1 of this Section (d). The Existing Shareholders 2015 shall procure a respective treatment at the level of their Affiliates and related persons, as applicable. |
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For the purpose of this Section 23.3(d), BMGF’s compliance as an Existing Shareholder 2015 shall be voluntary.
23.4 | For this purpose, in case of an exercise event under the VESOP the Existing Shareholders 2015 shall transfer Shares up to the maximum amounts set forth below to the Corporation in order to enable the Corporation to fulfill the claims of the beneficiaries under the VESOP. For the avoidance of doubt, by transferring their relevant Shares up to the maximum amounts set forth below, the Existing Shareholders 2015 shall have fully met their obligations under this Section 23 and the Existing Shareholders 2015 shall not be required to make any additional payments or transfer any additional Shares to the Corporation. |
Existing Shareholders 2015 | Maximum number of Shares that will be transferred | |||
Dievini | 55,766 | |||
Dr. Hörr | 789 | |||
Dr. von der Mülbe | 573 | |||
Prof. Dr. Jung | 240 | |||
Dr. Klein | 179 | |||
Prof. Dr. von Bohlen und Halbach | 169 | |||
Prof. Dr. Rammensee | 136 | |||
Dr. Tanner | 132 | |||
Bill & Melinda Gates Foundation | 2,191 |
23.5 | The Parties share the understanding that in case of a restructuring of the Corporation in preparation of an IPO (e.g., the transfer of the Shares to a foreign holding company in return for the issue of shares in that company as mentioned in Section 22.4) the obligation of the Existing Shareholders 2015 according to this Section 23.4 shall apply mutatis mutandis to the shares the Existing Shareholders 2015 receive in the course of such restructuring in return for the transfer of the Shares as defined in this Section 23.4. Notwithstanding Section 23.3(c) above, the number of Shares set forth above with respect to dievini and BMGF will be adjusted accordingly if BMGF has received from dievini 1/3 of the dievini Tranche II Series B Shares pursuant to Section 17.5(c) above. |
23.6 | The Shareholders agree to do everything necessary and possible so that the number of shares subject to a future participation plan (a “New VESOP”), being issued under the terms of such New VESOP are adapted to and shall at all times (unless otherwise approved by the shareholders meeting) be limited (together with the number of virtual shares issued under the VESOP) to 15% of the Corporation’s or CureVac NL’s share capital applicable following the Series B Capital Increase 2020, being EUR [174.210] (for the Corporation) less the VESOP Total. The additional (virtual) option rights that may be granted by increasing the amount of the virtual participation volume pursuant to sentence 1 of this Section 23.6 are intended for employees and members of the Management Board. The decision whether and to what extent this volume can and will be utilized is based on the sole and unfettered discretion of the Supervisory Board. An obligation by the Corporation to grant options therefrom will not be created; nor will there be any entitlement of the employees. |
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23.7 | Any Share Transfers of the Existing Shareholders 2015 in order to fulfill their respective obligations in relation to the VESOP as set forth in this Section 23 shall be deemed a Permitted Transfer in accordance with Sections 17.1 and 17.3; for the avoidance of doubt; Sections 18 through 20 shall not apply to the Share Transfers set forth herein. |
24. | Concentration of Business Activities/Non-Compete Obligation Management’s Obligation to Perform |
24.1 | With respect to their shareholdings in the Corporation or CureVac NL, each of the Parties under no. 4 and no. 5 agrees that until he exits as employee, advisor, member of management, Management Board or Supervisory Board of the Corporation or CureVac NL, shall during such period of time not form any other companies or businesses in the field of the Corporation’s Object of Business on his own or through third parties or take up any such participation on his own or through third parties or engage himself in any other way for such companies or businesses or persons except with the consent of a majority of Shareholders to be given on a case by case basis, which shall not be unreasonably withheld. |
24.2 | Subject to Section 24.7 the Parties under no. 4 and no. 5 are obliged for the duration of one (1) year calculated from the time they exit as employees, advisors, member of management, Management Board or Supervisory Board of the Corporation or CureVac NL, depending on which occurs later, that they will neither directly nor indirectly invest in a corporation in competition with the Corporation’s Object of Business, or work for such companies. |
24.3 | If the Corporation or CureVac NL, as applicable, does not waive the post-contractual non-compete obligation set out in Section 24.2 in writing with respect to the exiting party within one (1) month after receipt/declaration of termination, the exiting Party will receive compensation in the amount of the most recently drawn compensation (zuletzt bezogene vertragsmäßigen Leistungen) for the duration of the post-contractual non-compete provision. Any other revenue generated during this period is to be fully offset - except for investment income and social benefits. If this provision is legally impermissible, the amount of the compensation will be adjusted to the extent required. Related provisions on compensation are to be included in the employment or service contracts of the Managing Shareholder. |
24.4 | Restrictions on the non-commercial activity of the Founders as scientists are not associated with the above non-compete provisions. |
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24.5 | Investment in listed companies and investment companies up to an investment level of 5% of the respective share capital of companies active in line of the Corporation’s Object of Business do not fall under the non-compete provision in Sections 24.1 and 24.2. The Managing Shareholder and each of the Parties under no. 4, no. 7 and no. 8 represents (garantieren) to each Investor, dievini and BMGF that, as of the date of this Agreement, he does not hold any participation which would fall within Section 24.1. |
24.6 | The Parties under no. 4 und no. 5 undertake to the Investors, dievini and BMGF that during the aforementioned period they will publish materials in the Corporation’s Object of Business only after the prior written consent of the Supervisory Board of the Corporation or CureVac NL. |
24.7 | Should any of the Parties under no. 4 and no. 5 breach the obligation in accordance with Sections 24.1 and 24.2 or the representation given in Section 24.5 (“Other Business Activities”), the Investors, dievini and BMGF shall be entitled to demand that the respective Party ceases his Other Business Activities and to claim damages so that the Corporation or CureVac NL is put in such position by the respective Party as it would have been in if the respective Party had not engaged in such Other Business Activities. In addition, the respective Party has to transfer any and all profit to the Corporation which he has either directly or indirectly received on his own or through a third party by such Other Business Activities. |
24.8 | Each of the Parties under no. 4 and no. 5, in addition to the above provisions, hereby irrevocably offers for sale to all holders of Series B Shares (including the Series B Investors 2020), in proportion to their shareholdings in the Corporation or CureVac NL, in the event of a violation of the non-compete provision, all Shares (including any attendant preferential rights) that the relevant Party (4 and/or 5) holds at a price equivalent to the amount invested by said Party in the Corporation up to that point in cash. In each case, the holders of Series B Shares can demand that the Shares offered to them be transferred to a third party named by them. The holders of Series B Shares may exercise these rights from this Section only if the corresponding violation of the non-compete provision is not stopped within a period of twenty (20) Banking Days despite a written (Textform) warning to the breaching Party. |
24.9 | The provisions of this Section 24 (with respect to the position of the Parties under no. 4 and no. 5 as Shareholders of the Corporation or CureVac NL) shall co-exist with non-compete obligations of the Parties under no. 4 and 5. under their respective service or employment agreements with the Corporation or as member of the Supervisory Board or the Management Board of the Corporation or CureVac NL but shall not lead to an extension of non-compete obligations of the Parties under no. 4 and 5 under their respective service or employment agreements with the Corporation or as member of the Supervisory Board or the Management Board of the Corporation or CureVac NL; for the avoidance of doubt, any compensation with regard to the non-compete obligation shall only be owed once – either on the basis of the employment or service contracts or on the basis of this Agreement. |
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25. | Assignment of Patents and Other Intellectual Property Rights |
25.1 | The Founders declare that they have already assigned to the Corporation all of their present intellectual property rights (including but not limited to inventions, patents, copyrights, trade secrets, trademarks, domain names, rights of use and exploitation etc.) (“IP-Rights”) related to the Corporation’s Object of Business. |
25.2 | The Managing Shareholder is obliged to inform the Corporation at the latest until the expiration of the respective employment or service agreement about, and upon demand of the Corporation to transfer to the Corporation, all IP-Rights arising from inventions made by him in the period between foundation of the Corporation and expiration of his respective employment or service agreement related to the Corporation’s Object of Business without any further consideration, if such IP-Rights can be used by the Corporation in the Corporation’s Object of Business, as far as this is admissible in the context of the applicable mandatory law (in particular with respect to the German law on employee inventions (Gesetz über Arbeitnehmererfindungen)). |
25.3 | The Parties under no. 4, no. 7 and no. 8 declare that they have already assigned to the Corporation (free of charge) their respective IP-Rights developed within the Corporation’s RNA vaccination division on or before 31 December 2015. |
25.4 | The Corporation shall bear any costs with respect to any transfer of the IP-Rights and/or the application for registration of such IP-Rights. Each Founder shall inform the Corporation with respect to such IP Rights or the coming into existence of such IP Rights. |
25.5 | If the Managing Shareholder or one of the Parties under no. 4, no. 7 and no. 8 wants to be released from the obligation described in Section 25.2 after expiration of the post-contractual non-compete provision (Section 24.2) (the “Former Employee”), the Former Employee will declare this to the Corporation. In that case, the Former Employee hereby offers his Shares for sale to each holder of Series B Shares pro rata (relative ownership in the Corporation’s or CureVac NL’s share capital). This offer is subject to the condition that the Corporation or CureVac NL is not yet listed on a stock exchange when the post-contractual non-compete provision expires. If a stock exchange listing then exists, the above offer will be void. Each holder of Series B Shares may accept the offer set out in sentence 2 of this Section 25.5 within one (1) month after the Former Employee has notified it accordingly. The holders of Series B Shares (including the Series B Investors 2020) are entitled to demand that the Shares be transferred to each of them pro rata (relative ownership in the Corporation’s or CureVac NL’s share capital) or to a Third Party. |
25.6 | Any further transfer obligation regarding IP-Rights which might result from corporate law or from an underlying service or employment agreement of the relevant Founder, Managing Shareholder or Party under no. 7 or no. 8 shall remain unaffected. |
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26. | Sanction of the Obligation to Assign Patents and Intellectual Property Rights |
In the event of a violation of the above obligations to assign IP-Rights pursuant to Section 25, each Shareholder is entitled to demand compensatory damages and the withholding and transfer of the profits generated by the breaches of contract to the Corporation, in addition to the stopping of the breaches of contract.
VIII. General
27. | Scope; Legal Succession |
27.1 | The Parties shall endeavour to procure that all present and future shareholders of the Corporation and of CureVac NL are also parties to this Agreement for the duration of this Agreement. The Parties to this Agreement hereby grant every natural or legal entity that is (respecting the provisions set forth herein, in the Articles and in the Articles NL) entitled to purchase, to subscribe or to takeover Shares in the Corporation or CureVac NL an offer to become a party to this Agreement and – except for the Corporation (if shareholdings in the Corporation are concerned) and CureVac NL (if shareholdings in CureVac NL are concerned) – waive the receipt of the acceptance declaration pursuant to § 151 sentence 1 BGB or applicable comparable provisions under the Dutch law. All prospective future shareholders shall make the acceptance of this offer by written declaration in the form set forth in Annex 27.1 hereto certified by a notary public (notariell beglaubigte Annahmeerklärung) to the Corporation (if shareholdings in the Corporation are concerned) or to CureVac NL (if shareholdings in CureVac NL are concerned) with effect for all Parties (an “Accession Agreement”) and the Corporation or CureVac NL, as applicable, shall inform the Shareholders without undue delay of such accession. The entering into this Agreement shall only take effect provided that it is not subject to any unreasonable conditions (for the avoidance of doubt, conditions may be reasonable, e.g. if a third party accedes to this Agreement under the condition precedent (aufschiebende Bedingung) that a lawful right of first refusal as set forth in the sale and purchase agreement by which such third party has purchased its Shares shall not be executed) and without amendment. In the event an acquirer of Shares is not willing to accede to this Agreement, the Shareholders shall not consent to the transfer, issuance to or takeover of Shares in the Corporation or CureVac NL by such acquirer. |
27.2 | Shares may be transferred with or without consideration by way of individual legal succession only if the acquirer has previously agreed to be bound by this Agreement according to Section 27.1 above. This applies equally to encumbrances on the Shares and the granting of third-party rights with respect to the Shares. For the avoidance of doubt, if a Shareholder transfers Shares, then the attendant preferential rights pursuant to Sections 21.2 and 21.3 will be considered as included in the assignment. |
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27.3 | All rights and obligations arising under this Agreement shall commence for the Parties on the day of the legal validity of this Agreement. In this context, the Shareholders shall treat each other as if the Series B Capital Increase 2020 has already been registered with the commercial register as on this day. All rights and obligations of a Shareholder under this Agreement shall cease on the day on which the respective Shareholder ceases to be a shareholder of the Corporation or CureVac NL and all rights and duties of the withdrawing shareholder as set forth in this Agreement have been settled in full. If, at any time after signing of this Agreement, a meeting of the shareholders of the Corporation is held prior to the date on which the Series B Capital Increase 2020 has been registered with the Corporation’s commercial register, the Corporation shall notify each Series B Investor 2020 of the proposed resolution and the notified Series B Investor 2020 shall inform the Corporation on the basis of the provisions set forth herein whether it would intend to vote for, against or abstain in respect of such resolution as if its name had been entered in the Corporation’s share register (Aktienregister) as a holder of Shares in the Corporation. Following receipt of such notifications, the Existing Shareholders undertake to vote in respect of the resolution in such manner as to ensure that the vote on the resolution is the same as it would have been if all of the Shareholders had voted on the resolution. |
27.4 | In the event of death or insolvency of a Party, such event shall have no effect on the validity of this Agreement. For the avoidance of doubt, it is understood that this Agreement shall be legally effective and continued between the remaining Parties, the legal successor and or the administrator, as the case may be. The same shall apply in case this Agreement is terminated by one Shareholder. In this case this Agreement shall be legally effective and continued between the remaining Parties. |
27.5 | This Agreement shall be binding upon, and shall inure to the benefit of, the Parties hereto and their respective heirs, executors, administrators, successors, permitted assignees and other transferees, including Persons who purchase or receive Shares from a Shareholder, and the Parties hereto agree for themselves and their respective heirs, executors, administrators, successors, permitted assignees and other transferees to execute any instruments which may be necessary or proper to carry out the purposes and intent of this Agreement. |
27.6 | Notwithstanding any restrictions on the disposal of Shares under this Agreement, all Parties undertake to transfer their Shares (e.g., after termination of a trust agreement or upon intra group transfer) only to such person and/or legal entity who by written declaration towards the remaining parties undertakes to enter into all rights and obligations in accordance with this Agreement. |
28. | No Assignment of Rights and Obligations |
Any single rights and/or single obligations (e.g., payment obligations, information rights etc.) defined under this Agreement cannot be transferred or assigned in whole or in part without the prior written consent of the other Parties hereto, provided that dievini, BMGF and the Investors may assign such right without such consent to any Person to whom a transfer of Shares is unrestricted under this Agreement, e.g., in the case of dievini pursuant to Sections 17.5(a) and 17.5(c), in the case of BMGF pursuant to Section 17.5(b), and, to any transferee pursuant to a Permitted Transfer, and provided further that where such transfer is to more than one person or entity, such permitted Third Parties shall be joint and several creditors (Gesamtgläubiger) with respect to the rights under this Agreement and jointly and severally liable (Gesamtschuldner) with respect to the obligations under this Agreement. A consent to a share transfer given by the Shareholders shall concurrently be deemed as consent to the transfer of rights and/or obligations under this Agreement.
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29. | Founders’ Covenants |
29.1 | Each Founder and the Parties under no. 9 and no. 10 covenant to the other Parties to obtain and maintain, by way of separate legally binding and effective agreements with their respective spouses, that such Founder or Party under no. 9 and no. 10 may act to comply with the Drag Along Right. In this regard each Founder shall specifically obtain the agreement from his spouse that he will not be restricted from disposing of his Shares (e.g., consent according to § 1365 German Civil Code (BGB) or applicable comparable provisions under the Dutch law). The Founders and the Parties under no. 9 and no. 10 shall also procure that their respective Shares are exempt from the statutory property regime of the community of surplus (Zugewinngemeinschaft). |
29.2 | Each Founder and Party under no. 9 and no. 10 hereby covenant to inform the Supervisory Board of the Corporation or CureVac NL, as the case may be, in case of entering into any side-shareholders’, voting, pool or similar agreement with other Founders or Party under no. 9 and no. 10 with respect to the exercise of voting rights from their respective Shares or the rights deriving from this Agreement except as otherwise stated herein. |
30. | Confidentiality/Sharing of Information |
30.1 | The Parties undertake to keep all information in this Agreement as well as the fact that the Party under no. 4. at the date of this Agreement is under legal guardianship (Betreuung) and will be represented by Dr. Sara Hoerr as his legal custodian (Betreuerin) in accordance with the judicial proceedings as conducted at the local court (Amtsgericht) Mitte (Berlin) under the case number (Aktenzeichen) 55 XVII 32/20 completely confidential. However, such information may be disclosed to or filed with |
(a) | employees, directors and advisors and Affiliates (and to their employees, directors and advisors) of each Party who are subject to a corresponding duty of confidentiality on behalf of the other Parties but only on a strict need to know basis; |
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(b) | present and future investors or exit partners who directly or indirectly participate in the Corporation if they are subject to a non-disclosure or confidentiality agreement according to industry standards; |
(c) | banks or other advisers in the course of the IPO of the Shares in the Corporation or CureVac NL; |
(d) | tax and other authorities to the extent required by law or to fulfil information requests made by such authorities; |
(e) | investors of the Investors, dievini and BMGF in the course of the internal reporting obligations of the Investors, dievini and BMGF provided that such investors are subject to a corresponding duty of confidentiality; |
(f) | to the extent disclosure is required by a court or administrative order, applicable stock exchange rules, law or regulation or if it has been made with the consent of the holders of Series B Shares and the Management Board; |
(g) | to the extent disclosure is required by any contract to which the Corporation is a party and that is listed on Annex 30.1(g) and |
(h) | the SEC, NASDAQ, FINRA and any other securities exchange or regulatory authorities in connection with the IPO or subsequent securities offering by the Corporation or CureVac NL. |
30.2 | The Corporation and CureVac NL shall not disclose, and shall use commercially reasonable efforts to prevent any of the members of its Management Board or Supervisory Board of the Corporation and CureVac NL or the Corporation’s employees or Shareholders from disclosing that the Corporation has any commercial arrangement with BMGF or any of its affiliates without first obtaining BMGF’s prior written consent to the scope and content of such disclosure, except as otherwise required by applicable law. |
30.3 | In no event shall the Corporation or any Party to this Agreement make any public statement of any kind regarding BMGF’s investment and / or the respective investments of the Series B Investors 2015 and / or the respective investments of the Series B Investors 2016 and / or the Series B Investor 2017 and / or Series B Investor 2019, and / or the Series B Investors 2020 in the Corporation or any commercial arrangement with BMGF and / or the respective Series B Investors 2015 and / or the respective Series B Investors 2016, and / or the Series B Investor 2017 and / or the Series B Investor 2019, and / or the Series B Investors 2020, as the case may be, or any of its respective Affiliates (including those specified in Section 17.3(c) above) without first obtaining BMGF’s and / or the respective Series B Investor’s 2015, Series B Investor’s 2016, Series B Investor’s 2017, Series B Investor’s 2019, and Series B Investors 2020, as the case may be, prior written consent to the scope and content of any such statement. |
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31. | Term |
31.1 | This Agreement shall become effective on the day the last one of the Parties has signed the Agreement. |
31.2 | This Agreement shall remain in force for an indefinite period and may be terminated at the end of each half calendar year by any Shareholder only with the effect for such Shareholder but not for other Parties by giving three (3) months’ notice, but for the first time on 31 December 2024. |
31.3 | The right to terminate this Agreement for cause (Kündigung aus wichtigem Grund) remains unaffected hereby. |
31.4 | Subject to Section 31.2, in the event of an IPO as per the day of the first listing of the Corporation’s or CureVac NL’s Shares with a Recognized Stock Exchange in accordance with this Agreement, the Agreement shall continue, but limited to the content of the following provisions: (i) Section 7.7; (ii) sharing of information which is mandatory for tax purposes set out in Section 7.9; (iii) Section 7.10; (iv) use of proceeds set out under Section 8(b); (v) Section 10; (vi) Section 13.3 (on the level of the Corporation for as long as the Corporation’s Supervisory Board is obligatory); (vii) Sections 13.13 and 13.14; (viii) Sections 22.4(b) as well as 22.6 through 22.9; (ix) Sections 23.3 and 23.4; (x) Section 30; (xi) Sections 31.2 through 31.5, 31.7 and 31.8 as well as (xii) Section 32. Any lock-ups agreed to on the occasion of an IPO will be fully observed by all Parties. |
31.5 | If a Shareholder (i) exits the Corporation or CureVac NL (whichever occurs later) or (ii) terminates this Agreement in accordance with Sections 31.2 or 31.3 above, then the remaining Shareholders, the Corporation and CureVac NL will remain bound to this Agreement. Section 31.8 remains unaffected. |
31.6 | Notwithstanding the provision in Section 31.2 above, the Agreement will completely terminate (Vollbeendigung) in case of an Exit Event before the IPO after distribution of the proceeds in accordance with this Agreement and, in particular, Section 21. In such case, Sections 30, 31.7 and 32 shall survive. |
31.7 | Notwithstanding anything in this Agreement, in case of a termination of this Agreement (whether in whole or in part), |
(a) | with respect to KfW or a KfW Affiliate (solely if and for as long as being a Shareholder of the Corporation or CureVac NL), Sections 7.7 and 13.3 shall continue to apply; |
(b) | until the consummation of the IPO or Exit Event, Section 18 shall continue to apply; |
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(c) | with respect to a Major Shareholder (as long as being a Major Shareholder), Sections 22.6 through 22.9 shall continue to apply and |
(d) | the Corporation or CureVac NL, respectively, shall approve any Share Transfer requested by a Shareholder or a Shareholder’s Affiliate to a Shareholder’s Affiliate to the extent that the approval is required under either statute, the Articles, or the Articles NL, respectively, |
provided that all provisions referenced in each of lit. (a) through (d) above as well as Sections 31.7 and 32 shall continue to bind the Corporation, CureVac NL and the Shareholders.
31.8 | Any claims that have accrued during the term of this Agreement and not satisfied or discharged prior to the consummation of the IPO, the distribution of the proceeds following an Exit Event, the cessation or complete termination of this Agreement shall remain unaffected. |
32. | Final Provisions |
32.1 | This Agreement (including the Annexes, which constitute a material part of the Agreement) contains all of the agreements between each and every of the Parties with regard to its subject-matter (except from the notarial transfer agreement between dievini and BMGF (deed no. 129/2015 of the notary Dr. Jochen Scheel, Frankfurt am Main) dated 15 July 2015) and – except from the notarial transfer agreement between dievini and BMGF (deed no. 129/2015 of the notary Dr. Jochen Scheel, Frankfurt am Main) dated 15 July 2015) – replaces all prior agreements and declarations (of all or of some) of the Parties with regard to this subject-matter. In particular, this Agreement replaces the Investment and Shareholders’ Agreement. The Investment and Shareholders’ Agreement is hereby cancelled, except for the provisions contained in the investment and shareholders’ agreement dated 13 February 2015 as amended by amendment to the investment and shareholders’ agreement dated 15 July 2015 under following sections: 8 (Legal Title Warranties), 9 (Business Warranties), 10 (Legal Consequences of Breach of Warranty), and except for the provisions contained in the investment and shareholders agreement dated 2 October 2015 under the following sections 4 (Legal Title Warranties), 5 (Business Warranties) and 6 (Legal Consequences of Breach of Warranty) as well as the provisions contained in the investment and shareholders agreement dated 14 October 2016, in the investment and shareholders agreement dated 13 October 2017 and in the investment and shareholders agreement dated 18 December 2019 under the following sections 4 (Legal Title Warranties), 5 (Business Warranties) and 6 (Legal Consequences of Breach of Warranty), and except for the provisions contained in the investment and shareholders agreement dated 18 December 2019 under sections 11.2 and 11.3 (Anti-Dilution And Downround Protection), or unless and to the extent not explicitly referred to otherwise herein. |
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32.2 | Except where an amendment of or supplement to this Agreement requires notarization (in which case such amendment or supplement shall require the consent in notarial form of all Parties), amendments and supplements to this Agreement must be made in writing and require the consent by all Parties in order to be valid. This also applies to any waiver of the written-form requirement. |
32.3 | The Parties agree that any amendments to this Agreement that would adversely affect or eliminate the information and disclosure rights of any of SMI, Vanguard 1 and/or Vanguard 2 or eliminates the approval rights of any of SMI, Vanguard 1 and/or Vanguard 2 in this Agreement shall require the specific approval of SMI, Vanguard 1 and/or Vanguard 2, as the case may be. The provisions in Section 32.2 shall remain unaffected hereby. |
32.4 | The Parties agree that L-Bank – or its legal successors in accordance with this Agreement – shall have no obligation whatsoever to invest further funds into the Corporation or CureVac NL. The same shall apply mutatis mutandis to LBBW AM. |
32.5 | Internally between the Parties, the provisions of this Agreement shall take precedence over the provisions of the Articles and Articles NL in the event of a conflict between them. |
32.6 | This Agreement is subject to German law. |
32.7 | Any amount expressed in this Agreement in US Dollars (USD or $) shall, to the extent that it requires, in whole or in part, to be expressed in Euros (EUR or €) in order to implement and/or give full effect to this Agreement, be deemed for that purpose to have been converted into Euros immediately before the close of business on the Banking Day immediately prior to the date of this Agreement. Subject to any applicable legal requirements governing conversions into that currency, the rate of exchange shall be European Central Bank’s spot rate for the purchase of Euros with US Dollars at the time of the deemed conversion. |
32.8 | Any dispute, disagreement, controversy or claim arising out of or in connection with this Agreement or its Annexes or the transactions contemplated hereby or thereby shall be finally and exclusively settled in accordance with the Rules of Arbitration of the German Institution of Arbitration e.V. (Deutsche Institution für Schiedsgerichtsbarkeit, DIS) without recourse to the ordinary courts of law. The arbitral tribunal shall consist of three (3) arbitrators. The arbitration shall take place in Stuttgart (Germany). The arbitration shall be conducted in English and written evidence (Beweismittel) will be submitted in English. |
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32.9 | In the event that applicable mandatory law requires any matter arising out of or in connection with this Agreement and its implementation to be decided by an ordinary court of law, the competent courts in Stuttgart (Germany) shall have the exclusive jurisdiction. |
32.10 | The Parties hereto acknowledge and agree, for the avoidance of doubt, that each Party may request injunctive relief (vorläufiger Rechtsschutz - Arrest und einstweilige Verfügung) with the competent ordinary courts of any jurisdiction. |
32.11 | Notwithstanding the provisions of Section 32.8 each Party hereto shall be entitled to issue a third party notice (Streitverkündung) to the other Party in the event that it has initiated or is otherwise involved in litigation with a third party or third parties before the ordinary courts of any jurisdiction in accordance with the procedural rules of the respective jurisdiction. |
32.12 | If and to the extent that the arbitral tribunal should, notwithstanding the choice of law provided for under Section 32.6, be required to resolve on any conflicts of law, such conflicts shall exclusively be resolved applying the rules on conflicts of law as set forth in articles 3 to 47 of the Introductory Act to the German Civil Code (Einführungsgesetz zum Bürgerlichen Gesetzbuch – EGBGB). |
32.13 | In the event any provision hereof is or shall become invalid or unenforceable, the validity of the other provisions shall remain unaffected. In lieu of the invalid or unenforceable provision, such valid and enforceable provision shall be deemed to be agreed upon which closely corresponds to the intended economic purpose of the invalid or unenforceable provision. The same shall apply to any supplementary interpretation (ergänzende Vertragsauslegung) of any of the terms of this Agreement. |
32.14 | In the event any provision hereof is or shall become invalid or unenforceable due to the fact that such provision is not included in the Articles, Articles NL or other corporate regulations, the Shareholders, the Corporation and CureVac NL shall take all actions required by law, the Articles, Articles NL, by-laws or other corporate regulations to validly implement such provision in the Articles, Articles NL or other corporate regulations. |
32.15 | The binding language of this Agreement shall be English (except as certain Annexes the binding language of which shall be German). If the English expression used herein is translated by a German or Dutch expression in brackets, the English expression shall be for convenience only. |
32.16 | Any notice or other declaration hereunder shall be in writing (including by telecopy), unless notarization or any other specific form is required under this Agreement, and shall become effective upon receipt by the recipient Party or otherwise expressly stipulated in this Agreement. |
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32.17 | Each Party shall bear its own costs, except as otherwise set forth herein and except that the Corporation shall bear all costs regarding the consummation of this Agreement including all costs (including but not limited to any court fees) with respect to the registration of the Series B Capital Increase 2020 Shares with the Corporation’s commercial register or the respective court. The foregoing shall apply mutatis mutandis with respect to any transfer tax (Verkehrssteuern). |
32.18 | The Parties are entitled to the rights under or in connection with this Agreement to the exclusion of any joint entitlement, i.e., in such a way that each relevant Party, as the case may be, may individually exercise the rights to which such relevant Party is entitled, unless otherwise expressly provided. Joint and several liability (gesamtschuldnerische Haftung) of the Parties, as the case may be, shall be explicitly excluded except as otherwise provided in this Agreement. In any case, none of the Investors shall on the basis of and in connection with this Agreement be subject to a joint and several liability (gesamtschuldnerische Haftung). |
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Tübingen, July 17, 2020
CureVac AG
By: | /s/ Dr. Franz-Werner Haas |
Name: Dr. Franz-Werner Haas | |
Title: acting CEO |
By: | /s/ Pierre Kemula |
Name: Pierre Kemula | |
Title: CFO |
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Tübingen, July 17, 2020
CureVac B.V.
/s/ Franz-Werner Haas | |
Name: Dr. Franz-Werner Haas | |
Function: Managing Director |
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Exhibit 4.1
FORM OF REGISTRATION RIGHTS AGREEMENT
by and among
the Persons listed on Schedule A hereto,
and
CureVac N.V.
Dated as of [●], 2020
This REGISTRATION RIGHTS AGREEMENT, dated as of [●], 2020 (as it may be amended supplemented or otherwise modified from time to time, this “Agreement”), is made among CureVac N.V., a Dutch public limited liability company (naamloze vennootschap) incorporated under the law of the Netherlands (the “Company”) and the persons listed on Schedule A hereto (each such Person, a “Holder”). Capitalized terms used in this Agreement without definition have the meaning set forth in Section 1.
W I T N E S S E T H:
WHEREAS, the Company and Holders are parties to the Investment Shareholder Agreement (as defined below) pursuant to which the Company agreed to provide each Holder certain registration rights with respect to the Company Shares (as defined below); and
WHEREAS, the Company desires to grant registration rights to the Holders on the terms and conditions set out in this Agreement;
NOW, THEREFORE, in consideration of the mutual promises made herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1. Certain Definitions. As used herein, the following terms shall have the following meanings:
“Additional Piggyback Rights” has the meaning set forth in Section 2.2(c).
“Affiliate” means with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with, such Person and with respect to (i) KfW also includes the Federal Republic of Germany and its special estates (Sondervermögen), corporate bodies (Körperschaften) and institutions (Anstalten) as well as their respective Affiliates, (ii) dievini Hopp BioTech holding GmbH & Co. KG (“dievini”), also includes (A) Mr. Dietmar Hopp or an entity that is the beneficial owner of dievini, determined as of the date hereof, (together “Ultimate Benefeciary”) (B) a member of the immediate family of an Ultimate Beneficiary referred to under clause (A) above, with “immediate family” meaning any family member by blood, marriage or adoption, not more remote than the first cousin, (C) an Affiliate of an Ultimate Beneficiary referred to under clause (A) above), including (i) Hopp LT Vermögensverwaltungs GmbH, registered with the commercial register of Mannheim, Germany, under HRB 724834, and (ii) trusts, foundations, or similar asset funds for the potential benefit of an Ultimate Beneficiary or the immediate family as referred to under clause (B), (D) an Affiliate of a member of the immediate family of an Ultimate Beneficiary referred to under clause (B) above or (E) members of the management board of dievini and/or its general partner and, for the avoidance of doubt, the dievini management board members Prof. Dr. Christof Hettich and Prof. Dr. Friedrich von Bohlen also as private individuals and, in each case, their respective Affiliates; provided that no Holder shall be deemed an Affiliate of any other Holder solely by reason of any investment in the Company or by its being a party to the Investment and Shareholders’ Agreement.
“Agreement” has the meaning set forth in the preamble.
“Assign” means to directly or indirectly sell, transfer, assign, distribute, exchange, pledge, hypothecate, mortgage, grant a security interest in, encumber or otherwise dispose of Registrable Securities, whether voluntarily or by operation of law, including by way of a merger. “Assignor,” “Assignee,” “Assigning” and “Assignment” have meanings corresponding to the foregoing.
“Business Day” means any day other than a Saturday, Sunday or day on which banking institutions in New York, New York or Frankfurt, Germany are authorized or obligated by law or executive order to close.
“Company” has the meaning set forth in the preamble.
“Company Shares” means common shares of the Company, par value €0.12 per share, and any and all securities of any kind whatsoever of the Company that may be issued by the Company after the date hereof in respect of, in exchange for, or in substitution of, Company Shares, pursuant to any stock dividends, splits, reverse splits, combinations, reclassifications, recapitalizations, reorganizations and the like occurring after the date hereof.
“Company Shares Equivalents” means, with respect to the Company, all options, warrants and other securities convertible into, or exchangeable or exercisable for (at any time or upon the occurrence of any event or contingency and without regard to any vesting or other conditions to which such securities may be subject) Company Shares or other equity securities of the Company (including, without limitation, any note or debt security convertible into or exchangeable for Company Shares or other equity securities of the Company).
“Damages” has the meaning set forth in Section 2.9(a).
“Demand Exercise Notice” has the meaning set forth in Section 2.1(a).
“Demand Registration” has the meaning set forth in Section 2.1(a).
“Demand Registration Request” has the meaning set forth in Section 2.1(a).
“Exchange Act” means the Securities Exchange Act of 1934, as amended.
“Expenses” means any and all fees and expenses incident to the Company’s performance of or compliance with Article 2, including, without limitation: (i) SEC, stock exchange or FINRA, and all other registration and filing fees and all listing fees and fees with respect to the inclusion of securities on the Nasdaq Global Market or on any other securities market on which the Company Shares are listed or quoted, (ii) fees and expenses of compliance with state securities or “blue sky” laws of any state or jurisdiction of the United States or compliance with the securities laws of foreign jurisdictions and in connection with the preparation of a “blue sky” survey, including, without limitation, reasonable fees and expenses of outside “blue sky” counsel and securities counsel in foreign jurisdictions, (iii) word processing, printing and copying expenses, (iv) messenger and delivery expenses, (v) expenses incurred in connection with any road show, (vi) fees and disbursements of counsel for the Company, (vii) fees and disbursements of all independent public accountants (including the expenses of any audit and/or comfort letter and updates thereof), retained by the Company, (viii) fees and expenses payable to any Qualified Independent Underwriter, (ix) any other fees and disbursements of underwriters, if any, customarily paid by issuers or sellers of securities, including reasonable fees and expenses of counsel for the underwriters in connection with any filing with or review by FINRA (excluding, for the avoidance of doubt, any underwriting discount, commissions, or spread), (x) fees and expenses of any transfer agent or custodian, (xi) all internal expenses of the Company, (xii) reasonable and documented fees, out-of-pocket costs and expenses of the Participating Holders, including the reasonable fees and disbursements of one counsel for all of the Participating Holders participating in the offering selected by the Participating Holders holding a majority of the Registrable Securities to be sold for the account of all Participating Holders in the offering, provided, however, that all such fees, costs and expenses under this clause (xii) shall not exceed $50,000 in the aggregate for all Participating Holders per registration pursuant to this Agreement and provided, further, that such fees, costs and expenses shall not include the payment of any underwriting commissions or discounts, and (xiii) expenses for securities law liability insurance of the Company and any rating agency fees.
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“FINRA” means the Financial Industry Regulatory Authority, Inc.
“Fully-Diluted Basis” means, with respect to the Company Shares, all issued and outstanding Company Shares and all Company Shares issuable in respect of securities convertible into or exchangeable for such Company Shares, all stock appreciation rights, options, warrants and other rights to purchase or subscribe for such Company Shares or securities convertible into or exchangeable for such Company Shares, including any of the foregoing stock appreciation rights, options, warrants or other rights to purchase or subscribe for such Company Shares that are subject to vesting.
“Holder” or “Holders” has the meaning set forth in the preamble.
“Indemnified Party” has the meaning set forth in Section 2.9(c).
“Indemnifying Party” has the meaning set forth in Section 2.9(c).
“Initiating Holder(s)” has the meaning set forth in Section 2.1(a).
“Investment and Shareholders’ Agreement” means the Investment and Shareholders’ Agreement entered between the Company and several shareholders parties thereto dated July 17, 2020.
“IPO” means the first underwritten public offering of the ordinary shares of the Company to the general public pursuant to a registration statement filed with the SEC completed on or about the date of this Agreement.
“Lock-Up Agreement” means any agreement entered into by a Holder that provides for restrictions on the transfer of Registrable Securities held by such Holder.
“Majority Participating Holders” means the Participating Holders holding more than 50% of the Registrable Securities proposed to be included in offerings of Registrable Securities by such Participating Holders pursuant to Section 2.1 or Section 2.2.
“Majority Holder(s)” means any Holder that (i) owns or beneficially owns 10% or more of the then outstanding Company Shares, until 90 days after such Holder ceases to own or beneficially own at least 10% of such Company Shares and (ii) Mr. Dietmar Hopp and Affiliates, in particular DH-LT-Investments GmbH, for so long as Mr. Dietmar Hopp is an Affiliate of the Company considering the controlling situation of Mr. Dietmar Hopp as of the date of this Agreement.
“Manager” has the meaning set forth in Section 2.1(c).
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“Participating Holders” means all Majority Holders of Registrable Securities, which are proposed to be included in any registration or offering of Registrable Securities pursuant to Section 2.1 or Section 2.2.
“Person” means any individual, corporation (including not-for-profit), general or limited partnership, limited liability company, joint venture, estate, trust, association, organization, governmental entity or agency or other entity of any kind or nature.
“Piggyback Holders” means the Majority Holders.
“Piggyback Shares” has the meaning set forth in Section 2.3(a)(iv).
“Qualified Independent Underwriter” means a “qualified independent underwriter” within the meaning of FINRA Rule 5121.
“Registrable Securities” means any Company Shares held of record or beneficially owned by the Majority Holders and/or any of their respective Affiliates, as applicable, at any time (including the underlying shares held as a result of the conversion or exercise of Company Shares Equivalents), whether now owned or acquired by the Holders and/or any of their respective Affiliates at a later time; provided that, as to any Registrable Securities held or beneficially owned by a particular Holder and/or any of their respective Affiliates, such securities shall cease to be Registrable Securities when (A) a registration statement with respect to the sale of such securities shall have been declared effective under the Securities Act and such securities shall have been disposed of in accordance with such registration statement, (B) such securities are eligible to be sold by such Holder in a single transaction in compliance with the requirements of Rule 144 under the Securities Act, as such Rule 144 may be amended (or any successor provision thereto).
“Rule 144” and “Rule 144A” have the meaning set forth in Section 4.2.
“SEC” means the U.S. Securities and Exchange Commission.
“Section 2.3(a) Sale Number” has the meaning set forth in Section 2.3(a).
“Section 2.3(b) Sale Number” has the meaning set forth in Section 2.3(b).
“Securities Act” means the United States Securities Act of 1933, as amended, and any successor thereto, and any rules and regulations promulgated thereunder, all as the same shall be in effect from time to time.
“Subsidiary” means any direct or indirect subsidiary of the Company on the date hereof and any direct or indirect subsidiary of the Company organized or acquired after the date hereof.
“Transfer” means, with respect to any Company Shares, (i) when used as a verb, to sell, assign, dispose of, exchange, pledge, mortgage, encumber, hypothecate or otherwise transfer, in whole or in part, any of the economic consequences of ownership of such Company Shares, whether directly or indirectly, or agree or commit to do any of the foregoing and (ii) when used as a noun, a direct or indirect sale, assignment, disposition, exchange, pledge, mortgage, encumbrance, hypothecation or other transfer, in whole or in part, of any of the economic consequences of ownership of such Company Shares or any agreement or commitment to do any of the foregoing. For the avoidance of doubt, a transfer, sale, exchange, assignment, pledge, hypothecation or other encumbrance or other disposition of an interest in any Holder, or direct or indirect parent thereof, all or substantially all of whose assets are, directly or indirectly, Company Shares shall constitute a “Transfer” of Company Shares for purposes of this Agreement. For the avoidance of doubt, a transfer, sale, exchange, assignment, pledge, hypothecation or other encumbrance or other disposition of an interest in any Holder, or direct or indirect parent thereof, which has substantial assets in addition to Company Shares shall not constitute a “Transfer” of Company Shares for purposes of this Agreement.
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“Valid Business Reason” has the meaning set forth in Section 2.1(a)(iii).
2. Registration Rights.
2.1. Demand Registrations. (a) If the Company shall receive from any Majority Holder at any time on or following the earlier to occur of (a) 180 days after the closing of the IPO and (b) July 17, 2022, a written request that the Company file a registration statement with respect to all or a portion of the Registrable Securities (a “Demand Registration Request,” and the registration so requested is referred to herein as a “Demand Registration,” and the sender(s) of such request pursuant to this Agreement shall be known as the “Initiating Holder(s)”), then the Company shall, (i) within 10 Business Days of the receipt thereof, give written notice (the “Demand Exercise Notice”) of such request to all other Holders, and subject to the limitations of this Section 2.1, (ii) use its reasonable best efforts to file a Registration Statement in respect of such Demand Registration as soon as possible, but in no event later than 75 days of receipt of the request, and (iii) use its reasonable best efforts to effect, as soon as practicable, the registration under the Securities Act (including, without limitation, by means of a shelf registration pursuant to Rule 415 thereunder if so requested and if the Company is then eligible to use such a registration) of all Registrable Securities that the Holders request to be registered. Pursuant to this Section 2.1, the Company shall not be required in any event to effect more than three Demand Registrations on Form F-1 or S-1, as applicable, or three Demand Registrations of each Holder in any twelve month period in case of a shelf registration on Form F-3 or S-3, as applicable (pursuant to Rule 415 thereunder if so requested and if the Company is then eligible to use such a registration). However, the Company shall not be obligated to take any action to effect any Demand Registration:
(i) within three months after a Demand Registration pursuant to this Section 2.1 that has been declared or ordered effective;
(ii) during the period starting with the date 15 days prior to its good faith estimate of the date of filing of, and ending on a date 90 days after the effective date of, a Company-initiated registration (other than a registration relating solely to the sale of securities to directors of the Company pursuant to a stock option, stock purchase or similar plan or to an SEC Rule 145 transaction), provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective;
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(iii) where the anticipated offering price, before any underwriting discounts or commissions and any offering-related expenses, is equal to or less than $35,000,000 with respect to a Demand Registration on Form F-1 or S-1 and $15,000,000 with respect to a Demand Registration on Form F-3 or S-3, as applicable; provided, however, that if any Majority Holder demands to register at least one-third of all Registrable Securities beneficially owned by such Majority Holder and its Affiliates, this section 2.1(iii) shall not be applicable;
(iv) if the Company shall furnish to such Holders a certificate signed by the Chief Executive Officer of the Company stating that in the good faith judgment of the Company, any registration of Registrable Securities should not be made or continued (or sales under a shelf registration statement should be suspended) because (i) such registration (or continued sales under a shelf registration statement) would materially and adversely interfere with a proposal or plan by the Company to engage in (directly or indirectly through any of its Subsidiaries): a material acquisition or divestiture of assets; a merger, consolidation, tender offer, reorganization, offering of the Company's securities or similar material transaction; or a material financing or any other material business transaction with a third party or (ii) the Company is in possession of material non-public information, and has determined that the disclosure of such information is not in the Company’s best interests (in either case of (i) or (ii), a “Valid Business Reason”), then (x) the Company may postpone filing a registration statement relating to a Demand Registration Request or suspend sales under an existing shelf registration statement until 10 Business Days after such Valid Business Reason no longer exists, but in no event for more than 90 days after the date the Company determines a Valid Business Reason exists and (y) in case a registration statement has been filed relating to a Demand Registration Request, if the Valid Business Reason has not resulted from actions taken by the Company, the Company may cause such registration statement to be withdrawn and its effectiveness terminated or may postpone amending or supplementing such registration statement until 10 Business Days after such Valid Business Reason no longer exists, but in no event for more than 90 days after the date the Company determines a Valid Business Reason exists; and the Company shall give written notice to the Participating Holders of its determination to postpone or withdraw a registration statement or suspend sales under a shelf registration statement and of the fact that the Valid Business Reason for such postponement, withdrawal or suspension no longer exists, in each case, promptly after the occurrence thereof; provided, however, that the Company shall not defer its obligation in this manner for more than 90 days in any 12 month period;
(v) in any particular jurisdiction in which the Company would be required to qualify to do business or to execute a general consent to service of process in effecting such registration, qualification or compliance;
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Each Holder of Registrable Securities agrees that, upon receipt of any notice from the Company that the Company has determined to withdraw any registration statement pursuant to clause (iv) of this Section 2.1(a), such Holder will discontinue its disposition of Registrable Securities pursuant to such registration statement and, if so directed by the Company, will deliver to the Company (at the Company’s expense) all copies, other than permanent file copies, then in such Holder’s possession of the prospectus covering such Registrable Securities that was in effect at the time of receipt of such notice. If the Company shall have withdrawn or prematurely terminated a registration statement filed pursuant to a Demand Registration (whether pursuant to clause (iv) of this Section 2.1(a) or as a result of any stop order, injunction or other order or requirement of the SEC or any other governmental agency or court), the Company shall not be considered to have effected an effective registration for the purposes of this Agreement until the Company shall have filed a new registration statement covering the Registrable Securities covered by the withdrawn registration statement and such registration statement shall have been declared effective and shall not have been withdrawn. If the Company shall give any notice of withdrawal or postponement of a registration statement, the Company shall, not later than 10 Business Days after the Valid Business Reason that caused such withdrawal or postponement no longer exists (but in no event later than 180 days after the date of the postponement or withdrawal), use its reasonable best efforts to effect the registration under the Securities Act of the Registrable Securities covered by the withdrawn or postponed registration statement in accordance with Section 2.1 (unless the Initiating Holders shall have withdrawn such request, in which case the Company shall not be considered to have effected an effective registration for the purposes of this Agreement), and such registration shall not be withdrawn or postponed pursuant to clause (iv) of this Section 2.1(a).
(b)
(i) The Company, subject to Sections 2.3 and 2.6, shall include in a Demand Registration (x) the Registrable Securities of the Initiating Holders and (y) the Registrable Securities of any other Majority Holder of Registrable Securities, which shall have made a written request to the Company for inclusion in such registration pursuant to Section 2.2 (which request shall specify the maximum number of Registrable Securities intended to be disposed of by such Participating Holder) within 10 Business Days after the receipt of the Demand Exercise Notice.
(ii) The Company shall, as expeditiously as possible, but subject to the limitations set forth in this Section 2.1, use its reasonable best efforts to (x) effect such registration under the Securities Act (including, without limitation, by means of a shelf registration pursuant to Rule 415 under the Securities Act if so requested and if the Company is then eligible to use such a registration) of the Registrable Securities, which the Company has been so requested to register, for distribution in accordance with such intended method of distribution and (y) if requested by the Initiating Holder(s), obtain acceleration of the effective date of the registration statement relating to such registration.
(c) In connection with any Demand Registration, the Company shall select the underwriter(s), which underwriter or underwriters shall be reasonably acceptable to the Requesting Shareholder.
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(d) If so requested by the Initiating Holder(s), the Company (together with all Majority Holders proposing to distribute their securities through such underwriting) shall enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company and the Initiating Holder(s).
(e) Any Majority Holder that intends to sell Registrable Securities by means of a shelf registration pursuant to Rule 415 thereunder, shall give the Company two Business Days’ prior notice of any such sale.
2.2. Piggyback Registrations.
(a) If, at any time or from time to time the Company proposes or is required to register or commence an offering of any of its securities for its own account or otherwise (other than pursuant to registrations on Form F-4 or Form S-8 or any similar successor forms thereto) (including but not limited to the registrations or offerings pursuant to Section 2.1), the Company will:
(i) promptly give to each Piggyback Holder written notice thereof (in any event within 5 Business Days) prior to the filing of any registration statement under the Securities Act; and
(ii) include in such registration and in any underwriting involved therein (if any), all the Registrable Securities specified in a written request or requests, made within 5 Business Days after mailing or personal delivery of such written notice from the Company, by any of the Piggyback Holders, except as set forth in Sections 2.2(b) and 2.2(f), with the securities which the Company at the time proposes to register or sell to permit the sale or other disposition by the Piggyback Holders (in accordance with the intended method of distribution thereof) of the Registrable Securities to be so registered or sold, including, if necessary, by filing with the SEC a post-effective amendment or a supplement to the registration statement filed by the Company or the prospectus related thereto. There is no limitation on the number of such piggyback registrations pursuant to the preceding sentence which the Company is obligated to effect. No registration of Registrable Securities effected under this Section 2.2(a) shall relieve the Company of its obligations to effect Demand Registrations under Section 2.1 hereof.
(b) If the registration in this Section 2.2 involves an underwritten offering, the right of any Piggyback Holder to include its Registrable Securities in a registration or offering pursuant to this Section 2.2 shall be conditioned upon such Piggyback Holder’s participation in the underwriting and the inclusion of such Piggyback Holder’s Registrable Securities in the underwriting to the extent provided herein. All Piggyback Holders proposing to distribute their Registrable Securities through such underwriting shall (together with the Company) enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company or the Initiating Holder(s) in the event of a registration or offering pursuant to Section 2.1.
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(c) The Company, subject to 2.3 and 2.6, may elect to include in any registration statement and offering pursuant to demand registration rights by any Person, (i) authorized but unissued shares of Company Shares or Company Shares held by the Company as treasury shares and (ii) any other Company Shares which are requested to be included in such registration pursuant to the exercise of piggyback registration rights granted by the Company after the date hereof and which are not inconsistent with or more favorable than the rights granted in, or otherwise conflict with the terms of, this Agreement (“Additional Piggyback Rights”); provided, however, that such inclusion shall be permitted only to the extent that it is pursuant to, and subject to, the terms of the underwriting agreement or arrangements, if any, entered into by the Initiating Holders.
(d) Other than in connection with a Demand Registration, if, at any time after giving written notice of its intention to register or sell any equity securities and prior to the effective date of the registration statement filed in connection with such registration or sale of such equity securities, the Company shall determine for any reason not to register or sell or to delay registration or sale of such equity securities, the Company may, at its election, give written notice of such determination to all Piggyback Holders of record of Registrable Securities and (i) in the case of a determination not to register or sell, shall be relieved of its obligation to register or sell any Registrable Securities in connection with such abandoned registration or sale, without prejudice, however, to the rights of Holders under Section 2.1, and (ii) in the case of a determination to delay such registration or sale of its equity securities, shall be permitted to delay the registration or sale of such Registrable Securities for the same period as the delay in registering such other equity securities.
(e) Notwithstanding anything contained herein to the contrary, the Company shall, at the request of any Piggyback Holder, file any prospectus supplement or post-effective amendments and otherwise take any action necessary to include therein all disclosure and language deemed necessary or advisable by such Piggyback Holder if such disclosure or language was not included in the initial registration statement, or revise such disclosure or language if deemed necessary or advisable by such Piggyback Holder including filing a prospectus supplement naming the Piggyback Holders, partners, members and shareholders to the extent required by law. Any Piggyback Holder shall have the right to withdraw its request for inclusion of its Registrable Securities in any registration statement pursuant to this Section 2.2 without prejudice to the rights of such Holders under Section 2.1, by giving written notice to the Company of its request to withdraw; provided, however, that such request must be made in writing prior to the earlier of the execution by such Piggyback Holder of the underwriting agreement or the execution by such Piggyback Holder of the custody agreement with respect to such registration or as otherwise required by the underwriters.
(f) Notwithstanding anything in this Agreement to the contrary, the rights of any Piggyback Holder set forth in this Agreement shall be subject to any Lock-Up Agreement that such Piggyback Holder has entered into.
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2.3. Allocation of Securities Included in Registration Statement or Offering.
(a) Notwithstanding any other provision of this Agreement, in connection with an underwritten offering initiated by a Demand Registration Request, if the Manager advises the Initiating Holders in writing that marketing factors require, or the SEC advises, as applicable, a limitation of the number of shares to be underwritten (such number, the “Section 2.3(a) Sale Number”) within a price range acceptable to the Initiating Holders, the Manager shall so advise all Piggyback Holders of Registrable Securities that would otherwise be underwritten pursuant hereto, and the Company shall use its reasonable best efforts to include in such registration or offering, as applicable, the number of shares of Registrable Securities in the registration and underwriting as follows:
(i) first, all Registrable Securities requested to be included in such registration or offering by the Majority Holders thereof (including pursuant to the exercise of piggyback rights pursuant to Section 2.2); provided, however, that if such number of Registrable Securities exceeds the Section 2.3(a) Sale Number, the number of such Registrable Securities (not to exceed the Section 2.3(a) Sale Number) to be included in such registration shall be allocated among all such Holders requesting inclusion thereof in proportion, as nearly as practicable, to the respective amounts of Registrable Securities held by such Majority Holders at the time of filing of the registration statement or the time of the offering, as applicable.
(ii) second, if by the withdrawal of Registrable Securities by a Majority Holder, a greater number of Registrable Securities held by other Majority Holders may be included in such registration or offering (up to the Section 2.3(a) Sale Number), then the Company shall offer to all Holders who have included Registrable Securities in the registration or offering the right to include additional Registrable Securities in the same proportions as set forth in Section 2.3(a) (i).
(iii) third, to the extent that the number of Registrable Securities to be included pursuant to clauses (i) and (ii) of this Section 2.3(a) is less than the Section 2.3(a) Sale Number, and if the underwriter so agrees, any securities that the Company proposes to register or sell, up to the Section 2.3(a) Sale Number; and
(iv) fourth, to the extent that the number of securities to be included pursuant to clauses (i), (ii) and (iii) of this Section 2.3(a) is less than the Section 2.3(a) Sale Number, the remaining securities to be included in such registration or offering shall be allocated on a pro rata basis among all Persons requesting that securities be included in such registration or offering pursuant to the exercise of Additional Piggyback Rights (“Piggyback Shares”), based on the aggregate number of Piggyback Shares then owned by each Person requesting inclusion in relation to the aggregate number of Piggyback Shares owned by all Persons requesting inclusion, up to the Section 2.3(a) Sale Number.
(b) In a registration or offering made pursuant to Section 2.2 that involves an underwritten primary offering on behalf of the Company, which was initiated by the Company, if the Manager determines that marketing factors require a limitation of the number of shares to be underwritten (such number, the “Section 2.3(b) Sale Number”) in order for the sale of the securities to be within a price range acceptable to the Company, the Company shall so advise all Piggyback Holders whose securities would otherwise be registered and underwritten pursuant hereto, and the number of shares of Registrable Securities that may be included in the registration and underwriting shall be allocated as follows:
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(i) first, all equity securities that the Company proposes to register for its own account;
(ii) second, to the extent that the number of securities to be included pursuant to clause (i) of this Section 2.3(b) is less than the Section 2.3(b) Sale Number, the remaining Registrable Securities (not to exceed the Section 2.3(b) Sale Number) to be included in the underwritten offering shall be allocated among all Holders requesting inclusion pursuant to exercise of rights under Section 2.2 in proportion, as nearly as practicable, to the respective amounts of Registrable Securities held by such Holders based on the number of Registrable Securities then owned by each such Holder requesting inclusion in relation to the aggregate number of Registrable Securities owned by all Holders requesting inclusion;
(iii) third, to the extent that the number of securities to be included pursuant to clauses (i) and (ii) of this Section 2.3(b) is less than the Section 2.3(b) Sale Number, the remaining securities to be included in such underwritten offering shall be allocated on a pro rata basis among all Persons requesting that securities be included in such registration pursuant to the exercise of Additional Piggyback Rights, based on the aggregate number of Piggyback Shares then owned by each Person requesting inclusion in relation to the aggregate number of Piggyback Shares owned by all Persons requesting inclusion, up to the Section 2.3(b) Sale Number.
(c) If any registration pursuant to Section 2.2 involves an underwritten offering by any Person(s) other than a Holder to whom the Company has granted registration rights which are not more favorable than or inconsistent with the rights granted in, or otherwise conflict with the terms of, this Agreement, the Manager (as selected by the Company or such other Person) shall advise the Company that, in its view, the number of securities requested to be included in such registration exceeds the number (the “Section 2.3(c) Sale Number”) that can be sold in an orderly manner in such registration within a price range acceptable to the Company, the Company shall include shares in such registration as follows:
(i) first, the shares requested to be included in such underwritten offering shall be allocated on a pro rata basis among such Person(s) requesting the registration and all Holders requesting that Registrable Securities be included in such registration pursuant to the exercise of piggyback rights pursuant to Section 2.2, based on the aggregate number of securities or Registrable Securities, as applicable, then owned by each of the foregoing requesting inclusion in relation to the aggregate number of securities or Registrable Securities, as applicable, owned by all such Holders and Persons requesting inclusion, up to the Section 2.3(c) Sale Number;
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(ii) second, to the extent that the number of securities to be included pursuant to clause (i) of this Section 2.3(c) is less than the Section 2.3(c) Sale Number, the remaining shares to be included in such underwritten offering shall be allocated on a pro rata basis among all Persons requesting that securities be included in such registration pursuant to the exercise of Additional Piggyback Rights, based on the aggregate number of Piggyback Shares then owned by each Person requesting inclusion in relation to the aggregate number of Piggyback Shares owned by all Persons requesting inclusion, up to the Section 2.3(c) Sale Number; and
(iii) third, to the extent that the number of securities to be included pursuant to clauses (i) and (ii) of this Section 2.3(c) is less than the Section 2.3(c) Sale Number, the remaining shares to be included in such registration shall be allocated to shares the Company proposes to register for its own account, up to the Section 2.3(c) Sale Number.
(d) If any Piggyback Holder of Registrable Securities disapproves of the terms of the underwriting, or if, as a result of the proration provisions set forth in clauses (a), (b) or (c) of this Section 2.3, any Piggyback Holder shall not be entitled to include all Registrable Securities in a registration or offering that such Piggyback Holder has requested be included, such Piggyback Holder may elect to withdraw such Piggyback Holder’s request to include Registrable Securities in such registration or offering or may reduce the number requested to be included; provided, however, that (x) such request must be made in writing, to the Company, Manager and, if applicable, the Initiating Holder(s), prior to the execution of the underwriting agreement with respect to such registration and (y) such withdrawal or reduction shall be irrevocable and, after making such withdrawal or reduction, such Piggyback Holder shall no longer have any right to include such withdrawn Registrable Securities in the registration as to which such withdrawal or reduction was made to the extent of the Registrable Securities so withdrawn or reduced, without prejudice, however, to the rights of Holders under Section 2.1.
2.4. Registration Procedures. If and whenever the Company is required by the provisions of this Agreement to use its reasonable best efforts to effect or cause the registration of any Registrable Securities under the Securities Act as provided in this Agreement, the Company shall, as expeditiously as possible (but, in any event, within 90 days after a Demand Registration Request in the case of Section 2.4(a) below) and, to the fullest extent permitted by applicable law, in connection with the Registration of the Registrable Securities and, where applicable, a takedown off of a shelf registration statement:
(a) prepare and file all filings with the SEC and FINRA required for the consummation of the offering, including preparing and filing with the SEC a registration statement on an appropriate registration form of the SEC for the disposition of such Registrable Securities in accordance with the intended method of disposition thereof, which registration form (i) shall be selected by the Company and (ii) shall, in the case of a shelf registration, be available for the sale of the Registrable Securities by the selling Holders thereof and such registration statement shall comply as to form in all material respects with the requirements of the applicable registration form and include all financial statements required by the SEC to be filed therewith, and the Company shall use its reasonable best efforts to cause such registration statement to become effective and remain continuously effective from the date such registration statement is declared effective until the earliest to occur (A) the first date as of which all of the Registrable Securities included in the registration statement have been sold or (B) a period of 180 days in the case of an underwritten offering effected pursuant to a registration statement other than a shelf registration statement and a period of three years in the case of a shelf registration statement (provided, however, that before filing a registration statement or prospectus or any amendments or supplements thereto, or comparable statements under securities or state “blue sky” laws of any jurisdiction, or any free writing prospectus related thereto, the Company will furnish to one counsel for the Piggyback Holders participating in the planned offering (selected by the Initiating Holder(s), or if there are no Initiating Holder(s), by the Majority Participating Holders) and to one counsel for the Manager, if any, copies of all such documents proposed to be filed (including all exhibits thereto), which documents will be subject to the reasonable review and reasonable comment of such counsel (provided that the Company shall be under no obligation to make any changes suggested by the Participating Holders);
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(b) prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection therewith and such free writing prospectuses and Exchange Act reports as may be necessary to keep such registration statement continuously effective for the period set forth in Section 2.4(a) and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all Registrable Securities covered by such registration statement;
(c) furnish, without charge, to each Participating Holder and each underwriter, if any, of the securities covered by such registration statement such number of copies of such registration statement, each amendment and supplement thereto (in each case including all exhibits), the prospectus included in such registration statement (including each preliminary prospectus and any summary prospectus), any other prospectus filed under Rule 424 under the Securities Act and each free writing prospectus utilized in connection therewith, in each case, in conformity with the requirements of the Securities Act, and other documents, as such seller and underwriter may reasonably request in order to facilitate the public sale or other disposition of the Registrable Securities owned by such seller (the Company hereby consenting to the use in accordance with all applicable law of each such registration statement (or amendment or post-effective amendment thereto) and each such prospectus (or preliminary prospectus or supplement thereto) or free writing prospectus by each such Participating Holder and the underwriters, if any, in connection with the offering and sale of the Registrable Securities covered by such registration statement or prospectus);
(d) use commercially reasonable efforts to register or qualify the Registrable Securities covered by such registration statement under such other securities or state “blue sky” laws of such jurisdictions as any sellers of Registrable Securities or any managing underwriter, if any, shall reasonably request in writing, and do any and all other acts and things which may be reasonably necessary or advisable to enable such sellers or underwriter, if any, to consummate the disposition of the Registrable Securities in such jurisdictions (including keeping such registration or qualification in effect for so long as such registration statement remains in effect), except that in no event shall the Company be required to qualify to do business as a foreign corporation in any jurisdiction where it would not, but for the requirements of this paragraph (e), be required to be so qualified, to subject itself to taxation in any such jurisdiction or to consent to general service of process in any such jurisdiction;
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(e) promptly notify each Participating Holder and each managing underwriter, if any: (i) when the registration statement, any pre-effective amendment, the prospectus or any prospectus supplement related thereto, any post-effective amendment to the registration statement or any free writing prospectus has been filed and, with respect to the registration statement or any post-effective amendment, when the same has become effective; (ii) of any request by the SEC or state securities authority for amendments or supplements to the registration statement or the prospectus related thereto or for additional information; (iii) of the issuance by the SEC of any stop order suspending the effectiveness of the registration statement or the initiation of any proceedings for that purpose; (iv) of the receipt by the Company of any notification with respect to the suspension of the qualification of any Registrable Securities for sale under the securities or state “blue sky” laws of any jurisdiction or the initiation of any proceeding for such purpose; (v) of the existence of any fact of which the Company becomes aware which results in the registration statement or any amendment thereto, the prospectus related thereto or any supplement thereto, any document incorporated therein by reference, any free writing prospectus or the information conveyed to any purchaser at the time of sale to such purchaser containing an untrue statement of a material fact or omitting to state a material fact required to be stated therein or necessary to make any statement therein not misleading; and, if the notification relates to an event described in clause (v), the Company shall promptly prepare and furnish to each such seller and each underwriter, if any, a reasonable number of copies of a prospectus supplemented or amended so that, as thereafter delivered to the purchasers of such Registrable Securities, such prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein in the light of the circumstances under which they were made not misleading;
(f) The Company shall otherwise use all commercially reasonable efforts to comply with all applicable rules and regulations of the SEC, and make available to its security holders, as soon as reasonably practicable, an earnings statement covering a period of 12 months, beginning within three months after the effective date of the registration statement (unless such report is filed pursuant to the Exchange Act), which earnings statement satisfies the requirements of Rule 158 under the Securities Act;
(g) The Company may request each Participating Holder promptly to furnish in writing to the Company (as the Company may reasonably request) information (i) identifying the respective Participating Holder, (ii) regarding the respective Participating Holder’s title to the Shares being registered, (iii) regarding the respective Participating Holder’s intended method of distribution of such the Registrable Securities, and (iv) any other information the Company reasonably believes, after consultation with counsel, is required in connection with such registration. In connection with a registration, any Participating Holder that does not provide such information within two Business Days of a request by the Company (which request is made before filing of the registration) may have its Registrable Securities excluded from such registration.
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(h) (i) (A) cause all such Registrable Securities covered by such registration statement to be listed on the principal securities exchange on which similar securities issued by the Company are then listed (if any), if the listing of such Registrable Securities is then permitted under the rules of such exchange, or (B) if no similar securities are then so listed, to cause all such Registrable Securities to be listed on a national securities exchange;
(i) In the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the Manager of such offering;
(j) provide and cause to be maintained a transfer agent and registrar for all such Registrable Securities covered by such registration statement not later than the effective date of such registration statement;
(k) use commercially reasonable efforts (i) to obtain an opinion from the Company’s counsel and a comfort letter and updates thereof from the Company’s independent public accountants who have certified the Company’s financial statements included or incorporated by reference in such registration statement, in each case, in customary form and covering such matters as are customarily covered by such opinions and comfort letters (including, in the case of such comfort letter, events subsequent to the date of such financial statements) delivered to underwriters in underwritten public offerings, which opinion and letter shall be dated the dates such opinions and comfort letters are customarily dated and otherwise reasonably satisfactory to the underwriters, if any, and to the Initiating Holder(s) and the Majority Participating Holders, and (ii) furnish to each Participating Holder participating in the offering and to each underwriter, if any, a copy of such opinion and letter addressed to such underwriter;
(l) upon receipt of such confidentiality agreements as the Company may reasonably request, make reasonably available for inspection by counsel for each Participating Holder, by counsel for any underwriter participating in any disposition to be effected pursuant to such registration statement and by any accountant or other agent retained by any Participating Holder or any such underwriter, all pertinent financial and other records, pertinent corporate documents and properties of the Company, and cause all of the Company’s officers, directors and employees to supply all information reasonably requested by any such counsel for a Participating Holder, counsel for an underwriter, accountant or agent in connection with such registration statement;
(m) use commercially reasonable efforts to prevent the issuance or obtain the prompt withdrawal of any order suspending the effectiveness of the registration statement, or the prompt lifting of any suspension of the qualification of any of the Registrable Securities for sale in any jurisdiction, in each case, as promptly as reasonably practicable;
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(n) use commercially reasonable efforts to make available its senior management, employees and personnel for participation in “road shows” and other marketing efforts and otherwise provide reasonable assistance to the underwriters (taking into account the reasonable needs of the Company’s businesses and the requirements of the marketing process) in marketing the Registrable Securities in any underwritten offering;
(o) furnish to counsel for each Participating Holder and to each managing underwriter, without charge, at least one signed copy of the registration statement and any post-effective amendments or supplements thereto, including financial statements and schedules, all documents incorporated therein by reference, the prospectus contained in such registration statement (including each preliminary prospectus and any summary prospectus), any other prospectus filed under Rule 424 under the Securities Act and all exhibits (including those incorporated by reference) and any free writing prospectus utilized in connection therewith;
(p) cooperate with the Participating Holders and the managing underwriter, if any, to facilitate the timely preparation and delivery of certificates not bearing any restrictive legends representing the Registrable Securities to be sold, and cause such Registrable Securities to be issued in such denominations and registered in such names in accordance with the underwriting agreement at least two Business Days prior to any sale of Registrable Securities to the underwriters or, if not an underwritten offering, in accordance with the instructions of the Participating Holders at least two Business Days prior to any sale of Registrable Securities and instruct any transfer agent and registrar of Registrable Securities to release any stop transfer orders in respect thereof;
(q) cooperate with any due diligence investigation by any Manager, underwriter or Participating Holder and make available such documents and records of the Company and its Subsidiaries that they reasonably request (which, in the case of the Participating Holder, may be subject to the execution by the Participating Holder of a customary confidentiality agreement in a form which is reasonably satisfactory to the Company);
(r) in connection with any underwritten offering, if at any time the information conveyed to a purchaser at the time of sale includes any untrue statement of a material fact or omits to state any material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading, promptly file with the SEC such amendments or supplements to such information as may be necessary so that the statements as so amended or supplemented will not, in light of the circumstances, be misleading.
If the Company files any shelf registration statement for the benefit of the holders of any of its securities other than the Majority Holders, the Company agrees that it shall include in such registration statement such disclosures as may be required by Rule 430B under the Securities Act (referring to the unnamed selling security holders in a generic manner by identifying the initial offering of the securities to the Holders) in order to ensure that the Majority Holders may be added to such shelf registration statement at a later time through the filing of a prospectus supplement rather than a post-effective amendment.
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It shall be a condition precedent to the obligations of the Company to take any action pursuant to Sections 2.1, 2.2, or 2.3 that each Participating Holder shall furnish to the Company such information regarding themselves, the Registrable Securities held by them, and the intended method of disposition of such securities as the Company may from time to time reasonably request so long as such information is necessary for the Company to consummate such registration and shall be used only in connection with such registration.
If any such registration statement or comparable statement under state “blue sky” laws refers to any Holder by name or otherwise as the Holder of any securities of the Company, then such Holder shall have the right to require (i) the insertion therein of language, in form and substance satisfactory to such Holder and the Company, to the effect that the holding by such Holder of such securities is not to be construed as a recommendation by such Holder of the investment quality of the Company’s securities covered thereby and that such holding does not imply that such Holder will assist in meeting any future financial requirements of the Company, or (ii) in the event that such reference to such Holder by name or otherwise is not in the judgment of the Company, as advised by counsel, required by the Securities Act or any similar federal statute or any state “blue sky” or securities law then in force, the deletion of the reference to such Holder.
2.5. Registration Expenses. All Expenses incurred in connection with any registration, filing, qualification or compliance pursuant to Article 2 shall, to the fullest extent permitted by applicable law, be borne by the Company, whether or not a registration statement becomes effective or the offering is consummated. All underwriting discounts and all selling commissions relating to securities registered by the Participating Holders shall be borne by the holders of such securities pro rata in accordance with the number of shares sold in the offering by such Participating Holder.
2.6. Certain Limitations on Registration Rights. In the case of any registration under Section 2.1 pursuant to an underwritten offering, or, in the case of a registration under Section 2.2, if the Company has determined to enter into an underwriting agreement in connection therewith, all securities to be included in such registration shall be subject to the underwriting agreement and no Person may participate in such registration or offering unless such Person (i) agrees to sell such Person’s securities on the basis provided therein and completes and executes all reasonable questionnaires, and other documents (including custody agreements and powers of attorney) which must be executed in connection therewith; provided, however, that all such documents shall be consistent with the provisions hereof, (ii) provides such other information to the Company or the underwriter as may be necessary to register such Person’s securities; and (iii) cooperates with the Company’s reasonable requests in connection with such Registration (it being understood that the Company’s failure to perform its obligations hereunder, which failure is caused by such Holder’s failure to cooperate, will not constitute a breach by the Company of this Agreement).
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2.7. Limitations on Sale or Distribution of Other Securities.
(a) Each Holder agrees, (i) to the extent requested in writing by a managing underwriter, if any, of any registration effected pursuant to Section 2.1 in which such Holder is selling Company Shares, not to sell, transfer or otherwise dispose of, including any sale pursuant to Rule 144 under the Securities Act, any Company Shares, or any other equity security of the Company or any security convertible into or exchangeable or exercisable for any equity security of the Company (other than as part of such underwritten public offering) during the time period reasonably requested by the managing underwriter, not to exceed 90 days and (ii) to the extent requested in writing by a managing underwriter of any underwritten public offering effected by the Company for its own account in which such Holder is selling Company Shares, not to sell any Company Shares (other than as part of such underwritten public offering) during the time period reasonably requested by the managing underwriter, which period shall not exceed 90 days subject to the same exceptions as provided in the lock-up provisions contained in the underwriting agreement for the IPO; and, if so requested, each Holder agrees to enter into a customary lock-up agreement with such managing underwriter.
2.8. No Required Sale. Nothing in this Agreement shall be deemed to create an independent obligation on the part of any Holder to sell any Registrable Securities pursuant to any effective registration statement. A Holder is not required to include any of its Registrable Securities in any registration statement, is not required to sell any of its Registrable Securities which are included in any effective registration statement, and may sell any of its Registrable Securities in any manner in compliance with applicable law even if such shares are already included on an effective registration statement.
2.9. Indemnification.
(a) The Company agrees to indemnify and hold harmless each Participating Holder beneficially owning any Registrable Securities covered by a registration statement, its officers, directors, employees, partners and agents, and each Person, if any, who controls such Participating Holder within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act from and against any and all losses, claims, damages, liabilities and expenses (including reasonable expenses of investigation and reasonable attorneys’ fees and expenses) (collectively, “Damages”) caused by or relating to any untrue statement or alleged untrue statement of a material fact contained in any registration statement or prospectus relating to the Registrable Securities (as amended or supplemented if the Company shall have furnished any amendments or supplements thereto) or any preliminary prospectus or free writing prospectus, or caused by or relating to any omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, except insofar as such Damages are caused by or related to any such untrue statement or omission or alleged untrue statement or omission so made based upon information furnished in writing to the Company by such Participating Holder or on such Participating Holder’s behalf expressly for use therein; provided that, with respect to any untrue statement or omission or alleged untrue statement or omission made in any preliminary prospectus, or in any prospectus, as the case may be, the indemnity agreement contained in this Section 2.9(a) shall not apply to the extent that any Damages result from the fact that a current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) was not sent or given to the Person asserting any such Damages at or prior to the written confirmation of the sale of the Registrable Securities concerned to such Person if it is determined that the Company has provided such prospectus to such Participating Holder and it was the responsibility of such Participating Holder to provide such Person with a current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) and such current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) would have cured the defect giving rise to such Damages. The Company also agrees to indemnify any underwriters of the Registrable Securities, their officers and directors and each Person who controls such underwriters within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act on substantially the same basis as that of the indemnification of the Participating Holders provided in this Section 2.9(a).
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(b) Each Participating Holder holding Registrable Securities included in any registration statement agrees, severally but not jointly, to indemnify and hold harmless the Company, its officers, directors and agents and each Person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act to the same extent as the indemnity from the Company to such Participating Holder provided in Section 2.9(a), but only (i) with respect to the information specified in Section 2.4(g) furnished in writing by such Participating Holder or on such Participating Holder’s behalf expressly for use in any registration statement or prospectus relating to the Registrable Securities, or any amendment or supplement thereto, or any preliminary prospectus or free writing prospectus or (ii) to the extent that any Damages result from the fact that a current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) was not sent or given to the Person asserting any such Damages at or prior to the written confirmation of the sale of the Registrable Securities concerned to such Person if it is determined that it was the responsibility of such Participating Holder to provide such Person with a current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) and such current copy of the prospectus (or such amended or supplemented prospectus, as the case may be) would have cured the defect giving rise to such loss, claim, damage, liability or expense. Each such Participating Holder also agrees to indemnify and hold harmless the underwriters of the Registrable Securities, their officers and directors and each Person who controls such underwriters within the meaning of either Section 15 of the Securities Act or Section 20 of the Exchange Act on substantially the same basis as that of the indemnification of the Company provided in this Section 2.9(b). As a condition to including Registrable Securities in any registration statement filed in accordance with this Agreement, the Company may require that it shall have received an undertaking reasonably satisfactory to it from any underwriter to indemnify and hold it harmless to the extent customarily provided by underwriters with respect to similar securities. No Participating Holder shall be liable under this Section 2.9(b) for any Damages in excess of the net proceeds realized by such Participating Holder in the sale of Registrable Securities of such Participating Holder to which such Damages relate.
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(c) If any proceeding (including any governmental investigation) shall be brought or asserted against any Person in respect of which indemnity may be sought pursuant to this Section 2.9, such Person (an “Indemnified Party”) shall promptly notify the Person against whom such indemnity may be sought (the “Indemnifying Party”) in writing and the Indemnifying Party shall assume the defense thereof, including the employment of counsel reasonably satisfactory to such Indemnified Party, and shall assume the payment of all fees and expenses; provided that the failure of any Indemnified Party so to notify the Indemnifying Party shall not relieve the Indemnifying Party of its obligations hereunder except to the extent that the Indemnifying Party is materially prejudiced by such failure to notify. In any such proceeding, any Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party unless (i) the Indemnifying Party and the Indemnified Party shall have mutually agreed to the retention of such counsel, (ii) in the reasonable judgment of such Indemnified Party, representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them, including one or more defenses or counterclaims that are different from or in addition to those available to the Indemnifying Party, or (iii) the Indemnifying Party shall have failed to assume the defense within 60 days of notice pursuant to this Section 2.9(c). It is understood that, in connection with any proceeding or related proceedings in the same jurisdiction, the Indemnifying Party shall not be liable for the reasonable fees and expenses of more than one separate firm of attorneys at any time for all such Indemnified Parties, and that all such fees and expenses shall be reimbursed as they are incurred. In the case of any such separate firm for the Indemnified Parties, such firm shall be designated in writing by the Indemnified Parties. The Indemnifying Party shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent, or if there be a final judgment for the plaintiff, the Indemnifying Party shall indemnify and hold harmless such Indemnified Parties from and against any loss or liability (to the extent stated above) by reason of such settlement or judgment. Without the prior written consent of the Indemnified Party, no Indemnifying Party shall effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Party is or could have been a party and indemnity could have been sought hereunder by such Indemnified Party, unless such settlement includes an unconditional release of such Indemnified Party from all liability arising out of such proceeding.
(d) If the indemnification provided for in this Section 2.9 is unavailable to the Indemnified Parties in respect of any Damages, then each Indemnifying Party, in lieu of indemnifying the Indemnified Parties, shall contribute to the amount paid or payable by such Indemnified Party, in such proportion as is appropriate to reflect the relative fault of the Indemnifying Party and Indemnified Party in connection with the actions, statements or omissions that resulted in such Damages as well as any other relevant equitable considerations. The relative fault of such Indemnifying Party and Indemnified Party shall be determined by reference to, among other things, whether any action in question, including any untrue or alleged untrue statement of a material fact or omission or alleged omission of a material fact, has been taken or made by, or relates to information supplied by, such Indemnifying Party or Indemnified Party, and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such action, statement or omission. The amount paid or payable by a party as a result of any Damages shall be deemed to include, subject to the limitations set forth in this Agreement, any reasonable attorneys’ or other reasonable fees or expenses incurred by such party in connection with any proceeding to the extent such party would have been indemnified for such fees or expenses if the indemnification provided for in this Section 2.9, was available to such party in accordance with its terms. The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 2.9(d), were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. Notwithstanding the provisions of this Section 2.9(d), no Participating Holder shall be required to contribute, in the aggregate, any amount in excess of the amount by which the proceeds actually received by such Participating Holder from the sale of the Registrable Securities subject to the proceeding exceeds the amount of any damages that such Participating Holder has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission, except in the case of fraud by such Participating Holder. Each Participating Holder’s obligation to contribute pursuant to this Section 2.9(d), shall be several in the proportion that the proceeds of the offering received by such Participating Holder bears to the total proceeds of the offering received by all such Participating Holders and not joint. No Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation. The indemnity and contribution agreements contained in this Section 2.9(d) are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties.
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(e) Other Indemnification. Indemnification similar to that provided in this Section 2.9 (with appropriate modifications) shall be given by the Company and each Participating Holder participating therein with respect to any required registration or other qualification of securities under any foreign, federal or state law or regulation or governmental authority other than the Securities Act.
3. Underwritten Offerings.
3.1. Underwriting Agreement in Underwritten Offerings. If requested by the Manager for any underwritten offering, the Company shall enter into a customary underwriting agreement with the underwriters. Every Participating Holder shall be a party to such underwriting agreement; provided, however, that no Participating Holder shall be required to make any representations or warranties to the Company or the underwriters (other than representations and warranties regarding (i) such Participating Holder’s ownership of Registrable Securities to be transferred free and clear of all liens, claims and encumbrances created by such Participating Holder, (ii) such Participating Holder’s power and authority to effect such transfer, (iii) such matters pertaining to such Participating Holder’s compliance with securities laws as reasonably may be requested and (iv) such Participating Holder’s intended method of distribution and any written information specifically provided by such Participating Holder for inclusion in the registration statement) or to undertake any indemnification obligations to the Company with respect thereto, except as otherwise provided in Section 2.9 hereof.
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4. General.
4.1. Adjustments Affecting Registrable Securities. The provisions of this Agreement shall apply, to the full extent set forth herein with respect to the Registrable Securities, to any and all shares of capital stock of the Company or any successor or assign of the Company (whether by merger, share exchange, consolidation, sale of assets or otherwise) which may be issued in respect of, in exchange for or in substitution of, Registrable Securities and shall be appropriately adjusted for any stock dividends, splits, reverse splits, combinations, recapitalizations and the like occurring after the date hereof.
4.2. Rule 144 and Rule 144A. If the Company shall have filed a registration statement pursuant to the requirements of Section 12 of the Exchange Act or a registration statement pursuant to the requirements of the Securities Act in respect of the Company Shares or Company Shares Equivalents, the Company covenants that (i) so long as it remains subject to the reporting provisions of the Exchange Act, it will use reasonable best efforts to timely file the reports required to be filed by it under the Securities Act or the Exchange Act (including, but not limited to, the reports under Sections 13 and 15(d) of the Exchange Act referred to in subparagraph (c)(1) of Rule 144 under the Securities Act, as such Rule may be amended (“Rule 144”)) or, if the Company is not required to file such reports, it will, upon the request of any Majority Holder, make publicly available other information so long as necessary to permit sales by such Majority Holder under Rule 144, Rule 144A under the Securities Act, as such Rule may be amended (“Rule 144A”), or any similar rules or regulations hereafter adopted by the SEC, and (ii) it will take such further action as any Majority Holder may reasonably request, all to the extent required from time to time to enable such Holder to sell Registrable Securities without registration under the Securities Act within the limitation of the exemptions provided by (A) Rule 144, (B) Rule 144A or (C) any similar rule or regulation hereafter adopted by the SEC. Upon the request of any Majority Holder of Registrable Securities, the Company will deliver to such Majority Holder a written statement by the Company that it has complied with the reporting requirements of Rule 144, the Securities Act and the Exchange Act (at any time after it has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form F-3 (at any time after it so qualifies), a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company and such other information as may be reasonably requested in availing any Majority Holder of any rule or regulation of the SEC which permits the selling of any such securities without registration or pursuant to such form.
4.3. Amendments and Waivers; Termination. Any provision of this Agreement may be amended and the observance thereof may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the Company and the Majority Holders. Notwithstanding the foregoing, a waiver or consent to depart from the provisions hereof with respect to a matter that relates exclusively to the rights of Holders of Registrable Securities whose securities are being sold pursuant to a Registration Statement and that does not directly or indirectly affect the rights of other Holders of Registrable Securities may be given by Holders of at least two-thirds of the Registrable Securities being sold by such holders pursuant to such Registration Statement. Any amendment or waiver effected in accordance with the first sentence of this Section 4.3 shall be binding upon each Holder and the Company. Any waiver of any breach or default by any other party of any of the terms of this Agreement effected in accordance with this Section 4.3 shall not operate as a waiver of any other breach or default, whether similar to or different from the breach or default waived. No waiver of any provision of this Agreement shall be implied from any course of dealing between the parties hereto or from any failure by any party to assert its or his or her rights hereunder on any occasion or series of occasions.
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4.4. If Registrable Securities are held by a nominee for the beneficial owner thereof, the beneficial owner thereof may, at its option, be treated as the Majority Holder of such Registrable Securities for purposes of any request or other action by any Majority Holder(s) of Registrable Securities pursuant to this Agreement (or any determination of any number or percentage of shares constituting Registrable Securities held by any Holder(s) of Registrable Securities contemplated by this Agreement); provided, however, that the Company shall have received evidence reasonably satisfactory to it of such beneficial ownership.
4.5. Notices.
(a) Unless otherwise specified herein, all notices, consents, approvals, reports, designations, requests, waivers, elections and other communications authorized or required to be given pursuant to this Agreement shall be in writing and shall be given, made or delivered (and shall be deemed to have been duly given, made or delivered upon receipt) by personal hand-delivery, by facsimile transmission or electronic mail (so long as receipt of such facsimile transmission or email is requested and received), by mailing the same in a sealed envelope, registered first-class mail, postage prepaid, return receipt requested, or by air courier guaranteeing overnight delivery, in each case addressed to the Company at the address set forth below or to the applicable Holder at the address indicated on Schedule A hereto (or at such other address for a Holder as shall be specified by like notice):
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if to the Company, to it at: | |
CureVac N.V. | |
Friedrich-Miescher-Strasse 15, 72076 | |
Tübingen, Germany | |
Attention: Franz-Werner Haas | |
E-mail: | franz-werner.haas@curevac.com |
with copies (which shall not constitute actual notice) to: | |
Davis Polk & Wardwell LLP | |
450 Lexington Avenue | |
New York, New York 10017 | |
Attention: Richard D. Truesdell, Jr. | |
Facsimile: (212) 701-5674 | |
E-mail: | richard.truesdell@davispolk.com |
(b) Any notice shall be deemed received on the date of receipt by the recipient thereof if received prior to 5:00 p.m. in the place of receipt and such day is a Business Day in the place of receipt. Otherwise, such Notice shall be deemed not to have been received until the next succeeding Business Day in the place of receipt.
4.6. Successors and Assigns.
(a) This Agreement shall inure to the benefit of and be binding upon the parties hereto and their respective heirs, successors, legal representatives and permitted assigns.
(b) A Majority Holder may Assign his, her or its rights under this Agreement without the Company’s consent to an Assignee of Registrable Securities which (i) is with respect to any Majority Holder, the spouse, parent, sibling, descendant, niece or nephew of such Majority Holder, or the spouse or descendant thereof, and any trust, limited liability company, limited partnership, private foundation or other estate planning vehicle for such Majority Holder or for the benefit of any of the foregoing or other persons pursuant to the laws of descent and distribution, or (ii) is a legatee, executor or other fiduciary pursuant to a last will and testament of the Holder or pursuant to the terms of any trust which take effect upon the death of the Holder. In addition, any Holder may Assign his, her or its rights under this Agreement without the Company’s prior written consent so long as such Assignment (i) occurs in connection with the transfer of all, but not less than all, of such Majority Holder’s Registrable Securities in a single transaction in the case of such an Assignment by a Majority Holder and results in an Assignment to a single Assignee who is an Affiliate of such Majority Holder or (ii) occurs in connection with a transaction where the recipient of such Registrable Securities will become immediately after the transaction a Majority Holder of Registrable Securities (for purposes of determining whether a transferee is a Majority Holder under this clause (ii), the Company Shares owned or beneficially owned by such transferee shall be deemed to include those of its Affiliates). For the avoidance of doubt, if a Holder assigns rights under this clause and remains a Majority Holder himself, hereself or itself, such assigning Holder shall continue to have the rights and obligations under this Agreement as long as he, she or it is a Majority Holder. Subject to subsection (c) below, any Assignment shall be conditioned upon prior written notice to the Company identifying the name and address of such Assignee and any other material information as to the identity of such Assignee as may be reasonably requested, and Schedule A hereto shall be updated to reflect such Assignment.
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(c) Notwithstanding anything to the contrary contained in this Section 4.6, any Holder may elect to transfer all or a portion of its Registrable Securities to any third party without Assigning its rights hereunder with respect thereto, provided that in any such event all rights under this Agreement with respect to the Registrable Securities so transferred shall cease and terminate.
4.7. Limitations on Subsequent Registration Rights. From and after the effective date of the first registration statement filed by the Company for the offering of its securities to the general public, the Company may, without the prior written consent of the Holders, enter into any agreement with any holder or prospective holder of any securities of the Company which provides such holder or prospective holder of securities of the Company comparable, but not conflicting, registration rights granted to the Holders hereby.
4.8. Entire Agreement. This Agreement and the other agreements referenced herein and therein constitute the entire agreement among the parties hereto with respect to the subject matter hereof, and supersede any prior agreement or understanding among them with respect to the matters referred to herein.
4.9. Governing Law; Waiver of Jury Trial; Jurisdiction.
(a) Governing Law. This Agreement is governed by and will be construed in accordance with the laws of the State of New York, excluding any conflict-of-laws rule or principle (whether of New York or any other jurisdiction) that might refer the governance or the construction of this Agreement to the law of another jurisdiction.
(b) Waiver of Jury Trial. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVE ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF THE PARTIES HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT THEREOF. The Company or any Holder may file an original counterpart or a copy of this Section 4.9(b) with any court as written evidence of the consent of any of the parties hereto to the waiver of their rights to trial by jury.
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(c) Jurisdiction. Each of the parties hereto (i) consents to submit itself to the personal jurisdiction of the courts of the State of New York located in the county and city of New York in the event any dispute arises out of this Agreement or any of the transactions contemplated by this Agreement, (ii) agrees that it will not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from such court, (iii) agrees that it will not bring any action relating to this Agreement or any of the transactions contemplated by this Agreement in any court other than the courts of the State of New York located in the county and city of New York and (iv) to the fullest extent permitted by law, consents to service being made through the notice procedures set forth in Section 4.5. Each party hereto hereby agrees that, to the fullest extent permitted by law, service of any process, summons, notice or document by U.S. registered mail to the respective addresses set forth in Section 4.5 shall be effective service of process for any suit or proceeding in connection with this Agreement or the transactions contemplated hereby.
4.10. Interpretation; Construction.
(a) The headings herein are for convenience of reference only, do not constitute part of this Agreement and shall not be deemed to limit or otherwise affect any of the provisions hereof. Where a reference in this Agreement is made to a Section, such reference shall be to a Section of this Agreement unless otherwise indicated. Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”
(b) The parties have participated jointly in negotiating and drafting this Agreement. In the event that an ambiguity or a question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provision of this Agreement.
4.11. Counterparts. This Agreement may be executed (including by facsimile transmission or other electronic signature of this Agreement signed by such party (via PDF, TIFF, JPEG or the like)) with counterpart pages or in one or more counterparts, each of which shall be deemed an original and all of which shall, taken together, be considered one and the same agreement, it being understood that both parties need not sign the same counterpart. The words “execution,” “signed,” “signature,” “delivery” and words of like import in or relating to this Agreement or any document to be signed in connection with this Agreement shall be deemed to include electronic signatures, deliveries or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature, physical delivery thereof or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act, and the parties hereto consent to conduct the transactions contemplated hereunder by electronic means
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4.12. Severability. In the event that any provision of this Agreement shall be invalid, illegal or unenforceable, such provision shall be construed by limiting it so as to be valid, legal and enforceable to the maximum extent provided by law and the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby.
4.13. Specific Performance. It is hereby agreed and acknowledged that it will be impossible to measure the money damages that would be suffered if the parties fail to comply with any of the obligations imposed on them by this Agreement and that, in the event of any such failure, an aggrieved party will be irreparably damaged and will not have an adequate remedy at law. Each party hereto shall, therefore, be entitled (in addition to any other remedy to which such party may be entitled at law or in equity) to injunctive relief, including specific performance, to enforce such obligations, without the posting of any bond, and if any action should be brought in equity to enforce any of the provisions of this Agreement, none of the parties hereto shall raise the defense that there is an adequate remedy at law.
4.14. Independent Nature of Holders’ Obligations and Rights. The obligations of each Holder hereunder are several and not joint with the obligations of any other Holder hereunder, and no Holder shall be responsible in any way for the performance of the obligations of any other Holder hereunder. Nothing contained herein or in any other agreement or document delivered at any consummation of securities pursuant hereto, and no action taken by any Holder pursuant hereto or thereto, shall be deemed to constitute the Holders as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Holders are in any way acting in concert with respect to such obligations or the transactions contemplated by this Agreement. Each Holder shall be entitled to protect and enforce its rights, including the rights arising out of this Agreement, and it shall not be necessary for any other Holder to be joined as an additional party in any proceeding for such purpose.
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COMPANY | |||
CureVac N.V. | |||
By: | |||
Name: | |||
Title: |
[Signature Page to Registration Rights Agreement]
HOLDERS:
Dievini Hopp BioTech holding GmbH & Co. KG | ||
By: | ||
Kreditanstalt für Wiederaufbau | ||
By: | ||
DH-LT-Investments GmbH | ||
By: |
[Signature Page to Registration Rights Agreement]
SCHEDULE A
Party | Address |
Dievini Hopp BioTech holding GmbH & Co. KG | dievini Hopp BioTech holding GmbH & Co KG Johann-Jakob-Astor-Str. 57 D-69190 Walldorf Germany |
Kreditanstalt für Wiederaufbau (“KfW”) | Palmengartenstrasse 5-9 60325 Frankfurt am Main Federal Republic of Germany |
DH-LT-Investments GmbH | Opelstraße 28, 68789 St. Leon-Rot, Germany, registered with the commercial register of Mannheim under HRB 732866 |
Exhibit 10.1
Collaboration and License Agreement
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
COLLABORATION AND LICENSE AGREEMENT
dated
19 DECEMBER, 2019
by
CUREVAC
AG
(“CureVac”)
and
GENMAB
B.V.
(“Genmab”)
1
Table of Contents
1. | DEFINITIONS | 5 |
2. | LICENSES; EXCLUSIVITY | 29 |
3. | REPLACEMENT TARGET; RESERVED TARGETS; OPTIONED TARGETS | 35 |
4. | LNP TECHNOLOGY | 37 |
5. | RESEARCH AND DEVELOPMENT COLLABORATION | 40 |
6. | MANUFACTURING AND COMMERCIALIZATION | 46 |
7. | CUREVAC’S OPT-IN AND CO-PROMOTION RIGHTS | 49 |
8. | CO-PROMOTION IN LIEU OF AN OPT-IN | 54 |
9. | GOVERNANCE | 56 |
10. | CONSIDERATION | 63 |
11. | INTELLECTUAL PROPERTY | 70 |
12. | ENFORCEMENT AND DEFENSE | 76 |
13. | CONFIDENTIALITY | 81 |
14. | INDEMNIFICATION AND REPRESENTATIONS AND WARRANTIES | 85 |
15. | TERM AND TERMINATION | 90 |
16. | CONSEQUENCES OF TERMINATION | 91 |
17. | GENERAL PROVISIONS | 94 |
2
Exhibits
Exhibit 1.13 | Patent Rights licensed to BioNTech |
Exhibit 1.54 | CureVac Know How |
Exhibit 1.59 | CureVac Patent Rights |
Exhibit 1.77 | First Program Antibody |
Exhibit 1.90 | Genmab Know-How |
Exhibit 1.111 | LNP Technology |
Exhibit 1.144 | Other Technologies |
Exhibit 3.2.2 | Templates for clearance of proposed Research Program Antibody and Research Program Antibody Combination |
Exhibit 5.1.1 | First Program Research Plan |
Exhibit 5.11 | Approved Subcontractors |
Exhibit 6.2 | Summary of key terms of the Early Clinical Supply Agreement |
Exhibit 10.6.2 | Examples of calculations of royalties |
Exhibit 11.3 | List of non-limiting examples of ownership of different types of potential Inventions |
Exhibit 13.6 | Draft Press Release |
Exhibit 14.4 | Disclosure Letter |
3
COLLABORATION AND LICENSE AGREEMENT
between
CUREVAC AG
And
GENMAB B.V.
This COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is effective as of the 19th of December, 2019 (“Effective Date”) and is entered into by and between:
CUREVAC AG, a German corporation, having a place of business at Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany
on the one side;
and
GENMAB B.V., KvK No. 3016 9902, a Dutch corporation, having a place of business at Uppsalalaan 15, 3584 CM Utrecht, the Netherlands
on the other side.
INTRODUCTION
A. | WHEREAS, CureVac is a biotechnology company that is a pioneer and technology leader in messenger ribonucleic acid (“mRNA”) based therapeutic approaches and especially discovers, designs and optimizes first-in-class mRNA therapies for, inter alia, the treatment of oncological diseases with unmet medical need. |
B. | WHEREAS, Genmab is a pharmaceutical company and has expertise and intellectual property relating to the identification, design and optimization of recombinant antibodies and validated proprietary antibody technologies, including the DuoBody® platform, HexaBody® and HexaBody® related platforms and other antibody-engineering platforms for, inter alia, the generation of bispecific antibodies and antibodies with enhanced effector functions. |
C. | WHEREAS, the Parties wish to collaborate in (i) the further development of one mRNA- encoded antibody designed to express Genmab’s proprietary [*****] and (ii) the generation of preclinical data packages for up to four (4) other Product candidates from which a maximum of three (3) could be selected for further development and commercialization by Genmab; all such products incorporating (a) CureVac’s mRNA technology; (b) monoclonal, bispecific and/or multispecific antibodies (or combination of antibodies) proprietary to Genmab; and (c) a selected lipid nanoparticle (LNP) delivery technology. |
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D. | WHEREAS, CureVac wishes to grant to Genmab an exclusive license to the product referenced under (C)(i); and exclusive options for exclusive licenses to the products referenced under (C)(ii) above; provided that CureVac wishes to retain certain opt-in rights for up to one (1) of the products referenced under (C)(ii) that is a Cocktail Product (as defined below). |
NOW THEREFORE, in consideration of the foregoing premises and the following mutual covenants and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1. | DEFINITIONS. |
For purposes of this Agreement, the following capitalized terms shall have the following meanings, whether used in the singular or plural:
1.1 | “Acuitas License” shall mean licenses available to CureVac at the Effective Date under the Development and Option Agreement made between Curevac and Acuitas Therapeutics Inc. dated April 29, 2016 and amended as of December 1, 2016 relating to LNP Technology owned by Acuitas. |
1.2 | “Affiliate” shall mean any corporation or other entity that controls, is controlled by, or is under common control with a Party. A corporation or other entity will be regarded as under the control of another corporation or entity if the latter corporation or entity owns or directly or indirectly controls fifty percent (50%) or more of the voting stock or other ownership interest of the former corporation or other entity, or if the latter corporation or entity possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the former corporation or other entity or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the former corporation or other entity, provided, however, that regarding CureVac, Affiliate shall not include Mr. Dietmar Hopp, dievini Hopp BioTech holding GmbH & Co.KG and/or any other companies controlled by Mr. Dietmar Hopp and/or dievini Hopp BioTech holding GmbH & Co.KG that are not subsidiaries of CureVac. For avoidance of doubt, the term “Affiliate” shall include CureVac’s subsidiary company currently called CureVac Real Estate GmbH. |
1.3 | “Agreement” shall have the meaning set forth in the Preamble. |
1.4 | “Alliance Manager” shall have the meaning set forth in Section 9.1.1. |
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1.5 | “Antibody” shall mean a molecule, defined by its amino acid sequence, including an engineered molecule that comprises one (1) or more immunoglobulin variable domains or functional parts of such domains. [*****] shall be considered one and the same Antibody; provided, however, that any such [*****]. For clarity, an “Antibody” can be a [*****]. The maximum number of Targets that a single Antibody can bind to is [*****]. For purposes of this Agreement, and unless otherwise set forth herein, Antibody shall include an Antibody Combination, as applicable. |
1.6 | “Antibody Combination” shall mean a combination of [*****] Antibodies and so binding to a maximum of [*****] distinct Targets. |
1.7 | “Applicable Laws” shall mean all applicable provisions of all national, supranational regional, state and local, laws, treaties, statutes, rules, regulations, directives, administrative codes, ordinances, decrees, orders, decisions, guidance documents, injunctions, awards, judgments, and permits of or from any court, arbitrator, stock exchange, regulatory authority or governmental authority having jurisdiction over or related to the subject item. |
1.8 | “Arcturus License” shall mean licenses available to CureVac at the Effective Date under the Development and Option Agreement made between Curevac and Arcturus Therapeutics Inc. dated January 1, 2018 and amended as of May 3, 2018, as of September 28, 2018 and as of July 24, 2019 relating to LNP Technology owned by Arcturus. |
1.9 | “Assigning Party” shall have the meaning set forth in Section 7.8.2. |
1.10 | “Assigned Invention” shall have the meaning set forth in Section 11.4. |
1.11 | “Background Technology” shall mean the CureVac Background Technology and/or Genmab Background Technology, as applicable. |
1.12 | “Breaching Party” shall have the meaning set forth in Section 15.4. |
1.13 | “BioNTech License” shall mean the non-exclusive license made between CureVac and BioNTech AG dated [*****] granting BioNTech certain non-exclusive rights under [*****] listed in Exhibit 1.13. For the purposes of this Agreement, the term “BioNTech License” shall not include any amendments made to the non-exclusive license agreement between CureVac and BioNTech AG after the Effective Date. |
1.14 | “BLA” shall mean (i) a Biologic License Application or New Drug Application submitted and filed with the FDA (or successor regulatory agency) necessary for approval of a drug or biologic in connection with the commercial sale or use of such drug or biologic in conformance with Applicable Laws and regulations in the United States or (ii) the equivalent application submitted to another Regulatory Agency including a Marketing Authorization Application (“MAA”). |
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1.15 | “Business Day” shall mean any day other than Saturday, Sunday, or any day that banks are authorized or required to be closed in Tübingen, Germany or Utrecht, the Netherlands. |
1.16 | “Calendar Quarter” shall mean each successive period of three (3) months ending on March 31, June 30, September 30 and December 31 of each Calendar Year; provided, that the first Calendar Quarter under this Agreement will be the period beginning on the Effective Date and ending on the end of the Calendar Quarter in which the Effective Date is encompassed and the last Calendar Quarter of the Term will be the period beginning on January 1, April 1, July 1 or October 1, as applicable, and ending on the effective date of expiration or termination of this Agreement. |
1.17 | “Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, however, that the first Calendar Year under this Agreement will be the period beginning on the Effective Date and ending on the end of the Calendar Year in which the Effective Date is encompassed and the last Calendar Year of the Term will be the period beginning on January 1 and ending on the effective date of expiration or termination of this Agreement. |
1.18 | “CDO” shall mean Chief Development Officer (or equivalent C-level manager) of each Party. |
1.19 | “CDR” shall mean complementarity-determining regions. |
1.20 | “Change of Control” shall mean, with respect to CureVac, (i) the sale or disposition to a Third Party of all or substantially all of the assets of CureVac to which the subject matter of this Agreement relates (including as part of the sale or disposition to a Third Party of all or substantially all of the assets of CureVac); (ii) the acquisition by a single Third Party, or two (2) or more Third Parties acting in concert, of beneficial ownership of fifty percent (50%) or more of the shares in CureVac; or (iii) the acquisition, merger or consolidation of CureVac with or into another Person, other than, in the case of this definition, an acquisition or a merger or consolidation of CureVac in which the holders of shares of voting capital stock of CureVac, immediately prior to such acquisition, merger or consolidation will beneficially own, directly or indirectly, at least fifty percent (50%) of the shares of voting capital stock of the acquiring Third Party or the surviving entity in such acquisition, merger or consolidation, as the case may be, immediately after such acquisition, merger or consolidation. |
1.21 | “Clinical Phase I Study” shall mean a clinical study of a product as further defined in 21 CFR §312.21(a) or the non-United States equivalent thereof. A Clinical Phase I Study is a clinical study in humans, the primary objective of which is to determine preliminary safety in healthy volunteers or patients. Such clinical study may also have secondary objectives, including tolerability, pharmacological activity or pharmacokinetics and preliminary efficacy parameters and may therefore be regarded as a phase I/II clinical trial. For the purposes of this Agreement, (i) the term Clinical Phase I Study shall also cover such phase I/II clinical trial; and (ii) at the point in such study when the cohort is expanded beyond the original phase I/II design so that the study becomes prospectively designed to generate sufficient data (if successful) to commence a Pivotal Study, a Clinical Phase II Study shall be deemed to have commenced. |
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1.22 | “Clinical Phase II Study” shall mean a clinical study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence Pivotal/Clinical Phase III Studies, as further defined in 21 CFR §312.21(b) or (or the non-United States equivalent thereof). |
1.23 | “Clinical Phase III Study” shall mean a controlled, and usually multicenter, clinical study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in humans in the indication being investigated in a manner sufficient to submit a BLA to obtain Regulatory Approval to market such product, as further defined in 21 CFR §312.21(c) (or the non-United States equivalent thereof). |
1.24 | “Clinical Studies” shall mean all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including Pivotal Studies. |
1.25 | “CMC Development” shall mean all research and development activities conducted in respect of the Manufacture of Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale-up, qualification and validation, quality assurance and quality control processes and techniques. |
1.26 | “CMO” shall mean a contract manufacturing organization. |
1.27 | “Cocktail Product” shall mean a Product that is designed to express a Program Antibody Combination. |
1.28 | “CoGs” shall mean the total cost of Manufacture of a unit of Product and shall include Direct Cost, Indirect Cost and Pass-Through Cost as defined below: |
1.28.1 | “Direct Costs” within CoGs shall include: |
(i) | direct labor costs, based on the actual hours consumed by manufacturing and facility personnel charged at an average hourly wage rate which is designed to approximate actual cost for each employee’s position; and |
(ii) | direct labor fringe benefit costs, including, without limitation, compensation expense (other than wages included in direct labor cost in paragraph (i), payroll taxes and benefits allocated based on a proportionate percentage of direct labor costs charged to the manufacture of the Product to total actual plant-wide labor costs. |
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1.28.2 | “Indirect Costs” within CoGs shall include: |
(i) | facility and occupancy cost including, without limitation, rent, site insurance, depreciation, electricity and water charges, other services, waste removal, such cost to be allocated pro-rata to (i) the percent time-utilization of the manufacturing line in the Calendar Year out of the total time the manufacturing line is potentially capable of being utilized (including idle time); and (ii) the percent occupancy represented by the manufacturing line to the total plant; |
(ii) | the cost of plant support services, which includes quality control, process sciences, quality assurance and validation services and being labor, payroll taxes and fringe benefit costs, allocated to the cost of supplies based on the proportion of actual labor hours consumed in relation to the Manufacture of the supplies to total actual labor hours consumed on all of the Products being Manufactured in the plant; and |
(iii) | the cost of allocable overhead, being an amount added to an item of cost to reflect central or other overhead costs incurred by a Party or for its account including overhead costs attributable to the operation by it of its information systems, payroll, purchasing, supervisory and other internal groups being such costs normally allocated by such Party to its departments or project groups based on space occupied or headcount or other activity-based method consistently applied. Allocable overhead shall not include costs for general corporate activities including, by way of example only, investor relations, business development, legal affairs, human resources and finance, and any other activities not supporting activities conducted under this Agreement. |
1.28.3 | “Pass-Through Costs” within CoGs shall include the actual invoiced amounts paid by a Party to a CMO, excluding recoverable taxes such as VAT, and cost of materials and supplies for Manufacturing Product, based on actual costs including any applicable freight, taxes, duties, customs or import fees, less any discounts or free goods. |
1.29 | “Collaboration Committee” shall have the meaning set forth in Section 9.8. |
1.30 | “Collaboration Target” shall mean a Target in relation to which the Parties have agreed to seek to Develop a Product under this Agreement. For purposes of this Agreement, and unless otherwise set forth herein, Collaboration Target shall include Collaboration Target Combinations, the First Collaboration Target, the Replacement Target, the Reserved Targets, and the Optioned Targets, as applicable. |
1.31 | “Collaboration Target Combination” shall mean a Target Combination in relation to which the Parties have agreed to seek to Develop a Product under this Agreement. For purposes of this Agreement, and unless otherwise set forth herein, Collaboration Target Combination shall include Reserved Target Combinations, and Optioned Target Combinations, as applicable. |
1.32 | “Combination Product” shall mean: |
(i) | a single pharmaceutical formulation containing as its active pharmaceutical ingredients both the active ingredients licensed hereunder and one or more other therapeutically or prophylactically active pharmaceutical ingredients; |
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(ii) | any combination therapy comprised of the Product and one or more other therapeutically or prophylactically active products, that is (i) priced and sold in a single package containing such multiple products; or (ii) packaged separately but sold together for a single price; or |
(iii) | a product comprised of a Product and a companion or complementary diagnostic, priced and sold in a single package containing such multiple products or packaged separately but sold together for a single price; |
in each case, including all dosage forms, formulations, presentations, line extensions, and package configurations.
1.33 | “Commercialization” shall mean any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, importing and exporting such Products, interacting with Regulatory Agencies regarding any of the foregoing and medical affairs functions. For the avoidance of doubt, “Commercialization” shall not include the Manufacture of Products. When used as a verb, to “Commercialize” and “Commercializing” shall mean to engage in Commercialization, and “Commercialized” has a correlative meaning. |
1.34 | “Commercialization Agreement” shall mean the meaning set forth in Section 7.7. |
1.35 | “Commercially Reasonable Efforts” shall mean, with respect to a Party, those efforts, expertise and resources commensurate with efforts, expertise and resources commonly used in the biotechnology industry by a company of comparable size in connection with the development, manufacture and/or commercialization of a comparable pharmaceutical product which is of similar market potential at a similar stage of development or commercialization in light of issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, product reimbursement, and other relevant factors such as technical, legal, scientific, or medical factors. For purposes of clarity, Commercially Reasonable Efforts will be determined on a country-by-country basis within the Territory, and it is anticipated that the level of effort may be different for different countries and may change over time, reflecting changes in the status of such product and the country(ies) involved. |
1.36 | “Confidential Information” shall mean all Know-How, Development Data or other information of a Party whether or not marked confidential or proprietary, including: |
(i) | all communications between the Parties or information of whatever kind whether recorded or not and, if recorded, in whatever medium, relating to or arising out of this Agreement, whether disclosed prior to or after entering into this Agreement; and |
(ii) | all copies and excerpts of the communications, information, notes, reports and documents in whatever form referred to in paragraph (i) of this definition. |
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For purposes of the confidentiality obligations set forth herein, (a) Genmab Know-How, Genmab Materials and Genmab Inventions shall be deemed Confidential Information of Genmab; and CureVac Know-How, CureVac Materials and CureVac Inventions (to the extent not incorporated in any Genmab Inventions) shall be deemed Confidential Information of CureVac; (b) Confidential Information jointly owned by the Parties shall be deemed Confidential Information of both Parties; and (c) the terms and conditions of this Agreement shall be deemed Confidential Information of both Parties (and both Parties shall be deemed the Receiving Party with respect thereto). “Confidential Information” also includes all information exchanged between the Parties pursuant to the Confidentiality Agreements and Material Transfer Agreement. Without limiting the foregoing, all Know-How and Development Data generated under this Agreement that is specific to a Genmab Invention, Genmab Other Invention, Collaboration Target, Collaboration Target Combination, Program Antibody, Program Antibody Combination, an mRNA construct expressing a Program Antibody or Program Antibody Combination, and/or Product shall be deemed the Confidential Information of Genmab. All Know-How and CMC Development data generated under this Agreement that is specific to any CureVac Invention or CureVac Other Invention shall, to the extent such CureVac Invention or CureVac Other Invention is not incorporated in any Genmab Invention, be considered Confidential Information of CureVac.
1.37 | “Confidentiality Agreements” shall mean Confidentiality Agreement No. 1 and Confidentiality Agreement No. 2. |
1.38 | “Confidentiality Agreement No. 1” shall mean that certain Mutual Confidentiality and Nondisclosure Agreement entered into between the Parties as of October 10, 2016. |
1.39 | “Confidentiality Agreement No. 2” shall mean that certain Mutual Confidentiality and Nondisclosure Agreement entered into between the Parties as of 12 April 2018. |
1.40 | “Control” shall mean, with respect to any material, information or intellectual property right, that a Party (i) owns such material, information or intellectual property right; or (ii) has a license to or right to use or grant access to such material, information or intellectual property right, in each case of (i) or (ii), without violating the terms of any agreement or other arrangement with a Third Party. |
1.41 | “Co-Promote” shall mean, with respect to the Co-Promotion Territory, to promote a Product through Genmab’s and CureVac’s respective sales forces under a single trademark in such Co-Promotion Territory. “Co-Promotion” shall have a correlative meaning. |
1.42 | “Co-Promotion Agreement” shall have the meaning as set forth in Section 8.2. |
1.43 | “Co-Promotion Committee” shall have the meaning set forth in Section 8.2(i). |
1.44 | “Co-Promotion Product” shall have the meaning set forth in Section 8.1. |
1.45 | “Co-Promotion Territory” shall have the meaning as set forth in Section 8.1. |
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1.46 | “Co-Promotion Territory Commercialization Plan” shall have the meaning as set forth in Section 8.2(iii). |
1.47 | “Cover” shall mean, with respect to a claim of a Patent Right, that such claim would be infringed, absent a license, by the Development, Manufacture or Commercialization of a Product. |
1.48 | “CRO” shall mean a contract research organization. |
1.49 | “CureVac Alliance Manager” shall have the meaning set forth in Section 9.1.1. |
1.50 | “CureVac Background Technology” shall have the meaning set forth in Section 11.1. |
1.51 | “CureVac Co-Promotion Option” shall have the meaning set forth in Section 8.1. |
1.52 | “CureVac Indemnified Parties” shall have the meaning set forth in Section 14.1. |
1.53 | “CureVac Invention” shall have the meaning set forth in Section 11.3.2. |
1.54 | “CureVac Know-How” shall mean all Know-How within the CureVac Background Technology and all Know-How, including Know-How comprised in the CureVac Manufacturing Technology, Controlled by CureVac or its Affiliates arising or generated during the Research Period in connection with the performance of activities under this Agreement, in including performance of activities under the R&D Plans (to be determined on a Collaboration Target-by-Collaboration Target basis) that is required for the Parties to Develop the Programs and/or to Develop, Manufacture and Commercialize Products under this Agreement, provided, however, that CureVac Know-How does not include (i) Know-How included in the LNP Technology; (ii) Know-How included in CVCMs; (iii) Know-How included in the Other Technologies; and (iv) Know-How that may be Controlled by CureVac in the future as a result of a Change of Control; i.e., that was Developed by a Third Party prior to such Change of Control, or by CureVac after the Change of Control, and is fully or partly based on technology Controlled by a Third Party prior to such Change of Control. CureVac Know-How shall also include Know-How related to CureVac Inventions and other Know-How generated by CureVac under a Program. The CureVac Know-How as so defined existing at the Effective Date is further described in Exhibit 1.54. |
1.55 | “CureVac Manufacturing Technology” shall mean Patent Rights and Know-How Controlled by CureVac or its Affiliates (including CureVac Real Estate GmbH even if it does not remain an Affiliate) related to CMC Development and/or the Manufacture of Products actually used in the CMC Development and/or Manufacture of a Product by or on behalf of CureVac and/or its Affiliates during the Development and/or Manufacture of such Product under an R&D Plan during the Research Period. For the avoidance of doubt, such CureVac Manufacturing Technology shall be licensed to Genmab for all subsequent Products under this Agreement no matter whether CureVac or its Affiliates (or their approved subcontractor or approved CMO) Manufactures the particular Product. |
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1.56 | “CureVac Materials” shall mean any compounds, assays or other materials that are disclosed or otherwise made available by or on behalf of CureVac and/or its Affiliate(s) to Genmab hereunder for the purposes of this Agreement, including the compounds, assays, negative and positive mRNA control constructs (excluding, for clarity, any Product) and other materials set forth on Exhibit 5.1.1, and progeny, modifications or derivatives thereof that do not include use of Genmab Materials. |
1.57 | “CureVac Other Invention” shall have the meaning set forth in Section 11.3.3. |
1.58 | “CureVac Other Invention Patent Right” shall have the meaning set forth in Section 11.7.4 |
1.59 | “CureVac Patent Right(s)” shall mean (i) all Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as of the Effective Date; and (ii) all CureVac Program Patent Rights, CureVac Other Invention Patent Rights and CureVac’s interest in Joint Patent Rights that (in case of each of (i) and (ii)) are required for the Development of the Programs and/or for the Development, Manufacture and Commercialization of Products (including Product candidates under the research license) under the Agreement; and (iii) all Patent Rights within the CureVac Manufacturing Technology to the extent not within (i) or (ii); and (iv) any New Patent Rights that Genmab notifies CureVac it desires to include pursuant to Section 2.9. provided, however, that CureVac Patent Rights do not include (i) Patent Rights included in the LNP Technology or the Patent Rights referred to in Section 1.63 (Definition of CVCM); (ii) Patent Rights included in the Other Technologies; and (iii) Patent Rights that may be Controlled by CureVac in the future as a result of a Change of Control; i.e., that were Developed by a Third Party prior to such Change of Control. The CureVac Patent Rights as of the Effective Date are listed in Exhibit 1.59. For avoidance of doubt, the CureVac Patent Rights shall include any future Patent Rights Controlled by CureVac or its Affiliates that claim priority from any of the patents and patent applications listed in Exhibit 1.59. |
1.60 | “CureVac Program Patent Right” shall mean a Program Patent Right owned by CureVac, as set forth in Section 11.3 below, that Covers a CureVac Invention. |
1.61 | “CureVac Project Leader” shall have the meaning set forth in Section 9.1.2. |
1.62 | “CureVac Technology” shall mean CureVac Patent Rights, CureVac Inventions, CureVac Other Inventions, CureVac Know-How, CureVac Manufacturing Technology (to the extent not within the foregoing) and Third Party IP that is deemed to be CureVac Technology pursuant to Section 2.8. |
1.63 | “CVCM” shall mean CureVac’s next generation mRNA delivery vehicle, also referred to as CureVac Carrier Molecule™, which is disclosed in CureVac’s patent families [*****], that is appropriate for formulation of an mRNA construct. |
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1.64 | “Development” shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the Collaboration Targets, Program Antibodies and Products, including those necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining Regulatory Approvals and to successfully Develop, Manufacture and Commercialize the Products for use in the Field. “Development” shall include CMC Development, delivery system development, non-clinical testing, mechanism studies, toxicology, pharmacokinetics, clinical studies, regulatory affairs activities, statistical analysis and report writing, submission of documents, market research, pharmacoeconomic studies, and epidemiological/real world data studies. Development shall mean both (a) non-clinical and clinical Development; and (b) CMC Development. “Develop” and “Developed” have a correlative meaning. |
1.65 | “Development Data” shall mean (i) reports of non-clinical studies and Clinical Studies, (ii) CMC Development data; and (iii) all other documentation containing or embodying any non- clinical or clinical data relating to the Collaboration Targets, Program Antibodies and the Products or the use of the Products in the Field, such data in each case (i), (ii) and (iii) required for the Development and Commercialization of the Products, including but not limited to, registration dossiers. |
1.66 | “Disclosing Party” shall have the meaning set forth in Section 13.1 |
1.67 | “Disclosure Letter” shall have the meaning set forth in Section 14.4. |
1.68 | “Early Clinical Supply Agreement” shall the meaning set forth in Section 6.1. |
1.69 | “Effective Date” shall have the meaning set forth in the Preamble. |
1.70 | “FDA” shall have the meaning set forth in the definition of Regulatory Agency. |
1.71 | “Field” shall mean any and all uses for the prophylaxis or treatment of human conditions and diseases. |
1.72 | “Financial Partner” shall have the meaning set forth in Section 13.4.1(vi) below. |
1.73 | “First Collaboration Program” shall mean the Program addressing the First Collaboration Target and First Program Antibody, as described in the First Program Research Plan. |
1.74 | “First Collaboration Target” shall mean the target named [*****]. For purposes of this Agreement, and unless otherwise set forth herein, First Collaboration Target shall include the Replacement Target, as applicable. |
1.75 | “First Commercial Sale” shall mean, on a Product-by-Product and country-by-country basis, the first sale by Genmab or its Affiliates or Sublicensees or subcontractors to, such as but not limited to, a Third Party wholesaler, pharmacy, outpatient clinic, inpatient clinic, hospital, or dispensing physician in a given country after necessary Regulatory Approval has been granted with respect to such Product in such country. For avoidance of doubt, any sale of a Product by Genmab to an Affiliate or Sublicensee or subcontractor is not a First Commercial Sale. |
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1.76 | “First Composition of Matter Patent Rights” shall mean, Product-by-Product, all Patent Rights within the first “composition of matter” Genmab Program Patent Rights (i.e. Genmab Program Patent Rights where the earliest priority date is the same) that Cover and claim the specific composition of matter of the particular Product. For clarity, such first “composition of matter” Genmab Program Patent Rights may not be the first to be filed Patent Rights Covering the particular Product if such first to be filed Patent Rights do not also claim the specific composition of matter of such Product. |
1.77 | “First Program Antibody” shall mean Genmab’s proprietary [*****] as described in detail in Exhibit 1.77, that binds to the First Collaboration Target. |
1.78 | “First Program Research Plan” shall have the meaning set forth in Section 5.1.1, such First Program Research Plan as of the Effective Date being attached hereto as Exhibit 5.1.1. |
1.79 | “FTE” shall mean, with respect to a person, the equivalent of the work of one (1) employee full time for one (1) year (consisting of at least [*****] working hours per year (with no further reductions for vacations and holidays)). Overtime, and work on weekends, holidays and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. The portion of a FTE billable by CureVac or Genmab for one (1) individual during a given accounting period shall be determined by dividing the number of hours worked by said individual on the work to be conducted under the Agreement during such accounting period and the number of FTE hours applicable for such accounting period based on [*****] working hours per calendar year. For clarity, no individual person can ever constitute more than a single FTE. |
1.80 | “FTE Rate” shall mean, for the period commencing on the Effective Date until such time as the Parties mutually agree otherwise, an annual rate of [*****]. The FTE Rate shall include all fully loaded costs, including costs of salaries, benefits, supplies, other employee costs, consumables, overhead and supporting general and administration allocations. In the event of Opt-In by CureVac, the Parties will renegotiate and agree in good faith on a new FTE Rate which should be reflective of the stage of development and market conform. |
1.81 | “FTO License” shall have the meaning set forth in Section 10.6.4. |
1.82 | “Force Majeure” shall have the meaning set forth in Section 17.2. |
1.83 | “Generally Applicable Patent Right” shall mean a claim of a Genmab Program Patent Right Covering (i) a [*****] (“Target Class Inventions”); (ii) an Antibody or Antibody Combination functionally defined in such claim as [*****] and (iii) a [*****] provided, however, that for each of (i), (ii) and (iii), where the Invention is made, conceived and/or reduced to practice after the Research Period, such claim shall only be considered a Generally Applicable Patent Right if [*****] with respect to such claim. For avoidance of doubt, the term Generally Applicable Patent Right shall not include any claim where the Program Antibody or Program Antibody Combination is functionally defined as binding to a Collaboration Target or Collaboration Target Combination or even more specifically, such as e.g. where the Program Antibody or Program Antibody Combination is functionally defined as binding to an epitope on a Collaboration Target or epitopes on the Collaboration Targets included in the Collaboration Target Combination or where the Program Antibody or Program Antibody Combination is defined by sequences. |
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1.84 | “Generic Product” shall mean, with respect to a particular Product in a particular country in the Territory, any pharmaceutical product (other than the Product) that (i) contains the same active ingredient(s) (including biosimilar or bioequivalent biologic API) in a comparable quality and quantity as such Product, irrespective of its pharmaceutical form, and is approved for the same indication as such Product, as applicable, and (ii) is approved for sale in the country pursuant to a regulatory approval process governing the approval of generic, interchangeable, biosimilar or bioequivalent biologic products, with the Product being the reference product. |
1.85 | “Generic Therapeutic Concept” shall mean an Invention consisting of a new approach to therapy or treatment that has general applicability beyond use of such approach in relation to the Collaboration Target or specific Collaboration Target Combination (i.e. the Optioned Target Combination) that is targeted by a Program Antibody or Program Antibody Combination, as applicable. By way of non-limiting examples, a Generic Therapeutic Concept would include (i) an Invention consisting of combining [*****] different Antibodies targeting [*****] different pathways such as an anti-apoptotic pathway, an anti-proliferative pathway and an anti- metastatic pathway to obtain a certain therapeutic effect; and (ii) an Invention relating to a [*****]. The term Generic Therapeutic Concept shall not comprise Target Class Inventions. Further, the term Generic Therapeutic Concept shall not comprise the therapeutic or treatment approach to the extent that such approach applies to a Collaboration Target or specific Collaboration Target Combination. |
1.86 | “Genmab Alliance Manager” shall have the meaning set forth in Section 9.1.1. |
1.87 | “Genmab Background Technology” shall have the meaning as set forth in Section 11.1. |
1.88 | “Genmab Indemnified Parties” shall have the meaning set forth in Section 14.2. |
1.89 | “Genmab Invention” shall have the meaning set forth in Section 11.3.1. |
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1.90 | “Genmab Know-How” shall mean all Know-How Controlled by Genmab or its Affiliates as of the Effective Date or thereafter during the Term that (a) is necessary for CureVac to perform the obligations and other activities pursuant to this Agreement, or (b) is used by or on behalf of Genmab its Affiliates or Sub-licensees to Develop, Manufacture and Commercialize Products under this Agreement. Genmab Know-How shall include (i) Know-How comprised in the Genmab Background Technology; (ii) Know-How related to Genmab Inventions; and (iv) other Know-How generated by Genmab under a Program. Notwithstanding the foregoing, if any Third Party becomes an Affiliate of Genmab after the Effective Date, Genmab Know-How will exclude any Know-How that is Controlled by such Third Party before such Third Party became Genmab’s Affiliate. The Genmab Know-How as so defined existing at the Effective Date is further described in Exhibit 1.90. |
1.91 | “Genmab Materials” shall mean any compounds, assays or other materials, including sequences and recombinant proteins, that are disclosed or otherwise made available by or on behalf of Genmab and/or its Affiliate(s) to CureVac hereunder for the purposes of this Agreement, including materials set forth on Exhibit 5.1.1, and progeny, modifications or derivatives thereof that do not include use of CureVac Materials. |
1.92 | “Genmab Other Invention” shall have the meaning set forth in Section 11.3.3. |
1.93 | “Genmab Other Invention Patent Right” shall have the meaning set forth in Section 11.7.5. |
1.94 | “Genmab Patent Right(s)” shall mean all Patent Rights Controlled by Genmab or its Affiliates as of the Effective Date or thereafter during the Term that (a) is necessary for CureVac to perform the obligations and other activities pursuant to this Agreement, or (b) [*****] Genmab its Affiliates or Sub-licensees to Develop, Manufacture and Commercialize Products under this Agreement. Genmab Patent Rights shall include Patent Rights comprised in the Genmab Background Technology, Genmab Program Patent Rights, Genmab Other Invention Patent Rights and Genmab’s interest in Joint Patent Rights. |
1.95 | “Genmab Program Patent Right” shall mean a Program Patent Right owned by Genmab, as set forth in Section 11.3 below, that Covers a Genmab Invention. |
1.96 | “Genmab Project Leader” shall have the meaning set forth in Section 9.1.2. |
1.97 | “Genmab Technology” shall mean any and all Genmab Patent Rights, Genmab Inventions and Genmab Know-How. |
1.98 | “GxP” shall mean the good practice regulations in the pharmaceutical industry with respect to distribution, manufacturing, clinical and laboratory practices (GDP, GMP, GCP and GLP). |
1.99 | “IND” shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the USA, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto including the European Medicines Authority (“EMA”) prior to beginning clinical trials in humans in that country or in that group of countries. |
1.100 | “Indication” shall mean, with respect to a particular Product, the use of such Product for treating a separate and distinct disease or medical condition. |
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1.101 | “Invention” shall mean an invention or discovery, whether or not patentable, discovered, made, conceived and/or first reduced to practice during the Term by or on behalf of CureVac or Genmab or Affiliates of CureVac or Genmab, alone or jointly with each other and/or any Third Party, which arise from the performance of activities under this Agreement, including performance of activities under the R&D Plans, or under the Material Transfer and Technology Evaluation Agreement. |
1.102 | “IP Sub-committee” shall mean the sub-committee to be established pursuant to Section 9.6. |
1.103 | “Joint Commercialization Committee”, and “JCC” shall have the meaning set forth in Section 7.7(i). |
1.104 | “Joint Development and Manufacturing Agreement” shall have the meaning set forth in Section 7.6. |
1.105 | “Joint Invention” shall have the meaning set forth in Section 11.3.3. |
1.106 | “Joint Patent Rights” shall have the meaning set forth in Section10.8.1 |
1.107 | “Joint Research Committee”, and “JRC” shall have the meaning set forth in Section 9.2. |
1.108 | “Joint Steering Committee”, and “JSC” shall have the meaning set forth in Section 7.2. |
1.109 | “Know-How” shall mean all technical, scientific and other information, inventions, discoveries, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, expressed ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, Development Data, results, non-clinical, clinical, safety, process and Manufacturing and quality control data and information (including trial designs and protocols), registration dossiers, in each case, solely to the extent confidential and proprietary and in written, electronic or any other form now known or hereafter Developed. |
1.110 | “LNP” shall mean a lipid nanoparticle system comprised of individual lipid components at specific ratios, which are manufactured in such a manner to encapsulate and deliver mRNA into a target cell. |
1.111 | “LNP Technology” shall mean Patent Rights and Know-How covering an LNP system (i.e. a lipid nanoparticle system which is used to formulate and deliver mRNA), as further defined in Exhibit 1.111 hereto. |
1.112 | “LNP Technology License Documentation Package” shall have the meaning set forth in Section 4.2 below. |
1.113 | “Major Markets Countries” shall mean [*****]. |
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1.114 | “Manufacture” shall mean all manufacturing operations (including for mRNA, lipids and drug product as well as formulation, fill and finish, packaging and labelling) for Products, including all activities related to the preparation and use of master and working cell banks, making, production, processing, purifying, formulating, filling, and finishing, of the Product, or any intermediate thereof, pre-clinical, clinical and commercial production, product, stability testing, quality assurance, and quality control. “Manufacturing” has a correlative meaning. |
1.115 | “Materials” shall mean CureVac Materials and Genmab Materials. |
1.116 | “Material Transfer and Technology Evaluation Agreement” shall mean that certain Material Transfer and Technology Evaluation Agreement entered into between the Parties as of April 12, 2017. |
1.117 | “mRNA” shall have the meaning set forth in the Introduction. |
1.118 | “MSA” shall have the meaning set forth in Section 6.4.2 below. |
1.119 | “Negotiation Period” shall have the meaning as set forth in Section 7.8.2. |
1.120 | “Net Sales” shall mean, with respect to each Product, the gross amount invoiced for sales of such Product by or on behalf of Genmab and its Affiliates and Sublicensees to unrelated Third Parties (i.e., excluding Sublicensees), less the following deductions [*****]: |
a. | [*****] |
b. | [*****] |
c. | [*****] |
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d. | [*****] |
e. | [*****] |
f. | [*****] and |
g. | [*****] |
[*****].
Disposition of Product for, or use of the Product in, clinical trials or other scientific testing, as free samples, or under compassionate use, patient assistance, or test marketing programs or other similar programs or studies where a Product is supplied without charge shall not result in any Net Sales, however if Genmab or any of its Affiliates or Sublicensees charges for such Product, the amount billed will be included in the calculation of Net Sales, but for the sake of clarity such disposition or use of the Product shall never constitute a First Commercial Sale.
In the event a Product is sold as a Combination Product, Net Sales of the Combination Product will be calculated, on a [*****] as follows:
(i) | [*****]. |
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(ii) | [*****]. |
(iii) | [*****]. |
(iv) | [*****]. |
(v) | [*****]. |
1.121 | “New Patent Right” shall have the meaning set forth in Section 2.9. |
1.122 | “Non-Assigning Party” shall have the meaning set forth in Section 7.8.2. |
1.123 | “Non-Breaching Party” shall have the meaning set forth in Section 15.4. |
1.124 | “Non-Terminating Party” shall have the meaning set forth in Section 7.9. |
1.125 | “Opt-In” shall have the meaning set forth in Section 7.1. |
1.126 | “Opt-In Data Package” shall have the meaning set forth in Section 7.1. |
1.127 | “Opt-In Product” shall have the meaning set forth in Section 7.1. |
1.128 | “Opt-In Product Assignment” shall have the meaning set forth in Section 7.8.2. |
1.129 | “Opt-In Program” shall mean a Program (for a [*****]) for which CureVac has exercised its right to Opt-In. |
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1.130 | “Opt-In R&D Plan” shall have the meaning set forth in Section 7.2. |
1.131 | “Opt-In Target” shall have the meaning set forth in Section 7.1. |
1.132 | “Opt-In Termination Notice” shall have the meaning set forth in Section 7.9. |
1.133 | “Option Exercise” shall have the meaning set forth in Section 3.4. |
1.134 | “Option Exercise Fee” shall have the meaning set forth in Section 10.2. |
1.135 | “Option Period” shall have the meaning set forth in Section 3.4 below. |
1.136 | “Optioned Target” shall mean a Reserved Target for which Genmab has exercised its option under Section 3.4 below. For purposes of this Agreement, and unless otherwise set forth herein, Optioned Target shall include an Optioned Target Combination, as applicable. |
1.137 | “Optioned Target Combination” shall have the meaning set forth in Section 3.4. |
1.138 | “Other Pre-IND Program” shall mean a Program envisaged in Section 5.2.3 directed against an Optioned Target and including an Other Program Antibody (for clarity, excluding the First Collaboration Program) and LNP Technology. |
1.139 | “Other Pre-IND Program Research Plan” shall have the meaning set forth in Section 5.2.3 below. |
1.140 | “Other Program Antibody” shall mean a Program Antibody (i) that binds to an Optioned Target, or to an Optioned Target Combination; and (ii) that Genmab has elected to use and is to be used in an Other Pre-IND Program as described in Section 5.2.3. To the extent applicable, and unless otherwise set forth, Other Program Antibody shall include Other Program Antibody Combinations. |
1.141 | “Other Program Antibody Combination” shall mean a Program Antibody Combination that (i) binds to an Optioned Target, or to an Optioned Target Combination; and (ii) Genmab has elected to use and is to be used in an Other Pre-IND Program as described in Section 5.2.3. |
1.142 | “Other Invention” shall have the meaning set forth in Section 11.3.3. |
1.143 | “Other Invention Patent Right” shall mean a CureVac Other Invention Patent Right or Genmab Other Invention Patent Right, as applicable. |
1.144 | “Other Technologies” shall mean the technologies licensed to CureVac (i) by GeneArt AG under a license agreement dated [*****] concerning [*****]; (ii) by TriLink Biotechnologies LLC under a license Agreement dated [*****], [*****]. The respective Patent Rights are listed in Exhibit 1.144. |
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1.145 | “Parties” shall mean CureVac and Genmab. |
1.146 | “Party” shall mean CureVac or Genmab. |
1.147 | “Patent Rights” shall mean any and all patents and patent applications, including provisional and non-provisional applications, reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, re-validations, patents of addition, supplementary protection certificates or the equivalents thereof, continuations, continuations-in-part and divisionals thereof and all foreign counterparts, and the like of any of the foregoing. |
1.148 | “Patent Term Extensions” shall have the meaning set forth in Section 10.9. |
1.149 | “Person” shall mean an individual, firm, company, corporation, association, trust, estate, state or agency of a state, government or government department or agency, municipal or local authority and any other entity, whether or not incorporated and whether or not having a separate legal personality. |
1.150 | “Pivotal Study” shall mean a Clinical Study of Product in human patients intended to provide evidence for drug marketing approval. Clinical Phase III Studies are typically Pivotal Studies, and in exceptional cases a Clinical Phase II Study may become a Pivotal Study, and may require additional confirmatory studies post approval. |
1.151 | “Product” shall mean any product that contains one or more mRNA construct(s) that is designed to express a Program Antibody or a Program Antibody Combination, and formulated with [*****]. Product includes both a [*****] or a [*****]. For clarification, a Product may consist of several mRNA constructs that together express a Program Antibody or Program Antibody Combination. |
1.152 | “Product Development Plan(s)” shall mean the development plans to be prepared upon Product Selection under any Program for the further Development of a Product, as set forth in Section 5.3. |
1.153 | “Product Selection” shall have the meaning set forth in Section 5.3. |
1.154 | “Product Selection Notice” shall have the meaning set forth in Section 5.3. |
1.155 | “Product Development Program” shall mean a program for the further Development of a Product pursuant to a Product Development Plan. |
1.156 | “Program” shall mean, on a Collaboration Target-by-Collaboration Target basis, any and all Development, Manufacturing and Commercialization activities conducted under R&D Plans. Programs shall include the First Collaboration Program. Save in respect of the First Collaboration Program, the sequence of a Program shall be (i) Research Program; then (ii) Other Pre-IND Program; then (iii) Product Development Program. |
1.157 | “Program Antibody” shall mean a [*****] that [*****] and that Genmab has elected to use in a Program and which has been finally cleared under Section 3.2.2. To the extent applicable, and unless otherwise set forth, [*****]. |
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1.158 | “Program Antibody Combination” shall mean an Antibody Combination that Genmab has elected to use in a Program and which has been finally cleared under Section 3.2.2. |
1.159 | “Program Breach” shall have the meaning set forth in Section 15.4. |
1.160 | “Program Patent Rights” shall mean Patent Rights Covering Inventions. |
1.161 | “Project Leaders” shall have the meaning set forth in Section 9.1.2 below. |
1.162 | “R&D Plan(s)” shall mean the research and development plans to be prepared under this Agreement and shall include the First Program Research Plan in Exhibit 5.1.1, the Reserved Target Research Plans, the Other Pre-IND Program Research Plans, the Opt-In R&D Plan, and the Product Development Plans. |
1.163 | “Receiving Party” shall have the meaning set forth in Section 13.1. |
1.164 | “Regulatory Agency” shall mean any one of the following: United States Food and Drug Administration (“FDA”) or any successor agency; or any counterparts thereof in jurisdictions outside of the U.S. |
1.165 | “Regulatory Approval” shall mean any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations (including marketing and labeling authorizations) of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local Regulatory Agency, department, bureau, commission, council or other governmental entity, that are necessary for the development, registration, manufacture (including formulation), distribution, use, sale, import or export of a Product in a given jurisdiction. |
1.166 | “Regulatory Exclusivity” shall mean any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Agency with respect to a Product, other than Patent Rights. |
1.167 | “Relevant Infringement” shall have the meaning set forth in Section 11.1. |
1.168 | “Replacement Target” shall have the meaning set forth in Section 3.1. |
1.169 | “Replacement Target Exclusivity Period” shall have the meaning set forth in Section 2.1.2. |
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1.170 | “Replacement Target Antibody” shall mean a single Antibody directed at a Replacement Target. |
1.171 | “Research Completion Deadline” shall have the meaning set forth in Section 5.2.1. |
1.172 | “Research Period” shall mean, on a Target-by-Target basis, the period during which research and Development activities under this Agreement are being conducted (i) under the First Program Research Plan (whether in relation to the First Program Antibody or in relation to a Replacement Target Antibody); and (ii) the Reserved Target Research Plans (to be determined on a Research Target-by-Research Target basis); and/or (iii) the Other Pre-IND Program Research Plans (to be determined on an Optioned Target -by- Optioned Target basis). |
1.173 | “Research Program” shall mean a program of research relating to a Reserved Target, a Research Program Antibody and LNP Technology. |
1.174 | “Research Program Antibody” shall mean a Program Antibody (i) that [*****] as applicable; and (ii) that Genmab has elected to use and is to be used in a Reserved Target Research Plan as described in Section 5.2.1. |
1.175 | “Research Program Antibody Combination” shall mean a Program Antibody Combination that [*****]. |
1.176 | “Reservation Fee” shall have the meaning set forth in Section 3.3 below. |
1.177 | “Reservation Period” shall have the meaning set forth in Section 3.2.1 below. |
1.178 | “Reserved Target” shall have the meaning set forth in Section 3.2.1 below. For purposes of this Agreement, and unless otherwise set forth herein, Reserved Target shall include a Reserved Target Combination, as applicable. |
1.179 | “Reserved Target Combination” shall have the meaning set forth in section 3.2.1 below. |
1.180 | “Reserved Target Data Package” shall have the meaning set forth in Section 5.2.2. |
1.181 | “Reserved Target Research Plan” shall have the meaning set forth in Section 5.2.1 below. |
1.182 | “Roche License” shall mean the non-exclusive license made between CureVac and F.Hoffmann-La Roche Ltd dated [*****] granting Roche [*****]. For the purposes of this Agreement, the term Roche License shall not include any amendments made to the non- exclusive license agreement between CureVac and Roche after the Effective Date. |
1.183 | “Royalty Product Patent Rights” shall mean, on a Product-by-Product basis the First Composition of Matter Patent Rights. For the avoidance of doubt, the term Royalty Product Patent Rights shall not include any later filed Patent Rights not claiming priority from or comprised in the First Composition of Matter Patent Rights, such as later filed Patent Rights that relate to other aspects of the Product (e.g., Patent Rights relating to formulation, processes, uses or other applications of the Product). |
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1.184 | “Royalty Term” shall have the meaning set forth in Section 10.6.3. |
1.185 | “Single Antibody Product” shall mean a Product that is designed to express one Program Antibody. Single Antibody Product includes the First Program Antibody and the Replacement Target Antibody. |
1.186 | “Sub-Committee” shall have the meaning set forth in Section 9.4 below. |
1.187 | “Sublicensee” shall mean any Third Party licensee (aside from Genmab’s Affiliates and any Third Party contractors used by Genmab in the Development, Manufacture or Commercialization of the Products on Genmab’s behalf), which obtains rights to the CureVac Technology or LNP Technology under a license granted by Genmab, its Affiliates or another such Third Party that was sublicensed such rights by Genmab, its Affiliates or another Sublicensee. |
1.188 | “Successful GLP Tox” shall mean the earlier of (i) the date where a formal decision by Genmab’s relevant project board or equivalent to file for IND submission is communicated to CureVac, whether or not the JRC has received data confirming that the success criteria as defined in the R&D Plan for the formal toxicology studies required for such IND submission have been fulfilled; or (ii) [*****] after the JRC has received data confirming that the success criteria as defined in the R&D Plan for the formal toxicology studies required for such IND submission have been fulfilled. |
1.189 | “Switching Costs” shall mean those incremental additional payments to be made by CureVac to a provider of LNP Technology other than under the Acuitas License or Arcturus License resulting from the decision by Genmab to switch from the First Collaboration Target to a Replacement Target, including payment of additional license or reservation fees and/or increased royalties because a new license of LNP Technology is required other than the Arcturus License or Acuitas License. For clarity, the term “Switching Costs” shall only comprise the delta between what CureVac would have had to pay to Arcturus under the Arcturus License or to Acuitas under the Acuitas License for an LNP Technology license relating to the First Collaboration Target and what CureVac will have to pay to a provider of LNP Technology other than under the Acuitas License or Arcturus License for an LNP Technology license relating to the Replacement Target. The Switching Costs shall be determined from time to time when any payment relating to the Replacement Target is due under such LNP Technology license other than Acuitas License or Arcturus License by comparing the actual total payments made or due under such other LNP Technology license with the payments that would have been made by or due from CureVac under the Arcturus License or Acuitas License with respect to the given Product. Whether the Arcturus License or Acuitas License will be used as reference point when making such calculations of the then current total Switching Costs will depend on which of the two LNP Technologies that were used for Product based on the First Program Antibody. |
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1.190 | “Target” shall mean a distinct single antigen defined by its unique UniProt/SwissProt number. For purposes of this Agreement, and unless otherwise set forth herein, Target shall include a Target Combination, as applicable. |
1.191 | “Target List” and “Target List Rep” shall have the meanings set forth in Section 3.2.2. |
1.192 | “Target Combination” shall mean a combination of up to [*****] distinct antigens per Product, as defined by their unique UniProt/SwissProt numbers. |
1.193 | “Target Subset” shall mean any individual Targets or subcombinations thereof within an Optioned Target Combination which does not contain the specific combination of Targets constituting an Optioned Target Combination targeted by an Other Program Antibody or Other Program Antibody Combination (e.g., if Genmab has exercised an Optioned Target Combination consisting of “a+b+c”, then any individual Target or other subcombination of Targets within the Optioned Target Combination of “a+b+c”, i.e. the combinations of “a+b”, “b+c” or “a+c” or the individual Targets “a” or “b” or “c”), would each constitute a Target Subset. |
1.194 | “Term” shall have the meaning set forth in Section 15.1. |
1.195 | “Terminating Party” shall have the meaning set forth in Section 7.9. |
1.196 | “Territory” shall mean the world. |
1.197 | “Third Party” shall mean any Person, other than CureVac or Genmab and their respective Affiliates. |
1.198 | “Third Party IP” shall have the meaning set forth in Section 2.8. |
1.199 | “Valid Claim” shall mean either (i) a claim of an issued and unexpired patent within (A) CureVac Patent Rights, excluding any claim within the CureVac Program Patent Rights, CureVac Other Invention Patent Rights or Joint Patent Rights Covering a Product where such CureVac Program Patent Right(s), CureVac Other Invention Patent Right(s) or Joint Patent Right(s) has a later priority date than any Royalty Product Patent Right Covering such Product; (B) Patent Rights within LNP Technology Controlled by CureVac and licensed by CureVac to Genmab under or in connection with this Agreement; or (C) Royalty Product Patent Rights, and, in each case of (A), (B) and (C), which has not been revoked or held permanently unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been found or admitted to be abandoned, disclaimed, denied, invalid or unenforceable through re-examination, reissue or disclaimer or otherwise; or (ii) a claim of a pending patent application within the CureVac Patent Rights, (excluding any claim within the CureVac Program Patent Rights, CureVac Other Invention Patent Rights or Joint Patent Rights Covering a Product where such CureVac Program Patent Right(s), CureVac Other Invention Patent Rights or Joint Patent Right(s) has a later priority date than any Royalty Product Patent Right Covering such Product), Patent Rights within LNP Technology Controlled by CureVac and licensed by CureVac to Genmab under or in connection with this Agreement, or Royalty Product Patent Rights, which claim has not been cancelled, withdrawn, abandoned or finally disallowed, and which claim has been prosecuted in good faith and not been pending for more than [*****] from the date of its earliest priority date. For avoidance of doubt, the term “Valid Claim” shall not include any claim of Third Party IP that has been deemed part of CureVac Technology pursuant to Section 2.8. |
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1.200 | Interpretation |
In this Agreement, unless the context otherwise requires, a reference to:
(i) | a paragraph, section, exhibit or schedule is a reference to a paragraph, section, exhibit or schedule to this Agreement; |
(ii) | any document includes a reference to that document (and, where applicable, any of its provisions) as amended, novated, supplemented or replaced from time to time; |
(iii) | a statute or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of them; |
(iv) | the singular includes the plural and vice versa, except as it regards the definitions of Party and Parties; |
(v) | one gender includes the other; |
(vi) | “written” and “in writing” include any means of reproducing words, figures or symbols in a tangible and visible form, including acknowledged email or facsimile; |
(vii) | a month or year is a reference to a calendar month or Calendar Year, as the case may be; |
(viii) | “include”, “includes” and “including” means including without limitation, or like expression unless otherwise specified, and “for example”, “e.g.”, “such as” and similar words or phrases are descriptive, not limiting; and |
(ix) | the official text of this Agreement and any Exhibits shall be in English, and any notices given or accounts or statements for communication between the Parties will be in English and in the event of any dispute concerning the construction or interpretation of this Agreement, reference shall be made only to this Agreement as written in English and not to any other translation into any other language. |
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2. | LICENSES; EXCLUSIVITY. |
2.1 | License Grants to Genmab. |
2.1.1 | First Collaboration Target License. With respect to the First Collaboration Target and the First Program Antibody, subject to the terms and conditions of the Agreement, and for the Term, CureVac hereby grants to Genmab, and Genmab hereby accepts, an exclusive (subject to Section 2.1.6) license under the CureVac Technology to Develop, Manufacture and Commercialize a Single Antibody Product in the Field and in the Territory. This license shall automatically terminate upon final clearance by CureVac of a Replacement Target and related Program Antibody nominated by Genmab in accordance with Section 3.2.2 below. For clarity, the grant of a license under this Section 2.1.1 to [*****], unless otherwise specified in this Agreement. |
2.1.2 | Replacement Target License. With respect to a Replacement Target nominated by Genmab and cleared by CureVac under the provisions of Section 3.2.2, as of the final clearance of such Replacement Target and related Program Antibody(-ies), and subject to the terms and conditions of this Agreement, and for a term starting upon clearance of the Replacement Target and ending at the earlier of (i) [*****], or (ii) [*****] after clearance of the respective Replacement Target (“Replacement Target Exclusivity Period”), CureVac hereby grants to Genmab, and Genmab accepts, an exclusive (subject to Section 2.1.6) license under the CureVac Technology to Develop, Manufacture and Commercialize a Single Antibody Product in the Field in the Territory. For clarity, the grant of a license under this Section 2.1.2 to Manufacture shall not require CureVac to transfer any Know-How comprised in the CureVac Manufacturing Technology, unless otherwise specified in this Agreement. |
2.1.3 | Reserved Target License. With respect to a Reserved Target, subject to the terms and conditions of this Agreement, and for a period of [*****] after the Effective Date, CureVac hereby grants to Genmab, and Genmab hereby accepts an exclusive (subject to Section 2.1.6) license under the CureVac Technology to conduct or have conducted research and pre-clinical Development on Antibody-based Products in the Field and in the Territory, such research and pre-clinical Development to enable Genmab to make a decision as to whether it wants to advance the Reserved Target to an Optioned Target. If the Reserved Target is a Reserved Target Combination, the exclusivity under this Section 2.1.3 shall apply to all combinations, including subsets of combinations within the respective Reserved Target Combination, but does not apply to individual Targets within such Reserved Target Combination. For illustration purposes, if the Reserved Target Combination was a+b+c, the exclusivity would also apply to the combination of a+b, b+c and a+c, but not to a, b or c individually. |
2.1.4 | Optioned Target License. With respect to any Optioned Target, subject to an Option Exercise under Section 3.4 below, and subject to the terms and conditions of this Agreement, and for a term starting upon Option Exercise and ending at the earlier of (i) [*****]; or (ii) [*****] after the Option Exercise (“Optioned Target Exclusivity Period”), CureVac hereby grants to Genmab, and Genmab hereby accepts an exclusive (subject to Section 2.1.6) license under the CureVac Technology to Develop, Manufacture and Commercialize Single Antibody Products or Cocktail Products, as applicable. If the Optioned Target is an Optioned Target Combination, the exclusivity under this Section 2.1.4 applies to the specific combination within the respective Optioned Target Combination, and neither applies to any other combinations, nor to individual Targets within such Optioned Target Combination. The grant of a license under this Section 2.1.4 to Manufacture shall not require CureVac to transfer any Know-How comprised in the CureVac Manufacturing Technology, unless otherwise specified in this Agreement. |
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2.1.5 | Other Product Licenses. With respect to any Product (and related Program Antibodies and Program Antibody Combinations) generated during Replacement Target Exclusivity Period, Reservation Period or Optioned Target Exclusivity Period, subject to the terms and conditions of this Agreement, and for the Term, CureVac hereby grants to Genmab, and Genmab hereby accepts, an exclusive (subject to Section 2.1.6) license under the CureVac Technology to Develop, Manufacture and Commercialize such Products in the Field and in the Territory. For clarity, the grant of a license under this Section 2.1.5 to [*****]. |
2.1.6 | BioNTech License and Roche License. Notwithstanding the above, until [*****] the licenses under the CureVac Technology granted to Genmab pursuant to this Section 2.1 shall be non-exclusive with respect to rights under Patent Rights [*****] listed in Exhibit 1.13 to the extent the non-exclusive license granted by CureVac to BioNTech AG is overlapping with the license granted to Genmab under said Patent Rights. Further, until [*****] the licenses under the CureVac Technology granted to Genmab pursuant to this Section 2.1 shall be non-exclusive with respect to rights under [*****] to the extent the non-exclusive license granted by CureVac to F.Hoffmann-La Roche Ltd is overlapping with the licenses granted to Genmab under [*****]”. |
2.1.7 | Other Technologies Licenses. The rights granted under this Section 2.1 (2.1.1, 2.1.2, 2.1.3, 2.1.4, and 2.1.5) include (i) an extension of CureVac’s rights to Genmab, its Affiliates, subcontractors and permitted Sublicensees as “Direct Collaboration Partner” or “Indirect Collaboration Partner” under the Patent Rights identified by the patent family identifier CV-P- Geneart in Exhibit 1.144; and (ii) a non-exclusive sublicense of CureVac to Genmab, under the Patent Rights identified by the patent family identifier [*****] in Exhibit 1.144. |
2.2 | Sublicenses. Subject to the terms and conditions of this Agreement, Genmab shall have the right to sublicense any and all rights licensed to Genmab under Section 2.1 to its Affiliates. With respect to any and all rights licensed to Genmab under Section 2.1, and subject to the terms and conditions of this Agreement, Genmab shall have the right to sublicense to any Third Party (with the right to sublicense in multiple tiers) [*****] only upon CureVac’s prior written consent which CureVac may grant or withhold in its sole discretion. [*****], Genmab shall have the right to sublicense any and all rights licensed to Genmab under Sections 2.1.1 (First Collaboration Target) or 2.1.2 (Replacement Target), Section 2.1.5 (other Product license) and Section 2.1.7 (Other Technologies License) to any Third Party (with the right to sublicense in multiple tiers) upon CureVac’s prior written consent which shall not be unreasonably withheld; and such consent is only required if such Third Party is either a direct competitor of CureVac within the field of the development of mRNA-based products (such as, but not limited to, [*****] and/or is residing in [*****] at the time when Genmab wishes to grant such sublicense. After [*****] Genmab shall have the right to sublicense any and all rights licensed to Genmab under Sections 2.1.1 or 2.1.2 Section 2.1.5 and Section 2.1.7 (Other Technologies License) without CureVac’s prior written consent. Any sublicense by Genmab to a Third Party shall be in writing and consistent with and subject to the terms of this Agreement, and shall include an obligation for each such Sublicensee to comply with the applicable obligations of Genmab set forth in this Agreement. Genmab will provide CureVac with written notice of any [*****]. |
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2.3 | License Grants to CureVac. Subject to the terms and conditions of the Agreement, Genmab hereby grants to CureVac, and CureVac hereby accepts, a non-exclusive, royalty-free license under the Genmab Technology to perform CureVac’s obligations under the Agreement with respect to the research and Development of Products on behalf of Genmab. |
2.4 | Exclusivity. |
2.4.1 | Genmab. Except for the exercise of rights hereunder with respect to Products, neither Genmab, its Affiliates nor its Sublicensees holding exclusive rights to the CureVac Technology in the Field and in the Territory, shall develop or commercialize an mRNA-based [*****] Antibody (including a [*****] Antibody) product or a [*****] Antibody that is based on [*****] as described in Exhibit 1.77. |
2.4.2 | CureVac on the First Collaboration Target. During the term of this Agreement, CureVac, itself or through its Affiliates, shall not, directly or indirectly, offer any rights to a Third Party under the LNP Technology for the First Collaboration Target or conduct or participate in the research, development, manufacture, use, offer for sale, or other exploitation of any mRNA-based product that is designed to express a Single Antibody (including monoclonal, bispecific or multispecific Antibody) product that is directed at the First Collaboration Target or any recombinant single Antibody (including monoclonal, bispecific or multispecific Antibody) product directed at the First Collaboration Target. Notwithstanding the above, if Genmab replaces the First Collaboration Target with a Replacement Target pursuant to Section 3.1, then CureVac shall be released from its exclusivity obligations set out above in this Section 2.4.2 as of the date of such replacement and instead Section 2.4.3 shall apply with respect to the Replacement Target. |
2.4.3 | CureVac on the Replacement Target. CureVac, itself or through its Affiliates, shall not, directly or indirectly, offer any rights to a Third Party under the CureVac Technology or LNP Technology for the Replacement Target or conduct or participate in the research, development, manufacture, use, offer for sale, or other exploitation of any recombinant or mRNA-based Antibody product directed at the Replacement Target until the earlier of (i) [*****]; and (ii) [*****] after final clearance of the Replacement Target under Section 3.2.2. |
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2.4.4 | CureVac on Reserved Targets and Reserved Target Combinations; Optioned Targets and Optioned Target Combinations; Opt-In Target. Once a Target or Target Combination, as applicable, becomes a Reserved Target or Reserved Target Combination, CureVac, itself or through its Affiliates, shall not directly or indirectly, offer any rights to a third party under the CureVac Technology or LNP Technology for such Reserved Target or Reserved Target Combination or conduct or participate in the research, development, manufacture, use, offer for sale, or other exploitation of any mRNA-based product that is designed to express an Antibody or Antibody Combination that is directed at such Reserved Target or Reserved Target Combination, or any recombinant Antibody product or Antibody Combination product directed at such Reserved Target or Reserved Target Combination. The non-compete obligations under this Section 2.4.4 shall continue until expiry of the Reservation Period for such Reserved Target or Reserved Target Combination, as applicable, unless Genmab exercises an Option with respect to a Reserved Target or Reserved Target Combination, as applicable, in which case the non-compete obligations with respect to such Target or Target Combination (then an Optioned Target or Optioned Target Combination) shall remain in effect until the end of the Optioned Target Exclusivity Period. CureVac retains its rights to conduct or participate in the research, development, manufacture, use, offer for sale, or other exploitation of mRNA or recombinant based products directed at single Targets of a Reserved Target Combination during the Reservation Period, but not for combinations of individual Targets within a Reserved Target Combination (e.g., a combination of a+b where the Reserved Target Combination consists of a+b+c). After the Reservation Period, the non-compete obligations under this Section 2.4.4 automatically expire with respect to any Target Combinations within the Reserved Target Combination that is not the Optioned Target Combination (e.g., if Genmab exercises an option for the combination a+b+c, then CureVac will get the rights back to work on e.g.; “a+b” or “a+b+c+d”); and after the Optioned Target Exclusivity Period, the non-compete obligations under this Section 2.4.4 automatically expire with respect to any Optioned Target and Optioned Target Combination that is not addressed by an Other Program Antibody. Notwithstanding anything to the contrary above, in the event of an Opt-In by CureVac under Section 7.1 and until the earlier of (i) an assignment by CureVac under Section 7.8 or (ii) CureVac’s termination of its [*****] collaboration of the Opt-In Program pursuant to Section 7.9, CureVac, itself or through its Affiliates, shall not, directly or indirectly, offer any rights to a Third Party under the CureVac Technology or LNP Technology for the Opt-In Target, or conduct or participate in the research, development, manufacture, use, offer for sale, or other exploitation of any mRNA-based product that is designed to express an Antibody product that is directed at the Opt-In Target or any recombinant Antibody product directed at the Opt-In Target. For avoidance of doubt, in the event of assignment by CureVac under Section 7.8 the exclusivity obligation set out above shall continue to apply with respect to the Third Party assignee. |
2.5 | Trademarks. Genmab will be free to use and to register in any trademark office in the Territory any trademark for use with a Product in its sole discretion; provided, however, nothing herein shall grant Genmab any right to use any trademark Controlled by CureVac and/or its Affiliates. Genmab will own all right, title and interest in and to any such trademark it selects in its own name during and after the Term. |
2.6 | Know-How Transfer; Availability of Employees. As and when required in relation to an R&D Plan (and from time to time during the Term if new Know-How comes to be Controlled by CureVac) or as soon as reasonably practicable upon Genmab’s request, CureVac shall disclose and/or deliver to Genmab copies of all Development Data and information in CureVac’s possession relating to the CureVac Know-How which is reasonably required for Genmab’s research and Development activity in accordance with the respective R&D Plan (including for regulatory purposes), with the exception, however, of all Know-How comprised in the CureVac Manufacturing Technology which shall be made available to Genmab or its designee as set forth in Sections 6.5 and/or pursuant to Tech Transfer Plan, the Early Clinical Supply Agreement and/or the MSA. [*****]. The technology transfer to be undertaken under Sections 2.6 and 6.5 shall be overseen by the Joint Research Committee. |
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2.7 | No Implied License. Nothing in this Agreement shall be deemed to constitute the grant of any license or other right to either Party in respect of any technology of the other Party, except as expressly set forth herein, and no license rights shall be created hereunder by implication, estoppel or otherwise. Neither Party shall represent to any Third Party that it enjoys, possesses, or exercises any proprietary or property right or otherwise has any other right, title or interest in the technology of the other Party except for such rights as are expressly set forth herein. Any rights of a Party not expressly granted to the other Party under the provisions of this Agreement shall be retained by such Party. |
2.8 | Third Party Intellectual Property – CureVac Activities. If, during the Term, CureVac obtains a sub-licensable license to any Patent Rights or Know-How Controlled by a Third Party that is necessary or useful to Develop, Manufacture, Commercialize or otherwise exploit Products in the Field in the Territory (“Third Party IP”), then CureVac shall notify Genmab of the rights that CureVac has obtained with respect such Third Party IP (including details of the financial and commercial terms and other obligations that would be placed on Genmab as a sublicensee) promptly after obtaining such rights or, if reasonably possible before obtaining such rights and only in the circumstances that the license relates solely to a Product, allow Genmab to provide input to the draft terms to be taken into good faith consideration by CureVac. Genmab shall notify CureVac within [*****] after receipt of such notice whether Genmab desires to include such Third Party IP under the licenses granted to Genmab by CureVac pursuant to Section 2.1. If Genmab notifies CureVac that it desires to include Third Party IP under the license granted to Genmab by CureVac pursuant to Section 2.1, then (a) such Third Party IP is and shall be automatically included in the definition of CureVac Technology and in the licenses under Section 2.1, and (b) as a sublicensee of CureVac Genmab will meet all obligations of CureVac that are applicable to Genmab’s activities as a sub-licensee and have been disclosed by CureVac to Genmab; and (c) to the extent necessary CureVac will grant to Genmab a formal sublicense, and (d) subject to the below in this Section 2.8, [*****]. For avoidance of doubt, in the event that CureVac uses the Third Party IP for its own products or other Third Party products, [*****]. The proportionate amount shall be judged at the time of any payment by CureVac under the license, and shall be calculated by reference to the number of Products under Development by Genmab at that time in comparison to the number of products under research or development by CureVac or any licensee of CureVac and, if applicable, the number of available product slots (license options). For illustration purposes only, if Genmab then had one Product under Development, and CureVac and its licensees had five products under research or development and four available product slots (license options), the proportionate amount would be [*****] Genmab shall make such [*****] within [*****] after receipt of an invoice therefor from CureVac. For the avoidance of doubt, the obligations of [*****] amounts payable by CureVac to a Third Party as set forth in this Section 2.8 apply solely with respect to licenses under Third Party IP that are entered into by CureVac after the Effective Date. CureVac shall be solely responsible for any amounts payable with respect to licenses to Third Party IP entered into by CureVac (or an Affiliate to CureVac) prior to the Effective Date and forming part of CureVac Background Technology or Other Technologies. Notwithstanding anything to the contrary above, to the extent the Patent Rights comprised in the Third Party IP sublicensed hereunder to Genmab were granted Patent Rights as of the Effective Date and are referenced in the Disclosure Letter, then Genmab shall have the right to deduct one hundred per cent (100%) of the amounts [*****] to CureVac under this Section 2.8 from milestone payments due to CureVac under Section 10.5 and/or from royalties due to CureVac under Section 10.6 subject always to the provisions of Section 10.6.9. If Genmab decides that it does not wish to take a sublicense to such Third Party IP from CureVac it shall not be treated as part of CureVac Technology. If Genmab subsequently takes a license to such Third Party IP to which CureVac holds a license and where CureVac has previously offered an equivalent sublicense, [*****]. For avoidance of doubt, with respect to sublicenses from CureVac to Third Party IP not referenced in the Disclosure Letter or Third Party Patent Rights referenced in the Disclosure Letter that are not granted as of the Effective Date, then to the extent that such sublicenses qualify as FTO Licenses, Genmab shall have the right to deduct [*****] made to CureVac in accordance with the provisions set out in Section 10.6.6 (Other Third Party Payments) and subject always to the provisions of Section 10.6.9. |
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2.9 | CureVac New Patent Rights. CureVac shall notify Genmab of any Patent Right and related Know-How Controlled by CureVac that (a) Cover an invention made by CureVac during the Term outside the scope of this Agreement and are unrelated to CVCM or LNP technology, and, for clarity, that are not in-licensed from a Third Party, and (b) are necessary or reasonably useful to Develop, Manufacture, Commercialize or otherwise exploit Products in the Field in the Territory (each, a “New Patent Right”). For avoidance of doubt this does not include Patent Rights and related Know-How Covering manufacturing processes outside the scope of CureVac Manufacturing Technology. Genmab shall notify CureVac within [*****] after receipt of such notice whether Genmab desires to include such New Patent Right under the licenses granted to Genmab by CureVac pursuant to Section 2.1. If Genmab notifies CureVac that Genmab desires to include such New Patent Right under the licenses granted to Genmab by CureVac pursuant to Section 2.1, then such New Patent Right is and shall be automatically included in the definitions of the CureVac Patent Rights and shall be considered within 1.199 (i) (Valid Claim) regardless of the priority date of the New Patent Right and shall be included in the licenses granted to Genmab by CureVac pursuant to Section 2.1. |
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3. | REPLACEMENT TARGET; RESERVED TARGETS; OPTIONED TARGETS. |
3.1 | Replacement of the First Collaboration Target. If the pre-clinical Program with respect to the First Collaboration Target does not meet the success criteria set forth in the First Program Research Plan attached hereto as Exhibit 5.1.1 (as may be modified by JRC), Genmab has the [*****] right, [*****] after the Effective Date, to seek to replace the First Collaboration Target by another Target (“Replacement Target”). Genmab shall nominate a Replacement Target by written notice to CureVac, and CureVac will then operate the clearance procedures, in accordance with Section 3.2.2. If CureVac gives written notice to Genmab that the Replacement Target is cleared and, upon written notice by Genmab that it wishes to replace the First Collaboration Target by such Replacement Target, the Replacement Target will replace the First Collaboration Target for purposes of this Agreement. Upon replacement, the Parties through the JRC will amend the First Program Research Plan as required to address any differences between the Replacement Target and the First Collaboration Target, as well as the changes in timeline resulting from the change of Target. |
3.2 | Target Reservation. |
3.2.1 | Reserved Targets and Reservation Period. During a period starting on the first anniversary of the Effective Date and ending [*****] after the Effective Date, Genmab shall have the right to exclusively reserve up to four (4) Targets or Target Combinations, in order to enable Genmab, to exercise up to three (3) options, to Develop, Manufacture and Commercialize Products against the Targets or Target Combinations, as applicable, for which the option is exercised, in addition to the Products against the First Collaboration Target or Replacement Target, as applicable. A Target or Target Combination shall become a “Reserved Target” or a “Reserved Target Combination” as applicable, upon (i) [*****], and (ii) [*****]. Such Reserved Target shall remain a Reserved Target until [*****] or such period as extended in accordance with Section 5.2.2 below (“Reservation Period”). If Genmab notifies CureVac that it does not wish to exercise an option with respect to a Reserved Target, latest upon expiry of the Reservation Period, the respective Target shall cease to be a Reserved Target; and upon exercise of three (3) options, any fourth (4th) Reserved Target shall cease to be such a Reserved Target. |
3.2.2 | Clearance of Targets. CureVac shall appoint a representative of CureVac (“Target List Rep”) who is a legal counsel in the legal department or IP department of CureVac or employed with an external law firm, to keep a list of all Targets and Target Combinations that are the subject of or related to any ongoing evaluation or research project of CureVac and/or in collaboration with or under option or license to any Third Party (“Target List”). CureVac shall provide to Genmab contact details of the Target List Rep. If Genmab wishes to reserve a Target or Target Combination, Genmab shall in writing request CureVac to perform a Target or Target Combination clearance. Clearance will be conducted in accordance with the following process: First, Genmab shall inform the Target List Rep in writing that Genmab wishes to conduct a Target or Target Combination clearance. Second, within [*****] from receipt of such information from Genmab the Target List Rep updates the Target List and confirms to Genmab that the Target List is updated. Third, Genmab shall set out details of the Target or Target Combination to the Target List Rep and within [*****] the Target List Rep shall indicate to Genmab whether the Target or Target Combination is available. If the Target or Target Combination, as applicable, is available and Genmab wishes to go ahead, Genmab shall then submit to CureVac the full sequences of the proposed Research Program Antibody(-ies) as specified in the clearance templates in Exhibit 3.2.2, as applicable. Unless Genmab informs CureVac that it will independently secure rights to an appropriate LNP Technology, CureVac shall within a further [*****] review and investigate whether LNP Technology for a Product based on the Target or Target Combination and proposed Research Program Antibody(-ies) is potentially available through CureVac. In connection with such review and investigation, CureVac shall be authorized to provide the full sequences of the proposed Research Program Antibody(-ies) to the in-house legal or IP counsel of the potential LNP Technology provider or an external legal or IP representative handling any gatekeeping clearance procedures that it operates, provided that the LNP Technology provider and, if applicable, its external legal or IP representative is subject to confidentiality obligations at least as stringent as the confidentiality obligations on the Parties set forth herein as well as an obligation not to disclose the sequence to any Third Party. If CureVac determines that LNP Technology for a Product based on the Target or Target Combination and proposed Research Program Antibody(-ies) is available through CureVac, it shall give notice to Genmab hereof. If CureVac cannot identify any such LNP Technology the JRC shall consider the position to recommend a way forward. The Reserved Target or Reserved Target Combination, as applicable, shall be deemed finally cleared for purposes of this Agreement, if CureVac informs Genmab that the LNP Technology is available for the respective Product(s) and related Program Antibody/Program Antibody Combination, or if Genmab waives CureVac’s obligations to support Genmab with respect to the LNP Technology under this Agreement. |
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3.2.3 | Costs. Subject to CureVac’s Opt-in Right and except as otherwise stated in this Agreement, all Development costs under any Program relating to Reserved Targets shall be borne by Genmab. |
3.3 | Reservation Fee. Within [*****] after a Target or Target Combinations becomes a Reserved Target or Reserved Target Combination, as applicable, in accordance with Section 3.2.1, Genmab shall pay to CureVac a reservation fee of US Dollars [*****] per Reserved Target or Reserved Target Combination, as applicable, (“Reservation Fee”), provided, however, that in the event the Reservation Fee has not been paid within [*****] after the date that the Target or Target Combination became a Reserved Target or Reserved Target Combination, as applicable, pursuant to Section 3.2.1, such Target or Target Combination shall no longer be reserved for purpose of this Agreement. The Reservation Fee shall be creditable against the Option Exercise Fee for the respective Reserved Target or Reserved Target Combination, in the event Genmab advances such Reserved Target or Reserved Target Combination to an Optioned Target or Optioned Target. |
3.4 | Exclusive Option. As of the Effective Date and in consideration for the respective Option Exercise Fee as set forth in Section 10.2, CureVac hereby grants to Genmab, and Genmab hereby accepts, three (3) exclusive options for the shorter of (i) a term of [*****] after the Effective Date; or (ii) on a Reserved Target-by-Reserved Target basis, the Reservation Period (“Option Period”), to obtain exclusive licenses to Reserved Targets, as set forth in Section 2.1.3 above. Genmab may exercise the option under this Section 3.4 on a Reserved Target-by-Reserved Target basis by way of written notice to CureVac during the Option Period (“Option Exercise”). As of the date of the Option Exercise, and provided the Option Exercise Fee has been timely paid in accordance with Section 10.2 below, the Reserved Target or Reserved Target Combination shall become an “Optioned Target” or “Optioned Target Combination”, as applicable. For clarity, in order to protect Genmab’s exclusive option, during the Option Period the exclusivity obligations set out in Section 2.4 shall apply. |
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4. | LNP TECHNOLOGY. |
4.1 | First Program Antibody. CureVac will at its own cost secure the rights to the LNP Technology required for Genmab to Develop, Manufacture and Commercialize a Single Antibody Product identified under the First Program Research Plan (whether in relation to the First Collaboration Target or a Replacement Target) with the exception of any Switching Costs which will be borne by Genmab and/or CureVac pursuant to the mechanism set forth below in this Section 4.1. The rights may be exclusive or non-exclusive, and may be under the Arcturus License, the Acuitas License or utilizing any other suitable LNP Technology of a Third Party other than Arcturus or Acuitas. CureVac shall hold the license required and, if CureVac decides to source other suitable LNP Technology, shall be responsible for (i) investigating the availability of such other suitable LNP Technology and in connection with such investigation, upon Genmab’s prior written approval (not to be unreasonably withheld), CureVac shall be authorized to provide the full sequences of the First Program Antibody or Replacement Target Antibody to the in-house legal or IP counsel of the potential LNP Technology provider or an external legal or IP representative handling any gatekeeping clearance procedures that it operates on behalf of said provider, provided that the LNP Technology provider and, if applicable, its external legal or IP representative is subject to confidentiality obligations at least as stringent as the confidentiality obligations on the Parties set forth herein and, in addition, an obligation not to share the sequences with any Third Party; and (ii) negotiating and agreeing the terms for the license under the LNP Technology for the conduct of the First Collaboration Program for the First Collaboration Target and, if applicable and subject to the below in this Section 4.1 and in Section 4.2, the Replacement Target. Prior to CureVac deciding on the use of a particular LNP Technology for the First Collaboration Target that is not the LNP Technology licensed under the Arcturus License or the Acuitas License, Genmab shall have the right to review and consider all terms relevant to Genmab for such LNP Technology license, including any relevant agreements with any Third Party provider for such LNP Technology, relevant Patent Rights, and FTO reports (if any). If CureVac decides to source other suitable LNP Technology and Genmab, having considered the terms available from the provider of the LNP Technology, suggests certain amendments to such terms, CureVac will use Commercially Reasonable Efforts to obtain such amendments, but if CureVac cannot obtain such amendments, CureVac shall be entitled to proceed with such LNP Technology license for the First Collaboration Target without such amendments. For avoidance of doubt, CureVac shall not enter into any LNP Technology license other than the Acuitas License or Arcturus License for the Replacement Target without Genmab’s prior written consent. In the event that the First Program Research Plan is amended to include a Replacement Target, the procedure for selection of a suitable LNP Technology set out in Section 4.2 below shall apply. CureVac shall obtain the LNP Technology license in relation to the Single Antibody Product identified under the First Program Research Plan and grant to Genmab a sublicense in the form required by the license to CureVac from the LNP Technology provider. If an LNP Technology license other than Acuitas License or Arcturus License is chosen with respect to the Replacement Target and Genmab is granted a sublicense pursuant to the procedure set out in Section 4.2, [*****] any applicable Switching Costs within [*****] of the date of CureVac invoice therefor, provided, however, that if the Switching Costs at a given time exceed [*****] of the total costs for such LNP Technology license, then [*****] the then current total costs for such LNP Technology license for the Replacement Target pursuant to the principles applicable to Reserved Targets and Optioned Targets set out in Section 4.3 below. Upon Genmab’s reasonable request at any time following the Effective Date, CureVac shall provide to a representative of Genmab’s legal department (and on the basis that such legal department representative may share such copies with other representatives of Genmab’s legal department as reasonably necessary and may also summarize the contents for other Genmab stakeholders who need to know the relevant information) accurate, current and unredacted copies of (i) the Acuitas License, including any future amendments thereto and (ii) the Arcturus License, including any future amendments thereto. |
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4.2 | Selection of LNP Technology for Replacement Target Antibody and Other Program Antibodies. Genmab shall not have the right to source the LNP Technology to be used in the First Program Research Plan for the First Collaboration Target (including any Replacement Target). Genmab may request CureVac in writing to source LNP Technology itself for use in a Reserved Target Research Plan. Subject to the below in this Section 4.2, such request shall be made by Genmab prior to submitting to CureVac the full sequences of the Research Program Antibody(ies) under Section 3.2.2. For avoidance of doubt, in such eventuality CureVac shall have no responsibility to source such LNP Technology. Absent such a notice from Genmab CureVac shall use Commercially Reasonable Efforts to ensure the availability of license rights to an LNP Technology which is suitable for the Development, Manufacture and Commercialization of Products Research Program Antibody(ies) in accordance with this Agreement. Such rights may be non-exclusive. As part of the clearance procedures under Section 3.2.2 (including as a result of the provisions of Section 3.1 in relation to a Replacement Target) CureVac will present a proposal to Genmab identifying the LNP Technology CureVac suggests is used and is available for in-licensing, considering Genmab’s preference for either an exclusive or non-exclusive license to the LNP Technology. As part of this process CureVac shall evaluate LNP Technologies it has been working with in the past with respect to both their suitability and availability for the respective Replacement Target Antibody or Research Program Antibody(ies). Genmab and CureVac shall consider together the options for LNP Technology to be used at the JRC, including if a new license is required, whether CureVac should hold the license and sub-license to Genmab (with the exception of a license for Product related to the Replacement Target where CureVac shall hold the license and sublicense to Genmab), or whether each Party should hold whatever licenses it requires. CureVac shall be responsible for negotiating and agreeing the terms for the license under the LNP Technology for the conduct of the Development of Products based on the Replacement Target Antibody or Research Program Antibody(ies) and the Commercialization of Products arising therefrom. In the case of the Replacement Target Antibody or the Research Program Antibody(ies) prior to finalizing any such new license for a particular LNP Technology to be used in relation to a First Collaboration Program (for the Replacement Target) or a Research Program, Genmab shall have the right to review the terms and conditions of a license of the respective LNP Technology, including the license agreement with a Third Party, whether an exclusive and non-exclusive is available, the financial terms (identifying the separate fees for an exclusive and non-exclusive license), the Patent Rights under the LNP Technology, FTO reports (if any), and other documentation the JRC may consider relevant for the selection of an LNP Technology (“LNP Technology License Documentation Package”). For clarity, CureVac will not guarantee that a suitable LNP Technology will be available for any Program except the First Collaboration Program based on the First Program Antibody. Within [*****] of receipt by Genmab of a complete LNP Technology License Documentation Package under Section 5.2.2, Genmab shall indicate by written notice to CureVac (i) whether or not Genmab agrees to take sub-license rights to the LNP Technology on the terms specified in the LNP Technology License Documentation Package; and, if it so agrees (ii) whether the license rights should be non- exclusive or exclusive, if both such options are available. If Genmab agrees to take sub-license rights, CureVac shall obtain the license and grant to Genmab the sublicense in the form required by the license to CureVac from the LNP Technology provider as specified in the LNP Technology License Documentation Package and approved in advance by Genmab. If Genmab does not agree to take sub-license rights to the LNP Technology on the terms specified in the LNP Technology License Documentation Package, then with the exception of LNP Technology being licensed in relation to Product based on the Replacement Target, Genmab shall have the right to source LNP Technology itself. |
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4.3 | LNP Technology License Fees. Subject to the provisions of Section 4.1 concerning Switching Costs the license fees under any LNP Technology for use in relation to the first Product directed against the First Collaboration Target or Replacement Target, as applicable, are included in the license fees under this Agreement and CureVac shall thus be solely responsible for all and any payments related to the LNP Technology for use in relation to such first Product. With respect to Reserved Targets and Optioned Targets, and save where Genmab seeks to source the LNP Technology license directly from the provider (in which case Genmab shall be responsible for [*****] of all license fees), all license fees to be paid for the rights to the respective LNP Technologies to the Third Party licensor of the respective LNP Technologies (whether signature fees, annual fees, milestone payments or royalties) shall be [*****] shared by Genmab and CureVac to the extent that such payments relate only to a license of rights for the Development, Manufacturing or Commercialization of a Research Program Antibody and any subsequent Other Program Antibody and/or the related Product. If the license fees (for example an upfront or signature fee) cover license rights to several potential products but will be used for a Product, [*****]. The [*****] amount shall be judged at the time of any payment by CureVac under the license, and shall be calculated by reference to (i) the [*****] at that time; and (ii) in comparison to the number of products under research or development by CureVac or any licensee of CureVac at that time and/or, if applicable, product slots (license options) capable of use by CureVac. For illustration purposes only, [*****]. Notwithstanding the above, if Genmab in its sole discretion elects that the Parties should obtain an exclusive license although a non-exclusive license was available at the same time, [*****] provided, however, that if the Parties agree that an exclusive license to LNP Technology is to be obtained for any Opt-In Product the full costs for such exclusive license shall be [*****]. In cases where CureVac is the licensee under the LNP Technology license, CureVac shall invoice Genmab for Genmab’s share of the license fees to a licensor of LNP Technology as and when such fees fall due. If Genmab is the licensee, it shall invoice CureVac for its share of license fees as and when such fees fall due. For clarity, if CureVac obtains the license to the LNP Technology, and grants a sublicense to Genmab, the [*****] of all license fees for a non-exclusive license shall be a pass through license fee, without any mark-up for the benefit of CureVac. For further clarity, if Genmab waives CureVac’s obligation to support Genmab with respect to the LNP Technology under this Agreement, CureVac shall have no obligation to share in the license fees payable to a licensor of LNP Technology. |
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5. | RESEARCH AND DEVELOPMENT COLLABORATION. |
5.1 | First Collaboration Target, and First Program Antibody. |
5.1.1 | Research Collaboration on the First Collaboration Target. The Parties shall jointly collaborate on the preclinical Development of the First Collaboration Target and First Program Antibody with the objective to identify and take a Product to IND stage (“First Collaboration Program”). The initial preclinical Development plan is attached hereto as Exhibit 5.1.1. It contains an outline of the activities to be performed by each Party, a budget for the research activities calculated by reference to the FTE Rate, success criteria, a target product profile and a high level Development plan up to IND for a Single Antibody Product, and may be amended from time to time by the JRC subject to the mechanisms in Section 9.5.1 (“First Program Research Plan”). CureVac will on a quarterly basis, within [*****] days after receipt of an invoice from Genmab, refund Genmab [*****] of the actual Development costs of Genmab [*****] as set forth in the then current First Program Research Plan by more than [*****] and subject always to the mechanisms in Section 8.5.1, provided, however that in the event Genmab replaces the First Collaboration Target by a Replacement Target, and the JRC amends the First Program Research Plan accordingly, [*****]. |
5.1.2 | Information Exchange. Following completion by CureVac and Genmab of the activities assigned to them in the First Program Research Plan, each Party shall provide the JRC with a data package containing all Development Data and other information necessary for Genmab to decide whether it will continue the Development of any Product identified in the First Program Research Plan by filing an IND and conducting Clinical Studies. The content of the data package, as well as criteria for evaluation and selection of a candidate for Product Selection, shall be determined by the JRC and is expected to include, inter alia, (i) in vivo PK and efficacy data, i.e., toxicology and any animal data; and (ii) CMC Development data. In addition, CureVac shall provide the LNP Technology License Documentation Package for the First Collaboration Program. |
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5.2 | Research and Development of Reserved Targets and Other Program Antibodies. |
5.2.1 | Reserved Target Research Plan. Once any Target or Target Combination, as applicable, has been finally cleared by CureVac under Section 3.2.2, Genmab shall, with CureVac providing adequate input and support, as soon as practicable, and in any event within [*****] under Section 3.2.2, provide a research plan to the JRC for discussion, which sets forth the contemplated nonclinical Development activities to be carried out by each Party during the Reservation Period to identify a Product such that Genmab may wish to undertake Option Exercise, and a budget for activities to be performed by CureVac calculated by reference to the FTE Rate, and including a preliminary target product profile (TPP) for such a Product based on the full antibody sequences of the proposed Research Program Antibody(-ies) and selected LNP Technology (“Reserved Target Research Plan”). The Reserved Target Research Plan shall include an overview of the studies and key data sets which should be included in the Reserved Target Data Package. The date for completion of the Reserved Target Research Plan shall be set to [*****] after the date of the JRC’s or CDOs’, as applicable, approval of the Reserved Target Research Plan if it relates to a Single Antibody Product, and [*****] after the date of the JRC’s or CDOs’, as applicable, approval of the Reserved Target Research Plan if it relates to a Cocktail Product (“Research Completion Deadline”) unless the Parties mutually agree to a different completion date. The Reserved Target Research Plan shall not include any IND-enabling or GxP Development activities. The Reserved Target Research Plan shall be discussed in the JRC and the JRC shall seek to approve the Reserved Target Research Plan within [*****] after final clearance of the Reserved Target or Reserved Target Combination in accordance with the clearance procedure set out in Section 3.2.2 above. At the expiry of such [*****] if the JRC has not approved the Reserved Target Research Plan, any remaining unresolved items regarding activities to be performed by or on behalf of CureVac or that fall within the scope of Sections 9.5.1(i) to 9.5.1(iii) (inclusive), where Genmab does not have final decision-making in the JRC, shall be referred to the Alliance Managers for resolution. If the Alliance Managers facilitate resolution of all issues by the JRC members, the Research Target Research Plan shall be sent back to the JRC for immediate JRC approval. If within [*****] of such referral to the Alliance Managers the Reserved Target Research Plan is still not approved, the dispute shall be deemed automatically referred to the CDOs. If within [*****] of such referral the Reserved Target Research Plan is still not approved by the CDOs, no further action under this Section 5.2.1 shall be required and the relevant Target or Target Combination shall not be designated a Reserved Target or Reserved Target Combination, as appropriate, and, for avoidance of doubt, the dispute resolution mechanisms set forth in Section 17.5.2 shall thus not apply. For clarity, this would not prevent Genmab from initiating a new reservation process under Section 3.2.1. For avoidance of doubt, any Reservation Period shall not commence until the JRC (or the CDOs, as applicable) have approved the related Reserved Target Research Plan. |
5.2.2 | Data Package. On a Reserved Target-by-Reserved Target basis, as soon as reasonably possible following completion of the activities under the applicable Reserved Target Research Plan, which shall, subject to the below, be completed by the Research Completion Deadline, the Parties shall provide the JRC with a data package containing the Development Data generated under the Reserved Target Research Plan and other information necessary for Genmab to evaluate its interest exercising an option with respect to the Reserved Target (“Reserved Target Data Package”). In addition to the Reserved Target Data Package, CureVac shall at the same time provide the LNP Technology License Documentation Package to Genmab. If the Parties cannot reasonably provide such complete Reserved Target Data Package, or if CureVac is unable to provide the LNP Technology License Documentation Package, or if certain activities in the Reserved Target Research Plan are delayed, by the Research Completion Deadline, and unless the Parties mutually agree an extension of the Research Completion Deadline and the Reservation Period (such agreement not to be unreasonably withheld if there are outstanding Development activities required under the Reserved Target Research Plan), the Reservation Period shall be extended to allow Genmab to evaluate its interest in exercising an option pursuant to Section 3.4 by the shorter of (i) [*****] after receipt by the JRC of the complete Reserved Target Data Package and LNP Technology License Documentation Package; or (ii) [*****] after the commencement of the Reservation Period where the corresponding Reserved Target Research Plan relates to a Single Antibody Product and [*****] after commencement of the Reservation Period where the corresponding Reserved Target Research Plan relates to a Cocktail Product. |
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5.2.3 | Other Pre-IND Program Research Plan. On an Optioned Target-by-Optioned Target basis, within [*****] after the Reserved Target becomes an Optioned Target pursuant to Section 3.4, Genmab will provide a draft Development plan for a Product directed at the respective Optioned Target up to IND stage which sets forth the detailed Development activities to be performed by each Party up to filing of IND for such Product, a budget for activities to be performed by CureVac calculated by reference to the FTE Rate, success criteria, and a preliminary target product profile (“Other Pre-IND Program Research Plan”). Such Other Pre-IND Program Research Plan will be discussed and agreed in the JRC, and requires approval by CureVac with respect to any activities to be undertaken by CureVac pursuant to such Other Pre-IND Program Research Plan. |
5.3 | Product Selection. When under (i) the First Program Research Plan (whether directed at the First Collaboration Target or a Replacement Target); or (ii) any Reserved Target Research Plan or Other Pre-IND Program Research Plan Genmab determines that a Product has been identified which it is selecting as a clinical candidate to conduct the remaining pre-IND Development activity and, if the same is successful, further Development through Clinical Studies and any further non-clinical Development, Genmab shall give written notice to CureVac of this fact (“Product Selection Notice” and “Product Selection” as appropriate). In such case, and within [*****] Genmab will either (i) in the case of a Product resulting from the First Program Research Plan provide to CureVac a detailed Development plan for such Product to reach IND together with an outline (high-level) Development Plan for such Product to reach Regulatory Approval (in the form of marketing authorization). Genmab will allow CureVac to comment on Manufacturing related matters in the Development plan for the Product to reach IND, such reasonable comments to be reflected by Genmab in a revised version of such Development Plan; or (ii) in the case of a Product resulting from an Other Pre-IND Program Research Plan Genmab shall provide to CureVac an outline (high-level) Development plan for such Product to reach Regulatory Approval (in the form of marketing authorization), (the plans at (i) and (ii) all being a “Product Development Plans”). |
5.4 | Diligence by CureVac. CureVac will act in good faith, using Commercially Reasonable Efforts, to perform its assigned tasks and responsibilities as described in the R&D Plans, and in accordance with all Applicable Laws. With respect to any Opt-In Target and Opt-In Product, CureVac shall use Commercially Reasonable Efforts to further Develop the Opt-In Product to market authorization and to Commercialize the Opt-In Product. |
5.5 | Diligence by Genmab. Genmab will use Commercially Reasonable Efforts to identify and Develop a Product during the First Collaboration Program and each Research Program; and, upon Product Selection or Option Exercise, as applicable, to further Develop each Product until market authorization. Further, Genmab shall use Commercially Reasonable Efforts to Commercialize each Product for which it obtains Regulatory Approval. |
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5.6 | Development Data, Results and records. Up until filing of IND, the Parties will with reasonable intervals make available to one another through formal reports for review and discussion within the JRC all preclinical Development Data and other results of the preclinical Development conducted pursuant to any Program, and will keep such records (paper and electronic) as described herein. The Parties will maintain records of the preclinical Development Data and other results in sufficient detail as required from Regulatory Agencies and in good scientific manner appropriate for patent purposes, and in a manner that properly reflects all work done and results achieved in the performance of such Programs. |
5.7 | Development by CureVac. CureVac will perform certain activities as agreed between the Parties and set forth in the R&D Plans. Subject only to the funding obligations of CureVac set forth in Section 5.1.1 above, [*****] at the FTE Rate. In addition to the FTE Rate, [*****]. The compensation is to be paid [*****] on a Calendar Quarter basis. Payments shall be made and within [*****] after receipt of an invoice, with supportive documentation detailing the FTE costs and out of pocket expenses applicable to CureVac’s efforts for such applicable Calendar Quarter period. |
5.8 | Materials. CureVac will furnish to Genmab CureVac Materials for Development use in the Programs, including those which comprise, embody or incorporate CureVac Background Technology, as expressly set forth in the respective R&D Plan. In particular, CureVac will provide to Genmab the CureVac Materials as set forth in Exhibit 5.1.1. Genmab will furnish to CureVac Materials for research and Development use in the Programs, including those which comprise, embody or incorporate Genmab Background Technology, as expressly set forth in the respective R&D Plan. In particular, Genmab will provide to CureVac the Genmab Materials as set forth in Exhibit 5.1.1. Genmab will use the CureVac Materials and CureVac will use the Genmab Materials, as applicable (i) only in accordance with the R&D Plans and otherwise in accordance with the terms and conditions of this Agreement; (ii) not in human subjects, in clinical trials, or for diagnostic purposes involving human subjects, or for any animal studies, except as expressly provided for in R&D Plans; and (iii) not reverse engineer or chemically analyze the same except as expressly provided for (if at all) in R&D Plans. The Materials will remain the sole property of the Party supplying them and will be used by the recipient Party in compliance with all Applicable Laws and only to perform activities set forth in R&D Plans. The receiving Party shall not sell, transfer, disclose or otherwise provide access to the other Party’s Materials without the written consent of the providing Party, except that the receiving Party may allow access to the other Party’s Materials to its and its Affiliates’ employees, officers, consultants, subcontractors and Sublicensees who require such access to perform its activities under this Agreement and solely for purposes consistent with this Agreement; provided that such employees, officers, consultants, subcontractors and Sublicensees are bound by agreement to retain and use the Materials in a manner that is consistent with the terms of this Agreement. THE MATERIALS ARE PROVIDED “AS IS”. NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OF ANY KIND, ARE GIVEN BY THE PROVIDING PARTY WITH RESPECT TO ANY OF THE MATERIALS, INCLUDING THEIR CONDITION, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The receiving Party acknowledges the experimental nature of the Materials and that accordingly, not all characteristics of the Materials are necessarily known. Upon termination or expiration of this Agreement if earlier, any and all remaining Materials will, within [*****] after such event, be returned to the Party supplying them (or destroyed, if the supplying Party shall so specify, with such destruction confirmed in writing). The provision of Materials hereunder will not constitute any grant, option or license to or under such Materials, or any Patent Rights or Know-how of the supplying Party, except as expressly set forth herein. |
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5.9 | Delays in Performance of Non-Clinical Development Activities. If, during the performance of any of the Programs, a Party reasonably believes that such Program cannot be performed in accordance with the respective R&D Plan (excluding the Product Development Plans, for which the obligations in this Section 5.9 shall not apply), such Party shall inform the JRC thereof. To the extent a Party reasonably believes that certain amendments to the R&D Plan (excluding the Product Development Plans) are necessary or advisable, such Party shall notify the JRC of such Party’s proposed amendments and the JRC shall review such proposed amendments and consider an update of the respective R&D Plan. The JRC can only amend any Reservation Period or Research Completion Deadline with consensus (i.e. Genmab shall not have casting vote in such matter). |
5.10 | Regulatory Approvals of Product. |
5.10.1 | Filing. Genmab shall prepare and file all INDs and NDAs and own all Regulatory Approvals and be responsible for all decisions in connection therewith for Regulatory Approvals of Products in the Field and in the Territory; provided, however, that for the First Collaboration Program (with respect to the First Collaboration Target but not the Replacement Target if applicable) CureVac shall review and comment on the portions of the first IND related to the Product where CureVac Manufacturing Technology such as CMC data is included in such IND filing. Such review shall be conducted at the agreed FTE Rate and subject to the agreed cost [*****]. For subsequent filings of the Product from the First Collaboration Program and for all other Products, upon CureVac’s request Genmab will to the extent reasonably possible allow CureVac at CureVac’s own cost to review and comment on (i) the portions of regulatory filings related to Products where CureVac Manufacturing Technology such as CMC data is included in such filings, and (ii) safety related documents. Genmab will take into good faith consideration any such comments provided by CureVac within [*****] of CureVac’s receipt of such draft filings. Notwithstanding the above, to the extent that Genmab requests CureVac to review any regulatory filing and safety related documents, [*****]. CureVac shall cooperate in these efforts as reasonably requested by Genmab, including by providing any CureVac Manufacturing Know-How reasonably required by Genmab for such Regulatory Approvals. |
5.10.2 | Cross Referencing. To the extent reasonably required by Genmab to achieve or maintain regulatory clinical trial or marketing authorizations or to comply with any related requests from Regulatory Agencies related to the Products, CureVac shall authorize and hereby authorizes Genmab, its Affiliates and Sublicensees to cross-reference sections of other IND/regulatory dossiers of clinical trials or marketing authorizations of other products Controlled by CureVac and to any other relevant regulatory filings and any other relevant documentation Controlled by CureVac. Genmab shall inform CureVac in writing prior to any such cross-referencing. If CureVac desires to cross-reference sections of the IND/regulatory dossiers of the clinical trials or marketing authorizations related to the Products, Genmab shall consider such request in good faith and not unreasonably withhold its consent to such cross-referencing by CureVac. |
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5.10.3 | Communications. Genmab shall have the sole right and be responsible for all regulatory interactions, including written communications and meetings with Regulatory Agencies, and safety management, including the reporting to the appropriate governmental authorities of all adverse events and any other information concerning the safety of Products. Prior to IND filing for a Product, Genmab will, as part of its regular updates through the JRC, inform CureVac of any material feedback from Regulatory Agencies relating to any Product. CureVac shall promptly notify Genmab in writing within [*****] of unannounced inspections by any Regulatory Agency and within a reasonable time in advance of an announced regulatory inspection with respect to Development, Manufacturing or Commercialization of a particular Product. |
5.10.4 | Diligence (Regulatory). Genmab will use Commercially Reasonable Efforts to seek Regulatory Approval for the Products in the Field in the Major Market Countries. |
5.10.5 | Global Safety Database. Genmab shall establish, hold (in-house or via an external vendor), and maintain the global safety database for Products with respect to information on adverse events concerning the Products, as and to the extent required by Applicable Law. If (a) any suspected unexpected serious adverse reactions (SUSAR) or any reportable serious adverse events (SAEs) may, in Genmab’s reasonable opinion, have a material impact on the Development of a Product or (b) a public announcement has to be made with respect to a SUSAR or SAE related to a Product, then in each case Genmab shall promptly notify CureVac in writing. If a public announcement has to be made with respect to any SUSAR or SAE related to a Product, Genmab shall, to the extent reasonably possible and provided that this can be done without risk of non-compliance with Applicable Law (including securities laws and stock exchange rules), notify CureVac thereof at least [*****] prior to making such public announcement to give CureVac an opportunity to comment. |
5.11 | Subcontracts. Subject to the terms and conditions of this Agreement, the Parties may subcontract to Affiliates and Third Parties, including CROs and CMOs, portions of the Programs to be performed. Any subcontractor shall be required to enter into appropriate agreements with respect to non-disclosure of Confidential Information and ownership of any intellectual property developed in the course of subcontracted activities, unless such subcontracting would not require the transfer of the other Party’s Confidential Information to the Affiliate or Third Party subcontractor and there is no reasonable possibility of the creation of new intellectual property. Each subcontractor shall agree to reasonable audit rights. Each Party shall remain liable to the other Party for any act or omission of its subcontractor. Any subcontractor of CureVac shall be subject to Genmab’s prior written consent, such consent not to be unreasonably withheld. Exhibit 5.11 contains a list of CureVac’s subcontractors which are approved for purposes of this Agreement, subject to the above. Genmab consents to the appointment of CureVac’s Affiliate company CureVac Real Estate GmbH as a subcontractor of CureVac for the purpose of Manufacturing Products under this Agreement and the Early Clinical Supply Agreement for the supply of Products to be used in Clinical Phase I Studies with respect to the First Collaboration Program (as opposed to any future Manufacture under future supply agreements that might be agreed between the Parties). Should CureVac Real Estate GmbH at any time no longer be an Affiliate of CureVac, CureVac shall inform Genmab of the details concerning the new structure, decision making and other relevant items of CureVac Real Estate GmbH. CureVac shall further ensure and confirm in writing to Genmab that as a result of CureVac Real Estate GmbH no longer being an Affiliate of CureVac there are no material changes, including no cost or timeline changes, that may affect Genmab with respect to the terms or operation of any then current supply agreement between the CureVac AG and CureVac Real Estate GmbH. |
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6. | MANUFACTURING AND COMMERCIALIZATION |
6.1 | Manufacture of Products. Manufacture by CureVac of Products for use in preclinical activities during the Research Period will take place under the First Program Research Plan, the Reserved Target Research Plan and the Other Pre-IND Program Research Plans, as the case may be. For the supply of Products to be used in Clinical Phase I Studies with respect to the First Collaboration Program (including in relation to a Product based upon a Replacement Target Antibody), subject to Section 6.2, the Parties shall negotiate and enter into a clinical supply agreement under which CureVac shall Manufacture or have Manufactured such Products on Genmab’s behalf. For the supply of Products to be used in Clinical Phase I Studies with respect to any other Pre-IND Program, the Parties will on a Product-by-Product basis negotiate an amendment to the Early Clinical Supply Agreement in good faith, subject to Section 6.2, whereby CureVac shall Manufacture or have Manufactured such Product on Genmab’s behalf. For other Manufacture of Products, CureVac shall have the right to provide an offer to Genmab to Manufacture Product under the provisions of Section 6.4. |
6.2 | Early Clinical Supply Agreement. Within [*****] after the Effective Date, the Parties will enter into a clinical supply agreement and related agreements (including a quality agreement) according to which CureVac shall Manufacture or have Manufactured for Genmab by an approved subcontractor under Section 5.11 or by a CMO approved by Genmab, and will supply or have supplied to Genmab, Genmab’s demand for the Single Antibody Product which is the subject of the First Program Research Plan (whether related to the First Collaboration Target or any Replacement Target) to perform Clinical Phase I Studies (“Early Clinical Supply Agreement”). The Early Clinical Supply Agreement and related quality agreement will contain the key terms and conditions set forth in Exhibit 6.2. The Early Clinical Supply Agreement and the related quality agreement with respect thereto, shall determine, in accordance with Applicable Law, all Product quality standards for such Product to be used in clinical trials, including but not limited to stability, validation and pre-approval inspection preparation, specifications, assay methodology, facilities, equipment and storage conditions. With respect to the First Collaboration Program, if CureVac is unable to provide capacity via its own facilities or that of its approved subcontractor under Section 5.11 or another approved CMO within the agreed timelines, Genmab shall have the right to Manufacture and have Manufactured Products for Genmab for Genmab’s Clinical Phase I Studies as well as in connection with Genmab’s (or its Affiliates’ or Sublicensees’, as applicable) Manufacture of Products for Development and Commercialization by another supplier. In such event, CureVac shall transfer all CureVac Manufacturing Technology to such supplier of Genmab in accordance with Section 6.5 and any applicable terms of the Early Clinical Supply Agreement. In connection with the negotiation of the Early Clinical Supply Agreement, the Parties will agree on a plan for the transfer of CureVac Manufacturing Technology to Genmab, including estimated timelines, scope, resources and other relevant details (the “Tech Transfer Plan”). Such Tech Transfer Plan may be updated from time to time by mutual written agreement between the Parties, including in the event that the Parties negotiate an MSA pursuant to Section 6.4.2. |
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6.3 | With respect to Other Pre-IND Programs and related Products, on a Product-by-Product basis, no later than [*****] prior to the anticipated commencement of Clinical Phase I Studies for such Product CureVac shall notify Genmab and inform Genmab whether CureVac or any approved subcontractor under Section 5.11 or other approved CMO already Manufacturing under the Early Clinical Supply Agreement has the capacity to Manufacture such Product for use in Clinical Phase I Studies within the timelines requested by Genmab. If CureVac gives notice that such capacity exists, the Parties will negotiate in good faith amendments to the Early Clinical Supply Agreement and related quality agreement to cover the Manufacture by CureVac or such approved subcontractor or approved CMO of such additional Product (arising from the relevant Other Pre-IND Program Research Plan) for use in Genmab’s Clinical Phase I Studies for such Product. If CureVac is unable to provide capacity to Manufacture such Product via its own facilities or that of its approved subcontractor or approved other CMO within the requested timelines, or the Parties are unable to agree on an amendment to the Early Clinical Supply Agreement with respect to such Product despite using good faith efforts to negotiate such amendment to the Early Clinical Supply Agreement, Genmab shall have the right to Manufacture and have Manufactured such Product for Genmab for Genmab’s Clinical Phase I Studies by another supplier. In such event, CureVac shall transfer all Know-How comprised in the CureVac Manufacturing Technology as reasonably required to Manufacture such Product to such supplier of Genmab in accordance with Section 6.5 and the applicable terms of the Early Clinical Supply Agreement. |
6.4 | Other Manufacture of Products for Development and Commercialization |
6.4.1 | In relation to each Product, provided that CureVac has Manufactured and supplied such Product for use in Genmab’s Clinical Phase I Studies, then no later than [*****] prior to a requirement of Genmab for supplies of such Product for the first Clinical Phase II Study for such Product, Genmab shall submit to CureVac its non-binding forecast quantities, proposed delivery schedule for such Product quantities and other relevant criteria. Within [*****] of receipt of such forecast, CureVac shall indicate to Genmab if CureVac is able to supply such quantities (whether Manufactured by CureVac itself or an approved subcontractor or other approved CMO) in accordance with the criteria provided by Genmab; and proposed pricing and other high-level terms for such supply, which may include a proposal that any such approved subcontractor or approved CMO contract directly with Genmab. |
6.4.2 | If Genmab declines to appoint CureVac, its approved subcontractor or other approved CMO, it shall give written notice to CureVac specifying in high-level the reasons why CureVac itself or an approved subcontractor or other approved CMO was not appointed to Manufacture the Product. If Genmab accepts the proposal made by CureVac for supplies of Product for the first Clinical Phase II Study and is agreeable to appoint CureVac, the Parties shall within [*****] negotiate in good faith a master services agreement (“MSA”) and related quality agreement and a first work order for the Manufacture and supply of such Product quantities, Manufactured to the specifications specified by Genmab, and for payment [*****] on customary market-based terms. Any such MSA shall contain detailed provisions for tech transfer of the Manufacturing process, e.g. in the event of a failure to supply by CureVac or its approved subcontractor or approved CMO or upon Genmab’s request. If Genmab does not accept the proposal made by CureVac or if the Parties are unable to reach agreement on the MSA within the above period despite exercising good faith efforts, Genmab shall have the right to choose another CMO to Manufacture the Products for Genmab. If, during Genmab’s negotiation of a supply agreement with another CMO, Genmab changes the criteria for such supply as were presented to CureVac, then Genmab will provide such updated criteria to CureVac so that CureVac can provide an updated proposal. |
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6.4.3 | The process described in Sections 6.4.1 and 6.4.2 shall apply equally to the following circumstances (i) where CureVac itself or an approved subcontractor or other approved CMO have Manufactured Genmab’s requirements of a Product for Clinical Phase II Studies, in relation to Genmab’s requirements of such Product for Clinical Phase III Studies; and (ii) where CureVac itself or an approved subcontractor or other approved CMO have Manufactured Genmab’s requirements of a Product for Clinical Phase III or Pivotal Studies, in relation to Genmab’s requirements of such Product for Commercialization. |
6.5 | Transfer of CureVac Manufacturing Technology. If (i) pursuant to the terms of this Agreement, the Early Clinical Supply Agreement and/or the MSA CureVac and/or its approved subcontractor or other approved CMO is obliged to transfer to Genmab or a CMO nominated by Genmab (which CMO shall fulfill the criteria specified in Section 6.6) the Know-How comprised in the CureVac Manufacturing Technology for the particular Product affected; or (ii) under Section 6.2 or Section 6.4 Manufacture is not going to be conducted by CureVac or its approved subcontractor or other approved CMO for a particular Product, then (in each of (i) and (ii)) CureVac and/or its approved subcontractor or other approved CMO shall as soon as reasonably possible, and in accordance with the applicable Tech Transfer Plan and the timelines set out therein transfer to Genmab, or a CMO nominated by Genmab (which CMO shall fulfill the criteria specified in Section 6.6) the Know-How comprised in the CureVac Manufacturing Technology required to Manufacture the particular Product so that Genmab, an Affiliate or the appointed Third Party CMO can take over Manufacture of such Product for Genmab. If the particular Product has been Manufactured by CureVac’s approved subcontractor or other approved CMO, then CureVac shall see to it that the technology transfer shall also comprise all and any Know-How Controlled by such party that is required to Manufacture such Product. In the event of a technology transfer, the JRC or Collaboration Committee, as applicable, shall establish a Manufacturing Tech Transfer Sub-Committee, which shall oversee the tech transfer relating to such Product, subject to applicable provisions in the Early Clinical Supply Agreement or MSA regarding tech transfer and the applicable Tech Transfer Plan. CureVac shall use Commercially Reasonable Efforts to make available key employees with respect to carry out the Tech Transfer Plan and to provide the support needed to enable Genmab, or its designated CMO, to take over the Manufacture of the relevant Product. Such tech transfer for any particular Product shall only be carried out once, to representatives of the entity nominated by Genmab. Genmab will compensate CureVac and/or its approved subcontractor or other approved CMO for such tech transfer support work provided by CureVac and/or the approved subcontractor or other approved CMO at the FTE Rate. CureVac shall be responsible for ensuring that its approved subcontractor or other approved CMO complies with all and any obligations applicable to CureVac and/or the subcontractor or other approved CMO with respect to such technology transfer. |
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6.6 | Third Party CMOs. If under Section 6.2 or Section 6.4 Genmab wishes to engage a Third Party CMO to Manufacture Products it must provide notice of such intent and the identity of the CMO to CureVac. If such Third Party CMO is (i) a direct competitor of CureVac within the field of development of mRNA-based products (such as, but not limited to, [*****]); or (ii) located inside [*****] at the time when Genmab wishes to engage such Third Party CMO, then Genmab’s engagement of such Third Party CMO to Manufacture Products requires CureVac’s prior written consent not to be unreasonably withheld. Upon Genmab’s request, in the event of (i) or (ii) above, CureVac shall within [*****] of receipt of such request notify Genmab if CureVac opposes to Genmab’s engagement of such Third Party CMO and otherwise CureVac shall be deemed to have consented to such engagement. If, in the event of (i) or (ii) above, CureVac consents to the appointment of such CMO nominated by Genmab, such consent may be conditional upon the Third Party CMO entering into direct undertakings with CureVac for the protection of Confidential Information and Know-How within CureVac Manufacturing Technology. For clarity, such CMO shall not be permitted to transfer any such Know-How to any other Third Party. For avoidance of doubt, Genmab shall not be required to obtain the prior consent of CureVac before engaging a Third Party CMO as allowed for under Section 6.2 and Section 6.4 if such Third Party CMO is not comprised by (i) or (ii) above. |
6.7 | Commercialization of Products. Subject only to the terms and conditions applying to the Opt-In Product, Genmab shall have all rights and responsibilities, and shall bear all costs associated with, the Commercialization of Products and will book all sales of Products. Genmab will use Commercially Reasonable Efforts to Commercialize each Products in the Major Market Countries where it obtains Regulatory Approval. In addition to the royalty reports provided by Genmab to CureVac under Section 10.6, beginning with the First Commercial Sale of the first Product and continuing, on a Product-by-Product basis, until expiry of the last Valid Claim, Genmab shall provide CureVac, at least [*****] with a written report summarizing the current status of, estimated timeline and high-level commercialization plans for the Commercialization of any Products. |
7. | CUREVAC’S OPT-IN AND CO-PROMOTION RIGHTS. |
DEVELOPMENT & COMMERCIALIZATION OF OPT-IN PRODUCTS.
7.1 | Opt-In. Subject to the terms and conditions of this Agreement, CureVac has the option to join Genmab [*****] [*****] on the Development, Manufacture and Commercialization of any [*****] Product that is a Cocktail Product, at CureVac’s sole election (“Opt-In”). If within [*****] of Genmab’s Option Exercise with respect to such Reserved Target Combination (then an Optioned Target Combination) which might result in a Cocktail Product, CureVac requests to receive an Opt-In Data Package (as defined below), Genmab shall within [*****] of such Option Exercise supply CureVac with (i) a comprehensive preclinical data package generated under the respective Program, including all Development Data available at such time; and (ii) a high-level draft Development plan (specifying in high-level the contemplated Clinical Studies and non-clinical studies to be conducted) up until and including contemplated Clinical Phase I Studies; and (iii) a proposed budget of costs, internal and external, for the draft Development Plan, and (iv) a copy of the documentation (with any reasonably required redactions, including redactions to exclude information not directly related to the Product data such as information from Genmab’s board of directors, financial information etc.) provided to Genmab’s portfolio board as basis for Genmab taking the decision to undertake Option Exercise in relation to the relevant Cocktail Product (“Opt-In Data Package”). Within [*****] of receipt of the Opt-In Data Package, CureVac shall notify Genmab whether or not CureVac wishes to Opt-In. Upon CureVac’s Opt-In and payment of the Opt-In Fee in accordance with Section 10.3 below, the Optioned Target Combination will become an “Opt-In Target” and any Product resulting therefrom will be an “Opt-In Product”. If CureVac requests an Opt-In Data Package the Option Exercise Fee under Section 10.2 shall be deferred until [*****] after CureVac has given Genmab notice under this Section 7.1, that CureVac is not exercising its right to Opt-In. For avoidance of doubt, if CureVac does not request any Opt-In Data Package within [*****] of the Option Exercise, Genmab shall have no obligation to provide such Opt-In Data Package and CureVac shall no right to Opt-In with respect to the particular Cocktail Product. |
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7.2 | Joint Steering Committee. Within [*****] of CureVac Opt-In under Section 7.1 the Parties will establish a Joint Steering Committee as set out in Section 9.9 (“Joint Steering Committee”) which shall oversee the Development and Commercialization of the Opt-In Product. A first task of the Joint Steering Committee shall be to discuss any potential update to the Development plan submitted by Genmab to CureVac for the Opt-In Product. Until the Joint Steering Committee agrees on such update, the Development plan submitted by Genmab shall be the Opt-In R&D Plan (“Opt-In R&D Plan”) |
7.3 | Opt-In Product – general principle for sharing of costs and profit. With respect to any Opt-In Target and Opt-In Product, all costs for the Development, Manufacturing and Commercialization of the Opt-In Product, as well as all profits generated by exploiting such Opt-In Product in the Field and in the Territory (including Net Sales and payments from Third Party licensees) will be [*****]. |
7.4 | Opt-In Product – sharing of Development and Manufacturing costs. Unless otherwise agreed in the Joint Development and Manufacturing Agreement, then the below shall apply with respect to sharing of Development and Manufacturing costs with respect to an Opt-In Product. Within [*****] of the end of each Calendar Quarter during Development of the Opt-In Product, each Party shall notify the other Party in writing of the Development and Manufacturing costs incurred by them and their Affiliates in that Calendar Quarter. Within [*****] thereafter the Parties shall agree a reconciliation such that [*****] the total costs for the Development and Manufacturing [*****], and the Party which has paid less than its [*****] share shall pay to the other Party the balancing amount required so that such total costs have been [*****]. Records and audit provisions the same as Section 10.8 shall apply to such Development and Manufacturing Costs. |
7.5 | Co-Promotion and Co-Commercialization. [*****] in the [*****] with CureVac having a right to co-promote up to [*****] of the sales effort, provided that upon Genmab’s prior written consent (which Genmab may give or withhold at its sole discretion) from the commencement of such Commercialization until the end of the second full Calendar Year thereafter CureVac may use a contract sales organization to assist it in respect of such co-promotion activities, but not thereafter. CureVac will lead the Commercialization of the Opt-In Product by promoting and detailing in [*****] and detailing with its own sales force or, or upon Genmab’s prior written consent (which Genmab may give or withhold at its sole discretion), using a contract sales organization, provided, however, that Genmab shall be solely responsible for establishing and maintaining pricing in all [*****] Genmab will book [*****] sales, with the exception of sales in [*****] where CureVac will book sales. Should CureVac decide not to lead commercialization by promoting and detailing in [*****]. Genmab shall have the right to lead commercialization and book sales in such countries, unless Genmab elects not to exercise such right, in which case the Parties will jointly find a partner to handle the commercialization in such countries. Any sublicensing of the rights under the Opt-In Program, including any rights to the Opt-In Product requires agreement by both Parties, and the Parties shall act in good faith to arrive at a commercially sound and viable exploitation of the Opt-In Product. |
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7.6 | Joint Development and Manufacturing Agreement. No later than [*****] following the date of CureVac’s exercise of its Opt-In rights, Genmab and CureVac shall in good faith negotiate and conclude the terms and conditions of the joint development and manufacture covering the Opt-In Product (“Joint Development and Manufacturing Agreement”). For clarity, with respect to Manufacturing the provisions of Section 6.2 and Section 6.4 shall apply mutatis mutandis. The Joint Development and Manufacturing Agreement shall be consistent with this Agreement, including this Article 7, and shall cover the following additional provisions: |
(i) | provisions for the generation and approval of detailed development plans under the Opt-In R&D Plan, including protocols for Clinical Studies and the corresponding budget; |
(ii) | provisions concerning the appointment of CRO’s and CMO’s and other subcontractors; |
(iii) | provisions for handling regulatory matters including dealings with Regulatory Agencies; |
(iv) | provisions for the calculation of and sharing of costs for Development and for Manufacture of Product for Development reflecting Section 7.3; |
(v) | in circumstances where CureVac is supplying the Opt-In Product or any part of it, detailed supply provisions and an associated quality agreement; |
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(vi) | liability, indemnification and insurance during the period of Development and associated Manufacture; |
(vii) | the provisions of this Agreement that apply in such circumstances unchanged, for example concerning the Joint Steering Committee, assignment of rights with respect to the Opt-In Product, termination of the Opt-in Program, dispute resolution and others. |
7.7 | Commercialization Plan and Commercialization Agreement. At least [*****] prior to anticipated First Commercial Launch and in no event later than [*****] after the first dosing of the first patient of the first Phase III Clinical Trial with respect to the Opt-In Product, the Joint Steering Committee shall prepare and approve an initial commercialization plan for the Opt-In Product for the balance of the then current calendar year plus the following [*****] The Joint Steering Committee shall, at an appropriate (at the Joint Steering Committee’s discretion) time following an Opt-In, but no later than [*****] prior to the anticipated First Commercial Sale of the Opt-In Product anywhere in the Territory as determined by the Joint Steering Committee, establish a joint commercialization team to be responsible for the operations related to Commercialization of the Opt-In Product. In addition the Parties will in good faith negotiate and agree on a commercialization agreement, which shall be consistent with the applicable provisions of this Agreement and shall govern in detail the co-promotion and co-commercialization provisions for the Opt-In Product based on the outline in Section 7.5 (“Commercialization Agreement”). In particular, the Commercialization Agreement will provide for: |
(i) | the establishment of a joint commercialization committee that will govern the Commercialization activities of the Opt-In Product and will be a subsidiary of the Joint Steering Committee (“Joint Commercialization Committee”); |
(ii) | detailed definitions of Commercialization Costs, profit and net profit that are to be [*****] by the Parties, and the terms for such calculation and sharing, reporting and audit rights; |
(iii) | detailed provisions for the operation of the Co-Promote, including the [*****] of first position, second position and third position details; |
(iv) | supervision and training by Genmab of the CureVac Co-Promote sales force in USA; |
(v) | the provision of promotional materials by Genmab; |
(vi) | compliance provisions; |
(vii) | Amendment to and updates of the commercialization plan; |
(viii) | Regulatory issues, dealings with Regulatory Agencies, recalls and medical inquiries and medical interaction, |
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(ix) | Public statements and other information concerning the Opt-In Product; |
(x) | Liability; |
(xi) | Indemnification; and |
(xii) | Use of subcontractors. |
7.8 | Assignment of Rights and Obligations with respect to Opt-In Product |
7.8.1 | Either Party shall have the right to make an assignment in full of its rights and obligations under this Agreement with regard to an Opt-In Product to the other Party or a Third Party as set out below. |
7.8.2 | If a Party (“Assigning Party”) desires to make an assignment in full of all its rights and obligations, including without limitation its [*****] share and co-funding obligation, with respect to an Opt-In Product (“Opt-In Product Assignment”), the Assigning Party shall provide a written offer to the other Party (“Non-Assigning Party”), which offer shall include the entire proposed terms in relation to such Opt-In Product Assignment to the Non-Assigning Party, including the exclusive right to Develop, Manufacture and Commercialize the Opt-In Product, under all intellectual property and using all regulatory filings Controlled by the Assigning Party. Upon the Non-Assigning Party’s receipt of such written offer, a [*****] negotiation period (“Negotiation Period”) shall be initiated during which the Parties shall engage in good faith negotiations regarding the Assigning Party’s Opt-In Product Assignment offer. The Non-Assigning Party shall have the right to appoint a Third Party as assignee in relation to the Opt-In Product Assignment on the same terms as offered to the Non-Assigning Party. If the Parties have not reached an agreement regarding an Opt-In Product Assignment to the Non-Assigning Party or a Third Party assignee appointed by the Non-Assigning Party upon expiry of the Negotiation Period, the Assigning Party is entitled to offer the Opt-In Product Assignment to an independent Third Party on the same key financial and commercial terms as comprised by the Assigning Party’s latest written offer during the Negotiation Period to the Non-Assigning Party, provided that such Third Party prior to receiving such Opt-In Product Assignment offer has undertaken obligations of confidentiality that are at least as restrictive as the Parties’ confidentiality obligations under this Agreement. Such negotiations with and assignment to an independent Third Party shall be finalized within [*****] after expiry of the Negotiation Period, unless otherwise mutually agreed in writing between the Parties. If such negotiations and assignment has not been finalized within said [*****] period, the Assigning Party shall be deemed to have provided an Opt-In Termination Notice to the Non- Assigning Party and Section 7.9 shall apply. |
The Assigning Party shall keep the Non-Assigning Party reasonably informed about the developments in relation to the Assigning Party’s negotiations with any Third Party regarding an Opt-In Product Assignment. If the terms of offer from a Third Party differ from the key financial and commercial terms as comprised by the Assigning Party’s latest written offer during the Negotiation Period to the Non-Assigning Party, then the Non-Assigning party shall have the right to match such offer, before the Assigning Party may accept the offer from the Third Party. Such right to match the offer shall be exercised within [*****] after the Non- Assigning Party’s receipt of notice of the applicable key financial and commercial terms, and otherwise the Non-Assigning Party shall be deemed to have forfeited its right of first refusal.
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7.8.3 | For the avoidance of doubt, until an Opt-In Product Assignment is duly executed and has become effective, all and any the Assigning Party’s rights and obligations under this Agreement shall continue to apply, including without limitation the co-funding obligation, and the Parties shall continue to use Commercial Reasonable Efforts to perform their obligations with respect to the Development and Commercialization of the Opt-In Product. |
7.9 | Termination of the Opt-In Program. If under Section 7.8.2 an Assigning Party (in this Section 7.9 “Terminating Party”) has given notice (or is deemed to have given notice) to the other Party that it terminates (“Opt-In Termination Notice”) the [*****] collaboration of the Opt-In Program and withdraws from the future Development, Manufacture and Commercialization of the Opt-In Target and the Opt-In Product, then within [*****] of receipt of such Opt-In Termination Notice, the non-terminating Party (“Non-Terminating Party”) shall give written notice to the Terminating Party whether the Non-Terminating Party wishes to assume sole responsibility for the Opt-In Program (which can include finding other collaboration partners or assignees for the Opt-In Program) or whether it wishes the Opt-In Program to terminate completely. Until such notice is given by the Non-Terminating Party, the Parties shall cooperate in the further Development, Manufacture and Commercialization of the Opt-In Product under the terms of this Agreement and the Commercialization Agreement (if the same exists by then) in a commercially reasonable manner. If the Non-Terminating Party gives notice that it intends to assume responsibility for the Opt-In Program and to so continue the further Development and commercialization of the Opt-In Product(s), the JSC shall within [*****] of such notice agree to a transition plan for transition of the conduct of the Opt-In Program to the Non- Terminating Party that shall include (i) transfer of all Development, Manufacturing and Commercialization activity and related regulatory approvals as soon as practicable, and, until then, for the period between termination of the collaboration and such transfer, reimbursement of the Terminating Party for the cost incurred by it in connection with such Development, Manufacturing and Commercialization activity; and (ii) payment of the cost of such transition by the Terminating Party, including FTEs of the Non-Terminating Party involved with the transition; and (iii) the grant of and other terms for an exclusive, fully paid up, royalty free, perpetual, irrevocable sub-licensable license through multiple tiers to all intellectual property Controlled by the Terminating Party and required by the Non-Terminating Party to continue the Opt-In Program and Commercialization of the Opt-In Product. If the Non-Terminating Party gives notice that it does not wish to assume responsibility for the Opt-In Program, the JSC shall within [*****] agree a wind-down plan for the Opt-In Program, the costs of which shall be borne by the Terminating Party. |
8. | CO-PROMOTION IN LIEU OF AN OPT-IN. |
8.1 | Co-Promotion in lieu of an Opt-In. In the event Genmab has not started research on a Research Program Antibody Combination or does not exercise an option with respect to any Reserved Program Antibody Combination within the Option Period, and CureVac consequently cannot exercise its Opt-In right under Section 7.1 above, CureVac has the right to elect to Co-Promote [*****] Single Antibody Product which is granted Regulatory Approval (in the form of marketing authorization) in the [*****] (“Co-Promotion Product”; “Co-Promotion Territory”), subject to the terms and conditions set forth in Sections 8.1 and 8.2 and the Co-Promotion Agreement (“CureVac Co-Promotion Option”). No later than [*****] prior to the anticipated First Commercial Sale of any Single Antibody Product, Genmab shall give written notice to CureVac that this is anticipated, specifying the Single Antibody Product in question, and providing a data package on such Single Antibody Product which reasonably allows CureVac to evaluate its option to Co-Promote such Product. Within [*****] of receipt of both such notice and the data package, CureVac shall notify Genmab in writing whether CureVac is exercising the CureVac Co-Promotion Option in relation to such Single Antibody Product. For the avoidance of doubt, following CureVac’s exercise of its Co-Promotion Option, Genmab shall no longer be required to provide notice of anticipated First Commercial Sale to CureVac with respect to other Products. |
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8.2 | Conclusion of a Co-Promotion Agreement. No later than [*****] following the date of CureVac’s exercise of the CureVac Co-Promotion Option, Genmab and CureVac shall in good faith negotiate and conclude the terms and conditions of a co-promotion agreement covering the Co-Promotion of the Co-Promotion Product in the Co-Promotion Territory (“Co-Promotion Agreement”). The Co-Promotion Agreement shall be consistent with this Article 7 and shall cover the following additional provisions: |
(i) | establishment of a Co-Promotion committee that will govern the Co-Promotion activities and will be a subsidiary of the Collaboration Committee (“Co-Promotion Committee”); |
(ii) | detailed provisions for the operation of the Co-Promote, including the equitable sharing of first line, second line and third line details based upon the principle that the CureVac sales force shall constitute, at the election of CureVac, up to [*****] of the overall number of sales representatives needed to promote the Co-Promotion Product in the Co-Promotion Territory upon First Commercial Sale of the Product in the Co-Promotion Territory, as determined by Genmab and in accordance with the Co-Promotion Territory Commercialization Plan; |
(iii) | at the latest [*****] prior to the estimated date of the First Commercial Sale of the Co-Promotion Product in the Co-Promotion Territory, Genmab will propose to the Co-Promotion Committee for discussion, comment, review, amendment and approval a plan to Commercialize the Co-Promotion Product in the Co-Promotion Territory for the period up to the end of the first full Calendar Year following first Commercial Sale (“Co-Promotion Territory Commercialization Plan”). The Co-Promotion Committee shall use best endeavors to agree the form of the first Co-Promotion Territory Commercialization Plan within [*****] of its initial submission. Not later than [*****] of each Calendar Year the Co-Promotion Committee shall prepare and agree an updated Co-Promotion Territory Commercialization Plan for the following Calendar Year; |
(iv) | performance criteria for CureVac sales force, and consequences of non-performance; |
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(v) | Genmab shall [*****] specifically related to CureVac’ detailing efforts in relation to the given Product in the Co-Promote Territory. For avoidance of doubt, Genmab shall not be required to reimburse CureVac for any build-up or overhead costs of CureVac establishing a sales force for Products, including rent for office space; |
(vi) | such additional customary terms and conditions (including terms regarding training, marketing materials, responsibility for recalls and adverse event reporting, and maintenance of records relating to detail activities) as may be appropriate to provide for such co-promotion activities; |
(vii) | Compliance provisions; and |
(viii) | Termination provisions. |
9. | GOVERNANCE. |
9.1 | Management. |
9.1.1 | Alliance Management. Management of the collaborative alliance reflected in this Agreement will be under the responsibility of the individual designated in writing within [*****] of the Effective Date for CureVac (“CureVac Alliance Manager”) and of the individual designated in writing within [*****] of the Effective Date for Genmab (“Genmab Alliance Manager”, and together, the “Alliance Managers”). Each Alliance Manager will be the primary point of contact for the other Party on all matters relating to the operation of this Agreement other than Program activities. |
9.1.2 | Program Management. Management of the activities under the Programs will be under the responsibility of the individual designated in writing within [*****] of the Effective Date for CureVac (“CureVac Project Leader”) and of the individual designated in writing within [*****] of the Effective Date for Genmab (“Genmab Project Leader”, and together with the CureVac Project Leader, the “Project Leaders”). Each Project Leader will be the primary point of contact for the other Party on all matters relating to the Program activities. After IND filing for a particular Product, the Project Leaders shall no longer be required, unless CureVac has exercised its Opt-In with respect to such Product (a Cocktail Product). |
9.2 | Joint Research Committee. |
9.2.1 | Establishment. Within [*****] after the Effective Date the Parties will establish a joint research committee (“Joint Research Committee” or “JRC”). The JRC will govern the collaboration represented by this Agreement up to IND filing for all Products. The JRC shall be comprised of [*****] representatives of CureVac and [*****] representatives of Genmab. Each Party may replace its JRC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use Commercially Reasonable Efforts to ensure continuity on the JRC. The Alliance Manager of each Party should always attend meetings of the JRC. In addition, each Party may invite a reasonable number of participants, in addition to its representatives, to attend JRC meetings; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party. Such Party shall ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement. |
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9.2.2 | JRC Meetings. The JRC shall meet on a quarterly basis by teleconference, videoconference or in person, provided that at least every [*****] the meeting shall be in person (which in- person meeting will be held at alternate facilities of each Party), unless agreed otherwise by the JRC representatives The JRC will have a quorum if at least [*****] representatives of each Party is present or participating. Each Party will be responsible for all of its own expenses of participating in the JRC meetings. The Parties will endeavor to schedule meetings of the JRC at least [*****] in advance. Each Party may call special meetings of the JRC with at least [*****] prior written notice, except in exigent circumstances, to resolve particular matters requested by such Party and within the decision-making responsibility of the JRC. Genmab shall prepare the meeting agenda with input from CureVac, and Genmab shall chair the meeting. |
9.2.3 | JRC Minutes. The Alliance Manager of Genmab shall record the minutes of each JRC meeting in writing. Such minutes shall be circulated by Genmab’s Alliance Manager to CureVac’ Alliance Manager no later than [*****] following the meeting for review, comment and approval of CureVac. If no comments are received within [*****] of the receipt of the minutes by CureVac, unless otherwise agreed, they shall be deemed to be approved by CureVac. Furthermore, if the Parties are unable to reach agreement on the minutes within [*****] of the applicable meeting, the sections of the minutes that have been mutually agreed between the Parties by that date shall be deemed approved and, in addition, each Party shall record in the same document its own version of those sections of the minutes on which the Parties were not able to agree. |
9.3 | JRC Functions and Powers. The JRC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development activities up to IND filing. The JRC has no jurisdiction (i) to make any amendments to this Agreement, which right is reserved to the Parties; and (ii) no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement. The principal functions of the JRC will include: |
(i) | overseeing the First Collaboration Program on the First Collaboration Target or any Replacement Target and all Research Programs; |
(ii) | reviewing and approving the First Program Research Plan in relation to a Replacement Target, the Reserved Target Research Plans, and the Other Pre-IND Program Research Plans and considering and approving any amendments thereto; |
(iii) | For the First Collaboration Program (with respect to the First Collaboration Target, not the Replacement Target, if applicable), approving the budget for all Development activities up until IND. For the First Collaboration Program with respect to the Replacement Target, if applicable, and any other Programs approving the budget with respect to Development activities to be performed by CureVac up until IND; |
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(iv) | reviewing and deciding upon suitable LNP Technology and exclusivity status; |
(v) | exchanging preclinical Development Data and other technical information; |
(vi) | discussing Product-related Manufacturing; |
(vii) | creating Sub-Committees; |
(viii) | serving as a forum where Genmab as part of its regular updates to the JRC shall inform CureVac of any material feedback received from Regulatory Agencies in relation to any Product prior to IND filing; |
(ix) | discussing material regulatory filings and regulatory interactions related to the Products if required by Genmab or if such material regulatory filings contain information on CureVac Technology; |
(x) | fostering the collaborative relationship between the Parties; |
(xi) | resolving disputes between the Parties; |
(xii) | such other functions as agreed by the Parties. |
9.4 | JRC Sub-Committees. From time to time, the JRC may establish sub-committees (each, a “Sub-Committee”) to oversee particular projects or activities, such as Sub-Committees on IP, CMC, Manufacturing tech transfer and/or supply chain matters. Each Sub-Committee shall undertake the activities delegated to it by the JRC. Subject to Section 9.6, during the process of establishing each Sub-Committee, such Sub-Committee and the JRC shall agree which matters such Sub-Committee will resolve on its own, and on which matters such Sub-Committee will advise the JRC for resolution by such matters by the JRC. Generally there shall be a range of matters specified by the JRC on which the Sub-Committee will make recommendations to the JRC for consideration by the JRC. Unless otherwise agreed between the Parties, the governance rules with respect to the JRC shall apply to the Sub-Committees mutatis mutandis, provided, however, that upon mutual agreement between the Parties a Sub-Committee may continue to operate even after the JRC is dissolved, as long as such Sub-Committee’s tasks are still ongoing. Subject to Section 9.6 deadlocks arising in any Sub-Committee will be referred to the JRC for resolution or, if the Sub-Committee continues after the JRC is dissolved, to the Collaboration Committee or Joint Steering Committee (solely for an Opt-In Product). |
9.5 | JRC Decisions. |
9.5.1 | Dispute Resolution. In conducting its activities, the JRC and each Sub-Committee shall operate and make decisions consistent with the terms of this Agreement. The JRC will seek to act by consensus. If the JRC cannot reach consensus or a dispute arises that cannot be resolved within the JRC, then such matter (except the matters (i) and (ii) below) shall be escalated to the Alliance Managers of each Party. The Alliance Managers should involve the relevant JRC members of each Party in such dispute resolution. If such matter is not resolved within [*****] after escalation to the Alliance Managers, Genmab may make final decisions for all matters within the purview of the JRC except: |
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(i) | disputes of a technical nature concerning use of the LNP Technology; and |
(ii) | disputes regarding proposed amendments to the budget for Development activities up until IND with respect to the First Collaboration Program (with respect to the First Collaboration Target, not the Replacement Target, if applicable) where such amendment would result in an increase of the total budget of more than [*****] percent compared to the latest approved budget. |
(iii) | disputes about Manufacture of Product by CureVac not subject to dispute resolution under the Early Clinical Supply Agreement or MSA, or disputes referred to the JRC from the Manufacturing Tech Transfer Sub-Committee. |
If the JRC, after escalation to the Alliance Managers, cannot reach consensus in relation to matters set out above in (i), (ii) and (iii) above, then such matter shall be escalated to the CDO of each Party. If such matter is not resolved within [*****] after escalation to the CDOs, the dispute resolution mechanisms set out in Section 17.5.2 shall apply.
9.5.2 | Restriction on Genmab Decision Making. Genmab shall not resolve such a matter in a manner that (a) would require CureVac to perform less or additional activities or incur additional expenses not contemplated by this Agreement or the R&D Plans (as each R&D Plan was initially agreed by the Parties or as it was last amended with CureVac’s consent), (b) excuses, reduces, or delays Genmab’s obligations under this Agreement, including with respect to payments to CureVac, (c) negates any consent right or other rights specifically granted or allocated to CureVac under this Agreement, or (d) amends, modifies, or waives compliances with the terms of this Agreement. |
9.6 | IP Sub-Committee. Within [*****] of the Effective Date the JRC shall establish an IP Sub-committee comprising one patent attorney of each Party (“IP Representatives”). The IP Sub-committee shall be the forum for discussion and liaison between the Parties concerning filings to be made for Program Patent Rights, Other Inventions Patent Rights and Joint Patent Rights during the Research Period. For avoidance of doubt, the IP Sub-committee is not a decision-making forum, but serves as a forum for discussion where the Parties may coordinate and consult with each other with respect to any such filings. |
9.7 | Information and Results. Except as otherwise provided in this Agreement, the Parties will make available and disclose to one another preclinical Development Data and other results of work conducted pursuant to each Program prior to and in preparation for the JRC meetings, by the deadline and in the level of detail, form and format to be designated by the JRC; provided, however, that, in any event, each Party shall to the extent reasonably possible provide the other Party with quarterly updates regarding its work pursuant to the Programs preferably [*****] prior to each JRC meeting. |
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9.8 | Collaboration Committee (All Programs except an Opt-In Program). The Parties agree to establish Collaboration Committee(s) for all Programs except an Opt-In Program. |
9.8.1 | Formation; Duration. Within [*****] after IND filing for a Program, the Parties shall establish a Collaboration Committee (the “Collaboration Committee”) that will oversee the Development of the Products within such Program as set forth in this Section 9.8. |
9.8.2 | Composition. Each Collaboration Committee will be comprised of [*****] named representatives of each Party. Each Collaboration Committee will be led by [*****] chair appointed by Genmab. Within [*****] after IND filing for a Product, each Party shall notify the other Party of its initial representatives on the respective Collaboration Committee. Each Party may replace one or more of its representatives effective upon written notice to the other Party. |
9.8.3 | Function and Powers of the Collaboration Committee. The Collaboration Committee will: |
a. | receive written reports or presentations from Genmab of its progress with each Product Development Plan summarizing Genmab’s Development activities and the results thereof with respect to the applicable Product and discuss at meetings the status, progress, and results of the Development of the respective Product in the Territory; |
b. | if CureVac exercises its Co-Promote Right with respect to a Product, direct and oversee the Co-Promotion Committee on all significant issues and resolve disputed matters that may arise at the Co-Promotion Committee, except as otherwise set out in the Co-Promotion Agreement. For clarity, the Collaboration Committee shall not have any right to amend the Co-Promotion Agreement; |
c. | in circumstances in which CureVac is supplying the Product or any part of the Product, discuss matters relating to Manufacturing; and |
d. | perform any and all tasks and responsibilities that are expressly attributed to the Collaboration Committee under this Agreement or as otherwise agreed by the Parties in writing. |
9.8.4 | Meetings. The Collaboration Committee will meet [*****] after its formation and during the remainder of the Term. The Collaboration Committee may conduct such meetings by telephone, videoconference, or in person as determined by the chair. Each Party’s Alliance Manager will ensure that its Collaboration Committee members receive adequate notice of such meetings. Genmab may call special meetings of the Collaboration Committee with at least [*****] prior written notice, except in exigent circumstances, to resolve particular matters requested by Genmab and within the decision-making responsibility of the Collaboration Committee. Meetings of the Collaboration Committee fulfill the requirements of this Section 9.8.4 only if at least [*****] representatives of each Party participate in such meeting. Each Party may invite a reasonable number of participants, in addition to its representatives, to attend Collaboration Committee meetings. Each Party is responsible for its own expenses incurred in connection with participating in and attending all such meetings. The Alliance Manager of Genmab shall record the minutes of each Collaboration Committee meeting in writing. Such minutes shall be circulated by Genmab’s Alliance Manager to CureVac’ Alliance Manager no later than [*****] following the meeting for review and comments of CureVac. If no comments are received within [*****] of the receipt of the minutes by CureVac, unless otherwise agreed, they shall be deemed to be approved by CureVac. Furthermore, if the Parties are unable to reach agreement on the minutes within [*****] of the applicable meeting, the sections of the minutes that have been mutually agreed between the Parties by that date shall be deemed approved and, in addition, each Party shall record in the same document its own version of those sections of the minutes on which the Parties were not able to agree. |
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9.8.5 | Collaboration Committee Decisions. In conducting its activities, the Collaboration Committee and each Sub-Committee (as applicable) shall operate and make decisions consistent with the terms of this Agreement. The Collaboration Committee will seek to act by consensus. If the Collaboration Committee cannot reach consensus or a dispute arises that cannot be resolved within the Collaboration Committee, then such matter shall be escalated to the Alliance Managers of each Party. The Alliance Managers should involve the relevant Collaboration Committee members of each Party in such dispute resolution. If such matter is not resolved within [*****] after escalation to the Alliance Managers, Genmab may make final decisions for all matters within the purview of the Collaboration Committee except disputes about the Manufacture by CureVac of Product which shall be governed by the relevant supply agreement, if applicable. |
9.9 | Joint Steering Committee (Opt-In Program). The Parties agree to establish and operate a Joint Steering Committee for the Opt-In Program as required by Section 7.2 and as set forth below in this Section 9.9. |
9.9.1 | Composition. The Joint Steering Committee will be comprised of [*****] named representatives of each Party. The chair of the Joint Steering Committee will alternate each calendar year, with Genmab to chair the first year. Within [*****] after an Opt-Inby CureVac, each Party shall notify the other Party of its initial representatives on the Joint Steering Committee. Each Party may replace one or more of its representatives effective upon written notice to the other Party. |
9.9.2 | Function and Powers of the Joint Steering Committee. The Joint Steering Committee shall: |
(i) | direct, coordinate and supervise the Development of the Opt-In Product, including discuss and agree to any update to the applicable R&D Plan; |
(ii) | discuss and agree on matters relating to Manufacturing of Opt-In Product; |
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(iii) | once it has been formed, direct and oversee the Joint Commercialization Committee on all significant issues, and resolve disputed matters that may arise at the Joint Steering Committee; |
(iv) | establish subcommittees as determined to be reasonably necessary or useful by the Joint Steering Committee, and oversee any operating subcommittee on all significant issues, and resolve disputed matters that may arise at the subcommittees; and |
(v) | perform any and all tasks and responsibilities that are expressly attributed to the Joint Steering Committee under this Agreement or as otherwise agreed by the Parties in writing. |
9.9.3 | Meetings. The will meet [*****] after its formation and for as long as the Parties jointly Develop, Manufacture and/or Commercialize the Opt-In Product. The Joint Steering Committee may conduct such meetings by telephone, videoconference, or in person as determined by the chair, provided, however, that the Joint Steering shall to the extent reasonably possible meet in person at least [*****] every calendar year. Each Party’s Alliance Manager will ensure that its Joint Steering Committee members receive adequate notice of such meetings. A Party may call special meetings of the Joint Steering Committee with at least [*****] prior written notice, except in exigent circumstances, to resolve particular matters requested by a Party and within the decision-making responsibility of the Joint Steering Committee. Meetings of the Joint Steering Committee fulfill the requirements of this Section 9.9.3 only if at least [*****] representatives of each Party participate in such meeting. Each Party may invite a reasonable number of participants, in addition to its representatives, to attend Joint Steering Committee meetings; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party. Such Party shall ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement. Each Party is responsible for its own expenses incurred in connection with participating in and attending all such meetings. The Alliance Manager of the Party chairing the meeting shall record the minutes of the Joint Steering Committee meeting in writing. Such minutes shall be circulated to the other Party’s Alliance Manager no later than [*****] following the meeting for review, comment and approval of the other Party. If no comments are received within [*****] of the receipt of the minutes by the other Party, unless otherwise agreed, they shall be deemed to be approved by the other Party. Furthermore, if the Parties are unable to reach agreement on the minutes within [*****] of the applicable meeting, the sections of the minutes that have been mutually agreed between the Parties by that date shall be deemed approved and, in addition, each Party shall record in the same document its own version of those sections of the minutes on which the Parties were not able to agree. |
9.9.4 | Decisions. A quorum of at least [*****] Joint Steering Committee member appointed by each Party shall be present at or shall otherwise participate in each Joint Steering Committee meeting. Each Party has one vote in the decisions of the Joint Steering Committee. Decisions of the Joint Steering Committee shall be unanimous. If the members of the Joint Steering Committee cannot agree on a particular issue, the issue shall be escalated pursuant to Section 17.5, unless otherwise explicitly provided for in the Joint Development and Manufacturing Agreement and/or Commercialization Agreement. |
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9.9.5 | Subcommittees. The Joint Steering Committee may establish and disband such subcommittees as deemed necessary by the Joint Steering Committee. In addition, the Joint Steering Committee shall establish the Joint Commercialization Committee as provided for in Section 7.7(i). Each such subcommittee will consist of the same number of representatives designated by each Party, which number shall be mutually agreed by the Parties. Each Party may change its representatives on written notice to the other Party or send a substitute representative to any subcommittee meeting. Each Party’s representatives and any substitute for a representative shall be bound by the obligations of confidentiality set forth in Section 13. Except as expressly provided in this Agreement, no subcommittee has the authority to bind the Parties hereunder and each subcommittee will report to the Joint Steering Committee. Each Party is responsible for its own expenses incurred in connection with participating in and attending all such meetings. If a dispute arises that cannot be resolved by a subcommittee, either Party may refer such dispute to the Joint Steering Committee for resolution. |
9.9.6 | Authority. The Joint Steering Committee and any subcommittees have only the powers assigned expressly to it in this Section 9 and elsewhere in this Agreement, and does not have any power to amend, modify, or waive compliance with this Agreement. Each Party retains the rights, powers, and discretion granted to it under this Agreement and neither Party may delegate or vest such rights, powers, or discretion in the Joint Steering Committee or subcommittee unless expressly provided for in this Agreement or the Parties expressly so agree in writing. |
10. | CONSIDERATION. |
10.1 | Upfront Payment. In partial consideration for the exclusive licenses granted hereunder, Genmab shall pay to CureVac a non-refundable and non-creditable fee in the amount of Ten Million US Dollars (US$10,000,000) within [*****] after Genmab’s receipt of an invoice of the respective amount from CureVac. |
10.2 | Option Exercise Fee. In partial consideration for the exclusive options granted hereunder for up to three (3) Reserved Targets, Genmab shall pay to CureVac on an Option Exercise-by-Option Exercise basis a non-refundable and non-creditable (except as otherwise explicitly provided for in the Agreement) Option Exercise Fee in the amount of [*****] i.e., a maximum of Thirty Million US Dollars (US$30,000,000) for all potential options hereunder (“Option Exercise Fee”). Such payment shall be made within [*****] after Genmab’s receipt of an invoice of the respective amount from CureVac; provided, however, that a Reservation Fee paid by Genmab to CureVac for the corresponding Reserved Target shall be deducted from the Option Exercise Fee, [*****]. |
10.3 | Product Selection Fee. Genmab shall pay CureVac a one time non-refundable and non-creditable fee of five million USD ($5,000,000) upon Product Selection by a Product Selection Notice covering a Product based upon the First Program Antibody or a Replacement Target Antibody, as applicable. Such payment shall be made within [*****] after Genmab’s receipt of an invoice of the respective amount from CureVac. |
10.4 | Opt-In fee. If CureVac exercises its option to Opt-In under Section 7.1 above, CureVac shall pay Genmab a non-refundable and non-creditable Opt-In fee of Three Million Dollars (US$ 3,000,000) within [*****] after CureVac’s receipt of an invoice of the respective amount from Genmab; and no Option Exercise Fee shall be payable by Genmab for the respective Optioned Target. If the Option Exercise Fee has already been paid, CureVac shall reimburse such payment to Genmab within [*****] of receipt of invoice. |
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10.5 | Development and Regulatory Milestone Payments. In addition to the payments under Sections 10.1, to 10.4 inclusive, in further consideration for the exclusive licenses granted hereunder, and subject to the terms and conditions set forth in this Agreement, Genmab shall make the following non-refundable and non-creditable Development and regulatory milestone payments to CureVac: |
10.5.1 | Single Antibody Products. On a Single Antibody Product-by-Single Antibody Product basis, the following payments shall be made for all Single Antibody Products (including the First Collaboration Program – including if it is amended to cover a Replacement Target, and any Other Pre-IND Program, as applicable): |
Development Milestone Event | In US$ Million |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
Regulatory Milestone Event | 1st BLA/MAA | 2nd BLA/MAA |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
Sales Milestone event | In US$ Million |
Genmab shall make the following one-off, sales-based milestone payments, for the Calendar Year in which aggregated annual worldwide Net Sales exceed for the first time the following amounts: | |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
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10.5.2 | Cocktail Products. On a Cocktail Product-by-Cocktail Product basis, the following payments shall be made for all Cocktail Products (with the exception of any Opt-In Product): |
Development Milestone Event | In US$ Million |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
Regulatory Milestone Event | 1st BLA/MAA | 2nd BLA/MAA |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
Sales Milestone event | In US$ Million |
Genmab shall make the following one-off, sales-based milestone payments, for the Calendar Year in which aggregated annual worldwide Net Sales exceed for the first time the following amounts: | |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
If any one of the milestone events under Section 10.5 is not required for the Development of a Product, such milestone payment shall become payable upon achieving the respective milestone event following the milestone event which was not required, [*****]. For purposes of clarity, the maximum aggregate amount payable by Genmab pursuant to this Section 10.5 is [*****] for each Single Antibody Product, and [*****] for each Cocktail Product.
10.5.3 | Obligation to Inform. Genmab shall inform CureVac on the occurrence of a milestone event under Sections 10.5.1 and 10.5.2 [*****] after the occurrence thereof. |
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10.5.4 | Milestone Payment Terms. Each milestone payment shall be due and payable within [*****] after the receipt of the respective invoice by Genmab. Notwithstanding the foregoing, each sales milestone payment shall be paid together with the royalty payments for the Calendar Quarter during which the respective milestone has been achieved. |
10.6 | Royalties. |
10.6.1 | Royalty Rates. As further consideration for the rights and licenses granted by CureVac to Genmab under this Agreement, Genmab shall pay royalties to CureVac in the following amounts, in all cases considered on a Product-by-Product basis: |
Single Antibody Products:
Aggregate annual Net Sales of each Single Antibody Product (Product-by-Product) | Royalty Rate |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
Cocktail Products (with the exception of any Opt-In Product):
Aggregate annual Net Sales of each Cocktail Product (except any Opt-In Product) (Product-by-Product) | Royalty Rate |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
10.6.2 | Royalty Calculation. The royalties shall be calculated on the basis of aggregate annual Net Sales in the Territory Product-by-Product, with the royalty tiers set out above being calculated on a Product-by-Product basis from First Commercial Sale until the expiration of the applicable Royalty Term. Examples of royalty calculations are included in the enclosed Exhibit 10.6.2. |
10.6.3 | Royalty Term. Genmab’s obligation to pay royalties shall begin, on a country-by-country basis, with the First Commercial Sale, and expire, on a country-by-country and a Product-by-Product basis, upon the later of (i) expiry or abandonment of the last to expire Valid Claim in such country that Covers such Product; (ii) expiry of Regulatory Exclusivity for the respective Product in such country; or (iii) ten (10) years from the date of First Commercial Sale of the respective Product (“Royalty Term”). |
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10.6.4 | FTO License. If, during the Term, Genmab reasonably concludes, on the advice of patent counsel, that it might be required to seek a license under certain Third Party Patent Rights in order to have freedom to operate in practicing or making use of the CureVac Background Technology and/or LNP Technology by the Development, Manufacture, Commercialization or other exploitation of Products in accordance with this Agreement in any country (“FTO License”), Genmab shall be free to take such FTO License, and the circumstances of Sections 10.6.5 and 10.6.6 may be applicable, subject to their provisions. Before taking such FTO License, Genmab will consult with CureVac in good faith regarding the need for such FTO License and other available options, such as seeking to invalidate certain claims of the relevant Third Party Patent Rights. |
10.6.5 | Third Party Payments–Granted Patent Rights in the Disclosure Letter. Subject to Section 10.6.9, with respect to Third Party Patent Rights referenced in the Disclosure Letter that are granted as of the Effective Date, and subject to compliance with the procedures of Section 10.6.4, in the event Genmab seeks and obtains an FTO License under such Third Party Patent Rights and is required to make any payments (milestone, royalties or other payments, including settlement payments) to one or more Third Party licensors to obtain such license, then milestone payments and/or royalties due to CureVac for the respective Product shall be reduced by [*****] of the amount of such Third Party licensor payments payable by Genmab until Genmab has been reimbursed [*****] of all such payments. For clarity, subject to Section 10.6.9 Genmab shall also have the right to reduce milestone payments and royalties to CureVac by [*****] of any payments made by Genmab to CureVac under Section 2.8 with respect to any Third Party IP of the type the subject of this 10.6.5. The Parties acknowledge and agree that this mechanism for deduction of Third Party payments does not imply in any way that the Third Party Patent Rights referenced in the Disclosure Letter may constitute any risk with respect to freedom to operate. |
10.6.6 | Other Third Party Payments. Subject to Section 10.6.9, with respect to Third Party Patent Rights not referenced in the Disclosure Letter or Third Party Patent Rights referenced in the Disclosure letter that are not granted as of the Effective Date, and subject to compliance with the procedures of Section 10.6.4 in the event Genmab seeks and obtains an FTO License under such Third Party Patent Rights and is required to make any payments (milestone, royalties or other payments, including settlement payments) to one or more Third Party licensors to obtain such license, then royalties due to CureVac for the respective Product shall be reduced by [*****] of the amount of such Third Party licensor payments payable by Genmab until Genmab has been reimbursed in full for [*****] of all such payments. For clarity, subject to Section 10.6.9, Genmab shall also have the right to reduce royalties to CureVac by [*****] of any payments made by Genmab to CureVac under Section 2.8 with respect to any Third Party IP of the type the subject of this Section 10.6.6. The Parties acknowledge and agree that this mechanism for deduction of Third Party payments does not imply in any way that the Third Party Patent Rights referenced in the Disclosure Letter may constitute any risk with respect to freedom to operate. |
10.6.7 | Countries Without Patent Protection. During the Royalty Term with respect to the First Collaboration Target and the related Product and subject to Section 10.6.9, in countries where sales of the Product do not or no longer fall under any Valid Claim, but where Regulatory Exclusivity is still in effect, royalties set forth above in Section 10.6.1 shall be reduced by [*****] for Net Sales in such country in the first [*****] period during which no Valid Claim exists, but Regulatory Exclusivity is in effect, [*****] for Net Sales in such country in the second [*****] period during which no Valid Claim exists, but Regulatory Exclusivity is in effect, and [*****] for Net Sales in such country for the remainder of the Royalty Term. For avoidance of doubt, in countries where sales of Products do not or no longer fall under any Valid Claim and Regulatory Exclusivity is not available or has expired, royalties set forth above in Section 10.6.1 shall be reduced by [*****] for Net Sales in such country. During the Royalty Term with respect to any Optioned Target or Optioned Target Combination, as applicable, and the related Products and subject to Section 10.6.9, in countries where sales of Products do not or no longer fall under any Valid Claim, royalties set forth above in Section 10.6.1 shall be reduced by [*****] for Net Sales in such country. |
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10.6.8 | Generic Competition. In countries where Generic Products are being marketed by a Third Party, royalties set forth above shall be further reduced by the greater of: (a) [*****] for Net Sales in such country as long as such Generic Product is on the market in such country; or (b) [*****] for Net Sales in such country in circumstances where the total unit sales of such Generic Products in such country in a Calendar Year equal or exceed [*****] of the total sales in such country of the respective Product and Generic Products combined. |
10.6.9 | Cumulative Deductions. Notwithstanding the above, any royalty reduction made pursuant to Section 10.6.5, Section 10.6.6, Section 10.6.7 and/or Section 10.6.8 or reimbursements made under Section 2.8 that are creditable against royalties shall in no event reduce the applicable royalty rate for such Products sold in the respective country to less than [*****] for Single Antibody and [*****] for Cocktail Products. For avoidance of doubt, in the event that the minimum royalty rates are reached in connection with royalty deductions made pursuant to Section 2.8, Section 10.6.5 and/or Section 10.6.6, Genmab shall be allowed to reduce its future royalty payments, always subject to the above royalty floor, until Genmab has been settled in full with respect to its right to deduct payments made to any Third Party licensor or reimbursements to Curevac, as applicable. |
10.6.10 | Blended Royalties. With respect to a potential step down in royalty rates to account for the expiry of certain Patent Rights, the Parties acknowledge and agree that the CureVac Technology licensed under this Agreement may justify royalty rates and/or royalty terms of differing amounts for sales of Products in the Territory, which rates could be applied separately to Products involving the exercise of CureVac Patent Rights in the Territory and/or the incorporation of CureVac Know-How, and that if such royalties were calculated separately, royalties relating to the CureVac Patent Rights in the Territory and royalties relating to the CureVac Know-How would last for different terms. For practicality reasons the Parties have agreed on a blended royalty rate. For clarity, this Section 10.6.10 solely explains the rationale behind the royalty rates agreed on by the Parties and does not modify any of the other provisions of this Agreement. |
10.6.11 | Royalty Payments. Within [*****] after the end of each Calendar Quarter in which any Net Sales occur, Genmab shall calculate the royalty payments owed to CureVac and shall remit to CureVac the amount owed to CureVac. All royalty payments shall be computed by converting the Net Sales in each country in the Territory into the currency of US Dollars, using the monthly exchange rates as customarily used by Genmab in preparing its audited financial statements for the applicable Calendar Quarter. |
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10.7 | Reports. Each royalty payment shall be accompanied by a written report describing the Net Sales of each Product sold by or on behalf of Genmab, its Affiliates and Sublicensees during the applicable Calendar Quarter for each country in which sales of any Product occurred, specifying: [*****]. |
10.8 | Records. Genmab, its Affiliates and/or its Sublicensees shall keep and maintain records of sales of the Product(s) so that the royalties payable and the royalty reports may be verified. Such records shall upon reasonable written notice be open to inspection during business hours for a [*****] period after the Calendar Quarter to which such records relate, but in any event not more than once per calendar year, by a nationally recognized independent certified public accountant selected by CureVac reasonably acceptable to Genmab and retained at CureVac’s expense. Said accountant shall sign a confidentiality agreement prepared by Genmab and reasonably acceptable to CureVac and shall then have the right to audit the records kept pursuant to this Agreement to confirm Net Sales, royalties and other payments for a period covering not more than [*****] following the Calendar Quarter to which they pertain. If said examination of records reveals any underpayment(s) of the royalty payable, then Genmab shall promptly pay the balance due to CureVac, and if the underpayment(s) is/are more than [*****] then Genmab shall also bear the expenses of said accountant. If said examination of records reveals any overpayment(s) of royalty payable, then CureVac shall credit the amount overpaid against Genmab’s future royalty payment(s) (and if no further payments are due, shall be refunded by CureVac at the request of Genmab). |
10.9 | Participation Payment. In the event Genmab grants a sublicense to a Third Party (i.e., a Sublicensee) for a Product expressing the First Program Antibody before [*****], Genmab shall pay to CureVac a one time payment of Ten Million US Dollars (US$ 10,000,000), in addition to the milestone and royalty payments to be made under this Article 10. |
10.10 | Payment Terms. |
10.10.1 | All payments by Genmab to CureVac shall be made by wire transfer payment in US dollars, except with respect to payments of FTE costs which shall be made in Euros, and shall be remitted to the following bank account: |
[*****]
Invoices shall be issued to Genmab A/S, or to the assignee Affiliate as specified in Section 17.1 on a Program-by-Program basis. Invoices shall be sent to Genmab by email at the following address and stating the following VAT number or as otherwise designated by Genmab in writing:
Genmab B.V.
[*****]
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10.10.2 | Payments not paid within [*****] after the due date under this Agreement shall bear interest at an annual rate of [*****] above the three-month-LIBOR rate of the respective currency for the time period in which such amount is outstanding, as disclosed from time to time by the European Central Bank which applied on the due date. Calculation of interest will be made for the exact number of days in the interest period based on a year of 360 days (actual/360) by Genmab. |
10.11 | Taxes. |
10.11.1 | Each Party shall be responsible for its own income taxes assessed by a tax or other authority except as otherwise set forth in this Agreement. |
10.11.2 | The Parties acknowledge and agree that it is their mutual objective and intent to optimize, to the extent feasible and in compliance with Applicable Laws, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use reasonable efforts to cooperate and coordinate with each other to achieve such objective. |
10.11.3 | CureVac shall bear and pay any and all taxes levied on account of any payments made to it under this Agreement. If any taxes are required to be withheld by Genmab from any payment to be made to CureVac under this Agreement, Genmab shall (a) deduct such taxes from the payment to be made to CureVac, (b) timely pay the taxes to the proper taxing authority, and (c) send proof of payment to CureVac with an explanation of payment of such taxes within [*****] following such payment. If Genmab had a duty to withhold taxes in connection with any payment it made to CureVac but Genmab failed to withhold, and such taxes were assessed against and paid by Genmab, then CureVac shall, at Genmab’s request and upon receipt of proof of Genmab’s payment of such taxes, reimburse to Genmab the amount equivalent to such taxes (including interest but excluding penalties) paid by Genmab. For purposes of this Section 10.11.3, each Party shall provide the other with reasonably requested assistance to enable the due deduction by Genmab or CureVac, as applicable, and appropriate recovery by CureVac or Genmab, as applicable, which assistance includes provision of any tax forms and other information that may be reasonably necessary for Genmab or CureVac not to withhold tax. |
10.11.4 | All payments due to the terms of this Agreement are expressed to be exclusive of value added tax (VAT) or similar indirect taxes. VAT/indirect taxes shall be added to the payments due to the terms if legally applicable. |
11. | INTELLECTUAL PROPERTY. |
11.1 | Background Technology. As between the Parties, all right, title and interest in and to all [*****] shall be Controlled by [*****] and all right, title and interest in and to all [*****] shall be Controlled by [*****]. As between the Parties, each Party shall have the sole right, in its sole discretion and at its sole expense, to prosecute, maintain and defend Patent Rights within its Background Technology; provided, however, that CureVac shall consider in good faith the interests of Genmab in the prosecution, maintenance and defense of [*****]. |
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11.2 | Disclosure of Inventions. During the Research Period, on a Collaboration Target-by- Collaboration Target basis, each Party shall as soon as reasonably practical disclose to the other Party, through the forum of the IP Sub Committee, the making, conception, or reduction to practice of any Inventions. After the Research Period, each Party shall as soon as reasonably practical disclose to the other Party, through the forum of the IP Sub Committee if it is continued after the Research Period, or otherwise through the Alliance Manager, the making, conception, or reduction to practice of any Invention that may be owned in part or in whole by the other Party pursuant to this Section 11. |
11.3 | Ownership of Inventions. The Parties agree that all right, title and interest in any and all Inventions (including all Patent Rights resulting from such Inventions and all Know-How embodied in such Inventions) shall be owned as follows, [*****]. |
11.3.1 | Genmab Inventions. Genmab shall own all right, title and interest in and to |
(A) | [*****] and |
(B) | [*****] |
Any such Invention as described under (A) or (B) above shall be considered an Invention of Genmab (“Genmab Invention”). The types of inventions listed in Section 2 of Exhibit 11.3 are all Inventions that are not to be considered a [*****] as applicable.
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11.3.2 | CureVac Inventions. CureVac shall own all right, title and interest in and to all Inventions that [*****] Controlled by [*****] and can be [*****]. The types of Inventions listed in [*****]. Any such Invention as described above in this Section 11.3.2 shall be considered an Invention of CureVac (“CureVac Invention”). |
11.3.3 | Other Inventions; Joint Inventions. For all other Inventions (i.e., Inventions that do not fall within the categories described in Section 11.3.1 or 11.3.2 above) that are invented by or on behalf of Genmab and/or CureVac (including the non-limiting example set out in Section 3 of Exhibit 11.3) (“Other Inventions”), [*****]. Any such Other Invention shall be referred to as “Genmab Other Invention” if owned by Genmab, and as “CureVac Other Invention” if owned by CureVac. Except to the extent either Party is restricted by the licenses granted to the other Party under this Agreement or the other terms of this Agreement, each Party shall have the right to [*****] the Other Invention under any Other Invention Patent Right and related Know-How, i.e., shall have a [*****] license to such Other Invention, and any consent from the other Party as may be required under Applicable Law for a Party to practice and exploit such Other Invention and Other Invention Patent Right and related Know-How shall hereby be given by the other Party. If the Parties [*****] shall be jointly owned by the Parties (“Joint Invention”). Except to the extent either Party is restricted by the licenses granted to the other Party under this Agreement or the other terms of this Agreement, each Party may freely practice and exploit its interest in the Joint Inventions, Joint Patent Rights and related Know-How, and any consent from the other Party as may be required under Applicable Law for a Party to practice and exploit such Joint Inventions and Joint Patent Rights shall hereby be given by the other Party. For the avoidance of doubt, the licenses granted under this Section 11.3.3 do not include any license to use any Background Technology of the other Party. |
11.4 | Assignment and transfer of Inventions. To give effect to the ownership principles described in Section 11.3 each Party shall assign and transfer, and hereby assigns and transfers, to such other Party (or with respect to assignments and transfers to Genmab, to Genmab A/S or Genmab B.V. as designated by Genmab in writing on a Program-by-Program basis) [*****] as the case may be, of its present and future rights, interest and title to any such Invention that is to vest in the other Party pursuant to the ownership principles described in Section 11.3, and the other Party shall accept and hereby accepts such assignment and transfer (“Assigned Invention”). At the written instruction of the other Party, the transferring Party agrees to make or procure all such assignments from its employees, consultants and subcontractors as are necessary to give effect to the provisions of this Section 11.4 and to assist the transfer in every way reasonably required by the transferee (i) to obtain Patent Rights to such Assigned Invention in any and all countries for which Patent Rights are being sought; and (ii) to maintain and defend Patent Rights in all Assigned Inventions which have been or may be assigned as provided above. The transferring Party shall execute and deliver, and cause its employees, consultants and subcontractors to execute and deliver, all such documents, instruments and other papers and take all such other action which the transferee may reasonably request in order to give effect to the provisions of this Section 11.4. |
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11.5 | Cooperation. Each Party represents and agrees that all its employee(s), contractor(s) and agent(s) will be obligated under a binding written agreement or otherwise to assign to such Party all Inventions discovered, created, conceived, developed or reduced to practice by such employee(s), contractor(s) or agent(s) in connection with this Agreement. Notwithstanding anything to the contrary herein, to the extent the German Laws on Employee Inventions (Arbeitnehmererfindungsgesetz) applies, each Party shall claim the unlimited use of any Invention discovered, created, conceived, developed or reduced to practice in accordance with such laws. Regardless of which Party is the ultimate assignee of an Invention under this Agreement, each Party shall be solely responsible for payments to be made to its employees or other persons engaged by such Party in consideration for the Invention under the German Laws on Employee Inventions, or any corresponding laws in other countries. For clarity, each Party shall be and remain solely responsible towards its own employees for compliance with the requirements of the German Laws on Employee Inventions (Arbeitnehmererfindungsgesetz) if applicable. |
11.6 | Non-exclusive License to Generally Applicable Patent Rights. Except to the extent CureVac is restricted by the licenses granted to Genmab under this Agreement or the other terms of this Agreement, Genmab hereby grants to CureVac, and CureVac hereby accepts, a fully paid-up, royalty-free, perpetual, irrevocable, worldwide, non-exclusive, transferable and sub-licensable (through multiple tiers) license to freely practice and use the Generally Applicable Patent Rights for activities in connection with the CureVac Background Technology, CureVac Technology, Know-How generated by CureVac outside this Agreement and/or the LNP Technology, in each case to the extent that such activities are outside the scope of this Agreement. For the avoidance of doubt, subject to the provisions of Section 13.4.4 CureVac shall not have any right to use, exploit or disclose any Confidential Information of Genmab in connection with such activities. |
11.7 | Filing, Prosecution, Maintenance and Defense. |
11.7.1 | CureVac Program Patent Rights. Subject to Section 11.7.3 below, CureVac shall have the first right, but not the obligation, to file, prosecute, maintain and defend the CureVac Program Patent Rights throughout the Territory at its sole expense. Upon Genmab’s request, CureVac shall keep Genmab advised of the status of prosecution of all such Patent Rights included within the CureVac Program Patent Rights, and shall give Genmab before filing or response to office actions, as applicable, reasonable opportunity to review and comment upon the text of any applications or amendments for CureVac Program Patent Rights. CureVac shall not unreasonably refuse to address any of Genmab’s comments made in accordance with this Section 11.7.1. Notwithstanding the above, prior to filing any application for a CureVac Invention that may disclose, in part or in full, a Genmab Invention, Other Invention or Joint Invention, CureVac shall provide Genmab with a copy of the draft application and provide Genmab with at least [*****] to review and comment upon the text of such draft application. If Genmab notifies CureVac within the above [*****] deadline that Genmab desires to file an application for a Genmab Invention, Joint Invention or Genmab Other Invention, the Parties shall coordinate the filing of the application for a CureVac Invention with the filing of Genmab’s application for such Genmab Invention, Other Invention or Joint Invention so that CureVac’s application and Genmab’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. CureVac shall promptly give notice to Genmab of the grant, lapse, revocation, surrender or invalidation of any CureVac Program Patent Rights for which CureVac is responsible for the filing, prosecution and maintenance. CureVac shall give notice to Genmab of any desire to not file patent applications claiming CureVac Program Patent Rights on a country by country basis and, in such cases, shall permit Genmab, in its sole discretion, to file such patent applications at its own expense and in its own name. If Genmab elects to file, such Patent Right shall be deemed a Genmab Patent Right and CureVac shall execute such documents and perform such acts at CureVac’s reasonable expense as may be reasonably necessary for Genmab to perform such filing. For avoidance of doubt, CureVac will not include a Genmab Invention, Other Invention or Joint Invention in a separate patent claim of a patent application to be filed by CureVac without Genmab’s prior written consent. |
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11.7.2 | Genmab Program Patent Rights. Genmab shall have the sole right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Genmab Program Patent Rights throughout the Territory in good faith consistent with its customary patent policy and its reasonable business judgment and shall consider in good faith the reasonable interests of CureVac in so doing. Upon CureVac’s request, Genmab shall keep CureVac advised of the status of prosecution of all Royalty Product Patent Rights. Notwithstanding the above, prior to filing any application for a Genmab Invention that may disclose, in part or in full, a CureVac Invention, Other Invention or Joint Invention, Genmab shall provide CureVac with a copy of the draft application and provide CureVac with at [*****] to review and comment upon the text of such draft application. If CureVac notifies Genmab within the above [*****] deadline that CureVac desires to file an application for a CureVac Invention or CureVac Other Invention, the Parties shall coordinate the filing of the application for a Genmab Invention with the filing of CureVac’s application for such CureVac Invention or CureVac Other Invention so that CureVac’s application and Genmab’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest, such as by agreeing to follow the principles for filing, prosecution, maintenance and defense outlined in Section 11.7.3. For avoidance of doubt, Genmab will not include a CureVac Invention, Other Invention or Joint Invention in a separate patent claim of a patent application to be filed by Genmab without CureVac’s prior written consent. |
11.7.3 | Filing, Prosecution, Maintenance and Defense of certain Patents claiming both Genmab Inventions and CureVac Inventions. Notwithstanding the above in Section 11.7.1, if Genmab reasonably finds that the planned filing of a patent application by CureVac claiming a CureVac Invention may be damaging to Genmab’s possibilities of obtaining adequate Patent Rights for a particular Product, Genmab shall have the right to request in writing, through the IP Sub- Committee or the Alliance Manager, as applicable, and providing detailed reasons that CureVac does not file such application at that time, always giving due consideration to CureVac’s interest in obtaining an adequate patent protection of the CureVac Inventions and Genmab’s interest in obtaining an adequate patent protection for Genmab Inventions and that particular Product. For avoidance of doubt, [*****]. As a result of such written request from Genmab, CureVac will not file such application at such time. Instead, CureVac can file such application on the earlier of (i) [*****] after Genmab has promptly informed CureVac in writing that Genmab has obtained sufficient data to support an application for Patent Rights for a Genmab Invention relating to the Product making use of such CureVac Invention, or (ii) [*****] following Product Selection under Section 5.3 or Option Exercise under Section 3.4 (whichever occurs sooner) according to the R&D Plan relating to the Product which is the subject of the Genmab patent application; or (iii) when Genmab decides not to pursue Product Selection under Section 5.3 or Option Exercise under Section 3.4 for that particular Product. [*****]. If CureVac believes it would be beneficial that such Genmab application should contain claims for such CureVac Invention, it may request Genmab to include the relevant CureVac Invention in the Genmab filing, and Genmab shall consider such request in good faith. Subject to the restrictions of the licenses granted by CureVac to Genmab under this Agreement and any other restrictions explicitly set out in this Agreement, Genmab shall and hereby does grant to CureVac, and CureVac shall and hereby does accept, an exclusive, worldwide, fully paid, perpetual, fully transferable license, with the right to grant sublicenses in multiple tiers, under any such Genmab Program Patent Rights covering a CureVac Invention to practice and exploit such CureVac Invention and only such CureVac Invention. In addition, upon CureVac’s request, Genmab shall collaborate in good faith with CureVac with a view to filing, where possible, specific divisional application(s) claiming such CureVac Invention(s), that would be prosecuted, maintained and defended under the control of CureVac and at its expense, and, to the extent possible without damaging Genmab’s patent position with respect to a given Product, which divisional application(s) shall be assigned to CureVac for its further prosecution, maintenance and defense at CureVac’s cost. Such assigned divisional Patent Rights shall then be deemed CureVac Program Patent Rights. Upon such filing of a divisional application, Genmab shall abandon the patent claim(s) for such CureVac Invention. |
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11.7.4 | CureVac Other Invention Patent Rights. CureVac shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights for CureVac Other Inventions (“CureVac Other Invention Patent Rights”) throughout the Territory, at its sole expense, and CureVac shall as soon as reasonably practicable give notice to Genmab of any desire to not file patent applications claiming CureVac Other Invention Patent Rights or to cease prosecution and/or maintenance and/or defense of CureVac Other Invention Patent Rights on a country by country basis and, in such cases, shall permit Genmab, in its sole discretion, to file such patent applications or to continue prosecution or maintenance or defense of such CureVac Other Invention Patent Rights (in which case thereafter they will be deemed a Genmab Other Invention Patent Right) at its own expense and in its own name. At the latest [*****] before filing, and except where CureVac has given up the right to prosecute as provided above, CureVac shall give Genmab an opportunity to review and comment upon the text of any application with respect to any CureVac Other Invention Patent Right, shall consult with Genmab with respect thereto, shall not unreasonably refuse to address any of Genmab’s comments and supply Genmab with a copy of the application as filed, together with notice of its filing date and serial number. CureVac shall keep Genmab reasonably informed of the status of the actual and prospective prosecution, maintenance and defense, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and CureVac shall to the extent reasonably possible give Genmab a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with Genmab with respect thereto, and shall not unreasonably refuse to address any of Genmab’s comments. Notwithstanding anything to the contrary above, prior to filing any application for a CureVac Other Invention that may disclose, in part or in full, a Genmab Invention, CureVac shall provide Genmab with a copy of the draft application and provide Genmab with at least [*****] to review and comment upon the text of such draft application. If Genmab notifies CureVac within the above [*****] deadline that Genmab desires to file an application for a Genmab Invention, the Parties shall coordinate the filing of the application for a CureVac Other Invention with the filing of Genmab’s application for such Genmab Invention so that the CureVac application and Genmab application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. |
11.7.5 | Genmab Other Invention Patent Rights. Genmab shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights for Genmab Other Inventions (“Genmab Other Invention Patent Rights”) throughout the Territory, at its sole expense, and Genmab shall as soon as reasonably practicable give notice to CureVac of any desire to not file patent applications claiming Genmab Other Invention Patent Rights or to cease prosecution and/or maintenance and/or defense of Genmab Other Invention Patent Rights on a country by country basis and, in such cases, shall permit CureVac, in its sole discretion, to file such patent applications or to continue prosecution or maintenance or defense of such Genmab Other Invention Patent Rights (in which case thereafter they will be deemed a CureVac Other Invention Patent Right) at its own expense and in its own name. At the latest [*****] before filing, and except where Genmab has given up the right to prosecute as provided above, Genmab shall [*****]. Notwithstanding anything to the contrary above, prior to filing any application for a Genmab Other Invention that may disclose, in part or in full, a CureVac Invention, Genmab shall provide CureVac with a copy of the draft application and provide CureVac with at least [*****] to review and comment upon the text of such draft application. If CureVac notifies Genmab within the above [*****] deadline that CureVac desires to file an application for a CureVac Invention, the Parties shall coordinate the filing of the application for a Genmab Other Invention with the filing of CureVac’s application for such CureVac Invention so that the CureVac application and Genmab application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. |
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11.8 | Joint Patent Rights. |
11.8.1 | Genmab shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights relating to Joint Inventions (“Joint Patent Rights”) throughout the Territory, at its sole expense, and Genmab shall give timely notice to CureVac, and, if during the Research Period, with a copy to the IP Sub-Committee, of any desire to not file patent applications claiming Joint Patent Rights or to cease prosecution and/or maintenance of Joint Patent Rights on a country-by-country basis and, in such cases, shall permit CureVac, in its sole discretion, to file such patent applications or to continue prosecution, maintenance or defense of such Joint Patent Rights at its own expense. At the latest [*****] before filing, the prosecuting Party shall give the non-prosecuting Party an opportunity to review and comment upon the text of any application with respect to such Joint Patent Right, shall consult with the non-prosecuting Party with respect thereto, shall not unreasonably refuse to address any of the non-prosecuting Party’s comments and supply the non-prosecuting Party with a copy of the application as filed, together with notice of its filing date and serial number. The prosecuting Party shall keep the non-prosecuting Party reasonably informed of the status of the actual and prospective prosecution, and maintenance, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and the prosecuting Party shall give the non-prosecuting Party a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with such non- prosecuting Party with respect thereto, and shall not unreasonably refuse to address any of such non-prosecuting Party’s comments. |
11.9 | Patent Term Extension. [*****]. It is acknowledged that Genmab has the ultimate decision-making authority with regard to the filing for Patent Term Extensions, but Genmab agrees that when making that decision it shall not unreasonably take any action or inaction that causes CureVac significant financial detriment, [*****]. CureVac shall cooperate with Genmab with regard to obtaining Patent Term Extensions and shall provide to Genmab prompt and reasonable assistance as requested by Genmab, at Genmab’s expense, including by taking such action as may be required of the patent holder under any Applicable Laws to obtain such Patent Term Extension. [*****]. |
12. | ENFORCEMENT AND DEFENSE. |
12.1 | Notice. Each Party shall notify the other Party in writing as soon as reasonably possible upon learning of any actual or suspected infringement by a Third Party of any CureVac Patent Rights, Genmab Patent Rights, CureVac Other Invention Patent Right, Genmab Other Invention Patent Right, Joint Patent Right or Patent Rights comprised in the LNP Technology Controlled by CureVac that may adversely affect any Program Antibody, Program Antibody Combination or Product in the Field in the Territory (“Relevant Infringement”), or of any claim by a Third Party alleging the invalidity, unenforceability, or non-infringement of any CureVac Patent Rights, Genmab Patent Rights, CureVac Other Invention Patent Right, Genmab Other Invention Patent Right or Joint Patent Right. |
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12.2 | Enforcement. |
12.2.1 | CureVac Patent Rights, Patent Rights in LNP Technology, CureVac Other Invention Patent Rights. Except as set forth in Section 12.2.2 below, as between the Parties, CureVac will have the first right, but not the obligation, to seek to abate any Relevant Infringement of any CureVac Patent Right, Patent Rights comprised in the LNP Technology Controlled by CureVac (to the extent CureVac is authorized to do so by the LNP Technology licensor) or CureVac Other Invention Patent Right by a Third Party, or to file suit against any such Third Party for such Relevant Infringement, and CureVac shall bear all the expense of such suit or abatement of such Relevant Infringement. Genmab may, at its own expense, be represented in any such action by counsel of its own choice. If CureVac does not bring such legal action within the earlier of (i) [*****] after the notice provided pursuant to Section 12.1, or (ii) within [*****] prior to any deadline under Applicable Law for bringing such legal action; or if CureVac decides to discontinue any ongoing legal action, Genmab may bring and control any legal action in connection with such Relevant Infringement of CureVac Patent Rights, Patent Rights comprised in the LNP Technology (to the extent possible under CureVac’s license to such LNP Technology) or CureVac Other Invention Patent Rights at its own expense as it reasonably determines appropriate. |
12.2.2 | Genmab Patent Rights. As between the Parties, Genmab will have the sole right, but not the obligation, to seek to abate any infringement of Genmab Patent Rights by a Third Party, or to file suit against any such Third Party for such infringement. Genmab shall bear all the expense of such suit or abatement of infringement. With respect to any infringement by a Third Party of a Genmab Patent Right where such infringement relates to a claim for a CureVac Invention included in such Genmab Patent Right pursuant to Section 11.7.3, Genmab agrees to collaborate with CureVac in good faith at CureVac’s cost to enforce such claim against such Third Party infringement [*****]; provided that in the reasonable opinion of Genmab such enforcement will not entail any significant risk with respect to upholding an adequate patent protection for Genmab Inventions and the Product. |
12.2.3 | Genmab Other Invention Patent Right and Joint Patent Rights. Genmab shall have the first right, but not the obligation, to seek to abate any infringement of Genmab Other Invention Patent Rights or Joint Patent Rights by a Third Party, or to file suit against any such Third Party for such infringement, and Genmab shall bear all the expense of such suit or abatement of infringement. CureVac may, at its own expense, be represented in any such action by counsel of its own choice. If Genmab does not bring such legal action within the earlier of (i) [*****] after the notice provided pursuant to Section 12.1, or (ii) within [*****] prior to any deadline under Applicable Law for bringing such legal action; or if Genmab decides to discontinue any ongoing legal action, CureVac may bring and control any legal action in connection with such infringement of Genmab Other Invention Patent Rights and Joint Patent Rights at its own expense as it reasonably determines appropriate. |
12.2.4 | Assistance. The non-enforcing Party shall provide such assistance as the enforcing Party shall reasonably request in connection with any action or suit hereunder to prevent or enjoin any such infringement or unauthorized use of a CureVac Patent Right or Genmab Patent Right, including agreeing to be joined as a party to such action or suit and executing legal documents as reasonably requested by the enforcing Party. Such assistance will be provided by a Party, at the enforcing Party’s cost. |
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12.3 | Defense. |
12.3.1 | Defense of CureVac Patent Rights, Patent Rights in LNP Technology and CureVac Other Invention Patent Rights. Except as set forth in subsection 12.3.2 below, as between the Parties, CureVac will have the first right, but not the obligation, to defend against a declaratory judgment action or other action challenging any CureVac Patent Right or Patent Right comprised in LNP Technology Controlled by CureVac or CureVac Other Invention Patent Rights. |
12.3.2 | Defense of Genmab Other Invention Patent Rights and/or Joint Patent Rights. As between the Parties, Genmab will have the first right, but not the obligation, to defend against a declaratory judgment action or other action challenging any Genmab Other Invention Patent Right or Joint Patent Rights. Genmab shall bear all the expense of such defense. |
12.3.3 | Taking over the defense. If the Party first responsible for such defense does not take steps to defend (or have defended) within a commercially reasonably time period, or elects not to continue any such defense (in which case it will promptly provide notice thereof to the other Party), then (A) in the case of an election by CureVac not to defend (or have defended) a CureVac Patent Right, Patent Right in LNP Technology Controlled by CureVac or CureVac Other Invention Patent Right, Genmab shall have the right, but not the obligation, to defend such CureVac Patent Right, Patent Right in LNP Technology (to the extent possible under CureVac’s license to such LNP Technology) or CureVac Other Invention Patent Right with respect to a Program Antibody, Program Antibody Combination or Product; provided, however, that Genmab shall bear all the expenses of such suit, and (B) in the case of an election by Genmab not to defend a Genmab Other Invention Patent Right or Joint Patent Right, CureVac shall have the right, but not the obligation, to take action or bring suit to defend such Patent Right; provided, however that CureVac shall bear all the expenses of such suit. |
12.3.4 | Control. Notwithstanding the foregoing, any response to a Third Party infringer’s counterclaim of invalidity or unenforceability of any CureVac Patent Rights, Patent Right in LNP Technology Controlled by CureVac (to the extent authorized under CureVac’s license to such LNP Technology), CureVac Other Invention Patent Rights, Genmab Other Invention Patent Rights or Joint Patent Right shall be controlled by the Party who controls the relevant enforcement proceeding pursuant to this Article 12 unless otherwise mutually agreed by the Parties in writing. |
12.3.5 | Defense of Genmab Patent Rights. As between the Parties, Genmab shall have the sole right, but not the obligation, to defend against a declaratory judgment action or other action challenging any Genmab Patent Right. Genmab shall bear all the expenses of such defense. With respect to any defense of a Genmab Patent Right where such defense relates to a claim for a CureVac Invention included in such Genmab Patent Right pursuant to Section 11.7.3, Genmab agrees to collaborate with CureVac in good faith at CureVac’s cost to defend such claim against such declaratory judgment action or other action challenging such claim [*****]; provided that in the reasonable opinion of Genmab such defense will not entail any significant risk with respect to upholding an adequate patent protection for Genmab Inventions and the Product. |
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12.4 | Participation. With respect to any infringement or defensive action identified above in this Article 12, the enforcing or defending Party shall keep the other Party updated and reasonably consult with the other Party with respect to any such action, it being understood that in such consultation the enforcing or defending Party shall take the other Party’s comments reasonably into account, provided, however, that the enforcing or defending Party will have the right to make the final determination in the event of any disagreement between the Parties related to any decision in connection with such action. |
12.5 | Damages. Unless otherwise agreed by the Parties, all monies recovered upon the final judgment or settlement of any infringement action relating to the Development, Manufacture or Commercialization of Product(s) under this Agreement which may be controlled by either Genmab or CureVac and described in this Article 12, in each case will be used as follows: |
(i) | first to reimburse the controlling Party, and thereafter the non-controlling Party, for each of their reasonable out-of-pocket costs and expenses relating to the action; |
(ii) | second, the remaining recovery shall then be used to compensate each Party for the respective damages suffered from the infringement of the respective Patent Right based on a lost profits calculation, provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party’s damages, such compensation shall be paid on a pro-rata share based on the respective damages/lost profits suffered, provided, however, if such respective damages/lost profits suffered cannot be reasonably ascertained, then (a) with respect to an action controlled by Genmab, Genmab shall receive [*****] of the recovery and CureVac shall receive [*****] except in the event that the recovery relates to an Opt-In Product in which case the recovery shall be [*****] and (b) with respect to an action controlled by CureVac, the recovery shall be [*****]; |
(iii) | third, the remaining portion of any such recovery to be allocated between the Parties in the same ratio used for the calculation under Section 12.5(ii). |
12.6 | Consent and Consultation. Neither Party shall settle any claim or demand in any such litigation admitting the invalidity or non-infringement of the other Party’s Patent Rights (for clarity, including Joint Patent Rights), or otherwise materially negatively impacting the other Party’s rights or interests under this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. In addition to the foregoing, to the extent any action initiated by Genmab involves any infringement of CureVac Patent Rights, Genmab will consult with CureVac regarding issues relating to such CureVac Patent Rights, and take CureVac’s input into good faith consideration. |
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12.7 | Defense and Settlement of Third Party Claims. |
12.7.1 | If the Development, Manufacture or Commercialization of any Program Antibody, Program Antibody Combination or Product in any country in accordance with this Agreement or other activity of either of the Parties pursuant to the Agreement is alleged by a Third Party to infringe a Third Party’s Patent Right, the Party becoming aware of such allegation shall promptly notify the other Party. CureVac has the first right, but not the obligation, to control any defense of any such claim involving alleged infringement of Third Party rights by CureVac’s activities under any Program at its own expense and by counsel of its own choice, and Genmab may, at its own expense, choose to be represented in any such action by counsel of its own choice. Genmab has the sole right to control any defense of any such claim involving alleged infringement of Third Party rights by Genmab’s activities under the Program at its own expense and by counsel of its own choice, and CureVac may, at its own expense, choose to be represented in any such action by counsel of its own choice. Neither Party may settle any patent infringement litigation under this Section 12.7.1 in a manner that admits the invalidity or unenforceability of the other Party’s Patent Rights or Joint Patent Rights or imposes on the other Party restrictions or obligations or other liabilities, without the written consent of such other Party, which consent shall not be unreasonably withheld. Notwithstanding the above, with respect to any Opt-In Product, the Parties shall mutually agree on a common strategy for the defense of any such claim involving alleged infringement of Third Party rights. |
12.7.2 | If a Third Party sues Genmab or CureVac or any of their Affiliates, distributors or permitted Sublicensees alleging that Genmab’s practice of a right granted by CureVac to Genmab hereunder through the Development, Manufacture and/or Commercialization of any Program Antibody, Program Antibody Combination or Product pursuant to this Agreement infringes or will infringe said Third Party’s Patent Rights, then, upon the defending Party’s request and in connection with the defense of any such Third Party infringement suit, the non-defending Party shall provide reasonable assistance to the defending Party for such defense and/or shall join in any such action if reasonably required by the defending Party in order to defend such claim or to assert all available defenses and claims, and to cooperate reasonably with the defending Party. The defending Party shall not enter into a settlement that imposes a financial obligation upon the non-defending Party or which limits the scope or invalidates any Patent Right of either Party without such Party’s prior written consent, which consent shall not be unreasonably withheld or delayed, and in any settlement the defending Party shall always take into consideration the interest of the non-defending Party. |
12.8 | Common Interest Disclosures. With regard to any information (including materials) disclosed pursuant to this Agreement by one Party to the other Party regarding intellectual property rights owned or controlled by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the Development, Manufacturing and/or Commercialization of any Product, and have a further common legal interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual property rights relating to the Development, Manufacturing and/or Commercialization of any Product. Accordingly, the Parties agree that all such information obtained by one Party from the other Party will be used solely for purposes of the Parties’ common legal interests with respect to the conduct of this Agreement. All information will be treated as protected by the attorney-client privilege, the work product privilege, and any other privilege or immunity that may otherwise be applicable. By sharing any information, neither Party intends to waive or limit any privilege or immunity that may apply to the shared information. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party without such other Party’s prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be deemed to apply against any other Party. |
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13. | CONFIDENTIALITY. |
13.1 | Obligation of Confidentiality. As of and after the Effective Date, all Confidential Information disclosed, revealed or otherwise made available to one Party or its Affiliates (“Receiving Party”) by or on behalf of the other Party (“Disclosing Party”) under, or as a result of, this Agreement is made available to the Receiving Party solely to permit the Receiving Party to exercise its rights, and perform its obligations, under this Agreement. The Receiving Party shall not use any of the Disclosing Party’s Confidential Information for any other purpose, and shall not disclose, reveal or otherwise make any of the Disclosing Party’s Confidential Information available to any other person, firm, corporation or other entity, without the prior written authorization of the Disclosing Party, except as explicitly stated in this Article 13. |
13.2 | Additional Obligations. |
13.2.1 | Appropriate Safeguards. In furtherance of the Receiving Party’s obligations under Section 13.1 hereof, the Receiving Party shall take all reasonable steps, and shall implement all appropriate and reasonable safeguards, to seek to prevent the unauthorized use or disclosure of any of the Disclosing Party’s Confidential Information. |
13.2.2 | Unauthorized Use or Disclosure. The Receiving Party shall furnish the Disclosing Party with written notice immediately of it becoming aware and indicating details of any unauthorized use or disclosure of any of the Disclosing Party’s Confidential Information by any employee, officer, director, consultant, CRO, CMO, contractors, agent(s), consultant(s), and Sublicensees (in the case of Genmab), or Financial Partner of/the Receiving Party, and shall take all actions reasonably required in order to prevent any further unauthorized use or disclosure of the Disclosing Party’s Confidential Information. Notwithstanding the foregoing, the Receiving Party remains responsible and liable for any unauthorized use by any employee, officer, director, consultant, CRO, CMO, contractors, agent(s), consultant(s), and Sublicensees (in the case of Genmab), or Financial Partner of the Receiving Party. |
13.3 | Limitations. The Receiving Party’s obligations under Sections 13.1 shall not apply to the extent that the Receiving Party can demonstrate by competent written evidence that any of the Disclosing Party’s Confidential Information: |
(i) | is known by the Receiving Party at the time of its receipt, and not through a prior disclosure by or on behalf of the Disclosing Party; |
(ii) | is in the public domain by use and/or publication before its receipt from the Disclosing Party, or thereafter enters the public domain through no fault of the Receiving Party; |
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(iii) | is subsequently disclosed to the Receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality regarding the Confidential Information; or |
(iv) | is developed by the Receiving Party independently of Confidential Information or material received from the Disclosing Party. |
13.4 | Authorized Disclosures. |
13.4.1 | Necessary Disclosures. Each Party may disclose the other Party’s Confidential Information as expressly permitted by this Agreement or if and to the extent such disclosure is reasonably necessary in the following instances: |
(i) | disclosure to judicial, governmental or other regulatory agencies or authorities in connection with the filing, prosecution, maintenance and defense of Patent Rights as permitted by this Agreement; |
(ii) | disclosure to judicial, governmental or other regulatory agencies or authorities to gain or maintain approval, authorizations or the like to Develop, Manufacture or Commercialize a given Product that such Party has a license or right to Develop, Manufacture or Commercialize hereunder in a given country or jurisdiction; |
(iii) | prosecuting or defending litigation as permitted by this Agreement; |
(iv) | disclosure to its and its Affiliates’ employees, officers, directors, consultants, CROs, CMOs, contractors, agent(s), consultant(s), and to Sublicensees (in the case of Genmab), in each case on a need-to-know basis for the purposes as expressly authorized and contemplated by this Agreement, including for the Development, Manufacturing and/or Commercialization of the Program Antibodies or Products (or for such entities to determine their interest in performing such activities) in accordance with this Agreement, on the condition that such Affiliates or Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement; |
(v) | disclosure to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, on the condition that such attorneys, independent accountants and financial advisors agree to be bound by the confidentiality and non-use obligations contained in this Agreement; or |
(vi) | disclosure to any bona fide potential or actual investor, insurer, acquirer, merger partner, Sub-Licensee (in the case of Genmab) or other bona fide potential or actual financial partner or funding source (“Financial Partner”) solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, license or collaboration, and to any related persons directly connected with such activity being contemplated with the Financial Partner, such as an advisory firm or investment bank; provided that in connection with such disclosure, the Disclosing Party shall inform each disclosee of the confidential nature of such Confidential Information and disclosure shall be subject to the agreement of each disclosee to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement. |
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13.4.2 | Required Disclosures. If a Party is required by judicial, governmental or administrative process, including to comply with Applicable Laws (including stock exchange rules) or pursuant to Section 13.4.1(iii), to disclose Confidential Information that is subject to the non-disclosure provisions of Section 13.1, such Party shall to the extent reasonably possible provide the other Party with reasonable advance notice of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial, governmental or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 13, and the Party disclosing Confidential Information pursuant to judicial, governmental or administrative process shall take all steps reasonably necessary, including without limitation to seek an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information. |
13.4.3 | Disclosure to the LNP Technology provider. [*****] solely to the extent required under the agreement between the LNP Technology provider and CureVac, and in any case provided that such LNP Technology provider agrees to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement. |
13.4.4 | Disclosure to a sublicensee of CureVac of the rights granted in Section 11.6. [*****]. For avoidance of doubt, CureVac may not disclose any other Confidential Information of Genmab to such sublicensee, including Genmab Know-How relating to such Generally Applicable Patent Rights which is not disclosed in said Patent Rights. |
13.5 | Survival. All of the Receiving Party’s obligations under this Article 13 hereof, with respect to the protection of the Disclosing Party’s Confidential Information, shall for a period of [*****] survive the expiration or termination of this Agreement for any reason whatsoever. |
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13.6 | Public Announcements, Press Releases. The Parties shall issue a press release in the form attached hereto as Exhibit 13.6 at an agreed time promptly after the Effective Date. Thereafter, except as otherwise expressly permitted in this Agreement, and except as may be required by Applicable Law, including the listing standards or agreements of any national or international securities exchange, neither Party shall issue any press release or public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party, not to be unreasonably withheld, conditioned, or delayed; provided, that notwithstanding the foregoing, to the extent reasonably possible on prior notice to CureVac, and in reasonable time for CureVac to consider if the content requires an announcement by CureVac, Genmab may make disclosures relating to the development or commercialization of a Product, including publication of the results of research or development activities, any clinical trial conducted on a Product whether or not conducted by Genmab, Regulatory Filings, Regulatory Approvals or any health or safety matter related to a Product. For all other public disclosures, subject to Section 13.7, if either Party desires to issue a press release or other public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof, the issuing Party will provide the other Party with a copy of the proposed press release or public statement. The issuing Party shall specify with each such proposed press release or public statement, taking into account the urgency of the matter being disclosed, a reasonable period of time within which the Receiving Party may provide any comments on such proposed press release or public statement (but in no event less than [*****], unless reasonably necessary to comply with Applicable Law). If the reviewing Party provides any comments, the Parties will consult on such proposed press release or public statement and work in good faith to prepare a mutually acceptable proposed press release or public statement. For avoidance of doubt, neither Party may make such other public disclosure without the other Party’s prior written consent, unless reasonably necessary to comply with any Applicable Law. Each Party may repeat any information relating to this Agreement that has already been publicly disclosed in accordance with this Section 13.6, provided such information continues as of such time to be accurate. |
13.7 | Publication. With respect to any paper or presentation proposed for disclosure by Genmab that includes Confidential Information of CureVac (excluding any information that falls under the exceptions of Section 13.6), CureVac may review and comment and approve any such proposed paper or presentation, such approval not to be unreasonably withheld, conditioned, or delayed. Genmab shall submit to CureVac the proposed publication or presentation (including posters, slides, abstracts, manuscripts, marketing materials and written descriptions of oral presentations) at least [*****] prior to the date of submission for publication or the date of presentation, whichever is earlier, of any of such submitted materials. CureVac shall review such submitted materials and respond to Genmab as soon as reasonably possible, but in any case, within [*****] ([*****]) after receipt thereof. [*****]. For avoidance of doubt, CureVac shall not make any publication without Genmab’s prior written consent. |
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14. | INDEMNIFICATION AND REPRESENTATIONS AND WARRANTIES. |
14.1 | Indemnification by Genmab. Genmab will defend, indemnify and hold CureVac and its Affiliates and their directors, officers, employees, consultants, agents and contractors (the “CureVac Indemnified Parties”) harmless from and against [*****] resulting or arising from (A) [*****] (B) [*****] or (iii) [*****]; except, in each case, to the extent caused by the negligence or willful misconduct of any of the CureVac Indemnified Parties. CureVac will give Genmab prompt notice of any such claim or lawsuit. Such notice shall include a reasonable identification of the alleged facts giving rise to such claim for indemnification. The failure to deliver written notice to CureVac within a reasonable time after the commencement of any action with respect to a claim shall only relieve CureVac of its indemnification obligations if and to the extent CureVac is actually and materially prejudiced thereby. Without limiting the foregoing indemnity, Genmab will have the right to compromise, settle or defend any such claim or lawsuit (to the extent subject to indemnity by Genmab as set forth herein); provided that (i) no offer of settlement, settlement or compromise by Genmab shall be binding on CureVac without its prior written consent, not to be unreasonably withheld, conditioned or delayed, unless such settlement fully releases CureVac without any liability, loss, cost or obligation incurred by CureVac and in no event shall any settlement or compromise admit or concede that any aspect of any of the CureVac Patent Rights, CureVac Other Invention Patent Rights or the Joint Patent Rights is invalid or unenforceable or adversely affect the scope of any of the CureVac Patent Rights, CureVac Other Invention Patent Rights or the Joint Patent Rights; and (ii) Genmab shall not have authority to admit any wrongdoing or misconduct on the part of CureVac Indemnified Parties, any licensor of LNP Technology or contractors except with CureVac’s prior written consent. |
14.2 | Indemnification by CureVac. CureVac will defend, indemnify and hold Genmab and its Affiliates and their directors, officers, employees, consultants, agents, Sublicensees and contractors (the “Genmab Indemnified Parties”) harmless from and against any and all losses, liabilities, claims, suits, proceedings, expenses, fees, recoveries and damages, including reasonable legal expenses and costs including attorneys’ fees, resulting or arising out of any claim by any Third Party resulting or arising from (i) [*****] or (ii) [*****] or (iii) [*****] except, in each case, to the extent caused by the negligence or willful misconduct of any of the Genmab Indemnified Parties. Genmab will give CureVac prompt notice of any such claim or lawsuit. Such notice shall include a reasonable identification of the alleged facts giving rise to such claim for indemnification. The failure to deliver written notice to CureVac within a reasonable time after the commencement of any action with respect to a claim shall only relieve CureVac of its indemnification obligations if and to the extent CureVac is actually and materially prejudiced thereby. Without limiting the foregoing indemnity, CureVac will have the right to compromise, settle or defend any such claim or lawsuit (to the extent subject to indemnity by CureVac as set forth herein); provided that (A) no offer of settlement, settlement or compromise by CureVac shall be binding on Genmab without its prior written consent, not to be unreasonably withheld, conditioned or delayed, unless such settlement fully releases Genmab without any liability, loss, cost or obligation incurred by Genmab and in no event shall any settlement or compromise admit or concede that any aspect of any of the Genmab Program Patent Rights, Genmab Other Patent Rights or the Joint Patent Rights is invalid or unenforceable or adversely affect the scope of any of the Genmab Program Patent Rights, Genmab Other Patent Rights or the Joint Patent Rights; and (B) CureVac shall not have authority to admit any wrongdoing or misconduct on the part of any Genmab Indemnified Parties except with Genmab’s prior written consent. |
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14.3 | Additional Indemnification Procedures. The indemnifying Party shall notify the indemnified Party of its intentions as to the defense of the claim in writing within [*****] after the indemnifying Party’s receipt of notice of the claim from the indemnified Party. If the indemnifying Party assumes the defense of a claim against an indemnified Party, the indemnifying Party shall have no obligation or liability under this Article 14 as to any claim for which settlement or compromise of such claim or an offer of settlement or compromise of such claim is made by the indemnified Party without the prior written consent of the indemnifying Party. The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the claim (including copying and making documents and records available for review and making persons within its control available for pertinent testimony in accordance with the confidentiality provisions of Article 14) at the indemnifying Party’s reasonable, pre-approved expense. If the indemnifying Party assumes defense of the claim, the indemnified Party may participate in, but not control, the defense of such claim using attorneys of its choice and at its sole cost and expense (i.e., with such cost and expense not being covered by the indemnifying Party). If the indemnifying Party does not agree to assume the defense of the claim asserted against the indemnified Party (or does not give notice that it is assuming such defense), or if the indemnifying Party assumes the defense of the Claim in accordance with this Section 14.3, but yet fails to defend or take other reasonable, timely action, in response to such claim asserted against the indemnified Party, the indemnified Party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such claim; provided, however, that no Party shall have the right to settle a claim in a manner that would adversely affect the rights granted to the other Party hereunder, or would materially conflict with this Agreement, without the prior written consent of the Party entitled to control the defense of such claim, which consent shall not be unreasonably withheld, delayed or conditioned. |
14.4 | CureVac Representations and Warranties. Subject to the disclosures in the attached Exhibit 14.4 (“Disclosure Letter”) CureVac represents and warrants to Genmab as of the Effective Date that: |
(i) | it is the sole and exclusive owner of the Patent Rights listed in Exhibit 1.59; |
(ii) | to CureVac’s knowledge, all inventors have assigned their rights to the Patent Rights listed in Exhibit 1.59 to CureVac, and there have been no inventorship or ownership challenges with respect to these Patent Rights; |
(iii) | CureVac has the full right, power and authority to grant the rights and licenses it purports to grant hereunder, and neither CureVac nor any of its Affiliates has granted any Third Party any rights or licenses that would interfere or be inconsistent with Genmab’s rights and licenses hereunder; |
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(iv) | to CureVac’s knowledge, use of the CureVac Technology by Genmab in accordance with the terms of this Agreement, including Genmab’s further Development, Manufacturing and/or Commercialization of each Product will not infringe on the rights of any Third Party, including any Third Party intellectual property rights; |
(v) | to CureVac’s knowledge, CureVac has received no written notice of or any written demand relating to any threatened or pending litigation which would reasonably lead it to believe that Genmab’s exercise of any rights granted by CureVac under this Agreement in respect of the CureVac Technology will infringe any Patent Rights or misappropriate other intellectual property right of any Third Party; |
(vi) | to CureVac’s knowledge, CureVac has received no currently pending administrative proceedings or litigation or threatened administrative proceedings or litigation seeking to invalidate or otherwise challenge any Curevac Patent Right(s); |
(vii) | CureVac has not given any written notice to any Third Party asserting infringement by such Third Party of any of the CureVac Technology and, to CureVac’s knowledge, there is no unauthorized use, infringement or misappropriation of the CureVac Technology; |
(viii) | CureVac Controls all right, title and interest in and to the CureVac Technology; |
(ix) | The CureVac Technology is free and clear of all encumbrances, security interests, options, and charges of any kind; |
(x) | To CureVac’s knowledge, the CVCMs are not required for the Development, Manufacture or Commercialization of Products under this Agreement; |
(xi) | CureVac has provided to Genmab an accurate, current copy of the BioNTech License and Roche License, respectively, and it will not without Genmab’s prior written consent amend the BioNTech License or Roche License in any way that may have an adverse effect on the licenses granted to Genmab herein; |
(xii) | CureVac has provided to Genmab accurate, current and redacted copies via the data room of (i) the Acuitas License and (ii) the Arcturus License and (iii) License Agreement for [*****] between CureVac AG and GeneArt AG dated [*****] including any amendments thereto; and (iv) Licensed Agreement between CureVac AG and TriLink Biotechnologies LLC, including any amendments thereto; and CureVac will not without Genmab’s prior written consent amend or terminate any of these agreements in any way that may have an adverse effect on the licenses granted to Genmab herein; and |
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(xiii) | to CureVac’s knowledge, CureVac is not in material breach of the Acuitas License or Arcturus License, there is no current dispute under the Acuitas License or Arcturus License and any such agreement is in full force and effect in accordance with its terms. |
14.5 | Genmab Representations and Warranties. Genmab represents and warrants to CureVac that at the time of [*****]. For avoidance of doubt, such representation and warranty shall only apply with respect to the Antibody or Antibody Combination to be included in the Product and shall not apply to any Curevac Technology, Other Technology or LNP Technology. |
14.6 | Representations, Warranties of the Parties to Each Other. CureVac and Genmab each represents and warrants and covenants with respect to itself only as of the Effective Date that: |
(i) | the execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of such Party, its officers and directors, and does not conflict with, violate, or breach any agreement to which such Party is a party, or such Party’s corporate charter, bylaws or similar organizational documents; |
(ii) | this Agreement constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms, except as such enforceability may be limited by general principles of equity or to applicable competition, bankruptcy, insolvency, reorganization, moratorium, liquidation and other similar laws relating to, or affecting generally, the enforcement of applicable creditors’ rights and remedies; |
(iii) | it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated; |
(iv) | it has not, and will not, after the Effective Date and during the Term, grant any right to any Third Party that would conflict with the rights granted to the other Party hereunder (but only while such rights remain in effect in accordance with the terms of this Agreement); and |
(v) | it has not, and will not, after the Effective Date and during the Term, knowingly use any employee, agent, contractor or consultant in connection with the Development or Commercialization of Products who has been debarred by any governmental authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a governmental authority. |
14.7 | Compliance with Law. Each Party shall comply with all Applicable Laws in its performance of activities contemplated under this Agreement. |
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14.8 | Diligence of Genmab. [*****]. CureVac acknowledges and agrees that it has provided all information relating to CureVac Technology that CureVac reasonable believes is necessary for Genmab to conduct and complete a proper due diligence relating to the Collaboration Targets and Products, and that it has answered truthfully to all questions of Genmab relating to the due diligence of the CureVac Technology. |
14.9 | Disclaimer THE REPRESENTATIONS AND WARRANTIES OF THE PARTIES SET FORTH IN THIS AGREEMENT ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES OF THE PARTIES RELATING TO OR MADE IN CONNECTION WITH THIS AGREEMENT, AND NEITHER PARTY MAKES OR HAS MADE ANY REPRESENTATIONS OR WARRANTIES NOT EXPRESSLY SET FORTH IN THIS AGREEMENT. CUREVAC AND GENMAB ARE NOT RELYING ON, AND EACH HEREBY DISCLAIMS, ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY CONTAINED HEREIN (WHETHER EXPRESS OR IMPLIED), INCLUDING WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS, OR THE NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS. |
14.10 | Limitation of Liability. IN NO EVENT SHALL EITHER CUREVAC OR GENMAB BE LIABLE FOR REMOTE, SPECULATIVE, PUNITIVE OR EXEMPLARY, OR OTHER SPECIAL DAMAGES, INCLUDING LOST PROFITS, ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY (OTHER THAN (A) PUNITIVE OR EXEMPLARY DAMAGES REQUIRED TO BE PAID TO (I) A THIRD PARTY PURSUANT TO A NON-APPEALABLE ORDER OF A COURT OF COMPETENT JURISDICTION IN CONNECTION WITH A THIRD PARTY CLAIM FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER OR (II) A PARTY PURSUANT TO A NON-APPEALABLE ORDER OF A COURT OF COMPETENT JURISDICTION IN CONNECTION WITH A VIOLATION OF PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS, (B) SUCH DAMAGES ARISING OUT OF ANY BREACH OF ARTICLE 13 OR (C) SUCH DAMAGES ARISING OUT OF THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF THE LIABLE PARTY). Notwithstanding the foregoing, it is expressly understood and agreed that nothing contained in this Section 14.10 shall limit, alter, or waive in any manner or respect any defenses available to any Person, any burdens of proof or legal standards required to be met by any Person under Applicable Laws or any indemnification rights or obligations of either Party. |
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15. | TERM AND TERMINATION. |
15.1 | Term. The term of this Agreement will commence on the Effective Date and end on the expiration of all applicable royalty payment obligations to CureVac under this Agreement, unless terminated earlier according to the terms and conditions of this Agreement (“Term”). Upon expiry of this Agreement in a country and provided and to the extent that this Agreement is not terminated after such expiry by CureVac in accordance with Sections 15.4 and 15.5, Genmab’s licenses under Article 2 for such country shall become a fully paid-up, perpetual, and non-exclusive license. |
15.2 | Termination by CureVac. CureVac is entitled to terminate this Agreement in its entirety, if Genmab has not made a Product Selection in relation to the First Collaboration Program within [*****] after the Effective Date or has not exercised an Option within the Option Period. |
15.3 | Termination at Will by Genmab. Genmab may terminate this Agreement in its entirety or on a Program-by-Program (excluding any Opt-In Program), at any time without cause upon (i) [*****] prior written notice to CureVac before the end of the last to expire Research Period (to be determined on a Program-by-Program basis or (ii) upon [*****] prior written notice to CureVac after the end of the last to expire Research Period (to be determined on a Program-by-Program basis). In the event Genmab decides to cease permanently the further research and Development under the First Collaboration Program, or under any Other Pre-IND Program, including the Development of a Product resulting from any such Program, it shall promptly inform the JRC or Collaboration Committee, as applicable, hereof for discussion with the JRC/Collaboration Committee, and unless otherwise agreed within the JRC/Collaboration Committee, Genmab shall terminate this Agreement with respect to the First Collaboration Target and First Program Antibody, or the Optioned Target and respective Other Program Antibody, as applicable. For the termination of an Opt-In Program the terms and conditions of Sections 7.8 and 7.9 shall apply. During such termination periods, as applicable, the Parties shall cooperate in the wind down of activities under this Agreement or under the Program being terminated in a commercially reasonable manner. |
15.4 | Termination for Cause by Either Party. In the event that either Party (“Breaching Party”) commits a material breach or default of any of its obligations hereunder of a general nature under this Agreement or in relation to any specific Program (“Program Breach”) the other Party hereto (“Non-Breaching Party”) may give the Breaching Party written notice of such material breach or default, and shall request that such material breach or default be cured as soon as reasonably practicable. In the event that the Breaching Party fails to cure such breach or default within [*****] after the date of the Non-Breaching Party’s written notice thereof (in the event of default of payment within [*****] after the date of the Non- Breaching Party’s notice), the Non-Breaching Party may (i) terminate this Agreement in the event of a material breach of general nature; or (ii) terminate the Program in the case of a Program Breach, by giving written notice of termination to the Breaching Party. In the event the Breaching Party indicates in writing that it will be unable or is unwilling to cure the breach, this Agreement or the Program, as applicable, may be terminated by the Non-Breaching Party with immediate effect. If following the Commercialization of a Product the breach relates to one country only or a group of countries of the Territory the Non-Breaching Party shall only have the right to terminate this Agreement in relation to such country or countries. If the Breaching Party in good faith disputes such material breach or disputes the failure to cure or remedy such material breach and provides written notice of that dispute to the Non-Breaching Party within the [*****] period, then the matter will be addressed under the dispute resolution provisions in Section 17.5, and the Non-Breaching Party may not terminate this Agreement, or the Program as applicable, until it has been determined under such dispute resolution procedure that the Non-Breaching Party is in material breach of this Agreement or has committed a Program Breach, as the case may be. Termination of this Agreement in accordance with this Section 15.4 shall not affect or impair the Non-Breaching Party’s right to pursue any legal remedy, including the right to recover damages, for any harm suffered or incurred by the Non-Breaching Party as a result of such breach or default. |
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15.5 | [*****]. |
15.6 | Termination Generally. The termination of the Agreement in whole or in part under this Section 15 shall not create any obligations to undo or refund (in Dutch “ongedaanmakingsverbintenissen”) services rendered and payments made in accordance with the Agreement prior to the effective date of the termination. |
16. | CONSEQUENCES OF TERMINATION. |
16.1 | Termination Due to CureVac’s Breach. If Genmab terminates this Agreement or a Program under Section 15.3, the rights and obligations of the Parties hereunder shall terminate (either in their entirety or in relation to the particular Program) as of the effective date of such termination and there shall be the following consequences (to be interpreted on a Program basis in the event of termination of a Program) |
(i) | no later than [*****] after the effective date of such termination, each Party shall return or cause to be returned to the other Party or, at the other Party’s option, destroy (and certify in writing the destruction of) all Confidential Information in tangible form received from the other Party and all copies in any medium thereof; provided, however, that each Party may retain any Confidential Information reasonably necessary for such Party’s continued practice under any license(s) which do not terminate pursuant to this Section 16.1, and may retain the Confidential Information solely for the purpose of ensuring its compliance with this Agreement and Applicable Law by electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information so long as such electronic files are (A) maintained only on centralized storage servers (and not on personal computers or devices), (B) not accessible by any of its personnel (other than its information technology specialists), and (C) are not otherwise accessed subsequently except with the written consent of the other Party or as required by law. Such retained copies of documents and Confidential Information shall remain subject to the confidentiality and non-use obligations set forth in this Agreement; |
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(ii) | Subject to Section 16.1(iii) below CureVac shall, within [*****] after the effective date of such termination return or cause to be returned to Genmab all substances or compositions delivered or provided by Genmab, as well as any other Genmab Material provided by Genmab in any medium; |
(iii) | each Party shall pay all amounts then due and owing as of the termination effective date; |
(iv) | CureVac shall provide access to Genmab, to the extent not previously provided, to the CureVac Know-How (other than the Know-How included in the CureVac Manufacturing Technology) in its possession or under its Control relating to the Collaboration Targets and Products; |
(v) | Unless otherwise explicitly agreed in the Early Clinical Supply Agreement or any MSA, termination shall not affect the operation of the Early Clinical Supply Agreement or any MSA; |
(vi) | effective only in the event of such termination, CureVac hereby grants to Genmab an exclusive (even as to CureVac) and sublicensable license in the Field and in the Territory under the CureVac Technology to Develop, Manufacture and Commercialize any Products identified prior to termination, provided, however, that any payment obligations under Article 10 shall survive the termination of the Agreement in consideration for the exclusive license of Genmab under this Section 16.1(vi); and |
(vii) | except as set forth in this Section 16.1 and for the surviving provisions set forth in Section 16.3 below, the rights and obligations of the Parties hereunder shall terminate. |
For the avoidance of doubt, the rights and obligations of Genmab and CureVac under this Section 16.1 in the event of a termination due to CureVac’s breach shall not exceed or be in any way broader than the rights and obligation of Genmab and CureVac under the Agreement.
16.2 | Termination Due to Genmab’s Breach under 15.4, [*****], CureVac’s termination under Section 15.2 or Genmab’s termination under Section 15.3. If CureVac terminates this Agreement as a whole or with respect to a specific Program under Sections 15.2, 15.4 or 15.5, or if Genmab terminates this Agreement as a whole or with respect to a specific Program under Section 15.3, the rights and obligations of the Parties hereunder with respect to the specific Program or all Programs, as the case may be, shall terminate as of the effective date of such termination and: |
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(i) | Genmab’s licenses under Article 2 of this Agreement and any sub-licenses under Article 4 shall automatically lapse and all of CureVac’s rights to the CureVac Technology automatically revert back to CureVac; |
(ii) | no later than [*****] after the effective date of such termination, each Party shall return or cause to be returned to the other Party or, at the other Party’s option, destroy (and certify in writing the destruction of), all Confidential Information of the Disclosing Party in tangible form received from the other Party and all copies in any medium thereof; provided, however, that each Party may retain any Confidential Information reasonably necessary for such Party’s continued practice under any license(s) which do not terminate pursuant to this Article 16, and may retain the Confidential Information solely for the purpose of ensuring its compliance with this Agreement and Applicable Law by electronic files created in the ordinary course of business during automatic system back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information so long as such electronic files are (A) maintained only on centralized storage servers (and not on personal computers or devices), (B) not accessible by any of its personnel (other than its information technology specialists), and (C) are not otherwise accessed subsequently except with the written consent of the other Party or as required by law. Such retained copies of documents and Confidential Information shall remain subject to the confidentiality and non-use obligations set forth in this Agreement; |
(iii) | each Party shall pay all amounts then due and owing as of the termination effective date; |
(iv) | at the request of CureVac, Genmab grants to CureVac a non-exclusive, royalty-free, perpetual and worldwide license [*****] under the Genmab Program Patent Rights required to Develop, Manufacture and/or Commercialize products containing one or more mRNA construct(s) that is/are designed to express an Antibody or Antibody Combination, as applicable, directed at the respective Collaboration Target(s) or Collaboration Target Combination(s) covered by the termination. For clarity, such unblocking license to Genmab Program Patent Rights shall only comprise rights to target class-related or target-related Genmab Inventions, including the examples of Inventions set out in Exhibit 11.3, Sections 2(b), 2(c), 2(d), 2(e), 2(f), 2(g) (solely to the extent referring to Sections 2(b), 2(c), 2(d), 2(e) or 2(f)), 2(h) (solely to the extent referring to Sections 2(b), 2(c), 2(d), 2(e) or 2(f) via Section 2(g)), 2(q), 2(r), 2(u) and 2(v), and shall not include a license to any specific Antibody sequence(s), Program Antibody(-ies), Program Antibody Combination(s) or Products nor any rights in Genmab Background Technology; and |
(v) | at the request of CureVac, Genmab will enter into good faith discussions with CureVac regarding the possibility of [*****]. For avoidance of doubt, neither Party shall have any obligation to enter into any agreement regarding [*****] comprised by the termination. |
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16.3 | Effect of Expiration or Termination; Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination. The provisions of Articles 1, (to the extent required to give effect to other surviving provisions), 11, 12, 13 and 16 and Sections 2.5, 2.7, 5.8, 14.1, 14.2, 14.3, 14.9, 14.10, 17.3, 17.4, 17.5, 17.7, 17.8, 17.11, 17.12, 17.13, 17.14 and all other provisions contained in this Agreement that by their explicit terms or from which it is clear from the context survive expiration or termination of this Agreement, and any schedules contained in this Agreement to which reference is made in any surviving term, shall survive the expiration or termination of this Agreement. In the event of a termination of this Agreement with respect to only one of the Programs, and continuation of other Programs under this Agreement, the termination and consequences of termination provisions only apply to the terminated Program, and the Agreement will remain in full force and effect with respect to the continuing Programs. |
17. | GENERAL PROVISIONS. |
17.1 | Assignment. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent will not be unreasonably withheld, conditioned or delayed; provided, however, each of the Parties may, without such consent, but with notification, assign this Agreement and its rights and obligations hereunder to any of its Affiliates or in connection with the transfer or sale of all or substantially all of the portion of its business to which this Agreement relates or in the event of its merger or consolidation with a Third Party. Further, Genmab may, without such consent but with notification, assign its rights and obligations on a Program-by-Program basis to an Affiliate [*****]. Any permitted assignee will assume all obligations of its assignor under this Agreement in writing concurrent with the assignment. Any purported assignment in violation of this Section 17.1 will be void. Except as otherwise provided herein, this Agreement shall be binding upon and inure to the benefit of the Parties and their successors and permitted assignors under this Section 17.1. |
17.2 | Force Majeure. If the performance of any part of this Agreement by either Party, or any obligation under this Agreement, is prevented, restricted, interfered with or delayed by reason of any cause beyond the reasonable control of the Party liable to perform, unless conclusive evidence to the contrary is provided, the Party so affected shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party shall use its Commercially Reasonable Efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise and persist for a period of at least [*****], the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution. |
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17.3 | Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by e-mail, sent by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows: |
(i) | if to CureVac, addressed to: |
CureVac AG | |||
Attention: | Chief Executive Officer | ||
with copy to: General Counsel | |||
Address: | Paul-Ehrlich-Str. 15 | ||
72076 Tübingen, Germany | |||
Email: | [*****] |
(ii) | if to Genmab, addressed to: |
Genmab A/S | ||
Attention: [*****] | ||
Email: [*****] | ||
or | ||
[*****] | ||
or | ||
[*****] |
or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by e-mail on a Business Day (or if delivered or sent on a non-business day, then on the next Business Day); (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the [*****] Business Day following the date of mailing, if sent by mail.
17.4 | Governing Law. This Agreement and all disputes arising hereunder, shall be exclusively governed by, and interpreted and enforced in accordance with the laws of the Netherlands, without reference to its conflict of laws principles. The United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention) does not apply to this Agreement. |
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17.5 | Dispute Resolution. |
17.5.1 | Unless otherwise set forth in this Agreement, in the event of any dispute arising out of or in connection with this Agreement, including any alleged breach under this Agreement or any dispute relating to the validity, performance, construction or interpretation of this Agreement, the Parties shall refer such dispute to the CEO (or its C-level delegate) of CureVac and the CEO (or its C-level delegate) of Genmab. If the dispute has not been settled pursuant to the said rules within [*****] following the reference of the dispute to the senior management representatives of the Parties, either Party may submit the dispute to final and binding arbitration. |
17.5.2 | Any dispute arising out of or in connection with this Agreement, including any issue relating to the validity, performance, construction or interpretation of this Agreement, which cannot be resolved amicably between the Parties after following the procedure set forth in Section 17.5.1, shall be submitted to and settled by arbitration in accordance with the NAI Arbitration Rules of the Netherlands Arbitration Institute (the “NAI”) in effect on the date of the commencement of the arbitration proceedings. The existence, nature and details of any such dispute(s), and all communications between the Parties related thereto, shall be considered Confidential Information of the Parties and shall be treated in accordance with the terms of Article 12 above. Any Confidential Information may be disclosed by either Party to counsel, experts or other advisors on the arbitration under obligations of confidentiality. The decision of the arbitrators shall be final and binding upon the Parties. The location of arbitration will be Amsterdam, the Netherlands. The arbitration will be heard and determined by [*****] arbitrator, who will be jointly selected by Genmab and CureVac. If, within [*****] following the date upon which a claim is received by the respondent, the Parties cannot agree on a mutually appointed arbitrator, the arbitration will be heard and determined by [*****] arbitrators, with [*****] arbitrator being appointed by each Party and the [*****] arbitrator being appointed by the NAI directly (without application of the list procedure of article 14 NAI Arbitration Rules). The language of the arbitration proceeding will be English. Notwithstanding the provisions of this Section 17.5.2, each Party shall have the right to seek interim injunctive relief in any court of competent jurisdiction as such Party deems necessary to preserve its rights and to protect its interests. |
17.6 | Severability. If any provision of this Agreement is determined by any court or administrative tribunal of competent jurisdiction to be invalid or unenforceable, the Parties shall negotiate in good faith a replacement provision that is commercially equivalent, to the maximum extent permitted by Applicable Law, to such invalid or unenforceable provision. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of the other provisions of this Agreement. Nor shall the invalidity or unenforceability of any provision of this Agreement in one country or jurisdiction affect the validity or enforceability of such provision in any other country or jurisdiction in which such provision would otherwise be valid or enforceable. |
17.7 | Entire Agreement and Amendments. This Agreement, together with all Exhibits attached hereto, constitutes the entire agreement between the Parties regarding the subject matter hereof (including the Products), and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof (including the Products), including the Confidentiality Agreements and Material Transfer Agreement. The foregoing may not be interpreted as a waiver of any remedies available to either Party as a result of any breach prior to the Effective Date, by the other Party of its obligations under the Confidentiality Agreements or Material Transfer Agreement. No modification or amendment of this Agreement shall be binding upon the Parties unless in writing and executed by the duly authorized representative of each of the Parties; this shall also apply to any change of this Section 17.7. |
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17.8 | Waivers. The failure by either Party hereto to assert any of its rights hereunder, including the right to terminate this Agreement due to a breach or default by the other Party hereto, shall not be deemed to constitute a waiver by that Party of its right thereafter to enforce each and every provision of this Agreement in accordance with its terms. |
17.9 | Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. |
17.10 | Independent Contractors. The Parties are independent contractors and this Agreement shall not constitute or give rise to an employer-employee, agency, partnership or joint venture relationship among the Parties and each Party’s performance hereunder is that of a separate, independent entity. |
17.11 | Language. This Agreement, and any amendments or modifications thereto, shall be executed in the English language. No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto. |
17.12 | Headings. The headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement. |
17.13 | Third Parties. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party which shall be a Third Party beneficiary to this Agreement. |
17.14 | Costs. Except as is otherwise expressly set forth herein, each Party shall bear its own expenses in connection with the activities contemplated and performed hereunder. |
— Signature page follows —
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In Witness Whereof, the Parties have executed this Agreement to be effective as of the Effective Date.
Signed on behalf of | |
Genmab B.V. | |
/s/ Jan van de Winkel | |
Signature of Authorized Officer | Jan van de Winkel |
Name of Authoirzed Officer (please print) | Prsident & CEO |
Date Signed | 19 December 2019 |
Signed on behalf of | |
Genmab B.V. | |
/s/ David Eatwell | |
Signature of Authorized Officer | David Eatwell |
Name of Authorized Officer (please print) | Executive Vice President & CFO |
Date Signed | 19 December 2019 |
Signed on behalf of | |
CureVac AG | |
Signature of Authorized Officer | |
Name of Authorized Officer (please print) | |
Date Signed | |
/s/ Franz-Werner Haas | |
Signed on behalf of | Franz-Werner Haas |
CureVac AG | Chief Operating Officer |
Signature of Authoriized Officer | |
Name of Authoirzed Officer (please print) | |
Date Signed | |
/s/ Daniel Menichella | |
CEO, CureVac AG | Daniel Menichella |
CEO, CureVac AG |
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Exhibit
1.13
Patent Rights licensed to BioNTech
[*****]
99
Exhibit
1.54
CureVac Know How
[*****]
100
Exhibit
1.59
CureVac Patent Rights
[*****]
101
Exhibit
1.77
First Program Antibody
[*****]
102
Exhibit
1.90
Genmab Know-How
[*****]
103
Exhibit
1.111
LNP Technology
[*****]
104
Exhibit
1.144
Other Technologies
[*****]
105
Exhibit
3.2.2
Templates for clearance of proposed Research Program Antibody
and Research Program Antibody Combination
The Research Program Antibody and Research Program Antibody Combination shall be described by providing available information in the following table:
[*****] | [*****] | [*****] | [*****] | [*****] | [*****] |
The Research Program Antibody and Research Program Antibody Combination shall be described by providing the following information for each Antibody:
[*****] |
106
Exhibit
5.1.1
FIRST PROGRAM RESEARCH PLAN
[*****]
107
Exhibit 5.11
Approved Subcontractors
[*****]
108
Exhibit 6.2
Early Clinical Supply – Key Terms
[*****]
109
Exhibit 10.6.2
Example of royalty calculations for Single Antibody Products
[*****]
110
Exhibit 11.3
List of non-limiting examples of ownership of different types of potential Inventions
[*****]
111
Exhibit 13.6
Press Release
Company Announcement
· | Genmab and CureVac enter broad strategic partnership |
· | Companies to conduct joint research on first program; option for Genmab to initiate three additional programs during 5-year research term |
· | Genmab will provide CureVac with a USD 10 million upfront payment and make an equity investment in CureVac of 20 million euro |
· | CureVac eligible to receive milestones between USD 275 million and USD 368 million for each of the potential product candidates, depending on specific product concept |
Copenhagen, Denmark and Tübingen, Germany, xx, xxx, 2019 – Genmab A/S (Nasdaq: GMAB) and CureVac, AG announced today that Genmab and CureVac have entered into a research collaboration and license agreement. This strategic partnership will focus on the research and development of differentiated mRNA-based antibody products by combining CureVac’s mRNA technology and know-how with Genmab’s proprietary antibody technologies and expertise.
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“As part of Genmab’s effort to fundamentally transform cancer treatment we have once again entered into a collaboration that will further provide us with the potential to lead innovation in the antibody space,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “CureVac’s unique mRNA technology, which uses the body’s own ability to produce specific proteins from nucleic acid, combined with Genmab’s world-class antibody expertise and robust proprietary technology platforms could create multiple novel options for the treatment of patients with cancer.”
“We are delighted to partner with Genmab. Through our agreement focused on mRNA encoding antibodies, we will continue to demonstrate the robustness of our mRNA technology,” said Daniel L. Menichella, Chief Executive Officer of CureVac. “We believe that the collaboration with Genmab represents the first antibody deal in the field of mRNA. It is our hope that the collaboration will be successful for patients, the two companies and their shareholders.”
Under the terms of the agreement Genmab will provide CureVac with a USD 10 million upfront payment. Genmab will also make a 20 million euro equity investment in CureVac. The companies will collaborate on research to identify an initial product candidate and CureVac will contribute a portion of the overall costs for the development of this product candidate, up to the time of an Investigational New Drug Application. Genmab would thereafter be fully responsible for the development and commercialization of the potential product, in exchange for undisclosed milestones and tiered royalties to CureVac. The agreement also includes three additional options for Genmab to obtain commercial licenses to CureVac’s mRNA technology at pre-defined terms, exercisable within a five-year period. If Genmab exercises any of these options, it would fund all research and would develop and commercialize any resulting product candidates with CureVac eligible to receive between USD 275 million and USD 368 million in development, regulatory and commercial milestone payments for each product, dependent on the specific product concept. In addition, CureVac is eligible to receive tiered royalties in the range from mid-single digits up to low double digits per product. CureVac would retain an option to participate in development and/or commercialization of one of the potential additional programs under pre-defined terms and conditions.
Today’s news does not impact Genmab’s 2019 Financial Guidance.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.
About CureVac AG
CureVac is a leading clinical stage company in the field of messenger RNA (mRNA) technology with more than 19 years’ expertise in developing and optimizing this versatile molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. The company applies its technologies for the development of cancer therapies, antibody therapies, the treatment of rare diseases, and prophylactic vaccines. CureVac has received significant investments, amongst others from dievini Hopp BioTech holding and the Bill & Melinda Gates Foundation. CureVac has also entered into collaborations with multinational corporations and organizations, including Boehringer Ingelheim, Eli Lilly & Co, CRISPR Therapeutics, the Bill & Melinda Gates Foundation, and others.
For more information, please visit www.curevac.com or follow us on Twitter at @CureVacAG.
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Forward Looking Statement for Genmab
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.
Genmab Contacts:
Marisol Peron, Corporate Vice President,
Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations:
Andrew Carlsen, Senior Director, Investor
Relations
T: +45 3377 9558; E: acn@genmab.com
CureVac Contact:
Thorsten Schüller, Director Communication
T: +49 7071 9883 -1577; E: Thorsten.Schueller@curevac.com
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Exhibit 14.4
Disclosure Letter
[*****]
115
Exhibit 10.2
EXECUTION COPY
CONFIDENTIAL
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (“Agreement”), effective as of November 9, 2017 (the “Effective Date”), is made by and between CureVac AG, a German stock corporation organized under the laws of Germany, having its principal place of business at Paul-Ehrlich-Strasse 15, 72076 Tuebingen, Germany (“CureVac”), and CRISPR Therapeutics AG, a Swiss corporation organized under the laws of Switzerland (“CRISPR”), having its principal place of business at Baarerstrasse 14, 6300 Zug, Switzerland. CureVac and CRISPR are each sometimes referred to herein as a “Party” and collectively as the “Parties.”
RECITALS
A. WHEREAS, CRISPR has an interest in developing and accessing Cas9 mRNA Constructs (as defined below) for use in gene editing therapeutics.
B. WHEREAS, CureVac has a proprietary mRNA technology platform, and an interest in developing Cas9 mRNA Constructs for CRISPR for gene editing applications;
C. WHEREAS, the Parties intend to collaborate with the goals of identifying and optimizing Cas9 mRNA Constructs for certain Programs (as defined below); and
D WHEREAS, CRISPR and CureVac will enter into a supply agreement, under which CureVac will supply CRISPR such optimized Cas9 mRNA Constructs for use in gene editing applications in certain Programs.
NOW, THEREFORE, the Parties hereby agree as follows:
Article 1
DEFINITIONS
1.1 “Affiliate” means any Person that directly or indirectly is controlled by, controls or is under common control with another Person. For the purposes of this definition, the term “control” (including with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast 50% or more of the votes in the election of directors, (b) in the case of a non-corporate entity, direct or indirect ownership of 50% or more of the equity interests with the power to direct the management and policies of such entity, or (c) any other arrangement whereby a Person controls or has the right to control the board of directors or equivalent governing body or management of a corporation or other entity. For the avoidance of doubt, on the Effective Date Casebia Therapeutics LLP (“Casebia”) is an Affiliate of CRISPR for all purposes under this Agreement. Regarding CureVac, Affiliate shall not include Mr. Dietmar Hopp and dievini Hopp BioTech holding GmbH & Co. KG and/or any other entity controlled by Mr. Hopp and/or dievini Hopp BioTech holding GmbH & Co. KG. Any such Person shall only be an Affiliate for purposes of this Agreement when and as long as it meets the requirements of this Section 1.1.
1.2 “Applicable Law” means any federal, state, local or foreign law (including, common law), statute or ordinance, or any rule, regulation, judgment, order, writ or decree of or from any court, Regulatory Authority or other governmental authority having jurisdiction over or related to the subject item that may be in effect from time to time.
1.3 “Background Intellectual Property” shall mean, as applicable, CRISPR Background Intellectual Property or CureVac Background Intellectual Property.
1.4 “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31; provided, however, that (a) the first Calendar Quarter of any particular period shall extend from the commencement of such period to the end of the first complete Calendar Quarter thereafter, and (b) the last Calendar Quarter shall end upon the expiration or termination of this Agreement.
1.5 “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.6 “Cas9 mRNA Construct” [*****].
1.7 “Combination Product” shall have the meaning set forth in Section 1.60 below.
1.8 “Commercial Supply Agreement” means an agreement for the supply of Cas9 mRNA Constructs for use by CRISPR, its Affiliates and Sublicensees in Pivotal Clinical Trials and Commercialization.
1.9 "Commercially Reasonable Efforts" shall mean, with respect to the efforts to be expended by a Party with respect to any objective, the reasonable, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances. It is understood and agreed that with respect to the Development and Commercialization of Licensed Products by CRISPR, such efforts shall be substantially equivalent to those efforts and resources commonly used by similarly situated biotechnology companies with resources similar to CRISPR in the European Union and the United States for products owned by them or to which they have rights, which products are at a similar stage in its Development or product life and are of similar market potential taking into account all scientific, commercial and other factors that such pharmaceutical company would take into account, including efficacy, safety, approved labelling, the competitiveness of alternative products in the marketplace, the expected and actual market exclusivity of the Licensed Products, and the likelihood of receipt of a Regulatory Approval given the Regulatory Authority involved.
1.10 “Commercialization” shall mean any and all activities directed to the preparation for sale of, offering for sale of, or sale of Licensed Products, including activities related to marketing, promoting, labelling, packaging, distributing, importing and exporting such Licensed Products, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to “Commercialize” and “Commercializing” shall mean to engage in Commercialization, and “Commercialized” has a correlative meaning.
1.11 “Competitive Infringement” shall have the meaning set forth in Section 8.4(b).
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1.12 “Confidential Information” means subject to the exceptions in Section 6.2, the information of any nature and in any form that a Party may learn of (including, but not limited to, all documents and/or all data, nucleic acid and protein sequences, chemical structures, software and/or hardware samples, models, methods, descriptions, Know-How, processes, applications and/or knowledge, whether patentable or not), in the performance of the Agreement, and in particular any confidential information relating to the Licensed Intellectual Property, Licensed Products, names of business partners, business strategy, developing strategy, data regarding Licensed Products, their prices and markets, that a Party may receive in the performance of this Agreement. The Know-How within the Licensed Intellectual Property for use in the Field and the terms and conditions of this Agreement are Confidential Information of both Parties.
1.13 “Controlled” or “Controls” means, when used in reference to a subject item or a right, the legal authority or right of a Party (or any of its Affiliates) (whether by ownership or license, other than pursuant to this Agreement) to grant the right to use such item or right to the other Party, or to otherwise disclose proprietary or trade secret information to such other Party, without violating the terms of any agreement or other arrangement by which such Party is bound.
1.14 “Cover” means, with respect to a particular subject matter at issue and the relevant Patent Rights and Know-How, that, but for a license granted to a Party under a claim included in such Patent Rights or under the Know-How, or such Party’s ownership or Control of such Patent Rights or Know-How, the manufacture, use, sale, offer or sale or importation by such Party of the subject matter at issue would infringe such claim or exploit or otherwise use such Know-How or, in the case of a Patent Right that is a patent application, would infringe a claim in such patent application if it were to issue as a patent in a particular country or countries.
1.15 “CRISPR Background Intellectual Property” means CRISPR Background Know-How and CRISPR Background Patent Rights and that is not Foreground Intellectual Property. The CRISPR Background Intellectual Property as of the Effective Date is identified in Attachment A hereto.
1.16 “CRISPR Background Know-How” means any Know-How Controlled by CRISPR as of the Effective Date or thereafter during the Term that is reasonably necessary or useful for the Parties to conduct activities under the Development Program and/or to Develop, Manufacture and Commercialize Licensed Products in accordance with this Agreement.
1.17 “CRISPR Background Patent Rights” means any Patent Rights Controlled by CRISPR as of the Effective Date or thereafter during the Term that are reasonably necessary or useful for the Parties to conduct the activities under the Development Program and/or to Develop, Manufacture and Commercialize Licensed Products in accordance with this Agreement.
1.18 “CRISPR Improvement” means any improvement, change, modification, variation, revision, update or enhancement to the CRISPR Background Intellectual Property.
1.19 “CRISPR System” means a system comprising one or more of the following:
(a) [*****]
(b) [*****] and
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(c) [*****]
1.20 “CureVac Background Intellectual Property” means the CureVac Background Patent Rights and CureVac Background Know-How, and that is not Foreground Intellectual Property. The CureVac Background Intellectual Property is identified in Attachment B hereto. For clarity, CureVac Background Intellectual Property does not include Patent Rights and Know-How in-licensed by CureVac from Acuitas Therapeutics, Inc. and from PharmaJet, Inc.
1.21 “CureVac Background Know-How” means all Know-How Controlled by CureVac or its Affiliates as of the Effective Date or thereafter during the Term that is reasonably necessary or useful for Parties to conduct the activities under the Development Program and/or to Develop, Manufacture and Commercialize Licensed Products.
1.22 “CureVac Background Patent Rights” means all Patent Rights Controlled by CureVac or its Affiliates as of the Effective Date or thereafter during the Term that are reasonably necessary or useful for the Parties to conduct the activities under the Development Program and/or to Develop, Manufacture and Commercialize Licensed Products.
1.23 “CureVac Competitor” means a pharmaceutical and/or biotechnological company that has a primary focus of its business in the development, manufacture (for its own account) or commercialization of therapeutic products or services (for its own account) in the field of pDNA and/or mRNA provided that the Parties acknowledge and agree that the term “CureVac Competitor” does not include contract manufacturing organizations, contract research organizations, or entities that do work on a fee-for-services basis as contract manufacturers for others. For clarity, Boehringer Ingelheim’s contract manufacturing organization would not be deemed a “CureVac Competitor,” even if a Boehringer Ingelheim affiliate (including a parent entity) is developing or commercializing therapeutic products in the field of pNDA and/or mRNA).
1.24 “CureVac Improvement” means any improvement, change, modification, variation, revision, update or enhancement to the CureVac Background Intellectual Property.
1.25 “Development” shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the Licensed Products for use in the Field, including those reasonably necessary or useful or required by a Regulatory Authority in support of obtaining Regulatory Approvals. “Development” shall include generation, validation and optimization, formulation development, delivery system development, non-clinical testing, mechanism studies, toxicology, pharmacokinetics, clinical studies, regulatory affairs activities, statistical analysis and report writing, submission of documents, market research, pharmacoeconomic studies, and epidemiological/real world data studies. “Develop” and "Developed" have a correlative meaning.
1.26 “Development Program” means the research and development program regarding the identification, optimization and selection of Cas9 mRNA Constructs funded as agreed in this Agreement and to be conducted in accordance with the Work Plan and this Agreement. For clarity, all activities conducted under the Development Program shall be distinct from the Development of the Licensed Products and shall not extend to any activities which shall be conducted under the Manufacturing Services Agreement.
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1.27 “Development Term” means the period set forth in the Work Plan to perform all of the activities of the Work Plan.
1.28 “Dual Improvement Intellectual Property” shall have the meaning set forth in Section 7.1(d)(iii)(C).
1.29 “EMA” means European Medicines Agency and any successor agency or authority thereto.
1.30 “Executive Officer” means (a) in the case of CureVac, the Chief Corporate Officer, and (b) in the case of CRISPR, the Chief Business Officer, neither of which may be a member of the JSC. Each Party may change its Executive Officer from time to time by providing written notice to the other Party in accordance with the terms of this Agreement.
1.31 “FDA” means the United States Food and Drug Administration or its successor.
1.32 “Field” means all human therapeutic applications in the Programs that make use of a CRISPR System.
1.33 “First Commercial Sale” means on a Licensed Product-by-Licensed Product and country-by-country basis, the first arm’s-length transaction, transfer or disposition for value by or on behalf of CRISPR or any Affiliate or Sublicensee of CRISPR to a Third Party of such Licensed Product for end use or consumption of such Licensed Product. First Commercial Sale excludes (a) the distribution of reasonable quantities of promotional samples of Licensed Products, or (b) the transfer of Licensed Product to a Third Party to use Licensed Product for the sole purpose of performing preclinical or clinical studies or (c) the transfer of Licensed Product to a Third Party solely for charitable or compassionate use purposes on a named patient basis if the Selling Party transfers Licensed Product at cost of goods or below.
1.34 “First Exercise Period” has the meaning set forth in Section 7.4.
1.35 “Foreground Intellectual Property” means the Foreground Patent Rights and the Foreground Know-How.
1.36 “Foreground Know-How” means the Know-How first conceived, discovered, developed, reduced to practice or generated by either Party or jointly by the Parties under this Agreement.
1.37 “Foreground Patent Rights” means all Patent Rights that arise from the Foreground Know-How.
1.38 “FTE” means one employee working full-time for one year, or more than one person working the equivalent of a full-time person, working directly on performing activities under the Development Program, as applicable, where “full-time” is considered [*****] hours for one Calendar Year. No additional payment will be made with respect to any individual who works more than [*****] hours per Calendar Year and any individual who devotes less than [*****] hours per Calendar Year will be treated as an FTE on a pro rata basis based upon the actuâ] number of hours worked divided by [*****].
5
1.39 “FTE Costs” means the product of (a) the number of FTEs (proportionately, on a per-FTE basis) used by CureVac or its Affiliates in directly performing activities assigned to CureVac under and in accordance with the Development Program, and (b) the FTE Rate.
1.40 “FTE Rate” means € [*****].
1.41 “Full Sublicense Rate” has the meaning set forth in Section 5.3.
1.42 “GLP” means the then-current practices and procedures set forth in Title 21, United States Code of Federal Regulations, Part 58 (as amended), and any other regulations, guidelines or guidance documents relating to good laboratory practices, or any foreign equivalents thereof in the country in which such studies or clinical trials are conducted or that are otherwise applicable.
1.43 “GLP Toxicology Study” means, with respect to a Licensed Product, a study conducted in a species, in compliance with GLP, for the purposes of assessing the efficacy, safety or the onset, severity, and duration of toxic effects and their dose dependency with the goal of establishing a profile sufficient to support the filing of an IND.
1.44 “IND” means any Investigational New Drug application, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any supplements or amendments thereto. References herein to IND will include, to the extent applicable, any comparable filings outside the United States.
1.45 “Infringement Action” shall have the meaning set forth in Section 8.4(c).
1.46 “Joint Steering Committee” shall have the meaning set forth in Section 3.1(a).
1.47 “Jointly-Owned Foreground Intellectual Property” shall have the meaning set forth in Section 7.1(d)(ii).
1.48 “Jointly-Owned Foreground Know-How” shall have the meaning set forth in Section 7.1(d)(ii).
1.49 “Jointly-Owned Foreground Patent Rights” shall have the meaning set forth in Section 7.1(d)(ii).
1.50 “Know-How” means any and all proprietary data, inventions, methods, information, processes, trade secrets, techniques and technology, whether patentable or not, including discoveries, formulae, practices, biological sequences, test data, analytical and quality control data, manufacturing technology and data, registration dossiers and specifications. Know-How includes any such information comprised or embodied in the Materials, if any.
1.51 "Licensed Intellectual Property" means the CureVac Background Intellectual Property and any Foreground Intellectual Property solely or jointly owned by CureVac.
1.52 "Licensed Patent Rights" means any Patent Right which is part of the Licensed Intellectual Property.
1.53 “Licensed Product” means any product comprising a Cas9 mRNA Construct, where such Cas9 mRNA Construct (a) the research, Development, Manufacture, use, sale, offer for sale or importation of which relies on the use of Know-How within the Licensed Intellectual Property, or (b) the research, Development, Manufacture, use, sale, offer for sale or importation of which in or into a country is Covered by a Valid Claim of a Patent Right or by Know-How within the Licensed Intellectual Property.
6
1.54 “Losses” shall have the meaning set forth in Section 9.1.
1.55 “Manufacture” means all manufacturing operations for Cas9 mRNA Constructs and Licensed Products, including all activities related to the synthesis, making, production, processing, purifying, of the Cas9 mRNA Constructs, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and Commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. “Manufacturing” has a correlative meaning.
1.56 “Manufacturing Services Agreement” means the Manufacturing Services Agreement between the Parties, dated as of the Effective Date for the pre-clinical and clinical (up to Pivotal Clinical Trials) Manufacture of Cas9 mRNA Constructs.
1.57 “Marketing Authorization Application” or “MAA” means an application for Regulatory Approval in a country, territory or possession.
1.58 “Materials” means the biological materials set forth on Attachment C hereto, whether by themselves or incorporated into another material, and any progeny, modifications, mutants, components or derivatives thereof. Attachment C may be amended upon the mutual written agreement by the Parties.
1.59 “NDA” means a new drug application that is submitted to the FDA for marketing approval for a Licensed Product, pursuant to 21 C.F.R. § 314.3, or any foreign equivalent.
1.60 “Net Sales” means with respect to any Licensed Product, the gross amounts received by CRISPR, its Affiliates, distributors and Sublicensees (each, a “Selling Party”) from Third Party customers for sales of such Licensed Product, less the following deductions actually incurred, allowed, paid, accrued or specifically allocated in its financial statements in accordance with such Selling Party’s accounting principles, for:
(a) [*****]
(b) [*****]
(c) [*****] and
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(d) [*****]
1.61 “Non-Royalty Sublicense Income” means any payments, including upfront and milestone payments, that CRISPR or its Affiliate receives in consideration of CRISPR, its Affiliate or Sublicensees granting any sublicense to a Third Party under any Licensed Intellectual Property to a Sublicensee, other than: [*****].
1.62 “Patent Rights” means patents and patent applications, together with any unlisted patents and patent applications claiming priority thereto, and any continuations, continuations-in-part, reissues, reexamination certificates, substitutions, divisionals, supplementary protection certificates, renewals, registrations, extensions including all confirmations, revalidations, patents of addition, PCTs, and pediatric and other exclusivity periods and all foreign counterparts thereof, and any patents issued or issuing with respect to any of the foregoing.
1.63 “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental authority, association or other entity.
1.64 “Phase 1 Clinical Trial” means a clinical study of a drug candidate in patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. 312.21(a), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.
1.65 “Phase 2 Clinical Trial” means a clinical study of a drug candidate in patients with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information as described in 21 C.F.R. 312.21(b), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical Trial (e.g., a phase 1/2 trial). The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.
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1.66 “Phase 3 Clinical Trial” means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents
1.67 “Pivotal Clinical Trial” means a clinical study of a drug candidate in patients, performed after preliminary evidence suggesting efficacy of such product has been obtained, conducted for inclusion in (a) that portion of the FDA submission and approval process that provides for the continued trials of such product in sufficient numbers of human patients to confirm with statistical significance the safety and efficacy of such Licensed Product sufficient to support Regulatory Approval in the proposed indication, as more fully defined in 21 C.F.R. §312.21(c) or (b) equivalent Regulatory Authority submissions in a country other than the United States.
1.68 “Program” means applying the CRISPR System and using a Cas9 mRNA Construct for the following programs: (i) the [*****], in accordance with Section 4.2(a). below, [*****] being set forth on Attachment G, or as substituted in accordance with Section 4.2(b) ("Program 1"); (ii) [*****] or (iii) [*****] or as substituted in accordance with Section 4.3 (“[*****]”).
1.69 “Reduced Sublicense Rate” has the meaning set forth in Section 5.3.
1.70 “Regulatory Approval” means any and all approvals (including pricing and reimbursement approvals, if any), licenses, registrations or authorizations of any national or international or local Regulatory Authority, department, bureau or other governmental entity, necessary for the Manufacture and Commercialization of a Licensed Product in any regulatory jurisdiction. Regulatory Approvals include approvals by Regulatory Authorities of MAAs.
1.71 “Regulatory Authority” means, with respect to a country or region, any national (e.g., the FDA for the United States, EMA for the European Union), supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental authority involved in the granting of any approval required by Applicable Laws to Manufacture and Commercialize a relevant Licensed Product in such country or region or, to the extent required in such country or region, price approval, for pharmaceutical products in such country or region.
1.72 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product.
1.73 “Reserved Program” shall mean any program that is the subject of a signed agreement between CureVac and a Third Party, or the subject of bona fide ongoing research, development or commercialization activities by CureVac, in each case, that would be breached if such proposed [*****] under this Agreement at the time CRISPR provides the written notice to CureVac as described in Section 4.3(b).
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1.74 “Royalty Term” on a Licensed-Product by Licensed-Product, and country-by-country basis, the period commencing on the First Commercial Sale of a Licensed Product and ending upon the later of (i) the date on which there is no Valid Claim that would be infringed, absent a license, by the Development, Manufacture or Commercialization of such Licensed Product in such country,(ii) the date on which the Regulatory Exclusivity in such country for such Licensed Product expires; or (iii) ten (10) years after the First Commercial Sale of such Licensed Product in such country.
1.75 “Solely-Owned Foreground Intellectual Property” shall have the meaning set forth in Section 7.1(d)(i).
1.76 “Solely-Owned Foreground Know-How” shall have the meaning set forth in Section 7.1(d)(i).
1.77 “Solely-Owned Foreground Patent Rights” shall have the meaning set forth in Section 7.1(d)(i).
1.78 “Sublicensee” means an Affiliate or any Third Party that is granted a sublicense as permitted under Section 7.2, either directly by CRISPR or indirectly by any other Sublicensee hereunder.
1.79 “Term” means the period of time beginning on the Effective Date and ending on the expiration of the Royalty Term for all Licensed Products, unless sooner terminated in accordance with the provision of this Agreement.
1.80 “Territory” means worldwide.
1.81 “Third Party” means any Person other than CRISPR, CureVac and their respective Affiliates.
1.82 “Third Party Agreement” has the meaning set forth in Section 7.4
1.83 “Valid Claim” means (a) a claim of an issued and unexpired patent which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b) a claim of a pending patent application that was filed and has been prosecuted in good faith and has not been (i) cancelled, withdrawn, abandoned or finally disallowed without the possibility of appeal or refiling of such application, or (ii) pending for more than [*****] years since such claim was first presented or is the result of amending another claim pending for more than [*****] years (either in the same application or in another application in the same jurisdiction) so as to add or delete an obvious limitation, so as to make a trivial or non-substantive change, or so as to change a matter of form.
1.84 “Work Plan” means the plan setting forth (a) the activities to be undertaken as part of the Development Program, (b) the Party responsible for each such activity, (c) the deliverables, (d) the budget, and (e) timeline for performance, as set forth in Attachment D hereto, and as may be amended from time to time with written approval of the JSC during the Development Term. For clarity, on a Program-by-Program basis, the Work Plans shall be limited to the identification, optimization and selection of Cas9 mRNA Constructs and shall not extend to any activities which shall be conducted under the Manufacturing Services Agreement.
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Article 2
CAS9 mRNA DEVELOPMENT PROGRAM
2.1 Purpose and Term. The Parties have agreed to engage in the Development Program on the terms and conditions set forth in this Agreement. As part of the Development Program, the Parties will work together to identify and optimize Cas9 mRNA Constructs for use in gene editing therapeutics. The Development Program will be undertaken and performed during the Development Term.
2.2 Diligence; Standards of Conduct with respect to the Work Plan. Each Party agrees to use Commercially Reasonable Efforts to perform the tasks assigned to such Party under the Work Plan in a timely and effective manner, and each Party further agrees to conduct its activities under the Work Plan in a good scientific manner and in compliance in all material respects with Applicable Law. In the event of any inconsistency between the Work Plan and this Agreement, the terms of this Agreement will prevail. Without limiting the foregoing, in all events, both Parties will provide all resources necessary to support the Development Program, including providing the appropriate technical resources and personnel with the appropriate skill, training and expertise. All disputes regarding the level of efforts and resources dedicated by a Party to the performance of the Development Program will be escalated to the JSC.
2.3 Amendments to the Work Plan. During the Development Term, each Party will have the right to propose modifications or amendments to the Work Plan; provided, however, that any modifications or amendments to the Work Plan that are proposed by either Party will be subject to review and prior written approval by the JSC pursuant to Section 3.1(b)(ii) and subject to Section 3.2.
2.4 Decision Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Work Plan will be decided by consensus by the JSC pursuant to Section 3.1(d) and subject to Section 3.2.
2.5 Progress. During the Development Term each Party will keep the other Party reasonably informed regarding the progress and results of performance of the Development Program. Without limiting the foregoing, following the end of each Calendar Quarter, each Party will prepare a summary of all work performed to date, such summary to include a discussion of progress against goals set forth in the Work Plan. The Parties will discuss such summary at the next JSC meeting.
2.6 Records. CureVac will maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate) of all work conducted by it under the Work Plan and all Know-How resulting from such work. Such records will fully and properly reflect all work done and results achieved in the performance of the Work Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. CRISPR will have the right to receive copies of such records maintained by CureVac, including in electronic format if maintained in such format, at reasonable times to the extent reasonably necessary to perform obligations or exercise rights under this Agreement. Promptly following completion of the Work Plan, CureVac will deliver a final report to CRISPR summarizing all work performed pursuant to the Work Plan, the results thereof and comparing the results thereof against any goals set forth in the Work Plan.
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2.7 Subcontracts. Except as outlined in the Work Plan, CureVac may not subcontract any of its obligations under this Agreement absent CRISPR’s prior written consent.
2.8 Manufacture and Supply. All Cas9 mRNA Constructs required for use by CRISPR, its Affiliates and Sublicensees in accordance with this Agreement for the non-clinical and Phase 1 Clinical Trial and Phase 2 Clinical Trial Development of the Licensed Products shall comport with or incorporate CureVac’s most advanced required Manufacturing technology, methods and materials and shall be Manufactured by or on behalf of CureVac in accordance with Applicable Laws and the terms and conditions of the Manufacturing Services Agreement attached hereto as Attachment E. The potential supply of Cas9 mRNA Constructs required for use by CRISPR its Affiliates and Sublicensees for Pivotal Clinical Trials and Commercial supply and a technology transfer in the event CureVac will not supply such Cas9 mRNA Constructs is set forth in the Manufacturing Services Agreement.
2.9 Supply of Material. CureVac will use Commercially Reasonable Efforts to supply to CRISPR, its Affiliates and Sublicensees the Materials set forth in Attachment C hereof. CRISPR will use such Materials only in accordance with the Work Plan as set forth in Attachment D and otherwise in accordance with the terms and conditions of this Agreement and will not reverse engineer or chemically analyze the Material except as expressly provided for in the Work Plan.
2.10 Regulatory Filings. CureVac hereby grants to CRISPR and its Affiliates, the right of cross-reference in any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) Controlled by CureVac or its Affiliates in any country in the Territory that relate to any Licensed Product to permit CRISPR or its Affiliates to comply with its regulatory obligations with respect to the Licensed Product in the Field in the Territory, or to exercise CRISPR’s or its Affiliate’s rights hereunder or under the Manufacturing Services Agreement or the Commercial Supply Agreement. CureVac shall do and cause to be done such reasonable acts and things, as may be necessary under, or as CRISPR may reasonably request, to effectuate the rights of cross-reference contemplated in this Section 2.10. The foregoing grant is sublicenseable (through multiple tiers) by CRISPR and its Affiliates. Notwithstanding anything to the contrary in this Agreement, unless required by any Applicable Law or Regulatory Authority, CureVac shall not withdraw or inactivate any regulatory filing that CRISPR references or otherwise uses pursuant to this Section 2.10.
Article 3
GOVERNANCE
3.1 Joint Steering Committee.
(a) Formation; Composition. Within [*****] days following the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) comprised of two (2) representatives from each Party (or appointed representatives of an Affiliate of such Party) with sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities and each Party will appoint one of its representatives to the JSC as such Party’s “Work Plan Leader”. The Parties’ initial representatives to the JSC, and Work Plan Leaders, are set forth on Attachment F hereto. The JSC may change its size from time to time by mutual consent of its members; provided that the JSC will consist at all times of an equal number of representatives of each of CureVac and CRISPR. Each Party may replace any or all of its JSC representatives at any time upon written notice to the other Party. The JSC may invite non-members to participate in the discussions and meetings of the JSC; provided that such participants (i) will have no voting authority at the JSC and (ii) are bound under written obligations of confidentiality no less protective of the other Party’s Confidential Information than those set forth in this Agreement. Each meeting of the JSC will be co-chaired by a representative of each Party. The role of the chairpersons will be to convene and preside at meetings of the JSC. The chairpersons will have no additional powers or rights beyond those held by the other JSC representatives. Each Party’s Work Plan Leader will be the primary point of contact for the other Party on all matters relating to the activities of the Work Plan.
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(b) Specific Responsibilities. The JSC will:
(i) oversee the performance of the Work Plan;
(ii) review the progress of activities under the Work Plan, all reports submitted by the Parties in accordance with Section 2.5, and review and approve any amendments thereto, including any necessary amendments to the Work Plan budget as a result of any amendment to the Work Plan, any other amendment to the Work Plan budget and any amendment to the timelines or activities under the Work Plan;
(iii) agree on amendments of the Work Plan;
(iv) work to resolve any disagreement between the Parties relating to the Work Plan;
(v) coordinate Patent Right applications regarding Foreground Intellectual Property; and
(vi) perform such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties.
(c) Meetings. During the Development Term, the JSC will meet at least quarterly for the first year, and at least twice a year thereafter. Following the expiration of the Development Term, the Parties may agree to reduce the number of meetings to at least twice a year until all [*****] Programs have initiated a Phase 1 Clinical Trial, unless otherwise agreed by the Parties. The JSC may meet in person, by videoconference or by teleconference. Notwithstanding the foregoing, at least [*****] per year will be in person unless the Parties mutually agree in writing to waive such requirement. In-person JSC meetings will be held at locations alternately selected by CureVac and by CRISPR. Each Party will bear the expense of its respective JSC members’ participation in JSC meetings. Meetings of the JSC will be effective only if at least [*****] of each Party is present or participating in such meeting. Prior to each meeting of the JSC, CureVac and CRISPR will take turns to (i) prepare a written report detailing the work performed to date under the Work Plan and evaluating such work in relation to the goals of the Work Plan and (ii) provide such other information as is reasonably requested by the JSC. On a Program-by-Program basis, after each Program has initiated a Phase 1 Clinical Trial, CRISPR shall provide CureVac with bi-annual reports summarizing all material matters and data relating to the Programs, the results achieved in performance of the Development and outlining its further Development activities with respect to such Program. Furthermore, CRISPR will, subject to confidentiality obligations, provide to CureVac copies of Final Study Reports, once they are available, and will respond to any reasonable request from CureVac to obtain information on the status of the Programs. Such reporting shall be available on a Program-by-Program basis until the date of the First Commercial Sale of a Licensed Product for such Program.
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(d) Decision Making. The representatives from each Party on the JSC will have, collectively, [*****] on behalf of that Party, and all decision making will be by consensus. Disputes at the JSC will be handled in accordance with Section 3.2.
3.2 Resolution of JSC Disputes.
(a) Within the JSC. Subject to the exception specified below in this Section 3.2, all decisions within the JSC will be made by consensus. If the JSC is unable to reach consensus on any issue for which it is responsible, within [*****] days after a Party affirmatively states that a decision needs to be made, either Party may elect to submit such issue to the Parties’ Executive Officers, in accordance with Section 3.2(b).
(b) Referral to Executive Officers. If a Party makes an election under Section 3.2(a) to refer a matter to the Executive Officers, the JSC will submit in writing the respective positions of the Parties to the Executive Officers. The Executive Officers will use good faith efforts in compliance with Section 3.3, which will include at least one in person meeting between such Executive Officers within [*****] days after the JSC’s submission of such matter to them. If the Executive Officers are unable to reach unanimous agreement on any such matter, CRISPR will decide such matter, provided that no exercise of such CRISPR’s decisionmaking authority on any matter may, without CureVac’s prior written consent, not to be unreasonably withheld, conditioned or delayed, (i) result in a material change to the Work Plan that significantly accelerates or decelerates the planned activities or requires allocation by CureVac of personnel significantly greater than or less than those provided for in the Work Plan “significantly”to include anything beyond [*****] percent of the agreed scope, (ii) result in a reduction of CRISPRs diligence obligations under this Agreement, or (iii) otherwise conflict with this Agreement.
3.3 Good Faith. In conducting themselves on the JSC, and in exercising their rights under Section 3.2, all representatives of each Party will consider reasonably and in good faith all input received from the other Party. In exercising any decision making authority granted to it under Section 3.2, each Party will act based on its good faith judgment taking into consideration the best interests of the Development Program
Article 4
DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS
4.1 Development and Commercialization. CRISPR shall have the sole right and responsibility for Developing and Commercializing Licensed Products in the Field, including obtaining necessary Regulatory Approvals, at its sole cost and expense.
4.2 Back-up Approach and Substitution for Program 1.
(a) CRISPR will pursue the primary gene (as set forth in Attachment G) under Program 1. In the event the results of the Development show that the primary gene should not be further pursued, such results to be discussed within the JSC, and CRISPR may select one of the back-up genes in Attachment G to replace the primary gene.
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(b) With respect to Program 1, during the [*****] commencing on the Effective Date, CRISPR shall be permitted once to substitute the treatment of [*****] upon notice to CureVac, at no additional cost.
4.3 Program Substitution [*****]
(a) Substitution. With respect to the [*****] Program, during the first [*****] years of this Agreement, CRISPR shall be permitted once to substitute an alternative program for [*****] using the procedures set forth in Section 4.3(b), provided the intended indication has an incidence approximately the same or less than the indication [*****]. The substitution is subject to the substitution fee set forth below, and the milestones set forth in Section 5.4(c) shall not be adjusted for any [*****] Program substitution. For clarity, even if the [*****] Program had already achieved several milestones, the substitution program would have to pay those milestones again.
(b) [*****] Program Substitution Process. CRISPR shall provide CureVac written notice of its request to substitute a target for the [*****] Program within the [*****] years of the Effective Date. If CureVac provides CRISPR notice that a proposed substitution for the [*****] Program is a Reserved Program, CureVac shall notify CRISPR within [*****] days after the date on which CureVac receives notice of the proposed substitution if such proposed substitution is a Reserved Program. CureVac shall, if requested by CRISPR in writing, provide CRISPR with such evidence to support that such proposed substitution is a Reserved Program. If after providing such evidence, CRISPR concludes that such a substitution is not a Reserved Program, CRISPR will so notify CureVac, CureVac will provide such evidence as CureVac believes is reasonably required to establish that such substitution is a Reserved Program to an independent attorney or other expert with experience that is relevant to the dispute and reasonably acceptable to both Parties. Such independent expert will review and make a determination in accordance with this Agreement regarding whether such proposed substitution is a Reserved Program. The independent expert shall promptly notify the Parties of its determination as to whether a proposed substitution is a Reserved Program, but shall not disclose to CRISPR information provided by CureVac in connection with such determination. The independent expert’s determination shall be binding on the Parties, absent a manifest error of such expert’s determination. If the independent expert determines such proposed substitution is a Reserved Program, CRISPR shall be permitted to select another target for the [*****] Program; if the independent expert determines such proposed substitution is not a Reserved Program, such proposed substitution shall become the target for the [*****] Program.
(c) Substitution Fee. In the event CRISPR choses to substitute the [*****] Program a Substitution Fee of [*****] US dollars (US$ [*****]) is due within [*****] days of confirmation of the new target by CureVac, or once the target is confirmed not to be a Reserved Program in accordance with Section 4.3(b) above.
4.4 Diligence. Subject to the terms of this Agreement, CRISPR shall use its Commercially Reasonable Efforts to progress the Development and Commercialization of the Licensed Products in all three Programs in the Field in the Territory. CRISPR shall, inter alia,
(a) conduct all non-clinical and clinical Development activities in a timely manner, and allocate such Development budgets as are commercially reasonable and adequate to progress the non-clinical and clinical Development of Licensed Products hereunder;
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(b) when appropriate based on satisfactory data obtained during the nonclinical and clinical Development, use its Commercially Reasonable Efforts to secure all required Regulatory Approvals in at least the EU, the US and Japan (with respect to Japan only, after taking into account, among other things, commercial considerations and disease prevalence of a Program in Japan), following completion of all appropriate clinical trials; and
(c) use its Commercially Reasonable Efforts to make the First Commercial Sale of the Licensed Products in each country following the issuance of the Regulatory Approvals for such country.
The diligence obligations set forth in this Section 4.4 may be satisfied by CRISPR, an Affiliate, or its or their Sublicensees.
Article 5
PAYMENTS; PAYMENT TERMS
5.1 Technology Access Fee. Within [*****] business days following the Effective Date, CRISPR shall pay to CureVac a one-time payment of three million US dollars (US$ 3,000,000).
5.2 Research Support Payments. On a quarterly basis, CureVac shall provide an invoice to CRISPR setting forth the total FTE Costs (including the amount of time actually spent by CureVac’s FTEs on activities under the Work Plan and a brief description of the work performed by such FTEs), and any reasonable and documented out-of-pocket expenses incurred by CureVac in the performance of the CureVac activities under the Work Plan until the date of such invoice, and CRISPR shall, within [*****] days after receiving such invoice, reimburse CureVac for the full amount of such FTE Costs and reasonable out-of-pocket expenses incurred by CureVac; provided that, CRISPR shall not be responsible for the payment of any costs and expenses (including FTE Costs) that are incurred by CureVac for any activities that are not set forth in the then-current Work Plan, and such costs and expenses will be borne entirely by CureVac unless otherwise approved by CRISPR in writing.
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5.3 Non-Royalty Sublicense Income.
(a) On a Sublicensee-by-Sublicensee basis, CRISPR will, in addition to Development and Commercial Milestones in accordance with Section 5.4 and royalties on Net Sales in accordance with Section 5.5, pay CureVac the percentage set forth below of Non-Royalty Sublicense Income received by CRISPR or its Affiliates in accordance with the following table:
Stage at which sublicense is granted by | % of Non-Royalty | % of Non-Royalty |
CRISPR | Sublicense Income | Sublicense Income |
Payable to CureVac for | from Casebia Payable | |
Such Sublicense (“Full | to CureVac for Such | |
Sublicense Rate”) | Sublicense (“Reduced | |
Sublicense Rate”) | ||
[*****] | [*****] | [*****] |
[*****] | ||
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
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In the event CRISPR receives the Non-Royalty Sublicense Income at the Reduced Sublicense Rate from Casebia, CRISPR shall pay the difference to the Non-Royalty Sublicense Income at the Full Sublicense Rate once and if the Third Party who obtained the sublicense from Casebia grants a sub-sublicense to another Third Party. For illustration purposes: If Casebia receives an upfront payment from its Sublicensee in the amount of [*****] US dollars (US$ [*****]), CRISPR shall pay [*****] US dollars (US$ [*****] rather than [*****] US dollars (US$ [*****]) to CureVac. The difference between the Non-Royalty Sublicense Income calculated at the Full Sublicense Rate and the Non-Royalty Sublicense Income calculated at the Reduced Sublicense Rate [*****] shall be paid if and once Casebia’s Sublicensee grants a sub-sublicense to a Third Party and makes a first upfront or milestone payment to Casebia. For clarity, no license or sublicenses between CRISPR and any of its Affiliates shall give rise to any payments under this Agreement.
5.4 Development & Commercial Milestones. In consideration of the performance of the Development Program and the licenses granted under this Agreement, CRISPR will pay to CureVac the amounts set forth below within [*****] calendar days following achievement of the applicable milestone by a Licensed Product. Milestones listed below shall be paid one time per Program under this Agreement, and can be satisfied anywhere in the Territory. In the event a milestone event is being skipped, the respective milestone payment is payable once the next consecutive milestone has been achieved, jointly with the milestone payment for such consecutive milestone.
(a) The first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates or any Sublicensee in connection with the Program 1:
[*****]
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(b) The first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates or any Sublicensee in connection with the [*****] Program:
[*****]
(c) The first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates or any Sublicensee in connection with the [*****]:
[*****]
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5.5 Running Royalties.
(a) Subject to the terms and conditions of this Agreement, on a country-by-country and Licensed Product-by-Licensed Product basis, CRISPR will pay to CureVac a royalty equal to [*****] percent ([*****]%) of Net Sales of Licensed Products sold or transferred by CRISPR, its Affiliates and its Sublicensees in those countries during the Royalty Term applicable to such Licensed Product.
(b) On a country-by-country and Licensed Product-by-Licensed Product basis, the royalty rate that CRISPR shall pay CureVac pursuant to Section 5.5(a) shall be reduced by [*****] percent ([*****]%) if at the time of sale (i) no Valid Claims exist and (ii) Regulatory Exclusivity has expired.
(c) No Multiple Royalties. If the Development, Manufacture, Commercialization or other use of any Licensed Product is (i) Covered in a given country by more than one Patent Right or by a Patent Right and Know-How within the Licensed Intellectual Property, multiple royalties with respect to Net Sales of that Licensed Product in that country shall not be due.
(d) Blended Royalties. With respect to a potential step down in royalty rates to account for the expiry of certain Patent Rights, the Parties acknowledge and agree that the Licensed Intellectual Property licensed under this Agreement may justify royalty rates and/or royalty terms of differing amounts for sales of Licensed Products in the Territory, which rates could be applied separately to Licensed Products involving the exercise of Licensed Patent Rights in the Territory and/or the incorporation of Know How comprised in the Licensed Intellectual Property, and that if such royalties were calculated separately, royalties relating to the Licensed Patent Rights in the Territory and royalties relating to the Know How comprised in the Licensed Intellectual Property would last for different terms. For practicality reasons the Parties have agreed on a blended royalty rate. For clarity, this Section 5.5(d) solely explains the rationale behind the royalty rates agreed by the Parties and does not modify any of the other provisions of this Agreement.
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(e) Fully Paid-Up Licenses. With respect to a Licensed Product in a given country, as of the date on which the Royalty Term applicable to such Licensed Product ends, the license grants contained in Section 7.1(a) shall become fully paid-up, royalty-free, perpetual and irrevocable for such Licensed Product in such country.
(f) Timing of Royalty Payments. CRISPR shall make royalty payments owed to CureVac hereunder in arrears, within [*****] days after the end of each Calendar Quarter in which such payment accrues. Each royalty payment shall be accompanied by a report for each country in which sales of Licensed Products occurred in the Calendar Quarter. Such report shall describe the Net Sales of each Licensed Product sold by or on behalf of CRISPR, its Affiliates or Sublicensees during the applicable Calendar Quarter for each country in which sales of any Licensed Product occurred, specifying: the gross sales (if available) and Net Sales in each country’s currency, including an accounting of deductions taken in the calculation of Net Sales; the applicable exchange rate to convert from each country’s currency to US Dollars; and the royalties payable in US Dollars.
5.6 Royalty Records. CRISPR and its Affiliates and Sublicensees shall keep, for at least [*****] years from the end of the Calendar Year to which they pertain, complete and accurate records of sales by CRISPR, its Affiliates and Sublicensees, as the case may be, of each Licensed Product, in sufficient detail to allow the accuracy of the payments hereunder to be confirmed.
5.7 Third Party Payments. To the extent CRISPR enters into a Third Party Agreement pursuant to Section 7.4, CRISPR shall be entitled to deduct from the then-current sales milestone and royalty payments due to CureVac under this Article 5 the amounts paid (including milestone payments, royalties or other license fees) by CRISPR to such Third Party under such Third Party Agreement; provided, however, that in no event shall the amounts due to CureVac from CRISPR in any Calendar Quarter be reduced by more than [*****]. Any amount that CRISPR is entitled to deduct that is reduced by the foregoing limitation on the deduction, or is otherwise not deducted in a particular Calendar Quarter (for example, if the amount due to CureVac is less than the amount due to such Third Party during such Calendar Quarter), such amount that was not deducted shall be carried forward and CRISPR may deduct such amount from subsequent amounts due to CureVac until the full amount that CRISPR was entitled to deduct is deducted. CureVac agrees to fully cooperate with CRISPR to acquire such rights.
5.8 Review. Subject to the other terms of this Section 5.8, at the request of CureVac, which shall not be made more frequently than once per Calendar Year during the Term, upon at least [*****] days’ prior written notice, and at CureVac’s expense, CRISPR shall permit an independent certified public accountant selected by CureVac and reasonably acceptable to CRISPR to inspect (during regular business hours) the records required to be maintained by CRISPR relating to royalties payable pursuant to this Agreement. In every case the accountant must have previously entered into a confidentiality agreement with all Parties substantially similar to the provisions of Article 6 and limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to this Section 5.8. The Parties shall treat the results of any such accountant’s review of such records under this Section 5.8 as Confidential Information of the applicable Party subject to the terms of Article 6. If any such review reveals a deficiency in the calculation and/or payment of royalties by CRISPR, then CRISPR shall promptly reimburse CureVac for such accountant’s fees and pay CureVac the revealed amount remaining to be paid.
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5.9 Method of Payment. All payments under this Agreement will be transferred to the following CureVac account:
[*****]
5.10 Accounting. All payments due under this Agreement will be made in United States dollars. Conversion of foreign currency to United States Dollars shall be made at the average monthly rate of exchange, using Bloomberg foreign exchange rates, using the conversion rates beginning the second to last business Day of the month preceding the month in which such sales are recorded and ending on the second to last business day of the month in which the sales are recorded.
5.11 Interest. Payments not paid within [*****] business days after the due date under this Agreement shall bear interest at an annual rate of [*****] percent ([*****]%) above the three-month-LIBOR rate of the respective currency for the time period in which such amount is outstanding. If CRISPR disputes the amount of a payment hereunder and does make such payment nonetheless, CRISPR shall be reimbursed the payment plus statutory interest as of the date of CureVac’s receipt of CRISPR’s notice disputing such payment, once the Parties agree or it is finally adjudicated that CRISPR was not obligated to make such payment.
5.12 Tax Withholding; Restrictions on Payment. All payments under or in connection with this Agreement shall be inclusive of any income taxes and each Party shall be responsible for its own income taxes assessed by a tax or other authority. If laws, regulations or rules require that taxes be withheld with respect to any payments by CRISPR to CureVac under this Agreement, CRISPR will: (a) deduct those taxes from the remittable payment as required by law from, (b) pay the taxes to the proper taxing authority, and (c) send evidence of the obligation together with proof of tax payment to CureVac on a timely basis following that tax payment. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect, and CRISPR shall forward any refund payments to CureVac without undue delay. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with Applicable Laws, regulations and rules.
5.13 VAT. All payments due to the terms of this Agreement are expressed to be exclusive of value added tax (VAT) or similar indirect taxes (e.g., Goods and Service tax). VAT/indirect taxes shall be added to the payments due to the terms if legally applicable.
5.13 Refund; Offset. The payments made under this Article 5 are in no event refundable or creditable.
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Article 6
CONFIDENTIALITY
6.1 Confidential Obligations. Each Party agrees that a Party (the “Receiving Party”) receiving Confidential Information of the other Party (the “Disclosing Party”) (or that has received any such Confidential Information from the other Party prior to the Effective Date) in connection with this Agreement shall, subject to Section 6.2 and Section 6.3, (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, but in no circumstances less than a reasonable standard of care, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose except those expressly permitted by this Agreement, including the exercise of rights and satisfaction of obligations under this Agreement.
6.2 Exceptions. The obligations in Section 6.1 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent written proof:
(a) is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party by or on behalf of the Disclosing Party;
(b) was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;
(c) is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
(d) is published by a Third Party or otherwise becomes publicly available or enters the public domain without violation of this Agreement by the Receiving Party or any person for whom the Receiving Party is responsible pursuant to Section 6.3(c), either before or after it is disclosed to the Receiving Party; or
(e) is independently Developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s Confidential Information.
6.3 Authorized Disclosure. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party, and Confidential Information deemed to belong to both Parties under the terms of this Agreement, to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:
(a) subject to Section 6.4, complying with Applicable Laws (including the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial or administrative process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance, provided that the Disclosing Party is informed, to the extent practicable, of the obligation of disclosure, so that the Disclosing Party may oppose or limit such disclosure obligation and provided the Receiving Party limits the disclosure to the strict minimum in order to comply with its obligations;
(b) disclosure by the Parties of the existence of this Agreement in any annual report to stockholders, filings with the Securities and Exchange Commission and other Regulatory Authorities and communications with securities analysts and stockholders; and
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(c) disclosure, solely on a “need to know basis,” to Affiliates, potential or actual research and development collaborators, subcontractors, investment bankers, investors, lenders, shareholders, or other potential or actual financial or strategic partners, and each of the Parties’ respective directors, employees, contractors, agents, legal counsel and accountants, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 6, which for avoidance of doubt, will not permit use of such Confidential Information for any purpose except those permitted by this Agreement, including the exercise of rights and satisfaction of obligations under this Agreement; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 6.3 to treat such Confidential Information as required under this Article 6.
If and whenever any Confidential Information is disclosed in accordance with this Section 6.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Agreement). Where reasonably possible and subject to Section 6.4, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make any disclosures pursuant to Section 6.3(a) or 6.3(b) sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing Party with respect thereto; provided that, in any event, the Receiving Party will use reasonable measures to ensure confidential treatment of such information and shall only disclose such Confidential Information of the Disclosing Party as is necessary to comply with such Applicable Laws or judicial process.
6.4 Securities Filings. If either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document that describes or refers to the terms and conditions of this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other Applicable Law, the Party shall notify the other Party of such intention and shall provide such other Party with a copy of relevant portions of the proposed filing prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including any exhibits thereto relating to the terms and conditions of this Agreement, and shall use reasonable and diligent efforts to obtain confidential treatment of the terms and conditions of this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information that is requested by the Securities and Exchange Commission or legally required to be disclosed. No such notice shall be required under this Section 6.4 if the description of or reference to this Agreement contained in the proposed filing has been included in the press release or in any previous filing made by the either Party hereunder or otherwise approved by the other Party.
6.5 Publicity. Except as otherwise provided herein, each Party agrees not to issue any other press release or other public statement disclosing terms of this Agreement or using the name or trademark of the other Party, its Affiliates or its employees, in either case, without the prior written consent of such other Party.
6.6 Existing Confidentiality Agreement. The Parties hereby agree that all confidential information disclosed by one Party to the other pursuant to that certain Confidentiality Agreement, by and between the Parties, dated February 26, 2017, will be governed by the terms of this Agreement.
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6.7 Return of Confidential Information. Upon expiry or earlier termination of the Agreement, upon written request of a Party (such request, if made, to be made within three (3) months of such expiry or termination) the other Party will destroy or return (as shall be specified in such request) to the requesting Party all copies of the Confidential Information of the requesting Party; provided that the Party may retain: (i) one copy of such Confidential Information for recordkeeping purposes, for the sole purpose of ensuring compliance with this Agreement; (ii) any copies of such Confidential Information as is required to be retained under Applicable Law; (iii) any copies of such Confidential Information as is necessary or useful for such Party to exercise a right or fulfill an obligation towards a Sublicensee, if any, or as set forth in this Agreement; and (iv) any copies of any computer records and files containing Confidential Information that have been created by such Party’s routine archiving/backup procedures.
Article 7
INTELLECTUAL PROPERTY
7.1 Ownership; License Grants.
(a) Exclusive License. CureVac hereby grants to CRISPR, and CRISPR hereby accepts, an exclusive (even as to CureVac and its Affiliates), sublicenseable (in accordance with Section 7.2), worldwide, royalty-bearing license under the Licensed Intellectual Property to Develop, Manufacture, Commercialize and otherwise use, including, but not limited to the right to research, have researched, develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import, have imported, export, otherwise exploit and otherwise have exploited, Licensed Products in the Field in the Territory, in accordance with the terms and conditions, and subject to the limitations of this Agreement, the Manufacturing Services Agreement and the Commercial Supply Agreement.
(b) Exclusive Back License. On a Licensed Product-by-Licensed Product basis, as so long as CureVac is supplying Cas9 mRNA Constructs to CRISPR for a Licensed Product under the Manufacturing Services Agreement or any Commercial Supply Agreement, and on a Licensed Product-by-Licensed Product basis, CRISPR hereby grants to CureVac, and CureVac hereby accepts, an exclusive (even as to CRISPR and its Affiliates) worldwide, cost-free sublicense of the rights granted to CRISPR under Section 7.1(a), to Manufacture and have Manufactured Licensed Products in the Field in the Territory. For clarity, CureVac has no license to use, sell or otherwise exploit such Licensed Products and consequently will Manufacture such Licensed Products solely to supply to CRISPR, its Affiliates and their respective Sublicensees under such agreements.
(c) Background Intellectual Property. CureVac acknowledges and agrees that with signing this Agreement it does not acquire a license or any other right to CRISPR Background Intellectual Property except for the limited purpose of carrying out its duties and obligations under this Agreement and that such limited, non-exclusive, cost-free license will expire upon the completion of such duties and obligations or the termination or expiration of this Agreement, whichever is the first to occur. CRISPR acknowledges and agrees that CureVac retains all rights to the CureVac Background Intellectual Property, subject only to the licenses granted hereunder.
(d) Ownership of Foreground Intellectual Property.
(i) Except as set forth in subsection (iii) below, each Party will solely own all right, title and interest in and to all Foreground Intellectual Property that is discovered, created, conceived or reduced to practice solely by or on behalf of such Party (“Solely-Owned Foreground Know-How”) and all Patent Rights arising therefrom that Cover such Solely-Owned Foreground Know-How (“Solely-Owned Foreground Patent Rights”), and together with the Solely-Owned Foreground Know-How, the “Solely-Owned Foreground Intellectual Property”. All right, title and interest in and to all Solely-Owned Foreground Intellectual Property will automatically vest solely in such Party.
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(ii) Except as set forth in subsection (iii) below, the Parties will jointly own all right, title and interest in and to all Foreground Intellectual Property that is discovered, created, conceived or reduced to practice jointly by or on behalf of the Parties (“Jointly-Owned Foreground Know-How”) and all Patent Rights arising therefrom that Cover such Jointly-Owned Foreground Know-How (“Jointly-Owned Foreground Patent Rights”), and together with the Jointly-Owned Foreground Know-How, the “Jointly-Owned Foreground Intellectual Property”. Each Party will have an undivided one-half interest in and to such Jointly-Owned Foreground Intellectual Property. CRISPR will have a right to grant non-exclusive licenses (with the right to grant sublicenses through multiple tiers) to CureVac’s share in such Jointly-Owned Foreground Intellectual Property to the extent such license is required to exercise or exploit CRISPR Background Intellectual Property; and CureVac will have a right to grant non-exclusive licenses (with the right to grant sublicenses through multiple tiers) to CRISPR’s share in such Jointly-Owned Foreground Intellectual Property to the extent such license is required to exercise or exploit CureVac Background Intellectual Property; i.e., neither Party is to be blocked in the use of its Background Intellectual Property. Subject to the licenses granted herein, any further license to Jointly-Owned Foreground Intellectual Property requires the prior written consent of the other Party. Each Party, for itself and on behalf of its and its Affiliates’ employees, subcontractors, consultant and agents, hereby assigns and agrees to assign, without additional consideration, to the other Party a joint and undivided interest in and to all Jointly-Owned Foreground Intellectual Property to effect such joint ownership, which assignment such other Party hereby accepts.
(iii) Notwithstanding subsections (i) and (ii) above,
(A) CRISPR will solely own any Foreground Intellectual Property that is a CRISPR Improvement and that is not also a CureVac Improvement at the time such CRISPR Improvement is discovered, created, conceived, developed or reduced to practice, regardless of the Party or Parties such Foreground Intellectual Property was discovered, created, conceived, developed or reduced to practice by or on behalf of, and CureVac, for itself and on behalf of its and its Affiliates’ employees, subcontractors, consultants and agents hereby assigns and agrees to assign, all of its rights, title and interest in such Intellectual Property to CRISPR. CureVac shall execute and deliver to CRISPR, to the extent necessary, any deed(s) of such assignment, in a mutually agreeable form and will take whatever actions reasonably necessary, including the appointment of CureVac as its attorney in fact solely to make such assignment, to effect such assignment.
(B) CureVac will solely own any Foreground Intellectual Property that is a CureVac Improvement that is not also a CRISPR Improvement at the time such CureVac Improvement is discovered, created, conceived, developed or reduced to practice, regardless of the Party or Parties such Foreground Intellectual Property was discovered, created, conceived, developed or reduced to practice by or on behalf of, and CRISPR, for itself and on behalf of its and its Affiliates’ employees, subcontractors, consultants and agents hereby assigns and agrees to assign, all of its rights, title and interest in such Intellectual Property to CureVac. CRISPR shall execute and deliver to CureVac, to the extent necessary, any deed(s) of such assignment, in a mutually agreeable form and will take whatever actions reasonably necessary, including the appointment of CRISPR as its attorney in fact solely to make such assignment, to effect such assignment.
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(C) To the extent a particular item of Foreground Intellectual Property constitutes both a CRISPR Improvement and a CureVac Improvement, (“Dual Improvement Intellectual Property”), the Parties shall discuss in good faith whether any such Foreground Intellectual Property can be divided and owned in accordance with subsections (A) and (B) above, made subject to separate patent filings to be assigned accordingly; and to the extent no such division is possible, such Dual Improvement Intellectual Property shall be treated as part of the Jointly-Owned Foreground Intellectual Property for all purposes under this Agreement.
7.2 Right to Sublicense. CRISPR shall be entitled to sublicense (through multiple tiers) its rights under Section 7.1(a) to any Affiliates and to any Third Parties, provided that sublicenses to Third Parties require CureVac’s prior written consent which CureVac will not unreasonably withhold, condition or delay and that such sublicenses are subject to the Non-Royalty Sublicense Income in accordance with Section 5.3 above. For any sublicense it must be provided that the respective sublicense agreement contains terms and conditions that are not inconsistent with those contained in this Agreement, and shall include provisions regarding confidentiality, indemnification, audit, record-keeping and termination. CRISPR shall remain liable to CureVac for all obligations under this Agreement. CRISPR shall furnish CureVac with a fully executed copy of any sublicense agreement promptly after its execution, subject to reasonable redactions to the extent not necessary for CureVac to understand the scope of such sublicense, to calculate the Non-Royalty Sublicense Income and to determine if CRISPR is in compliance with this Section 7.2, and subject to the confidentiality provisions therein. The terms of any such sublicense agreement shall be Confidential Information of CRISPR.
7.3 Disclosure. Each Party will promptly disclose to the other Party all Foreground Know-How that is discovered, created, conceived or reduced to practice by or on behalf of such Party, and will provide documentation regarding the same as the other Party may reasonably request, including, information obtained by CureVac relating to CureVac’s proprietary mRNA technology platform generally that would reasonably have an impact on any Cas9 mRNA Constructs or Licensed Products.
7.4 Third Party Licenses. To the extent CRISPR identifies any Patent Rights controlled by a Third Party that are reasonably necessary for a Party to freely exercise, practice or otherwise use the CureVac Background Patent Rights or the Foreground Patent Rights solely owned by CureVac, in each case, in connection with a Party’s direct or indirect performance of its rights or obligations under this Agreement, and with respect to CRISPR’s exploitation of Cas9 mRNA Constructs included in a Licensed Product in accordance with this Agreement, only if such Cas9 mRNA Constructs are defined by CureVac, CRISPR will promptly notify CureVac of such Patent Rights, Know-How or other intellectual property and CureVac will have the first right to negotiate for and enter into a license agreement (“Third Party Agreement”) with respect to such Patent Rights, Know-How, or other intellectual property, provided that CureVac will notify CRISPR if CureVac wishes to exercise such right within [*****] days of CRISPR’s notice, and such first right will continue until the earlier of (x) [*****] days after the date of CureVac’s notice to CRISPR exercising such right or (y) CureVac is no longer actively negotiating such agreement, in which case CureVac will so notify CRISPR (such period is referred to the “First Exercise Period”), and CureVac will keep CRISPR reasonably informed as to the status of such negotiations. If CureVac does not notify CRISPR of its intent to exercise such right or the First Exercise Period expires, CRISPR will have the right to negotiate for and enter into a Third Party Agreement with respect to such Patent Rights, Know-How or other intellectual property.
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Article 8
PROSECUTION AND ENFORCEMENT
8.1 Patent Prosecution. As between the Parties, each Party will have the sole right, but not the obligation, to file, prosecute and maintain the Patent Rights owned solely by such Party. During the Term, CureVac will consult with CRISPR as to the preparation, filing, prosecution, and maintenance of any of its Foreground Patent Rights reasonably prior to any deadline or action with the United States Patent & Trademark Office or any foreign patent office and will furnish CRISPR with copies of all relevant documents reasonably in advance of consultation. CureVac will reasonably consider any of CRISPR’s reasonable comments on any documents to be submitted to such patent offices. In the event CureVac (i) decides not to file a patent application pertaining to any Foreground Know-How in any given country or countries, or (ii) desires to abandon any patent or patent application within the Foreground Patent Rights, then, in each case, CureVac shall provide CRISPR with reasonable prior written notice of such intended decision not to file or such intended decision of abandonment or decline of responsibility. If CRISPR elects to file any such patent application on behalf of CureVac, or if CRISPR elects to continue such patent or patent application on behalf of CureVac, the Parties shall promptly consult and CureVac may elect to retain responsibility therefor provided that any such decision shall be made in a sufficiently prompt time so as not to jeopardize CRISPR’s ability to file such patent application or its ability to pursue or maintain such patent or patent application. Otherwise, CRISPR shall have the right, but not the obligation, to prepare, file, prosecute and maintain the relevant Foreground Patent Rights, as applicable, or seek patent protection in the first instance, on behalf of CureVac and at CRISPR’s expense.
8.2 Prosecution of Jointly-Owned Foreground Patent Rights. CRISPR will have the first right, but not the obligation to file, prosecute and maintain Jointly-Owned Foreground Patent Rights, and will bear the costs incurred by CRISPR in connection with such efforts. CRISPR will consult with CureVac as to the preparation, filing, prosecution and maintenance of the Jointly-Owned Foreground Patent Rights reasonably prior to any deadline or action with any patent office and will furnish CureVac with copies of all relevant documents reasonably in advance of consultation. CRISPR will reasonably consider any of CureVac’s reasonable comments on any documents to be submitted to such patent offices. In the event CRISPR (i) decides not to file a patent application pertaining to any Jointly-Owned Foreground Know-How in any given country or countries, or (ii) desires to abandon any patent or patent application within the Jointly-Owned Foreground Patent Rights, then, in each case, CRISPR shall provide CureVac with reasonable prior written notice of such intended decision not to file or such intended decision of abandonment or decline of responsibility. If CureVac elects to file any such patent application, or if CureVac elects to continue such patent or patent application, the Parties shall promptly consult and CRISPR may elect to retain responsibility therefor provided that any such decision shall be made in a sufficiently prompt time so as not to jeopardize CureVac’s ability to file such patent application or its ability to pursue or maintain such patent or patent application. Otherwise, CureVac shall have the right, but not the obligation, to prepare, file, prosecute and maintain the relevant Foreground Patent Rights, as applicable, or seek patent protection in the first instance, at CureVac’s expense.
8.3 Cooperation. Each Party will provide the other Party, at the other Party’s request and expense, all reasonable assistance and cooperation in connection with this Article 8, including providing any necessary powers of attorney and executing any other required documents or instruments for such filing, prosecution or maintenance, and joining any lawsuit as needed for standing.
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8.4 Third Party Actions.
(a) Patent Infringement Claims Against a Party. Each Party shall notify the other if it is aware of any claim that the Development, Manufacture, Commercialization or other use of a Licensed Product in the Field infringes a Patent Right Controlled by a Third Party, setting forth the facts of such claim in reasonable detail. CRISPR shall have the first right, but not the obligation, at its own expense, to defend and control the defense of any such claim, by counsel of its own choice. CRISPR shall not enter into a settlement that imposes a financial obligation upon CureVac or which limits the scope or invalidates any CureVac’s intellectual property rights without CureVac’s prior written consent and in any settlement CRISPR shall always take into consideration the interest of CureVac. In case CRISPR elects not to defend and control the defense of any such claim, it shall notify CureVac of such election within due term to allow CureVac to defend and control the defense of any such claim.
(b) Notice. If either Party learns of any (i) actual, alleged or threatened infringement or misappropriation of any of the Licensed Patent Rights in the Field, including based on the Development or Commercialization of a product that competes with a Licensed Product; (ii) declaratory judgment initiated by a Third Party naming a Party, or a Party’s Affiliate or a Sublicensee as a defendant and alleging invalidity, unenforceability or non-infringement of any of the Licensed Patent Rights Covering the Development or Commercialization of a Licensed Product in the Field (“Competitive Infringement”), or (iii) declaratory judgment initiated by a Third Party naming a Party or a Party’s Affiliate or Sublicensee as a defendant and alleging invalidity, unenforceability or non-infringement of any Licensed Patent Rights Covering the Manufacture of a Licensed Product in the Field, such Party shall promptly notify the other Party and shall provide the other Party with available evidence of such infringement or declaratory action.
(c) Enforcement and Defense. CRISPR shall have the first and exclusive right, but not the obligation, to take any reasonable measures it deems appropriate with respect to any Competitive Infringement in the Territory of any Licensed Patent Rights. Such measures may include (a) initiating or prosecuting an infringement, misappropriation or other appropriate suit or action (each an “Infringement Action”) in the Territory, or (b) granting adequate rights and licenses to any Third Party necessary to render continued Competitive Infringement in the Territory non-infringing. Notwithstanding the foregoing, if CRISPR does not inform CureVac that it intends to either initiate such an Infringement Action or grant adequate rights and licenses to such Third Party within [*****] after CRISPR’s receipt of a notice of infringement, then CureVac will have the second right, but not the obligation, to initiate such Infringement Action with respect to such Licensed Patent Rights. For any infringement other than a Competitive Infringement, and except as set forth below, each Party will have the first right, but not the obligation to enforce and defend the Licensed Patent Rights owned solely by such Party, and CRISPR will have the first right, but not the obligation to enforce and defend the Jointly Owned Foreground Patent Rights, with the exception only of Jointly-Owned Foreground Patent Rights which solely Cover the Manufacture of the Licensed Products, for which CureVac will have the first right, but not the obligation to enforce and defend. If within [*****] after having been notified of any alleged Third Party infringement of any Licensed Patent Right or any declaratory action contemplated by Section 8.4(d), in each case, in the Field, the Party enforcing or defending the Patent Right is unsuccessful in persuading the alleged infringer to desist, or the respective competent Party shall not have brought an infringement action within such [*****] period, or if the respective competent Party has not responded to such declaratory action, then, in any such event the other Party shall have the right, but not the obligation, to prosecute and defend the respective Licensed Patent Rights in connection with any such matter. The Party taking action to enforce and defend under this Section 8.4(c) shall bear all of its costs related to such enforcement and defense, including any costs incurred by the other Party providing support to such enforcement and defense at the request of the enforcing and defending Party.
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(d) Standing to Sue; Collaboration. In any litigation brought by either Party pursuant to this Section 8.4, the enforcing Party shall notify the non-enforcing Party of the commencement of that litigation and shall have the right and standing to use and sue in the other Party’s name. Irrespective of which Party brings the infringement action hereunder, (i) the Parties shall collaborate with respect to such action; (ii) the non-enforcing Party shall have the right, at its own expense, to be represented by independent counsel in any such litigation; and (iii) the Parties shall consult with each other regarding and agree on strategic decisions and their implementation in connection with such action. The Party bringing the infringement action hereunder shall bear all the expenses of any suit brought by it claiming infringement of any Licensed Patent Right.
(e) Recovery. In the event that either Party exercises the rights conferred in this Article 8 and recovers any damages or other sums in such action, such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith (including, without limitation, attorneys’ fees). If such recovery is insufficient to cover all such costs and expenses of both Parties, the Parties’ costs shall be paid on a pro-rated basis. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be [*****] the Parties
Article 9
INDEMNIFICATION
9.1 Indemnification by CRISPR. Subject to the terms and conditions hereof, CRISPR shall indemnify CureVac, its Affiliates, and its and their directors, officers, employees, approved subcontractors and agents (“CureVac Indemnitees”) and defend and hold each of them harmless, from and against any and all Third Party claims and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) that such CureVac Indemnitees may be required to pay to one or more Third Parties to the extent arising from or occurring as a result of (a) an uncured material breach of any of CRISPR’s representations, warranties or covenants set forth in this Agreement, (b) the exercise by CRISPR and/or any of its Affiliates or Sublicensees of the rights granted to CRISPR pursuant to Sections 4.1 and 7.1 (including the Development, Manufacture, Commercialization or other use of Licensed Products), except to the extent such Losses are in connection with the CureVac Background Intellectual Property or the Foreground Intellectual Property solely owned by CureVac; or (c) the negligence, recklessness, or willful misconduct by CRISPR or its Affiliates. Notwithstanding the foregoing, CRISPR will have no obligations under this Section to the extent Losses arise from or occur as a result of (i) gross negligence or willful misconduct (including noncompliance with any Applicable Laws, regulations, or rules) on the part of a CureVac Indemnitee, or (ii) a breach by CureVac of any representations, warranties or covenants set forth in this Agreement.
9.2 Indemnification by CureVac. Subject to the terms and conditions hereof, CureVac shall indemnify CRISPR, its Affiliates, and its and their directors, officers, employees, subcontractors, and agents (“CRISPR Indemnitees”), and defend and hold each of them harmless, from and against any Third Party claims and all Losses that such CRISPR Indemnitees may be required to pay one or more Third Parties to the extent arising from or occurring as a result of (a) an uncured material breach of any of CureVac’s representations, warranties or covenants set forth in this Agreement, or (b) the negligence, recklessness, or willful misconduct by CureVac or its Affiliates. Notwithstanding the foregoing, CureVac will have no obligations under this Section to the extent Losses arise from or occur as a result of (i) gross negligence or willful misconduct (including non-compliance with any Applicable Laws, regulations, or rules) on the part of a CRISPR Indemnitee, or (ii) a breach by CRISPR of any representations, warranties or covenants set forth in this Agreement.
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9.3 Indemnification Procedures. Except as set forth in Section 8.4(a), the person claiming indemnity under this Article 9 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of any claim, provided, that the failure to provide such notice shall not affect the Indemnifying Party’s obligations hereunder, except to the extent it is materially prejudiced thereby. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the claim with counsel of its choice. The Indemnifying Party shall not settle a claim in any manner that would require payment by the Indemnified Party, or would materially adversely affect the rights granted to the Indemnified Party hereunder, or would materially conflict with the terms of this Agreement, or adversely affect such Party or its products, without first obtaining the indemnified Party’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed. So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle or compromise any such claim without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld, conditioned or delayed. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (a) the Indemnified Party may defend against, consent to the entry of any judgment, or enter into any settlement with respect to such claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article 9.
Article 10
REPRESENTATIONS AND WARRANTIES
10.1 CureVac Representations. Subject to the disclosures in Attachment H hereto, CureVac represents, warrants and covenants to CRISPR, on the Effective Date, as follows.
(a) CureVac is a stock corporation, validly existing and in good standing under the laws of Germany, with full power and authority to operate its properties and to carry on its business as presently conducted.
(b) CureVac has full power and authority to execute, deliver and perform this Agreement. This Agreement constitutes legally binding and valid obligations of CureVac, enforceable in accordance with their terms;
(c) The execution and delivery of this Agreement and the performance of the obligations contemplated hereby have been duly authorized by all appropriate CureVac corporate action;
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(d) The execution, delivery and performance by CureVac of this Agreement and the consummation of the transactions contemplated hereby will not result in any violation of, conflict with, result in a breach of or constitute a default under any contract or agreement to which CureVac is a party or by which it is bound.
(e) To the knowledge of CureVac, no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state or local governmental authority on the part of CureVac is required in connection with the execution, delivery and performance of this Agreement.
(f) There is no action, suit, proceeding or investigation pending or, to the knowledge of CureVac, currently threatened in writing against or affecting CureVac that questions the validity of this Agreement or the right of CureVac to enter into this Agreement or perform CureVac’s obligations hereunder.
(g) There are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial, administrative or legal proceedings pending or, to the knowledge of CureVac, threatened, against CureVac, including with respect to administrative or other governmental investigations, which would (a) be reasonably expected to affect or restrict the ability of CureVac to perform its obligations under this Agreement, or (b) affect in any manner the Licensed Intellectual Property or CureVac’s Control thereof.
(h) To the knowledge of CureVac, no Third Party is conducting or engaging in any activity that would constitute infringement or misappropriation of the Licensed Intellectual Property; and to the knowledge of CureVac, the performance of activities contemplated by this Agreement (including the practice of the Licensed Intellectual property in accordance with the terms and conditions of this Agreement) would not itself constitute infringement or misappropriation of Third party’s intellectual property rights in existence on the Effective Date.
(i) To CureVac’s knowledge, no objection or proceeding is pending or threatened that questions the validity or enforceability of the CureVac Background Intellectual Property or the issuance of any patent applications included therein.
(j) As of and following the Effective Date, CureVac has undertaken reasonable efforts to secure and will continue to use reasonable efforts to secure from all employees, consultants, contractors and other Persons who have contributed or will contribute to the development, creation, conception or invention of any of the Licensed Intellectual Property a written agreement assigning to CureVac or its Affiliates all rights to such developments, creations, conceptions or inventions and such Affiliates have assigned such rights to CureVac, and, to CureVac’s knowledge, neither CureVac nor any of its Affiliates has received any written communication challenging CureVac’s ownership or right to such Licensed Intellectual Property, unless such an agreement with the inventor is not required under Applicable Law for ownership in such Licensed Intellectual Property to vest in CureVac.
10.2 CRISPR’s Representations. CRISPR represents and warrants to CureVac, on and as of the Effective Date, that:
(a) CRISPR is a corporation, duly incorporated, validly existing and in good standing under the laws of Switzerland, with full corporate power and authority to operate its properties and to carry on its business as presently conducted;
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(b) CRISPR has full power and authority to execute, deliver and perform this Agreement. This Agreement constitutes the legally binding and valid obligations of CRISPR, enforceable in accordance with their terms;
(c) the execution, delivery and performance by CRISPR of this Agreement and the consummation of the transactions contemplated thereby will not result in any violation of, conflict with, result in a breach of or constitute a default under any contract or agreement to which CRISPR is a party or by which it is bound, its business or assets;
(d) no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state or local governmental authority on the part of CRISPR is required in connection with the execution, delivery and performance of this Agreement; and
(e) there is no action, suit, proceeding or investigation pending or, to the knowledge of CRISPR, currently threatened against or affecting CRISPR or that questions the validity of this Agreement, or the right of CRISPR to enter into this Agreement or consummate the transactions contemplated hereby.
10.3 Covenants. Each Party covenants and agrees that during the Term, neither it, nor its Affiliates, will take any action or cause or permit the taking of any action that would have the effect of invalidating or breaching any of the representations or warranties contained in Section 10.1 or 10.2, including, without limitation, any action that would result in any invalidity of any of the Licensed Patent Rights. Without limiting the foregoing, CureVac covenants and agrees that during the Term, neither it, nor its Affiliates, will take any action or cause or permit the taking of any action that would materially adversely affect the rights of CRISPR under this Agreement. For clarity, CureVac cannot and will not grant a license to any Third Party to the extent CRISPR has obtained exclusive rights under this Agreement.
10.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER WARRANTIES CONCERNING PATENT RIGHTS OR ANY OTHER MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR ARISING OUT OF COURSE OF CONDUCT OR TRADE CUSTOM OR USAGE, AND EACH PARTY DISCLAIMS ALL SUCH EXPRESS OR IMPLIED WARRANTIES.
Article 11
INSURANCE; LIMITATION OF LIABILITY
11.1 Insurance. CRISPR shall maintain, at its own cost, a program of insurance and/or self-insurance against liability (including product liability) and any other risks associated with its activities and obligations under this Agreement, the Commercialization of any Licensed Products, and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for companies similar to CRISPR for the activities to be conducted by them under this Agreement. Such insurance coverage shall be kept as long as any Licensed Product is Commercialized. CureVac shall maintain, at its own cost, a program of insurance and/or self-insurance against liability and any other risks associated with its activities and obligations under this Agreement, and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for companies similar to CureVac for the activities to be conducted by CureVac under this Agreement. Such insurance coverage shall be kept as long as any Licensed Product is commercialized.
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11.2 Consequential Damages. EXCEPT WITH RESPECT TO WILLFUL MISCONDUCT, GROSS NEGLIGENCE, ANY BREACH OF ARTICLE 6 (CONFIDENTIALITY), OR ANY INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 9, TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAWS, IN NO EVENT WILL EITHER PARTY OR ITS AFFILIATES OR ITS OR THEIR OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) ARISING FROM OR RELATED TO THIS AGREEMENT.
Article 12
GENERAL COMPLIANCE WITH LAW
Each Party will use reasonable commercial efforts to comply with all Applicable Law relating to the exercise of rights and satisfaction of obligations under this Agreement.
Article 13
TERM AND TERMINATION
13.1 Term. The Term will commence as of the Effective Date, and unless earlier terminated in accordance with this Section 13, will expire on a Licensed Product-by-Licensed Product and country-by-country basis, upon such time as the Royalty Term with respect to the sale of such Licensed Product in such country expires.
13.2 Termination for Breach.
(a) Material Breach. Subject to the other terms of this Agreement, this Agreement may be terminated, on a Program-by-Program basis, by either Party for a material breach by the other Party to this Agreement, provided that the breaching Party has not cured such breach within [*****] after the date of written notice to the breaching Party, which notice shall describe such breachnn reasonable detail and shall state the non-breaching Party’s intention to terminate this Agreement pursuant to this Section, provided further that in no event will the failure of CRISPR to pay a disputed amount under this Agreement, the Manufacturing Services Agreement or any Commercial Supply Agreement be considered a material breach of this Agreement.
(b) Program by Program; Development Program. In the event the facts giving rise to termination under Section 13.2(a) relate to one or more Programs but not all Programs, such termination, if any, will relate only to the affected Program(s) and this Agreement will otherwise continue with respect to all other Programs in all respects. Further, if CRISPR exercises any of its termination rights under this Article 13, CRISPR may terminate the Development Program without terminating the remainder of this Agreement.
13.3 Voluntary Termination by CRISPR. CRISPR may terminate this Agreement, in its entirety or on a Program-by-Program basis, at any time upon [*****] prior written notice to CureVac.
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13.4 Termination for Bankruptcy. If any Party hereto files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not discharged within [*****] of the filing thereof, then the respective other Party may terminate this Agreement effective immediately upon written notice to the insolvent Party.
13.5 Change of Control of CRISPR. In the event of (i) a direct or indirect acquisition of beneficial ownership of fifty percent (50%) or more of the voting power in CRISPR by a CureVac Competitor; or (ii) the sale or other disposition of all or substantially all of the assets of CRISPR to a CureVac Competitor; or (iii) the merger, amalgamation or other form of business combination or similar transaction between CRISPR and a CureVac Competitor (“Change of Control”) the following shall apply:
(a) CRISPR shall promptly give written notice of such Change of Control to CureVac; and
(b) CureVac shall have the right to be released of any or all of its ongoing obligations under the Development Program, and of its obligations of disclosure and information exchange relating solely thereto. In addition, the JSC shall be dissolved upon CureVac’s request. For clarity, CureVac shall not have the right to be released from any obligations under this Agreement, the Manufacturing Services Agreement, or the Commercial Supply Agreement relating to the Programs or Licensed Products outside of the Development Program. For further clarity, CRISPR shall retain all rights hereunder to all Cas9 mRNA Constructs and any other deliverables delivered to CRISPR under the Development Program prior to such Change of Control, and CRISPR shall have the right to exploit such Cas9 mRNA Constructs and any other deliverables in accordance with the license grant set forth in Section 7.1.
(c) In addition to the confidentiality obligations according to Article 6, CRISPR shall take reasonable steps to ensure that any Confidential Information of CureVac provided under this Agreement is not shared with any others within CRISPR that are not required to manage, perform and exercise CRISPR’s rights and obligations under this Agreement.
13.6 Termination for Challenge of CureVac Licensed Patent Rights. CureVac may terminate this Agreement by providing [*****] prior written notice to CRISPR in the event CRISPR or any of its Affiliates directly or indirectly challenges the validity of the Licensed Patent Rights in a legal proceeding or supports a Third Party in the challenge of a Licensed Patent Right in a legal proceeding (in each case before a court of competent jurisdiction). Any such termination shall only become effective if CRISPR or its Affiliate has not withdrawn such action before the end of the above notice period. In the event a Sublicensee of CRISPR challenges the validity of a CureVac Licensed Patent Right, CureVac may terminate this Agreement hereunder, if CRISPR does not terminate such sublicense agreement within the [*****] notice period.
13.7 Remedies. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 13 are in addition to any other relief and remedies available to either Party under this Agreement and at law.
13.8 Effects of Expiration or Termination.
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(a) License Upon Expiration. Upon expiration, but not upon earlier termination of this Agreement, the licenses granted to CRISPR in Section 7.1 shall automatically covert to the license set forth in Section 5.5(e).
(b) Termination of Licenses. Upon any termination of this Agreement by a Party prior to expiration, except as otherwise provided in Section 13.5, as of the effective date of such termination, all licenses granted by CureVac to CRISPR under this Agreement shall terminate automatically, and the Licensed Intellectual Property shall automatically revert back to CureVac.
(c) Notwithstanding the foregoing, no termination of this Agreement shall be construed as a termination of any sublicense of any Sublicensee hereunder, and thereafter each such Sublicensee shall be considered a direct licensee of CureVac, provided (i) CureVac has approved such sublicense in accordance with Section 7.2; (ii) CureVac does not assume undertakings and liabilities towards the Sublicensee beyond those stipulated herein; and (iii) the Sublicensee is then in full compliance with all terms and conditions of its sublicense.
(d) Post-Termination Activities. Upon termination of this Agreement CRISPR shall provide CureVac with a written inventory of all Licensed Products that are in the process of Manufacture, in use or in stock; provided, however, that if CRISPR terminates this Agreement in part under Section 13.3, such inventory shall only apply to the Licensed Products subject to such partial termination. All Licensed Products that are not disposed of as provided above shall be delivered to CureVac or otherwise disposed of in CureVac’s sole discretion and at CRISPR’s sole expense.
(e) Accrued Payment Claims. Termination of this Agreement for any reason whatsoever shall not relieve CRISPR of its obligations to pay all royalties, milestones and other amounts payable to CureVac which have accrued prior to, but remain unpaid as of, the date of expiration or termination hereof.
(f) Reversion. In the event of termination of this Agreement by CRISPR pursuant to Section 13.3 or by CureVac pursuant to Section 13.2 or 13.4, CureVac shall be entitled to demand from CRISPR the transfer and/or assignment, as applicable, of all right, title and interest in and to any Cas9 mRNA Constructs, and all data related thereto. Under no circumstance shall CureVac be entitled to any CRISPR Background Intellectual Property, CRISPR Improvement, CRISPR’s Solely-Owned Foreground Intellectual Property, CRISPR’s interest in and to any Jointly-Owned Foreground Intellectual Property, or to any CRISPR Drug Product (as defined in the Manufacturing Services Agreement) or any data related to or generated through the use of or reference to a CRISPR Drug Product.
13.9 Surviving Provisions. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Article 6 (Confidentiality), Article 7 (Intellectual Property) (provided that Sections 7.1(a), 7.1(c), 7.2, and 7.3 shall not survive termination by CRISPR under Section 13.3 (Voluntary Termination by CRISPR) or any termination by CureVac under Article 13), Article 8 (with respect to Patent Rights Covering Know-How developed prior to Termination), Article 9 (Indemnification), Section 11 (Insurance, Limitation of Liability), Section 13.7 (Remedies), Section 13.8 (Effects of Expiration or Termination), Section 13.9 (Surviving Provisions), Article 14 (Dispute Resolution) and Article 15 (Miscellaneous, to the extent applicable), as well as any rights or obligations otherwise accrued hereunder (including any accrued payment obligations), shall survive the expiration or termination of this Agreement. Termination shall not relieve any Party from any liability which has accrued prior to such termination.
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Article 14
DISPUTE RESOLUTION
14.1 Mandatory Procedures. The Parties agree that any dispute arising out of or relating to this Agreement will be resolved solely by means of the procedures set forth in this Article 14, and that such procedures constitute legally binding obligations that are an essential provision of this Agreement. If either Party fails to observe the procedures of this Article 14, as may be modified by their written agreement, the other Party may bring an action for specific performance of these procedures in any court of competent jurisdiction.
14.2 Dispute Resolution Procedures. In the event of a dispute between the Parties (other than disputes arising out of the JSC), relating to the validity performance, construction or interpretation of this Agreement, upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Executive Officers of each Party. If the matter is not resolved within [*****] following the written request for discussions, either Party may then invoke the provisions of Section 14.3.
14.3 Any dispute (other than disputes arising from the JSC) relating to the validity performance, construction or interpretation of this Agreement, which cannot be resolved amicably between the Parties after following the procedure set forth in Section 14.2, shall be submitted to arbitration in accordance with the Arbitration Rules of WIPO in effect on the date of the commencement of the arbitration proceedings. The location of the arbitration proceedings will be London, England. The number of arbitrators will be three (3). The language of the arbitration proceeding will be English. The decision of the arbitrators shall be final and binding upon the Parties (absent manifest error on the part of the arbitrator(s)) and enforceable in any court of competent jurisdiction.
14.4 Performance to Continue. Each Party will continue to perform its undisputed obligations under this Agreement pending final resolution of any dispute arising out of or relating to this Agreement; provided, however, that a Party may suspend performance of its undisputed obligations during any period in which the other Party fails or refuses to perform its undisputed obligations.
14.5 Tolling. The Parties agree that all applicable statutes of limitation and time-based defenses, as well as all time periods in which a Party must exercise rights or perform obligation hereunder, will be tolled once the dispute resolution procedures set forth in this Section 14.5 have been initiated and for so long as they are pending, and the Parties will cooperate in taking all actions reasonably necessary to achieve such a result. In addition, during the pendency of any dispute under this Agreement initiated before the end of any applicable cure period, (a) this Agreement will remain in full force and effect, (b) the provisions of this Agreement relating to termination for material breach with respect to such dispute will not be effective, (c) the time period for cure as to any termination notice given prior to the initiation of arbitration will be tolled, (d) any time periods to exercise rights or perform obligations will be tolled; and (e) neither Party will issue a notice of termination pursuant to this Agreement based on the subject matter of the arbitration, until the arbitral tribunal has confirmed the material breach and the existence of the facts claimed by a Party to be the basis for the asserted material breach; provided, that if such breach can be cured by (i) the payment of money, the defaulting Party will have an additional [*****] within its receipt of the arbitral tribunal’s decision to pay such amount or (ii) the taking of specific remedial actions, the defaulting Party will have a reasonably necessary period to diligently undertake and complete such remedial actions within such reasonably necessary period or any specific timeframe established by such arbitral tribunal’s decision before any such notice of termination can be issued. Further, with respect to any time periods that have run during the pendency of the dispute, the applicable Party will have a reasonable period of time or any specific timeframe established by such arbitral tribunal’s decision to exercise any rights or perform any obligations affected by the running of such time periods.
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Article 15
MISCELLANEOUS
15.1 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof, unless the invalid or unenforceable provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid or unenforceable provision. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
15.2 Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be (a) delivered by hand or by FedEx, UPS or any other similar service with tracking capabilities, (b) registered mail, or (c) delivered by facsimile followed by delivery via any of the methods set forth in this Section 15.2, in each case, addressed as set forth below unless changed by notice so given:
If to CRISPR: | |||
CRISPR Therapeutics AG | |||
Baarerstrasse 14 | |||
6300 Zug | |||
Switzerland | |||
Attention: Chief Executive Officer | |||
and | |||
CRISPR Therapeutics Limited | |||
85 Tottenham Court Road | |||
London W1T 4TQ | |||
United Kingdom | |||
Attention: Chief Legal Officer | |||
with copies (which shall not constitute notice) to: | |||
Goodwin Procter LLP | |||
100 Northern Avenue | |||
Boston, MA 02210 | |||
Attention: | [*****] | ||
Facsimile: | [*****] | ||
Telephone: | [*****] | ||
and | |||
[*****] | |||
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If to CureVac: | ||
CureVac AG | ||
Paul-Ehrlich-Str. 15 | ||
72076 Tübingen | ||
Germany | ||
Attention: CEO and General Counsel |
Any such notice shall be deemed given on the date received. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 15.2.
15.3 Assignment. Neither Party may, without the consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, assign or transfer any of its rights and obligations hereunder; provided that no such consent is required for an assignment or transfer (in whole or in part) by either Party (a) to an Affiliate or (b) to a successor-in-interest by reason of merger or consolidation or sale of all or substantially all of the respective Party’s assets to which this Agreement relates; provided further that, with respect to an assignment or transfer by a Party in accordance with the prior provisions, (i) with respect to an assignment to a successor-in-interest, such assignment includes all relevant rights and obligations under this Agreement, and (ii) any assignee or transferee shall have agreed as of such assignment or transfer to be bound by the terms of this Agreement in a writing provided to the other Party. Subject to the foregoing, this Agreement shall inure to the benefit of and be binding on the Parties’ successors and permitted assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning, non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer. Upon request by CRISPR, the Parties shall cooperate to enter into a separate agreement or agreements with respect to one or more Programs covered under this Agreement (i.e. severing such Program(s) from this Agreement and covering them instead in a separate agreement having the same terms as this one but being limited to such Program or Programs), which separate agreement(s) may be assigned in accordance with the foregoing provisions of this Section 15.3.
15.4 Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by both Parties.
15.5 Governing Law. This Agreement shall be governed by and construed and interpreted in accordance with the laws of Switzerland; irrespective of the choice of laws principles of the laws of Switzerland, as to all matters, including matters of validity, construction, effect, enforceability, performance and remedies, provided, that questions affecting the construction and effect of any Patent Rights shall be determined by the law of the country in which the Patent Rights have been filed, granted or issued.
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15.6 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute CureVac and CRISPR as partners, agents, or joint venturers. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder.
15.7 Entire Agreement. This Agreement and the attached attachments constitutes the entire agreement between the Parties as to the subject matter of this Agreement and, as of the Effective Date, supersedes and merges all prior and contemporaneous negotiations, representations, agreements, and understandings regarding the same. The Material Transfer Agreement between the Parties dated June 13, 2016, as amended from time to time, and the Confidentiality Agreement between the Parties dated February 26, 2016 are being replaced as of the Effective Date, provided that the ownership rights with respect to any Intellectual Property (as defined in the Material Transfer Agreement) discovered, created, conceived or reduced to practice under the Material Transfer Agreement prior to the Effective Date will remain to be governed by the Material Transfer Agreement. This Agreement, and its attachments, may not be amended except in a writing signed by duly authorized representatives of the Parties expressly stating that it is amending this Agreement and identifying each provision being amended.
15.8 Counterparts. This Agreement may be executed in counterparts (whether delivered by facsimile or otherwise) with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
15.9 Interpretation.
(a) Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel, and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
(b) The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any and all” unless otherwise clearly indicated by context. The word “including” will be construed as “including without limitation.” The word “or” will be interpreted in the inclusive sense commonly associated with the term “and/or”.
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(c) Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument, or other document herein shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein or therein), (b) any reference to any Applicable Laws herein shall be construed as referring to such Applicable Laws as from time to time enacted, repealed, or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (d) all references herein to Articles, Sections, or Attachments, unless otherwise specifically provided, shall be construed to refer to Articles, Sections, and Attachments of this Agreement, and references to this Agreement includes all Articles, Sections, and Attachments hereof, (e) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in each of their entirety, as the context requires, and not to any particular provision hereof, (f) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, and (g) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging).
(d) Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.
15.10 Section 365(n).
(a) All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined in Section 101 of such Code. Each Party, as licensee, may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and any foreign equivalent thereto in any country having jurisdiction over a Party or its assets. The Parties further agree that, if a Party elects to retain its rights as a licensee under such Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the licensee Party not later than:
(i) the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under the Agreement, or
(ii) if not delivered under Section 15.10(a)(i), upon the rejection of this Agreement by or on behalf of the licensor, upon written request.
(b) Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code.
[Signature page follows.]
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CONFIDENTIAL
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement effective as of the Effective Date.
CureVac AG | CRISPR Therapeutics AG | ||
By: | /s/ Dr. Ingmar Hoerr | By: | |
Name: | Dr. Ingmar Hoerr | Name: | |
Title: | Chief Executive Officer | Title: |
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CONFIDENTIAL
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement effective as of the Effective Date.
CureVac AG | CRISPR Therapeutics AG | ||
By: | By: | /s/ Rodger Novak | |
Name: | Name: | Rodger Novak | |
Title: | Title: | Chief Executive Officer |
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EXECUTION COPY
CONFIDENTIAL
ATTACHMENT A
CRISPR Background Intellectual Property
A. [*****]
ATTACHMENT B
CureVac Background Intellectual Property
[*****]
ATTACHMENT C
Materials
Cas9 mRNA Constructs developed under this Agreement
ATTACHMENT D
Work Plan
[*****]
ATTACHMENT E
Manufacturing Services Agreement
[*****]
ATTACHMENT F
JSC Participants
[*****]
ATTACHMENT G
Alternative Program 1 Target List
[*****]
ATTACHMENT H
Disclosure Letter
[*****]
Exhibit 10.3
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT
- by and between -
CUREVAC GMBH
- and -
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
AUGUST 21, 2014
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
TABLE OF CONTENTS
1. | DEFINITIONS | 6 | |
2. | GRANT AND SCOPE OF LICENSE | 19 |
2.1 | LICENSE TO DEVELOP AND COMMERCIALIZE LICENSED VACCINES AND LICENSED PRODUCTS | 19 | |
2.2 | RIGHT TO SUBLICENSE | 19 | |
2.3 | TECHNOLOGY DATA PACKAGE TRANSFER | 20 | |
2.4 | DOCUMENTS AND DECLARATIONS | 20 | |
2.5 | NO ADDITIONAL RIGHTS | 21 | |
2.6 | TRADEMARKS, ETC | 21 |
3. | EXCLUSIVE OPTION | 21 |
3.1 | OPTION | 21 | |
3.2 | EXERCISE OF THE OPTION | 21 | |
3.3 | EXTENSION OF CUREV AC LICENSED INTELLECTUAL PROPERTY | 21 | |
4. | DEVELOPMENT OF LICENSED VACCINES | 22 | |
4.1 | NON-CLINICAL AND CLINICAL DEVELOPMENT SUPPORT | 22 | |
4.2 | DILIGENCE | 23 | |
4.3 | REGULATORY MATTERS | 25 | |
4.4 | COMPETING PRODUCTS | 26 | |
4.5 | DEVELOPMENT AND COMMERCIALIZATION COSTS | 26 |
5. | REPORTING OBLIGATIONS . | 27 |
5.1 | REGULATORY REPORTING | 27 | |
5.2 | SALES PROJECTIONS | 27 | |
5.3 | PHARMACOVIGILANCE | 27 |
6. | MANUFACTURE AND SUPPLY | 27 |
6.1 | CLINICAL SUPPLY | 27 | |
6.2 | PHASE III CLINICAL SUPPLY AND COMMERCIAL SUPPLY | 27 | |
6.3 | MANUFACTURING BY BI. | 29 | |
6.4 | PLASMID DNA AS PRECURSOR FOR LICENSED VACCINES | 32 | |
6.5 | MANUFACTURING BY BI AFTER EXPIRY OF THE AGREEMENT | 33 | |
6.6 | FILL AND FINISH | 33 | |
6.7 | CUREVAC'S LICENSE TO MANUFACTURE | 33 |
7. | CONSIDERATION | 34 |
7.1 | UPFRONT PAYMENT | 34 | |
7.2 | OPTION FEE | 34 | |
7.3 | DEVELOPMENT AND REGULATORY MILESTONE PAYMENTS | 34 | |
7.4 | SALES MILESTONE PAYMENTS | 36 | |
7.5 | OBLIGATION TO INFORM | 37 |
2
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
7.6 | MILESTONE PAYMENT TERMS | 37 | |
7.7 | NON-REFUNDABLE PAYMENTS | 37 | |
7.8 | ROYALTIES | 37 | |
7.9 | PAYMENT TERMS | 41 | |
7.10 | TAXES | 41 |
8. | JOINT STEERING COMMITTEE AND JOINT PROJECT TEAM | 42 |
8.1 | FORMATION OF THE JSC | 42 | |
8.2 | DECISION MAKING IN THE JSC | 42 | |
8.3 | RESPONSIBILITIES OF THE JSC | 42 | |
8.4 | MINUTES | 43 | |
8.5 | DECISION MAKING AUTHORITY | 43 | |
8.6 | EXPERT PANEL RESOLUTION | 44 | |
8.7 | JOINT PROJECT TEAM | 44 |
9. | INTELLECTUAL PROPERTY | 44 |
9.1 | OWNERSHIP OF BACKGROUND INTELLECTUAL PROPERTY | 44 | |
9.2 | OWNERSHIP OF COLLABORATION INTELLECTUAL PROPERTY | 45 | |
9.3 | ASSIGNMENT AND TRANSFER OF COLLABORATION INTELLECTUAL PROPERTY | 46 | |
9.4 | ASSIGNMENT AND TRANSFER OF CV9202 SPECIFIC PATENT RIGHTS | 47 | |
9.5 | MANAGEMENT OF CUREVAC LICENSED PATENT RIGHTS | 47 | |
9.6 | ENFORCEMENT OF CUREVAC LICENSED PATENT RIGHTS, JOINT PATENT RIGHTS, CV9202 SPECIFIC PATENT RIGHTS AND ASSIGNED PATENT RIGHTS | 49 | |
9.7 | INFRINGEMENT AND THIRD PARTY LICENSES | 51 | |
9.8 | PATENT TERM EXTENSION AND SUPPLEMENTARY PROTECTION CERTIFICATE | 52 | |
9.9 | CREATE ACT | 52 |
10. | CONFIDENTIALITY | 52 |
10.1 | OBLIGATION OF CONFIDENTIALITY | 52 | |
10.2 | ADDITIONAL OBLIGATIONS | 53 | |
10.3 | LIMITATIONS | 53 | |
10.4 | MATERIALS | 54 | |
10.5 | RETURN OF CONFIDENTIAL INFORMATION | 54 | |
10.6 | SURVIVAL | 55 | |
10.7 | PUBLIC ANNOUNCEMENTS | 55 | |
10.8 | APPLICABLE LAWS | 55 | |
10.9 | PUBLICATION | 56 |
11. | WARRANTIES AND LIABILITIES | 56 |
11.1 | REPRESENTATIONS AND WARRANTIES OF EACH PARTY | 56 |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
11.2 | ADDITIONAL REPRESENTATIONS AND WARRANTIES OF CUREVAC | 56 | |
11.3 | DISCLAIMER | 57 | |
11.4 | .LIMITATION OF LIABILITY | 58 |
12. | INDEMNIFICATION | 58 |
12.1 | CUREVAC'S OBLIGATIONS TO INDEMNIFY | 58 | |
12.2 | BI'S OBLIGATIONS TO INDEMNIFY | 59 | |
12.3 | INDEMNIFICATION PROCEDURES | 60 |
13. | TERM AND TERMINATION | 61 |
13.1 | EXPIRY | 61 | |
13.2 | TERMINATION FOR CONVENIENCE | 61 | |
13.3 | TERMINATION FOR MATERIAL BREACH | 61 | |
13.4 | TERMINATION FOR CHALLENGE OF CUREVAC LICENSED PATENT RIGHTS | 62 |
14. | CONSEQUENCES OF TERMINATION | 62 |
14.1 | REVERSION OF RIGHTS | 62 | |
14.2 | SELL OFF | 63 | |
14.3 | ACCRUED PAYMENT CLAIMS | 63 | |
14.4 | ACCESS TO REGULATORY APPROVALS AND BIINTELLECTUAL PROPERTY | 63 | |
14.5 | RE-ASSIGNMENT AND RE-TRANSFER OF CV9202 SPECIFIC PATENT RIGHTS AND ASSIGNED PATENT RIGHTS | 64 | |
14.6 | TERMINATION FOR CAUSE BY BI. | 64 | |
14.7 | WIND DOWN OR TRANSFER OF DEVELOPMENT WORK | 64 | |
14.8 | SURVIVAL | 65 |
15. | GENERAL PROVISIONS | 65 |
15.1 | ASSIGNMENT | 65 | |
15.2 | CHANGE OF CONTROL OF CUREVAC | 65 | |
15.3 | FORCE MAJE URE | 66 | |
15.4 | NOTICES | 66 | |
15.5 | GOVERNING LAW | 67 | |
15.6 | DISPUTE RESOLUTION | 67 | |
15.7 | SEVERABILITY | 68 | |
15.8 | ENTIRE AGREEMENT AND AMENDMENTS | 68 | |
15.9 | WAIVERS | 69 | |
15.10 | COUNTERPARTS | 69 | |
15.11 | INDEPENDENT CONTRACTORS | 69 | |
15.12 | LANGUAGE | 69 | |
15.13 | HEADINGS | 69 | |
15.14 | THIRD PARTIES | 69 | |
15.15 | COSTS | 69 |
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EXHIBITS | |
Exhibit 1.3 | BI Background Intellectual Property |
Exhibit 1.17 | CureVac Background Intellectual Property |
Exhibit 1.23 | CV9202 Specific Patent Rights |
Exhibit 1.34 | Requirements with respect to Invoices |
Exhibit 4.2 | CV9202 Development Plan |
Exhibit 4.3 | CMC Development-related and Manufacturing-related Documentation |
Exhibit 4.5A | Ongoing Clinical Trials as of the Effective Date |
Exhibit 4.5B | Description of CureVac's License Agreements with the Ludwig Institute for Cancer Research, the University of Zurich and Geneart AG |
Exhibit 6.1 | Clinical Supply Agreement |
Exhibit 6.2A | Terms and Conditions of a Phase III Clinical Supply Agreement between CureVac and BI |
Exhibit 6.2B | Terms and Conditions of a Commercial Supply Agreement between • CureVac and BI |
Exhibit 6.4A | Material Transfer and Feasibility Study Agreement |
Exhibit 6.4B | Terms and Conditions of a License Agreement with respect to the BI pDNA Process |
Exhibit 11.2 | Disclosures Regarding Representations and Warranties of CureVac |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT
This Exclusive Collaboration and License Agreement ("Agreement") is entered into on August 21, 2014 ("Effective Date"),
BY AND BETWEEN
CureVac GmbH, a German limited liability company with offices at Paul-Ehrlich-Str. 15, 72076 Tubingen, Germany ("CureVac");
AND
Boehringer Ingelheim International GmbH, a German limited liability company with offices at Binger StraBe 173, 55216 Ingelheim am Rhein, Germany ("BI").
RECITALS
WHEREAS, CureVac is a biotechnology company that is a pioneer and technology leader in mRNA-based vaccination approaches and especially discovers, designs and develops first-in-class mRNA vaccines and immune-therapies for the treatment of oncological diseases with unmet medical need;
WHEREAS, BI is a research based pharmaceutical company which possesses expertise relating to the research, development, manufacture, marketing and sale of pharmaceutical products, and BI aims to enter into the immunotherapeutic treatment of oncological diseases;
WHEREAS, CureVac wishes to grant an exclusive license and an exclusive option to BI, and BI wishes to take, an exclusive license and an exclusive option under such intellectual property rights; and
WHEREAS, the Parties wish (i) to mutually collaborate to Develop and Manufacture (each as defined below) the Licensed Vaccines and Licensed Products (as defined below) in the Territory (as defined below), and (ii) for BI to Commercialize (as defined below) the Licensed Vaccines and Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, the Parties hereby agree as follows:
1. | DEFINITIONS. |
For purposes of this Agreement, the following capitalized terms shall have the following meanings, whether used in the singular or plural:
1.1 | "Affiliate" shall mean and include with respect to any Party, (i) any legal entity of which the securities or other ownership interests representing fifty percent (50%) or more of the equity or fifty percent (50%) or more of the ordinary voting power or fifty percent (50%) or more of the general partnership interest are, at the time such determination is being made, owned, controlled or held, directly or indirectly, by such Party, or (ii) any legal entity which, at the time such determination is being made, is controlling or under common control with, such Party, provided, however, that regarding CureVac, Affiliate shall not include Mr. Dietmar Hopp and dievini Hopp BioTech holding GmbH & Co. KG and/or any other companies controlled by Mr. Dietmar Hopp and/or dievini Hopp BioTech holding GmbH & Co. KG. As used in this definition, the term "control", whether used as a noun or verb, refers to the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of a legal entity, whether through the ownership of voting securities, by contract or otherwise. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.2 | "Applicable Laws" shall mean all applicable provisions of all statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents, injunctions, awards, judgments, and permits as well as licenses of or from Regulatory Authorities relating to the development, use, manufacture, marketing or regulation of the subject item. |
1.3 | "BI Background Intellectual Property" shall mean Intellectual Property Controlled by BI or its Affiliates on the Effective Date and which is necessary or useful for the Manufacture, Development and Commercialization of the Licensed Vaccines and/or a Licensed Product (including an Afatinib Vaccine) in accordance with this Agreement, but excluding Intellectual Property related to the manufacture of plasmid DNA. The BI Background Intellectual Property includes the Intellectual Property listed in Exhibit 1.3 hereto. |
1.4 | "BI Collaboration Intellectual Property" shall mean the Collaboration Intellectual Property Controlled by BI including Bl's share in jointly owned Collaboration Intellectual Property. |
1.5 | "BI Intellectual Property" shall mean |
(a) | BI Background Intellectual Property; and |
(b) | BI Collaboration Intellectual Property. |
1.6 | “Biosimilar Product” shall mean a biological medicinal product that is equivalent to a biological medicinal product that has previously obtained regulatory approval and which has an active substance that is equivalent to the active substance of the biological reference medicinal product. |
1.7 | "Calendar Quarter(ly)" shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect. |
1.8 | "Clinical Trials" shall mean all clinical trials to be conducted with respect to the Development of the Licensed Vaccines, including Phase I Clinical Trials, Phase II Clinical Trials and Phase III Clinical Trials. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.9 | "CMC Development" shall mean all research and development activities conducted in respect of the Manufacture of the Licensed Vaccines, including chemistry, manufacturing and control (CMC), test method development and stability testing, process development, manufacturing scale-up, qualification and validation, and any other activity necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining Regulatory Approvals to successfully Manufacture the Licensed Vaccines for use in the Field. |
1.10 | "Collaboration Intellectual Property" shall mean any Intellectual Property generated by or on behalf of either Party under this Agreement with the exception of Intellectual Property related to the BI pDNA Process and generated under a Related Agreement specific to such BI pDNA Process. |
1.11 | "Combination Product" shall mean a pharmaceutical formulation containing as its active ingredients both a Licensed Vaccine and one or more other therapeutically active ingredients, that is packaged and labeled for sale in the Territory. |
1.12 | "Commercialization" shall mean any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Product, including activities related to marketing, promoting, labelling, packaging, distributing, importing and exporting such Licensed Products, and interacting with Regulatory Authorities regarding any of the foregoing. For the avoidance of doubt, "Commercialization" shall not include the Manufacture of Licensed Vaccines. When used as a verb, to "Commercialize" and "Commercializing" shall mean to engage in Commercialization, and "Commercialized" has a correlative meaning. |
1.13 | "Commercially Reasonable Efforts" shall mean, with respect to the efforts to be expended by a Party with respect to any objective, the reasonable, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances. It is understood and agreed that with respect to the Development and Commercialization of Licensed Vaccines and Licensed Products by BI, such efforts shall be substantially equivalent to those efforts and resources commonly used by BI for pharmaceutical development candidates or products owned by it or to which it has rights, which development candidate or product is at a similar stage in its Development or product life and is of similar market potential taking into account all scientific, commercial and other factors that BI would take into account, including efficacy, safety, expected and actual cost and time to Develop, expected and actual profitability, approved labelling, the competitiveness of alternative products in the marketplace, the expected and actual market exclusivity (including patent and other proprietary position and regulatory exclusivity) of the Licensed Vaccines and Licensed Products, the expected and actual amounts of marketing and promotional expenditures and the likelihood of receipt of a Regulatory Approval given the Regulatory Authority involved. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.14 | "Confidential Information" shall mean and include all Know How including Know How comprised in the CureVac Licensed Intellectual Property, and Know How comprised in the BI Intellectual Property, and all other proprietary information, Development Data and Materials, not in the public domain, relating to the Licensed Vaccines and Licensed Products, Afatinib, the Field, the indications, or the business, affairs, research and development activities, results of pre-clinical and clinical trials, national and multinational regulatory proceedings and affairs, finances, plans, contractual relationships and operations of the Parties. The terms and conditions of this Agreement shall be considered Confidential Information of both Parties. |
1.15 | "Co-Packaged Product" shall mean a single packaged product containing a Licensed Vaccine and one or more other therapeutically or prophylactically active products (including [*****]) as separate components in a co-packaged form, that is packaged and labeled for sale in the Territory. |
1.16 | "Control" or "Controlled" shall mean with respect to the subject item or right, the ability (whether by ownership or license, other than pursuant to this Agreement) by a Party to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement or other arrangement with any Third Party. |
1.17 | "CureVac Background Intellectual Property" shall mean Intellectual Property Controlled by CureVac or its Affiliates on the Effective Date and which is necessary or useful for the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products in accordance with this Agreement. The CureVac Background Intellectual Property includes the Intellectual Property listed in Exhibit 1.17 hereto. CureVac Background Intellectual Property includes the CV9202 Specific Patent Rights until such CV9202 Specific Patent Rights are assigned and transferred to BI in accordance with Section 9.4 below. CureVac Background Intellectual Property will also include the antigen specific Intellectual Property, if any, to be licensed upon exercise of the Option in accordance with Section 3.3 below. |
1.18 | "CureVac Collaboration Intellectual Property" shall mean the Collaboration Intellectual Property Controlled by CureVac or its Affiliates including CureVac's share in jointly owned Collaboration Intellectual Property and where such Collaboration Intellectual Property is necessary or useful for the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products in accordance with this Agreement. |
1.19 | "CureVac Licensed Intellectual Property" shall mean |
(a) | CureVac Background Intellectual Property; and |
(b) | CureVac Collaboration Intellectual Property. |
1.20 | "CureVac Licensed Patent Rights" shall mean the Patent Rights which form part of the CureVac Licensed Intellectual Property. |
1.21 | "CureVac Licensed Manufacturing Intellectual Property" shall mean the Intellectual Property including the Collaboration Intellectual Property including CureVac's share in jointly owned Collaboration Intellectual Property, in each case as Controlled by CureVac or its Affiliates on the date when BI takes over the CMC Development and Manufacturing of the Licensed Vaccines in accordance with Sections 6.3 or 6.5 below, if ever, and where such Intellectual Property is necessary or useful for the CMC Development and/or Manufacturing of the Licensed Vaccines and Licensed Products in accordance with this Agreement. The CureVac Licensed Manufacturing Intellectual Property as of the date when BI takes over the CMC Development and Manufacture will be listed at the respective time. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.22 | "CV9202" shall mean CureVac's clinical product candidate which consists [*****]. |
1.23 | "CV9202 Specific Patent Rights" shall mean the Patent Rights listed in Exhibit 1.23 hereto which will be assigned and transferred to BI under the conditions set forth in Section 9.4 below. |
1.24 | "Development" shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the Licensed Vaccines and Licensed Products, including those necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining Regulatory Approvals and to successfully Develop, Manufacture and Commercialize the Licensed Vaccines and Licensed Products for use in the Field. "Development" shall include chemistry, Manufacturing and control (CMC), test method development and stability testing, formulation development, delivery system development, non-clinical testing, mechanism studies, toxicology, pharmacokinetics, clinical studies, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, regulatory affairs activities, statistical analysis and report writing, submission of documents, market research, pharmacoeconomic studies, and epidemiological/real world data studies. Development shall mean both (a) Non-clinical and Clinical Development; and (b) CMC Development. "Develop" and "Developed" have a correlative meaning. |
1.25 | "Development Data" shall mean (i) reports of non-clinical studies and Clinical Trials, (ii) CMC Development data; and (iii) all other documentation containing or embodying any non-clinical or clinical data relating to the Licensed Vaccines and Licensed Products or the use of the Licensed Vaccines and Licensed Products in the Field, such data in each case (i) and (ii) required for the Development and Commercialization of the Licensed Vaccines and Licensed Products, including but not limited to, registration dossiers. |
1.26 | "Development Plan(s)" shall mean a plan to be mutually agreed between the Parties, as amended by the JSC from time to time, that describes the Development work to be carried out with respect to a Licensed Vaccine and/or Licensed Product, including the responsibilities of each Party, timelines and resource allocation. |
1.27 | "Field" shall mean all uses for cancer (including all infection induced tumor types) in humans, including the treatment, prevention, diagnosis and control of cancer. |
1.28 | "First Commercial Sale" shall mean, on a country-by-country basis, the first sale of each Licensed Product by or on behalf of BI, its Affiliates or Sublicensees to a Third Party customer in such country in exchange for cash or some equivalent to which financial value can be assigned after such Licensed Product has been granted all Regulatory Approvals by the applicable authorities of such country. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.29 | "FTE" shall mean a full time equivalent person-year based upon a total of [*****] working hours per calendar year of scientific or technical work carried out by a duly qualified employee of CureVac on or directly related to the work to be conducted under the Agreement. Overtime, and work on weekends, holidays and the like shall not be counted with any multiplier (e.g. time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. The portion of a FTE billable by CureVac for one (1) individual during a given accounting period shall be determined by dividing the number of hours worked by said individual on the work to be conducted under the Agreement during such accounting period and the number of FTE hours applicable for such accounting period based [*****] working hours per calendar year. |
1.30 | "FTE Rate(s)" shall mean, with respect to the following categories of CureVac employees: |
(a) | Clinical: [*****]; |
(b) | Scientist: [*****]; |
(c) | Technician: [*****], |
The FTE Rates include all internal overhead and costs of consumables (unless explicitly specified otherwise in the Development Plans). Excluded are consumable costs for immunomonitoring and exploratory biomarker work as specified in the Development Plans and the costs of Licensed Vaccines. If the consumer price index as published by the German Federal Statistical Office (Statistisches Bundesamt) changes by more than [*****] compared to the month of the Effective Date, the FTE Rates shall be adjusted accordingly with effect as of the month following such adjustment. The preceding sentence shall apply mutatis mutandis for subsequent changes of the consumer price index compared to the month of the last adjustment of the FTE Rates.
1.31 | "Generic Competition" shall mean and shall be deemed to exist in a particular country in the Territory with respect to a particular Licensed Product in a given calendar quarter if in such country during such calendar quarter one or more Generic Products (other than a Generic Product sold by BI or its Affiliates or by a Sublicensee under a license granted by BI or its Affiliates) in the aggregate account for more than [*****] of the sum of (i) the aggregate unit sales of such Licensed Product sold by BI or its Affiliates or Sublicensees in such country, and (ii) the aggregate unit sales of the respective Generic Product in such country, as measured by IMS standard units sold based on data provided by IMS International or, if such data is not available, such other reliable data source as reasonably agreed upon by CureVac and BI. If no data is commercially available, then the Parties shall agree upon a methodology for estimating the percentage unit-based market share of Generic Products in such country. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.32 | "Generic Product" shall mean, with respect to a particular Licensed Product in a particular country, (i) any pharmaceutical product (other than the Licensed Product) that contains the same active ingredient(s) in a comparable quality and quantity as such Licensed Product, irrespective of its pharmaceutical form, and is approved for the same indication as such Licensed Product, as applicable, under an Abbreviated New Drug Application or under 505(b)(2) of the United States Federal Food, Drug and Cosmetic Act or any similar abbreviated route of approval in such country, or (ii) any biologic medicinal product (other than the Licensed Product) that is a Biosimilar Product of such Licensed Product, and is approved under a Biological Product Licensure application submitted by any person under 42 U.S.C. § 262(k) or any similar abbreviated route of approval in such country. |
1.33 | "Intellectual Property" shall mean any and all Know How (including copyright and other rights therein), Patent Rights and any trade secrets, trade dress, housemarks and trademarks. |
1.34 | "Invoice" shall mean an original invoice sent by CureVac to BI with respect to payment due hereunder containing the information and meeting the requirements as set forth in Exhibit 1.34. The Parties shall modify the Invoice requirements by written agreement in the event of a change in the Applicable Laws. |
1.35 | "Know How" shall mean all technical, scientific and other information, inventions, discoveries, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, expressed ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, Development Data, results, pre-clinical, clinical, safety, manufacturing and quality control data and information (including trial designs and protocols), registration dossiers and assay and biological methodology, in each case, solely to the extent confidential and proprietary and in written, electronic or any other form now known or hereafter developed. For the avoidance of doubt, Know How includes any such information comprised or embodied in the Materials, if any. For the further avoidance of doubt, any of the foregoing that, through no fault of either of the Parties hereto, its Affiliates or Sublicensees is published or otherwise falls within the public domain shall no longer be deemed Know How. |
1.36 | "Licensed Product(s)" shall mean a Licensed Vaccine packaged and labeled for sale in the Territory. Unless otherwise set forth herein, Licensed Products shall include Combination Products and Co-Packaged Products. For purposes of this Agreement, Licensed Products (i) being based on different Licensed Vaccines and/or (ii) being Commercialized under a different label and brand (and not only under a label extension of the original Licensed Product) shall be considered separate Licensed Products. For clarity, the Afatinib Vaccine, the Chemo-Radiation Vaccine and the Checkpoint Inhibitor Vaccine shall be considered one and the same Licensed Product, provided they are based on CV9202. Changes to the delivery system and/or formulation of a Licensed Vaccine and/or the addition of a new indication do not result in an additional Licensed Product unless such altered Licensed Product is Commercialized under a different label and brand (and not only under a label extension of the original Licensed Product). |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.37 | "Licensed Vaccine(s)" shall mean any of the following vaccines: (i) CV9202; and (ii) the [*****] possible vaccines each consisting of [*****], in each case for use in the Field. Upon exercise of the option in accordance with Section 3.2 below, the definition of Licensed Vaccine(s) shall be expanded by the inclusion of (iii) the Option Vaccine. For the avoidance of doubt, subject only to the Option Vaccine, a vaccine comprising CV9202 plus one or more additional RNActive-encoded antigen components is not a Licensed Vaccine. For clarity, this Agreement applies to [*****] Licensed Vaccines including the one (1) Option Vaccine. |
1.38 | "Major Market Country" shall mean the [*****]. |
1.39 | "Manufacture" shall mean all manufacturing operations (including bulk and formulation as well as fill and finish) for Licensed Vaccines, including all activities related to the synthesis, making, production, processing, purifying, formulating, filling, and finishing, of the Licensed Vaccine, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. "Manufacturing" has a correlative meaning. |
1.40 | "Materials" shall mean any and all proprietary tangible materials (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical materials), including reagents, research tools and compositions of matter. For the avoidance of doubt, Material shall include CV9202. |
1.41 | "Net Sales" shall mean the gross amount of sales of Licensed Products invoiced by BI, its Affiliates or Sublicensees to Third Parties, less: |
(a) | sales returns and allowances actually paid, granted or accrued, including trade, quantity and cash discounts and any other adjustments, including those granted on account of price adjustments or billing errors, rejected goods, damaged or defective goods, recalls, returns; |
(b) | rebates, chargeback rebates, compulsory rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions and compulsory payments to governmental authorities and any other governmental charges imposed upon the sale of such Licensed Product to Third Parties; |
(c) | adjustments arising from consumer discount programs or other similar programs; |
(d) | non-collectable receivables related to such Licensed Product; |
(e) | customs or excise duties, sales tax, consumption tax, value added tax, and other taxes (except income taxes); and |
(f) | charges for packing, freight, shipping and insurance (to the extent that BI, its Affiliates or Sublicensees bear such cost). |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
Each of the foregoing deductions shall be determined as incurred in the ordinary course of business in type and amount consistent with good industry practice and in accordance with generally accepted accounting principles or more specifically, the principles of the German commercial code (Handelsgesetzbuch) on a basis consistent with Bl's audited consolidated financial statements. All such discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated to the Licensed Products and other products of BI and its Affiliates and Sublicensees such that the Licensed Product does not bear a disproportionate portion of such deductions.
For sake of clarity and avoidance of doubt, sales by BI, its Affiliates or Sublicensees of a Licensed Product to any Third Party which distributes products directly to customers in countries where BI has no Affiliate or Sublicensee (e.g., a permitted recognized agent or a third party distributor) shall be considered sales to a Third Party.
Supply of Licensed Products other than for cash shall be substituted to price on bona fide arm's length sales; whereas the price shall be the average price of such Licensed Product sold for cash during the period based on quantity of drug substance sold.
Any Licensed Product used for promotional or advertising purposes or used for clinical trials or other research purposes shall not be included in Net Sales. Donations for charity reasons shall also not be Net Sales.
1.42 | "Non-clinical and Clinical Development" shall mean any Development other than CMC Development. |
1.43 | "Party" or "Parties" shall mean BI or CureVac, or BI and CureVac, as the context admits. |
1.44 | "Patent Right" shall mean any and all (i) issued patents, patent applications, and future patents issued from any such patent applications; (ii) future patents issued from a patent application filed in any country worldwide which claims priority from a patent or patent application of (i); and (iii) reissues, confirmations, renewals, extensions, counterparts, divisions, continuations, continuations-in-part, supplemental protection certificates or utility models based on any patent or patent application of (i) or (ii). |
1.45 | "Person" shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
1.46 | "Phase I Clinical Trial" shall mean a study of a Licensed Vaccine in human subjects principally for determining initial tolerance, immunogenicity, safety and/or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens. |
1.47 | "Phase I/II Clinical Trial" shall mean a study of a Licensed Vaccine in human subjects which meets the objectives of both a Phase I Clinical Trial and a Phase II Clinical Trial. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.48 | "Phase II Clinical Trial" shall mean a study of a Licensed Vaccine in human subjects principally to determine initial clinical efficacy, immunogenicity, and dose range finding before embarking on Phase III Clinical Trials, including any Phase II Clinical Trial which is part of a Phase I/II Clinical Trial or a Phase I through Phase III seamless design Clinical Trial. |
1.49 | "Phase II/III Clinical Trial" shall mean a study of a Licensed Vaccine in human subjects which meets the objectives of both a Phase II Clinical Trial and a Phase III Clinical Trial. |
1.50 | "Phase III Clinical Trial" shall mean a pivotal study of a Licensed Vaccine in human subjects with a defined dose or a set of defined doses of a Licensed Vaccine principally for the purpose of preparing and submitting applications for Regulatory Approval to the competent Regulatory Authorities in a country of the world, including any Phase III Clinical Trial which is part of a Phase II/III Clinical Trial or a Phase I through Phase III seamless design Clinical Trial. |
1.51 | "Related Agreements" shall mean and include all present and future clinical and commercial supply agreements, feasibility agreements, development agreements and license agreements related to the Licensed Vaccines and/or the BI pDNA Process and concluded between the Parties, including the Clinical Supply Agreement, or concluded between CureVac and BI Bio. |
1.52 | "Regulatory Approvals" shall mean and include all licenses, permits, authorizations and approvals of, and all registrations, filings and other notifications to, any Regulatory Authority within the Territory, including the United States Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA), necessary or appropriate for the Development and Commercialization of the Licensed Vaccines and Licensed Products within the Field and in a particular country or region of the Territory. |
1.53 | "Regulatory Authorities" shall mean any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country in the Territory involved in the reviewing, granting or revoking of Regulatory Approvals. |
1.54 | "RNActive" shall mean CureVac's technology with respect to mRNA encoding an antigenic protein that is expressible in human cells as well as the same mRNA formed as a complex with protamine. |
1.55 | "Sublicensee" shall mean any Third Party licensee (aside from Bl's Affiliates and any Third Party contractors used by BI in the Non-clinical and Clinical Development and Commercialization of the applicable Licensed Vaccine and/or Licensed Product on Bl's behalf) which obtains rights to the CureVac Licensed Intellectual Property, regardless of whether such license is granted by BI, its Affiliates or any Sublicensee. |
1.56 | "Target Product Profile (TPP)" shall mean the comprehensive description of the properties which each of the Licensed Vaccines and Licensed Products is intended to have at approval. For each Licensed Vaccine more than one TPP may be defined (e.g., the Afatinib Vaccine and the Chemo-Radiation Vaccine). The Target Product Profile defines the objectives for the Development and creates the basis for the respective Development Plan. |
15
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
1.57 | "Taxes" shall mean all present and future taxes, import deposits assessments, and other governmental charges and any related penalties and interest not attributable to the fault or delay of BI. |
1.58 | "Territory" shall mean the entire world. |
1.59 | "Third Party" shall mean any Person aside from BI and its Affiliates and/or CureVac and its Affiliates. |
1.60 | "Valid Claim" shall mean with respect to a particular country, and in each case to the extent contained within (i) a Patent Right which forms part of the CureVac Background Intellectual Property or (ii) a CV9202 Specific Patent Right |
(a) | any claim of an issued and unexpired patent in such country that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is un-appealed or un-appealable within the time allowed for appeal; and (ii) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise in such country; or |
(b) | a claim of a pending patent application, which claim has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application; provided, however, that once the priority date or earliest filing date to which the pending patent application that comprises such claim refers is more than [*****] old, such claim shall not constitute a Valid Claim for purposes of this Agreement anymore unless and until a patent issues with such claim. |
The word "including" or any variation thereof means "including without limitation" or any variation thereof and shall not be construed to limit any general statement which it follows to the specific or similar items or matters immediately following it.
Each of the following definitions is set forth in the Section of this Agreement indicated below:
DEFINITION | SECTION |
[*****] Process | 6.3.1 |
Additional Cure Period | 13.3 |
Afatinib Vaccine | 4.2.3 |
Agreement | Preamble |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
DEFINITION | SECTION |
Alleged Breaching Party | 13.3 |
Assigned Patent Rights | 9.5.3 |
BI | Preamble |
BI Bio | 6.4 |
BI Claim | 12.1 |
BI Losses | 12.1 |
BI Party | 12.1 |
BI pDNA Process | 6.4 |
Breaching Party | 13.3 |
Change of Control | 15.2 |
Checkpoint Inhibitor Vaccine | 7.3.1 |
Chemo-Radiation Vaccine | 4.2.3 |
Claim | 12.3.1 |
Clinical Supply Agreement | 6.1 |
Commercial Facility | 6.3.1 |
Competing Product | 4.4 |
Continuation | 7.3.2 |
CureVac | Preamble |
CureVac Claim | 12.2 |
CureVac Losses | 12.2 |
CureVac DMF | 4.3 |
CureVac Party | 12.2 |
CV9202 Development Plan | 4.2.1 |
Data Package | 2.3 |
Disclosing Party | 10.1 |
Dispute Resolution Panel | 13.3 |
DIS Rules | 15.6.2 |
Effective Date | Preamble |
Expert Panel | 8.6 |
Initiation | 7.3.2 |
Joint Collaboration Intellectual Property | 9.2.2 |
Joint Invention(s) | 9.2.2 |
Joint Patent Right(s) | 9.2.2 |
Joint Project Team | 8.7 |
Joint Steering Committee | 8.1 |
JSC | 8.1 |
LICR | 4.2.5 |
LICR Collaboration Agreement | 4.2.5 |
Non-Breaching Party | 13.3 |
Option Period | 3.1 |
Option Vaccine | 3.1 |
Permitted Third Party CMO | 6.3.2 |
Receiving Party | 10.1 |
Royalty Term | 7.8.3 |
Third Party Licensor | 9.7.1 |
17
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
2. | GRANT AND SCOPE OF LICENSE. |
2.1 | License to Develop and Commercialize Licensed Vaccines and Licensed Products. CureVac hereby grants to BI as of the Effective Date and for the term of this Agreement, and BI hereby accepts, the exclusive license to the CureVac Licensed Intellectual Property for the Non-clinical and Clinical Development, and the Commercialization of Licensed Vaccines and Licensed Products for use in the Field and in the Territory, in accordance with the terms and conditions, and subject to the limitations of this Agreement. Furthermore, BI is entitled to manufacture Licensed Products (but not to Manufacture Licensed Vaccines, subject only to Sections 6.3, 6.5 and 6.6 below). The license shall include the right for the research, development, manufacture, use and commercialization of any diagnostic tools and delivery systems (including formulations required for such delivery systems) required or useful for the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products, provided, however, that (i) as of the Effective Date the CureVac Licensed Intellectual Property, except for the Patent Rights identified by the patent family identifier [*****], does not contain any Intellectual Property specific to delivery systems, (ii) CureVac is not obligated to grant rights to BI under Intellectual Property specific to delivery systems and in-licensed by CureVac from Third Parties, and (iii) CureVac gives no representation or warranty that such research, development, manufacture use or commercialization may be possible or successful. The license is exclusive (even as to CureVac), except to the extent set forth in Exhibit 11.2. For example, the rights granted under this Section 2.1 (a) include a non-exclusive sublicense under the Patent Rights identified by the patent family identifiers as [*****] in Exhibit 1.17; (b) include an extension of CureVac's rights to BI, its Affiliates, subcontractors and permitted Sublicensees as "Direct Collaboration Partner" or "Indirect Collaboration Partner" under the Patent Rights identified by the patent family identifiers [*****] in Exhibit 1.17 and licensed to CureVac by Geneart AG, and (c) the Patent Rights identified by the patent family identifiers [*****] in Exhibit 1.17 are subject to a non¬exclusive license granted to BioNTech AG, as applicable; the terms and conditions being disclosed to BI and listed in Exhibit 11.2 hereto, and all the rights and licenses listed in (a) to (b) above are subject to the respective head license agreement as set forth in Exhibit 11.2. Furthermore, the licenses are subject to CureVac's right to perform its obligations hereunder. |
2.2 | Right to Sublicense. |
2.2.1 | BI shall be entitled to sublicense its rights under Section 2.1 above to any of its Affiliates. Furthermore, BI is entitled to (i) engage Third Party contractors to Non-clinically and Clinically Develop and Commercialize the Licensed Vaccines and Licensed Products on BI's behalf and (ii) to authorize wholesalers and other distributors to Commercialize the Licensed Vaccines and the Licensed Products. Any other sublicenses to Third Parties require CureVac's prior written consent. CureVac will not unreasonably withhold or delay its consent with respect to sub licenses for the Commercialization of the Licensed Vaccines and Licensed Products after receipt of Regulatory Approval on a country-by-country basis. |
19
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
2.2.2 | Any right to sublicense to a Sublicensee is subject to the respective sublicense agreement containing terms and conditions that are not inconsistent with those contained in this Agreement, and shall include provisions regarding CureVac's back licenses, CureVac's rights to Collaboration Intellectual Property, confidentiality, indemnification, audit, record¬keeping and termination for CureVac's protection that are consistent with those provided herein. BI shall remain liable to CureVac for all obligations under this Agreement, including payment to CureVac of any amounts due on account of sales or other disposition of Licensed Products by Sublicensees. BI shall notify CureVac in writing of any sublicensing agreement (except intra company sublicensing agreements with Bl's Affiliates and any agreements with CMOs, CROs, distributors and wholesalers) within [*****] after its execution. Upon request, BI shall provide to CureVac a copy of such sublicensing agreement (except intra company sublicensing agreements with Bl's Affiliates and any agreements with CMOs, CROs, distributors and wholesalers), provided that the agreement may be redacted to the extent not necessary for CureVac to understand the scope of such sublicense and determine if BI is in compliance with this Section 2.2.2. All information provided by BI to CureVac under this Section 2.2.2 will be deemed to be Confidential Information of BI and will be subject to the terms of Article 10 hereof. |
2.3 | Technology Data Package Transfer. In furtherance of the rights and licenses granted by CureVac to BI under this Agreement, during the first [*****] after the Effective Date CureVac shall furnish to BI within [*****] of Bl’s prior request, a data package that shall include all details of the CureVac Licensed Intellectual Property which are required for the Non-clinical and Clinical Development by BI of the Licensed Vaccines ("Data Package"). For clarity and subject to Sections 6.3 and 6.5 below, while CureVac will remain the holder of the CureVac DMF and BI has no right under this Agreement to modify or amend the CureVac DMF or to file the same with any authority, such Data Package shall include all CMC-related documents to the extent such documents are existing and Controlled by CureVac and which are needed for regulatory purposes, in particular the most recent, entire drug master file for CV9202. For the avoidance of doubt, failure by BI to request the Data Package shall not constitute a waiver of any of Bl’s rights under this Agreement. BI shall not use any of the Data Package furnished by CureVac under this Section 2.3 for any purpose whatsoever, except as authorized in this Agreement or any Related Agreement. In the event BI reasonably believes that the Data Package furnished by CureVac under this Section 2.3 is incomplete, within [*****] of receipt of the Data Package, BI shall provide written notice thereof to CureVac, and CureVac shall furnish such missing data concerning such Data Package within [*****] after receipt of BI's written notice hereunder. As part of the Non-clinical and Clinical Development Support to be provided by CureVac under Section 4.1 below, CureVac shall answer all reasonable questions received from BI regarding such transferred Data Package as soon as reasonably possible after receipt. |
2.4 | Documents and Declarations. CureVac shall execute all documents, give all declarations regarding the licenses granted hereunder and reasonably cooperate with BI to the extent such documents, declarations and/or cooperation are required for the recording or registration of the licenses granted hereunder at the various patent offices in the Territory for the benefit of BI. BI shall reimburse CureVac for its reasonable external out-of-pocket costs associated therewith. ‘ |
20
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
2.5 | No Additional Rights. Nothing in this Agreement shall be deemed or implied to be, and the Parties disclaim all implied rights to, the grant by either Party to the other Party of any right, title or interest in any product, Intellectual Property, any formulation technology, operating procedures, marketing materials or strategies, intangibles, material or proprietary rights except as are expressly set forth in this Agreement. |
2.6 | Trademarks, Etc. For the avoidance of doubt, BI, its Affiliates and its permitted Sublicensees shall be solely responsible for selecting and shall retain all ownership and control over all designs, trade dress and trademarks, and Bl's, its Affiliates' and its permitted Sublicensees' use with respect to the Licensed Products, and subject only to Section 14.4, CureVac shall have no rights whatsoever to the use thereof. |
3. | EXCLUSIVE OPTION |
3.1 | Option. As of the Effective Date and in consideration for the option fee as set forth in Section 7.2, CureVac hereby grants to BI, and BI hereby accepts, an exclusive option for a maximum term of ten (10) years after the Effective Date ("Option Period") to obtain one additional exclusive license, for no additional fee, to use the CureVac Licensed Intellectual Property with regard to one additional vaccine that consists of [*****] for use in the Field ("Option Vaccine"). For clarity, in order to protect Bl's exclusive option, during the Option Period CureVac shall not grant any license to any Third Party for [*****]. |
3.2 | Exercise of the Option. BI may exercise the option under Section 3.1 once by way of written notice to CureVac during the Option Period. In such notice, BI shall propose to CureVac a [*****] and CureVac shall only be entitled to withhold its consent to such [*****] if - at the time BI exercises the option and proposes a [*****] - neither CureVac nor BI Controls the rights required to include the proposed [*****] in the Option Vaccine. Upon written agreement on the identity of such [*****] the exercise of such option shall become effective for the Option Vaccine in respect of such agreed [*****], and the option rights under this Article 3 shall terminate. |
3.3 | Extension of CureVac Licensed Intellectual Property. In the event CureVac Controls any additional Intellectual Property which is specific to [*****] selected by BI (e.g., Patent Rights protecting the composition of matter or use of such antigen) and is not licensed under Section 2.1, it shall inform BI hereof and upon exercise of the Option the CureVac Background Intellectual Property shall also include such specific additional Intellectual Property, provided, that BI reimburses CureVac for all past and future payments towards Third Parties, if any, solely to the extent such payments are required for the use of such additional Intellectual Property for the Non-clinical and Clinical Development and Commercialization of the Option Vaccine. |
21
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
4. | DEVELOPMENT OF LICENSED VACCINES. |
4.1 | Non-clinical and Clinical Development Support. |
4.1.1 | BI and CureVac will collaborate on the Development of the Licensed Vaccines, and CureVac will provide certain activities to progress the Non-clinical and Clinical Development of the Licensed Vaccines. Such activities shall include the wind down in an orderly fashion of all already ongoing Phase I Clinical Trials set forth in Exhibit 4.5A as sponsor of such study, and CureVac shall provide electronic copies of all Development Data, in particular all safety, efficacy and immunomonitoring data, of such Clinical Trials to BL Furthermore, CureVac will provide certain activities to ensure, inter alia, a smooth transition of the Non-clinical and Clinical Development of the Licensed Vaccines to BL The scope of the activities to be performed by CureVac, the number of Cure Vac's FTEs to perform such activities, and the budget estimations to perform such activities (including CureVac’s out of pocket expenses) are set out in the respective Development Plans for the Licensed Vaccines. In addition to the FTE Rates, BI shall compensate any out of pocket expenses incurred by CureVac in accordance with the Development Plans. CureVac shall be required to make the FTEs set forth in the Development Plans available, and BI shall fully compensate such agreed FTE resources during the agreed time period and at the FTE Rates. The FTE resource commitments shall be binding on both Parties on a [*****] rolling basis. The compensation is to be paid by BI to CureVac on a Calendar Quarterly basis. Payment shall be made in arrears and within [*****] upon receipt of an Invoice detailing with supportive documentation, the FTE costs and out of pocket expenses applicable to CureVac’s efforts for such applicable Calendar Quarter period, such information to include the work packages of the Development Plans worked on, the number and type of FTE assigned to each work package and the out of pocket expenses. Notwithstanding the foregoing, CRO costs incurred by CureVac after the Effective Date in connection with the Phase I Clinical Trials listed in Exhibit 4.5A shall be invoiced separately by CureVac upon CureVac’s receipt of such CRO's invoice, and irrespective of whether such payments are made in advance or in arrears, such Invoice to be due and payable within [*****] upon receipt of such Invoice by BI, provided that if BI reimburses CureVac for advance payments made by CureVac to CROs, CureVac shall provide the final actual cost per invoiced period and a true up of actual cost compared to advance payment (planned cost) to BL If the advance payment(s) turn out to be higher than the actual cost incurred by CureVac, CureVac shall reimburse the respective amount of the advance payment to BL |
4.1.2 | As long as CureVac provides Non-clinical and Clinical Development support under Section 4.1.1 above, CureVac shall maintain complete and accurate books and records regarding the FTEs and all out of pocket expenses (including CRO costs) invoiced to BI, as necessary to allow the accurate calculation of payments due hereunder. CureVac shall retain these records for [*****] after the end of the calendar year to which they pertain. Once per calendar year, and no more than once for the records as to any given calendar year, BI shall have the right to engage an independent accounting firm reasonably acceptable to CureVac, at BI’s expense, which shall have the right to examine in confidence the relevant CureVac records as may be reasonably necessary to determine and/or verify the amount of payments due hereunder. In the event there was an over-payment by BI hereunder, CureVac shall promptly (but in no event later than [*****] after CureVac’s receipt of the independent auditor’s report) make payment to BI of any overpayment amounts. In the event that there was an under-payment by BI hereunder, BI shall promptly (but in no event later than [*****] after BI’s receipt of the independent auditor’s report) pay CureVac the underpayment amount. In the event any payment by BI shall prove to have been incorrect by more than five percent (5%) to BI’s detriment for the entire period audited, CureVac will pay the reasonable fees and costs of BI’s independent auditor for conducting such audit. |
22
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
4.2 | Diligence. |
4.2.1 | Subject to the terms of this Agreement, BI shall use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Licensed Vaccines and Licensed Products in accordance with the respective Development Plans, including the Development Plan attached hereto as Exhibit 4.2 and as modified and amended by the JSC from time to time in accordance with Section 8 below ("CV9202 Development Plan") and to Commercialize the Licensed Products in the Territory, provided, however that Development activities listed in the CV9202 Development Plan under the heading "Life Cycle Management" shall be at Bl’s sole discretion. Notwithstanding the foregoing, after First Commercial Sale of the first Licensed Product in a Major Market Country the JSC shall discuss and decide whether such Licensed Product will be Developed in a second and/or third indication. If the JSC decides to Develop such Licensed Product in a second and/or third indication, the Parties shall amend the respective Development Plan and Bl’s diligence obligations will be increased so that BI shall use its Commercially Reasonable Efforts to also progress the Non-clinical and Clinical Development of such second and/or third indication. The Development Plans are to set forth, inter alia, (a) the Development work (including CMC Development) to be performed by BI and by CureVac under and during the term of this Agreement; (b) the activities to be performed by CureVac to support the Non-clinical and Clinical Development as further specified in Section 4.1 above; (c) the Clinical Trials to be performed for each clinical phase, including (i) the Clinical Trials to be performed for the Afatinib Vaccine; and (ii) the Clinical Trials to be performed for the Chemo-Radiation Vaccine; and (d) the time estimated for each Clinical Trial. |
4.2.2 | In the event BI exercises its option under Article 3 above, BI shall promptly prepare a Development Plan for the Option Vaccine, such Development Plan to meet the criteria set forth under Section 4.2.1 above, coordinate such Development Plan for approval within the JSC, and use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Option Vaccine and any Licensed Product containing such Option Vaccine in accordance with the Development Plan, and to Commercialize such Licensed Product in the Territory. For the avoidance of doubt, the diligence obligations under Section 4.2.4 below shall also apply to the Option Vaccine in the event BI exercises such option. |
4.2.3 | BI shall initiate the clinical development with CV9202 of: |
(a) | [*****]; and |
(b) | [*****], |
and not terminate or halt the Non-clinical and Clinical Development unless there are substantial and reasonable technical, safety, efficacy and/or regulatory reasons for doing so, and details of such technical safety, efficacy and/or regulatory have been notified to CureVac in writing through the JSC.
23
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
4.2.4 | The diligence obligations set forth above include the following specific activities: BI shall |
(a) | use its Commercially Reasonable Efforts, subsequent to the respective positive Phase I and Phase II Clinical Trials referenced in Section 4.2.3 above, to initiate Phase III Clinical Trials regarding the Licensed Vaccines; |
(b) | conduct all Non-clinical and Clinical Development activities in a timely manner and allocate such Development budgets as are reasonable and adequate to progress the Non-clinical and Clinical Development of Licensed Vaccines hereunder; |
(c) | when appropriate based on satisfactory data obtained during the Non-clinical and Clinical Development, use its Commercially Reasonable Efforts to secure all required Regulatory Approvals in the Major Market Countries following completion of all appropriate Clinical Trials; and |
(d) | use its Commercially Reasonable Efforts to make the First Commercial Sale of the Licensed Products in each Major Market Country following the issuance of the Regulatory Approvals as well as pricing and reimbursement approvals (if any). |
For the avoidance of doubt, the specific diligence obligations under (a) to (d) shall not apply outside of the Major Market Countries.
4.2.5 | The Parties agree that Bl will assume all of CureVac’s rights and obligations (Vertragsubernahme) under the collaboration agreement between CureVac, the Cancer Research Institute and the Ludwig Institute for Cancer Research (the Cancer Research Institute and the Ludwig Institute for Cancer Research collectively "LICR") entered into as of October 21, 2013 ("LICR Collaboration Agreement"), and CureVac shall use Commercially Reasonable Efforts to procure LICR’s consent thereto. BI will use Commercially Reasonable Efforts and collaborate with LICR to [*****], provided, however, that BI is not obliged to (a) [*****]; or (b) perform studies with a commercially available [*****]. For purposes of this Agreement, any data and information generated by the LICR in such combination trials and not in the public domain shall be considered Confidential Information of BI. BI will grant and hereby grants to CureVac a non-exclusive license to any such Confidential Information generated by the LICR and Controlled by BI with respect to the [*****] for CureVac to use such Confidential Information in support and promotion of its RNActive technology for any purposes other than the Licensed Vaccines, provided, however, that (i) CureVac shall disclose such Confidential Information to a Third Party solely under an appropriate confidentiality agreement with such Third Party and (ii) prior to such disclosure to a Third Party CureVac shall send to BI the Confidential Information CureVac wishes to disclose and CureVac agrees to withhold disclosure of same for the time necessary to permit BI to obtain optimum patent protections such time period not to exceed [*****] except as required for coordination of such patent protection with Bl’s collaboration partners other than CureVac. CureVac shall comply with Bl's request to withhold disclosure for the time necessary to permit BI to obtain optimum patent protection. In the event CureVac is, despite its Commercially Reasonable Efforts, unable to transfer its rights and obligations regarding the Licensed Vaccines under the LICR Collaboration Agreement to BI, CureVac will exercise the LICR Collaboration Agreement with respect to the Licensed Vaccines upon the direction of BI and BI shall refund any payments to be made to LICR and any costs incurred by CureVac under the collaboration with LICR with respect to the Licensed Vaccines to CureVac. |
24
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
4.2.6 | Subject to Section 6.3 below, CureVac shall use its Commercially Reasonable Efforts to progress the CMC Development of the Licensed Vaccines in accordance with the respective Development Plans for the Licensed Products. In particular, CureVac shall conduct all CMC Development activities in a timely manner and allocate such budgets as are reasonable and adequate to progress the CMC Development of Licensed Vaccines at CureVac hereunder in accordance with the Development Plans. Upon CureVac's request, BI shall use its Commercially Reasonable Efforts to support CureVac in the CMC Development by providing any information and/or documentation required by CureVac for the CMC Development. |
4.3 | Regulatory Matters. With the exception of the drug master file (or equivalent) for Licensed Vaccines and Licensed Products ("CureVac DMF") and all Manufacturing permits and authorizations necessary for the Manufacture of the Licensed Vaccines, BI shall be solely responsible for all regulatory matters including the filing for approvals to the Licensed Vaccines and Licensed Products in the Field. BI shall own, directly or through an Affiliate, all Regulatory Approvals. With the exception only of matters which require prompt attendance, CureVac shall have the right and the obligation to review and comment on all regulatory filings inasmuch as they relate to the Licensed Vaccines and Licensed Products, and BI will take such comments into reasonable consideration. Furthermore, BI will provide copies of all regulatory approvals and material correspondence with Regulatory Authorities in the Major Market Countries relating to the Clinical Trials with respect to Licensed Vaccines and Licensed Products to CureVac, and will reasonably consider a request by CureVac to participate in a meeting with Regulatory Authorities. Notwithstanding the foregoing, CureVac shall have the right and the obligation to participate in a meeting with Regulatory Authorities if and to the extent such meeting relates to the CMC Development. For the avoidance of doubt, BI will have final say on all regulatory matters of the Licensed Vaccines, and the dispute resolution process laid down in Sections 8.5 and 8.6 of this Agreement does not apply. CureVac shall use Commercially Reasonable Efforts to support BI on all regulatory matters with respect to the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products and shall maintain all permits and authorizations necessary for the Manufacture of the Licensed Vaccines, including the CureVac DMF. CureVac shall use Commercially Reasonable Efforts to generate and provide to BI (i) CMC Development-related and Manufacturing-related documentation, data and reports, including those listed in Exhibit 4.3, and (ii) CMC Development-related technical and other assistance, in each case (i) and (ii) as reasonably required for obtaining Regulatory Approvals and for required interactions with Regulatory Authorities regarding the Licensed Vaccines, including scientific advices. In addition to the obligations under Section 10 below, BI shall ensure that such CMC Development- and/or Manufacturing-related documentation, data and reports are not circulated within Bl’s and Bl’s Affiliates’ organizations except as required for the purposes mentioned in the foregoing sentence. Each Party shall designate one or more individual(s) to facilitate the provision of the documentation, materials, data and reports as described in this Section 4.3. To the extent required by a Party, a BI Affiliate or a CureVac Affiliate to achieve or maintain regulatory clinical trial and/or marketing application approvals or to comply with any related requests from regulatory authorities related to the Licensed Vaccines, or, if so required by CureVac or by a CureVac Affiliate, to any RNA based product owned or in-licensed by CureVac or its Affiliate, the Parties shall authorize and hereby authorize each other or their respective Affiliate (but not licensees of the other Party) to cross reference to the sections of the IND/regulatory dossiers of the clinical trials related to vaccines or RNA based products Controlled by the other Party or its Affiliate and to any other relevant regulatory filings and any other relevant documentation Controlled by the other Party or its Affiliate. The Parties shall inform each other in writing prior to any such cross-referencing. BI shall consider in good faith any request by CureVac to authorize a future licensee of CureVac to cross-reference to the sections of the IND/regulatory dossiers of the Clinical Trials related to Licensed Vaccine or Licensed Product. |
25
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
4.4 | Competing Products. In the event BI, any of its Affiliates or any of its Sublicensees outside the scope of this Agreement commences clinical trials or commercialization of any mRNA-based, protamine-complexed vaccine targeting any of the indications for which BI is Developing the Licensed Vaccines or Commercializing the Licensed Products ("Competing Product"), and irrespective of whether BI used the CureVac Licensed Intellectual Property to develop such Competing Product, CureVac shall be entitled to terminate the exclusivity of the licenses under Section 2.1 above, so that BI shall retain non-exclusive licenses under Section 2.1, but the remaining provisions of this Agreement remain in full force and effect; and BI shall grant to CureVac a non-exclusive license, including the right to grant sublicenses in multiple tiers, to use any of the BI Collaboration Intellectual Property (other than [*****] BI Background Intellectual Property) for the Development, Manufacture and Commercialization of the Licensed Vaccines. |
4.5 | Development and Commercialization Costs. As of the Effective Date and unless otherwise agreed, BI will bear (i) any and all costs regarding the Non-clinical and Clinical Development in accordance with the Development Plans, and Commercialization of the Licensed Vaccines and Licensed Products in the Field and in the Territory, (ii) any ongoing costs related to running Clinical Trials with respect to the Licensed Vaccines, as specified in Exhibit 4.5A, and (iii) the costs of future combination trials under the LICR Collaboration Agreement. Notwithstanding the foregoing, any payment obligations arising from the existing license agreements between CureVac and (i) [*****], (ii) the [*****] and (iii) [*****] as such license agreements are further specified in Exhibit 4.5B hereto, shall be solely borne by CureVac. Subject to Section 8.5 (fourth sentence) below, any costs incurred by CureVac in relation to CMC Development in accordance with the Development Plans will be solely borne by CureVac. |
26
EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
5. | REPORTING OBLIGATIONS. |
5.1 | Regulatory Reporting. BI shall be responsible for filing all reports required to be filed in order to maintain any Regulatory Approvals granted for Licensed Vaccines and Licensed Products in the Territory. |
5.2 | Sales Projections. Commencing on the first December 1 following the date of the First Commercial Sale in the Territory, BI shall provide CureVac on or before December 1 in each calendar year with a confidential, non-binding sales forecast for the upcoming calendar year of the estimated aggregate (i) worldwide sales of Licensed Products and (ii) sales of Licensed Products in each Major Market Country. Subject to its diligence obligations hereunder, BI shall be solely responsible for all aspects of the commercialization and sale of Licensed Products. |
5.3 | Pharmacovigilance. The Parties shall have in place and will maintain until the expiration (or earlier termination) of this Agreement (or, as applicable, until the obligations intended to survive termination of this Agreement have been fulfilled) systems, procedures, training programs and documentation needed to perform and comply with their pharmacovigilance regulatory obligations, and each Party shall promptly inform the other Party of any safety issues that may arise and that need to be reported under Applicable Laws. Each Party will ensure that it complies with all Applicable Laws regarding the Licensed Vaccine and Licensed Product relating to risk management, drug safety and pharmacovigilance. The Parties shall negotiate in good faith and conclude, on or before [*****] a pharmacovigilance agreement. |
6. | MANUFACTURE AND SUPPLY. |
6.1 | Clinical Supply. All Licensed Vaccines required for use by BI in accordance with this Agreement for the Non-clinical and Clinical Development of the Licensed Vaccines up to and including Phase II Clinical Trials shall be Manufactured by CureVac in accordance with Applicable Laws and the terms and conditions of the Clinical Supply Agreement attached hereto as Exhibit 6.1 ("Clinical Supply Agreement"). |
6.2 | Phase III Clinical Supply and Commercial Supply. CureVac shall have the right and the obligation to Manufacture Licensed Vaccines for use in Phase III Clinical Trials and for the Commercialization of Licensed Products under this Agreement, the right and the obligation to Manufacture being subject to the right of CureVac to |
(a) | waive its right and obligation to Manufacture all Licensed Vaccines for use in Phase III Clinical Trials and for the Commercialization of the Licensed Products by notifying BI of such waiver in writing on or before [*****] and, if CureVac has not provided such notice, |
(b) | waive its right and obligation to Manufacture all Licensed Vaccines for the Commercialization of the Licensed Products by notifying BI of such waiver in writing on or before [*****]; provided, however, that if CureVac does not notify BI in writing on or before [*****] that CureVac will not waive its right and obligation to Manufacture all Licensed Vaccines for the Commercialization of the Licensed Products, BI shall have the right to request by written notice to CureVac that CureVac (i) authorizes a BI Affiliate located in Austria or Germany, such Affiliate to be designated by BI in said written notice, to conduct non-GMP production of CV9202 in lab scale experiments (on "process-science" level only), provided, that CureVac shall have the right to observe and consult on such lab scale experiments, and (ii) provide access to such BI Affiliate to the following data and information and such additional data and information as may be agreed to by the JSC, in each case to the extent necessary or useful for such activities and Controlled by CureVac (such data and information shall be considered Confidential Information of CureVac): |
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o | Protocols for [*****]; |
o | Information on [*****]; and |
o | Protocols for [*****] |
in each case (i) and (ii) to enable BI to prepare for a potential future GMP Manufacturing of Licensed Vaccines by a BI Affiliate or a Permitted Third Party CMO (as defined in Section 6.3.2 below). In the event CureVac does not provide notice of waiver as set forth under (a) and (b) above and achieves all milestone events set forth under Section 6.3.1(b) below, BI shall return or destroy, as instructed by CureVac, all Confidential Information of CureVac set forth above and any materials and results generated in the course of the lab scale experiments and confirm such return or destruction in writing to CureVac, save that BI may retain copies of such results and of CureVac’s Confidential Information as set forth in Section 10.5 below.
Before [*****] the Parties shall negotiate in good faith commercially reasonable terms and conditions of an amendment to the Clinical Supply Agreement and conclude such amendment in order to cover Phase III Clinical Trial supply in accordance with the terms and conditions of the binding term sheet attached as Exhibit 6.2A hereto, unless CureVac is providing notice of waiver as set forth in (a) above before or during such negotiations. If CureVac has not provided the notice of waiver as set forth in (a) above within the prescribed time, before [*****] the Parties shall negotiate in good faith commercially reasonable terms and conditions of a commercial supply agreement and conclude such commercial supply agreement in accordance with the terms and conditions of the binding term sheet attached as Exhibit 6.2B hereto, unless CureVac has provided notice of waiver as set forth in (b) above before or during such negotiations. The Parties will negotiate in good faith any amendment to the commercial supply agreement which either Party requests and which may be necessary or useful to adapt the agreement to potential changes in the Development Plan or to the Licensed Vaccine after [*****]. In order to reach a common understanding about the methods of cost allocation for the Licensed Vaccine cost calculation for the Phase III Clinical Trial supply and for the commercial supply as well as in order to be able to audit such costs, BI and CureVac shall agree upon the calculation method and the content of the calculation in good faith. On or before [*****] CureVac shall describe its current methods of cost allocation for product cost calculation, such description to detail the following elements:
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o | cost center structure and costs booked to these cost centers |
o | method of allocation for cost centers |
o | calculation of hourly rates for personnel |
o | calculation of hourly rates for plants |
o | differentiation of idle capacity |
o | overhead calculation method |
o | definition of standard price for negotiation |
6.3 | Manufacturing by BI. |
6.3.1 | If CureVac |
(a) | provides notice of waiver as set forth in Section 6.2 (a) or (b) above within the prescribed time to BI; |
(b) | fails to achieve any one of the following milestone events |
(i) | CureVac provides the results of the ongoing feasibility study concerning the (x) upscaling of the current [*****] Manufacturing process (such upscaled Manufacturing process being defined as the "[*****] Process"); (y) the reconstruction of CureVac’s existing pilot plant to implement the [*****] Process at said pilot plant; and (z) the construction of a commercial facility for, inter alia, the Manufacturing of Licensed Vaccines for the Commercialization of the Licensed Products ("Commercial Facility"), such results (including an evaluation of at least one (1) of the CV9202 plasmid DNAs if such material has been provided to CureVac under the Material Transfer and Feasibility Study Agreement (Exhibit 6.4A) below on or before [*****], provided, however, that the outcome of the evaluation of the CV9202 plasmid DNAs shall not determine the achievement of this milestone) of the feasibility study to be provided to BI on or before [*****] or any later point in time agreed by the JSC, and the JSC confirms that the results of the ongoing feasibility study with respect to (x), (y) and (z) demonstrates that it meets the objectives set by the JSC prior to completion of the feasibility study and consequently supports CureVac’s ability to Manufacture for Phase III Clinical Trial supply and commercial supply for purposes of this Agreement; |
(ii) | the comparability concept of the [*****] Process to the existing [*****] Manufacturing process at CureVac’s pilot plant has been discussed and clarified with the EMA and the FDA on or before [*****] or any later point in time if so delayed by the JSC or such delay is caused by BI internal processes; |
(iii) | the EMA and the FDA accept the comparability of the [*****] Process to the existing [*****] Manufacturing process at CureVac’s pilot plant on or before [*****] or any later point in time if so delayed by the JSC or such delay is caused by BI internal processes; and |
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(iv) | CureVac makes a final decision to build a Commercial Facility and notifies BI of such decision on or before [*****]; or |
(c) | is in material breach of its obligations - if any - to Manufacture and supply Licensed Vaccines in accordance with a Related Agreement, has been notified by BI of such material breach and does not cure such material breach within the time periods set forth in the respective Related Agreement, |
BI shall be entitled to Manufacture Licensed Vaccines, and CureVac shall grant and hereby grants to BI and BI accepts a non-exclusive, royalty-free and perpetual, non-transferable license (with the right to grant sub-licenses solely to Affiliates located in [*****], provided such Affiliate enters into a direct agreement with CureVac containing a direct extension of rights in-licensed by CureVac from Geneart with respect to the Manufacture of Licensed Vaccines and confidentiality obligations corresponding to the ones set forth in Sections 4.3 and 10 below, under CureVac's then existing CureVac Licensed Manufacturing Intellectual Property for the CMC Development and the Manufacturing of Licensed Vaccines and Licensed Products solely for use by BI under the license granted in Section 2.1, provided that any sub-license or extensions of rights granted to BI shall be subject to the terms and conditions of any then existing head¬license agreements. Any dispute concerning the achievement of one of the milestone events set forth above shall be resolved in accordance with the provisions of Sections 8.5 and 8.6 below.
6.3.2 | BI shall have the right to engage a Third Party contract manufacturer located [*****] ("Permitted Third Party CMO") to Manufacture Licensed Vaccines by providing written notice of such intent and the identity of the contract manufacturer to CureVac, provided that |
(a) | CureVac shall be permitted to veto the engagement of such contract manufacturer if (i) CureVac has reasonable grounds to believe that such contract manufacturer will not (x) protect CureVac’s Confidential Information including CureVac's proprietary Materials in accordance with the standards set forth in Sections 4.3 and 10 or (y) be able to Manufacture the Licensed Vaccines in accordance with Applicable Laws, and (ii) CureVac provides to BI written documentation supporting such reasonable grounds to BI within [*****] of receipt by CureVac of Bl’s written notice identifying the contract manufacturer; |
(b) | BI ensures that the Permitted Third Party CMO meets all obligations of BI under this Section 6, including the obligation set forth in Section 6.3.3 below, and BI makes available a copy of the agreement (redacted to exclude only information on compensation of the Permitted Third Party CMO) with the Permitted Third Party CMO to CureVac; and |
(c) | the Third Party contract manufacturer enters into a direct agreement with CureVac containing a direct extension of rights from Geneart with respect to the Manufacture of the Licensed Vaccines, confidentiality obligations and Material transfer obligations corresponding to the ones set forth in Sections 4.3 and 10. |
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6.3.3 | Any improvements generated by or on behalf of BI to any CureVac Licensed Manufacturing Intellectual Property will be assigned and transferred, and are hereby assigned and transferred to CureVac (and CureVac will accept and hereby accepts such assignment and transfer) and licensed back to BI, on a non-exclusive, cost-free and perpetual basis, with the right to (a) grant sub-licenses to Affiliates and (b) enable the Permitted Third Party CMO to make use of such improvements; and any other Intellectual Property generated by BI with respect to the Manufacturing of the Licensed Vaccine, except for such Intellectual Property related to the BI pDNA Process and generated under a Related Agreement specific to such pDNA Process, will be licensed, and is hereby licensed to CureVac on a non-exclusive, cost-free and perpetual basis, with the right to sublicense, for any purpose other than the Commercialization of the Licensed Products during the term of this Agreement. |
6.3.4 | Furthermore, (a) each Party shall be released from its respective obligations to enter into any agreement contemplated by Sections 6.2 and 6.4 of this Agreement; (b) upon Bl’s written request, BI shall be released from any obligation under the Related Agreements to purchase Licensed Vaccines from CureVac except for such deliveries listed in a Related Agreement’s Delivery Schedule which have already become binding on the date of Bl’s written request; and (c) BI shall have the right to request from CureVac by written notice the transfer of CureVac's CMC Development activities and the Manufacturing technology required for the Manufacture of Licensed Vaccines solely to the entity which will be Manufacturing the Licensed Vaccine under the licenses granted under Section 6.3.1, i.e., to BI, to a BI Affiliate or to the Permitted Third Party CMO. Upon receipt of such written notice by CureVac, CureVac shall, use Commercially Reasonable Efforts to (aa) transfer all data and information to the extent necessary or useful for such activities and Controlled by CureVac (such data and information shall be considered Confidential Information of CureVac) and (bb) provide all support, in each case (aa) and (bb) as reasonably required for BI, the BI Affiliate or the Permitted Third Party CMO, as applicable, to take over the CMC Development activities and the Manufacturing of the Licensed Vaccines. The transfer of such data and information and the support under (aa) and (bb) shall be at no cost to BI, with the exception only of travel costs and travel time, if and to the extent the transfer or support is to be provided at any place outside of Europe. - |
6.3.5 | In consideration for CureVac's significant past investments and established Manufacturing Intellectual Property, technology and processes, BI shall pay to CureVac a one-off technology transfer fee in the amount of [*****] solely when and if the following conditions are met: (a) the Manufacturing by BI was triggered by the events as set forth in Section 6.3.1 (a); 6.3.1 (b)(i); or Section 6.3.1 (b)(iv); (b) BI makes the First Commercial Sale of a Licensed Product in the USA; and (c) at the time of such First Commercial Sale BI, a BI Affiliate or a Permitted Third Party CMO has Manufactured Licensed Vaccines and CureVac is not Manufacturing Licensed Vaccines or is Manufacturing Licensed Vaccines only as a second source supplier of BI under a separate supply agreement with BI. Such payment shall be due and payable within [*****] after receipt of a respective Invoice. |
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6.4 | Plasmid DNA as Precursor for Licensed Vaccines. The Parties aspire that CureVac will manufacture plasmid DNA needed as a precursor for the Manufacture of Licensed Vaccines for Phase III Clinical Trials and commercial supply and potentially also for other RNA based products owned or in-licensed by CureVac in accordance with a manufacturing process to be developed by Bl’s Affiliate Boehringer Ingelheim Biopharmaceuticals GmbH ("BI Bio") and transferred to CureVac ("BI pDNA Process"). To this end, CureVac will provide all necessary materials (e.g., plasmid DNA samples) as well as information and a BI Affiliate will conduct a feasibility study in accordance with the Material Transfer and Feasibility Study Agreement (Exhibit 6.4A). As soon as possible after both Parties have generated all data necessary for assessing whether the quality of the BI pDNA Process (i.e., the analytical results are within the specifications agreed between the Parties at the start of the pDNA feasibility study) meets CureVac's requirements and the plasmid DNA manufactured in accordance with the BI pDNA Process meets the requirements agreed between the Parties, including requirements for RNA based products other than Licensed Vaccines, the Parties shall discuss such data in the Joint Project Team, and the Joint Project Team will provide a recommendation to the JSC. If the JSC decides that the BI pDNA Process and the plasmid DNA manufactured in accordance with the BI pDNA Process meet the requirements set forth in the foregoing sentence, CureVac shall and BI shall ensure that BI Bio will negotiate in good faith commercially reasonable terms and conditions of a license agreement concerning the BI pDNA Process, such terms and conditions to (i) be in accordance with the terms and conditions of the binding term sheet attached hereto as Exhibit 6.4B and (ii) insofar as Exhibit 6.4B does not provide otherwise, substantially correspond to the terms and conditions of the license agreement between CureVac and its plasmid DNA development partner on the Effective Date. In order to ensure the availability of plasmid DNA as a precursor for the manufacture of Licensed Vaccines in case the JSC decides that the quality of the BI pDNA Process and/or the plasmid DNA manufactured in accordance with the BI pDNA Process does not meet the requirements agreed between the Parties or CureVac and BI Bio do not reach agreement on a BI pDNA Process license agreement, CureVac shall and BI shall ensure that BI Bio will negotiate in good faith commercially reasonable terms and conditions of and conclude on or before [*****] either |
(a) | a license agreement concerning a manufacturing process to be developed by BI Bio and transferred to CureVac for the manufacture of plasmid DNA that will be used as precursor solely for the manufacture of Licensed Vaccines; or |
(b) | a supply agreement under which BI Bio would supply plasmid DNA to CureVac, such plasmid DNA to be used solely as precursor for the manufacture of Licensed Vaccines. |
If the Parties, despite good faith efforts, do not conclude one of the plasmid DNA-related agreements set forth above by [*****] the Parties shall agree on involving a Third Party in the manufacturing of plasmid DNA needed as a precursor for the Manufacture of Licensed Vaccines.
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6.5 | Manufacturing by BI After Expiry of the Agreement. Upon expiry of the Agreement in all countries and for all Licensed Products, and if CureVac was still Manufacturing the Licensed Vaccines under this Agreement at the time of expiry, CureVac will reasonably consider to continue supplying BI at terms and conditions corresponding to the ones applicable before the expiry of the Agreement, subject only to reasonable price adjustment to reflect any changes in raw material and labor costs, and the Parties shall conduct good faith negotiations for CureVac to continue supplying Licensed Vaccines. In the event the Parties cannot agree in such good faith negotiations, BI shall have the right to request from CureVac, by written notice prior to expiry of this Agreement, the grant to BI of a non-exclusive, royalty-free and perpetual license under CureVac’s then existing CureVac Licensed Manufacturing Intellectual Property for the CMC Development and the Manufacturing of Licensed Vaccines and Licensed Products, with the right to grant sub-licenses to Affiliates and to engage Permitted Third Party CMOs, for use by BI under the retained license of Section 13.1. Upon receipt of such written notice by CureVac, CureVac shall use Commercially Reasonable Efforts to (i) transfer all data and information to the extent necessary or useful for such activities and Controlled by CureVac (such data and information to be considered Confidential Information of CureVac), and (ii) provide all support, in each case (i) and (ii) as reasonably required for BI, the BI Affiliate or the Permitted Third Party CMO to take over the Manufacturing of the Licensed Vaccines, such license and transfer being subject to the additional limitations set forth in the last paragraph of Section 6.3.1 and Sections 6.3.2 and 6.3.3 applied by analogy. The transfer of such data and information and the support under (i) and (ii) shall be at no cost to BI, with the exception only of travel costs and travel time, if and to the extent the transfer or support is to be provided at any place outside of Europe. In consideration for CureVac's significant past investments and established Manufacturing Know How, technology and processes, BI shall pay to CureVac a one-off technology transfer fee in the amount of Five Million Euros (€ 5,000,000) to become due and payable within [*****] of the later of the first commercial sale by BI, a BI Affiliate or a Sublicensee of a Licensed Vaccine Manufactured by BI, a BI Affiliate or a Permitted Third Party CMO and the receipt by BI of an Invoice from CureVac. |
6.6 | Fill and Finish. For Licensed Vaccines used for Commercialization by BI under this Agreement, CureVac and BI shall discuss in good faith the filling and finishing of CureVac Licensed Vaccines by either CureVac, BI, a BI Affiliate or a Third Party contract manufacturer with respect to the costs and quality of such filling and finishing. In case of quality issues at CureVac or if the Parties cannot reach agreement on prices for the filling and finishing of CureVac Licensed Vaccines, CureVac shall grant to BI a non-exclusive, royalty-free license, with the right to grant sub-licenses to Affiliates and to engage a Third Party contract manufacturer, under the CureVac Licensed Manufacturing Intellectual Property solely to the extent required for filling and finishing Licensed Vaccines intended for such Commercialization purposes. |
6.7 | CureVac's License to Manufacture. For the term during which CureVac Manufactures the Licensed Vaccines under this Agreement and the Clinical Supply Agreement and the Related Agreements to be concluded in accordance with Section 6.2, BI shall grant and hereby grants to CureVac a non-exclusive license to any Intellectual Property Controlled by BI and its Affiliates (including any BI Collaboration Intellectual Property but excluding any Intellectual Property related to the BI pDNA Process and generated under a Related Agreement specific to such pDNA Process) solely to the extent required for CureVac to Manufacture the Licensed Vaccines. |
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7. | CONSIDERATION. |
7.1 | Upfront Payment. In consideration for the exclusive licenses granted hereunder, BI shall pay to CureVac a non-refundable and non-creditable fee in the amount of Thirty Million Euros (€ 30,000,000) within thirty (30) days after Bl’s receipt of an Invoice of the respective amount from CureVac; provided that such amount shall not become payable until such time as BI has received a duly signed original of the Agreement from CureVac. |
7.2 | Option Fee. In consideration for the exclusive option granted hereunder, BI shall pay to CureVac a non-refundable and non-creditable option fee in the amount of Five Million Euros (€ 5,000,000) within thirty (30) days after Bl’s receipt of an Invoice of the respective amount from CureVac; provided that such amount shall not become payable until such time as BI has received a duly signed original of the Agreement from CureVac. |
7.3 | Development and Regulatory Milestone Payments. In addition to the payments under Sections 7.1 and 7.2, in further consideration for the exclusive licenses granted hereunder, and subject to the terms and conditions set forth in this Agreement, BI shall make the following Development and regulatory milestone payments to CureVac: |
7.3.1 | Development and Regulatory Milestone Payments for the First Indication (on the Effective Date expected to be Lung Cancer): |
(a) | [*****] |
(b) | [*****] |
(c) | [*****] |
(d) | [*****] |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
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(e) | For regulatory milestones see table below: |
[*****]
Provided, however, that if BI suspends the Development of the Afatinib Vaccine and/or the Chemo-Radiation Vaccine and replaces such TPP by another TPP (e.g., the combination of a Licensed Vaccine with a checkpoint inhibitor and/or a co-stimulatory molecule, a "Checkpoint Inhibitor Vaccine"), the applicable above milestone payments under (a) to (e) shall be payable for the other TPP replacing the Afatinib Vaccine and/or the Chemo-Radiation Vaccine. For the avoidance of doubt, milestone payments already paid for the Development of a TPP prior to suspension shall not be payable for the other TPP replacing the Afatinib Vaccine and/or the Chemo-Radiation Vaccine.
7.3.2 | Development and Regulatory Milestone Payments for the Second and Third Indications: |
In the event a Licensed Vaccine or Licensed Product is Developed in a second or third indication (e.g., head and neck cancer and/or cervical cancer) BI shall make the following Development and regulatory milestone payments for the first Licensed Vaccine reaching the respective milestones in the second indication and for the first Licensed Vaccine reaching the respective milestones in the third indication:
(a) | [*****] |
(b) | [*****] |
(c) | For regulatory milestones for the second and third indications see below: |
[*****]
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
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"Initiation" of a Clinical Trial for purposes of this Article 7 shall mean dosing of the first patient in such Clinical Trial; and "continuation" shall mean the final decision of a BI steering committee (International Development Committee, the International Medical Committee or an equivalent body of BI) to continue a Phase I/II Clinical Trial, a Phase II/III Clinical Trial or a Phase I through Phase III seamless design Clinical Trial. The competent steering committee shall use Commercially Reasonable Efforts to make such final decision in a timely manner and to inform CureVac on the achievement of milestones.
If any one of the milestone events under Section 7.3.1 and 7.3.2 is not required for the Development of a Licensed Vaccine or Licensed Product, such milestone payment shall become payable upon achieving the respective milestone event following the milestone event which was not required, i.e., upon the achievement of such following milestone event two milestone payments become payable hereunder. For clarity, the achievement of an Afatinib Vaccine-related milestone event does not trigger payment of a Chemo-Radiation- related milestone payment, and the achievement of a Chemo-Radiation-related milestone event does not trigger payment of an Afatinib Vaccine-related milestone payment. Further, the achievement of a regulatory milestone event for a certain territory (e.g., the EU) does not trigger payment of a regulatory milestone payment for a different territory (e.g., the USA). Each Development and regulatory milestone payment under Section 7.3.1 and Section 7.3.2 for each indication set forth above is payable only upon first achievement of such milestone for the first Licensed Vaccine or Licensed Product, and no further payments are due for repeated achievements of such milestones for such indication. For purposes of clarity, the maximum aggregate amount payable by BI pursuant to this Section 7.3 is [*****].
7.4 | Sales Milestone Payments. |
In addition to the upfront and milestone payments specified in Sections 7.1 to 7.3 above, in further consideration for the exclusive licenses granted by CureVac to BI hereunder; and subject to the terms and conditions set forth in this Agreement, BI shall make the following one-off, sales based milestone payments:
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
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(a) | If aggregated annual worldwide Net Sales exceed for the first time [*****]: |
[*****]
(b) | if aggregated annual worldwide Net Sales exceed for the first time [*****]: |
[*****];
(c) | if aggregated annual worldwide Net Sales exceed for the first time [*****]: |
[*****]; and
(d) | if aggregated annual worldwide Net Sales exceed for the first time [*****]: |
[*****].
For purposes of clarity, the maximum aggregate amount payable by BI pursuant to this Section 7.4 is [*****].
7.5 | Obligation to Inform. BI shall inform CureVac on the occurrence of a milestone event under Sections 7.3 and 7.4 as soon as possible but in any event within [*****] after the occurrence thereof. |
7.6 | Milestone Payment Terms. Each milestone payment shall be due and payable within [*****] after the receipt of the respective Invoice by BI. Notwithstanding the foregoing, each sales milestone payment shall be paid together with the royalty payments of the Calendar Quarter during which the respective milestone has been achieved. |
7.7 | Non-Refundable Payments. All payments to be made by BI to CureVac under Sections 7.1 to 7.4 hereof are non-refundable upon expiry or termination of this Agreement for any reason. None of the payments to be made by BI to CureVac under Sections 7.1 to 7.4 may be credited against any of Bl's royalty obligations under Section 7.8 hereof. |
7.8 Royalties.
7.8.1 | Royalty Rates. As further consideration for the rights and licenses granted by CureVac to BI under this Agreement, BI shall pay or cause payment of royalties to CureVac in an amount equal to [*****] of Net Sales of the Licensed Products. |
7.8.2 | Royalty Calculation. The royalties shall be calculated on the basis of Net Sales, which shall be calculated on a Licensed Product-by-Licensed Product and country-by-country basis from First Commercial Sale until the expiration of the applicable Royalty Term. |
7.8.3 | Royalty Term. Bl's obligation to pay royalties shall begin, on a country-by-country basis, with the First Commercial Sale, and expire, on a country-by-country and Licensed Product- by-Licensed Product basis, upon the later of (i) expiry of the last to expire Valid Claim in such country; (ii) expiry of regulatory exclusivity for the respective Licensed Product in such country, provided, however, that no Generic Competition exists for such Licensed Product in such country or BI does not enforce existing regulatory exclusivity to enjoin Generic Competition despite preponderant chances of success of such action; or (iii) twelve (12) years from the date of First Commercial Sale of the respective Licensed Product (each a "Royalty Term"), provided, however, with respect to any country other than the Major Market Countries the Royalty Term shall expire on a Licensed Product-by-Licensed Product basis in such country at the latest fifteen (15) years from the date of First Commercial Sale of the respective Licensed Product in any country other than the Major Market Countries. |
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7.8.4 | Third Party Royalties Offset. In the event that BI, after consultation with CureVac, reasonably determines that, in order to have freedom to operate in practicing the CureVac Licensed Intellectual Property in accordance with this Agreement in any country, BI is required to make royalty payments to one or more Third Party Licensors to obtain a license under their Patent Rights, then royalties due to CureVac for the respective Licensed Product in the respective country under this Section 7.8 shall be reduced by [*****] of the amount of such Third Party Licensor payments. Notwithstanding the foregoing, such reductions shall in no event reduce the royalty payable for such Licensed Product to less than [*****] of Net Sales in such country. For clarity, the provisions of this Section 7.8.4 shall not apply with respect to the license agreements referred to in Exhibit 4.5B. |
7.8.5 | Countries without Patent Protection; Generic Competition. In countries (a) where (i) sales of Licensed Product do not or no longer fall under any Valid Claim and (ii) regulatory exclusivity for the Licensed Product has expired, or (b) where the Licensed Product is experiencing Generic Competition (except where (x) BI has the primary right in accordance with Section 9.6.2 of this Agreement to bring a patent infringement action to enjoin such Generic Competition and, despite preponderant chances of success of such infringement action, notifies CureVac that BI will not take action or bring suit to prosecute such infringement; or (y) BI does not enforce existing regulatory exclusivity to enjoin such Generic Competition despite preponderant chances of success of such action), royalties set forth above shall be reduced by [*****]. Should BI obtain evidence that any of the above requirements for such royalty reduction were met during a Calendar Quarter after BI has completed preparing its Net Sales report for such Calendar Quarter, BI shall be entitled to a credit, to be applied by BI against subsequent royalty payments, in the amount by which royalties would have been reduced had due account been taken of such royalty reduction when preparing such Net Sales report. If royalties are subject to the reductions under both Section 7.8.4 and 7.8.5, the reduction under Section 7.8.4 shall be applied before the reduction under Section 7.8.5. |
7.8.6 | Blended Royalties. With respect to a potential step down in royalty rates to account for the expiry of certain Patent Rights, the Parties acknowledge and agree that the CureVac Licensed Intellectual Property licensed under this Agreement may justify royalty rates and/or royalty terms of differing amounts for sales of Licensed Products in the Territory, which rates could be applied separately to Licensed Products involving the exercise of CureVac Licensed Patent Rights in the Territory and/or the incorporation of Know How comprised in the CureVac Licensed Intellectual Property, and that if such royalties were calculated separately, royalties relating to the CureVac Licensed Patent Rights in the Territory and royalties relating to the Know How comprised in the CureVac Licensed Intellectual Property would last for different terms. For practicality reasons the Parties have agreed on a blended royalty rate. For clarity, this Section 7.8.6 (i) solely explains the rationale behind the royalty rates agreed on by the Parties and (ii) does not modify any of the other provisions of this Agreement. |
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7.8.7 | No Multiple Royalties. No multiple royalties shall be payable because a Licensed Product, its manufacture, use or sale is or shall be covered by (i) more than one Valid Claim and/or (ii) more than one patent under the Patent Rights which form part of the CureVac Background Intellectual Property and/or the CV9202 Specific Patent Rights. |
7.8.8 | Net Sales Adjustments Related to Combination Products and Co-Packaged Products. In the event a Licensed Product is sold as a Combination Product or Co-Packaged Product, Net Sales of the Combination Product or Co-Packaged Product will be calculated, on a country-by-country basis, as follows: |
If the Licensed Product and the other product are also sold separately in the applicable country, Net Sales of the Licensed Product portion of Combination Products and Co-Packaged Products will be calculated by multiplying the total Net Sales of the Combination Product or Co-Packaged Product by the fraction A/(A+B), where A is the average gross selling price in the applicable country of the Licensed Product sold separately in the same formulation and dosage, and B is the sum of the average gross selling prices in the applicable country of all other therapeutically or prophylactically active ingredients or products in the Combination Product or Co-Packaged Product sold separately in the same formulation and dosage, during the applicable Calendar Quarter.
If the Licensed Product is sold separately, but the average gross selling price of the other product(s) cannot be determined, Net Sales of the Combination Product or the Co-Packaged Product shall be equal to the Net Sales of the Combination Product or Co-Packaged Product multiplied by the fraction A/C wherein A is the average gross selling price of the Licensed Product and C is the average gross selling price of the Combination Product or Co-Packaged Product.
If the other product(s) is/are sold separately, but the average gross selling price of the Licensed Product cannot be determined, Net Sales of the Combination Product and/or Co-Packaged Product shall be equal to the Net Sales of the Combination Product and/or Co-Packaged Product multiplied by the following formula: one (1) minus B/C wherein B is the average gross selling price of the other product(s) and C is the average gross selling price of the Combination Product and/or Co-Packaged Product.
If the average gross selling price of neither the Licensed Product nor the other product(s) can be determined, Net Sales of the Combination Product or Co-Packaged Product shall be equal to Net Sales of the Combination Product or Co-Packaged Product multiplied by a mutually agreed percentage.
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL |
EXECUTION VERSION |
The average gross selling price for such other product(s) contained in the Combination Product or Co-Packaged Product shall be calculated for each calendar year by dividing the sales amount by the units of such other product(s), as published by IMS or another mutually agreed independent source. In the initial calendar year during which a Combination Product or Co-Packaged Product is sold, forecasted average gross selling prices shall be used for royalty calculation purposes. Any over or under payment due to a difference between forecasted and actual average gross selling prices shall be paid or credited in the second royalty payment of the following calendar year. In the following calendar year the average gross selling price of the previous year shall apply from the second royalty payment on.
7.8.9 | Royalty Payments. Within [*****] after the end of each Calendar Quarter in which any Net Sales occur, BI shall calculate the royalty payments owed to CureVac and shall remit to CureVac the amount owed to CureVac. All royalty payments shall be computed by converting the Net Sales in each country in the Territory into the currency of Euros, using the monthly exchange rates as customarily used by BI in its regular accounting system (momentarily average rates published by the European Central Bank in Frankfurt/Main, Germany). |
7.8.10 | Reports. Each royalty payment shall be accompanied by a written report describing the Net Sales of each Licensed Product sold by or on behalf of BI, its Affiliates and Sublicensees during the applicable Calendar Quarter for each country in which sales of any Licensed Product occurred, specifying: the gross sales (if available) and Net Sales in each country’s currency, including an accounting of deductions taken in the calculation of Net Sales; the applicable exchange rate to convert from each country’s currency to Euros; and the royalties payable in Euros. |
7.8.11 | Records. BI, its Affiliates and/or its Sublicensees shall keep and maintain records of sales of the Licensed Product(s) so that the royalties payable and the royalty reports may be verified. Such records shall be open to inspection during business hours for a [*****] period after the Calendar Quarter to which such records relate, but in any event not more than once per calendar year, by a nationally recognized independent certified public accountant selected by CureVac to whom BI has no reasonable objections and retained at CureVac’s expense. Said accountant shall sign a confidentiality agreement prepared by BI and reasonably acceptable to CureVac and shall then have the right to examine the records kept pursuant to this Agreement and report to CureVac the findings (but not the underlying data) of said examination of records as necessary to evidence that the records were or were not maintained and used in accordance with this Agreement. CureVac shall ensure that a copy of any report provided to CureVac by the accountant is given concurrently to BI. If said examination of records reveals any underpayment(s) of the royalty payable, then BI shall promptly pay the balance due to CureVac, and if the underpayment(s) is/are more than 5%, then BI shall also bear the expenses of said accountant. If said examination of records reveals any overpayment(s) of royalty payable, then CureVac shall credit the amount overpaid against Bl's future royalty payment(s). |
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7.9 Payment Terms.
7.9.1 | All payments by BI to CureVac shall be made by wire transfer payment, and shall be remitted to the following bank account: |
[*****]
Invoices shall be sent to BI at the following address: Boehringer Ingelheim International GmbH [*****]
Quote the BI in-house contact person in a corresponding reference field or anywhere on the invoice/credit note outside of the address field:
Contact: [*****]
7.9.2 | Payments not paid within five (5) days after the due date under this Agreement shall bear interest at an annual rate of three percent (3%) above the three-month-LIBOR rate of the respective currency for the time period in which such amount is outstanding, as disclosed from time to time by the European Central Bank which applied on the due date. Calculation of interest will be made for the exact number of days in the interest period based on a year of 360 days (actual/360) by BI. |
7.10 | Taxes. |
7.10.1 | All payments under or in connection with this Agreement shall be inclusive of any income taxes and each Party shall be responsible for its own income taxes assessed by a tax or other authority except as otherwise set forth in this Agreement. |
7.10.2 | If applicable laws require withholding of BI of any taxes imposed upon CureVac on account of any royalties and payments, paid under this Agreement, such taxes shall be deducted by BI as required by law from such remittable royalty and payment and shall be paid by BI to the proper tax authorities. Official receipts of payment of any withholding tax shall be secured and sent to CureVac as evidence of such payment. The Parties shall exercise their best efforts to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of any relevant tax treaty, and BI shall forward any refund payments to CureVac without undue delay, provided, however, in the event BI transferred its domicile outside of Germany, BI shall bear the risk and compensate CureVac for such withholding tax not being partly or fully refunded, and if CureVac transfers its domicile outside of Germany, CureVac shall bear the risk of such withholding tax not being partly or fully refunded. |
7.10.3 | All payments due to the terms of this Agreement are expressed to be exclusive of value added tax (VAT) or similar indirect taxes (e.g., Goods and Service tax). VAT/indirect taxes shall be added to the payments due to the terms if legally applicable. |
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8. | JOINT STEERING COMMITTEE AND JOINT PROJECT TEAM. |
8.1 | Formation of the JSC. The Parties shall form a Joint Steering Committee (the "Joint Steering Committee" or "JSC"), which shall monitor the Development of the Licensed Vaccines as described in more detail in Section 8.3 below. Each Party shall be equally represented on the Joint Steering Committee with an equal number of participants. The Joint Steering Committee shall be comprised of at least six (6) professionally and technically qualified representatives, three (3) from each Party. The Joint Steering Committee shall meet for the first time within six (6) weeks after the Effective Date and thereafter at least once a Calendar Quarter, with additional meetings to be held as the Parties deem necessary or in case a situation occurs in which a decision by the JSC is required, within [*****] after written request for such meeting by either Party. BI shall designate the chairperson of the JSC. The meeting place shall alternate between the offices of BI in [*****] and the offices of CureVac in [*****] or as otherwise decided by the JSC. JSC meetings may be conducted in person, by telephone or videoconference as agreed between the Parties, provided, however, that at least twice a year the JSC meeting shall be held in person. Each Party shall provide the other Party with written notice of its representatives for the JSC within [*****] after the Effective Date of this Agreement and, thereafter, immediately upon replacement, provided, however, that the Parties shall use Commercially Reasonable Efforts to ensure continuity on the JSC. Each Party may invite guests to the meetings, in order to discuss special technical or commercial topics relevant to the applicable agenda, provided, however, such guests are bound by confidentiality obligations corresponding to Sections 4.3 and 10. Prior to each meeting of the JSC each Party will make available to the other Party written copies of Development Data regarding the Development and other information relating to its respective activities and timelines. Furthermore, the Parties shall inform each other in writing at least [*****] prior to each JSC meeting of any event which could result in a material deviation from the activities and timelines set forth in the Development Plans. |
8.2 | Decision Making in the JSC. The JSC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever at least one representative appointed by each Party is present. The representatives from each Party may give proxy to the other representatives from such Party. The representatives from each Party will collectively have one vote in decisions of the JSC, with decisions of the JSC made by unanimous vote at a meeting at which a quorum exists. |
8.3 | Responsibilities of the JSC. The Parties shall be jointly responsible for directing the activities of the JSC, which activities shall include but not be limited to |
(a) | the review, validation, material modification, update and amendment of the Development Plans; |
(b) | the monitoring of the Development activities under the Development Plans; |
(c) | the exchange of Development Data and other technical information; |
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(d) | the resolution of any disputes within the Joint Project Team; and |
(e) | the coordination of patents and other intellectual property rights applications regarding Joint Inventions. |
For the avoidance of doubt, the JSC is not permitted to change any terms of this Agreement.
8.4 | Minutes. The JSC shall keep accurate and complete minutes of its meetings. The chairperson for each meeting shall be responsible for taking such minutes and distributing them to CureVac for its review and comment within two (2) weeks after the date of each meeting, and within one (1) week after the receipt thereof, CureVac shall remit such minutes back to the chairperson with its comments, if any. The Parties shall in good faith attempt as quickly as is reasonably possible to resolve any disputes as to the content of such minutes so as to have a final agreed version as quickly as is reasonably possible. |
8.5 | Decision Making Authority. All decisions of the JSC shall be made in good faith in the best interest of this Agreement and the Parties shall use their Commercially Reasonable Efforts to take decisions unanimously. In the event that the JSC is unable to agree on any matter after good faith attempts to resolve such disagreement in a commercially reasonable fashion, then either Party may refer the disagreement to a personal face-to-face meeting between the board member representing RD&M or his/her nominated designee of BI and the CEO or CCO of CureVac, and each Party shall ensure that such meeting takes place within [*****] after the date of the relevant referral. If the board member representing RD&M or his/her nominated designee of BI and the CEO or CCO of CureVac cannot resolve such disagreement in a mutually acceptable manner within a further [*****] period after such personal face-to-face meeting, then the vote of BI with appropriate consideration of the interests of CureVac shall be decisive regarding Development and Commercialization, except in the event the disputed topic would result in (a) a substantial reduction of Bl's diligence obligations under Section 4.2 hereof; (b) a delay of the Non-clinical and Clinical Development of more than [*****]; (c) a substantial change regarding the Manufacture of the Licensed Vaccines; (d) less FTE support of CureVac or an increase in FTE support of CureVac by more than [*****]; (e) the evaluation of the outcome of the ongoing feasibility study as referenced in Section 6.3.1(b) above; or (f) the evaluation of the outcome of the feasibility study with respect to the BI pDNA Process as referenced in Section 6.4 above. If BI casts its decisive vote in relation to a CMC Development matter, BI shall pay to CureVac compensation at the FTE Rates for any CureVac FTEs needed for the additional CMC Development activities demanded by BI (if any) and reimburse CureVac for any reasonable out of pocket costs incurred by CureVac in relation to such additional CMC Development activities. For the avoidance of doubt, the FTE resource commitments in the Development Plans, as set forth in Section 4.1.1 above, can only be reduced by the Parties and are not subject to the decision making process in the JSC. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
8.6 | Expert Panel Resolution. In the event that the Parties are unable to reach an agreement on any of the issues under Section 8.5 (a) to (e) or on any Manufacturing matter within [*****] after the personal face-to-face meeting between the board member representing RD&M or his/her nominated designee of BI and the CEO or CCO of CureVac, either Party is entitled to request that the question be referred to a panel of three (3) independent experts in the Development of biologic products for the treatment of cancer in humans and on the specific issue at dispute ("Expert Panel"). Such request shall be made by written notice explicitly referring to this Section 8.6. Each Party shall nominate within [*****] of the request one expert, while the third expert shall be mutually agreed by the Parties within another [*****]. If a Party does not nominate the one expert within such first [*****] such expert shall be nominated by the respective other Party. If the Parties are unable to agree on the third expert, the third expert shall be selected and nominated by the two experts appointed by the Parties. Each Party shall submit to the Expert Panel a written report setting forth its proposed resolution of such dispute within the later of (i) [*****] following a referral to the panel, or (ii) [*****] after selection of such Expert Panel. The Expert Panel shall meet face-to-face to discuss the written reports and shall be entitled, at its discretion to invite for a hearing representatives of the Parties. The Expert Panel shall then select as its decision one of the proposals from the Parties, and shall not have the authority to render any substantive decision other than the proposal of either BI or CureVac. The decision of the Expert Panel shall be final and binding on the Parties and the Party whose proposal has not been selected by the Expert Panel will pay all costs of the Expert Panel. |
8.7 | Joint Project Team. In addition to the JSC, the Parties shall jointly, unless otherwise mutually agreed, agree on and establish a project team ("Joint Project Team"), which shall be comprised of experts from the development disciplines of the Parties and which shall oversee and bring forward the Development. BI will have the lead of the Joint Project Team. The Joint Project Team shall meet regularly, but at least once per Calendar Quarter. Meetings of the Joint Project Team may be conducted in person, by telephone or videoconference as agreed between the Parties. Each Party shall provide the other Party with written notice of its representatives for the Joint Project Team within [*****] after the Effective Date of this Agreement and, thereafter, immediately upon replacement. Each Party may invite guests to the meetings, in order to discuss special technical or commercial topics relevant to the applicable agenda, provided, however, such guests are bound by confidentiality obligations corresponding to Sections 4.3 and 10. All decisions of the Joint Project Team shall be by unanimous agreement and any dispute within the Joint Project Team which cannot be resolved within four weeks will be brought to the attention of and for decision within the JSC. |
9. | INTELLECTUAL PROPERTY. |
9.1 | Ownership of Background Intellectual Property. BI retains all rights to the BI Background Intellectual Property, and CureVac retains all rights to the CureVac Background Intellectual Property, subject only to the licenses granted hereunder and the assignment and transfer of the CV9202 Specific Patent Rights to BI under Section 9.4 below. |
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9.2 | Ownership of Collaboration Intellectual Property. |
9.2.1 | For any invention comprised within Collaboration Intellectual Property, CureVac and BI will inform each other and determine in good faith whether it is |
(a) | either (i) dependent upon or covered by the BI Background Intellectual Property, and (x) neither dependent upon nor covered by the CureVac Background Intellectual Property and (y) not applicable to the CMC Development and/or Manufacture of the Licensed Vaccine or the manufacture of any other RNA-based product owned or in-licensed by CureVac; or (ii) solely directed to the composition of matter, the formulation or use of the Licensed Vaccine, i.e., not applicable to any other vaccine, compound or product, and not applicable to the Manufacture of the Licensed Vaccine or the manufacture of any other RNA-based product owned or in-licensed by CureVac, in which event such invention shall be solely owned by BI and shall be considered BI Collaboration Intellectual Property, irrespective as to which Party generated such Collaboration Intellectual Property. For the avoidance of doubt, any invention comprised within Collaboration Intellectual Property that is solely directed to the CV9202 Specific Patent Rights shall be solely owned by BI and shall be considered BI Collaboration Intellectual Property; |
(b) | (i) dependent upon or covered by the CureVac Background Intellectual Property, and neither dependent upon nor covered by the BI Background Intellectual Property nor directed to the composition of matter, the formulation or use of the Licensed Vaccine or the CV9202 Specific Patent Rights; or (ii) directed to the CMC Development (except any invention that is solely directed to the composition of matter, the formulation or use of the Licensed Vaccines) and/or Manufacture of the Licensed Vaccines or the manufacture of any other RNA-based product owned or in-licensed by CureVac, in which event such invention shall be solely owned by CureVac and shall be considered CureVac Collaboration Intellectual Property, irrespective as to which Party generated such Collaboration Intellectual Property; |
(c) | either (i) relates to both: (x) the composition of matter, the formulation or use of the Licensed Vaccine; and (y) any other CureVac Background Intellectual Property or any other vaccine, compound or product owned or in-licensed by CureVac; or (ii) relates to both: (xx) the BI Background Intellectual Property; and (yy) any other CureVac Background Intellectual Property or to the CMC Development (except any invention that is solely directed to the composition of matter, the formulation or use of the Licensed Vaccines) or Manufacture of the Licensed Vaccines or to the manufacture of any other RNA-based product owned or in¬licensed by CureVac; in which event, the Parties shall discuss in good faith whether any such invention can be divided and owned in accordance with Sections (a) and (b) above, made subject to separate patent filings to be assigned accordingly; and if no such division is possible, such Collaboration Intellectual Property shall be treated as provided under Section 9.2.2. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
9.2.2 | Any Collaboration Intellectual Property which is neither solely owned by BI nor solely owned by CureVac shall be jointly owned by the Parties ("Joint Collaboration Intellectual Property"). Any invention within the Joint Collaboration Intellectual Property shall be a "Joint Invention" and any Patent Right filed with respect to such Joint Invention shall be a "Joint Patent Right". For the avoidance of doubt, CureVac's share in Joint Collaboration Intellectual Property which falls within the scope of Bl's licenses under Sections 2.1 and/or 2.2, shall be automatically included within such license(s), on the terms and conditions contained in this Agreement. |
9.3 | Assignment and transfer of Collaboration Intellectual Property. |
9.3.1 | Assignment and Transfer. The initial holder of Collaboration Intellectual Property which is to be wholly or jointly owned by the other Party in accordance with Section 9.2 above shall assign and transfer, and hereby assigns and transfers, to such other Party all or a 50 percent share, as the case may be, of its present and future rights, interest and title to any such Collaboration Intellectual Property, and the other Party shall accept and hereby accepts such assignment and transfer. At the written instruction and, if the transferring Party incurs out-of-pocket costs, at the expense of the other Party, the transferring Party agrees to make or procure all such assignments from its employees, consultants and subcontractors as are necessary to give effect to this provision and to assist the transferee in every way reasonably required by the transferee (i) to obtain Patent Rights to such Collaboration Intellectual Property in any and all countries for which Patent Rights are being sought, and to (ii) maintain and defend Patent Rights in all Collaboration Intellectual Property which have been or may be assigned as provided above. At the expense (solely for out-of-pocket costs incurred) of the other Party, the transferring Party shall execute and deliver all such documents, instruments and other papers and take all such other action which the transferee may reasonably request in order to effect the provisions of this Section 9.3. |
9.3.2 | Back license to CureVac. BI hereby grants to CureVac, and CureVac hereby accepts, a cost-free, fully-paid, irrevocable, perpetual, sublicensable in multiple tiers and transferable license to use the Collaboration Intellectual Property assigned and transferred hereunder from CureVac to BI for the Manufacture of the Licensed Vaccine, the exploitation of any product other than a Licensed Vaccine or Licensed Product and/or for any use outside the Field. Such license shall be exclusive with regard to the Collaboration Intellectual Property described in Section 9.2.1(a)(ii) and non-exclusive with regard to the Collaboration Intellectual Property described in Section 9.2.1(a)(i) above. |
9.3.3 | Back license to BI. CureVac hereby grants to BI, and BI hereby accepts, a cost-free, fully- paid, non-exclusive, irrevocable, perpetual, sublicensable in multiple tiers and transferable license to use the Collaboration Intellectual Property assigned and transferred hereunder from BI to CureVac for the exploitation outside the scope of this Agreement. |
9.3.4 | Exploitation of joint inventions and results. Each Party may exploit any Joint Collaboration Intellectual Property in any and all fields (except, in the case of BI, for the CMC Development or Manufacture of the Licensed Vaccines or the manufacture of any other mRNA-based product), on a non-exclusive, cost-free basis, and with no accounting or obligation to the other, and each Party hereby grants to the other Party, and the other Party hereby accepts, a non-exclusive, cost-free, perpetual, irrevocable and worldwide license (in case of CureVac with the right to transfer and sublicense in multiple tiers and in case of BI with the right to sublicense in accordance with Section 2.2 above) to the other Party's share in such Joint Collaboration Intellectual Property, subject to the licenses granted hereunder. |
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9.4 | Assignment and Transfer of CV9202 Specific Patent Rights. |
9.4.1 | Upon [*****], CureVac shall assign and transfer to BI the CV9202 Specific Patent Rights. Upon such assignment, the CV9202 Specific Patent Rights shall no longer be included in the definition of CureVac Background Intellectual Property. In order to effect the assignment and transfer, CureVac will support BI, upon Bl's request in executing all assignment documentation and providing any declaration which may be necessary to effect the assignment and transfer of the CV9202 Specific Patent Rights from CureVac to BL BI shall be responsible for, and will pay all out-of-pockets expenses with respect to the assignment and transfer of the CV9202 Specific Patent Rights, including the fees for notarization and legalization of the assignment documents, and for recording such assignment documents with the competent patent offices. |
9.4.2 | As of the assignment and transfer of the CV9202 Specific Patent Rights, BI shall use its best efforts to prosecute, maintain and defend the CV9202 Specific Patent Rights in at least all Major Market Countries, shall keep CureVac informed of all such prosecution, maintenance and defense efforts, and shall give CureVac reasonable opportunity to review and comment on such prosecution, maintenance and defense. BI shall not unreasonably refuse to address any of CureVac's comments made in accordance with this Section 9.4.2. |
9.4.3 | BI hereby grants to CureVac, and CureVac hereby accepts, an exclusive, irrevocable, perpetual, cost-free, sublicensable in multiple tiers and transferable license to use the CV9202 Specific Patent Rights for the Manufacture of the Licensed Vaccines, the exploitation of any product other than a Licensed Vaccine or Licensed Product and/or for any use outside the Field. |
9.5 | Management of CureVac Licensed Patent Rights. |
9.5.1 | Filing and Prosecution of CureVac Licensed Patent Rights. During the term of this Agreement, and subject to Sections 9.5.2 and 9.5.5 below, CureVac shall be responsible for preparing and filing the CureVac Licensed Patent Rights, and prosecuting, maintaining and defending, throughout the Territory, all of the CureVac Licensed Patent Rights and, upon Bl's request, shall keep BI advised of the status of prosecution of all such patent applications included within the CureVac Licensed Patent Rights, and shall give BI before filing or response to office actions, as applicable, reasonable opportunity to review and comment upon the text of any applications or amendments for CureVac Licensed Patent Rights. CureVac shall not unreasonably refuse to address any of Bl's comments made in accordance with this Section 9.5.1. |
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EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT | CONFIDENTIAL EXECUTION VERSION |
9.5.2 | Filing and Prosecution of Joint Patent Rights. BI shall have the right, but not the obligation, of preparing, filing, prosecuting, maintaining and defending Joint Patent Rights anywhere in the Territory. At the latest [*****] before filing, the prosecuting Party shall give the non-prosecuting Party an opportunity to review and comment upon the text of any application with respect to such Joint Patent Right, shall consult with the non¬prosecuting Party with respect thereto, shall not unreasonably refuse to address any of the non-prosecuting Party's comments and supply the non-prosecuting Party with a copy of the application as filed, together with notice of its filing date and serial number. The prosecuting Party shall keep the non-prosecuting Party reasonably informed of the status of the actual and prospective prosecution, maintenance and defense, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and the prosecuting Party shall give the non-prosecuting Party a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with such non-prosecuting Party with respect thereto, and shall not unreasonably refuse to address any of such non-prosecuting Party's comments. |
9.5.3 | Assigned Patent Rights. Upon assignment, BI shall have the right but not the obligation, of preparing, filing, prosecuting, maintaining and defending Patent Rights within the Collaboration Intellectual Property assigned and transferred, wholly or in part, as the case may be, by CureVac to BI in accordance with Section 9.3 (the "Assigned Patent Rights"), anywhere in the Territory, and shall keep CureVac advised of the status of prosecution of all such Patent Rights, and shall give CureVac before filing or response to office actions, as applicable, reasonable opportunity to review and comment upon the text of any applications or amendments or other substantive actions for such Patent Rights. BI shall not unreasonably refuse to address any of CureVac's comments made in accordance with this Section 9.5.3. |
9.5.4 | Costs. The costs of filing, prosecuting, maintaining and defense of the CureVac Licensed Patent Rights under Section 9.5.1 and 9.5.2 shall be borne by the Party responsible for such filing, prosecution, maintenance and defense, except for and subject to such Party's right to elect to discontinue the patent prosecution and maintenance as set forth in Section 9.5.5 below. |
9.5.5 | Abandonment of Patent Rights. If CureVac elects to cease the filing, prosecution, maintenance and/or defense of a CureVac Licensed Patent Right or if BI elects not to participate in filing of a patent application on a Joint Invention or to cease the prosecution, maintenance or defense of any Joint Patent Right, a CV9202 Specific Patent Right or an Assigned Patent Right in any country of the Territory, such Party shall provide the other Party with written notice immediately upon the decision to abandon the filing, prosecution, maintenance and/or defense of such CureVac Licensed Patent Right, Joint Patent Right, CV9202 Specific Patent Right or Assigned Patent Right, as the case may be, in any event, however, not later than [*****] before any relevant deadline relating to or any public disclosure of the relevant Patent Rights. In such event, the abandoning Party shall permit the other Party, at such other Party's sole discretion, to take over or continue, as the case may be, the filing, prosecution, maintenance and defense of such Patent Right on behalf of and in the name of the owner of such Patent Right and at such other Party's own expense. If the abandoning Party was also the prosecuting Party and if the other Party elects to take over and continue such filing, prosecution, maintenance and defense, the abandoning Party shall execute such documents and perform such acts, at the expense of the Party taking over prosecution, as may be reasonably necessary to permit such Party to take over and continue the filing, prosecution, maintenance and/or defense of such Patent Right on behalf and in the name of the respective owner or co-owners of such Patent Right and at its own expense. For the avoidance of doubt, the abandoning Party shall remain an owner or co-owner of the abandoned Patent Right but has no further say in the filing, prosecution, maintenance and defense of the Patent Right, provided, however, that the prosecuting Party shall timely inform such abandoning Party if it is decided to finally abandon the respective Patent Right, in which event the other Party shall have the right to assume sole responsibility for ongoing prosecution, maintenance and defense of such Patent Right in accordance with this Section 9.5. |
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9.6 | Enforcement of CureVac Licensed Patent Rights, Joint Patent Rights, CV9202 Specific Patent Rights and Assigned Patent Rights. |
9.6.1 | If either BI or CureVac becomes aware of any infringement, anywhere in the world, of any issued CureVac Licensed Patent Right, Joint Patent Right, CV9202 Specific Patent Right or Assigned Patent Right, it will promptly notify the other Party in writing thereof. |
9.6.2 | CureVac shall have the primary right, but not the obligation, to take action to obtain a discontinuance of infringement or bring suit against a Third Party infringer of a CureVac Licensed Patent Right it is responsible for under Section 9.5.1. Upon assignment to BI under Section 9.4 of this Agreement, BI shall have the primary right to take action to obtain a discontinuance of infringement or bring suit against a Third Party infringer of CV9202 Specific Patent Rights or Assigned Patent Rights. The Party prosecuting and maintaining the Joint Patent Right shall have the primary right, but not the obligation, to take action to obtain a discontinuance of infringement or bring suit against a Third Party infringer of such Patent Right. The enforcing Party shall bear all expenses of such action or suit. |
9.6.3 | If the Party which has the primary right to bring an infringement action elects not to take action or to bring suit to prosecute such infringement, it shall notify the other Party of such election within [*****] after receipt of the notice of the infringement or after the election to stop any such suit. If after the expiration of the [*****] period (or, if earlier, the date upon which the Party which has the primary right to bring an infringement action provides written notice that it does not plan to bring such action), the Party which has the primary right to bring action has neither obtained a discontinuance of infringement of the CureVac Licensed Patent Right, the Joint Patent Right, the CV9202 Specific Patent Right or the Assigned Patent Right, as the case may be, nor filed suit against any such Third Party infringer of such Patent Rights, then the other Party shall have the right, but not the obligation, to take action or bring suit against such Third Party infringer of such Patent Rights, provided that such other Party shall bear all the expenses of such suit. |
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9.6.4 | In any litigation brought by either Party pursuant to this Section 9.6, the enforcing Party shall notify the non-enforcing Party of the commencement of that litigation and shall have the right and standing to use and sue in the other Party's name. Notwithstanding the first sentence of this paragraph, irrespective of which Party brings the infringement action hereunder, (i) the Parties shall collaborate with respect to such action; (ii) the non¬enforcing Party shall have the right, at its own expense, to be represented by independent counsel in any such litigation; and (iii) the Parties shall consult with each other regarding, and agree on strategic decisions and their implementation in connection with such action. The Party bringing the infringement action hereunder shall bear all the expenses of any suit brought by it claiming infringement of any CureVac Licensed Patent Right, Joint Patent Right, CV9202 Specific Patent Right or Assigned Patent Right. |
9.6.5 | Any recoveries obtained by either Party as a result of any proceeding against a Third Party infringer under this Section 9.6 shall be allocated as follows: |
(a) | Such recovery shall first be used to reimburse each Party for all reasonable litigation costs in connection with such litigation incurred by that Party; |
(b) | such recovery shall then be used to compensate each Party for the respective damages suffered from the infringement of the respective Patent Right, provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party's damages, such compensation shall be paid on a pro-rata share based on the respective damages suffered, provided, however, if such respective damages suffered cannot be reasonably ascertained, the recovery shall be equally shared between the Parties; and |
(c) | the remaining portion of such recovery, if any, shall be equally shared between CureVac and BI to the extent it relates to Licensed Vaccines and Licensed Products, and shall belong to the Party Controlling the respective Patent Right to the extent it does not relate to Licensed Vaccines and Licensed Products. |
9.6.6 | Neither Party shall settle any claim or demand in any such litigation that materially negatively impacts the other Party's rights or interests under this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. In addition to the foregoing, to the extent any action initiated by BI involves any infringement of CureVac Licensed Patent Rights, Joint Patent Rights, the CV9202 Specific Patent Rights or the Assigned Patent Right and is reasonably likely to relate to CureVac’s products and/or technologies other than a Licensed Vaccine, BI will consult with CureVac regarding issues relating to such CureVac Licensed Patent Rights, Joint Patent Rights, the CV9202 Specific Patent Rights or the Assigned Patent Rights, CureVac’s products and technologies, and the Parties will mutually agree on strategic litigation decisions regarding such issues. |
9.6.7 | The non-enforcing Party shall provide such assistance as the enforcing Party shall reasonably request in connection with any action or suit hereunder to prevent or enjoin any such infringement or unauthorized use of an issued Patent Right within the CureVac Licensed Patent Rights, Joint Patent Rights, the CV9202 Specific Patent Rights or the Assigned Patent Rights, including agreeing to be joined as a party to such action or suit and executing legal documents as reasonably requested by the enforcing Party. Such assistance will be provided by a Party, at the enforcing Party's cost. The Parties agree that, irrespective of which Party brings the action or suit pursuant to this Section 9.6, the Parties will update each other as to the status of such actions through the JSC and the enforcing Party will not unreasonably reject comments from the other Party relating to the management of such litigation. |
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9.7 | Infringement and Third Party Licenses. |
9.7.1 | If the Development and Commercialization or use of any Licensed Vaccine or Licensed Product in accordance with this Agreement is alleged by a Third Party to infringe a Third Party's Patent Right, or such allegation can be reasonably expected, the Party becoming aware of such allegation shall promptly notify the other Party. Additionally, if either Party determines that, based upon the review of a Third Party's Patent Right, it may be desirable to obtain a license from such Third Party with respect thereto, such Party shall promptly notify the other Party of such determination and the Parties shall consult with each other and attempt to agree on a common strategy to either obtain a reasonable license or otherwise. If BI reasonably determines that such license from a Third Party ("Third Party Licensor") is necessary in order to have freedom to operate in practicing the CureVac Licensed Intellectual Property in accordance with this Agreement in any country, then BI shall have the sole right, but not the obligation, to negotiate and obtain a license from such Third Party Licensor as necessary for BI, its Affiliates, and permitted Sublicensees to Non- clinically and Clinically Develop and Commercialize the Licensed Vaccines and Licensed Products in such country. |
9.7.2 | If a Third Party sues BI or CureVac or any of their Affiliates, distributors or permitted Sublicensees alleging that Bl's practice of a right granted by CureVac to BI hereunder through the Development and Commercialization of any Licensed Vaccine or Licensed Product pursuant to this Agreement infringes or will infringe said Third Party's Intellectual Property, then, upon the defending Party's request and in connection with the defense of any such Third Party infringement suit, the non-defending Party shall provide reasonable assistance to the defending Party for such defense and/or shall join in any such action if required in order to defend such claim or to assert all available defenses and claims, and to cooperate reasonably with the defending Party. |
9.7.3 | The defending Party shall not enter into a settlement that imposes a financial obligation upon the non-defending Party or which limits the scope or invalidates any Patent Right of either Party without such Party's prior written consent, which consent shall not be unreasonably withheld or delayed, and in any settlement the defending Party shall always take into consideration the interest of the non-defending Party. |
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9.8 | Patent Term Extension and Supplementary Protection Certificate. The JSC shall decide on any patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, in order to secure the optimal protection for the Licensed Vaccine available under Applicable Laws. The JSC shall not decide to extend a Patent Right that is not a CureVac Licensed Patent Right, Joint Patent Right, CV9202 Specific Patent Right or an Assigned Patent Right in any country or other jurisdiction, without CureVac's prior written consent which CureVac shall not unreasonably delay or withhold. The Party having the responsibility to prosecute the respective Patent Right shall have the sole obligation of applying for any extension or supplementary protection certificate with respect to a Licensed Vaccine and such Patent Right in the Territory, and such Party shall keep the other Party fully informed of its efforts to obtain such extension or supplementary protection certificate. The other Party shall provide prompt and reasonable assistance, as requested by the applying Party, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. BI shall pay all expenses in regard to obtaining and maintaining any extension or supplementary protection certificate in respect of the Licensed Vaccine in the Territory. |
9.9 | CREATE Act. This Agreement includes a joint research agreement as defined in §§ 100(h) and 102(c) of title 35, United States Code as amended by the America Invents Act. If either Party intends to disqualify as prior art subject matter in a Patent Right within the Collaboration Intellectual Property that would otherwise qualify as prior art under 35 U.S.C. §102 (a)(2) with respect to a claimed invention in any such Patent Right pursuant to the provisions of 35 U.S.C. §102(c), such Party shall first obtain the prior written consent of the other Party (including the terms and conditions under which any Patent Rights subject to a terminal disclaimer and the Patent Rights over which the application is disclaimed shall be enforced and licensed), which consent shall not be unreasonably withheld. Following receipt of such written consent, such Party shall limit any statement added to the specification of any Patent Right within the Collaboration Intellectual Property to such information which is strictly required by 35 U.S.C. § 102(c)(3) and the rules and regulations promulgated thereunder to disqualify as prior art subject matter that would otherwise qualify under 35 U.S.C. §102 (a)(2) as contemplated by the CREATE Act, and which is consistent with the terms and conditions of this Agreement. |
10. | CONFIDENTIALITY. |
10.1 | Obligation of Confidentiality. As of and after the Effective Date, all Confidential Information disclosed, revealed or otherwise made available to one Party ("Receiving Party") by or on behalf of the other Party ("Disclosing Party") under, or as a result of, this Agreement is made available to the Receiving Party solely to permit the Receiving Party to exercise its rights, and perform its obligations, under this Agreement or any Related Agreement. The Receiving Party shall not use any of the Disclosing Party's Confidential Information for any other purpose, and shall not disclose, reveal or otherwise make any of the Disclosing Party's Confidential Information available to any other Person, firm, corporation or other entity, without the prior written authorization of the Disclosing Party, except as explicitly stated in this Article 10. |
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10.2 | Additional Obligations. In furtherance of the Receiving Party's obligations under Section 10.1 hereof, the Receiving Party shall take all reasonable steps, and shall implement all appropriate and reasonable safeguards, to seek to prevent the unauthorized use or disclosure of any of the Disclosing Party's Confidential Information. Without limiting the generality of this Section 10.2, the Receiving Party shall disclose any of the Disclosing Party's Confidential Information only to those of its officers, employees, Affiliates, Sublicensees and consultants, and its potential Sublicensees, and consultants that have a need to know the Disclosing Party's Confidential Information, in order for the Receiving Party to exercise or confirm its rights or the scope of the licenses granted hereunder, and/or to perform its obligations under this Agreement. Furthermore, the Receiving Party shall be permitted to disclose the existence and a reasonably redacted version of this Agreement (excluding its exhibits) to its assignees and investors, and to potential assignees and investors who have a reasonable need to review the terms of this Agreement. The disclosures under this Section 10.2 are subject to such officers, employees, Affiliates, Sublicensees, consultants, assignees and investors, and potential Sublicensees, consultants, assignees and investors having executed appropriate agreements containing substantially similar terms regarding confidentiality and non-use as those set out in this Agreement or are otherwise bound by obligations of confidentiality effectively prohibiting the unauthorized use or disclosure of the Disclosing Party's Confidential Information. The Receiving Party shall furnish the Disclosing Party with written notice immediately of it becoming aware of any unauthorized use or disclosure of any of the Disclosing Party's Confidential Information by any officer, employee, Affiliate, Sublicensee, consultant, assignee or investor, or potential Sublicensee, consultant, assignee or investor of the Receiving Party, and shall take all actions that the Disclosing Party reasonably requests in order to prevent any further unauthorized use or disclosure of the Disclosing Party's Confidential Information. Furthermore, CureVac is entitled to disclose the terms and conditions of this Agreement to licensees and potential licensees, subject to redaction to show only the provisions which are relevant for the scope of the licenses granted hereunder [*****] and further subject to such licensee or potential licensee having executed an appropriate confidentiality agreement. |
10.3 | Limitations. The Receiving Party's obligations under Sections 10.1 and 10.2 hereof shall not apply to the extent that the Receiving Party can demonstrate by competent evidence that any of the Disclosing Party's Confidential Information: |
(a) | passes into the public domain, or becomes generally available to the public through no fault of the Receiving Party; |
(b) | was known to the Receiving Party or its Affiliates prior to being made available hereunder without restriction of use or disclosure; |
(c) | is disclosed, revealed or otherwise made available to the Receiving Party or its Affiliates by a Third Party, without restriction of use or disclosure, that is under no obligation of non-disclosure and/or non-use to the Disclosing Party in relation to the subject item; |
(d) | has been independently developed or created by the Receiving Party or its Affiliates without access to the Disclosing Party’s Confidential Information; |
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(e) | is necessary or useful to be disclosed by the Receiving Party for making applications or submissions to or otherwise dealing with Regulatory Authorities in connection with the Development, Manufacture or Commercialization of a Licensed Vaccine or Licensed Product or for obtaining Patent Rights protecting Collaboration Intellectual Property, provided, however, that the Receiving Party shall furnish the Disclosing Party with as much prior written notice of such disclosure requirement as reasonably practicable; or |
(f) | is required to be disclosed under Applicable Laws and to the extent required to be disclosed under Applicable Laws; provided, however, that the Receiving Party shall furnish the Disclosing Party with as much prior written notice of such disclosure requirement as reasonably practicable, so as to permit the Disclosing Party, in its sole discretion, to take appropriate action, including seeking a protective order, in order to prevent the Disclosing Party's Confidential Information from passing into the public domain or becoming generally available to the public. |
10.4 | Materials. The Parties hereby agree that any Material to be transferred from CureVac to BI under this Agreement, other than Licensed Vaccines transferred under the Clinical Supply Agreement or any Related Agreement to be concluded in accordance with Section 6.2 above, shall remain the exclusive property of CureVac, and BI shall use such Material only for purposes of this Agreement. In particular, for any Materials transferred to BI under Article 6 (i.e., to enable BI, its Affiliates or a Permitted Third Party CMO to Manufacture Licensed Vaccines) BI further agrees not use such Materials other than to Manufacture Licensed Vaccines in accordance with the terms of this Agreement. BI shall not transfer such Material to or use such Material on behalf of a Third Party other than a Permitted Third Party CMO. Furthermore, BI undertakes to keep such Materials secure and safe from loss, damage, theft, misuse and unauthorized access and to use such Materials in accordance with all Applicable Laws. Upon termination of this Agreement, BI shall cease use of and return to CureVac or destroy (as CureVac shall specify in writing promptly upon termination of this Agreement) all such Materials in its possession upon such termination, and shall certify such return or destruction in writing to CureVac. |
10.5 | Return of Confidential Information. Subject to Sections 13.1 and 14.4 and subject to any other right to retain Confidential Information, upon expiration or termination of this Agreement for any reason whatsoever, the Receiving Party shall cease all use of and return to the Disclosing Party, or destroy, as the Disclosing Party shall specify in writing promptly upon such expiration or termination, all copies of all documents and other materials that contain or embody any of the Disclosing Party's Confidential Information, except to the extent that the Receiving Party is required by Applicable Laws to retain such documents and materials, and provided further that each Party may keep a single copy of all Confidential Information within its legal archives solely to assure compliance with the provisions of this Article 10. The obligation to destroy shall also apply to copies of any computer records and files containing such Confidential Information, except to the extent created by the Receiving Party's automatic archiving and backup computer systems. Within [*****] after the date of expiration or termination of this Agreement, the Receiving Party shall confirm that the Receiving Party has complied with its obligations under this Section 10.5. |
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10.6 | Survival. All of the Receiving Party's obligations under Sections 10.1 and 10.2 hereof, with respect to the protection of the Disclosing Party's Confidential Information, shall for a period of [*****] survive the expiration or termination of this Agreement for any reason whatsoever. |
10.7 | Public Announcements. No public announcement concerning the existence of, terms, or subject matter of this Agreement shall be made, either directly or indirectly, by any Party, without first obtaining the prior written approval of the other Party and agreement upon the nature and text of such public announcement which such agreement and approval shall not be unreasonably withheld or delayed; except as may be legally required (i) by Applicable Laws, (ii) by the listing standards or agreements of any national or international securities exchange or other similar laws of a governmental authority, market or agency, (iii) to respond to an inquiry of a governmental authority or agency, or (iv) in a judicial, administrative or arbitration proceeding. In all instances, the Party concerned shall seek appropriate confidential treatment of this Agreement and the subject matter hereof and the Parties shall agree in advance on any redacted forms of this Agreement that are filed publicly, such agreement not to be unreasonably withheld or delayed. The Party desiring to make any such public announcement (including those which are legally required) shall inform the other Party of the proposed announcement or disclosure in reasonably sufficient time prior to public release, which shall be not less than [*****] (or such shorter period as the Parties may agree upon in writing, or such shorter period applicable to those public announcements which are legally required) prior to release of such proposed public announcement, and shall provide the other Party with a written copy thereof in order to allow such other Party to comment upon such public announcement. Each Party agrees that it shall co-operate fully with the other Party with respect to all disclosures regarding this Agreement to any governmental or regulatory agencies, including requests for confidential treatment of proprietary information of either Party included in any such disclosure. Neither Party will issue a press release without the prior written consent of the other Party. The Parties agree that each Party may, following the Effective Date, issue a press release describing this Agreement in general terms, provided that the content of such press release shall first be approved by the other Party. For such purpose, the Party intending to issue the press release shall provide the other Party with a draft press release at least [*****] prior to the proposed date of disclosure. |
10.8 | Applicable Laws. Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with Applicable Laws governing activities and obligations undertaken pursuant to this Agreement in any manner which it reasonably deems appropriate, including, for example, by disclosing to Regulatory Authorities confidential or other information received from the other Party, subject to Sections 10.3 (e) and (f) and 10.7. |
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10.9 | Publication. Prior to the First Commercial Sale of a Licensed Product, publications in a journal, paper, magazine or any other such similar disclosure relating to or arising from this Agreement and/or the Development or Commercialization of Licensed Vaccines and/or Licensed Products shall not take place without the prior written agreement of both BI and CureVac, such agreement not to be unreasonably withheld, provided, however, that with respect to the Licensed Vaccines and Licensed Products CureVac shall only be permitted to use the Development Data on the Licensed Vaccines and Licensed Products as reference to market its mRNA based technologies and shall not make any other publication regarding the Licensed Vaccines and Licensed Products unless expressly permitted by BI. Any draft publication intended to be submitted for publication or disclosure by one of the Parties hereto shall first be sent to the other Party in order to allow such Party to make comments thereon, and to preserve its Intellectual Property by delaying such publication and/or removing its Confidential Information. Each Party shall comply with the other Party’s request to delete references to the other Party’s Confidential Information in any such publication, and agrees to withhold publication of same for the time necessary to permit the other Party to obtain optimum patent protection, such time period not to exceed [*****]. Bl’s obligation to provide CureVac with any draft publication intended to be submitted for publication or disclosure by BI in respect of a Licensed Product ceases upon the First Commercial Sale of such Licensed Product. Each Party's contribution shall be acknowledged in any publication by co-authorship or acknowledgment, whichever is appropriate in accordance with customary scientific practice. Once approval has been granted for a particular disclosure, such disclosed information may be subsequently disclosed without requiring additional approval for each instance of disclosure. |
11. | WARRANTIES AND LIABILITIES. |
11.1 | Representations and Warranties of each Party. Each of CureVac and BI hereby represents and warrants to the other Party hereto as follows on the Effective Date: |
(a) | it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation; |
(b) | the execution, delivery and performance of this Agreement by such Party does not conflict with any other agreement by which it is bound, and has been duly authorized by all requisite corporate action and does not require any shareholder action or approval; |
(c) | it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder; and |
(d) | it shall at all times comply with all Applicable Laws relating to its activities under this Agreement. |
11.2 | Additional Representations and Warranties of CureVac. Subject to the disclosures in the attached Exhibit 11.2, CureVac hereby represents and warrants that, on the Effective Date: |
(a) | it Controls the right, title and interest in the Patent Rights comprised in the CureVac Background Intellectual Property as listed in Exhibit 1.17, and to the extent licensed under this Agreement; |
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(b) | it is the sole and exclusive owner (free and clear of any liens, mortgages, security interests, charges, encumbrances or otherwise) of the CV9202 Specific Patent Rights listed on Exhibit 1.23; |
(c) | all employee inventions covered by the Patent Rights listed in part (A)(1) of Exhibit 1.17 and on Exhibit 1.23 have been duly claimed by CureVac in accordance with the German Arbeitnehmererfindungsgesetz or CureVac has entered into binding agreements transferring the rights in and to such inventions to CureVac; |
(d) | it has the right to enter into this Agreement and to grant the licenses contained herein, and neither CureVac nor any of its Affiliates is a party to or otherwise bound by any agreement that will result in any person or entity obtaining any interest in, or that would give to any entity or person any right to assert any claim in or with respect to, any of Bl's exclusive rights granted under this Agreement; |
(e) | to its knowledge, no Third Party has any right, title or interest in or to any of the CureVac Licensed Patent Rights within the scope of the exclusive licenses granted hereunder; |
(f) | all of the Patent Rights listed on part (A)(1) of Exhibit 1.17 and on Exhibit 1.23 are pending or issued and have not been abandoned as of the Effective Date; |
(g) | to CureVac’s knowledge, no claim, suit, litigation, arbitration, opposition or other proceeding before a court of law, arbitral body, Regulatory Authority or patent office is pending or has been rendered or is threatened by any Third Party which would limit, cancel or question the validity, enforceability, ownership or use of any of the Patent Rights listed on part (A)(1) of Exhibit 1.17 and on Exhibit 1.23; |
(h) | Exhibits 1.17 and 1.23 list all of CureVac’s and CureVac’s Affiliates’ Patent Rights that to the knowledge of CureVac would be infringed by the Non-CIinical and Clinical Development or Commercialization of Licensed Vaccines or Licensed Products; |
(i) | to CureVac’s knowledge, no Patent Rights or other Intellectual Property owned or controlled by a Third Party exist that could materially conflict with the grant of rights by CureVac to Bl under this Agreement; and |
(j) | it has furnished or made available to Bl all material information that is in its possession concerning CV9202 and relevant to the safety or efficacy of CV9202, and, to CureVac’s knowledge, such information is accurate, complete and true in all material respects. |
11.3 | Disclaimer. CureVac makes no representation or warranty and specifically disclaims any guarantee that the Development of the Licensed Vaccines will be successful, in whole or in part, or that the CureVac Licensed Intellectual Property will be suitable for Development and/or Commercialization of Licensed Products. Subject only to Sections 11.1 and 11.2 above, CureVac expressly disclaims any warranties or conditions, express, implied, statutory or otherwise with respect to the CureVac Licensed Intellectual Property and Licensed Vaccines and Licensed Products, including any warranty of merchantability or fitness for a particular purpose. In particular, subject only to Sections 11.1 and 11.2, CureVac expressly disclaims any warranties or conditions, express, implied, statutory or otherwise with respect to the non-infringement of the CureVac Licensed Intellectual Property and the Licensed Vaccines and Licensed Products. |
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11.4 | Limitation of Liability. Subject to Section 12 of this Agreement and except in the case of gross negligence (grobe Fahrlassigkeif), an intentional act (Vorsatz) or bodily injury, neither Party shall be liable to the other Party for any indirect, incidental, punitive or consequential damages including lost profits, whether based on contract or tort, or arising under Applicable Laws or otherwise. |
12. | INDEMNIFICATION. |
12.1 | CureVac's Obligations to Indemnify. CureVac shall indemnify, defend and hold BI and its Affiliates, and its and their employees, agents, officers, and directors (individually and/or collectively referred to herein as a "BI Party") harmless from and against any and all losses, liabilities, damages, expenses (but excluding indirect, incidental, special, consequential or punitive losses or damages, etc.) or fees (but only reasonable attorneys fees and expenses and costs of litigation pertaining to such BI Claim) paid or payable by BI or a BI Party to a Third Party (collectively, "BI Losses") to the extent that such BI Losses result from or arise in connection with a claim, suit or other proceeding made or brought by a Third Party against BI or a BI Party (a "BI Claim") based on, resulting from, or arising in connection with: |
(a) | any claim by [*****] regarding an allegation that the manufacture, use, sale or offer for sale of Licensed Vaccine and/or Licensed Product pursuant to and consistent with this Agreement infringes such claimant’s intellectual property rights, provided, however, CureVac grants rights (in particular sub-licenses) to such intellectual property rights to BI under this Agreement; |
(b) | any material breach of any of CureVac's representations or warranties set forth in this Agreement; or |
(c) | any other grossly negligent, willful or intentionally wrongful act, error or omission on the part of CureVac, or any officer, director, employee, agent or representative of CureVac; |
provided, however, that CureVac shall not be obligated to indemnify, defend or hold harmless BI or a BI Party from any BI Claim or for any BI Loss incurred by BI or a BI Party to the extent arising out of, or attributable to, (A) a material breach by BI, or any BI Party of any obligation, covenant, agreement, representation or warranty of BI, or a BI Party contained in this Agreement or under a Related Agreement; (B) any material violation of Applicable Laws by BI, or a BI Party, in connection with the performance of Bl's or its Affiliates' obligations under this Agreement or under a Related Agreement; (C) any act or omission by BI, or a BI Party, which constitutes gross negligence, or willful or intentional misconduct on the part of BI, or a BI Party; or (D) BI Claims to the extent BI is responsible for indemnifying, defending and holding CureVac and CureVac Parties harmless for such claims as set forth in Section 12.2 or in the Clinical Supply Agreement or any Related Agreement to be concluded in accordance with Section 6.2 above.
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12.2 | Bl's Obligations to Indemnify. BI shall indemnify, defend and hold CureVac and its Affiliates, and its and their officers, directors, trustees, agents and employees (individually and/or collectively referred to herein as a "CureVac Party") harmless from and against any and all losses, liabilities, damages, expenses (but excluding indirect, incidental, special, consequential or punitive losses or damages, etc.) or fees (but only reasonable attorney fees and expenses and costs of litigation pertaining to such CureVac Claim) paid or payable by CureVac or a CureVac Party to a Third Party (collectively, "CureVac Losses") to the extent that such CureVac Losses result from or arise in connection with a claim, suit or other proceeding made or brought by a Third Party against CureVac or a CureVac Party (a "CureVac Claim") based on, resulting from, or arising in connection with: |
(a) | any material breach of any of Bl's representations or warranties set forth in this Agreement; |
(b) | any other grossly negligent, willful or intentionally wrongful act, error or omission on the part of BI, or any officer, director, employee, agent or representative of BI; |
(c) | any claim that any of the Licensed Vaccines and Licensed Products fail to conform with the requirements of any Applicable Laws, including the failure by BI to obtain any required Regulatory Approvals for the Licensed Vaccines and Licensed Products; |
(d) | any product liability claim regarding the Licensed Vaccine or Licensed Product; |
provided, however, that BI shall not be obligated to indemnify, defend or hold harmless CureVac or a CureVac Party from any CureVac Claim or for any CureVac Loss incurred by CureVac or an CureVac Party to the extent arising out of or attributable to: (A) a material breach by CureVac, or any CureVac Party of any obligation, covenant, agreement, representation or warranty of CureVac, or any CureVac Party contained in this Agreement or in any Related Agreement; or (B) any material violation of Applicable Laws by CureVac or a CureVac Party, in connection with the performance of CureVac's or its Affiliates' obligations under this Agreement or under any Related Agreement; or (C) any act or omission by CureVac, or a CureVac Party, which constitutes gross negligence, or wilful or intentional misconduct on the part of CureVac, or a CureVac Party; or (D) CureVac Claims to the extent CureVac is responsible for indemnifying, defending and holding BI and/or any BI Party harmless for such claims as set forth in Section 12.1 or in the Clinical Supply Agreement or any Related Agreement to be concluded in accordance with Section 6.2 above.
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12.3 | Indemnification Procedures. |
12.3.1 | Each indemnified Party shall notify in English the indemnifying Party in writing (and in reasonable detail) of the Claim within [*****] after receipt by such indemnified Party of notice of the BI Claim or the CureVac Claim, as the case may be, or otherwise becoming aware of the existence or threatened existence thereof (such BI Claim or CureVac Claim being referred to as a "Claim"). Failure to give such notice shall not constitute a defense, in whole or in part, to any claim by an indemnified Party hereunder except to the extent the rights of the indemnifying Party are materially prejudiced by such failure to give notice. The indemnifying Party shall notify in English the indemnified Party of its intentions as to defense of the Claim or potential Claim in writing within [*****] after receipt of notice of the Claim. If the indemnifying Party assumes the defense of a Claim against an indemnified Party, the indemnifying Party shall have no obligation or liability under this Article 12 as to any Claim for which settlement or compromise of such Claim or an offer of settlement or compromise of such Claim is made by the indemnified Party without the prior written consent of the indemnifying Party. |
12.3.2 | The indemnifying Party shall assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such Claim (so long as it has confirmed its indemnification obligation responsibility to such indemnified Party under this Section 12.3 with respect to a given Claim); provided, however, that the indemnifying Party may not settle such Claim in any manner that would require payment by the indemnified Party, or would materially adversely affect the rights granted to the indemnified Party hereunder, or would materially conflict with the terms of this Agreement, or adversely affect such Party or its products, without first obtaining the indemnified Party's prior written consent, which consent shall not be unreasonably withheld. |
12.3.3 | The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the Claim (including, without limitation, copying and making documents and records available for review and making persons within its control available for pertinent testimony in accordance with the confidentiality provisions of Article 10, and neither Party shall be required to divulge privileged material to the other) at the indemnifying Party's expense. If the indemnifying Party assumes defense of the Claim, the indemnified Party may participate in, but not control, the defense of such Claim using attorneys of its choice and at its sole cost and expense, with such cost and expense not being covered by the indemnifying Party. If the indemnifying Party does not agree to assume the defense of the Claim asserted against the indemnified Party (or does not give notice that it is assuming such defense), or if the indemnifying Party assumes the defense of the Claim in accordance with this Section 12.3 yet fails to defend or take other reasonable, timely action, in response to such Claim asserted against the indemnified Party, the indemnified Party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such Claim; provided, however, that no Party shall have the right to settle a Claim in a manner that would adversely affect the rights granted to the other Party hereunder, or would materially conflict with this Agreement, or would require a payment by the Party, or adversely affect the Party (its Affiliates) or its products in or outside the Territory, without the prior written consent of the Party entitled to control the defense of such Claim, which consent shall not be unreasonably withheld. |
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13. | TERM AND TERMINATION. |
13.1 | Expiry. This Agreement shall automatically become effective as of the Effective Date. It shall remain in full force and effect on a country-by-country and Licensed Product-by-Licensed Product basis, for the duration of the Royalty Term, unless terminated earlier by either Party for whatever reason. Upon expiry of this Agreement for a Licensed Product in any country, BI shall retain its license granted under Sections 2.1 (including the right to sublicense in accordance with Section 2.2) and 6.3 as an irrevocable, perpetual, fully paid- up and royalty free right to use the CureVac Licensed Intellectual Property and/or the CureVac Licensed Manufacturing Intellectual Property, as applicable, solely for such Licensed Produces) in such country and in the Field, such license to be exclusive for the longer of (i) the term during which CureVac supplies at least [*****] of Bl's demand for Licensed Vaccines to BI; and (ii) [*****] upon expiry of this Agreement; and to be non-exclusive thereafter. |
13.2 | Termination for Convenience. BI shall be entitled to terminate this Agreement at its sole discretion at any time by giving [*****] prior written notice. |
13.3 | Termination for Material Breach. In the event that either Party ("Breaching Party") commits a material breach of any of its obligations hereunder, such material breach to include a breach of the obligations under Section 4.2, the other Party hereto ("Non-Breaching Party") may give the Breaching Party written notice of such material breach, which notice shall clearly identify the material breach, the intent to terminate this Agreement for such material breach and the actions or conduct that it considers to be an acceptable cure of such material breach. In the event that the Breaching Party fails to cure such material breach within [*****] in the event of a default in payment, and within [*****] in the event of any other breach, after the date of the Non-Breaching Party's notice thereof, the Non-Breaching Party may terminate this Agreement by giving written notice of termination to the Breaching Party. In case the Party receiving a notice of a material breach ("Alleged Breaching Party") disputes to have materially breached this Agreement, such party shall provide written notice hereof to the other Party within [*****] following its receipt of notice of termination. In such event termination of this Agreement shall not occur if the Alleged Breaching Party within [*****] after such written notice refers the dispute for resolution through a dispute resolution panel of three (3) independent legal arbitrators with expertise in pharmaceutical licensing ("Dispute Resolution Panel"). Each Party shall nominate within [*****] of the request one arbitrator, while the third arbitrator shall be mutually agreed by the Parties within another [*****]. If the Parties are unable to agree on the third arbitrator, the third arbitrator shall be selected and nominated by the two arbitrators appointed by the Parties. Each Party shall submit to the Dispute Resolution Panel a written report setting forth its arguments to support or to rebut a material breach which justifies a termination for cause under this Section 13.3 within the later of (i) [*****] following a referral to the Dispute Resolution Panel, or (ii) [*****] after selection of such Dispute Resolution Panel. The Dispute Resolution Panel shall meet face-to-face to discuss the written reports and shall be entitled, at its discretion to invite for a hearing representatives of the Parties or other Third Party experts, subject to each Third Party expert executing an appropriate confidentiality agreement. The Dispute Resolution Panel shall then select one of the proposals from the Parties, and shall not have the authority to render any substantive decision other than the proposal of either BI or CureVac. The decision of the Dispute Resolution Panel shall be final and binding on the Parties and the Party whose proposal has not been selected by the Dispute Resolution Panel will pay all costs of the Dispute Resolution Panel. If, as a result of such dispute resolution process, it is determined that the Alleged Breaching Party materially breached this Agreement and such Party does not cure such breach within [*****] after the date of the decision by the Dispute Resolution Panel (or within [*****] in the event of a default in payment) (the "Additional Cure Period"), then such termination shall be effective as of the expiration of the Additional Cure Period. Such dispute resolution proceeding does not suspend any obligations of either Party hereunder, and each Party shall use reasonable efforts to mitigate any damage. If as a result of such dispute resolution proceeding it is determined that the Alleged Breaching Party did not materially breach this Agreement (or such breach was cured during the Additional Cure Period), then no termination shall be effective, and this Agreement shall continue in full force and effect. Notwithstanding the foregoing, in the case of an allegation that BI has failed to devote Commercially Reasonable Efforts in relation to a Licensed Vaccine or a Licensed Product, CureVac shall not have the right to terminate this Agreement (a) if no Change of Control had occurred at the time of termination: following the first acceptance of a marketing authorization application/NDA filing in a Major Market Country; and (b) if a Change of Control had occurred at the time of termination: following initiation of or continuation into the first Phase III Clinical Trial of a Licensed Vaccine, provided that BI pays CureVac the amount of such damages that have been awarded by a dispute resolution proceeding pursuant to Section 15.6. Termination of this Agreement in accordance with this Section 13.3 shall not affect or impair the Non-Breaching Party's right to pursue any legal remedy, including the right to recover direct damages, for any harm suffered or incurred by the Non-Breaching Party as a result of such breach. |
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13.4 | Termination for Challenge of CureVac Licensed Patent Rights. CureVac may terminate this Agreement by providing [*****] prior written notice to BI in the event BI or any of its Affiliates directly or indirectly challenges the validity of the CureVac Licensed Patent Rights in a legal proceeding or supports a Third Party in the challenge of a CureVac Licensed Patent Right in a legal proceeding (in each case before a court of competent jurisdiction). Any such termination shall only become effective if BI or its Affiliate has not withdrawn such action before the end of the above notice period. In the event a Sublicensee of BI challenges the validity of a CureVac Licensed Patent Right, CureVac may terminate this Agreement hereunder, if BI does not terminate such sublicense agreement within the [*****] notice period. |
14. | CONSEQUENCES OF TERMINATION |
14.1 | Reversion of Rights. Subject to Section 14.6(b) below, upon termination, but not expiration, of this Agreement, Bl's licenses under Article 2 and Article 6 of this Agreement automatically lapse and all of CureVac's rights to the CureVac Licensed Intellectual Property automatically revert back to CureVac. |
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14.2 | Sell Off. Immediately upon the termination of this Agreement by BI in accordance with Section 13.2 above or by CureVac in accordance with Sections 13.3 or 13.4, BI shall cease all Development and Commercialization of the Licensed Vaccines and Licensed Products under the licenses granted hereunder; provided, however, that BI shall have the right to distribute and sell its existing inventory of the Licensed Products for a period of not more than [*****] following the date of the termination hereof, subject to Bl's continuing obligation to pay sales milestones and royalties with respect to the Net Sales derived from the distribution and sale of such existing inventory of the Licensed Products, in accordance with the requirements of Sections 7.3, 7.4 and 7.8 above. |
14.3 | Accrued Payment Claims. Termination of this Agreement for any reason whatsoever shall not relieve BI of its obligations to pay all royalties, milestones and other amounts payable to CureVac which have accrued prior to, but remain unpaid as of, the date of expiration or termination hereof, or which accrue thereafter, in accordance with Section 14.2 hereof. |
14.4 | Access to Regulatory Approvals and BI Intellectual Property. |
In the event of termination of this Agreement by BI pursuant to Section 13.2 or by CureVac pursuant to Section 13.3 or 13.4, CureVac shall be entitled to demand from BI the transfer and/or assignment, as applicable, of the following:
(a) | all rights and titles which were taken from a Third Party during the course of the license and which are necessary to ongoing activities, provided that CureVac shall refund any payments to be made by BI to such Third Party after the effective date of termination for the use of such rights and titles; |
(b) | Regulatory Approvals held by BI, its Affiliates or Sublicensees, and if Regulatory Approvals have not been obtained by BI, its Affiliates or Sublicensees, CureVac may require that BI transfers to CureVac the status of any application for the Regulatory Approvals and notifies the competent Regulatory Authority thereof and supplies CureVac with all documents and clinical data already prepared by BI, its Affiliates or Sublicensees for the filing of applications for Regulatory Approvals (with BI using its reasonable efforts to promptly undertake such actions); and/or |
(c) | a non-exclusive, cost-free, perpetual and worldwide license (with the right to sublicense) to the BI Intellectual Property (other than Afatinib-related BI Background Intellectual Property) to the extent such BI Intellectual Property has been used for the Development, Manufacture and/or Commercialization of the Licensed Vaccines and Licensed Products, in each instance for the continued Development, Manufacture and Commercialization of the Licensed Vaccines and Licensed Products, the Patent Rights comprised in such BI Intellectual Property to be listed or otherwise identified upon CureVac's request of such license. |
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14.5 | Re-assignment and Re-transfer of CV9202 Specific Patent Rights and Assigned Patent Rights. In the event of a termination by BI pursuant to Section 13.2 or pursuant to Section 13.3, if BI elects to terminate the Agreement (Section 14.6 (a) below) or by CureVac pursuant to Section 13.3 or 13.4, BI shall re-assign and re-transfer, and hereby re-assigns and re-transfers to CureVac effective as of such termination (i) the CV9202 Specific Patent Rights and (ii) the Assigned Patent Rights or the share thereof that was assigned and transferred from CureVac to BI pursuant to Section 9.3, as the case may be, and CureVac hereby accepts such re-assignment and re-transfer. In order to effect the re-assignment and re-transfer, BI will support CureVac, upon CureVac's request in executing all assignment documentation and providing any declaration which may be necessary to effect the re¬assignment and re-transfer of the CV9202 Specific Patent Rights and the Assigned Patent Rights from BI to CureVac. Except in the case of termination by BI in accordance with Sections 13.3 and 14.6(a), BI shall be responsible for, and will pay all necessary out-of- pockets expenses with respect to the re-assignment and re-transfer of the CV9202 Specific Patent Rights and the Assigned Patent Rights, including the fees for notarization and legalization of the assignment documents, and for recording such assignment documents with the competent patent offices. |
14.6 | Termination for Cause by BI. In the event of a termination by BI in accordance with Section 13.3 above, BI may elect to |
(a) | terminate the Agreement, in which case all licenses and rights granted by either Party to the other Party shall terminate, BI shall cease to Develop, Manufacture and Commercialize the Licensed Vaccines and Licensed Products and, in addition to any other legal remedy BI might have, CureVac shall reimburse BI for all reasonable expenses related to the orderly wind down of all ongoing Clinical Trials; or |
(b) | continue to exercise its rights and obligations (except as set forth in this Section 14.6(b)) hereunder, and in such case the JSC shall be disbanded, BI shall have no further diligence obligations with respect to the Licensed Vaccines and Licensed Products, and CureVac shall pay to BI the amount of such damages that have been awarded by a dispute resolution proceeding pursuant to Section 15.6 below. For the avoidance of doubt, in the event BI elects to continue to exercise its rights and obligations under this Agreement, the terms and conditions of this Agreement, including the payment obligations, shall continue to apply with the exception only of the diligence obligations and the obligation to convene and exchange information in the Joint Steering Committee. |
14.7 | Wind Down or Transfer of Development Work. In the event of termination of this Agreement by BI pursuant to Section 13.2 or by CureVac pursuant to Section 13.3 or 13.4 and provided such termination occurs while Development activities regarding the Licensed Vaccines are still ongoing, BI shall |
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(a) | promptly inform CureVac on the status of the ongoing Clinical Trials, the estimated timelines, budgets and required resources of such Clinical Trials and answer any reasonable question CureVac may have regarding such Clinical Trials; and |
(b) | wind down in an orderly fashion any Clinical Trials and cease all other Development activities, or, at the election of CureVac, permit CureVac to take over such Development activities, provided that BI informs CureVac in writing on all material Development activities and associated costs and CureVac provides written notice to BI of its intent to take over such Development activities prior to effective termination of this Agreement or within [*****] after receipt of the information on the ongoing Development activities, whichever is later. Upon receipt of such written notice by BI, BI shall use Commercially Reasonable Efforts to (i) transfer all data and information and (ii) provide all support, in each case (i) and (ii) as reasonably required for CureVac to take over the Development activities, and the Parties shall discuss in good faith the details of a transfer of the respective Clinical Trials and other Development activities to CureVac. If - and only if - CureVac decides to take over the Development activities, CureVac shall be responsible for the costs of such Development activities which are being incurred by either Party after the effective date of termination, with the exception only of the internal costs incurred at BI. |
14.8 | Survival. Sections 1, 4.1.2, 6.5, 7.8.11, 7.9, 9.1 to 9.6, 10.1 to 10.8, 11.4, 12, 13.1, 13.3, 14, 15.1, 15.3 to 15.15 shall survive the expiration or termination of this Agreement. |
15. | GENERAL PROVISIONS. |
15.1 | Assignment. Subject to the other terms of this Agreement, neither Party shall have the right or the power to assign any of its rights or obligations under this Agreement without the prior written consent of the other Party, such written authorization not to be unreasonably withheld or delayed; provided, however, that the prior written authorization of the other Party shall not be required for a Party to assign all its rights and delegate the performance of all of its obligations hereunder to (i) an Affiliate; or (ii) to a Third Party which acquires all or substantially all of its assets related to this Agreement and the Related Agreements between the Parties. Any permitted assignment hereunder by either Party to an Affiliate or to a Third Party pursuant to this Section 15.1 shall not relieve such Party of any of its obligations under this Agreement, including, but not limited to, the Party's obligation to make the payments under Article 7. |
15.2 | Change of Control of CureVac. In the event of (i) a direct or indirect acquisition by any pharmaceutical company of beneficial ownership of fifty percent (50%) or more of the shares in CureVac; or (ii) the sale or other disposition to any pharmaceutical company of all or substantially all of the assets of CureVac; or (iii) the merger, amalgamation or other form of business combination or similar transaction between CureVac and one or more pharmaceutical companies ("Change of Control") the following shall apply: |
(a) | CureVac shall promptly give written notice of such Change of Control to BI; |
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(b) | Upon Bl’s written request, CureVac and its Affiliates shall promptly: (i) return any and all Confidential Information and Materials of BI to BI within [*****] upon Bl's request, save that CureVac may retain copies of Bl’s Confidential Information as set forth in Section 10.5; |
(c) | BI shall have the right to be released of its ongoing disclosure and information exchange obligations according to Sections 4.3 (regulatory matters including the grant of any further right of cross referencing) and 5.2 (sales forecast). In addition, the JSC and/or the Joint Project Team shall be dissolved upon Bl's request. |
(d) | In addition to the confidentiality obligations according to Section 10, CureVac shall take reasonable steps to ensure that any Confidential Information of BI is not shared with any others within CureVac that are not required to manage, perform and exercise CureVac’s rights and obligations under this Agreement, |
provided, however, that no Change of Control for purposes of this Section 15.2 shall occur if the pharmaceutical company taking control over CureVac is controlled by Mr. Dietmar Hopp and/or dievini Hopp BioTech holding GmbH & Co. KG. The term "controlled" as used in the aforementioned sentence refers to the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of a legal entity, whether through the ownership of voting securities, by contract or otherwise.
15.3 | Force Majeure. If the performance of any part of this Agreement by either Party, or any obligation under this Agreement, is prevented, restricted, interfered with or delayed by reason of any cause beyond the reasonable control of the Party liable to perform, unless conclusive evidence to the contrary is provided, the Party so affected shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party shall use its Commercially Reasonable Efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution. |
15.4 | Notices. All notices, reports and other communications between the Parties under this Agreement shall be sent by registered mail, postage prepaid and return receipt requested, by courier, or by facsimile, with a confirmation copy sent by registered mail or courier, addressed as follows: |
To: | CureVac | CureVac GmbH | |
Attention: | Chief Executive Officer/Geschaeftsfuehrer | ||
Address: | Paul-Ehrlich-Str. 15 | ||
72076 Tubingen, Germany | |||
Fax: | [*****] |
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With copy to: | CureVac GmbH | ||
Attention: | General Counsel | ||
Address: | Paul-Ehrlich-Str. 25 | ||
72076 Tubingen, Germany | |||
Fax: | [*****] |
To: | BI | Boehringer Ingelheim International GmbH | |
Attention: | Head of PM Business Development & Licensing/Strategy | ||
Address: | Binger StraBe 173 55216 Ingelheim am Rhein | ||
Fax: | [*****] |
With copy to: | BI | Boehringer Ingelheim International GmbH | |
Attention: | Head of Legal Strategic Transactions | ||
Address: | Binger StraBe 173 55216 Ingelheim am Rhein | ||
Fax: | [*****] |
or such other addresses or facsimile numbers as shall be furnished by like notice by such Party. Any such notice or communication given by mail shall be deemed to have been given [*****] after the date so mailed unless sent by an internationally recognized express courier and receipt confirmed, and any such notice or communication given by facsimile shall be sent with confirmation copy and shall be deemed to have been given when sent by facsimile and the appropriate answer back received, provided however, that should such answer back be automatically generated outside of regular business hours of the recipient Party, such notice shall be deemed to have been given on the next regular business day of such Party.
15.5 | Governing Law. This Agreement and all disputes arising hereunder, shall be exclusively governed by, and interpreted and enforced in accordance with the laws of Germany, without reference to conflicts of laws principles. The validity or enforceability of the intellectual property rights shall be subject to an evaluation under the law of the country in which the intellectual property rights were applied for or have been issued. |
15.6 | Dispute Resolution. |
15.6.1 | In the event of any dispute arising out of or in connection with this Agreement that cannot be settled by good faith negotiations over a period of [*****] within the JSC, and thereafter over an additional period of [*****] between senior management representatives of the Parties, the Parties agree to try to solve such dispute amicably by mediation. The Parties shall conduct a mediation procedure according to the Mediation Rules of the Deutsche Institution fur Schiedsgerichtsbarkeit e.V. (DIS) in effect on the date of the commencement of the mediation proceedings. The location of the mediation proceedings will be Frankfurt, Germany. The number of mediators will be one (1). The language of the mediation proceeding will be English. If the dispute has not been settled pursuant to the said rules within [*****] following the filing of a request for mediation or within such other period as the Parties may agree in writing, either Party may submit the dispute to final and binding arbitration. |
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15.6.2 | Any dispute relating to the validity, performance, construction or interpretation of this Agreement, which cannot be resolved amicably between the Parties after following the procedure set forth in Section 15.6.1, shall be submitted to arbitration in accordance with the Arbitration Rules of the Deutsche Institution fur Schiedsgerichtsbarkeit e.V. ("DIS Rules"). The existence, nature and details of any such dispute(s), and all communications between the Parties related thereto, shall be considered Confidential Information of the Parties and shall be treated in accordance with the terms of Article 10 above. The decision of the arbitrators shall be final and binding upon the Parties (absent manifest error on the part of the arbitrator(s)) and enforceable in any court of competent jurisdiction. The location of arbitration will be Frankfurt, Germany. The arbitration will be heard and determined by one (1) arbitrator, who will be jointly selected by BI and CureVac. If, within [*****] following the date upon which a claim is received by the respondent, the Parties cannot agree on a single arbitrator, the arbitration will be heard and determined by three (3) arbitrators, with one arbitrator being appointed by each Party and the third arbitrator being selected by the two Party-appointed arbitrators. If either Party fails to select an arbitrator, or if the Party-appointed arbitrators cannot agree on a third arbitrator within [*****] of the respondent receiving the claim, such arbitrator will be appointed in accordance with the DIS Rules. The arbitration award that is consistent with the provisions of this Agreement that is so given will be binding upon the Parties, accompanied by a reasoned opinion in writing (in English), and the judgment on the award may be entered in any court having competent jurisdiction thereof. Each Party will bear its own costs and expenses (including its attorney's fees) associated with any arbitration initiated under this section, and each Party will bear an equal share of the arbitrators' and administrative fees associated with any arbitration initiated under this section. The language of the arbitration proceeding will be English. Notwithstanding the provisions of this Section 15.6.2, each Party shall have the right to seek preliminary or permanent injunctive relief in any court of competent jurisdiction as such Party deems necessary to preserve its rights and to protect its interests. |
15.7 | Severability. If any provision of this Agreement is determined by any court or administrative tribunal of competent jurisdiction to be invalid or unenforceable, the Parties shall negotiate in good faith a replacement provision that is commercially equivalent, to the maximum extent permitted by Applicable Laws, to such invalid or unenforceable provision. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of the other provisions of this Agreement. Nor shall the invalidity or unenforceability of any provision of this Agreement in one country or jurisdiction affect the validity or enforceability of such provision in any other country or jurisdiction in which such provision would otherwise be valid or enforceable. |
15.8 | Entire Agreement and Amendments. This Agreement, together with all Exhibits attached hereto, constitutes the entire agreement between the Parties regarding the subject matter hereof, and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof, provided, however, that confidentiality agreements between of the Parties regarding the subject matter hereto and entered into before the Effective Date, including the reciprocal confidential disclosure agreement entered into by and between the Parties effective as of October 30, 2012, as amended by the 2nd amendment effective as of July 25, 2014, shall remain effective with respect to information exchanged between the Parties before the Effective Date. No modification or amendment of this Agreement shall be binding upon the Parties unless in writing and executed by the duly authorized representative of each of the Parties; this shall also apply to any change of this clause. |
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15.9 | Waivers. The failure by either Party hereto to assert any of its rights hereunder, including the right to terminate this Agreement due to a breach by the other Party hereto, shall not be deemed to constitute a waiver by that Party of its right thereafter to enforce each and every provision of this Agreement in accordance with its terms. |
15.10 | Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. |
15.11 | Independent Contractors. The Parties are independent contractors and this Agreement shall not constitute or give rise to an employer-employee, agency, partnership or joint venture relationship among the Parties and each Party's performance hereunder is that of a separate, independent entity. |
15.12 | Language. This Agreement, and any amendments or modifications thereto, shall be executed in the English language. No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto. |
15.13 | Headings. The headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement. |
15.14 | Third Parties. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party which shall be a Third Party beneficiary to this Agreement. |
15.15 | Costs. Except as is otherwise expressly set forth herein, each Party shall bear its own expenses in connection with the activities contemplated and performed hereunder. |
- Signature page follows -
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IN WITNESS WHEREOF, this Agreement has been signed by the Parties hereto in two (2) originals, each Party acknowledging receipt of one original.
CureVac GmbH | CureVac GmbH | |||
/s/ Dr. Florian von der Mülbe | /s/ Ingmar Hörr | |||
Name | : Dr. Florian von der Mülbe | Name | : Ingmar Hörr | |
Title | : COO | Title | : CEO |
Boehringer Ingelheim International GmbH
ppa. |
Boehringer Ingelheim International GmbH
ppa. | |||||
/s/ Dr. Stephan Lensky | /s/ Dorothee Schwall-Rudolph | |||||
Name | : | Dr. Stephan Lensky | Name | : | Dorothee Schwall-Rudolph | |
Title | : | Corporate Vice President | Title | : | Legal Counsel |
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Exhibit 1.3
BI Background Intellectual Property
[*****]
Exhibit 1.17
CureVac Background Intellectual Property
[*****]
Exhibit 1.23
CY9202 Specific Patent Rights
[*****]
EXHIBIT 1.34
REQUIREMENTS FOR INVOICES
[*****]
Exhibit 4.2
[*****]
Exhibit 4.3
Regulatory CMC DATA
[*****]
Exhibit 4.5A
[*****]
Exhibit 4.5B
SpecifÏcation of License Agreements
between CureVac and the Ludwig Institute for
Cancer Research, the University of Zurich and Geneart AG
[*****]
Appendix 2.3: Handling Protocol v 2.0SEP2013for CureVac Product(s)
[*****]
Appendix 3.5: IP Disclosure Letter
[*****]
Appendix 3.5
IP Disclosure Letter Regarding Manufacture
of CureVac Product using the Manufacturing
Process
[*****]
Appendix 5.2: Delivery Schedule
[*****]
Appendix 6.1a: Vial Price
[*****]
Appendix 6.1b: Calculation
[*****]
Appendix 6.4
Requirements for Invoices
[*****]
Appendix 8.2:
Framework of QAA
(to be replaced by Quality Assurance Agreement)
[*****]
Appendix 13:
CUREVAC's commercial liability insurance
[*****]
Exhibit 6.2A
BINDING TERM SHEET
Clinical Trial Supply
[*****]
Exhibit 6.2B
Binding Term Sheet for Commercial Supply
[*****]
Exhibit 11.2
Disclosures Regarding Representations and Warranties of CureVac
[*****]
Exhibit 10.7
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Global Access Commitments Agreement
This Global Access Commitments Agreement (including all appendices, exhibits and attachments hereto, the “Agreement”), is entered into as of February 13, 2015 (“Effective Date”), by and between the Bill & Melinda Gates Foundation, a Washington charitable trust that is a tax-exempt private foundation (the “Foundation”), and CureVac GmbH, a German limited company, together with its Affiliates (“CureVac” or the “Company”), in connection with the Foundation making a program-related investment in the Company by acquiring Series B Shares of the Company issued from the Company as part of one or more capital increases (the “Shares”) (the acquisition of Shares is referred to herein as the “Foundation Investment”). The Foundation Investment is subject to the terms and conditions of the investment documents executed in connection with the closing (“Closing”), including, without limitation, this Agreement, and the Investment and Shareholders’ Agreement (the “Shareholders’ Agreement”) among the Company’s shareholders, dated February 13, 2015, and related documents, in each case as amended from time to time (collectively, the “Investment Documents”). Capitalized terms not defined herein shall have the same meaning as in the Investment Documents. The Foundation and Company are each referred to as a “Party” and collectively as the “Parties”. In consideration of the Foundation making the Foundation Investment on the terms and conditions in the Investment Documents, and for other good and valuable consideration, the undersigned hereby irrevocably agree as follows:
1. Charitable Purposes and Use of Funds
The Foundation is making the Foundation Investment as a “program-related investment” within the meaning of Section 4944(c) of the Code. The Foundation is committed to accelerating the development of lifesaving and low-cost vaccines and drugs to reduce the burden of disease in Access Countries in furtherance of its mission to help all people lead healthy, productive lives. The Foundation requires that the innovations, products and information developed with its funding be created and managed to ensure “Global Access” can be achieved, in particular that (i) knowledge gained using its funding be promptly and broadly disseminated and (ii) the intended products developed with its funding and owned or Controlled by the Company be made available and accessible at reasonable cost to people most in need in Access Countries. The Foundation’s primary purpose in making the Foundation Investment is to further the accomplishment of the Foundation’s charitable purposes, including securing Global Access rights to new, low-cost vaccines and drugs developed (in whole or in part) through the use of the Company’s Platform Technology and for certain selected Target Diseases and Conditions (collectively, the “Charitable Purpose”). In furtherance of the Charitable Purpose, the Foundation’s investment in the Company will secure the Global Access Commitments set forth below.
The Company agrees to use the funds from the Foundation Investment solely (a) to fund the Company’s new manufacturing facility which is planned to have the capacity to produce at least [*****] doses which inter alia can be used to manufacture vaccines and drugs in support of the Foundation’s Charitable Purpose, and which is described in Appendix 1 (“New Facility”) and/or (b) to continue development of the Company’s Platform Technology and use of the Platform Technology to advance drug and vaccine candidates in support of the Foundation’s Charitable Purpose.
2. Certain Definitions
The following terms shall have the following meanings:
(a) “Access Countries” means the countries (each an “Access Country”) on the World Bank list of low-income and lower middle-income economies (http://www.worldbank.org/data/countryclass/classgroups.htm) on the Effective Date, which are set forth on Appendix 2. If after the Effective Date a country which was an Access Country on the Effective Date (i) is removed from such list and (ii) if such country becomes part of the European Union or is subject to another treaty with other non-Access Countries which leads to a material increase of the risk of parallel imports, the Parties will cooperate in good faith to reasonably reduce the risk of parallel imports and if it is not possible to reduce the risk to a degree that is acceptable to both Parties, such country will be removed from the list of Access Countries for purposes of this Agreement.
(b) “Access Country Doses” means vaccines and drugs the Company has developed using funds from the Foundation or Foundation-supported Entities in connection with Projects and that are intended for use in the Access Countries (including, without limitation, vaccines and drugs for use in clinical trials).
(c) “Affiliate” means, as to any Person, any other Person that directly or indirectly controls, or is under common control with or is controlled by such Person, provided, however, that regarding CureVac, Affiliate shall not include Mr. Hopp and Dievini Hopp biotech holding GmbH & Co. KG and/or any other companies controlled by Mr. Hopp and/or Dievini Hopp biotech holding GmbH & Co. KG.
(d) “Change in Control” means (i) the acquisition after the date of this Agreement, directly or indirectly, by any Person or group (within the meaning of Section 13(d)(3) of the Exchange Act) of the beneficial ownership of securities of the Company possessing more than 50% of the total combined voting power of all outstanding voting securities of the Company; (ii) a merger, consolidation or other similar transaction involving the Company, except for a transaction in which the holders of the outstanding voting securities of the Company immediately prior to such merger, consolidation or other transaction hold, in the aggregate, securities possessing more than 50% of the total combined voting power of all outstanding voting securities of the surviving entity immediately after such merger, consolidation or other transaction; or (c) the sale, transfer, license or other disposition (in one transaction or a series of related transactions) of all or substantially all of the assets of the Company.
(e) “Charitable Purpose” has the meaning given in Section 1.
(f) “Charitability Default” means any event in which Company:
(i) commits a material breach of the Global Access Commitments;
(ii) fails to comply with the restrictions on the use of funds set forth in this Agreement; or
(iii) fails to comply with the U.S. tax code-related obligations set forth in Sections 9, 11 and 13 below.
(g) “Claim” has the meaning set forth in Section 6.
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(h) “Code” means the Internal Revenue Code of 1986, as amended, and the regulations thereunder.
(i) “COGS” means [*****]. In the event the Company and the Foundation are unable to agree on the COGS amount for a Product within [*****], then the determination of COGS will be made by an independent internationally recognized accounting firm mutually acceptable to the Company and the Foundation that does not provide accounting services to the Company or the Foundation and that has expertise in calculating COGS for a pharmaceutical product.
(j) “COGS Methodology Handbook” means the methodology described in the “COGS Principles & Assessment Methodology Handbook” and the “COGS Handbook Appendix A Template Tables” attached at Appendix 3.
(k) “Commitment Period” means the period from the Effective Date until the date on which all funds received from the Foundation pursuant to the Investment Agreements have been expended in accordance with the terms of this Agreement.
(l) “Competitor” means a company engaged in the development of RNA vaccines and/or drugs.
(m) “Control” means with respect to the subject item, the possession (whether by ownership or license) by a Party of the ability to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement or other arrangements with any third party.
(n) “Cure Period” has the meaning set forth in Section 8(a).
(o) “Developed Country” means any country that is not an Access Country (collectively, the “Developed Countries”).
(p) “Dispute” has the meaning set forth in Section 4.
(q) “Exchange Act” means the Securities Exchange Act of 1934, as amended (and any successor thereto) and the rules and regulations promulgated thereunder.
(r) “Existing Agreements” means the collaboration agreements between the Company and third parties as such agreements exist on the Effective Date, which are listed on Appendix 4.
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(s) “Foundation-supported Entity” means an entity that receives funding, directly or indirectly, from the Foundation, collaborates with the Foundation, or both, for the purpose of accomplishing the Foundation’s charitable objectives. For the avoidance of doubt, the Company will not be required to collaborate with and/or provide confidential information or rights to a Foundation-supported Entity that is a Competitor of the Company unless the Company determines to its reasonable satisfaction that such information is or rights are, as the case may be, protected by an appropriate confidentiality agreement and such information or rights will only be used by the Foundation-supported Entity in connection with and solely for achieving the Charitable Purpose.
(t) “Funded Developments” means products, services, processes, technologies, materials, software, data, other innovations, and intellectual property developed using funds from the Foundation in connection with any Project.
(u) “GAAP” means Generally Accepted Accounting Principles in the United States.
(v) “Global Access” has the meaning set forth in Section 1.
(w) “Global Access Commitments” has the meaning set forth in Section 3.
(x) “Global Access License” has the meaning set forth in Section 3(d).
(y) “Indemnitees” has the meaning set forth in Section 6.
(z) “Listed Person” has the meaning set forth in Section 155.
(aa) “New Facility” has the meaning given in Section 1.
(bb) “Option Agreement” means the agreement between the Company and [*****], which is listed in Appendix 4, as such agreement existed on the Effective Date.
(cc) “Person” means any individual, partnership, corporation, limited liability company, association, trust, joint venture, unincorporated organization or other legal entity.
(dd) “Platform Technology” means the Company’s technology for development of prophylactic and therapeutic mRNA vaccines and drugs against infectious diseases and vaccine adjuvants, comprised of long, non-coding RNA molecules and formulation/delivery technology necessary to develop the mRNA vaccines and drugs. For the avoidance of doubt, the intent of the Parties is that development activities will include the full process from pre-clinical development to delivery of Product.
(ee) “Product” means any drug or vaccine that is developed pursuant to a Project.
(ff) “Project” has the meaning set forth in Section 3(a)(i).
(gg) “Project Commencement Period” means the period ending on the 10-year anniversary of this Agreement.
(hh) “Target Diseases and Conditions” means [*****].
(ii) “Total Manufacturing Capacity” means Company’s capacity in vials based on its ability over any time period to manufacture and produce vaccines and/or drugs at its New Facility, which shall be forecasted and determined on a rolling quarterly basis.
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(jj) “Withdrawal Rights” has the meaning set forth in Section 8(a).
3. Global Access Commitments
As a condition to the Foundation making the Foundation Investment at the initial closing and committing to invest a subsequent tranche, subject to the terms and conditions of the Investment Documents, and to ensure satisfaction of the Charitable Purpose, the Company agrees to the following “Global Access Commitments”. Unless the Parties and [*****] agree otherwise, if the Parties would agree on a Project which relates to an [*****] non-exclusive pathogen under the Option Agreement, the Global Access Commitments hereunder would be subject to the rights granted to [*****] under the Option Agreement.
(a) Vaccine and Drug Development Projects.
(i) The Company will work together with the Foundation on all stages of vaccine and drug development and commercialization for Target Diseases and Conditions. Each Project will be documented in a definitive agreement between the Foundation or a Foundation-supported Entity which Project is chosen by the Foundation and approved by the Company (such approval not to be unreasonably withheld or delayed) for such Project and the Company and a project plan (each a “Project”), which may include work to be undertaken, responsibilities, participation by other parties, timelines and milestones, project management, contributions in-kind and funding requirements, a product development and marketing plan, product registration in the Access Countries, any additional global access commitments specific to the Project, terms for manufacturing and commercialization of Access Country Doses and the price for Access Country Doses, which must be an affordable price for sales for use in the Access Countries that the Parties agree will not exceed [*****]. The Company will permit the Foundation or a representative designated by the Foundation to reasonably inspect twice every [*****] during regular business hours and at the Foundation’s cost the Company’s books and records as well as manufacturing documentation (including but not limited to the detailed bill of materials) for the purpose of determining cost of goods sold for each Product.
(ii) The Foundation - and the Company, under the conditions set forth below - will contribute in kind or through funding to agreed-upon Projects. The specific level and allocation of funding responsibilities for a specific Project will be decided on a Project-by-Project basis as mutually agreed in good faith in writing by the Parties based on a fair allocation of the expected benefits. For the avoidance of doubt, if a Project serves solely the Foundation’s charitable purposes, the expectation of the Parties is that the Foundation will fully fund the direct costs associated with such specific Project. The Company agrees that as part of the Global Access Commitments, it will accept and work on three Projects proposed by the Foundation at a time, subject to the Foundation or a Foundation-supported Entity selected by the Foundation and approved by the Company (such approval not to be unreasonably withheld or delayed) for such Project agreeing to pay its proportionate share of the funding responsibilities associated with such Projects. If the Company is working on three Foundation (or Foundation-supported Entity) Projects, then the Company will not be required to commence work on a new Project until one of the three Projects has been completed, terminated or if the Parties agreed to put a Project on hold in accordance with the terms of such Project; provided that the Company and the Foundation can work on more than three Projects in parallel if they mutually agree to do so. A Project is deemed to be completed if, as set forth in the respective project plan, no more work is to be performed on the Project by Company or its sublicensees, contractors or other collaborators. Any Project which has been terminated or put on hold shall no longer be considered an active Project for purposes of this Agreement. For the avoidance of doubt, there is no limitation on the number of Projects the Foundation can request the Company to perform (subject to the requirement that the Company is not required to work on more than three Projects at a time); provided that the Company is not obligated to accept an additional Project if the start of the proposed Project is scheduled to be after the expiry of the Project Commencement Period, but if a Project is commenced prior to the end of the Project Commencement Period, the Company will continue such Project to completion, even if this occurs after the end of the Project Commencement Period, provided, however, that the Foundation has no right to request to increase the scope of work after the end of the Project Commencement Period without the Company’s consent.
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(iii) Unless provided otherwise in a specific Project Agreement (as defined below), the Parties agree that any results, information, invention, patent right and other intellectual property right and any know how generated by or on behalf of the Company with respect to the Platform Technology and/or the Funded Developments shall be owned by the Company and the Company shall be responsible, in its sole discretion, to file, prosecute, maintain and defend such intellectual property rights.
(iv) The Company further agrees that it will not reject any Projects proposed by the Foundation unless the Company can demonstrate that accepting such Project would be reasonably likely to have a material adverse effect on the Company (“Good Reason”). By way of example, the Company agrees that it will not constitute Good Reason for the Company to reject a Project because the Company could make a higher profit by performing other work, but the Company will not be required to accept a Project on terms that would cause the Company to operate at a loss without any offsetting benefit.
(b) Access to Project Data and Information. Subject to Existing Agreements, the Company will [*****] to:
(i) Publish the results and information developed in connection with each Project within a reasonable period of time after such information or results are obtained in a manner that satisfies the requirement that such research be published in a form that is “available to the interested public” as described in Treasury Regulation 1.501(c)(3)-1(d)(5)(iii)(c)(2), which could include publication in a treatise, thesis, trade publication or a scientific journal, the presentation of a paper at a research conference or symposium and electronic publication, with due regard to delays or limitations on content of such publications that are necessary or useful (i) to protect the Company’s intellectual property, trade secrets and confidential information covering, inter alia, the Platform Technology itself and/or (ii) to allow the Company to obtain any intellectual property rights based on the results and information developed in connection with each Project.
(ii) Promptly provide to the Foundation from time to time, upon the Foundation’s request and with the agreement of the relevant Foundation-supported Entity (as appropriate), access to data and information regarding each Project, subject to the conclusion of a confidential disclosure agreement among the Foundation, the Company and, as necessary and appropriate and only upon the Company’s prior written consent (not to be unreasonably withheld or delayed) the relevant Foundation-supported Entity.
(iii) Promptly provide to the Foundation from time to time, upon the Foundation’s request, rights to share data and information developed in connection with each Project, with due regard to the need to protect confidential information and to avoid untimely public disclosures that may bar access to patent protection or public disclosures that may undermine trade secret protection.
(c) Manufacture of Access Country Doses. The Company agrees to manufacture Access Country Doses in an amount based on a rolling forecast provided by the Foundation to the Company of expected demand for Access Country Doses up to a maximum of [*****] of its New Facility Total Manufacturing Capacity (or the reasonable equivalent thereof in the event the New Facility is combined with or replaced by other manufacturing facilities, including, without limitation, as a result of a Change in Control). For such purpose, the Foundation will provide the Company with at least [*****] prior notice before it is required to begin manufacturing Access Country Doses. Unless and until such notice has been given by the Foundation, the Company will have the right to allocate 100% of its New Facility Total Manufacturing Capacity at the Company’s discretion. For the avoidance of doubt, the Company will not be required to manufacture vaccines and drugs that have been developed by third parties (other than Foundation-supported Entities participating in any Project as provided above) unrelated to the Company using funds received from the Foundation.
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(d) Non-exclusive License. Subject to the Existing Agreements, in connection with and relating solely to each Project the Company will grant the Foundation a worldwide, non-exclusive, perpetual, irrevocable, fully-paid up, royalty-free license to the Funded Developments and the background intellectual property Controlled by the Company that is covering the Platform Technology to the extent reasonably required to use, research, develop, make, sell, and offer-for-sale the Funded Developments for the specific Project, including the Products developed under such Project (the “Global Access License”), but any development, manufacture, sale, offer-for-sale, importation or distribution of products is limited to importation into and distribution to people in Access Countries in a manner consistent with the Foundation’s charitable purpose; provided that the Global Access License will only come into force (condition precedent) in the event of the Company’s insolvency, dissolution or an uncured Charitability Default (Section 8(a) shall apply accordingly). The Global Access License is sublicensable to (i) Foundation-supported Entities, (ii) to CROs and CMOs acting on behalf of the Foundation or the Foundation-supported Entities or (iii) to third party licensees of the Company who have entered into a collaboration and license or asset transfer agreement with the Company with respect to a pathogen covered under a Project, provided, however, that if such third party licensee refuses to enter into a sublicense agreement with the Foundation in spite of a good faith approach of the Foundation to conclude such sublicense agreement, the Foundation may grant a sublicense to any other third party. Any agreement to be concluded in the future under the Existing Agreements will have to respect and cannot limit or restrict the Global Access Commitments.
(i) The Company agrees to take such further actions, including technology transfer, as would be typical industry practice at the time for a company providing a license to a third party, to ensure that the Foundation (or its potential permitted sub-licensee) can effectively take advantage of the Global Access License if a triggering event occurs. Without limiting the foregoing, in connection with any Global Access License hereunder, the Company will take any actions reasonably necessary to grant the Foundation a license or sub-license to any third-party intellectual property applicable to the Platform Technology or the Funded Developments that is necessary to enable the Foundation to effectively take advantage of the Global Access License for the selected Projects.
(ii) Subject to the Existing Agreements, the Company shall permit the Foundation (or its sublicensees) the right to access and cross-reference any applicable IND, BLA or regulatory file Controlled by Company and relating to any Projects and shall, upon request, provide an electronic copy of each such file.
(e) The Global Access Commitments will be ongoing and will continue for as long as the Foundation continues to pursue its charitable mission except that the Company’s obligation to accept additional Projects (in lieu of abandoned Projects) will terminate upon expiry of the Project Commencement Period.
(f) The Company will provide to the Foundation the reports regarding program-related investments and such other reports as may be agreed upon between the Company and the Foundation and reasonable audit rights regarding the Company’s compliance with the use of the Foundation’s funds and the Global Access Commitments.
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(g) Except for rights granted in the Existing Agreements as of the Effective Date, the Company will not grant to a third party any rights or enter into any arrangements or agreements that would limit or restrict the Foundation’s rights related to the Global Access Commitments, including the Foundation’s right during the Project Commencement Period to enter into Projects with the Company with respect to any Target Diseases and Conditions. For the avoidance of doubt, nothing in this Agreement prohibits the Company from entering into an agreement with a third party with respect to the development, manufacture and commercialization of a product for a Target Disease and Condition provided that such agreement does not limit or restrict the Company’s ability to fulfill the Global Access Commitments, and the Foundation’s consent will not be required for such an agreement. In order to confirm that CureVac’s agreements with third parties relating to any Target Disease and Condition do not limit or restrict the Foundation’s rights, CureVac agrees that it will include language substantially similar to the following in such agreements:
The Company and [third party] acknowledge that the Company and the Bill & Melinda Gates Foundation (the “Foundation”) have entered into a Global Access Commitments Agreement (the “Global Access Agreement”) pursuant to which the Company has agreed to work together with the Foundation on vaccine and drug development for certain Target Diseases and Conditions pursuant to the terms of the Global Access Agreement and any subsequent agreements entered into by the Company with respect to a particular project (each, a “Project Agreement”). The Company and [third party] agree that this [third party agreement] shall be subject to the terms of the Global Access Agreement and in no way shall this [third party agreement] limit or restrict the Foundation’s rights or the Company’s obligations pursuant to the Global Access Agreement or any existing Project Agreement. The Company and [third party] agree that the Foundation is a third party beneficiary of this provision and will have the right to enforce this provision in order to protect the Foundation’s rights pursuant to the Global Access Agreement and any applicable Project Agreements. For the avoidance of doubt, unless otherwise agreed with the [third party], the Foundation has no claims to the results generated and to the intellectual property rights and know how Controlled by [third party]; provided that nothing in this [third party agreement] will limit or restrict the Global Access Commitments.
In the event the Company collaborates with a third party with respect to any Target Disease and Condition that becomes the subject matter of a Project hereunder, the Foundation and the Company will negotiate in good faith with such third party to attempt to combine the development efforts and align the respective project plans; provided that if the Foundation and the third party cannot reach agreement, the Foundation and the Company can proceed with such Project in accordance with the terms of this Agreement and the applicable Project Agreement.
(h) The Company and BMGF will mutually use reasonable and diligent efforts to execute and cause [*****] to execute an amendment substantially in the form attached hereto as Appendix 5, to the Option Agreement dated as of [*****] by and between the Company and [*****] as soon as reasonably possible.
4. Representations, Warranties, Covenants of the Company
The Company hereby represents, warrants and covenants to the Foundation:
(a) Project Diligence and Necessary Skill. The Company will use all reasonable and diligent efforts to perform its obligations under a Project Agreement and to complete each Project and the Company has, and will maintain, the necessary expertise, personnel, facilities and equipment to perform each Project and its obligations under the Investment Documents.
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(b) Continuation of Business. The Company will continue activity in those lines of business or in comparable new lines of business that are necessary to complete the Projects and to fulfill the Global Access Commitments for the Projects.
(c) Compliance with Applicable Laws & Regulations. The Company is in compliance and will remain in compliance in all material respects with all applicable laws and regulations (including all laws and regulations related to clinical trials, human health and safety, the protection of the environment, research, development and manufacture of vaccines and drugs intended for human use) necessary to enable the Company to perform its obligations under the Investment Documents and in connection with each Project, and as of the Effective Date the Company is not aware of any action filed or commenced against the Company alleging any failure to comply. The Company is and will remain in compliance with all applicable cGMPs, Good Clinical Practices, Good Laboratory Practices and Good Industry Practices. The Company is not aware of facts that (with or without notice or lapse of time, or both) could reasonably be expected to result in the Company being in violation in any material respect of any law materially applicable to the Company’s performance of its obligations under the Investment Documents and in connection with each Project. The Company has in place and shall continue to maintain for the duration of its obligations under this Agreement and each Project, a compliance program reasonably designed to identify, prevent, and address any compliance issues.
(d) Licenses and Permits. The Company currently holds and will continue to hold all necessary foreign, federal, state, local and other governmental licenses, approvals and permits necessary to perform its obligations under the Investment Documents and in connection with each Project.
(e) Records Compliance. The Company will maintain, in accordance with and for the period required under cGMPs and applicable laws, complete and adequate records of the Funded Development pertaining to the methods, and the facilities, manufacture, procedures, testing and the like, related to each Project.
(f) IP Due Diligence. On the Effective Date, the Company has conducted commercially reasonable due diligence with respect to the Project Agreements, including intellectual property and freedom to operate analyses related to the Project Agreements. To the Company’s knowledge on the Effective Date it owns or possesses sufficient legal rights to all trademarks, service marks, tradenames, copyrights, trade secrets, licenses, information and proprietary rights and processes and all patents necessary for its current business without any conflict with, or infringement of, the rights of others. On the Effective Date, the Company has not received any communications alleging that the Company has violated or, by conducting its business, would violate any of the patents, trademarks, service marks, tradenames, copyrights, trade secrets or other proprietary rights or processes of any other Person.
(g) Product Modification. In the event of any injunction or prohibition against the Company’s manufacture, licensure, import, export, sale, offer-for-sale, distribution, or use of any Product by reason of infringement of a patent, proprietary, or intellectual property right, or if in Company’s opinion any Product is likely to become the subject of a claim of infringement of a patent, proprietary, or intellectual property right the Company and the Foundation and/or the Foundation-supported Entity will, either: (a) procure (such as by licensing or otherwise) the right to continue to make, have made, import, export, sell, offer-for-sale, distribute, and use such Product, or (b) replace or modify such Product so it becomes non-infringing, but is equivalent or superior in terms of efficacy, quality and safety.
(h) No Disputes. The Company agrees to notify the Foundation of any claims with regard to any third party intellectual property or disputes with a third party with regard to a Product which arise during the term of this Agreement (including its commercialization, manufacture, sale, offer for sale, distribution, import, export and use as contemplated by the applicable Project).
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(i) Disqualification and Debarment. On the Effective Date, the Company, its employees or contractors or agents are not and the Company will undertake reasonable efforts not to be, at the time of performance of any activity contemplated by this Agreement or in connection with any Project, (a) disqualified or debarred by any Governmental Authority for any purpose pursuant to applicable law or regulation or threatened with any such disqualification or debarment or (b) charged or convicted for conduct relating to the development or approval of, or otherwise relating to the regulation of, any Product under any applicable law or regulation.
(j) Warranty. Each Product is or will be manufactured by the Company (and/or its CMOs or partners) in conformity in all material respects with all applicable requirements of a vaccine or drug for human use, including all express and implied warranties related thereto.
(k) Company is Sponsor. In no event shall the Foundation be a sponsor of any trial, study, Product, registration, or marketing authorization or the like. Except as may be required by law, the Company shall not include the Foundation on any document relating to the foregoing or in any communication with any governmental or regulatory body without the express prior written consent of the Foundation. Any input, consultation, or communication to the Company by the Foundation or any Foundation-supported Entity shall not diminish the foregoing.
(l) Insurance. The Company will maintain liability, property, casualty, flood, and other insurance coverage (including product liability, clinical trial insurance) by such insurers and in such forms and amounts and against such risks as are generally consistent with the insurance coverage maintained by similarly-situated companies in like industries, including to address any risks applicable to the Projects.
(m) Compliance with Confidentiality Obligations; No Infringement. The Company shall perform its activities under this Agreement and in connection with each Project using reasonable efforts to prevent violation of any of its confidentiality obligations to any third party and violation or infringement of any third party trade secrets, patent rights or other intellectual property rights.
(n) Full Power. The Company has the full and unrestricted power and authority to enter into this Agreement, to perform its activities under this Agreement and in connection with each Project, and to disclose any information which it makes available to the Foundation under this Agreement or in connection with any Project.
5. Representations, Warranties, Covenants of the Foundation
The Foundation hereby represents, warrants and covenants to the Company:
(a) Full Power. The Foundation has the full and unrestricted power and authority to enter into this Agreement, to perform its activities under this Agreement and in connection with each Project, and to disclose any information which it makes available to the Company under this Agreement or in connection with any Project.
(b) Compliance with Confidentiality Obligations; No Infringement. The Foundation shall perform its activities under this Agreement and in connection with each Project using reasonable efforts to prevent violation of any of its confidentiality obligations to any third party and violation or infringement of any third party trade secrets, patent rights or other intellectual property rights.
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(c) Use of Product in Access Countries Only. The Foundation acknowledges that the Company intends to take reasonable and diligent efforts to ensure that the Products intended for use in the Access Countries will be utilized in Access Countries only and to prevent parallel imports of such Products into non-Access Countries, which efforts may include the Company placing an indication on the packaging of the Products that they are for use in Access Countries only and are not to be exported into any other countries. If the Company reasonably believes that parallel imports of such Products outside the Access Countries are occurring, the Company will notify the Foundation and the Parties will cooperate in good faith to verify the circumstances and take such reasonable action as they mutually agree is necessary; provided that the Foundation will not be responsible for the actions of any third party or any actions outside of its control. For the avoidance of doubt and unless otherwise agreed, the Company is not required to arrange for the commercialization of Products in the Access Countries.
6. Indemnification
The Company will indemnify, hold harmless, and defend the Foundation and its co-chairs, trustees, directors, officers, employees, agents, representatives, consultants and grantees (collectively, the “Indemnitees”) from and against any and all third party causes of action, claims, suits, legal proceedings, judgments, settlements, damages, penalties, losses, liabilities and costs (including reasonable attorneys’ fees and costs) (each a “Claim”) arising out of or relating to: (a) negligence or wilful misconduct of the Company (including its officers, agents, employees, subgrantees, contractors or subcontractors) in connection with any Project; (b) bodily injury, death or property damage caused by any Project or Product; or (c) a material breach by the Company of any of its obligations, representations, warranties, or covenants under this Agreement or a Project Agreement, except, in each of the foregoing cases, the Company will have no obligation to indemnify, defend, or hold harmless the Foundation for any liability, loss, or expense to the extent resulting from the gross negligence or willful misconduct on the part of the Foundation.
The Company will have control over the defense and settlement of each Claim, with counsel of its own choosing; provided that the Company conducts the defense actively and diligently at the sole cost and expense of the Company and provided further that the Company will not enter into any settlement that adversely affects any Indemnitee without the applicable Indemnitee’s prior written consent, such consent not to be unreasonably withheld or delayed. The Foundation will provide the Company, upon request and at no charge, with reasonable cooperation in connection with the defense and settlement of the Claim. Subject to the Company’s rights above to control the defense and settlement of Claims, the Foundation and any Indemnitee may, at its own expense, employ separate counsel to monitor the defense of any Claim.
7. Survival of Rights
As a condition of any acquisition of the Platform Technology or the Company’s manufacturing facilities directly, or through a Change in Control, the Global Access Commitments described above will survive and be assumed by the acquirer to the extent required to carry out the Global Access Commitments, and the Foundation shall have the right to review such provisions of the written agreement with such third party that relate to the assumption of the Global Access Commitments to confirm that the Global Access Commitments will survive and be assumed by the acquirer to the extent required to carry out the Global Access Commitments, and the Company will not grant to a third-party any rights to, or enter into any arrangements with respect to, the Platform Technology or its manufacturing facilities to the extent such rights or arrangements would prevent the Company (or any acquirer of the Platform Technology or manufacturing facilities) from fulfilling the above stated Global Access Commitments.
In order to confirm the Global Access Commitments will survive and be assumed by the acquirer, the Company will add language substantially similar to the following to its acquisition agreements with third parties:
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The Company and [third party] acknowledge that the Company and the Bill & Melinda Gates Foundation (the “Foundation”) have entered into a Global Access Commitments Agreement (the “Global Access Agreement”) pursuant to which the Company has agreed to certain Global Access Commitments pursuant to the terms of the Global Access Agreement and subsequent agreements entered into by the Company with respect to particular projects (each, a “Project Agreement”).
[Third party] agrees that the Global Access Agreement will continue in full force and effect following consummation of the transactions contemplated by this [acquisition agreement] and [third party] will ensure performance of the terms of the Global Access Agreement and that in no way shall this [third party agreement] limit or restrict the Foundation’s rights or the Company’s obligations pursuant to the Global Access Agreement or any existing Project Agreement. The Company and [third party] agree that the Foundation is a third party beneficiary of this [third party agreement] with respect to the Global Access Commitments and will have the right to enforce this provision in order to protect the Foundation’s rights pursuant to the Global Access Agreement and any applicable Project Agreements.
8. Withdrawal Right, Termination for Good Cause
(a) Charitability Default. Each Party agrees that if it becomes aware of a Charitability Default it will promptly notify the other Party, and the Company shall thereafter provide to the Foundation a proposed strategy to remedy the Charitability Default, such strategy to be provided within [*****] of notification. Notwithstanding anything in this Agreement to the contrary, the Foundation will not lose any rights or remedies solely as a result of a failure to notify the Company after it becomes aware of a Charitability Default. In addition, the Company agrees to promptly notify the Foundation of any facts and circumstances it becomes aware of which - in its reasonable opinion - could reasonably cause a Charitability Default hereunder. If the Company fails to cure the Charitability Default within [*****] of notice of a Charitability Default (provided that such [*****] period will be extended by an additional [*****] if at the end of the [*****] period the Company demonstrates to the Foundation’s reasonable satisfaction that despite the Company’s reasonable and diligent efforts to cure the Charitability Default during the initial cure period, additional time is necessary) (the “Cure Period”), then, in addition to all other rights and remedies available at law or in equity, including the Global Access License set forth above and all other applicable remedies in the Investment Documents, the Foundation will have the withdrawal rights (the “Withdrawal Right”) set forth in the Shareholders’ Agreement.
(b) Withdrawal Right.
(i) The Company agrees that if for any reason the Withdrawal Right is removed from the Shareholders’ Agreement or the Shareholders’ Agreement is amended or terminated while this Agreement remains in effect, the terms of the Withdrawal Right will continue in full force and effect as if contained in this Agreement.
(ii) Notwithstanding any exercise of the Withdrawal Right, the Foundation will continue to be entitled to enforce its rights under the Global Access Commitments and in relation to any agreed Projects.
(iii) Irrespective of the Project Commencement Period, the Company has the right to terminate this Agreement without any survival of any provision of this Agreement for good cause if the Foundation does not make an initial investment in the Company (by payment into the capital reserves and the nominal capital of the Company) in the amount set forth in the definition of Financing Round I in the Shareholders’ Agreement (the “Initial Investment”) by [*****] and the default on payment of the Initial Investment is not cured within [*****] after the Foundation receives a respective payment request from the Company.
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9. Required Reporting
In addition to any and all reports required to be delivered to the Foundation under the Investment Documents, the Company shall furnish, or cause to be furnished, to the Foundation the following reports and certifications:
(a) Within [*****] after the end of the Company’s fiscal year during which the Foundation owns any shares of stock of the Company, a certificate from the Company signed by an officer or director of the Company and substantially in the form attached to this Agreement as Appendix 6, certifying that the requirements of the Foundation Investment were met during the immediately preceding fiscal year, describing the use of the proceeds of the Foundation Investment and evaluating the Company’s development of the Platform Technology and use of the Platform Technology to advance drug and vaccine candidates in support of the Foundation’s Charitable Purpose, and progress on the New Facility, and the Projects including, specifically, information regarding progress against the Global Access Commitments;
(b) Within [*****] after the end of the Company’s fiscal year during which the Foundation ceases to own any shares of stock of the Company, a certificate from the Company signed by an officer or director of the Company and substantially in the form attached to this Agreement as Appendix 7, certifying that the requirements of the Foundation Investment were met during the term of the Foundation Investment, describing the use of proceeds of the Foundation Investment and evaluating the Company’s development of the Platform Technology and use of the Platform Technology to advance drug and vaccine candidates in support of the Foundation’s Charitable Purpose, and progress on the New Facility, and the Projects including, specifically, information regarding progress against the Global Access Commitments;
For the avoidance of doubt, if the Company has provided timely reports pursuant to Sections 9(a) and 9(b) that contain information sufficient to enable the Foundation to discharge any expenditure responsibility of the Foundation, within the meaning of Sections 4945(d)(4) and 4945(h) of the Code, with respect to the Foundation Investment, the Company will not be liable for a Charitability Default pursuant to Sections 9(a) or 9(b).
(c) Any other information respecting the operations, activities and financial condition of the Company as the Foundation may from time to time request to discharge any expenditure responsibility of the Foundation, within the meaning of Sections 4945(d)(4) and 4945(h) of the Code, with respect to the Foundation Investment, and to otherwise monitor the charitable benefits intended to be served by the Foundation Investment (the Foundation will pay the reasonable costs associated with preparing such information at its request);
(d) At least [*****], full and complete financial reports of the type ordinarily required by commercial investors under similar circumstances; and
(e) During the Project Commencement Period, within [*****] of the end of each calendar quarter, Company will (A) provide the Foundation with written reports in form and detail reasonably satisfactory to the Foundation and confer with the Foundation (by teleconference or in scheduled site visits as appropriate) regarding progress with respect to the Projects including information regarding progress against the Global Access Commitments and (B) coordinate with the Foundation to determine reasonable times for the Foundation’s representatives to make site visits to the Company’s facilities and to conduct any inspections with respect to the Projects. Such site visits may be conducted in [*****] by a consultant selected by the Foundation and approved by the Company (such approval not to be unreasonably withheld or delayed) who is subject to a confidentiality agreement that is reasonably acceptable to the Company and the Foundation.
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10. Assignment by Foundation
Notwithstanding anything in this Agreement to the contrary, the Foundation will have the right to assign this Agreement to (a) any successor charitable organization of the Foundation from time to time that is a tax-exempt organization as described in Section 50l(c)(3) of the Code, or (b) any tax-exempt organization as described in Section 50l(c)(3) of the Code controlled by one or more trustees of the Foundation. The Foundation will notify the Company of any such assignment, including the identity of the assignee, in a timely manner. For the avoidance of doubt, if the Foundation transfers the Shares as permitted by this section, the Foundation may assign to any such transferee all of its rights attached to such Shares, including the Withdrawal Right.
11. Access to Records
The Company shall maintain books and records adequate to provide information ordinarily required by commercial investors under similar circumstances. The Company shall provide the Foundation or its designee(s) access at reasonable times to such books and records pertaining to the period during which the Foundation owned any shares of stock of the Company and continuing for a period of [*****] after the later of: (a) the date on which the Foundation no longer owns any shares of stock of the Company or (b) the date on which this Agreement is no longer in effect. Notwithstanding the foregoing, as long as the funds from the Foundation Investment are fully expended prior to the [*****] anniversary of the Effective Date, the Company shall not be required to maintain or provide the Foundation access to such books and records for more than [*****] from generation of the individual information. For the avoidance of doubt, the Foundation’s access to records under this Section shall not be dependent upon the Foundation’s percentage ownership in the Company.
12. Public Reports
The Foundation may include information about the Company in its periodic public reports to the extent such information is not confidential, except as otherwise may be required by applicable law.
13. Prohibited Uses
The Company shall not expend any proceeds of the Foundation Investment to carry on propaganda or otherwise to attempt to influence legislation, to influence the outcome of any specific public election or to carry on, directly or indirectly, any voter registration drive, or to participate or intervene in any political campaign on behalf of or in opposition to any candidate for public office within the meaning of Section 4945(d) of the Code. The proceeds of the Foundation Investment shall not (a) be earmarked to be used for any activity, appearance or communication associated with the activities described in the foregoing sentence, nor (b) be intended for benefit, and will not benefit, any Person having a personal or private interest in the Foundation, including descendants of the founders of the Foundation, or Persons related to or controlled by, directly or indirectly, such private interests.
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14. Disqualified Person
To the knowledge of each of the Foundation and the Company: (1) the Company is not a “disqualified person” with respect to the Foundation (as the term “disqualified person” is defined in Section 4946(a) of the Code), and (2) no disqualified person with respect to the Foundation owns any of the Company’s outstanding stock, and (3) the Foundation does not, and one or more disqualified persons with respect to the Foundation do not, directly or indirectly, control Company.
15. Compliance with Anti-Corruption, Anti-Bribery and Anti-Terrorism Laws
The Company will not offer or provide money, gifts or any other thing of value, directly or indirectly, to anyone in order to improperly influence any act or decision relating to the sale of the Company’s products and services or the other matters contemplated by this Agreement, including by assisting any party to secure an improper advantage. Training and information on anti-bribery act compliance requirements is available here: www.learnfoundationlaw.org.
The Company will not use any proceeds of the Foundation Investment, directly or indirectly, in support of activities (i) prohibited by US laws related to combatting terrorism; (ii) with any Person on the List of Specially Designated Nationals (www.treasury.gov/sdn) (a “Listed Person”) or any Person that is, directly or indirectly, controlled by a Listed Person or in which a Listed Person, directly or indirectly, holds a significant ownership interest; or (iii) with or related to countries against which the US maintains a comprehensive embargo (currently, Cuba, Iran, (North) Sudan, Syria, and North Korea), unless such activities are fully authorized by the US government under applicable law and specifically approved by the Foundation in its sole discretion.
16. Use of Name
Each of the Foundation and the Company may include information on this investment in its periodic public reports or other documents required to be filed with governmental authorities, if any. In addition, the Foundation and the Company may make the investment public at any time on their web pages and as part of press releases, public reports, speeches, newsletters and other public documents. Any announcement of the Foundation Investment by any other Person, will require the Company’s and Foundation’s prior written approval. Any other use of the Foundation’s or the Company’s name or logo in any respect depends upon their respective pre-approval in writing. Notwithstanding the foregoing, the Foundation’s name and logo will not be used by any Person in any manner to market, sell or otherwise promote the Company, its products, services and/or business.
17. Entire Agreement; Modification
This Agreement and the other Investment Documents, including all exhibits hereto and thereto, the Confidentiality Agreement executed between the Parties on June 6, 2012, and the Project Agreements set forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties with respect to the subject matter of the Investment Documents, and supersede and terminate all prior agreements, negotiation and understandings between the Parties, whether oral or written, with respect to such subject matter. No subsequent alteration, modification, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties. For the avoidance of doubt, to the extent any other Investment Document conflicts with any provisions of this Agreement that are required by the Code, the provisions of this Agreement shall control.
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18. Confidentiality
(a) During the course of this Agreement and the Project Agreements each Party (as a “Disclosing Party”) may disclose certain Confidential Information owned or rightfully possessed by it to the other Party (as the “Receiving Party”). For the purposes of this Agreement, “Confidential Information” means all information, including data, communicated by the Disclosing Party to the Receiving Party in either (i) a documentary or written form, marked as confidential, or (ii) in an oral form, in which case a written record, marked as confidential, shall be provided to the Receiving Party within [*****] of the oral disclosure for the information to be considered as Confidential Information; provided that a written record of an oral disclosure will not be required if based on the nature of the information or circumstances surrounding its disclosure, the Receiving Party should reasonably regard such information as Confidential Information.
(b) Each Party, as a Receiving Party, agrees that it will (i) use the Confidential Information received from a Disclosing Party solely for the purposes contemplated by this Agreement and the Project Agreements and (ii) treat the Confidential Information of the Disclosing Party as it would treat its own confidential information but in no event less than reasonable care to avoid disclosure of the Confidential Information to any third party (which, for the avoidance of doubt, includes any Foundation-supported Entities), person, firm or corporation that is not bound by confidentiality and restricted use obligations at least as strict as those set out herein or as otherwise expressly stated herein.
(c) Notwithstanding anything to the contrary in this Agreement, the Receiving Party shall have no obligation with respect to the Confidential Information received from a Disclosing Party to the extent such information is and which the Receiving Party is clearly able to demonstrate: (i) already known by the Receiving Party at the time of disclosure as evidenced by written documentation; (ii) publicly known, or subsequently becomes publicly known, without the wrongful act or breach of this Agreement by the Receiving Party; (iii) rightfully received by the Receiving Party from a third party having the lawful right to make such a disclosure, where said disclosure is rightfully made without any obligation of confidence to the Disclosing Party; (d) approved for release or disclosure by written authorization of the Disclosing Party; (e) independently developed by or for the employees or agents of the Receiving Party or its Affiliates without the use or knowledge of the Confidential Information provided by the Disclosing Party; or (f) required to be disclosed pursuant to any competent judicial or government request, requirement or order, provided that the Receiving Party so disclosing takes reasonable steps to provide the Disclosing Party with sufficient prior notice in order to allow the Disclosing Party to contest such request, requirement or order, and provided further that such Confidential Information is disclosed only subject to reasonably available restrictions on further disclosure and use, and otherwise remains subject to the obligations of confidentiality and restricted use set forth in this Agreement.
(d) Each Receiving Party shall be entitled to disclose the Disclosing Party’s Confidential Information to its employees, board members as well as its agents and consultants who are bound by confidentiality and restricted use obligations no less strict than those set out herein.
(e) Subject to exemptions and limitations elsewhere in this Agreement, the obligations of confidentiality of Confidential Information shall remain in effect for a period of seven years from the date the Confidential Information is communicated to the Receiving Party; provided that this period is extended to [*****] with regard to any Confidential Information disclosed pursuant to the DARPA-agreements, which information the Company has identified as being subject to such longer confidentiality period pursuant to the DARPA agreements.
(f) For the avoidance of doubt, the Confidential Disclosure Agreement entered into by the Parties effective as of June 6, 2012 (the “Initial Confidentiality Agreement”), and Article 6 (“Confidentiality”) of the Framework Agreement for Cooperation entered into between the Parties effective December 11, 2013 (the “Framework Agreement”) are terminated as of the Effective Date. All Confidential Information (as defined in either the Initial Confidentiality Agreement or the Framework Agreement) that was disclosed by a Disclosing Party to a Receiving Party prior to the Effective Date, is deemed to be Confidential Information as defined in and for purposes of this Agreement and is subject to the protections and terms set forth herein for the term specified in this Agreement.
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19. Specific Performance
The Company acknowledges and agrees that the Foundation would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached or violated. Accordingly, the Company agrees that the Foundation will be entitled to seek an injunction or injunctions to prevent breaches or violations of the provisions of this Agreement and to enforce specifically this Agreement and the terms and provisions hereof in any action instituted in any court having jurisdiction over the Parties and the matter in addition to any other remedy to which it may be entitled, at law or in equity. The Company further agrees that, in the event of any action for specific performance in respect of such breach or violation, it will not assert the defense that a remedy at law would be adequate.
20. Authority
Each of the Company and the Foundation covenants, represents and warrants with respect to itself that it has all authority necessary to execute this Agreement and that, on execution, this Agreement will be fully binding and enforceable in accordance with its terms, and that no other consents or approvals of any other Person or third parties are required or necessary for this Agreement to be so binding.
21. Governing Law
This Agreement is made pursuant to, and shall be construed and enforced in accordance with, the laws of the State of New York, U.S.A. irrespective of the principal place of business, residence or domicile of the Parties hereto and without giving effect to otherwise applicable principles of conflicts of law that would give effect to the laws of another jurisdiction.
22. Expenses
Each of the Parties shall bear and pay for all of its own costs, fees and expenses (including legal, accounting and other professional or advisory fees and expenses) incurred or to be incurred by it, in each case, in negotiating and preparing this Agreement.
23. Dispute Resolution
The Parties will resolve any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity hereof (“Dispute”) in accordance with this Section 23.
(a) [*****]
(b) [*****]
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[*****]
(c) [*****]
(d) [*****]
24. Waiver
Failure or delay by either Party in exercising or enforcing any provision, right, or remedy under this Agreement, or waiver of any remedy hereunder, in whole or in part, shall not be deemed a waiver thereof, or prevent the subsequent exercise of that or any other rights or remedy.
25. Further Assurances
From time to time after the Effective Date, each Party shall execute, acknowledge and deliver to each other any further documents, assurances, and other matters, and will take any other action consistent with the terms and conditions of this Agreement, that may reasonably be requested by a Party and necessary or desirable to carry out the purpose of this Agreement.
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26. Interpretation
The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Whenever the words “include,” “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”
27. Counterparts
This Agreement may be executed in one or more counterparts, including by signatures delivered by facsimile or pdfs, each of which shall be deemed an original, but all of which shall be deemed to be and constitute one and the same instrument.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this Global Access Commitments Agreement to be executed by their duly authorized representatives as of the date first written above.
CUREVAC GMBH | ||
By: | /s/ Ingmar Hoerr | |
Name: | Ingmar Hoerr | |
Title: | CEO |
BILL & MELINDA GATES FOUNDATION | ||
By: | /s/ Jim Bromley | |
Name: | /s/ Jim Bromley | |
Title: | CFO |
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EXECUTION COPY
Appendix 1
New Facility
EXECUTION COPY
Appendix 2
Access Countries
[*****]
EXECUTION COPY
Appendix 3
COGS Methodology
EXECUTION COPY
Appendix 4
Existing Agreements
EXECUTION COPY
Appendix 5
Form of Amendment to Option Agreement
EXECUTION COPY
Appendix
6
[OFFICER’S/DIRECTOR’S] CERTIFICATE
CUREVAC GMBH
[DATE]
This certificate is being delivered by CureVac GmbH is a private, for-profit company having its business address at Paul-Ehrlich-Str. 15, 72076 Tübingen (the “Company”), pursuant to Section 9(a) of the Global Access Commitments Agreement between the Company and the Bill & Melinda Gates Foundation dated as of [ ] (the “Agreement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Agreement.
The Company certifies as follows:
1. During the fiscal year ended [DATE], the Company met the requirements of the Foundation Investment as set forth in the Agreement that were required to be complied with or performed by the Company during such time period.
2. Attached as Exhibit A to this certificate is a description of the Company’s use of proceeds of the Foundation Investment during the fiscal year ended [DATE].
3. Attached as Exhibit B to this certificate is the Company’s evaluation of the Company’s development of the Platform Technology and use of the Platform Technology to advance drug and vaccine candidates in support of the Foundation’s Charitable Purpose, and progress with respect to the New Facility and Projects, including information regarding progress against the Global Access Commitments (as set forth in the Investment Documents) during the fiscal year ended [DATE].
IN WITNESS WHEREOF, the undersigned has executed this certificate and has caused this certificate to be delivered on the date first above written.
CureVac GmbH | |||
By: | |||
Name: | |||
Title: |
EXECUTION COPY
Appendix 7
[OFFICER’S/DIRECTOR’S] CERTIFICATE
CUREVAC GMBH
[DATE]
This certificate is being delivered by CureVac GmbH is a private, for-profit company having its business address at Paul-Ehrlich-Str. 15, 72076 Tübingen (the “Company”), pursuant to Section 9(b) of the Global Access Commitments Agreement between the Company and the Bill & Melinda Gates Foundation dated as of [ ] (the “Agreement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Agreement.
The Company certifies as follows:
1. During the term of the Foundation Investment, the Company met the requirements of the Foundation Investment as set forth in the Agreement that were required to be complied with or performed by the Company during such time period.
2. Attached as Exhibit A to this certificate is a description of the Company’s use of proceeds of the Foundation Investment during the term of the Foundation Investment.
3. Attached as Exhibit B to this certificate is the Company’s evaluation of the Company’s development of the Platform Technology and use of the Platform Technology to advance drug and vaccine candidates in support of the Foundation’s Charitable Purpose, and progress with respect to the New Facility and Projects, including information regarding progress against the Global Access Commitments (as set forth in the Investment Documents) during the term of the Foundation Investment.
IN WITNESS WHEREOF, the undersigned has executed this certificate and has caused this certificate to be delivered on the date first above written.
CureVac GmbH | |||
By: | |||
Name: | |||
Title: |
AMENDMENT
NO. 2 TO THE
OPTION AGREEMENT
[*****]
Exhibit 10.12
Confidential
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
EXECUTION COPY
SIDE AGREEMENT AND AMENDMENT NUMBER ONE
to the
DEVELOPMENT AND OPTION AGREEMENT
THIS SIDE AGREEMENT AND AMENDMENT (“Amendment Agreement”) to the DEVELOPMENT AND OPTION AGREEMENT is entered into effective as of December 1, 2016 (the “Amendment One Date”), by and between ACUITAS THERAPEUTICS INC., with offices at 2714 West 31st Avenue, Vancouver, British Columbia, V6L 2Al, Canada (“Acuitas”), and CUREVAC AG, a company incorporated in Germany whose registered office is at Paul-Ehrlich-Straf3e 15, 72076 Tübingen, Germany (“CureVac”).
RECITALS
WHEREAS, Acuitas and CureVac entered into that certain Development and Option Agreement effective April 29th 2016 (the “D&O Agreement”) relating to the evaluation of and options to licence Acuitas LNP Technology for the research, development, manufacture and/or commercialisation of products incorporating Acuitas LNP Technology and CureVac Technology;
WHEREAS, both Acuitas and CureVac desire to include in the Work Plan the evaluation of Acuitas LNP Technology together with CureVac Technology relating to Gene Editing; and
WHEREAS, to enable the prompt commencement of such evaluation both Acuitas and CureVac desire to agree to certain side terms and conditions to, and to make certain amendments to the provisions of, the D&O Agreement so that a limited such evaluation may be commenced.
NOW, THEREFORE, in consideration of the mutual covenants and representations contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
AGREEMENT
1. | Definitions. |
1.1. | “DNA Sequence” means, for the purpose of this Amendment Agreement only, any sequence of DNA [*****] as such DNA Sequence(s) and Gene Target(s) are specified in Exhibit 3.1 or are subsequently reserved in accordance with Paragraph 2.3 hereof. |
1.2. | “Gene Target” means, for the purpose of this Amendment Agreement only [*****] and/or pre-defined variants thereof, as such coding or non-coding sequence(s) and/or variant(s) are specified in Exhibit 3.1 or are subsequently reserved in accordance with Paragraph 2.3 hereof. |
Confidential
1.3. | “DNA Editing Protein” means, for the purpose of this Amendment Agreement only, a Target encoded by an mRNA that upon delivery to a cell or micro-organism is intended to Gene Edit a human, animal, microorganism or virus coding or non-coding sequence within the genome of the human or animal cell, or microorganism or virus. |
1.4. | “Gene Edit” means, for the purpose of this Amendment Agreement only, to correct, modify, insert, delete, activate, inactivate or repair a coding or non-coding sequence within the genome of a human or animal cell, or microorganism or virus; and “Gene Editing” has the corresponding meaning. |
1.5. | “Guide RNA” means, for the purpose of this Amendment Agreement only, [*****] |
1.6. | The definition of “Approved Partner” in Section 1.11 of the D&O Agreement shall be replaced in its entirety by the following: |
“1.11 “Approved Partner” means with respect to any Third Party to whom CureVac wishes to disclose Acuitas Confidential Information or transfer Acuitas LNP Technology or Materials provided by Acuitas to CureVac: (i) any Third Party licensee of CureVac Technology; (ii) any Third Party providing services set forth in the Work Plan to CureVac; or (iii) [*****].
1.7. | All capitalised terms used in this Amendment Agreement and not otherwise defined in this Amendment Agreement have the meanings assigned them in the D&O Agreement. |
2. | Target Reservation. |
2.1. | On the Amendment One Date, the DNA Editing Protein [*****] on the Reserved Target List as a non-exclusive Target. |
2.2. | Until the conclusion of the Gene Editing Work Plan, CureVac hereby covenants to not submit any Target Notice for any other DNA Editing Protein. |
2.3. | In addition to the DNA Editing Protein Target, for the purpose of this Amendment Agreement only CureVac may non-exclusively reserve up to [*****] Gene Targets, and optionally up to [*****] DNA Sequences for each Gene Target, in each case at [*****]. The DNA Editing Protein Target counts as a single Reserved Target, however, [*****] available to CureVac under Article 4 of the D&O Agreement. CureVac will however be required to submit to the Escrow Agent for clearance and reservation all Gene Targets and DNA Sequences in accordance with Gene Target/DNA Sequence preclearance and reservation requirements analogous to those set forth for Targets in Sections 4.2 of the D&O Agreement. |
3. | Program extension and Work-Plan for Gene Editing. |
3.1. | The Parties hereby append Exhibit 3.1 (the “Gene Editing Work Plan”) as attached to this Amendment Agreement to the Work-Plan. |
Confidential
3.2. | On the Amendment One Date, the Gene Editing Work Plan relates: (i) only to the use of [*****] as a DNA Editing Protein; and (ii) only to the Gene Targets and (iii) only to the DNA Sequences, such Gene Targets and DNA Sequences having been pre-cleared by the Escrow Agent by a mechanism analogous to that set forth in Section 4.2 of the D&O Agreement. |
3.3. | Acuitas hereby acknowledges that certain parts of the Gene Editing Work Plan include the evaluation of: (i) LNPs containing [*****] mRNA Constructs intended to express the DNA Editing Protein [*****] without containing [*****] Guide RNA(s), and/or without containing [*****] DNA Sequences; and (ii) separate LNPs containing [*****] Guide RNA(s), and/or containing [*****] DNA Sequences, in each case without containing said mRNA Construct(s), although the LNPs of (ii) are intended to be evaluated only in connection with those of (i). |
3.4. | Until the conclusion of the Gene Editing Work Plan, CureVac hereby covenants to neither: (i) submit any additional DNA Editing Proteins for pre-clearance by the Escrow Agent; nor (ii) change the scope of the Gene Editing Work Plan beyond that stated in (i) to (iii) of Paragraph 3.2 hereof, without obtaining the prior consent of Acuitas, such consent not to be unreasonably withheld or conditioned. |
3.5. | For the period during which [*****] is on the Reserved Target List, Acuitas hereby covenants not to provide any Third Party with any exclusive right, or option to obtain any exclusive right, under the Acuitas LNP Technology that would prevent CureVac from taking non-exclusive rights to any Gene Target or DNA Sequence which has been reserved in accordance with Section 2.3. |
3.6. | The second to last sentence of Section 3.4 of the D&O Agreement shall be replaced in its entity by the following: |
“CureVac shall use commercially reasonable efforts to obtain the foregoing assignment for Approved Partners, and if CureVac is unable to obtain such assignment, CureVac shall obtain: (x) [*****]; or (y) [*****], or seek to protect any such Know-How by any other form of intellectual property, without prior written permission from CureVac. CureVac shall not give such permission without the prior consent of Acuitas, such consent not to be unreasonably withheld or conditioned.”
4. | Licensed Product Option for Gene Editing. Acuitas and CureVac shall discuss and negotiate in good faith, for the duration of the Gene Editing Work Plan, on the terms and conditions under which the D&O Agreement (and associated License Agreements) will be amended to encompass Licensed Products useful for Gene Editing for the purposes of Article 5 CureVac License Options; it being hereby agreed between the Parties that, with reference to the D&O Agreement (and associated License Agreements) on the Amendment One Date, the financial terms (including reservation costs, option exercise fees, milestones and royalties applied to any such Licensed Products useful for Gene Editing will be consistent with the corresponding financial terms already provided for in the D&O Agreement (and associated License Agreements) provided, that: (i) [*****] (ii) [*****] will be applied for Guide RNAs (with the applicability of such reservation costs for multiple Gene Targets to be discussed during such negotiations); and (iii) each DNA Editing Protein as a Target will count as a single Reserved Target, [*****] Reserved Targets available to CureVac under Article 4 of the D&O Agreement. For clarity, the terms “DNA Sequence” and “Gene Target” (and correspondingly, “Guide RNA”), as used in this Paragraph 4, will not be limited to those sequences specified in Exhibit 3. I hereof, but will be redefined by such amendment based on the definitions herein. |
Confidential
5. | Amendment of Section 3.5(c) of the D&O Agreement. |
5.1. | Section 3.5(c) of the D&O Agreement is hereby amended to add the following at the end of such section: |
“Acuitas shall not be required to maintain the licenses to In-Licensed Technology with respect to which CureVac shall not have exercised the option set forth in this subsection (c). Accordingly, Acuitas is free to enter into new licenses and modify or terminate existing licenses to any In-Licensed Technology until such time as it is licensed to CureVac; provided, that Acuitas has given CureVac at least [*****] days’ prior written notice of any modification or termination of any existing license to any In-Licensed Technology, such notice to specify the In-Licensed Technology to be modified or terminated. The parties acknowledge that any exercise of a sublicense to any In-Licensed Technology must be in accordance with the terms of Acuitas’ main Third Party license agreement.”
5.2. | Acuitas represents and warrants that, on the Amendment One Date, it has no intent to immediately modify or terminate any existing license to any In-Licensed Technology to which CureVac has the option under Section 3.5(c) of the D&O Agreement. |
6. | Miscellaneous. |
6.1. | Except as expressly stated in this Amendment Agreement, the D&O Agreement remains unchanged and in full force and effect. |
6.2. | The provisions of ARTICLE IO of the D&O Agreement shall be applied by analogy to this Amendment Agreement. |
IN WITNESS WHEREOF, the Parties have caused Amendment Agreement to be executed by their respective duly authorised officers as of the Amendment One Date.
CureVac AG | |||
By: | /s/ Dr. Florian von der Mülbe | /s/ Pierre Kemula | |
Name: | Dr. Florian von der Mülbe | Pierre Kemula | |
Title: | Chief Operating Officer | Chief Financial Officer |
CureVac AG | ||
By: | /s/ Thomas Madden | |
Name: | Thomas Madden | |
Title: | President and CEP |
Confidential
EXHIBIT 3.1: Gene Editing Work Plan
[*****]
Exhibit 10.35
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Execution Version
CUREVAC (IDFF)
FINANCE FEE LETTER
From:
The European Investment
Bank
100 blvd Konrad Adenauer
Luxembourg
L-2950 Luxembourg
(the “Bank”)
To:
CureVac Real Estate GmbH
Friedrich-Miescher-Str. 15
72076 Tübingen
Germany
(the “Borrower”)
Date: | 27 June 2020 |
Subject: | Finance Contract between The European Investment Bank and CureVac Real Estate GmbH dated 27 June 2020 |
Contract numbers (FI No) [*****]; Serapis No: [*****]
Dear Sirs,
We refer to the EUR 75,000,000 finance contract dated 27 June 2020 between the Bank as lender and the Borrower as borrower (the “Finance Contract”).
This letter (the “Fee Letter”) is the Finance Fee Letter as referred to in the Finance Contract.
1. | Definitions |
1.1 | Terms defined in the Finance Contract shall have the same meaning when used in this Fee Letter, unless a contrary indication appears. This Fee Letter is a Finance Document. |
1.2 | In this Fee Letter: |
“Cancellation Fee” means a fee of [*****]% ([*****] basis points) of the cancelled amount.
“Drop Dead Fee” has the meaning given to such term in Article 2.1 (Drop Dead Fee) below.
Page 1/5
Execution Version
"Prepayment Fee" means, in relation to a Prepayment Amount in respect of a Tranche, a fee as follows:
(a) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the relevant Disbursement Date but before or on the [*****] of such Disbursement Date; |
(b) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the [*****] of the relevant Disbursement Date but before or on the [*****] of such Disbursement Date; |
(c) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the [*****] of the relevant Disbursement Date but before or on the [*****] of such Disbursement Date; |
(d) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the [*****] of the relevant Disbursement Date but before or on the [*****] of such Disbursement Date; |
(e) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the [*****] of the relevant Disbursement Date but before or on the [*****] of such Disbursement; or |
(f) | a fee of [*****]% ([*****] basis points) of the Prepayment Amount if the Prepayment Date is after the [*****] of the relevant Disbursement Date but before the |
Maturity Date,
with such fee being payable on the applicable Prepayment Date.
"Prepayment Amount" means the amount of a Tranche to be prepaid by the Borrower in accordance with any voluntary prepayment or compulsory prepayment.
2. | Drop Dead Fee |
2.1 | If no disbursement is made within [*****] months from the date of the Finance Contract or in case the Credit is cancelled in full under Article 2.6 (Cancellation) of the Finance Contract prior to the expiry of this term, the Borrower shall pay to the Bank a one-off contractual fee equal to [*****]% ([*****] basis points) of the Credit (the "Drop Dead Fee"). |
2.2 | The Drop Dead Fee shall be payable by the Borrower to the Bank within [*****] days of the Borrower's receipt of the Bank's demand or within any longer period specified in the Bank's demand. |
2.3 | For the avoidance of doubt, the Drop Dead Fee payable under this Article 2 (Drop Dead Fee) is independent of any other fees stipulated in this Fee Letter or the Finance Contract. |
3. | Cancellation Fee |
3.1 | If the Borrower pursuant to Sub-Paragraph (a) of Article 2.6 (Cancellation) of the Finance Contract cancels an Accepted Tranche, the Borrower shall pay to the Bank the Cancellation Fee. |
3.2 | If the Bank pursuant to Sub-Paragraph (b) of Article 2.6 (Cancellation) of the Finance Contract cancels all or part of an Accepted Tranche, the Borrower shall pay to the Bank the Cancellation Fee. |
3.3 | If an Accepted Tranche is not disbursed on the Disbursement Date because the conditions precedent set out in Article 2.5.3 (All Tranches – Other Conditions) of the Finance Contract are not satisfied on such date, such Tranche shall be cancelled and the Borrower shall pay to the Bank the relevant Cancellation Fee. |
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Execution Version
4. | PREPAYMENT FEE |
If:
(a) | the Borrower prepays a Tranche in accordance with Article 5.2 (Voluntary prepayment) of the Finance Contract; or |
(b) | a Prepayment Event in relation to a Tranche (other than in relation to a prepayment pursuant to Article 5.3.3 (Illegality) of the Finance Contract) occurs in accordance with Article 5.3 (Compulsory prepayment) of the Finance Contract; |
the Borrower shall pay to the Bank the Prepayment Fee.
5. | MISCELLANEOUS |
5.1 | The provisions of Article 2.10 (Sums due under Article 2) and Article 8.1 (Taxes, duties and fees) of the Finance Contract shall apply to all payments made or to be made under this Fee Letter. |
5.2 | If the date on which a fee under this Fee Letter is due to be paid is not a Relevant Business |
Day, payment shall be made on the next Relevant Business Day.
6. | COUNTERPARTS |
This Fee Letter may be executed in any number of counterparts, and this has the same effect as if the signatures on the counterparts were on a single copy of this Fee Letter.
7. | GOVERNING LAW |
This Fee Letter and any non-contractual obligations arising out of or in connection with it are governed by Luxembourg law. The parties to this Fee Letter submit to the exclusive jurisdiction of the Luxembourg courts.
If you agree to the above, please sign and return to the Bank the enclosed copy of this Fee Letter.
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Yours faithfully
/s/ Tero Pietila | /s/ Ayse Nil ADA | ||||
Name: | Tero Pietila | Name: | Ayse Nil ADA | ||
Title: | Head of Division | Title: | Legal Counsel |
For and on behalf of
European Investment Bank
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We acknowledge and agree to the above:
/s/ Florian von der Mülbe | /s/ Rein hard Rapp | ||||
Name: | Florian von der Mülbe | Name: | Rein hard Rapp | ||
Title: | Managing Director | Title: | Managing Director |
For and on behalf of
CureVac Real Estate GmbH
Exhibit 10.36
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Execution Version
Contract number (FI No): [*****]
Serapis No: [*****]
CUREVAC (IDFF)
Finance Contract
between the
European Investment Bank
and
CureVac Real Estate GmbH
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WHEREAS: | 6 | |
ARTICLE 1 | 7 | |
1.1 | INTERPRETATION | 7 |
1.2 | DEFINITIONS | 7 |
ARTICLE 2 | 16 | |
2.1 | AMOUNT OF CREDIT | 16 |
2.2 | DISBURSEMENT PROCEDURE | 16 |
2.2.1 | TRANCHES | 16 |
2.2.2 | DISBURSEMENT OFFER | 16 |
2.2.3 | DISBURSEMENT ACCEPTANCE | 17 |
2.3 | DISBURSEMENT ACCOUNT | 17 |
2.4 | CURRENCY OF DISBURSEMENT | 17 |
2.5 | CONDITIONS OF DISBURSEMENT | 17 |
2.5.1 | INITIAL DOCUMENTARY CONDITIONS PRECEDENT | 17 |
2.5.2 | ALL TRANCHES - DOCUMENTARY CONDITIONS PRECEDENT | 17 |
2.5.3 | ALL TRANCHES–OTHER CONDITIONS | 18 |
2.5.4 | TRANCHE A–ADDITIONAL CONDITIONS PRECEDENT | 18 |
2.5.5 | TRANCHE B–ADDITIONAL CONDITIONS PRECEDENT | 18 |
2.5.6 | TRANCHE C–ADDITIONAL CONDITIONS PRECEDENT | 18 |
2.6 | CANCELLATION | 19 |
2.7 | FEE FOR CANCELLATION OF AN ACCEPTED TRANCHE | 19 |
2.8 | CANCELLATION AFTER EXPIRY OF THE CREDIT | 19 |
2.9 | DROP DEAD FEE | 20 |
2.10 | SUMS DUE UNDER ARTICLE 2 | 20 |
ARTICLE 3 | 20 | |
3.1 | AMOUNT OF LOAN | 20 |
3.2 | CURRENCY OF REPAYMENT, INTEREST AND OTHER CHARGES | 20 |
ARTICLE 4 | 20 | |
4.1 | DEFERRED INTEREST FIXED RATE | 20 |
4.2 | VARIABLE REMUNERATION | 20 |
4.3 | INTEREST ON OVERDUE SUMS | 22 |
ARTICLE 5 | 23 | |
5.1 | NORMAL REPAYMENT | 23 |
5.2 | VOLUNTARY PREPAYMENT | 23 |
5.2.1 | PREPAYMENT OPTION | 23 |
5.2.2 | PREPAYMENT FEE | 23 |
5.2.3 | PREPAYMENT MECHANICS | 23 |
5.3 | COMPULSORY PREPAYMENT | 23 |
5.3.1 | COST REDUCTION | 23 |
5.3.2 | CHANGE EVENTS | 23 |
5.3.3 | ILLEGALITY | 24 |
5.3.4 | DISPOSALS | 24 |
5.3.5 | EXPIRY OF GUARANTEE AGREEMENT | 24 |
5.3.6 | PARI PASSU TO NON-EIB FINANCING | 24 |
5.3.7 | PREPAYMENT FEE | 25 |
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5.3.8 | PREPAYMENT MECHANICS | 25 |
5.4 | GENERAL | 25 |
ARTICLE 6 | 25 | |
6.1 | DAY COUNT CONVENTION | 25 |
6.2 | TIME AND PLACE OF PAYMENT | 25 |
6.3 | NO SET-OFF BY THE BORROWER | 26 |
6.4 | DISRUPTION TO PAYMENT SYSTEMS | 26 |
6.5 | APPLICATION OF SUMS RECEIVED | 26 |
6.5.1 | GENERAL | 26 |
6.5.2 | PARTIAL PAYMENTS | 26 |
6.5.3 | ALLOCATION OF SUMS RELATED TO TRANCHES | 27 |
ARTICLE 7 | 27 | |
ARTICLE 8 | 27 | |
8.1 | TAXES, DUTIES AND FEES | 27 |
8.2 | OTHER CHARGES | 27 |
8.3 | INCREASED COSTS, INDEMNITY AND SET-OFF | 28 |
ARTICLE 9 | 28 | |
9.1 | RIGHT TO DEMAND REPAYMENT | 28 |
9.2 | OTHER RIGHTS AT LAW | 29 |
9.3 | PREPAYMENT FEE | 30 |
9.4 | NON-WAIVER | 30 |
ARTICLE 10 | 30 | |
10.1 | GOVERNING LAW | 30 |
10.2 | JURISDICTION | 30 |
10.3 | PLACE OF PERFORMANCE | 30 |
10.4 | EVIDENCE OF SUMS DUE | 30 |
10.5 | THIRD PARTY RIGHTS | 30 |
10.6 | ENTIRE AGREEMENT | 30 |
10.7 | INVALIDITY | 31 |
10.8 | AMENDMENTS | 31 |
10.9 | COUNTERPARTS | 31 |
10.10 | ASSIGNMENT AND TRANSFER BY THE BANK | 31 |
ARTICLE 11 | 31 | |
11.1 | NOTICES | 31 |
11.1.1 | FORM OF NOTICE | 31 |
11.1.2 | ADDRESSES | 32 |
11.1.3 | DEMAND AFTER NOTICE TO REMEDY | 33 |
11.2 | ENGLISH LANGUAGE | 33 |
11.3 | CONCLUSION OF THIS CONTRACT (VERTRAGSSCHLUSS) | 33 |
SCHEDULE A | 36 |
INVESTMENT SPECIFICATION AND REPORTING | 36 |
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SCHEDULE B | 39 |
DEFINITIONS OF EURIBOR | 39 |
SCHEDULE C | 40 |
FORM OF DISBURSEMENT OFFER/ACCEPTANCE | 40 |
SCHEDULE D | 42 |
FORM OF DRAWDOWN CERTIFICATE | 42 |
SCHEDULE E | 43 |
FORM OF COMPLIANCE CERTIFICATE | 43 |
SCHEDULE F | 44 |
CONDITIONS PRECEDENT | 44 |
PART A - INITIAL DOCUMENTARY CONDITIONS PRECEDENT | 44 |
PART B - GUARANTOR CONDITIONS PRECEDENT | 45 |
SCHEDULE G | 47 |
REPRESENTATIONS AND WARRANTIES | 47 |
SCHEDULE H | 50 |
GENERAL UNDERTAKINGS | 50 |
SCHEDULE I | 59 |
INFORMATION AND VISITS | 59 |
SCHEDULE J | 62 |
EXISTING INDEBTEDNESS | 62 |
SCHEDULE K | 62 |
EXISTING SECURITY | 62 |
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THIS CONTRACT IS MADE ON 27 JUNE 2020 BETWEEN:
The European Investment Bank having its seat at 100 blvd Konrad Adenauer,Luxembourg, L-2950 Luxembourg, represented by Tero PIETILA, Head of Division and Ayse Nil ADA, Legal Counsel |
|
(the “Bank”) | |
and |
Curevac Real Estate GmbH a limited liablility company (Gesellschaft mit beschränkter Haftung) incorporated in Germany, having its office at Friedrich-Miescher-Str. 15, 72076 Tübingen, Germany, registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Stuttgart under HRB 757523, represented by Dr. Florian von der Mülbe and Dr. Reinhard Rapp | (the “Borrower”) |
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WHEREAS:
(A) | The Borrower has stated that it is undertaking together with CureVac AG a research and development project relating to infectious disease vaccines, including a SARS-CoV-2 Vaccine, and is furnishing and validating a good manufacturing practice compliant messenger ribonucleic acid (RNA) production facility (the “GMP IV”), both in Germany as more particularly described in the technical description (the “Technical Description”) set out in Schedule A (Investment Specification and Reporting) (the “Investment”). The total cost of the Investment, as estimated by the Bank, is EUR [*****] ([*****] euro). |
(B) | The Bank, considering that the financing of the Investment falls within the scope of its functions, agreed to provide the Borrower with a credit in an amount of EUR 75,000,000 (seventy five million euro) under this finance contract (the “Contract”) to partially finance the Investment; provided that the amount of the loan hereunder shall not, in any case, exceed 50% (fifty per cent.) of the cost of the Investment. The parties to this Contract being aware of the differences between a participation credit (partiarisches Darlehen) and a silent partnership (stille Gesellschaft), that the Bank will not participate in any loss of the Borrower and that this Contract provides for a participation credit (partiarisches Darlehen), have consciously decided to enter into this Contract. |
(C) | The Credit falls under a joint initiative between the Bank and the European Commission, which is intended as a new Bank financing instrument, to finance inter alia research projects and research infrastructure under the Horizon 2020 framework programme of the European Union for Research and Technological Development (2014-2020) (the “Horizon 2020 Framework EU Programme”). |
(D) | The statute of the Bank provides that the Bank shall ensure that its funds are used as rationally as possible in the interests of the European Union; and, accordingly, the terms and conditions of the Bank’s loan operations must be consistent with relevant policies of the European Union. |
(E) | The financing of the Investment includes certain state subsidies or grants and the provision of such funds has been duly authorised and will be provided in compliance with all relevant legislation of the European Union. |
(F) | The Bank considers that access to information plays an essential role in the reduction of environmental and social risks, including human rights violations, linked to the projects it finances and has therefore established its transparency policy, the purpose of which is to enhance the accountability of the Bank’s group towards its stakeholders and the citizens of the European Union in general. |
(G) | The processing of personal data shall be carried out by the Bank in accordance with applicable European Union legislation on the protection of individuals with regard to the processing of personal data by the European Union institutions and bodies and on the free movement of such data. |
(H) | The Bank supports the implementation of international and EU standards in the field of anti-money laundering and countering the financing of terrorism and promotes tax good governance standards. It has established policies and procedures to avoid the risk of misuse of its funds for purposes which are illegal or abusive in relation to applicable laws. The Bank’s group statement on tax fraud, tax evasion, tax avoidance, aggressive tax planning, money laundering and financing of terrorism is available on the Bank’s website and offers further guidance to the Bank’s contracting counterparties. |
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It is hereby agreed as follows:
ARTICLE 1
Interpretation and definitions
1.1 Interpretation
In this Contract:
(a) | references to Articles, Recitals, Schedules and (Sub-)Paragraphs are, save if explicitly stipulated otherwise, references respectively to articles of, and recitals, schedules and (sub-)paragraphs of schedules to, this Contract. All Recitals and Schedules form part of this Contract; |
(b) | references to “law” or “laws” mean (i) any applicable law and any applicable treaty, constitution, statute, legislation, decree, normative act, rule, regulation, judgement, order, writ, injunction, determination, award or other legislative or administrative measure or judicial or arbitral decision in any jurisdiction which is binding or applicable case law, and (ii) EU Law; |
(c) | references to applicable law, applicable laws or applicable jurisdiction means (i) a law or jurisdiction applicable to the Borrower or any other Obligor (as the context requires), its respective rights and/or obligations (in each case arising out of or in connection with the Finance Documents), its capacity and/or assets and/or the Investment; and/or, as applicable, (ii) a law or jurisdiction (including in each case the Bank’s Statute) applicable to the Bank, its rights, obligations, capacity and/or assets; |
(d) | references to a provision of law are references to that provision as amended or re-enacted; |
(e) | references to any Finance Document or other agreement or instrument are references to that Finance Document or other agreement or instrument as amended, novated, supplemented, extended or restated; |
(f) | words and expressions in plural shall include singular and vice versa; |
(g) | “promptly” is to be construed as unverzüglich (without undue delay) within the meaning of Section 121 para. 1 sentence 1 of the BGB; |
(h) | a Default (other than an Event of Default) is “continuing” if it has not been remedied or waived and an Event of Default is “continuing” if it has not been waived; and |
(i) | terms defined in the GDPR (as defined below), including the terms, “data subject”, “personal data” and “processing” have the same meanings when used in Paragraph 26 (Data Protection) of Schedule G (General Undertakings) of this Contract. |
This Contract is made in the English language. For the avoidance of doubt, the English language version of this Contract shall prevail over any translation of this Contract. However, where a German translation of a word or phrase appears in the text of this Contract, the German translation of such word or phrase shall prevail.
1.2 Definitions
In this Contract:
“Accepted Tranche” means a Tranche in respect of a Disbursement Offer which has been duly accepted by the Borrower in accordance with its terms on or before the Disbursement Acceptance Deadline.
“acting in concert” means acting together pursuant to an agreement or understanding (whether formal or informal).
“AktG” means the German stock corporation act (Aktiengesetz).
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“Auditor” means an independent, international and leading firm of accounts (which has at least offices in Luxembourg and Frankfurt am Main) appointed by the Bank and accepted by the Borrower. If the Bank and the Borrower have not agreed on an Auditor within 60 (sixty) days of any such request, the Bank will have sole discretion to appoint an Auditor.
“Authorisation” means an authorisation, permit, consent, approval, resolution, licence, exemption, filing, notarisation or registration.
“Authorised Signatory” means a person authorised to sign individually or jointly (as the case may be) Disbursement Acceptances on behalf of the Borrower and named in the most recent List of Authorised Signatories and Accounts received by the Bank prior to the receipt of the relevant Disbursement Acceptance.
“Batch” means a pre-defined quantity of units of a medicinal product all of the same pharmaceutical form, manufactured at GMP IV and having undergone a single series of manufacturing operations to yield the final desired formulated medicinal product. It is estimated that the production capacity GMP IV will be 80 Batches per annum.
“Buy-Back Amount” has the meaning given to it in Paragraph (g) of Article 4.2 (Variable Remuneration).
“BGB” means the German Civil Code (Bürgerliches Gesetzbuch).
“Building Leasing Agreements” means (i) the lease agreement (Mietvertrag) between the Borrower as lessee (Mieter) and Technologieförderung Reutlingen-Tübingen GmbH as lessor (Vermieterin) with effect from 1 January 2011 and (ii) lease agreement (Mietvertrag) between the Borrower as lessee (Mieter) and Fränkel Immobilien-Service GmbH as lessor (Vermieter) originally dated 8 June 2018, in each case as amended from time to time.
“Business Day” means a day (other than a Saturday or Sunday) on which the Bank and commercial banks are open for general business in Luxembourg.
“Cancellation Fee” has the meaning given to such term in Article 1.2 (Definitions) of the Finance Fee Letter.
“Change in the Beneficial Ownership” means a change in the ultimate ownership or control of the Borrower according to the definition of “beneficial owner” set out in article 3(6) of Directive 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, as amended, supplemented or restated.
“Change-of-Control Event” means:
(a) | any person or group of persons acting in concert gains Control of the Borrower, CureVac AG or of any entity directly or indirectly Controlling the Borrower; or |
(b) | CureVac AG ceases: |
(i) | to be the beneficial owner directly or indirectly through wholly owned subsidiaries of at least 75.1% (seventy five point one per cent) of the issued share capital of the Borrower; |
(ii) | the power to cast, or to control the casting of, at least 75.1% (seventy five point one per cent) of the total number of votes held by all shareholders of the Borrower; |
(iii) | the power to appoint or remove all, or the majority, of the directors of the Borrower; and/or |
(iv) | the power to direct the management and policies of the Borrower, whether through the ownership of voting capital, by contract. |
“Change-of-Law Event” means the enactment, promulgation, execution or ratification of or any change in or amendment to any law, rule or regulation (or in the application or official interpretation of any law, rule or regulation) that occurs after the date of this Contract and which, in the opinion of the Bank, would materially impair an Obligor’s ability to perform its obligations under the Finance Documents.
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“Co-Funding” means any funding by a Group Company to finance the activities of the Borrower in relation to infectious diseases, which must be made by way of equity or by loans which are subordinated to any claims of the Bank, satisfactory to the Bank.
“Compliance Certificate” means a certificate substantially in the form set out in Schedule E (Form of Compliance Certificate).
“Contract Number” shall mean each Bank generated number identifying this Contract and indicated on the cover page of this Contract after the letters “FI N°”.
“Control” means:
(a) | owning (directly or indirectly) more than 50% (fifty per cent) of the shares in an entity; |
(b) | the power to cast, or to control the casting of, more than 50% (fifty per cent) of the total number of votes held by all shareholders of an entity; |
(c) | the power to appoint or remove all, or the majority, of the directors of an entity; and/or |
(d) | the power to direct the management and policies of an entity, whether through the ownership of voting capital, by contract or otherwise, |
and “Controlling” and “Controlled” has the corresponding meaning.
“COVID-19 Syndrome” means the disease resulting from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
“Credit” has the meaning given to it in Article 2.1 (Amount of Credit).
“Criminal Offence” means any of the following criminal offences as applicable: tax crimes (as referred to in the directive (EU) 2015/849 of 20 May 2015), fraud, corruption, coercion, collusion, obstruction, money laundering, financing of terrorism or any illegal activity that may affect the financial interests of the EU, according to applicable laws.
“CureVac AG” means CureVac AG, a stock corporation (Aktiengesellschaft) incorporated in Germany, having its office at Friedrich-Miescher-Str. 15, 72076 Tübingen, Germany, registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Stuttgart under HRB 754041.
“CureVac IPO” means the admission to trading of any part of the share capital of CureVac AG or the respective entity into which CureVac AG is merged or otherwise transferred or to which CureVac AG is converted, on any recognised stock or investment exchange or any sale or issue of share capital of CureVac AG by way of initial public offering.
“Default” means an Event of Default or any event or circumstance specified in Article 9 (Events of Default) which would (with the expiry of a grace period, the giving of notice, the making of any determination under this Contract or any combination of any of the foregoing) be an Event of Default.
“Deferred Interest Fixed Rate” means a fixed rate of 0.5% (fifty basis points) per annum for Tranche A, Tranche B and Tranche C.
“DH Investment” means (i) the investment of Mr. Dietmar Hopp in connection with the CureVac IPO by purchasing newly issued shares in this CureVac IPO in an amount of EUR 100,000,000.00 (or more) or (ii) another equity investment of Mr. Dietmar Hopp in an amount of EUR 100,000,000.00 (or more) into CureVac AG or the respective entity into which CureVac AG is merged or otherwise transferred or to which CureVac AG is converted.
“DH Convertible Loan Agreement” means the EUR 50,000,000 and USD 70,000,000 convertible loan between Mr. Dietmar Hopp and CureVac AG dated 3 May 2019 with a disbursed amount of approx. EUR 70,300,000 as at the date of this Finance Contract.
“Disbursement Acceptance” means a copy of the Disbursement Offer duly countersigned by the Borrower.
“Disbursement Acceptance Deadline” means the date and time of expiry of a Disbursement Offer as specified therein.
“Disbursement Account” means, in respect of each Tranche, the bank account set out in the most recent List of Authorised Signatories and Accounts.
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“Disbursement Date” means the date on which disbursement of a Tranche is made by the Bank.
“Disbursement Offer” means a letter substantially in the form set out in Schedule C (Form of Disbursement Offer/Acceptance).
“Dispute” has the meaning given to it in Article 10.2 (Jurisdiction).
“Disruption Event” means either or both of:
(a) | a material disruption to those payment or communications systems or to those financial markets which are, in each case, required to operate in order for payments to be made in connection with this Contract; or |
(b) | the occurrence of any other event which results in a disruption (of a technical or systems-related nature) to the treasury or payments operations of either the Bank or the Borrower, preventing that party from: |
(i) | performing its payment obligations under this Contract; or |
(ii) | communicating with other parties in accordance with the terms of this Contract, |
and which disruption (in either such case as per Paragraph (a) or (b) above) is not caused by, and is beyond the control of, the party whose operations are disrupted.
“Drop Dead Fee” has the meaning given to such term in Article 2.1 (Drop Dead Fee) of the Finance Fee Letter.
“EBITDA” means, in respect of any Relevant Period, the consolidated operating profit of the Group before taxation (excluding the results from discontinued operations):
(a) | before deducting any interest, commission, fees, discounts, prepayment fees, premiums or charges and other finance payments whether paid, payable or capitalised by any Group Company (calculated on a consolidated basis) in respect of that Relevant Period; |
(b) | not including any accrued interest owing to any Group Company; |
(c) | after adding back any amount attributable to the amortisation or depreciation of assets of members of the Group; |
(d) | before taking into account any Exceptional Items; |
(e) | after deducting the amount of any profit (or adding back the amount of any loss) of any Group Company which is attributable to minority interests; |
(f) | plus or minus the Group’s share of the profits or losses (after finance costs and tax) of entities which are not Group Companies; |
(g) | before taking into account any unrealised gains or losses on any financial instrument (other than any derivative instrument which is accounted for on a hedge accounting basis); and |
(h) | before taking into account any gain arising from an upward revaluation of any other asset, |
in each case, to the extent added, deducted or taken into account, as the case may be, for the purposes of determining operating profits of the Group before taxation.
“Environment” means the following, insofar as they affect human health or social well-being:
(a) | fauna and flora; |
(b) | soil, water, air, climate and the landscape; and |
(c) | cultural heritage and the built environment, |
and includes, without limitation, occupational and community health and safety.
“Environmental Approval” means any Authorisation required by Environmental Law.
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“Environmental Claim” means any claim, proceeding, formal notice or investigation by any person in respect of any Environmental Law.
“Environmental Law” means EU Law including principles and standards, and national laws and regulations, of which a principal objective is the preservation, protection or improvement of the Environment.
“EU Directives” means the directives of the European Union.
“EU Law” means the acquis communautaire of the European Union as expressed through the Treaties of the European Union, the regulations, the EU Directives, delegated acts, implementing acts, and the case law of the Court of Justice of the European Union.
“EUR” or “euro” means the lawful currency of the Member States of the European Union which adopt or have adopted it as their currency in accordance with the relevant provisions of the Treaty on European Union and the Treaty on the Functioning of the European Union or their succeeding treaties.
“EURIBOR” has the meaning given to it in Schedule B (Definition of EURIBOR).
“Event of Default” means any of the circumstances, events or occurrences specified in Article 9 (Events of Default).
“Exceptional Items” means any material items of an unusual or non-recurring nature which represent gains or losses including those arising on:
(a) | the restructuring of the activities of an entity and reversals of any provisions for the cost of restructuring; |
(b) | disposals, revaluations, write downs or impairment of non-current assets or any reversal of any write down or impairment; |
(c) | disposals of assets associated with discontinued operations; and |
(d) | any other examples of “exceptional items” (as such term has the meaning attributed to it in IFRS). |
“Existing Indebtedness” means any Indebtedness of members of the Group arising under any arrangement listed in Schedule J (Existing Indebtedness).
“Existing Security” means any Security granted by members of the Group which is listed in Schedule K (Existing Security).
“Expert Determination” has the meaning given to it in Article 4.2(c)(i) (Variable Remuneration).
“Fee Letters” means the Finance Fee Letter and the Initial Fee Letter and “Fee Letter” means each of them.
“Final Availability Date” means:
(a) | for Tranche A, the day falling [*****] months after the date of this Contract; |
(b) | for Tranche B, the day falling [*****] months after the date of this Contract; and |
(c) | for Tranche C, the day falling [*****] months after the date of this Contract. |
“Finance Documents” means this Contract, any Guarantee Agreement, the Security Documents, the Fee Letters and any other document designated as a “Finance Document” by the Borrower and the Bank.
“Finance Fee Letter” means the Luxembourg law governed fee letter from the Bank to the Borrower dated on or about the date hereof.
“Finance Lease” means any lease or hire purchase contract which would, in accordance with IFRS in force as at the date of this Contract, be treated as a finance or capital lease.
“GAAP” means generally accepted accounting principles in (Grundsätze ordnungsgemäßer Buchführung) in Germany, including IFRS.
“GDPR” means General Data Protection Regulation (EU) 2016/679.
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“Germany” means the Federal Republic of Germany.
“GMP IV” has the meaning given to that term in Recital (A).
“Group” means the Group Companies, taken together as a whole.
“Group Companies” means CureVac AG, the Borrower, CureVac, US (250 Summer St 3rd Fl Boston, MA 02210, USA) and their Subsidiaries.
“Guarantee Agreement” means a guarantee and indemnity agreement in form and substance satisfactory to the Bank to be entered into by any of the Guarantors as guarantor and the Bank as beneficiary.
“Guarantors” means CureVac AG and each Material Subsidiary which enters into a Guarantee Agreement in accordance with Sub-Paragraph (b) of Paragraph 17 (Guarantees) of Schedule H (General Undertakings).
“Horizon 2020 Framework EU Programme” has the meaning given in Recital (C).
“Horizon 2020 Legal Basis” means the Regulation 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 and Council Decision of 3 December 2013 establishing the specific programme implementing Horizon 2020.
“IFRS” means international accounting standards within the meaning of IAS Regulation 1606/2002 to the extent applicable to the relevant financial statements.
“Indebtedness” means any:
(a) | obligations for borrowed money; |
(b) | indebtedness under any acceptance credit; |
(c) | indebtedness under any bond, debenture, note or similar instrument; |
(d) | instrument under any bill of exchange; |
(e) | indebtedness in respect of any interest rate or currency swap or forward currency sale or purchase or other form of interest or currency hedging transaction (including without limit caps, collars and floors); |
(f) | indebtedness under any Finance Lease; |
(g) | indebtedness (actual or contingent) under any guarantee, bond security, indemnity or other agreement; |
(h) | indebtedness (actual or contingent) under any instrument entered into for the purpose of raising finance; |
(i) | indebtedness in respect of a liability to reimburse a purchaser of any receivables sold or discounted in the event that any amount of those receivables is not paid; |
(j) | indebtedness arising under a securitisation; or |
(k) | other transaction which has the commercial effect of borrowing. |
“Initial Fee Letter” means the Luxembourg law governed fee letter from the Bank to the Borrower dated 18 March 2020.
“InsO” means the German Insolvency Code (Insolvenzordnung).
“Intellectual Property Rights” means intellectual property rights (gewerbliche Schutzrechte; Immaterialgüterrechte) of every designation (including, without limitation, patents, utility patents, copyrights, design rights, trademarks, software, service marks and know how) whether capable of registration or not.
“Investment” has the meaning given to that term in Recital (A).
“Land Charge” means the first ranking land charge without certificate (Buchgrundschuld) in the amount of EUR 75,000,000 (plus 16% interest p.a. and 10% one-time supplementary payment) created under the Land Charge Creation Deed by which the Borrower will encumber its Property and certain of its assets falling within the statutory scope of the Land Charge (Grundschuldhaftungsverband) in favour of the Bank.
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“Land Charge Creation Deed” means any document by means of which the Land Charge is created and which includes, inter alia, an abstract acknowledgement of debt of the Borrower in the amount of the Land Charge (in each case subject to the submission to the immediate enforcement (sofortige Zwangsvollstreckungsunterwerfung) in personam and in rem for the full Land Charge amount), the Borower’s approval for registration (Eintragungsbewilligung) of the Land Charge in the land register, regardless of whether such document will be officially certified (öffentlich beglaubigt) or notarially recorded (notariell beurkundet).
“Lead Organisation” means the European Union, the United Nations and international standard setting organisations including the International Monetary Fund, the Financial Stability Board, the Financial Action Task Force, the Organisation for Economic Cooperation and Development and the Global Forum on Transparency and Exchange of Information for Tax Purposes and any successor organisations.
“List of Authorised Signatories and Accounts” means a list (signed by Authorised Signatories), in form and substance satisfactory to the Bank, setting out: (i) the Authorised Signatories, accompanied by evidence of signing authority of the persons named on the list and specifying if they have individual or joint signing authority, (ii) the specimen signatures of such persons, and (iii) the bank account(s) to which disbursements may be made under this Contract (specified by IBAN code if the country is included in the IBAN Registry published by SWIFT, or in the appropriate account format in line with the local banking practice), BIC/SWIFT code of the bank and the name of the bank account(s) beneficiary.
“Loan” means the aggregate of the amounts disbursed from time to time by the Bank under this Contract.
“Loan Outstanding” means the aggregate of the amounts disbursed from time to time by the Bank under this Contract that remains outstanding.
“Material Adverse Change” means, any event or change of condition, which, in the reasonable opinion of the Bank has a material adverse effect on:
(a) | the ability of any Obligor to perform its respective obligations under the Finance Documents; |
(b) | the business, operations, property or condition (financial or otherwise) of any Obligor or the Group as a whole; or |
(c) | the legality, validity or enforceability of, or the effectiveness or ranking or value of, any Security granted to the Bank, or the rights or remedies of the Bank under the Finance Documents. |
“Material Subsidiary” means any Subsidiary of CureVac AG or the Borrower from time to time, whose gross revenues, Total Assets or EBITDA represents not less than 10% of (i) the consolidated gross revenues of the Group or, (ii) the Total Assets, or, (iii) as the case may be, the consolidated EBITDA of the Group, as calculated based on the then latest consolidated audited accounts of the Group.
“Maturity Date” means, for each Tranche, the sole Repayment Date of that Tranche as specified in the relevant Disbursement Offer, being the date falling seven (7) years from the respective Disbursement Date of the relevant Tranche. In case such date is not a Relevant Business Day, it means the preceding Relevant Business Day, with adjustment to the interest due under Article 4 (Interest).
“Non-EIB Financing” includes any loan (save for the Loan and any other direct loans from the Bank to the Borrower (or any other Group Company)), credit bond or other form of financial indebtedness or any obligation for the payment or repayment of money originally granted to the Borrower (or any other Group Company)) from an entity or person that is not a member of the Group for a term of more than 3 (three) years.
“Obligor” means the Borrower and each Guarantor.
“Permitted Disposal” means each disposal permitted in accordance with Sub-Paragraph (b) of Paragraph 7 (Disposal of assets) of Schedule H (General Undertakings).
“Permitted Guarantees” means each and every guarantee permitted in accordance with Paragraph 17 (Guarantees) of Schedule H (General Undertakings).
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“Permitted Hedging” has the meaning given to such term in Paragraph 18 (Hedging) of Schedule H (General Undertakings).
“Permitted Indebtedness” means the Existing Indebtedness (if any) and the Indebtedness of the Borrower and/or any Group Company which is permitted in accordance with Paragraph 16 (Indebtedness) of Schedule H (General Undertakings).
“Permitted Security” means the Existing Security (if any) and the Security of the Borrower and/or any Group Company which is permitted in accordance with Sub-Paragraph (c) of Paragraph 24 (Negative pledge) of Schedule H (General Undertakings).
“Prepayment Amount” means the amount of a Tranche to be prepaid by the Borrower in accordance with Articles 5.2 (Voluntary prepayment), 5.3 (Compulsory prepayment) or 9.1 (Right to demand repayment).
“Prepayment Date” means the date on which the Borrower proposes or is requested by the Bank, as applicable, to effect prepayment of a Prepayment Amount (for the avoidance of doubt, including a prepayment resulting from a cancellation of a Tranche).
“Prepayment Event” means any of the events described in Article 5.3 (Compulsory Prepayment).
“Prepayment Fee” has the meaning given to such term in the Finance Fee Letter.
“Prepayment Notice” means a written notice from the Bank to the Borrower in accordance with Article 5.2.3 (Prepayment mechanics).
“Prepayment Request” means a written request from the Borrower to the Bank to prepay all or part of the Loan Outstanding, in accordance with Article 5.2.1 (Prepayment option).
“Property” means the property of the Borrower at Waldhäuser Str., 72076 Tübingen, , Germany, registered with the land register (Grundbuch) of Tübingen, Germany, local court (Amtsgericht) of Böblingen, Germany, folio 99853.
“Qualified Person” means a qualified person as referred to in Article 48 of Directive 2001/83/EC for medicinal products for human use, as may be amended from time to time.
“Released Batch” means a Batch or Batches of a medicinal product that have been certified by a Qualified Person that the Batch is in compliance with the specification and satisfies the applicable legislation and all provisions and requirements for human use stipulated within authorisations approved by the competent authorities.
“Relevant Business Day” means a day on which the Trans-European Automated Real-time Gross Settlement Express Transfer payment system which utilises a single shared platform and which was launched on 19 November 2007 (TARGET2) is open for the settlement of payments in EUR.
“Relevant Period” means each period of 12 (twelve) months ending on or about the last day of the financial year.
“Remuneration Cap” means, at any time, an amount of EUR 75,000,000 (seventy five million euro) or any other amount agreed between the Bank and the Borrower in writing.
“Remuneration Payments” has the meaning given to that term in Paragraph (a) of Article 4.2 (Variable Remuneration).
“Remuneration Payment Date” means the first 31 March within the Remuneration Period and, afterwards, any 31 March within the Remuneration Period following the first 31 March within the Remuneration Period.
“Remuneration Period” means a period commencing on the earlier of:
(a) | the first financial year in which CureVac AG has a positive EBITDA; and |
(b) | the year 2025 (i.e. payment in 2025, function of the actual number of Batches produced in 2024), |
and terminating on the date falling 12 (twelve) years later.
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“Repayment Date” shall mean the sole payment date specified in the Disbursement Offer for the repayment of a Tranche in accordance with Article 5.1 (Normal repayment).
“Repeating Representations” means each of the representations set out in Schedule G (Representations and Warranties) other than the representations set out in the Paragraphs thereof which are identified with the words “(Non-repeating)” at the end of the Paragraphs.
“SARS-CoV-2 Vaccine” means a vaccine against SARS-CoV-2, the virus that causes COVID-19 Syndrome developed by a Group Company.
“Security” means any mortgage, land charge (Grundschuld), security purpose agreement (Sicherungszweckvereinbarung), pledge, lien, charge, assignment, security transfer (Sicherungsübereignung), retention of title arrangements, hypothecation, or other security interest securing any obligation of any person or any other agreement or arrangement having a similar effect.
“Security Purpose Agreement” means the security purpose agreement (Sicherungszweckvereinbarung) to be entered into by the Borrower as security grantor and the Bank as beneficiary in relation to the Land Charge.
“Security Documents” means each Guarantee Agreement, the Land Charge Creation Deed, the Security Purpose Agreement and any other document entered into by any person creating or expressed to create any Security over all or any part of its assets in respect of the obligations of any of the Obligors under any of the Finance Documents.
“Senior Management Change” means that any Senior Management Personnel has ceased to be actively involved in the management of the Borrower without the Bank having given its prior written consent to such a change.
“Senior Management Personnel” means each of Ingmar Hoerr, Franz-Werner Haas, Florian von der Mülbe, Mariola Fotin-Mleczek and Pierre Kemula.
“Subsidiary” means a subsidiary (abhängiges Unternehmen) of which the Borrower (herrschendes Unternehmen) has direct or indirect control within the meaning of Section 17 AktG.
“Tax” means any tax, levy, impost, duty or other charge or withholding of a similar nature (including any penalty or interest payable in connection with any failure to pay or any delay in paying any of the same).
“Technical Description” has the meaning given to it in Recital (A).
“Total Assets” means the total consolidated assets of the Group, as shown in CureVac AG´s latest consolidated financial statements, as at the end of any Relevant Period.
“Tranche” means each disbursement made or to be made under this Contract consisting of Tranche A, Tranche B and Tranche C. In the event that no Disbursement Acceptance has been received, Tranche shall mean a Tranche as offered under Article 2.2.2 (Disbursement Offer).
“Tranche A” means the first Tranche in the amount set out in Paragraph (a) of Article 2.2.1 (Tranches), in relation to which certain variable payments are granted to the Bank in accordance with Article 4.2 (Variable Remuneration) and a Deferred Interest Fixed Rate shall be paid in accordance with Article 4.1 (Deferred Interest Fixed Rate).
“Tranche B” means the second Tranche in the amount set out in Paragraph (b) of Article 2.2.1 (Tranches), in relation to which certain variable payments are granted to the Bank in accordance with Article 4.2 (Variable Remuneration) and a Deferred Interest Fixed Rate shall be paid in accordance with Article 4.1 (Deferred Interest Fixed Rate).
“Tranche C” means the third Tranche in the amount set out in Paragraph (c) of Article 2.2.1 (Tranches), in relation to which certain variable payments are granted to the Bank in accordance with Article 4.2 (Variable Remuneration) and a Deferred Interest Fixed Rate shall be paid in accordance with Article 4.1 (Deferred Interest Fixed Rate).
“Voluntary Non EIB Prepayment” means a voluntary prepayment by any Group Company, including any Guarantor, (for the avoidance of doubt, prepayment shall include a repurchase, redemption or cancellation where applicable) of a part or the whole of any Non-EIB Financing where:
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(a) | such prepayment is not made within a revolving credit facility (save for the cancellation of a revolving credit facility); or |
(b) | such prepayment is not made out of the proceeds of a loan or other indebtedness having a term at least equal to the unexpired term of the Non-EIB Financing prepaid; or |
(c) | such prepayment is not made under the DH Convertible Loan Agreement. |
ARTICLE 2
Credit and Disbursements
2.1 Amount of Credit
By this Contract, the Bank establishes in favour of the Borrower, and the Borrower accepts, a credit in an amount of EUR 75,000,000 (seventy five million euro) for the financing of the Investment (the “Credit”).
2.2 Disbursement procedure
2.2.1 Tranches
The Bank shall disburse the Credit in Euros in three (3) Tranches, as set out below:
(a) | Tranche A, in an amount of at least EUR 15,000,000 (fifteen million euro) and up to EUR 25,000,000 (twenty five million euro); |
(b) | Tranche B, in an amount of at least EUR 15,000,000 (fifteen million euro) and up to EUR 25,000,000 (twenty five million euro); and |
(c) | Tranche C, in an amount of at least EUR 15,000,000 (fifteen million euro) and up to the undrawn balance of the Credit. |
2.2.2 Disbursement Offer
Upon request by the Borrower and subject to Article 2.5 (Conditions of Disbursement), provided that no event mentioned in Sub-Paragraph (b) of Article 2.6 (Cancellation) has occurred and is continuing, the Bank shall send to the Borrower a Disbursement Offer for the disbursement of a Tranche. The latest time for receipt by the Borrower of a Disbursement Offer is [*****] days before the relevant Final Availability Date. The Disbursement Offer shall specify:
(a) | the amount of the Tranche; |
(b) | the Disbursement Date, which shall be a Relevant Business Day, falling at least [*****] days after the date of the Disbursement Offer and on or before the Final Availability Date; |
(c) | the interest rate basis of the Tranche, namely the Deferred Interest Fixed Rate; |
(d) | the terms and frequency for repayment of principal (bullet); |
(e) | the Maturity Date / Repayment Date; and |
(f) | the Disbursement Acceptance Deadline. |
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2.2.3 Disbursement Acceptance
(a) | The Borrower may accept a Disbursement Offer by delivering a Disbursement Acceptance to the Bank no later than the Disbursement Acceptance Deadline. The Disbursement Acceptance shall be signed by an Authorised Signatory with individual representation rights or 2 (two) or more Authorised Signatories with joint representation rights and shall specify the Disbursement Account to which disbursement of the Tranche should be made in accordance with Article 2.3 (Disbursement Account). |
(b) | If a Disbursement Offer is duly accepted by the Borrower in accordance with its terms on or before the Disbursement Acceptance Deadline, and provided the conditions in Article 2.5.3 (All Tranches – Other Conditions) are met, the Bank shall make the Accepted Tranche available to the Borrower in accordance with the relevant Disbursement Offer and subject to the terms and conditions of this Contract. |
(c) | The Borrower shall be deemed to have refused any Disbursement Offer which has not been duly accepted in accordance with its terms on or before the Disbursement Acceptance Deadline, in which case the Tranche shall not be made available to the Borrower by the Bank, and the Credit shall not be affected. |
2.3 Disbursement Account
(a) | Disbursement shall be made to the Disbursement Account specified in the relevant Disbursement Acceptance, provided that such Disbursement Account is acceptable to the Bank. |
(b) | Only one Disbursement Account may be specified for each Tranche. |
2.4 Currency of disbursement
The Bank shall disburse each Tranche in EUR.
2.5 Conditions of Disbursement
2.5.1 Initial Documentary Conditions Precedent
No Disbursement Offer will be provided by the Bank under this Contract unless the Bank has confirmed that it has received all of the documents and other evidence listed in Part A of Schedule F (Initial Documentary Conditions Precedent) in form and substance satisfactory to it.
2.5.2 All Tranches - Documentary Conditions Precedent
No Disbursement Offer, including the first Disbursement Offer, will be provided by the Bank under this Contract unless the Bank has confirmed that it has received, in form and substance satisfactory to it:
(a) | a certificate from the Borrower in the form of Schedule D (Form of Drawdown Certificate), signed by one or more Authorised Signatories of the Borrower (as appropriate) and dated no earlier than the date falling 14 (fourteen) days before the relevant Disbursement Date; |
(b) | a liquidity forecast for the next [*****] months of the Borrower; and |
(c) | a certificate on the Borrower’s solvency position signed by one or more Authorised Signatories of the Borrower (as appropriate) which confirms that the Borrower has sufficient resources to pay its debts as they fall due for at least [*****] months from the Disbursement Date, not taking into account the disbursement of the proposed Tranche, including, without limitation, a current extract from the commercial register (Handelsregisterauszug) of the Borrower and an up-to-date search on www.insolvenzbekanntmachungen.de in relation to the Borrower attached to such certificate. |
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2.5.3 All Tranches – Other Conditions
The Bank will only be obliged to make any Accepted Tranche available to the Borrower if on the Disbursement Date for the proposed Tranche:
(a) | the Repeating Representations are correct in all respects; and |
(b) | no event or circumstance has occurred and is continuing which constitutes or would with the expiry of a grace period and/or the giving of notice under this Contract constitute: |
(i) | an Event of Default; or |
(ii) | a Prepayment Event, other than pursuant to Article 5.3.1 (Cost Reduction), or would, in each case, result from the disbursement of the proposed Tranche. |
2.5.4 Tranche A – Additional Conditions Precedent
Without prejudice to the generality of Articles 2.5.1 (Initial Documentary Conditions Precedent) to 2.5.3 (All Tranches – Other Conditions), no Disbursement Offer will be provided by the Bank under this Contract in respect of Tranche A unless the Bank has confirmed that it has received in form and substance satisfactory to it:
(a) | evidence of Co-Funding to the Investment equal to the amount drawn under Tranche A; and |
(b) | evidence that immunogenicity data has been generated in animals for the SARS-CoV-2 Vaccine candidate and that the immune response induced by the SARS-CoV-2 Vaccine candidate has been characterised; and |
2.5.5 Tranche B – Additional Conditions Precedent
Without prejudice to the generality of Articles 2.5.1 (Initial Documentary Conditions Precedent) to 2.5.3 (All Tranches – Other Conditions), no Disbursement Offer will be provided by the Bank under this Contract in respect of Tranche B unless
(a) | Tranche A has been disbursed and the Bank has confirmed that it has received in form and substance satisfactory to it: |
(b) | evidence of Co-Funding to the Investment equal to the amount drawn under Tranche B; and |
(c) | evidence that the first patient has been successfully enrolled in a phase I clinical trial for a SARS-CoV-2 Vaccine. |
2.5.6 Tranche C – Additional Conditions Precedent
Without prejudice to the generality of Articles 2.5.1 (Initial Documentary Conditions Precedent) to 2.5.3 (All Tranches – Other Conditions), no Disbursement Offer will be provided by the Bank under this Contract in respect of Tranche C unless
(a) | Tranche A and Tranche B have been disbursed and the Bank has confirmed that it has received in form and substance satisfactory to it: |
(b) | evidence of Co-Funding to the Investment equal to the amount drawn under Tranche C; and |
(c) | evidence that the detailed design process of GMP IV is completed; and |
(d) | either of the following: |
(i) | evidence that |
(1) | the pivotal clinical trial for a SARS-CoV-2 Vaccine has met its endpoint and no further clinical supporting data is required to file for a marketing authorisation application in the EU for the SARS-CoV-2 Vaccine; and |
(2) | the necessary arrangements have been made with a contract supplier to provide fill and finish facilities for CureVac’s SARS-CoV-2 Vaccine; |
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or
(ii) | evidence that CureVac has other products in the development pipeline targeting infectious disease, for which, subject to successful progress, CureVac will utilise GMP IV to manufacture a proprietary infectious disease medicinal product; |
or
(iii) | evidence that CureVac is engaged in discussions with other companies for the manufacture of products targeting infectious diseases on behalf of said companies in CureVac’s GMPIV facility. |
2.6 Cancellation
(a) | The Borrower may send a written notice to the Bank requesting the cancellation of the undisbursed portion of the Credit. The written notice: |
(i) | must specify whether the Borrower would like to cancel the undisbursed portion of the Credit in whole or in part and, if in part, the amount of the Credit the Borrower would like to cancel; and |
(ii) | must not relate to an Accepted Tranche which has a Disbursement Date falling within [*****] Business Days of the date of the written notice. |
Upon receipt of such written notice, the Bank shall cancel the requested undisbursed portion of the Credit with immediate effect.
(b) | At any time upon the occurrence of the following events, the Bank may notify the Borrower in writing that the undisbursed portion of the Credit shall be cancelled in whole or in part: |
(i) | a Prepayment Event, which in case of a cancellation pursuant to Article 5.3.1 (Cost Reduction) only shall be in respect of an amount equal to the amount by which it is entitled to cancel the Credit under such Article 5.3.1 (Cost Reduction); |
(ii) | an Event of Default or Default; or |
(iii) | an event or circumstance which would with the passage of time or giving of notice under this Contract constitute a Prepayment Event other than pursuant to Article 5.3.1 (Cost Reduction). |
On the date of such written notification the relevant undisbursed portion of the Credit shall be cancelled with immediate effect.
2.7 Fee for cancellation of an Accepted Tranche
(a) | If pursuant to Sub-Paragraph (a) of Article 2.6 (Cancellation) the Borrower cancels an Accepted Tranche, the Borrower shall pay to the Bank the Cancellation Fee in accordance with the terms of the Finance Fee Letter. |
(b) | If pursuant to Sub-Paragraph (b) of Article 2.6 (Cancellation) the Bank cancels all or part of an Accepted Tranche, the Borrower shall pay to the Bank the Cancellation Fee in accordance with the terms of the Finance Fee Letter. |
(c) | If an Accepted Tranche is not disbursed on the Disbursement Date because the conditions precedent set out in Article 2.5.3 (All Tranches – Other Conditions) are not satisfied on such date, such Tranche shall be cancelled and the Borrower shall pay to the Bank the relevant Cancellation Fee in accordance with the terms of the Finance Fee Letter. |
2.8 Cancellation after expiry of the Credit
On the day following the Final Availability Date, and unless otherwise specifically agreed to in writing by the Bank, any part of the Credit in respect of which no Disbursement Acceptance has been received in accordance with Article 2.2.3 (Disbursement Acceptance) shall be automatically cancelled, without any notice being served by the Bank to the Borrower.
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2.9 Drop Dead Fee
(a) | The Borrower shall pay to the Bank the Drop Dead Fee in accordance with the terms of the Finance Fee Letter. |
(b) | For the avoidance of doubt, the Drop Dead Fee payable under the Finance Fee Letter is independent of any other fees stipulated in this Contract. |
2.10 Sums due under Article 2
Sums due under this Article 2 shall be payable in EUR. Sums due under this Article 2 shall be payable within [*****] days of the Borrower’s receipt of the Bank’s demand or within any longer period specified in the Bank’s demand.
ARTICLE 3
The Loan
3.1 Amount of Loan
The Loan shall comprise the aggregate amount of Tranches disbursed by the Bank under the Credit.
3.2 Currency of repayment, interest and other charges
(a) | Interest, Remuneration Payments, repayments and other charges payable in respect of each Tranche shall be made by the Borrower in EUR. |
(b) | Any other payment shall be made in the currency specified by the Bank having regard to the currency of the expenditure to be reimbursed by means of that payment. |
ARTICLE 4
Interest
4.1 Deferred Interest Fixed Rate
Interest shall accrue on the outstanding balance of each Tranche at the Deferred Interest Fixed Rate, and calculated on the basis of Article 6.1 (Day count convention), and such interest shall be due and payable on the Maturity Date of each Tranche or, where a Tranche is cancelled or prepaid, on the Prepayment Date. For the avoidance of doubt, any such interest shall not be capitalised and shall not bear interest (no compound interest (Zinseszins) within the meaning of Section 248 para. 1 BGB).
4.2 Variable Remuneration
(a) | Subject to Paragraph (b) below, in addition to the interest payable pursuant to Article 4.1 (Deferred Interest Fixed Rate) above and in consideration of the Bank making the Credit available to the Borrower in accordance with this Contract, the Borrower hereby grants and reserves for the benefit of the Bank, irrespectively of the amount disbursed under this Contract, a participation in each Released Batch during the Remuneration Period equal to EUR [*****] ([*****] euros) per Released Batch (the “Remuneration Payments”) and hereby undertakes to pay the relevant Remuneration Payments to the Bank subject to the terms of this Contract. For the avoidance of doubt and by way of distinction from a silent partnership (stille Beteiligung), the Bank does not participate in any loss of the Borrower or any other Group Company. |
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(b) | The obligation of the Borrower to make Remuneration Payments pursuant to Paragraph (a) above shall exist only for so long as and to the extent that a due Remuneration Payment together with the aggregate amount of all preceding Remuneration Payments does not exceed the Remuneration Cap. For the avoidance of doubts, the cumulative amount of Remuneration Payments shall not exceed the Remuneration Cap. |
(c) | Each Remuneration Payment shall: |
(i) | be determined by an Independent Expert (the “Expert Determination”); |
(ii) | be calculated on the actual number of Released Batches of the respective previous financial year (such information to be provided to the Bank by no later than March 1st of the current year); and |
(iii) | become due and payable on the relevant Remuneration Payment Date, |
within the Remuneration Period.
(d) | If the Bank and the Borrower have not appointed an Independent Expert within [*****] days of any such request, the Independent Expert shall be appointed by the President of the Chamber of Industry and Commerce Berlin (Industrie- und Handelskammer Berlin) upon application by either the Bank or the Borrower. The costs related to the Expert’s Determination shall be borne by the Borrower and the Expert’s Determination shall, in the absence of manifest error, be conclusive and binding on both parties to this Contract as to the matters to which it relates. The Borrower shall, within [*****] Business Days of delivery of the Expert’s Determination and upon the Bank’s demand, pay to the Bank the amount determined by the Expert Determination. |
(e) | The Bank has at any time, and nothwithstanding the Expert Determination referred to above, the right to request the validation of any calculation of the number of Batches by an auditor, at any point in time, at the expenses of the Borrower. |
(f) | The Borrower shall, notwithstanding the Expert Determinations, permit an Auditor, at reasonable times and at reasonable notice, to audit the books and records maintained by the Borrower to ensure the accuracy of the Remuneration Payments. The cost of this audit shall be borne by the Borrower. If any such audit concludes that additional amounts are owed to the Bank, subject to the Remuneration Cap, the Borrower shall pay the Bank such additional amounts with interest in accordance with Article 4.3 (Interest on overdue sums) within [*****] days of the date of the completion of such audit. |
(g) | Instead of Remuneration Payments on an annual basis pursuant to the preceding Paragraphs (a) to (d), the Borrower shall have the right (but no obligation) to buy back any unpaid Remuneration Payments at any time with at least 30 (thirty) calendar days prior notice in full with a cash payment equal to the higher of (the “Buy-Back Amount”): |
(i) | EUR [*****]; and |
(ii) | “x-times” the disbursed amount under this Contract (irrespectively of whether or not such amount is still outstanding), where “x” equals: |
(1) [*****] during the first year after first disbursement under this Contract;
(2) [*****] during the second year after first disbursement under this Contract;
(3) [*****] during the third year after first disbursement under this Contract;
(4) [*****] during the fourth year after first disbursement under this Contract; and
(5) [*****] thereafter,
provided that the total Buy-Back Amount (cumulative) shall not exceed the Remuneration Cap. For the avoidance of doubt, the Remuneration Cap includes the Remuneration Payments already paid on an annual basis as well as the Buy-Back Amount.
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(h) | In case a Tranche is cancelled, prepaid pursuant to Articles 5.2 (Voluntary prepayment) or 5.3 (Compulsory prepayment), or prepaid due to an Event of Default within the Remuneration Period, the Bank shall have the right (but not the obligation) to demand from the Borrower the payment of the Buy-Back Amount (up to the Remuneration Cap) at its discretion. The Borrower shall, within [*****] Business Days upon the Bank’s demand, pay to the Bank the Buy-Back Amount. |
(i) | For the avoidance of doubt, the Borrower’s obligation under this Article 4.2 (Variable Remuneration) to make payments shall continue regardless of: |
(i) | any cancellation or prepayment in respect of a Tranche within the Remuneration Period pursuant to Articles 5.2 (Voluntary prepayment) or 5.3 (Compulsory prepayment), or |
(ii) | any repayment of a Tranche in accordance with Article 5.1 (Normal repayment), |
unless the Bank has exercised its rights under Paragraphs (h) of this Article 4.2 (Variable Remuneration) and the Borrower has made the payment required under such Paragraph.
(j) | The Borrower shall withhold any statutory withholding tax (Kapitalertragssteuer) from the Remuneration Payments and shall pay it to the competent tax office. |
(k) | Sums due under this Article 4.2 (Variable Remuneration) shall be payable in EUR. For the calculation of the Remuneration Payment, where amounts relating to such calculation are received by the Borrower in currencies other than EUR, the applicable rate published by the European Central Bank in Frankfurt on the Business Day preceding the relevant Remuneration Payment Date shall apply to determine such amounts equivalent in EUR. |
4.3 Interest on overdue sums
(a) | Without prejudice to Article 9 (Events of default) and by way of exception to Article 4.1 (Deferred Interest Fixed Rate), if the Borrower fails to pay any amount (other than any interest amount or any Remuneration Payment) payable by it under this Contract on its due date, interest shall accrue on any such overdue amount (other than any interest amount) from the due date to the date of actual payment at an annual rate equal to: |
(i) | for overdue sums related to a Tranche, the higher of (A) the applicable Deferred Interest Fixed Rate plus [*****]% ([*****] basis points) or (B) EURIBOR plus [*****]% ([*****] basis points); |
(ii) | for overdue sums other than under Sub-Paragraph (i) above, EURIBOR plus [*****]% ([*****] basis points), |
and shall be payable in accordance with the demand of the Bank.
(b) | If the Borrower fails to pay any interest amount or any Remuneration Payment due and payable by it under this Contract on its due date, it shall make a liquidated damages payment (pauschalierter Schadensersatz) from the due date up to the date of actual payment at an annual rate equal to the higher of (i) the applicable Fixed Rate plus [*****]% ([*****] basis points) or (ii) EURIBOR plus [*****]% ([*****] basis points), provided that the Borrower shall have the right to prove that no damages have arisen, or that damages have not arisen in the asserted amount. The amount determined in accordance with this Sub-Paragraph (b) of Article 4.3 (Interest on overdue sums) shall be payable in accordance with the demand of the Bank. |
(c) | For the purpose of determining EURIBOR in relation to this Article 4.3 (Interest on overdue sums), the relevant periods within the meaning of Schedule B (Definition of EURIBOR) shall be successive periods of one month commencing on the due date. |
(d) | If the overdue sum is in a currency other than the currency of the Loan, the relevant interbank rate that is generally retained by the Bank for transactions in that currency plus [*****]% ([*****] basis points) shall apply, calculated in accordance with the market practice for such rate. |
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ARTICLE 5
Repayment
5.1 Normal repayment
The Borrower shall repay each Tranche, together with all other amounts outstanding under this Contract in relation to that Tranche, in a single instalment on the Maturity Date of that Tranche.
5.2 Voluntary prepayment
5.2.1 Prepayment option
(a) | Subject to Articles 5.2.2 (Prepayment Fee), 5.2.3 (Prepayment mechanics) and 5.4 (General), the Borrower may prepay all or part of any Tranche, together with accrued interest (including any interest under Article 4.1 (Deferred Interest Fixed Interest) and any Remuneration Payment (up to the Remuneration Cap) specified under Article 4.2 (Variable Remuneration)), any Prepayment Fee and indemnities if any, upon giving a Prepayment Request with at least [*****] calendar days prior notice specifying: |
(i) the Prepayment Amount;
(ii) the Prepayment Date; and
(iii) the Contract Number.
(b) | The Prepayment Request shall be irrevocable. |
5.2.2 Prepayment Fee
If the Borrower prepays a Tranche, the Borrower shall pay the relevant Prepayment Fee in accordance with the terms of the Finance Fee Letter.
5.2.3 Prepayment mechanics
Upon presentation by the Borrower to the Bank of a Prepayment Request, the Bank shall issue a Prepayment Notice to the Borrower, not later than [*****] days prior to the Prepayment Date. The Prepayment Notice shall specify the Prepayment Amount, the accrued interest due thereon, the Remuneration Payments and the Prepayment Fee. If the Prepayment Notice specifies the Prepayment Fee, it shall also specify the deadline by which the Borrower may accept the Prepayment Notice, and the Borrower must accept the Prepayment Notice no later than such deadline as a condition to prepayment.
The Borrower shall make a prepayment in accordance with the Prepayment Notice and shall accompany the prepayment by the payment of accrued interest (including any interest under Articles 4.1 (Deferred Interest Fixed Rate) and any Remuneration Payment (up to the Remuneration Cap) specified under Article 4.2 (Variable Remuneration)) and the Prepayment Fee or indemnity, if any, due on the Prepayment Amount, as specified in the Prepayment Notice, and shall identify the Contract Number in the prepayment transfer.
5.3 Compulsory prepayment
5.3.1 Cost Reduction
If the total cost of the Investment at completion by the final date specified in the Technical Description falls below the figure stated in Recital (A) so that the amount of the Credit exceeds 50% (fifty per cent.) of such total cost, the Bank may forthwith, by notice to the Borrower, cancel the undisbursed portion of the Credit and/or demand prepayment of the Loan Outstanding up to the amount by which the Credit exceeds 50% (fifty per cent.) of the total cost of the Investment.
5.3.2 Change Events
The Borrower shall promptly inform the Bank if:
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(a) | a Change-of-Control Event has occurred or is likely to occur in respect of itself or a Guarantor; |
(b) | there is or is likely to be an enactment, promulgation, execution or ratification of or any change in or amendment to any law, rule or regulation (or in the application or official interpretation of any law, rule or regulation) that occurs or is likely to occur after the date of this Contract and which, in the opinion of the Borrower, would impair an Obligor’s ability to perform its obligations under the Finance Documents; or |
(c) | a Senior Management Change has occurred or is likely to occur. |
In such case, or if the Bank has reasonable cause to believe that a Change-of-Control Event, a Change-of-Law Event or a Senior Management Change has occurred or is likely to occur, the Borrower shall, on request of the Bank, consult with the Bank as to the impact of such event. If [*****] days have passed since the date of such request and the Bank is of the opinion that the effects of such event cannot be mitigated to its satisfaction, or in any event if a Change-of-Control Event, Change-of-Law Event or Senior Management Change has actually occurred, the Bank may by notice to the Borrower, cancel the undisbursed portion of the Credit and/or demand prepayment of the Loan Outstanding, together with accrued interest and all other amounts accrued or outstanding under this Contract.
5.3.3 Illegality
If it becomes unlawful in any applicable jurisdiction for the Bank to perform any of its obligations as contemplated in this Contract or to fund or maintain the Loan, the Bank shall promptly notify the Borrower and may immediately cancel the undisbursed portion of the Credit and/or demand prepayment of the Loan Outstanding, together with accrued interest and all other amounts accrued or outstanding under this Contract.
5.3.4 Disposals
If the Borrower disposes of assets forming part of the Investment or shares in subsidiaries holding assets forming part of the Investment, without the approval of the Bank or not in accordance with Sub-Paragraph (b) of Paragraph 7 (Disposal of assets) of Schedule H (General Undertakings), then the Borrower shall apply all proceeds of such disposal to prepay the Loan Outstanding (in part or in whole), together with accrued interest, promptly following receipt of such proceeds in accordance with Sub-Paragraph (b) of Paragraph 7 (Disposal of assets) of Schedule H (General Undertakings).
5.3.5 Expiry of Guarantee Agreement
If:
(a) | a Guarantee Agreement has a shorter duration than this Contract (as modified, extended and/or prolonged from time to time); and |
(b) | on the date falling [*****] days prior to the initial expiry date or, as the case may be, to any subsequent expiry date agreed under that Guarantee Agreement, the Borrower has failed to procure extension of the duration of the obligations of that Guarantor under that Guarantee Agreement or, as the case may be, to replace that Guarantor by another guarantor on terms acceptable to the Bank or provide additional security for the Loan in manner, form and substance satisfactory to the Bank, |
the Bank may, without prejudice to its other rights, require the Borrower to prepay the Loan Outstanding (in part or in whole), together with accrued interest (if any) and all other amounts accrued or outstanding under this Contract.
5.3.6 Pari Passu to Non-EIB Financing
If:
(a) | a Voluntary Non EIB Prepayment has occurred the Bank may, by notice to the Borrower, cancel the undisbursed portion of the Credit and demand prepayment of the Loan; or |
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(b) | (i) a Voluntary Non EIB Prepayment is likely to occur, (ii) the Bank has requested a consultation in respect of such Voluntary Non EIB Prepayment, (iii) the Borrower has complied with such request (to the satisfaction of the Bank) and (iv) at least [*****] days have passed since the date of such request, the Bank may, by notice to the Borrower, cancel the undisbursed portion of the Credit and demand prepayment of the Loan; or |
(c) | (i) a Voluntary Non EIB Prepayment is likely to occur, (ii) the Bank has requested a consultation in respect of such Voluntary Non EIB Prepayment, (iii) the Borrower has not complied with such request within a reasonable period set by the Bank and (iv) at least [*****] days have passed since the date of such request, the Bank may, by notice to the Borrower, cancel the undisbursed portion of the Credit and demand prepayment of the Loan. |
The proportion of the Loan that the Bank may require to be prepaid shall in each case of Paragraphs (a) to (c) above be the same as the proportion that the prepaid amount of the Non-EIB Financing bears to the aggregate outstanding amount of all Non-EIB Financing.
5.3.7 Prepayment Fee
In the case of a Prepayment Event in relation to a Tranche (except pursuant to Article 5.3.3 (Illegality)), the Borrower shall pay the relevant Prepayment Fee in accordance with the terms of the Finance Fee Letter.
5.3.8 Prepayment mechanics
Any sum demanded by the Bank pursuant to Articles 5.3.1 (Cost Reduction) to 5.3.6 (Pari Passu to Non-EIB Financing) shall be paid on the date indicated by the Bank in its notice of demand, such date being a date falling not less than [*****] days from the date of the demand (or, if earlier, the last day of any applicable grace period permitted by law in respect of the event in Article 5.3.3 (Illegality)).
5.4 General
(a) | A repaid or prepaid amount may not be reborrowed. |
(b) | If the Borrower prepays a Tranche on a date other than a relevant Repayment Date, or if the Bank exceptionally accepts, solely upon the Bank’s discretion, a Prepayment Request with prior notice of less than [*****] calendar days, the Borrower shall pay to the Bank an administrative fee in such an amount as the Bank shall notify to the Borrower. |
ARTICLE 6
Payments
6.1 Day count convention
Any amount due under this Contract and calculated in respect of a fraction of a year shall be determined based on a year of 360 (three hundred and sixty) days and a month of 30 (thirty) days.
6.2 Time and place of payment
(a) | If neither this Contract nor the Bank’s demand specifies a due date, all sums other than sums of interest, indemnity and principal are payable within [*****] days of the Borrower’s receipt of the Bank’s demand. |
(b) | Each sum payable by the Borrower under this Contract shall be paid to the following account: |
Bank: | [*****] |
City: | [*****] |
Account number: | [*****] |
SWIFT Code/BIC: | [*****] |
Remark: | [*****] |
or such other account notified by the Bank to the Borrower.
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(c) | The Borrower shall provide the Contract Number as a reference for each payment made under this Contract. |
(d) | Any disbursements by and payments to the Bank under this Contract shall be made using account(s) acceptable to the Bank. Any account in the name of the Borrower held with a duly authorised financial institution in the jurisdiction where the Borrower is incorporated or where the Investment is undertaken is deemed acceptable to the Bank. |
6.3 No set-off by the Borrower
All payments to be made by the Borrower under this Contract shall be calculated and be made without (and free and clear of any deduction for) set-off or counterclaim, unless the counterclaim is undisputed (unbestritten) or has been confirmed in a final non-appealable judgement (rechtskräftig festgestellt).
6.4 Disruption to Payment Systems
If either the Bank determines (in its discretion) that a Disruption Event has occurred or the Bank is notified by the Borrower that a Disruption Event has occurred:
(a) | the Bank may, and shall if requested to do so by the Borrower, consult with the Borrower with a view to agreeing with the Borrower such changes to the operation or administration of this Contract as the Bank may deem necessary in the circumstances; |
(b) | the Bank shall not be obliged to consult with the Borrower in relation to any changes mentioned in Sub-Paragraph (a) of Article 6.4 (Disruption to Payment Systems) above if, in its opinion, it is not practicable to do so in the circumstances and, in any event, shall have no obligation to agree to such changes; and |
(c) | the Bank shall not be liable for any damages, costs or losses whatsoever arising as a result of a Disruption Event or for taking or not taking any action pursuant to or in connection with this Article 6.4 (Disruption to Payment Systems). |
6.5 Application of sums received
6.5.1 General
Sums received from the Borrower shall only discharge its payment obligations if and when received in accordance with the terms of this Contract.
6.5.2 Partial payments
If the Bank receives a payment that is insufficient to discharge all the amounts then due and payable by the Borrower under this Contract, the Bank shall apply that payment in or towards payment of:
(a) first, any unpaid fees, costs, indemnities and expenses due under this Contract;
(b) secondly, any accrued interest due but unpaid under this Contract;
(c) thirdly, any principal due but unpaid under this Contract; and
(d) fourthly, any Remuneration Payments due but unpaid under this Contract; and
(e) lastly, any other sum due but unpaid under this Contract.
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6.5.3 Allocation of sums related to Tranches
(a) | Sums received by the Bank following a partial prepayment pursuant to Article 5.3 (Compulsory prepayment) or a demand under Article 9.1 (Right to demand repayment) and applied to a Tranche, shall reduce the outstanding instalments in inverse order of maturity. The Bank may apply sums received between Tranches at its discretion. |
(b) | In case of receipt of sums which cannot be identified as applicable to a specific Tranche, and on which there is no agreement between the Bank and the Borrower on their application, the Bank may apply these between Tranches at its discretion. |
ARTICLE 7
Borrower undertakings and representations
(a) | The Borrower makes the representations and warranties set out in Schedule G (Representations and Warranties) to the Bank on the date of this Contract in respect of itself and, where applicable, the other Obligors. |
(b) | The Repeating Representations are deemed to be made by the Borrower (in respect of itself and, where applicable, the other Obligors) on the date of each Disbursement Acceptance, each Disbursement Date, Remuneration Payment Date and each Repayment Date by reference to the facts and circumstances then existing. |
(c) | The undertakings in Schedule H (General Undertakings) and Schedule I (Information and Visits) remain in force from the date of this Contract for so long as any amount is outstanding under this Contract or the Credit is available. |
ARTICLE 8
Charges and expenses
8.1 Taxes, duties and fees
The Borrower shall pay all Taxes, duties, fees and other impositions of whatsoever nature, including stamp duty and registration fees, arising out of the execution or implementation of each Finance Document or any related document and the creation, perfection, registration or enforcement of any security for the Loan to the extent applicable.
The Borrower shall pay all principal, interest, Remuneration Payments, indemnities and other amounts due under this Contract gross without any withholding or deduction of any national or local impositions whatsoever, provided that if the Borrower is required by law or an agreement with a governmental authority or otherwise to make any such withholding or deduction, it will gross up the payment to the Bank so that after withholding or deduction, the net amount received by the Bank is equivalent to the sum due.
8.2 Other charges
(a) | The Borrower shall bear all charges and expenses, including any notarial and legal fees, professional, banking or exchange charges: |
(i)
(1) | reasonably incurred in connection with the preparation, execution and implementation; and |
(2) | incurred in connection with the enforcement and termination, |
of the Finance Documents (including, but not limited to, any Guarantee Agreement entered into pursuant to Paragraph 17 (Guarantees) of Schedule H (General Undertakings)); and
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(ii) | incurred in connection with any related document, any amendment, supplement or waiver in respect of the Finance Documents or any related document; and |
(iii) |
(1) | reasonably incurred in connection with the amendment, creation and management; and |
(2) | incurred in connection with the enforcement and realisation, of any security for the Loan. |
(b) | The Bank shall provide documentary support for any such charges or expenses upon the Borrower’s request. |
8.3 Increased costs, indemnity and set-off
(a) | The Borrower shall pay to the Bank any costs or expenses incurred or suffered by the Bank as a consequence of the introduction of or any change in (or in the interpretation, administration or application of) any law or regulation or compliance with any law or regulation which occurs after the date of this Contract, in accordance with or as a result of which (i) the Bank is obliged to incur additional costs in order to fund or perform its obligations under this Contract, or (ii) any amount owed to the Bank under this Contract or the financial income resulting from the granting of the Credit or the Loan by the Bank to the Borrower is reduced or eliminated. |
(b) | Without prejudice to any other rights of the Bank under this Contract or under any applicable law, the Borrower shall indemnify and hold the Bank harmless from and against any loss incurred as a result of any full or partial discharge that takes place in a manner other than as expressly set out in this Contract. |
(c) | The Bank may set off any matured obligation due from the Borrower under any Finance Document (to the extent beneficially owned by the Bank) against any satisfiable (erfüllbar) obligation (within the meaning of Section 387 BGB) owed by the Bank to the Borrower regardless of the place of payment, booking branch or currency of either obligation. If the obligations are in different currencies, the Bank may convert either obligation at a market rate of exchange in its usual course of business for the purpose of the set-off. If either obligation is unliquidated or unascertained, the Bank may set off in an amount estimated by it in good faith to be the amount of that obligation. |
ARTICLE 9
Events of default
9.1 Right to demand repayment
The Bank may demand (in writing) without prior notice or any judicial or extra judicial step immediate repayment by the Borrower of all or part of the Loan Outstanding (as requested by the Bank), together with accrued interest, any Remuneration Payment, any Prepayment Fee and all other accrued or outstanding amounts under this Contract, if:
(a) | any amount payable pursuant to any Finance Document is not paid on the due date at the place and in the currency in which it is expressed to be payable, unless (i) its failure to pay is caused by an administrative or technical error or a Disruption Event and (ii) payment is made within [*****] Business Days of its due date; |
(b) | any information or document given to the Bank by or on behalf of any Obligor or any representation, warranty or statement made or deemed to be made by the Borrower in, pursuant to or for the purpose of entering into any Finance Document or in connection with the negotiation or performance of any Finance Document is or proves to have been incorrect, incomplete or misleading in any material respect; |
(c) | following any default of any Obligor in relation to any loan, or any obligation arising out of any financial transaction, other than the Loan, |
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(i) | such Obligor is required or is capable of being required or will, following expiry of any applicable contractual grace period, be required or be capable of being required to prepay, discharge, close out or terminate ahead of maturity such other loan or obligation; or |
(ii) | any financial commitment for such other loan or obligation is cancelled or suspended. |
(d) | any Obligor is or admits to be unable to pay its debts as they fall due, or suspends any of its debts, or makes or seeks to make a composition with its creditors including a moratorium, or commences negotiations with one or more of its creditors with a view to rescheduling any of its financial indebtedness; |
(e) | any corporate action, legal proceedings or other procedure or step is taken in relation to the suspension of payments, a moratorium of any indebtedness, dissolution, administration or reorganisation (by way of voluntary arrangement, scheme of arrangement or otherwise) or an order is made or an effective resolution is passed for the winding up of any Obligor, or if any Obligor takes steps towards a substantial reduction in its capital, is declared insolvent or ceases or resolves to cease to carry on the whole or any substantial part of its business or activities or any situation similar to any of the above occurs under any applicable law; |
(f) | if the DH Convertible Loan Agreement is repaid, but the DH Investment is not made by 31 December 2020; |
(g) | any Obligor incorporated in Germany is unable to pay its debts as they fall due (zahlungsunfähig) within the meaning of Section 17 InsO or is overindebted (überschuldet) within the meaning of Section 19 InsO; |
(h) | an encumbrancer takes possession of, or a receiver, liquidator, administrator, administrative receiver or similar officer is appointed, whether by a court of competent jurisdiction or by any competent administrative authority or by any person, of or over, any part of the business or assets of any Obligor or any property forming part of the Investment; |
(i) | any Obligor defaults in the performance of any obligation in respect of any other loan granted by the Bank or financial instrument entered into with the Bank; |
(j) | any Obligor defaults in the performance of any obligation in respect of any other loan made to it from the resources of the Bank or the European Union; |
(k) | any distress, execution, sequestration or other process is levied or enforced upon the property of any Obligor or any property forming part of the Investment and is not discharged or stayed within [*****] days; |
(l) | a Material Adverse Change occurs, as compared with the position at the date of this Contract; |
(m) | it is or becomes unlawful for any Obligor to perform any of its obligations under the Finance Documents, or the Finance Documents are not effective in accordance with its terms or is alleged by any Obligor to be ineffective in accordance with its terms; or |
(n) | any Obligor fails to comply with any other provision under the Finance Documents (including, without limitation, each of the undertakings in Schedule H (General Undertakings) and Schedule I (Information and Visits)), unless the non-compliance or circumstance giving rise to the non-compliance is capable of remedy and is remedied within [*****] Business Days from the earlier of the Borrower becoming aware of the non-compliance and a notice served by the Bank on the Borrower. |
9.2 Other rights at law
Article 9.1 (Right to demand repayment) shall not restrict any other right of the Bank at law (e.g. pursuant to Sections 314 or 490 BGB) to require prepayment of the Loan Outstanding together with any sum, interest, fee or accrued amount, irrespectively of the fact that this Contract might convert into a so called settlement contractual relationship (Abwicklungsschuldverhältnis).
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9.3 Prepayment Fee
In case of demand under Article 9.1 (Right to demand repayment), the Borrower shall pay the Bank the amount demanded together with the relevant Prepayment Fee.
9.4 Non-Waiver
No failure or delay or single or partial exercise by the Bank in exercising any of its rights or remedies under this Contract shall be construed as a waiver of such right or remedy. The rights and remedies provided in this Contract are cumulative and not exclusive of any rights or remedies provided by law.
ARTICLE 10
Law and jurisdiction, miscellaneous
10.1 Governing Law
This Contract and any non-contractual obligations arising out of or in connection with it shall be governed by the laws of Germany.
10.2 Jurisdiction
(a) | The courts of Frankfurt am Main, Germany have exclusive jurisdiction to settle any dispute (a “Dispute”) arising out of or in connection with this Contract (including a dispute regarding the existence, validity or termination of this Contract or the consequences of its nullity) or any non-contractual obligation arising out of or in connection with this Contract. |
(b) | The parties agree that the courts of Frankfurt am Main, Germany are the most appropriate and convenient courts to settle Disputes between them and, accordingly, that they will not argue to the contrary. |
(c) | This Article 10.2 (Jurisdiction) is for the benefit of the Bank only. As a result and notwithstanding Sub-Paragraph (a) above, it does not prevent the Bank from taking proceedings relating to a Dispute in any other courts with jurisdiction. To the extent allowed by law, the Bank may take concurrent proceedings in any number of jurisdictions. |
10.3 Place of performance
Unless otherwise specifically agreed by the Bank in writing, the place of performance under this Contract, shall be the seat of the Bank.
10.4 Evidence of sums due
In any legal action arising out of this Contract the certificate of the Bank as to any amount or rate due to the Bank under this Contract shall, in the absence of manifest error, be prima facie evidence of such amount or rate.
10.5 Third party rights
A person who is not a party to this Contract has no right to enforce or to enjoy the benefit of any term of this Contract (no echter Vertrag zugunsten Dritter within the meaning of Section 328 para. 1 BGB).
10.6 Entire Agreement
This Contract (together with the other Finance Documents) constitutes the entire agreement between the Bank and the Borrower in relation to the provision of the Credit hereunder, and supersedes any previous agreement, whether express or implied, on the same matter.
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10.7 Invalidity
If at any time any term of this Contract is or becomes illegal (nichtig), invalid or unenforceable in any respect, or this Contract is or becomes ineffective (unwirksam) in any respect, under the laws of any jurisdiction, such illegality (Nichtigkeit), invalidity, unenforceability or ineffectiveness (Unwirksamkeit) shall indisputably (unwiderlegbar) not affect:
(a) | the legality, validity or enforceability in that jurisdiction of any other term of this Contract or the effectiveness in any other respect of this Contract in that jurisdiction; or |
(b) | the legality, validity or enforceability in other jurisdictions of that or any other term of this Contract or the effectiveness of this Contract under the laws of such other jurisdictions, |
without any party to this Contract having to argue (darlegen) and prove (beweisen) such party’s intent to uphold this Contract even without the void, invalid or ineffective provisions.
The illegal, invalid, unenforceable or ineffective provision shall be deemed replaced by such legal, valid, enforceable and effective provision that in legal and economic terms comes closest to what the parties to this Contract intended or would have intended in accordance with the purpose of this Contract if they had considered the point at the time of conclusion of this Contract. The same applies in the event that this Contract or any other Finance Document does not contain a provision which it needs to contain in order to achieve the economic purpose as expressed herein (Regelungslücke).
10.8 Amendments
Any amendment to this Contract (including this Article 10.8) or any other Finance Document shall be made in writing (or in notarial form, if required) and shall be signed by the parties hereto.
10.9 Counterparts
This Contract may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument.
10.10 Assignment and transfer by the Bank
(a) | The Bank may assign or transfer (by way of novation, assumption of contract (Vertragsübernahme), sub-participation or otherwise) all or part of its rights, benefits or obligations under the Finance Documents. The Borrower herewith consents to any such assignment or transfer. |
(b) | The Bank shall have the right to disclose all information relating to or concerning the Borrower, the Group, the Finance Documents and the Loan in connection with or in contemplation of any such assignment or transfer. |
ARTICLE 11
Final Articles
11.1 Notices
11.1.1 Form of notice
(a) | Any notice or other communication given under this Contract must be in writing and, unless otherwise stated, may be made by letter or electronic mail. |
(b) | Notices and other communications for which fixed periods are laid down in this Contract or which themselves fix periods binding on the addressee, may be made by hand delivery, registered letter or by electronic mail. Such notices and communications shall be deemed to have been received by the other party: |
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(i) | on the date of delivery in relation to a hand-delivered or registered letter; or |
(ii) | in the case of any electronic mail, only when actually received in readable form and in the case of an electronic mail sent by an Obligor to the Bank only if it is addressed in such a manner as the Bank shall specify for this purpose. |
(c) | Any notice provided by an Obligor to the Bank by electronic mail shall: |
(i) | mention the Contract Number in the subject line; and |
(ii) | be in the form of a non-editable electronic image (pdf, tif or other common non-editable file format agreed between the parties) of the notice signed by one or more Authorised Signatories of the Borrower as appropriate, attached to the electronic mail. |
(d) | Notices issued by the Borrower pursuant to any provision of this Contract shall, where required by the Bank, be delivered to the Bank together with satisfactory evidence of the authority of the person or persons authorised to sign such notice on behalf of the Borrower and the authenticated specimen signature of such person or persons. |
(e) | Without affecting the validity of electronic mail or communication made in accordance with this Article 11.1 (Notices), the following notices, communications and documents shall also be sent by registered letter to the relevant party at the latest on the immediately following Business Day: |
(i) | Disbursement Acceptance; |
(ii) | any notices and communication in respect of the cancellation of a disbursement of any Tranche, Prepayment Request, Prepayment Notice, Event of Default, any demand for prepayment, and |
(iii) | any other notice, communication or document required by the Bank. |
(f) | The parties agree that any above communication (including via electronic mail) is an accepted form of communication, shall constitute admissible evidence in court and shall have the same evidential value as an agreement under hand. |
(g) | Any communication or document made or delivered to the Borrower in accordance with this Article 11.1 (Notices) will be deemed to have been made or delivered to each of the Obligors or any other member of the Group party to a Finance Document. Each Obligor incorporated in Germany, for this purpose, appoints the Borrower as its receipt agent (Empfangsboten). |
11.1.2 Addresses
The address and electronic mail address (and the department or officer, if any, for whose attention the communication is to be made) of each party for any communication to be made or document to be delivered under or in connection with this Contract is:
For the Bank | Attention: [*****] | |
100 boulevard Konrad Adenauer | ||
L-2950 Luxembourg | ||
Email address: [*****] | ||
For the Borrower | Attention: [*****] | |
Friedrich-Miescher-Str 15 | ||
72076 Tübingen | ||
Germany | ||
Email address: [*****] [*****] |
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11.1.3 Demand after notice to remedy
The Bank and the Borrower shall promptly notify the other party in writing of any change in their respective communication details.
11.2 English language
(a) | Any notice or communication given under or in connection with this Contract must be in English. |
(b) | To the extent required by local law, Security Documents shall be in the language required under the relevant local law; in particular any documentation in relation to the Land Charge to be filed with the land register (Grundbuchamt) shall be in German. |
(c) | All other documents provided under or in connection with this Contract must be: |
(i) | in English; or |
(ii) | if not in English, and if so required by the Bank, accompanied by a certified English translation and, in this case, the English translation will prevail. |
11.3 Conclusion of this Contract (Vertragsschluss)
(a) | The parties to this Contract may choose to conclude this Contract by an exchange of signed signature page(s), transmitted by any means of telecommunication (telekommunikative Übermittlung) such as by way of fax or attached as an electronic photocopy (.pdf, .tif, etc) to electronic mail. |
(b) | If the parties to this Contract choose to conclude this Contract pursuant to this Article 11.3 (Conclusion of this Contract (Vertragsschluss)), they will transmit the signed signature page(s) of this Contract to [*****] (each a “Recipient”). This Contract will be considered concluded once a Recipient has actually received the signed signature page(s) (Zugang der Unterschriftsseite(n)) from both parties to this Contract (whether electronic photocopy or other means of telecommunication and at the time of the receipt of the last outstanding signature page(s) by such one Recipient). |
(c) | For the purposes of this Article 11.3 (Conclusion of this Contract (Vertragsschluss)) only, the parties to this Contract appoint each Recipient as their attorney (Empfangsvertreter) and expressly allow (gestatten) each Recipient to collect the signed signature page(s) from both and for both parties to this Contract. For the avoidance of doubt, each Recipient will have no further duties connected with its position as Recipient. In particular, each Recipient may assume the conformity to the authentic original(s) of the signature page(s) transmitted to it by means of telecommunication, the genuineness of all signatures on the original signature page(s) and the signing authority of the signatories. |
(d) | For the purposes of proof and confirmation, each party to this Contract has to provide the Recipients with original signature page(s) promptly, but no later than [*****] Business Days, after signing this Contract in accordance with this Article 11.3 (Conclusion of this Contract (Vertragsschluss)). The Bank may demand that the Borrower subsequently sign one or more copies of this Contract. |
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IN WITNESS WHEREOF the parties hereto have caused this Contract to be executed in three (3) originals (two (2) originals for the Bank and one (1) original for the Borrower) in the English language.
Signed for and on behalf of | Signed for and on behalf of | |||||||
EUROPEAN INVESTMENT BANK | CUREVAC REAL ESTATE GMBH | |||||||
/s/ Tero PIETILA | /s/ Ayse Nil ADA | |||||||
Name: Tero PIETILA | Name:Ayse Nil ADA | Name: | Name: | |||||
Title: Head of Division | Title: Legal Counsel | Title: | Title: |
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IN WITNESS WHEREOF the parties hereto have caused this Contract to be executed in three (3) originals (two (2) originals for the Bank and one (1) original for the Borrower) in the English language.
Signed for and on behalf of | Signed for and on behalf of | |||
EUROPEAN INVESTMENT BANK | CUREVAC REAL ESTATE GMBH | |||
/s/ Florian von der Mülbe | /s/ Reinhard Rapp | ||||||
Name: | Name: | Name: Florian von der Mülbe | Name: Reinhard Rapp | ||||
Title: | Title: | Title: Managing Director | Title: Managing Director | ||||
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Schedule A
Investment Specification and Reporting
A.1 Technical Description
[*****]
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A.2 Information Duties
1. Dispatch of information: designation of the person responsible
The information below has to be sent to the Bank under the responsibility of:
[*****] | |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
[*****] | [*****] |
The above-mentioned contact person(s) is (are) the responsible contact(s) for the time being.
The Borrower shall inform the EIB immediately in case of any change.
2. Information on the project’s implementation
The Borrower shall deliver to the Bank the following information on project progress during implementation at the latest by the deadline indicated below.
[*****] | [*****] | [*****] |
[*****] | [*****] | [*****] |
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3. Information on the end of works and first year of operation
The Borrower shall deliver to the Bank the following information on project completion and initial operation at the latest by the deadline indicated below.
[*****] | [*****] |
[*****] | [*****] |
Language of reports | English |
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Schedule B
Definitions of EURIBOR
EURIBOR
“EURIBOR” means:
[*****]
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Schedule C
Form of Disbursement Offer/Acceptance
To: | CureVac Real Estate GmbH |
From: | European Investment Bank |
Date:
Subject: | Disbursement Offer/Acceptance for the Finance Contract between European Investment Bank and CureVac Real Estate GmbH dated [*****] (the “Finance Contract”) |
Contract Number [*****]
Serapis Number [*****]
Dear Sirs,
We refer to the Finance Contract. Terms defined in the Finance Contract have the same meaning when used in this letter.
Following your request for a Disbursement Offer from the Bank, in accordance with Article 2.2.2 (Disbursement Offer) of the Finance Contract, we hereby offer to make available to you the following Tranche:
(a) Tranche [A/B/C]
(b) Amount to be disbursed:
(c) Disbursement Date:
(d) Deferred Interest Fixed Rate:
(e) Repayment Date:
(f) Terms and frequency for repayment of principal:
(g) Maturity Date:
To make the Tranche available subject to the terms and conditions of the Finance Contract, the Bank must receive a Disbursement Acceptance in the form of a copy of this Disbursement Offer duly signed on your behalf, to the following electronic mail [·] no later than the Disbursement Acceptance Deadline of [time], Luxembourg time, on [date].
The Disbursement Acceptance below must be signed by an Authorised Signatory and must be fully completed as indicated, to include the details of the Disbursement Account.
If not duly accepted by the above stated time, the offer contained in this document shall be deemed to have been refused and shall automatically lapse.
If you do accept the Tranche as described in this Disbursement Offer, all the related terms and conditions of the Finance Contract shall apply, in particular, the provisions of Article 2.5 (Conditions of Disbursement).
Yours faithfully,
EUROPEAN INVESTMENT BANK
We hereby accept the above Disbursement Offer for and on behalf of the Borrower:
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Date:
Account to be credited1:
Account N°:
Account Holder/Beneficiary:
(please, provide IBAN format if the country is included in IBAN Registry published by SWIFT, otherwise an appropriate format in line with the local banking practice should be provided)
Bank name, identification code (BIC) and address:
Payment details to be provided:
Please transmit information relevant to:
Name(s) of the Borrower’s Authorised Signatory(ies):
Signature(s) of the Borrower’s Authorised Signatory(ies):
Name(s) / Title(s)
IMPORTANT NOTICE TO THE BORROWER: | |
BY COUNTERSIGNING ABOVE YOU CONFIRM THAT THE LIST OF AUTHORISED SIGNATORIES AND ACCOUNTS PROVIDED TO THE BANK WAS DULY UPDATED PRIOR TO THE PRESENTATION OF THE ABOVE DISBURSEMENT OFFER BY THE BANK. | |
IN THE EVENT THAT ANY SIGNATORIES OR ACCOUNTS APPEARING IN THIS DISBURSEMENT ACCEPTANCE ARE NOT INCLUDED IN THE LATEST LIST OF AUTHORISED SIGNATORIES AND ACCOUNTS RECEIVED BY THE BANK, THE ABOVE DISBURSEMENT OFFER SHALL BE DEEMED AS NOT HAVING BEEN MADE. |
1 The details concerning banking intermediary are also to be provided if such intermediary has to be used to make the transfer to the Beneficiary’s Account.
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Schedule D
Form of Drawdown Certificate
To: | European Investment Bank |
From: | CureVac Real Estate GmbH |
Date:
Subject: | Finance Contract between European Investment Bank and CureVac Real Estate GmbH dated [*****] (the “Finance Contract”) |
Contract Number [*****]
Serapis Number [*****]
Dear Sirs,
Terms defined in the Finance Contract have the same meaning when used in this letter.
For the purposes of Article 2.5 (Conditions of Disbursement) of the Finance Contract we hereby certify to you as follows:
(a) | no Prepayment Event has occurred and is continuing; |
(b) | no security of the type prohibited under Paragraph 24 (Negative pledge) of Schedule H (General Undertakings) has been created or is in existence; |
(c) | there has been no material change to any aspect of the Investment or in respect of which we are obliged to report under the Finance Contract, save as previously communicated by us; |
(d) | no Default, Event of Default or a Prepayment Event other than pursuant to Article 5.3.1 (Cost Reduction) of the Finance Contract has occurred or is continuing, or would, in each case, result from the disbursement of the proposed Tranche; |
(e) | no litigation, arbitration administrative proceedings or investigation is current or to our knowledge is threatened or pending before any court, arbitral body or agency which has resulted or if adversely determined is reasonably likely to result in a Material Adverse Change, nor is there subsisting against us or any of our subsidiaries any unsatisfied judgement or award; |
(f) | the Repeating Representations are correct in all respects; |
(g) | no Material Adverse Change has occurred, as compared with the situation at the date of the Finance Contract; and |
(h) | the borrowing of the Credit, or any part thereof, by the Borrower is within the corporate powers of the Borrower. |
Yours faithfully,
For and on behalf of CureVac Real Estate GmbH
Date:
Name(s) / Title(s)
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Schedule E
Form of Compliance Certificate
To: | European Investment Bank |
From: | CureVac Real Estate GmbH |
Date:
Subject: | Finance Contract between European Investment Bank and CureVac Real Estate GmbH dated [*****] (the “Finance Contract”) |
Contract Number [*****]
Serapis Number [*****]
Dear Sirs,
We refer to the Finance Contract. This is a Compliance Certificate. Terms defined in the Finance Contract have the same meaning when used in this Compliance Certificate.
We hereby confirm:
(a) [insert information regarding asset disposal];
(b) | [no security of the type prohibited under Paragraph 24 (Negative pledge) of Schedule H (General Undertakings) has been created or is in existence;] |
(c) | [no Default, Event of Default or a Prepayment Event other than pursuant to Article 5.3.1 (Cost Reduction) of the Finance Contract has occurred or is continuing.] [If this statement cannot be made, this certificate should identify any potential event of default that is continuing and the steps, if any, being taken to remedy it]. |
Yours faithfully,
For and on behalf of CureVac Real Estate GmbH
Name(s) / Title(s)
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Schedule F
Conditions Precedent
Part A - Initial Documentary Conditions Precedent
(a) | The following, duly executed Finance Documents: |
(i) | originals of this Contract; |
(ii) | originals of the Guarantee Agreement with CureVac AG; |
(iii) | originals of each Security Document, including an enforceable copy (vollstreckbare Ausfertigung) of the Land Charge Creation Deed; and |
(iv) | originals of the Finance Fee Letter. |
(b) | The constitutional documents of each Obligor, being in relation to an Obligor incorporated in Germany electronic copies of (i) an up-to-date (dated no earlier than the date falling [*****] days before the Disbursement Date) electronic extract from the commercial register (Handelsregisterauszug), (ii) its articles of association (Gesellschaftsvertrag) and copies of any by-laws and rules of procedures (Geschäftsordnungen) and (iii) its list of shareholders (Gesellschafterliste) or list of supervisory board members (if applicable). |
(c) | A copy of the resolution of the competent body (board of directors (Vorstand), supervisory board (Aufsichtsrat), administrative board (Verwaltungsrat) or general meeting of shareholders (Gesellschafterversammlung)) of each Obligor: |
(i) | approving the terms of, and the transactions contemplated by, the Finance Documents to which it is a party as and duly authorising the execution of the Finance Documents to which it is a party; |
(ii) | duly authorising the relevant signatory or signatories to execute and perform the Finance Documents to which it is a party on its behalf; and |
(iii) | authorising the relevant signatory or signatories, on its behalf, to sign and/or despatch all documents and notices to be signed and/or despatched by it under or in connection with the Finance Documents to which it is a party. |
(d) | An up-to-date (dated no earlier than the date falling [*****] days before the Disbursement Date) structure chart showing the Group certified as being complete and correct by an Authorised Signatory of the Borrower provided such certification is dated no earlier than the date falling [*****] days before the Disbursement Date. |
(e) | A certificate of an Authorised Signatory of each Obligor certifying that each copy document relating to it specified in Paragraph (b) and (c) of this Part A of Schedule F (Initial Documentary Conditions Precedent) is correct, complete and in full force and effect as at a date no earlier than the date falling [*****] days before the Disbursement Date. |
(f) | The List of Authorised Signatories and Accounts. |
(g) | A legal enforceability opinion of Noerr LLP, addressed to the Bank on the legality, validity and enforceability of the German law governed Finance Documents. |
(h) | A legal enforceability opinion of Arendt & Medernach, addressed to the Bank on the legality, validity and enforceability of the Luxembourg law governed Finance Fee Letter. |
(i) | A legal opinion of Baker McKenzie, legal adviser to the Borrower, addressed to the Bank, and dated no earlier than the date falling [*****] days before the Disbursement Date: |
(i) | which includes an insolvency search on www.insolvenzbekanntmachungen.de on the relevant Obligor conducted on the date of such legal opinion; and |
(ii) | on the due incorporation and valid existence of each Obligor, the authority and capacity of each Obligor to enter into the Finance Documents and perform its obligations thereunder, non-conflict with constitutional documents and on laws applicable to companies generally in Germany, no consents, registrations or filings are required and no stamp duty is to be paid in respect of the Finance Documents, all corporate and other action required to be taken has indeed been taken, the due execution of the Finance Documents, choice of law and enforceability of judgments and that the Obligor is not entitled to claim immunity. |
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(j) | The audited financial statements of the Obligors for the financial year 2019. |
(k) | Evidence of payment of all the fees (including lawyer fees) and expenses as required under the Finance Documents. |
(l) | A copy of any other document, authorisation, opinion or assurance which the Bank has notified the Borrower is necessary in connection with the entry into and performance of, and the transactions contemplated by, the Finance Documents or the validity and enforceability of the same. |
Part B - Guarantor Conditions Precedent
(a) | The duly executed Guarantee Agreement or, as applicable, accession letter to the Guarantee Agreement. |
(b) | The constitutional documents of such Guarantor(s). |
(c) | If applicable, an original of a certificate of incorporation and an encumbrance certificate of the Guarantor(s) not incorporated or established in Germany (“Non-German Guarantor”) dated no more than [*****] Business Days from the date of execution of the Guarantee Agreement or accession letter to the Guarantee Agreement (as applicable) (or any equivalent document in the jurisdiction of incorporation of such Non-German Guarantor(s)). |
(d) | A copy of the resolution of the competent body (board of directors, supervisory board (Aufsichtsrat), administrative body (Verwaltungsrat), advisory board (Beirat) or general meeting of shareholders (Gesellschafterversammlung)) of each Obligor: |
(i) | approving the terms of, and the transactions contemplated by, the Finance Documents to which it is a party as and duly authorising the execution of the Finance Documents to which it is a party; |
(ii) | duly authorising the relevant signatories to execute the Finance Documents to which it is a party on its behalf; and |
(iii) | authorising a signatory or signatories, on its behalf, to sign and/or despatch all documents and notices to be signed and/or despatched by it under or in connection with the Finance Documents to which it is a party. |
(e) | A certificate of an authorised signatory of the respective Guarantor(s) certifying that each copy document relating to it specified in Paragraphs (b) to (d) of this Part B of Schedule F (Conditions Precedent) is correct, complete and in full force and effect as at a date no earlier than the date of their/its entry into or accession to the Guarantee Agreement, including a specimen of the signature of each person authorised by the resolution in Paragraph (d) above and, if applicable, confirming that guaranteeing or securing, as appropriate, the Loan would not cause any guarantee, security or similar limit or restriction binding on it to be exceeded. |
(f) | A legal opinion of a reputable law firm, addressed to the Bank, on the valid existence of the Guarantor(s), the authority and capacity of the Guarantor(s) to enter into or accede to the Guarantee Agreement (and execute its/their obligations therein) and on the due execution of the Guarantee Agreement (or the accession letter). |
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(g) | Copies of such documentation and other evidence as the Bank may request to carry out and be satisfied with the results of all necessary “know your customer” requirements or other checks in relation to the identity of any person that it is required (in order to comply with applicable money laundering laws and regulations) to carry out in relation to the concerned Guarantor(s). |
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Schedule G
Representations and Warranties
1. Authorisations and Binding Obligations
(a) | Each Obligor is duly incorporated and validly existing as a corporation or company with limited liability under the laws of its jurisdiction of incorporation. No Obligor’s shares are publicly traded. |
(b) | Each Obligor has the power to carry on its business as it is now being conducted and to own its property and other assets, and to execute, deliver and perform its obligations under the Finance Documents. |
(c) | Each Obligor has obtained all necessary Authorisations in connection with the execution, delivery and performance of the Finance Documents and in order to lawfully comply with its obligations thereunder, and in respect of the Investment, and all such Authorisations are in full force and effect and admissible in evidence. |
(d) | The execution and delivery of, the performance of each Obligor’s obligations under and compliance with the provisions of the Finance Documents do not and will not contravene or conflict with: |
(i) | any applicable law, statute, rule or regulation, or any judgement, decree or permit to which it is subject; |
(ii) | any agreement or other instrument binding upon it which might reasonably be expected to have a material adverse effect on its ability to perform its obligations under the Finance Documents; or |
(iii) | any provision of its constitutional documents. |
(e) | The obligations expressed to be assumed by each Obligor in each Finance Document to which it is a party are legal, valid, binding and enforceable obligations. |
2. No default or other adverse event
(a) | There has been no Material Adverse Change since [*****]. (Non-repeating) |
(b) | No event or circumstance which constitutes an Event of Default has occurred and is continuing unremedied or unwaived. |
3. No proceedings
(a) | No litigation, arbitration, administrative proceedings or investigation is current or to its knowledge is threatened or pending before any court, arbitral body or agency which has resulted or if adversely determined is reasonably likely to result in a Material Adverse Change, nor is there subsisting against it or any of its Subsidiaries any unsatisfied judgement or award. |
(b) | To the best of its knowledge and belief (having made due and careful enquiry) no material Environmental Claim has been commenced or is threatened against any Obligor. |
(c) | As at the date of this Contract, no Obligor has taken any action to commence proceedings for, nor have any other steps been taken or legal proceedings commenced or, so far as the Borrower is aware, threatened against any Obligor for its insolvency, winding up or dissolution, or for any Obligor to enter into any arrangement or compositions for the benefit of creditors, or for the appointment of an administrator, receiver, administrative receiver, examiner, trustee or similar officer. (Non-repeating) |
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4. Security
It is the sole legal and beneficial owner and has good title to the assets which it charges or purports to charge pursuant to the Security Documents. At the date of this Contract, no Security exists over the assets of any Group Company other than Permitted Security.
5. Ranking
(a) | Its payment obligations under this Contract rank not less than pari passu in right of payment with all other present and future unsecured and unsubordinated obligations under any of its debt instruments except for obligations mandatorily preferred by law applying to companies generally. |
(b) | No financial covenants have been concluded with any other creditor of any Obligor. |
(c) | No Voluntary Non EIB Prepayment has occurred. |
6. Anti-Corruption
(a) | Each Obligor is in compliance with all applicable European Union and its national legislation, including any applicable anti-corruption legislation. |
(b) | To the best of its knowledge, no funds invested in the Investment by any Obligor or any other Group Company are of illicit origin, including products of money laundering or linked to the financing of terrorism. |
(c) | No Obligor is engaged in any Criminal Offence and to the best of the Obligor’s knowledge no Criminal Offence have occurred in connection with the Investment. (Non-repeating) |
7. Accounting and Tax
(a) | The latest available consolidated and unconsolidated audited accounts of the Borrower and the other Obligors have been prepared on a basis consistent with previous years and have been approved by its auditors as representing a true and fair view of the results of its operations for that year and accurately disclose or reserve against all the liabilities (actual or contingent) of the Borrower and the other Obligors, as relevant. |
(b) | The accounting reference date of the Borrower and each Obligor is 31 December. |
(c) | No Obligor is required to make any deduction for or on account of any Tax from any payment it may make under the Finance Documents, except for withholding tax (Kapitalertragssteuer) which have to be deducted pursuant to Sub-Paragraph (j) of Article 4.2 (Variable Remuneration). (Non-repeating) |
(d) | All Tax returns required to have been filed by each Obligor or on its behalf under any applicable law have been filed when due and contain the information required by applicable law to be contained in them. |
(e) | Each Obligor has paid when due all Taxes payable by it under applicable law except to the extent that it is contesting payment in good faith and by appropriate means. |
(f) | With respect to Taxes which have not fallen due or which it is contesting, each Obligor is maintaining reserves adequate for their payment and in accordance, where applicable, with GAAP. |
(g) | Under the laws of the jurisdiction of incorporation of each Obligor, it is not necessary that the Finance Documents be filed, recorded or enrolled with any court or other authority or that any stamp, registration or similar tax be paid on or in relation to the Finance Documents, or the transactions contemplated by the Finance Documents, other than the official certification (öffentliche Beglaubigung) of the Land Charge Creation Deed (Grundschuldbestellungsurkunde) and payment of related notary fees and the registration of the Land Charge in the land register (Grundbuch) and payment of the related registration fees. (Non-repeating) |
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8. Information provided
(a) | Any factual information provided by any Group Company for the purposes of entering into this Contract and any related documentation was true and accurate in all material respects as at the date it was provided or as at the date (if any) at which it is stated and continues to be true and accurate in all material respect as at the date of this Contract. (Non-repeating) |
(b) | The Group structure chart is true, complete and accurate in all material respects and represents the complete corporate structure of the Group as at the date of this Contract, and other than as set out therein the Borrower owns no other equity and/or shares in any other business entity. (Non-repeating) |
(c) | As at the date of this Contract, (i) information provided by the Borrower during the due diligence in [*****] is complete, accurate and true in all respects. (Non-repeating) |
9. No indebtedness
No Obligor has Indebtedness outstanding other than Permitted Indebtedness. (Non-repeating).
10. No Immunity
No Obligor, nor any of its assets, is entitled to immunity from suit, execution, attachment or other legal process.
11. Pensions
The pension schemes for the time being operated by the Obligors (if any) are funded in accordance with their rules and to the extent required by law or otherwise comply with the requirements of any law applicable in the jurisdiction in which the relevant pension scheme is maintained.
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Schedule H
General Undertakings
1. Use of Loan
The Borrower shall use all amounts borrowed by it under the Loan to carry out the Investment. For the avoidance of doubt, the Loan shall in no case be used for the repayment of the DH Convertible Loan Agreement.
2. Completion of Investment
The Borrower shall or shall procure that the Investment is carried out in accordance with the Technical Description as may be modified from time to time with the approval of the Bank, and complete it by the final date specified therein.
3. Procurement procedure
The Borrower shall secure goods and services for the Investment (a) in so far as they apply to it or to the Investment, in accordance with EU Law in general and in particular with the relevant EU Directives, and (b) in so far as EU Directives do not apply, by procurement procedures which, to the satisfaction of the Bank, respect the criteria of economy and efficiency and, in case of public contracts, the principles of transparency, equal treatment and non-discrimination on the basis of nationality.
4. Compliance with laws
The Borrower shall comply in all respects with all laws and regulations to which it or the Investment is subject.
5. Environment
The Borrower shall:
(i) | implement and operate the Investment in compliance with Environmental Law; |
(ii) | obtain, maintain and comply with requisite Environmental Approvals for the Investment, and upon becoming aware of any breach of this Paragraph 5 (Environment): |
(i) | the Borrower shall promptly notify the Bank; |
(ii) | the Borrower and the Bank will consult for up to [*****] Business Days from the date of notification with a view to agreeing the manner in which the breach should be rectified; and |
(iii) | the Borrower shall remedy the breach within [*****] Business Days of the end of the consultation period. |
6. Integrity
The Borrower shall take, within a reasonable timeframe, appropriate measures in respect of any member of its management bodies who has been convicted by a final and irrevocable court ruling of a Criminal Offence perpetrated in the course of the exercise of his/her professional duties, in order to ensure that such member is excluded from any Borrower’s activity in relation to the Loan or the Investment.
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7. Disposal of assets
(a) | Except as provided under Sub-Paragraph (b) below, the Borrower shall not, and shall procure that none of its Subsidiaries shall, either in a single transaction or in a series of transactions whether related or not and whether voluntarily or involuntarily dispose of all or any part of any of its or its Subsidiaries business, undertaking or assets (including any shares, real estate or security of any entity or a business or undertaking, or any interest in any of them). |
(b) | Sub-Paragraph (a) above does not apply to any such disposal (a “Permitted Disposal”): |
(i) | made with the prior written consent of the Bank; |
(ii) | made on arm’s length terms in the ordinary course of business of the Borrower or one of its Subsidiaries, provided that these are made between Obligors only; |
(iii) | made on arm’s length terms and at fair market value for cash, which is reinvested in assets of comparable or superior type, value and quality; |
(iv) | made on arm’s length terms in exchange for other assets (other than shares, businesses and real estate) comparable or superior as to type, value and quality; |
(v) | by one of its Subsidiaries which is (A) an Obligor to another Obligor, or (B) not an Obligor to another Group Company which is not an Obligor; |
(vi) | constituted by a licence of Intellectual Property Rights on arm’s length terms in the ordinary course of business of the Borrower or any one of its Subsidiaries; |
(vii) | made in relation to non-material assets which have depreciated to less than [*****]% ([*****] per cent.) of their initial value or which are obsolete; or |
(viii) | arising as a result of Permitted Security, |
provided that the disposal is not of assets forming part of the Investment or shares in subsidiaries holding assets forming part of the Investment, which may not be disposed of unless either (A) the Borrower consults the Bank in relation to such disposal, and the Bank approves the disposal, or (B) the proceeds of the disposal are applied to prepay the Bank in accordance with Article 5.3.4 (Disposals).
For the purposes of this Paragraph 7 (Disposal of assets), “dispose” and “disposal” includes any act effecting sale, transfer, lease or other disposal (Verfügung).
8. Maintenance of assets
The Borrower shall maintain, repair, overhaul and renew all assets required in relation to the Investment as required to keep such assets in good working order.
9. Insurances
The Borrower shall, and shall procure that each of its Subsidiaries shall, maintain insurances on and in relation to its business and assets with reputable underwriters or insurance companies against those risks and to the extent as is usual for companies carrying on the same or substantially similar business.
10. Change in business
The Borrower shall procure that no substantial change is made to the general nature of its business or the business of any of its Subsidiaries from that carried on at the date of this Contract.
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11. Change in ownership
The Borrower will inform the Bank promptly about any intended change in any of its ownership.
12. Merger
The Borrower shall not, and shall procure that none of its Subsidiaries shall, enter into any amalgamation, demerger, merger or corporate reconstruction (including the conclusion of any domination and/or profit and loss transfer agreements (Beherrschungsund/oder Gewinnabführungsverträge) or any other enterprise agreements (Unternehmensverträge) with the meaning of section 291 AktG) unless:
(a) | with the prior written consent of the Bank; or |
(b) | such amalgamation, demerger, merger or corporate reconstruction does not result in a Material Adverse Change and is on a solvent basis, and provided that: |
(i) | only Group Companies are involved and if a Guarantor is involved, the surviving entity will also be or become a Guarantor; |
(ii) | the resulting entity will not be incorporated or located in a country which is in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax practices as such blacklist may be amended from time to time; and |
(iii) | if the Borrower is involved, (A) the rights and obligations of the Borrower under this Contract will remain with the Borrower, (B) the surviving entity will be the Borrower and the statutory seat of the Borrower would not as a result of such merger be transferred to a different jurisdiction, (C) the merger will not have an effect on the validity, legality or enforceability of the Borrower’s obligations under this Contract; and (D) all of the business and assets of the Borrower are retained by it. |
13. Books and records
The Borrower shall, and shall procure that each of its Subsidiaries shall ensure that it has kept and will continue to keep proper books and records of account, in which full and correct entries shall be made of all financial transactions and its assets and business, including expenditures in connection with the Investment, in accordance with GAAP as in effect from time to time.
14. Ownership
(a) | The Borrower shall maintain Control and shall, in any event and in addition, at all times maintain more than 50% (fifty per cent.) of the share capital, directly or indirectly of each of its Material Subsidiaries, unless a prior written consent of the Bank is received by the Borrower. |
(b) | The Borrower shall immediately notify the Bank in the event of a new entity becoming a Subsidiary of the Borrower through any means, including but not limited to acquisition, creation and spin-off. |
(c) | The undertakings in Sub-Paragraphs (a), and (b) above shall be calculated in accordance with GAAP as applied by the Borrower on the date of this Contract and as GAAP is amended from time to time and tested annually. |
15. Acquisitions
The Borrower shall not, and shall procure that none of its Subsidiaries shall, invest in (including by way of payment into the capital reserve (Kapitalrücklage)) or acquire any entity or a business going concern or an undertaking (whether whole or substantially the whole of the assets or business), or any division or operating unit thereof, or any shares or securities of any entity or a business or undertaking (or in each case, any interest in any of them) (or agree to any of the foregoing), save for an acquisition or investment:
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(a) | with the prior written consent of the Bank; |
(b) | by one of its Subsidiaries which is an Obligor of an asset sold, leased, transferred or otherwise disposed of by another Obligor; |
(c) | by one of its Subsidiaries of all the shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, provided that: |
(i) | such entity has not yet commenced commercial operations; |
(ii) | such entity is incorporated in a country that is a member of either or both of the European Union or the Organisation of Economic Co-Operation and Development; and |
(iii) | no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition; or |
(d) | of shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, the consideration for which does not exceed an aggregate amount of EUR [*****] ([*****] euro) during any financial year, provided that: |
(i) | no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition; |
(ii) | the acquired entity is engaged in a business similar or complementary to the business carried on by the Group as at the date of this Contract; |
(iii) | the acquired entity is not incorporated or located in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax practices as such blacklist may be amended from time to time; |
(iv) | in respect of any acquisition where the consideration exceeds EUR [*****] ([*****] euro), legal and financial due diligence reports (including customary reliance letters in favour of the Bank) and a business plan (in the form of the most recent budget adjusted for the expected effects of the acquisition) in respect of the [*****] next following financial years and any other due diligence reports received in connection with the acquisition (if any) are provided to the Bank; and |
(v) | the Borrower provides a Compliance Certificate for the [*****] month financial periods immediately following the acquisition, updated on a pro forma basis as if the acquisition has occurred. |
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16. Indebtedness
The Borrower shall not, and shall procure that none of its Subsidiaries shall, incur any Indebtedness, save for Indebtedness (“Permitted Indebtedness”):
(a) | incurred with the prior written consent of the Bank; |
(b) | incurred under this Contract; |
(c) | under the existing Building Leasing Agreements and any other existing building lease agreements entered into by the Borrower prior to the date of this Finance Contract in the aggregate liability under such Building Leasing Agreements and any other existing building lease agreements of not more than EUR [*****] at the date of this Finance Contract; |
(d) | under any future building lease agreements entered into by the Borrower, to the extent the aggregate liability under such future building lease agreements does not at any time exceed EUR [*****] ([*****] euro) (or its equivalent in another currency or currencies) over the lifetime of this Contract |
(e) | under any Finance Leases if the aggregate liability in respect of the equipment leased does not at any time exceed EUR [*****] ([*****] euro over the lifetime of this Contract (or its equivalent in another currency or currencies); |
(f) | under Permitted Hedging; |
(g) | under any letters of credit provided that such Indebtedness does not, singularly or in aggregate, exceed EUR [*****] ([*****] euro) in any financial year (or its equivalent in another currency or currencies); |
(h) | in respect of a Permitted Guarantee; |
(i) | owing by one of its Subsidiaries which is an Obligor to another Obligor; |
(j) | incurred by way of one or more unsecured revolving credit facilities with an overall maximum amount of EUR [*****] and a maximum term of [*****] years; or |
(k) | not permitted by the preceding Sub-Paragraphs and the outstanding amount of which does not exceed (i) EUR [*****] ([*****] euro in any financial year and (ii) EUR [*****] ([*****] euro) over the lifetime of this Contract, (or its equivalent) in aggregate for the Group at any time, provided that (i) any debt cannot be repaid, not even partially, prior to the maturity of the Loan; and (ii) has to be subordinated to the Loan. |
17. Guarantees
(a) | The Borrower shall not, and shall procure that none of its Subsidiaries shall, issue or allow to remain outstanding any guarantees or sureties (Bürgschaften) in respect of any liability or obligation of any person save for: |
(i) | any guarantee or surety (Bürgschaft) under any Guarantee Agreement or with the prior written consent of the Bank; or | |
(ii) | guarantees or sureties (Bürgschaften) issued by any of its Subsidiaries : |
(1) | under any negotiable instruments in the ordinary course of trade; |
(2) | under or in connection with any performance bond in the ordinary course of trade; |
(3) | under or in connection with any Permitted Indebtedness (except for the DH Convertible Loan Agreement); |
(4) | which is an Obligor to another Obligor; |
(5) | under or in connection with any bank guarantee issued for the benefit of a contractor in connection with construction work to secure such contractor’s claims (Bauhandwerkersicherung); or |
(6) | under any guarantee created or subsisting in order to comply with Section 8a of the German Altersteilzeitgesetz (AltTZG) or pursuant to Section 7e of the German Social Law Act No. 4 (Sozialgesetzbuch IV). |
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(b) | The Borrower shall procure that, as soon as any of its Subsidiaries becomes a Material Subsidiary (as identified in any accounts delivered to the Bank from time to time pursuant to Paragraph 2 (Information concerning the Borrower) of Schedule I (Information and Visits), that Subsidiary shall promptly notify the Bank and on the Bank’s request enter into a Guarantee Agreement and provide the Bank with the documentary conditions precedent (each in form and substance satisfactory to the Bank) listed in Part B of Schedule F (Guarantor Conditions Precedent) within [*****] Business Days following the date on which such Subsidiary qualifies as a Material Subsidiary, subject to general statutory limitations, financial assistance, capital maintenance, corporate benefit, fraudulent preference, “thin capitalisation” rules, retention of title claims and similar principles may limit the ability of a Guarantor to provide a guarantee or security or may require that the guarantee be limited by an amount or otherwise provided that the Borrower and each of its Subsidiaries will ensure to overcome such obstacles and, if applicable, to assist in demonstrating that adequate corporate benefit accrues to each Guarantor. |
18. Hedging
The Borrower shall not, and shall procure that none of its Subsidiaries shall, enter into any derivative transaction other than Permitted Hedging, where “Permitted Hedging” means:
(a) | any derivative transaction by one of its Subsidiaries to hedge actual or projected exposure arising in the ordinary course of trading and not for speculative purposes; and |
(b) | any derivative instrument of one of its Subsidiaries which is accounted for on a hedge accounting basis but is not entered into for speculative purposes. |
19. Restrictions on distributions
The Borrower shall not, and shall procure that none of its Subsidiaries shall, declare or distribute dividends, or return or purchase shares, save for:
(a) | with the prior written consent of the Bank; |
(b) | payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor; |
(c) | any dividend payments made by any Subsidiary; and |
(d) | any dividend payments made by an Obligor to another Obligor. |
20. Restrictions on loans
The Borrower shall not, and shall ensure that none of its Subsidiaries will, be a creditor in respect of any Indebtedness, save for:
(a) | with the prior written consent of the Bank; |
(b) | any trade credit extended by it or any of its Subsidiaries to its customers on normal commercial terms and in the ordinary course of its trading activities; |
(c) | any loan made by one of its Subsidiaries (other than an Obligor) to another Subsidiary (other than an Obligor); |
(d) | a loan made by one Obligor to another Obligor; or |
(e) | any other Indebtedness or loan advanced to or made available by any member of the Group with the prior written consent of the Bank. |
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21. Restrictions on intercompany loans
The Borrower shall not, and shall procure that none of its Subsidiaries shall, make any payment in respect of any intercompany loan, save for:
(a) | with the prior written consent of the Bank; |
(b) | where the lender of the intercompany loan is the Borrower or an Obligor; or |
(c) | the payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor. |
22. Intellectual Property Rights
The Borrower shall, and shall procure that none of its Subsidiaries shall, (i) obtain, safeguard and maintain its rights with respect to the Intellectual Property Rights required for the implementation of the Investment in accordance with this Contract, including complying with all material contractual provisions and that the implementation of the Investment in accordance with this Contract will not result in the infringement of the rights of any person with regard to the Intellectual Property Rights and (ii) ensure that any Intellectual Property Rights required for the implementation of the Investment will be owned by or licensed to the Borrower, and where such Intellectual Property Rights which are owned by a Group Company are capable of registration, are registered to such party.
23. Maintenance of Status
The Borrower shall, and shall procure that each of its Subsidiaries shall, remain duly incorporated and validly existing as a corporate entity with limited liability under the jurisdiction in which it is incorporated and that it will have no centre of main interests, permanent establishment or place of business outside the jurisdiction in which it is incorporated, and that it will continue to have the power to carry on its business as it is now being conducted and continue to own its property and other assets.
24. Negative pledge
(a) | The Borrower shall not (and shall procure that none of its Subsidiaries shall) create or permit to subsist any Security over any of its assets. |
(b) | For the purposes of this Paragraph 24 (Negative pledge), the term Security shall also include any arrangement or transaction on assets or receivables or money (such as the sale, transfer or other disposal of assets on terms whereby they are or may be leased to or re-acquired by the Borrower or any of its Subsidiaries, the sale, transfer or other disposal of any receivables on recourse terms or any arrangement under which money or the benefit of a bank account or other account may be applied or set off or any preferential arrangement having a similar effect) in circumstances where the arrangement or transaction is entered into primarily as a method of raising credit or of financing the acquisition of an asset. |
(c) | Sub-Paragraph (a) above does not apply to any Security, listed below (“Permitted Security”): |
(i) | any netting or set-off arrangement entered into by any Group Company in the ordinary course of its banking arrangements for the purpose of netting debit and credit balances and any Security arising under general business; |
(ii) | conditions (Allgemeine Geschäftsbedingungen) of banks or financial institutions; |
(iii) | any payment or close out netting or set-off arrangement pursuant to any Permitted Hedging, but excluding any Security under a credit support arrangement in relation to a hedging transaction; |
(iv) | any Security arising by operation of law and in the ordinary course of trading; |
(v) | any Security over or affecting any asset acquired by Group Company after the date of this Contract if: |
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(1) | the Security was not created in contemplation of the acquisition of that asset by a Group Company; |
(2) | the principal amount secured has not been increased in contemplation of or since the acquisition of that asset by a Group Company; and |
(3) | the Security is removed or discharged within [*****] months of the date of acquisition of such asset; |
(vi) | any Security over or affecting any asset of any company which becomes a Group Company after the date of this Contract, where the Security is created prior to the date on which that company becomes a Group Company, if: |
(1) | the Security was not created in contemplation of the acquisition of that company; |
(2) | the principal amount secured has not increased in contemplation of or since the acquisition of that company; and |
(3) | the Security is removed or discharged within [*****] of that company becoming a Group Company; |
(vii) | any Security entered into pursuant to this Contract; |
(viii) | any Security provided with the prior written consent of the Bank; |
(ix) | any Security arising under any retention of title (including extended retention of title (verlängerter Eigentumsvorbehalt)), hire purchase or conditional sale arrangement or arrangements having similar effect in respect of goods supplied to a Group Company in the ordinary course of trading and on the supplier’s standard or usual terms and not arising as a result of any default or omission by any Group Company; |
(x) | in respect of the Property to the extent restrictions on further charges are prohibited by Section 1136 BGB; |
(xi) | in respect of the Property interests, rights, easements or other matter whatsoever evidenced in section II of the land register (Grundbuch) as reflected in the copy of the land register excerpt (Grundbuchauszug) provided to the Bank; |
(xii) | any Security created or subsisting in order to comply with Section 8a of the German Altersteilzeitgesetz (AltTZG) or pursuant to Section 7e of the German Social Law Act No. 4 (Sozialgesetzbuch IV); or |
(xiii) | any contractor’s lien arising by operation of law (Werkunternehmerpfandrecht) in connection with repairs and maintenance work and any landlord’s pledge (Vermieterpfandrecht) arising by operation of law under a lease in favour of the relevant third party landlord. |
25. Other Undertakings
The Borrower shall take note of the Bank’s group statement on tax fraud, tax evasion, tax avoidance, aggressive tax planning, money laundering and financing of terrorism (as published on the Bank’s website and as may be amended from time to time).
26. Data Protection
Before disclosing any personal data (other than mere contact information relating to the Borrower’s personnel involved in the management of this Contract) to the Bank in connection with this Contract, the Borrower shall ensure that each data subject of those personal data:
(a) | has been informed of the disclosure (including the categories of personal data to be disclosed); and |
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(b) | has the information in (or has been provided with an appropriate link to) the Bank’s privacy statement in relation to its lending and investment activities set out at the relevant time at https://www.eib.org/en/privacy/lending (or such other address as the Bank may notify to the Borrower in writing from time to time). |
27. European Union Distributions and Sales
Subject to receipt of approval to commercialise the SARS-CoV-2 Vaccine from the European Medicines Agency, the Borrower shall use best commercial efforts to ensure that a reasonable and equitable amount of the future distribution of the SARS-CoV-2 Vaccine as well as other vaccines and products to be manufactured in the GMP IV occurs within the European Union.
28. Sanctions
The Borrower shall ensure that all amounts borrowed by it under this Contract are not made available to, or for the benefit of, persons or entities designated by restrictive measures adopted pursuant to Article 215 of the Treaty on the Functioning of the European Union insofar as the giving of and compliance with such undertaking does not and will not result in a violation of or conflict with or liability under section 7 of the German Foreign Trade Regulation (Außenwirtschaftsverordnung, AWV) (in conjunction with sections 4, 19 paragraph 3 no. 1a) of the German Foreign Trade Act (Außenwirtschaftsgesetz, AWG) and section 81 paragraph 1 no. 1 AWV) where the Borrower need not comply but only to the extent of the breach.
29. Clauses by inclusion
If the Borrower or any of its Subsidiaries concludes with any other secured and unsubordinated creditor a financing agreement that includes a loss-of-rating clause or a covenant or other provision regarding its financial ratios, if applicable, that is not provided for in this Contract or is more favourable to the relevant creditor than any equivalent provision of this Contract is to the Bank, the Borrower shall promptly inform the Bank and shall provide a copy of the more favourable provision to the Bank. The Bank may request that the Borrower promptly executes an agreement to amend this Contract so as to provide for an equivalent provision in favour of the Bank.
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Schedule I
Information and Visits
1. Information concerning the Investment
(a) The Borrower shall deliver to the Bank:
(i) | the information in content and in form, and at the times, specified in Part A.2 (Information Duties) of Schedule A (Investment Specification and Reporting) or otherwise as agreed from time to time by the parties to this Contract; |
(ii) | any such information or further document concerning the Investment as the Bank may require to comply with its obligations under the Horizon 2020 Legal Basis; and |
(iii) | any such information or further document concerning the financing, procurement, implementation, operation and environmental matters of or for the Investment as the Bank may reasonably require within a reasonable time; |
provided always that if such information or document is not delivered to the Bank on time, and the Borrower does not rectify the omission within a reasonable time set by the Bank in writing, the Bank may remedy the deficiency, to the extent feasible, by employing its own staff or a consultant or any other third party, at the Borrower’s expense and the Borrower shall provide such persons with all assistance necessary for the purpose.
(b) | The Borrower shall submit for the approval of the Bank without delay any material changes to the Investment, also taking into account the disclosures made to the Bank in connection with the Investment prior to the signing of this Contract, in respect of, inter alia, the total cost, plans, timetable or to the expenditure programme or financing plan for the Investment. |
(c) | The Borrower shall promptly inform the Bank of: |
(i) | any action initiated or any objection raised by any third party or any genuine complaint received by the Borrower or any Environmental Claim that is to its knowledge commenced, pending or threatened against it with regard to environmental or other matters affecting the Investment; and |
(ii) | any fact or event known to the Borrower, which may substantially prejudice or affect the Borrower’s ability to execute the Investment; |
(iii) | a genuine allegation, complaint or information with regard to Criminal Offences related to the Loan and/or the Investment; |
(iv) | any non-compliance by it with any applicable Environmental Law; and |
(v) | any suspension, revocation or modification of any Environmental Approval, and set out the action to be taken with respect to such matters; |
(d) | If the total cost of the Investment exceeds the estimated figure set out in Recital (A), the Borrower shall notify the Bank without delay and shall inform the Bank of its plans to fund the increased costs. |
(e) | The Borrower shall, and shall procure that each of its Subsidiaries shall, promptly inform the Bank if at any time it becomes aware of the illicit origin (including products of money laundering or linked to the financing of terrorism) of any funds invested in the Investment by the Borrower or another Group Company. |
(f) | The Borrower shall provide to the Bank, if so requested: |
(i) | a certificate of its insurers showing that all assets required in order to carry out the Investment are insured with reputable underwriters or insurance companies against those risks and to the extent as is usual for companies carrying on the same or substantially similar business; and |
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(ii) | annually, a list of policies in force covering any aspect of the Investment, together with confirmation of payment of the current premiums. |
2. Information concerning the Borrower
(a) The Borrower shall deliver to the Bank:
(i) | as soon as they become available but in any event within [*****] days after the end of each of its financial years its and CureVac AG’s audited consolidated and unconsolidated annual report, balance sheet, cash flow statement, profit and loss account and auditors report for that financial year together with a Compliance Certificate signed by [*****] directors (Geschäftsführer); |
(ii) | as soon as they become available but in any event within [*****] days after the end of each of the relevant accounting periods its interim consolidated and unconsolidated quarterly report, balance sheet, profit and loss account and cash flow statement for each of the first three quarters of each of its financial years together with a Compliance Certificate signed by [*****] (Geschäftsführer); |
(iii) | as soon as they become available but in any event within [*****] days after the end of each relevant period its liquidity forecasts for the next twelve months on a rolling basis, satisfactory to the Bank; |
(iv) | such further information, evidence or document concerning its general financial situation or such certificates of compliance with the undertakings of Article 7 (Borrower undertakings and representations) as the Bank may deem necessary or may reasonably require to be provided within a reasonable time; |
(v) | any such further information, evidence or document concerning the compliance with the due diligence requirements of the Bank, including, but not limited to “know your customer” (KYC) or similar identification procedures, when requested and within a reasonable time; |
(vi) | such further information, evidence or document concerning the factual information or documents provided to the Bank for the purposes of this Contract, as the Bank may deem necessary or may reasonably require to be provided within a reasonable time; and |
(vii) | and any other information reasonably requested by the Bank in order to determine/calculate the Remuneration Payments. |
(b) The Borrower shall inform the Bank immediately of:
(i) | any Default or Event of Default having occurred or being threatened or anticipated; |
(ii) | to the extent permitted by law, any material litigation, arbitration, administrative proceedings or investigation carried out by a court, administration or similar public authority, which, to the best of its knowledge and belief is current, threatened or pending: |
(1) | against the Borrower or its controlling entities or members of the Borrower’s management bodies in connection with Criminal Offences related to the Loan or the Investment; or |
(2) | which might if adversely determined result in a Material Adverse Change; |
(iii) | any measure taken by the Borrower pursuant to Paragraph 6 (Integrity) of Schedule H (General Undertakings); |
(iv) | any Change in the Beneficial Ownership of the Borrower; and |
(v) | any Voluntary Non EIB Prepayment that has occurred or is likely to occur. |
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3. Visits by the Bank
(a) | The Borrower shall allow persons designated by the Bank, as well as persons designated by other institutions or bodies of the European Union when so required by the relevant mandatory provisions of European Union law or pursuant to the Horizon 2020 Legal Basis, other competent EU institutions including the European Court of Auditors, the Commission, the European Anti-Fraud Office, the European Public Prosecutor’s Office as well as persons designated by the foregoing; |
(i) | to visit the Property, sites, installations and works comprising the Investment; |
(ii) | to interview representatives of the Borrower and each of its Subsidiaries that is an Obligor, and not obstruct contacts with any other person involved in or affected by the Investment; and |
(iii) | to conduct such investigations, inspections, on the spot audits and checks as they may wish and review the books and records of the Borrower and each of its Subsidiaries that is an Obligor in relation to the execution of the Investment and to be able to take copies of related documents to the extent not prohibited by the law. |
(b) | The Borrower shall, and shall ensure that each of its Subsidiaries which is an Obligor shall, provide the Bank, or ensure that the Bank is provided, with all necessary assistance for the purposes described in this Paragraph 3 (Visits by the Bank). |
(c) | In the case of a genuine allegation, complaint or information with regard to Criminal Offences related to the Loan and/or the Investment, the Borrower shall consult with the Bank in good faith regarding appropriate actions. In particular, if it is proven that a third party committed Criminal Offences in connection with the Loan and/or the Investment with the result that the Loan or the financing under the Horizon 2020 Framework EU Programme were misapplied, the Bank may, without prejudice to the other provisions of this Contract, inform the Borrower if, in its view, the Borrower should take appropriate recovery measures against such third party. In any such case, the Borrower shall in good faith consider the Bank’s views and keep the Bank informed. |
4. Disclosure and publication
(a) The Borrower acknowledges and agrees that:
(i) | the Bank may be obliged to communicate information relating to any Obligor and the Investment to any competent institution or body of the European Union in accordance with the relevant mandatory provisions of European Union law or pursuant to the Horizon 2020 Legal Basis; and |
(ii) | the Bank may publish in its website or produce press releases containing information related to the financing provided pursuant to this Contract, including the name, address and country of establishment of the Borrower the purpose of the financing, and the type and amount of financial support received under this Contract. |
(b) | The Borrower agrees to cooperate with the Bank to ensure that any press releases or publications made by the Borrower regarding the financing and the Investment include an appropriate acknowledgement of the financial support provided by the Bank with the backing of the European Union through the Horizon 2020 Framework EU Programme. |
(c) | If requested by the Bank, the Borrower undertakes to refer to this financing and other Bank financings in its public communications, if appropriate, during the availability period, and in connection with any drawdowns, and communications on major corporate events. |
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Schedule J
Existing Indebtedness
The DH Convertible Loan Agreement
Schedule K
Existing Security
1. Deposits (Mietkautionen) rented under the Building Leasing Agreements.
2. Building cost subsidy (Baukostenzuschuss) provided to the lessor(s) under Building Leasing Agreements
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Exhibit 10.37
Execution Version
REDACTED
Certain identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed.
Contract number (FI No): [*****]
Serapis No: [*****]
CUREVAC (IDFF)
Guarantee Agreement
between the
European Investment Bank
and
CureVac AG
Page 1/34
WHEREAS: | 5 | |
ARTICLE 1 | 6 | |
1.01 | INTERPRETATION | 6 |
1.02 | DEFINITIONS | 7 |
ARTICLE 3 | 9 | |
3.01 | GUARANTEE (GARANTIE) AND INDEMNITY (AUSFALLHAFTUNG) | 9 |
3.02 | DEMANDS AND PAYMENTS | 9 |
3.03 | INDEPENDENT PAYMENT OBLIGATION | 10 |
3.04 | NO DEFENCE | 11 |
3.05 | IMMEDIATE RECOURSE | 12 |
3.06 | APPROPRIATIONS | 12 |
3.07 | DEFERRAL OF GUARANTOR’S RIGHTS | 12 |
3.08 | ADDITIONAL SECURITY | 12 |
ARTICLE 4 | 13 | |
4.01 | TERM | 13 |
4.02 | REINSTATEMENT | 13 |
ARTICLE 5 | 13 | |
5.01 | REPRESENTATIONS AND WARRANTIES OF THE GUARANTOR | 13 |
5.02 | UNDERTAKINGS OF THE GUARANTOR | 18 |
5.03 | FINANCIAL INFORMATION | 25 |
5.04 | INFORMATION DUTIES | 26 |
ARTICLE 6 | 27 | |
6.01 | TAXES | 27 |
6.02 | INTEREST ON OVERDUE SUMS | 27 |
6.03 | OTHER CHARGES | 27 |
6.04 | CURRENCY CONVERSION | 28 |
6.05 | SET-OFF | 28 |
ARTICLE 7 | 28 | |
ARTICLE 8 | 28 |
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ARTICLE 9 | 28 | |
9.01 | GOVERNING LAW | 29 |
9.02 | JURISDICTION | 29 |
9.03 | PLACE OF PERFORMANCE | 29 |
9.04 | EVIDENCE OF SUMS DUE | 29 |
9.05 | ENTIRE AGREEMENT | 29 |
9.06 | INVALIDITY | 29 |
9.07 | AMENDMENTS | 30 |
9.08 | COUNTERPARTS | 30 |
9.09 | ASSIGNMENT AND TRANSFER BY THE BANK | 30 |
ARTICLE 10 | 31 | |
10.01 | FORM OF NOTICE | 31 |
10.02 | ADDRESSES | 32 |
10.03 | DEMAND AFTER NOTICE TO REMEDY | 32 |
10.04 | ENGLISH LANGUAGE | 32 |
10.05 | CONCLUSION OF THIS GUARANTEE AGREEMENT (VERTRAGSSCHLUSS) | 33 |
Page 3/34
THIS GUARANTEE AGREEMENT IS MADE ON 27 JUNE 2020 BETWEEN:
The European Investment Bank having its | (the “Bank”) | |
seat at 100 blvd Konrad Adenauer, | ||
Luxembourg, L-2950 Luxembourg, | ||
represented by Tero PIETILA, Head of | ||
Division and Ayse Nil ADA, Legal Counsel | ||
and | ||
(the “Guarantor”) | ||
CureVac AG a stock corporation | ||
(Aktiengesellschaft) incorporated in | ||
Germany, having its office at Friedrich- | ||
Miescher-Str. 15, 72076 Tübingen, | ||
Germany, registered with the commercial | ||
register (Handelsregister) of the local court | ||
(Amtsgericht) of Stuttgart under HRB 754041 | ||
represented by Dr. Franz-Werner Haas and | ||
Pierre Kemula |
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WHEREAS:
(A) | Pursuant to a finance contract dated as of 27 June 2020 and entered into between the Bank and CureVac Real Estate GmbH, a limited liability company (Gesellschaft mit beschränkter Haftung) incorporated in Germany, having its office at Friedrich-Miescher-Str. 15, 72076 Tübingen, Germany, registered with the commercial register (Handelsregister) of the local court (Amtsgericht) of Stuttgart under HRB 757523 (the “Borrower”), the Bank has agreed to grant in favour of the Borrower a credit in the amount of EUR 75,000,000 (seventy five million euro) (the “Finance Contract”). |
(B) | As a condition precedent to any disbursement under the Finance Contract, the Borrower has undertaken that the Guarantor shall, and the Guarantor has agreed to, grant a guarantee (Garantie) in favour of the Bank pursuant to the terms of this guarantee agreement (the “Guarantee Agreement”). |
(C) | Each Guarantor declares that the entry into, execution and performance of its obligations under this Guarantee Agreement are in its best corporate interest. |
(D) | The parties to this Guarantee Agreement expressly agree that the terms of this Guarantee Agreement shall survive, stay in play and are under no circumstances negatively affected by the intended CureVac IPO and any corporate measures or restructurings in connection with or in preparation of such CureVac IPO. The parties to this Guarantee Agreement will do any acts and will enter into any documents (including, without limitation, new guarantee agreements or similar arrangements) to achieve the aforementioned agreement. |
(E) | The entry into, execution and performance by the Guarantor of its obligations under this Guarantee Agreement have been duly authorised and the signatories of the Guarantor are duly entitled and authorised to execute this Guarantee Agreement on its behalf. |
(F) | The parties to this Guarantee Agreement expressly agree that any reference in this Guarantee Agreement to the Finance Contract shall under no circumstances be construed as affecting the independent, unconditional and irrevocable nature of the guarantee (Garantie) granted pursuant to this Guarantee Agreement. |
NOW THEREFORE it is hereby agreed as follows:
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It is hereby agreed as follows:
ARTICLE 1
Interpretation and definitions
1.01 Interpretation
In this Guarantee Agreement, unless a contrary indication appears:
(a) | “Guarantor”, the “Bank” or the “Borrower” shall be construed as to include its and any subsequent successors in title, permitted assigns and permitted transferees; |
(b) | references to Articles, Recitals, Schedules and (Sub-)Paragraphs are, save if explicitly stipulated otherwise, references respectively to articles of, and recitals, schedules and (sub-)paragraphs of schedules to, this Guarantee Agreement. All Recitals and Schedules form part of this Guarantee Agreement; |
(c) | references to “law” or “laws” mean (i) any applicable law and any applicable treaty, constitution, statute, legislation, decree, normative act, rule, regulation, judgement, order, writ, injunction, determination, award or other legislative or administrative measure or judicial or arbitral decision in any jurisdiction which is binding or applicable case law, and (ii) EU Law; |
(d) | references to applicable law, applicable laws or applicable jurisdiction means (i) a law or jurisdiction applicable to the Guarantor, its rights and/or obligations (in each case arising out of or in connection with the Finance Documents), its capacity and/or assets, and/or, as applicable, (ii) a law or jurisdiction (including in each case the Bank’s Statute) applicable to the Bank, its rights, obligations, capacity and/or assets; |
(e) | references to a provision of law are references to that provision as amended or re-enacted; |
(f) | references to this Guarantee Agreement and any other Finance Document or other agreement or instrument are references to this Guarantee Agreement or that Finance Document or other agreement or instrument as amended, novated, supplemented, extended or restated; | |
(g) | words and expressions in plural shall include singular and vice versa; |
(h) | “promptly” is to be construed as unverzüglich (without undue delay) within the meaning of Section 121 para. 1 sentence 1 of the BGB; |
(i) | a “person” includes any person, firm, company, corporation, government, state or agency of a state or any association, trust or partnership (whether having separate legal personality or not); and |
(j) | a Default (other than an Event of Default) is “continuing” if it has not been remedied or waived and an Event of Default is “continuing” if it has not been waived. |
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A term used in any notice given under or in connection with this Guarantee Agreement has the same meaning as ascribed to it in this Guarantee Agreement. This Guarantee Agreement is made in the English language. For the avoidance of doubt, the English language version of this Guarantee Agreement shall prevail over any translation of this Guarantee Agreement. However, where a German translation of a word or phrase appears in the text of this Guarantee Agreement, the German translation of such word or phrase shall prevail.
1.02 Definitions
A reference to a term defined in the Finance Contract has the same meaning in this Guarantee Agreement, unless otherwise defined herein. In this Guarantee Agreement:
“Bank’s Account” has the meaning given to such term in Article 3.02(c) (Demands and payments).
“BGB” means the German Civil Code (Bürgerliches Gesetzbuch).
“Demand” has the meaning given to such term in Article 3.02 (Demands and payments).
“EUR” or “euro” means the lawful currency of the Member States of the European Union which adopt or have adopted it as their currency in accordance with the relevant provisions of the Treaty on European Union and the Treaty on the Functioning of the European Union or their succeeding treaties.
“Fee Letters” means the Luxembourg law governed letter from the Bank to the Borrower dated 18 March 2020 and dated on or about 27 June 2020.
“Finance Documents” means this Guarantee Agreement, the Finance Contract, the Security Documents, the Fee Letters and any other document designated as a “Finance Document” by the Borrower and the Bank.
“GAAP” means generally accepted accounting principles in (Grundsätze ordnungsgemäßer Buchführung) in Germany, including IFRS.
“Guarantee” means the guarantee and indemnity granted pursuant to Article 3.01 (Guarantee (Garantie) and Indemnity (Ausfallhaftung)).
“InsO” means the German Insolvency Code (Insolvenzordnung).
“Land Charge” means the first ranking land charge without certificate (Buchgrundschuld) in the amount of EUR 75,000,000 (plus [*****]% interest p.a. and [*****]% one-time supplementary payment) created under the Land Charge Creation Deed by which the Borrower will encumber its Property and certain of its assets falling within the statutory scope of the Land Charge (Grundschuldhaftungsverband) in favour of the Bank.
“Land Charge Creation Deed” means any document by means of which the Land Charge is created and which includes, inter alia, an abstract acknowledgement of debt of the Borrower in the amount of the Land Charge (in each case subject to the submission to the immediate enforcement(sofortige Zwangsvollstreckungsunterwerfung) in personam and in rem for the full Land Charge amount), the Borrower’s approval for registration (Eintragungsbewilligung) of the Land Charge in the land register, regardless of whether such document will be officially certified (öffentlich beglaubigt) or notarially recorded (notariell beurkundet).
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“Notification” has the meaning given to such term in Article 3.02 (Demands and payments).
“Payment Period” has the meaning ascribed to such term in Article 3.02(e) (Demands and payments).
“Secured Obligations” has the meaning given to such term in Article 3.01(a) (Guarantee (Garantie) and Indemnity (Ausfallhaftung)).
“Security” means any mortgage, land charge (Grundschuld), security purpose agreement (Sicherungszweckvereinbarung), pledge, lien, charge, assignment, security transfer (Sicherungsübereignung), retention of title arrangements, hypothecation, or other security interest securing any obligation of any person or any other agreement or arrangement having a similar effect.
“Security Documents” means each Guarantee Agreement (including, for the avoidance of doubt, this Guarantee Agreement), the Land Charge Creation Deed, the Security Purpose Agreement and any other document entered into by any person creating or expressed to create any Security over all or any part of its assets in respect of the obligations of any of the Obligors under any of the Finance Documents.
“Security Purpose Agreement” means the security purpose agreement (Sicherungszweckvereinbarung) to be entered into by the Borrower as security grantor and the Bank as beneficiary in relation to the Land Charge.
“Tax” means any tax, levy, impost, duty or other charge or withholding of a similar nature (including any penalty or interest payable in connection with any failure to pay or any delay in paying any of the same).
“ZPO” means the German Code of Civil Procedure (Zivilprozessordnung).
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ARTICLE 2
Finance Documents
The Guarantor hereby confirms that it has received a copy of the Finance Documents and that it is aware of the contents of the Finance Documents and the transactions contemplated thereby. The Guarantor further confirms that, to the extent the Finance Documents are in the English language, it is in command of the English language or has obtained a translation thereof, and to the extent necessary, has made itself familiar with the contents of the Finance Documents and the transactions contemplated thereby.
ARTICLE 3
Guarantee
3.01 Guarantee (Garantie) and Indemnity (Ausfallhaftung)
The Guarantor irrevocably and unconditionally:
(a) | guarantees (garantiert) by way of an independent payment obligation (selbständiges Zahlungsversprechen) to the Bank to pay to the Bank any amount of principal, interest, Renumeration Payments, costs, expenses or other amount under or in connection with the Finance Documents that has not been fully and irrevocably paid by the Borrower or any other Guarantor, in each case including, for the avoidance of doubt, any obligation arising out of damages (Schadenersatz), unjust enrichment (ungerechtfertigte Bereicherung), tort (unerlaubte Handlung) or any claims arising from an insolvency administrator’s discretion to perform obligations in agreements according to Section 103 InsO (the “Secured Obligations”); and |
(b) | undertakes vis-à-vis the Bank to indemnify (schadlos halten) the Bank against any cost, loss or liability suffered by the Bank if any obligation of the Borrower under or in connection with any Finance Document or any obligation guaranteed by it is or becomes unenforceable, invalid or illegal. The amount of the cost, loss or liability shall be equal to the amount which the Bank would otherwise have been entitled to recover (Ersatz des positiven Interesses), unless such will be caused by gross negligence or wilful misconduct of the Bank; in this event the principles of contributory negligence (Mitverschulden) will apply. |
For the avoidance of doubt this Guarantee does not constitute a surety (Bürgschaft) or a guarantee upon first demand (Garantie auf erstes Anfordern) and, in particular, receipt of such written demand shall not preclude any rights and/or defences the Guarantor may have with respect to any payment requested by the Bank under this Guarantee.
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3.02 Demands and payments
Any demand made by the Bank to the Guarantor under this Guarantee Agreement (each, a “Demand”) shall be made by way of a written notification addressed by the Bank to the Guarantor, sent in accordance with the provisions set forth in Article 10.01 (Form of notice) below and having the following content (each a “Notification”):
(a) specifying that the Bank is making a Demand under this Guarantee Agreement;
(b) | specifying the amount due and payable by the Guarantor and that such amount is an amount of principal, interest, Renumeration Payments, costs, expenses or other amount under or in connection with the Finance Documents that has not been fully and irrevocably paid by the Borrower or any other Guarantor as well as the currency of payment of such sums; and |
(c) | providing details of the relevant bank account into which payment should be made (the “Bank’s Account”) together with relevant instructions as to how payment should be made (if any), |
it being understood that:
(d) | the Bank shall be under no obligation to provide the Guarantor with any additional document nor to support its claim with any other justification or evidence; and |
(e) | the payment obligation of the Guarantor under this Guarantee Agreement is not subject to the accuracy or the merit of any statement, declaration or information contained in any Notification. |
The Guarantor shall make the payment requested in the Notification within [*****] Business Days as from the date of receipt (included) of the relevant Notification (the “Payment Period”) and in the currency as requested within the Notification.
The Bank is entitled to request the payment of any amount in one or several instalments.
3.03 Independent payment obligation
This Guarantee:
(a) | is independent and separate from the other obligations of the Borrower and is a continuing guarantee and indemnity which will extend to the ultimate balance of sums payable by the Borrower under the Finance Documents, regardless of any intermediate payment or discharge in whole or in part; and |
(b) | shall extend to any additional obligations of the Borrower resulting from any amendment, novation, supplement, extension, restatement or replacement of any Finance Document, including without limitation any extension of or increase in any Loan or the addition of a new loan or tranche under the Finance Contract. |
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3.04 No defence
(a) | The obligations of the Guarantor under this Guarantee Agreement will not be affected by an act, omission, matter or thing which relates to the principal obligation (or purported obligation) of the Borrower or any other Guarantor and which would reduce, release or prejudice any of its obligations under this Guarantee Agreement, including any personal defences of the Borrower (Einreden des Hauptschuldners) or any right of revocation (Anfechtung) or set-off (Aufrechnung) of the Borrower. In particular, the Guarantor by its execution of this Guarantee Agreement: |
(i) | consents (willigt ein), as required pursuant or analogue to Section 418 sub-section 1 sentence 3 BGB, to any assumption of debt (Schuldübernahme) or assignment and transfer by assumption of contract (Vertragsübernahme) which relates to any such principal obligation (or purported obligation); and |
(ii) | waives (verzichtet auf) (A) any defences (Einreden) to which a Borrower in its respective capacity as principal debtor (Hauptschuldner) of any such principal obligation (or purported obligation) may be entitled and which may be asserted by the Guarantor pursuant or analogue to Section 768 sub-section 1 BGB as well as (B) any defences of voidability (Anfechtbarkeit) and set-off (Aufrechenbarkeit) pursuant or analogue to Section 770 sub-section 1 BGB or, respectively, section 770 sub-section 2 BGB. |
(b) | The obligations of the Guarantor under this Guarantee Agreement are independent from any other security or guarantee which may have been or will be given to the Bank. In particular, the obligations of the Guarantor under this Guarantee Agreement will not be affected by any of the following: |
(i) | the release of, or any time (Stundung), waiver or consent granted to, the Borrower or any other Guarantor from or in respect of its obligations under or in connection with any Finance Document, |
(ii) | the taking, variation, compromise, exchange, renewal or release of, or refusal or neglect to perfect, take up or enforce, any rights against, or Security over assets of, the Borrower or any other Guarantor or any other person or any failure to realise the full value of any Security, |
(iii) | any incapacity or lack of power, authority or legal personality of or dissolution or a deterioration of the financial condition of the Borrower or any other Guarantor, or |
(iv) | any unenforceability, illegality or invalidity of any obligation of the Borrower or any other Guarantor under the Finance Documents. |
(c) | For the avoidance of doubt nothing in this Article 3.04 (Excluded defences) shall preclude: |
(i) | any defences that the Guarantor (in its capacity as Guarantor only) may have against the Bank that the Guarantee does not constitute its legal, valid, binding or enforceable obligations, in particular respective limitations of enforceability based on corporate or insolvency laws which may be applicable to the Guarantor in its jurisdiction; and |
(ii) | asserting and invoking any objections or defences which the Guarantor itself may have against the Bank under this Guarantee Agreement. |
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3.05 Immediate recourse
The Bank will not be required to proceed against or enforce any other rights or Security or claim payment from any person before claiming from the Guarantor under this Guarantee. This applies irrespective of any law or provision of a Finance Document to the contrary.
3.06 Appropriations
Until all amounts which may be or become payable by the Borrower and the Guarantor under or in connection with the Finance Documents have been unconditionally and irrevocably paid in full, the Bank may:
(a) | refrain from applying or enforcing any other moneys, Security or rights held or received by the Bank in respect of those amounts, or apply and enforce the same in such manner and order as it sees fit (whether against those amounts or otherwise) and the Guarantor shall not be entitled to the benefit of the same; and |
(b) | hold in an account any moneys received from the Guarantor or on account of the Guarantor’s liability under this Guarantee until further notice by the Guarantor in which case the moneys shall be applied towards the discharge of the Secured Obligations. |
3.07 Deferral of Guarantor’s rights
(a) | Until all amounts which may be or become payable by the Borrower and the Guarantor under or in connection with the Finance Documents have been irrevocably paid in full and unless the Bank otherwise directs, the Guarantor will not exercise any rights which it may have by reason of performance by it of its obligations under the Finance Documents or by reason of any amount being payable, or liability arising, under this Guarantee: |
(i) | to be indemnified by the Borrower or any other Guarantor; |
(ii) | to claim any contribution from any other guarantor of any Borrower’s or any Guarantor’s obligations under the Finance Documents; |
(iii) | to exercise any right of set-off against the Borrower or any other Guarantor; and/or |
(iv) | to take the benefit (in whole or in part and whether by way of legal subrogation or otherwise) of any rights of the Bank under the Finance Documents or of any other guarantee or Security taken pursuant to, or in connection with, the Finance Documents by the Bank. |
(b) | If the Guarantor receives any benefit, payment or distribution in relation to such rights it shall hold that benefit, payment or distribution to the extent necessary to enable all amounts which may be or become payable to the Bank by the Borrower and any other Guarantor under or in connection with the Finance Documents to be repaid in full on trust for the Bank and shall promptly pay or transfer the same to the Bank or as the Bank may direct. |
3.08 Additional Security
This Guarantee is in addition to and is not in any way prejudiced by any other guarantee or Security now or subsequently held by the Bank.
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ARTICLE 4
Term of the Guarantee
4.01 Term
This Guarantee shall take effect on the date of execution of this Guarantee Agreement and expire on the date on which the Secured Obligations have been unconditionally and irrevocably been paid to the satisfaction of the Bank.
4.02 Reinstatement
If any payment by the Borrower or the Guarantor is avoided or reduced as a result of insolvency or any similar event:
(a) | the liability of the Guarantor shall continue as if the payment, discharge, avoidance or reduction had not occurred; and |
(b) | the Bank shall be entitled to recover the value or amount of that security or payment from the (other) Guarantor(s), as if the payment, discharge, avoidance or reduction had not occurred. |
(c) | Guarantor shall pay or reimburse the Bank for all expenses incurred by the Bank in the defence of any claim that a payment received by the Bank in respect of all or any part of the obligations under the Finance Documents must be refunded. |
(d) | The provisions of this Article 4.02 shall survive the termination of this Guarantee Agreement and any satisfaction and discharge of Borrower by virtue of any payment, court order, or law |
ARTICLE 5
Representations and Warranties
5.01 Representations and Warranties of the Guarantor
The Guarantor hereby represents and warrants to the Bank on the date of this Guarantee Agreement in respect of itself and, where applicable, the other Obligors:
(a) Authorisations and Binding Obligations
(i) | Each Obligor is duly incorporated and validly existing as a corporation or company with limited liability under the laws of its jurisdiction of incorporation. No Obligor’s shares are publicly traded. |
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(ii) | Its place of incorporation or establishment is not (a) a jurisdiction classified by any Lead Organisation as being weakly regulated and/or weakly supervised and/or non-transparent and/or uncooperative or any equivalent classification used by any Lead Organisation, in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax practices, and/or (b) a jurisdiction that is blacklisted by any Lead Organisation in connection with such activities.1 |
(iii) | Each Obligor has the power to carry on its business as it is now being conducted and to own its property and other assets, and to execute, deliver and perform its obligations under the Finance Documents. |
(iv) | Each Obligor has obtained all necessary Authorisations in connection with the execution, delivery and performance of the Finance Documents and in order to lawfully comply with its obligations thereunder, and in respect of the Investment, and all such Authorisations are in full force and effect and admissible in evidence. |
(v) | The execution and delivery of, the performance of each Obligor’s obligations under and compliance with the provisions of the Finance Documents do not and will not contravene or conflict with: |
(A) | any applicable law, statute, rule or regulation, or any judgement, decree or permit to which it is subject; |
(B) | any agreement or other instrument binding upon it which might reasonably be expected to have a material adverse effect on its ability to perform its respective obligations under this Guarantee Agreement; or |
(C) | any provision of its constitutional documents. |
(vi) | The execution and delivery of the Guarantee Agreement and the performance and compliance with its respective duties under this Guarantee Agreement do not and will not cause any representations made pursuant to this Article 5.01 to be untrue. |
(vii) | The obligations expressed to be assumed by it in this Guarantee Agreement are legal, valid, binding and enforceable obligations. |
1 Relevant jurisdictions may be identified on the basis of lists of Lead Organisations, as such lists are updated, amended or supplemented from time to time, including: jurisdictions with strategic deficiencies in the area of AML-CFT as identified by FATF (http://www.fatf-gafi.org/countries/#high-risk); jurisdictions listed “partially compliant”, “provisionally partially compliant” or “non-compliant” in the OECD Global Forum progress reports/ Global Forum rating (http://www.oecd.org/tax/transparency/GFratings.pdf; http://www.oecd.org/tax/transparency/exchange-of-information-on- request/ratings/); jurisdictions identified in EU delegated regulation 2016/1675 of 14.7.2016 supplementing Directive (EU) 2015/849 as high-risk third countries with strategic deficiencies (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R1675); and jurisdictions included in the EU list of non-cooperative jurisdictions for tax purposes (https://ec.europa.eu/taxation_customs/tax-common-eu-list_en).
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(b) No default or other adverse event
(i) | There has been no Material Adverse Change since [*****]. (Non-repeating) |
(ii) | No event or circumstance which constitutes an Event of Default has occurred and is continuing. |
(c) No Insolvency
As at the date of this Guarantee Agreement, no Obligor has taken any action to commence proceedings for, nor have any other steps been taken or legal proceedings commenced or, so far as the Borrower is aware, threatened against any Obligor for its insolvency, winding up or dissolution, or for any Obligor to enter into any arrangement or compositions for the benefit of creditors, or for the appointment of an administrator, receiver, administrative receiver, examiner, trustee or similar officer. (Non-repeating)
(d) No Proceedings
(i) | No litigation, arbitration, administrative proceedings or investigation is current or to its knowledge is threatened or pending before any court, arbitral body or agency which has resulted or if adversely determined is reasonably likely to result in a Material Adverse Change, nor is there subsisting against it or any of its Subsidiaries any unsatisfied judgement or award. (Non-repeating) |
(ii) | To the best of its knowledge and belief (having made due and careful enquiry) no material Environmental Claim has been commenced or is threatened against any Obligor. |
(iii) | As at the date of this Guarantee Agreement, no Obligor has taken any action to commence proceedings for, nor have any other steps been taken or legal proceedings commenced or, so far as the Borrower is aware, threatened against any Obligor for its insolvency, winding up or dissolution, or for any Obligor to enter into any arrangement or compositions for the benefit of creditors, or for the appointment of an administrator, receiver, administrative receiver, examiner, trustee or similar officer. |
(e) Security
At the date of this Guarantee Agreement, no Security exists over its assets other than any Permitted Security.
(f) Ranking
(i) | Its payment obligations under this Guarantee Agreement rank not less than pari passu in right of payment with all other present and future unsecured and unsubordinated obligations under any of its debt instruments except for obligations mandatorily preferred by law applying to companies generally. |
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(ii) | No financial covenants have been concluded with any other creditor of any Obligor. |
(iii) | No Voluntary Non-EIB Prepayment has occurred. |
(g) Anti-Corruption
(i) | Each Obligor is in compliance with all applicable European Union and national legislation, including any applicable anti-corruption legislation. |
(ii) | To the best of its knowledge, no funds invested in the Investment by any Obligor or any other Group Company are of illicit origin, including products of money laundering or linked to the financing of terrorism. |
(iii) | No Obligor is engaged in any Criminal Activities and to the best of the Obligor’s knowledge no Criminal Activities have occurred in connection with the Investment. (Non-repeating) |
(h) Accounting and Tax
(i) | The latest available consolidated and unconsolidated audited accounts of the Guarantor and the Borrower have been prepared on a basis consistent with previous years and have been approved by its auditors as representing a true and fair view of the results of its operations for that year and accurately disclose or reserve against all the liabilities (actual or contingent) of the Guarantor and the Borrower, as relevant. |
(ii) | The Accounting Reference Date of it is 31 December. |
(iii) | No Obligor is required to make any deduction for or on account of any Tax from any payment it may make under the Finance Documents, except for withholding tax (Kapitalertragssteuer) which have to be deducted pursuant to Sub-Paragraph (j) of Article 4.2 (Variable Renumeration) of the Finance Contract. (Non-repeating) |
(iv) | All Tax returns required to have been filed by each Obligor or on its behalf under any applicable law have been filed when due and contain the information required by applicable law to be contained in them. |
(v) | Each Obligor has paid when due all Taxes payable by it under applicable law except to the extent that it is contesting payment in good faith and by appropriate means. |
(vi) | With respect to Taxes which have not fallen due or which it is contesting, each Obligor is maintaining reserves adequate for their payment and in accordance, where applicable, with GAAP. |
(vii) | Under the laws of the jurisdiction of incorporation of each Obligor, it is not necessary that the Finance Documents be filed, recorded or enrolled with any court or other authority or that any stamp, registration or similar tax be paid on or in relation to the Finance Documents, or the transactions contemplated by the Finance Documents, other than the official certification (öffentliche Beglaubigung) of the Land Charge Creation Deed (Grundschuldbestellungsurkunde) and payment of related notary fees and the registration of the Land Charge in the land register (Grundbuch) and payment of the related registration fees. (Non-repeating) |
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(i) Information provided
Any factual information provided by any Group Company for the purposes of entering into this Guarantee Agreement and any related documentation was true and accurate in all material respects as at the date it was provided or as at the date (if any) at which it is stated and continues to be true and accurate in all material respect as at the date of this Guarantee Agreement. (Non-repeating)
(j) No indebtedness
No Obligor has Indebtedness outstanding other than Permitted Indebtedness. (Non-repeating)
(k) No Immunity
No Obligor, nor any of its assets, is entitled to immunity from suit, execution, attachment or other legal process.
(l) Pensions
The pension schemes for the time being operated by the Obligors (if any) are funded in accordance with their rules and to the extent required by law or otherwise comply with the requirements of any law applicable in the jurisdiction in which the relevant pension scheme is maintained.
(m) Environment
The Guarantor is in compliance with Paragraph 5. (Environment) of Schedule H (General Undertakings) of the Finance Contract, as if all references to the Borrower were to the Guarantor.
(n) Borrower Information
The Guarantor has and will continue to have full and complete access to any and all information concerning the transactions contemplated by the Finance Documents or referred to therein, the value of the assets owned or to be acquired by Borrower, Borrower’s financial status, and Borrower’s ability to pay and perform any obligation under or in connection with any Finance Document. So long as any obligation of Borrower under or in connection with any Finance Document remains unsatisfied or owing to the Bank, Guarantor shall keep itself fully informed as to all aspects of Borrower’s financial condition and ability to pay and perform such obligations.
(o) Other
In respect of this Guarantee Agreement and the transaction contemplated by, referred to in, provided for or effected by this Guarantee Agreement, it has entered into this Guarantee Agreement (i) in good faith and for the purpose of carrying out its business, (ii) on arms’ length commercial terms and (iii) without any intention to defraud or deprive of any legal benefit any other parties (such as third parties and in particular creditors other than the Bank) or to circumvent any applicable mandatory laws or regulations of any jurisdiction.
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The representations and warranties set out in this Article 5.01 – other than those Paragraphs which are identified with the words “(Non-repeating)” at the end of the Paragraphs - shall survive the execution of this Guarantee Agreement and shall be repeated on each Disbursement Date Acceptance and each Disbursement Date, by reference to the facts and circumstances then prevailing.
The Guarantor hereby confirms that it has made the representations and warranties contained in this Article with the intention of inducing the Bank to enter into the Finance Contract and accepting this Guarantee as security for the Finance Contract and that the Bank has entered into the Finance Contract and has accepted this Guarantee as security for the Finance Contract on the basis of, and in full reliance on, each of such representations and warranties.
5.02 Undertakings of the Guarantor
The Guarantor acknowledges and agrees that during the subsistence of this Guarantee Agreement:
(a) Authorisations
It shall obtain, comply with the terms of and do all that is necessary to maintain in full force and effect all authorisations, approvals, licences and consents required in or by the laws and regulations of its jurisdiction of incorporation to enable it lawfully to enter into, exercise its rights and perform the obligations expressed to be assumed by it under this Guarantee Agreement and to ensure the legality, validity, enforceability and admissibility in evidence of this Guarantee Agreement in its jurisdiction of incorporation.
(b) No Security
It shall not create or permit to subsist any Security over any of its assets other than:
(i) | any Permitted Security; and |
(ii) | any Security created with the prior approval of the Bank. |
(c) Pari passu with other creditors
The Guarantor shall ensure that its payment obligations under this Guarantee Agreement rank, and will rank not less than pari passu in right and priority of payment with all other present and future unsecured and unsubordinated obligations under any of its debt instruments except for obligations mandatorily preferred by law applying to companies generally.
(d) No action
It shall not take any action which would cause any of the representations made in Article 5.01 (Representations and Warranties of the Guarantor) above to be untrue at any time during the continuation of this Guarantee Agreement.
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(e) Know your Customer
The Guarantor shall deliver to the Bank any such information or further document concerning customer due diligence matters of or for the Guarantor as the Bank may reasonably require within a reasonable timeframe.
(f) Notification duty
The Guarantor shall notify the Bank of the occurrence of any event which results in or may reasonably be expected to result in any of the representations made in Article 5.01 (Representations and Warranties of the Guarantor) above being untrue.
(g) Completion of Investment
The Guarantor shall or shall procure that the Investment is carried out by the Borrower in accordance with the Technical Description as may be modified from time to time with the approval of the Bank, and is completed by the final date specified in the Finance Contract.
(h) Procurement procedure
The Guarantor shall and shall ensure that the Borrower secures goods and services for the Investment (a) in so far as they apply to it or to the Investment, in accordance with EU Law in general and in particular with the relevant EU Directives, and (b) in so far as EU Directives do not apply, by procurement procedures which, to the satisfaction of the Bank, respect the criteria of economy and efficiency and, in case of public contracts, the principles of transparency, equal treatment and non-discrimination on the basis of nationality.
(i) Compliance with laws
The Guarantor shall comply in all respects with all laws and regulations to which it or the Investment is subject.
(j) Environment
The Guarantor shall, and shall procure that the Borrower shall:
(i) | implement and operate the Investment in compliance with Environmental Law; and |
(ii) | obtain, maintain and comply with requisite Environmental Approvals for the Investment, |
and upon becoming aware of any breach of this Paragraph (j) (Environment) the Guarantor shall, or shall ensure that the Borrower will:
(i) | promptly notify the Bank; |
(ii) | consult with the Bank for up to [*****] Business Days from the date of notification with a view to agreeing the manner in which the breach should be rectified; and |
(iii) | remedy the breach within [*****] Business Days of the end of the consultation period. |
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(k) Integrity
The Guarantor shall take, within a reasonable timeframe, appropriate measures in respect of any member of its management bodies who has been convicted by a final and irrevocable court ruling of a Criminal Offence perpetrated in the course of the exercise of his/her professional duties, in order to ensure that such member is excluded from any Guarantor’s activity in relation to the Loan or the Investment.
(l) Disposal of assets
(i) | Except as provided under Sub-Paragraph (b) below, the Guarantor shall not, and shall procure that no Group Company shall, either in a single transaction or in a series of transactions whether related or not and whether voluntarily or involuntarily dispose of all or any part of any Group Company’s business, undertaking or assets (including any shares, real estate or security of any entity or a business or undertaking, or any interest in any of them). |
(ii) | Sub-Paragraph (i) above does not apply to any such disposal (“Permitted Disposal”): |
(A) | made with the prior written consent of the Bank; |
(B) | made on arm’s length terms in the ordinary course of business of a Group Company, provided that these are made between Obligors only; |
(C) | made on arm’s length terms and at fair market value for cash, which is reinvested in assets of comparable or superior type, value and quality; |
(D) | made on arm’s length terms in exchange for other assets (other than shares, businesses and real estate) comparable or superior as to type, value and quality; |
(E) | by one Group Company which is (A) an Obligor to another Obligor, or (B) not an Obligor to another Group Company which is not an Obligor; |
(F) | constituted by a licence of Intellectual Property Rights on arm’s length terms in the ordinary course of business of a Group Company; |
(G) | made in relation to non-material assets which have depreciated to less than [*****]% ([*****] per cent.) of their initial value or which are obsolete; or |
(H) | arising as a result of Permitted Security, |
provided that the disposal is not of assets forming part of the Investment or shares in subsidiaries holding assets forming part of the Investment, which may not be disposed of unless either (A) the Guarantor consults the Bank in relation to such disposal, and the Bank approves the disposal, or (B) the proceeds of the disposal are applied to prepay Loan.
For the purposes of this Paragraph (l) (Disposal of assets), “dispose” and “disposal” includes any act effecting sale, transfer, lease or other disposal (Verfügung).
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(m) Maintenance of assets
The Guarantor shall, or shall ensure that the Borrower maintain, repair, overhaul and renew all assets required in relation to the Investment as required to keep such assets in good working order.
(n) Insurances
The Guarantor shall, and shall procure that each Group Company shall, maintain insurances on and in relation to its business and assets with reputable underwriters or insurance companies against those risks and to the extent as is usual for companies carrying on the same or substantially similar business.
(o) Change in business
The Guarantor shall procure that no substantial change is made to the general nature of its business, the business of the Borrower or the business of the Group as a whole from that carried on at the date of this Agreement.
(p) Merger
The Guarantor shall not, and shall procure that that no Group Company shall, enter into any amalgamation, demerger, merger or corporate reconstruction (including the conclusion of any domination and/or profit and loss transfer agreements (Beherrschungs- und/oder Gewinnabführungsverträge) or any other enterprise agreements (Unternehmensverträge) with the meaning of section 291 AktG) unless:
(i) | with the prior written consent of the Bank; or |
(ii) | such amalgamation, demerger, merger or corporate reconstruction does not result in a Material Adverse Change and is on a solvent basis, and provided that: |
(A) | only Group Companies are involved and if a Guarantor is involved, the surviving entity will also be or become a Guarantor; |
(B) | the resulting entity will not be incorporated or located in a country which is in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax practices as such blacklist may be amended from time to time; and |
(C) | if the Borrower is involved, (1) the rights and obligations of the Borrower under the Finance Contract will remain with the Borrower, (2) the surviving entity will be the Borrower and the statutory seat of the Borrower would not as a result of such merger be transferred to a different jurisdiction, (3) the merger will not have an effect on the validity, legality or enforceability of the Borrower’s obligations under this Contract; and (4) all of the business and assets of the Borrower are retained by it. |
(q) Books and records
The Guarantor shall, and shall procure that each Group Company shall ensure that it has kept and will continue to keep proper books and records of account, in which full and correct entries shall be made of all financial transactions and its assets and business, including expenditures in connection with the Investment, in accordance with GAAP as in effect from time to time.
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(r) Ownership
(i) | The Guarantor shall maintain not less than [*****]% ([*****] per cent.) of the issued share capital, directly or indirectly through wholly owned subsidiaries, of the Borrower, unless a prior written consent of the Bank is received by the Guarantor. |
(ii) | The Guarantor shall immediately notify the Bank in the event of a new entity becoming a Subsidiary of the Guarantor through any means, including but not limited to acquisition, creation and spin-off. |
(iii) | The undertakings in Sub-Paragraphs (i), and (ii) above shall be calculated in accordance with GAAP as applied by the Guarantor on the date of this Agreement and as GAAP is amended from time to time and tested annually. |
(s) Acquisitions
The Guarantor shall not, and shall procure that no Group Company shall, invest in (including by way of payment into the capital reserve (Kapitalrücklage)) or acquire any entity or a business going concern or an undertaking (whether whole or substantially the whole of the assets or business), or any division or operating unit thereof, or any shares or securities of any entity or a business or undertaking (or in each case, any interest in any of them) (or agree to any of the foregoing), save for an acquisition or investment:
(i) | with the prior written consent of the Bank; |
(ii) | by a Group Company which is an Obligor of an asset sold, leased, transferred or otherwise disposed of by another Obligor; |
(iii) | by a Group Company of all the shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, provided that: |
(A) | such entity has not yet commenced commercial operations; |
(B) | such entity is incorporated in a country that is a member of either or both of the European Union or the Organisation of Economic Co-Operation and Development; and |
(C) | no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition; or |
(iv) | of shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, the consideration for which does not exceed an aggregate amount of EUR [*****] ([*****] euro) during any financial year, provided that: |
(A) | no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition; |
(B) | the acquired entity is engaged in a business similar or complementary to the business carried on by the Group as at the date of this Contract; |
(C) | the acquired entity is not incorporated or located in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax practices as such blacklist may be amended from time to time; |
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(D) | in respect of any acquisition where the consideration exceeds EUR [*****] ([*****] euro), legal and financial due diligence reports (including customary reliance letters in favour of the Bank) and a business plan (in the form of the most recent budget adjusted for the expected effects of the acquisition) in respect of the 3 (three) next following financial years and any other due diligence reports received in connection with the acquisition (if any) are provided to the Bank; and |
(E) | the Borrower provides a Compliance Certificate for the [*****] month financial periods immediately following the acquisition, updated on a pro forma basis as if the acquisition has occurred. |
(t) Indebtedness
The Guarantor shall not, and shall procure that no other Group Company shall, incur any Indebtedness, save for any Permitted Indebtedness.
(u) Guarantees
(i) | The Guarantor shall not, and shall procure that no other Group Company shall, issue or allow to remain outstanding any guarantees or sureties (Bürgschaften) in respect of any liability or obligation of any person save for any guarantee or surety (Bürgschaft) which is expressly permitted under Paragraph 16(a)(i) and (ii) (Guarantees) of Schedule H (General Undertakings) of the Finance Contract: |
(ii) | The Guarantor shall procure that, as soon as any Group Company becomes a Material Subsidiary (as identified in any accounts delivered to the Bank from time to time pursuant to Article 6.01 (Financial Information), that Group Company shall promptly notify the Bank and on the Bank’s request enter into a Guarantee Agreement and provide the Bank with the documentary conditions precedent (each in form and substance satisfactory to the Bank) listed in Part B of Schedule F (Guarantor Conditions Precedent) of the Finance Contract within [*****] Business Days following the date on which such Subsidiary qualifies as a Material Subsidiary, subject to general statutory limitations, financial assistance, capital maintenance, corporate benefit, fraudulent preference, “thin capitalisation” rules, retention of title claims and similar principles may limit the ability of a Guarantor to provide a guarantee or security or may require that the guarantee be limited by an amount or otherwise provided that the Guarantor and each Group Company will ensure to overcome such obstacles and, if applicable, to assist in demonstrating that adequate corporate benefit accrues to each Guarantor. |
(v) Hedging
The Guarantor shall not, and shall procure that no other Group Company shall, enter into any derivative transaction other than a Permitted Hedging.
(w) Restrictions on distributions
The Guarantor shall not, and shall procure that no other Group Company shall, declare or distribute dividends, or return or purchase shares, save for:
(i) | with the prior written consent of the Bank; |
(ii) | payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor; |
(iii) | any dividend payments made by any Subsidiary; and |
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(iv) | any dividend payments made by an Obligor to another Obligor. |
(x) Restrictions on loans
The Guarantor shall not, and shall ensure that no other Group Company will, be a creditor in respect of any Indebtedness, save for:
(i) | with the prior written consent of the Bank; |
(ii) | any trade credit extended by it or any other Group Company to its customers on normal commercial terms and in the ordinary course of its trading activities; |
(iii) | any loan made by one Group Company (other than an Obligor) to another Group Company (other than an Obligor); |
(iv) | a loan made by one Obligor to another Obligor; or |
(v) | any other Indebtedness or loan advanced to or made available by any member of the Group with the prior written consent of the Bank. |
(y) Restrictions on intercompany loans
The Guarantor shall not, and shall procure that no other Group Company shall, make any payment in respect of any intercompany loan, save for:
(i) | with the prior written consent of the Bank; |
(ii) | where the lender of the intercompany loan is the Guarantor, the Borrower or an Obligor; or |
(iii) | the payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor. |
(z) Intellectual Property Rights
The Guarantor shall, and shall procure that no other Group Company shall, (i) obtain, safeguard and maintain its rights with respect to the Intellectual Property Rights required for the implementation of the Investment in accordance with this Contract, including complying with all material contractual provisions and that the implementation of the Investment in accordance with the Finance Contract will not result in the infringement of the rights of any person with regard to the Intellectual Property Rights and (ii) ensure that any Intellectual Property Rights required for the implementation of the Investment will be owned by or licensed to the Borrower, and where such Intellectual Property Rights which are owned by a Group Company are capable of registration, are registered to such party.
(aa) Maintenance of Status
The Guarantor shall, and shall procure that each other Group Company shall, remain duly incorporated and validly existing as a corporate entity with limited liability under the jurisdiction in which it is incorporated and that it will have no centre of main interests, permanent establishment or place of business outside the jurisdiction in which it is incorporated, and that it will continue to have the power to carry on its business as it is now being conducted and continue to own its property and other assets.
(bb) Negative pledge
(i) | The Guarantor shall not (and shall procure that no other Group Company shall) create or permit to subsist any Security over any of its assets, unless it constitutes a Permitted Security. |
(ii) | For the purposes of Paragraph (i) above, the term Security shall also include any arrangement or transaction on assets or receivables or money (such as the sale, transfer or other disposal of assets on terms whereby they are or may be leased to or re-acquired by the Guarantor or any Group Company, the sale, transfer or other disposal of any receivables on recourse terms or any arrangement under which money or the benefit of a bank account or other account may be applied or set off or any preferential arrangement having a similar effect) in circumstances where the arrangement or transaction is entered into primarily as a method of raising credit or of financing the acquisition of an asset. |
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(cc) Other Undertakings
The Guarantor shall take note of the Bank’s group statement on tax fraud, tax evasion, tax avoidance, aggressive tax planning, money laundering and financing of terrorism (as published on the Bank’s website and as may be amended from time to time).
(dd) Data Protection
Before disclosing any personal data (other than mere contact information relating to the Guarantor’s personnel involved in the management of this Guarantee Agreement) to the Bank in connection with this this Guarantee Agreement, the Guarantor shall ensure that each data subject of those personal data:
(i) | has been informed of the disclosure (including the categories of personal data to be disclosed); and |
(ii) | has the information in (or has been provided with an appropriate link to) the Bank’s privacy statement in relation to its lending and investment activities set out at the relevant time at https://www.eib.org/en/privacy/lending (or such other address as the Bank may notify to the Borrower in writing from time to time). |
(ee) European Union Distributions and Sales
Subject to receipt of approval to commercialise the SARS-CoV-2 Vaccine from the European Medicines Agency, the Guarantor shall procure that the Borrower shall use its best commercial efforts to ensure that a reasonable and equitable amount of the future distribution of the SARS-CoV-2 Vaccine as well as other vaccines and products to be manufactured in the GMP IV occurs within the European Union.
Information to the Bank
5.03 Financial Information
The Guarantor shall deliver to the Bank:
(a) | as soon as they become available but in any event within [*****] days after the end of each of its financial years, a copy of its audited consolidated and unconsolidated annual reports, balance sheets, cash flow statements, profit and loss accounts for that financial year together with all other such information as the Bank may reasonably require as to the Guarantor’s and the Group’s financial situation; and |
(b) | from time to time, such further information on its general financial position, business and operation as the Bank may reasonably request. |
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5.04 Information duties
During the subsistence of this Guarantee Agreement, the Guarantor shall immediately inform the Bank of:
(a) | any material alteration to its constitutional documents and of any proposal or decision known to it which envisages the introduction of such alteration as well as of any material change in its corporate status or powers, in each case in so far as such event could reasonably be expected to affect the validity and enforceability of this Guarantee Agreement or the ability of the Guarantor to perform the obligations expressed to be assumed by it under this Guarantee Agreement; |
(b) | a Change-of-Law Event with respect to the Guarantor; and |
(c) | deliver any other information on its financial position likely to have a detrimental effect on its ability to perform the obligations expressed to be assumed by it under this Guarantee Agreement. |
For the purposes of this Article 5.04, “Change-of-Law Event” means the enactment, promulgation, execution or ratification of or any change in or amendment to any law, rule or regulation (or in the application or official interpretation of any law, rule or regulation) that occurs after the date of this Guarantee Agreement and which, in the opinion of the Bank, would materially impair the Guarantor’s ability to perform its obligations under this Guarantee Agreement.
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ARTICLE 6
Default interest and Taxes
6.01 Taxes
All Taxes, charges, duties, fees as well as any other expenses or impositions of whatsoever nature, arising out or in connection with this Guarantee Agreement shall be borne by the Guarantor. The Guarantor shall make all payments under this Guarantee Agreement gross without withholding or deduction of any Tax, charges, duties, fees, expenses or impositions of whatsoever nature
If any amount in respect of any applicable Taxes, charges, duties, fees as well as any other expenses or impositions must be deducted, withheld or retained from any amount due under this Guarantee Agreement, the Guarantor undertakes to pay such additional amount as may be necessary to ensure that the Bank receives a net amount equal to the full amount to which it is entitled under this Guarantee Agreement.
The Guarantor undertakes to pay and indemnify the Bank against any amount, cost or loss incurred by the Bank in relation to any stamp duty, registration or similar Tax or notarial fee payable in respect of the Guarantor.
6.02 Interest on overdue sums
If the Guarantor fails to pay any amount (other than any interest amount) payable by it under this Guarantee Agreement within the relevant Payment Period in accordance with Article 3.02 (Demands and payments), interest shall accrue on any such overdue amount (other than any interest amount) payable under the terms of this Guarantee Agreement, as from the expiration of the relevant Payment Period up to the date of payment by the Guarantor, at the rate and on the terms specified in Article 4.4 (a) (Interest on overdue sums) of the Finance Contract.
If the Guarantor fails to pay interest payable by it under this Guarantee Agreement on its due date, Article 4.4 (b) (Interest on overdue sums) of the Finance Contract shall apply.
For the purpose of determining EURIBOR, the relevant periods within the meaning of Schedule B (Definition of EURIBOR) of the Finance Contract shall be successive periods of [*****] commencing on the expiration of the Payment Period. If the overdue sum is in a currency other than the currency of the Loan, the following rate per annum shall apply, namely the relevant interbank rate that is generally retained by the Bank for transactions in that currency plus [*****]% ([*****] basis points), calculated in accordance with the market practice for such rate.
6.03 Other charges
All reasonable fees, charges and expenses (including legal fees) incurred as result or in connection with the negotiation, preparation, execution, implementation, registration, enforcement, termination or translation of this Guarantee Agreement or any related document, any amendment, supplement or waiver in respect of this Guarantee Agreement or any related document shall be borne by the Guarantor.
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6.04 Currency conversion
Any payment to be made by the Guarantor under this Guarantee Agreement shall be made in the currency as set out in the relevant Notification. The Bank shall apply the exchange rate published by the European Central Bank in Frankfurt for the purpose of any currency conversion.
If the Bank has received a payment under this Guarantee in a currency other than the currency requested in the relevant Notification and must convert this payment, the Guarantor shall indemnify the Bank, upon first demand, for any loss resulting from the difference in exchange rates between the date of conversion and the date on which the payment is received in the other currency, as well as for any fees (including legal fees, Taxes and any other charges) connected with this conversion.
6.05 Set-off
All payments to be made by the Guarantor under this Guarantee Agreement shall be made without (and free and clear of any deduction for) set-off or counterclaim unless the counterclaim is undisputed or has been confirmed in a final non-appealable judgement.
ARTICLE 7
Continuing obligations
It is hereby expressly agreed that any change, whatsoever, in the legal situation of the Guarantor shall not affect its obligations under this Guarantee Agreement and that in particular, in case of merger, demerger or absorption, the absorbing new or beneficiary company shall take over, under the merger treaty or agreement, the commitments of the Guarantor under this Guarantee Agreement and in case of demerger, the demerger companies benefiting from the partial assignment of assets resulting from the split will be bound to:
(a) | take over with joint liability the commitments of the Guarantor under this Guarantee Agreement; and |
(b) | if requested by the Bank, grant additional security or guarantees. |
ARTICLE 8
Non waiver
No failure or delay or single or partial exercise by the Bank in exercising any of its rights or remedies under this Guarantee Agreement shall be construed as a waiver of such right or remedy and the Bank shall not be liable for any such failure, delay or single or partial exercise of any such right and remedy.
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ARTICLE 9
Law and jurisdiction, miscellaneous
9.01 Governing Law
This Guarantee Agreement and any non-contractual obligations arising out of or in connection with it shall be governed by the laws of Germany.
9.02 Jurisdiction
(a) | The courts of Frankfurt am Main, Germany, have exclusive jurisdiction to settle any dispute (a “Dispute”) arising out of or in connection with this Guarantee Agreement (including a dispute regarding the existence, validity or termination of this Guarantee Agreement or the consequences of its nullity) or any non-contractual obligation arising out of or in connection with this Guarantee Agreement. |
(b) | The parties agree that the courts of Frankfurt am Main, Germany., are the most appropriate and convenient courts to settle Disputes between them and, accordingly, that they will not argue to the contrary. |
(c) | This Article 9.02 is for the benefit of the Bank only. As a result and notwithstanding Sub-Paragraph (a) above, it does not prevent the Bank from taking proceedings relating to a Dispute in any other courts with jurisdiction. To the extent allowed by law, the Bank may take concurrent proceedings in any number of jurisdictions. |
9.03 Place of performance
Unless otherwise specifically agreed by the Bank in writing, the place of performance under this Guarantee Agreement, shall be the seat of the Bank.
9.04 Evidence of sums due
In any legal action arising out of this Guarantee Agreement the certificate of the Bank as to any amount or rate due to the Bank under this Guarantee Agreement shall, in the absence of manifest error, be prima facie evidence of such amount or rate.
9.05 Entire Agreement
This Guarantee Agreement constitutes the entire agreement between the Bank and the Guarantor in relation to the provision of this Guarantee Agreement hereunder, and supersedes any previous agreement, whether express or implied, on the same matter.
9.06 Invalidity
If at any time any term of this Guarantee Agreement is or becomes illegal (nichtig), invalid or unenforceable in any respect, or this Guarantee Agreement is or becomes ineffective (unwirksam) in any respect, under the laws of any jurisdiction, such illegality (Nichtigkeit), invalidity, unenforceability or ineffectiveness (Unwirksamkeit) shall indisputably (unwiderlegbar) not affect:
(a) | the legality, validity or enforceability in that jurisdiction of any other term of this Guarantee Agreement or the effectiveness in any other respect of this Guarantee Agreement in that jurisdiction; or |
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(b) | the legality, validity or enforceability in other jurisdictions of that or any other term of this Guarantee Agreement or the effectiveness of this Guarantee Agreement under the laws of such other jurisdictions, |
without any party to this Guarantee Agreement having to argue (darlegen) and prove (beweisen) such parties’ intent to uphold this Guarantee Agreement even without the void, invalid or ineffective provisions.
The illegal, invalid, unenforceable or ineffective provision shall be deemed replaced by such legal, valid, enforceable and effective provision that in legal and economic terms comes closest to what the parties to this Guarantee Agreement intended or would have intended in accordance with the purpose of this Guarantee Agreement if they had considered the point at the time of conclusion of this Guarantee Agreement. The same applies in the event that this Guarantee Agreement does not contain a provision which it needs to contain in order to achieve the economic purpose as expressed herein (Regelungslücke).
9.07 Amendments
Any amendment to this Guarantee Agreement (including this Article 9.07) shall be made in writing (or in notarial form, if required) and shall be signed by the parties hereto Any amendment to this Guarantee Agreement shall be made in writing (or in notarial form, if required) and shall be signed by the parties hereto.
9.08 Counterparts
This Guarantee Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument.
9.09 Assignment and transfer by the Bank
(a) | The Bank may assign or transfer (by way of assumption of debt (Vertragsübernahme), novation, sub-participation or otherwise) all or part of its rights, benefits or obligations under the Finance Documents. The Guarantor herewith consents to any such assignment or transfer. |
(b) | The Bank shall have the right to disclose all information relating to or concerning the Guarantor, the Group, the Finance Documents and the Loan in connection with or in contemplation of any such assignment or transfer. |
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ARTICLE 10
Final Articles
10.01 Form of notice
(a) | Any notice or other communication given under this Guarantee Agreement must be in writing and, unless otherwise stated, may be made by letter and electronic mail. |
(b) | Notices and other communications for which fixed periods are laid down in this Guarantee Agreement or which themselves fix periods binding on the addressee, may be made by hand delivery, registered letter or by electronic mail. Such notices and communications shall be deemed to have been received by the other party: |
(i) | on the date of delivery in relation to a hand-delivered or registered letter; or |
(ii) | in the case of any electronic mail, when the electronic mail is received in readable form. |
(c) | Any notice provided by the Guarantor to the Bank by electronic mail shall: |
(i) | mention the Contract Number in the subject line; and |
(ii) | be in the form of a non-editable electronic image (pdf, tif or other common non-editable file format agreed between the parties) of the notice signed by one or more Authorised Signatories of the Guarantor as appropriate, attached to the electronic mail. |
(d) | Notices issued by the Guarantor pursuant to any provision of this Guarantee Agreement shall, where required by the Bank, be delivered to the Bank together with satisfactory evidence of the authority of the person or persons authorised to sign such notice on behalf of the Guarantor and the authenticated specimen signature of such person or persons, unless such person is listed in the then current List of Authorised Signatories. |
(e) | Without affecting the validity of electronic mail or communication made in accordance with this Article 10.01 (Form of notice), the following notices, communications and documents shall also be sent by registered letter to the relevant party at the latest on the immediately following Business Day: |
(i) | Disbursement Acceptance; |
(ii) | any notices and communication in respect of the cancellation of a disbursement of any Tranche, Prepayment Request, Prepayment Notice, Event of Default, any demand for prepayment, and |
(iii) | any other notice, communication or document required by the Bank. |
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(f) | The parties agree that any above communication (including via electronic mail) is an accepted form of communication, shall constitute admissible evidence in court and shall have the same evidential value as an agreement under hand. |
(g) | Any communication or document made or delivered to the Guarantor in accordance with this Article 10.01 (Form of notice) will be deemed to have been made or delivered to each of the Obligors or any other member of the Group party to a Finance Document. Each Obligor incorporated in Germany, for this purpose, appoints the Borrower as its receipt agent (Empfangsboten). |
10.02 Addresses
The address and electronic mail address (and the department or officer, if any, for whose attention the communication is to be made) of each party for any communication to be made or document to be delivered under or in connection with this Guarantee Agreement is:
For the Bank | Attention: [*****] |
98 - 100 boulevard Konrad Adenauer, L-2950 Luxembourg | |
Email address: [*****] | |
For the Guarantor | Attention: [*****] |
Friedrich-Miescher-Str 15, 72076 Tübingen, | |
Germany Email address: [*****] | |
[*****] |
10.03 Demand after notice to remedy
The Bank and the Guarantor shall promptly notify the other party in writing of any change in their respective communication details.
10.04 English language
(a) | Any notice or communication given under or in connection with this Guarantee Agreement must be in English. |
(b) | All other documents provided under or in connection with this Guarantee Agreement must be: |
(i) | in English; or |
(ii) | if not in English, and if so required by the Bank, accompanied by a certified English translation and, in this case, the English translation will prevail. |
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10.05 Conclusion of this Guarantee Agreement (Vertragsschluss)
(a) | The parties to this Guarantee Agreement may choose to conclude this Guarantee Agreement by an exchange of signed signature page(s), transmitted by any means of telecommunication (telekommunikative Übermittlung) such as by way of electronic photocopy. |
(b) | If the parties to this Guarantee Agreement choose to conclude this Guarantee Agreement pursuant to this Article 10.05 (Conclusion of this Guarantee Agreement (Vertragsschluss)), they will transmit the signed signature page(s) of this Guarantee Agreement to [*****] (each a “Recipient”). This Guarantee Agreement will be considered concluded once a Recipient has actually received the signed signature page(s) (Zugang der Unterschriftsseite(n)) from all Parties (whether electronic photocopy or other means of telecommunication and at the time of the receipt of the last outstanding signature page(s) by such one Recipient). |
(c) | For the purposes of this Article 10.05 (Conclusion of this Guarantee Agreement (Vertragsschluss)) only, the parties to this Guarantee Agreement appoint each Recipient as their attorney (Empfangsvertreter) and expressly allow (gestatten) each Recipient to collect the signed signature page(s) from all and for all parties to this Guarantee Agreement. For the avoidance of doubt, each Recipient will have no further duties connected with its position as Recipient. In particular, each Recipient may assume the conformity to the authentic original(s) of the signature page(s) transmitted to it by means of telecommunication, the genuineness of all signatures on the original signature page(s) and the signing authority of the signatories. |
(d) | For the purposes of proof and confirmation, each party to this Guarantee Agreement has to provide the Recipients with original signature page(s) promptly, but no later than [*****] Business Days, after signing this Guarantee Agreement in accordance with this Article 10.05 (Conclusion of this Guarantee Agreement (Vertragsschluss)). The Bank may demand that the Guarantors subsequently sign one or more copies of this Guarantee Agreement. |
Page 33/34
IN WITNESS WHEREOF the parties hereto have caused this Guarantee Agreement to be executed in three (3) originals (two (2) originals for the Bank and two (1) original for the Guarantor) in the English language.
Signed for and on behalf of | Signed for and on behalf of | ||||||
EUROPEAN INVESTMENT BANK | CUREVAC AG | ||||||
/s/ Tero Pietila | /s/ Ayse Nil ADA | ||||||
Name: | Name: | Name: | Name: | ||||
Tero Pietila | Ayse Nil ADA | ||||||
Title: Head of Division | Title: Legal Counsel | Title: | Title: | ||||
Page 34/34
IN WITNESS WHEREOF the parties hereto have caused this Guarantee Agreement to be executed in three (3) originals (two (2) originals for the Bank and two (1) original for the Guarantor) in the English language.
Signed for and on behalf of | Signed for and on behalf of | ||||||
EUROPEAN INVESTMENT BANK | CUREVAC AG | ||||||
/s/ Franz Werner Haas | /s/ Pierre Kemula | ||||||
Name: | Name: | Name: Franz Werner Haas | Name: Pierre Kemula | ||||
Title: | Title: | Title: Acting CEO | Title: C.F.O |
Exhibit 14.1
Code of Conduct and Ethics |
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Table of Content
1 | COVER LETTER | 2 |
2 | DEFINITIONS | 4 |
3 | INTRODUCTION | 7 |
4 | INTEGRITY AT CUREVAC | 7 |
4.1 | HONESTY AND INTEGRITY | 7 |
4.2 | ETHICAL BEHAVIOR, MUTUAL RESPECT AND EQUALITY | 7 |
4.3 | HEALTH, SAFETY AND ENVIRONMENT | 8 |
4.4 | CONFLICTS OF INTEREST AND CORPORATE OPPORTUNITIES | 8 |
4.5 | LAW COMPLIANCE | 9 |
5 | INTEGRITY WITH OUR BUSINESS PARTNERS | 10 |
5.1 | GOOD FAITH | 10 |
5.2 | COMPETITION, ANTI-TRUST | 10 |
5.3 | ANTI-BRIBERY AND ANTI-CORRUPTION | 11 |
5.4 | ANTI-MONEY LAUNDERING | 12 |
5.5 | INTERNATIONAL TRADE, EXPORT CONTROLS | 12 |
6 | PROTECTION OF COMPANY ASSETS | 12 |
6.1 | USE OF COMPANY ASSETS | 12 |
6.2 | CONFIDENTIALITY, INSIDER TRADING | 13 |
6.3 | DATA PROTECTION AND IT SECURITY | 13 |
6.4 | DOCUMENTATION, SIGNATURE POLICY AND BOOKS, RECORDS AND ACCOUNTING | 14 |
6.5 | PUBLIC COMMUNICATION | 14 |
7 | CORPORATE SOCIAL RESPONSIBILITY | 15 |
7.1 | PRINCIPLES OF MEDICAL RESEARCH | 15 |
7.2 | HEALTHCARE CODICES | 15 |
8 | CONTACT AND SUPPORT | 16 |
8.1 | WHISTLEBLOWER | 16 |
8.2 | CONTACT AND SUPPORT | 17 |
Code of Conduct and Ethics |
1 | COVER LETTER |
This document sets out CureVac's code of conduct, consisting of the principal business, ethical, moral and legal standards which the CureVac, its subsidiaries, all Employees and all members of the Supervisory Board and the Executive Board (together “Member/s”) are expected to observe.
The reputation of CureVac is our highest priority and we must ensure that it is preserved and safeguarded. We have a tradition of conducting our business activities in accordance with ethical principles. This constitutes a supporting pillar of our success. While our conduct is in compliance with these principles, we all ensure that CureVac is successful in its business endeavors and that it enjoys an outstanding reputation.
As an international biopharmaceutical company, CureVac is subject to statutory provisions that vary from one country to the next. Furthermore, we are committed to upholding international agreements such as those aimed at protecting human rights, combating Corruption, and promoting sustainability. We used these commitments to establish rules of conduct for ourselves, which are described in this CureVac Code of Conduct and Ethics in a transparent manner.
All Members as well as all Employees are responsible for ensuring that their conduct is in compliance with these binding principles set forth in this CureVac Code of Conduct and Ethics, which is intended to serve as a set of guidelines and standards and describes the conduct that is expected of us in day-to-day business and work life. As always, no business deal or action is worth endangering the high degree of trust and the excellent reputation that CureVac enjoys.
We expect that the Members as well as the Employees of all CureVac companies adhere to the law, comply with rules, and conduct themselves in a manner that is in accordance with our principles. The conduct of CureVac’s executives and Managers serves as an example to be followed. They embody our principles and put them into practice every day. They are the first point of contact for matters pertaining to our principles of conduct.
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Code of Conduct and Ethics |
In addition, CureVac’s Compliance organization provides assistance and advice to Employees. Don’t hesitate to take advantage of the support offered by the Compliance organization. We cannot and will not tolerate violations of the CureVac Code of Conduct and Ethics. We are confident that every single one of our Employees deserves the trust that we place in them. We also expect all Employees to live up to the standards of conduct that we have set for ourselves.
The provisions of this policy replace any materially similar provisions of any existing code of conduct (or similar policy) adopted by any subsidiary of CureVac on the date this policy was first adopted, but shall apply without prejudice of any supplementary policies and guidelines which may apply from time to time to CureVac and its Affiliates. For further details and links, the Employees and Members can consult CureVac's intranet.
This policy shall be posted on the CureVac's website.
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Code of Conduct and Ethics |
2 | DEFINITIONS |
Affiliates: CureVac N.V. and all other companies, partnerships, corporations, associations with or without legal personality (rechtspersoonlijkheid), cooperatives, mutual insurance societies, foundations or any other entity or body which operates externally as an independent unit or organization, including state or governmental institutions, departments and agencies and other entities under public law CureVac N.V. directly or indirectly has a controlling interest in.
Alleged Irregularity: An irregularity of a general, operational or financial nature which is detected, or is suspected on reasonable grounds, within the Company's organization, including the imminent or actual:
§ | performance of criminal acts, such as fraud, bribery or corruption; |
§ | violation of applicable laws and regulations; |
§ | violation of ethical or professional standards, including the standards set out in this policy; |
§ | endangerment of public health, safety or the environment; |
§ | suppression, destruction, withholding or manipulation of information on the irregularity concerned. |
Anti-Trust Laws: all U.S, EU and national anti-trust or competition laws
Anything of Value: includes, but is not limited to:
§ | Cash, stocks, bonds or other cash equivalents; |
§ | Gifts (no matter how small); |
§ | Employment offers, promises of future employment or hiring of relatives; |
§ | Travel and travel-related expenses, meals and hospitality; |
§ | Political contributions or charitable donations; |
§ | Discounts, loans, per diem payments or subsidies; |
§ | Medical expenses; |
§ | Sponsorships, educational and research grants or college scholarships; |
§ | Shopping excursions; |
§ | Personal use of company premises or equipment. |
Even intangibles such as services or information are included, such as state secrets, trade secrets, political information or any information that can be advantageous to the individual receiving it. Providing Anything of Value to relatives, friends, or colleagues of a relevant person are likewise covered as indirect benefits to that person.
Bribe or Bribery: an inducement, benefit, gift, reward or Anything of Value, in any form whatsoever, offered, promised, given, rewarded or provided in order to gain a commercial, contractual, regulatory or personal advantage
Business Partner(s): any Third Party CureVac does business with, including suppliers, consultants and customers
Chairman: the chairman of the Supervisory Board.
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Code of Conduct and Ethics |
Company or CureVac: CureVac N.V. and, where applicable, its Affiliates
Compliance: the compliance functions at CureVac N.V.
Compliance Committee: a permanently established committee consisting of members from CureVac's Compliance, Legal, Human Resources and Finance departments that considers facts obtained in connection with a Compliance matter and renders advice.
Compliance Management Policy: defines the principles of the Compliance Management System (CMS) and, therefore, provides Members and Employees with orientation and assistance.
Compliance Management System (CMS): the system of compliance described in the Compliance Management Policy
Compliance Officer: an individual appointed by CureVac to serve and oversee Compliance functions with a direct reporting line to the Management Board.
Corruption: the abuse of a position of employment, authority or trust to gain an Improper (Personal) Advantage in breach of duty.
Employee(s): employees, as well as officers, including permanent and temporary employees, leased and contract employees of CureVac N.V. and/or any of its Affiliates (including Managing Directors or Affiliates).
Gifts: gifts include any kind of benefit to someone as a sign of appreciation or friendship without expectation of receiving anything in return. This includes, for example, small gifts given at culturally recognized occasions (e.g. weddings, funerals) or special times of the year (e.g. Christmas, New Year). Gifts are also promotional items of nominal value which might bear CureVac’s company logo.
Improper (Personal) Advantage: improper commercial or other advantage means an advantage which is brought about because of someone performing (or failing to perform) a function or activity illegally, unethically, in bad faith, not impartially, or in breach of a position of trust.
Insider Trading Policy: the policy on insider trading established by CureVac.
Kickbacks: kickbacks are typically payments or other benefits made in return for a business favor or advantage.
Legal Department: CureVac N.V.’s legal department
Manager(s): all CureVac employees who have personnel responsibility
Management Board: the board of directors or managing directors of CureVac N.V.
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Code of Conduct and Ethics |
Member(s): a member of either the Management Board or the Supervisory Board, as the case may be, or any of its Affiliates.
Supervisory Board: Supervisory Board of CureVac N.V.
Third Party(ies): includes, but is not limited to, suppliers, vendors, contractors/consultants, sub-contractors and contract manufacturers.
Whistleblower: A person reporting an Alleged Irregularity.
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Code of Conduct and Ethics |
3 | INTRODUCTION |
It is the policy of the Company that the Members and all Employees of the Company and of each of its Affiliates adhere to the following principles governing our professional behavior and ethical conduct in the fulfilment of our respective responsibilities and, thereby, through our own actions, each and every one of us shall contribute to the shared corporate culture of the RNApeople®. This Code of Conduct and Ethics defines the main principles in a general form. Some of these are further described in specific guidelines referenced herein.
Failure to observe this policy may not only result in legal difficulties for the Company, but could also give rise to legal and/or disciplinary action against the Employee or Member concerned, including dismissal. Depending on the nature of the non-compliance, failure to observe this policy may be reported to the appropriate authorities.
4 | INTEGRITY AT CUREVAC |
4.1 | HONESTY AND INTEGRITY |
Each Member and Employee shall act with honesty and integrity and in an ethical manner. Each Member and Employee shall endeavor to deal fairly with the Company’s Business Partners, suppliers, competitors and with other Employees.
4.2 | ETHICAL BEHAVIOR, MUTUAL RESPECT AND EQUALITY |
Each Member and Employee shall proactively attempt to promote ethical behavior among his or her subordinates, peers and other Employees as well as towards Business Partners. When dealing with each other and Third Parties, each Member and Employee shall maintain an atmosphere of openness and tolerance, respect and politeness as well as fairness and trust and shall, therefore, not tolerate statements or behavior that may lead to animosity or hostility towards any of our shareholders, Members, Employees, Business Partners or any other Third Party.
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Code of Conduct and Ethics |
Each Member and Employee shall discriminate no-one based on a person’s gender and/or sexual identity, race or color, ethnic origin or nationality, age, religion, ideology or philosophy of life, or due to a (physical and/or mental) disability, medical condition or otherwise.
Any treatment, which intends to systematically belittle, exclude or impose unfair pressure on Employees either conducted by colleagues or by superiors, will not be tolerated by CureVac and will lead to legal consequences.
CureVac is an equal opportunity employer and each Member and Employee shares the responsibility for fulfilling CureVac’s commitment to equal employment opportunities.
4.3 | HEALTH, SAFETY AND ENVIRONMENT |
The operations of CureVac are conducted in compliance with applicable health, safety and environmental laws and regulations, Company standards and best practices. CureVac takes all reasonable and practical steps to ensure that a safe, healthy and clean working environment is provided. CureVac is consistently evaluating and undertaking appropriate measures in the workplace to sustainably save resources and the natural environment. Likewise, the Employees must ensure that the working environment is safe and healthy. Therefore, it is absolutely necessary that all regulations regarding the protection of Employees, all safety and environmental regulations are strictly followed.
It is forbidden to illegally possess or consume drugs while working on CureVac and its subsidiaries premises or otherwise conducting Company business. Employees and Members may not be impaired by drugs or alcohol at work.
4.4 | CONFLICTS OF INTEREST AND CORPORATE OPPORTUNITIES |
Each Employee shall avoid Conflicts of Interest between his or her personal, private interests and the interests of the Company and seek to avoid the appearance of such Conflicts of Interest. A Conflict of Interest may arise when an individual takes action or has interests that complicate or influence the objectivity and effectiveness of his or her Company-work performance or when an individual takes advantage of his or her position at the Company for improper (financial or other) personal benefit.
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Code of Conduct and Ethics |
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Members with a Conflict of Interest should consult CureVac's Management Board Rules or Supervisory Board Rules, as the case may be.
Members and Employees are expected to advance the Company's legitimate business interests.
A Member and Employee shall not:
a. | enter into competition with the Company; |
b. | provide unjustified advantages to third parties to the detriment of the Company; or |
c. | take advantage of business opportunities available to the Company for himself or for his spouse, registered partner or other life companion, foster child or any relative by blood or marriage up to the second degree. |
If an Employee or Member discovers, or is presented with, a business opportunity through the use of property or resources of the Company, or because of his position with the Company, he shall first disclose the terms and conditions of such business opportunity to his direct supervisor, who shall consult with the appropriate level of management to determine whether the Company wishes to pursue the business opportunity concerned.
If the decision is made not to pursue a business opportunity as referred hereto for the benefit of the Company, Employees and Members may, upon review and approval by their direct supervisor, pursue such business opportunity substantially on the original terms and conditions presented to the Company.
4.5 | LAW COMPLIANCE |
Each Member and Employee shall comply with all applicable laws and orders of governmental or public entities applicable to the Company, the rules and regulations of agencies having jurisdiction over the Company – as the case may be – and any internal rules and guidelines as may be implemented or amended from time to time. Each Employee and Officer is expected to familiarise himself with these laws and regulations, to the extent relevant and appropriate in relation to the performance of his activities for the Company.
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Code of Conduct and Ethics |
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5 | INTEGRITY WITH OUR BUSINESS PARTNERS |
5.1 | GOOD FAITH |
Each Member and Employee shall act in good faith, responsibly, with due care and diligence, without misrepresenting or omitting material facts or allowing his or her independent judgment to be compromised.
5.2 | COMPETITION, ANTI-TRUST |
CureVac is a company which is mainly involved in research and development of substances and products that are supposed to become medicinal products for individual patients upon receipt of marketing authorization and their commercialization.
Hence, CureVac does not compete with other companies on product markets. It is rather the market for RNA-based research and development where CureVac competes with other companies. CureVac also competes with other companies on the talent market. CureVac is well aware that under Anti-Trust Laws, it is illegal to enter into agreements, understandings or coordinated activities with actual or potential competitors; in particular, it is illegal to coordinate with competitors in violation of Anti-Trust Laws to:
§ | Fix prices (e.g. upfront and milestone payments, royalties), premiums or specific elements thereof; |
§ | Limit or restrict the output of products and services supplied; |
§ | Allocate markets geographically or with regard to customer segments or product lines. |
Members and Employees might meet representatives from competitors at conferences, at trade fairs, associations or otherwise. In those instances, Members and Employees shall not share any commercially confidential information nor shall they receive any such information (see also below on Confidentiality).
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Code of Conduct and Ethics |
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Furthermore, CureVac concludes all sorts of agreements, mostly in the areas of research, development, services and licensing of intellectual property, which might include clauses that could raise Anti-Trust concerns.
Therefore, all agreements are to be assessed by the Legal Department. In this regard, Anti-Trust Compliance is accomplished.
5.3 | ANTI-BRIBERY AND ANTI-CORRUPTION |
It is a serious offense throughout the world to accept or grant benefits for the purpose of obtaining a material or immaterial advantage for oneself personally or a Third Party. In connection with business activities of all types, no Member or Employee may seek to provide himself/herself, Business Partners, their Employees or other Third Parties (e.g. government officials, test persons, study leaders as well as other members of clinical studies) with such impermissible advantages.
This is to be assumed in particular whenever the type and scope of said advantage are apt to unduly influence actions and decisions of the recipient.
Third Parties (for example consultants, service providers, sponsors, representatives or other intermediaries) must not be taken advantage of to circumvent these regulations.
So-called “cultural expectations” such as an alleged custom in a certain country or region to accept Gifts and other benefits in exchange for business or, otherwise, to engage in Bribery and Kickbacks, are no excuse to violate this Code of Conduct and Ethics and the applicable laws.
Individual violations of the Anti-Corruption Laws can possibly also jeopardize CureVac as a corporation and its reputation (by loss of trust etc.). Any violation of this paragraph will, therefore, have labor law and, as the case may be, criminal law consequences.
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Code of Conduct and Ethics |
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5.4 | ANTI-MONEY LAUNDERING |
CureVac complies with all relevant national and international laws and regulations relating to anti-money laundering.
We are committed to the international fight against money laundering and financing of terrorism or drug trafficking. It is our objective to conduct business only with reputable Business Partners.
Payment transactions (except for petty cash transactions) are never conducted in cash. We do not transfer payments to bank accounts in countries or to persons embargoed by the U.S. or the EU. Transfers to private bank accounts of Business Partners are prohibited.
5.5 | INTERNATIONAL TRADE, EXPORT CONTROLS |
We are committed to complying with all applicable export and import laws, including, without limitation, sanctions, embargoes and other laws, regulations, government orders or policies.
6 | PROTECTION OF COMPANY ASSETS |
6.1 | USE OF COMPANY ASSETS |
Each Member and Employee shall use Company assets, facilities and resources accessible or employed by or entrusted to him or her in a responsible manner for legitimate business purposes and not for Improper Personal Advantage. An Employee or Member shall promptly report to his direct supervisor any misuse of Company property or resources.
Without proper authorization from their direct supervisor, Employees and Members shall not:
a. obtain, use or divert property or resources of the Company for personal gain; or
b. materially alter, remove or destroy property or resources of the Company or use services provided by the Company, except in the ordinary course of performing activities for the Company.
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Code of Conduct and Ethics |
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6.2 | CONFIDENTIALITY, INSIDER TRADING |
Each Member and Employee shall respect the confidentiality of information (incl. but not limited to personal data of others as well as business information and know-how in which form ever) acquired in the course of the performance of his or her responsibilities, except when authorized by persons with appropriate authority or legally obligated to disclose such information. No Member or Employee shall use confidential information acquired in the course of the performance of his or her responsibilities for Improper Personal Advantage. The prohibitions of this paragraph are intended to be in addition to, and not in limitation of, any other obligations of confidentiality a Member or Employee owes to the Company (e.g. based on the basis of the individual engagement or employment agreement).
The applicable restrictions and prohibitions on market abuse, including concerning the unlawful use and disclosure of inside information, tipping and market manipulation, are specific and complex. Employees and Officers should refer to and familiarise themselves with the Company's Insider Trading Policy, which contains detailed rules on the possession of, and conducting and effecting transactions in, the Company's shares and certain other financial instruments.
6.3 | DATA PROTECTION AND IT SECURITY |
Personal data must be processed exclusively within the framework of the relevant data-protection regulations.
Handling sensitive data (e.g. patient data) is subject to strict requirements. Violations involving transfer of sensitive data can also be charged as criminal offense. Sensitive data must be protected at all times. A transfer of such data to Third Parties is restricted. In any case, personal data may only be used for the purposes for which they were collected.
Passwords (e.g. for computers, laptops) must be kept secret. Confidential information must be stored securely.
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Code of Conduct and Ethics |
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6.4 | DOCUMENTATION, SIGNATURE POLICY AND BOOKS, RECORDS AND ACCOUNTING |
All business transactions must be documented in a timely manner, completely and correctly in accordance with the legal regulations and, additionally, according to the internal CureVac policies. Every Member and Employee is committed to this goal. In this respect, the following applies:
§ | Employees are entitled only within the framework of the Signature Policy to make binding statements and Declarations of Will on behalf of CureVac or to sign contracts, respectively. In this respect, the four-eye-principle is a key principle. |
§ | Correct accounting is an important part for controlling Company decisions, for correct financial statements and for the required information about the financial situation. To the extent Members and Employees are responsible for accounting tasks, they are expected to be familiar with all current financial and accounting policies and comply with them. |
6.5 | PUBLIC COMMUNICATION |
The Company will disclose information to the public only through specific channels, and promotes the full, fair accurate and timely and understandable disclosure in reports filed with the relevant authorities and other public communications.
Unless a Member or Employee has received proper authorisation to speak on behalf of the Company by the appropriate level of management, an Employee or Member should decline to comment in response to any media requesting information about matters relating to the Company, regardless of whether the request is made off the record, for background, or confidentially.
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Code of Conduct and Ethics |
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Each Member and Employee shall ensure, for opinions expressed at events, in public or in publicly accessible communication forums, that personal views are labelled as such. During public appearances on behalf of CureVac, each Member and Employee shall ensure that their actions or statements do not cause harm to CureVac, its shareholders and its Employees or damage their good reputation.
Members and Employees are not permitted to make any disclosure of material non-public information about the Company to any person or entity outside the Company.
7 | CORPORATE SOCIAL RESPONSIBILITY |
7.1 | PRINCIPLES OF MEDICAL RESEARCH |
Ethical principles as well as all applicable laws shall be analyzed and followed in any research activities of CureVac taking place either internally or commissioned by Third Parties. This includes the following in particular:
§ | The observance of ethical principles such as the “Declaration of Helsinki” when conducting clinical studies with humans. |
§ | The observance of ethical principles and regulations for carrying out animal testing. |
§ | The observance of scientific rules for obtaining research results. In particular, the observance of scientific standards in obtaining research results and data. In this respect, we follow the recommendations of the commission “Professional self-regulation in science” – proposals for safeguarding good scientific practice (e.g. guidelines of the German Research Foundation). |
§ | The correct handling of the publication of scientific studies and of the protection of the data contained therein. |
§ | The applicable laws and guidelines for conducting clinical studies (e.g. European GCP and GMP legislation, German Pharmaceuticals Act, country-specific laws and regulations, GCP and GMP Guidelines). |
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Code of Conduct and Ethics |
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7.2 | HEALTHCARE CODICES |
CureVac is aware that not only laws and regulations stipulated by governments and multinational institutions are setting minimum levels of required business conduct. As an active player, we carefully analyze standards such as:
§ | EFPIA HCP Code (European Federation of Pharmaceutical Industries and Associations) |
§ | FSA Code of Conduct for Healthcare Professionals (“Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.”) |
§ | PhRMA Code on Interactions with Healthcare Professionals (“Pharmaceutical Research and Manufacturers of America”) |
8 | CONTACT AND SUPPORT |
8.1 | WHISTLEBLOWER |
Current and former Employees and Members may report Alleged Irregularities to the Compliance Officer. Alleged Irregularities shall be reported in writing or in person. Anyone reporting an Alleged Irregularity should provide as much relevant and concrete information as possible in order for the Alleged Irregularity to be investigated properly. Each reported Alleged Irregularity shall be treated seriously.
Each Whistleblower has the right, and shall be given the opportunity by the Company, to consult with an independent confidential counsellor concerning the Alleged Irregularity reported by such Whistleblower. Such counsellor shall be designated by the Compliance Officer.
To the extent that the Dutch Act on the Whistleblowers' Institute (Wet Huis voor Klokkenluiders) is applicable in relation to the Company, a Whistleblower may also turn to the Whistleblowers' Institute (Huis voor klokkenluiders), subject to and in accordance with the provisions of such Act, in order to report an Alleged Irregularity.
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Code of Conduct and Ethics |
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Alleged Irregularities concerning the functioning of:
a. the Compliance Officer may be reported to any Managing Director;
b. a Managing Director or a Supervisory Director who is not the Chairman may be reported to the Chairman; and
c. the Chairman may be reported to the Chief Executive Officer.
The Company shall treat and safeguard as private and confidential the identity of each Whistleblower, as well as any Alleged Irregularity reported by such Whistleblower. Such information shall not be disclosed by the Company, unless:
a. with the consent of the Whistleblower concerned;
b. this is required under applicable laws or regulations, stock exchange requirements and/or by any competent authority; or
c. it concerns a disclosure to the professional advisors of the Company or of the Whistleblower concerned, subject to a duty of confidentiality and only to the extent necessary for any lawful purpose.
The Company shall not take disciplinary action or other adverse employment action against a Whistleblower in retaliation for properly reporting Alleged Irregularities in good faith, or for providing truthful information in good faith in connection with any investigation, inquiry, hearing or legal proceedings involving Alleged Irregularities. However, a Whistleblower who knowingly reports Alleged Irregularities in a manner which is not truthful and in good faith, or does so in a reckless or frivolous manner, may be subject to legal and/or disciplinary action, including dismissal.
8.2 | CONTACT AND SUPPORT |
This Code of Conduct and Ethics as well as all policies are meant to give you guidance and help to a safe way to Compliance in a complex area of many rules.
The first contact for any Member or Employee in relation to questions or uncertainty regarding principles of conduct or other areas of suspicion and legal doubt is their Manager. Everyone can also contact the Compliance Officer, the Legal Department or the central Compliance mailbox.
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Code of Conduct and Ethics |
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A Conflict of Interest, as described above, can, but may not necessarily, constitute an infringement – depending on the individual case - if properly addressed.
Actual and potential Conflicts of Interest must be promptly called to the attention of the Chief Executive Officer or Chief Operating Office of the Company (from time to time).
Any transactions or relationships of an Employee potentially contaminated with any such Conflict of Interest are prohibited except with the prior written consent of the Supervisory Board of CureVac. Any such Conflicts of Interest or potential Conflicts of Interest shall be resolved in an ethical manner with due consideration being given to the legitimate interests of the Company.
Any violation or potential violation of this Code by a Member should be promptly reported to the Chief Operating Officer of the Company or the Chief Executive Officer of the Company (from time to time). In case of violation or potential violation of this Code by the Chief Executive Officer and/or the Chief Corporate Officer – as the case may be -, reporting of all such violations and potential violations will be made to the Supervisory Board of CureVac. Any such violation or potential violation may also be reported directly to the Chairman of the Supervisory Board or to any other Member that the person reporting deems to be appropriate.
With respect to Members, the Supervisory Board of CureVac has the power and authority to monitor Compliance with this Code, investigate potential or alleged violations of the Code, make determinations (including acting on requests for waivers from the provisions hereof) and take decisions (or recommendations to appropriate Members) with respect to penalties and consequences for violations of this Code (after opportunity to be heard).
Any violation or potential violation of this Code by an Employee, other than a Member, should be promptly reported to the Compliance Officer of the Company (compliance@curevac.com). With regards to Employees, the Management Board has the power and authority to monitor Compliance with this Code, investigate potential or alleged violations of the Code, make determinations (including acting on requests for waivers from the provisions hereof) and take decisions with respect to penalties and consequences for violations of this Code (after opportunity to be heard). Such power and authority may be delegated as a whole or partially to the Compliance Officer.
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Code of Conduct and Ethics |
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It is also important to understand that violation of certain policies set forth in this Code and legal requirement may subject the individual(s) concerned to civil liability and damages, regulatory sanction and/or criminal prosecution. There will be no reprisals for reporting an actual or possible violation of this Code, provided the reporting person is not a party to or responsible for (alone or with others) the violation.
Each Member and each Employee shall be required to individually acknowledge and certify as to his or her Compliance with this Code. Managers are expected to convey the Compliance message and provide guidance to the Employees they oversee.
Any waivers (including the reasons for the waiver) of this Code for Members must be approved by the Supervisory Board and appropriately disclosed in accordance with all laws and rules applicable to the Company – as the case may be.
CureVac expects the Members of its Supervisory Board as well as of its Management Board and its Employees to obey to this Code. All Members and Employees are required to familiarize themselves with its contents, acknowledge and act in compliance with them. After all, it forms the foundation of our daily work and interaction with each other as well as with Third Parties. It is our responsibility that we all know and adhere to this Code. CureVac’s Managers are the first point of contact for questions and will support their staff in acting in accordance with our values.
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Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the reference to our firm under the caption “Experts” and to the use of our report dated April 29, 2020, with respect to the consolidated financial statements of CureVac AG, included in Amendment No. 1 to the Registration Statement (Form F-1 No. 333-240076) and related Prospectus of CureVac B.V. for the registration of its common shares.
/s/ Dr. Elia Napolitano | /s/ Steffen Maurer |
Wirtschaftsprüfer | Wirtschaftsprüfer |
(German Public Auditor) | (German Public Auditor) |
Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft
Munich, Germany
July 31, 2020