Exhibit 2.5

 

DESCRIPTION OF THE RIGHTS OF EACH CLASS OF SECURITIES REGISTERED UNDER SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 AS OF DECEMBER 31, 2020.

 

As of the date of the Annual Report on Form 20-F of which this Exhibit 2.5 is a part, CureVac N.V. (the “Company”, “we”, “us” or “our”) has only one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended: the Company’s registered common shares.

 

The following description of our common shares is a summary and does not purport to be complete. It is subject to and qualified in its entirety by reference to our articles of association, which are incorporated by reference as an exhibit to this Annual Report on Form 20-F of which this Exhibit 2.5 is a part.

 

As of the date of the Annual Report on Form 20-F of which this Exhibit 2.5 is a part, our authorized share capital was €92,700,000, consisting of 386,250,000 common shares and 386,250,000 preferred shares, par value €0.12 per share, of which we had 186,599,758 common shares outstanding.

 

Common Shares

 

The following summarizes the main rights of holders of our common shares:

 

·

each holder of common shares is entitled to one vote per share on all matters to be voted on by shareholders generally, including the appointment of managing directors and supervisory directors;

 

·

there are no cumulative voting rights;

 

·

the holders of our common shares are entitled to dividends and other distributions as may be declared from time to time by us out of funds legally available for that purpose, if any, following payment of the preferred dividend if any preferred shares are outstanding;

 

·

upon our liquidation, dissolution or winding up, the holders of common shares will be entitled to share ratably in the distribution of all of our assets remaining available for distribution after satisfaction of all our liabilities, following payment of the preferred dividend if any preferred shares are outstanding; and

 

·

the holders of common shares have preemptive rights in case of share issuances or the grant or rights to subscribe for shares, except if such rights are limited or excluded by the corporate body authorized to do so and except in such cases as provided by Dutch law and our articles of association.

 

Limitations on the Rights to Own Securities

 

Our common shares may be issued to individuals, corporations, trusts, estates of deceased individuals, partnerships and unincorporated associations of persons. Our articles of association contain no limitation on the rights to own our common shares and no limitation on the rights of nonresidents of the Netherlands or foreign shareholders to hold or exercise voting rights. Our preferred shares shall only be issued to the protective foundation, if and when incorporated.

 

Shareholders’ Meetings

 

General meetings may be held in Amsterdam, Arnhem, Assen, The Hague, Haarlem, Hertogenbosch, Groningen, Leeuwarden, Lelystad, Maastricht, Middelburg, Rotterdam, Schiphol (Haarlemmermeer), Utrecht or Zwolle, all in the Netherlands. The annual general meeting must be held within six months of the end of each financial year. Additional extraordinary general meetings may also be held, whenever considered appropriate by the management board or the supervisory board and shall be held within three months after our management board has considered it to be likely that our equity has decreased to an amount equal to or lower than half of its paid-in and called-up share capital, in order to discuss the measures to be taken if so required.

 

 

Pursuant to Dutch law, one or more shareholders or others with meeting rights under Dutch law who jointly represent at least one-tenth of the issued share capital may request us to convene a general meeting, setting out in detail the matters to be discussed. If we have not taken the steps necessary to ensure that such meeting can be held within six weeks after the request, the requesting party/parties may, on their application, be authorized by the competent Dutch court in preliminary relief proceedings to convene a general meeting. The court shall disallow the application if it does not appear that the applicants have previously requested our management board and our supervisory board to convene a general meeting and neither our management board nor our supervisory board has taken the necessary steps so that the general meeting could be held within six weeks after the request.

 

General meetings must be convened by an announcement published in a Dutch daily newspaper with national distribution. The notice must state the agenda, the time and place of the meeting, the record date (if any), the procedure for participating in the general meeting by proxy, as well as other information as required by Dutch law. The notice must be given at least 15 days prior to the day of the meeting. The agenda for the annual general meeting shall include, among other things, the adoption of the annual accounts, appropriation of our profits and proposals relating to the composition of the management board and supervisory board, including the filling of any vacancies in such bodies. In addition, the agenda shall include such items as have been included therein by the management board or the supervisory board. The agenda shall also include such items requested by one or more shareholders, or others with meeting rights under Dutch law, representing at least 3% of the issued share capital. Requests must be made in writing or by electronic means and received by us at least 60 days before the day of the meeting. No resolutions shall be adopted on items other than those that have been included in the agenda.

 

In accordance with the Dutch Corporate Governance Code (the “DCGC”) and our articles of association, shareholders having the right to put an item on the agenda under the rules described above shall exercise such right only after consulting the management board in that respect. If one or more shareholders intend to request that an item be put on the agenda that may result in a change in the company’s strategy (for example, the removal of managing directors or supervisory directors), the management board must be given the opportunity to invoke a reasonable period to respond to such intention. Such period shall not exceed 180 days (or such other period as may be stipulated for such purpose by Dutch law and/or the DCGC from time to time). If invoked, the management board must use such response period for further deliberation and constructive consultation, in any event with the shareholders(s) concerned, and shall explore the alternatives. At the end of the response time, the management board shall report on this consultation and the exploration of alternatives to the general meeting. This shall be supervised by our supervisory board. The response period may be invoked only once for any given general meeting and shall not apply (a) in respect of a matter for which a response period has been previously invoked; or (b) if a shareholder holds at least 75% of the company’s issued share capital as a consequence of a successful public bid. The response period may also be invoked in response to shareholders or others with meeting rights under Dutch law requesting that a general meeting be convened, as described above.

 

The general meeting is presided over by the chairman of the supervisory board. If no chairman has been elected or if he or she is not present at the meeting, the general meeting shall be presided over by the vice-chairman of the supervisory board. If no vice-chairman has been elected or if he or she is not present at the meeting, the general meeting shall be presided over by another supervisory director present at the meeting. If no supervisory director is present, the meeting shall be presided over by our CEO. If no CEO has been elected or if he or she is not present at the meeting, the general meeting shall be presided over by another managing director present at the meeting. If no managing director is present at the meeting, the general meeting shall be presided over by any other person appointed by the general meeting. In each case, the person who should chair the general meeting pursuant to the rules described above may appoint another person to chair the general meeting instead. Managing directors and supervisory directors may always attend a general meeting. In these meetings, they have an advisory vote. The chairman of the meeting may decide, at his or her discretion, to admit other persons to the meeting.

 

 

All shareholders and others with meeting rights under Dutch law are authorized to attend the general meeting, to address the meeting and, in so far as they have such right, to vote pro rata to his or her shareholding. Shareholders may exercise these rights, if they are the holders of shares on the record date, if any, as required by Dutch law, which is currently the 28th day before the day of the general meeting. Under our articles of association, shareholders and others with meeting rights under Dutch law must notify us in writing or by electronic means of their identity and intention to attend the general meeting. This notice must be received by us ultimately on the seventh day prior to the general meeting, unless indicated otherwise when such meeting is convened.

 

Each common share and each preferred share confers the right on the holder to cast one vote at the general meeting. Shareholders may vote by proxy. No votes may be cast at a general meeting on shares held by us or our subsidiaries or on shares for which we or our subsidiaries hold depository receipts. Nonetheless, the holders of a right of use and enjoyment (vruchtgebruik) and the holders of a right of pledge (pandrecht) in respect of shares held by us or our subsidiaries in our share capital are not excluded from the right to vote on such shares, if the right of use and enjoyment (vruchtgebruik) or the right of pledge (pandrecht) was granted prior to the time such shares were acquired by us or any of our subsidiaries. Neither we nor any of our subsidiaries may cast votes in respect of a share on which we or such subsidiary holds a right of use and enjoyment (vruchtgebruik) or a right of pledge (pandrecht). Shares which are not entitled to voting rights pursuant to the preceding sentences will not be taken into account for the purpose of determining the number of shareholders that vote and that are present or represented, or the amount of the share capital that is provided or that is represented at a general meeting.

 

Decisions of the general meeting are taken by a simple majority of votes cast, except where Dutch law or our articles of association provide for a qualified majority or unanimity.

 

Dividends and Other Distributions

 

Dividends

 

We may only make distributions, whether a distribution of profits or of freely distributable reserves, to our shareholders to the extent our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-in and called-up share capital plus any reserves required by Dutch law or by our articles of association. Under our articles of association, our management board with the approval of our supervisory board may decide that all or part of the profits are carried to reserves. Before reservation of any profit, to the extent that preferred shares have been canceled and preferred distributions on those canceled shares are outstanding, the profits are first to be used to satisfy the outstanding claim to those who held those preferred shares at the moment of such cancellation becoming effective and subsequently if any preferred shares are outstanding, the preferred dividend is paid out on those preferred shares in accordance with our articles of association. The remaining profit will be at the disposal of the general meeting at the proposal of the management board for distribution on the common shares, subject to restrictions of Dutch law and approval by our supervisory board of such proposal of our management board.

 

We only make a distribution of dividends to our shareholders after the adoption of our annual accounts demonstrating that such distribution is legally permitted. The management board is permitted, subject to certain requirements, to declare interim dividends without the approval of the general meeting, but only with the approval of the supervisory board.

 

Dividends and other distributions shall be made payable not later than the date determined by the management board. Claims to dividends and other distributions not made within five years from the date that such dividends or distributions became payable will lapse and any such amounts will be considered to have been forfeited to us (verjaring).

 

Exchange Controls

 

Under Dutch law, there are no exchange controls applicable to the transfer to persons outside of the Netherlands of dividends or other distributions with respect to, or of the proceeds from the sale of, shares of a Dutch company, subject to applicable restrictions under sanctions and measures, including those concerning export control, pursuant to European Union regulations, the Sanctions Act 1977 (Sanctiewet 1977) or other legislation, applicable anti-boycott regulations and similar rules. There are no special restrictions in the articles of association or Dutch law that limit the right of shareholders who are not citizens or residents of the Netherlands to hold or vote shares.

 

 

Squeeze-Out Procedures

 

Pursuant to Section 2:92a of the Dutch Civil Code, a shareholder who holds at least 95% of our issued share capital for his or her own account, alone or together with group companies, may initiate proceedings against the other shareholders jointly for the transfer of their shares to such shareholder. The proceedings are held before the Enterprise Chamber of the Amsterdam Court of Appeal, or the Enterprise Chamber (Ondernemingskamer), and can be instituted by means of a writ of summons served upon each of the other shareholders in accordance with the provisions of the Dutch Code of Civil Procedure (Wetboek van Burgerlijke Rechtsvordering). The Enterprise Chamber may grant the claim for squeeze-out in relation to the other shareholders and will determine the price to be paid for the shares, if necessary, after appointment of one or three experts who will offer an opinion to the Enterprise Chamber on the value to be paid for the shares of the other shareholders. Once the order to transfer becomes final before the Enterprise Chamber, the person acquiring the shares shall give written notice of the date and place of payment and the price to the holders of the shares to be acquired whose addresses are known to him. Unless the addresses of all of them are known to the acquiring person, such person is required to publish the same in a daily newspaper with a national circulation.

 

Dissolution and Liquidation

 

Under our articles of association, we may be dissolved by a resolution of the general meeting, subject to a proposal of the management board approved by our supervisory board. In the event of a dissolution, the liquidation shall be effected by the management board, under supervision of our supervisory board, unless the general meeting decides otherwise. During liquidation, the provisions of our articles of association will remain in force as far as possible. To the extent that any assets remain after payment of all debts, if any preferred shares are outstanding, the preferred dividend is first paid out on those preferred shares in accordance with our articles of association. Any remaining assets shall be distributed to the holders of common shares in proportion of their number of shares.

 

 

 

Exhibit 4.45

 

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]

 

EUROPEAN COMMISSION Directorate-General for Health and Food Safety

 

ADVANCE PURCHASE AGREEMENT (“APA”)¹ for the development, production, advance purchase and supply of a COVID-19 vaccine for EU Member States

 

NUMBER — [*****]

 

1.        The European Commission (the “Commission”), acting on behalf and in the name of the Member States listed in Annex I (the “participating Member State(s)”)² being represented for the purposes of the signature of this APA by Ms Stella Kyriakides, Commissioner for Health and Food Safety

 

and

 

 

2.        CUREVAC AG, Friedrich-Miescher-Str. 15, 72076 Tübingen, Deutschland, HRB 754041, Stuttgart District Court, DE 221 393 632,

 

(the “contractor”), represented for the purposes of the signature of this APA which has the form of a framework contract by [*****],

 

The Commission, acting on behalf and in the name of the participating Member States, and the contractor are together referred to as the “Parties” and each individually as a “Party”.

 

HAVE AGREED

 

to the special conditions and the general conditions of this APA and the following annexes:

 

Annex I –	List of participating Member States
Annex II –	Template Vaccine Order Form
Annex III –	Annex 7 to Commission Decision C(2020) 4192 final of 18 June 2020 - Agreement between the Commission and Member States on procuring COVID-19 vaccines on behalf of the Member States and related procedures
Annex IV –	Preliminary Specification of the Product
Annex V –	List of (planned) manufacturing network partners

 

 

1	This APA is based on the agreement between the Commission and the Member States as approved by Commission Decision C(2020) 4192 final on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures.
2	As provided for in Article 4(5)(b) of Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak.

 

 

Annex VI –	Template Goods Received Form
Annex VII –	Description of the contractor's intended utilisation of the up-front payment and the second up-front payment

 

which form an integral part of this APA.

 

Recitals

 

A.

The world is experiencing an emergency healthcare crisis due to the SARS-CoV-2 (“COVID-19”) pandemic (the “COVID-19 pandemic”) and the global demand for vaccines to prevent COVID-19 virus infection is expected to be in order of magnitude of billions of doses.

 

B.

The contractor and its affiliates are currently working to develop and manufacture an mRNA-based vaccine to help protect against COVID-19 virus infection in humans (the “Product” as further defined below).

 

C.

The contractor's project for the development of the Product has completed dose selection and is about to enter pivotal Phase IIB/III clinical trial studies towards regulatory submission. Furthermore, the contractor is currently establishing its own and external manufacturing capacities in Europe through partnerships with experienced contract manufacturing organisations (“CMOs”) in order to meaningfully contribute to controlling the COVID-19 pandemic. While the contractor has prioritised and accelerated its efforts to develop and manufacture the Product in light of the current COVID-19 pandemic, there is nonetheless substantial uncertainty around these efforts, in particular with respect to (i) the clinical development of the Product, with respect to (ii) the Product's ability to show sufficient efficacy to prevent a COVID-19 infection, with respect to (iii) the question whether the Product might have inacceptable adverse event symptoms beyond what will be documented in the ongoing and planned clinical trials and with respect to (iv) obtaining timely EU marketing authorisation for the Product as well as with respect to (v) the establishment of sufficient production and manufacturing capacity.

 

D.

The Commission intends to create the environment required to support a secure manufacturing network and optimisation for the production of vaccines against COVID-19. To this effect the Commission has concluded an agreement with all Member States of the European Union to conclude, on behalf and in the name of the Member States, Advance Purchase Agreements with vaccine manufacturers with the objective to procure vaccines for the purposes of combatting the COVID-19 pandemic at Union level.

 

E.

The Commission wishes to secure supply of the Product for human use for the participating Member States during the COVID-19 Pandemic as promptly as possible.

 

F.

The intention of the Commission, on behalf of the Member States, is to ensure that the population in the European Union will be able to access a vaccine in sufficient quantities and at a fair price, but also in safe conditions. The vaccine should only be available to the population once its safety and efficacy will have been cleared by the competent regulatory bodies.

 

 

G.

According to the Agreement between the Commission and the Member States3 and in particular Article 4 thereof, the Commission can conclude an Advance Purchase Agreement that contains a right and an obligation for participating Member States to acquire vaccine doses. Where the Commission intends to enter into such an agreement, it shall inform the Member States of such intention and the detailed terms. In case a Member State does not agree with the conclusion of an APA containing an obligation to acquire vaccine doses or its terms, it has the right to opt out by explicit notification to the Commission. All participating Member States not having opted out in accordance with the Agreement between the Commission and the Member States are deemed to have authorised the Commission to negotiate and conclude an Advance Purchase Agreement with the vaccine manufacturer in their name and on their behalf.

 

H.

This APA is such an agreement which the Commission enters into on behalf and in the name of the Member States which have not opted out of the agreement. These participating Member States will then have an obligation to acquire the Product and a right to be supplied with the respective Product doses. While the APA is legally binding upon those participating Member States, it will be further implemented by means of the conclusion of contracts between the participating Member States and the contractor. The present APA will be complemented by a Vaccine Order Form (“Vaccine Order Form”) between each of the participating Member States and the contractor. A template Vaccine Order Form for the agreement between each of the participating Member States and the contractor is attached in Annex II.

 

I.

The development, production, advance sale and supply of the Product as per this APA require significant investments by the contractor to increase the speed of vaccine research and development and clinical trials and the preparation of the at-scale production capacity along the entire production value chain in the EU required for a rapid deployment of the millions of doses of the Product. The Commission as well as the participating Member States are willing to contribute to financing of those investments in the form of up-front payments.

 

J.

Pursuant to these terms and conditions, access to Product doses will be allocated to Member States according to a population distribution key, unless a different allocation would be communicated by the Commission to the contractor. The up-front payments, paid by the Commission, should be taken into account in equal terms per dose ordered by the Member States.

 

K.

The Parties recognise that the accelerated development timelines to deliver the clinical trial and follow-up programme agreed with EMA means that the contractor under no circumstance can warrant, or assume any liability, at the time of entry into force of this APA that the Product will be ultimately available or will produce the desired results, i.e. shows sufficient efficacy to prevent a COVID-19 infection, or be without inacceptable side effects. The participating Member States are willing to share those risks, which includes an obligation of the participating Member States to indemnify the contractor and its CMOs in case of liability incurred, settlements paid and certain costs relating to third party claims with respect to those risks under the conditions set out in this APA. The Commission and participating Member States acknowledge that the use of Products will happen under epidemic conditions requiring such use, and that the administration of the Product will therefore be conducted under the sole responsibility of the participating Member States.

 

 

3

Such agreement is based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union, OJ L 70, 16.3.2016, p.1, as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak, OJ L 117, 15.4.2020, p. 3. The agreement was approved Decision C(2020) 4192 final of 18 June 2020 (see Annex III to this APA).

 

 

L.

The participating Member States acknowledge that, in light of the uncertainties both with respect to the development of the Product and the accelerated establishment of sufficient manufacturing capacities, the delivery dates set out in this APA are the contractor's current best estimates only and subject to change. Due to possible delays in the authorisation, production and release of the Product, no Product or only reduced volumes of the Product may be available at the estimated delivery dates set out in this APA. In the case of delays to the anticipated availability of the Product, the contractor aims to allocate the doses of the Product fairly across the demand of doses, which the contractor has or will contractually commit to towards its present and future customers, as such doses become available.

 

M.

The participating Member States further acknowledge that the specification of the Product has not yet been fully determined and still contains target specifications, which are being refined as supporting data emerges. In particular, the vaccination regimen ([*****]) and product shelf-life and stability profile ([*****]) have not yet been fully established. Also, the final presentation of the Product is still under consideration. The preliminary specification provided in Annex IV to this APA is therefore only indicative. The final specification will be determined by the EU marketing authorisation.

 

N.

Against this background, the Commission wishes to enter into, on behalf and in the name of the participating Member States, an Advance Purchase Agreement with the contractor to secure the availability of a total of 225 million doses of the Product, to be allocated among the participating Member States in accordance with the allocation principles set out in this APA. The Commission, on behalf and in the name of the participating Member States, shall furthermore have the option to order up to a total of 180 million additional doses of the Product within [*****] from the contractor obtaining (conditional) EU marketing authorisation, subject to the terms and conditions of this APA.

 

This APA sets out:

 

a.

the procedure and conditions by which the Commission and the participating Member States shall pay for the purchase from and supply of the Product by the contractor;

b.

the supply obligations of the contractor for the Product and the estimated delivery schedule;

c.

the provisions that apply to any Vaccine Order Form which the participating Member States and the contractor may conclude under this APA; and

d.

the obligations of the Parties during and after the duration of this APA.

 

 

TABLE OF CONTENTS

 

	Recitals		2
TABLE OF CONTENTS			5
I.	Special Conditions		7
	I.1.	Order of priority of provisions	7
	I.2.	Definitions	7
	I.3.	Subject matter	10
	I.4.	Entry into force and duration of the APA	11
	I.5.	Implementation of the APA	11
	I.6.	Product	12
	I.7.	Contract Volume	13
	I.8.	Allocation and Vaccine Order Forms	13
	I.9.	Development Timeline; Special Commitments	14
	I.10.	Right of the participating Member States to re-sell, export and/or distribute the Product	15
	I.11.	Delivery; Estimated Delivery Schedule; Delays	16
	I.12.	Delays	17
	I.13.	Packaging; Labelling	17
	I.14.	Warranties; Acceptance mechanism	18
	I.15.	Product recalls	19
	I.16.	Price of the Product	19
	I.17.	Payment obligations	20
	I.18.	Contractor's bank account	21
	I.19.	Communication details	22
	I.20.	Exploitation of the results of the APA	22
	I.21.	Applicable law and settlement of disputes	22
	I.22.	Reporting	23
	I.23.	Indemnification	23
II.	GENERAL CONDITIONS		26
	II.1.	Severability	26
	II.2.	Provision of Supplies	26
	II.3.	Communication between the parties	26
	II.4.	Liability	27
	II.5.	Conflict of interest and professional conflicting interests	27
	II.6.	Confidentiality and public announcements	28
	II.7.	Processing of personal data	29

 

 

	II.8.	Subcontracting	29
	II.9.	Amendments	29
	II.10.	Assignment	30
	II.11.	Force majeure	30
	II.12.	Reduction in price	30
	II.13.	Suspension of the APA	31
	II.14.	Termination of the APA	32
	II.15.	Payment Requests, Invoices, Value Added Tax and e-invoicing	35
	II.16.	Payments	35
	II.17.	Checks and audits	37

 

Annex I   List of participating Member States	40
Annex II   Template Vaccine Order Form	41
Annex III   Annex 7 to Commission Decision C(2020) 4192 final of 18 June 2020 - Agreement between the Commission and Member States on procuring COVID-19 vaccines on behalf of the Member States and related procedures	45
Annex IV   Preliminary Specification of the Product	52
Annex V   List of (planned) manufacturing network partners	53
Annex VI   Goods Received Form (preliminary)	54
Annex VII   Description of the contractor's intended utilisation of the up-front payment and the second up-front payment	56

 

 

I.             Special Conditions

 

I.1.

Order of priority of provisions

 

If there is any conflict between different provisions in this APA, the following rules must be applied:

 

(a)

The provisions set out in the special conditions take precedence over those in the other parts of this APA, including all annexes.

(b)

The provisions set out in the special conditions and the general conditions (including all annexes other than Annexes II and VI) take precedence over those in the template Vaccine Order Form (Annex II) and in any Vaccine Order Form concluded between a participating Member State and the contractor.

(c)

The provisions set out in the special conditions and the general conditions (including all annexes other than Annex VI) take precedence over Annex VI.

 

All documents issued by the contractor (such as end-user agreements, general terms and conditions, etc.) are held inapplicable, unless they are issued under or in accordance with this APA (such as the final specifications, (formal) notifications, etc.). In all circumstances, in the event of contradiction between this APA and documents issued by the contractor, this APA prevails, regardless of any provision to the contrary in the contractor’s documents.

 

I.2.

Definitions

 

For the purpose of this APA, the following definitions (indicated in italics in the text) apply:

 

‘Additional Doses up-front payment’: the up-front payment relating to the Additional European Doses as specified in Article I.17.2(b).

 

‘Additional European Doses’: the additional number of doses, which may be ordered by the Commission in accordance with Article I.7.2.

 

‘Affiliate’: any company, partnership or other entity that controls, is controlled by, or is under common control with the contractor. For purposes of this definition only, "control" means (a) to possess, directly or indirectly, the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise, or (b) to own, directly or indirectly, more than 50 % of the outstanding voting securities or other ownership interest of such entity, provided that, if applicable law requires a minimum percentage of local ownership, control will be established by direct or indirect beneficial ownership of 100 % of the maximum ownership interest that may, under such applicable law, be owned by foreign interests, provided, however, that regarding the contractor, the term affiliate shall not include [*****], [*****] and/or any other companies controlled by [*****] and/or [*****] that are not subsidiaries of the contractor.

 

‘Apparent defect’: any defect of the Product existent at the moment of delivery at the delivery site of the relevant participating Member State that has been identified or could have been identified upon visual inspection of the pallet or grouping box of the Product or the temperature monitoring device. It may include a physical damage, a leakage, an incorrect labelling or temperature readings or recordings that deviate from the required cold chain specifications.

 

‘Breach of obligations’: failure by the contractor to fulfil one or more of its contractual obligations, unless the APA (i) states explicitly that the non-fulfilment of an obligation shall not result in any consequences or (ii) provides for a specific consequence other than those set forth in Article II.14.

 

 

‘CMO’: a contract manufacturing organisation.

 

‘Commission’: the European Commission.

 

‘Confidential information or document’: any information or document disclosed or given between the Parties or on their behalf in the context of the negotiation and conclusion of the APA (including the terms of the APA and the Vaccine Order Forms) and/or the performance of the APA. It does not include any information (i) the receiving Party can prove was known to it prior to the date of disclosure; (ii) the receiving Party can prove was lawfully obtained from a third party without any obligation of confidentiality; (iii) is or becomes part of the public domain other than through any act or omission of the receiving Party; or (iv) is independently developed by the receiving Party without use of or reference to the disclosing Party’s confidential information or documents, as evidenced by the receiving Party’s records.

 

‘Conflict of interest’: a situation where the impartial and objective performance of this APA by the contractor is compromised for reasons involving family, emotional life, political or national affinity, economic interest, any other direct or indirect personal interest, or any other shared interest with the Commission, the participating Member State or any third party related to the subject matter of this APA, it being understood that the conclusion, implementation and performance of further agreements on the provision of the Product shall not constitute a conflict of interest.

 

‘Contractor’: CUREVAC AG with its seat in Tübingen, registered with the commercial register of the local court of Stuttgart under HRB 754041.

 

‘COVID-19 pandemic’: the pandemic as further described in the Recitals.

 

‘Delivery site(s)’: the delivery site as indicated in the relevant Vaccine Order Form.

 

‘Dose’: the amount of the Product as specified in Article I.6.3.

 

‘EMA’: the European Medicines Agency.

 

‘EU marketing authorisation’: the approval under the relevant provisions of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervisions of medicinal products for human and veterinary use and establishing a European Medicines Agency, by the European Commission necessary for the placing on the market of the Product for vaccination in the territory of the European Union, including conditional marketing authorisation in accordance with Article 14-a of Regulation 726/2004 and Commission Regulation 507/2006/EC.

 

‘Final specification’: the final specification of the Product as to be determined by contractor in accordance with in Article I.6.2.

 

‘Force majeure’: any unforeseeable, exceptional situation or event beyond the control of the Parties that prevents either of them from fulfilling any of their obligations under the APA. The situation or event must not be attributable to error or negligence on the part of the Parties or on the part of the subcontractors and must prove to be inevitable despite their exercising due diligence. Defaults of service, defects in equipment or material or delays in making them available, labour disputes, strikes and financial difficulties may not be invoked as force majeure, unless they are caused by a relevant case of force majeure.

 

‘Formal notification’ (or ‘formally notify’): form of communication between the Parties made in writing by mail or e-mail in English, which provides the sender with compelling evidence that the message was delivered to the specified recipient.

 

 

‘Fraud’: an act or omission committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the Union's financial interests, and relating to: i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the non-disclosure of information in violation of a specific obligation, with the same effect or iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted, which damages the Union's financial interests.

 

‘GDP’: good distribution practices in accordance with standards currently required by EU legislation, regulation and guidance, in particular those set out in its Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use published by the European Commission (2013/C 343/01) and other applicable regulation pertaining to distribution practices throughout the supply chain, all as updated, amended and revised from time to time.

 

‘GMP’: good manufacturing practices in accordance with standards currently required by EU legislation, regulation and guidance and in particular those set out in Directive 2001/83/EC (as amended), Directive 2003/94/EC, Directive 2017/1572 and the guidelines set out in EudraLex - Volume 4 of the Rules Governing Medical Products in the European Union entitled “Good Manufacturing Practice (GMP)”, all as updated, amended and revised from time to time.

 

‘Goods Received Form’: acknowledgement of receipt of the Products in the form of the template attached as Annex VI to be issued by the participating Member States as specified in Article I.14.5.

 

‘Grave professional misconduct’: a violation of applicable laws or regulations or ethical standards of the profession to which a contractor or a related person belongs, including any conduct leading to sexual or other exploitation or abuse, or any wrongful conduct of the contractor or a related person which has an impact on its professional credibility where such conduct denotes wrongful intent or gross negligence.

 

‘Hidden defect’: a physical damage or product manufacturing defect of the Product that does not qualify as an apparent defect.

 

‘Indemnified Person(s)’: the persons specified as Indemnified Persons in Article I.23.3.

 

‘Initial European Doses’: the initial number of doses as specified in Article I.7.1.

 

‘Irregularity’: any infringement of a provision of Union law resulting from an act or omission by an economic operator, which has, or would have, the effect of prejudicing the Union’s budget.

 

‘Loss(es)’: any harm, damage or loss as specified in Article I.23.3.

 

‘Notification’ (or ‘notify’): form of communication between the Parties made in writing in English, including by electronic means.

 

‘Participating Member States’: the Member States listed in Annex I.

 

‘Party’ (or ‘Parties’): the persons specified as Parties in the beginning of this Agreement..

 

‘Performance of a Vaccine Order Form’: the delivery of the Product by the contractor to the participating Member State.

 

‘Product’: the pandemic COVID-19 vaccine as specified in Article I.6.

 

‘Product IP Rights’: the intellectual property rights generated during the development, manufacture, and supply of the Product, including know-how, as specified in Article I.20.1.

 

 

‘Product Price’: the price for the Product per dose as specified in Article I.16.1.

 

‘Professional conflicting interest’: a situation in which the contractor’s previous or ongoing professional activities affect its capacity to implement this APA or to perform a Vaccine Order Form to an appropriate quality standard, it being understood that the conclusion, implementation and performance of further agreements on the provision of the Product shall not constitute a professional conflicting interest.

 

‘Related person’: any natural or legal person who is a member of the administrative, management or supervisory body of the contractor, or who has powers of representation, decision or control with regard to the contractor.

 

‘Reasonable best efforts’: a reasonable degree of best effort to accomplish a given task, acknowledging that such things as, without limitation, the complex and highly regulated nature of the Product; the timely availability of raw materials, inventories and liquid funds; yield of process; the success of necessary clinical trials programs to support safety and immunogenicity data for the Product; the approval of the final Product formulation; contractor's commitments to other purchasers of the Product; other reasons relating to the uncertainties of producing a new vaccine for a new disease with an mRNA platform for which vaccines have not yet been registered by regulatory authorities; and any other currently unknown factors which may delay or render impossible, contractor's successful completion of the particular task, including without limitations, developing a suitable production process as may be required for a new strain of virus, ramping up capacity at contract manufacturing partners, meeting delivery schedules and obtaining the EU marketing authorisation may be beyond the complete control of the contractor, provided, however, that the contractor shall not be required to take any actions inconsistent with past practice, ordinary course of business, prudent and reasonable business behaviour and/or the contractor's budget plannings at the date hereof.

 

‘Result’: any intended outcome of the implementation of the APA, whatever its form or nature. A result may be further defined in this APA as a deliverable. A result may, in addition to newly created materials produced specifically for the participating Member States by the contractor or at its request, also include pre-existing materials.

 

‘Second up-front payment’: the further up-front payment as specified in Article I.17.2(a).

 

‘Specific deliveries’: the delivery terms under the Vaccine Order Form as specified in Article I.8.4.

 

‘Temporary national authorisation’: the temporary distribution authorisation granted by the relevant participating Member State in accordance with national laws and Article 5 (2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

 

‘Third Party Claim’: any damages claim brought against any of the Indemnified Persons as specified in Article I.23.9.

 

‘Up-front payment’: the up-front payment specified in Article I.17.1.

 

‘Vaccine Order Form’: a contract concluded between the contractor and a participating Member State, substantially in the form of Annex II as attached to this APA, specifying details of the delivery site.

 

I.3.

Subject matter

 

The subject of this APA is the advance purchase of 225 million doses of the Product, as defined below in Article I.6, to be allocated among the participating Member States by the Commission in accordance with the allocation principles set out below in Article I.8.1. Additionally, this APA gives the Commission the option to order, on behalf and in the name of the participating Member States, up to 180 million additional doses of the Product once EU marketing authorisation has been granted, such additional doses to be allocated between the participating Member States by the Commission as set out below in Article I.8.3.

 

 

On the basis of this APA, the contractor commits to use reasonable best efforts (i) to obtain EU marketing authorisation for the Product and (ii) to establish sufficient manufacturing capacities to enable the manufacturing and supply of the contractually agreed volumes of the Product to the participating Member States in accordance with the estimated delivery schedule set out below in Article I.11 once at least a conditional EU marketing authorisation has been granted.

 

The delivery of the Product to the individual participating Member States, which, without prejudice to Article I.6.2, shall in principle be subject to the grant of at least a conditional EU marketing authorisation, shall be carried out in accordance with the terms and conditions of this APA and in particular the allocation decision formally notified by the Commission, as well as the additional detailed terms of delivery set out in the Vaccine Order Forms to be concluded between the contractor and the participating Member States using the template Vaccine Order Form provided as Annex II to this APA.

 

I.4.

Entry into force and duration of the APA

 

I.4.1.

This APA enters into force on the date on which the contractor and the Commission have signed it.

 

I.4.2.

This APA has a term of 24 months from the date of its entry into force. Its duration may be extended if at the end of the term of 24 months not all of the Initial European Doses or Additional European Doses, as the case may be, have been supplied. In such case, its duration will be extended until the delivery of all of the Initial European Doses or all of the Additional European Doses, as the case may be.

 

I.4.3.

During the term of this APA, the contractor shall not enter into any agreements or accept any commitments which would impede the contractor's ability to fulfil its main performance obligations under this APA.

 

I.4.4.

The participating Member States and the contractor may not sign any Vaccine Order Form after this APA expires.

 

Articles I.23 and II.6 shall remain in full force and effect, and this APA continues to apply to all Vaccine Order Forms signed prior to its expiry, even after the expiry of this APA.

 

I.5.

Implementation of the APA

 

This APA shall be implemented following entry into force as follows:

 

I.5.1.

Following entry into force of this APA, this APA is binding upon the contractor, the Commission and all participating Member States on behalf and in the name of which the Commission has concluded this APA, as identified in Annex I.

 

I.5.2.

Following entry into force of this APA, the Commission will determine the allocation of the contractually agreed doses of the Product between the participating Member States in accordance with the procedure set out below in Article I.8 and will formally notify this allocation to the contractor. The allocation formally notified to the contractor by the Commission on behalf and in the name of the participating Member States is binding upon all participating Member States.

 

 

I.5.3.

Each participating Member State and the contractor will conclude a Vaccine Order Form, using the template Vaccine Order Form attached as Annex II to this APA, setting out the details of the delivery of the doses of the Product allocated to the respective participating Member State. For the avoidance of doubt, each participating Member State is obligated to purchase and pay for the doses contractually allocated to it as formally notified by the Commission regardless of whether such Vaccine Order Form is concluded or not. The general conditions and the special conditions under this APA shall apply to, and, pursuant to Article I.1, prevail over, the Vaccine Order Forms.

 

I.5.4.

Wherever this APA provides that certain rights enjoyed by the participating Member States under the APA shall be exercised by the Commission, the Commission alone shall be entitled to notify the contractor of the exercise of such rights. Such notification shall be binding upon all participating Member States.

 

I.5.5.

Wherever this APA provides that certain notifications of the contractor shall be issued to the Commission, such notification to the Commission shall bind all participating Member State(s). The Commission is acting on behalf and in the name of the participating Member States in such cases.

 

I.5.6.

The foregoing Articles I.5.4 and I.5.5 shall not apply to the Vaccine Order Forms, unless provided otherwise in the APA or the relevant Vaccine Order Form. The Vaccine Order Forms shall only be implemented, performed and consummated by the contractor and the relevant participating Member State (but not the Commission).

 

I.6.

Product

 

I.6.1.

The "Product" to be supplied by the contractor under this APA is a pandemic preservative-containing mRNA-based CVnCoV COVID-19 vaccine. More specifically, the mechanism of the technology of the vaccine will be an mRNA-based vaccine coding for the full length pre fusion conformation stabilised version of the full length spike (S) protein of SARS-CoV-2 virus.

 

I.6.2.

An indicative specification of the Product is provided in Annex IV to this APA. However, due to the early stage of development of the Product, this specification is subject to change. The "final specification" of the Product will be determined by the contractor's documentation of the Product as approved in the EU marketing authorisation. If a participating Member State should request delivery of the Product prior to the grant of the EU marketing authorisation and if contractor accepts such request (where the withholding of such acceptance is at the contractor's discretion pursuant to Article I.7.1), the relevant specification of the Product will be determined by the documentation submitted by the contractor as approved in the temporary national authorisation granted by that participating Member State.

 

I.6.3.

In the context of this APA, a "dose" of the Product refers to the amount of vaccine, including diluent, needed for one injection; this amount corresponds to [*****], the dose which is taken forward to the pivotal Phase III clinical trial.

 

I.6.4.

The Product will be provided in the form of [*****] that will require a [*****]. However, the packaging characteristics (final presentation) are still in consideration. The [*****] will likely be presented in [*****] boxes and the [*****]. Packaging will also include [*****]. The injected volume for one dose is expected to be 0.5 ml (after dilution).

 

 

It is expected that a vaccination regimen will encompass [*****].

 

I.7.

Contract Volume

 

I.7.1.

Subject to the grant of an EU marketing authorisation, the contractor agrees to supply to the participating Member States a total of 225 million doses of the Product (the “Initial European Doses”) in accordance with the estimated delivery schedule set out in Article I.11 below (as adjusted pursuant to Article I.12, as the case may be). The contractor also agrees to supply to a participating Member State the relevant portion of the Initial European Doses in accordance with the estimated delivery schedule set out in Article I.11 below (as adjusted pursuant to Article I.12, as the case may be) if the participating Member State in question has granted a temporary national authorisation and if the contractor accepts the supply on the basis of such temporary national authorisation, it being understood that such acceptance may not be unreasonably withheld, provided, however, that the contractor may, inter alia, reject its acceptance if it sees a potential risk of undermining the public's confidence (in the relevant country or more broadly, in Europe given cross-border social media reach) in the safety and efficacy of potential vaccines without the approval of the Commission.

 

I.7.2.

The Commission may, on behalf and in the name of the participating Member States, place an additional order for up to 180 million doses of the Product by formal notification to the contractor within [*****] following the grant of the EU marketing authorisation for the Product (the “Additional European Doses”).

 

I.7.3.

The Initial European Doses and Additional European Doses correspond to the maximum number of doses of the Product that the contractor is able to allocate to this APA in accordance with the delivery schedule set out below in Article I.11.

 

I.7.4.

In addition to these contractually agreed volumes under this APA, the contractor agrees to discuss in good faith any participating Member State’s request to purchase additional quantities of the Product after satisfying its contractual commitments to other partners and customers. Until the date that the COVID-19 pandemic is considered to be over, the contractor agrees [*****]; for this purpose, the contractor and the participating Member State concerned will decide in good faith, taking into account expert advice, including the advice of the WHO, the date that the COVID-19 pandemic is considered to be over. For the avoidance of doubt, any such additional quantities requested are subject to a separate agreement between the participating Member State and the contractor outside the scope of this APA. For the avoidance of doubt, the contractor shall not be required to enter into any such separate agreement or be held liable under this APA for failure to enter into any such separate agreement.

 

I.8.           Allocation and Vaccine Order Forms

 

I.8.1.

The Initial European Doses will be allocated by the Commission among the participating Member States according to a population distribution key, unless a different allocation would be communicated by the Commission to the contractor. The contractor will plan deliveries to each participating Member State in accordance with the allocation key communicated by the Commission pursuant to the foregoing sentence. In order to avoid too small deliveries which could put the supply chain at risk and increase complexity and costs of the deliveries, the Parties agree that the minimum size per delivery will be the lower of either 1,000,000 doses or 12% of the total number of doses allocated to the relevant participating Member State in accordance with the first sentence of this Article.

 

 

I.8.2.

The Commission will formally notify to the contractor the volumes of the Product allocated to each participating Member State under this APA within thirty (30) calendar days after entry into force of this APA. This formal notification is binding upon all Parties.

 

I.8.3.

The Commission will allocate the Additional European Doses between the participating Member States in accordance with the principles set out above in Article I.8.1 and will formally notify the allocation decision to the contractor within thirty (30) calendar days following its order of the Additional European Doses. This formal notification is binding upon all Parties.

 

I.8.4.

Following the formal notification of the allocation decision by the Commission pursuant to Article I.8.2 or I.8.3 above, as the case may be, the participating Member States and the contractor will conclude Vaccine Order Forms using the template Vaccine Order Form attached to this APA as Annex II. The purpose of these Vaccine Order Forms is to specify further details of the delivery to the respective participating Member State, such as the place of delivery (the "specific deliveries"). Each Vaccine Order Form shall be signed by the relevant representative of the participating Member State and the contractor.

 

The participating Member States shall send the completed and duly signed Vaccine Order Form attached to this APA as Annex II, within fifteen (15) calendar days after the Commission formally notifies to the contractor its allocation decision. The terms of such Vaccine Order Form, in particular but without limitation, the volume stated therein, shall be aligned with – and do not affect in any manner – the overall volumes, dates and phasing set forth in the delivery schedule set out in Article I.11 below. Within ten (10) calendar days as of receipt of a Vaccine Order Form in compliance with the terms of this APA, in particular the allocation decision of the Commission and the delivery schedule set out Article I.11 below, the contractor will send back to the participating Member States the Vaccine Order Form duly signed and dated.

 

I.9.

Development Timeline; Special Commitments

 

I.9.1.

The contractor is currently concluding a dose escalating Phase I clinical trial for the Product and is preparing recruitment and start of pivotal Phase IIb/III clinical trial studies. The contractor currently anticipates that the rolling submission of the dossier to the EMA for EU marketing authorisation of the Product will begin in [*****] and that conditional EU marketing authorisation may be granted within one or two months after submission, based on anticipated accelerated EMA timelines. However, the Parties acknowledge that there is a risk that (i) a conditional EU marketing authorisation may not be granted and that the placing of the Product on the market may instead require a full EU marketing authorisation and that (ii) an EU marketing authorisation may not be granted at all.

 

I.9.2.

Subject to Article I.7.1, the delivery of the Product to the participating Member States is in principle subject to prior grant of EU marketing authorisation for the Product.

 

I.9.3.

The contractor commits to perform required clinical trials on specific relevant populations such as the elderly, individuals with comorbidities and pediatric populations, as to be further discussed and agreed with EMA, to obtain the EU marketing authorisation.

 

 

 

I.9.4.

To produce the Initial European Doses, the contractor may not manufacture or have manufactured the Product at manufacturing sites located outside the territory of the European Union, the UK, the EEA or Switzerland without the prior consent of the Commission, which consent may not be unreasonably withheld or delayed if the manufacturing at such sites is required to accelerate the production of the Initial European Doses. The CMOs and their manufacturing sites as identified in Annex V are deemed pre-approved.

 

I.10.       Right of the participating Member States to re-sell, export and/or distribute the Product

 

I.10.1.

The participating Member States will be entitled to re-sell, export and/or distribute any of the Products supplied to them pursuant to this APA to any other EU or EEA Member State and Switzerland, provided however that such re-sale, export and/or distribution may not take place before the concerned other EU or EEA Member State or Switzerland expressly agrees in writing to fully assume the indemnity obligations as set out under Article I.23 below and to provide a formally executed confirmation to the contractor.

 

I.10.2.

The participating Member States shall take the appropriate measures to ensure that the Products supplied to them pursuant to this APA will not be (i) re-sold or (ii) exported, distributed or donated for free to another country outside the EU and EEA and Switzerland, including for donation via NGOs or the World Health Organization, without prior consent of the contractor.

 

I.10.3.

The contractor is free to grant or withhold its consent to a re-sale pursuant to Article I.10.2 (i) at its own discretion, it being understood, however, that (i) no re-sale pursuant to Article I.10.2 (i) shall take place at a price higher than the Purchase Price as agreed in this APA and (ii) no re-sale pursuant to Article I.10.2 (i) shall take place unless the receiving country first confirms to the satisfaction of the contractor (i) that it will fully assume the indemnity obligations as set out under Article I.23 below or, alternatively, that there are other protection arrangements that the contractor accepts as being adequate (such acceptance not to be unreasonably withheld) and (ii) that the indemnity by the receiving country or other protection arrangement (as the case may be) is equivalent to the rights of the contractor under Article I.23 below, both from a legal and commercial perspective. The Parties acknowledge that, should re-sale to any third country, including EEA Member States and Switzerland, take place the participating Member State re-selling doses has an obligation to reimburse the Commission the up-front payment per dose paid by the Commission to the contractor.

 

I.10.4.

The contractor shall not unreasonably withhold its consent to the export, distribution or donation for free pursuant to Article I.10.2 (ii), it being understood, however, that no export, distribution or donation pursuant to Article I.10.2 (ii) shall take place unless the receiving country first confirms to the satisfaction of the contractor (i) that it will fully assume the indemnity obligations as set out under Article I.23 below or, alternatively, that there are other protection arrangements that the contractor accepts as being adequate (such acceptance not to be unreasonably withheld) and (ii) that the indemnity by the receiving country or other protection arrangement (as the case may be) is equivalent to the rights of the contractor under Article I.23 below, both from a legal and commercial perspective.

 

I.10.5.

In addition, the participating Member State envisaging a re-sale, export, distribution or donation pursuant to Articles I.10.1 or I.10.2 shall ensure, at its expense or at the expense of the receiving country, that the required regulatory/quality/GMP/GDP processes to enable such re-sale, export, distribution or donation (i.e. for the transport of the Product from the participating Member State envisaging such re-sale, export, distribution or donation to the central warehouse of the receiving country) are in place, for instance as pertains to (re)-labelling, validated transportation or cold chain integrity assurance. For the avoidance of doubt, the participating Member State envisaging such re-sale, export, distribution or donation shall bear (or have the receiving country bear) any liabilities, claims, costs (including costs for the transport of the Product from the participating Member State envisaging such re-sale, export, distribution or donation to the central warehouse of the receiving country), damages and other losses resulting from such re-sale, export, distribution or donation.

 

 

I.10.6.

In case of a donation or a re-sale to another EU or EEA Member State or Switzerland, the contractor may, at its sole discretion and without incurring additional costs, attempt to support or execute implementation of regulatory/quality/GMP/GDP requirements, particularly if the Products have not yet been delivered to the participating Member State.

 

I.11. Delivery; Estimated Delivery Schedule; Delays

 

I.11.1.

The Products must be delivered according to DAP Incoterms 2020 at the delivery site as indicated in the relevant Vaccine Order Form, it being noted, however, that each participating Member State shall select one single place of delivery, within the EU territory, applicable to all deliveries to the said participating Member State as per this APA. The participating Member States will be responsible for securing – and provide the contractor with – any required import license to the delivery site.

 

I.11.2.

Title to, and risk of loss of, the Product shall pass upon delivery in accordance with DAP Incoterms 2020.

 

I.11.3.

The Parties acknowledge that the placing on the market, making available, distribution and administration of the Product may require additional authorisations under local laws of the participating Member State. The responsibility for compliance with local laws, including those regarding the handling, distribution and administration of the Product, after the delivery at the relevant delivery site remains exclusively with the participating Member States.

 

I.11.4.

Estimated Delivery Schedule

 

(a)

Subject to Article I.7.1, availability of the Product is subject to successful development of the Product, the granting of the EU marketing authorisation and the successful manufacturing ramp up.

 

(b)

Subject to the above and subject to the EU marketing authorisation being granted by [*****], the estimated delivery schedule for the Products is as follows:

 

Estimated delivery periods	Volume (in millions of doses)
INITIAL EUROPEAN DOSES	225
Q1 2021	[*****]
Q2 2021	[*****]
Q3 2021	[*****]
Q4 2021	[*****]
Q1 2022	[*****]

 

 

ADDITIONAL EUROPEAN DOSES	180
Q2 2022	[*****]
Q3 2022	[*****]
Q4 2022	[*****]

 

(c)

The first delivery to a participating Member State shall take place at the latest by the later of (i) the end of the estimated delivery periods as specified in Article I.11.4(b) above or (ii) the end of a period of [*****] calendar days after the EU marketing authorisation or the relevant temporary national authorisation (as the case may be) is granted or (iii) the end of a period of [*****] calendar days after the EU marketing authorisation in case the authorisation granted requires package labelling in deviation from the standardised generally acceptable packaging as set out in Article I.13.1 below. Whilst the preceding sentence indicates the latest delivery dates for the first delivery, the Parties agree that doses will be delivered if and when lots are released and not necessarily at the end of a quarter, the [*****] period or the [*****] period (as the case may be).

 

I.12. Delays

 

I.12.1.

The Parties acknowledge that there is a risk that (i) the time-line for the EU marketing authorisation or (ii) the time-line for scaling up the production of the Product may be delayed or that (iii) an EU marketing authorisation may not be granted at all or (iv) the production of the Product may not be feasible.

 

I.12.2.

If there is a delay in the supply of the Product compared to the estimated delivery schedule, the contractor will inform the Commission as soon as reasonably possible, explain the reasons for such delay and submit a revised delivery schedule to the Commission which should be as close as possible to the estimated delivery schedule while taking into account the reasons for the delay.

 

I.12.3.

The consequences if no EU marketing authorisation is granted or the production of the Product is not feasible are exclusively dealt with in Article II.14.

 

I.13. Packaging; Labelling

 

I.13.1.

Unless and to the extent required otherwise under Union law or the laws of a participating Member State, the Product supplied under this APA and/or under the Vaccine Order Forms shall be in a standardised generally acceptable international packaging, including the package inserts and trade dress. For the sake of clarity, this means that the Product packaging and/or inserts shall be in the English language or multilingual, but will not necessarily include the specific languages of each of the participating Member States. To the extent that the contractor should be required to modify the Product packaging (and/or package inserts) from the aforementioned planned packaging due to the regulatory requirements in a certain participating Member State, the impact of such regulatory requirements on the timeline for availability of the Product shall be taken into account in the Estimated Delivery Dates as set forth in Article I.11.4(c) above.

 

I.13.2.

The contractor shall comply with labelling requirements for the Product under Union law and the respective laws of a participating Member State in all material respects, subject to any exceptions or procedural relief that may be granted by a competent authority under such laws.

 

 

I.14. Warranties; Acceptance mechanism

 

I.14.1.

The contractor warrants to the Commission and the participating Member States that

 

(a)

as of the date hereof, this APA has been duly executed and is a legal, valid and binding obligation on it, enforceable against it in accordance with its terms; and

 

(b)

as of the date hereof, it is not under any obligation, contractual or otherwise, to any third party in respect of the delivery of the Initial European Doses or that conflicts with or is inconsistent in any material respect with the terms of this APA or that would impede the complete fulfillment of its obligations under this APA.

 

I.14.2.

The contractor warrants to the Commission and the participating Member States that

 

(a)

all Products supplied to the participating Member States shall at the time of delivery comply with the final specifications;

 

(b)    all Products supplied to the participating Member States shall at the time of delivery be free from any product manufacturing defects; and

 

(c)     at the time of delivery, it has good title to the Products delivered to the participating Member States pursuant to this APA and it shall pass such title to the participating Member States free and clear of any security interests, liens, or other encumbrances, including having obtained any necessary IP rights.

 

I.14.3.

Given the current status of the clinical development program and in light of the extraordinary circumstances of the execution and performance of this APA, the contractor, in particular, does not warrant that the Products will show sufficient efficacy to prevent a COVID-19 infection and/or be without inacceptable adverse event symptoms beyond what will be documented in the ongoing and planned clinical trials or what will be documented in the leaflet of the Product.

 

I.14.4.

The participating Member States' [*****] remedy for a breach of a warranty set forth in Article I.14.2 above and in respect of any circumstances relating to the status and condition of the Product, shall be, at the contractor's election, (i) the issuance to the relevant participating Member State and/or to the Commission of a credit note (or refund) for the payments made in accordance with Articles I.17.1 and I.17.2 with respect to the non-conforming Product or (ii) the supply of a replacement Product to the relevant participating Member State for the non-conforming Product in a timeframe (of [*****] calendar days at maximum) mutually agreed to by the contractor and the relevant participating Member State. [*****].

 

I.14.5.

Upon delivery, the participating Member States shall immediately conduct a visual inspection of (i) the pallet(s) or grouping boxes of the Product and (ii) the temperature monitoring device. The relevant participating Member State shall conduct such visual inspection in a manner allowing it to complete the Goods Received Form properly and promptly. The Parties agree that, if reasonably requested by the contractor, such inspection shall be conducted in the presence of a representative and/or designee of the contractor.

 

 

I.14.6.

If an apparent defect is detected in the course of the visual inspection pursuant to Article I.14.5, the relevant participating Member State shall (i) document such apparent defect in the form of detailed comments in the relevant section of the Goods Received Form and (ii) provide comprehensive proof of the relevant issue in the form of photographs or other digital recordings together with the Goods Received Form. The participating Member State shall hand-over to the courier a copy of the Goods Received Form properly completed in accordance with Article I.14.5 and this Article I.14.6 and, as the case may be, transmit (by email) the comprehensive proof of the apparent defect to the contractor as soon as possible and no later than [*****] calendar days after delivery.

 

I.14.7.

If the Goods Received Form does not document any apparent defect or if a participating Member State fails to comply with Article I.14.5 and/or I.14.6, then the Product at stake shall be conclusively presumed to be free of apparent defects and the contractor shall be authorised to send the corresponding invoice, this even if the participating Member State did not issue formal proof of delivery. The contractor shall in that case have [*****] to the participating Member State or the Commission in relation to such Product with respect to apparent defects.

 

I.14.8.

For any hidden defect, the participating Member State will be obligated to notify the contractor in writing within [*****] calendar days following discovery of the said hidden defect. If participating Member State fails to provide such notification within [*****] calendar days, the participating Member State ceases its defect-related rights.

 

I.14.9.

The participating Member States shall observe and comply with such storage, handling, stock control and operational requirements relating to Product as set forth in the final specification or otherwise required by the Product labelling and applicable laws.

 

I.15. Product recalls

 

The contractor and the participating Member States shall maintain at their own cost records necessary to permit a recall of any Product delivered to a participating Member State. Each Party shall promptly notify the other Parties of any information, which might affect the marketability, safety, or effectiveness of the Product or which might result in the recall or seizure of the Product in a participating Member State. Upon receiving this notice or upon this discovery, each Party shall stop making any further shipments, administration and/or use of any product in the relevant country in its possession or control until a decision has been made whether a recall or some other corrective action is necessary. The contractor is responsible for making any required notifications to EMA and/or any relevant national competent authority with respect to a potential recall or abnormal restriction on supply. The decision to initiate a recall or to take some other corrective action, if any, with respect to the product will be made by the contractor and/or the competent authority in accordance with applicable laws. The [*****] shall implement such recall with respect to any Product delivered to [*****] in close coordination with the [*****].

 

I.16. Price of the Product

 

I.16.1.

The Product Price (as defined in Article I.16.2 below applies to both the Initial European Doses and the Additional European Doses.

 

I.16.2.

The "Product Price" for the Product per dose shall be EUR [*****].

 

 

I.16.3.

The Product Price (including, for the avoidance of doubt, the up-front payments on the Product Price pursuant to Article I.17.1 below), is exclusive of sales, value-added and other taxes, as well as customs and import fees and duties (sales, value-added and other taxes, as well as customs and import fees and duties together, the "ancillary expenses") to the delivery site. Such ancillary expenses will be charged in addition to the Product Price if applicable and provided that no exemption for the respective participating Member State applies.

 

I.16.4.

The participating Member States will be responsible, at their own expenses and risks, for any secondary distribution, storage and administration of the Product.

 

I.17. Payment obligations

 

I.17.1.

Up-front payment

 

(a)

In order to de-risk the necessary investments of the contractor to increase the speed of vaccine research and development and clinical trials and the preparation of the at-scale production capacity along the entire production value chain in the EU required for a rapid deployment of the millions of doses of the Product according to the terms of this APA, and in full understanding of the uncertainties associated with the aforementioned process, subject to EU marketing authorisation or temporary national authorisation (as the case may be), the Commission, acting on behalf and in the name of the participating Member States, and the participating Member States themselves shall contribute to financing the relevant costs in the form of an up-front payment on the total Product Price of the Initial European Doses (the "up-front payment") as set forth in this Article I.17.1 as well as in the form of the second upfront payment as set forth in Article I.17.2 and, as the case may arise, in the form of the Additional Doses up-front payment as set forth in this Article I.17.2.

 

(b)

The up-front payment is EUR 450 million total (which will equal an up-front payment of EUR [*****]).

 

(c)

Within [*****] calendar days following entry into force of the APA, the contractor shall send to the Commission a payment request for the payment of the up-front payment in accordance with Article II.15 below.

 

(d)

The Commission, acting on behalf and in the name of the participating Member States, shall pay the up-front payment within [*****] calendar days after receipt of a payment request from the contractor in accordance with Article I.17.1(c) above.

 

I.17.2.

Payments under Vaccine Order Forms

 

Pursuant to this Article I.17.2 and in accordance with their respective Vaccine Order Forms, the participating Member States shall make further payments to the contractor as follows:

 

(a)

With respect to the Initial European Doses, each participating Member State shall make a further up-front payment to the contractor in the amount of EUR [*****] for the volumes of the Product allocated to it pursuant to Articles I.8.1 and I.8.2 (the "second up-front payment"). The second up-front payment (plus value-added taxes, if any) shall be paid by the participating Member State within [*****] calendar days after notification by the contractor that the interim data package has been submitted to the EMA for the purpose of obtaining EU marketing authorisation for the Product, but no sooner than [*****] calendar days after receipt of a corresponding payment request from the contractor in accordance with Article II.15 below.

 

 

(b)

With respect to the Additional European Doses, and assuming that the Commission has formally notified the contractor that a participating Member State wishes to acquire Additional European Doses in accordance with Article I.8.3, each such participating Member State shall make an up-front payment to the contractor in the amount of [*****] % of the Purchase Price per dose for the volumes of the Product allocated to it pursuant to Article I.8.3 (the "Additional Doses up-front payment"). Such Additional Doses up-front payment (plus value-added taxes, if any) shall be paid by the participating Member State within [*****] calendar days after conclusion of the relevant Vaccine Order Form (or, if a participating Member State refuses to conclude the relevant Vaccine Order Form, [*****] calendar days after the contractor's explicit request to sign the relevant Vaccine Order Form), but no sooner than [*****] calendar days after receipt of a corresponding payment request from the contractor in accordance with Article II.15 below.

 

(c)

Each participating Member State shall pay the balance (plus ancillary expenses (as defined in Article I.16.3) due on the Product Price for the volumes of the Product allocated to it pursuant to Articles I.8.1 through I.8.3 within [*****] calendar days of each delivery (or offer to deliver if the participating Member State illegitimately refuses acceptance of delivery), but no sooner than [*****] calendar days after receipt of a corresponding invoice from the contractor in accordance with Article II.15 below. The balance due will be calculated on the basis of the relevant Product Price of the delivered (or offered to deliver, as the case may be) Products as set out in Article I.16.1 above and under deduction of any up-front payment, second up-front payment and/or Additional Doses up-front payment already received by the contractor for the relevant volumes of the Product delivered (or offered to deliver, as the case may be).

 

I.17.3.

Utilisation of the up-front payment and the second up-front payment

 

The contractor intends to use the up-front payment and the second up-front payment as further specified in Annex VII.

 

I.18. Contractor's bank account

 

Payments must be made to the contractor’s bank account denominated in euro, identified as follows:

 

Name of bank:	[*****]
Address of branch:	[*****]
Account holder:	CureVac AG
Account number:	[*****]

 

 

I.19. Communication details

 

For the purpose of this APA, communications must be made in English and sent to the following addresses:

 

If to the Commission to:

 

Directorate-General for Health and Food Safety

 

E-mail: SANTE-PROCUREMENT@ec.europa.eu

 

If to a participating Member State to

 

Cf. Annex I [*****]

 

If to the contractor to:

 

[*****]

 

CUREVAC AG

 

Friedrich-Miescher-Str. 15, 72076 Tübingen, Deutschland

 

E-mail: [*****]

 

By derogation from this Article, different contact details for the Commission, the participating Member States or the contractor may be provided in Vaccine Order Forms.

 

I.20. Exploitation of the results of the APA

 

I.20.1.

The Parties acknowledge and agree that the contractor shall be the sole owner of all intellectual property rights generated during the development, manufacture, and supply of the Product, including all know-how (collectively, the “Product IP Rights”). The contractor shall be entitled to exclusively exploit any such Product IP Rights. Except as expressly set forth in this APA, the contractor does not grant to the Commission and/or the participating Member States by implication, estoppel or otherwise, any right, title, licence or interest in the Product IP Rights.

 

I.20.2.

All rights not expressly granted by the contractor hereunder are reserved by the contractor.

 

I.21. Applicable law and settlement of disputes

 

I.21.1.

This APA shall be governed by the laws of Belgium.

 

I.21.2.

Dispute Resolution

 

(a)

In the event of a dispute between the Parties arising under or in connection with this APA or the legal relationships established by this APA, the Parties shall first refer such dispute to informal dispute resolution discussions between their respective representatives. Each of the contractor and the Commission, on behalf of itself or on behalf of the participating Member States (as the case may be), may initiate such informal dispute resolution by sending written notice of the dispute to the contractor or the Commission (as the case may be), and, within twenty (20) calendar days of such notice, the representatives shall meet and attempt to resolve the dispute amicably by good faith negotiations.

 

(b)

If the Parties are not able to settle their dispute in accordance with lit. (a) above, the Commission, the participating Member States and the contractor irrevocably submit to the exclusive jurisdiction of the courts located in Brussels, Belgium to settle any dispute which may arise under or in connection with this APA or the legal relationships established by this APA.

 

 

I.22. Reporting

 

I.22.1.

The contractor will provide to the Commission, at the latter’s request until full EU marketing authorisation for the Product has been granted, the following physical or electronic data:

 

(i)

updates on progress made in terms of clinical development of the Product; included interim and final results of clinical studies of the Product;

 

(ii)

progress on the build-up of manufacturing capacities;

 

(iii)

updates on progress, challenges and opportunities on establishment of the supply chain; and

 

(iv)

the use of the upfront payments by the Commission and the participating Member States, linked to points (i) to (iii), in general terms;

 

it being understood that the information pursuant to points (i) through (iii) above shall not [*****].

 

I.22.2.

In addition, the contractor shall keep the Commission and the participating Member States informed about any signal detected during the pharmacovigilance or vaccine monitoring programs in relation to the Product within five (5) working days from notifying the EMA.

 

I.23. Indemnification

 

I.23.1.

The Commission, on behalf of the participating Member States, declares that the use of the Products delivered under this APA and/or the Vaccine Order Forms will happen under epidemic conditions requiring such use, and that the administration of the Products will therefore be conducted under the sole responsibility of the participating Member States.

 

I.23.2.

The Parties further declare that the provisions contained in this indemnification clause, including the exceptions to the indemnification undertakings, reflect the exceptional circumstances of the COVID-19 pandemic and the need to develop new vaccines at an unprecedented speed in order to allow for very large scale immunisation.

 

I.23.3.

On this basis, each participating Member State shall indemnify and hold harmless the contractor, its Affiliates, sub-contractors and sub-licensees, including contract partners involved in the research, development (including pre-clinical and clinical testing), manufacturing and/or delivery; and officers, directors, employees and other agents, representatives and service providers of each (together, the “Indemnified Persons”) for liability incurred and normally borne by them relating to harm, damages and losses (together, the "Losses") as further specified in Article I.23.5 arising from the use and deployment of the Products supplied to the participating Member State (or another entity appointed by that participating Member State) under this APA, irrespective of the time when the Losses occur.

 

I.23.4.

Such indemnification will not be available to the Indemnified Persons to the extent that [*****].

 

 

I.23.5.

Indemnification pursuant to Article I.23.3 will only be available for Losses that consist of: (i) liability towards the injured Party [*****] for death, physical, mental or emotional injury, illness, disability, cost of care, property loss or damage, loss of earnings, and business interruption; and (ii) all reasonable and necessary costs related to such Losses including legal fees, expert fees and other litigation or settlement expenses.

 

I.23.6.

[*****].

 

I.23.7.

In case liability has been incurred by the Indemnified Persons for Losses, the contractor shall give the participating Member State in question, or an independent expert as referred to in Article I.23.8, access to all information reasonably necessary for the participating Member State to indemnify the Indemnified Persons and to verify whether the above mentioned conditions are fulfilled.

 

I.23.8.

The participating Member State shall be allowed to access the information through an independent expert in the field of damage claims, in particular in the field of public health, subject to an obligation of strict confidentiality. In that case, the participating Member State shall notify the contractor in advance of its intention to use an expert and the identity of such expert. The contractor shall be allowed to object to the use of an expert within 30 days counted from such notification, if it puts forward reasonable grounds on the basis of which the specific expert in question should not be permitted access to such information, such as conflict of interest. In such case, the participating Member State shall be allowed to appoint a new independent expert and notify that expert to the contractor.

 

I.23.9.

The contractor shall promptly inform the relevant participating Member State of any damage claims brought against any of the Indemnified Persons (a “Third Party Claim”), stating the nature and basis of the damage claim in question and, if possible, the estimated amount of damages. The contractor shall use reasonable efforts to keep the participating Member State informed of any developments relating to such Third Party Claim, including updates on the estimated amount of damages.

 

I.23.10.

The contractor shall ensure that the Indemnified Persons take such commercially reasonable actions to avoid, defend or settle the Third Party Claim and to mitigate the liability incurred. Within [*****] calendar days of the submission by the contractor of an invoice for such actually incurred Losses (also when they arise during the course of legal proceedings or settlement discussions), the participating Member State shall provide written confirmation to the contractor that it will indemnify such losses, subject to the conditions set out in the present indemnification clause, in particular the conditions set above. [*****]. The contractor shall keep the participating Member State reasonably informed in relation to the Third Party Claim and the contractor may settle the Third Party Claim only with the prior consent of the participating Member State (such consent not to be unreasonably conditioned, withheld or delayed).

 

I.23.11.

Alternatively, the contractor may request, to the extent possible under the applicable rules of procedure, the participating Member State to assume (with its own counsel and at its own costs) sole control of the defence or settlement of the Third Party Claim; provided that: (i) the participating Member State shall reasonably take the contractor's interests into consideration and shall not settle such Third Party Claim without the prior written consent of the contractor (such consent not to be unreasonably conditioned, withheld or delayed); and (ii) the contractor shall have the right, but not the obligation, to participate in the defence or settlement of the Third Party Claim and to retain its own counsel in connection with such Third Party Claim at its own expense. [*****].

 

 

I.23.12.

These provisions apply until a final determination by the competent courts of a ground for exception to the indemnification, as stipulated in Articles I.23.4. Any claims of contractor under this Article I.23 shall be time barred not earlier than [*****] after the final expiration of all relevant statutes of limitation periods for the relevant Third Party Claim.

 

I.23.13.

The Parties acknowledge and agree that the provisions of this indemnification clause are reasonable and necessary to protect the legitimate interest of the Indemnified Persons. However, if any provision in this clause were to be held to be illegal, invalid or unenforceable, in whole or in part, then such provision shall not be nullified but the Parties, including the participating Member States, shall be deemed to have agreed to such provision that conforms with the limitations imposed by applicable law and that is as close as possible to the original intention of the Parties and has the same or as similar as possible economic effect, and such provision shall be automatically reformed accordingly.

 

 

 

II.           GENERAL CONDITIONS

 

II.1. Severability

 

Each provision of this APA is severable and distinct from the others. If a provision is or becomes illegal, invalid or unenforceable to any extent, it must be severed from the remainder of the APA. This does not affect the legality, validity or enforceability of any other provisions of the APA, which continue in full force and effect. The illegal, invalid or unenforceable provision must be replaced by a legal, valid and enforceable substitute provision which corresponds as closely as possible with the actual intent of the Parties under the illegal, invalid or unenforceable provision. The APA must be interpreted as if it had contained the substitute provision as from its entry into force.

 

II.2. Provision of Supplies

 

II.2.1.

The contractor must provide supplies that are at the time of delivery free from any Product Manufacturing Defects.

 

II.2.2.

All periods specified in the APA are calculated in calendar days, unless otherwise specified.

 

II.2.3.

The contractor must immediately notify the Commission of any changes in the exclusion situations as declared, according to Article 137 (1) of Regulation (EU) 2018/1046.

 

II.3. Communication between the parties

 

II.3.1.

Form and means of communication

 

Any communication of information, notices or documents under the APA must:

 

(a)

be made in writing in paper or electronic format in the language of the contract;

 

(b)

bear the APA number and, if applicable, the Vaccine Order Form number;

 

(c)

be made using the relevant communication details set out in Article I.8; and

 

(d)

be sent by mail or e-mail.

 

If a Party requests written confirmation of an e-mail within a reasonable time, the other Party must provide an original signed paper version of the communication as soon as possible.

 

The Parties agree that any communication made by e-mail has full legal effect and is admissible as evidence in judicial proceedings.

 

II.3.2.

Date of communications by mail and e-mail

 

Any communication is deemed to have been made when the receiving Party receives it, unless this APA contract refers to the date when the communication was sent.

 

E-mail is deemed to have been received by the receiving Party on the day of dispatch of that e-mail, provided that it is sent to the e-mail address indicated below. The sending Party must be able to prove the date of dispatch. In the event that the sending Party receives a non- delivery report, it must make every effort to ensure that the other Party actually receives the communication by e-mail or mail. In such a case, the sending Party is not held in breach of its obligation to send such communication within a specified deadline.

 

 

Mail sent to the Commission or the participating Member State is deemed to have been received on the date on which the department responsible referred to below registers it.

 

Formal notifications are considered to have been received by the receiving Party on the date of receipt indicated in the proof received by the sending Party that the message was delivered to the specified recipient.

 

II.4. Liability

 

II.4.1.

[*****], the Commission and the participating Member States are not liable for any damage or loss caused by the contractor, including any damage or loss to third parties occurred during or as a consequence of the performance of the APA or any Vaccine Order Forms.

 

II.4.2.

If required by the relevant applicable legislation, the contractor must take out an insurance policy against risks and damage or loss relating to the performance of the APA or any Vaccine Order Forms. Upon request, the contractor must provide evidence of insurance coverage to the Commission.

 

II.4.3.

If a third party brings any action against the Commission or the participating Member State in connection with the performance of the APA or any Vaccine Order Forms, including any action for alleged breach of intellectual property rights, the contractor must provide reasonable assistance to the Commission or the participating Member State.

 

II.5. Conflict of interest and professional conflicting interests

 

II.5.1.

The contractor must take all the necessary measures to prevent any situation of conflict of interest or professional conflicting interest.

 

II.5.2.

The contractor must notify the Commission in writing as soon as possible of any situation that could constitute a conflict of interest or a professional conflicting interest during the performance of the APA. The contractor must immediately take action to rectify the situation.

 

The Commission may do any of the following:

 

(a)

verify that the contractor’s action is appropriate;

 

(b)

require the contractor to take further action within a specified deadline;

 

(c)

decide, on behalf of the participating Member States, not to award a Vaccine Order Form to the contractor.

 

II.5.3.

The contractor must pass on all the relevant obligations in writing to:

 

(a)

its personnel;

 

(b)

any natural person with the power to represent it or take decisions on its behalf;

 

(c)

third parties involved in the performance of the APA, including subcontractors.

 

The contractor must also ensure that the persons referred to above are not placed in a situation which could give rise to conflicts of interest.

 

 

II.6. Confidentiality and public announcements

 

II.6.1.

The Commission, the participating Member States and the contractor must treat with strict confidentiality any confidential information or documents in connection with the APA.

 

II.6.2.

The Commission, the participating Member States and the contractor shall:

 

(a)

not use confidential information or documents for any purpose other than to perform their respective obligations under the APA or a Vaccine Order Form without the prior written agreement of the disclosing Party;

 

(b)

ensure the protection of such Confidential information or documents with the same level of protection as their own confidential information or documents and in any case with due diligence;

 

(c)

not disclose, directly or indirectly, confidential information or documents to third parties without the prior written agreement of the other Party.

 

II.6.3.

Notwithstanding the above, the Parties may disclose confidential information or documents to their directors, officers and employees and, in the case of the contractor, to its subcontractors and their directors, officers and employees as well as to those of any corporation directly or indirectly controlling, controlled by, or under common control with the contractor (control being the ownership of more than fifty percent (50 %) of the outstanding voting stock of a corporation), and/or any company, individual or organisation retained by them to assist in the implementation of the APA, provided that each such company, individual and organisation must be legally bound to comply with this Article.

 

II.6.4.

The confidentiality obligations set out in this Article are binding on the Commission, the participating Member State and the contractor during the performance of the APA and for as long as the information or documents remain confidential unless:

 

(a)

the disclosing Party agrees to release the receiving Party from the confidentiality obligation earlier;

 

(b)

the confidential information or documents become public through other means than a breach of the confidentiality obligation;

 

(c)

the applicable law requires the disclosure of the confidential information or documents.

 

II.6.5.

The contractor must obtain from any natural person with the power to represent it or take decisions on its behalf, as well as from third parties involved in the performance of the APA a commitment that they will comply with this Article. At the request of the Commission, the contractor must provide a document providing evidence of this commitment.

 

II.6.6.

The contractor acknowledges that the Commission is subject to requirements laid down under Regulation (EC) 1049/2001. The Commission commits that it will consult with the contractor on any disclosure request concerning documents containing confidential information as provided for in Article 4(4) of said Regulation.

 

II.6.7.

Notwithstanding the above, each Party may issue a press release and/or other public statement disclosing the total contract volume and value of the APA and/or the Vaccine Order Form. The Parties shall consult together on the timing, contents and manner of any press release relating to this APA.

 

 

II.7. Processing of personal data

 

II.7.1.

Processing of personal data by the Commission

 

Any personal data included in or relating to the APA, including its implementation, shall be processed in accordance with Regulation (EU) 2018/1725. Such data shall be processed solely for the purposes of the implementation, management and monitoring of the APA by the data controller. For the purpose of this provision, the data controller for the Commission shall be the Director-General of the European Commission's Directorate-General for Health and Food Safety. The data protection notice is available at https://ec.europa.eu/info/data-protection- public-procurement-procedures_en.

 

The contractor or any other person whose personal data is processed by the data controller in relation to this APA has specific rights as a data subject under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, rectify or erase their personal data and the right to restrict or, where applicable, the right to object to processing or the right to data portability.

 

Should the contractor or any other person whose personal data is processed in relation to this APA have any queries concerning the processing of its personal data, it shall address itself to the data controller. They may also address themselves to the Data Protection Officer of the data controller. They have the right to lodge a complaint at any time to the European Data Protection Supervisor.

 

II.7.2.

Processing of personal data by the contractor

 

The processing of personal data by the contractor shall meet the requirements of Regulation (EU) 2018/1725 and be processed solely for the purposes set out by the controller.

 

II.8. Subcontracting

 

II.8.1.

The contractor may not subcontract and have the APA (including Vaccine Order Forms entered into under the APA) implemented by third parties without prior written authorisation of the Commission, it being noted that the Commission will not unreasonably withhold or delay such authorisation. The manufacturing network partners and their manufacturing sites as identified in Annex V are deemed pre-approved for the purpose of the foregoing sentence.

 

II.8.2.

In the case of subcontracting, the contractor remains bound by its contractual obligations and is solely responsible for the performance of the APA.

 

II.8.3.

The contractor must ensure that the subcontract does not affect the rights of the Commission and the participating Member States under this APA.

 

II.8.4.

The Commission may request the contractor to replace a subcontractor found to be in a situation provided for in Article II.14.2(d) and (e).

 

II.9. Amendments

 

II.9.1.

Any amendment to the APA must be made in writing by the contractor and the Commission, (also) acting in the name and on behalf of all participating Member States, and any amendment to a Vaccine Order Form must be made in writing by the contractor and the relevant participating Member State. The conclusion of a Vaccine Order Form does not constitute an amendment to the APA.

 

II.9.2.

No amendment can make changes to the APA or a Vaccine Order Form that might alter the initial conditions of the procurement procedure or result in unequal treatment of tenderers or contractors.

 

 

II.10. Assignment

 

II.10.1.

The contractor cannot assign any of the obligations arising from the APA, without prior written authorisation from the Commission. In such cases, the contractor must provide the Commission with the identity of the intended assignee.

 

II.10.2.

Any obligation assigned by the contractor without authorisation is not enforceable against the Commission.

 

II.11. Force majeure

 

II.11.1.

If the contractor, or one of its subcontractors, is affected by force majeure, the contractor must immediately notify the Commission or, if only the performance of certain Vaccine Order Forms are affected, the relevant participating Member State(s), stating the nature of the circumstances, their likely duration and foreseeable effects. If the Commission and/or a participating Member State is affected by force majeure, the Commission and/or the relevant participating Member State(s) must immediately notify the contractor, stating the nature of the circumstances, their likely duration and foreseeable effects.

 

II.11.2.

A Party is not liable for any delay or failure to perform its obligations under the APA if that delay or failure results from a force majeure. As long as the contractor is unable to fulfil its contractual obligations owing to force majeure, it has the right to remuneration only for the doses of the Product actually delivered.

 

II.11.3.

The Parties must take all necessary measures to limit any damage due to force majeure.

 

II.12. Reduction in price

 

II.12.1.

Quality standards

 

If the contractor fails to deliver the Product in accordance with the APA, the participating Member State in question may reduce or recover payments in accordance with Article I.14.4.

 

II.12.2.

Procedure

 

The participating Member State in question must formally notify the contractor of its intention to reduce payment and the corresponding calculated amount.

 

The contractor has 30 days following the date of receipt to submit observations. Failing that, the decision becomes enforceable the day after the time limit for submitting observations has elapsed.

 

If the contractor submits observations, the participating Member State in question, taking into account the relevant observations, must notify the contractor:

 

(a)

of the withdrawal of its intention to reduce payment; or

 

(b)

of its final decision to reduce payment and the corresponding amount.

 

 

 

II.13.

Suspension of the APA

 

II.13.1.

Suspension by the contractor

 

If and to the extent the contractor, including any of its subcontractors, is affected by force majeure, it may suspend the performance of the APA and/or the Vaccine Order Forms.

 

If the performance of the APA or both the performance of the APA and the performance of all Vaccine Order Forms are affected, the contractor must immediately notify the Commission of the suspension or, if only the performance of certain Vaccine Order Forms is affected, the contractor must immediately notify the relevant participating Member State(s) of the suspension. The notification must include a description of the force majeure and state when the contractor expects to resume the performance of the APA and/or the Vaccine Order Forms.

 

The contractor must notify the Commission or the relevant participating Member State(s) (as the case may be) as soon as it is able to resume performance of the APA and/or Vaccine Order Form, unless the APA or the Vaccine Order Form has already been terminated.

 

II.13.2.

Suspension by the Commission or the Participating Member State

 

The Commission or the participating Member State with respect to its Vaccine Order Form may suspend the performance of the APA or performance of a Vaccine Order Form, respectively, or any part of it:

 

(a)

if the procedure for awarding the APA or a Vaccine Order Form or the performance of the APA proves to have been subject to irregularities or fraud on the part of the contractor;

 

(b)

in order to verify whether the presumed irregularities or fraud on the part of the contractor have actually occurred.

 

The Commission or the participating Member State in question must formally notify the contractor of the suspension and the reasons for it. Suspension takes effect on the date of formal notification, or at a later date if the formal notification so provides.

 

The Commission or the participating Member State in question must notify the contractor as soon as the verification is completed whether:

 

(a)

it is lifting the suspension; or

 

(b)

it intends to terminate the APA or a Vaccine Order Form under Article II.14.2 e).

 

The contractor is entitled to compensation for suspension of any part of the APA or a Vaccine Order Form if the verification comes to the result that the presumed irregularities or fraud on the part of the contractor did not occur.

 

The Commission may in addition suspend the time allowed for payments in accordance with Article II.16.4.

  

 

II.14.

Termination of the APA

 

II.14.1.

Grounds for automatic termination of the APA

 

The APA will be automatically terminated if and when the contractor notifies the Commission of its inability to provide the Product because of, and only because of, the following reasons: (i) the clinical trial results not being satisfactory, (ii) the clinical trial results not meeting their end point in terms of efficacy or safety or (iii) the EU marketing authorisation not being granted. The notification of the contractor shall set out in detail the underlying reasons for automatic termination of the APA. The termination will be effective unless the Commission objects in writing within thirty (30) calendar days following the notification by the contractor, such objection may only be issued based on reasonable grounds given the evidence of one the three reasons (points (i) through (iii)) stated above and taking into account the severity of the impact that the continuation of the APA would have on the contractor's business. If and once the termination becomes effective the contractor may not sell and/or deliver the Product to any third party.

  

II.14.2.

Grounds for termination by the Commission or the participating Member States

 

The Commission, acting on behalf and in the name of the participating Member States, may terminate the APA in the following circumstances (a) through (h), and the participating Member States may terminate their respective Vaccine Order Forms in the following circumstances (b) through (h). Except for the termination right in case of (a) below, a right of termination only exists if the reason giving rise of the right to terminate is not cured, removed or otherwise no longer existent within [*****] calendar days of receipt by the contractor of formal notification from the Commission of the intention to terminate the APA or participating Member States to terminate the respective Vaccine Order Forms, which formal notification shall include a reasonably detailed description of the alleged breach.

 

(a)

If no EU marketing authorisation is granted by [*****], or any other day mutually agreed upon by the Commission and the contractor in writing or if by that date no doses of the Initial European Doses have been supplied to any of the participating Member States. If the contractor expects that such a situation may occur, it will inform the Commission well in advance of such possibility, explain the reasons behind such delays and, if possible, propose a remedy for the situation, including a revised delivery schedule.

 

(b)

If the contractor is in material breach of obligations (i) in relation to the main performance obligations such as the obligations under the [*****], (ii) in relation to the obligations under [*****] or (iii), in the case of a participating Member State, in relation to the obligations under a Vaccine Order Form, or if the contractor [*****] refuses to sign one or several Vaccine Order Form(s).

 

(c)

If the contractor is in one of the situations provided for in points (a) and (b) of Article 136(1) of the Financial Regulation4.

 

(d)

If the contractor, any of the members of its management board or any of its key employees involved in the performance of this APA is in one of the situations provided for in points (c) to (h) of Article 136(1) or to Article 136(2) of the Financial Regulation.

 

(e)

If the procedure for awarding the APA or the performance of the APA prove to have been subject to irregularities or fraud on the part of the contractor.

 

(f)

If the contractor is in a situation that constitutes a conflict of interest or a professional conflicting interest and such situation is not resolved by the contractor in accordance with Article II.5.2.

 

⁴ Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, OJ L 193 of 30.7.2018, p.1 https://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1544791836334&uri=CELEX:32018R1046

 

 

(g)

If a change to the contractor’s legal, financial, technical, organisational or ownership situation substantially affects the performance of the APA or substantially modify the conditions under which the APA was initially awarded or a change regarding the exclusion situations listed in Article 136 of Regulation (EU) 2018/1046 that calls into question the decision to award the contract.

 

(h)

In the event of force majeure, where either resuming implementation is impossible or the necessary ensuing amendments to the APA or a Vaccine Order Form would mean that the tender specifications are no longer fulfilled or result in unequal treatment of tenderers or contractors.

 

II.14.3.

Grounds for termination by the contractor

 

The contractor may terminate the APA or the respective Vaccine Order Form in the following circumstances:

 

(a)

If the Commission or any of the participating Member States [*****].

 

(b)

In the event of force majeure, where either resuming implementation is impossible or the necessary ensuing amendments to the APA or a Vaccine Order Form would mean that the tender specifications are no longer fulfilled or result in unequal treatment of tenderers or contractors.

 

II.14.4.

Procedure for termination

 

The contractor or the Commission (as the case may be) must formally notify the Commission or the contractor (as the case may be) of its intention to terminate the APA. The foregoing sentence shall apply mutatis mutandis to the Vaccine Order Forms, it being understood, however, that formal notification shall be issued by or to (as the case may be) the relevant participating Member State.

 

The Party receiving a termination notice pursuant to the foregoing paragraph shall have thirty (30) calendar days following the date of receipt to submit observations, including the measures it has taken or will take to continue fulfilling its contractual obligations. Failing that, the decision to terminate becomes enforceable the day after the time limit for submitting observations has elapsed.

 

If the other Party submits observations, the Party intending to terminate must formally notify it either of the withdrawal of its intention to terminate or of its final decision to terminate.

 

In the cases referred to in points (a) to (c), (f) and (g) of Article II.14.2 and in Article II.14.3, the date on which the termination takes effect must be specified in the formal notification.

 

In the cases referred to in points (d), (e) and (h) of Article II.14.2, the termination takes effect on the day following the date on which the contractor receives formal notification of termination.

 

II.14.5.

Effects of termination

 

(a)

in case of an automatic termination pursuant to Article II.14.1

 

No liability is incurred by any Party in case of an automatic termination according to Article II.14.1.

 

The up-front payment and the second up-front payments shall [*****] in the following way:

 

  

The contractor shall send to the Commission within sixty (60) days from notifying the Commission about the automatic termination of the APA, a financial statement (the “Financial Statement”), detailing for which expenses the up-front payments have been used in relation to the purposes as set out in the APA. Expenses to be taken into account include the full amount of internal and/or external expenses which have been, or will be, incurred as well as such which have been committed by, or relate to commitments made by, the contractor at the time when the contractor notified the Commission, it being understood that such 'expenses' shall include, without limitation, costs, expenses and liabilities, write-offs and value adjustments in connection with research, development, ramp up, IP, real estate, construction, administration, manufacturing, production, packaging, delivery, preservation, transportation, personnel, redundancy, litigation, agreements, terminations of agreements, advice and services, penalties and fines, whether incurred directly or indirectly by the contractor, a provider, a contractor or a subcontractor of the contractor.

 

In the Financial Statement, the contractor will set out such amounts as well as those amounts of the up-front payments that have neither been incurred nor committed (“unspent amounts”). Such unspent amounts will be reimbursed by the contractor to the Commission and the participating Member States in proportion to their respective up-front payments within thirty (30) days from the receipt of the Financial Statement by the Commission, it being understood that the Financial Statement and the unspent amounts shall be final and binding upon all Parties to the extent the Commission and the participating Member States have not provided to the contractor a written statement of objections, specifying in reasonable detail the grounds of objections, within thirty (30) days from the receipt of the Financial Statement by the Commission.

 

In addition, the contractor will transfer, upon the Commission's request to be provided within forty-five (45) days after the receipt of notification about the automatic termination, to the Commission, or a third party named by the Commission, any raw materials and primary components not used and paid for with the up-front payments (the “Refundable Items”). The contractor will also facilitate the discussion of a transfer of reserved capacity with CMOs paid for with the up-front payments to a third party selected by the Commission. [*****].

 

(b)

in case of termination pursuant to Article II.14.2

 

In case of a termination by the Commission according to Article II.14.2(a), the provisions on the effect of the termination and refunding of the unspent amounts and the Refundable Items as set out in Article II.14.5(a) apply mutatis mutandis.

 

In case of a termination of the APA by the Commission or a Vaccine Order Form by a participating Member State according to Article II.14.2(b) to (g), the contractor may be liable for damage incurred by the Commission or the participating Member State [*****]. The Commission or the participating Member State may claim compensation for such damage, as allowed by applicable laws.

 

(c)

in case of termination pursuant to Article II.14.3

 

The contractor is not entitled to compensation for any damage resulting from the termination of the APA or a Vaccine Order Form, including loss of anticipated profits, if the contractor terminated the APA or the relevant Vaccine Order Form in accordance with Article II.14.3(b).

 

The Commission and the participating Member State are liable for damage incurred by the contractor as a result of the termination of the APA or a Vaccine Order Form by the contractor on the basis of Article II.14.3(a). The contractor may claim compensation for such damage against the Commission and/or the participating Member State(s), as allowed by applicable laws.

 

 

The Parties must take all appropriate measures to minimise costs, prevent damage and cancel or reduce their commitments.

 

Within sixty (60) calendar days of the date of termination, the contractor must submit any report and any invoice required for Products that were provided before the date of termination.

 

Articles I.10.3, I.10.4, I.10.5, I.23, II.6, II.7 and II.17 shall survive any termination of this APA and/or the Vaccine Order Forms.

  

II.15.

Payment Requests, Invoices, Value Added Tax and e-invoicing

 

II.15.1.

Payment Requests, Invoices and value added tax

 

Payment requests and invoices shall contain the following information: (i) the contractor’s full name and address, (ii) the reference to this APA and to the Vaccine Order Form (to the extent already concluded), (iii) the full name and address of the recipient, (iv) the name of the participating Member State concerned, (v) the invoiced amount, (vi) the currency, (vii) the quantity of Product doses delivered (or offered to be delivered if the participating Member State illegitimately refuses acceptance of delivery), or, with respect to the up-front payment, the second up-front payment and the Additional Doses up-front payment, the quantity of Product doses allocated to the relevant participating Member State pursuant to Articles I.8.1 through I.8.3, (viii) the date of delivery (if relevant), and (ix) the date of issuance of the payment request or invoice.

 

Invoices must indicate the place of taxation of the contractor for value added tax (VAT) purposes and must specify separately amounts not including VAT and amounts including VAT.

 

The Commission is exempt from all taxes and duties, including VAT, in accordance with Articles 3 and 4 of the Protocol 7 of the Treaty on the Functioning of the European Union on the privileges and immunities of the European Union. The Parties shall cooperate in good faith to ensure the tax exemption of the Commission at all steps of the APA and take all necessary actions to ultimately ensure such exemption in connection with the execution of the APA.

 

Notwithstanding the preceding paragraph, for the avoidance of doubt, VAT may be charged on doses of the Product under the conditions of national legislation. In such cases, the taxable amount may include the amount paid by the participating Member State as well as the respective portion of the up-front payment paid by the Commission.

 

For the further avoidance of doubt, the Parties agree that all prices set forth in the APA shall be exclusive of VAT and that VAT, if any, shall be paid in addition to the prices set forth in the APA.

 

II.15.2.

E-invoicing

 

Receipt of invoices by standard format (pdf) or e-mail is accepted.

  

II.16.

Payments

 

II.16.1.

Date of payment

 

The date of payment is deemed to be the date on which the Commission’s account or the account of the participating Member State in question is debited.

 

 

 

II.16.2.

Currency

 

Payments are made in euros.

 

II.16.3.

Costs of transfer

 

The costs of the transfer are borne as follows:

 

(a)

the Commission or the participating Member State in question bears the costs of dispatch charged by its bank;

 

(b)

the contractor bears the costs of receipt charged by its bank;

 

(c)

the Party causing repetition of the transfer bears the costs for repeated transfer.

 

II.16.4.

Suspension of the time allowed for payment

 

The Commission or the participating Member State in question may suspend the payment periods specified in Article I.17 at any time by notifying the contractor that its payment request or invoice (as the case may be) cannot be processed if the Commission or the participating Member State in question is not able to process a payment request or invoice (as the case may be):

 

(a)

because the payment request or invoice (as the case may be) does not comply with the APA; or

 

(b)

because the Commission or the participating Member State in question has legitimate objections against the documents submitted with the payment request or invoice (as the case may be).

 

The Commission or the participating Member State in question must notify the contractor as soon as possible of any such suspension, giving the reasons for it.

 

Suspension takes effect on the date the Commission or the participating Member State in question sends the notification. The remaining payment period resumes from the date on which the requested information or revised documents are received or the necessary further verification is carried out. Where the suspension period exceeds two months, the contractor may request the Commission or the participating Member State in question to justify the continued suspension.

 

II.16.5.

Interest on late payments of the Commission and/or the participating Member States

 

On expiry of the payment periods specified in Article I.17, the contractor is entitled to interest on late payment at the rate applied by the European Central Bank for its main refinancing operations in euros (the reference rate) plus five points. The reference rate is the rate in force, as published in the C series of the Official Journal of the European Union, on the first day of the month in which the payment period ends.

 

Suspension of the payment period pursuant to Article II.16.4 is not considered as giving rise to late payment.

 

Interest on late payment covers the period running from the day following the due date for payment up to and including the date of payment as defined in Article II.16.1.

 

II.16.6.

Interest on late payments of the contractor

 

If the contractor does not honour the obligation to pay the unspent amount when due, the amount due bears interest at the rate indicated in Article II.16.5. Interest on late payments will cover the period starting on the day after the due date for payment and ending on the date when the Commission or the participating Member State in question receives the full amount owed. Any partial payment is first entered against charges and interest on late payment and then against the principal amount.

  

 

II.17.

Checks and audits

 

II.17.1.

The Commission and the European Anti-Fraud Office (‘the OLAF’) may check or require an audit on the performance of the APA. This may be carried out either by OLAF’s own staff or by any outside body authorised to do so on its behalf.

 

Such checks and audits may be initiated at any moment during the provision of the vaccines and up to five years starting from the payment of the balance of the last Vaccine Order Form issued under this APA.

 

The audit procedure is initiated on the date of receipt of the relevant letter sent by the Commission. Audits are carried out on a confidential basis.

 

II.17.2.

The contractor must keep all original documents stored on any appropriate medium, including digitised originals if authorised under national law, for a period of five years starting from the payment of the balance of the last Vaccine Order Form issued under this APA.

 

II.17.3.

The contractor must grant the appropriate right of access to sites and premises where the APA is implemented and to all the information, including information in electronic format, needed to conduct such checks and audits. The contractor must ensure that the information is readily available at the moment of the check or audit and, if so requested, that information is handed over in an appropriate format.

 

II.17.4.

On the basis of the findings made during the audit, a provisional report is drawn up. The Commission or its authorised representative must send it to the contractor, who has 30 days following the date of receipt to submit observations. The contractor must receive the final report within 60 days following the expiry of the deadline to submit observations.

 

II.17.5.

In accordance with Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspection carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office, the European Anti- Fraud Office may carry out investigations, including on the spot checks and inspections, to establish whether there has been fraud, corruption or any other illegal activity under the contract affecting the financial interests of the Union. Findings arising from an investigation may lead to criminal prosecution under national law.

 

The investigations may be carried out at any moment during the provision of the vaccines and up to five years starting from the payment of the balance of the last Vaccine Order Form issued under this APA.

 

II.17.6.

The Court of Auditors and the European Public Prosecutor’s Office established by Council Regulation (EU) 2017/19395 (‘the EPPO’) have the same rights as the Commission, particularly right of access, for the purpose of checks, audits and investigations.

 

 

⁵ Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office

 

 

II.17.7.

The Commission and/or any participating Member State shall have the right to use, at their exclusive costs, an internationally recognised expert (not engaged on a contingent basis) to perform an audit in order to verify (a) any clinical trial data, and/or (b) the manufacturing conditions including by subcontractors. The contractor will enable such an audit and will make available to the third-party auditor, upon reasonable request, any documents or information for that purpose.

  

*** Signature page to follow ***

  

 

SIGNATURES

  

This APA has been executed on the place and dates mentioned hereunder, in two original copies, each of the contractor and the Commission acknowledging having received one original signed copy.

 

For the contractor,			For the Commission,
[*****]			[*****]
[*****]			[*****]
Signature:	/s/ [*****]		Signature:	/s/ [*****]
Done at [*****]			Done at [*****]
[*****]
[*****]
Signature:	/s/ [*****]
Done at [*****]

 

 

Annex I  
List of participating Member States

 

Full name	Contact person	Full official address	Email address
Republic of Austria
Kingdom of Belgium
Republic of Bulgaria
Republic of Croatia
Republic of Cyprus
Czech Republic
Kingdom of Denmark
Republic of Estonia
Republic of Finland
French Republic
Federal Republic of Germany
Hellenic Republic
Hungary
Ireland
Italian Republic
Republic of Latvia
Republic of Lithuania
Grand Duchy of Luxembourg
Republic of Malta
Kingdom of the Netherlands
Republic of Poland
Portuguese Republic
Romania
Slovak Republic
Republic of Slovenia
Kingdom of Spain
Kingdom of Sweden

 

  

Annex II  
Template Vaccine Order Form

 

1.

[Name of Member State] (the “Member State”), represented for the purposes of signing this specific order form by [forename, surname, function, department of authorising officer],

 

and

 

2.

CureVac AG

 

Friedrich-Miescher-Straße 15, 72076 Tübingen

 

[VAT registration number]

 

("the contractor"), represented for the purposes of signing this specific order form by [forename, surname and function of legal representative,]

 

WHEREAS, the contractor and the Commission acting on behalf of and in the name of the participating Member States entered into that Advance Purchase Agreement for the production, purchase and supply of Vaccine against COVID-19 in the European Union dated [l] September 2020 (the “APA”).

 

WHEREAS, the APA provides that each participating Member State will execute an order form with the information filled in (a “Vaccines Order Form”);

 

WHEREAS, in line with the conditions set out in the APA, the Member State wishes to order doses of the Product from the contractor in accordance with the terms of the APA.

 

WHEREAS in accordance with the provisions set out in the APA, the contractor has agreed to supply the doses of the Product allocated to each participating Member State in a given timeframe, should it manage to obtain a (conditional) EU marketing authorisation.

 

WHEREAS defined terms used but not defined herein shall have the meaning ascribed to them in the APA.

  

HAVE AGREED

 

Article 1

 

Subject matter

 

1.1       This Vaccine Order Form is entered into as contemplated by the APA, signed by the Commission, acting on behalf and in the name of the participating Member States and the contractor on [complete date]. This Vaccine Order Form is an integral part of the APA and the terms and conditions of the APA are incorporated into this Vaccine Order Form by reference.

 

1.2       In line with the terms and conditions of the APA, the undersigned Member State hereby purchases [insert the number of doses] doses of the Product in accordance with Article I.8 of the APA and re-confirms to be obliged to perform all obligations imposed on the Member State by the APA with respect to such purchase.

 

 

Article 2

 

Price, method of payment and invoicing

 

2.1       The Price per does shall equal the price as determined in Article I.16 of the APA.

 

2.2       All payments to the contractor under this Vaccine Order Form shall be made in accordance with Article I.17 of the APA and they shall be made by deposit of Euros by wire transfer of immediately available funds in the requisite amount to the bank account referred to in Article I.18 of the APA.

 

2.3        Invoices shall be issued in accordance with Article II.15 of the APA.

 

2.4       The undersigned Member State hereby undertakes to comply with the payment obligations referred to in the APA, including but not limited to the payments as set forth in Article I.17.2 of the APA, with respect to the quantities of doses allocated to the undersigned Member State.

  

Article 3

 

Distribution

 

3.1        The delivery hub for the undersigned Member State is as follows:

 

[Member State to enter unique location of the delivery hub]

 

3.2       The contractor shall notify the representative of the undersigned Member State in good time prior to such time that the contractor expects doses of the Product to be delivered. The first notification should be done up to [*****] weeks before the start of the first delivery and continue on a rolling basis. Such notifications shall include an estimate of the number of doses expected to be delivered and the expected dates that such doses will be available to be shipped to the delivery hub designated by the undersigned Member State.

 

The contractor shall deliver the doses of Product at the unique point of delivery indicated by the undersigned Member State. For the avoidance of doubt, the undersigned Member State shall bear the costs of setting up of the delivery hub and the distribution of the Product as of the delivery hub.

  

Article 4

 

Communication details; Notices

 

Any notice given under this Vaccine Order Form shall be in writing in English, shall refer to the APA and this Vaccine Order Form and shall be sent by either pre-paid post/pre-paid airmail or courier to the principal office or registered office of the recipient or by electronic transmission (e-mail and/or pdf) to the addresses set forth below:

 

If to the Member State to:

 

[Full name]

 

[Function]

 

[Name of Participating Member State]

 

[Full official address]

 

E-mail: [complete]

 

If to the contractor to:

 

[*****]

 

CUREVAC AG

 

 

Friedrich-Miescher-Str. 15, 72076 Tübingen, Deutschland

 

E-mail: [*****]

  

Article 6

 

Indemnification

 

The undersigned Member State acknowledges and agrees to be bound by the provisions of Article I.23 of the APA.

  

Article 7

 

Termination

 

This Vaccine Order Form shall remain in full force and effect until all obligations under this Vaccine Order Form are duly fulfilled, unless and to the extent this Vaccine Order Form is terminated in accordance with the APA.

  

*** Signature page to follow ***

 

  

SIGNATURES

 

This Vaccine Order Form has been executed on the place and dates mentioned hereunder, in two original copies, each of the contractor and the Member State acknowledging having received one original signed copy.

 

For the contractor,			For the Member State,
[*****]			[*****]
Signature:			Signature:
Done at [*****], [*****]			Done at [*****], [*****]
[*****]
Signature:
Done at [*****], [*****]

  

  

Annex III  
Annex 7 to Commission Decision C(2020) 4192 final of 18 June 2020 - Agreement between the Commission and Member States on procuring COVID-19 vaccines on behalf of the Member States and related procedures

 

 

EUROPEAN COMMISSION

 

Brussels, 18.6.2020

C(2020) 4192 final

 

ANNEX

 

ANNEX

 

to the

 

Commission Decision

 

on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures

 

EN

EN

 

 

16.06.2020

 

Agreement

 

Preamble

 

Having regard to Article 4(5)(b) of Council regulation (EU) 2016/369 on the provision of emergency support within the Union¹ as amended by Council regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak (hereinafter “ESI” or “ESI regulation”);

  

***

 

The European Commission (“the Commission”)

 

and

 

The following Member States: (XXX), hereinafter referred to as “the Participating Member States”

 

Together referred to as “the Parties”

 

Agree on the Following:

 

Article 1: Objective and mandate of the Commission

 

On the basis of the present agreement, the Commission is mandated to conclude, on behalf of the Participating Member States, Advance Purchase Agreements (“APA”) with vaccine manufacturers with the objective to procure vaccines for the purposes of combatting the COVID 19 pandemic at Union level.

 

The Annex to this agreement sets out the negotiating directives for this purpose.

 

Article 2: Acquisition of vaccine doses

 

It is the Participating Member States, and not the Commission, that shall acquire vaccine doses from the manufacturers on the basis of the APAs unless otherwise agreed. All relevant vaccination policies shall therefore remain matters for the Participating Member States.

 

Article 3: APAs containing a right to acquire vaccine doses

 

Where the Commission concludes an APA in conformity with the present agreement that provides the right for the Participating Member States to acquire vaccine doses, the use of such a right shall take place by means of the conclusion of contracts between the Participating Member States and the vaccine manufacturers. There shall be no obligation for any Participating Member State to conclude such a contract on the basis of the APA. The APA shall contain a clause to this end.

 

 

Article 4: APAs containing an obligation to acquire vaccine doses

 

Where the Commission intends to conclude, in conformity with the present agreement, an APA containing an obligation to acquire vaccine doses, it shall inform the Participating Member States of such intention and the detailed terms. In case a Participating Member State does not agree with the conclusion of an APA containing an obligation to acquire vaccine doses or its terms, it has the right to opt out by explicit notification to the Commission within 5 working days after the Commission has communicated its intention to conclude the APA. All Participating Member States not having opted out within the period of 5 working days are deemed to have authorised the Commission to negotiate and conclude the APA with the vaccine manufacturer in their name and on their behalf.

 

Article 5: The legally binding nature of APAs

 

Once concluded, the terms of the APA shall be legally binding on the Participating Member States, except for those who have exercised their right to opt out.

 

Article 6: Responsibility and liability

 

The present Agreement regulates only the division of potential liability and indemnification between the Commission and the Participating Member States. It does not regulate the extent to or the conditions under which potential liability of the vaccine manufacturer may be taken over or indemnified under the APAs.

 

The Commission shall be exclusively responsible for the procurement process and the conclusion of APAs including any liability arising out of the conduct of the negotiations.

 

Participating Member States acquiring a vaccine shall be responsible for the deployment and use of the vaccines under their national vaccination strategies, and shall bear any liability associated with such use and deployment. This shall extend to and include any indemnification of vaccine manufacturers under the terms and conditions of the relevant APA for liability related to the use and deployment of vaccines normally borne by such manufacturer.

 

Article 7: Obligation not to negotiate separately

 

By signing the present Agreement, the Participating Member States confirm their participation in the procedure and agree not to launch their own procedures for advance purchase of that vaccine with the same manufacturers.

 

In case an APA containing an obligation to acquire vaccine doses has been concluded with a specific manufacturer, the Member States having made use of the opt-out provided under the present Agreement can enter into separate negotiations with the same manufacturer after the APA under the present Agreement has been signed.

 

 

Annex

 

Initial considerations

 

A permanent solution to the COVID-19 crisis is most likely to be brought about by the development and deployment of a safe and effective vaccine against the virus. Every month gained in the deployment of a vaccine will save many lives, many jobs and billions of euros.

 

Therefore, it is the objective of the present Agreement that the EU takes steps to secure sufficient supplies of a safe and effective vaccine for Member States.

 

Structure and purpose of the procurement

 

Work on a COVID-19 vaccine is challenging for many reasons: the shortened development timeframe, the large upfront costs for manufacturers, the high failure rate during clinical trials. If vaccine producers follow their usual practice of making investments in production capacity only when they are sure of a viable product, this will result in considerably longer waiting times for a vaccine. Investments need to be made now in order to ensure that vaccines are being produced at the scale required as early as possible.

 

Under the present agreement, this challenge will be addressed through concluding EU-level Advance Purchase Agreements (“APA”) with vaccine manufacturers when necessary, to secure access to vaccine candidates where they are successful, including up-front EU financing to de-risk essential investments to increase the speed and scale of manufacturing successful vaccines. Funding for the up-front payments will come from the Emergency Support Instrument (ESI).

 

The Parties understand that developing a safe and effective vaccine is a highly complex process and the risk of failure in any such venture is very high. Therefore, the aim is to put in place APAs with a number of manufacturers of leading vaccine candidates, to maximise the chances of having access to at least one successful vaccine.

 

The Commission will invite all vaccine manufacturers to manifest interest. In general, the Commission will give priority to negotiating specific APAs with those manufacturers that (a) have entered or have firm plans to enter clinical trials still in 2020, (b) have the capacity to develop a successful vaccine and (c) have a proven capacity to produce at scale already in 2021.

 

Process and governance

 

In order to run the procurement centrally and efficiently, the European Commission will set up a steering board for the process subject to Article 6 of the present Agreement. It will be co-chaired by the European Commission and a Participating Member State with experience in the negotiations and production capacities for vaccines. The steering board will include senior officials from all Participating Member States to assist and provide guidance throughout the evaluation process.

 

The co-chairs of the steering board will propose a team of a limited number of experts with relevant experience for the ongoing negotiations from six Participating Member States with production capacities for vaccines. These experts will join with the European Commission in a negotiation team (“joint negotiation team”), which will work on a continuous basis as one unit. That joint negotiation team will start work immediately building on previous contacts with individual companies by the European Commission and Participating Member States. In order to launch negotiations with a specific manufacturer, there needs to be support from at least four Participating Member States. The joint negotiation team will make its best effort to take the advice of the steering board into account in the negotiations and will report back to the steering board on a regular basis on the progress made in negotiating with individual companies.

 

 

For compliance with the applicable rules, all members of the steering board and the joint negotiation team will obtain the status of experts associated to the procurement process as provided in the Financial Regulation. Given their access to highly sensitive business information, all those members will be required to sign strict confidentiality and no-conflict-of-interest agreements.

 

Assisted by the steering board, the European Commission will then decide which of the resulting APAs should be concluded, in particular if financing under ESI is insufficient to finance all relevant packages. The Commission will only consider those APAs for financing where at least four Participation Member States have expressed agreement. Before making any final decisions, the Commission will seek independent scientific advice on the state of progress and the available data on quality, safety and efficacy for the vaccine candidate in question.

 

Should financing under ESI be insufficient, Participating Member States can decide to top up ESI funding to make up the gap to finance all packages. In such a case where there are opportunities to conclude further APAs but money from ESI is no longer sufficient, Participating Member States will have the opportunity to express their interest in such opportunities. If at least four Participating Member States express interest, those Participating Member States will make use of the possibility of a voluntary contribution to ESI to the required amount allowing the Commission to proceed with signing the APA only on behalf of those Member States that have expressed interest and contributed the funds to ESI.

 

For full transparency, the European Commission will report to the IPCR at least once every two weeks on overall progress more generally.

 

Advanced Purchase Agreements and conditions

 

To conclude APAs, the joint negotiating team will negotiate funding packages with individual vaccine producers in return for the right to buy a specific number of vaccine doses in a given timeframe and at a certain price.

 

As outlined in the present Agreement, the European Commission also has the possibility to conclude APAs including an obligation to procure the vaccine if it becomes available, where the conditions (notably the pricing) of those APAs make this worthwhile and in line with the conditions in the present Agreement. If in such a case the distinction between upfront payments and purchase price is difficult to draw, the Commission will share the total cost related to the vaccine purchase but will in any case contribute no more than 50% of the total cost.

 

Funding provided up front will be considered as an advance payment for any eventual purchase by Member States, thus reducing the amount that Member States will have to pay when eventually purchasing that vaccine.

 

The up-front payments under the APAs shall be used by manufacturers to de-risk the necessary investments related to both vaccine development and clinical trials, and the preparation of the at-scale production capacity along the entire vaccine production value chain in the EU required for a rapid deployment of millions of doses of an eventual vaccine. The relevant payments should be structured according to the need of the manufacturer, but subject to the state of the vaccine development, in particular relying on transparency of the associated clinical data and its assessment, at the time of payment. This is in order to avoid obligations to pay in situations where the development work has shown a vaccine candidate likely to be unsuccessful.

 

 

The purchase price of the vaccine, as well as the amount of funding provided up front will take into account a transparent estimation of production costs (supported by independent audits where available), as well as the resources already granted from other public sources. Under the APA, the manufacturer can be asked to provide ex post proof supported by independent audits concerning the activities financed by these payments.

 

The aim of the negotiation is to conclude APAs with individual companies under the best possible conditions. These APAs should specify details with respect to:

 

a)

Payments to be made, such as payment amounts, payment schedules, type of payments requested and the use of those payments related to de-risk investment, financing clinical trials, providing working capital and scaling-up production capacity;

 

b)

Delivery details of the vaccine if successful, such as price per person immunised (or alternatively, number of doses required per person immunised and price per dose), quantity of doses to be delivered and delivery timeline following approval; and

 

c)

Any other relevant conditions, such as production capacity built or used in the EU or liability arrangements.

 

For liability arrangements, the joint negotiation team will make its best effort to limit what is required by individual companies for the purpose of indemnification to be included in the terms and conditions of the APA.

 

The APAs will contain provisions to clarify the law applicable to both the APA and resulting purchase orders as well as the competent courts. The Participating Member States agree that each APA negotiated by the Commission on their behalf with a vaccine manufacturer will have the same applicable law for all Participating Member States, and that the courts corresponding to that applicable law will be competent to hear disputes arising from that APA.

 

When taking a decision to finance individual APAs, the European Commission, in consultation with the steering board, will take into account the following elements: any available data on quality, safety and efficacy of the vaccine at time of negotiation of the contract, speed of delivery at scale, cost, risk-sharing, diversification of technologies, capacity to supply through development of production capacity within the EU, possible flexible future use of any capacity funded, engagement at an early stage with EU regulators with the intention to apply for an EU marketing authorisation for the candidate vaccine(s), commitment to supply vulnerable countries.

 

The procedure outlined above complies with the ESI Regulation and the Financial Regulation. The latter is aligned to the European procurement Directives, which also provide the basis for national procurement rules. Participating Member States may rely on the procedure run by the European Commission to directly purchase vaccines from the manufacturers as and when any of the vaccines becomes available based on the conditions laid down in the APA. Access to vaccine doses will be allocated to Participating Member States according to the population distribution key.

 

In the negotiations with the pharmaceutical industry under the present Agreement, the Commission will promote a Covid-19 vaccine as a global public good. This promotion will include access for low and middle income countries to these vaccines in sufficient quantity and at low prices. The Commission will seek to promote related questions with the pharmaceutical industry regarding intellectual property sharing, especially when such IP has been developed with public support, in order to these objectives. Any vaccines available for purchase under the APAs concluded but not needed and purchased by Participating Member States can be made available to the global solidarity effort.

 

 

Annex IV

Preliminary Specification Of The Product

 

[*****]

 

 

Annex V  
List of (planned) manufacturing network partners

 

[*****]

 

 

Annex VI  
Goods Received Form
(preliminary)

 

Receiver XXX Street City Country

Shipper CureVac Street City Country

 

Acknowledgment of goods received

 

Product and name:      [COMMERCIAL NAME] – CureVac Covid-19 Vaccine

Shipment number:       ______________________

Courier Services:         ______________________

 

To whom it may concern

 

The undersigned hereby acknowledge receipt of goods (Covid-19 vaccine) of shipment referenced above and declare after visual inspection that (check one of the following)

 

¨	said goods do not present apparent defects upon initial visual inspection and are complete
¨	said goods present some apparent defects upon initial visual inspection (see description on next page)
¨	said goods do not appear complete (see description on next page)

 

Receiver

 

Name (CAPITALS) Signature	Date

 

Please provide a copy of this completed form to the courier and send any other documentation of apparent defects such as photographs via E-Mail to CureVac Logistics [*****] (shipment number in email title) as soon as possible and no later than four (4) calendar days after delivery.

 

 

 

 

Visual inspection checklist

 

1.

Quantity received

 

a.

Concentrated vaccine _____________ pallets / boxes (circle as appropriate)

 

b.

Diluent _____________ pallets / boxes

 

c.

Package inserts (information leaflets) _____________ pallets / boxes

 

2.

Temperature check

 

Temperature indicated on measurement device: _________°C

 

Evidence of temperature excursion: (Yes/No): ___________

 

3.

Apparent defects

 

	No apparent defect		Some apparent defect
	¨ No apparent defect visible		¨ Broken or damaged boxes
			¨ Absence of labelling or mis-labelling
			¨ Leakage
			¨ Temperature of goods received
			¨ Other: _______________________

 

Comments or short description of apparent defects or of elements apparently missing                   PLEASE PROVIDE PHOTOGRAPHS OF APPARENT ISSUE SEPARATELY IN EMAIL

 

  

 

 

Annex VII  
Description of the contractor's intended utilisation of the up-front payment and the second up-front payment

 

[*****]

 

  

 

Exhibit 4.49

 

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.

 

 

2020 CLA AMENDMENT AND RESTATEMENT AGREEMENT

 

 

dated

 

APRIL 2, 2021

 

by and between

 

CUREVAC AG

 

and

 

GLAXOSMITHKLINE BIOLOGICALS SA

CONTENTS

 

Section		Page
1.	Interpretation	3
2.	Condition Precedent	4
3.	Amendment and Restatement	4
4.	Representations and Warranties	4
5.	General Provisions	4
Schedule
1.	Amended and Restated CLA	7

AMENDMENT AND RESTATEMENT AGREEMENT

 

This Amendment and Restatement Agreement (“Agreement”) is entered into on April 2, 2021 (“Effective Date”)

 

BY AND BETWEEN

 

CUREVAC AG, a German cooperation with offices at [*****] (“CureVac”);

 

AND

 

GLAXOSMITHKLINE BIOLOGICALS SA, a Belgium corporation with offices at [*****] (“GSK”).

 

INTRODUCTION

 

A.

This Agreement is supplemental to and amends and restates a Collaboration and License Agreement dated July 15, 2020 on collaborating in the research, development and commercialization of prophylactic and therapeutic non-replicating mRNA based vaccines and antibodies targeting certain infectious disease pathogens, such pathogens among others not including SARS-CoV-2 (the “2020 CLA”).

 

B.	On the date of this Agreement, the Parties have also entered into a separate agreement concerning the development of vaccines targeting SARS-CoV-2 (the (“2021 CLA”).

 

C.	The Parties have consented to the amendments to the 2020 CLA set out in this Agreement, subject to the commencement of the 2021 CLA in accordance with its terms.

 

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.	INTERPRETATION

 

1.1	In this Agreement, unless the contrary intention appears, a paragraph, section, exhibit or schedule is a reference to a section, exhibit or schedule to this Agreement. Schedule 1 forms part of this Agreement.

 

1.2

Unless otherwise specified in this Agreement, the words and expressions defined in the Amended and Restated CLA (as defined below) shall have the same meanings when used in this Agreement and the rules and principles of interpretation set out in Section 1 of the Amended and Restated CLA shall apply to this Agreement.

1.3	In this Agreement, “Closing Date” means the date of commencement of the 2021 CLA in accordance with its terms.

 

1.4	In the event of any conflict or inconsistency between the terms of the Amended and Restated CLA and this Agreement, this Agreement shall prevail.

 

2.	CONDITION PRECEDENT

 

This Agreement shall commence only on and from the Closing Date.

 

3.	AMENDMENT AND RESTATEMENT

 

3.1

Subject to Section 3.2, the Parties agree that the 2020 CLA will be amended and restated in the form set out in Schedule 1 (the “Amended and Restated CLA”) on and from the Closing Date so that the rights and obligations of the Parties to the 2020 CLA shall, on and from the Closing Date, be governed by and construed in accordance with the provisions of the Amended and Restated CLA.

 

3.2	The 2020 CLA will remain in full force and effect, except to the extent amended and restated by this Agreement, and each Party’s rights, responsibilities and liabilities relating to any act or omission prior to Closing Date shall continue to be determined by the 2020 CLA.

 

4.	REPRESENTATIONS AND WARRANTIES

 

CureVac and GSK each represents and warrants and covenants with respect to itself only as at the Effective Date that:

 

(a)

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;

 

(b)

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;

 

(c)

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.

 

5.	GENERAL PROVISIONS

 

5.1	This Agreement and all disputes arising hereunder, shall be exclusively governed by, and interpreted and enforced in accordance with Belgian law. The United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention) does not apply to this Agreement.

 

5.2

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.

5.3

This Agreement, together with Schedule 1 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, including the Confidentiality Agreements. 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. 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 5.3.

 

5.4	This Agreement may be executed in any number of counterparts, by original or electronic (including “pdf”) signature, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

5.5	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

 

5.6	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.

 

Signature page follows .

In Witness Whereof, the Parties have executed this Agreement to be effective as at the Effective Date.

 

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

 

[*****]

[*****]

Date Signed: April 2, 2021

 

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

 

[*****]

[*****] 

Date Signed: April 2, 2021

 

Signed on behalf of

CureVac AG

 

[*****]

[*****]

Date Signed: April 2, 2021

 

Signed on behalf of

CureVac AG

 

[*****]

[*****]

Date Signed: April 2, 2021

SCHEDULE 1

 

AMENDED AND RESTATED CLA

EXECUTION VERSION

 

 

COLLABORATION AND LICENSE AGREEMENT

 

 

dated

 

15 JULY, 2020

 

(AS AMENDED AND RESTATED 2 APRIL, 2021)

 

by and between

 

CUREVAC AG

 

and

 

GLAXOSMITHKLINE BIOLOGICALS SA

Table of Contents

 

1.	DEFINITIONS.	5
2.	LICENSES; EXCLUSIVITY	28
3.	PRODUCT ADJUSTMENTS; REPLACEMENT RIGHT; EXCLUSIVE OPTION	34
4.	RESEARCH AND DEVELOPMENT COLLABORATION.	40
5.	MANUFACTURING AND COMMERCIALIZATION.	47
6.	COMMERCIALIZATION OF PRODUCTS IN THE CUREVAC TERRITORY	50
7.	GOVERNANCE	50
8.	CONSIDERATION AND PAYMENTS	55
9.	INTELLECTUAL PROPERTY	62
10.	ENFORCEMENT AND DEFENSE.	68
11.	CONFIDENTIALITY.	71
12.	COMPLIANCE, QUALITY, INTEGRITY	75
13.	INDEMNIFICATION AND REPRESENTATIONS AND WARRANTIES	79
14.	TERM AND TERMINATION.	83
15.	CONSEQUENCES OF TERMINATION.	84
16.	GENERAL PROVISIONS	90

Exhibits

 

Exhibit 1.29	List of Collaboration Pathogens and Products
Exhibit 1.44	CureVac Know How
Exhibit 1.50	CureVac Patent Rights
Exhibit 1.70	Excluded Pathogens
Exhibit 1.115	In-Licensing Agreements
Exhibit 2.1.2 Part A	[*****]
Exhibit 2.1.2 Part B	Licensed LNPs
Exhibit 2.1.4	[*****]
Exhibit 3.4	Clearance Template
Exhibit 3.5.2	Reserved Antigens
Exhibit 4.1	First Product R&D Plan
Exhibit 4.2	Second Product R&D Plan
Exhibit 4.3	Other Products R&D Plans
Exhibit 5.2.1	Key Supply Terms
Exhibit 6.2	Key Distribution Terms
Exhibit 8.7.5	Third Party Offset
Exhibit 11.6	Draft Press Release
Exhibit 12.5	Data Protection
Exhibit 13.4	Disclosure Letter
Exhibit 15.4	Post-Termination Royalties

COLLABORATION AND LICENSE AGREEMENT

 

This Collaboration and License Agreement (“Agreement”) is entered into on 15 July, 2020 (“Effective Date”) and amended and restated on 2 April, 2021

 

BY AND BETWEEN

 

CUREVAC AG, a German cooperation with offices at [*****] (“CureVac”);

 

AND

 

GLAXOSMITHKLINE BIOLOGICALS SA, a Belgium corporation with offices at [*****] (“GSK”).

 

INTRODUCTION

A.

WHEREAS, CureVac is a biotechnology company that is a pioneer and technology leader in mRNA-based prophylactic and therapeutic approaches and discovers, designs and develops first- in-class mRNA therapies for the prevention and treatment of diseases with unmet medical need.

 

B.

WHEREAS, GSK is a world leading global healthcare company developing, manufacturing and commercializing innovative pharmaceuticals, vaccines and consumer healthcare products worldwide.

 

C.

WHEREAS, GSK made an equity investment into CureVac pursuant to the terms of the investment and shareholders agreement on or around the date of this Agreement (the “Equity Investment”).

 

D.

WHEREAS, the Parties wish to collaborate in the research, development and commercialization of prophylactic and therapeutic non-replicating mRNA based vaccines and antibodies targeting infectious disease pathogens.

 

E.

WHEREAS, the Parties have agreed to amend and restate this Agreement, to amend the list of Excluded Pathogens, to vary the exclusive option granted by CureVac to GSK and to make certain other amendments to align it with the 2021 Collaboration Agreement.

 

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	“2021 Preliminary Agreement” means the preliminary agreement between the Parties regarding CureVac mRNA-based coronavirus vaccines dated 3 February, 2021.

 

1.2

“2021 Collaboration Agreement” means the collaboration and license agreement between the Parties regarding CureVac mRNA-based SARS-Cov-2 vaccines (and certain other vaccines targeting coronaviruses, in the event of effective Option Exercise under this Agreement, if CureVac elects the profit share option under Section 3.7.3(a)(i)) dated 2 April, 2021.

 

1.3

“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 fifty percent (50%) or more 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.

 

1.4	“Agreement” shall have the meaning set forth in the Preamble.

 

1.5	“Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.6	“Ancillary Agreement” shall mean any of the following agreements between the Parties (or their respective Affiliates) relating to this Agreement: any Clinical Supply Agreement; any Commercial Supply Agreement; any Distribution Agreement; any Quality Agreement and any pharmacovigilance agreement.

 

1.7	“Antibody” shall mean a molecule, defined by its amino acid sequence, including an engineered [*****].

1.8	“Antibody Combination” shall mean a combination of [*****] Antibodies and so binding to a maximum of [*****] distinct Antigens.

 

1.9	“Antigen” shall mean any antigen, defined by its amino acid sequence, associated with a Pathogen, together with all Antigen Variants thereof.

 

1.10

“Antigen Variant” shall mean any variant of an Antigen, including the wild type, naturally occurring variants, engineered variants wherein modifications to the native amino acid sequence have been introduced (for example, mutated versions, derivatives or fragments), provided, however, that any such variant possesses substantially similar biological activity to the naturally occurring antigen.

 

1.11	“Antigen/Antibody List Rep” shall have the meaning set forth in Section 3.4.

 

1.12

“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.

 

1.13	“Assigned Invention” shall have the meaning set forth in Section 9.4.

 

1.14	“Background Technology” shall mean the CureVac Background Technology and/or GSK Background Technology, as applicable.

 

1.15

“Brand IP” shall mean any and all rights and privileges in trade names, domain names, brand names, product names, logos and trade dress (and the goodwill of any business symbolized thereby), including trademarks, service marks, copyrights and design rights for any of the above, and any similar intellectual property right recognized from time to time in any jurisdiction, as well as any and all registrations, applications, recordings and other legal protections to the foregoing.

 

1.16	“Breaching Party” shall have the meaning set forth in Section 14.4.

 

1.17	“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 Rixensart, Belgium.

 

1.18

“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 Closing Date and ending on the end of the Calendar Quarter in which the Closing 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 expiry or termination of this Agreement, and “Calendar Quarterly” shall be construed accordingly.

1.19

“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 Closing Date and ending on the end of the Calendar Year in which the Closing 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 expiry or termination of this Agreement.

 

1.20	“Clearance Template” shall have the meaning set forth in Section 3.4.

 

1.21

“Change of Control” shall mean a transaction in which a Party (or any direct or indirect shareholder(s), unitholder(s) or partner(s) together holding (directly or indirectly) over fifty percent (50%) of the voting rights attached to the shares, units or partnership interests in a Party): (i) sells, conveys or otherwise disposes of all or substantially all of the Party’s (or their indirect interest(s) in the Party’s) property, assets or business; or (ii) merges or consolidates with any other entity; or (iii) effects any other transaction or series of transactions; in each case of clause (ii) or (iii), such that the ultimate direct or indirect shareholder(s), unitholder(s) or partner(s)of such Party immediately prior thereto, in aggregate, no longer own, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting securities or capital stock of the surviving entity following the closing of such merger, consolidation, other transaction or series of transactions. For the avoidance of doubt, “Change of Control” shall not mean a transaction which, in the case of paragraph (ii) or (iii), results in a person owning, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting securities or capital stock of the surviving entity and where there is an agreement or arrangement between that person (or any of its direct or indirect shareholders, unitholders or partners) and the relevant Party (or any of its direct or indirect shareholders, unitholders or partners) to reverse the effects of this transaction or to implement a further transaction so that the ultimate shareholders, unitholders or partners of the relevant Party immediately prior thereto will again own, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting shares, units or partnership interests of the relevant Party or surviving entity.

 

1.22

“Clinical Phase I Study” shall mean a study in humans which provides for the first administration to humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) or the non-United States equivalent thereof. For the avoidance of doubt, a Clinical Phase I Study may generate sufficient data (if successful) to commence pivotal studies/Clinical Phase III Studies, but it shall not constitute a Clinical Phase II Study.

 

1.23

“Clinical Phase II Study” shall mean a clinical study (other than a Clinical Phase I 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 studies/Clinical Phase III Studies, as further defined in 21 CFR §312.21(b) or the non-United States equivalent thereof.

1.24

“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 an application to obtain Regulatory Approval to market such product, as further defined in 21 CFR §312.21(c) or the non-United States equivalent thereof.

 

1.25	“Closing Date” means 15 July, 2020.

 

1.26	“Clinical Studies” shall mean all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including pivotal studies.

 

1.27

“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.

 

1.28	“CMO” shall mean a contract manufacturing organization.

 

1.29

“Collaboration Pathogen” shall mean a Pathogen other than an Excluded Pathogen in relation to which the Parties have agreed to seek to Develop a Product under this Agreement (including any Replacement Product or Optioned Product) for as long as such Product is being Developed and/or Commercialized under this Agreement. As at the Effective Date of this Agreement, Collaboration Pathogen shall mean the Pathogens set out in Exhibit 1.29. For clarity, if GSK replaces a Product pursuant to Section 3.6 or terminates a Program pursuant to Section 14.2, the Pathogen targeted by such Replaced Product or targeted under such terminated Program shall no longer be a Collaboration Pathogen, but shall be an Excluded Pathogen.

 

1.30	“Combination Product” shall mean a product that is:

 

(i)

a single pharmaceutical formulation containing Drug Substances associated with a Product and one or more other therapeutically or prophylactically active pharmaceutical ingredients [*****];

 

(ii)

any combination therapy comprised of a Finished Product and one or more other therapeutically or prophylactically active products, that is (x) priced and sold in a single package containing such multiple products; or (y) packaged separately but sold together for a single price; or

(iii)

comprised of a Finished 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. For clarity, a Pathogen Combination Product shall not be a Combination Product, unless it is (A) combined with another therapeutically or prophylactically active ingredient/product or (B) comprised of a Finished Product and a companion or complementary diagnostic product, as set forth in (i), (ii) or (iii) above.

 

1.31	“Commercial Supply Agreement” shall have the meaning given in Section 5.2.2.

 

1.32

“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 of Products, interacting with Regulatory Authorities 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.

 

1.33	“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.

 

For purposes of the confidentiality obligations set forth herein, (a) GSK Know-How, GSK Materials and GSK Inventions shall be deemed Confidential Information of GSK; and CureVac Know-How, CureVac Materials and CureVac 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 Agreement.

 

1.34	“Confidentiality Agreement” shall mean that certain Confidential Disclosure Agreement entered into between the Parties as at January 9, 2020.

 

1.35

“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, provided that any intellectual property right in-licensed by a Party from the other Party under the 2021 Collaboration Agreement shall not be Controlled by such Party for the purpose of this Section 1.35.

1.36

“Cover” shall mean, (i) 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, or (ii) with regard to Know-How, that the use or disclosure of such Know-How without a license would be actionable.

 

1.37	“COVID Product” shall have the meaning given to it in the 2021 Collaboration Agreement.

 

1.38	“CRO” shall mean a contract research organization or a contract development and manufacturing organization.

 

1.39	“CureVac Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.40	“CureVac Background Technology” shall have the meaning set forth in Section 9.1.

 

1.41	“CureVac Elements” has the meaning given in Section 2.7.1.

 

1.42	“CureVac Indemnified Parties” shall have the meaning set forth in Section 13.1.

 

1.43	“CureVac Invention” shall have the meaning set forth in Section 9.3.1.

 

1.44

“CureVac Know-How” shall mean (i) all Know-How within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that is necessary or useful for the Parties to Develop, Manufacture and/or Commercialize Products under this Agreement, provided that (x) with respect to Know-How within the CureVac Background Technology owned by a Third Party that is not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of Products in the Field in the Territory and that comes under CureVac’s Control, this shall only include Know-How which is deemed CureVac Know-How pursuant to Section 2.7.1; and (y) this shall not include the Know- How of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac after the Effective Date solely as a result of a Change of Control in CureVac; and (ii) all Know- How Controlled by CureVac or its Affiliates arising or generated during the Research Period in connection with the performance of activities under this Agreement; provided, however, that CureVac Know-How does not include Know-How related to (A) LNP Technology Controlled by a Third Party; and (B) [*****]. CureVac Know-How shall include (i) Know-How comprised in the CureVac Background Technology; and (ii) Know-How related to CureVac Inventions, CureVac’s share in Joint Product Inventions or Joint Other Inventions, (iii) other Know- How generated by CureVac under a Program, (iv) Know-How related to LNP technology owned by CureVac, and (v) Know-How related to CVCMs. Without limiting Section 9.1, the CureVac Know-How existing at the Effective Date is further described in Exhibit 1.44.

 

1.45	“CureVac Manufacturing Technology” shall mean CureVac Patent Rights and CureVac Know- How that are required for the Manufacture of Products.

 

1.47	“CureVac Materials” shall mean [*****] that are supplied or otherwise made available by or on behalf of CureVac and/or its Affiliate(s) to GSK hereunder for the purposes of this Agreement (excluding, for clarity, any Confidential Information, or any Product).

 

1.48	“CureVac mRNA” shall mean the non-replicating mRNA Covered by the CureVac Technology on the Effective Date or during the Term.

 

1.49	“CureVac mRNA-Based” shall mean, with respect to a vaccine or Antibody, that such vaccine or Antibody is encoded by one or more CureVac mRNAs.

 

1.50

“CureVac Patent Right(s)” shall mean (i) all Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that are necessary or useful for the Development, Manufacture and/or Commercialization of Products under this Agreement, provided that (x) with respect to Patent Rights within the CureVac Background Technology owned by a Third Party that are not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of Products in the Field in the Territory and that come under CureVac’s Control after the Effective Date, this shall only include Patent Rights which are deemed CureVac Patent Rights pursuant to Section 2.7.1; and (y) this shall not include the Patent Rights of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac, and (ii) all CureVac Program Patent Right and CureVac’s interest in Joint Patent Rights; provided, however, that CureVac Patent Rights do not include Patent Rights within (A) LNP Technology Controlled by a Third Party; and (B) [*****]. CureVac Patent Rights shall include (i) Patent Rights comprised in the CureVac Background Technology; and (ii) CureVac’s share in Joint Patent Rights, and (iii) CureVac Program Patent Rights, and (iv) Patent Rights related to LNP technology owned by CureVac and CVCMs. The CureVac Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date are listed in Exhibit 1.50.

 

1.51	“CureVac Program Patent Right” shall have the meaning set forth in Section 9.6.1.

 

1.52	“CureVac Project Leader” shall have the meaning set forth in Section 7.1.2.

 

1.53	“CureVac Technology” shall mean CureVac Patent Rights and CureVac Know-How.

 

1.54	“CureVac Territory” shall mean Austria, Germany and Switzerland.

 

1.55	“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 the formulation of Drug Substance.

 

1.56

“Development” shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the 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, mRNA sequence optimization, protein design, non-clinical testing, mechanism of action 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.

 

1.57

“Development Costs” shall mean: (i) demonstrable costs and expenses invoiced by Third Parties for the activities specified in the applicable R&D Plan; and (ii) the costs and expenses of scientific, medical, technical personnel directly engaged in such efforts, which costs shall be determined based on the FTE Rate based on time actually spent performing the applicable activities, in each case as further detailed in the Development budget set out in the applicable R&D Plan.

 

1.58

“Development Data” shall mean: (i) CMC Development data (including records of Manufactured batches); (ii) any non-clinical or clinical findings, results and other research data relating to the Products, in any format; and (iii) the formal reports of preclinical toxicology studies and Clinical Studies, such data in each case of (i), (ii) and (iii) required for the Development, Manufacture and Commercialization of the Products, including but not limited to, INDs and other regulatory filings and registration dossiers.

 

1.59	“Development & Regulatory Milestone Event” shall have the meaning set forth in Section 8.3.

 

1.60	“Development & Regulatory Milestone Payment” shall have the meaning set forth in Section 8.3.

 

1.61	“Development Transfer Materials” shall have the meaning set forth in Section 4.7.

 

1.62

“Diligent Efforts” shall mean, with respect to a Party, those efforts, expertise and resources commensurate with efforts, expertise and resources commonly used in the biopharmaceutical 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, public health, 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. Diligent Efforts shall be determined on a market-by-market and indication-by- indication basis for each Product, and it may change over time.

1.63	“Disclosing Party” shall have the meaning set forth in Section 11.1

 

1.64	“Disclosure Letter” shall have the meaning set forth in Section 13.4.

 

1.65	“Distribution Agreement” shall have the meaning set forth in Section 6.2.

 

1.66	“Drug Product” shall mean, for a given Product, the drug product form thereof, i.e. comprising of one or more Drug Substance(s) of that Product and formulated with a Licensed LNP, an LNP Controlled by CureVac or a CVCM, and any excipients.

 

1.67	“Drug Substance” shall mean the active ingredient(s) of a Product, being one or more mRNA molecules which contains the genetic information for the relevant Antigen(s) or Antibody(ies).

 

1.68	“Effective Date” shall have the meaning set forth in the Preamble.

 

1.69	“EMA” shall mean the European Medicines Agency.

 

1.70

“Excluded Pathogen” shall mean (i) any of the Pathogens listed in Exhibit 1.70, (ii) in case GSK exercises its Replacement Right pursuant to Section 3.6, any Pathogen targeted by a Replaced Product (unless that Pathogen is targeted by another Product, including any Replacement Product), and (iii) in case GSK terminates a Program for a Product pursuant to Section 14.2, the Pathogen targeted under such terminated Program (unless that Pathogen is targeted under another Program).

 

1.71	“Exclusive Option” shall have the meaning set forth in Section 3.7.1.

 

1.72	“Executive Officers” the Chief Executive Officer of CureVac (or a senior executive officer of CureVac designated by CureVac’s Chief Executive Officer) and the President of GSK Vaccines (or a senior executive officer of GSK designated by the President of GSK Vaccines).

 

1.73	“FDA” shall mean the U.S. Food and Drug Administration.

 

1.74	“Field” shall mean any and all prophylactic and/or therapeutic uses for the prevention, delay of onset or treatment of infectious disease pathogens, conditions or disorders.

 

1.75	“[*****] Product” shall have the meaning set forth in Exhibit 1.29.

 

1.76	“Filled Containers” shall mean, for a given COVID Product, Drug Product, diluted and filled in vials, without labelling or packaging.

 

1.77	“Financial Partner” shall have the meaning set forth in Section 11.4.1 below.

1.78	“Finished Product” shall mean, for a given Product, the final presentation of such Product, following labelling and packaging of Filled Containers, as registered in the applicable Regulatory Approval.

 

1.79

“First Commercial Sale” shall mean, on a Product-by- Product and country-by-country basis, the first sale of a Product by or on behalf of GSK or its Affiliates or Sublicensees, such as but not limited to, sales to a Third Party wholesaler, pharmacy, outpatient clinic, inpatient clinic, hospital, dispensing physician or government agency in a given country after necessary Regulatory Approval has been granted with respect to such Product in such country, provided, however, that in the event of a sale of a Product prior to Regulatory Approval which is substantially comparable to a commercial sale effected only after Regulatory Approval is obtained, then the first sale in any such arrangement shall also constitute a First Commercial Sale. For the avoidance of doubt, “treatment IND sales”, “named patient sales” and “compassionate use sales” shall not be construed as a First Commercial Sale if the aggregate, annual Net Sales for all such programs are less than EUR [*****]. For avoidance of doubt, any sale of a Product by GSK to an Affiliate or Sublicensee or subcontractor is not a First Commercial Sale.

 

1.80	“First Product” shall have the meaning set forth in Exhibit 1.29.

 

1.81	“First Product R&D Plan” shall have the meaning set forth in Section 4.1.

 

1.82

“First Regulatory Approval” shall mean, in relation to each Product, unless expressly stated otherwise in this Agreement, the earlier of (i) final marketing authorization for a Product in any jurisdiction of the Territory and (ii) the grant of any conditional authorization for a COVID Product in any jurisdiction of the Territory.

 

1.83	“Force Majeure” shall have the meaning set forth in Section 16.2.

 

1.84	“Fourth Product” shall have the meaning set forth in Exhibit 1.29.

 

1.85

“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 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 by the number of FTE hours applicable for such accounting period based on [*****] working hours per year. FTE shall include the employee required to execute the R&D Plans provided however that employees falling under the COGS definition of the Clinical Supply Agreement or the Commercial Supply Agreement shall not be included. FTE shall not include personnel undertaking general corporate activities including, by way of example only, investor relations, business development, legal affairs, and any other activities not supporting activities conducted under this Agreement.

 

1.86

“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 EUR [*****] The FTE Rate shall include all fully loaded costs, including costs of salaries (including overtime), benefits, other employee costs, overhead and supporting general and administration allocations. CureVac may increase the FTE Rate for inflation on an annual basis based upon the percentage increase in the Consumer Price Index for Germany.

 

1.87	“Force Majeure” shall have the meaning set forth in Section 16.2.

 

1.88	“GMP Manufacturing Facilities” shall mean a production facility for the manufacture of drug products, including the manufacturing space, the storage warehouse for raw and finished product, and support lab areas, which conforms to GMP.

 

1.89	“GMP-III Manufacturing Facility” shall mean CureVac’s GMP manufacturing facility at [*****].

 

1.90	“GMP-IV Manufacturing Facility” shall mean CureVac’s new GMP manufacturing facility currently under construction at [*****].

 

1.91	“GMP-IV Reservation Fee”shall have the meaning set forth in Section 8.2.

 

1.92

“Good Clinical Practices” or “GCP” shall mean, in connection with a Clinical Study, current practices set forth in or required by (1) the World Medical Association’s Declaration of Helsinki entitled ‘Ethical Principles for Medical Research Involving Human Subjects’ (2) the principles of International Conference on Harmonization Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) E6 and E11; (3) the Directive 2001/20/EC of the European Union and in guidance published by the European Commission in relation to such Directive and any local laws, rules and regulations that implement such Directive and guidance; (4) provisions of Title 21 of the Code of Federal Regulations (including Parts 11, 50, 54, 56, 312, 314, 320, 601 and 610) and all rules, regulations, order and guidance’s published thereunder; and (5) any other country in which the Clinical Study is conducted;

 

1.93

“Good Distribution Practices” or “GDP” shall mean the current (at a given time) standards, practices and procedures regarding the distribution of pharmaceutical products promulgated or endorsed by a Regulatory Authority and all Applicable Laws with respect thereto, as defined further or otherwise in the Distribution Agreement or a quality agreement ancillary thereto.

 

1.94

“Good Laboratory Practices” or “GLP” shall mean, at a given time, the current good laboratory practice standards promulgated or endorsed by the US Food and Drug Administration as defined in Part 58 of the Code of Federal Regulations Title 21, or comparable regulatory standards promulgated by the EMA or other applicable Regulatory Authority, as may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

 

1.95	“Good Data Management Practices” shall have the meaning set forth in Section 12.2.

1.96	“Good Manufacturing Practices” or “GMP” shall mean the current (at a given time) standards, practices and procedures regarding the Manufacturing of human vaccines promulgated or endorsed by a Regulatory Authority and all Applicable Laws with respect thereto, including:

 

(i)

the standards, rules, principles and guidelines set out in Chapter II of EC Commission Directive 2003/94/EC together with the guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC and 91/412/EEC, contained in Volume 4 of “The Rules Governing Medicinal Products in the European Union”.

 

(ii)

Parts 210 and 211 of Title 21 of the Code of Federal Regulations and all related guidance published by the FDA;

 

(iii)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Quality Guidelines relating to good manufacturing practice;

 

(iv)

the “Good Manufacturing Practices for Pharmaceutical Products” promulgated by the World Health Organization (“WHO”),

 

provided that term may be defined further or otherwise in the Quality Agreements regarding the supply of Drug Products for clinical or commercial purposes entered pursuant to this Agreement.

 

1.97

“Government Official” (where ’government’ means all levels and subdivisions of governments, i.e. local, regional, national, administrative, legislative, executive, or judicial, and royal or ruling families) shall mean: (a) any officer or employee of a government or any department, agency or instrumentality of a government (which includes public enterprises, and entities owned or controlled by the state); (b) any officer or employee of a public international organization such as the World Bank or United Nations; (c) any officer or employee of a political party, or any candidate for public office; (d) any person defined as a government or public official under Applicable Law (including anti-bribery and corruption laws) and not already covered by any of the above; and/or; (e) any person acting in an official capacity for or on behalf of any of the above. “Government Official” shall include any person with close family members who are Government Officials (as defined above) with the capacity, actual or perceived, to influence or take official decisions affecting either Party’s business.

 

1.98	“GSK Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.99	“GSK Background Technology” shall have the meaning as set forth in Section 9.1.

 

1.100

“GSK Continue Option” shall have the meaning given to it in the 2021 Collaboration Agreement.

1.101

“GSK COVID Continue Option” shall have the meaning given to it in the 2021 Collaboration Agreement.

 

1.102

“GSK Indemnified Parties” shall have the meaning set forth in Section 13.2.

 

1.103

“GSK Invention” shall have the meaning set forth in Section 9.3.2.

 

1.104

“GSK Know-How” shall mean all Know-How Controlled by GSK or its Affiliates as at 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 GSK its Affiliates or Sublicensees to Develop, Manufacture and Commercialize Products under this Agreement. GSK Know-How shall include (i) Know-How comprised in the GSK Background Technology; and (ii) Know-How related to GSK Inventions, Joint Product Inventions or Joint Other Inventions, and (iii) other Know-How generated by GSK under a Program.

 

1.105

“GSK Materials” shall mean any [*****] that are supplied or otherwise made available by or on behalf of GSK and/or its Affiliate(s) to CureVac for the purposes of this Agreement (excluding, for clarity, any Confidential Information, or any Product).

 

1.106

“GSK Patent Right(s)” shall mean all Patent Rights Controlled by GSK or its Affiliates as at the Effective Date or thereafter during the Term that (a) are necessary for CureVac to perform the obligations and other activities pursuant to this Agreement, or (b) are used by or on behalf of GSK its Affiliates or Sublicensees to Develop, Manufacture and/or Commercialize Products under this Agreement. GSK Patent Rights shall include Patent Rights comprised in the GSK Background Technology, GSK Program Patent Rights and GSK’s interest in Joint Patent Rights.

 

1.107

“GSK Program Patent Right” shall have the meaning set forth in Section 9.6.2.

 

1.108

“GSK Project Leader” shall have the meaning set forth in Section 7.1.2.

 

1.109

“GSK Technology” shall mean any and all GSK Patent Rights and GSK Know-How.

 

1.110

“GSK Territory” shall mean all countries of the world other than the countries included in the CureVac Territory.

 

1.111

“GxP” shall mean the good practice regulations in the pharmaceutical industry, including Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices and Good Distribution Practices (GMP, GLP, GCP and GDP).

 

1.112

“Human Biological Samples” shall mean human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including, but not limited to, hair, nail clippings, teeth, urine, faeces, breast milk, and sweat.

1.113

“IND” shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the United States, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto, including EMA, prior to beginning clinical trials in humans in that country or in that group of countries.

 

1.114

“In-Licensed IP” shall have the meaning set forth in Section 2.7.1.

 

1.115

“In-Licensing Agreement” shall mean each of the LNP Agreements, the agreements listed in Exhibit 1.115, and any other agreement with a Third Party pursuant to which CureVac Controls CureVac Technology or LNP Technology.

 

1.116

“Initial Products” shall mean the [*****].

 

1.117

“Initial Other Products” shall mean each of the following Products: [*****].

 

1.118

“Initiation” shall mean, with respect to a Clinical Study, the first administration of the first subject in such Clinical Study.

 

1.119

“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 GSK or Affiliates of CureVac or GSK, 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.

 

1.120

“IP Sub-Committee” shall mean the sub-committee to be established pursuant to Section 7.4.

 

1.121

“Joint Product Invention” shall have the meaning set forth in Section 9.3.3.

 

1.122

“Joint Other Invention” shall have the meaning set forth in Section 9.3.4.

 

1.123

“Joint Patent Rights” shall have the meaning set forth in Section 10.2.

 

1.124

“Joint Steering Committee”, and “JSC” shall have the meaning set forth in Section 7.2.

 

1.125

“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.

1.126

“Licensed LNP” shall mean an LNP that is Controlled by CureVac as at the Effective Date or during the Term pursuant to (i) one or more non-exclusive license agreement(s) between CureVac and [*****], as amended from time to time (including by the Amendment Two to the Development and Option Agreement dated July 10, 2020); or (ii) in case GSK exercises its option under the Option LNP Technology pursuant to Section 2.1.4 and upon the execution of the Option LNP Agreement, a non-exclusive license agreement between CureVac and [*****], as amended from time to time (all such agreement(s), as applicable, “LNP Agreement(s)”, and such counterparty, “LNP Provider”). Subject to Section 2.7.1, any amendment to either LNP Agreement made after the Effective Date shall not adversely affect the rights or increase the obligations of GSK or CureVac under this Agreement.

 

1.127

“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.

 

1.128

“LNP Agreement” shall have the meaning set forth in Section 1.126. For clarity, the use of any LNP Technology under this Agreement in relation to a COVID Product under the 2021 Collaboration Agreement shall not count towards the limit on the number of LNP Licenses under this Agreement.

 

1.129

“LNP COVID Agreement” shall mean the Non-Exclusive License Agreement between CureVac and [*****]. For clarity, the use of any LNP Technology under this Agreement in relation to a COVID Product shall not count towards the limit on the number of LNP Licenses under the 2020 Collaboration Agreement.

 

1.130

“LNP License” shall have the meaning set forth in Section 2.1.2.

 

1.131

“LNP Provider” shall have the meaning set forth in Section 1.126.

 

1.132

“LNP Technology” shall mean the Patent Rights and Know-How Covering the Licensed LNPs that CureVac Controls pursuant to the LNP Agreements.

 

1.133

“Major Markets” shall mean [*****].

 

1.134

“Manufacture” shall mean all manufacturing operations (including for Drug Substance, Drug Product, 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 Finished Product, or any intermediate thereof, pre-clinical, clinical and commercial production, product, stability testing, quality assurance, and quality control. “Manufacturing” has a correlative meaning.

1.135

“Manufacturing Technology Transfer Materials” shall have the meaning set forth in Section 5.2.3.

 

1.136

“Materials” shall mean CureVac Materials and GSK Materials.

 

1.137

“mRNA” shall mean a replicating or non-replicating polynucleotide that is capable of directing the cellular machinery of a cell to produce polypeptide and contains naturally occurring nucleosides (e.g. Cytosine, Guanine, uracil, adenine) or chemical analogues thereof. The term encompasses analogues such as those containing modified backbones.

 

1.138

“mRNA-Based” shall mean, with respect to a vaccine or Antibody, that the vaccine Antigen or Antibody is encoded by one or more mRNAs.

 

1.139

“Net Sales” shall mean the gross invoice price of Product sold by GSK or its Affiliates or Sublicensees directly to a Third Party, less the following deductions if and to the extent such deductions to unaffiliated entities are actually allowed and granted:

 

(i)

trade, quantity, and/or cash discounts, charge-back payments, allowances or rebates, including promotional or similar discounts or rebates, and discounts or rebates to governmental or managed care organizations;

 

(ii)

discounts provided in connection with coupon, voucher or similar patient programs;

 

(iii)

credits or allowances given or made with respect to Product by reason of rejection, defects, recalls, returns, rebates, or retroactive price reductions;

 

(iv)

any tax, tariff, duty or government charge (including any sales, value added, excise or similar tax or government charge, but excluding any income tax) levied on the sale, transportation or delivery of Product and borne by GSK, its Affiliates or Sublicensees without reimbursement from any Third Party;

 

(v)

any charges for freight, postage, shipping or transportation, or for insurance, in each case to the extent borne by GSK, its Affiliates or Sublicensees without reimbursement from any Third Party; and

 

(vi)

any administrative fees paid to group purchasing organizations or managed care entities for the sale of Product (provided, however, that such deduction may not exceed two percent (2%) of the gross sales in the corresponding accounting period).

 

All such discounts, allowances, credits, rebates and other deductions shall be fairly and equitably allocated to the sale of the relevant Product by GSK, its Affiliates or Sublicensees, such that the Product does not bear a disproportionate portion of such deductions as compared to other products sold separately from but with a certain link or other connection to the Product. For the avoidance of doubt, the Net Sales shall be calculated only once for the first bona fide arm’s length sale of the Product by either GSK, its Affiliate or its Sublicensee, to a Third Party which is neither an Affiliate nor a Sublicensee of GSK. Net Sales shall be determined in accordance with International Financial Reporting Standards (IFRS) applied in a consistent manner.

 

In the event a Product is sold as part of a Combination Product, (either as a separate Finished Product sold together with other products or because the Drug Substances associated with that Product formulated with additional other active pharmaceutical ingredients, [*****], or as a companion or complementary diagnostic), Net Sales of the Combination Product will be calculated, on a country-by-country basis, as follows:

 

(i)

If (x) the Product and (y) the other product(s) or active pharmaceutical ingredient are also sold separately in the applicable country, Net Sales of the Product portion of the Combination Product will be calculated by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in the applicable country of the 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 products or active ingredients in the Combination Product sold separately during the applicable Calendar Quarter.

 

(ii)

If the Product is sold separately, but the average gross selling price of the other product(s) or active ingredients cannot be determined, Net Sales of the Combination Product shall be equal to the Net Sales of the Combination Product multiplied by the fraction A/C wherein A is the average gross selling price of the Product and C is the average gross selling price of the Combination Product.

 

(iii)

If the other product(s) or other active ingredients is/are sold separately, but the average gross selling price of the Product cannot be determined, Net Sales of the Combination Product shall be equal to the Net Sales of the Combination Product multiplied by the following formula: one (1)    minus B/C wherein B is the average gross selling price of the other product(s) or active ingredients and C is the average gross selling price of the Combination Product.

 

(iv)

If the average gross selling price of neither the Product, nor the other product(s) or active ingredients, can be determined, e.g., because neither the Product, nor the other product in a Combination Product, are being sold separately, Net Sales of the Combination Product shall be equal to Net Sales of the Combination Product multiplied by A/B wherein A is the number of Products comprised in the Combination Product and B is the sum of “one” for each Product and the relative value of the other product(s) and/or other active pharmaceutical ingredients comprised in the Combination Product, such value to be determined by the patent protection status of the respective products, the development costs of the respective products, and the pricing of comparable products in the Major Markets. For illustration purposes, if there are two additional active ingredients in a Combination Product, one valued at 30 percent of the average price of the Products, and one valued at 50 percent of the average price of the Products, A/B equals 2/2.8, and Net Sales are multiplied by 0.71. The Parties will agree on the respective values in the JSC. If the JSC are unable to agree on the respective values within [*****] of the matter being referred by either Part to the JSC, either Party may refer the matter for resolution in accordance with Section 15.4h, provided that the reference to “fair market value” shall be replaced with the value of the respective Product and the relative value of the other product(s) and/or other active pharmaceutical ingredients. Each Party will bear equally the cost of the experts appointed in accordance with Section 15.4h.

 

(v)

The average gross selling price for such other product(s) or active ingredients contained in the Combination Product shall be calculated for each [*****] period 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 [*****] period during which a Combination 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 [*****] period. In the following Calendar Year the average gross selling price of the previous year shall apply from the second royalty payment on.

 

To the extent an In-Licensing Agreement existing before the Effective Date disqualifies [*****], the Parties, acting good faith, shall adjust the above mechanism for determining Net Sales of Combination Products to account for the loss suffered by CureVac as a result of the difference in qualification of [*****] between this Agreement and the In-Licensing Agreement in question. CureVac shall, in light of the available data and information regarding [*****], use commercially reasonable efforts to renegotiate such In-Licensing Agreement so that [*****] becomes part of [*****] under such In-Licensing Agreement, provided that if CureVac cannot agree with the counterparty of such In-licensing Agreement on the same mechanism for determining Net Sales of Combination Products as provided for in this Agreement, the Parties will adjust the mechanism for determining Net Sales of Combination Products under this Agreement accordingly to account for the loss suffered by CureVac as a result of the different calculation mechanisms. For the avoidance of doubt, the obligation of CureVac to use commercially reasonable efforts to renegotiate an In- licensing Agreement does not require CureVac to make any financial concessions towards the counterparty of such In-licensing Agreement which are unrelated to the definition of [*****] or the calculation of Net Sales.

 

1.140

“Non-Breaching Party” shall have the meaning set forth in Section 14.4.

 

1.141

“Optioned Product” shall have the meaning set forth in Section 3.7.1.

 

1.142

“Option Exercise Fee” shall have the meaning set forth in Section 3.7.5.

 

1.143

“Option Exercise Notice” shall have the meaning set forth in Section 3.7.4.

1.144

“Option LNP” shall mean an LNP in respect of which CureVac has Control under the Option LNP Agreement.

 

1.145

“Option LNP Agreement” shall mean [*****], as amended, supplemented or replaced from time to time (such counterparty, the “Option LNP Provider”).

 

1.146

“Option LNP Provider” shall have the meaning set forth in Section 1.145.

 

1.147

“Option LNP Technology” shall mean the Patent Rights and Know-How Covering the Option LNPs.

 

1.148

“Option Period” shall have the meaning set forth in Section 3.7.1.

 

1.149

“Option Request” shall have the meaning set forth in Section 3.7.4.

 

1.150

“Other Product” shall mean (i) each of the [*****] Initial Other Products, (ii) any Product Adjustment, Replacement Product and Optioned Product, (iii) any COVID Product that is the subject of the GSK COVID Continue Option, or the GSK Continue Option, under the 2021 Collaboration Agreement, if applicable; provided, however, that if GSK replaces an Initial Other Product pursuant to Section 3.6 or terminates a Program for an Other Product pursuant to Section 14.2, such Replaced Product or Product developed under the terminated Program, as applicable, shall no longer qualify as an Other Product.

 

1.151

“Other Product R&D Plan” shall have the meaning set forth in Section 4.3.1.

 

1.152

“Pandemic Pathogen” shall mean all Coronaviruses and any virus denoted by either, or both, of Part 1 and Part 2 of Exhibit 1.152.

 

1.153

“Party” shall mean CureVac or GSK (together, “Parties”).

 

1.154

“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.

 

1.155

“Pathogen” shall mean any infectious disease causing agent such as a virus, bacterium, fungus, protozoan or other type of microorganism.

 

1.156

“Pathogen Combination Product” shall mean CureVac mRNA-Based vaccines or CureVac mRNA-Based Antibodies targeting two or more different Collaboration Pathogens other than Excluded Pathogens. For the avoidance of doubt, the [*****] Product shall be considered a Pathogen Combination Product. The Parties may decide to work on further Pathogen Combination Products, subject to the availability of licenses under the LNP Technology (if required). For clarity, unless GSK exercises the GSK COVID Continue Option under the 2021 Collaboration Agreement, any Pathogen Combination Product which targets SARS-Cov-2 shall be subject to the 2021 Collaboration Agreement.

1.157

“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.

 

1.158

“Product” shall mean each CureVac mRNA-Based vaccine or CureVac mRNA-Based Antibody targeting one or more Pathogen(s), other than an Excluded Pathogen, which the Parties have agreed to Develop and Commercialize under this Agreement during the Term, which may be in Drug Product or Finished Product form (or precursors thereto), as the case may be, comprising: (i) the First Product, (ii) the Second Product, and (iii) any Other Product (comprising the [*****] Initial Other Products, any Replacement Product and any Optioned Product, if applicable), in each case including any Product Adjustment as adjusted in accordance with Section 3.3.

 

1.159

“Product Adjustment” shall have the meaning set forth in Section 3.3.

 

1.160

“Product Adjustment Notice” shall have the meaning set forth in Section 3.3.2.

 

1.161

“Program” shall mean, on a Product-by-Product basis, any and all Development activities for such Product, including under an R&D Plan, and all Manufacturing and Commercialization activities conducted in respect of a Product.

 

1.162

“Program Patent Rights” shall mean Patent Rights Covering Inventions.

 

1.163

“Project Leaders” shall have the meaning set forth in Section 7.1.2.

 

1.164

“Proof of Concept Data” shall mean [*****].

 

1.165

“Quality Agreement” shall mean a quality agreement between CureVac and GSK setting out further administrative, technical and quality provisions regarding the Manufacture and supply of a Product (or intermediary version thereof) for Development or Commercialization purposes, as applicable.

 

1.166

“R&D Plan(s)” shall mean the research and development plans attached hereto, or to be prepared under this Agreement and shall include the First Product R&D Plan, the Second Product R&D Plan and each Other Product R&D Plan.

 

1.167

“Receiving Party” shall have the meaning set forth in Section 11.1.

1.168

“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.

 

1.169

“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, regional, state or local Regulatory Authority, 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.

 

1.170

“Regulatory Authority” shall mean any competent regulatory or governmental authority which regulates any aspect of the Development, Manufacturing or Commercialization of a Product, including those specifically referred to in this Agreement or any Ancillary Agreement.

 

1.171

“Regulatory Exclusivity” shall mean, on a country-by-country and Product-by-Product basis, an additional protection, other than patent protection, granted by a Regulatory Authority that confers an exclusive period during which a Party or its Affiliates or Sublicensees have the exclusive right to market or sell a Product in such country through a regulatory exclusivity right (e.g., new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity), provided that regulatory exclusivity shall only be deemed to exist in a country if (i) Applicable Laws, and the guidance, policies and practice of the competent Regulatory Authority allow other mRNA-Based products to qualify as generic or biosimilar versions of a Product; and (ii) as a result, absent or after the expiry of the regulatory exclusivity right, such mRNA-Based products can enter the market of the country in question with substantially lower development investment.

 

1.172

“Replaced Product” shall have the meaning set forth in Section 3.6.2.

 

1.173

“Replacement Product” shall have the meaning set forth in Section 3.6.1.

 

1.174

“Replacement Exercise Fee” shall have the meaning set forth in Section 3.6.3.

 

1.175

“Replacement Notice” shall have the meaning set forth in Section 3.6.2.

 

1.176

“Replacement Request” shall have the meaning set forth in Section 3.6.2.

 

1.177

“Replacement Right” shall have the meaning set forth in Section 3.6.1.

 

1.178

“Reservation Period” shall have the meaning set forth in Section 3.5.2.

 

1.179

“Reserved Antigen” shall have the meaning set forth in Section 3.5.2.

1.180

“Research Period” shall mean, the period commencing on the Closing Date and ending, on a Program-by-Program basis, at the later of [*****].

 

1.181

“RNA Printer” shall mean the automation solution for CureVac’s processes of mRNA manufacturing developed by CureVac and Tesla Grohmann Automation Solution GmbH under the Development and Intellectual Property Agreement dated December 22, 2017, including the Know- How licensed from Tesla Grohmann Automation Solution GmbH thereunder.

 

1.182

“Royalty Term” shall have the meaning set forth in Section 8.7.2.

 

1.183

“RSV” shall have the meaning set forth in Exhibit 1.70.

 

1.184

“Sales Milestone Payment” shall have the meaning set forth in Section 8.4.

 

1.185

“Sanctions & Trade Controls” shall have the meaning set forth in Section 12.8.

 

1.186

“Second Product” shall have the meaning set forth in Exhibit 1.29.

 

1.187

“Second Product R&D Plan” shall have the meaning set forth in Section 4.2.

 

1.188

“Sublicensee” shall mean any Third Party licensee (aside from GSK’s Affiliates and any Third Party contractors used by GSK in the Development, Manufacture or Commercialization of the Products on GSK’s behalf), which obtains rights to the CureVac Technology or LNP Technology under a license granted by GSK, its Affiliates or another Sublicensee, in each case in accordance with Section 2.2.

 

1.189

“Term” shall have the meaning set forth in Section 14.1.

 

1.190

“Territory” shall mean the entire world.

 

1.191

“Third Party” shall mean any Person, other than CureVac or GSK and their respective Affiliates.

 

1.192

“Third Party Infringement” shall have the meaning set forth in Section 10.2.

 

1.193

“[*****] Product” shall have the meaning set forth in Exhibit 1.29.

 

1.194

“[*****] Product R&D Plan” shall have the meaning given in Section 4.3.1.

 

1.195

“Valid Claim” shall mean either (a) a claim of an issued and unexpired patent within the CureVac Patent Rights or (ii) the LNP Technology 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 (b) a claim of a pending patent application within (i) the CureVac Patent Rights or (ii) the LNP Technology which application has not been pending for more than [*****] from the date of its priority filing date and which claim has not been irretrievably revoked, irretrievably cancelled, irretrievably withdrawn, held invalid or abandoned by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period), or finally determined to be unallowable in a decision from which an appeal cannot or can no longer be taken. For clarity, a claim of an issued patent that ceased to be a Valid Claim before it issued because it had been pending too long, but subsequently issues and is otherwise described by clause (a), shall again be considered to be a Valid Claim once it issues. The same principle shall apply in similar circumstances such as if, for example (but without limitation), a final rejection of a claim is overcome.

1.196

“VAT and Indirect Taxes” shall mean any value added, sales, purchase, turnover or consumption tax as may be applicable in any relevant jurisdiction, including but not limited to value added tax chargeable under legislation implementing Council Directive 2006/112/EC.

 

1.197

“WIPO” shall have the meaning set forth in Section 16.5.2.

 

1.198

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)

“written” and “in writing” include any means of reproducing words, figures or symbols in a tangible and visible form, including acknowledged email or facsimile;

 

(vi)

“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

 

(vii)

any reference to “demonstrable” costs and expenses means those costs and expenses can be evidenced in writing.

1.199

2021 Preliminary Agreement

 

It is agreed by the Parties that all amendments made to this Agreement by the 2021 Preliminary Agreement are null and void.

 

2.	LICENSES; EXCLUSIVITY.

 

2.1	License Grants to GSK.

 

2.1.1

License under CureVac Technology. Subject to the terms and conditions of this Agreement and subject to the disclosures as set forth in items (ii) and (iii) of the Disclosure Letter, on a Product- by-Product basis, CureVac hereby grants to GSK, and GSK hereby accepts: (i) a royalty-free, exclusive license to use the CureVac Technology for the Development and Manufacture of Products for use in the Field in the Territory; and (ii) a royalty-bearing, exclusive license to use the CureVac Technology for the Commercialization of Products for use in the Field in the Territory, subject to CureVac’s rights with respect to the CureVac Territory under Section 6 and the Distribution Agreement. Subject to the disclosures as set forth in items (ii) and (iii) of the Disclosure Letter, the license granted hereunder shall be exclusive as to Third Parties and to CureVac, provided that CureVac retains the right to perform the Development and Manufacturing activities allocated to CureVac under this Agreement.

 

2.1.2

License under LNP Technology. Subject to the terms and conditions of this Agreement, the terms and conditions set forth in Exhibit 2.1.2 Part A, and subject to the disclosures as set forth in items (ii) and (iii) of the Disclosure Letter, on a Product-by-Product basis, CureVac hereby grants to GSK, and GSK hereby accepts: (i) a royalty-free, non-exclusive sublicense under the LNP Agreements to use the LNP Technology for the Development and Manufacture of the Initial Products and the Initial Other Products for use in the Field in the Territory; and (ii) a corresponding royalty-bearing, non-exclusive license to use the LNP Technology for the Commercialization of the Initial Products and the Initial Other Products for use in the Field in the Territory, subject to CureVac’s rights with respect to the CureVac Territory under Section 6 and the Distribution Agreement (“LNP License”). CureVac shall not (i) grant a sublicense to any Third Party under the LNP Technology for the Development and Manufacture of Products for use in the Field in the Territory, subject to the disclosures as set forth in items (ii) and (iii) of the Disclosure Letter, and (ii)    itself carry out any activities under the LNP Technology for the Development and Manufacture of Products for use in the Field in the Territory other than under this Agreement; in each case of (i) and (ii) on a Product-by-Product basis for as long as the respective Product is Developed and/or Commercialized under this Agreement. The LNP License shall:

 

(i)

as at the Closing Date be limited to Licensed LNP from [*****] for the primary vaccine Antigen and the additional vaccine Antigen for the [*****] as listed in Exhibit 2.1.2 Part B for use as part of the [*****] Product in the Field;

 

(ii)

within [*****] following the Closing Date, include Licensed LNPs from [*****] for the primary vaccine Antigens and the associated additional vaccine Antigens for the [*****] as listed in Exhibit 2.1.2 Part B for use as part of the corresponding Product in the Field;

 

 

(iii)

include a Licensed LNP from [*****] for a primary Antibody and associated additional Antibodies (if any) for the [*****] provided that GSK has provided the Antibody sequence to CureVac before [*****] (and CureVac may suspend activities, to the extent required and acting reasonably, under this Program until GSK has selected such sequence, in light of the potential detrimental effects on the Program and the ownership rights in Inventions of continuing activities without having licensed this LNP), and subject to clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1; it being understood that CureVac shall secure such Licensed LNP within [*****] upon receipt of the confirmation from [*****] that the Antibody(ies) is/are available for licensing; and

 

(iv)

with respect to a Product Adjustment, include Licensed LNP under a then existing LNP Agreement with [*****] for an additional vaccine Antigen or an additional Antibody, subject to clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1; it being understood that CureVac shall secure the Licensed LNP for such additional vaccine Antigen or an additional Antibody, as applicable, from [*****] in accordance with Section 3.3.2;

 

(v)

in case GSK exercises the GSK Continue Option or the GSK COVID Continue Option, include Licensed LNP under the LNP COVID Agreement for the COVID Products.

 

Within [*****] following the Closing Date, the Parties will agree on a redacted copy of this Agreement (excluding any commercially confidential information) that CureVac can provide to the LNP Provider(s) in accordance with its obligations under the LNP Agreements.

 

2.1.3

Exchange of Licensed LNPs. For a period commencing on the Closing Date and ending on [*****] GSK shall have [*****] cost-free options to exchange for the original LNP Licenses granted under Section 2.1.2 the primary vaccine Antigen or primary Antibody of those LNP Licenses (together with any additional vaccine Antigen(s) or additional Antibody(ies) of those LNP Licenses, if any) for an alternate primary vaccine Antigen or an alternate primary Antibody, with or without one or more additional vaccine Antigen(s) or additional Antibody(ies), as applicable, subject to clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1, and subject the terms and conditions set forth in Exhibit 2.1.2 Part A. GSK can exercise the exchange options granted hereunder, at GSK’s discretion, for Replacement Products or Optioned Products, and can exercise this right either for different original LNP Licenses or multiple times for the same LNP License (or a combination of both), provided that GSK may exercise this exchange option right a maximum of [*****] times. On an option-by-option basis, CureVac shall secure the LNP License for an alternate primary vaccine Antigen or alternate primary Antibody and the additional vaccine Antigen(s) or additional Antibody(ies) in accordance with Section 3.6.2 or 3.7.4, as applicable.

 

2.14

Option under Option LNP Technology. For a period commencing on the Closing Date and ending on [*****] GSK shall have the cost-free, one-time option to obtain a non-exclusive sublicense under an Option LNP Agreement to use the Option LNP Technology to Develop, Manufacture and Commercialize a Product for use in the Field in the Territory, subject to CureVac’s rights with respect to the CureVac Territory under Section 6 and the Distribution Agreement, and subject to clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1, and the terms and conditions set forth in Exhibit 2.1.4, the terms and conditions of this Agreement and the disclosures set forth in items (ii) and (iii) of the Disclosure Letter. GSK can exercise the option granted hereunder, at GSK’s discretion, for an Initial Product, an Initial Other Product, a Replacement Product or an Optioned Product, provided that GSK may exercise this option [*****] CureVac shall secure the Option LNP for the respective Product from the Option LNP Provider within [*****] upon receipt of the confirmation from the Option LNP Provider that the Antigen(s) are available for licensing.

 

2.2	Sublicenses.

 

2.2.1

Right to Sublicense. GSK shall have the right to sublicense its rights under Section 2 to any of its Affiliates. GSK’s right to sublicense any of its Development rights or any of its Manufacturing rights for Development purposes (subject to Section 5) under Section 2.1.1, or any of its rights to the LNP Technology under Section 2.1.2 to any other Third Party shall be subject to CureVac’s prior written consent which CureVac may grant or withhold in its sole discretion. GSK’s right to sublicense (in multiple tiers) any of its Manufacturing rights for commercial purposes (subject to Section 5) and/or Commercialization rights under Section 2.1.1 to a Third Party shall be subject to CureVac’s prior written consent which shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, this Section 2.2.1 shall not restrict GSK or any of its Affiliates to subcontract any of its Development or Manufacturing activities to a CRO, CMO or other service provider to GSK or its Affiliate, subject to Section 5.2.3.

 

2.2.2

Sublicensing Requirements. The right to sublicense to a Third Party is subject to a written sublicense agreement containing terms and conditions that are consistent with those contained in this Agreement, and shall include, inter alia, provisions regarding confidentiality, non-compete, indemnification, audit, record-keeping, termination and consequences of termination that are consistent with the corresponding terms and conditions provided herein. GSK shall remain liable to CureVac for all obligations under this Agreement, including all payment obligations, and shall send to CureVac a copy of the signed sublicensing agreement within [*****] after its execution, subject to the reasonable redaction of confidential information. CureVac acknowledges that all information provided to CureVac by GSK under this Section 2.2.2 shall be deemed Confidential Information of GSK and shall be subject to the terms and conditions of Section 11.

2.3	Pathogen Exclusivity.

 

2.3.1

GSK. GSK shall work exclusively with CureVac on the Development, Manufacture and Commercialization of Products targeting a Collaboration Pathogen, and GSK shall not, and shall procure that its Affiliates and Sublicensees holding rights to the CureVac Technology in the Field and in the Territory will not, develop, manufacture or commercialize, solely or with a Third Party, any prophylactic and/or therapeutic mRNA-Based vaccine or mRNA-Based antibody targeting a Collaboration Pathogen other than a Product Developed and/or Commercialized under this Agreement. This Section 2.3.1 and the covenants set forth herein shall not apply to activities of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of GSK solely as a result of a Change of Control in GSK, provided that such activities are performed without using the mRNA technology described in the Know-How, or within the scope of the specification of the Patents Rights, Controlled by GSK (excluding, for clarity any CureVac Know-How or CureVac Patent Rights). Notwithstanding the foregoing, GSK shall be permitted to continue development activities targeting the same Collaboration Pathogen immediately prior to the Effective Date, and which accordingly fall within the scope of the exclusivity commitment set out in this Section 2.3.1, for up to [*****] from the Effective Date, whilst GSK carries out an orderly wind-down of those activities.

 

2.3.2

CureVac. Subject to CureVac’s obligations as set forth in items (ii) and (iii) of the Disclosure Letter, CureVac shall work exclusively with GSK on the Development, Manufacture and Commercialization of Products targeting a Collaboration Pathogens, and CureVac shall not, and shall procure that its Affiliates will not, develop, manufacture or commercialize, solely or with a Third Party, any prophylactic and/or therapeutic mRNA-Based vaccine or mRNA-Based antibody targeting a Collaboration Pathogen other than a Product Developed and/or Commercialized under this Agreement. This Section 2.3.2 and the covenants set forth herein shall not apply to activities of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac, provided that such activities are performed without using the CureVac mRNA technology described in the CureVac Know-How or within the scope of specification of the CureVac Patent Rights.

 

2.3.3

Exclusivity Term.The covenants laid down in this Section 2.3 shall apply for a period commencing on the Effective Date, or in case of a Collaboration Pathogen targeted by a Replacement Product or an Optioned Product, the date of receipt of the Replacement Notice or Option Notice, as applicable, by CureVac until the expiry or termination of this Agreement. For the avoidance of doubt, in case GSK has replaced an Initial Other Product pursuant to Section 3.6 or has terminated a Program pursuant to Section 14.2, the Pathogen targeted by such Replaced Product or under such terminated Program, as applicable, shall no longer qualify as Collaboration Pathogen if that Pathogen is no longer targeted by another Product, and consequently, the exclusivity obligations laid down in this Section 2.3 shall terminate with respect to such Pathogen, unless the respective Pathogen is targeted under another ongoing Program. In relation to the Initial Products only, if the Program for one of the Initial Products is terminated or replaced by a Replacement Product, the covenants laid down in this Section 2.3.3 shall continue to apply with respect to any other Initial Product targeting the same Pathogen, but no longer in relation to the terminated or replaced Initial Product (even though it targets the same Pathogen). For the avoidance of doubt, upon termination or replacement of such Initial Product, all rights and licenses with respect to such Initial Product will return to CureVac subject to and in accordance with Section 15, and GSK will not be allowed to use the CureVac Technology, including the CureVac Know-How, any Joint Product Invention or any Joint Other Invention, unless expressly set forth in Section 15 or unless CureVac has granted a license to GSK under terms to be negotiated.

2.4	Trademarks.

 

2.4.1

Registration. As between the Parties and their Affiliates, GSK shall be solely authorized to determine the brand, trade name, logo and trade dress under which the Finished Products shall be Commercialized in the Territory. GSK shall have the first right, but not the obligation, to prepare, file, prosecute and maintain, at its own expense, any Brand IP for the Finished Products in the Territory; provided, however, that nothing herein shall grant GSK any right to use any trademark Controlled by CureVac and/or CureVac’s Affiliates. GSK will own all right, title and interest in and to any such trademark it selects in its own name during and after the Term, subject to the licenses granted to CureVac with respect to the CureVac Territory under Section 6.

 

2.4.2

Restrictions. Subject to any separate agreement(s) amongst the Parties (or their Affiliates), CureVac shall not, and shall cause their respective Affiliates not to, during the Term: (i) use or attempt to use any marks, brands or trade dress identical or similar to those covered by the Brand IP of GSK or its Affiliates, except as permitted by this Agreement or any Ancillary Agreement; (ii) register or attempt to register or procure the registration anywhere in the world of any mark as a trademark for any goods or services or as a domain name that is same as or confusingly similar to the Brand IP for the Finished Products; (iii) use any Brand IP for any of the Finished Products in any way which could tend to allow it to become generic, to lose its distinctiveness, to become liable to mislead the public or which would otherwise be detrimental or inconsistent with the good name, goodwill, reputation or image of the Parties; (iv) challenge the ownership of the Brand IP belonging to GSK or its Affiliates except if Brand IP is prosecuted in breach of this Agreement; or (v) register or attempt to register or procure the registration of or use any mark or domain name that incorporates the letters “[*****]” either as a prefix or a suffix for use in connection with a pharmaceutical product. This Section 2.4.2 and the covenants set forth herein shall not apply to a Third Party (or such Third Party’s Affiliate) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac.

 

2.5

Documents and Declarations. CureVac shall execute all documents, give all declarations regarding the licenses granted hereunder and reasonably cooperate with GSK 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 GSK Territory for the benefit of GSK. GSK shall reimburse CureVac for its reasonable and demonstrable external out of pocket costs associated therewith up to a total amount of EUR 20,000.

 

2.6

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.

2.7	In-Licensing Agreements.

 

2.7.1

Future In-Licensed IP. If during the Term, CureVac obtains, other than by way of a Change of Control, a sublicensable license to any Patent Rights or Know-How Controlled by a Third Party that is useful, but which is not necessary to obtain freedom to operate with respect to the use or exploitation of the mRNA, LNP, CVCM and other technology or information, each as described in the CureVac Know-How or within the scope of the specification of the CureVac Patent Rights (excluding any Invention or Know-How jointly owned by the Parties) (the “CureVac Elements”), for the Development, Manufacture and Commercialization of Products under this Agreement (“In- Licensed IP”), CureVac shall (i) notify GSK of the rights that CureVac has obtained with respect to such In-Licensed IP, (ii) use commercially reasonable endeavors to obtain the right to sub-license those Patent Rights or Know How, and (iii) notify GSK of the applicable financial terms, which shall be non-discriminatory (as between GSK and any other sublicensee of CureVac). GSK shall notify CureVac within [*****] after receipt of such notice whether GSK desires to include such In-Licensed IP under the license granted to GSK by CureVac pursuant to Section 2.1. If GSK notifies CureVac that it desires to include such In-Licensed IP under the license granted to GSK by CureVac pursuant to Section 2.1, then (i) such In-Licensed IP is and shall be automatically included in the definition of CureVac Know-How or CureVac Patent Rights, as applicable, and be licensed to GSK under Section 2.1, and (ii) as a sublicensee of CureVac, GSK will meet all obligations of CureVac that are applicable to GSK’s activities as a sub-licensee (to the extent notified by CureVac to GSK in advance in writing); and (iii) GSK shall reimburse CureVac for additional amounts payable by CureVac under such license to such Third Party to the extent directly arising as a result of (x) the grant of such sublicense to GSK or (y) the use of the In- Licensed IP by the Development, Manufacture or Commercialization of Products by GSK, its Affiliates, and Sublicensees.

 

2.7.2

Enforcement, Maintenance and Amendment of In-Licensing Agreements. CureVac will reasonably enforce (including in connection with any counterparty’s breach of any representations or warranties under the applicable In-Licensing Agreements), or otherwise take the actions necessary to enable GSK to enforce, CureVac’s rights, benefits and the obligations of the respective counterparties under the In-Licensing Agreements that may impact the rights, benefits and obligations of GSK hereunder, and will inform GSK of any action it may take under the In- Licensing Agreements to the extent such action may impact GSK’s interest under the respective In- Licensing Agreement. CureVac shall: (i) fulfil all of its obligations, including its payment obligations, under the In-Licensing Agreements; and (ii) not take any action or omit to take any action that would materially adversely affect, or would reasonably be expected to materially adversely affect, GSK’s rights, benefits and obligations under this Agreement. CureVac shall reasonably notify GSK of any default, termination or amendment of, the In-Licensing Agreements, to the extent such default, termination or amendment may have an impact of GSK.

3.	PRODUCT ADJUSTMENTS; REPLACEMENT RIGHT; EXCLUSIVE OPTION.

 

3.1

Product Composition. As between the Parties, subject to Sections 2.1.3 and 2.1.4 with respect to the LNP Technology and subject to the replacement mechanism under Section 3.6, the clearance mechanism under Section 3.4 and Section 3.5, the composition restrictions under Section 3.2, the adjustment mechanism under Section 3.3, and the limitations to GSK’s decision-making rights set forth in Section 7.5.2b(i), GSK shall have the right, in its sole discretion, to determine the composition of a Product, including [*****].

 

3.2	Composition Restrictions.

 

3.2.1

General Restriction. Each Product must incorporate CureVac mRNA containing [*****].

 

3.2.2

Vaccine Restrictions. Initial Products and Other Products (including any Product Adjustments) that are vaccines shall be subject to the following restrictions: each shall consist of a maximum number of [*****]. For each such vaccine Product, GSK shall designate the primary vaccine Antigen and the additional vaccine Antigens as of the Effective Date or upon selection of the Replacement Product.

 

3.2.3

Antibody Restrictions. For the purposes of this Agreement, (i) the maximum number of Antigens that a single Antibody can bind to is [*****] Antigens and (ii) unless otherwise set forth herein, Antibody shall include an Antibody Combination, as applicable. For each such Antibody Product, GSK shall designate the primary Antibody and the additional Antibodies as of the Effective Date or upon selection of the Replacement Product.

 

3.3	Product Adjustments.

 

3.3.1

Product Adjustments. If, further to Section 3.1 and subject to the restrictions laid down in Section 3.1, GSK wishes to only change the additional vaccine Antigen(s) or additional Antibody(ies), but not the primary vaccine Antigen or the primary Antibody of a Product, such change shall constitute a “Product Adjustment” and be handled in accordance with this Section 3.3. Where GSK wishes to change the primary Antigen or the primary Antibody of a Product, with or without changing the Pathogen or combination of Pathogens targeted by such Product, such change shall constitute a Product Replacement and be handled in accordance with Section 3.6.

 

3.3.2

Product Adjustment Notice. If GSK intends to make a Product Adjustment, GSK shall send a written request to CureVac identifying the details of such Product Adjustment, including, if a change to an LNP License is needed for such Product Adjustment, all details necessary for CureVac to perform the clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1. Within [*****] following receipt of the adjustment request, the Antigen/Antibody List Rep will perform the Antigen/Antibody clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1. Within [*****] upon receipt of the confirmation from the LNP Provider that the additional Antigen or additional Antibody is available for licensing, CureVac shall secure the LNP License for such additional vaccine Antigen or additional Antibody, as applicable, from the LNP Provider, and the Parties will work on an amendment to the R&D Plan for the respective Product.

3.4	Clearance in relation to LNP.

 

If GSK intends to make a Product Adjustment, exercise its Replacement Right or exercise its Exclusive Option, GSK may request CureVac in writing to perform an Antigen clearance under the LNP Agreement or an Antigen or Antibody clearance under the Option LNP Agreement, such clearance to be conducted in accordance with the following process: First, GSK shall notify a specific representative designated by CureVac in writing that GSK wishes to conduct an Antigen or Antibody clearance (“Antigen/Antibody List Rep”) and shall provide all information required to perform such clearance by using the clearance template attached hereto as Exhibit 3.4 (“Clearance Template“). Second, within [*****] from receipt of such information from GSK, the Antigen/Antibody List Rep shall contact the antigen or antibody list representative of the LNP Provider or the Option LNP Provider, as applicable, to confirm whether the Antigen or Antibody is available for licensing.

 

3.5	Further Clearance and Reservation.

 

3.5.1

Clearance. If applicable, GSK may request CureVac in writing to perform an Antigen clearance under CureVac’s pre-existing agreement as listed in paragraph 4 of item (iii) in the Disclosure Letter, such clearance to be conducted in accordance with the following process:

 

(i)

GSK shall notify the Antigen/Antibody List Rep in writing that GSK wishes to conduct such Antigen clearance, and shall provide all information required to perform such clearance by using the Clearance Template.

 

(ii)

Within [*****] from receipt of such information from GSK, the Antigen/Antibody List Rep shall verify that the requested Antigen is not associated with an Excluded Pathogen and shall confirm whether the Antigen is available, meaning it has not been reserved previously by the counterparty to a pre-existing agreement as listed in paragraph 4 of item (iii) in the Disclosure Schedule in accordance with its terms.

 

(iii)

Upon confirmation, the Antigen/Antibody List Rep shall notify GSK thereof, and the Antigen shall become a Reserved Antigen, provided that the maximum number of reserved Antigens may not be exceeded.

 

3.5.2

Reservation of Antigens. For a term of [*****] after the Closing Date (“Reservation Period”), and, subject to the clearance mechanism under Section 3.5.1, GSK shall have the right to reserve a maximum number of [*****] under the CureVac Technology for use in the Field (each, a “Reserved Antigen”). Subject to the clearance mechanism under Section 3.5.1, GSK may change the Antigens that constitute Reserved Antigens during the Reservation Period. The Antigens listed in Exhibit 3.5.2 shall be deemed Reserved Antigens as at the Closing Date. Without limiting any other obligation of CureVac under this Agreement (including under Section 2.3 and 3.7.6), during the Reservation Period, CureVac, itself or through its Affiliates, may not grant any rights to a Third Party for a Reserved Antigen under the CureVac Technology for use in the Field.

 

3.6	Replacement of Products.

 

3.6.1

Replacement Right. Until [*****] subject to the composition restrictions under Section 3.2, the clearance mechanism under Section 3.4 and, if applicable, Section 3.5.1, and subject to Sections 2.1.3 and 2.1.4 with respect to the LNP Technology, GSK has the right to replace any of the then- current Products with a CureVac mRNA-Based vaccine or CureVac mRNA-Based Antibody that consists of a different primary Antigen or primary Antibody respectively, and which may target a different Pathogen or combination of Pathogens, other than an Excluded Pathogen (“Replacement Right”), provided that GSK may exercise its Replacement Right a maximum of [*****] times. GSK may replace a Product with (i) a new CureVac mRNA-Based vaccine or CureVac mRNA- Based Antibody (including for the same Pathogen or combination of Pathogens, but with a different primary Antigen or primary Antibody), or (ii) a CureVac mRNA-Based vaccine or CureVac mRNA-Based Antibody which is, at the time when GSK exercises its Replacement Right, under development by CureVac outside the scope of this Agreement (each, a “Replacement Product”). For the purposes of this Section 3.6, “under development by CureVac” shall mean that CureVac has generated Proof of Concept Data with respect to the Replacement Product.

 

3.6.2

Replacement Notice. If GSK intends to exercise its Replacement Right, GSK shall send a written replacement request to CureVac (at any time before the expiry of the period specified in Section 3.6.1) identifying: (i) the Product to be replaced (“Replaced Product”); (ii) the Replacement Product that GSK seeks to Develop; (iii) the LNP or CVCM that GSK desires to use for the Replacement Product; and (iv) if applicable, the Antibody and/or Antigens that GSK wishes to clear in accordance with Section 3.4 and Section 3.5 (“Replacement Request”). Within [*****] following the Replacement Request, the Parties will hold a JSC meeting for discussing the details with respect to the Replacement Product and the desired LNP or CVCM for such Replacement Product, and CureVac will provide to GSK all data, documents and information reasonably required by GSK to assess whether it wishes to exercise its Replacement Right with respect to the respective Replacement Product, including the amount of the Replacement Exercise Fee, if any. Within [*****] following this JSC and unless directed otherwise by GSK in writing, the Antigen/Antibody List Rep will perform the requisite Antigen/Antibody clearance in accordance with Section 3.4 and, if applicable, Section 3.5.1, GSK shall exercise its Replacement Right by sending written notice to CureVac within [*****] following the confirmation by the Antigen/Antibody List Rep that the Antibodies and/or Antigens are available to GSK (“Replacement Notice”). Following receipt of the Replacement Notice by CureVac, the Parties shall as soon as reasonable practicable work on an initial R&D Plan for the Replacement Product in accordance with Section 4.3.2, and CureVac shall, if an LNP is selected by GSK and cleared, secure the LNP License from the respective LNP Provider.

3.6.3

Replacement Exercise Fee. If GSK exercises its Replacement Right for an existing Replacement Product, i.e., a CureVac mRNA-Based Vaccine or CureVac mRNA-Based Antibody already under development by CureVac, GSK shall make the following payments to CureVac: (i) GSK shall compensate CureVac for all reasonable, duly documented and demonstrable development costs and expenses exclusively relating to such Replacement Product incurred by CureVac or its Affiliates since (and in respect of the period after) the Closing Date (including in case of a Replacement Product acquired by CureVac from a Third Party that portion of the fee paid to that Third Party that relates to the Replacement Product), provided, however, that with respect to any Replacement Product targeting [*****], such compensation shall also include costs and expenses incurred by CureVac or any of its Affiliates before the Closing Date in the amount specified in Section 3.7.5; and (ii) GSK shall pay to CureVac any milestone payments which would have been due since the Closing Date, if such Replacement Product had been an Other Product as at the Closing Date, if any (the payments under (i) and (ii) together, the “Replacement Exercise Fee”). The Replacement Exercise Fee is to be paid by GSK to CureVac within [*****] after receipt of an invoice from CureVac, with supportive documentation reasonably detailing the costs and expenses incurred by CureVac. By way of example: If GSK exercises its Replacement Right for a Replacement Product under development by CureVac outside the scope of this Agreement for which CureVac has [*****] at the time GSK exercises its Replacement Right, GSK shall reimburse CureVac for any reasonable, duly document Development costs and expenses incurred by CureVac since (and in respect of the period after) the Closing Date and exclusively relating to such Replacement Product and, in addition, shall pay to CureVac accrued, non-refundable and non-creditable Development & Regulatory Milestone Payments in the amounts of [*****].

 

3.6.4

Replacement. Upon (i) receipt of a Replacement Notice by CureVac, (ii) full payment of the Replacement Exercise Fee from GSK to CureVac, if applicable, and (iii) the Parties having agreed on an initial R&D Plan for the Replacement Product, the relevant Replacement Product shall become an Other Product. The Parties shall Develop such Replacement Product pursuant to Section 4.3.2, and, unless set forth otherwise, all terms and conditions relevant for the Development, Manufacture and Commercialization of Other Products shall apply to such Replacement Product (including licenses, milestone payments and royalties). All rights of GSK with respect to the Replaced Product shall terminate, the Pathogen targeted by the Replaced Product shall become an Excluded Pathogen (unless such Pathogen is targeted by another Product), and Section 14.6 and Section 15.1 shall apply with respect to the replaced Program and the Replacement Product. For the avoidance of doubt, a Product Adjustment shall not constitute a replacement for the purposes of this Section 3.6.

3.7	Exclusive Option.

 

3.7.1

Option Grant. Until [*****] (“Option Period”), and subject to Sections 3.7.2 and the composition restrictions under Section 3.2, the clearance mechanism under Section 3.4 and, if applicable, Section 3.5.1, and subject to Sections 2.1.3 and 2.1.4 with respect to the LNP Technology, CureVac hereby grants to GSK, and GSK hereby accepts, the exclusive option to obtain exclusive licenses under the CureVac Technology to Develop, Manufacture and Commercialize further CureVac mRNA-Based vaccines (other than the First-Gen COVID Vaccine Product, as defined in the 2021 CLA) or CureVac mRNA-Based Antibodies, in addition to the then- current Products, targeting a different Pathogen or combination of Pathogens other than an Excluded Pathogen in the Field (“Exclusive Option”). GSK may exercise its Exclusive Option only with respect to a CureVac mRNA-Based vaccine or a CureVac mRNA-Based Antibody which is, at the time when GSK exercises its Exclusive Option, under development by CureVac outside the scope of this Agreement (each, an “Optioned Product”). For the purposes of this Section 3.7, “under development by CureVac” shall mean that CureVac has generated Proof of Concept Data with respect to the Optioned Product.

3.7.2

Timing for exercise of Exclusive Option in a pandemic setting. As long as an outbreak of a Pathogen or combination of Pathogens targeted by a Product covered by the Exclusive Option is declared by the WHO of a “public health emergency of international concern” (or equivalent, to the extent the WHO adjusts its system of classifications from time to time), the Option Period for such Product shall expire within [*****] from the later of (i) such declaration or (ii) the date of receipt by GSK of the Proof of Concept Data with respect to the Optioned Product.

 

3.7.3

Exclusive Option for Pandemic Pathogens. If the Pathogen or combination of Pathogens targeted by a Product covered by the Exclusive Option is or includes a Pandemic Pathogen (other than SARS-CoV-2):

 

a.

CureVac may elect, within [*****] after receipt of an Option Request, that the Optioned Product shall be subject to either the terms of (i) the 2021 Collaboration Agreement, in which case the Optioned Product shall upon effective Option Exercise be treated as a COVID Product under the 2021 Collaboration Agreement and this Agreement shall no longer apply to that Optioned Product, or (ii) this Agreement, in which case it shall upon effective Option Exercise be treated as an additional Other Product under this Agreement (and, for clarity, the 2021 Collaboration Agreement shall not apply to that Optioned Product);

 

b.

GSK shall will determine, in relation to each agreement entered into by CureVac with any government or other authority pursuant to the activities permitted pursuant to Section 3.7.8, on or before the effective date of Option Exercise, on whether (i) such agreement will be transferred to GSK, together with a transfer of associated regulatory responsibilities and a supply chain for the relevant Product(s) enabling GSK’s fulfilment of the respective agreement, and subject to CureVac’s rights to Commercialize in the CureVac Territory and consent of the respective Third Party to such assignment and transfer, or (ii) such agreement shall remain with CureVac, and, in that case, on the involvement of GSK in the manufacturing of the relevant Products and the provision by GSK of regulatory services, pharmacovigilance services, quality and supply chain management services required by CureVac to meet its binding obligations under those agreements; the Option Exercise being conditioned upon GSK making a decision as between either (i) or (ii). If GSK elects that any agreement with any government or other authority shall remain with CureVac, any supply of an Optioned Product by CureVac pursuant to that agreement shall, if carried out under this Agreement, be carried out on the terms of a Distribution Agreement in accordance with the terms set out in Exhibit 6.2 (with references to the CureVac Territory replaced, where applicable, with references to the relevant GSK Territory covered by the relevant agreement with such government or other authority). For clarity, this Section 3.7.3b shall not apply in case CureVac elects that the Optioned Product shall be subject to the terms of the 2021 Collaboration Agreement.

3.7.4

Option Exercise Notice. If GSK intends to exercise its Exclusive Option, GSK shall send (at any time before the expiry of the Option Period) a written notice to CureVac identifying the Optioned Product that GSK seeks to Develop (“Option Request”). Within [*****] following receipt of the Option Request, the Antigen/Antibody List Rep will perform an LNP clearance in accordance with Section 3.4. Within [*****] following the request, the Parties will hold a JSC meeting for discussing the details of the envisaged collaboration, and CureVac will notify GSK of the amount of the Option Exercise Fee and will provide to GSK all data, documents and information reasonably required by GSK to assess whether it wishes to exercise its Exclusive Option with respect to the respective Optioned Product. GSK shall exercise its Exclusive Option by sending written notice to CureVac within [*****] following such JSC meeting (“Option Exercise Notice”). Following receipt of the Option Exercise Notice by CureVac, the Parties shall as soon as reasonably practicable work on an initial R&D Plan for the Optioned Product in accordance with Section 4.3.2, and CureVac shall secure the LNP License from the LNP Provider, or in case GSK exercises its option, from the Option LNP Provider.

 

3.7.5

Option Exercise Fee. If GSK exercises its Exclusive Option, GSK shall make the following payments to CureVac: (i) GSK shall compensate CureVac for all reasonable and demonstrable Development costs and expenses exclusively relating to such Optioned Product incurred by CureVac or its Affiliates since (and in respect of the period after) the Closing Date (including in case of an Optioned Product acquired by CureVac from a Third Party that portion of the fee paid to that Third Party that relates to the Optioned Product), provided, however, that with respect to any Optioned Product targeting [*****], the compensation by GSK shall also include the costs and expenses incurred by CureVac or any of its Affiliates before the Closing Date in the amount of EUR [*****]; and (ii) GSK shall pay to CureVac any milestone payments which would have been due since the Closing Date, if such Optioned Product had been an Other Product as at the Closing Date, if any (the payments under (i) and (ii) together, the “Option Exercise Fee”). The Option Exercise Fee is to be paid by GSK to CureVac within [*****] after receipt of an invoice from CureVac, with supportive documentation reasonably detailing the costs and expenses incurred by CureVac. By way of example: If GSK exercises its Exclusive Option for an Optioned Product under development by CureVac outside the scope of this Agreement for which CureVac has [*****] at the time GSK exercises its Exclusive Option, GSK shall reimburse CureVac for any reasonable, demonstrable and duly documented Development costs and expenses incurred by CureVac since (and in respect of the period after) the Closing Date and exclusively relating to such Optioned Product and, in addition, shall pay to CureVac accrued, non- refundable and non-creditable Development & Regulatory Milestone Payments in the amounts of [*****].

3.7.6

Option Exercise. Upon (i) receipt of an Option Exercise Notice by CureVac, (ii) full payment of the Option Exercise Fee from GSK to CureVac, and (iii) the Parties having agreed on an initial R&D Plan for the Optioned Product, the relevant Optioned Product shall become an additional Other Product. The Parties shall Develop such additional Optioned Product pursuant to Section 4.3.2, and, unless set forth otherwise, all terms and conditions relevant for the Development, Manufacture and Commercialization of Other Products shall apply to such Optioned Product (including licenses, milestone payments and royalties).

 

3.7.7

Exclusivity during Option Period. Subject to Section 3.7.8, CureVac’s obligations as set forth in items (ii) and (iii) of the Disclosure Letter, during the Option Period, CureVac shall not commercialize, and shall not grant any rights to a Third Party for the development or commercialization of any prophylactic or therapeutic mRNA-Based vaccine or mRNA-Based antibody targeting a Pathogen other than an Excluded Pathogen in the Field without GSK’s express, written waiver of its rights under the Exclusive Option, which GSK may grant or withhold in its sole discretion. For clarity, subject to Section 2.3.2, the Exclusive Option granted to GSK does not prevent CureVac from initiating or continuing internal Development programs for mRNA-Based vaccines or Antibodies.

 

3.7.8

Exception to Exclusivity for Pre-Pandemic Preparedness Activities. Section 3.7.7 shall not prevent or restrict CureVac from entering into agreements or arrangements with any supranational institution, national government, or any regional state or equivalent authority, or non-governmental organization pursuant to which CureVac provides pre-pandemic preparedness services in relation to any prophylactic or therapeutic mRNA-Based vaccines targeting any Pandemic Pathogen (other than SARS-CoV-2), comprising designing, developing and implementing rapid response vaccine solutions for use in health emergencies, including establishing “ever-warm” manufacturing facilities, development activities for vaccines targeting Pandemic Pathogens that are deemed a potential public health threat by the requesting government, supranational institution or non- governmental organization and the implementation of stockpiling and/or advance purchasing arrangements in connection with such vaccines.

 

4.	RESEARCH AND DEVELOPMENT COLLABORATION.

 

4.1	First Product.

 

The Parties shall collaborate on the further Development of the First Product. The initial Development plan for the First Product that the Parties will implement is attached hereto as Exhibit 4.1, and may be amended from time to time by the JSC in accordance with this Agreement (“First Product R&D Plan”). CureVac will complete preclinical validation and sponsor a Clinical Phase I Study of this First Product, unless the Parties agree on a different clinical Development approach within the JSC. Unless GSK replaces the Product in accordance with Section 3.6 or the Program is terminated, GSK will conduct all subsequent Development activities, including activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products. Each Party will perform the aforementioned activities in accordance with this Agreement and the First Product R&D Plan (as amended from time to time).

4.2	Second Product.

 

The Parties shall collaborate on the Development of the Second Product. The initial R&D Plan for the Second Product is attached hereto as Exhibit 4.2, and may be amended from time to time by the JSC in accordance with this Agreement (“Second Product R&D Plan”). Subject to the terms and conditions of this Agreement and in accordance with the Second Product R&D Plan, the Parties will perform the following Development activities in respect of the Second Product:

 

(i)

the Parties will collaborate on the Antigen design and the identification of the precise target;

 

(ii)

CureVac will perform the mRNA design and formulation and will conduct the pre-clinical validation;

 

(iii)

CureVac will sponsor a first Clinical Phase I Study, unless the Parties agree on a different clinical development approach within the JSC; and

 

(iv)

unless GSK replaces the Product in accordance with Section 3.6 or the Program is terminated, GSK will conduct all subsequent Development activities, including regulatory activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products.

 

4.3	Other Products.

 

4.3.1

Initial Other Product. The Parties shall collaborate on the Development of the Initial Other Products. An initial R&D Plan for each of these Products is attached hereto as Exhibit 4.3.1(A)- (C), and may be amended from time to time by the JSC in accordance with this Agreement (each, an “Other Product R&D Plan”). Subject to the terms and conditions of this Agreement and in accordance with the respective Other Product R&D Plan, the Parties will perform the following Development activities in respect of each of the Other Products:

 

(i)

the Parties will collaborate on the Antigen design and the identification of the precise target;

 

(ii)

CureVac will perform the mRNA design and formulation, and will conduct the pre-clinical validation; and

 

(iii)

CureVac will sponsor a first Clinical Phase I Study, unless in light of achieving the subsequent clinical development and Regulatory Approval of this Product expediently, the Parties agree on a different clinical development approach within the JSC; and

(iv)

unless GSK replaces the Product in accordance with Section 3.6 or the Program is terminated, GSK will conduct all subsequent Development activities, including regulatory activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products.

 

4.3.2

Subsequent Other Products. If GSK has exercised its (i) Replacement Right pursuant to Section 3.6, (ii) its Exclusive Option pursuant to Section 3.7, or (iii) the GSK COVID Continue Option or GSK Continue Option under the 2021 Collaboration Agreement, the Parties shall collaborate on the Development of such Replacement Product, Optioned Product or COVID Product, as applicable. As soon as reasonably practicable following the exercise of the Replacement Right, Exclusive Option, GSK COVID Continue Option or GSK Continue Option by GSK, as applicable, the Parties shall jointly work on an R&D Plan for such Replacement Product, Optioned Product or COVID Product, as applicable, and shall submit such draft R&D Plan to the JSC for approval. Following approval of such R&D Plan by the JSC, each Party shall perform the activities allocated to such Party under the respective R&D Plan. The Parties shall jointly work on the Development of such Product up to and including the Clinical Phase I Study and, unless the Program is terminated, GSK will conduct all subsequent Development activities, including activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products, all in accordance with this Agreement and the applicable R&D Plan.

 

4.4

Development Data, results and records. On a Program-by-Program basis, at such intervals as set forth in the applicable R&D Plan for the respective Program, or in the absence of any such provision in the applicable R&D Plan, at reasonable intervals, the Parties will make available to one another through formal reports for review and discussion within the JSC all Development Data and other results of the Development conducted pursuant to any Program, and will keep such records (paper and electronic) as described herein. The Parties will maintain records of the Development Data and other results in sufficient detail as required by Regulatory Authorities 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.

 

4.5

Development Funding. GSK shall, subject to the remainder of this Section 4.5, compensate CureVac for the Development Costs CureVac incurs performing the Development activities set forth in each R&D Plan (with FTE calculated at the FTE Rate) in accordance with the budget and assumptions as agreed under that R&D Plan. The Parties shall in good faith consider means of gaining efficiencies in the performance of the R&D Plans that have a positive impact on the associated budget, such as outsourcing of certain research activities to a subcontractor. The compensation is to be paid by GSK to CureVac on a Calendar Quarterly basis. GSK shall make payments to CureVac within [*****] after receipt of an invoice from CureVac, which CureVac shall provide on a Calendar Quarterly basis, with supportive documentation reasonably detailing the composition of the agreed budgeted cost (with FTE calculated at the FTE Rate) for the applicable Calendar Quarter period. CureVac shall notify GSK as soon as reasonably practicable in the event that it becomes aware that Development Costs are expected to deviate from the amounts approved in the Development budget, as a result of a change to the assumptions under the R&D Plan, whereupon the Parties shall discuss the causes of such deviation and evaluate potential mitigation measures relating thereto, and an appropriate adjustment (if any) to the Development budget. The Parties shall refer any Development budget increase amounting to greater than [*****] of the previously approved amount to the JSC for prior approval. Unless such budget increase is approved by the JSC, GSK shall not be liable to compensate any amounts to CureVac in excess of [*****] of the amount set out in the agreed Development budget from time to time. GSK shall not unreasonably withhold its approval to any budget increase which is reasonably required as a result of the change to a budgeting assumption set out in a R&D Plan.

4.6

Materials. CureVac will provide GSK with any CureVac Materials required for Development use in the Programs, including those which comprise, embody or incorporate CureVac Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the respective R&D Plan. GSK will provide CureVac with any GSK Materials required for research and Development use in the Programs, including those which comprise, embody or incorporate GSK Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the respective R&D Plan. GSK will use the CureVac Materials and CureVac will use the GSK Materials, as applicable (i) only 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”. Except as expressly set out in this Agreement, 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 expiry 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.

4.7

Know-How Transfer. As and when required in relation to an R&D Plan (and from time to time during the Term if new Know-How within the CureVac Know-How comes to be Controlled by CureVac) or as soon as reasonably practicable upon GSK’s request, CureVac shall (at its cost and expense) disclose and/or deliver to GSK copies of all Development Data and information in CureVac’s possession relating to the CureVac Know-How which is reasonably required for GSK’s Development activities in accordance with the respective R&D Plan (including for regulatory purposes) (“Development Transfer Materials”), with the exception, however, of all Know-How comprised in the CureVac Manufacturing Technology which shall be made available to GSK or its designee as set forth in Section 5.2.3. The technology transfer to be undertaken under this Section 4.7 and under Section 5.2.3 shall be overseen by the Joint Steering Committee. Any transfer of Know-How pursuant to this Section 4.7 shall be carried out on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Development Transfer Materials; (ii) the procurement by CureVac of the services of such qualified and experienced scientists and technicians, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Development Transfer Materials. Until completion of the transfer of the Development Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Development Transfer Materials.

 

4.8	Regulatory Approvals of Product.

 

4.8.1

Filing and Transfer of INDs. On a Product-by-Product basis, CureVac shall prepare and file INDs in accordance with the applicable R&D Plans. GSK shall have the right to review and comment on all such filings, and CureVac will take into good faith consideration any such comments provided by GSK within [*****] of GSK’s receipt of such draft filings. As soon as is reasonably practicable after the completion of the [*****] for a Product, and in accordance with the instructions of GSK, CureVac shall (or shall cause its Affiliate to) assign and transfer to GSK the IND for such Product, and all of CureVac’s and its Affiliates rights, interest and title therein, and GSK shall accept such assignment and transfer. GSK and CureVac each agree to use Diligent Efforts to take all actions required by a Regulatory Authority to effect the transfer of such IND and further agree to cooperate with each other in order to effectuate the foregoing transfer of such IND. At GSK’s direction, an IND may also occur by GSK’s filing of a new separate IND for the same Product, cross-referring to the first IND, followed by a later transfer and joining of the first IND, or by a close-out of the first IND. Following the transfer of the IND for a Product, GSK shall reimburse CureVac for all reasonable and demonstrable costs and expenses (including FTE costs at the FTE Rate) incurred by CureVac for the filing and transfer of that IND under the applicable R&D Plan. Until the transfer of an IND for a Product, CureVac shall be responsible for all regulatory interactions, including written communications and meetings with Regulatory Authorities, for any INDs filed by CureVac, provided that GSK shall have the right (i) to participate in meetings with Regulatory Authorities if permissible under Applicable Laws and/or (ii) to prepare and file INDs itself for any Product as set forth above. Furthermore, except in cases where this is not reasonably practicable, e.g. due to a deadline set by a Regulatory Authority, GSK shall have the right to review and comment on any written communications, and CureVac will take into good faith consideration any such comments provided by GSK.

4.8.2

Other Regulatory Filings. GSK has the sole right to prepare and file all new drug applications (or equivalents) and shall own all Regulatory Approvals and be responsible for all decisions in connection with the Regulatory Approvals for Products in the Field and in the Territory, subject to GSK’s diligence obligations under Section 4.10 and the rights granted to CureVac with respect to the Regulatory Approvals relevant for the CureVac Territory under Section 6 and the respective Distribution Agreement. With regard to CMC Development and Manufacturing, CureVac shall contribute the necessary sections for such filings, subject to review by GSK. On request by GSK, CureVac shall review and comment on all such filings and safety related documents, and GSK shall reimburse CureVac’s reasonable FTE costs incurred on account of GSK’s request at the FTE Rate. GSK will share with CureVac any regulatory filings before submission. CureVac shall cooperate in, and provide reasonable assistance to support, these efforts as reasonably requested by GSK. GSK shall provide CureVac with a final copy of each filing.

 

4.8.3

Communications. Subject to Sections 4.8.1 and 4.8.6, and subject to the rights and obligations of CureVac under Section 6 and the respective Distribution Agreement with respect to the Regulatory Approvals relevant for the CureVac Territory, GSK shall be responsible for all regulatory interactions, including written communications and meetings with Regulatory Authorities, and safety management, including the reporting to the appropriate governmental authorities of all adverse events and any other information concerning the safety of Products. GSK will, as part of its regular updates through the JSC, inform CureVac in writing of any material feedback from Regulatory Authorities relating to any Product. Furthermore, at CureVac’s request, GSK will provide copies of all Regulatory Approvals and material correspondence with Regulatory Authorities in the Major Markets relating to the Clinical Studies with respect to all Products to CureVac. CureVac shall have the right to participate as a silent observer in a meeting with Regulatory Authorities if and to the extent such meeting relates to the CureVac Technology. Furthermore, upon request of GSK, CureVac shall participate in a meeting with a Regulatory Authority, and GSK shall reimburse all of CureVac’s FTE costs (at the FTE Rate) and expenses incurred on account of GSK’s request.

 

4.8.4

Sharing of information. CureVac will reasonably support GSK, at GSK’s request at reasonable intervals (considering CureVac’s limited personnel resources), on all regulatory matters with respect to the Development and Commercialization of the Products, at GSK’s cost, including by providing data and documents as reasonably required for obtaining Regulatory Approvals and for interactions with Regulatory Authorities regarding the Products, provided that such documents and data will remain the property and Confidential Information of CureVac, and GSK will only use such documents and data in accordance with Section 11. CureVac, on receipt of a request of GSK shall provide to GSK a summary of the safety, reactogenicity and immunogenicity data resulting from the [*****]. Subject to Section 11, any First-Gen COVID Vaccine Products Dossiers/Data (as defined in the 2021 Collaboration Agreement) received from CureVac under the 2021 Collaboration Agreement shall be deemed Confidential Information of CureVac under this Agreement, and GSK may, notwithstanding any restriction under the 2021 Collaboration Agreement, use such data for the Development or Manufacture of Products under this Agreement.

4.8.5

Cross-referencing. To the extent required by GSK, or an Affiliate or Sublicensee of GSK to the Products, CureVac hereby authorizes GSK, its Affiliates and Sublicensees to cross reference to the sections of the regulatory dossiers of the clinical trials related to any other mRNA-Based product in the Field in development by CureVac or its Affiliates to the extent under the Control of CureVac. GSK shall notify CureVac in writing prior to any such cross-referencing. GSK will consider in good faith any request of CureVac or any of its Affiliates to authorize cross-referencing to the sections of the regulatory dossiers of the clinical trials related to the Products.

 

4.8.6

Pharmacovigilance. The Parties shall have in place and will maintain during the Term (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 notify 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 Products relating to risk management, drug safety and pharmacovigilance. The Parties shall negotiate in good faith and conclude a pharmacovigilance agreement within [*****] as of the Closing Date.

 

4.9

CureVac Development Diligence. Subject to GSK complying with its obligations under this Agreement, CureVac will conduct all Development activities assigned to it the R&D Plans in a timely manner and in accordance with the R&D Plan, and obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources as are reasonable and adequate to complete the R&D Plans.

 

4.10	GSK Development and Regulatory Diligence. Subject to CureVac complying with its obligations under this Agreement, GSK will:

 

(i)

conduct all Development activities assigned to it in the R&D Plans, progress the Products into the next appropriate Clinical Study, and obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources as reasonably required to complete the R&D Plans; and

 

(ii)

use its Diligent Efforts to secure biologics licensure by the FDA and marketing authorization by EMA following completion of all appropriate Clinical Studies.

 

4.11

Use of GSK Technology. Subject to the terms and conditions of this Agreement, GSK hereby grants to CureVac, and CureVac accepts, a royalty-free, non-exclusive, license (with the right to sub-license in accordance with Section 4.12) to use the GSK Technology for performing the Development and Manufacturing activities allocated to CureVac under this Agreement (and, subject to the terms of each Ancillary Agreement, under the Ancillary Agreements).

4.12	Right to Sublicense. CureVac shall have the right to sublicense its rights under Section 4.11 to any of its Affiliates, but not to any Third Party, subject only to the right to subcontract as set forth under Section 4.13 below.

 

4.13

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 Party shall remain liable to the other Party for any act or omission of its subcontractor.

 

5.	MANUFACTURING AND COMMERCIALIZATION.

 

5.1

Manufacturing Facility. CureVac shall plan and carry out the completion of the installation and Regulatory Approval of the GMP-IV Manufacturing Facility, with two Drug Substance production lines each with a targeted scale up of five times compared to the current production process established at the GMP-III Manufacturing Facility and targeting a Drug Substance batch size of [*****] and the production of [*****] per year, at its own cost, due for completion by the Initiation of the [*****]. Furthermore, CureVac shall use Diligent Efforts to complete by the same date: (i) in-sourcing and process development of the Drug Product formulation process, including the LNP Technology; (ii) in- sourcing of the capability to produce DNA plasmids using the pDNA technology; and (iii) development of the supply chain for sourcing critical raw materials (the “Manufacturing Facility Enhancements”); provided that if the Parties agree in good faith that a CMO would be better suited to perform any of the activities under (i) and (ii), GSK shall relieve CureVac from its obligations with respect to (i) and/or (ii), as applicable, and provided further that the only and exclusive remedy in case of a breach by CureVac of its obligations to use Diligent Efforts to complete the Manufacturing Facility Enhancements under this Section 5.1 shall be that CureVac covers the costs for a bridging study in humans, if required solely as a result of such breach by CureVac, in the maximum amount of EUR [*****]. Subject to Section 5.2, up to once per quarter, GSK shall have the right to request and assess the plans proposed by CureVac regarding the foregoing and to monitor the progress, provided that, if and to the extent it is necessary for GSK to undertake an on- site visit for this purpose, GSK shall not be permitted to do so more than twice per Calendar Year. GSK may, where relevant and at its discretion, suggest appropriate improvements and provide additional support in connection with enhancement of the Manufacturing Process for Drug Product and the installation of the GMP-IV Manufacturing Facility, which CureVac may freely decide to implement or not. CureVac will reasonably consider to use the [*****] for the Manufacture of the Products; it being understood and agreed between the Parties that GSK may not request the disclosure of any Know-How or any technology transfer from CureVac with respect to the [*****] other than to the extent necessary for any Regulatory Filing for a Product.

5.2

GSK Consultancy. GSK’s assessment and suggestions with respect to enhancements and capacity expansion of Manufacturing of Drug Product in the GMP Manufacturing Facility will be according to GSK’s best understanding at that time of the applicable requirements, practice and quality standards. In no circumstances shall GSK be liable in case of a discrepancy between the plans assessed by GSK and applicable standards, or a competent Regulatory Authority’s disagreement with the proposed plans or a recommendation provided by GSK, nor if CureVac fails to correctly implement the GSK recommendations. Any consultancy provided by GSK under Section 5.1 shall be limited to providing advice and guidance, but shall exclude any activities regarding the actual implementation of such advice or guidance, which shall be CureVac’s sole responsibility.

 

5.2.1

Clinical Supply. All doses of Products required for use by GSK in accordance with this Agreement for the Development of Products (including for Clinical Studies) shall be Manufactured and supplied by CureVac or its Affiliates, as Drug Product filled in vials (without labelling and packaging or with labels agreed upon by GSK) for use in the Clinical Studies, whereby Drug Product must in each case be Manufactured by CureVac or its Affiliates at a GMP Manufacturing Facility and filling may be subcontracted to a CMO, each in accordance with GMP and Applicable Laws and the terms and conditions of one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) to be negotiated and agreed between GSK and either or both CureVac, the CureVac Affiliate and/or CMO supplying the Products to GSK, no later than [*****] after the Closing Date, and in accordance with the terms and conditions set forth in Exhibit 5.2.1(B). CureVac and its Affiliates will reserve the required capacity for the Manufacture of Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s).

 

5.2.2

Commercial Supply. On a Product-by-Product basis, upon the request of GSK, but in any case no later than the [*****] for the respective Product, GSK and CureVac, or the CureVac Affiliate supplying Drug Product to GSK, will negotiate and agree in good faith on a commercial supply agreement (each a “Commercial Supply Agreement”) with respect to such Product (including a Quality Agreement) according to which CureVac or its Affiliates will Manufacture or have Manufactured for GSK, GSK’s demand for bulk of Drug Product in accordance the terms and conditions set forth in Exhibit 5.2.1(A). CureVac shall reserve, or shall procure that its Affiliates will reserve, [*****] of the annual batch capacity of the GMP-IV Manufacturing Facility for the Manufacture of bulk of Drug Product on behalf of GSK for supply in the Territory in accordance with the Commercial Supply Agreements.

5.2.3

Manufacture by GSK. Upon the request of GSK, CureVac shall transfer all Know-How comprised in the CureVac Manufacturing Technology (“Manufacturing Technology Transfer Materials”) to GSK, an Affiliate of GSK or the Third Party CMO designated by GSK and approved by CureVac, as applicable, so that GSK itself, the Affiliate of GSK or the appointed Third Party CMO (approved by CureVac), as applicable, can take over the Manufacture for GSK. In the event of a technology transfer, the JSC shall establish a Manufacturing tech-transfer sub-committee, which shall oversee the Manufacturing technology transfer. GSK will compensate CureVac or, if applicable, its CMO, for such technology transfer provided by CureVac and/or its CMO FTE at the FTE Rate. CureVac’s obligation to reserve [*****] of CureVac’s GMP-IV Manufacturing Facility shall reduce proportionately, on a country-by-country basis, as GSK (or the appointed Third Party CMO) obtains Regulatory Approval for the Manufacture of the Products following completion of the Manufacturing technology transfer, provided that GSK shall in such case use Diligent Efforts to obtain such Regulatory Approval as soon as reasonably practicable, prioritizing the countries with the highest demand for Product, and provided further that CureVac’s obligation to reserve capacity shall terminate in any event [*****] after the completion of the technology transfer. Any transfer of Know-How pursuant to this Section 5.2.3 shall be carried on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Manufacturing Technology Transfer Materials; (ii) the procurement by CureVac of the services of such qualified and experienced scientists, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Manufacturing Technology Transfer Materials; and (iii) the provision by CureVac to the personnel of GSK or its Affiliate with reasonable access to its facilities to observe the Manufacture at such times as the Parties may agree; provided such access shall be coordinated in a manner to minimize the disruption of CureVac’s activities and CureVac may require any personnel of a Third Party with access to its facilities to sign a confidentiality agreement and to abide by the rules and guidelines applicable to the CureVac facility. Until the completion of the transfer of the Manufacturing Technology Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Manufacturing Technology Transfer Materials.

 

5.3

Commercialization of Products; Diligence. Subject to the terms and conditions of this Agreement, GSK shall have the rights and the responsibility, and shall bear all costs associated with the Commercialization of Products in the Field in the GSK Territory. Unless terminated or replaced in accordance with this Agreement, GSK will use Diligent Efforts to Commercialize: (i) the First Product, (ii) the Second Product, (iii) each of the Initial Other Products, and (iv) each Replacement Product and each Optioned Product, as applicable, in each case of (i), (ii), (iii) and (iv) in the Field and in the Major Markets (other than Germany, unless waived by CureVac pursuant to Section 6.1) (subject to obtaining Regulatory Approval in the relevant Major Market). Without limiting the generality of the Diligent Efforts obligations under this Section 5.3, GSK shall:

 

(i)

on a Product-by- Product basis make the First Commercial Sale of a Product in a country as soon as reasonably practicable following the issuance of the Regulatory Approval for such Product in such country;

 

(ii)

in addition to the royalty reports provided by GSK to CureVac under Section 8.7, beginning with the First Commercial Sale of the first Product in the Territory and continuing until expiry of the Royalty Term, provide CureVac, at least once annually by March 31 of each Calendar Year, with a confidential, non-binding sales forecast for that Calendar Year for discussion in the JSC (or the commercialization sub-committee, as applicable) of the estimated aggregate (x) sales of Products in the GSK Territory and (y) sales of Products in each Major Market, provided that GSK shall not be required to provide supporting materials in relation to such forecast.

5.4

CureVac Resources: CureVac shall obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources necessary to meet its obligations under this Section 5, in accordance with the timelines specified in and in accordance with this Section 5.

 

6.	COMMERCIALIZATION OF PRODUCTS IN THE CUREVAC TERRITORY.

 

6.1

Commercialization in CureVac Territory. CureVac shall have the sole and exclusive right to Commercialize the Products in the Field in the CureVac Territory. On a Product-by-Product basis, until the execution of a Distribution Agreement between the Parties under Section 6.2 for a Product, CureVac shall have the right to waive its right to Commercialize such Product in the CureVac Territory by giving written notice to GSK. Upon receipt of such waiver notice by GSK, with respect to the respective Product, the CureVac Territory shall become part of the GSK Territory, and GSK shall have the right to Commercialize the Product in such extended GSK Territory, and the obligation to use Diligent Efforts to Commercialize the Product in Germany, subject to and in accordance with the terms and conditions of this Agreement.

 

6.2

Distribution Agreement. On a Product-by-Product basis, upon request of CureVac, but no later than [*****] prior to the estimated First Commercial Sale of the respective Product in the Field in the CureVac Territory, the Parties shall negotiate and agree in good faith on a distribution agreement under which CureVac has the exclusive rights to Commercialize such Product in the Field in the CureVac Territory in accordance with the terms and conditions set forth in the key distribution terms in Exhibit 6.2 (“Distribution Agreement”). CureVac shall comply with all policies, practices, standards, guidelines, codes and requirements generally inferred by the GlaxoSmithKline group on distributors of its products in the CureVac Territory, which shall be further detailed in the Distribution Agreement and compliance with which shall be subject to audit by GSK as specified in the Distribution Agreement.

 

7.	GOVERNANCE.

 

7.1	Management.

 

7.1.1

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 Closing Date for CureVac (“CureVac Alliance Manager”) and of the individual designated in writing within [*****] of the Closing Date for GSK (“GSK Alliance Manager”, and together with the CureVac Alliance Manager, 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.

7.1.2

Program Management. On a R&D Plan-by-R&D Plan basis, the management of the activities under the Programs will be under the responsibility of the individual designated in writing within [*****] of the Closing Date for CureVac (“CureVac Project Leader”) and of the individual designated in writing within [*****] of the Closing Date for GSK (“GSK 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 R&D Plan.

 

7.2	Joint Steering Committee.

 

7.2.1

Establishment. Within [*****] after the Closing Date the Parties will establish a joint steering committee (“Joint Steering Committee” or “JSC”) to oversee the Development, Manufacture and Commercialization of the Products and to facilitate the exchange of information between the Parties. The JSC shall be comprised of two (2) representatives of CureVac and two (2) representatives of GSK, one representative being the Alliance Manager of the respective Party, in each case with appropriate scientific and technical expertise and sufficient seniority within the applicable Party consistent with the scope of the JSC’s responsibilities. Each Party may replace its JSC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts (obligation de moyen) to ensure continuity on the JSC.

 

7.2.2

JSC Meetings. The JSC shall meet at least on a quarterly basis, or such other frequency as agreed by the Parties, by teleconference, videoconference or in person, provided that at least every [*****] or such other frequency as agreed by the Parties, the meeting shall be in person (which in- person meeting will be held at alternate facilities of each Party), unless agreed otherwise by the JSC representatives The JSC will have a quorum if at least one (1) representatives of each Party is present or participating. Each Party will be responsible for all of its own expenses of participating in the JSC meetings. The Parties will endeavor to schedule meetings of the JSC at least [*****] in advance. Each Party may call special meetings of the JSC 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 JSC. Each Party may invite guest participants to certain items on the agenda of the meetings, with reasonable prior notice, in order to discuss special technical or commercial topics, provided that such guest participants shall be bound by confidentiality and non-use obligations consistent with the terms of this Agreement and shall not have a voting right in such meeting. The chair of the JSC will alternate each Calendar Year, with CureVac to chair the first year. The Party chairing the JSC shall prepare the meeting agenda with input from the other Party.

 

7.2.3

JSC Minutes. The Alliance Manager of the Party chairing the JSC shall record the minutes of each JSC 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

 

 

7.3

JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the Products. The JSC has (i) no jurisdiction 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 JSC will include:

 

(i)

overseeing the Development of Products in accordance with the R&D Plans;

 

(ii)

reviewing and approving the R&D Plans in relation to a Product Adjustment, Replacement Product or an Optioned Product;

 

(iii)

updating the initial R&D Plans to include the further Development work and discussing and approving the annual Development budgets under the R&D Plans;

 

(iv)

the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the R&D Plans, including but not limited to modifications of the budget and timelines;

 

(v)

receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each Product summarizing their 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;

 

(vi)

exchanging Development Data and other technical information;

 

(vii)

upon GSK’s request, serving as a forum where CureVac shall inform GSK of new internal development programs covered by GSK’s Exclusive Option;

 

(vii)

upon GSK’s request, serving as a forum where CureVac shall inform GSK of new internal development programs covered by GSK’s Exclusive Option;

 

(viii)

creating sub-committees, including the IP Sub-Committee pursuant to Section 7.4, a Commercialization sub-committee for the coordination of Commercialization activities for Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing Product-related and/or Product-related Manufacturing and supply;

(ix)

serving as a forum where each Party shall inform the other Party of any material feedback received from Regulatory Authorities in relation to any Product;

 

(x)

informing on material regulatory filings and regulatory interactions related to the Products; (xi) fostering the collaborative relationship between the Parties;

 

(xii)

resolving disputes between the Parties; and

 

(xiii)

such other functions as agreed by the Parties.

 

If the JSC establishes a sub-committee in accordance with this Section 7.3, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee.

 

In line with the completion of the Programs, the Parties shall, within the JSC, in good faith evolve the composition and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the Products.

 

7.4

IP Sub-Committee. Within [*****] of the Closing Date the JSC shall establish an IP Sub-Committee comprising up to two patent attorneys of each Party. The IP Sub- Committee shall be the forum for discussion and liaison between the Parties concerning filings to be made for Program Patent Rights and Joint Patent Rights. For the avoidance of doubt, the IP Sub- Committee is not a decision-making forum, except (in the first instance) with respect to matters concerning the maintenance of the Program Patent Rights and Joint Patent Rights, and, in relation to the Program Patent Rights and Joint Patent Rights, the patent term extension strategy, patent litigation, patent defense and enforcement, but serves as a forum for discussion where the Parties may coordinate and consult with each other with respect to any such filings. The IP Sub-Committee shall in particular: (i) convene no less than once every [*****] to facilitate regular interaction regarding the intellectual property matters arising from this Agreement (or any Ancillary Agreement); (ii) exchange information necessary to keep the Parties reasonably informed of each other’s prosecution of patents and trademarks that form part of the intellectual property rights licensed under this Agreement; (iii) review any Invention arising under a Program (including any Joint Product Invention and Joint Other Invention) and determine in good faith the ownership thereof, in accordance with this Agreement; (iv) coordinate intellectual property aspects of publications or presentation of Development Data, in accordance with Section 11.7; (v) cooperatively review and discuss potential material infringements by Third Parties as well as the potential infringement by either Party or its Affiliates of any intellectual property of a Third Party pursuant to Development, Manufacturing or Commercialization under this Agreement; and (vi) escalate any intellectual property-related issue on which the Parties are not in agreement to the JSC.

7.5	JSC Decisions.

 

7.5.1

Initial Dispute Resolution. Actions to be taken by the JSC and any subcommittee shall be taken only following a unanimous vote, with each Party’s representatives collectively having one (1) vote. If any subcommittee fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****] the matter shall be referred to the JSC.

 

7.5.2

Final Decision-Making.

 

a.

If the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****] the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] and attempt to resolve such matter in good faith.

 

b.

If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting, the final decision on such undecided matter shall be made by GSK in good faith with the following exceptions:

 

(i)

GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments to an R&D Plan (including the budget and the number of FTEs agreed in the R&D Plan) which have an adverse impact on CureVac, adopt a decision that would cause significant delay of the Development timelines as set forth in an R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or an R&D Plan;

 

(ii)

without limiting any right of GSK at law, GSK shall not unilaterally decide on any matter concerning Joint Patent Rights, Joint Product Inventions or Joint Other Inventions, with the exception of decisions relating to (i) obtaining and maintaining supplementary protection certificates (ii) enforcement against Third Parties in the Territory within the Field in accordance with Section 10;

 

(iii)

GSK shall not unilaterally decide any matter with respect to the CMC Development and, for so long as CureVac Manufactures a Product under this Agreement, Manufacture of that Product; and

 

(iv)

GSK shall not unilaterally alter or amend the terms and conditions of this Agreement and shall have no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement.

 

7.6

Information and results. Except as otherwise provided in this Agreement, the Parties will make available and disclose to one another Development Data and other results of work conducted pursuant to each Program prior to and in preparation for the JSC meetings, by the deadline and in the level of detail, form and format to be designated by the JSC; 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 JSC meeting.

8.	CONSIDERATION AND PAYMENTS.

 

8.1

Upfront Payment. In partial consideration for the exclusive licenses granted to GSK under the CureVac Technology, GSK shall pay to CureVac a non-refundable and non-creditable fee in the amount of one hundred and twenty million Euro (EUR 120,000,000) within [*****] after GSK’s receipt of an invoice of the respective amount from CureVac.

 

8.2

GMP-IV Reservation Fee. In consideration for the reservation of Manufacturing capacity in the GMP-IV Manufacturing Facility pursuant to Section 5.2.2, GSK shall pay to CureVac a non- refundable fee in the amount of thirty million Euro (EUR 30,000,000) upon [*****] (“GMP-IV Reservation Fee”). Such payment shall be made within [*****] after GSK’s receipt of an invoice of the respective amount from CureVac. GSK may credit:

 

(i)

ten million Euro (EUR 10 million) against [*****],

 

(ii)

ten million Euro (EUR 10 million) against [*****]; and

 

(iii)

ten million Euro (EUR 10 million) against [*****].

 

8.3

Development and Regulatory Milestone Payments. In consideration for the exclusive licenses granted to GSK under the CureVac Technology, on a Product-by-Product basis, GSK shall pay to CureVac the one-time, non-refundable, non-creditable development milestone payments set forth in this Section 8.3 (each a “Development & Regulatory Milestone Payment”) upon the first occurrence of the applicable milestone event with respect to any Product, provided that each such milestone payment shall be due only once for each Product (each a “Development & Regulatory Milestone Event”). On a Product-by-Product basis, if any one of the Development & Regulatory Milestone Events is not required for the Development of a Product, such Development & Regulatory Milestone Payment shall become payable upon achieving the Development & Regulatory Milestone Event following the Development & Regulatory Milestone Event which was not required, i.e., upon the achievement of such following Development & Regulatory Milestone Event two Development & Regulatory Milestone Payments become payable hereunder.

8.3.1

First Product. The following Development & Regulatory Milestone Payments shall be made for the First Product:

 

Development & Regulatory Milestone Event		In EUR million
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

8.3.2

Second Product and Other Products. The following Development & Regulatory Milestone Payments shall be made for the Second Product and for each Other Product (including any Replacement Product and Optioned Product):

 

Development & Regulatory Milestone Event		In EUR million
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

8.4

Sales Milestone Payments. In consideration for the licenses granted to GSK under the CureVac Technology and the LNP Technology, on a Product-by- Product basis, GSK shall pay to CureVac each of the non-refundable, non-creditable milestone payments set forth in this Section 8.4 (each a “Sales Milestone Payment”) for the Calendar Year in which aggregated annual Net Sales in the GSK Territory of all Products developed from the respective Product meet or exceed for the first time the thresholds set forth below (each a “Sales Milestone Payment”).

 

8.4.1

First Product. The following Sales Milestone Payments shall be made for the First Product:

 

Sales Milestone Event		In EUR million
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

8.4.2

Second Product and Other Products. The following Sales Milestone Payments shall be made for the Second Product and for each of the Other Products (including any Replacement Product and Optioned Product):

Sales Milestone Event		In EUR million
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

8.5	Obligation to Inform. GSK shall notify CureVac on the occurrence of a milestone event under Sections 8.3 and 8.4 (other than the milestone events under the control of CureVac) as soon as possible but in any event within [*****] after becoming aware of the occurrence of the relevant milestone.

 

8.6

Milestone Payment Terms. Each milestone payment shall be due and payable within [*****] after the receipt of the respective invoice by GSK. 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.

 

8.7	Royalties.

 

8.7.1

Royalty Rates. As further consideration for the rights and licenses granted by CureVac to GSK to the CureVac Technology and the LNP Technology under this Agreement, GSK shall pay royalties to CureVac in the amounts set forth below:

 

(i)

First Product. GSK shall pay to CureVac the following royalties on Net Sales in each Calendar Quarter in the GSK Territory of all Products developed from the First Product in the amounts set forth below:

 

Annual Net Sales of First Product		Royalty Rate
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

First Product shall include any Product with the same Antigen composition as Developed under the same Program, even if such Product is sold under a different label. For illustration purposes, if the First Product is approved in certain countries for an indication or use associated only with the Second Product, the Net Sales for such Product will still be Net Sales of the First Product.

(ii)

Second Product. GSK shall pay to CureVac the following royalties on Net Sales in each Calendar Quarter in the GSK Territory of all Products developed from the Second Product in the amounts set forth below:

 

Annual Net Sales of Second Product		Royalty Rate
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

(iii)

Other Products. On a Product-by-Product basis, for each Other Product (including any Replacement Product and Optioned Product), GSK shall pay to CureVac the following royalties on Net Sales in each Calendar Quarter in the GSK Territory of all Products developed from the respective Other Product in the amounts set forth below:

 

Aggregate annual Net Sales of all Products developed from an Other Product		Royalty Rate
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

 

8.7.2

Royalty Term. On a country-by-country and Product-by-Product basis, GSK’s royalty obligations as set forth in this Section 8.7 shall begin with the First Commercial Sale of such Product in such country, and shall expire upon the later to occur of:

(i)

the expiry of the last to expire Valid Claim of any Patent Rights Controlled by CureVac (whether alone or jointly with GSK or a Third Party) Covering such Product in such country;

 

(i)

the earlier of (A) expiry of Regulatory Exclusivity for such Product in such country and (B) twelve (12) years following the First Commercial Sale of such Product in such country; or

 

(ii)

ten (10) years following the First Commercial Sale of such Product in such country, provided that such Product incorporates CureVac Know-How or CureVac Know-How is required to Develop, Manufacture and/or Commercialize the Product in such country,

 

and provided further that GSK’s royalty obligations under this Section 8.7 with respect to a Product shall expire for all countries of the GSK Territory on the twentieth (20^th) anniversary of the First Commercial Sale of such Product in the first country of the GSK Territory (the “Royalty Term”).

 

8.7.3

Know-How Reduction. During the applicable Royalty Term and on a country-by-country and Product-by- Product basis, the royalty rate for a Product in a country shall be reduced by [*****] of the applicable rate determined pursuant to Section 8.7.1, if such Product is not or no longer Covered by a Valid Claim in such country.

 

8.7.4

Exhaustiveness. Except as set forth otherwise in this Agreement, the Royalty shall be the exhaustive consideration for the maintenance by CureVac of the CureVac Technology, and CureVac shall be responsible for the payment of any royalties, fees, costs or expenses under the In-Licensing Agreements.

 

8.7.5

Third Party Offset. Without limiting any other right or remedy of GSK under this Agreement, or any obligation of CureVac, on a country-by-country and Product-by- Product basis, if, during the Term, GSK or any of its Affiliates is required to obtain a license under certain Third Party Patent Rights to obtain freedom to operate with respect to the use or exploitation of any CureVac Elements for the Development, Manufacture and Commercialization of Products under this Agreement and to pay a royalty or other consideration under such license (including milestone payments or any payment in connection with the settlement of a patent infringement claim), then the Parties shall discuss obtaining an FTO license in accordance with Section 10.14. Royalties due to CureVac for the respective Product in the respective country(ies) Covered by the Third Party Patent Rights in- licensed by GSK to obtain at its discretion freedom to operate under this Section 8.7.5 shall, subject to Section 8.7.6, be reduced by: (i) [*****] of the reasonable amount payable by GSK to the Third Party for licenses required in respect of the Patent Right listed in Exhibit 8.7.5 relevant to the Initial Products; and (ii) and [*****] of the amount payable by GSK to the Third Party for any other licenses. For the avoidance of doubt, chemically modified mRNA will not be used by CureVac under this Agreement, and CureVac will therefore not be responsible for, and will not bear any payments to Third Parties with respect to such chemically modified mRNA.

 

8.7.6

Cumulative Deductions. Notwithstanding the above, any royalty reduction made pursuant to Section 8.7.3 and/or Section 8.7.5 shall in no event reduce the applicable royalty rate for the respective Finished Product in the respective country to less than [*****] of the amounts determined pursuant to Section 8.7.1.

8.7.7

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 and the LNP Technology licensed hereunder may justify royalty rates for sales of Products in the GSK Territory in different amounts, which rates could be applied separately to Products involving the exercise of CureVac Technology and the Licensed LNP (namely in a ratio of [*****]). Furthermore, 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 GSK Territory, which rates could be applied separately to Products involving the exercise of CureVac Patent Rights in the GSK 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 GSK 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 8.7.7 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.

 

8.7.8

Royalty Payments. Within [*****] after the end of each Calendar Quarter in which any Net Sales occur, GSK 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 GSK Territory into the currency of Euro, using the monthly exchange rates as customarily used by GSK. All costs and expenses shall be computed by converting the relevant costs and expenses into the currency of Euro, using the monthly exchange rates as customarily used by GSK.

 

8.8

Reports. Each royalty payment shall be accompanied by a written report describing the Net Sales of each Product sold by or on behalf of GSK, its Affiliates and Sublicensees during the applicable Calendar Quarter for each country in which sales of any Product occurred, specifying: (i) 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; (ii) the applicable exchange rate to convert from each country’s currency to Euro; and (iii) the royalties payable in Euro. All costs and expenses invoiced by CureVac shall be accompanied by a detailed breakdown of those costs and expenses, together with the applicable exchange rate to convert from the currency in which the costs and expenses were incurred to Euro.

 

8.9

Records and Audit. Each Party and its Affiliates and/or its Sublicensees shall keep and maintain records of: (i) in the case of GSK, sales of the Product(s) so that the royalties payable and the royalty reports may be verified; and (ii) in the case of CureVac, all costs and expenses incurred by it which are reimbursable under this Agreement, so that the costs and expenses reimbursable may be verified, and, where applicable, decisions and communications relating to the operation of the clearance process as set out in Section 3.5.1 to the extent carried out by CureVac or its external counsel. 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 the auditing Party and retained at the auditing Party’s expense. Said accountant shall have the right to audit the records kept pursuant to this Agreement for a period covering not more than [*****]. If said examination of records reveals any underpayment(s) or over payment(s) of any amounts payable, then the audited Party shall promptly pay or credit the balance due to the auditing Party, and if the underpayment(s) or overpayment(s) is/are more than [*****] then the audited Party shall also bear the expenses of said accountant (and if no further payments are due, shall be refunded or paid by the audited at the request of the auditing Party).

8.10	Payment Terms.

 

8.10.1

All payments by GSK to CureVac shall be made by wire transfer payment in Euro and shall be remitted to the following bank account:

 

[*****]:

 

Invoices shall be issued to GSK on a Program-by-Program basis. Electronic invoicing is GSK’s preferred method for receiving invoices. [*****] is GSK’s e-invoicing partner for submitting electronic invoices. The Parties shall collaborate to sign CureVac up to such platform to allow for electronic invoicing.

 

All invoices should include the following information: Invoice Date, Number and Amount; Sender’s Address, and Phone Number; Purchase Order Number; Tax Identification Number; Agreement Reference No (if applicable).

 

8.10.2

If any sum payable by GSK under this Agreement is subject to a good faith dispute between GSK and CureVac: (i) GSK shall, pay to CureVac, by the due date, all amounts not disputed in good faith by GSK; (ii) GSK shall notify CureVac, within [*****] after the due date, of any disputed amounts and shall, as soon as reasonably practicable after it has provided that notification, describe in reasonable detail its reasons for disputing each amount; and (iii) the Parties shall seek to resolve the dispute in accordance with Section 16.5. When any dispute regarding the amounts payable under this Agreement is resolved, GSK shall pay any sum which is agreed or determined (in accordance with Section 16.5) to be payable by GSK within [*****] after the date of resolution of that dispute (or such other period as is agreed between the Parties or determined by arbitration pursuant to Section 16.5), plus interest thereon at the interest rate set forth in Section 8.10.3 from the time such payment was due.

8.10.3

Any undisputed payments not paid within [*****] after the due date under this Agreement shall bear interest at an annual rate of [*****] above the three-month- EURIBOR 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).

 

8.11

Taxes.

 

8.11.1

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. The Parties agree, in accordance with Section 16.10, that the relationship between the parties is one of independent contractors and does not constitute a partnership or joint venture, and agree not to take (or cause any person to take) any position on any tax return or in the course of any audit, examination or other proceeding inconsistent with such treatment, unless otherwise required by Applicable Laws and except upon a final determination of the applicable tax authority.

 

8.11.2

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.

 

8.11.3

If any taxes are required to be withheld under Applicable Laws, from any payment to be made by GSK to CureVac under this Agreement, GSK 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. For purposes of this Section 8.11.3, each Party shall provide the other with reasonably requested assistance which assistance includes provision of any tax forms and other information that may be reasonably necessary for GSK or CureVac not to withhold tax.

 

8.11.4

All payments due to the terms of this Agreement are expressed to be exclusive of VAT and Indirect Taxes. VAT and Indirect Taxes shall be added to the payments due to the terms if legally applicable.

 

9.	INTELLECTUAL PROPERTY.

 

9.1

Background Technology. As between the Parties, all right, title and interest in and to all CureVac Patent Rights and CureVac Know-How Controlled by CureVac at the Effective Date or generated or acquired by or on behalf of CureVac during the Term outside the scope of this Agreement (“CureVac Background Technology”) shall remain under the Control of CureVac; and all right, title and interest in and to all Patent Rights and Know-How Controlled by GSK at the Effective Date or generated or acquired by or on behalf of GSK during the Term outside the scope of this Agreement (“GSK Background Technology”) shall remain under the Control of GSK. 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 GSK in the prosecution, maintenance and defense of the CureVac Patent Rights within CureVac Background Technology.

9.2

Disclosure of Inventions. During the Research Period, on a Product-by-Product basis, each Party shall as soon as reasonably practical disclose to the other Party (including representatives of the IP Sub-Committee), the discovery, 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 (including representatives 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 9.

 

9.3

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, and CureVac and GSK will notify each other and determine in good faith which of the below categories such Invention falls within:

 

9.3.1

CureVac Inventions. Subject to Section 9.3.3, CureVac shall own all right, title and interest in and to

 

(i)

all Inventions that are invented by or on behalf of CureVac or GSK (or jointly by CureVac and GSK) and improve the CureVac Background Technology (other than any intellectual property rights subsisting in a Product), the LNP Technology or the CureVac Elements, and cannot be practiced independently of such CureVac Background Technology, the LNP Technology or the CureVac Elements, as applicable, and such Inventions shall become part of the CureVac Background Technology or the LNP Technology, as applicable;

 

(ii)

subject to Section 9.3.1(i), all Inventions that are invented as part of the GSK consultancy under Section 5.1 or 5.2 by or on behalf of CureVac or GSK (or jointly by CureVac and GSK) as long as, and to the extent that, CureVac or its Affiliates Manufacture the Products, and are involved, used or exploited in the Manufacture of the Products and/or CMC Development Data;

 

(iv)

subject to Section 9.3.2(i), all Inventions that are invented by or on behalf of CureVac, alone or in collaboration with a Third Party (each, a “CureVac Invention”).

 

9.3.2

GSK Inventions. Subject to Section 9.3.3, GSK shall own all right, title and interest in and to

 

(i)

all Inventions that are invented by or on behalf of GSK or CureVac (or jointly by GSK and CureVac) and improve the subject matter of any GSK Background Technology, and cannot be practiced independently of such GSK Background Technology, and such Inventions shall become part of the GSK Background Technology; and

(ii)

subject to Sections 9.3.1(i), (ii) and (iii), all Inventions that are invented by or on behalf of GSK, alone or in collaboration with a Third Party (each, a “GSK Invention”).

 

9.3.3

Joint Product Inventions. All Inventions that are invented by or on behalf of GSK and/or CureVac that are incorporated in any Product shall be jointly owned by the Parties (a “Joint Product Invention”).

 

9.3.4

Other Inventions. With respect to all other Inventions that do not fall within the categories described in Sections 9.3.1, 9.3.2 or 9.3.3, each Party shall own the Inventions invented solely by or on behalf of such Party (and such other Inventions shall become part of the CureVac Inventions or the GSK Inventions, as applicable), and all Inventions jointly invented by or on behalf of the Parties shall be jointly owned by the Parties (each, a “Joint Other Invention”).

 

9.3.5

Cross-Licenses under Joint Other Inventions. Except to the extent either Party is restricted by other terms of this Agreement, either Party may freely practice, exploit and license to Affiliates its interest in the Joint Other Inventions, and any resulting Joint Patent Rights and related Know-How, in connection with the use or exploitation of the respective Party’s Background Technology and any consent or license from the other Party as may be required under Applicable Law for a Party to practice and exploit such Joint Other Inventions, Joint Patent Rights and related Know-How in connection with the use or exploitation of the respective Party’s Background Technology shall hereby be given by the other Party. Without limiting the exclusive rights granted to CureVac pursuant to Section 15.4e, CureVac hereby grants to GSK, and GSK accepts, a perpetual, irrevocable, royalty-free, non-exclusive license to freely practice and exploit (including sublicensing to Affiliates, but not to Third Parties) all intellectual property rights owned by CureVac pursuant to Sections 9.3.1(ii) that are invented by or on behalf of GSK (or together with a Third Party), or jointly by CureVac and GSK.

 

9.4

Assignment and transfer of Inventions. To give effect to the ownership principles described in Section 9.3 each Party shall assign and transfer, and hereby assigns and transfers, to such other Party or such other Party’s designee all or a [*****] share, 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 9.3, 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 9.4 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 9.4.

9.5

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.

 

9.6	Filing, Prosecution, Maintenance and Defense.

 

9.6.1

CureVac Program Patent Rights. CureVac shall have the first right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a CureVac Invention (each, a “CureVac Program Patent Right”) throughout the Territory. At the latest [*****] before filing, CureVac shall give GSK an opportunity to review and comment upon the text of any application with respect to any CureVac Program Patent Right, shall consult with GSK with respect thereto, shall not unreasonably refuse to address any of GSK’s comments and supply GSK with a copy of the application as filed, together with notice of its filing date and serial number. CureVac shall keep GSK, through the IP Sub-Committee, 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 GSK a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with GSK with respect thereto, and shall not unreasonably refuse to address any of GSK’s comments. Notwithstanding the above, prior to filing any application for a CureVac Invention that may disclose, in part or in full, a GSK Invention, a Joint Product Invention or Joint Other Invention, CureVac shall provide GSK with a copy of the draft application and provide GSK with at least [*****] to review and comment upon the text of such draft application. If GSK notifies CureVac within the above [*****] deadline that GSK has decided to file an application for a GSK Invention, Joint Product Invention or Joint Other Invention, the Parties shall coordinate the filing of the application for a CureVac Invention with the filing of GSK’s application for such GSK Invention, Joint Product Invention or Joint Other Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, CureVac will not include a GSK Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by CureVac without GSK’s prior written consent. CureVac shall promptly give notice to GSK of the grant, lapse, revocation, surrender or invalidation of any CureVac Program Patent Rights. CureVac shall as soon as reasonably practicable give notice to GSK of any final decision to not file patent applications claiming CureVac Program Patent Rights or to cease prosecution and/or maintenance and/or defense of CureVac Program Patent Rights on a country by country basis and, in such cases, shall permit GSK, in GSK’s sole discretion, to file such patent applications or to continue prosecution or maintenance or defense of such CureVac Program Patent Rights (in which case thereafter they will be deemed a GSK Program Patent Right) at its own expense and in its own name.

9.6.2

GSK Program Patent Rights. GSK shall have the sole right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a GSK Invention (each, a “GSK Program Patent Right”) 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. GSK shall keep CureVac, through the IP Sub- Committee, reasonably informed of the status of the actual and prospective prosecution, maintenance and defense, of all GSK Program Patent Rights. Notwithstanding the above, prior to filing any application for a GSK Invention that may disclose, in part or in full, a CureVac Invention, Joint Product Invention or Joint Other Invention, GSK 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 GSK within the above [*****] deadline that CureVac decides to file an application for a CureVac Invention, the Parties shall coordinate the filing of the application for a GSK Invention with the filing of CureVac’s application for such CureVac Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, GSK will not include a CureVac Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by GSK without CureVac’s prior written consent. CureVac shall as soon as reasonably practicable give notice to GSK of any desire to cease prosecution and/or maintenance and/or defense of GSK Program Patent Rights on a country by country basis and, in such cases, shall permit CureVac, in CureVac’s sole discretion, to continue prosecution or maintenance or defense of such GSK Program Patent Rights (in which case thereafter they will be deemed a CureVac Program Patent Right) at its own expense and in its own name.

 

9.7

Joint Patent Rights. GSK shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights relating to Joint Product Inventions or Joint Other Inventions (“Joint Patent Rights”) throughout the Territory, at its sole expense, and GSK shall give timely notice to CureVac, and, if during the Research Period, with a copy to the IP Sub-Committee, of any final decision 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 CureVac’s 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.

9.8

Patent Term Extension and Supplementary Protection. The IP Sub-Committee shall decide on any patent term extensions, including supplementary protection certificates and any other extensions, including pediatric extensions, for a Product that are now or become available in the future, wherever applicable, in order to secure the optimal protection for the Products available under Applicable Laws. The Party holding the marketing authorization for the Product Covered by any Patent Rights shall have the obligation for applying for any such extension or supplementary protection certificate, 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. GSK shall pay all expenses for obtaining and maintaining any extension or supplementary protection certificate in respect of a Product in the GSK Territory.

 

9.9

Development Data. Except to the extent the Development Data enter the public domain pursuant to Section 11.7, the Development Data shall be treated as Confidential Information of the Party or Parties owning it. Each Party may use, and allow its Affiliates to use, the Development Data for the purpose of obtaining adequate protection and prosecution of their respective Know-How and Patent Rights, or as provided for otherwise in accordance with this Agreement, provided that in each case it provides the other Party with prior written notice of its intent to use the Development Data for such purpose. The other Party may, within a reasonable time following receipt of such notice, request the notifying Party to delay the use of the Development Data, in order to safeguard the protection and prosecution of other Know-How and Patent Rights. Following such request, the Parties shall cooperate in good faith to align the protection and prosecution of each Party’s Know- How and Patent Rights. For the avoidance of doubt, the terms and conditions of this Article 9 shall govern the intellectual property rights of the Parties in the Development Data.

 

9.10

Challenges. If GSK or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the CureVac Patent Rights or the Patent Rights included in the LNP Technology, or supports a Third Party in the challenge of a CureVac Patent Right or a Patent Right included in the LNP Technology in such legal proceeding, it shall promptly, and in no event later than [*****] prior to initiating such challenge (or such shorter period as required due to a court’s, patent office’s or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****] prior to initiating such challenge), notify CureVac hereof. If CureVac or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the GSK Patent Rights in a legal proceeding, or supports a Third Party in the challenge of a GSK Patent Right in such legal proceeding, it shall promptly, and in no event later than [*****] prior to initiating such challenge (or such shorter period as required due to the court or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****] prior to initiating such challenge), notify GSK thereof. The Parties, through the IP Sub-Committee, shall promptly discuss any such issue in good faith, including the grant of a freedom to operate license at terms to be negotiated, and, if they cannot find an agreement, escalate the issue to the Executive Officers. If the Executive Officers despite good faith negotiations cannot find a solution, and a CureVac Patent Right or Patent Right within the LNP Technology is not granted or is declared invalid upon a successful challenge by GSK or any of its Affiliates (either alone or with a Third Party), such CureVac Patent Right or Patent Right within the LNP Technology shall be deemed to have been granted or shall be deemed valid until the expiry of regular patent protection for such CureVac Patent Right that would have applied if such CureVac Patent Right or Patent Right within the LNP Technology had been granted or had not been successfully declared invalid for the purposes of Section 1.195 (Valid Claim) and Section 8.7.2 (Royalty Term).

9.11

Challenges to Third Party Patent Rights. If either Party or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of any Third Party Patent Rights potentially Covering the Development, Manufacture or Commercialization of a Product (including, but not limited to, any request for, or filing or declaration of, any invalidity proceedings, interference, deviation proceeding, opposition, inter partes review, post-grant review, third party observations or re-examination), it shall, prior to initiating such challenge, notify the other Party through the IP Sub-Committee. The Parties, through the IP Sub-Committee shall discuss the strategy for such challenge. If the Parties agree to pursue a joint challenge, (i) the Parties shall collaborate with respect to such challenge, (ii) the Parties shall consult with each other regarding, and agree on, strategic decisions and their implementation in connection with such challenge, and (iii) the Parties shall [*****] all costs and expenses of such challenge, provided that if the total costs and expenses exceed [*****], any additional costs require prior approval of the JSC. Either Party and its Affiliates shall also be entitled, if agreed by the Parties, or if the IP Sub-Committee does not agree on a joint challenge, without the other Party, to challenge the validity of any Third Party Patent Rights. In this case, the Party bringing the challenge (i) shall have no obligation to consult with the other Party regarding its strategy and (ii) shall bear all the costs and expenses of such challenge.

 

10.	ENFORCEMENT AND DEFENSE.

 

10.1	Enforcement.

 

10.2

Notice. Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any CureVac Patent Rights, GSK Patent Rights or Joint Patent Rights which competes with the Development, Manufacture or Commercialization of Products in the Territory (collectively “Third Party Infringement”).

 

10.3

GSK Rights. Subject to Section 10.4, GSK shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the Territory at its own expense. GSK shall keep CureVac closely informed as to any legal courses of action it pursues pursuant to this Section 10.3, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.

 

10.4

CureVac Rights. On a Product-by-Product basis, for as long as CureVac holds the exclusive right to Commercialize a Product in the CureVac Territory pursuant to Section 6, CureVac shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the CureVac Territory at its own expense. CureVac shall keep GSK closely informed as to any legal courses of action it pursues pursuant to this Section 10.3, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.

 

10.5

Taking over. If the Party having the primary right to enforce its rights against such Third Party Infringement pursuant to Sections 10.3 or 10.4, respectively, elects not to enforce its rights against such Third Party Infringement or not to further pursue the enforcement of its rights, such Party shall notify the other Party of such decision as soon as reasonably practicable and in any event within [*****] after receipt of the Third Party Infringement notice or after the decision not to further pursue the enforcement of its rights. If after the expiry of the [*****] period (or, if earlier, the date upon which the Party which has the primary right to enforce its rights against such Third Party Infringement provides written notice that it has decided not to or to no longer enforce its rights against such Third Party Infringement), the Party which has the primary right to enforce its rights against such Third Party Infringement has neither obtained a discontinuance of the Third Party Infringement, nor filed suit with regard to such Third Party Infringement, then the other Party shall have the right, but not the obligation, to take action or bring suit with respect to such Third Party Infringement at its own expense.

 

10.6

Collaboration. If such course of action includes litigation, 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 an action with respect to a Third Party Infringement 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. Except as set forth otherwise herein, the Party bringing the action shall bear all costs and expenses of such action.

 

10.7	Recoveries. Any recoveries obtained by either Party as a result of any proceeding with regard to a Third Party Infringement under this Section 10.1 shall be allocated as follows:

 

(i)

such recovery shall first be used to reimburse each Party for all reasonable costs incurred in connection with such proceeding;

 

(ii)

such recovery shall then be used to compensate each Party for the respective damages suffered from the Third Party Infringement (in the case of damage suffered by CureVac, as calculated at the Royalty Rate), provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party’s damages, such compensation shall be shared on a pro- rata basis depending on the amount of the respective damages suffered; and

(iii)

the remaining portion of such recovery, if any, shall be [*****] between CureVac and GSK.

 

10.8

Settlements. 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 GSK involves any infringement of CureVac Patent Rights and/or Joint Patent Rights, as the case may be, and is reasonably likely to relate to CureVac’s products and/or technologies other than a Product, GSK will consult with CureVac regarding issues relating to such CureVac Patent Rights, Joint Patent Rights, and/or CureVac’s products and technologies, and the Parties will mutually agree on strategic litigation decisions regarding such issues.

 

10.9

Assistance. The non-enforcing Party shall provide such assistance as the enforcing Party reasonably requests in connection with any action or suit hereunder to prevent or enjoin a Third Party Infringement at the enforcing Party’s cost. At the request of the enforcing Party, the non- enforcing Party shall provide reasonable assistance to the enforcing Party, at the enforcing Party’s expense, in connection with such enforcement, including by executing reasonably appropriate documents, and joining as a party to the action. The Parties agree that, irrespective of which Party brings the action or suit pursuant to this Section 10.1, the Parties will update each other as to the status of such actions through the IP Sub-Committee and the enforcing Party will not unreasonably reject comments from the other Party relating to the management of such litigation.

 

10.10

Defense.

 

10.11

Notice. If the Development, Manufacture or Commercialization of any 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.

 

10.12

Control. CureVac has the first right, but not the obligation, to control any defense of any such claim involving an alleged infringement of Third Party rights by (i) the exploitation or use of the CureVac Technology, where such alleged infringement is allegedly not caused solely by the Development, Manufacturing or the Commercialization of one or more Products or (ii) CureVac’s activities under this Agreement (including Development, Manufacturing or the Commercialization of one or more Products, and the Commercialization of Products in the CureVac Territory), at its own expense and by counsel of its own choice, and GSK may, at its own expense, choose to be represented with respect to any such claim by counsel of its own choice. GSK has the first right, but not the obligation, to control any defense of any such claim other than where CureVac has the first right to control the defense of a claim, at its own expense and by counsel of its own choice, and CureVac may, at its own expense, choose to be represented with respect to any such claim by counsel of its own choice.

10.13

Assistance. Upon the defending Party’s request and cost, the non-defending Party shall provide reasonable assistance to the defending Party with respect to a defense and/or shall join in any action if reasonably required by the defending Party in order to defend such claim or to assert all available defenses and claims, and shall reasonably cooperate 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 the other 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.

 

10.14

FTO Licenses. Without prejudice to other provisions of Section 13.4, and the rights and remedies of GSK thereunder, where a Party reasonably concludes that use or exploitation of: (i) in the case of GSK, any CureVac Elements; or (ii) in the case of CureVac, any mRNA technology or other technology used by or on behalf of GSK, its Affiliates or Sublicensees to Develop, Manufacture and/or Commercialize Products under this Agreement that is described in the Know-How, or within the scope of the specification of the Patents Rights, Controlled by GSK (excluding, for clarity any CureVac Know-How or CureVac Patent Rights), in each case for the Development, Manufacturing or Commercialization of Products, infringes Third Party rights and will require a freedom-to- operate license from such Third Party, the Parties will discuss the issue and the strategy for obtaining a sublicensable license in the IP Sub-Committee, with final endorsement by the JSC. Upon request of such Third Party or the other Party, the requested Party will consider in good faith whether and how it may support obtaining a freedom-to-operate license, e.g., by granting a cross- license under its Background Technology to such Third Party. If the Third Party rights are reasonably expected to affect the Products as well as other products, and if they are necessary to obtain freedom to operate with respect to any CureVac Elements, CureVac shall reasonably consider obtaining such freedom-to-operate license, and that license, if sublicensable, will become an additional In-Licensing Agreement as set forth in Section 2.7.1 at no additional cost to and with no further consideration payable by GSK. If such license is obtained by GSK and required to obtain freedom-to-operate under CureVac Elements, as between the Parties, any costs shall be borne in accordance with Section 8.7.5. If such license is required to obtain freedom-to-operate with respect to a Product (but not under any CureVac Elements), the costs will be borne by GSK.

 

11.	CONFIDENTIALITY.

 

11.1

Obligation of Confidentiality. As at 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 and the 2021 Collaboration 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 Section 11. Without limiting the foregoing no Receiving Party shall be permitted under this Agreement to share any Confidential Information supplied by a Disclosing Party with (i) any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of that Receiving Party solely as a result of a Change of Control in that Receiving Party or (ii) in the case of CureVac, any Third Party sublicensee under the CureVac Technology (including those identified in item (iii) of the Disclosure Letter).

11.2	Additional Obligations.

 

11.2.1

Appropriate Safeguards. In furtherance of the Receiving Party’s obligations under Section 11.1 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. The Parties will jointly agree a protocol with information security measures to be implemented to safeguard secured exchange of Confidential Information and personal information, within [*****] following the Closing Date.

 

11.2.2

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, 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, or Financial Partner of the Receiving Party.

 

11.3	Limitations. The Receiving Party’s obligations under Sections 11.1 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 under this Agreement;

 

(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;

 

(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.

11.4	Authorized Disclosures.

 

11.4.1

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), to Sublicensees (in the case of GSK) or permitted sublicensees (in the case of CureVac) or the LNP Provider, 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 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, Sublicensee (in the case of GSK), or permitted sublicensees (in the case of CureVac) 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 notify 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.

11.4.2

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 11.4.1 to disclose Confidential Information that is subject to the non-disclosure provisions of Section 11.1, 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 Section 11, and the Party disclosing Confidential Information pursuant to judicial, governmental or administrative process shall take all steps reasonably necessary, including to seek an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

 

11.5	Survival. All of the Receiving Party’s obligations under this Section 11 hereof, with respect to the protection of the Disclosing Party’s Confidential Information, shall for a period of [*****] survive the expiry or termination of this Agreement for any reason whatsoever.

 

11.6

Public Announcements, Press Releases. The Parties shall issue a press release in the form attached hereto as Exhibit 11.6 at an agreed time promptly after the Closing 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. Each Party may repeat any information relating to this Agreement that has already been publicly disclosed in accordance with this Section 11.6, provided such information continues as of such time to be accurate.

 

11.7

Publication of Development Data. The Parties acknowledge the merit of publishing Development Data regarding the Products (other than CMC Development data) in searchable, peer-reviewed scientific literature in accordance with international scientific publishing practices and standards (including regarding the recognition of contribution and authorship). Either Party may request the other Party to discuss and determine in good faith a joint publication strategy for the Development Data regarding the Products, which shall be effective upon endorsement by the IP Sub-Committee and the respective Alliance Managers. As between the Parties, the Party by whom or on whose behalf the experiment or study generating such Development Data has been conducted, shall be responsible for the publication of such Development Data, unless defined otherwise in a joint publication strategy. Any intended publication of Development Data regarding a Product (including presentations to Third Parties or publication in intellectual property filings) shall be notified to the IP Sub-Committee by the relevant Party as soon as reasonably practicable and in any event at least [*****] before the final decision to publish, to allow the other Party to review and comment on the publication. The other Party may demand that the publication of the proposed presentation or publication is delayed for a period of [*****] in order to assess whether the Development Data intended to be published is patentable. If the other Party decides to pursue patent protection, it may request the publishing Party to further delay the publication of the proposed presentation or publication for a time not exceeding [*****] from the date of the publishing Party’s notification, to enable adequate protection and prosecution of Patent Rights by either Party or their Affiliates.

With respect to any agreements between a Party and Third Parties (including clinical investigators) that a Party enters into after the Closing Date relating to the Development of any Product or otherwise relating to Development activities under this Agreement, such Party shall use reasonable efforts to include publication provisions regarding results of the experiments and studies for such Products that allow such Party to receive and provide a copy of any proposed publications or public presentations to the other Party, which such Party shall submit to the other Party with a reasonable amount of time for review as described in this Section 11.7.

 

Subject to the above review, a Party shall have the right as required by Applicable Law or its policies and standard operating procedures to (a) publish protocol summaries, results summaries, protocols, clinical study reports, plain language summaries and other study documents of all Clinical Studies conducted by or on behalf of such Party during the Term of this Agreement in any clinical trial register, including any of its own clinical trial registers; (b) publicly disclose results from other Clinical Studies where that Party determines that the results are scientifically important or relevant for patient care; and (c) make any other public disclosures of clinical Development Data that become required by GSK or CureVac due to Applicable Laws.

 

12.	COMPLIANCE, QUALITY, INTEGRITY

 

12.1	Legal Compliance. Each Party shall procure that it and its personnel performs this Agreement in accordance with Applicable Laws.

 

12.2

GxP. GSK and CureVac shall undertake the Development activities regarding the Products, in compliance with GxP. With regard to any Clinical Studies conducted by CureVac under this Agreement, GSK may require CureVac to comply with the policies and standards of the GSK regarding the human subject research conducted to its benefit, and shall in this respect allow GSK, at its request, to review and approve at least the protocol and informed consent forms associated with such Clinical Studies.

 

12.3

Data Integrity. GSK and CureVac shall carry out their respective Development activities under this Agreement, and collect and record any data generated therefrom, in a manner consistent with the following good data management practices: (i) Development Data shall be generated using sound scientific techniques and processes; (ii) Development Data shall be analyzed appropriately, without bias and in accordance with good scientific practices; and (iii) Development Data shall be accurately recorded in accordance with good scientific practices by the individuals performing the research and in accordance with the ALCOA CCEA data integrity principles: (A) Attributable: data are traceable to the originator, (person and/or a computerized system, a device, an instrument), including any changes made to data, i.e. who performed an action and when, so that key decisions made during the conduct of the research, presentations made about the research and conclusions reached in respect of the research can be easily demonstrated and reconstructed; (B) Legible: data are readable and understandable; (C) Contemporaneous: data are recorded at the time they are generated or observed as per regulatory requirements; or in absence of regulatory requirements, local business practices; (D) Original (true copy): data as the file or format in which it was first generated, e.g. first paper record of manual observation, or electronic raw data file from a computerized system as per regulatory requirements; or in absence of regulatory requirements, local business practices; (E) Accurate: data, including error corrections and edits, are correct, truthful and to the appropriate precision; (F) Complete: all expected elements of the data are present (i.e., no unexplained gaps in the data) and the full meaning and context is preserved with the data; (G) Consistent: all elements of the record follow in the expected sequence; (H) Enduring: data are recorded in a permanent medium (paper or electronic) and continue to be retained in a human readable format for as long as specified in applicable record retention requirements; and (I) Available: data are maintained securely in such a way that they are accessible and retrievable in reasonable times (“Good Data Management Practices”). Each Party shall maintain written policies and standards related to Good Data Management Practices and shall ensure appropriate, documented training of its relevant personnel with respect to Good Data Management Practices.

12.4

Human Biological Samples. If the Parties wish to source Human Biologicals Samples on each other’s behalf or exchange Human Biological Samples between them, such exchange shall be recorded in separate addendums to this Agreement setting forth further terms and conditions for the specific purpose. GSK and CureVac undertake that the Human Biological Samples used or collected in connection with the Development have been obtained and will be stored, transferred, used and disposed of in accordance with all Applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue, including with regard to consents from patients, volunteers and other donors.

 

12.5

Privacy; Information Security. The Parties shall comply with Data Protection Laws (as defined in Exhibit 12.5), including those concerning medical confidentiality and privacy in relation to human subjects of the Development activities regarding the Products. The Parties acknowledge that they do not intend that one Party processes personal information for and on behalf of the other Party. If personal information is transferred between the Parties (as between controllers) pursuant to the performance of this Agreement or any Ancillary Agreement, the Parties shall comply with Exhibit 12.5, which may be amended from time to time by the Parties as is required by Applicable Laws. The Parties will enter into further data protection agreements if required by Applicable Laws.

12.6

Ethical Care of Animals. The Parties shall comply with all Applicable Laws for the care, welfare and ethical treatment of animals in the country where animal testing or animal research is performed. The Parties shall implement the “3Rs” Principles – reducing the number of animals used, replacing animal with non-animal methods whenever possible and refining the research techniques used. All work shall be performed in adherence to the core principles for animals identified below. Local customs, norms, practices or laws may be additive to the core principles, but each Party agrees to comply and shall procure and ensure that those acting for or on behalf of such Party (including its subcontractors) comply, as a minimum, with these core principles: (i) access to species appropriate food and water; (ii) access to species specific housing, including species appropriate temperature and humidity levels; (iii) provision of humane care and a program of veterinary care through guidance of a veterinarian; (iv) animal housing that minimizes the development of abnormal behaviors; (v) adherence to principles of replacement, refinement and reduction in the design of in vivo or ex vivo studies with processes to optimize animal use and to ensure effective population management; (vi) supported by a relevant scientific justification/rationale, approved by an institutional ethical review process and subjected to independent scientific review; (vii) commitment to minimizing pain and distress during in vivo and ex vivo studies; and (viii) work is performed by personnel documented as trained and competent to conduct the procedures for which they are responsible. Each Party agrees that all protocols involving animal research or animal testing for in connection with the Products shall undergo an ethical review, whether or not required by Applicable Law, and that written documentation confirming ethical review shall be maintained by such Party until [*****] after the completion of the experiment or test, demonstrating that the review was completed. If a Party is currently accredited by AAALACi, such Party agrees to make commercially reasonable efforts to maintain its AAALACi accreditation during the life of this Agreement. Each Party shall have procedures in place to assess and approve its external suppliers and distributors who supply animals to it to: (i) ascertain and confirm the quality of the animals supplied; (ii) ensure legal requirements for the care and welfare of animals are met; and (iii) ensure that only purpose bred animals are used to perform the animal testing or research. The distance of suppliers from the test facility shall be minimized (where practicable) and transport processes (e.g. stocking densities, carrying crates, food and water) shall ensure minimum stress. On arrival, each Party shall ensure checks are in place to confirm only healthy animals are used. Each Party shall document the approval of its animal suppliers and distributors, which documentation shall be made available to the other Party upon request. GSK shall have the right, but not the obligation, to approve any supplier of non-human primates or other animals, which right may be invoked upon notice to CureVac.

 

12.7

Environment, Health and Safety. CureVac shall: (i) maintain an “EHS” (environment, health and safety) policy and risk-based management system with a commitment to provide a safe and healthy workplace and protect the environment surrounding its operations; (ii) ensure there is at least one senior executive with responsibility for EHS and the organization has access to technical expertise to support the company in meeting EHS obligations; (iii) provide relevant information, education and training to workers on the hazards, risks and controls associated with their job; (iv) provide the physical infrastructure, workplace and engineering controls necessary to ensure safe storage, handling and processing of materials and waste in order to protect people, the environment and local communities from harm; and (v) provide and maintain emergency detection systems and an effective response and healthcare capabilities.

 

12.8

Sanctions and export controls. The Parties represent and warrant that they are aware of, and undertake in carrying out their obligations under this Agreement and the agreements referred to within this Agreement that they will not violate and prevent becoming exposed to penalties under, all sanctions, export control, and anti-boycott laws, regulations, orders, directives, designations, licenses, and decisions of the European Union, the United Kingdom, the United States of America, and of any other country with jurisdiction over activities undertaken in connection with this Agreement, if applicable (“Sanctions & Trade Controls”). Each Party undertakes that, at all times, in the performance of their obligations under this Agreement and the agreements referred to within this Agreement, they will not take any action that causes the other Party to violate or otherwise become exposed to penalties under any Sanctions & Trade Controls. Neither Party shall be required to take or refrain from taking any action, nor shall it be required to furnish any information, that would be prohibited under any Sanctions & Trade Controls (as defined above).

12.9

Anti-bribery and corruption. Each Party shall comply fully at all times with all Applicable Laws, including but not limited to anti-corruption laws, and represents and warrants that it has not, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and warrants that it has taken reasonable measures to prevent subcontractors, agents or any other Third Parties, subject to its control or determining influence, from doing so. For the avoidance of doubt this includes facilitating payments, which are unofficial, improper, small payments or gifts offered or made to Government Officials to secure or expedite a routine or necessary action to which a Party is legally entitled. Either Party shall be entitled to terminate this Agreement immediately on written notice to the other Party, if the other Party fails to perform its obligations in accordance with this Section 12.9. A Party shall have no claim against the other Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 12.9. Either Party shall inform the other Party in writing, if, during the course of this Agreement, it is convicted of or pleads guilty to a criminal offence involving fraud or corruption, or becomes the subject of any government investigation for such offenses, or is listed by any government agency as debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs. Either Party shall ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and each document upon which entries such books and records are based is complete and accurate in all material respects. Either Party must maintain a system of internal accounting controls reasonably designed to ensure that it maintains no off-the-books accounts.

 

12.10

Changes to Compliance Framework. At any time during the term of this Agreement, either Party may suggest reasonable amendments to this Section 12 and the clauses of this Agreement referencing this Section 12, or any provision of any Ancillary Agreement concerning compliance, quality, safety or integrity, where such Party reasonably believes such changes are required to ensure compliance with Applicable Laws, or such Party’s interpretation of Applicable Laws as reflected in the values, quality, integrity, safety or compliance framework of the group to which that Party belongs. The other Party shall not unreasonably refuse or delay its agreement to such amendments. In case of any conflict between the Parties’ interpretation of frameworks, the more stringent interpretation or framework shall be reflected in the amendment.

12.11

Breaches. Each Party shall promptly notify the other Party of any significant deficiencies impacting the performance of this Agreement having regard to its compliance with this Section 12 and any corrective actions taken.

 

12.12

Audit. GSK or its nominee shall have the right to enter the CureVac’s manufacturing facilities and any of CureVac’s other offices, facilities, records and information systems to carry out an audit to verify and monitor CureVac’s compliance with Section 12 [*****] per Calendar Year, save any For Cause audits. The scope of the audit may include, but need not be limited to, a tour of the facility, the opportunity to view relevant standard operating procedures (SOPs), training records, building management records, animal health records, ethical review documents, and any other documents reasonably necessary to assess compliance by CureVac. The duration of the inspection shall be at the sole reasonable discretion of GSK. Audits conducted under this Section 12.12 shall require reasonable prior notice of at least [*****], except in case of For Cause audits (as defined below), in which case such limitation a prior notice of [*****] shall suffice. Audits conducted under this Section 12.12 shall be scheduled in such a manner so as not to impact the production schedule or CureVac’s normal business activities and shall be conducted during regular business hours. For the purposes of this Section 12.12, a “For Cause” audit shall be an audit conducted based on a substantiated suspicion by GSK of a material lack of compliance with Section 12, in respect of which GSK has shared with CureVac documentation substantiating its suspicion prior to the audit. Persons conducting the on-site audits shall be required to comply with reasonable CureVac rules applicable to the site and GSK shall ensure that any person involved in any audit (including a document-only inspection) shall be bound by an obligation of confidentiality. CureVac shall use commercially reasonable efforts to ensure that the same audit rights for GSK as described in this Section 12.12 apply with respect to the premises of any subcontractors authorized in accordance with this Agreement.

 

13.	INDEMNIFICATION AND REPRESENTATIONS AND WARRANTIES.

 

13.1

Indemnification by GSK. GSK will defend, indemnify and hold CureVac and its Affiliates and their directors, officers, employees, consultants, agents, permitted sublicensees and contractors (the “CureVac Indemnified Parties”) harmless from and against any and all losses, liabilities, claims, suits, proceedings, expenses, fees, recoveries and damages, including reasonable and demonstrable legal expenses and costs including attorneys’ fees, resulting or arising out of any claim by any Third Party resulting or arising from (i) the negligence or willful misconduct of GSK, any of its Affiliates or Sublicensees, or any of their respective directors, officers, employees, agents or contractors; (ii) the Development, Manufacturing and/or Commercialization of the Products by or on behalf of GSK (other than as conducted by CureVac), any of its Affiliates or any of their respective Sublicensees or (iii) any breach of this Agreement by GSK, any of its Affiliates or any of their Sublicensees; except, in each case, to the extent caused by the negligence or willful misconduct of any of the CureVac Indemnified Parties.

13.2

Indemnification by CureVac. CureVac will defend, indemnify and hold GSK and its Affiliates and their directors, officers, employees, consultants, agents, Sublicensees and contractors (the “GSK Indemnified Parties”) harmless from and against any and all losses, liabilities, claims, suits, proceedings, expenses, fees, recoveries and damages, including reasonable and demonstrable legal expenses and costs including attorneys’ fees, resulting or arising out of any claim by any Third Party resulting or arising from (i) the negligence or willful misconduct of CureVac, any of its Affiliates, or any of their respective directors, officers, employees, consultants, agents or contractors (including an approved subcontractor or approved CMO); or (ii) the Development, Manufacture and/or Commercialization of any of the Products, if any, by or on behalf of CureVac (other than as conducted by GSK), any of its Affiliates, or their approved subcontractors or approved other CMOs); or (iii) any breach of this Agreement by CureVac, or any of its Affiliates; except, in each case, to the extent caused by the negligence or willful misconduct of any of the GSK Indemnified Parties.

 

13.3

Indemnification Procedures. The indemnified Party will give the indemnifying Party 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 the indemnifying Party within a reasonable time after the commencement of any action with respect to a claim shall only relieve the indemnifying Party of its indemnification obligations if and to the extent the indemnifying Party is actually and materially prejudiced thereby. 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 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). The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the claim at the indemnifying Party’s reasonable, pre-approved expense. The indemnifying Party will have the right to compromise, settle or defend any such claim or lawsuit; provided that (i) no offer of settlement, settlement or compromise by the indemnifying Party shall be binding on the indemnified Party without its prior written consent, not to be unreasonably withheld, conditioned or delayed, unless such settlement fully releases the indemnified Party without any liability, loss, cost or obligation incurred by the indemnified Party and in no event shall any settlement or compromise admit or concede that any aspect of any Patent Right owned or Controlled by the indemnified Party is invalid or unenforceable or adversely affect the scope of any Patent Right owned or Controlled by the indemnified Party; and (ii) the indemnifying Party shall not have authority to admit any wrongdoing or misconduct on the part of the indemnified Party except with the indemnified Party’s prior written consent. 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 13.3, 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.

13.4	CureVac Representations and Warranties. Subject to the disclosures in the attached Exhibit 13.4 (“Disclosure Letter”) CureVac represents and warrants to GSK as at the Effective Date, that:

 

(i)

it is the sole and exclusive owner of the Patent Rights listed in Exhibit 1.50 or otherwise Controls such Patent Rights;

 

(ii)

to CureVac’s knowledge, it has the full right, power and authority to grant the rights and licenses it purports to grant hereunder;

 

(iii)

neither CureVac nor any of its Affiliates has granted any Third Party any rights or licenses that would interfere or be inconsistent with GSK’s rights and licenses hereunder;

 

(iv)

CureVac has received no written notice of or any written demand relating to any threatened or pending litigation, and no other matters are within CureVac’s knowledge, which would reasonably lead it to believe that GSK’s exercise of any rights purported to be granted by CureVac under this Agreement will infringe any Patent Rights or infringe or misappropriate any other intellectual property right of any Third Party;

 

(v)

there is no currently pending administrative proceedings or litigation and no administrative proceedings or litigation seeking to invalidate or otherwise challenge any CureVac Patent Right(s) has been threatened in writing;

 

(vi)

CureVac has not given any written notice to any Third Party asserting infringement by such Third Party of any of the CureVac Technology or LNP Technology and, to CureVac’s Knowledge, there is no unauthorized use, infringement or misappropriation of the CureVac Technology;

 

(vii)

the CureVac Technology is free and clear of all encumbrances, security interests, options, and charges of any kind;

 

(viii)

to CureVac’s knowledge, the In-Licensing Agreements are valid and effective and CureVac has not received a written notice of termination for any of these In-Licensing Agreements;

 

(ix)

to CureVac’s knowledge, there is no ongoing litigation in respect of, litigation reasonably in prospect in connection with, and no reasonable prospect of termination under the In-Licensing Agreements by the respective counterparties under those agreements ahead of the respective expiry dates of such In-Licensing Agreements;

 

(x)

to CureVac’s knowledge, the information and documents set forth in or referred to in the Disclosure Letter are true, complete and accurate in all material respects;

(xi)

to CureVac’s knowledge, the information and documents regarding the In-Licensing Agreements, CureVac’s portfolio of Patent Rights, toxicology studies, clinical data, process and analytical information, manufacturing process information, material filing and correspondence with Regulatory Authorities, disclosed in the [*****] e-data room prior to the Effective Date as a part of GSK’s due diligence, is true, complete and accurate in all material respects; and

 

(xii)

CureVac has disclosed to GSK any written correspondence sent to or received from Regulatory Authorities, all drug safety monitoring board meeting minutes and internal safety review committee meeting minutes for the [*****] as of its Initiation.

 

13.5	LNP Warranties. To the extent permitted under the applicable LNP Agreement, CureVac hereby warrants to GSK on a pass-through basis each matter which is the subject of any representation or warranty given by each LNP Provider to CureVac under each applicable LNP Agreement.

 

13.6	Representations, Warranties of the Parties to Each Other. CureVac and GSK each represents and warrants and covenants with respect to itself only as at 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.

 

13.7

Due Diligence. Prior to the execution of any Ancillary Agreement, other than the Clinical Supply Agreement, GSK shall be entitled to perform further due diligence regarding CureVac’s capabilities to perform in accordance with terms defined herein for such agreement. Without prejudice to the Parties’ other rights and remedies, the Parties shall in good faith cooperate to address and remedy any issue identified during the due diligence referred to in this Section. For the avoidance of doubt, if GSK discovers a material issue regarding CureVac’s capabilities to comply with such agreement, GSK may in addition to its other rights and remedies suspend the execution of any such agreement until such ground has been remedied by CureVac.

 

13.8

Disclaimer Except as expressly set forth in this Agreement, each Party expressly disclaims, waives, releases, and renounces any representation or warranty of any kind, express or implied either in fact or by operation of law, by statute or otherwise, whether written or oral, or arising from course of performance, course of dealing or usage of trade, including any representation or warranty with respect to non-infringement, value, adequacy, freedom from fault, quality, efficiency, suitability, characteristics or usefulness, or merchantability or fitness for a particular purpose.

13.9

Limitation of Liability. Except in the case of any breach of Section 11 or in case of willful misconduct or gross negligence, neither Party shall be liable to the other Party for any indirect, punitive or consequential damages, or for damages for loss of profits or loss of business opportunity, whether based on contract or tort, or arising under Applicable Laws or otherwise.

 

14.	TERM AND TERMINATION.

 

14.1	Term. The term of this Agreement will commence on the Closing Date and end on the expiry of all applicable royalty payment obligations to CureVac under this Agreement, unless terminated earlier according to the terms and conditions of this Agreement (“Term”).

 

14.2	Termination at Will by GSK. GSK may terminate this Agreement in its entirety or on a Program- by-Program basis, at any time without cause upon [*****] prior written notice to CureVac.

 

14.3	Termination for Cause by Either Party in respect of a Program before First Commercial Sale.

On a Program-by-Program basis before the First Commercial Sale of a Product under a Program in a Territory, if either Party (“Breaching Party”) commits a material breach or default of any of its obligations hereunder, such breach to include a material breach by GSK of its diligence obligations under Section 4.10 with respect to a Product, 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. If the Breaching Party fails to cure such breach or default within [*****] after the date of the Non- Breaching Party’s written notice thereof, the Non-Breaching Party may terminate this Agreement in part in relation to the relevant Program by giving written notice of termination to the Breaching Party. If the Breaching Party indicates in writing that it will be unable or is unwilling to cure the breach, this Agreement may be terminated in part, in relation to the relevant Program (but not any other Program), by the Non-Breaching Party with immediate effect.

 

14.4	Termination for Cause by Either Party in respect of a Program after First Commercial Sale.

On a Program-by-Program basis after the First Commercial Sale of a Product under a Program in a Territory, if: (i) GSK fails to pay any amount payable under Section 8 or any Ancillary Agreement; (ii) CureVac fails to pay any amount payable under any Ancillary Agreement; (iii) either Party commits any willful and material breach of the restrictions on any license granted to that Party pursuant to this Agreement; (iv) either Party commits a material breach of the non-compete obligations under Section 2.3; (v) GSK commits a material breach of its diligence obligations under Section 5.3, or (vi) either Party commits any persistent and material breach of Section 11, and the Party in breach of this Agreement (the “Breaching Party”) fails to cure such breach or default within [*****] after the date of the written notice thereof from the other Party (“Non-Breaching Party”), the Non-Breaching Party may terminate this Agreement in relation to the relevant Product(s) (but not any other Program) by giving written notice of termination to the Breaching Party. If the Breaching Party indicates in writing that it will be unable or is unwilling to cure the breach, this Agreement may be terminated in relation to the relevant Product(s) by the Non-Breaching Party with immediate effect.

14.5	Termination in respect of Anti-bribery and Corruption. Either Party shall be entitled to terminate this Agreement in the circumstances specified in Section 12.9.

 

14.6

Termination in Part and Program Replacement. If either Party terminates this Agreement with respect to a specific Program under this Section 14, or if GSK replaces a Program under Section 3.6, the rights and obligations of the Parties hereunder with respect to the specific Program shall terminate as at the effective date of such termination and the consequences set forth in Section 15 shall apply on a Program-by-Program basis.

 

14.7

Non-exclusive remedy. Termination of this Agreement or in relation to a Program in accordance with Sections 14.3, 14.4, or 14.5 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.

 

15.	CONSEQUENCES OF TERMINATION.

 

15.1	Election by CureVac on Termination by GSK at Will or Termination by CureVac for Cause.

CureVac shall notify GSK in writing within [*****] of notice of termination in accordance with Sections 14.2, 14.3, 14.4, or 14.5 if CureVac wishes to:

 

a.

cease the Development and Commercialization of the relevant Product(s) under the relevant Program(s) and decline the transfer of any rights in relation to the Development, Manufacture and Commercialization of the relevant Products under this Agreement (the “CureVac Cease Option”); or

 

b

continue, itself or with a Third Party, with the Development and Commercialization of the relevant Product(s) under the relevant Program(s) (the “CureVac Continue Option”).

 

15.2	Election by GSK on Termination by GSK for Cause. GSK shall notify CureVac in writing within [*****] of notice of termination in accordance with Sections 14.3, 14.4, or 14.5 if GSK wishes to:

 

a

cease the Development and Commercialization of the relevant Product(s) under the relevant Program(s) and decline the transfer of any rights in relation to Development, Manufacture and Commercialization of the relevant Products under this Agreement, (the “GSK Cease Option”); or

 

b.

continue with the Development and Commercialization of the relevant Product(s) under the relevant Program(s) (the “GSK Continue Option”).

15.3	Specific consequences of CureVac Cease Option and the GSK Cease Option. If CureVac elects the CureVac Cease Option or GSK elects the GSK Cease Option, then with regard to the Program(s) in question:

 

a.

Reversion of Rights: At the effective date of termination, all of CureVac’s rights to the CureVac Technology and LNP Technology shall automatically revert back to CureVac and all of GSK’s rights to the GSK Technology shall automatically revert back to GSK.

 

b.

Wind-Down: Each Party shall, at its own cost (subject to Sections 15.3c and 15.3d), use all reasonable endeavors to wind-down any on-going activities and commitments in connection with this Agreement and the Ancillary Agreements by the effective date of termination.

 

c.

Costs (On Termination by GSK at Will): If CureVac elects the CureVac Cease Option following a termination of a Program by GSK in accordance with Section 14.2 while the R&D Plan for that Program has not been completed, GSK shall reimburse CureVac for the Development Costs set forth in the respective R&D Plan until the effective date of termination.

 

d.

Costs (On Termination by CureVac for Cause): If CureVac elects the CureVac Cease Option following a termination of a Program by CureVac for cause in accordance with Section 14.3, 14.4 or 14.5, GSK shall reimburse CureVac for the Development Costs set forth in the respective R&D Plan until the effective date of termination and reimburse CureVac for its demonstrable stranded costs arising from the early termination of the R&D Plan. CureVac shall use reasonable endeavors to mitigate those stranded costs.

 

15.4	Specific consequences of the CureVac Continue Option. If CureVac elects the CureVac Continue Option, then with regard to the Program(s) in question, the following shall apply:

 

a.

Transition: The JSC shall promptly meet to devise a transition plan, which provides for an orderly and cost-effective transition of, and which sets forth the responsibilities and a timetable for transferring, all Development, Manufacturing and Commercialization responsibilities to CureVac or a Third Party selected by CureVac for this purpose (the “Transition Plan”). Each Party will bear its own costs to agree and implement the Transition Plan unless CureVac has terminated this Agreement with respect to a specific Program for cause in accordance with Section 14.3, 14.4 or 14.5, in which case GSK shall reimburse CureVac for its reasonable and demonstrable direct costs incurred to implement the Transition Plan.

 

b.

Reversion of Rights: All of CureVac’s rights to the CureVac Technology and LNP Technology shall automatically revert back to CureVac, except that if the date of termination occurs after the First Commercial Sale of the relevant Product, (i) the termination of the rights and obligations of the Parties, and the transfer and/or return of rights pursuant to this Section 15, shall take effect on a country-by-country basis, at time as CureVac is able to take over the Commercialization of the Product in such country where that Product is sold with no adverse impact on the continuous availability of Products in that country (the “Cut-Over Date”) and (ii) until such date in such country, the licenses granted to GSK under this Agreement (including Article 2) and any rights and obligations associated with such licenses (including GSK’s payment obligations under Section 8) shall survive.

c.

Transfer of Development Data and Regulatory Approvals. CureVac shall have the right to request in writing, as part of the Transition Plan:

 

(i)

a complete copy of all Development Data Controlled by GSK to be provided in original form and access to all other Know-How in GSK’s possession or under its Control relating to the Products, such Development Data and other Know-How to be provided within [*****] of such request; and

 

(ii)

the transfer of Regulatory Approvals held by GSK, its Affiliates or Sublicensees, and if Regulatory Approvals have not been obtained by GSK, its Affiliates or Sublicensees, CureVac may require that GSK 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 GSK, its Affiliates or Sublicensees for the filing of applications for Regulatory Approvals (with GSK using its good faith efforts to promptly undertake such actions).

 

d.

GSK Trademark License: As part of the Transition Plan, on receipt of a written request from CureVac, GSK grants to CureVac an exclusive (even as to GSK), cost-free, perpetual and worldwide license (with the right to sublicense in multiple tiers) under the trademarks Controlled by GSK and used for the Products in the relevant jurisdiction(s) for the Manufacture and Commercialization of the Products in the Territory, excluding, however, any such trademarks – or such parts of a trademark - that include, in whole or part, any corporate name or logo of GSK, its Affiliates or Sublicensees, and excluding any trademark – or such part of a trademark - which contains the letters [*****] as prefix or suffix (in which case GSK will not oppose any application by CureVac to register a trademark which is similar to any trademark owned by GSK but does not use the letters [*****] as prefix or suffix).

 

e.

GSK Technology License. On a Product-by-Product and country-by-country basis effective from the Cut-Over Date, GSK grants to CureVac (i) an exclusive (even as to GSK), perpetual and worldwide license (with the right to sublicense in multiple tiers) under GSK’s interest in Joint Product Inventions and Joint Other Inventions, and, upon CureVac’s election, to be exercised no later than [*****] after the effective date of termination, (ii) a non- exclusive royalty-bearing, perpetual and worldwide license (with the right to sublicense in multiple tiers) under the other GSK Technology which has been used by GSK for the Development, Manufacture and/or Commercialization of the terminated Products and is required for the further Development, Manufacture and/or Commercialization of such Products, in each case of (i) and (ii) for the continued Development, Manufacture and Commercialization of the Products in the Territory.

 

f.

Post-Termination Financial Terms (Termination by GSK at Will): If GSK terminates this Agreement in its entirety or with respect to a specific Program in accordance with Section 14.2 and CureVac elects the CureVac Continue Option and the license to the GSK Technology under Section 15.4e(ii), then, on a Product-by-Product and country-by-country basis effective from the Cut-Over Date, in consideration of the licenses granted in Section 15.4e(ii), CureVac shall pay GSK royalties as forth in Exhibit 15.4.

g.

Post-Termination Financial Terms (Termination by CureVac for Cause): If CureVac terminates this Agreement with respect to a specific Program for cause in accordance with Section 14.3, 14.4 or 14.5, CureVac shall pay GSK the fair market value for acquisition by CureVac of the Program(s) and the associated rights and benefits pursuant to this Section 15.4, provided that CureVac may, if CureVac claims or seeks to claim damages in relation to breach of this Agreement by GSK, suspend the payment of such fair market value until the amount of damages suffered or incurred by CureVac has been agreed between the Parties or determined by an arbitration panel in accordance with Section 16.5, at which point those damages (if any) shall be set off against such fair market value payment (and any fair market value payment which would remain outstanding after the set off of damages shall become due and payable within [*****] after the agreement or determination of the amount of damages).

 

h.

For the purposes of Section 15.4h, the “fair market value” shall be agreed by the Parties, or if the Parties are unable to agree within [*****] from the date of election in accordance with Section 15.1, either Party may refer the matter to be determined by a panel of experts in accordance with this Section 15.4h. The Parties shall agree on the appointment of the panel of experts, comprising three members experienced in the biopharmaceutical sector, in transactions within the biopharmaceutical sector, and the valuation of technology of the biopharmaceutical sector, and shall agree with the experts the terms of their appointment. If the Parties are unable to agree on the identity of the experts within [*****] after expiry of the aforementioned term of [*****], or if any of the persons proposed is unable or unwilling to act, then each Party shall nominate one expert, which two experts shall together select the third and final expert, who shall preside the expert panel. The experts shall act on the following basis: (i) on their appointment, the experts shall confirm their neutrality, independence and the absence of conflicts in determining the fair market value for the rights granted pursuant to this Section 15; (ii) the experts shall act as experts and not arbitrators; (iii) the experts’ determination shall (in the absence of manifest error) be final and binding on the Parties and not subject to appeal; (iv) the experts shall decide the procedure to be followed in the determination in accordance with this Agreement; (v) the costs of the determination, including the fees and expenses of the experts (but excluding the parties’ own costs which shall be borne by the Party incurring those costs), shall be borne by GSK; and (vi) the expert determination and all matters connected with it shall be held in complete confidence by each of the Parties and shall not be disclosed to any other person except as permitted under Section 11.

15.5	Specific Consequences of the GSK Continue Option.

 

If GSK terminates this Agreement or a Program under Sections 14.3, 14.4 or 14.5, the rights and obligations of the Parties hereunder shall terminate as at the effective date of such termination (or, if later, the Cut-Over Date) and the consequences set forth in this Section 15 shall apply:

 

a.

Survival of licenses: The licenses granted to GSK under this Agreement (including under Section 2) and any rights associated with such licenses shall survive the termination of this Agreement.

 

b.

Post-Termination Financial Terms: All payment obligations under Section 8 shall remain in effect, provided that with respect to milestones and royalties arising after the effective date of termination, GSK may, if GSK also claims or seeks to claim damages in relation to breach of this Agreement by CureVac, suspend the payment of such milestone and royalty payments until the amount of damages suffered or incurred by GSK has been agreed between the Parties or determined by an arbitration panel in accordance with Section 16.5, at which point those damages (if any) shall be set off against such milestone and royalty payments (and any milestone or royalty payment which would remain outstanding after the set off of damages shall become due and payable within [*****] after the agreement or determination of the amount of damages).

 

c.

Costs (On Termination by GSK for Cause): CureVac shall undertake (at its own cost and without the right to be reimbursed) the transfer of Know-How in accordance with Sections 4.7 and 5.2.3, and shall reimburse all reasonable and demonstrable direct costs and expenses incurred by GSK in connection with those activities.

 

15.6

General Consequences of Expiry and Termination.

 

On any termination of this Agreement in its entirety or on a Program-by-Program basis the rights and obligations of the Parties hereunder shall terminate as at the effective date of such termination (unless stated otherwise in this Section 15) and the following shall apply:

 

a.

Reversion of Rights on Expiry: 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 Section 14.3, Section 14.4, or Section 14.5, or by GSK pursuant to Section 14.2, the licenses granted to GSK under Section 2 for such country shall become a fully paid-up, perpetual, and non-exclusive license.

 

b.

Reversion of Rights on Termination: Except as set forth in this Section 15, the rights and obligations of the Parties under this Agreement shall automatically lapse as at the effective date of the termination in question.

c.

Return of Information: No later than [*****] days after the effective date of 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 Development, Manufacture or Commercialization of the Products pursuant to this Section 15, 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 (i) maintained only on centralized storage servers (and not on personal computers or devices), (ii) not accessible by any of its personnel (other than its information technology specialists), and (iii) 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.

 

d.

Settlement of Outstanding Sums: Each Party shall pay all amounts then due and owing as at the termination effective date.

 

e.

Continuation of Ongoing Clinical Trials: In any event of termination, each Party may complete any clinical trial involving a Product it has initiated prior to the termination of this Agreement in accordance with the protocol for such trial, at its cost and such Party shall be granted by the other Party a cost-free, non-exclusive, sublicensable (as set forth in this Agreement), worldwide license under the CureVac Technology and the LNP Technology or respectively the GSK Technology to complete such clinical trials in accordance with their protocols.

 

15.7

Effect of Expiry or Termination; Survival. Expiry or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiry or termination. Any expiry 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 expiry or termination. The provisions of Sections 1, 2.6, 4.6, 4.8.6, 8.9, 9.1, 9.3, 9.4, 11, 13.1, 13.2, 13.3, 13.8, 13.9, 15, 16.3, 16.4, 16.5, 16.7, 16.8, 16.11 and 16.12 and all other provisions contained in this Agreement that by their explicit terms or from which it is clear from the context survive expiry or termination of this Agreement, and any schedules contained in this Agreement to which reference is made in any surviving term, shall survive the expiry 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.

16.	GENERAL PROVISIONS.

 

16.1

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. 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 16.1 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 16.1.

 

16.2

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 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 sixty (60) calendar days, 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.

 

16.3	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:	CEO and General Counsel
		with copy to: General Counsel
	Address:	[*****]
	Email:	[*****]

 

 

	(ii)	if to GSK, addressed to:
		GlaxoSmithKline Biologicals S.A.
		Attention:	President of GSK Vaccines
			with copy to: Vaccines General Counsel
		Address:	[*****]
		Email:	[*****]

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 [*****] following the date of mailing, if sent by mail.

 

16.4	Governing Law. This Agreement and all disputes arising hereunder, shall be exclusively governed by, and interpreted and enforced in accordance with Belgian law. The United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention) does not apply to this Agreement.

 

16.5	Dispute Resolution.

 

16.5.1

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 President of Vaccines (or another member of the global corporate execute team) of GSK. 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.

 

16.5.2

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 16.5.1, shall be submitted to and settled by arbitration in accordance with the arbitration rules of the World Intellectual Property Organization (the “WIPO”) 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 Section 11 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 Zurich, Switzerland. The arbitration will be heard and determined by three (3) arbitrators, with one arbitrator being appointed by each Party and the third arbitrator being appointed by the WIPO. The language of the arbitration proceeding will be English. Notwithstanding the provisions of this Section 16.5.2, 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.

16.6

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.

 

16.7

Entire Agreement and Amendments. This Agreement, together with all Exhibits attached hereto, constitutes the entire agreement between the Parties regarding the subject matter hereof, and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof, including the Confidentiality Agreements. 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. 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 16.7.

 

16.8

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.

 

16.9	Counterparts. This Agreement may be executed in any number of counterparts, by original or electronic (including “pdf”) signature, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

16.10

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.

 

16.11

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.

 

16.12

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.

16.13

Insurance. Each Party will procure and maintain during the Term and for [*****] after termination or expiry of this Agreement, insurance in line with industry standards. GSK will be permitted to satisfy any or all of its obligations under this Section 16.13 through a program of self-insurance. Such insurance policies will be primary and non-contributing with respect to any other similar insurance policies available to the other Party or its Affiliates. Any deductibles for such insurance will be assumed by insured Party. Each Party will provide the other Party with evidence of such insurance upon the other Party’s request and prior to expiry of any one coverage. Any insurance will not be construed to create a limit of the insured Party’s liability with respect to its indemnification obligations under this Agreement.

 

☐☐ Signature page follows ☐☐

In Witness Whereof, the Parties have executed this Agreement to be effective as at the Closing Date.

 

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

[*****] [*****]

Date Signed: July 15, 2020

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

[*****] [*****]

Date Signed: July 15, 2020

Signed on behalf of

CureVac AG

[*****]

[*****]

Date Signed: July 15, 2020

Signed on behalf of

CureVac AG

[*****]

[*****]

Date Signed: July 15, 2020

Exhibit 1.29
List of Collaboration Pathogens and Products

 

[*****] 

 

Exhibit 1.44
CureVac Know How

 

[*****] 

 

Exhibit 1.50
CureVac Patent Rights

 

[*****] 

 

Exhibit 1.70
Excluded Pathogens

 

[*****] 

 

Exhibit 1.115 

In-Licensing Agreements

 

[*****] 

 

Exhibit 1.152
Pandemic Pathogens

 

[*****] 

 

Exhibit 2.1.2 PART A 

[*****] Terms

 

[*****] 

 

Exhibit 2.1.2 PART B
Licensed LNP as at the Effective Date

 

[*****] 

 

Exhibit 2.1.4

[*****] Terms

 

[*****] 

 

Exhibit 3.4
Clearance Template

 

1. Vaccine Products

 

For vaccine Products, the below table must be used for the clearance of Antigens. For each clearance, the primary vaccine Antigen must be reported in the first row, and any additional vaccine Antigens (if any) must be reported in the subsequent rows.

 

Organism naturally encoding Target (e.g. virus, bacterium)	Transcript Identifier: NCBI Refseq transcript ID	Gene Identifier:   NCBI Refseq Gene ID	Gene Name and Synonyms	DNA Sequence coordinates or locus	Protein Amino Acid Sequence:   FASTA format

 

2. Antibody Products

 

For Antibody Products each clearance request shall (i) designate the primary Antibody and any additional Antibody(ies) (if any) of such Antibody Product, and (ii) contain for each Antibody the following information:

 

(A)          the common name for such Antibody and any known synonyms, if applicable;

 

(C)           a reference amino acid sequence for the baseline protein (i.e., the protein from which variants are established); and

 

(D)           a description of the biological activity of interest of such Antibody. In case the Antibody binds to a non-human protein or a non-human antigen the identity of the non-human protein or non-human antigen should be identified using the above table as for Vaccine Products.

Exhibit 3.5.2
Reserved Antigens

 

[*****] 

 

Exhibit 4.1

First Product R&D Plan

 

[*****]

 

Exhibit 4.2

Second Product R&D Plan

 

[*****]

 

Exhibit 4.3.1(A)

[*****] Product R&D Plan

 

[*****]

 

 Exhibit 4.3.1(B) 

[*****] Product R&D Plan

 

[*****]

 

 Exhibit 4.3.1(C) 

[*****] Product R&D Plan

 

[*****]

 

Exhibit 5.2.1
Key Supply Terms

 

Part (A) 

(for commercial supply)

 

[*****]

 

Part (B) 

(for clinical supply)

 

[*****]

 

Exhibit 6.2 

Key Distribution Terms

 

[*****]

 

Exhibit 8.7.5
Third Party Offset

 

[*****]

 

Exhibit 11.6
Draft Press Release

 

 

PRESS RELEASE

 

For media and investors only

 

Issued: [DAY + MONTH] 2020, London UK; Tübingen, Germany/ Boston, MA, USA

 

GSK and CureVac announce strategic mRNA technology collaboration

 

•	Companies to collaborate on mRNA vaccine and monoclonal antibody research programmes in infectious diseases

 

•	GSK to make equity investment of £130m (€150m) in CureVac, and an upfront payment of £104m (€120m)

 

  

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform.

 

mRNA (messenger RNA) technology is a rapidly progressing, cutting-edge platform for the development of new vaccines and medicines, potentially expanding the range of diseases which can be prevented or treated, while also promising to significantly speed up development and manufacturing. mRNA enables protein synthesis in the human body, carrying the genetic code required for cells to manufacture and express proteins. By using mRNA technology in vaccines and medicines, specific proteins, or antigens, can be produced by the body’s own cells, enabling the human immune system to prevent or fight disease.

 

CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSKs existing scientific leadership in vaccines, including GSKs own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSKs growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.

Roger Connor, President GSK Vaccines, said: “GSK’s self-amplifying mRNA (SAM) vaccine technology has shown us the potential of mRNA technology to advance the science of vaccine development, and CureVac’s experience complements our own expertise. Through the application of mRNA technology, including SAM, we hope to be able to develop and scale up advanced vaccines and therapies to treat and prevent infectious diseases quicker than ever before.”

 

Dr. Franz-Werner Haas, acting Chief Executive Officer of CureVac, added: “We are delighted to partner with GSK. With this collaboration, we are gaining a world-class partner whose expertise and global footprint will allow us to further develop and translate the value of our platform into potential products for the world.”

 

The companies will combine their mRNA expertise on development opportunities across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology, while addressing significant unmet medical need and economic burden. CureVac’s existing COVID-19 mRNA and rabies vaccines research programmes are not included in the collaboration announced today.

 

Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing an approximate 10%,stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.

 

CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.

 

GSK will fund R&D activities at CureVac related to the development projects covered by the collaboration. CureVac will be responsible for the preclinical- and clinical-development through Phase 1 trials of these projects, after which GSK will be responsible for further development and commercialization. CureVac will be responsible for the GMP manufacturing of the product candidates including for commercialization, and will retain commercialization rights for selected countries for all product candidates.

 

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

 

About CureVac’s mRNA technology platform

CureVac’s mRNA technology platform has shown potential in the development and production of mRNA based vaccines and therapeutics. CureVac’s RNAoptimizer platform aims to optimize the properties of mRNA medicines based on its three core pillars: protein design, mRNA optimization and mRNA delivery. The technology can be tailored to induce varying degrees of immune responses against specific protein antigens of choice, potentially providing potent prophylactic vaccines for the prevention of infectious diseases, such as Rabies, as well as immunotherapies for the treatment of cancer. The technology can also be adapted to avoid immune activation for purposes of protein therapy and antibodies, thereby providing potential new therapeutic modalities for patients suffering from a vast range of diseases.

 

About CureVac

CureVac is a leading clinical stage biotechnology company in the field of messenger RNA (mRNA) technology with 20 years of 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. In June 2020, the German Federal Ministry of Economics and Energy announced its commitment to invest 300 million Euros in CureVac through the Kreditanstalt für Wiederaufbau (KfW). CureVac has also entered into collaborations with multinational corporations and organizations, including Boehringer Ingelheim, Genmab, CRISPR Therapeutics, the Bill & Melinda Gates Foundation, CEPI and others. CureVac is headquartered in Tübingen, Germany with sites in Frankfurt and Boston, USA.

For more information, please visit www.curevac.com/ or follow CureVac on Twitter at @CureVacAG.

 

GSK media enquiries:
	Simon Steel	+44 (0) 20 8047 5502	(London)
	Simon Moore	+44 (0) 20 8047 5502	(London)
	Kristen Neese	+1 804 217 8147	(Philadelphia)
	Kathleen Quinn	+1 202 603 5003	(Washington DC)
Analyst/Investor enquiries:	Sarah Elton-Farr	+44 (0) 20 8047 5194	(London)
	Danielle Smith	+44 (0) 20 8047 0932	(London)
	James Dodwell	+44 (0) 20 8047 2406	(London)
	Jeff McLaughlin	+1 215 751 7002	(Philadelphia)
	Frannie DeFranco	+1 215 751 4855	(Philadelphia)

  

CureVac enquiries:

Media enquiries:

Thorsten Schüller, Corporate

Communications

CureVac AG, Tübingen,

Germany

T: +49 7071 9883-1577

thorsten.schueller@curevac.com

 

Investor enquiries:

Dr. Sarah Fakih, Vice President

Investor Relations

CureVac AG, Tübingen,

Germany

T: +49 7071 9883-1298

sarah.fakih@curevac.com

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk Factors” in the company’s Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS

Exhibit 12.5
Data Protection Terms

 

The Parties agree that the processing of Personal Information under or in connection with this Agreement shall be in accordance with this Exhibit, including all Annexes.

 

1.	Definitions

 

In this Exhibit:

 

“CureVac” means CureVac as defined in the Agreement and its Affiliates.

 

“Data Protection Authority” means each person having regulatory or supervisory authority over GSK or CureVac in the area of protection of Personal Information;

 

“Data Protection Laws” means: (a) the GDPR; and (b) all other laws concerning the processing of Personal Information;

 

“GDPR” means the General Data Protection Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data;

 

“GSK” means GSK as defined in the Agreement and its Affiliates.

 

“Party” or “Parties” means CureVac and GSK as defined in this Exhibit.

 

“Personal Information” means information relating to an identified or identifiable individual;

 

“Personal Information Breach” means any actual breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Personal Information transmitted, stored or otherwise processed; and

 

“Transferred Personal Information” means any Personal Information that is transferred pursuant to this Agreement (i) that is transferred to CureVac by GSK operating in the European Union; or (ii) that is transferred to GSK by CureVac operating in the European Union.

 

2.	Data Processing

 

a.

Status of each Party under Data Protection Laws

 

GSK and CureVac acknowledge that the status of each Party is a question of fact determined under Data Protection Laws. Without limiting the foregoing, GSK and CureVac each understand that, in relation to the Transferred Personal Information, GSK and CureVac independently determine how and why Transferred Personal Information is processed (and accordingly each acts as a controller) and all processing of Transferred Personal Information shall be undertaken in accordance with Annex 1 (Controller Terms) to this Exhibit 12.5. 

b.

Description of processing

 

The Parties will document the following information in writing (including in electronic form)

 

Duration, nature and purpose of processing
Duration of processing	[to be documented]
Nature and purpose of processing	[to be documented]
Personal Information
Individuals may include any of:	[to be documented]
Categories of Personal Information may include any of:	[to be documented]
Special categories of Personal Information may include any of:	[to be documented]

3.	Termination or expiry

 

On termination or expiry of this Agreement, this Exhibit shall survive and continue in full effect for as long as Transferred Personal Information is processed by the other Party.

 

4.	Further Assurance

 

a.

If any Data Protection Authority adopts revised standard contractual clauses for the matters addressed in this Exhibit (including any Annex) and one Party notifies the other Party that it wishes to incorporate any element of those standard contractual clauses into this Exhibit, the other Party shall agree to changes (limited only to the extent of the requirement under such revised standard contractual clauses) as reasonably requested by such Party.

 

b.

Both Parties agree that, upon the request of any Party, they shall execute any specific form of data transfer agreement as reasonably requested by such Party to enable the other Party to comply with applicable Data Protection Laws or the requirements of any Data Protection Authority.

ANNEX 1 TO EXHIBIT 12.5 - CONTROLLER TERMS

 

1.	General terms

 

a.

Subject to the remaining provisions of this Annex 1, in relation to the processing of all Transferred Personal Information, each Party:

 

i.

shall comply with its obligations under Data Protection Laws; and

 

ii.

acknowledges that, except as expressly stated otherwise under this Annex 1 or otherwise in the Agreement, it is (as between the Parties) solely responsible for meeting all of its obligations under Data Protection Law.

 

2.	Legal basis and privacy notices

 

a.

Unless expressly agreed otherwise in writing, each Party shall be responsible for the lawfulness of the collection and disclosure to the other Party of the Transferred Personal Information, in particular, for obtaining any consent required by law from all individuals to whom the Transferred Personal Information relates in respect of all processing undertaken by that Party (including any disclosure to the other Party).

 

b.

If the transferring Party obtains consent for the processing of Transferred Personal Information, such consent shall cover the transfer and the further processing of Transferred Personal Information by the other Party for the purposes identified in this Exhibit.

 

c.

Unless expressly agreed otherwise in writing, each Party shall be responsible for providing privacy notices to all individuals to whom the Transferred Personal Information relates in respect of all processing undertaken by that Party. If either Party expressly agrees in writing to provide a privacy notice on behalf of the other Party, it shall ensure that the relevant privacy notices effectively address all information required to be provided under Data Protection Laws and take account of any reasonable proposals by the other Party.

 

3.	Communications

 

a.

If either Party receives any communication from a Data Protection Authority which relates directly or indirectly to:

 

i.

the other Party’s processing of Transferred Personal Information; or

 

ii.

a potential failure to comply with Data Protection Laws in relation to the processing of Transferred Personal Information,

 

the receiving Party, shall, to the extent permitted by Applicable Laws, promptly forward the communication to the other Party and provide the other Party with reasonable cooperation and assistance in relation to the same.

4.	Handling of transferred personal information

 

a.

Each Party shall ensure that Transferred Personal Information supplied to it by or on behalf of the other Party:

 

i.

is only used for the purposes for which it was collected;

 

ii.

is not disclosed to any of its staff unless those persons that have committed themselves to confidentiality and have undergone appropriate training in data protection;

 

iii.

is transferred to another Party or Third Parties only: in accordance with Applicable Laws; and

 

iv.

is kept securely, including by application of the measures set out in Annex 2 (Information Security) to this Exhibit 12.5.

 

5.	Rights of individuals

 

If an individual makes a written request to either Party to exercise any of their rights under Data Protection Laws in respect of Transferred Personal Information, the receiving Party shall respond to that request in accordance with Data Protection Laws. To the extent the request concerns processing of Transferred Personal Information undertaken by the other Party, the receiving Party shall: (i) promptly forward the request to the other Party; and (ii) cooperate and provide reasonable assistance in relation to that request to enable the other Party to respond in accordance with Data Protection Laws.

 

6.	Personal information breach

 

a.

Without limiting any provision of Annex 2 (Information Security) to this Exhibit 12.5, if a Party becomes aware of a Personal Information Breach affecting Transferred Personal Information supplied to it by the other Party, the Party shall:

 

i.

notify the other Party without undue delay, and provide the other Party with a reasonable description of the Personal Information Breach without undue delay as such information becomes available; and

 

not publish any communication concerning the Personal Information Breach without first consulting the other Party, save that it may disclose a breach to the extent required by Applicable Laws (e.g. to Data Protection Authority or to individual(s)).

 

ANNEX 2 TO EXHIBIT 12.5 – INFORMATION SECURITY

 

[to be completed as soon as reasonably practicable after the Closing Date]

Exhibit 13.4
Disclosure Letter

 

[*****]

 

 Exhibit 15.4

Post-Termination Royalties

 

Where this Exhibit 15.4 applies, CureVac shall pay GSK, on a Product-by-Product and country-by-country basis, the royalty payments set forth below for Net Sales by CureVac, its Affiliates, or Sublicensees of such Product, depending in what stage of development that Product finds itself at the effective date of termination. With respect to any payments to be made by CureVac to GSK, the definition of “Net Sales” in Section 1.132 and the provisions of Sections 8.7.2, 8.7.3, 8.7.8, and 8.8 to 8.11 shall apply mutatis mutandis.

 

[*****]

 

 

Exhibit 4.50

 

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.

 

 

COVID COLLABORATION AND LICENSE AGREEMENT

 

 

dated

 

2 APRIL 2021

 

by and between

 

CUREVAC AG

 

and

 

GLAXOSMITHKLINE BIOLOGICALS SA

Exhibits
Exhibit 1.50	CureVac Know How
Exhibit 1.55	CureVac Patent Rights
Exhibit 1.79	Existing COVID Projects
Exhibit 1.102	Government and NGO Contracts
Exhibit 1.120	In-Licensing Agreements
Exhibit 2.1.2	License Terms under LNP Technology
Exhibit 2.7.4	Ever-Warm Strategy
Exhibit 4.1	Initial COVID R&D Plan
Exhibit 5.1	Key Terms of a Clinical Supply Agreement
Exhibit 5.2	Key Terms of a Commercial Supply Agreement
Exhibit 6.2	Key Distribution Terms
Exhibit 8.3.6	Third Party Offset Exhibit
Exhibit 12.5	Data Protection
Exhibit 13.4	Disclosure Letter
Exhibit 15.5	Post-Termination Royalties

COVID COLLABORATION AND LICENSE AGREEMENT

 

This COVID Collaboration and License Agreement (this “Agreement”) is entered into on 2 April 2021 (“Effective Date”)

 

BY AND BETWEEN

 

CUREVAC AG, a German cooperation with offices at [*****] (“CureVac”);

 

AND

 

GLAXOSMITHKLINE BIOLOGICALS SA (“GSK”)

 

INTRODUCTION

 

A.

WHEREAS, CureVac is a biotechnology company that is a pioneer and technology leader in mRNA-based prophylactic and therapeutic approaches and discovers, designs and develops first-in-class mRNA therapies for the prevention and treatment of diseases with unmet medical need. CureVac controls a first generation prophylactic mRNA based vaccine targeting SARS- CoV-2 which is in late stage development, and [*****].

  

B.

WHEREAS, GSK is a world leading global healthcare company developing, manufacturing and commercializing innovative pharmaceuticals, vaccines and consumer healthcare products worldwide.

 

C.

WHEREAS, CureVac and GSK have entered into a Collaboration and License Agreement dated July 15, 2020 on collaborating in the research, development and commercialization of prophylactic and therapeutic non-replicating mRNA based vaccines and antibodies targeting certain infectious disease pathogens, such pathogens among others not including SARS-CoV- 2, and have agreed to amend that agreement on the same date as this Agreement.

 

D.

WHEREAS, CureVac and GSK have decided to build upon their existing collaboration to also collaborate in the research, development and commercialization of mRNA based vaccines targeting SARS-CoV-2 based on the technology controlled by CureVac.

 

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

“2020 Collaboration Agreement” shall mean the Collaboration and License Agreement between CureVac and GSK dated July 15, 2020 (as amended).

 

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 fifty percent (50%) or more 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.

 

1.3

“Agreement” shall have the meaning set forth in the Preamble.

 

1.4

“Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.5

“Ancillary Agreement” shall mean any of the following agreements between the Parties (or their respective Affiliates) relating to this Agreement: any Clinical Supply Agreement; any Commercial Supply Agreement; any Distribution Agreement; any Quality Agreement and any pharmacovigilance agreement.

 

1.6

“Antigen” shall mean any antigen, defined by its amino acid sequence, associated with a Pathogen, together with all Antigen Variants thereof.

 

1.7

“Antigen List Rep” shall mean the representative of CureVac designated as Antigen List Rep under the 2020 Collaboration Agreement.

 

1.8

“Antigen Variant” shall mean any variant of an Antigen, including the wild type, naturally occurring variants, engineered variants wherein modifications to the native amino acid sequence have been introduced (for example, mutated versions, derivatives or fragments), provided, however, that any such variant possesses substantially similar biological activity to the naturally occurring antigen.

 

1.9

“APA Share Credit” shall have the meaning set forth in Section 8.2.2.

 

1.10

“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.

1.11

“Assigned Invention” shall have the meaning set forth in Section 9.4.

 

1.12

“Background Technology” shall mean the CureVac Background Technology and/or GSK Background Technology, as applicable.

 

1.13

“[*****]” shall have the meaning set forth in Section 1.14.

 

1.14	“[*****] Agreement” shall mean the [*****].
1.15	“[*****] Options” shall have the meaning set forth in Section 3.3.1.
1.16	“[*****] Agreement” shall mean [*****].

  

1.17

“[*****] Agreement” shall mean the agreement regarding the provision of COVID-19 Vaccine [*****].

 

1.18

“Brand IP” shall mean any and all rights and privileges in trade names, domain names, brand names, product names, logos and trade dress (and the goodwill of any business symbolized thereby), including trademarks, service marks, copyrights and design rights for any of the above, and any similar intellectual property right recognized from time to time in any jurisdiction, as well as any and all registrations, applications, recordings and other legal protections to the foregoing.

 

1.19

“Breaching Party” shall have the meaning set forth in Section 14.4.

 

1.20

“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 Rixensart, Belgium.

 

1.21

“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 Closing Date and ending on the end of the Calendar Quarter in which the Closing 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 expiry or termination of this Agreement, and “Calendar Quarterly” shall be construed accordingly.

 

1.22

“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 Closing Date and ending on the end of the Calendar Year in which the Closing 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 expiry or termination of this Agreement.

1.24

“Change of Control” shall mean a transaction in which a Party (or any direct or indirect shareholder(s), unitholder(s) or partner(s) together holding (directly or indirectly) over fifty percent (50%) of the voting rights attached to the shares, units or partnership interests in a Party): (i) sells, conveys or otherwise disposes of all or substantially all of the Party’s (or their indirect interest(s) in the Party’s) property, assets or business; or (ii) merges or consolidates with any other entity; or (iii) effects any other transaction or series of transactions; in each case of clause (ii) or (iii), such that the ultimate direct or indirect shareholder(s), unitholder(s) or partner(s)of such Party immediately prior thereto, in aggregate, no longer own, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting securities or capital stock of the surviving entity following the closing of such merger, consolidation, other transaction or series of transactions. For the avoidance of doubt, “Change of Control” shall not mean a transaction which, in the case of paragraph (ii) or (iii), results in a person owning, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting securities or capital stock of the surviving entity and where there is an agreement or arrangement between that person (or any of its direct or indirect shareholders, unitholders or partners) and the relevant Party (or any of its direct or indirect shareholders, unitholders or partners) to reverse the effects of this transaction or to implement a further transaction so that the ultimate shareholders, unitholders or partners of the relevant Party immediately prior thereto will again own, directly or indirectly, beneficially or legally, more than fifty percent (50%) of the voting rights attached to the outstanding voting shares, units or partnership interests of the relevant Party or surviving entity.

 

1.25

“Clinical Phase I Study” shall mean a study in humans which provides for the first administration to humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) or the non-United States equivalent thereof. For the avoidance of doubt, a Clinical Phase I Study may generate sufficient data (if successful) to commence pivotal studies/Clinical Phase III Studies, but it shall not constitute a Clinical Phase II Study.

 

1.26

“Clinical Phase II Study” shall mean a clinical study (other than a Clinical Phase I 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 studies/Clinical Phase III Studies, as further defined in 21 CFR §312.21(b) or the non-United States equivalent thereof.

 

1.27

“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 an application to obtain Regulatory Approval to market such product, as further defined in 21 CFR §312.21(c) or the non-United States equivalent thereof.

 

1.28

“Clinical Studies” shall mean all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including pivotal studies.

 

1.29

“Clinical Supply Agreement” shall have the meaning set forth in Section 5.1.

1.30

“Closing Date” shall mean the date on which the condition under Section 1.183 is fulfilled or waived by both Parties.

 

1.31

“CMC Development” shall mean all research and development activities conducted in respect of the Manufacture of COVID 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.

 

1.32

“CMO” shall mean a contract manufacturing organization.

    

1.33

“COGS” shall mean the total cost of Manufacture of a unit of COVID Product sold and shall include Manufacturing Costs and Pass-Through Costs, as defined below, and subject to periodic review and changes over time:

  

“Manufacturing Costs” shall mean [*****]:

 

(i)

“Standard Manufacturing Cost” is a budgeted cost per unit established to facilitate inventory evaluation, planning and budgeting, which shall include:

 

[*****].

 

(ii)

“Cost Variances” is the variance between, for a period to be agreed by the Parties, actual costs of Manufacturing versus the Standard Manufacturing Cost and may include [*****];

  

(iii)

“Other Manufacturing Costs” are additional costs of Manufacturing which [*****]; and

  

(iv)

“Freight” are costs incurred for [*****].

  

Manufacturing Costs shall exclude: (a) excess costs that result from a Party’s (or its Affiliate’s) negligence or willful misconduct.

 

Based on each Party’s accounting policies, Manufacturing Cost can be calculated [*****].

 

“Pass-Through Costs” within COGS shall include [*****]. 

 

1.34

“Collaboration COVID Vaccine Product” shall mean:

 

(i)

each CureVac mRNA-Based vaccine targeting the SARS-CoV-2 Pathogen and using the SARS-CoV-2 spike protein, or any Antigen Variant thereof, as primary vaccine Antigen that the Parties have agreed to Develop and Commercialize under this Agreement during the Term, but excluding any First-Gen COVID Vaccine Product and Pathogen Combination Product; and

 

(ii)

each vaccine product targeting coronaviruses in respect of which GSK exercises its exclusive option pursuant to Section 3.7.3 of the 2020 Collaboration Agreement, where CureVac elects, in accordance with Section 3.7.3(a)(i) of the 2020 Collaboration Agreement, to Develop and Commercialize such product on a cost and profit split basis under this Agreement.

For clarity, Collaboration COVID Vaccine Products shall incorporate a mRNA backbone (otherwise known as the non-coding region) that is not identical to the First-Gen mRNA Construct.

 

1.35

“Combination Product” shall mean a product that is:

 

(i)

a single pharmaceutical formulation containing Drug Substances associated with a COVID Product and one or more other therapeutically or prophylactically active pharmaceutical ingredients [*****];

 

(ii)

any combination therapy comprised of a Finished Product and one or more other therapeutically or prophylactically active products, that is (x) priced and sold in a single package containing such multiple products; or (y) packaged separately but sold together for a single price; or

 

(iii)

comprised of a Finished 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. For clarity, a Pathogen Combination Product shall not be a Combination Product, unless it is (A) combined with another therapeutically or prophylactically active ingredient/product or (B) comprised of a Finished Product and a companion or complementary diagnostic product, as set forth in (i), (ii) or (iii) above.

 

1.36

“Commercial Supply Agreement” shall have the meaning given in Section 5.2.

 

1.37

“Commercialization” shall mean any and all activities directed to the preparation for sale of, offering for sale of, or sale of a COVID Product, including activities related to marketing, promoting, distributing, importing and exporting of COVID Products, interacting with Regulatory Authorities regarding any of the foregoing and medical affairs functions. For the avoidance of doubt, “Commercialization” shall not include the Manufacture of COVID Products. When used as a verb, to “Commercialize” and “Commercializing” shall mean to engage in Commercialization, and “Commercialized” has a correlative meaning.

 

1.38

“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.

 

For purposes of the confidentiality obligations set forth herein, (a) GSK Know-How, GSK Materials and GSK Inventions shall be deemed Confidential Information of GSK; and CureVac Know-How, CureVac Materials and CureVac 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 Agreement.

1.39

“Confidentiality Agreement” shall mean that certain Confidential Disclosure Agreement entered into between the Parties as at January 9, 2020.

 

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, provided that any intellectual property right in-licensed by a Party from the other Party under the 2020 Collaboration Agreement shall not be Controlled by such Party for the purpose of this Section 1.40.

 

1.41

“Cover” shall mean, (i) 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 COVID Product, or (ii) with regard to Know-How, that the use or disclosure of such Know- How without a license would be actionable.

 

1.42

“COVID Product(s)” shall mean (i) the Collaboration COVID Vaccine Product(s); (ii) the Pathogen Combination Product(s); and (iii) upon the effective date of Option Exercise pursuant to Section 3.3.6, the First-Gen COVID Vaccine Products, in each case of (i), (ii) and (iii) including Product Adjustments. COVID Products may be in Drug Product or Finished Product form (or precursors thereto). For the avoidance of doubt, the term “COVID Products” shall not include the First-Gen COVID Vaccine Product(s) prior to effective Option Exercise by GSK.

 

1.43

“COVID R&D Plan” shall have the meaning set forth in Section 4.1.

 

1.44

“CRO” shall mean a contract research organization or a contract development and manufacturing organization.

 

1.45

“CureVac Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.46

“CureVac Background Technology” shall have the meaning set forth in Section 9.1.

 

1.47

“CureVac Elements” has the meaning given in Section 2.8.1.

 

1.48

“CureVac Indemnified Parties” shall have the meaning set forth in Section 13.1.

 

1.49

“CureVac Invention” shall have the meaning set forth in Section 9.3.1.

 

1.50

“CureVac Know-How” shall mean (i) all Know-How within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that is necessary or useful for the Parties to Develop, Manufacture and/or Commercialize COVID Products under this Agreement, provided that (x) with respect to Know-How within the CureVac Background Technology owned by a Third Party that is not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of COVID Products in the Field in the Territory and that comes under CureVac’s Control, this shall only include Know-How which is deemed CureVac Know-How pursuant to Section 2.8.1; and (y) this shall not include the Know-How of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac after the Effective Date solely as a result of a Change of Control in CureVac; and (ii) all Know-How Controlled by CureVac or its Affiliates arising or generated in connection with the performance of activities under this Agreement; provided, however, that CureVac Know-How does not include Know-How related to (A) LNP Technology Controlled by a Third Party; and (B) [*****]. CureVac Know-How shall include (i) Know-How comprised in the CureVac Background Technology; and (ii) Know-How related to CureVac Inventions, CureVac’s share in Joint Product Inventions or Joint Other Inventions, (iii) subject to Section 7.3, Know-How related to LNP technology owned or Controlled by CureVac (other than the Licensed LNP), (iv) subject to Section 7.3, Know-How related to CVCMs; and (v) other Know-How generated by CureVac under this Agreement. Without limiting Section 9.1, the CureVac Know-How existing at the Effective Date is further described in Exhibit 1.50.

 

1.51

“CureVac Manufacturing Technology” shall mean CureVac Patent Rights and CureVac Know-How that are required for the Manufacture of COVID Products.

 

1.52	“CureVac Materials” shall mean [*****] that are supplied or otherwise made available by or on behalf of CureVac and/or its Affiliate(s) to GSK hereunder for the purposes of this Agreement (excluding, for clarity, any Confidential Information, or any COVID Product).

 

1.53	“CureVac mRNA” shall mean [*****] on the Effective Date or during the Term.

 

1.54

“CureVac mRNA-Based” shall mean, with respect to a vaccine, that such vaccine is encoded by one or more CureVac mRNAs.

 

1.55

“CureVac Patent Right(s)” shall mean (i) all Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that are necessary or useful for the Development, Manufacture and/or Commercialization of COVID Products under this Agreement, provided that (x) with respect to Patent Rights within the CureVac Background Technology owned by a Third Party that are not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of COVID Products in the Field in the Territory and that come under CureVac’s Control after the Effective Date, this shall only include Patent Rights which are deemed CureVac Patent Rights pursuant to Section 2.8.1; and (y) this shall not include the Patent Rights of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac, and (ii) all CureVac Program Patent Right and CureVac’s interest in Joint Patent Rights; provided, however, that CureVac Patent Rights do not include Patent Rights within [*****]. CureVac Patent Rights shall include (i) Patent Rights comprised in the CureVac Background Technology; and (ii) CureVac’s share in Joint Patent Rights, (iii) CureVac Program Patent Rights; (iv) subject to Section 7.3, Patent Rights related to the LNP technology owned or Controlled by CureVac (other than the Licensed LNP) and CVCMs. The CureVac Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date are listed in Exhibit 1.55.

 

 

1.56

“CureVac Program Patent Right” shall have the meaning set forth in Section 9.6.1.

 

1.57

“CureVac Project Leader” shall have the meaning set forth in Section 7.1.2.

 

1.58

“CureVac Technology” shall mean CureVac Patent Rights and CureVac Know-How.

 

1.59

“CureVac Territory” shall mean Austria, Germany and Switzerland.

 

1.60

“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 the formulation of Drug Substance.

 

1.61

“CVnCoV” shall mean the vaccine named CVnCoV, Developed and Controlled by CureVac and targeting the SARS-CoV-2 Pathogen, which (i) is in Clinical Phase IIb/III Studies as at the Effective Date, (ii) uses the SARS-CoV-2 spike protein as primary vaccine Antigen, and (iii) incorporates the First-Gen mRNA Construct.

 

1.62

“Development” shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the COVID 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 COVID Products for use in the Field. “Development” shall include CMC Development, delivery system development, mRNA sequence optimization, protein design, non-clinical testing, mechanism of action 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.

 

1.63

“Development Costs” shall mean:

 

i.

the following costs, which are incurred in accordance with the applicable COVID R&D Plan and further detailed in the Development budget set out in the COVID R&D Plan: [*****];

 

j.

the following other costs (to the extent not covered by the COVID R&D Plan): [*****].

1.64

“Development Data” shall mean: (i) CMC Development data (including records of Manufactured batches); (ii) any non-clinical or clinical findings, results and other research data relating to the COVID Products, in any format; and (iii) the formal reports of preclinical toxicology studies and Clinical Studies, such data in each case of (i), (ii) and (iii) required for the Development, Manufacture or Commercialization of the COVID Products, including but not limited to, INDs and other regulatory filings and registration dossiers.

 

1.65

“Development Transfer Materials” shall have the meaning set forth in Section 4.7.

 

1.66

“Diligent Efforts” shall mean, with respect to a Party, those efforts, expertise and resources commensurate with efforts, expertise and resources commonly used in the biopharmaceutical industry by a company of comparable size in connection with the development, manufacture and/or commercialization of a comparable high priority 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, public health, 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. Diligent Efforts shall be determined on a market-by-market and indication-by-indication basis for each COVID Product, and it may change over time.

 

1.67

“Disclosing Party” shall have the meaning set forth in Section 11.1

 

1.68

“Disclosure Letter” shall have the meaning set forth in Section 13.4.

 

1.69

“Distribution Agreement” shall have the meaning set forth in Section 6.2.

 

1.70

“Drug Product” shall mean, for a given COVID Product, the drug product form thereof, comprising of one or more Drug Substance(s) of that COVID Product and formulated with the Licensed LNP (or, subject to Section 7.3, an LNP Controlled by CureVac or a CVCM), and any excipients.

 

1.71

“Drug Substance” shall mean the active ingredient(s) of a COVID Product, being one or more mRNA molecules which contains the genetic information for the relevant Antigen(s).

 

1.72

[*****].

 

1.73

“Effective Date” shall have the meaning set forth in the Preamble.

1.74

“EMA” shall mean the European Medicines Agency.

 

1.75

“Enhanced Diligent Efforts” means, with respect to GSK, marketing efforts that are equal to, or which exceed, in all material respects, those marketing efforts undertaken by GSK for the commercialization of any New Non-mRNA COVID Product, taking into account issues of safety and efficacy, product profile, public health, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, product reimbursement, and other relevant factors such as technical, legal, scientific, or medical factors. Enhanced Diligent Efforts shall be determined on a market-by-market and indication-by- indication basis for each COVID Product, and it may change over time.

 

1.76

“[*****] Agreements” shall have the meaning set forth in Section 2.7.4.

 

1.77

“Exclusive Option” shall have the meaning set forth in Section 3.3.2.

 

1.78

“Executive Officers” the Chief Executive Officer of CureVac (or a senior executive officer of CureVac designated by CureVac’s Chief Executive Officer) and the President of GSK Vaccines (or a senior executive officer of GSK designated by the President of GSK Vaccines).

 

1.79

“Existing COVID Projects” shall mean the following vaccine development projects in which GSK is involved:

 

[*****].

 

1.80

[*****].

 

1.81

“FDA” shall mean the U.S. Food and Drug Administration.

 

1.82

“Field” shall mean any and all prophylactic and/or therapeutic uses for the prevention, delay of onset or treatment of diseases caused by the SARS-CoV-2 Pathogen in humans.

1.83

“Filled Containers” shall mean, for a given COVID Product, Drug Product, diluted and filled in vials, without labelling or packaging.

 

1.84

“Financial Partner” shall have the meaning set forth in Section 11.4.1 below.

 

1.85

“Finished Product” shall mean, for a given COVID Product, the final presentation of such COVID Product, following labelling and packaging of Filled Containers, as registered in the applicable Regulatory Approval.

 

1.86

“First [*****] Option” shall have the meaning set forth in Section 3.3.1.

 

1.87

“First Commercial Sale” shall mean, on a COVID Product-by-COVID Product and country- by-country basis, the first sale of a COVID Product by or on behalf of GSK or its Affiliates or Sublicensees, or by CureVac or its Affiliates or Sublicensees, such as but not limited to, sales to a Third Party wholesaler, pharmacy, outpatient clinic, inpatient clinic, hospital, dispensing physician or government agency in a given country after necessary Regulatory Approval has been granted with respect to such COVID Product in such country, provided, however, that in the event of a sale of a COVID Product prior to Regulatory Approval which is substantially comparable to a commercial sale effected only after Regulatory Approval is obtained, then the first sale in any such arrangement shall also constitute a First Commercial Sale. For the avoidance of doubt, “treatment IND sales”, “named patient sales” and “compassionate use sales” shall not be construed as a First Commercial Sale if the aggregate, annual Net Sales for all such programs are less than EUR [*****]. For avoidance of doubt, any sale of a COVID Product by GSK to an Affiliate or Sublicensee or subcontractor is not a First Commercial Sale.

 

1.88

“First-Gen COVID Booster Vaccine” shall have the meaning set forth in Section 1.89.

 

1.89

“First-Gen COVID Vaccine Product” shall mean (i) CVnCoV, and each vaccine Controlled by CureVac targeting the SARS-CoV-2 Pathogen that incorporates the First-Gen mRNA Construct (and not, for the avoidance of doubt, any other mRNA backbone), including vaccines modified to address naturally occurring variants of the SARS-CoV-2 spike protein, and (ii) each vaccine that incorporates the First-Gen mRNA Construct (and not, for the avoidance of doubt, any other mRNA backbone) boosting the immune response from a primary vaccination with a First-Gen COVID Vaccine Product or another vaccine targeting the SARS-CoV-2 Pathogen (“First-Gen COVID Booster Vaccine”).

 

1.90

“First-Gen COVID Vaccine Products Dossiers/Data” shall have the meaning set forth in Section 4.8.4.

 

1.91

“First-Gen mRNA Construct” means the “backbone” (otherwise referred to as the non-coding region) of CVnCoV, further details of which are set out in the dossier forming part of each application for Regulatory Approval.

 

1.92

“First Regulatory Approval” shall mean, in relation to each COVID Product, unless expressly stated otherwise in this Agreement, the earlier of (i) final marketing authorization for a COVID Product in any jurisdiction of the Territory, or (ii) the grant of any conditional authorization for a COVID Product in any jurisdiction of the Territory.

1.93

“Force Majeure” shall have the meaning set forth in Section 16.2.

 

1.94

[*****].

  

1.95

“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 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 by the number of FTE hours applicable for such accounting period based on [*****] working hours per year. FTE shall include the employee required to execute the COVID R&D Plan provided however that the costs of employees already taken into account in the calculation of SG&A or COGS shall not be included. FTE shall not include personnel undertaking 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.

 

1.96

“FTE Rate” shall mean for GSK and CureVac, as applicable, for the period commencing on the Effective Date until such time as the Parties mutually agree otherwise, €[*****] per annum. The FTE Rate shall include all fully loaded costs, including costs of salaries (including overtime), benefits, other employee costs, overhead and supporting general and administration allocations. The Parties may agree on an increase of the FTE Rate for inflation on an annual basis based upon the percentage increase in the European Consumer Price Index.

 

1.97

“Good Clinical Practices” or “GCP” shall mean, in connection with a Clinical Study, current practices set forth in or required by (i) the World Medical Association’s Declaration of Helsinki entitled ‘Ethical Principles for Medical Research Involving Human Subjects’ (ii) the principles of International Conference on Harmonization Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) E6 and E11; (iii) the Directive 2001/20/EC of the European Union and in guidance published by the European Commission in relation to such Directive and any local laws, rules and regulations that implement such Directive and guidance; (iv) provisions of Title 21 of the Code of Federal Regulations (including Parts 11, 50, 54, 56, 312, 314, 320, 601 and 610) and all rules, regulations, order and guidance’s published thereunder; and (v) any other country in which the Clinical Study is conducted.

 

1.98

“Good Distribution Practices” or “GDP” shall mean the current (at a given time) standards, practices and procedures regarding the distribution of pharmaceutical products promulgated or endorsed by a Regulatory Authority and all Applicable Laws with respect thereto, as defined further or otherwise in the Distribution Agreement or a quality agreement ancillary thereto.

 

1.99

“Good Laboratory Practices” or “GLP” shall mean, at a given time, the current good laboratory practice standards promulgated or endorsed by the US Food and Drug Administration as defined in Part 58 of the Code of Federal Regulations Title 21, or comparable regulatory standards promulgated by the EMA or other applicable Regulatory Authority, as may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.100

“Good Data Management Practices” shall have the meaning set forth in Section 12.3.

 

1.101

“Good Manufacturing Practices” or “GMP” shall mean the current (at a given time) standards, practices and procedures regarding the Manufacturing of human vaccines promulgated or endorsed by a Regulatory Authority and all Applicable Laws with respect thereto, including:

 

(i)

the standards, rules, principles and guidelines set out in Chapter II of EC Commission Directive 2003/94/EC together with the guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC and 91/412/EEC, contained in Volume 4 of “The Rules Governing Medicinal Products in the European Union”.

 

(ii)

Parts 210 and 211 of Title 21 of the Code of Federal Regulations and all related guidance published by the FDA;

 

(iii)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Quality Guidelines relating to good manufacturing practice;

 

(iv)

the “Good Manufacturing Practices for Pharmaceutical Products” promulgated by the World Health Organization (“WHO”),

 

provided that term may be defined further or otherwise in the Quality Agreements regarding the supply of COVID Products (either in Drug Substance, Drug Product, Filled Containers or Finished Product format) for clinical or commercial purposes entered pursuant to this Agreement.

 

1.102

“Government and NGO Contracts” shall mean: (i) [*****] and (ii) all agreements with governments, supra-national organizations or non-profit organizations relating to the First-Gen COVID Vaccine Products entered into by CureVac before the Effective Date or following the Effective Date in accordance with Section 2.7.4; and (iii) all agreements with governments, supra-national organizations or non-profit organizations relating to the First-Gen COVID Vaccine Products and the Collaboration COVID Vaccine Products that are entered into by the Parties following the Effective Date in accordance with Section 2.7.4. The Government and NGO Contracts existing at the Effective Date are listed in Exhibit 1.102.

 

1.103

“Government Official” (where ‘government’ means all levels and subdivisions of governments, i.e. local, regional, national, administrative, legislative, executive, or judicial, and royal or ruling families) shall mean: (i) any officer or employee of a government or any department, agency or instrumentality of a government (which includes public enterprises, and entities owned or controlled by the state); (ii) any officer or employee of a public international organization such as the World Bank or United Nations; (iii) any officer or employee of a political party, or any candidate for public office; (iv) any person defined as a government or public official under Applicable Law (including anti-bribery and corruption laws) and not already covered by any of the above; and/or; (v) any person acting in an official capacity for or on behalf of any of the above. “Government Official” shall include any person with close family members who are Government Officials (as defined above) with the capacity, actual or perceived, to influence or take official decisions affecting either Party’s business.

1.104

“GSK Alliance Manager” shall have the meaning set forth in Section 7.1.1.

 

1.105

“GSK Background Technology” shall have the meaning as set forth in Section 9.1.

 

1.106

“GSK Indemnified Parties” shall have the meaning set forth in Section 13.2.

 

1.107

“GSK Invention” shall have the meaning set forth in Section 9.3.2.

 

1.108

“GSK Know-How” shall mean all Know-How Controlled by GSK or its Affiliates as at the Effective Date or thereafter during the Term that (i) is necessary for CureVac to perform the obligations and other activities pursuant to this Agreement, or (ii) is used by or on behalf of GSK its Affiliates or Sublicensees to Develop, Manufacture and Commercialize COVID Products under this Agreement. GSK Know-How shall include (i) Know-How comprised in the GSK Background Technology; and (ii) Know-How related to GSK Inventions, Joint Product Inventions or Joint Other Inventions, and (iii) other Know-How generated by GSK under this Agreement.

 

1.109

“GSK Materials” shall mean any [*****] that are supplied or otherwise made available by or on behalf of GSK and/or its Affiliate(s) to CureVac for the purposes of this Agreement (excluding, for clarity, any Confidential Information, or any COVID Product).

 

1.110

“GSK Patent Right(s)” shall mean all Patent Rights Controlled by GSK or its Affiliates as at the Effective Date or thereafter during the Term that (i) are necessary for CureVac to perform the obligations and other activities pursuant to this Agreement, or (ii) are used by or on behalf of GSK its Affiliates or Sublicensees to Develop, Manufacture and/or Commercialize COVID Products under this Agreement. GSK Patent Rights shall include Patent Rights comprised in the GSK Background Technology, GSK Program Patent Rights and GSK’s interest in Joint Patent Rights.

 

1.111

“GSK Program Patent Right” shall have the meaning set forth in Section 9.6.2.

 

1.112

“GSK Project Leader” shall have the meaning set forth in Section 7.1.2.

 

1.113

“GSK Technology” shall mean any and all GSK Patent Rights and GSK Know-How.

 

1.114

“GSK Territory” shall mean all countries of the world other than the countries included in the CureVac Territory.

1.115

“GxP” shall mean the good practice regulations in the pharmaceutical industry, including Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices and Good Distribution Practices (GMP, GLP, GCP and GDP).

 

1.116

[*****].

  

1.117

“Human Biological Samples” shall mean human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including, but not limited to, hair, nail clippings, teeth, urine, faeces, breast milk, and sweat.

 

1.118

“IND” shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the United States, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto, including EMA, prior to beginning clinical trials in humans in that country or in that group of countries.

 

1.119

“In-Licensed IP” shall have the meaning set forth in Section 2.8.1.

 

1.120

“In-Licensing Agreement” shall mean the LNP Agreement, the agreements listed in Exhibit 1.120, and any other agreement with a Third Party pursuant to which CureVac Controls CureVac Technology or LNP Technology.

 

1.121

“Initiation” shall mean, with respect to a Clinical Study, the first administration of the first subject in such Clinical Study.

 

1.122

“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 GSK or Affiliates of CureVac or GSK, 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 COVID R&D Plan.

 

1.123

“IP Sub-Committee” shall mean the sub-committee to be established pursuant to Section 7.6.

 

1.124

“Joint Product Invention” shall have the meaning set forth in Section 9.3.3.

 

1.125

“Joint Other Invention” shall have the meaning set forth in Section 9.3.4.

 

1.126

“Joint Patent Rights” shall have the meaning set forth in Section 9.7.

 

1.127

“Joint Steering Committee”, and “JSC” shall have the meaning set forth in Section 7.2.

 

1.128

“JST” shall have the meaning set forth in Section 4.8.4.

1.129

“JST Charter” shall have the meaning set forth in Section 4.8.4

 

1.130

“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.

 

1.131

“Licensed LNP” shall mean the LNP that is Controlled by CureVac as at the Effective Date pursuant to the LNP Agreement. Any amendment to the LNP Agreement made after the Effective Date shall not adversely affect the rights or increase the obligations of GSK or CureVac under this Agreement.

 

1.132

“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.

 

1.133

“LNP Agreement” shall mean the Non-Exclusive License Agreement between CureVac and [*****]. For clarity, the use of any LNP Technology under this Agreement in relation to a COVID Product shall not count towards the limit on the number of LNP Licenses under the 2020 Collaboration Agreement.

 

1.134

“LNP License” shall have the meaning set forth in Section 2.1.2.

 

1.135

“LNP Provider” shall mean [*****].

 

1.136

“LNP Technology” shall mean the Patent Rights and Know-How Covering the Licensed LNP.

 

1.137

“Major Markets” shall mean [*****].

  

1.138

“Manufacture” shall mean all manufacturing operations (including for Drug Substance, Drug Product, fill and finish, packaging and labelling) for COVID 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 Finished Product, or any intermediate thereof, pre-clinical, clinical and commercial production, product, stability testing, quality assurance, and quality control. “Manufacturing” has a correlative meaning.

 

1.139

“Manufacturing Technology Transfer Materials” shall have the meaning set forth in Section 5.6

 

1.140

“Materials” shall mean CureVac Materials and GSK Materials.

1.141

“mRNA” shall mean a replicating or non-replicating polynucleotide that is capable of directing the cellular machinery of a cell to produce polypeptide and contains naturally occurring nucleosides (e.g. Cytosine, Guanine, uracil, adenine) or chemical analogues thereof. The term encompasses analogues such as those containing modified backbones.

 

1.142

“mRNA-Based” shall mean, with respect to a vaccine, that the vaccine Antigen is encoded by one or more mRNAs.

 

1.143

“Net Profits” shall have the meaning set forth in Section 8.2.3.

 

1.144

“Net Sales” shall mean the gross invoice price of COVID Product sold by the selling Party or its Affiliates or Sublicensees directly to a Third Party, less the following deductions if and to the extent such deductions to unaffiliated entities are actually allowed and granted:

 

(i)

trade, quantity, and/or cash discounts, charge-back payments, allowances or rebates, including promotional or similar discounts or rebates, and discounts or rebates to governmental or managed care organizations;

 

(ii)

discounts provided in connection with coupon, voucher or similar patient programs;

 

(iii)

credits or allowances given or made with respect to a COVID Product by reason of rejection, defects, recalls, returns, rebates, or retroactive price reductions;

 

(iv)

any tax, tariff, duty or government charge (including any sales, value added, excise or similar tax or government charge, but excluding any income tax) levied on the sale, transportation or delivery of COVID Product and borne by the selling Party, its Affiliates or Sublicensees without reimbursement from any Third Party;

 

(v)

any charges for freight, postage, shipping or transportation, or for insurance, in each case to the extent borne by the selling Party, its Affiliates or Sublicensees without reimbursement from any Third Party; and

 

(vi)

any administrative fees paid to group purchasing organizations or managed care entities for the sale of COVID Product (provided, however, that such deduction may not exceed two percent (2%) of the gross sales in the corresponding accounting period).

 

All such discounts, allowances, credits, rebates and other deductions shall be fairly and equitably allocated to the sale of the relevant COVID Product by the selling Party, its Affiliates or Sublicensees, such that the COVID Product does not bear a disproportionate portion of such deductions as compared to other products sold separately from but with a certain link or other connection to the COVID Product. For the avoidance of doubt, the Net Sales shall be calculated only once for the first bona fide arm’s length sale of the COVID Product by either the selling Party, its Affiliate or its Sublicensee, to a Third Party which is neither an Affiliate nor a Sublicensee of the selling Party. Net Sales shall be determined in accordance with International Financial Reporting Standards (IFRS) applied in a consistent manner.

 

In the event a COVID Product is sold as part of a Combination Product (either as a separate Finished Product sold together with other products or because the Drug Substances associated with that COVID Product are formulated with additional other therapeutically or prophylactically active pharmaceutical ingredients (including, if mutually agreed between the Parties, [*****]) or companion or complementary diagnostic), Net Sales of the Combination Product will be calculated, on a country-by-country basis, as follows:

 

(i)

If (x) the COVID Product and (y) the other product(s) or active pharmaceutical ingredient are also sold separately in the applicable country, Net Sales of the COVID Product portion of the Combination Product will be calculated by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in the applicable country of the COVID 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 products or active ingredients in the Combination Product sold separately during the applicable Calendar Quarter.

 

(ii)

If the COVID Product is sold separately, but the average gross selling price of the other product(s) or active ingredients cannot be determined, Net Sales of the Combination Product shall be equal to the Net Sales of the Combination Product multiplied by the fraction A/C wherein A is the average gross selling price of the COVID Product and C is the average gross selling price of the Combination Product.

 

(iii)

If the other product(s) or other active ingredients is/are sold separately, but the average gross selling price of the COVID Product cannot be determined, Net Sales of the Combination Product shall be equal to the Net Sales of the Combination Product multiplied by the following formula: one (1) minus B/C wherein B is the average gross selling price of the other product(s) or active ingredients and C is the average gross selling price of the Combination Product.

 

(iv)

If the average gross selling price of neither the COVID Product, nor the other product(s) or active ingredients, can be determined, e.g., because neither the COVID Product, nor the other product in a Combination Product, are being sold separately, Net Sales of the Combination Product shall be equal to Net Sales of the Combination Product multiplied by A/B wherein A is the number of COVID Products comprised in the Combination Product and B is the sum of “one” for each COVID Product and the relative value of the other product(s) and/or other active pharmaceutical ingredients comprised in the Combination Product, such value to be determined by the patent protection status of the respective products, the development costs of the respective products, and the pricing of comparable products in the Major Markets. For illustration purposes, if there are two additional active ingredients in a Combination Product, one valued at 30 percent of the average price of the COVID Products, and one valued at 50 percent of the average price of the COVID Products, A/B equals 2/2.8, and Net Sales are multiplied by 0.71. The Parties will agree on the respective values in the JSC. If the JSC is unable to agree on the respective values within [*****] the matter being referred by either Party to the JSC, either Party may refer the matter for resolution in accordance with Section 15.5(viii), provided that the reference to “fair market value” shall be replaced with the value of the respective COVID Product and the relative value of the other product(s) and/or other active pharmaceutical ingredients. Each Party will bear equally the cost of the experts appointed in accordance with Section 15.5(viii).

 

(v)

The average gross selling price for such other product(s) or active ingredients contained in the Combination Product shall be calculated for each [*****] period 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 [*****] period during which a Combination 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 [*****] period. In the following Calendar Year the average gross selling price of the previous year shall apply from the second royalty payment on.

 

 

1.145

“New Non-mRNA COVID Product” means any non-mRNA Based vaccine for use in the Field, which falls outside the limitations set out in Section 2.3.1, except those resulting from an Existing COVID Project.

 

1.146

“NIAID” shall mean the U.S. National Institute of Allergy and Infectious Diseases, an institute of the U.S. National Institutes of Health.

 

1.147

“Non-Breaching Party” shall have the meaning set forth in Section 14.5.

 

1.148

“Option Exercise” shall have the meaning set forth in Section 3.3.6.

 

1.149

“Option Exercise Fee” shall have the meaning set forth in Section 3.3.5.

 

1.150

“Option Exercise Notice” shall have the meaning set forth in Section 3.3.3.

 

1.151

“Option Period” shall have the meaning set forth in Section 3.3.2.

 

1.152

“Other Allowable Expenses” shall mean shall mean (i) amounts paid to Third Parties ([*****]) in connection with a product liability claim or other claim, suit, proceeding, litigation or action relating to alleged defects in a COVID Product resulting from the Development, Manufacture or Commercialization of such COVID Product, (ii) expenses directly associated with notification, retrieval and return of a COVID Product, destruction of such returned Collaboration Product, replacement of a Collaboration Product and distribution of such replacement COVID Product, incurred with respect to a recall of such COVID Product, but in each of the foregoing cases excluding any such payments, costs and expenses caused by the negligence or willful misconduct of a Party or its Affiliates or Sublicensees, which amounts shall be solely borne by such Party.

 

1.153

“Party” shall mean CureVac or GSK (together, “Parties”).

 

1.154

“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.

 

1.155

“Pathogen” shall mean any infectious disease causing agent such as a virus, bacterium, fungus, protozoan or other type of microorganism.

1.156

“Pathogen Combination Product” shall mean a CureVac mRNA-Based vaccine that incorporates a mRNA construct that is not identical to the First-Gen mRNA Construct and targets the SARS-CoV-2 Pathogen and one or more Collaboration Pathogen(s) (as such term is defined in the 2020 Collaboration Agreement); provided that upon the effective date of Option Exercise a Pathogen Combination Product may also incorporate the First-Gen mRNA Construct.

 

1.157

“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.

 

1.158

“Product Adjustment” shall have the meaning set forth in Section 3.2.2.

 

1.159

“Program” shall mean, on a COVID Product by COVID Product basis, any and all Development activities for such Product, including under the COVID R&D Plan, and all Manufacturing and Commercialization activities conducted in respect of that COVID Product.

 

1.160

“Program Patent Rights” shall mean Patent Rights Covering Inventions.

 

1.161

“Project Leaders” shall have the meaning set forth in Section 7.1.2.

 

1.162

“Quality Agreement” shall mean a quality agreement between CureVac and GSK setting out further administrative, technical and quality provisions regarding the Manufacture and supply of a COVID Product (or intermediary version thereof) for Development or Commercialization purposes, as applicable.

 

1.163

“Receiving Party” shall have the meaning set forth in Section 11.1.

 

1.164

“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, regional, state or local Regulatory Authority, 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 COVID Product in a given jurisdiction.

 

1.165

“Regulatory Authority” shall mean any competent regulatory or governmental authority which regulates any aspect of the Development, Manufacturing or Commercialization of a COVID Product, including those specifically referred to in this Agreement or any Ancillary Agreement.

 

1.166

“Regulatory Exclusivity” shall mean, on a country-by-country and COVID Product-by- COVID Product basis, an additional protection, other than patent protection, granted by a Regulatory Authority that confers an exclusive period during which a Party or its Affiliates or Sublicensees have the exclusive right to market or sell a COVID Product in such country through a regulatory exclusivity right (e.g., new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity), provided that regulatory exclusivity shall only be deemed to exist in a country if (i) Applicable Laws, and the guidance, policies and practice of the competent Regulatory Authority allow other mRNA-Based products to qualify as generic or biosimilar versions of a COVID Product; and (ii) as a result, absent or after the expiry of the regulatory exclusivity right, such mRNA- Based products can enter the market of the country in question with substantially lower development investment.

 

1.167

“RNA Printer” shall mean the automation solution for CureVac’s processes of mRNA manufacturing developed by CureVac and Tesla Grohmann Automation Solution GmbH under the Development and Intellectual Property Agreement dated December 22, 2017, including the Know-How licensed from Tesla Grohmann Automation Solution GmbH thereunder.

 

1.168

“Royalty Term” shall have the meaning set forth in Section 8.3.2.

 

1.169

“Sanctions & Trade Controls” shall have the meaning set forth in Section 12.8.

 

1.170

“SG&A” shall mean following expenses, as determined in accordance with International Financial Reporting Standards, consistently applied:

 

(i)

expenses directly allocated to the COVID Product, comprising:

 

[*****];

 

(ii)

expenses indirectly allocated to the COVID Product in addition to the above, comprising:

 

[*****];

 

 

1.171

“SARS-CoV-2 Pathogen” shall mean the virus known as SARS-CoV-2.

 

1.172

“Second [*****] Option” shall have the meaning set forth in Section 3.3.1.

 

1.173

“Sublicensee” shall mean any Third Party licensee (aside from GSK’s Affiliates and any Third Party contractors used by GSK in the Development, Manufacture or Commercialization of the COVID Products on GSK’s behalf), which obtains rights to the CureVac Technology or LNP Technology under a license granted by GSK, its Affiliates or another Sublicensee, in each case in accordance with Section 2.2.

 

1.174

“Term” shall have the meaning set forth in Section 14.1.

 

1.175

“Territory” shall mean the entire world.

 

1.176

“Third Party” shall mean any Person, other than CureVac or GSK and their respective Affiliates.

 

1.177

“Third Party Infringement” shall have the meaning set forth in Section 10.1.1.

 

1.178

“[*****] Purchase Agreement” shall mean the [*****], as amended from time to time.

 

1.179

“Valid Claim” shall mean either (a) a claim of an issued and unexpired patent within the CureVac Patent Rights or (ii) the LNP Technology 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 (b) a claim of a pending patent application within (i) the CureVac Patent Rights or (ii) the LNP Technology which application has not been pending for more than [*****] from the date of its priority filing date and which claim has not been irretrievably revoked, irretrievably cancelled, irretrievably withdrawn, held invalid or abandoned by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period), or finally determined to be unallowable in a decision from which an appeal cannot or can no longer be taken. For clarity, a claim of an issued patent that ceased to be a Valid Claim before it issued because it had been pending too long, but subsequently issues and is otherwise described by clause (a), shall again be considered to be a Valid Claim once it issues. The same principle shall apply in similar circumstances such as if, for example (but without limitation), a final rejection of a claim is overcome.

1.180

“VAT and Indirect Taxes” shall mean any value added, sales, purchase, turnover or consumption tax as may be applicable in any relevant jurisdiction, including but not limited to value added tax chargeable under legislation implementing Council Directive 2006/112/EC.

 

1.181

“WIPO” shall have the meaning set forth in Section 16.5.2.

 

1.182

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)

“written” and “in writing” include any means of reproducing words, figures or symbols in a tangible and visible form, including acknowledged email or facsimile;

 

(vi)

“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

 

(vii)

any reference to “demonstrable” costs and expenses means those costs and expenses can be evidenced in writing.

1.183

Condition precedent

 

The commencement of this Agreement is conditional on all applicable filings having been made under the United States Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”) or the rules and regulations made thereunder and all applicable waiting periods (including any extensions thereof) under that Act or those rules and regulations having expired, lapsed or been terminated as appropriate, in each case in connection with the entry into this Agreement. If both Parties, acting reasonably, each conclude that no filing is required, either Party may waive this condition in whole or in part at any time by notice in writing to the other Party. Each Party must use all reasonable endeavors to procure (so far as it is able to procure) that the condition is fulfilled on or before [*****]. CureVac and GSK shall cooperate with each other and shall (a) promptly prepare and file all necessary documentation and (b) effect all necessary applications, notices, petitions and filings and execute all agreements and documents, in each case, to cause the waiting period under the HSR Act to terminate or expire. If the condition is not fulfilled or waived by the date specified, either Party shall be entitled to terminate this Agreement by written notice with immediate effect, and only Sections 1, 11, 16.4, 16.5, 16.11 and 16.12 shall survive termination. Each Party shall be responsible for paying its own costs and expenses (including legal and consultants’ fees) incurred in connection with obtaining clearance of the transactions contemplated hereby, and GSK will pay the filing fees incurred in connection with the filings required pursuant to the HSR Act.

 

2.

LICENSES; EXCLUSIVITY.

 

2.1

License Grants to GSK.

 

2.1.1

License under CureVac Technology. Subject to the terms and conditions of this Agreement and the disclosures set forth in paras (ii) and (iii) of the Disclosure Letter, on a COVID Product- by-COVID Product basis, CureVac hereby grants to GSK, and GSK hereby accepts: (i) a royalty-free, exclusive license to use the CureVac Technology for the Development and Manufacture of COVID Products for use in the Field in the Territory; and (ii) an exclusive license to use the CureVac Technology for the Commercialization of COVID Products for use in the Field in the Territory, bearing the financial consideration set forth in Section 8, subject to CureVac’s rights with respect to the CureVac Territory under Section 6 and the Distribution Agreement. Subject to the disclosures set forth in the Disclosure Letter, the license granted hereunder shall be exclusive as to Third Parties and to CureVac, provided that CureVac retains the right to perform the Development and Manufacturing activities allocated to CureVac under this Agreement.

 

2.1.2

License under LNP Technology. Subject to the terms and conditions of this Agreement, the terms and conditions set forth in Exhibit 2.1.2, and subject to paras (ii) and (iii) of the Disclosure Letter, on a COVID Product-by-COVID Product basis, CureVac hereby grants to GSK, and GSK hereby accepts: (i) a royalty-free, non-exclusive sublicense under the LNP Agreement to use the LNP Technology for the Development and Manufacture of the COVID Products for use in the Field in the Territory; and (ii) a corresponding non-exclusive license to use the LNP Technology for the Commercialization of the COVID Products for use in the Field in the Territory, bearing the financial consideration set forth in Section 8, subject to CureVac’s rights with respect to the CureVac Territory under Section 6 and the Distribution Agreement (“LNP License”). Subject to the disclosures as set forth in the Disclosure Letter, CureVac shall not (i) grant a sublicense to any Third Party under the LNP Technology for the Development, Manufacture and Commercialization of COVID Products for use in the Field in the Territory, and (ii) itself carry out any activities under the LNP Technology for the Development, Manufacture and Commercialization of COVID Products for use in the Field in the Territory other than under this Agreement. Within [*****] following the Closing Date, the Parties will agree on a redacted copy of this Agreement (excluding any commercially confidential information) that CureVac can provide to the LNP Provider in accordance with its obligations under the LNP Agreement.

 

2.2

Sublicenses.

 

2.2.1

Right to Sublicense.GSK shall have the right to sublicense its rights under Section 2 to any of its Affiliates. GSK’s right to sublicense any of its Development rights or any of its Manufacturing rights for Development purposes (subject to Section 5.2.1) under Section 2.1.1, or any of its rights to the LNP Technology under Section 2.1.2 to any other Third Party shall be subject to CureVac’s prior written consent which CureVac may grant or withhold in its sole discretion. GSK’s right to sublicense (in multiple tiers) any of its Manufacturing rights for commercial purposes (subject to Section 5.2.1) and/or Commercialization rights under Section 2.1.1 to a Third Party shall be subject to CureVac’s prior written consent which shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, this Section 2.2.1 shall not restrict GSK or any of its Affiliates to subcontract any of its Development or Manufacturing activities to a CRO, CMO or other service provider of GSK or its Affiliate, subject to Section 5.2.1.

 

2.2.2

Sublicensing Requirements.The right to sublicense to a Third Party is subject to a written sublicense agreement containing terms and conditions that are consistent with those contained in this Agreement, and shall include, inter alia, provisions regarding confidentiality, non- compete, indemnification, audit, record-keeping, termination and consequences of termination that are consistent with the corresponding terms and conditions provided herein. GSK shall remain liable to CureVac for all obligations under this Agreement, including all payment obligations, and shall send to CureVac a copy of the signed sublicensing agreement within [*****] after its execution, subject to the reasonable redaction of confidential information. CureVac acknowledges that all information provided to CureVac by GSK under this Section 2.2.2 shall be deemed Confidential Information of GSK and shall be subject to the terms and conditions of Section 11.

2.3

Pathogen Exclusivity.

 

2.3.1

GSK. GSK shall work exclusively with CureVac on the Development, Manufacture and Commercialization of mRNA-Based vaccine and mRNA-Based antibody products targeting the SARS-CoV-2 Pathogen, and GSK shall not, and shall procure that its Affiliates and Sublicensees holding rights to the CureVac Technology in the Field and in the Territory will not, develop, manufacture or commercialize, solely or with a Third Party, any mRNA-Based vaccine or mRNA-Based antibodies targeting the SARS-CoV-2 Pathogen other than a COVID Product Developed and/or Commercialized under this Agreement. This Section 2.3.1 and the covenants set forth herein shall not apply to activities of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of GSK solely as a result of a Change of Control in GSK, provided that such activities are performed without using the mRNA technology described in the Know-How, or within the scope of the specification of the Patents Rights, Controlled by GSK (excluding, for clarity any CureVac Know-How or CureVac Patent Rights). Notwithstanding the foregoing, GSK shall be permitted to perform Development and Manufacturing activities with respect to any mRNA-Based vaccine or mRNA-Based antibodies targeting the SARS-CoV-2 Pathogen, using the SARS-CoV-2 spike protein as an Antigen, up to (and including) [*****], provided that GSK shall not be permitted to Commercialize any mRNA-Based vaccine or mRNA-Based antibodies targeting the SARS-CoV-2 Pathogen, or to grant any Third Party a license to Commercialize any mRNA- Based vaccine targeting the SARS-CoV-2 Pathogen.

 

2.3.2

CureVac. Subject to CureVac’s obligations as set forth in paras (ii) and (iii) of the Disclosure Letter, CureVac shall work exclusively with GSK on the Development, Manufacture and Commercialization of mRNA-Based vaccine and mRNA-Based antibody products targeting the SARS-CoV-2 Pathogen, and CureVac shall not, and shall procure that its Affiliates will not, develop, manufacture or commercialize, solely or with a Third Party, any mRNA-Based vaccine or mRNA-Based antibody targeting the SARS-CoV-2 Pathogen other than: (i) a COVID Product Developed and/or Commercialized under this Agreement, and (ii) the First-Gen COVID Vaccine Products, subject to Section 3.3.7. This Section 2.3.2 and the covenants set forth herein shall not apply to activities of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac, provided that such activities are performed without using the CureVac mRNA technology described in the CureVac Know-How or within the scope of specification of the CureVac Patent Rights.

2.3.3

Exclusivity Term. The covenants laid down in this Section 2.3 shall apply for a period commencing on the Effective Date until the expiry or termination of this Agreement, provided that if GSK exercises the GSK COVID Cease Option for a COVID Product, the limitations set forth in Section 2.3.2 shall not apply with respect to such COVID Product, and CureVac may Develop, Manufacture and Commercialize such COVID Product (alone or in collaboration with a Third Party).

 

2.4

Trademarks

 

2.4.1

Registration. As between the Parties and their Affiliates, GSK shall be solely authorized to determine the brand, trade name, logo and trade dress under which the Finished Products shall be Commercialized in the Territory. GSK shall have the first right, but not the obligation, to prepare, file, prosecute and maintain, at its own expense, any Brand IP for the Finished Products in the Territory; provided, however, that nothing herein shall grant GSK any right to use any trademark Controlled by CureVac and/or CureVac’s Affiliates. GSK will own all right, title and interest in and to any such trademark it selects in its own name during and after the Term, subject to the licenses granted to CureVac with respect to the CureVac Territory under Section 6.

 

2.4.2

Restrictions. Subject to any separate agreement(s) amongst the Parties (or their Affiliates), CureVac shall not, and shall cause their respective Affiliates not to, during the Term: (i) use or attempt to use any marks, brands or trade dress identical or similar to those covered by the Brand IP of GSK or its Affiliates, except as permitted by this Agreement or any Ancillary Agreement; (ii) register or attempt to register or procure the registration anywhere in the world of any mark as a trademark for any goods or services or as a domain name that is same as or confusingly similar to the Brand IP for the Finished Products; (iii) use any Brand IP for any of the Finished Products in any way which could tend to allow it to become generic, to lose its distinctiveness, to become liable to mislead the public or which would otherwise be detrimental or inconsistent with the good name, goodwill, reputation or image of the Parties; (iv) challenge the ownership of the Brand IP belonging to GSK or its Affiliates except if Brand IP is prosecuted in breach of this Agreement; or (v) register or attempt to register or procure the registration of or use any mark or domain name that incorporates the letters [*****] either as a prefix or a suffix for use in connection with a pharmaceutical product. This Section 2.4.2 and the covenants set forth herein shall not apply to a Third Party (or such Third Party’s Affiliate) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac.

 

2.5

Documents and Declarations. CureVac shall execute all documents, give all declarations regarding the licenses granted hereunder and reasonably cooperate with GSK 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 GSK Territory for the benefit of GSK. GSK shall reimburse CureVac for its reasonable and demonstrable external out of pocket costs associated therewith up to a total amount of EUR 20,000. For clarity, these costs shall be included in the calculation of Net Profits in accordance with Section 8.2.3 (except to the extent relating to a Pathogen Combination Product).

2.6

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.

 

2.7

Existing Agreements and future Government and NGO Contracts.

 

2.7.1

Existing Agreements. Prior to the Effective Date, CureVac has entered into: (i) the Government and NGO Contracts listed in Exhibit 1.102, and (ii) the [*****] Agreement.

 

2.7.2

GSK Consent for Supply of COVID Vaccine Products under Government and NGO Contracts. Without prejudice to the rights of CureVac for the CureVac Territory under Section 6 and subject to Section 2.7.4, any supply of Collaboration COVID Vaccine Products under a Government and NGO Contract (including through an amendment of such Government and NGO Contract) is subject to prior approval by decision of the JSC. The allocation of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories shall be conducted in a fair, reasonable and non-discriminatory manner, and in accordance with the allocation principles endorsed by the JSC pursuant to Section 5.2.2.

 

2.7.3

Assignment and Transfer of Government and NGO Contracts. Upon receipt of the Option Exercise Notice by CureVac, GSK and CureVac will discuss and agree in good faith [*****] (i) on whether and to what extent it is [*****] that certain Government and NGO Contracts will be partially or wholly transferred to GSK, provided that the Parties also agree on a transfer of associated regulatory responsibilities and a supply chain for the relevant COVID Products enabling GSK’s fulfilment of such Government and NGO Contracts, and subject to CureVac’s rights to Commercialize in the CureVac Territory and consent of the respective Third Party to such assignment and transfer, or (ii) on whether and to what extent it is [*****] that certain Government and NGO Contracts remain with CureVac, and, in that case, on the involvement of GSK in the Manufacturing of the COVID Products (at COGS) and the provision by GSK of regulatory services, pharmacovigilance services, quality and supply chain management services required by CureVac to meet its binding obligations under the Government and NGO Contracts; the Option Exercise being conditioned upon agreement to either (i) or (ii), as further set forth in Section 3.3.6 below. For clarity, if and to the extent GSK supplies COVID Products to CureVac, the COGS for the supply of such COVID Products and the SG&A for providing the services will be included in the calculation of Net Profits in accordance with Section 8.2.3 (except to the extent relating to a Pathogen Combination Product).

 

2.7.4

Future Government and NGO Contracts.

 

a.

Prior to the effective date of Option Exercise, CureVac is free to amend the Government and NGO Contracts with respect to First-Gen COVID Vaccine Products, or to enter into further Government and NGO Contracts with respect to the First-Gen COVID Vaccine Products, but, subject to clause b) below, not with respect to Collaboration COVID Vaccine Products or Pathogen Combination Products, provided that such Government and NGO Contracts may not deprive GSK of its rights in connection with the Collaboration COVID Vaccine Products or Pathogen Combination Products under this Agreement or the 2020 Collaboration Agreement. CureVac will notify GSK promptly after (and provide a copy of the executed agreement, if necessary in redacted form), execution of any such amended or further Government and NGO Contracts with respect to the First-Gen COVID Vaccine Products.

 

b.

[*****].

2.8

In-Licensing Agreements.

 

2.8.1

Future In-Licensed IP. If during the Term, CureVac obtains, other than by way of a Change of Control, a sublicensable license to any Patent Rights or Know-How Controlled by a Third Party that is useful, but which is not necessary to obtain freedom to operate with respect to the use or exploitation of the mRNA, LNP, CVCM and other technology or information, each as described in the CureVac Know-How or within the scope of the specification of the CureVac Patent Rights (excluding any Invention or Know-How jointly owned by the Parties) (the “CureVac Elements”), for the Development, Manufacture and Commercialization of COVID Products under this Agreement (“In-Licensed IP”), CureVac shall (i) notify GSK of the rights that CureVac has obtained with respect to such In-Licensed IP, (ii) use commercially reasonable endeavors to obtain the right to sub-license those Patent Rights or Know-How, and (iii) notify GSK of the applicable financial terms, which shall be non-discriminatory (as between GSK and any other sublicensee of CureVac). Without limiting Section 7.3, and subject to a decision of the JSC to include any technology covered by In-Licensed IP in a COVID Product, (i) such In- Licensed IP is and shall be automatically included in the definition of CureVac Know-How or CureVac Patent Rights, as applicable, and be licensed to GSK under Section 2.1, and (ii) as a sublicensee of CureVac, GSK will meet all obligations of CureVac that are applicable to GSK’s activities as a sub-licensee (to the extent notified by CureVac to GSK in advance in writing); and (iii) with respect to COVID Products (other than Pathogen Combination Products) the costs under such In-Licensing Agreement will be included in the calculation of the Net Profit split in accordance with Section 8.2.3, and with respect to Pathogen Combination Products, GSK shall reimburse CureVac for additional amounts payable by CureVac under such license to such Third Party to the extent directly arising as a result of (x) the grant of such sublicense to GSK or (y) the use of the In-Licensed IP by the Development, Manufacture or Commercialization of COVID Products by GSK, its Affiliates, and Sublicensees.

 

2.8.2

Enforcement, Maintenance and Amendment of In-Licensing Agreements. CureVac will reasonably enforce (including in connection with any counterparty’s breach of any representations or warranties under the applicable In-Licensing Agreements), or otherwise take the actions necessary to enable GSK to enforce, CureVac’s rights, benefits and the obligations of the respective counterparties under the In-Licensing Agreements that may impact the rights, benefits and obligations of GSK hereunder, and will inform GSK of any action it may take under the In-Licensing Agreements to the extent such action may impact GSK’s interest under the respective In-Licensing Agreement. CureVac shall: (i) fulfil all of its obligations, including its payment obligations, under the In-Licensing Agreements; and (ii) not take any action or omit to take any action that would materially adversely affect, or would reasonably be expected to materially adversely affect, GSK’s rights, benefits and obligations under this Agreement. CureVac shall reasonably notify GSK of any default, termination or amendment of, the In- Licensing Agreements, to the extent such default, termination or amendment may have an impact of GSK.

3.

PRODUCT COMPOSITION; EXCLUSIVE OPTION.

 

3.1

COVID Product Composition. The Parties, through the JSC, will determine the composition of a COVID Product in accordance with Section 3.2.

 

3.2

Composition Restrictions.

 

3.2.1

General Restrictions. Each Collaboration COVID Vaccine Product must incorporate CureVac mRNA containing [*****].

  

3.2.2

Product Adjustments. Any of the following adjustments to a COVID Product (each, a “Product Adjustment”) requires prior approval of the JSC: (i) any adjustment to the precise dosage and precise approved use of a COVID Product (e.g., for priming or boosting purposes); and (ii) any adjustment of the composition of a COVID Product, including in terms of Antigen(s), its formulation (including LNP or other delivery vehicles such as CVCM), or presentation. For the avoidance of doubt, the addition of adjuvants is not a Product Adjustment, and requires mutual agreement between the Parties.

 

3.2.3

Additional Vaccine Targets. In the event that the Parties, through the JSC, agree to include one or more Antigen(s) which are associated with the SARS-CoV-2 Pathogen, in addition to the SARS-CoV-2 spike protein, into the COVID Product pursuant to Section 3.2.2, within [*****] following receipt of the adjustment request, the Antigen List Rep shall perform an Antigen clearance under the LNP Agreement in accordance with the LNP Agreement to inquire whether such Antigen(s) is/are available. Within [*****] upon receipt of the confirmation from the LNP Provider that the additional Antigen(s) is/are available for licensing, CureVac shall secure the LNP License for such additional Antigen(s), make the additional payment for such additional Antigen(s) that is due under the LNP Agreement and the Parties will, as soon as reasonably practicable, work on an amendment to the COVID R&D Plan for the respective COVID Product. Upon amendment of the LNP Agreement to include reference to such additional Antigen(s) in accordance with the terms of the LNP Agreement, such additional Antigen(s) will be automatically included in the license grant under Section 2.1.2. For clarity, these costs shall be included in the calculation of Net Profits in accordance with Section 8.2.3 (except to the extent relating to a Pathogen Combination Product).

 

3.2.4

Pathogen Combination Products. A decision to change the Development of a stand-alone Collaboration COVID Vaccine Product to a Pathogen Combination Product requires prior approval of the JSC. For clarity, other than in the circumstances set out in Section 15.7(i), any Pathogen Combination Product which targets the SARS-CoV-2 Pathogen shall be subject to the terms of this Agreement, not the 2020 Collaboration Agreement.

 

3.3

Exclusive Option for First-Gen COVID Vaccine Products.

3.3.1

[*****] Options. CureVac and [*****] collaborate with respect to the development, manufacture and supply of the First-Gen COVID Vaccine Products, and CureVac has granted to [*****] two exclusive options under the [*****] Agreement: (i) to negotiate exclusive licenses for the Commercialization of First-Gen COVID Vaccine Products (excluding the First-Gen COVID Booster Vaccines) in certain territories (the “First [*****] Option”); and (ii) to negotiate licenses to develop, manufacture and commercialize the First-Gen COVID Booster Vaccines (the “Second [*****] Option”, together with the First [*****] Option, the “[*****] Options”). [*****]:

 

[*****].

 

3.3.2

First-Gen Exclusive Option. Until [*****] (“Option Period”), subject to paras (ii) and (iii) of the Disclosure Letter, and the Government and NGO Agreements (to the extent entered into strictly in accordance with Section 2.7.4), CureVac hereby grants to GSK, and GSK hereby accepts, the exclusive option to obtain exclusive licenses under the CureVac Technology to Develop, Manufacture and Commercialize (in addition to the Collaboration COVID Vaccine Products and the Pathogen Combination Products) the First-Gen COVID Vaccine Products [*****] (“Exclusive Option”)..

 

3.3.3

Option Exercise Notice. If GSK intends to exercise its Exclusive Option, GSK shall send within the Option Period a written notice to CureVac exercising such Exclusive Option (“Option Exercise Notice”). Following receipt of the Option Exercise Notice by CureVac, the Parties shall as soon as reasonably practicable agree a COVID R&D Plan and/or Commercialization plan, as applicable, for the further Development, Manufacture and Commercialization of the First-Gen COVID Vaccine Products.

 

3.3.4

Access to Information. Upon GSK’s reasonable request at reasonable intervals during the Option Period, but in any event no more than once every [*****], provided that no restriction shall apply during the [*****] period that ends on the final day of the Option Period, CureVac will disclose to GSK (subject to its confidentiality obligations vis-à-vis Third Parties) all existing agreements and commitments with respect to the development, manufacture and commercialization of the First-Gen COVID Vaccine Products that would survive the exercise of the Exclusive Option by GSK, as well as all data, documents and information reasonably required by GSK to assess whether it wishes to exercise its Exclusive Option, as well as CureVac’s then-current calculation of the Option Exercise Fee.

3.3.5

Option Exercise Fee. If GSK exercises its Exclusive Option, GSK shall pay to CureVac a fee equal to [*****] of: (i) all reasonable and demonstrable: (A) costs and expenses of scientific, medical, technical personnel directly engaged in development (including regulatory) activities (which costs shall be determined based on the applicable FTE Rate), and (B) out-of- pocket expenses and other costs and expenses paid to Third Parties for the development (including regulatory activities) of the First-Gen COVID Vaccine Products, in each case which were incurred or forecast to be incurred before the effective date of Option Exercise in accordance with Section 3.3.6, including for pre-clinical research and development activities to design and develop the First-Gen COVID Vaccine Products, the CMC Development, the performance of Clinical Studies, the manufacture of clinical study material, safety monitoring, regulatory filing and regulatory approvals, and all support services relating hereto; [*****], and in each case which were incurred or forecast to be incurred before the effective date of Option Exercise in accordance with Section 3.3.6; and (iii) any amounts paid to Third Parties under In-Licensing Agreements for the development of the First-Gen COVID Vaccine Products (whether as upfront payments, milestone payments, royalties or any other form of payment) were incurred or forecast to be incurred before the effective date of Option Exercise in accordance with Section 3.3.6 (the “Option Exercise Fee”). There shall be no double counting of any amounts to be paid by GSK to CureVac pursuant to this Section 3.3.5. For purposes of this Section 3.3.5, and to the extent allowed for under the applicable funding agreement, development costs shall be net of any subsidies, grants or other non-refundable external Third Party funding received by CureVac for the development or manufacture of the CureVac First-Gen COVID Vaccine Products, provided that such subsidies, grants or other non-refundable external Third Party funding: (i) would not be repayable or forfeited by CureVac under the terms of the relevant funding agreement as a result of being applied to the calculation of Net Profit under this Agreement, and (ii) are not made as a pre-payment of consideration for the future supply of vaccines. The Parties agree that the payments received by CureVac under the [*****] Agreement and the [*****] Agreement are made as a pre-payment of consideration for the future supply of vaccines under the [*****] Agreement and [*****] Agreement, as applicable, and shall therefore not be considered for the calculation of the Option Exercise Fee. CureVac shall notify GSK of any subsidies, grants or other non-refundable external Third Party funding that are eligible to be credited against the development costs of First-Gen COVID Vaccine Products under this Section 3.3.5. For clarity, the costs for the development of the First-Gen COVID Vaccine Products shall not include the costs for constructing and upscaling Manufacturing facilities to Manufacture the First-Gen COVID Vaccine Products. The Option Exercise Fee is to be paid by GSK to CureVac within [*****] after receipt of an invoice from CureVac, with supportive documentation reasonably detailing the development (including regulatory) costs and expenses incurred by CureVac. For clarity, each of (i) the Option Exercise Fee and (ii) any repayment by CureVac of any pre-payment or consideration retained by CureVac for the future supply of vaccines in accordance with this Section 3.3.5 shall not be included in the calculation of Net Profits in accordance with Section 8.2.3. In addition to the Option Exercise Fee, GSK shall bear up-front all costs [*****], provided that these costs shall be included in the calculation of Net Profits in accordance with Section 8.2.3 (except to the extent relating to a Pathogen Combination Product).

3.3.6

Option Exercise. Upon (i) receipt of an Option Exercise Notice by CureVac; (ii) full payment of the Option Exercise Fee due from GSK to CureVac; (iii) the Parties having agreed a COVID R&D Plan and/or Commercialization plan (as applicable) to further Develop, Manufacture and Commercialize the First-Gen COVID Vaccine Products for which the Option was exercised; and (iv) the Parties having agreed in relation to each Government and NGO Contract on (x) either the whole or partial transfer of that Government and NGO Contract from CureVac to GSK, or (y) the retention of that Government and NGO Contract by CureVac, each in accordance with Section 2.7.2, the First-Gen COVID Vaccine Products shall become COVID Products from (A) [*****] or (B) [*****] (“Option Exercise”). Upon the effective date of Option Exercise, and unless set forth otherwise, such First-Gen COVID Vaccine Product shall become a COVID Product under this Agreement and all terms and conditions relevant for the Development, Manufacture and Commercialization of the Collaboration COVID Vaccine Products shall apply to the respective First-Gen COVID Vaccine Products including licenses, sharing of Development Costs, profit sharing arrangement and royalties (but only in relation to the period after the effective date of Option Exercise).

 

3.3.7

Exclusivity during Option Period. During the Option Period, subject to the [*****] Agreement, and CureVac’s right to enter into further Government and NGO Contracts regarding the development, manufacturing and/or supply of First-Gen COVID Vaccine Products in accordance with Section 2.7.4, CureVac shall not grant any rights to a Third Party for the commercialization of First-Gen COVID Vaccine Products in the Field without GSK’s express, written waiver of its rights under the Exclusive Option, which GSK may grant or withhold in its sole discretion. As between the Parties, if GSK does not exercise its Exclusive Option within the Option Period, CureVac shall have no further obligations towards GSK regarding the licensing of any rights for Development, Manufacture or Commercialization of the First-Gen COVID Vaccine Products, and shall be free to develop, manufacture and commercialize the First-Gen COVID Vaccine Products solely or in collaboration with Third Parties.

 

3.3.8

Provision of Services instead of Option Exercise. In case GSK does not exercise its Exclusive Option, upon the request of CureVac, the Parties shall negotiate in good faith a service agreement under which GSK will provide to CureVac [*****].

4.

DEVELOPMENT COLLABORATION.

 

4.1

COVID R&D Plan. The Parties shall collaborate on the further Development of the Collaboration COVID Vaccine Products, and will agree on R&D plans for each Collaboration COVID Vaccine Product (each such plan, a “COVID R&D Plan”). The initial COVID R&D Plan for two versions of the first Collaboration COVID Vaccine Product is attached hereto as Exhibit 4.1, and may be amended from time to time by the JSC in accordance with this Agreement. Each Party shall conduct all activities as outlined in the COVID R&D Plan (as amended from time to time) as part of its ordinary course of business, and the other Party shall support the conduct of those activities, in each case in accordance with this Agreement.

 

4.2

Development Data, results and records. As provided for in a COVID R&D Plan, at least, however, on a monthly basis, the Parties will make available to one another through formal reports for review and discussion within the JSC all Development Data and other results of the Development conducted hereunder, and will keep such records (paper and electronic) as described herein. The Parties will maintain records of the Development Data and other results in sufficient detail as required by Regulatory Authorities 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 Development.

 

4.3

Sharing of Development Costs for COVID Products. Subject to satisfaction of the condition set out in Section 1.183, the Parties shall from the Effective Date (or, in relation to the First-Gen COVID Vaccine Product, from the effective date of Option Exercise) equally share (50%/50%): [*****].

4.4

Development Funding for Pathogen Combination Products. GSK shall, subject to the remainder of this Section 4.4, compensate CureVac for the Development Costs CureVac incurs in performing the Development activities for a Pathogen Combination Product (with FTE calculated at the FTE Rate), where applicable in accordance with the budget and assumptions as agreed under that COVID R&D Plan.

 

4.5

All Development Costs. The Parties shall in good faith consider means of gaining efficiencies in the performance of the COVID R&D Plan(s) that have a positive impact on the associated budget, and in connection with incurring any other Development Costs, such as outsourcing of certain research activities to a subcontractor, provided these will not adversely impact the timeline for completion of Development activities. The Parties shall account for their respective Development Costs and non-refundable funding on a Calendar Quarterly basis, where applicable with supportive documentation reasonably detailing the composition of the agreed budgeted cost (with FTE calculated at the FTE Rate) for the applicable Calendar Quarter period. The respective undisputed balance to achieve the equal share of Development Costs and non- refundable funding shall be paid within [*****] after receipt of an invoice from the respective Party which is entitled to receive a payment from the other Party (whether under profit-sharing arrangement or otherwise). The Parties shall promptly notify each other as soon as reasonably practicable in the event that either Party becomes aware that Development Costs are expected to deviate, where applicable, from the amounts approved in the Development budget, as a result of a change to the assumptions under a COVID R&D Plan, whereupon the Parties shall discuss the causes of such deviation and evaluate potential mitigation measures relating thereto, and an appropriate adjustment (if any) to the Development budget. The Parties shall refer any Development budget increase amounting to greater than [*****] of the previously approved amount to the JSC for prior approval. Unless such budget increase is approved by the JSC, a Party shall not be liable to bear, as part of the sharing of Development activities where the Development Costs are budgeted under the relevant COVID R&D Plan, any Development Costs incurred by the other Party in excess of [*****] the amount set out in the agreed Development budget from time to time. The Parties shall not unreasonably withhold their approval in the JSC to any budget increase which is reasonably required as a result of the change to a budgeting assumption set out in a COVID R&D Plan. CureVac’s share in Development Costs to be refunded under Section 4.3 shall in no event exceed an amount of [*****], and any Development Costs to be refunded under Section 4.3 which exceed such amount shall be offset against up to [*****] of the Net Profit share payment to be made by GSK to CureVac for the Collaboration COVID Vaccine Products under Section 8.2 below.

 

4.6

Materials. CureVac will provide GSK with any CureVac Materials required for the Development under the COVID R&D Plan, including those which comprise, embody or incorporate CureVac Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the respective COVID R&D Plan. GSK will provide CureVac with any GSK Materials required for the Development under the COVID R&D Plan, including those which comprise, embody or incorporate GSK Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the COVID R&D Plan. GSK will use the CureVac Materials and CureVac will use the GSK Materials, as applicable: (i) only 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 the COVID R&D Plan; and (iii) not reverse engineer or chemically analyze the same except as expressly provided for (if at all) in the COVID R&D Plan. 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 the COVID R&D Plan. 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”. Except as expressly set out in this Agreement, 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 expiry 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.

 

4.7

Know-How Transfer. As and when required in relation to a COVID R&D Plan (and from time to time during the Term if new Know-How within the CureVac Know-How comes to be Controlled by CureVac) or as soon as reasonably practicable upon GSK’s request, CureVac shall disclose and/or deliver to GSK copies of all Development Data and the CureVac Know- How that is reasonably required for GSK’s Development activities in accordance with the COVID R&D Plan (including for regulatory purposes) (“Development Transfer Materials”), with the exception, however, of all Know-How comprised in the CureVac Manufacturing Technology which shall be made available to GSK or its designee as set forth in Section 5.2.1. The technology transfer to be undertaken under this Section 4.7 shall be overseen by the Joint Steering Committee. Any transfer of Know-How pursuant to this Section 4.7 shall be carried out on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Development Transfer Materials; (ii) the procurement by CureVac of the services of such qualified and experienced scientists and technicians, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Development Transfer Materials. Until completion of the transfer of the Development Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Development Transfer Materials.

4.8

Regulatory Approvals of COVID Products.

 

4.8.1

Regulatory Filing for the COVID Products. GSK shall prepare and file all INDs and all new drug applications (or equivalents) for the COVID Products and shall own all Regulatory Approvals and be responsible for all decisions in connection with the Regulatory Approvals for COVID Products in the Field and in the Territory, subject to GSK’s diligence obligations under Section 4.10. With regard to CMC Development and Manufacturing, CureVac shall contribute the necessary sections for such filings. CureVac shall have the right to review and comment on all such filings and safety related documents, and GSK shall be entitled to demand feedback within a reasonably short period. GSK will share with CureVac any regulatory filings before submission. CureVac shall cooperate in, and provide reasonable assistance to support, these efforts as reasonably requested by GSK. GSK shall provide CureVac with a final copy of each filing.

 

4.8.2

Transfer of Regulatory Approvals for the First-Gen COVID Vaccine Products. Upon the effective date of Option Exercise, CureVac shall (or shall cause the Affiliate or Third Party holding the Regulatory Approvals to) assign and transfer to GSK the Regulatory Approvals granted for the First-Gen COVID Vaccine Products, subject to GSK’s diligence obligations under Section 4.10 and the rights granted to CureVac with respect to the Regulatory Approvals relevant for the CureVac Territory under Section 6 and the respective Distribution Agreement. Any costs incurred in connection with this transfer shall be borne by the Parties in equal shares as part of the Development Costs in accordance with Section 4.3.

 

4.8.3

Communications. Subject to Sections 4.8.1 and 4.8.6, and subject to the rights and obligations of CureVac under Section 6 and the respective Distribution Agreement with respect to the Regulatory Approvals relevant for the CureVac Territory, GSK shall be responsible for all regulatory interactions, including written communications and meetings with Regulatory Authorities, and safety management, including the reporting to the appropriate governmental authorities of all adverse events and any other information concerning the safety of COVID Products. GSK will, as part of its regular updates through the JSC, inform CureVac in writing of any material feedback from Regulatory Authorities relating to any COVID Product. Furthermore, GSK will provide copies of all Regulatory Approvals and material correspondence with Regulatory Authorities in the Major Markets relating to the Clinical Studies with respect to all COVID Products to CureVac. Where permitted by Applicable Laws, CureVac shall have the right to participate as a silent observer in a meeting with Regulatory Authorities.

4.8.4

Sharing of information. CureVac will reasonably support GSK, at GSK’s request at reasonable intervals (considering CureVac’s limited personnel resources), on all regulatory matters with respect to the Development and Commercialization of the COVID Products, including by providing data and documents as reasonably required for obtaining Regulatory Approvals and for interactions with Regulatory Authorities regarding the COVID Products, provided that such documents and data will remain the property and Confidential Information of CureVac, and GSK will only use such documents and data in accordance with Section 4.8.5 and Section 11. Without limiting the generality of the foregoing, CureVac shall provide to GSK: [*****].

  

4.8.5

Cross-referencing. To the extent required by GSK, or an Affiliate or Sublicensee of GSK to the COVID Products, CureVac hereby authorizes GSK, its Affiliates and Sublicensees to cross- reference to the sections of the dossiers of any Regulatory Approval of the First-Gen COVID Vaccine Product for COVID Products and products developed under the 2020 Collaboration Agreement. GSK hereby authorizes CureVac, its Affiliates and licensees to cross-reference to the dossiers of the Regulatory Approvals of COVID Products for other CureVac mRNA-Based products. Each Party shall notify the other Party in writing prior to any such cross-referencing.

 

4.8.6

Pharmacovigilance. The Parties shall have in place and will maintain during the Term (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 notify 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 COVID Products relating to risk management, drug safety and pharmacovigilance. The Parties shall negotiate in good faith and conclude a pharmacovigilance agreement within [*****] after the Effective Date. As part of such pharmacovigilance agreement, a joint safety team (“JST”) shall be established by the Parties before Initiation of the first Clinical Study, with representatives of each Party, and the Parties shall develop a JST charter (“JST Charter”). The JST composition will be established as per the JST Charter. The JST Charter will define roles and responsibilities with regards to data compilation and review in order to ensure that JST is able to conduct proper activities and make/provide appropriate recommendations/input, which may include access to safety data (including safety data from post-marketing surveillance activities) relating to COVID Products and First-Gen COVID Vaccine Products, to allow the JST to ensure adequate safety reviews.

 

4.9

CureVac Development Diligence. Subject to GSK complying with its obligations under this Agreement, CureVac will conduct all Development activities assigned to it in a COVID R&D Plan in a timely manner and in accordance with the respective COVID R&D Plan, and obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources as are reasonable and adequate to complete such COVID R&D Plan.

4.10

GSK Development and Regulatory Diligence. Subject to CureVac complying with its obligations under this Agreement, GSK will:

 

(i)

conduct all Development activities assigned to it in the COVID R&D Plan(s), progress the COVID Products into the next appropriate Clinical Study, and obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources as reasonably required to complete the COVID R&D Plan(s); and

 

(ii)

use its Diligent Efforts to secure biologics licensure by the FDA and marketing authorization by EMA following completion of all appropriate Clinical Studies.

 

4.11

Use of GSK Technology. Subject to the terms and conditions of this Agreement, GSK hereby grants to CureVac, and CureVac accepts, a royalty-free, non-exclusive, license (with the right to sub-license in accordance with Section 4.12) to use the GSK Technology for performing the Development and Manufacturing activities allocated to CureVac under this Agreement (and, subject to the terms of each Ancillary Agreement, under the Ancillary Agreements).

 

4.12

Right to Sublicense. CureVac shall have the right to sublicense its rights under Section 4.11 to any of its Affiliates, but not to any Third Party, subject only to the right to subcontract as set forth under Section 4.13 below.

 

4.13

Subcontracts. Subject to the terms and conditions of this Agreement, and as further defined in the COVID R&D Plan, the Parties may subcontract to Affiliates and Third Parties, including CROs and CMOs, certain activities 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 Party shall promptly inform the other Party in writing of any subcontracting of activities under this Agreement providing the name of the subcontractor and the activities to be performed by such subcontractor, and shall remain liable to the other Party for any act or omission of its subcontractor.

 

5.

MANUFACTURING AND COMMERCIALIZATION.

 

5.1

Clinical Supply. Except to the extent GSK (or its Affiliate or a CMO designated by it) Manufactures the COVID Products as set forth in this Agreement, all doses of COVID Products required for use by GSK in accordance with this Agreement for the Development of COVID Products (including for Clinical Studies) shall be Manufactured and supplied by CureVac or its Affiliates for use in the Clinical Studies in accordance with GMP, Applicable Laws and the terms and conditions of one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) to be negotiated and agreed between GSK and CureVac no later than [*****] after the Effective Date, and in accordance with the terms and conditions set forth in Exhibit 5.1 (each, a “Clinical Supply Agreement”). CureVac and its Affiliates will reserve the required capacity for the Manufacture of COVID Products for timely supply of the COVID Products for use in their Development in accordance with the COVID R&D Plan.

 

5.2

Commercial Supply.

 

5.2.1

The Parties will determine a Manufacturing and supply strategy that for each COVID Product creates an efficient and reliable Manufacturing network and supply chain, so that the COVID Products are Manufactured in accordance with the Regulatory Approvals, GMP and Applicable Laws at sufficient volumes in light of the potential demand for such COVID Product. GSK shall have the right to perform prior due diligence on all elements of a proposed Manufacturing network and supply chain, including subjecting CureVac and any CMOs within the overall Manufacturing network of CureVac (subject to the CMOs’ consent and at the sole cost of GSK), and the respective Manufacturing facilities, to an audit to verify the ability to Manufacture sufficient volume of the COVID Products in accordance with the Regulatory Approvals, GMP and Applicable Laws, which audit shall be conducted in accordance with Section 12.12. After having completed such due diligence and audits, GSK shall have the final decision regarding the Manufacturing and supply chain strategy and the composition of the supply chain for a given COVID Product, including to select the facilities within the CureVac Manufacturing network (and that of its CMOs) to supply the COVID Products, or to let GSK, its Affiliate or another Third Party CMO Manufacture the COVID Products (or a part thereof) pursuant to a transfer of the Manufacturing of the COVID Product (or a part thereof) in accordance with Section 5.5, as well as regarding subsequent changes to Manufacturing and supply chain strategy; provided, however, that any such decision must not jeopardize CureVac’s and/or GSK’s performance of the Government and NGO Contracts, unless otherwise agreed with the relevant government, if and to the extent any Government and NGO Contract requires that the Manufacture of COVID Products is performed in a specific territory or by a specific CMO.

 

5.2.2

Once a Manufacturing and supply strategy for a given COVID Product has been determined as set forth in Section 5.2.1, GSK and CureVac will implement such strategy and will where applicable (i) negotiate and agree in good faith on a Commercial Supply Agreement in respect of that COVID Product, including a Quality Agreement, according to which CureVac or its Affiliates will Manufacture supply to GSK the respective COVID Product at COGS in accordance with the terms and conditions set forth in Exhibit 5.2 or, (ii) if the COVID Product in question is Manufactured in part or in full by a Third Party CMO within CureVac’s Manufacturing network, GSK and CureVac will reasonably facilitate the execution of a bilateral commercial supply agreement between GSK and that CMO in respect of the Manufacture and supply by that CMO of such COVID Product (each, a “Commercial Supply Agreement”). As part of the Manufacturing and supply chain strategy, where CureVac’s Manufacturing network is relied upon, the Parties will discuss and determine: (x) the reservation of Manufacturing capacity in CureVac’s network, and if the Parties approve such reservation, CureVac (or GSK, as of such time as GSK has entered into Commercial Supply Agreements with the CMOs in accordance with Section 5.2.1) will reserve the approved capacity in CureVac’s network, and (y) how to implement such Manufacturing and supply chain strategy, including how to manage critical raw materials, in a way that is fair and reasonable and takes into account potential impacts on cash flow and working capital. The Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply will meet within not more than [*****] of the Effective Date to determine as soon as practicable, for the COVID Products to be Manufactured in [*****], the Manufacturing capacity to be reserved in CureVac’s network, and the type and amount of critical raw materials to be sourced in accordance with the preceding sentence. Each Party shall, and shall procure that its Affiliates shall, act reasonably and in good faith when entering into or accepting any new agreements or commitments for the supply of COVID Products, and in the case of CureVac, the supply of First-Gen COVID Product, taking into account its commitments towards the other Party under, in the case of CureVac, the Commercial Supply Agreements, or, in the case of GSK, the Distribution Agreement, and its expected manufacturing capacity. The Parties acknowledge that the manufacturing capacity available for the Collaboration COVID Vaccine in CureVac’s Manufacturing network (including its CMO) for the calendar year of [*****] is estimated by CureVac at the Effective Date at a maximum of [*****], however the Parties will in good faith and in a timely manner consider means of increasing such capacity if required to meet expected demand. As part of the aforementioned Manufacturing and supply chain strategy, the Parties shall determine forecasting and allocation binding principles, to be endorsed by the JSC, for use by the Parties when a constraint on the availability of raw materials, components, ingredients, or other materials, or of manufacturing capacity (including by an unforeseen reduction of yield or loss of Manufacturing slots), makes it impossible to fulfill all valid and legitimate forecasts and orders of Collaboration COVID Products (across the GSK Territory and the CureVac Territory) and the First-Gen COVID Vaccine Product, so that any allocation of available resources is carried out in a fair, reasonable and non-discriminatory manner.

 

5.3

QP Release. GSK, as holder of the Regulatory Approvals of the COVID Products, shall be responsible for the certification by a qualified person and release of Manufactured batches of COVID Products in accordance with GMP, that are distributed under such Regulatory Approval (whether for Development or Commercialization purposes), and the Quality Agreements shall reflect the same.

 

5.4

Manufacture by GSK.

 

Upon the request of GSK [*****], CureVac shall transfer all Know-How comprised in the CureVac Manufacturing Technology (“Manufacturing Technology Transfer Materials”) to GSK, an Affiliate of GSK or a Third Party CMO designated by GSK and approved by CureVac (such approval not to be unreasonably withheld, conditioned or delayed), as applicable, so that GSK itself, the Affiliate of GSK or the appointed Third Party CMO (approved by CureVac), as applicable, can take over the Manufacture of COVID Products for GSK (of Finished Product, Filled Containers or Drug Product and Drug Substance, or a combination thereof); provided, however, that any such request must not jeopardize the Parties’ obligations under the [*****] Agreement unless otherwise agreed with the relevant government, if and to the extent any [*****] Agreement requires that the Manufacture of COVID Products is performed in a specific territory or by specific CMO, and (ii) [*****]. In the event of a technology transfer, the JSC shall establish a Manufacturing tech-transfer sub-committee, which shall agree, manage and oversee the Manufacturing technology transfer. Any transfer of Know-How pursuant to this Section 5.4 shall be carried on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Manufacturing Technology Transfer Materials; (ii) if and to the extent reasonably required, the procurement by CureVac of the services of such qualified and experienced scientists, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Manufacturing Technology Transfer Materials; and (iii) if and to the extent reasonably required by GSK, the provision by CureVac to the personnel of GSK or its Affiliate with reasonable access to its facilities to observe the Manufacture at such times as the Parties may agree; provided such access shall be coordinated in a manner to minimize the disruption of CureVac’s activities and considering CureVac’s limited personnel resources, and CureVac may require any personnel of a Third Party with access to its facilities to sign a confidentiality agreement and to abide by the rules and guidelines applicable to the CureVac facility. Until the completion of the transfer of the Manufacturing Technology Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Manufacturing Technology Transfer Materials. [*****].

GSK will bear all costs and expenses for the technology transfer contemplated under this Section 5.4 (including any work of the FTEs at the FTE Rate), any payments due under a CMO agreement as a result of the technology transfer to GSK (including reservation fees, cancellation costs or any kind of termination costs resulting from the fact that the COVID Product in question is no longer Manufactured at the site in question) and any increase in COGS (if any), i.e. such costs will not be split as part of the profit split, other than in the case GSK terminates this Agreement on the basis of CureVac’s material breach or otherwise for cause and GSK exercises the GSK Continue Option.

 

CureVac may also request that GSK Manufactures Finished Product, Filled Containers and/or Drug Product and Drug Substance, whether for Development or for Commercial supply. The Parties shall discuss such matter in good faith, but the final decision shall be with GSK.

Any relevant Clinical Supply Agreement, Commercial Supply Agreement or Quality shall be adapted (or terminated) as appropriate in light of the in-transfer by GSK (or a GSK-designated) CMO of the Manufacturing of COVID Products.

 

For the avoidance of doubt, GSK may only use the Manufacturing Technology Transfer Materials for the Manufacture of COVID Products under this Agreement. In case GSK manufactures an mRNA-Based product, GSK shall, at the request of CureVac, provide evidence to an independent expert agreed by the Parties in good faith proving that GSK is not using the Manufacturing Technology Transfer Materials for the manufacture of such mRNA-Based product. Unless the expert finds that GSK has used the Manufacturing Technology Transfer Materials for a purpose not permitted under this Agreement, CureVac shall be responsible for the expense of retaining the independent expert. This obligation shall survive the expiration or termination of this Agreement.

 

5.5

Commercialization of COVID Products; Diligence. Subject to the terms and conditions of this Agreement, GSK shall have the rights and the responsibility for the Commercialization of COVID Products in the Field in the GSK Territory. Unless terminated or replaced in accordance with this Agreement, GSK will use Diligent Efforts to Commercialize the COVID Products in the Field in the Major Markets (other than Germany, unless waived by CureVac pursuant to Section 6.1), subject to obtaining Regulatory Approval in the relevant Major Market, and subject to CureVac agreeing to, in the JSC, and supporting the COVID R&D Plans that are necessary for the Regulatory Approval for the marketing of the COVID Products in each Major Market. Without limiting the generality of and conditions for the Diligent Efforts obligations under this Section 5.5, GSK shall:

 

(i)

on a COVID Product-by-COVID Product basis make the First Commercial Sale of a COVID Product in a country as soon as reasonably practicable following the issuance of the Regulatory Approval for such COVID Product in such country;

 

(ii)

Commercialize at least [*****] Collaboration COVID Vaccine Product (besides Pathogen Combination Products) in the Major Markets in the GSK Territory;

 

(iii)

in addition to the reports provided by GSK to CureVac under Section 8.2, beginning with the First Commercial Sale of the first COVID Product in the Territory and continuing until expiry of the payment obligations under Article 8, provide CureVac, at least once annually by March 31 of each Calendar Year, with a confidential, non-binding sales forecast for that Calendar Year for discussion in the JSC (or the Commercialization sub-committee, as applicable) of the estimated aggregate (x) sales of COVID Products in the GSK Territory and (y) sales of COVID Products in each Major Market, provided that GSK shall not be required to provide supporting materials in relation to such forecast; and

 

(iv)

in countries where GSK commercializes a New Non-mRNA COVID Product, the level of diligence that GSK must apply regarding the Commercialization of COVID Products in that country shall be increased to Enhanced Diligent Efforts.

 

5.6

Resources. The Parties shall both obtain and maintain sufficient facilities, personnel (with appropriate qualifications and experience), equipment, materials and other resources necessary to meet their respective obligations under this Section 5, in accordance with the timelines specified in and in accordance with this Section 5.

 

6.	COMMERCIALIZATION OF COVID PRODUCTS IN THE CUREVAC TERRITORY.

 

6.1

Commercialization in CureVac Territory. CureVac shall have the sole and exclusive right to Commercialize the COVID Products in the Field in the CureVac Territory. On a COVID Product-by-COVID Product basis, until the execution of a Distribution Agreement between the Parties under Section 6.2 for a COVID Product, CureVac shall have the right to waive its right to Commercialize such COVID Product in the CureVac Territory by giving written notice to GSK. Upon receipt of such waiver notice by GSK, with respect to the respective COVID Product, the CureVac Territory shall become part of the GSK Territory, and GSK shall have the right to Commercialize the COVID Product in such extended GSK Territory, and the obligation to use Diligent Efforts to Commercialize the COVID Products in Germany, subject to and in accordance with the terms and conditions of this Agreement. Section 8 below sets forth the financial terms of Commercialization of COVID Products by CureVac in the CureVac Territories, more specifically with respect to the profit-share for COVID Products (other than Pathogen Combination Products) and the royalties to be paid by CureVac to GSK for Pathogen Combination Products.

 

6.2

Distribution Agreement. On a COVID Product-by-COVID Product and on a CureVac Territory by CureVac Territory basis, upon request of CureVac, but no later than [*****] prior to the estimated First Commercial Sale of the respective COVID Product in the Field in any CureVac Territory, the Parties shall negotiate and agree in good faith on a distribution agreement under which CureVac has the exclusive rights to Commercialize such COVID Product in the Field in the CureVac Territory in accordance with the terms and conditions set forth in the key distribution terms in Exhibit 6.2 (“Distribution Agreement”). Article 8 below sets forth the financial terms of such distribution, i.e., with respect to the profit-share for COVID Products (other than Pathogen Combination Products) and to the royalties to be paid by CureVac to GSK for Pathogen Combination Products. CureVac shall comply with all policies, practices, standards, guidelines, codes and requirements generally inferred by the GlaxoSmithKline group on distributors of its products in the CureVac Territory, which shall be further detailed in the Distribution Agreement and compliance with which shall be subject to audit by GSK as specified in the Distribution Agreement.

 

7.	GOVERNANCE.

 

7.1

Management.

 

7.1.1

Alliance Management. Management of the collaborative alliance reflected in this Agreement will be under the responsibility of the individual designated in writing no later than [*****] after the Closing Date for CureVac (“CureVac Alliance Manager”) and of the individual designated in writing no later than [*****] after the Closing Date for GSK (“GSK Alliance Manager”, and together with the CureVac Alliance Manager, the “Alliance Managers”), provided that the Alliance Managers under this Agreement and under the 2020 Collaboration Agreement shall be the same individuals. Each Alliance Manager will be the primary point of contact for the other Party on all matters relating to the operation of this Agreement and the 2020 Collaboration Agreement.

 

 

7.1.2

Development and Manufacturing Management. The management of the Development and Manufacturing activities hereunder will be under the responsibility of the individual designated in writing no later than [*****] after the Closing Date for CureVac (“CureVac Project Leader”) and of the individual designated in writing no later than [*****] after the Closing Date for GSK (“GSK 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 COVID R&D Plan.

 

7.2

Joint Steering Committee.

 

7.2.1

Establishment. No later than [*****] after the Closing Date the Parties will establish a joint steering committee (“Joint Steering Committee” or “JSC”) to oversee the Development, Manufacture and Commercialization of the COVID Products and to facilitate the exchange of information between the Parties. The JSC shall be comprised of four (4) representatives of CureVac and four (4) representatives of GSK, one representative being the Alliance Manager of the respective Party, in each case with appropriate scientific and technical expertise and sufficient seniority within the applicable Party consistent with the scope of the JSC’s responsibilities. Each Party may replace its JSC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use all reasonable efforts (obligation de moyen) to ensure continuity on the JSC.

 

7.2.2

JSC Meetings. The JSC shall meet at least on a quarterly basis, or such other frequency as agreed by the Parties, by teleconference, videoconference or in person, provided that at least every [*****], or such other frequency as agreed by the Parties, the meeting shall be in person (which in-person meeting will be held at alternate facilities of each Party), unless agreed otherwise by the JSC representatives The JSC will have a quorum if at least one (1)  representatives of each Party is present or participating. Each Party will be responsible for all of its own expenses of participating in the JSC meetings. The Parties will endeavor to schedule meetings of the JSC at least [*****] in advance. Each Party may call special meetings of the JSC 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 JSC. Each Party may invite guest participants to certain items on the agenda of the meetings, with reasonable prior notice, in order to discuss special technical or commercial topics, provided that such guest participants shall be bound by confidentiality and non-use obligations consistent with the terms of this Agreement and shall not have a voting right in such meeting. The chair of the JSC will alternate each Calendar Year, with CureVac to chair the first year. The Party chairing the JSC shall prepare the meeting agenda with input from the other Party.

 

7.2.3

JSC Minutes. The Alliance Manager of the Party chairing the JSC shall record the minutes of each JSC 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 [*****] Days 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.

 

7.3

JSC Functions and Powers. The JSC will be responsible generally for facilitating the Parties’ interactions under this Agreement and specifically for overseeing the Development, Manufacture and Commercialization of the COVID Products. The JSC has (i) no jurisdiction 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 JSC will include:

 

(i)

overseeing the Development of Collaboration COVID Vaccine Products in accordance with the COVID R&D Plan(s);

 

(ii)

approving Product Adjustments;

 

(iii)

approving the development of Pathogen Combination Products;

 

(iv)

updating the initial COVID R&D Plan to include the further Development work;

 

(v)

discussing and agreeing the Development budgets under the COVID R&D Plan(s);

 

(vi)

the resolution and approval of any issue and recommendation from the Parties with respect to the modification of the COVID R&D Plan(s), including but not limited to modifications of the budget and timelines;

 

(vii)

receiving written reports or presentations from GSK and CureVac of their respective progress with the further Development of each COVID Product summarizing their Development activities and the results thereof with respect to the applicable COVID Product and discuss at meetings the status, progress, and results of the Development of the respective COVID Product;

 

(viii)

exchanging Development Data and other technical information;

 

(ix)

discussing and agreeing on the entry of supply agreements that provide for the supply of Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product, across the GSK Territories and the CureVac Territories;

 

(x)

discussing and agreeing on the entry of new agreements with governments and/or non-governmental organizations regarding the Development, Manufacturing and supply of the Collaboration COVID Vaccine, and, as of the Option Exercise, the First-Gen COVID Vaccine Product;

 

(xi)

creating sub-committees, including the IP Sub-Committee pursuant to Section 7.6, a Commercialization sub-committee for the coordination of Commercialization activities for COVID Products by GSK in the GSK Territory and by CureVac in the CureVac Territory and a Manufacturing sub-committee for discussing COVID Product related Manufacturing and supply.

(xii)

serving as a forum where each Party shall inform the other Party of any material feedback received from Regulatory Authorities in relation to any COVID Product;

 

(xiii)

informing on material regulatory filings and regulatory interactions related to the COVID Products;

 

(xiv)

discussing and deciding on whether to Develop (temporarily or completely) several different COVID Products in parallel, and if several COVID Products are developed in parallel, decide on whether the Development will be completed only for one or for more than one COVID Product;

 

(xv)

fostering the collaborative relationship between the Parties;

 

(xvi)

discussing and agreeing, and reviewing no more than once each Calendar Year, the rate payable for distribution costs comprised in the COGS, taking into account possible cost savings, efficiency savings or increases in the underlying costs;

 

(xvii)

resolving disputes between the Parties; and

 

(xviii)

such other functions as assigned to it under this Agreement or as agreed by the Parties.

 

If the JSC establishes a sub-committee in accordance with this Section 7.3, unless otherwise agreed, the governance provisions of this Section 7 shall apply accordingly to such sub-committee.

 

The Parties shall, within the JSC, in good faith evolve the composition and operation of the JSC to reflect the change in roles and responsibilities of the Parties in the further Development, Manufacturing and Commercialization of the COVID Products.

 

Neither Party shall make its consent (whereby either Party may give or withhold its consent in its sole discretion) subject to a change of the financial model for the Development, Manufacturing and Commercialization of COVID Products set forth in this Agreement or on the payment by the other Party of any additional consideration under this Agreement (although, for clarity, any costs incurred by the other Party in respect of obtaining a license to any In-Licensed IP shall be taken in account in the calculation of Net Profits, as set forth in this Agreement).

 

7.4

JSC Decisions.

 

7.4.1

Initial Dispute Resolution. Without prejudice to the discretionary decision rights granted to a Party in this Agreement, a Clinical Supply Agreement, a Commercial Supply Agreement or a Quality Agreement, actions to be taken by the JSC and any subcommittee shall be taken only following a unanimous vote, with each Party’s representatives collectively having one (1) vote. If any subcommittee fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****], the matter shall be referred to the JSC.

 

7.4.2

Final Decision-Making.

 

(i)

On matters concerning COVID Products, other than the matters under (ii) and (iii) on which GSK has the deciding vote, if the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****], the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] and attempt to resolve such matter in good faith. If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting, the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below.

 

(ii)

Without limiting Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments to the COVID R&D Plan(s) for such Pathogen Combination Products (including the budget and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID Products, adopt a decision that would cause significant delay of the Development timelines as set forth in the respective COVID R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or the COVID R&D Plan for the respective Pathogen Combination Product.

 

(iii)

GSK shall also have the deciding vote on any matter that jeopardizes GSK’s (or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification of Manufactured batches by a qualified person and batch release in accordance with GMP).

 

7.5

Information and results. Except as otherwise provided in this Agreement, the Parties will make available and disclose to one another Development Data and other results of work conducted prior to and in preparation for the JSC meetings, by the deadline and in the level of detail, form and format to be designated by the JSC; provided, however, that, in any event, each Party shall to the extent reasonably possible provide the other Party with monthly updates regarding its activities hereunder, preferably [*****] prior to each JSC meeting.

 

7.6

IP Sub-Committee. No later than [*****] after the Closing Date the JSC shall establish an IP Sub-Committee comprising up to two patent attorneys of each Party. The IP Sub-Committee shall be the forum for discussion and liaison between the Parties concerning filings to be made for Program Patent Rights and Joint Patent Rights. For the avoidance of doubt, the IP Sub-Committee is not a decision-making forum, except (in the first instance) with respect to matters concerning the maintenance of the Program Patent Rights and Joint Patent Rights, and, in relation to the Program Patent Rights and Joint Patent Rights, the patent term extension strategy, patent litigation, patent defense and enforcement, but serves as a forum for discussion where the Parties may coordinate and consult with each other with respect to any such filings. The IP Sub-Committee shall in particular: (i) convene no less than once every [*****] to facilitate regular interaction regarding the intellectual property matters arising from this Agreement (or any Ancillary Agreement); (ii) exchange information necessary to keep the Parties reasonably informed of each other’s prosecution of patents and trademarks that form part of the intellectual property rights licensed under this Agreement; (iii) review any Invention arising under a Program (including any Joint Product Invention and Joint Other Invention) and determine in good faith the ownership thereof, in accordance with this Agreement; (iv) coordinate intellectual property aspects of publications or presentation of Development Data, in accordance with Section 11.7; (v) cooperatively review and discuss potential material infringements by Third Parties as well as the potential infringement by either Party or its Affiliates of any intellectual property of a Third Party pursuant to Development, Manufacturing or Commercialization under this Agreement; and (vi) escalate any intellectual property-related issue on which the Parties are not in agreement to the JSC.

 

8.

CONSIDERATION AND PAYMENTS.

 

8.1

Upfront Payment. In partial consideration for the exclusive licenses granted to GSK under the CureVac Technology, GSK shall pay to CureVac a non-refundable and non-creditable fee in the amount of seventy-five million Euro (EUR 75,000,000) within [*****] after the Closing Date. CureVac shall issue an invoice for that amount on or before the Closing Date.

 

8.2

Profit Sharing for COVID Products (other than Pathogen Combination Products).

 

8.2.1

Profit Split Allocation. As further consideration for the rights and licenses granted by CureVac to GSK to the CureVac Technology and the LNP Technology under this Agreement, subject to Section 8.2.2 and the royalty scheme which applies for Pathogen Combination Products under Section 8.3, the Parties agree to split the total Net Profit generated with the sale of COVID Products (other than Pathogen Combination Products) in the Territory as follows:

 

[*****].

 

8.2.2

APA Share Credit.

 

As further consideration for the rights and licenses granted by CureVac to GSK to the CureVac Technology and the LNP Technology under this Agreement, CureVac shall be entitled to receive the first [*****] of GSK’s share under the profit split for the sale of COVID Vaccines (other than Pathogen Combination Products) under Sections 8.2.1(i) and (ii)(A), (B) and (C) (the “APA Share Credit”).

 

As further consideration for the exclusive licenses granted to GSK under the CureVac Technology and the LNP Technology under this Agreement, the APA Share Credit set out in this Section 8.2.2 shall be increased by the amounts specified below upon achievement of the following events, provided achieved within the specified timelines:

 

[*****]		Timeline		Additional APA Share Credit in EUR million
[*****]		[*****]*		[*****]
[*****]		[*****]*		[*****]
[*****]		[*****]*		[*****]
[*****]		[*****]		[*****]

 

*   Parties acknowledge that readiness for shipment of clinical materials is also dependent on GSK’s diligence in connection with the timely review of the information relevant for the certification by GSK’s qualified person and batch release in accordance with GMP, and the taking of certification and release decisions on the basis thereof. As such, any delay beyond the term for GSK to undertake such activities as from the receipt by GSK of all information it requires to decide on such certification and release (as defined in the applicable Quality Agreement), and that is not caused by an issue with the Manufacturing of the clinical materials in accordance with GMP, Applicable Laws, the Regulatory Approval and the applicable Quality Agreement, nor with a failure of such clinical materials meet the specifications set forth in the Regulatory Approval, shall be added to the timeline for completion of the milestone. [*****].

 

 

8.2.3

Calculation of Profit Split.

 

For the purposes of Section 8.2.1:

 

“Net Profits” shall mean Net Sales less:

 

(i) COGS;

 

(ii)     royalties and intangible amortization payments (including in-licensing fees and other payments due as a result of sublicensing) arising under any existing and future agreements with any Third Party pursuant to which a Party Controls any intellectual property rights required to Develop, Manufacture or Commercialize any COVID Products (other than Pathogen Combination Products), including any In-Licensing Agreement (but excluding any expenses arising under CureVac’s existing agreements with [*****]) for COVID Products (other than Pathogen Combination Products); and

 

(iii) SG&A, subject to the caps on SG&A deductions specified in Section 8.2.4 below; and

 

(iv) Other Allowable Expenses.

 

For clarity, any liability of either Party to the other Party (or any third party beneficiary or indemnified party) under this Agreement (including for any breach of this Agreement, for breach of warranty, under any indemnity or otherwise) shall not be taken into account in the calculation of Net Profits.

Where this Agreement refers to the “generation” of a Net Profit, such term shall be interpreted to refer to the recognition of the revenue from the gross sale underlying the Net Profit in question, as determined in accordance with International Financial Reporting Standards. As such, subject to Section 8.2.1(iii), Net Profit shall be shared in full in light of when a sale of a COVID Product in question is recognized upon delivery thereof, irrespective of CureVac having received upfront payments with regard to the sale of such product when it was not yet a COVID Product.

 

8.2.4

SG&A deductions. For purposes of calculating Net Profits, the SG&A expenses of both Parties (to be deducted from Net Sales when calculating the Net Profits) are capped as follows:

 

(i)

For Net Sales generated anywhere in the Territory of a COVID Product, SG&A shall be capped (a) at [*****] of Net Sales for the first COVID Product which achieves Regulatory Approval during the first [*****] after the First Commercial Sale of such COVID Product; and (b) at [*****] of Net Sales for any further COVID Products, and for the first COVID Product which achieves Regulatory Approval after the first [*****] after the First Commercial Sale of such COVID Product; and

 

(ii)

For Net Sales generated anywhere in the Territory of a COVID Product through Government and NGO Contracts, SG&A shall be capped from and including the date of First Commercial Sale of such COVID Product at [*****] of such Net Sales.

 

8.2.5

Profit Sharing Term. Profit sharing payments under this Section 8.2 shall be made as long as GSK Commercializes COVID Vaccines.

 

8.3

Royalty Payment for Pathogen Combination Products.

 

8.3.1

Royalty Rate for the GSK Territory. As further consideration for the rights and licenses granted by CureVac to GSK to the CureVac Technology and the LNP Technology under this Agreement with respect to Pathogen Combination Products, GSK shall pay to CureVac the following royalties on Net Sales in each Calendar Quarter in the GSK Territory of all Pathogen Combination Products in the amounts set forth below:

 

Annual Net Sales of Pathogen Combination Product		Royalty Rate
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

8.3.2

Royalty Term. On a country-by-country and Pathogen Combination Product-by-Pathogen Combination Product basis, GSK’s royalty obligations as set forth in this Section 8.3 shall begin with the First Commercial Sale of such Pathogen Combination Product by GSK in such country, and shall expire upon the later to occur of:

 

(i)

the expiry of the last to expire Valid Claim of any Patent Rights Controlled by CureVac (whether alone or jointly) Covering such Pathogen Combination Product in such country;

 

(ii)

the earlier of (A) expiry of Regulatory Exclusivity for such Pathogen Combination Product in such country and (B) twelve (12) years following the First Commercial Sale of such Pathogen Combination Product in such country; or

 

(iii)

ten (10) years following the First Commercial Sale of such Pathogen Combination Product in such country, provided that such Pathogen Combination Product incorporates Know-How Controlled by CureVac, or Know-How of the other Party is required to Develop, Manufacture and/or Commercialize the Pathogen Combination Product in such country,

 

and provided further that GSK’s royalty obligations under this Section 8.3 with respect to a Pathogen Combination Product shall expire for all countries of the respective Party Territory on the twentieth (20^th) anniversary of the First Commercial Sale of such Pathogen Combination Product in the first country of the respective Party Territory (the “Royalty Term”). For clarity, the matters specified above shall not apply to the calculation of Net Sales for the purposes of the Net Profit split.

 

8.3.3

Know-How Reduction. During the applicable Royalty Term and on a country-by-country and Pathogen Combination Product-by-Pathogen Combination Product basis, the royalty rate for a Pathogen Combination Product in a country shall be reduced by [*****] of the applicable rate determined pursuant to Section 8.3.1, if such Pathogen Combination Product is not or no longer Covered by a Valid Claim in such country. For clarity, this reduction shall not apply to the calculation of Net Sales for the purposes of the Net Profit split.

 

8.3.4

No Milestones under the 2020 Collaboration Agreement. For clarity, if the Development of a stand-alone “Product” under the 2020 Collaboration Agreement is abandoned prior to Regulatory Approval of such product, and the SARS-CoV-2 Pathogen is included into such product for the Development of a Pathogen Combination Product, then any events which would trigger “Development & Regulatory Milestone Payments” and “Sales Milestone Payments” under the 2020 Collaboration Agreement, and that had not yet been achieved for such stand-alone abandoned product, will not be triggered by the Pathogen Combination Product, but the Pathogen Combination Product will then be subject to the terms and conditions of this Agreement.

 

8.3.5

Exhaustiveness. Except as set forth otherwise in this Agreement, the royalty shall be the exhaustive consideration for the maintenance by CureVac of the CureVac Technology with respect to Pathogen Combination Products, and CureVac shall be responsible for the payment of any royalties, fees, costs or expenses under the In-Licensing Agreements required for Pathogen Combination Products.

 

8.3.6

Third Party Offset. Without limiting any other right or remedy of GSK under this Agreement, or any obligation of CureVac, on a country-by-country and Pathogen Combination Product-by-Pathogen Combination Product basis, if, during the Term, GSK or any of its Affiliates is required to obtain a license under certain Third Party Patent Rights to obtain freedom to operate with respect to the use or exploitation of any CureVac Elements for the Development, Manufacture and Commercialization of Pathogen Combination Products under this Agreement and to pay a royalty or other consideration under such license (including milestone payments or any payment in connection with the settlement of a patent infringement claim), then the Parties shall discuss obtaining an FTO license in accordance with Section 10.2.4. Royalties due to CureVac for the respective Pathogen Combination Product in the respective country(ies) Covered by the Third Party Patent Rights in-licensed by GSK to obtain at its discretion freedom to operate under this Section 8.3.6 shall, subject to Section 8.3.7, be reduced by: (i) [*****] of the reasonable amount payable by GSK to the Third Party for licenses required in respect of the Patent Right listed in Exhibit 8.3.6 relevant to the Pathogen Combination Products; and (ii) [*****] of the amount payable to the Third Party for any other licenses. For the avoidance of doubt, chemically modified mRNA will not be used by CureVac under this Agreement, and CureVac will therefore not be responsible for, and will not bear any payments to Third Parties with respect to such chemically modified mRNA. For clarity, this offset shall not apply to the calculation of Net Sales for the purposes of the Net Profit split.

8.3.7

Cumulative Deductions. Notwithstanding the above, any royalty reduction made pursuant to Section 8.3.3 and/or Section 8.3.4 shall in no event reduce the applicable royalty rate for the respective Pathogen Combination Product in the respective country to less than [*****] of the amounts determined pursuant to Section 8.3.1.

 

8.4

Blended Payments. With respect to a potential step down in profit sharing or royalty rates to account for the expiry of certain Patent Rights, the Parties acknowledge and agree that the CureVac Technology, GSK Technology and the LNP Technology licensed hereunder may justify profit sharing and royalty rates for sales of COVID Products in different amounts, which rates could be applied separately to COVID Products involving the exercise of CureVac Technology, the LNP Technology and the GSK Technology. Furthermore, the Parties acknowledge and agree that the CureVac Technology licensed under this Agreement may justify profit sharing royalty rates and/or royalty terms of differing amounts for sales of COVID Products in the GSK Territory, which rates could be applied separately to COVID Products involving the exercise of CureVac Patent Rights in the GSK Territory and/or the incorporation of CureVac Know-How, and that if such profit sharing rates or royalties were calculated separately, profit sharing rates and royalties relating to the CureVac Patent Rights in the GSK Territory and profit sharing rates and royalties relating to the CureVac Know-How would last for different terms. For practicality reasons the Parties have agreed on blended profit sharing and royalty rates. For clarity, this Section 8.4 solely explains the rationale behind the profit sharing royalty rates agreed on by the Parties and does not modify any of the other provisions of this Agreement.

 

8.5

Profit Sharing and Royalty Payments. Within [*****] after the end of each Calendar Quarter in which any Net Sales occur, each Party shall calculate the profit sharing and royalty payments owed to the other Party and shall remit to the other Party the amount owed to such other Party. All profit sharing and royalty payments shall be computed by converting the Net Profits and Net Sales in each country in the GSK Territory and in the CureVac Territory into the currency of Euro, using the monthly exchange rates as customarily used by such Party. All costs and expenses shall be computed by converting the relevant costs and expenses into the currency of Euro, using the monthly exchange rates as customarily used by such Party.

8.6

Reports. Each payment shall be accompanied by a written report describing the Net Profits and Net Sales of each COVID Product sold by or on behalf of the respective Party, its Affiliates and Sublicensees during the applicable Calendar Quarter for each country in which sales of any COVID Product occurred, specifying: (i) 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; (ii)    the COGS and SG&A and other deductions made to calculate Net Profits in accordance with Section 8.2.3; (iii) the applicable exchange rate to convert from each country’s currency to Euro; and (iv) the profit share and royalties payable in Euro. All costs and expenses invoiced by either Party shall be accompanied by a detailed breakdown of those costs and expenses, together with the applicable exchange rate to convert from the currency in which the costs and expenses were incurred to Euro.

 

8.7

Records and Audit. Each Party and its Affiliates and/or its Sublicensees shall keep and maintain records of: (i) sales of the COVID Product(s) in the CureVac Territory or the GSK Territory, as the case may be, so that the profit share (including Net Profit) and royalties payable and the royalty reports may be verified; and (ii) all costs and expenses incurred by it which are reimbursable (or shared equally by the parties) under this Agreement, so that the costs and expenses reimbursable (or which are shared) 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 the auditing Party and retained at the auditing Party’s expense. Said accountant shall have the right to audit the records kept pursuant to this Agreement for a period covering not more than [*****]. If said examination of records reveals any underpayment(s) or over payment(s) of any amounts payable, then the audited Party shall promptly pay or credit the balance due to the auditing Party, and if the underpayment(s) is/are more than [*****] then the audited Party shall also bear the expenses of said accountant (and if no further payments are due, shall be refunded or paid by the audited at the request of the auditing Party).

 

8.8

Payment Terms.

 

8.8.1

All payments by GSK to CureVac shall be made by wire transfer payment in Euro and shall be remitted to the following bank account:

 

[*****]

 

Electronic invoicing is GSK’s preferred method for receiving invoices. [*****] is GSK’s e-invoicing partner for submitting electronic invoices. The Parties shall collaborate to sign CureVac up to such platform to allow for electronic invoicing.

All invoices should include the following information: Invoice Date, Number and Amount; Sender’s Address, and Phone Number; Purchase Order Number; Tax Identification Number; Agreement Reference No (if applicable).

 

All payments by CureVac to GSK shall be made by wire transfer payment in Euro and shall be remitted to the following bank account:

 

[*****]

 

8.8.2

If any sum payable by a Party under this Agreement is subject to a good faith dispute between GSK and CureVac: (i) such Party shall, pay to the other Party, by the due date, all amounts not disputed in good faith by such Party; (ii) such Party shall notify the other Party, within [*****] after the due date, of any disputed amounts and shall, as soon as reasonably practicable after it has provided that notification, describe in reasonable detail its reasons for disputing each amount; and (iii) the Parties shall seek to resolve the dispute in accordance with Section 16.5. When any dispute regarding the amounts payable under this Agreement is resolved, the Party owing the payment shall pay any sum which is agreed or determined (in accordance with Section 16.5) to be payable by such Party within [*****] after the date of resolution of that dispute (or such other period as is agreed between the Parties or determined by arbitration pursuant to Section 16.5), plus interest thereon at the interest rate set forth in Section 8.8.3 from the time such payment was due.

 

8.8.3

Any undisputed payments not paid within [*****] after the due date under this Agreement shall bear interest at an annual rate of [*****] above the three-month-EURIBOR 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).

 

8.9

Taxes.

 

8.9.1

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. The Parties agree, in accordance with Section 16.10, that the relationship between the parties is one of independent contractors and does not constitute a partnership or joint venture, and agree not to take (or cause any person to take) any position on any tax return or in the course of any audit, examination or other proceeding inconsistent with such treatment, unless otherwise required by Applicable Laws and except upon a final determination of the applicable tax authority.

 

8.9.2

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.

8.9.3

If any taxes are required to be withheld under Applicable Laws, from any payment to be made by either Party under this Agreement, that Party shall (a) deduct such taxes from the payment to be made to the other Party, (b) timely pay the taxes to the proper taxing authority, and (c) send proof of payment to the other Party with an explanation of payment of such taxes within [*****] following such payment. For purposes of this Section 8.9.3, each Party shall provide the other with reasonably requested assistance which assistance includes provision of any tax forms and other information that may be reasonably necessary for a Party not to withhold tax.

 

8.9.4

All payments due to the terms of this Agreement are expressed to be exclusive of VAT and Indirect Taxes. VAT and Indirect Taxes shall be added to the payments due to the terms if legally applicable.

 

9.	INTELLECTUAL PROPERTY.

 

9.1

Background Technology. As between the Parties, all right, title and interest in and to all CureVac Patent Rights and CureVac Know-How Controlled by CureVac at the Effective Date or generated or acquired by or on behalf of CureVac during the Term outside the scope of this Agreement (“CureVac Background Technology”) shall remain under the Control of CureVac; and all right, title and interest in and to all Patent Rights and Know-How Controlled by GSK at the Effective Date or generated or acquired by or on behalf of GSK during the Term outside the scope of this Agreement (“GSK Background Technology”) shall remain under the Control of GSK. 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 (i) CureVac shall consider in good faith the interests of GSK in the prosecution, maintenance and defense of the CureVac Patent Rights within CureVac Background Technology, and (ii) the prosecution, maintenance and defense of Background IP that is generated under the 2020 Collaboration Agreement shall be subject to the provisions of the 2020 Collaboration Agreement.

 

9.2

Disclosure of Inventions. Each Party shall as soon as reasonably practical disclose to the other Party through the IP Sub-Committee and 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 9.

 

9.3

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, and CureVac and GSK will notify each other and determine in good faith which of the below categories such Invention falls within:

 

9.3.1

CureVac Inventions. Subject to Section 9.3.3, CureVac shall own all right, title and interest in and to

 

(i)

all Inventions that are invented by or on behalf of CureVac or GSK (or jointly by CureVac and GSK) and improve the CureVac Background Technology (other than any intellectual property rights subsisting in a COVID Product), the LNP Technology or the CureVac Elements, and cannot be practiced independently of such CureVac Background Technology, the LNP Technology or the CureVac Elements, as applicable, and such Inventions shall become part of the CureVac Background Technology or the LNP Technology, as applicable;

(ii)

subject to Section 9.3.2(i), all Inventions that are invented by or on behalf of CureVac, alone or in collaboration with a Third Party; and

 

(iii)

all Inventions that Cover a First-Gen COVID Vaccine Product invented before the date of effective Option Exercise (each, a “CureVac Invention”).

 

9.3.2

GSK Inventions. Subject to Section 9.3.3, GSK shall own all right, title and interest in and to:

 

(i)

all Inventions that are invented by or on behalf of GSK or CureVac (or jointly by GSK and CureVac) and improve the subject matter of any GSK Background Technology, and cannot be practiced independently of such GSK Background Technology, and such Inventions shall become part of the GSK Background Technology; and

 

(ii)

subject to Sections 9.3.1(i), (ii) and (iii), all Inventions that are invented by or on behalf of GSK, alone or in collaboration with a Third Party (each, a “GSK Invention”).

 

9.3.3

Joint Product Inventions. All Inventions that are invented by or on behalf of GSK and/or CureVac under this Agreement and that Cover a Collaboration COVID Vaccine Product shall be jointly owned by the Parties (a “Joint COVID Product Invention”).

 

9.3.4

Other Inventions. With respect to all other Inventions that do not fall within the categories described in Sections 9.3.1, 9.3.2 or 9.3.3, each Party shall own the Inventions invented solely by or on behalf of such Party (and such other Inventions shall become part of the CureVac Inventions or the GSK Inventions, as applicable), and all Inventions jointly invented by or on behalf of the Parties shall be jointly owned by the Parties (each, a “Joint Other Invention”).

 

9.3.5

Cross-Licenses under Joint Other Inventions. Except to the extent either Party is restricted by other terms of this Agreement, either Party may freely practice, exploit and license to Affiliates its interest in the Joint Other Inventions, and any resulting Joint Patent Rights and related Know-How, in connection with the use or exploitation of the respective Party’s Background Technology and any consent or license from the other Party as may be required under Applicable Law for a Party to practice and exploit such Joint Other Inventions, Joint Patent Rights and related Know-How in connection with the use or exploitation of the respective Party’s Background Technology shall hereby be given by the other Party.

 

9.4

Assignment and transfer of Inventions. To give effect to the ownership principles described in Section 9.3 each Party shall assign and transfer, and hereby assigns and transfers, to such other Party or such other Party’s designee all or a [*****] share, 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 9.3, 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 9.4 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 9.4.

9.5

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.

 

9.6

Filing, Prosecution, Maintenance and Defense.

 

9.6.1

CureVac Program Patent Rights. CureVac shall have the first right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a CureVac Invention (each, a “CureVac Program Patent Right”) throughout the Territory. At the latest [*****] before filing, CureVac shall give GSK an opportunity to review and comment upon the text of any application with respect to any CureVac Program Patent Right, shall consult with GSK with respect thereto, shall not unreasonably refuse to address any of GSK’s comments and supply GSK with a copy of the application as filed, together with notice of its filing date and serial number. CureVac shall keep GSK reasonably informed, through the IP Sub Committee, 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 GSK a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with GSK with respect thereto, and shall not unreasonably refuse to address any of GSK’s comments. Notwithstanding the above, prior to filing any application for a CureVac Invention that may disclose, in part or in full, a GSK Invention, a Joint Product Invention or Joint Other Invention, CureVac shall provide GSK with a copy of the draft application and provide GSK with at least [*****] to review and comment upon the text of such draft application. If GSK notifies CureVac within the above [*****] deadline that GSK has decided to file an application for a GSK Invention, Joint Product Invention or Joint Other Invention, the Parties shall coordinate the filing of the application for a CureVac Invention with the filing of GSK’s application for such GSK Invention, Joint Product Invention or Joint Other Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, CureVac will not include a GSK Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by CureVac without GSK’s prior written consent. CureVac shall promptly give notice to GSK of the grant, lapse, revocation, surrender or invalidation of any CureVac Program Patent Rights. CureVac shall as soon as reasonably practicable give notice to GSK of any final decision to not file patent applications claiming CureVac Program Patent Rights or to cease prosecution and/or maintenance and/or defense of CureVac Program Patent Rights on a country by country basis and, in such cases, shall permit GSK, in GSK’s sole discretion, to file such patent applications or to continue prosecution or maintenance or defense of such CureVac Program Patent Rights (in which case thereafter they will be deemed a GSK Program Patent Right) at its own expense and in its own name.

9.6.2

GSK Program Patent Rights. GSK shall have the sole right, but not the obligation, at its sole expense, to file, prosecute, maintain and defend the Patent Rights Covering a GSK Invention (each, a “GSK Program Patent Right”) 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. GSK shall keep CureVac reasonably informed, through the IP Sub-Committee, of the status of the actual and prospective prosecution, maintenance and defense, of all GSK Program Patent Rights. Notwithstanding the above, prior to filing any application for a GSK Invention that may disclose, in part or in full, a CureVac Invention, Joint Product Invention or Joint Other Invention, GSK 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 GSK within the above [*****] deadline that CureVac decides to file an application for a CureVac Invention, the Parties shall coordinate the filing of the application for a GSK Invention with the filing of CureVac’s application for such CureVac Invention so that CureVac’s application and GSK’s application are filed on the same day or otherwise filed in a way that secures and protects each of the Parties’ interest. For the avoidance of doubt, GSK will not include a CureVac Invention, Joint Product Invention or Joint Other Invention in a separate patent claim of a patent application to be filed by GSK without CureVac’s prior written consent. CureVac shall as soon as reasonably practicable give notice to GSK of any desire to cease prosecution and/or maintenance and/or defense of GSK Program Patent Rights on a country by country basis and, in such cases, shall permit CureVac, in CureVac’s sole discretion, to continue prosecution or maintenance or defense of such GSK Program Patent Rights (in which case thereafter they will be deemed a CureVac Program Patent Right) at its own expense and in its own name.

 

9.7

Joint Patent Rights. GSK shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights relating to Joint Product Inventions or Joint Other Inventions (“Joint Patent Rights”) throughout the Territory, at its sole expense, and GSK shall give timely notice to CureVac of any final decision 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 CureVac’s 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.

9.8

Patent Term Extension and Supplementary Protection. The IP Sub Committee shall decide on any patent term extensions, including supplementary protection certificates and any other extensions, including pediatric extensions, for a COVID Product that are now or become available in the future, wherever applicable, in order to secure the optimal protection for the COVID Products available under Applicable Laws. The Party holding the marketing authorization for the COVID Product Covered by any Patent Rights shall have the obligation for applying for any such extension or supplementary protection certificate, 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. GSK shall pay all expenses for obtaining and maintaining any extension or supplementary protection certificate in respect of a COVID Product in the GSK Territory.

 

9.9

Development Data. Subject to Section 11, the Development Data shall be treated as Confidential Information of the Party or Parties owning it. Each Party may use, and allow its Affiliates to use, the Development Data for the purpose of obtaining adequate protection and prosecution of their respective Know-How and Patent Rights, or as provided for otherwise in accordance with this Agreement, provided that in each case it provides the other Party with prior written notice of its intent to use the Development Data for such purpose. The other Party may, within a reasonable time following receipt of such notice, request the notifying Party to delay the use of the Development Data, in order to safeguard the protection and prosecution of other Know-How and Patent Rights. Following such request, the Parties shall cooperate in good faith to align the protection and prosecution of each Party’s Know-How and Patent Rights. For the avoidance of doubt, the terms and conditions of this Section 9 shall govern the intellectual property rights of the Parties in the Development Data.

 

9.10

Challenges to CureVac Patent Rights, Patent Rights included in the LNP Technology or GSK Patent Rights. If GSK or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the CureVac Patent Rights or the Patent Rights included in the LNP Technology, or supports a Third Party in the challenge of a CureVac Patent Right or a Patent Right included in the LNP Technology in such legal proceeding, it shall promptly, and in no event later than [*****] prior to initiating such challenge (or such shorter period as required due to a court’s, patent office’s or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****] prior to initiating such challenge), notify CureVac hereof. If CureVac or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of the GSK Patent Rights in a legal proceeding, or supports a Third Party in the challenge of a GSK Patent Right in such legal proceeding, it shall promptly, and in no event later than [*****] prior to initiating such challenge (or such shorter period as required due to the court or other filing deadline associated with the relevant triggering event giving rise to the challenge, but in any event not less than [*****] prior to initiating such challenge), notify GSK thereof. The Parties, through the IP Sub-Committee, shall promptly discuss any such issue in good faith, including the grant of a freedom to operate license at terms to be negotiated, and, if they cannot find an agreement, escalate the issue to the Executive Officers. If the Executive Officers despite good faith negotiations cannot find a solution, and a CureVac Patent Right or Patent Right within the LNP Technology is not granted or is declared invalid upon a successful challenge by GSK or any of its Affiliates (either alone or with a Third Party), such CureVac Patent Right or Patent Right within the LNP Technology shall be deemed to have been granted or shall be deemed valid until the expiry of regular patent protection for such CureVac Patent Right that would have applied if such CureVac Patent Right or Patent Right within the LNP Technology had been granted or had not been successfully declared invalid for the purposes of Section 1.179 (Valid Claim) and Section 8.3.2 (Royalty Term).

9.11

Challenges to Third Party Patent Rights. If either Party or any of its Affiliates (directly or indirectly, individually or in association with any other person or entity) intends to challenge the validity of any Third Party Patent Rights potentially Covering the Development, Manufacture or Commercialization of a COVID Product (including, but not limited to, any request for, or filing or declaration of, any invalidity proceedings, interference, deviation proceeding, opposition, inter partes review, post-grant review, third party observations or re-examination), it shall, prior to initiating such challenge, notify the other Party through the IP Sub-Committee. The Parties, through the IP Sub-Committee shall discuss the strategy for such challenge. If the Parties agree to pursue a joint challenge, (i) the Parties shall collaborate with respect to such challenge, (ii) the Parties shall [*****], and (iii) the Parties shall [*****] all costs and expenses of such challenge, provided that if the total costs and expenses exceed [*****]. Either Party and its Affiliates shall also be entitled, if agreed by the Parties, or if the IP Sub-Committee does not agree on a joint challenge, without the other Party, to challenge the validity of any Third Party Patent Rights. In this case, the Party bringing the challenge (i) shall have no obligation to consult with the other Party regarding its strategy and (ii) shall bear all the costs and expenses of such challenge.

 

10.	ENFORCEMENT AND DEFENSE.

 

10.1	Enforcement.

 

10.1.1

Notice. Each Party shall promptly provide the other Party with written notice reasonably detailing any known or alleged infringement by a Third Party of any CureVac Patent Rights, GSK Patent Rights or Joint Patent Rights which competes with the Development, Manufacture or Commercialization of COVID Products in the Territory (collectively “Third Party Infringement”).

 

10.1.2

GSK Rights. Subject to Section 10.1.3, GSK shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the Territory at its own expense. GSK shall keep CureVac closely informed as to any legal courses of action it pursues pursuant to this Section 10.1.2, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.

10.1.3

CureVac Rights. On a COVID Product-by-COVID Product basis, for as long as CureVac holds the exclusive right to Commercialize a COVID Product in the CureVac Territory pursuant to Section 6, CureVac shall have the primary right to determine and control a course of action designed to curtail a Third Party Infringement in the Field in the CureVac Territory at its own expense. CureVac shall keep GSK closely informed as to any legal courses of action it pursues pursuant to this Section 10.1.2, and the Parties shall consult with each other, and agree on strategic decisions and their implementation in connection with such action.

 

10.1.4

Taking over. If the Party having the primary right to enforce its rights against such Third Party Infringement pursuant to Sections 10.1.2 or 10.1.3, respectively, elects not to enforce its rights against such Third Party Infringement or not to further pursue the enforcement of its rights, such Party shall notify the other Party of such decision as soon as reasonably practicable and in any event within [*****] after receipt of the Third Party Infringement notice or after the decision not to further pursue the enforcement of its rights. If after the expiry of the [*****] period (or, if earlier, the date upon which the Party which has the primary right to enforce its rights against such Third Party Infringement provides written notice that it has decided not to or to no longer enforce its rights against such Third Party Infringement), the Party which has the primary right to enforce its rights against such Third Party Infringement has neither obtained a discontinuance of the Third Party Infringement, nor filed suit with regard to such Third Party Infringement, then the other Party shall have the right, but not the obligation, to take action or bring suit with respect to such Third Party Infringement at its own expense.

 

10.1.5

Collaboration. If such course of action includes litigation, 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 an action with respect to a Third Party Infringement 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. Except as set forth otherwise herein, the Party bringing the action shall bear all costs and expenses of such action.

 

10.1.6

Recoveries. Any recoveries obtained by either Party as a result of any proceeding with regard to a Third Party Infringement (other than any Third Party Infringement of intellectual property rights subsisting in any Pathogen Combination Product) under this Section 10.1 shall be allocated as follows:

 

i.

such recovery shall first be used to reimburse the Party or Parties bringing the action for all reasonable costs incurred in connection with such proceeding;

 

ii.

the remaining portion of such recovery, if any, shall be [*****] between CureVac and GSK.

 

In relation to any Pathogen Combination Product: (A) such recovery shall first be used to reimburse each Party for all reasonable costs incurred in connection with such proceeding; (B) such recovery shall then be used to compensate each Party for the respective damages suffered from the Third Party Infringement (in the case of damage suffered by CureVac, as calculated at the Royalty Rate), provided that in the event the remaining portion of the recovery is not sufficient to compensate each Party’s damages, such compensation shall be shared on a pro-rata basis depending on the amount of the respective damages suffered; and (C) the remaining portion of such recovery, if any, shall be equally shared between CureVac and GSK.

10.1.7

Settlements. 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 GSK involves any infringement of CureVac Patent Rights and/or Joint Patent Rights, as the case may be, and is reasonably likely to relate to technologies other than a COVID Product, GSK will consult with CureVac regarding issues relating to such CureVac Patent Rights, Joint Patent Rights, and/or CureVac’s products and technologies, and the Parties will mutually agree on strategic litigation decisions regarding such issues.

 

10.1.8

Assistance. The non-enforcing Party shall provide such assistance as the enforcing Party reasonably requests in connection with any action or suit hereunder to prevent or enjoin a Third Party Infringement at its own cost (or the enforcing Party’s cost, in relation to any Pathogen Combination Product). At the request of the enforcing Party, the non-enforcing Party shall provide reasonable assistance to the enforcing Party, at the non-enforcing Party’s expense (or the enforcing Party’s expense, in relation to any Pathogen Combination Product), in connection with such enforcement, including by executing reasonably appropriate documents, and joining as a party to the action. The Parties agree that, irrespective of which Party brings the action or suit pursuant to this Section 10.1, the Parties will update each other as to the status of such actions through the IP Sub-Committee and the enforcing Party will not unreasonably reject comments from the other Party relating to the management of such litigation.

 

10.2

Defense.

 

10.2.1

Notice. If the Development, Manufacture or Commercialization of any COVID 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.

 

10.2.2

Control. CureVac has the first right, but not the obligation, to control any defense of any such claim involving an alleged infringement of Third Party rights by (i) the exploitation or use of the CureVac Technology, where such alleged infringement is allegedly not caused solely by the Development, Manufacturing or the Commercialization of one or more COVID Products or (ii) CureVac’s activities under this Agreement (including Development, Manufacturing or the Commercialization of one or more COVID Products, and the Commercialization of COVID Products in the CureVac Territory), by counsel of its own choice, and the costs of such defense shall be equally shared between the Parties; and GSK may choose to be represented with respect to any such claim at its own expense and by counsel of its own choice. GSK has the first right, but not the obligation, to control any defense of any such claim other than where CureVac has the first right to control the defense of a claim, by counsel of its own choice, and the costs of such defense shall be equally shared between the Parties; and CureVac may choose to be represented with respect to any such claim at its own expense and by counsel of its own choice.

10.2.3

Assistance. Upon the defending Party’s request, the non-defending Party shall provide reasonable assistance to the defending Party with respect to a defense and/or shall join in any action if reasonably required by the defending Party in order to defend such claim or to assert all available defenses and claims, and shall reasonably cooperate with the defending Party, provided the costs of such assistance shall be equally shared between the Parties. 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 the other 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.

 

10.2.4

FTO Licenses. Without prejudice to other provisions of Section 13.4, and the rights and remedies of GSK thereunder, where a Party reasonably concludes that use or exploitation of: (i) in the case of GSK, any CureVac Elements; or (ii) in the case of CureVac, any technology used by or on behalf of GSK, its Affiliates or Sublicensees to Develop, Manufacture and/or Commercialize COVID Products under this Agreement that is described in the Know-How, or within the scope of the specification of the Patents Rights, Controlled by GSK (excluding, for clarity any CureVac Know-How or CureVac Patent Rights), in each case for the Development, Manufacturing or Commercialization of COVID Products, infringes Third Party rights and will require a freedom-to-operate license from such Third Party, the Parties will discuss the issue and the strategy for obtaining a sublicensable license in the IP Sub-Committee, with final endorsement by the JSC. Upon request of such Third Party or the other Party, the requested Party will consider in good faith whether and how it may support obtaining a freedom-to-operate license, e.g., by granting a cross-license under its Background Technology to such Third Party. If the Third Party rights are reasonably expected to affect the COVID Products as well as other products, and if they are necessary to obtain freedom to operate with respect to any CureVac Elements, CureVac shall reasonably consider obtaining such freedom-to-operate license, and that license, if sublicensable, will become an additional In-Licensing Agreement as set forth in Section 2.7.1. For any COVID Product other than the Pathogen Combination Products, the license fees payable under such In-Licensing Agreement will be reflected in the profit sharing under Section 8.2.1. With respect to Pathogen Combination Products, if such license is obtained by GSK and required to obtain freedom-to-operate under CureVac Elements, as between the Parties, any costs shall be borne in accordance with Section 8.3.6. If such license is required to obtain freedom-to-operate with respect to a Pathogen Combination Product (but not under any CureVac Elements), the costs will be borne by GSK.

 

11.

CONFIDENTIALITY.

 

11.1

Obligation of Confidentiality. As at 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 and the 2020 Collaboration 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 Section 11. Without limiting the foregoing no Receiving Party shall be permitted under this Agreement to share any Confidential Information supplied by a Disclosing Party with (i) any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of that Receiving Party solely as a result of a Change of Control in that Receiving Party or (ii) in the case of CureVac, any Third Party sublicensee under the CureVac Technology (including those identified in item (iii) of the Disclosure Letter).

11.2

Additional Obligations.

 

11.2.1

Appropriate Safeguards. In furtherance of the Receiving Party’s obligations under Section 11.1 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. The Parties will jointly agree a protocol with information security measures to be implemented to safeguard secured exchange of Confidential Information and personal information, no later than [*****] after the Closing Date.

 

11.2.2

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, 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, or Financial Partner of the Receiving Party.

 

11.3	Limitations. The Receiving Party’s obligations under Sections 11.1 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 under this Agreement;

 

(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;

 

(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.

11.4

Authorized Disclosures.

 

11.4.1

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 COVID 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), to Sublicensees (in the case of GSK) or permitted sublicensees (in the case of CureVac) or the LNP Provider, 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 COVID 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, Sublicensee (in the case of GSK), or permitted sublicensees (in the case of CureVac) 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 notify 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;

 

provided, however, that before the effective date of Option Exercise, First-Gen COVID Vaccine Products Dossiers/Data, may not be disclosed under this Section 11.4.1, unless it is in the public domain through no fault of GSK.

11.4.2

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 11.4.1 to disclose Confidential Information that is subject to the non-disclosure provisions of Section 11.1, 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 Section 11, and the Party disclosing Confidential Information pursuant to judicial, governmental or administrative process shall take all steps reasonably necessary, including to seek an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

 

11.5	Survival. All of the Receiving Party’s obligations under this Section 11 hereof, with respect to the protection of the Disclosing Party’s Confidential Information, shall for a period of [*****] survive the expiry or termination of this Agreement for any reason whatsoever.

 

11.6

Public Announcements, Press Releases. 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. Each Party may repeat any information relating to this Agreement that has already been publicly disclosed in accordance with this Section 11.6, provided such information continues at such time to be accurate.

 

11.7

Publication of Development Data. The Parties acknowledge the merit of publishing Development Data regarding the COVID Products (other than CMC Development Data) in searchable, peer-reviewed scientific literature in accordance with international scientific publishing practices and standards (including regarding the recognition of contribution and authorship). Either Party may request the other Party to discuss and determine in good faith a joint publication strategy for the Development Data regarding the COVID Products, which shall be effective upon endorsement by the IP Sub-Committee and the respective Alliance Managers. As between the Parties, the Party by whom or on whose behalf the experiment or study generating such Development Data has been conducted, shall be responsible for the publication of such Development Data, unless defined otherwise in a joint publication strategy. Any intended publication of Development Data regarding a COVID Product (including presentations to Third Parties or publication in intellectual property filings) shall be notified to the IP Sub-Committee by the relevant Party as soon as reasonably practicable and in any event at least [*****] before the final decision to publish, to allow the other Party to review and comment on the publication. The other Party may demand that the publication of the proposed presentation or publication is delayed for a period of [*****] in order to assess whether the Development Data intended to be published is patentable. If the other Party decides to pursue patent protection, it may request the publishing Party to further delay the publication of the proposed presentation or publication for a time not exceeding [*****]  from the date of the publishing Party’s notification, to enable adequate protection and prosecution of Patent Rights by either Party or their Affiliates.

With respect to any agreements between a Party and Third Parties (including clinical investigators) that a Party enters into after the Closing Date relating to the Development of any COVID Product or otherwise relating to Development activities under this Agreement, such Party shall use reasonable efforts to include publication provisions regarding results of the experiments and studies for such COVID Products that allow such Party to receive and provide a copy of any proposed publications or public presentations to the other Party, which such Party shall submit to the other Party with a reasonable amount of time for review as described in this Section 11.7.

 

Subject to the above review, a Party shall have the right as required by Applicable Law or its policies and standard operating procedures to (a) publish protocol summaries, results summaries, protocols, clinical study reports, plain language summaries and other study documents of all Clinical Studies conducted by or on behalf of such Party during the Term of this Agreement in any clinical trial register, including any of its own clinical trial registers; (b) publicly disclose results from other Clinical Studies where that Party determines that the results are scientifically important or relevant for patient care; and (c) make any other public disclosures of clinical Development Data that become required by GSK or CureVac due to Applicable Laws.

 

12.	COMPLIANCE, QUALITY, INTEGRITY

 

12.1	Legal Compliance. Each Party shall procure that it and its personnel performs this Agreement in accordance with Applicable Laws.

 

12.2

GxP. GSK and CureVac shall undertake the Development activities regarding the COVID Products, in compliance with GxP. With regard to any Clinical Studies conducted by CureVac under this Agreement, GSK may require CureVac to comply with the policies and standards of the GSK regarding the human subject research conducted to its benefit, and shall in this respect allow GSK, at its request, to review and approve at least the protocol and informed consent forms associated with such Clinical Studies.

 

12.3

Data Integrity. GSK and CureVac shall carry out their respective Development activities under this Agreement, and collect and record any data generated therefrom, in a manner consistent with the following good data management practices: (i) Development Data shall be generated using sound scientific techniques and processes; (ii) Development Data shall be analyzed appropriately, without bias and in accordance with good scientific practices; and (iii) Development Data shall be accurately recorded in accordance with good scientific practices by the individuals performing the research and in accordance with the ALCOA CCEA data integrity principles: (A) Attributable: data are traceable to the originator, (person and/or a computerized system, a device, an instrument), including any changes made to data, i.e. who performed an action and when, so that key decisions made during the conduct of the research, presentations made about the research and conclusions reached in respect of the research can be easily demonstrated and reconstructed; (B) Legible: data are readable and understandable; (C) Contemporaneous: data are recorded at the time they are generated or observed as per regulatory requirements; or in absence of regulatory requirements, local business practices; (D) Original (true copy): data as the file or format in which it was first generated, e.g. first paper record of manual observation, or electronic raw data file from a computerized system as per regulatory requirements; or in absence of regulatory requirements, local business practices; (E) Accurate: data, including error corrections and edits, are correct, truthful and to the appropriate precision; (F) Complete: all expected elements of the data are present (i.e., no unexplained gaps in the data) and the full meaning and context is preserved with the data; (G) Consistent: all elements of the record follow in the expected sequence; (H) Enduring: data are recorded in a permanent medium (paper or electronic) and continue to be retained in a human readable format for as long as specified in applicable record retention requirements; and (I) Available: data are maintained securely in such a way that they are accessible and retrievable in reasonable times (“Good Data Management Practices”). Each Party shall maintain written policies and standards related to Good Data Management Practices and shall ensure appropriate, documented training of its relevant personnel with respect to Good Data Management Practices.

12.4

Human Biological Samples. If the Parties wish to source Human Biologicals Samples on each other’s behalf or exchange Human Biological Samples between them, such exchange shall be recorded in separate addendums to this Agreement setting forth further terms and conditions for the specific purpose. GSK and CureVac undertake that the Human Biological Samples used or collected in connection with the Development have been obtained and will be stored, transferred, used and disposed of in accordance with all Applicable Laws and any generally accepted ethical guidelines regarding the collection, use, transport and disposal of human tissue, including with regard to consents from patients, volunteers and other donors.

 

12.5

Privacy; Information Security. The Parties shall comply with Data Protection Laws (as defined in Exhibit 12.5), including those concerning medical confidentiality and privacy in relation to human subjects of the Development activities regarding the COVID Products. The Parties acknowledge that they do not intend that one Party processes personal information for and on behalf of the other Party. If personal information is transferred between the Parties (as between controllers) pursuant to the performance of this Agreement or any Ancillary Agreement, the Parties shall comply with Exhibit 12.5, which may be amended from time to time by the Parties as is required by Applicable Laws. The Parties will enter into further data protection agreements if required by Applicable Laws.

 

12.6

Ethical Care of Animals. The Parties shall comply with all Applicable Laws for the care, welfare and ethical treatment of animals in the country where animal testing or animal research is performed. The Parties shall implement the “3Rs” Principles – reducing the number of animals used, replacing animal with non-animal methods whenever possible and refining the research techniques used. All work shall be performed in adherence to the core principles for animals identified below. Local customs, norms, practices or laws may be additive to the core principles, but each Party agrees to comply and shall procure and ensure that those acting for or on behalf of such Party (including its subcontractors) comply, as a minimum, with these core principles: (i) access to species appropriate food and water; (ii) access to species specific housing, including species appropriate temperature and humidity levels; (iii) provision of humane care and a program of veterinary care through guidance of a veterinarian; (iv) animal housing that minimizes the development of abnormal behaviors; (v) adherence to principles of replacement, refinement and reduction in the design of in vivo or ex vivo studies with processes to optimize animal use and to ensure effective population management; (vi) supported by a relevant scientific justification/rationale, approved by an institutional ethical review process and subjected to independent scientific review; (vii) commitment to minimizing pain and distress during in vivo and ex vivo studies; and (viii) work is performed by personnel documented as trained and competent to conduct the procedures for which they are responsible. Each Party agrees that all protocols involving animal research or animal testing for in connection with the COVID Products shall undergo an ethical review, whether or not required by Applicable Law, and that written documentation confirming ethical review shall be maintained by such Party until [*****] after the completion of the experiment or test, demonstrating that the review was completed. If a Party is currently accredited by AAALACi, such Party agrees to make commercially reasonable efforts to maintain its AAALACi accreditation during the life of this Agreement. Each Party shall have procedures in place to assess and approve its external suppliers and distributors who supply animals to it to: (i) ascertain and confirm the quality of the animals supplied; (ii) ensure legal requirements for the care and welfare of animals are met; and (iii) ensure that only purpose bred animals are used to perform the animal testing or research. The distance of suppliers from the test facility shall be minimized (where practicable) and transport processes (e.g. stocking densities, carrying crates, food and water) shall ensure minimum stress. On arrival, each Party shall ensure checks are in place to confirm only healthy animals are used. Each Party shall document the approval of its animal suppliers and distributors, which documentation shall be made available to the other Party upon request. GSK shall have the right, but not the obligation, to approve any supplier of non-human primates or other animals, which right may be invoked upon notice to CureVac.

12.7

Environment, Health and Safety. CureVac shall: (i) maintain an “EHS” (environment, health and safety) policy and risk-based management system with a commitment to provide a safe and healthy workplace and protect the environment surrounding its operations; (ii) ensure there is at least one senior executive with responsibility for EHS and the organization has access to technical expertise to support the company in meeting EHS obligations; (iii) provide relevant information, education and training to workers on the hazards, risks and controls associated with their job; (iv) provide the physical infrastructure, workplace and engineering controls necessary to ensure safe storage, handling and processing of materials and waste in order to protect people, the environment and local communities from harm; and (v) provide and maintain emergency detection systems and an effective response and healthcare capabilities.

 

12.8

Sanctions and export controls. The Parties represent and warrant that they are aware of, and undertake in carrying out their obligations under this Agreement and the agreements referred to within this Agreement that they will not violate and prevent becoming exposed to penalties under, all sanctions, export control, and anti-boycott laws, regulations, orders, directives, designations, licenses, and decisions of the European Union, the United Kingdom, the United States of America, and of any other country with jurisdiction over activities undertaken in connection with this Agreement, if applicable (“Sanctions & Trade Controls”). Each Party undertakes that, at all times, in the performance of their obligations under this Agreement and the agreements referred to within this Agreement, they will not take any action that causes the other Party to violate or otherwise become exposed to penalties under any Sanctions & Trade Controls. Neither Party shall be required to take or refrain from taking any action, nor shall it be required to furnish any information, that would be prohibited under any Sanctions & Trade Controls (as defined above).

12.9

Anti-bribery and corruption. Each Party shall comply fully at all times with all Applicable Laws, including but not limited to anti-corruption laws, and represents and warrants that it has not, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and warrants that it has taken reasonable measures to prevent subcontractors, agents or any other Third Parties, subject to its control or determining influence, from doing so. For the avoidance of doubt this includes facilitating payments, which are unofficial, improper, small payments or gifts offered or made to Government Officials to secure or expedite a routine or necessary action to which a Party is legally entitled. Either Party shall be entitled to terminate this Agreement immediately on written notice to the other Party, if the other Party fails to perform its obligations in accordance with this Section 12.9. A Party shall have no claim against the other Party for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 12.9. Either Party shall inform the other Party in writing, if, during the course of this Agreement, it is convicted of or pleads guilty to a criminal offence involving fraud or corruption, or becomes the subject of any government investigation for such offenses, or is listed by any government agency as debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs. Either Party shall ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and each document upon which entries such books and records are based is complete and accurate in all material respects. Either Party must maintain a system of internal accounting controls reasonably designed to ensure that it maintains no off-the-books accounts.

 

12.10

Changes to Compliance Framework. At any time during the term of this Agreement, either Party may suggest reasonable amendments to this Section 12 and the clauses of this Agreement referencing this Section 12, or any provision of any Ancillary Agreement concerning compliance, quality, safety or integrity, where such Party reasonably believes such changes are required to ensure compliance with Applicable Laws, or such Party’s interpretation of Applicable Laws as reflected in the values, quality, integrity, safety or compliance framework of the group to which that Party belongs. The other Party shall not unreasonably refuse or delay its agreement to such amendments. In case of any conflict between the Parties’ interpretation of frameworks, the more stringent interpretation or framework shall be reflected in the amendment.

 

12.11

Breaches. Each Party shall promptly notify the other Party of any significant deficiencies impacting the performance of this Agreement having regard to its compliance with this Section 12 and any corrective actions taken.

12.12

Audit. GSK or its nominee shall have the right to enter the CureVac’s manufacturing facilities and any of CureVac’s other offices, facilities, records and information systems to carry out an audit to verify and monitor CureVac’s compliance with Section 12 [*****] per Calendar Year, save any “For Cause” audits. The scope of the audit may include, but need not be limited to, a tour of the facility, the opportunity to view relevant standard operating procedures (SOPs), training records, building management records, animal health records, ethical review documents, and any other documents reasonably necessary to assess compliance by CureVac. The duration of the inspection shall be at the sole reasonable discretion of GSK. Audits conducted under this Section 12.12 shall require reasonable prior notice of at least [*****], except in case of For Cause audits (as defined below), in which case such limitation a prior notice of [*****] shall suffice. Audits conducted under this Section 12.12 shall be scheduled in such a manner so as not to impact the production schedule or CureVac’s normal business activities and shall be conducted during regular business hours. For the purposes of this Section 12.12, a “For Cause” audit shall be an audit conducted based on a substantiated suspicion by GSK of a material lack of compliance with Section 12, in respect of which GSK has shared with CureVac documentation substantiating its suspicion prior to the audit. Persons conducting the on-site audits shall be required to comply with reasonable CureVac rules applicable to the site and GSK shall ensure that any person involved in any audit (including a document-only inspection) shall be bound by an obligation of confidentiality. CureVac shall use commercially reasonable efforts to ensure that the same audit rights for GSK as described in this Section 12.12 apply with respect to the premises of any subcontractors authorized in accordance with this Agreement. This Section 12.12 shall apply mutatis mutandis to the extent GSK is Manufacturing COVID Products under this Agreement.

 

13.	INDEMNIFICATION AND REPRESENTATIONS AND WARRANTIES.

 

13.1

Indemnification by GSK. GSK will defend, indemnify and hold CureVac and its Affiliates and their directors, officers, employees, consultants, agents, permitted sublicensees and contractors (the “CureVac Indemnified Parties”) harmless from and against any and all losses, liabilities, claims, suits, proceedings, expenses, fees, recoveries and damages, including reasonable and demonstrable legal expenses and costs including attorneys’ fees, resulting or arising out of any claim by any Third Party resulting or arising from (i) the negligence or willful misconduct of GSK, any of its Affiliates or Sublicensees, or any of their respective directors, officers, employees, agents or contractors; (ii) the Development, Manufacturing and/or Commercialization of the Pathogen Combination Products by or on behalf of GSK (other than as conducted by CureVac), any of its Affiliates or any of their respective Sublicensees or (iii)   any breach of this Agreement by GSK, any of its Affiliates or any of their Sublicensees; except, in each case, to the extent caused by the negligence or willful misconduct of any of the CureVac Indemnified Parties.

 

13.2

Indemnification by CureVac.CureVac will defend, indemnify and hold GSK and its Affiliates and their directors, officers, employees, consultants, agents, Sublicensees and contractors (the “GSK Indemnified Parties”) harmless from and against any and all losses, liabilities, claims, suits, proceedings, expenses, fees, recoveries and damages, including reasonable and demonstrable legal expenses and costs including attorneys’ fees, resulting or arising out of any claim by any Third Party resulting or arising from (i) the negligence or willful misconduct of CureVac, any of its Affiliates, or any of their respective directors, officers, employees, consultants, agents or contractors (including an approved subcontractor or approved CMO); or (ii) the Development, Manufacture and/or Commercialization of any of the Pathogen Combination Products, if any, by or on behalf of CureVac (other than as conducted by GSK), any of its Affiliates, or their approved subcontractors or approved other CMOs; or (iii) any breach of this Agreement by CureVac, or any of its Affiliates; except, in each case, to the extent caused by the negligence or willful misconduct of any of the GSK Indemnified Parties.

13.3

Indemnification Procedures. The indemnified Party will give the indemnifying Party 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 the indemnifying Party within a reasonable time after the commencement of any action with respect to a claim shall only relieve the indemnifying Party of its indemnification obligations if and to the extent the indemnifying Party is actually and materially prejudiced thereby. 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 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). The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the claim at the indemnifying Party’s reasonable, pre-approved expense. The indemnifying Party will have the right to compromise, settle or defend any such claim or lawsuit; provided that (i) no offer of settlement, settlement or compromise by the indemnifying Party shall be binding on the indemnified Party without its prior written consent, not to be unreasonably withheld, conditioned or delayed, unless such settlement fully releases the indemnified Party without any liability, loss, cost or obligation incurred by the indemnified Party and in no event shall any settlement or compromise admit or concede that any aspect of any Patent Right owned or Controlled by the indemnified Party is invalid or unenforceable or adversely affect the scope of any Patent Right owned or Controlled by the indemnified Party; and (ii) the indemnifying Party shall not have authority to admit any wrongdoing or misconduct on the part of the indemnified Party except with the indemnified Party’s prior written consent. 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 13.3, 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.

  

13.4	CureVac Representations and Warranties. Subject to the disclosures in the attached Exhibit 13.4 (“Disclosure Letter”) CureVac represents and warrants to GSK as at the Effective Date, that:

 

(i)

it is the sole and exclusive owner of the Patent Rights listed in Exhibit 1.55 or otherwise Controls such Patent Rights;

(ii)

to CureVac’s knowledge, it has the full right, power and authority to grant the rights and licenses it purports to grant hereunder;

 

(iii)

neither CureVac nor any of its Affiliates has granted any Third Party any rights or licenses that would interfere or be inconsistent with GSK’s rights and licenses hereunder;

 

(iv)

CureVac has received no written notice of or any written demand relating to any threatened or pending litigation, and no other matters are within CureVac’s knowledge, which would reasonably lead it to believe that GSK’s exercise of any rights purported to be granted by CureVac under this Agreement will infringe any Patent Rights or infringe or misappropriate any other intellectual property right of any Third Party;

 

(v)

there is no currently pending administrative proceedings or litigation and no administrative proceedings or litigation seeking to invalidate or otherwise challenge any CureVac Patent Right(s) has been threatened in writing;

 

(vi)

CureVac has not given any written notice to any Third Party asserting infringement by such Third Party of any of the CureVac Technology or LNP Technology and, to CureVac’s Knowledge, there is no unauthorized use, infringement or misappropriation of the CureVac Technology;

 

(vii)

the CureVac Technology is free and clear of all encumbrances, security interests, options, and charges of any kind;

 

(viii)

to CureVac’s knowledge, the In-Licensing Agreements are valid and effective and CureVac has not received a written notice of termination for any of these In-Licensing Agreements;

 

(ix)

to CureVac’s knowledge, there is no ongoing litigation in respect of, litigation reasonably in prospect in connection with, and no reasonable prospect of termination under the In-Licensing Agreements by the respective counterparties under those agreements ahead of the respective expiry dates of such In-Licensing Agreements;

 

(x)

to CureVac’s knowledge, the information and documents set forth in or referred to in the Disclosure Letter are true, complete and accurate in all material respects;

 

(xi)

to CureVac’s knowledge, the information and documents regarding the In-Licensing Agreements, CureVac’s portfolio of Patent Rights, toxicology studies, clinical data, process and analytical information, manufacturing process information, material filing and correspondence with Regulatory Authorities, disclosed in the [*****] e-data room prior to the Effective Date as a part of GSK’s due diligence, is true, complete and accurate in all material respects; and

 

(xii)

CureVac has disclosed to GSK all redacted drug safety monitoring board meeting minutes, internal safety review committee meeting minutes for the [*****] as of its Initiation, and there are no other material issues identified in any letters or notices to or from Regulatory Authorities (including EMA/Rapporteur meetings) involving these [*****].

13.5	LNP Warranties. To the extent permitted under the LNP Agreement, CureVac hereby warrants to GSK on a pass-through basis each matter which is the subject of any representation or warranty given by the LNP Provider to CureVac under the LNP Agreement.

 

13.6	Representations, Warranties of the Parties to Each Other. CureVac and GSK each represents and warrants and covenants with respect to itself only as at 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.

 

13.7

Due Diligence. Prior to the execution of any Ancillary Agreement, other than the Clinical Supply Agreement, GSK shall be entitled to perform further due diligence regarding CureVac’s capabilities to perform in accordance with terms defined herein for such agreement. Without prejudice to the Parties’ other rights and remedies, the Parties shall in good faith cooperate to address and remedy any issue identified during the due diligence referred to in this Section 13.7. For the avoidance of doubt, if GSK discovers a material issue regarding CureVac’s capabilities to comply with such agreement, GSK may in addition to its other rights and remedies suspend the execution of any such agreement until such ground has been remedied by CureVac.

 

13.8

Disclaimer. Except as expressly set forth in this Agreement, each Party expressly disclaims, waives, releases, and renounces any representation or warranty of any kind, express or implied either in fact or by operation of law, by statute or otherwise, whether written or oral, or arising from course of performance, course of dealing or usage of trade, including any representation or warranty with respect to non-infringement, value, adequacy, freedom from fault, quality, efficiency, suitability, characteristics or usefulness, or merchantability or fitness for a particular purpose.

 

13.9

Limitation of Liability. Except in the case of any breach of Section 11 or in case of willful misconduct or gross negligence, neither Party shall be liable to the other Party for any indirect, punitive or consequential damages, or for damages for loss of profits or loss of business opportunity, whether based on contract or tort, or arising under Applicable Laws or otherwise.

 

14.	TERM AND TERMINATION.

 

14.1	Term. The term of this Agreement will commence on the Closing Date and end on the expiry of all applicable payment obligations to CureVac under this Agreement, unless terminated earlier according to the terms and conditions of this Agreement (“Term”).

 

14.2	Termination at Will by GSK. GSK may terminate this Agreement in its entirety at any time without cause upon [*****] prior written notice to CureVac.

 

14.3

Opt-out Right of CureVac. On a COVID Product-by COVID Product basis, CureVac may notify GSK of its decision to opt-out of the funding of the Development, Manufacture and Commercialization of a COVID Product under this Agreement; that notice shall terminate this Agreement in part in relation to the relevant COVID Product(s) with immediate effect. CureVac may equally decide to opt-out of the funding of the Development of a COVID Product under this Agreement required specifically for obtaining Regulatory Approval for marketing in a Major Market; that notice shall terminate this Agreement in part in relation to that COVID Product for that Major Market with immediate effect.

 

14.4

Termination for Cause by Either Party before First Commercial Sale. Before the First Commercial Sale of a COVID Product in a Territory, if either Party (“Breaching Party”) commits a material breach or default of any of its obligations hereunder, such breach to include a material breach by GSK of its diligence obligations under Section 4.10 with respect to a COVID Product, 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. If the Breaching Party fails to cure such breach or default within [*****] after the date of the Non-Breaching Party’s written notice thereof, the Non-Breaching Party may terminate this Agreement by giving written notice of termination to the Breaching Party. If the Breaching Party indicates in writing that it will be unable or is unwilling to cure the breach, this Agreement may be terminated by the Non-Breaching Party with immediate effect.

 

14.5

Termination for Cause by Either Party after First Commercial Sale. After the First Commercial Sale of a COVID Product in a Territory, if: (i) GSK fails to pay any amount payable under Section 8 or any Ancillary Agreement; (ii) CureVac fails to pay any amount payable under any Ancillary Agreement; (iii) either Party commits any willful and material breach of the restrictions on any license granted to that Party pursuant to this Agreement; (iv) either Party commits a material breach of the non-compete obligations under Section 2.3; (v) GSK commits a material breach of its diligence obligations under Section 5.5, or (vi) either Party commits any persistent and material breach of Section 11, and the Breaching Party fails to cure such breach or default within [*****] after the date of the written notice thereof from the Non-Breaching Party, the Non-Breaching Party may terminate this Agreement by giving written notice of termination to the Breaching Party. If the Breaching Party indicates in writing that it will be unable or is unwilling to cure the breach, this Agreement may be terminated by the Non-Breaching Party with immediate effect.

 

14.6	Termination in respect of Anti-bribery and Corruption. Either Party shall be entitled to terminate this Agreement in the circumstances specified in Section 12.9.

 

14.7

Non-exclusive remedy. Termination of this Agreement in accordance with Sections 14.4, 14.5, or 14.6 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.

15.	CONSEQUENCES OF TERMINATION.

 

15.1

Opt-Out by CureVac. GSK shall notify CureVac in writing within [*****] of receipt of notice of an opt-out decision by CureVac in accordance with Section 14.3, it GSK wishes to:

 

(i)

cease the Development and Commercialization of the relevant COVID Product(s) and decline the transfer of any rights and be released from all obligations under this Agreement in relation to the Development, Manufacture and Commercialization of the relevant COVID Products under this Agreement (the “GSK COVID Cease Option”); or

 

(ii)

continue the Development and Commercialization of the COVID Product(s) (the “GSK COVID Continue Option”).

 

15.2	Election by CureVac on Termination by GSK at Will or Termination by CureVac for Cause. CureVac shall notify GSK in writing within [*****] of notice of termination in accordance with Sections 14.2, 14.4, 14.5, or 14.6 if CureVac wishes to:

 

(iii)

cease the Development and Commercialization of the COVID Products and decline the transfer of any rights in relation to the Development, Manufacture and Commercialization of the COVID Products under this Agreement (the “CureVac Cease Option”); or

 

(iv)

continue, itself or with a Third Party, with the Development and Commercialization of the COVID Product(s) (the “CureVac Continue Option”).

 

15.3	Election by GSK on Termination by GSK for Cause. GSK shall notify CureVac in writing within [*****] of notice of termination in accordance with Sections 14.4, 14.5, or 14.6 if GSK wishes to:

 

(i)

cease the Development and Commercialization of the COVID Products and decline the transfer of any rights in relation to Development, Manufacture and Commercialization of the COVID Products under this Agreement, (the “GSK Cease Option”); or

 

(ii)

continue with the Development and Commercialization of the COVID Products (the “GSK Continue Option”).

 

15.4	Specific consequences of CureVac Cease Option, the GSK Cease Option and the GSK COVID Cease Option. If CureVac elects the CureVac Cease Option or GSK elects the GSK Cease Option or the GSK COVID Cease Option, then:

 

(i)

Reversion of Rights: At the effective date of termination, all of CureVac’s rights to the CureVac Technology and LNP Technology shall automatically revert back to CureVac and all of GSK’s rights to the GSK Technology shall automatically revert back to GSK.

 

(ii)

Wind-Down (including costs): Each Party shall, at its own cost (subject to Sections 15.4(iii) and 15.4(iv)), wind-down any on-going activities and commitments in connection with this Agreement and the Ancillary Agreements and use all reasonable efforts (obligation de moyen) to do so by the effective date of termination. If GSK exercises the GSK COVID Cease Option, the Parties will work towards completion of those activities within [*****] after the date of the GSK COVID Cease Option.

 

(iii)

Costs (On Opt-Out by CureVac): If CureVac gives notice of an opt-out decision by CureVac in accordance with Section 14.3 and GSK exercises the GSK COVID Cease Option, neither party shall have any further obligation to reimburse Development Costs, from the date of notice of the opt-out decision by CureVac in accordance with Section 14.3.

(iv)

Costs (On Termination by GSK at Will): If CureVac elects the CureVac Cease Option following a termination by GSK in accordance with Section 14.2 while the COVID R&D Plan for a COVID Product has not been completed, GSK shall reimburse CureVac for the Development Costs until the effective date of termination.

 

(v)

Costs (On Termination by CureVac for Cause): If CureVac elects the CureVac Cease Option following a termination by CureVac for cause in accordance with Section 14.4, 14.5 or 14.6, GSK shall reimburse CureVac for the Development Costs until the effective date of termination and reimburse CureVac for its demonstrable stranded costs arising from the early termination of the COVID R&D Plan(s). CureVac shall use reasonable endeavors to mitigate those stranded costs.

 

15.5	Specific consequences of the CureVac Continue Option. If CureVac elects the CureVac Continue Option, then the following shall apply:

 

(i)

Transition: The JSC shall promptly meet to devise a transition plan, which provides for an orderly and cost-effective transition of, and which sets forth the responsibilities and a timetable for transferring, all Development, Manufacturing and Commercialization responsibilities to CureVac or a Third Party selected by CureVac for this purpose (the “Transition Plan”). Each Party will bear its own costs to agree and implement the Transition Plan unless CureVac has terminated this Agreement for cause in accordance with Section 14.4, 14.5 or 14.6, in which case GSK shall reimburse CureVac for its reasonable and demonstrable direct costs incurred to implement the Transition Plan.

 

(ii)

Reversion of Rights: All of CureVac’s rights to the CureVac Technology and LNP Technology shall automatically revert back to CureVac, except that if the date of termination occurs after the First Commercial Sale of a COVID Product, (i) the termination of the rights and obligations of the Parties, and the transfer and/or return of rights pursuant to this Section 15, shall take effect on a country-by-country basis, at time as CureVac is able to take over the Commercialization of the COVID Product in such country where that COVID Product is sold with no adverse impact on the continuous availability of COVID Products in that country (the “Cut-Over Date”) and (ii) until such date in such country, the licenses granted to GSK under this Agreement (including Article 2) and any rights and obligations associated with such licenses (including GSK’s payment obligations under Section 8) shall survive.

 

(iii)

Transfer of Development Data and Regulatory Approvals. CureVac shall have the right to request in writing, as part of the Transition Plan:

 

(a)

a complete copy of all Development Data Controlled by GSK to be provided in original form and access to all other Know-How in GSK’s possession or under its Control relating to the COVID Products, such Development Data and other Know-How to be provided within [*****] of such request; and

(b)

the transfer of Regulatory Approvals held by GSK, its Affiliates or Sublicensees, and if Regulatory Approvals have not been obtained by GSK, its Affiliates or Sublicensees, CureVac may require that GSK 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 GSK, its Affiliates or Sublicensees for the filing of applications for Regulatory Approvals (with GSK using its good faith efforts to promptly undertake such actions).

 

(iv)

GSK Trademark License: As part of the Transition Plan, on receipt of a written request from CureVac, GSK grants to CureVac an exclusive (even as to GSK), cost-free, perpetual and worldwide license (with the right to sublicense in multiple tiers) under the trademarks Controlled by GSK and used for the COVID Products in the relevant jurisdiction(s) for the Manufacture and Commercialization of the COVID Products in the Territory, excluding, however, any such trademarks – or such parts of a trademark - that include, in whole or part, any corporate name or logo of GSK, its Affiliates or Sublicensees, and excluding any trademark – or such part of a trademark - which contains the letters “[*****]” as prefix or suffix (in which case GSK will not oppose any application by CureVac to register a trademark which is similar to any trademark owned by GSK but does not use the letters “[*****]” as prefix or suffix).

 

(v)

GSK Technology License. On a COVID Product-by-COVID Product and country-by-country basis effective from the Cut-Over Date, GSK grants to CureVac (i) an exclusive (even as to GSK), perpetual and worldwide license (with the right to sublicense in multiple tiers) under GSK’s interest in Joint Product Inventions and Joint Other Inventions, and, upon CureVac’s election, to be exercised no later than [*****] after the effective date of termination, (ii) a non-exclusive royalty-bearing, perpetual and worldwide license (with the right to sublicense in multiple tiers) under the other GSK Technology which has been used by GSK for the Development, Manufacture and/or Commercialization of the terminated COVID Products and is required for the further Development, Manufacture and/or Commercialization of such COVID Products, in each case of (i) and (ii) for the continued Development, Manufacture and Commercialization of the COVID Products in the Territory.

 

(vi)

Post-Termination Financial Terms (Termination by GSK at Will): If GSK terminates this Agreement in its entirety in accordance with Section 14.2 and CureVac elects the CureVac Continue Option and the license to the GSK Technology under Section 15.5(ii), then, on a COVID Product-by-COVID Product basis, effective from the Cut-Over Date, in consideration of the licenses granted in Section 15.5(ii), CureVac shall pay GSK royalties as forth in Exhibit 15.5.

 

(vii)

Post-Termination Financial Terms (Termination by CureVac for Cause): If CureVac terminates this Agreement for cause in accordance with Section 14.4, 14.5 or 14.6, CureVac shall pay GSK the fair market value for acquisition by CureVac of the COVID Product(s) and the associated exclusive license rights and benefits pursuant to this Section 15.5, provided that CureVac may, if CureVac claims or seeks to claim damages in relation to breach of this Agreement by GSK, suspend the payment of such fair market value until the amount of damages suffered or incurred by CureVac has been agreed between the Parties or determined by an arbitration panel in accordance with Section 16.5, at which point those damages (if any) shall be set off against such fair market value payment (and any fair market value payment which would remain outstanding after the set off of damages shall become due and payable within [*****] after the agreement or determination of the amount of damages).

(viii)

Expert Panel. For the purposes of Section 15.4(iv), the “fair market value” shall be agreed by the Parties, or if the Parties are unable to agree within [*****] from the date of election in accordance with Section 15.2, either Party may refer the matter to be determined by a panel of experts in accordance with this Section 15.5. The Parties shall agree on the appointment of the panel of experts, comprising three (3) members experienced in the biopharmaceutical sector, in transactions within the biopharmaceutical sector, and the valuation of technology of the biopharmaceutical sector, and shall agree with the experts the terms of their appointment. If the Parties are unable to agree on the identity of the experts within [*****] after expiry of the aforementioned term [*****] term, or if any of the persons proposed is unable or unwilling to act, then each Party shall nominate one expert, which two experts shall together select the third and final expert, who shall preside the expert panel. The experts shall act on the following basis: (i) on their appointment, the experts shall confirm their neutrality, independence and the absence of conflicts in determining the fair market value for the rights granted pursuant to this Section 15; (ii) the experts shall act as experts and not arbitrators; (iii) the experts’ determination shall (in the absence of manifest error) be final and binding on the Parties and not subject to appeal; (iv) the experts shall decide the procedure to be followed in the determination in accordance with this Agreement; (v) the costs of the determination, including the fees and expenses of the experts (but excluding the parties’ own costs which shall be borne by the Party incurring those costs), shall be borne by GSK; and (vi) the expert determination and all matters connected with it shall be held in complete confidence by each of the Parties and shall not be disclosed to any other person except as permitted under Section 11.

 

15.6

Specific Consequences of the GSK Continue Option.

 

If GSK terminates this Agreement under Sections 14.4, 14.5 or 14.6, the rights and obligations of the Parties hereunder shall terminate as at the effective date of such termination (or, if later, the Cut-Over Date) and the consequences set forth in this Section 15.6 shall apply:

 

(i)

Survival of licenses: The licenses granted to GSK under this Agreement (including under Section 2) and any rights associated with such licenses shall survive the termination of this Agreement.

 

(ii)

Post-Termination Financial Terms: Save as set out in Section 15.6(iii) below, GSK shall pay CureVac the fair market value for acquisition by GSK of the COVID Product(s) (other than any Pathogen Combination Product) and the associated exclusive license rights and benefits pursuant to this Section 15.6, provided that GSK may, if GSK claims or seeks to claim damages in relation to breach of this Agreement by CureVac, suspend the payment of such fair market value until the amount of damages suffered or incurred by GSK has been agreed between the Parties or determined by an arbitration panel in accordance with Section 16.5, at which point those damages (if any) shall be set off against such fair market value payment (and any fair market value payment which remains outstanding after the set off of damages shall become due and payable within [*****] after the agreement or determination of the amount of damages).

(iii)

Post-Termination Financial Terms (Pathogen Combination Products): In relation to any Pathogen Combination Product, all payment obligations under Section 8 shall remain in effect. With respect to royalties arising after the effective date of termination, GSK may, if GSK also claims or seeks to claim damages in relation to breach of this Agreement by CureVac, suspend the payment of such royalty payments until the amount of damages suffered or incurred by GSK has been agreed between the Parties or determined by an arbitration panel in accordance with Section 16.5, at which point those damages (if any) shall be set off against such royalty payments (and royalty payment which would remain outstanding after the set off of damages shall become due and payable within [*****] after the agreement or determination of the amount of damages).

 

(iv)

Costs (On Termination by GSK for Cause): CureVac shall undertake (at its own cost and without the right to be reimbursed) the transfer of Know-How in accordance with Sections 4.7 and 5.2.1, and shall reimburse all reasonable and demonstrable direct costs and expenses incurred by GSK in connection with those activities.

 

15.7

Specific Consequences of the GSK COVID Continue Option.

 

If CureVac gives notice of an opt-out decision by CureVac in accordance with Section 14.3 and GSK exercises the GSK COVID Continue Option:

 

(i)

Continuation under 2020 Collaboration Agreement: GSK shall have the right to continue the further Development, Manufacture and Commercialization of the COVID Products pursuant to the 2020 Collaboration Agreement, and the respective COVID Product shall be deemed an “Other Product” under the 2020 Collaboration Agreement, and all provisions of the 2020 Collaboration Agreement applying to Other Products shall apply to the COVID Products, including diligence obligations, decision making in the JSC and milestone and royalty payments to CureVac. For clarity, the Program(s) relating to each COVID Product which is subject to the GSK COVID Continue Option shall not count towards the limit on the number of concurrent Programs under the 2020 Collaboration Agreement.

 

(ii)

Termination of this Agreement: For the avoidance of doubt, no further payment obligations shall arise under this Agreement (including Section 8).

 

15.8

General Consequences of Expiry and Termination.

 

On any termination of this Agreement the rights and obligations of the Parties hereunder shall terminate as at the effective date of such termination (unless stated otherwise in this Section 15) and the following shall apply:

 

(i)

Reversion of Rights on Expiry: 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 Section 14.4, Section 14.5, or Section 14.6, or by GSK pursuant to Section 14.2, the licenses granted to GSK under Section 2 for such country shall become a fully paid-up, perpetual, and non-exclusive license.

(ii)

Reversion of Rights on Termination: Except as set forth in this Section 15, the rights and obligations of the Parties under this Agreement shall automatically lapse as at the effective date of the termination in question.

 

(iii)

Return of Information: No later than [*****] after the effective date of 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 Development, Manufacture or Commercialization of the COVID Products pursuant to this Section 15, 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 (i) maintained only on centralized storage servers (and not on personal computers or devices), (ii) not accessible by any of its personnel (other than its information technology specialists), and (iii) 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.

 

(iv)

Settlement of Outstanding Sums: Each Party shall pay all amounts then due and owing as at the termination effective date. Except in cases where (i) CureVac exercises its opt-out right pursuant to Section 14.3 or (ii) GSK terminates at will pursuant to Section 14.2 at a time when GSK commercializes a vaccine product in a Major Market targeting SARS-CoV-2 other than a COVID Product and CureVac elects the CureVac Cease Option, CureVac shall be required to pay GSK [*****] of any Development Costs exceeding the cap set out in Section 4.5, to the extent those Development Costs were incurred by GSK and, at the date of termination, CureVac’s share of those Development Costs has not been reimbursed by CureVac by way of offset against Net Profits in accordance with Section 4.5; provided that: (i) in cases where GSK has exercised the GSK Continue Option or the GSK COVID Continue Option, CureVac may offset such Development Costs against up to [*****] of the royalty payments to be made by GSK to CureVac under Section 15.6 or Section 15.7 (and the 2020 Collaboration Agreement), as applicable; and (ii) in all other cases, the Parties shall agree in good faith on instalment payments over a period of [*****] as of the effective date of termination.

 

(v)

Continuation of Ongoing Clinical Trials: In any event of termination, each Party may complete any clinical trial involving a COVID Product it has initiated prior to the termination of this Agreement in accordance with the protocol for such trial, at its cost and such Party shall be granted by the other Party a cost-free, non-exclusive, sublicensable (as set forth in this Agreement), worldwide license under the CureVac Technology and the LNP Technology or respectively the GSK Technology to complete such clinical trials in accordance with their protocols.

15.9

Effect of Expiry or Termination; Survival. Expiry or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiry or termination. Any expiry 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 expiry or termination. The provisions of Sections 1, 2.6, 4.6, 4.8.6, 8.7, 9.1, 9.3, 9.4, 11, 13.1, 13.2, 13.3, 13.8, 13.9, 15, 16.3, 16.4, 16.5, 16.7, 16.8, 16.11 and 16.12 and all other provisions contained in this Agreement that by their explicit terms or from which it is clear from the context survive expiry or termination of this Agreement, and any schedules contained in this Agreement to which reference is made in any surviving term, shall survive the expiry or termination of this Agreement. In the event of a termination of this Agreement with respect to only one of the COVID Products, and continuation of other COVID Products under this Agreement, the termination and consequences of termination provisions only apply to the terminated COVID Product, and the Agreement will remain in full force and effect with respect to the continuing COVID Products.

 

16.	GENERAL PROVISIONS.

 

16.1

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. 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 16.1 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 16.1.

 

16.2

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 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 sixty (60) calendar days, 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.

 

16.3	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:

CEO and General Counsel

 

with copy to: General Counsel

 

Address:

[*****]

 

Email:

[*****]

 

(ii)

if to GSK, addressed to:

 

GlaxoSmithKline Biologicals S.A.

 

Attention:

President of GSK Vaccines

 

with copy to: Vaccines General Counsel

 

Address:

[*****]

 

Email:

[*****]

 

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 [*****] following the date of mailing, if sent by mail.

 

16.4	Governing Law. This Agreement and all disputes arising hereunder, shall be exclusively governed by, and interpreted and enforced in accordance with Belgian law. The United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention) does not apply to this Agreement.

 

16.5

Dispute Resolution.

 

16.5.1

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 President of Vaccines (or another member of the global corporate execute team) of GSK. If the dispute has not been settled pursuant to the said rules within [*****] days 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.

 

16.5.2

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 16.5.1, shall be submitted to and settled by arbitration in accordance with the arbitration rules of the World Intellectual Property Organization (the “WIPO”) 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 Section 11 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 Zurich, Switzerland. The arbitration will be heard and determined by three (3) arbitrators, with one arbitrator being appointed by each Party and the third arbitrator being appointed by the WIPO. The language of the arbitration proceeding will be English. Notwithstanding the provisions of this Section 16.5.2, 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.

16.6

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.

 

16.7

Entire Agreement and Amendments. This Agreement, together with all Exhibits attached hereto, constitutes the entire agreement between the Parties regarding the subject matter hereof, and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof, including the Confidentiality Agreements. 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. 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 16.7.

 

16.8

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.

 

16.9	Counterparts. This Agreement may be executed in any number of counterparts, by original or electronic (including “pdf”) signature, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

16.10

Independent Contractors. The Parties are independent contractors and it is the intention of the Parties that this Agreement does not constitute or give rise to an employer-employee, agency, partnership or joint venture relationship among the Parties, but that each Party’s performance hereunder is that of a separate, independent entity.

16.11

Third Parties. Except as set out in this Section 16.11, 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.

 

16.12

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.

 

16.13

Insurance. Each Party will procure and maintain during the Term and for [*****] after termination or expiry of this Agreement, insurance in line with industry standards. GSK will be permitted to satisfy any or all of its obligations under this Section 16.13 through a program of self-insurance. Such insurance policies will be primary and non-contributing with respect to any other similar insurance policies available to the other Party or its Affiliates. Any deductibles for such insurance will be assumed by insured Party. Each Party will provide the other Party with evidence of such insurance upon the other Party’s request and prior to expiry of any one coverage. Any insurance will not be construed to create a limit of the insured Party’s liability with respect to its indemnification obligations under this Agreement.

 

☐ ☐ Signature page follows ☐ ☐

In Witness Whereof, the Parties have executed this Agreement to be effective as at the Closing Date.

 

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

 

[*****]

[*****]

Date Signed:

 

Signed on behalf of

GlaxoSmithKline Biologicals S.A.

 

[*****]

[*****]

Date Signed:

 

Signed on behalf of

CureVac AG

 

[*****]

[*****]

Date Signed:

 

Signed on behalf of

CureVac AG

 

[*****]

[*****]

Date Signed:

 

Exhibit 1.50
CureVac Know How

 

[*****] 

 

Exhibit 1.55

CureVac Patent Rights

 

[*****]

 

Exhibit 1.79

Existing COVID Projects 

 

[*****] 

 

Exhibit 1.102

Existing Government and NGO Contracts 

 

[*****] 

 

Exhibit 1.120

In-Licensing Agreements 

 

[*****] 

 

Exhibit 2.1.2

License Terms under LNP Technology 

 

[*****] 

 

Exhibit 2.1.2 PART B

Licensed LNP as at the Effective Date 

 

[*****] 

 

Exhibit 2.7.4

Ever-Warm Strategy 

 

[*****] 

 

Exhibit 4.1

Initial Covid R&D Plan 

 

[*****] 

 

Exhibit 5.1

Key Terms of a Clinical Supply Agreement 

 

[*****] 

 

Exhibit 5.2

Key Terms of a Commercial Supply Agreement 

 

[*****] 

 

Exhibit 6.2

Key Distribution Terms 

 

[*****] 

 

Exhibit 8.3.6

Third Party Offset 

 

[*****] 

 

Exhibit 12.5 

Data Protection Terms 

 

The Parties agree that the processing of Personal Information under or in connection with this Agreement shall be in accordance with this Exhibit, including all Annexes.

 

1.	Definitions

 

In this Exhibit:

 

“CureVac” means CureVac as defined in the Agreement and its Affiliates.

 

“Data Protection Authority” means each person having regulatory or supervisory authority over GSK or CureVac in the area of protection of Personal Information;

 

“Data Protection Laws” means: (a) the GDPR; and (b) all other laws concerning the processing of Personal Information;

 

“GDPR” means the General Data Protection Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data;

 

“GSK” means GSK as defined in the Agreement and its Affiliates.

 

“Party” or “Parties” means CureVac and GSK as defined in this Exhibit.

 

“Personal Information” means information relating to an identified or identifiable individual;

 

“Personal Information Breach” means any actual breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, Personal Information transmitted, stored or otherwise processed; and

 

“Transferred Personal Information” means any Personal Information that is transferred pursuant to this Agreement (i) that is transferred to CureVac by GSK operating in the European Union; or (ii) that is transferred to GSK by CureVac operating in the European Union.

 

2.	Data Processing

 

a.

Status of each Party under Data Protection Laws

 

GSK and CureVac acknowledge that the status of each Party is a question of fact determined under Data Protection Laws. Without limiting the foregoing, GSK and CureVac each understand that, in relation to the Transferred Personal Information, GSK and CureVac independently determine how and why Transferred Personal Information is processed (and accordingly each acts as a controller) and all processing of Transferred Personal Information shall be undertaken in accordance with Annex 1 (Controller Terms) to this Exhibit 12.5.

b.

Description of processing

 

The Parties will document the following information in writing (including in electronic form)

 

Duration, nature and purpose of processing
Duration of processing	[to be documented]
Nature and purpose of processing	[to be documented]
Personal Information
Individuals may include any of:	[to be documented]
Categories of Personal Information may include any of:	[to be documented]
Special categories of Personal  Information may include any of:	[to be documented]

 

3.	Termination or expiry

 

On termination or expiry of this Agreement, this Exhibit shall survive and continue in full effect for as long as Transferred Personal Information is processed by the other Party.

 

4.	Further Assurance

 

a.

If any Data Protection Authority adopts revised standard contractual clauses for the matters addressed in this Exhibit (including any Annex) and one Party notifies the other Party that it wishes to incorporate any element of those standard contractual clauses into this Exhibit, the other Party shall agree to changes (limited only to the extent of the requirement under such revised standard contractual clauses) as reasonably requested by such Party.

 

b.

Both Parties agree that, upon the request of any Party, they shall execute any specific form of data transfer agreement as reasonably requested by such Party to enable the other Party to comply with applicable Data Protection Laws or the requirements of any Data Protection Authority.

ANNEX 1 TO EXHIBIT 12.5 - CONTROLLER TERMS

 

1.	General terms

 

a.

Subject to the remaining provisions of this Annex 1, in relation to the processing of all Transferred Personal Information, each Party:

 

i.

shall comply with its obligations under Data Protection Laws; and

 

ii.

acknowledges that, except as expressly stated otherwise under this Annex 1 or otherwise in the Agreement, it is (as between the Parties) solely responsible for meeting all of its obligations under Data Protection Law.

 

2.	Legal basis and privacy notices

 

a.

Unless expressly agreed otherwise in writing, each Party shall be responsible for the lawfulness of the collection and disclosure to the other Party of the Transferred Personal Information, in particular, for obtaining any consent required by law from all individuals to whom the Transferred Personal Information relates in respect of all processing undertaken by that Party (including any disclosure to the other Party).

 

b.

If the transferring Party obtains consent for the processing of Transferred Personal Information, such consent shall cover the transfer and the further processing of Transferred Personal Information by the other Party for the purposes identified in this Exhibit.

 

c.

Unless expressly agreed otherwise in writing, each Party shall be responsible for providing privacy notices to all individuals to whom the Transferred Personal Information relates in respect of all processing undertaken by that Party. If either Party expressly agrees in writing to provide a privacy notice on behalf of the other Party, it shall ensure that the relevant privacy notices effectively address all information required to be provided under Data Protection Laws and take account of any reasonable proposals by the other Party.

 

3.	Communications

 

a.

If either Party receives any communication from a Data Protection Authority which relates directly or indirectly to:

 

i.

the other Party’s processing of Transferred Personal Information; or

 

ii.

a potential failure to comply with Data Protection Laws in relation to the processing of Transferred Personal Information,

 

the receiving Party, shall, to the extent permitted by Applicable Laws, promptly forward the communication to the other Party and provide the other Party with reasonable cooperation and assistance in relation to the same.

4.	Handling of transferred personal information

 

a.

Each Party shall ensure that Transferred Personal Information supplied to it by or on behalf of the other Party:

 

i.

is only used for the purposes for which it was collected;

 

ii.

is not disclosed to any of its staff unless those persons that have committed themselves to confidentiality and have undergone appropriate training in data protection;

 

iii.

is transferred to another Party or Third Parties only: in accordance with Applicable Laws; and

 

iv.

is kept securely, including by application of the measures set out in Annex 2 (Information Security) to this Exhibit 12.5.

 

5.	Rights of individuals

 

If an individual makes a written request to either Party to exercise any of their rights under Data Protection Laws in respect of Transferred Personal Information, the receiving Party shall respond to that request in accordance with Data Protection Laws. To the extent the request concerns processing of Transferred Personal Information undertaken by the other Party, the receiving Party shall: (i) promptly forward the request to the other Party; and (ii) cooperate and provide reasonable assistance in relation to that request to enable the other Party to respond in accordance with Data Protection Laws.

 

6.	Personal information breach

 

a.

Without limiting any provision of Annex 2 (Information Security) to this Exhibit 12.5, if a Party becomes aware of a Personal Information Breach affecting Transferred Personal Information supplied to it by the other Party, the Party shall:

 

i.

notify the other Party without undue delay, and provide the other Party with a reasonable description of the Personal Information Breach without undue delay as such information becomes available; and

 

not publish any communication concerning the Personal Information Breach without first consulting the other Party, save that it may disclose a breach to the extent required by Applicable Laws (e.g. to Data Protection Authority or to individual(s)).

 

ANNEX 2 TO EXHIBIT 12.5 – INFORMATION SECURITY

 

[to be completed as soon as reasonably practicable after the Effective Date]

Exhibit 13.4  

Disclosure Letter 

 

[*****] 

 

Exhibit 15.5

Post-Termination Royalties

 

Where this Exhibit 15.5 applies, CureVac shall pay GSK, on a Product-by-Product and country-by-country basis, the royalty payments set forth below for Net Sales by CureVac, its Affiliates, or Sublicensees of such Product, depending in what stage of development that Product finds itself at the effective date of termination. With respect to any payments to be made by CureVac to GSK, the definition of “Net Sales” in Section 1.144 and the provisions of Sections 8.3.2, 8.3.3, 8.5, 8.6, 8.7 and 8.9 shall apply mutatis mutandis.

 

[*****] 

 

 

Exhibit 12.1

 

CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Franz-Werner Haas, certify that:

 

1.

I have reviewed this annual report on Form 20-F of CureVac N.V.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

 

4.

The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the company and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

[Paragraph omitted pursuant to Exchange Act Rule 13a-14];

 

(c)

Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financials reporting; and

 

5.

The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

 

Date:	April 27, 2021

/s/ Franz-Werner Haas

Franz-Werner Haas

 

Chief Executive Officer

 

 

 

Exhibit 12.2

 

CERTIFICATION BY THE CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Pierre Kemula, certify that:

 

1.

I have reviewed this annual report on Form 20-F of CureVac N.V.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

 

4.

The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the company and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

[Paragraph omitted pursuant to Exchange Act Rule 13a-14];

 

(c)

Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

 

5.

The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

 

Date:	April 27, 2021

/s/ Pierre Kemula

Pierre Kemula

 

Chief Financial Officer

 

 

 

Exhibit 13.1

 

CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

The certification set forth below is being submitted in connection with the Annual Report on Form 20-F of CureVac N.V. (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.

 

I, Franz-Werner Haas, the Chief Executive Officer of CureVac N.V., certify that, to the best of my knowledge:

 

1.

the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and

 

2.

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of CureVac N.V.

 

Date: April 27, 2021

 

	/s/ Franz-Werner Haas
	Name:  Franz-Werner Haas
	Chief Executive Officer

 

 

Exhibit 13.2

 

CERTIFICATION BY THE CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

  

The certification set forth below is being submitted in connection with the Annual Report on Form 20-F of CureVac N.V. (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.

 

I, Pierre Kemula, the Chief Financial Officer of CureVac N.V., certify that, to the best of my knowledge:

 

1.

the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and

 

2.

the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of CureVac N.V.

 

Date: April 27, 2021

 

	/s/ Pierre Kemula
	Name: Pierre Kemula
	Chief Financial Officer

 

 

 

Exhibit 15.1

 

Consent of Independent Registered Public Accounting Firm

 

We consent to the incorporation by reference in the Registration Statement (Form S-8 No. 333-246197) dated August 14, 2020, as amended, of our report dated April 27, 2021, with respect to the consolidated financial statements of CureVac N.V. included in this Annual Report (Form 20-F) for the year ended December 31, 2020.

 

/s/ Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft

 

Stuttgart, Germany
April 27, 2021