Amended and Restated collaboration AGREEMENT

Exhibit 4.44

Execution Version

THE SYMBOL “[***]” DENOTES PLACES WHERE CERTAIN

IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM

THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, AND

(ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE

COMPANY IF PUBLICLY DISCLOSED

Amended and Restated collaboration AGREEMENT

by and between

Pfizer inc.

and

biontech SE

March 17, 2020

Execution Version

Contents

Clause			Page

1	Definitions		2
2.	Scope and Spirit of Collaboration		23
	2.1	Scope of Collaboration	23
	2.2	Spirit of Collaboration	24
	2.3	Reviewing of and Commenting on Documents	24
	2.4	Escalation	24
3.	Licenses		24
	3.1	Research Licenses.	24
	3.2	Licenses for Commercial Manufacturing.	25
	3.3	Regulatory Dossier Licenses.	26
	3.4	Commercialization Licenses.	26
	3.5	Additional Licenses.	27
	3.6	Trademark Licenses	28
	3.7	Sublicensees	28
	3.8	BioNTech Current Licenses.	29
	3.9	Third Party Agreements	31
	3.10	No Implied Rights	31
	3.11	Exclusivity	31
	3.12	Adjustments to Commercialization Territories.	32
	3.13	Expansion of the Territory.	33
4.	Payments, Funding, Financial Matters		33
	4.1	Upfront Payment	33
	4.2	Equity Investment	33
	4.3	Regulatory Milestone Payment	33
	4.4	Sharing of Development Costs	34
	4.5	Third Party Funding	35
	4.6	Accounting Principles	36
	4.7	Commercialization Costs	36
	4.8	Commercialization Sales Milestones	36
	4.9	Gross Profit Sharing.	37
	4.10	Third Party License Payments	38


	-i-

Execution Version

	4.11	Taxes.	38
	4.12	Currency, Source of Payments	39
	4.13	Method of Payment	40
	4.14	Record Keeping and Audits.	40
	4.15	No Guaranty of Success.	41
	4.16	No Other Compensation	41
	4.17	Late Payment	41
	4.18	No Double Counting	42
5.	Research and Development Plan		42
	5.1	Scope of Development and Updating of Plans	42
	5.2	Research and Development Plan	42
	5.3	Allocation of Responsibilities.	42
	5.4	Materials and Permitted Activities.	44
	5.5	Human Materials	44
6.	Contract Governance		44
	6.1	Alliance Managers	44
	6.2	Program Directors	45
	6.3	Joint Steering Committee.	45
	6.4	Other Committees	48
	6.5	Committee Decision-Making	51
7.	Manufacturing		52
	7.1	Development of Manufacture Process	52
	7.2	Manufacture of Candidates Products	52
	7.3	Quality Requirements	53
	7.4	Manufacturing Agreements	53
	7.5	Allocation of Responsibilities	55
	7.6	Quality Audits	55
8.	Development, Regulatory and Pharmacovigilance		55
	8.1	Development Matters	55
	8.2	Regulatory Matters.	57
	8.3	Pharmacovigilance and Pharmacovigilance Agreement.	60
	8.4	Product Complaints and Returns	63
	8.5	Clinical Trial Register	63
	8.6	Regulatory Exclusivity	63


	-ii-

Execution Version

	8.7	Liability	63
	8.8	Objection Right	63
	8.9	Personal Data	64
9.	Commercialization		64
	9.1	Annual Plans.	64
	9.2	Pfizer Commercialization Responsibilities	65
	9.3	BioNTech Commercialization Responsibilities:	66
	9.4	Sales Force.	68
	9.5	Training Materials, Promotional Materials and Other Product Information	70
	9.6	Pricing, Reimbursement and Market Access	71
	9.7	Purchase Agreements with Governmental Authorities	72
	9.8	Product Packaging Configurations	73
	9.9	Product Orders; Invoicing; Distribution and Sales	73
	9.10	Returns	73
	9.11	Recalls and Withdrawals	73
	9.12	Co-branding	74
	9.13	Vaccine Technical Committees	74
	9.14	Diligence and Performance Standards	74
	9.15	Management of Representatives	75
10.	Medical Affairs		75
	10.1	Global Medical Activities	75
	10.2	Medical Science Liaisons.	75
	10.3	Training and Medical Education Materials	76
	10.4	Unsolicited Medical Requests	77
	10.5	Medical Information Content	78
	10.6	Medical Affairs Studies	78
11.	Intellectual Property		78
	11.1	Patent Committee	78
	11.2	Ownership of Intellectual Property	79
	11.3	Patent Rights.	80
	11.4	Enforcement of Patent Rights.	83
	11.5	Other Actions by Third Parties	87
	11.6	Purple Book Listings	87
	11.7	Allegations of Infringement and Right to Seek Third Party Licenses	87


	-iii-

Execution Version

	11.8	Third Party Infringement Suits	88
	11.9	Product Trademarks	89
	11.10	Packaging and Labeling Rights and Licenses	92
	11.11	No Implied Licenses	92
12.	Confidentiality, Publications and Press Releases		93
	12.1	Confidentiality	93
	12.2	Authorized Disclosure	93
	12.3	Confidential Treatment of the Terms and Conditions, SEC Filings and Other Disclosures	95
	12.4	Residual Knowledge Exception	95
	12.5	Public Announcements; Publications.	95
	12.6	Non-Disclosure in the Xxxxx Xxxxxxxxx	00
	12.7	Obligations in Connection with Change of Control	97
13.	Representations and Warranties		97
	13.1	Mutual Representations and Warranties	97
	13.2	Mutual Covenants	97
	13.3	Representations and Warranties of BioNTech	97
	13.4	Accuracy of Representations and Warranties.	101
	13.5	BioNTech Covenants	102
	13.6	Pfizer Covenants	106
	13.7	Notifications	108
	13.8	Representation by Legal Counsel	108
	13.9	BioNTech’s Knowledge	109
	13.10	Disclaimer	109
	13.11	Compliance Certificates	109
14.	Government Approvals; Term and Termination		109
	14.1	Government Approvals	109
	14.2	Term	109
	14.3	Termination for Cause by a Party	109
	14.4	Termination by Pfizer for Convenience.	110
	14.5	[***]	110
	14.6	Termination Following Certain Violations.	110
	14.7	Exclusion of termination rights	111
	14.8	Effects of Expiration or Termination	111
	14.9	Provision for Insolvency	115


	-iv-

Execution Version

15.	Change of Control		116
	15.1	Change of Control	116
	15.2	Effects of Change of Control	117
16.	Limitation of Liability, Indemnification and Insurance		117
	16.1	No Consequential Damages	117
	16.2	Indemnification by Pfizer	118
	16.3	Indemnification by BioNTech	118
	16.4	Procedure	118
	16.5	Insurance	120
17.	Miscellaneous		120
	17.1	Assignment	120
	17.2	Further Actions	121
	17.3	Force Majeure	121
	17.4	Interpretation	121
	17.5	Notices	122
	17.6	Amendment	122
	17.7	Waiver	122
	17.8	Severability	122
	17.9	Descriptive Headings	123
	17.10	Global Trade Control Laws	123
	17.11	Dispute Resolution	124
	17.12	Governing Law	124
	17.13	Consent to Jurisdiction and Venue	124
	17.14	Entire Agreement	124
	17.15	Flu Collaboration	125
	17.16	Relationship of the Parties	125
	17.17	Counterparts	126
	17.18	No Third Party Rights or Obligations	126
	17.19	Conflicting Terms	127
Exhibit A Research and Development Plan			129
Exhibit B Pfizer Anti-Bribery and Anti-Corruption Principles			130
Exhibit C Pfizer’s Corporate Policy regarding Animal Care and Use (v. 1.2, June 18, 2017)			133
Schedule 1.21 Candidates			135
Schedule 1.45 Current Licenses			136


	-v-

Execution Version

Schedule 1.49 Developing Countries List			137
Schedule 1.50 Development Budget			138
Schedule 1.94 Manufacturing Plan			139
Schedule 4.5 Potential Third Party Funders			140
Schedule 4.9.5 Form of Quarterly Consolidated Report and Illustrative Gross Profit Calculation			141
Schedule 6.5.2 Decision-Making Rights			142
Schedule 8.1.1 Responsibilities delegated to Pfizer in the USA or other countries in the Territory where it is the Lead Development Party			145
Schedule 8.3 Pharmacovigilance Agreement Term Sheet			146
Schedule 9.7.1 Idemnification Terms			147
Schedule 12.5.1 Public Announcements			148
Schedule 13.3 Disclosures			149
Schedule 13.9 BioNTech Management with Knowledge			182
Schedule 13.11 ABAC Compliance Certification			183


	-vi-

Execution Version

Amended and Restated COLLABORATION AGREEMENT

This Amended and Restated Collaboration Agreement (the “Agreement”) is entered into with effect as of March 17, 2020 (the “Effective Date”), by and between Pfizer Inc., a corporation organized and existing under the laws of Delaware and having a principal place of business at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, Xxx Xxxx, 00000 Xxxxxx Xxxxxx (“Pfizer”) and BioNTech SE, a corporation organized and existing under the laws of Germany and having a place of business at Xx xxx Xxxxxxxxx 00, X-00000 Xxxxx, Xxxxxxx (“BioNTech”). Pfizer and BioNTech are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, BioNTech owns or otherwise Controls (as defined below) certain patents, patent applications, technology, know-how, scientific and technical information and other proprietary rights and information relating to the identification, research and development of Candidates (as defined below) in the Field (as defined below) for delivery via Delivery Technology (as defined below);

WHEREAS, Pfizer has extensive experience and expertise in the development and commercialization of pharmaceutical and biopharmaceutical products;

WHEREAS, in view of the current COVID-19 crisis, Pfizer and BioNTech wish to engage in expedited collaborative research and development pursuant to the Research and Development Plan (as defined below) to identify and develop Candidates for inclusion in the Product, seek expedited regulatory approval for such Product, and launch such Product in all countries of the Territory (as defined below) as quickly as reasonably possible;

WHEREAS, Pfizer and BioNTech wish that Pfizer Commercializes the Product in all countries of the Territory, subject to BioNTech having the right to exclusively Commercialize the Product in the BioNTech Commercialization Territory;

WHEREAS, BioNTech and Pfizer have entered into a Collaboration Agreement effective as of March 17, 2020 (the “Original Collaboration Agreement”) to govern their collaboration in the Development, Manufacturing and Commercialization of the Product in the Field;

WHEREAS, under Section 4 of Original Collaboration Agreement BioNTech and Pfizer have agreed upon a term sheet setting forth material terms for Commercialization of the Products which shall form the basis of a definitive commercialization agreement to be entered into after the signing of the Original Collaboration Agreement;

WHEREAS, BioNTech and Pfizer have decided to integrate the definitive terms of such commercialization agreement into the Original Collaboration Agreement and to replace the Original Collaboration Agreement by this Amended and Restated Collaboration Agreement which shall now include also the definitive terms for the commercialization of the Product; and

WHEREAS, in addition, BioNTech and Pfizer wish to amend or modify some of the terms of the Original Collaboration Agreement such that they are restated in their amended form in this Agreement.

Execution Version

NOW THEREFORE, in consideration of the premises and the mutual promises set forth herein, and intending to be legally bound, the Parties hereby agree to amend and restate the Original Collaboration Agreement as follows:

1.	Definitions

As used in this Agreement, the following capitalized terms will have the meanings set forth below:

1.1“Affiliate” means any entity directly or indirectly controlled by, controlling, or under common control with, a Person, but only for so long as such control will continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of more than 50% of the voting securities or other ownership or general partnership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity; provided, however, that where an entity owns a majority of the voting power necessary to elect a majority of the board of directors or other governing board of another entity, but is restricted from electing such majority by contract or otherwise, such entity will not be considered to be in control of such other entity until such time as such restrictions are no longer in effect. Notwithstanding the foregoing, for the purposes of this Agreement, AT Impf GmbH, having its place of business at Xxxxxxxxxxx Xxxxx 0, 00000 Xxxxxx, Xxxxxxx, and any entity that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with AT Impf GmbH (other than BioNTech SE or any entity that is directly or indirectly controlled by BioNTech SE) (collectively, the "Impf Group") shall not be considered Affiliates of BioNTech.

1.2“Agreed Product Component” is defined in Section 6.4.1.2.

1.3“Amendment Signing Date” means 29 January 2021.

1.4“Annual Regional Commercialization Plan” means, with respect to a Commercialization Region and having regard to the objectives and principles of the Global Commercialization Plan, the applicable plan as may be established by the applicable RCC, and as updated from time to time by the applicable RCC, in each case pursuant to Section 9.1, for the applicable Calendar Year during the Term. It is acknowledged that if each Party has countries within its Commercialization Territory that lie within the same Commercialization Region, two separate Annual Regional Commercialization Plans may exist with each covering only those countries within one Party's Commercialization Territory.

1.5“Anti-Corruption Laws” means all applicable anti-bribery and anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Xxxxxxx Xxx 0000, and the local laws and regulations of any countries in which Candidates or Products, payments or services will be provided or procured under or pursuant to this Agreement.

1.6“Applicable Data Protection Law” means all applicable personal data protection laws, rules and regulations, including the EU General Data Protection Regulation (“GDPR”).

Execution Version

1.7“Bankruptcy Code” means Section 101(35A) of Title 11 of the United States Code, as amended, or such other legislation, Law or code with effect in another jurisdiction to which BioNTech or its Affiliates is subject having equivalent or reasonably similar purpose or provisions to the foregoing.

1.8“Binding Obligation” means, with respect to a Party (a) any oral or written agreement or arrangement that binds or affects such Party’s operations or property, including any assignment, license agreement, loan agreement, guaranty, or financing agreement, (b) the provisions of such Party’s charter, bylaws or other organizational documents or (c) any order, writ, injunction, decree or judgment of any court or Governmental Authority entered against such Party or by which any of such Party’s operations or property are bound.

1.9“Biologics License Application” or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries, including an MAA.

1.10“BioNTech Commercialization Territory” means (a) Germany and Turkey, until such time, on a country by country basis, a BioNTech Territory Exit Option is exercised by BioNTech in respect of one or both of those countries and (b) those countries, on a country by country basis, which become Pfizer Exit Countries (if any).

1.11“BioNTech Commercial Materials” means any and all BioNTech Promotional Materials, BioNTech Training Materials, and all other literature or other information related to the Product and, in each case, created and provided by or on behalf of BioNTech hereunder.

1.12“BioNTech House Marks” means (a) the corporate logo of BioNTech, (b) the trademark “BioNTech”, (c) any other Trademark, trade name or service xxxx (whether registered or unregistered) containing the word “BioNTech”, and (d) any other corporate logo or Trademark used by BioNTech to identify BioNTech or its Affiliates; and all intellectual property rights and goodwill associated with any and all of the foregoing in clauses (a) through (d).

1.13“BioNTech Improvement” means any Research and Development Program Technology, regardless of inventorship, that is a modification or improvement made to the RNA Technology or RNA Process Technology and (a) would also be applicable to one or more candidates or products in addition to or other than the Candidates or Products (b) is not predominantly directed to the Pfizer Technology and (c) could have reasonably been developed without the aid, use or application of Pfizer Materials, Pfizer Improvements or Pfizer’s Confidential Information or any improvements or enhancements thereto.

1.14“BioNTech Know-How” means [***].

1.15“BioNTech Materials” means any tangible materials (but not information about or contained in such materials) owned or Controlled by BioNTech that relate to or embody the BioNTech Know-How or BioNTech Patent Rights.

1.16“BioNTech Patent Right” means any Patent Right (other than Pfizer Patent Rights or Patent Rights jointly owned by BioNTech and Pfizer pursuant to Section 11.2) in any form and

Execution Version

whether pending or issued that (a) is Controlled by BioNTech or any of its Affiliates as of the Effective Date or comes into the Control of BioNTech or any of its Affiliates during the Term (other than, in either case, through the grant of a license by Pfizer) and (b) claims any BioNTech Know-How.

1.17“BioNTech Technology” means the BioNTech Patent Rights, BioNTech Materials, BioNTech Know-How. For avoidance of doubt, BioNTech Technology includes all Intellectual Property Rights Controlled by BioNTech pursuant to the Fosun Agreement.

1.18“BioNTech Third Party Agreement” means any agreement between BioNTech (or any of its Affiliates) and any Third Party (such Third Party, a “Third Party Licensor”) that (a) relates to any of the BioNTech Technology or Research and Development Program Technology, or (b) otherwise grants a license or otherwise transfers any right to practice under any Patent Rights or Know-How, in each case that relate to the Candidates or Products or activities under this Agreement. For clarity, all Current Licenses shall be deemed BioNTech Third Party Agreements hereunder and all Current Licensors shall be deemed Third Party Licensors hereunder.

1.19“Biosimilar Notice” means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the Public Health Service Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biopharmaceutical product, which application identifies a Product as the Reference Product with respect to such product, and other information that describes the process or processes used to manufacture the biopharmaceutical product.

1.20“Business Day ” means a day other than a Saturday, Sunday or bank or other public holiday in New York, New York, USA or Mainz, Germany.

1.21“Candidate” means an immunogenic composition in the Field that comprises Unmodified RNA Technology, Modified RNA Technology or Replicon Technology that (a) is Developed pursuant to the Research and Development Plan, (b) is Controlled by BioNTech as of the Effective Date or from time to time during the Term or (c) is Exploited by any of the Parties or their Affiliates pursuant to this Agreement. Those Candidates Controlled by BioNTech and existing as of the Effective Date are set forth in Schedule 1.21.

1.22“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.23“Calendar Year” means any twelve (12) month period beginning on January 1 and ending on the next subsequent December 31.

1.24“Capex Costs” means any capital expenditure costs associated with (a) the Research and Development Program or (b) the build-out, establishment, construction, expansion or investment in any Manufacturing facilities.

1.25“Change of Control” means, with respect to a Party (a) the acquisition of beneficial ownership, directly or indirectly, by any Person (other than such Party or an Affiliate of such Party, and other than by virtue of obtaining irrevocable proxies) of securities or other voting interest of such Party representing of the combined voting power of such Party’s then outstanding securities or other voting interests, (b) any merger, reorganization, consolidation or business combination

Execution Version

involving such Party with a Third Party that results in the holders of beneficial ownership (other than by virtue of obtaining irrevocable proxies) of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or business combination, (c) any sale, lease, exchange, contribution or other transfer (in one transaction or a series of related transactions) of all or substantially all of the assets of such Party to which this Agreement relates, other than a sale or disposition of such assets to an Affiliate of such Party or (d) the approval of any plan or proposal for the liquidation or dissolution of such Party (other than in circumstances where such Party is deemed a Debtor pursuant to Section 14.9).

1.26“Clinical Trial” means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product. Without limiting the foregoing, Clinical Trial includes any Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial or other expedited clinical trial conducted by or on behalf of one or both Parties in connection with this Agreement.

1.27“CMC” means chemistry, manufacturing and controls.

1.28“Combination Product” means a product comprising a Candidate or Product in combination with one or more other therapeutically active ingredients (which includes any prophylactic activity) that are co-formulated as part of the same dosage form or packaged and administered to patient together. For the avoidance of doubt, adjuvants, including molecular adjuvants, are not considered therapeutically active ingredients for the purposes of this definition regardless of whether or not such adjuvant is packaged together with a Candidate or Product but in a separate container.

1.29“Commercialization Activities” means those activities to be performed by each Commercializing Party with respect to the Commercialization of the Product in the Commercialization Territory, including those under Section 9 of this Agreement.

1.30“Commercializing Party” shall mean, as applicable, (a) Pfizer (including Pfizer’s Affiliates) with respect to the countries included within the Pfizer Commercialization Territory or (b) BioNTech (including BioNTech’s Affiliates) with respect to the countries included with the BioNTech Commercialization Territory.

1.31“Commercialization Territory” shall mean either the Pfizer Commercialization Territory or the BioNTech Commercialization Territory, as applicable.

1.32“Commercialize” or “Commercializing” means to market, promote, distribute, offer for sale, sell, have sold, import, have imported, export, have exported or otherwise commercialize a compound or product. When used as a noun, “Commercialization” and “Commercialized” means any and all activities involved in Commercializing.

Execution Version

1.33“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances, in particular taking into account the then-current urgency of the COVID-19 crisis. With respect to any efforts relating to the Development, Regulatory Approval or Commercialization of a Candidate or Product by a Party, generally or with respect to any particular country in the Territory, a Party will be deemed to have exercised Commercially Reasonable Efforts if such Party has exercised those efforts normally used by such Party having regard to the circumstances, in the relevant country, with respect to a compound or protein, product or product candidate, as applicable (a) of similar modality Controlled by such Party, (b) to which such Party has similar rights, (c) which is of similar market potential in such country, and (d) which is at a similar stage in its development or product life cycle, as any Candidate or Product, in each case, taking into account all Relevant Factors in effect at the time such efforts are to be expended. Further, to the extent that the performance of a Party’s obligations hereunder is adversely affected by the other Party’s failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such Party has used its Commercially Reasonable Efforts to perform any such affected obligations.

1.34“Committee” means one of the JSC, RCC, Patent Committee, Joint Safety Committee, JMC, JFC and JCC, and “Committees” means any two or more of the foregoing.

1.35“Compassionate Use Purposes” means, with respect to the Product, providing Product under any compassionate use or expanded access programs or other gratis donations, but excluding any sales of Product for cash or non-cash consideration under any Emergency Use Authorization.

1.36“Competitive Product” means a pharmaceutical product that incorporates an immunogenic composition comprising RNA in the Field that is intended to be, has been, or is being Exploited by a Third Party. For avoidance of doubt, Competitive Product does not include Product (a) Commercialized by or on behalf of BioNTech in the BioNTech Commercialization Territory pursuant to this Agreement; or (b) Commercialized outside of the Territory in accordance with the terms of the Fosun Agreement.

1.37“Compliance” means the adherence by the applicable Party and its Affiliates in all material respects to all applicable Laws and Party Specific Regulations, in each case with respect to the activities to be conducted by or on behalf of that Party under this Agreement.

1.38“Confidential Information” means, with respect to each Party, all Know-How or other information, including proprietary information and materials (whether or not patentable) regarding or embodying such Party’s or its Representatives’ technology, products, business information or objectives, that is communicated by or on behalf of the Disclosing Party to the Receiving Party or its permitted recipients, on or after the Effective Date, but only to the extent that: (a) such Know-How or other information in written form is marked in writing as “confidential” at the time of disclosure, (b) such Know-How or other information disclosed orally or in non-tangible form is identified by the Disclosing Party as “confidential” at the time of disclosure or within 30 days thereafter, or (c) such Know-How or other information (regardless of the form of disclosure) is disclosed in circumstances of confidence or would be understood by the Parties, exercising reasonable business judgment, to be confidential. Confidential Information does not

Execution Version

include any Know-How or other information to the extent the Receiving Party can demonstrate by competent proof that such Know-How or other information (a) was already known by the Receiving Party (other than under an obligation of confidentiality to the Disclosing Party) at the time of disclosure by or on behalf of the Disclosing Party, (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party, (c) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party, other than through any act or omission of the Receiving Party in breach of its obligations under this Agreement, (d) was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to the Receiving Party or (e) was independently discovered or developed by or on behalf of the Receiving Party without the use of any Confidential Information belonging to the Disclosing Party. Joint Know-How shall be deemed Confidential Information of either Party and either Party shall be deemed the Receiving Party in respect of Joint Know-How.

1.39“Contract Interest Rate” means one-half of one percent (0.5%) plus the rate for deposits in U.S. Dollars for a period of three-months as published by the ICE Benchmark Administration Limited, a United Kingdom Company (“LIBOR”); measured at 2 p.m. London/England time on the date payment is due. If the three-month LIBOR has been permanently discontinued, it will be replaced by a comparable or successor quoting service approved by the Parties. Interest will be calculated on a 365/360 basis.

1.40“Control” or “Controlled” means with respect to any Intellectual Property Right or material (including any Patent Right, Know-How or other data, information or material), the ability (whether by sole, joint or other ownership interest, license or otherwise, other than pursuant to this Agreement) to, without violating the terms of any agreement with a Third Party, grant a license or sublicense or provide access or other right in as provided in this Agreement, to or under such Intellectual Property Right or material.

1.41“Conversion Costs” means [***].

1.42“Copyright” means any copyright rights pertaining to the promotional materials and literature created or utilized by or on behalf of a Commercializing Party in connection with the Commercialization of Products in the by that Commercializing Party in its Commercialization Territory.

1.43“Cover”, “Covered” or “Covering” means, with respect to (a) a given Candidate or Product and Patent Right, that a valid claim of such Patent Right would, absent a license thereunder or ownership thereof, be infringed by the making, sale, offer for sale or importation of such Candidate or Product and (b) a given Candidate or Product and Know-How, that such Know-How would, absent a license thereunder or ownership thereof, be misappropriated or misused by the use or making of such Candidate or Product.

1.44“Current Good Manufacturing Practices” or “cGMP” means all applicable standards and applicable Laws relating to manufacturing practices for products (including ingredients, testing, storage, handling, intermediates) promulgated by the U.S. Food and Drug Administration and any other governmental authority (including, European Union or member state level and Japan), including, but not limited to, standards in the form of applicable Laws, guidelines, advisory opinions and compliance policy guides, and current interpretations of the applicable

Execution Version

authority or agency thereof (as applicable to pharmaceutical and biological products and ingredients), as the same may be updated, supplemented or amended from time to time, in each case of those jurisdictions in which the products are Manufactured.

1.45“Current Licenses” means any agreement (a) that BioNTech or its Affiliates has entered into prior to the Effective Date with a Third Party and (b) pursuant to which BioNTech or its Affiliates are (i) granted rights to any BioNTech Technology as of the Effective Date or (ii) granted a license or otherwise transferred any right to practice under any Patent Rights or Know-How, in each case that relate to the Candidates or Products or activities under this Agreement. BioNTech’s Current Licenses are disclosed on Schedule 1.45.

1.46“Current Licensor” means any Third Party that is a party to a Current License.

1.47“Delivery Technology” means the BioNTech Know-How applicable to formulating nucleic acids to enable the delivery of such nucleic acids to target cells in vivo. For clarity, Delivery Technology does not [***].

1.48“Develop”, “Developed” or “Developing” means to discover, research or otherwise develop or improve a process, compound or product, including planning and conducting non-clinical and clinical research and development activities prior to grant of a Market Authorization Approval or any research or development conducted after receipt of a Market Authorization Approval, including those required by any Regulatory Authority to maintain any Market Authorization Approval. When used as a noun, “Development” means any and all activities involved in Developing.

1.49“Developing Countries Territory” means, to the extent BioNTech or any of its Affiliates receive Third Party funding from [***] to fund Development or Manufacturing of the Candidates or Products pursuant to this Agreement, those countries listed in Schedule 1.49 which are also defined in the relevant funding documents as “Developing Countries”; provided that if prior to the execution of such funding documents, the price of any medicinal product (including the Product) in any country within Schedule 1.49 is made relevant as a reference price for the sale of the Product in any country outside of the countries listed within Schedule 1.49, then such country shall be automatically removed as a country within Schedule 1.49, unless otherwise mutually agreed in writing by the Parties.

1.50“Development Budget” means the budget to be agreed and updated [***] by the JSC pursuant to Section 5.1 for all activities, costs and expenses that are to be funded as Shared Development Costs. The Development Budget existing on the signing of this Amended and Restated Collaboration Agreement is attached hereto as Schedule 1.50.

1.51“EMA” means the European Medicines Agency or any successor agency thereto.

1.52“Emergency Use Authorization” means an emergency use authorization, or any analogous approval for emergency situations, granted by a Governmental Authority or Regulatory Authority to warrant limited or conditional distribution of a pharmaceutical or vaccine product, including any granted pursuant to §564 of the FD&C Act (or any equivalent or comparable authorization granted by a Regulatory Authority elsewhere), in each case which is separate from a Market Authorization Approval.

Execution Version

1.53“European Union” or “EU” means the countries of the European Union, as it is constituted as of the Effective Date, which consists of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and, notwithstanding its departure from the European Union, shall for the purposes of this definition include the United Kingdom of Great Britain and Northern Ireland.

1.54“Expedited Trial Pathway” means a Clinical Trial protocol or pathway recognized or authorized by any Regulatory Authority for the emergency or expedited approval of medicines for human use, as opposed to a traditional Clinical Trial.

1.55“Exploit” means to Develop, Manufacture, Commercialize, use or otherwise exploit. Cognates of the word “Exploit” will have correlative meanings.

1.56“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

1.57“FDA” means the United States Food and Drug Administration and any successor Governmental Authority having substantially the same function.

1.58“Field” means immunogenic compositions comprising RNA encoding a SARS-CoV-2 polypeptide or fragment thereof, including naturally occurring or engineered variants thereof, for prophylaxis against COVID-19 in humans.

1.59“First Commercial Sale” means, with respect to the Product in a given country in the Territory, the first shipment of the Product by the applicable Commercializing Party to a Third Party in such country for end use or consumption of the Product pursuant to an Emergency Use Authorization in such country or after grant of a Market Authorization Approval of such Product in such country or, if earlier, the invoicing of a Third Party for such shipment, excluding, however, any shipment or invoicing or other distribution of the Product for use in or for (a) a clinical trial, a Compassionate Use Purpose, named patient programs, sales under a treatment IND, test marketing, or any non-registrational studies or (b) any similar instance where the Product is supplied at or below the Commercializing Party’s Manufacturing Costs (excluding any margin) for such Product.

1.60“Flu Collaboration License” means the separate research collaboration and license agreement between, inter alia, the Parties for the development and commercialization of immunogenic compositions comprising RNA that encodes at least one Antigen for prophylaxis against influenza in humans dated July 20, 2018, as amended.

1.61“Fosun” means Shanghai Fosun Pharmaceutical Industrial Development, Co. Ltd, a company incorporated in China, and having a place of business at Xx. 0000 Xxxxxx Xxxx, Xxxxxxxx, Xxxxx.

1.62“Fosun Agreement” means the Development and License Agreement concluded between BioNTech and Fosun on March 13, 2020.

1.63“Future License” means an agreement approved by the Parties (a) that BioNTech or its Affiliates enters into on or after the Effective Date with a Third Party or (b) that Pfizer or its Affiliates enters into on or after the Effective Date with a Third Party; which in the case of (a) and

Execution Version

(b) grants a license (sublicensable in accordance with the licenses granted hereunder) to that Third Party's (“Future Licensor”) Intellectual Property Rights for the Development, Manufacture or Commercialization of the Candidates or Products by BioNTech and Pfizer in the Field, and which license is applicable to the Candidates or Products.

1.64“GAAP” means the then-current generally accepted accounting principles in the United States as established by the Financial Accounting Standards Board or any successor entity or other entity generally recognized as having the right to establish such principles in the United States, in each case, consistently applied.

1.65“GEIA” means the German Employee Invention Act.

1.66“GEIA Technology” means all BioNTech Technology and Research and Development Program Technology invented by employees of BioNTech or its Affiliates (solely or jointly with employees of Third Parties) under the jurisdiction of GEIA.

1.67“Global Commercialization Plan” means, the global plan established by the JCC pursuant to Section 9.1 with respect to the Territory as a whole, and as may be updated from time to time by the JCC for each Calendar Year during the Term, and from which any Annual Regional Commercialization Plan shall be derived.

1.68“Global Trade Control Laws” include, but are not limited to, the U.S. Export Administration Regulations; the U.S. International Traffic in Arms Regulations; the economic sanctions rules and regulations implemented under statutory authority or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control; European Union (EU) Council Regulations on export controls, including Nos.428/2009, 267/2012; other EU Council sanctions regulations, as implemented in EU Member States; United Nations sanctions policies; all relevant regulations and legislative instruments made under any of the above; other relevant economic sanctions, export and import control laws, and other laws, regulations, legislation, orders and requirements imposed by a relevant Governmental Authority.

1.69“Government” or “Governmental Authority” is to be broadly interpreted and includes (a) any national, federal, state, local, regional or foreign government, or level, branch, or subdivision thereof; (b) any multinational or public international organization or authority; (c) any ministry, department, bureau, division, authority, agency, commission, or body entitled to exercise any administrative, executive, judicial, legislative, police, regulatory, or taxing authority or power; (d) any court, tribunal, or governmental arbitrator or arbitral body; (e) any government-owned or controlled institution or entity; (f) any enterprise or instrumentality performing a governmental function; and (g) any political party.

1.70“Government Official”, to be broadly interpreted, means (a) any elected or appointed government official (e.g., a member of a ministry of health), (b) any employee or person acting for or on behalf of a government official, Governmental Authority, or other enterprise performing a governmental function, (c) any political party, candidate for public office, officer, employee, or person acting for or on behalf of a political party or candidate for public office, (d) any member of a military or a royal or ruling family, and (e) any employee or person acting for or on behalf of a public international organization (e.g., the United Nations). For clarity, healthcare

Execution Version

providers employed by Government-owned or -controlled hospitals, or a person serving on a healthcare committee that advises a Government, will be considered Government Officials.

1.71“Gross Profit” means [***].

1.72“GxP” means, collectively, all relevant good practice quality guidelines and regulations, encompassing such internationally recognized standards as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and Good Review Practice (GRP).

1.73“HCP” or “Healthcare Professional” includes any physician, nurse, pharmacist, or other person who may administer, prescribe, purchase or recommend pharmaceutical products or other healthcare products.

1.74“House Marks” means the Pfizer House Marks or the BioNTech House Marks, as the case may be.

1.75“Human Material” means any biological samples of one or more Subjects collected, provided or utilized by BioNTech during the Research and Development Plan pursuant to this Agreement.

1.76“ICF” means an informed consent form that was approved by a qualified Institutional Review Board or Independent Ethics Committee (“IRB / IEC”) in accordance with all applicable Laws and recognized international standards for the protection of human research subjects.

1.77“IFRS” means International Financing Reporting Standards, as in effect from time to time, together with its pronouncements thereon from time to time, consistently applied.

1.78“IND” means an Investigational New Drug Application submitted under the FD&C Act, or an analogous application or submission with any analogous agency or Regulatory Authority outside of the United States for the purposes of obtaining permission to conduct Clinical Trials.

1.79“Intellectual Property Rights” means any and all (a) Patent Rights, (b) proprietary rights in Know-How, including trade secret rights, (c) proprietary rights associated with works of authorship and software, including copyrights, moral rights, and copyrightable works, and all applications, registrations, and renewals relating thereto, and derivative works thereof, (d) other forms of proprietary or intellectual property rights however denominated throughout the world, other than trademarks, service marks, trade names, trade dress, domain names and other indicators of origin.

1.80“Internal Compliance Codes” means a Party’s internal policies and procedures intended to ensure that such Party and its Affiliates comply with applicable Laws, Party Specific Regulations, and such Party’s applicable internal policies and procedures, including such policies and procedures regarding compliance with such Party’s ethical, medical and similar standards.

1.81“Joint Commercialization Committee” or “JCC” has the meaning defined in Section 6.4.1.

Execution Version

1.82“Joint Steering Committee” or “JSC” means the steering committee described in Section 6.3.1.

1.83“Joint Know-How” means any Research and Development Program Know-How, whether or not patentable, made or created jointly by (a) BioNTech or any of its Representatives and (b) Pfizer or any of its Representatives, which does not constitute BioNTech Know-How, Product Know-How or Pfizer Know-How.

1.84“Joint Patent Rights” means Research and Development Program Patent Rights that claim or disclose any invention included in Joint Know-How.

1.85“Joint Steering Committee” or “JSC” means the steering committee described in Section 7.3.1 of this Agreement, and in the event the JSC is dissolved pursuant to Section 6.3.6 but this Agreement survives, all references to the JSC shall mean the Joint Commercialization Committee.

1.86“Joint Technology” means the Joint Know-How and the Joint Patent Rights.

1.87“Know-How” means any proprietary invention, discovery, development, data, information, process, method, technique, technology, result, cell line, cell, antibody or other protein, compound, probe, nucleic acid, (including RNAi) or other sequences or other know-how, whether or not patentable, and any physical embodiments of any of the foregoing or any information contained in any of the foregoing. Know-How does not include Patent Rights, Copyrights, Product Trademarks, Pfizer House Marks or BioNTech House Marks.

1.88“Law” means any law, statute, rule, regulation, order, judgment or ordinance of any Governmental Authority, including all applicable Anti-Corruption Laws, Applicable Data Protection Laws, accounting and recordkeeping laws, and laws relating to interactions with HCPs and Government Officials. For the avoidance of doubt, any specific references to any applicable Law or any portion thereof shall be deemed to include all then-current amendments thereto or any replacement or successor law, statute, standard, ordinance, code, rule, regulation, resolution, promulgation, order, writ, judgment, injunction, decree, stipulation, ruling or determination thereto.

1.89“MA Holder” means, on a country by country basis within the Territory, the Party (or its Affiliate or designee under its control) that holds the Regulatory Approval required for the Commercialization of the Product in such country.

1.90“Major EU Market Country” means any of France, Germany, Italy, Spain or the United Kingdom.

1.91“Major Market Country” means the Major EU Market Countries, the United States and Japan.

1.92“Manufacture” or “Manufacturing” means to make, produce, manufacture, process, fill, finish, package, label, perform quality assurance testing, release, ship or store, and, for the purposes of further Manufacturing, distribute, import or export, a compound or product or any component thereof. When used as a noun, “Manufacture”, “Manufactured” or “Manufacturing” means any and all activities involved in Manufacturing a compound or protein, device or product or any component thereof.

Execution Version

1.93“Manufacturing Costs” means [***].

1.94“Manufacturing Plan” means the plan for establishing Manufacturing and the Manufacturing facilities, as well as the Manufacturing obligations of each Party, in respect of the Candidates and Products, as such plan may be updated and modified from time to time pursuant to Section 5.1 and Section 6.4.4. The Manufacturing Plan existing on the signing of this Amended and Restated Collaboration Agreement is attached hereto as Schedule 1.94.

1.95“Manufacturing Variances” means [***].

1.96“Market Authorization Approval” means the approval by all relevant Governmental Authorities of a Marketing Authorization Application in a given country or regulatory jurisdiction (but which will not include any Pricing and Reimbursement Approvals).

1.97“Marketing Authorization Application” or “MAA” means an application to a Governmental Authority for approval to market the Product (but excluding Pricing and Reimbursement Approval) in a country or a regulatory jurisdiction including a BLA or an application for conditional use approval.

1.98“Medical Activities” means MSL Activities and Global Medical Activities.

1.99“Medical Science Liaison” or “MSL” means a field-based colleague that is part of a Party’s medical organization (whether or not such field-based colleagues are titled as such within the respective Party’s medical organization) and who will have no responsibility for promotion, detailing or marketing of the Product.

1.100“Materials” means the Pfizer Materials or the BioNTech Materials, as the context requires.

1.101“Modified RNA” means an mRNA that has been modified by the incorporation of one or more modified nucleosides, excluding the 5’ CAP.

1.102“Modified RNA Technology” means [***].

1.103“MSL Activities” means, for each country in the Territory, those activities not related to the promotion, detailing, or marketing of the Product, but which are otherwise set forth in the relevant medical section of the Annual Regional Commercialization Plan, if any, approved for such country, or where no such plan exists as determined by the applicable Commercializing Party, consisting of the following activities: (a) HCP-facing field-based medical communication activities utilizing Medical Education Materials and medical content approved by the applicable Commercializing Party to support the safe and effective use of the Product for approved indications, including indications authorized under an Emergency Use Authorization, or as permitted under applicable Laws other indications identified by the Commercializing Party for its Commercialization Territory; (b) responses to UMRs; (c) scientific exchange activities utilizing medical resources approved by the applicable Commercializing Party created for such purpose; (d) field-based medical support at medical congresses, including drafting post-congress summary reports for internal use; (e) gathering field-based customer insights for internal use and (f) other non-promotional activities approved for MSLs pursuant to the Parties’ compliance policies and

Execution Version

local laws and regulations. For clarity, MSL Activities specifically exclude Global Medical Activities.

1.104“Mutation” means [***].

1.105“Net Sales” means with respect to a Product [***]

1.106“Packaging Configuration” means the number of vial boxes, vials per box, and doses of Product per vial in the commercial packaging presentation of the Product for sale or use in the Territory.

1.107“Packaging and Labeling” means primary, secondary or tertiary packaging and labeling of Product (in its commercial packaging presentation) for sale or use in the Territory, including insertion of materials such as patient inserts, patient medication guides, and professional inserts and any other written, printed or graphic materials accompanying the Product and any brand security or anti-counterfeiting measures included in the packaging elements for the Product considered to be part of the finished packaged Product, and all testing and release thereof.

1.108“Party Specific Regulations” means all non-monetary judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.

1.109“Patent Rights” means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, non-provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals, applications sharing a priority claim and all patents granted thereon, (c) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government-issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing.

1.110“Patient or HCP Support Program Trademark” means any Trademark (whether or not registered) which is solely for use on, with, or to refer to a Party's patient or HCP support programs or patient assistance programs relating to the Product (where such Trademark does not incorporate a Product Trademark, the Pfizer House Marks or BioNTech House Marks, as applicable), and all intellectual property rights and goodwill associated with the foregoing.

1.111“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision or department or agency of a government.

1.112“Personal Data” means any information relating to an identified or identifiable natural person as further specified in Art. 4 no. 1 of the GDPR.

Execution Version

1.113“Pfizer Commercial Materials” means any and all Pfizer Promotional Materials, Pfizer Training Materials, and all other literature or other information related to the Product and, in each case, created and provided by or on behalf of Pfizer hereunder.

1.114“Pfizer Commercialization Territory” means the Territory, except for countries within the BioNTech Commercialization Territory from time to time.

1.115“Pfizer Exit Countries” means, on a country by country basis, those countries out of the United Arab Emirates, South-East Asia and the Developing Countries Territory where Pfizer elects, pursuant to this Agreement, not to Commercialize the Product pursuant to any Pfizer Country Exit Option as described in Section 3.12.2.

1.116“Pfizer House Marks” means (a) the corporate logo of Pfizer, (b) the trademark “Pfizer”, (c) any other Trademark, trade name or service xxxx (whether registered or unregistered) containing the word “Pfizer”, (d) any other corporate logo or Trademark of Pfizer used by Pfizer to identify Pfizer or its Affiliates; and all intellectual property rights and goodwill associated with any and all of the foregoing in clauses (a) through (d).

1.117“Pfizer Improvements” means any Research and Development Program Technology, regardless of inventorship, that is a modification or improvement to the Pfizer Technology and (a) would also be applicable to one or more candidates or products in addition to or other than the Candidates or Products, (b) is not predominantly directed to the Candidates or Products or the RNA Technology or RNA Process Technology and (c) could have reasonably been developed without the aid, use or application of BioNTech Materials, BioNTech Know-How or BioNTech’s Confidential Information or any improvements or enhancements thereto.

1.118“Pfizer Know-How” means [***].

1.119“Pfizer Patent Right” means any Patent Right (other than Patent Rights jointly owned by BioNTech and Pfizer pursuant to Section 11.2) in any form and whether pending or issued that (a) is Controlled by Pfizer or any of its Affiliates on the Effective Date or that comes into the Control of Pfizer or any of its Affiliates during the Term (other than, in either case, through the grant of a license by BioNTech), and (b) claims any Pfizer Know-How.

1.120“Pfizer Quarter” means each of the four (4) successive thirteen (13) week periods, the first such thirteen (13) week period (a) with respect to the United States, commencing on January 1 of any Pfizer Year and (b) with respect to any country in the Territory other than the United States, commencing on December 1 of any Pfizer Year. Wherever non-country specific timelines are specified in this Agreement in reference to a Pfizer Quarter, such reference shall be deemed to be made to the Pfizer Year applicable in the United States.

1.121“Pfizer Technology” means the Pfizer Patent Rights, Pfizer Materials and Pfizer Know-How.

1.122“Pfizer Year” means the twelve (12) month fiscal periods observed by Pfizer (a) commencing on January 1 with respect to the United States; and (b) commencing on December 1 with respect to any country in the Territory other than the United States.

Execution Version

1.123“Phase I Clinical Trial” means a Clinical Trial that generally provides for the first introduction into humans of a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product, in a manner that is generally consistent with 21 CFR § 312.21(a), as amended (or its successor regulation), provided, however, a Phase I Clinical Trial does not include any study generally characterized by the FDA as an “exploratory IND study” in CDER’s Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies, January 2006, irrespective of whether or not such study is actually performed in the United States or under an IND. A so-called Phase I/II Clinical Trial shall be deemed to be a Phase I Clinical Trial unless such trial, when completed, allows Pfizer to proceed directly to a Phase III Clinical Trial.

1.124“Phase II Clinical Trial” means a Clinical Trial, the principal purpose of which is to make a preliminary determination as to whether a pharmaceutical product is safe for it intended use and to obtain sufficient information about such product’s efficacy, in a manner that is generally consistent with 21 CFR § 312.21(b), as amended (or its successor regulation), to permit the design of further Clinical Trials.

1.125“Phase III Clinical Trial” means a pivotal Clinical Trial with a defined dose or a set of defined doses of a pharmaceutical product designed to ascertain efficacy and safety of such product, in a manner that is generally consistent with 21 CFR § 312.21(c), as amended (or its successor regulation), for the purpose of enabling the preparation and submission of an NDA.

1.126“Price Approval” means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

1.127“Product” means any pharmaceutical product in a formulation suitable for administration to humans that [***].

1.128“Product Component” means any component or consumable additional to the Product (e.g., diluent, needles or syringes) that are supplied by on behalf of a Commercializing Party for use in the administration of the Product to a patient, other than where such components or consumables are supplied through a separate sale or as part of the same sale, but where the customer is charged for such components or consumables at cost or at greater than cost thereof.

1.129“Product Know-How” means any Research and Development Program Know-How that is predominantly directed to the composition of matter, treatment with, or the delivery of, Manufacture, form, formulation, or use of a Candidate or Product in the Field and is not generally applicable to compositions or products in addition to or other than a Candidate or Product.

1.130“Product Materials” means all raw or intermediate materials (including, without limitation, active pharmaceutical ingredients and excipients, vectors, plasmids and mRNA), labeling or packaging materials and components needed for the Manufacture and supply of a given Candidate or Product.

1.131“Product Patent Rights” means any Patent Right that claims any invention included in Product Know-How.

Execution Version

1.132“Product Shipping and Storage Costs” means [***].

1.133“Product Technology” means the Product Know-How and Product Patent Rights.

1.134“Product Trademarks” means any Trademark, (whether registered or unregistered) selected with the mutual consent of the Parties through the JCC which is solely for use on, with, or to refer to the Product (other than Pfizer House Marks and BioNTech House Marks, as applicable), and all intellectual property rights and goodwill associated with the foregoing, but excluding any Patient or HCP Support Program Trademark.

1.135“Professional Requirements” means (a) FDA’s regulations and guidelines concerning the advertising of prescription drug products, (b) the American Medical Association’s Guidelines on Gifts to Physicians, (c) the ACCME Standards for Commercial Support of Continuing Medical Education, (d) the European Federation of Pharmaceutical Industries and Associations (EFPIA), (e) the Pharmaceutical Supply Chain Initiative (PSCI) Pharmaceutical Industry Principles for Responsible Supply Chain Management, (f) the relevant Codes and Guidelines established by PhRMA relating to marketing practices and (h) all other accepted national and international pharmaceutical industry codes of practice in and for the relevant countries in the Territory.

1.136“Professional Sales Representative” or “PSR” means a pharmaceutical sales representative employed (either full time or part time) by or on behalf of a Party or its Affiliates to promote and deliver details for the Product.

1.137“Prosecution and Maintenance” means (a) the preparation, filing, and prosecution of patent applications and maintenance of Patent Rights, as well as re-examinations and reissues with respect to such Patent Rights, together with the conduct of interferences, post–grant proceedings (including post-grant review, inter-parties review, and derivation proceedings in the U.S.) and the defense of oppositions with respect to such Patent Rights and (b) the preparation, filing, and prosecution of Trademark applications and maintenance and renewal of Trademarks, the handling of office actions, objections or rejections issued by trademark offices, and the defense of oppositions with respect to such Trademark application or Trademark; and “Prosecute and Maintain” has the correlative meaning.

1.138“Public Health Service Act” or “PHS Act” means the United States Public Health Service Act (42 U.S.C. 201 et seq), as amended from time to time (including any rules and regulations promulgated thereunder) or any subsequent or superseding law, statute or regulation.

1.139“Recall Costs” means actual costs incurred by a Party or its Affiliates as the direct result of a recall or withdrawal of the Product in a country in the Territory, such as administrative costs associated with administering the recall or withdrawal, notification, packing, shipping, distribution and destruction costs, Product replacement costs and reimbursements, penalties payable to customers and other payments to Third Parties as a direct result of such recall or withdrawal, but will not include internal costs to the extent such costs are not included in Manufacturing Costs or indirect costs such as loss of reputation or goodwill or loss of indirect profits.

1.140“Regional Commercialization Committee” or “RCC” means any of the regional committees established pursuant to Section 6.4.2.

Execution Version

1.141“Regulatory Approval” means all technical, medical and scientific licenses, registrations, authorizations and approvals (including conditional use approvals and approvals of INDs, NDAs, XXXx, XXXx, supplements and amendments, pre- and post- approvals and labeling approvals) of any Regulatory Authority, necessary or useful for the use, Development, Manufacture, and Commercialization of a pharmaceutical or biopharmaceutical product in a regulatory jurisdiction, including commercially reasonable Price Approvals and commercially reasonable Third Party reimbursement approvals, including for the avoidance of doubt any Emergency Use Authorization.

1.142“Regulatory Authority” means, with respect to a country in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of any license, approval or authorization (including a regulatory approval or emergency use authorization) to Develop, Manufacture, Commercialize or Exploit pharmaceutical products in such country.

1.143“Related Agreement” means the Pharmacovigilance Agreement entered into or to be entered into or amended pursuant to Section 8.3.3, supply agreements and quality agreements entered into or to be entered into or amended pursuant to Sections 7.4.1 and 7.4.2, and any other agreements entered into or to be entered into between the Parties or their Affiliates in connection with the Development, Regulatory Approval, Manufacture or Commercialization of a Candidate or Product.

1.144“Relevant Factors” means all relevant factors that may affect the Development, Regulatory Approval or Commercialization of a Candidate or Product, including (as applicable): [***].

1.145“Replicon” means an RNA molecule(s) that comprises a gene encoding a polymerase that can, when the RNA molecule(s) is introduced into a cell, replicate the same or a different RNA molecule(s), that also comprises a gene or a sequence encoding at least one non-human polypeptide that is capable of eliciting an immune response (an “Antigen”) and does not comprise the full set of genes required to make an infectious virus and is capable, when introduced into a cell, of expressing detectable levels of the encoded Antigen.

1.146“Replicon Product” means any Product comprising Replicon Technology.

1.147“Replicon Technology” means the BioNTech Know-How applicable to Replicons. For clarity, Replicon Technology does not include Modified RNA Technology, Unmodified RNA Technology or Delivery Technology.

1.148“Representatives” means (a) with respect to Pfizer, Pfizer, its Affiliates, its Sublicensees and subcontractors, and each of their respective officers, directors, employees, consultants, contractors and agents and (b) with respect to BioNTech, BioNTech, its Affiliates, its Sublicensees and subcontractors, and each of their respective officers, directors, employees, consultants, contractors and agents.

1.149“Research and Development Plan” means the research and development plan to define the Development activities pursuant to the collaboration anticipated under this Agreement

Execution Version

(including, for the avoidance of doubt, any post-Marketing Authorization Approval Development activities but excluding any Medical Activities and Medical Affairs Studies) as may be amended from time to time pursuant to Section 5.1. The Research and Development Plan existing on the signing of this Amended and Restated Collaboration Agreement is attached hereto as Exhibit A.

1.150“Research and Development Program” means the program of collaboration between the Parties to Develop and Manufacture (but not Commercialize) Candidates and Products in the Field, including the activities described in the Research and Development Plan.

1.151“Research and Development Program Know-How” means any and all Know-How, Candidates and Products, whether or not patentable, made or created solely by or on behalf of either Party or its Representatives in the conduct of activities under the Research and Development Plan, made or created jointly by or on behalf of (a) BioNTech or its Representatives and (b) Pfizer or its Representatives in the conduct of activities under the Research and Development Plan.

1.152“Research and Development Program Patent Rights” means any and all Patent Rights claiming or disclosing any invention included in Research and Development Program Know-How.

1.153“Research and Development Program Technology” means the Research and Development Program Patent Rights and Research and Development Program Know-How.

1.154“Residual Knowledge” means knowledge, techniques, experience and Know-How that (a) are, or are based on, any Confidential Information of the Disclosing Party and (b) are retained in the unaided memory of any authorized Representative of the Receiving Party after having access to such Confidential Information. An individual’s memory will be considered to be unaided if the individual has not intentionally memorized the Confidential Information for the purpose of retaining and subsequently using or disclosing it.

1.155“RNA” means ribonucleic acid.

1.156“RNA Process Technology” means the BioNTech Know-How used to Manufacture Candidates or Products.

1.157“RNA Technology” means Replicon Technology, Unmodified RNA Technology, Modified RNA Technology and Delivery Technology that is, in each case, used by BioNTech in the Research and Development Program.

1.158“Sales Manager” means a full or part time employee of a Commercializing Party (or a its subcontractor) that is responsible for the direct supervision of the PSRs of or on behalf of such Commercializing Party who detail the Product in the Territory under this Agreement.

1.159“Shared Development Cost” means [***].

1.160“Signing Date” means April 9, 2020.

1.161“South-East Asia” means [***].

1.162“Subject” means the individual donor of the Human Material or of the original tissues from which the Human Material was derived.

Execution Version

1.163“Sublicensee” means any Person to whom a Party grants or has granted, directly or indirectly, a license or sublicense of any of the same Intellectual Property Rights licensed to such Party by the other Party under this Agreement in accordance with Section 3.7. For the avoidance of doubt, distributors used by a Commercializing Party to Commercialize Product in a country or region shall not be regarded a Sublicensee.

1.164“Tax” means all corporation tax, advance corporation tax, income tax, capital gains tax, value added tax, customs and other import duties, inheritance tax, purchase tax, capital duties, social insurance contributions, foreign taxation and duties and all penalties, charges and interest relating to any of the foregoing or resulting from a failure to comply with the provisions of any enactment relating to any of the foregoing.

1.165“Territory” means worldwide, except for the People's Republic of China (including Hong Kong SAR and Macau SAR) and Taiwan.

1.166“Third Party” means any Person other than Pfizer, BioNTech or their respective Affiliates.

1.167“Third Party License” means a Current License or a Future License.

1.168“Third Party License Payment” shall mean a payment due to a Current Licensor or Future Licensor pursuant to a Current License or Future License, as applicable, that is [***]. For the avoidance of doubt, [***].

1.169“Trademark” means any trademark, trade name, service xxxx, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.

1.170“Transfer Price” shall mean [***] of such Candidate or Product, subject to any different percentage between [***] as determined by the JCC through mutual consent, to be applied for Products to be supplied to the Developing Countries Territory or to take account of any supply requirements of any Governmental Authority within the Territory or pursuant to the terms and conditions of any funding agreement with a Third Party Funder [***].

1.171“United States” or “U.S.” means the United States of America and its territories and possessions.

1.172“Unmodified RNA” means an mRNA that [***].

1.173“Unmodified RNA Technology” means the BioNTech Know-How applicable to Unmodified RNA. For clarity, Unmodified RNA Technology does not include Replicon Technology, Modified RNA Technology or Delivery Technology.

1.174“Unsolicited Medical Request” or “UMR” means unsolicited requests for medical information from any Third Party communicated to a Party in any manner addressing on-label use, off-label use or unapproved indications of a Product or Candidates under Development.

1.175“UPC Agreement” means the treaty Agreement on the Unified Patent Court signed 19 February 2013, as may be amended or superseded from time.

Execution Version

1.176“Vaccine Technical Committee” means a duly established and recognized multidisciplinary group of national medical and public health experts responsible for providing independent, evidence-based advice and recommendations to ministries of health or other relevant government policy makers on issues related to immunization and vaccines in a particular country or region.

The following terms are defined in the section of this Agreement listed opposite each term:

Defined Term	Section in Agreement
Acquirer	15.2.2
Acquisition Program	15.1.1
Additional Commitment Country	3.12.2
Additional Patent Jurisdictions	11.3.1.1
Affected Party	15.1
Agreement	Preamble
Alliance Managers	6.1
Annual Net Sales Level	4.8
Audited Party Auditing Party	4.14 4.14
BARDA	4.5.1
Benefit Plans	17.16.2
BioNTech	Preamble
BioNTech Deferred Development Costs	4.4.2
BioNTech Enforcement Patent Rights	11.4.2
BioNTech Indemnified Party	16.2
BioNTech JSC Members	6.3.1
BioNTech Medical Training Materials	10.3.2
BioNTech Promotional Materials	9.5.3
BioNTech Prosecution Patent Rights	11.3.1.1
BioNTech Territory Exit Option	3.12.1
BioNTech Training Materials	9.5.2
Branded Prescription Drug Fee	4.11.5
Budget Deviation	6.4.1.1
Capex Funding	4.5.1
Change of Control Party	12.7
Commercialization Materials	9.12
Commercialization Region	6.4.2
Commercialization Sales Milestone Payment	4.8
Compliance Committee	6.4.5
Consequential Damages	16.1
Competitive Product Infringement	11.4.3
Continuing Party	11.3.2
Croda	7.4.2.4
Croda Agreement	7.4.2.4
Cure Plan	3.8.3

Execution Version

Debtor	14.9.1
Declining Party	11.3.2
Deferred Payment Period	4.4.2
Disputed Matter	6.5.2
Disclosing Party	12.1
Enforcement Action	11.4.1
Effective Date	Preamble
Equity Investment	4.2
Executive Officer	6.5.4
Expedited Milestone Refund	4.10.2.3
Force Majeure	17.3
Fosun Territory	3.13.1
FTO Action	11.7.1
Global Medical Activities	10.1
Hiring Party	17.16.2
Impf Group	1.1
Incremental Withholding Taxes	4.11.1
Indemnified Party	16.4.1
Indemnifying Party	16.4.1
Infringements	11.9.7.1
Infringement Claim	11.8
Investment Agreement	4.2
IRB / IEC	1.76
JCC	6.4.1
JFC	6.4.3
JMC	6.4.4
JSC Chair	6.3.2
Key Patent Jurisdictions	11.3.1.1
Lead Development Party	8.1.1
Lead Party	4.5.1
Lead Regulatory Party	8.2.1
Liabilities	16.2
Licensed Activities	11.7.1
Litigation Conditions	16.4.2
Losses	17.16.3
Medical Affairs Studies	10.6
Medical Education Materials	10.3.4
Medical Information Content	10.5
MSL Activities	10.1
NHP	17.16.3
NHP Indemnitees	17.16.3
Notice of Dispute	17.11.1
Notified Party	4.9.3
Original Collaboration Agreement	Preamble
Party or Parties	Preamble
Patent Committee	11.1
Patent Term Extension	11.3.4
Paying Party	4.10.2.2
Pfizer	Preamble

Execution Version

Pfizer Country Exit Option	3.12.2
Pfizer Indemnified Party	16.3
Pfizer JSC Members	6.3.1
Pfizer Materials	5.4.1
Pfizer Medical Training Materials	10.3.1
Pfizer Promotional Materials	9.5.3
Pfizer Training Materials	9.5.1
Pharmacovigilance Agreement	8.3
Pricing and Reimbursement Guidelines	9.6.1
Prosecution Proceedings	11.3.5
Program Director and Program Directors	6.2
Promotional Materials	9.5.3
Proportional Adjustment	4.10.2.3
Receiving Party	12.1
Reference Product Sponsor	11.4.6.2
Regulatory Approval Milestone	4.3
Relevant Line Item	6.4.1.1
Reporting Party	4.9.3
Restricted Market	17.10.1
Restricted Parties	17.10.2
Restricted Party List	17.10.2
Review Period	12.5.2
ROW	8.1.2
Standard Conversion Cost	1.93
Standard Product Materials Cost	1.93
Term	14.2
Termination Effective Date	14.8.5.1
Terminated Product Data	14.8.6.2
Terminated Territory	14.8.5.2
Third Party Claim	16.4.1
Third Party Funder	4.5.1
Third Party Licensor	1.18
Third Party Royalties	4.10.1.1
Transfer Price True Up Period	4.9.4
Upfront Payment	4.1
VAT	4.11.2
Violating Party	14.6.1
Withholding Taxes	4.11.1

2.	Scope and Spirit of Collaboration

2.1Scope of Collaboration. Subject to the terms and conditions of this Agreement, the Parties shall (a) cooperate in good faith to conduct their respective activities under the Agreement; and (b) establish one or more committees as described in Section 6 of this Agreement to oversee and coordinate the Development, Manufacture and Commercialization of Candidates and Products in the Territory.

Execution Version

2.2Spirit of Collaboration. Without prejudice to the terms and conditions of this Agreement, each Party shall endeavor, in good faith, to conduct themselves in the collaboration hereunder, in all material respects, in the spirit of (i) honest and constructive good faith cooperation and (ii) with appropriate transparency between the Parties.

2.3Reviewing of and Commenting on Documents. Subject to Section 2.2, but without prejudice to the terms and conditions of this Agreement, to the extent either Party has the right or obligation to review, comment or approve any documents, filings or other activities of the other Party pursuant to this Agreement, such Party shall endeavor to conduct such review, or provide its comments or approval (where required), within a timeline that is reasonable under the circumstances, and the Party requesting such review, comment or approval shall endeavor to make such request in a timely manner, in each case in order to endeavor to mitigate or avoid unreasonable disruptions or delays. Where comments have been requested, the requesting Party shall, in good faith, consider all reasonable comments made by the commenting Party in the requesting Party's further preparation or pursuit of such document, filing or activity. Where appropriate, and to the extent time permits, the Parties may discuss any material comment made by the other Party. The foregoing provisions however shall be interpreted in the general spirit of the collaboration set forth in Section 2.2 and the Parties recognize that the foregoing is not intended to (a) cause any unreasonably delay or impede or burden a Party's actions, activities or pursuit of the objectives under this Agreement, (b) modify any rights of a Party or decision making right set forth elsewhere in this Agreement, nor (c) give rise to any breach of this Agreement unless there is repeated, material and persistent uncured noncompliance with its provisions which has been raised through written notice and through the escalation procedure under Section 2.4.

2.4Escalation. Without prejudice to the terms and conditions of this Agreement, to the extent one Party reasonably believes in good faith that the other Party is in material noncompliance with its obligations under Section 2.2 or 2.3, it shall escalate the relevant issues to the JSC or JCC, as applicable, and if such a relevant issue cannot be unanimously solved in such committee within [***], it shall be escalated to the Executive Officers for further discussion and resolution.

Licenses

3.1Research Licenses.

3.1.1Research License from BioNTech to Pfizer. Subject to the terms and conditions of this Agreement, effective as of the Effective Date, BioNTech on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to Pfizer a sole license under the BioNTech Technology to use, have used, Develop, have Developed, Manufacture, and have Manufactured [***] Candidates and Products within the Territory [***].

3.1.2Research License from Pfizer to BioNTech. Subject to the terms and conditions of this Agreement, effective as of the Effective Date, Pfizer on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to BioNTech a sole license under the Pfizer Technology to use, have used, Develop, have Developed, Manufacture, and have Manufactured [***] (a) Candidates and Products and within the Territory [***] and (b) Candidates or products identical to any Product within the Field for their Development (but not Manufacture) outside the Territory by or on behalf of BioNTech (including by Fosun or its Affiliates) pursuant to the Fosun Agreement. With respect to (b) above, such license shall (i) exclude and prohibit the disclosure and license by BioNTech of Pfizer Technology used for Manufacture or formulation of the Candidate

Execution Version

or Products, other than to the extent necessary for Fosun or its Affiliates to undertake fill/finish of a product identical to any Product in the Fosun Territory or to comply with information requirements of the China National Medical Products Administration (or equivalent), relating to such product required under applicable Law; and (ii) automatically terminate on the termination or expiration of the Fosun Agreement and will, unless earlier terminated, survive the termination or expiration of this Agreement in those circumstances described in Section 14.8.6.5.

3.1.3Scope of Research Licenses. Each of the licenses granted under Section 3.1.1 and 3.1.2 is (a) a sole license, such that the applicable licensor Party shall not grant a Third Party (unless it is necessary for the Third Party undertaking a fee-for-service Development or Manufacturing activity on its behalf pursuant to this Agreement) a license under the same Intellectual Property Rights for any Exploitation within the Field and within the Territory in respect of any product, whether or not it is a Candidate or Product; (b) royalty-free; (c) sub-licensable in accordance with and subject to Section 3.7; (d) non-assignable, in whole or part, other than where a Party's benefit under this Agreement may be assigned pursuant to Section 17.1 ; and (e) granted subject to the provisions of this Agreement, and for the duration of the Term or until termination or expiry of this Agreement if earlier, unless otherwise specified herein.

3.2Licenses for Commercial Manufacturing.

3.2.1License from BioNTech to Pfizer. Subject to the terms and conditions of this Agreement, effective as of the Effective Date, BioNTech on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to Pfizer a non-exclusive license under the BioNTech Technology to Manufacture and have Manufactured Candidates and Products for use within the Territory and, subject to Section 3.4, Commercialization within the Territory in any indication.

3.2.2License from Pfizer to BioNTech. Subject to the terms and conditions of this Agreement, effective as of the Effective Date, Pfizer on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to BioNTech a non-exclusive license under the Pfizer Technology to Manufacture and have Manufactured (a) Candidates and Products for Commercialization within the Territory in accordance with Section 3.4 in any indication and (b) Candidates and products identical to any Product within the Field for their use and Commercialization outside the Territory by BioNTech or Fosun and its Affiliates pursuant to the Fosun Agreement. With respect to (b) above, such license shall (i) exclude and prohibit the disclosure and license by BioNTech of Pfizer Technology used for Manufacture or formulation of the Candidate or Product, other than to the extent necessary for Fosun or its Affiliates to (x) undertake fill/finish of a product identical to any Product in the Fosun Territory or (y) comply with information requirements of the China National Medical Products Administration (or equivalent), relating to such product required under applicable Law; and (ii) shall automatically terminate on the termination or expiration of the Fosun Agreement and will, unless earlier terminated, survive the termination or expiration of this Agreement in those circumstances described in Section 14.8.6.5.

3.2.3Scope of Commercial Manufacturing Licenses. Each of the licenses granted under Section 3.2.1 and 3.2.2 is (a) royalty-free; (b) sub-licensable in accordance with and subject to Section 3.7; (c) non-assignable, in whole or part, other than where a Party's benefit under this Agreement may be assigned pursuant to Section 17.1; and (d) granted subject to the provisions of

Execution Version

this Agreement, and for the duration of the Term or until termination or expiry of this Agreement if earlier, unless otherwise specified herein.

3.3Regulatory Dossier Licenses.

3.3.1License from BioNTech to Pfizer. Effective as of the Effective Date, in respect of the Drug Master Files, Regulatory Approvals and Regulatory Documentation (as each is defined in the Fosun Agreement), BioNTech hereby grants to Pfizer a sole license to rely upon and make reference to such Drug Master Files, Regulatory Approvals and Regulatory Documentation (and the data referenced therein), to use the same in respect of any application for, and maintaining, any Regulatory Approvals (as defined in this Agreement) filed by Pfizer pursuant to this Agreement in respect of Candidates or Products. The license granted under this Section 3.3.1 is (a) royalty-free; (b) sub-licensable in accordance with and subject to Section 3.7; (c) non-assignable, in whole or part, other than where a Party's benefit under this Agreement may be assigned pursuant to Section 17.1; and (d) granted subject to the provisions of this Agreement, and for the duration of the Term or until termination or expiry of this Agreement if earlier, unless otherwise specified herein. BioNTech shall procure disclosure of such Drug Master Files, Regulatory Approvals and Regulatory Documentation upon Pfizer's request. Without limiting any of the foregoing, but subject to Section 3.11, BioNTech shall be permitted to use such Drug Master Files, Regulatory Approvals and Regulatory Documentation (to the extent not comprising Pfizer's Technology or Pfizer's Confidential Information) with respect to any application for or maintenance of any Regulatory Approvals outside the Field.

3.4Commercialization Licenses.

3.4.1License from BioNTech to Pfizer. Subject to the terms and conditions of this Agreement, BioNTech on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to Pfizer an exclusive (even as to BioNTech) license under the BioNTech Technology to Commercialize and have Commercialized Products within the Pfizer Commercialization Territory in any indication.

3.4.2License from Pfizer to BioNTech. Subject to the terms and conditions of this Agreement, Pfizer on behalf of itself and its Affiliates hereby grants (and will procure that its Affiliates grant) to BioNTech a license under the Pfizer Technology to Commercialize and have Commercialized (a) Products within the BioNTech Commercialization Territory in any indication, which license shall be granted on a sole basis; and (b) products identical to any Product within the Field but outside the Territory by BioNTech or by Fosun or its Affiliates pursuant to the Fosun Agreement. With respect to (b) above, such license shall (i) be sole; (ii) royalty-bearing; (iii) exclude and prohibit the disclosure and license by BioNTech of Pfizer Technology used for Manufacture or formulation of any Candidate or Product, other than to the extent necessary for Fosun or its Affiliates to (x) undertake fill/finish of a product identical to any Product in the Fosun Territory or (y) comply with information requirements of the China National Medical Products Administration (or equivalent), relating to such product required under applicable Law; and (iv) shall automatically terminate on the termination or expiration of the Fosun Agreement and will, unless earlier terminated, survive the termination or expiration of this Agreement in those circumstances described in Section 14.

Execution Version

3.4.3Scope of Commercialization Licenses. Each of the licenses granted under Section 3.4.1 and 3.4.2 is (a) sub-licensable in accordance with and subject to Section 3.7; (b) non-assignable, in whole or part, other than where a Party's benefit under this Agreement may be assigned pursuant to Section 17.1; and (c) granted subject to the provisions of this Agreement-and for the duration of the Term, unless otherwise specified herein. Furthermore, [***].

3.4.4Financial Provisions for Commercialization. The license under:

3.4.4.1Sections 3.4.1 and 3.4.2(a) is royalty-free, but each is subject to the Gross Profit share set out in Section 4.9; and

3.4.4.2Section 3.4.2(b) shall be royalty bearing at a rate of (i) [***] percent of net sales of the product(s) sold pursuant to the Fosun Agreement where such product(s) is Covered by any Pfizer Patent Right or any Joint Patent Rights; or (ii) if, or when, (i) does not apply, then [***] percent of net sales of the product(s) sold pursuant to the Fosun Agreement where such product(s) is Covered by any Pfizer Know-How or any Joint Know-How; with in each case of (i) or (ii) above, net sales having the same definition, mutatis mutandis, to Net Sales under this Agreement, with references under such Net Sales definition to “a Party” meaning BioNTech, its Affiliates and their respective licensees and “Product” meaning a product as described above, and with sales and royalty reporting every Pfizer Quarter, payments on a Pfizer Quarter basis, and Pfizer having audit rights comparable with those under this Agreement); provided, however, that (x) during the period in which a generic or biosimilar equivalent to such product(s) is Commercialized in any part of the territory that is the subject of the Fosun Agreement, the royalty under (i) above shall be reduced by [***]; or (y) if the gross profit share earned by BioNTech in connection with sale of products under the Fosun Agreement is lower than the royalty amount to be paid to Pfizer hereunder in respect of those same sales, then no royalty shall be payable hereunder for those sales. The foregoing royalty obligations shall commence on the first commercial sale of the product(s) sold pursuant to the Fosun Agreement, and extend (x) with respect to the royalty under (i) for so long as such product(s) is Covered by any such Patent Rights (until such Patent Right expires, is surrendered, or is otherwise irrevocably revoked or declared invalid), and (y) with respect to the royalty under (ii), the [***] anniversary of the date of the first commercial sale (having the same meaning, mutatis mutandis, to the definition of First Commercial Sale herein) of such product(s) in the territory that is the subject of the Fosun Agreement; and in each case, such provision shall survive the termination or expiry of this Agreement.

3.5Additional Licenses.

3.5.1Additional License To Pfizer. Without limiting any other license or sublicense granted under this Agreement and subject to the terms and conditions of this Agreement, BioNTech on behalf of itself and its Affiliates, effective as of the Effective Date, hereby grants (and will procure that its Affiliates grant) to Pfizer a non-exclusive, royalty-free, fully paid-up, sublicensable license under all BioNTech Improvements and Product Technology that were solely or jointly made or invented by Pfizer Representatives to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise Exploit any products or processes outside the Field. In addition to the obligations set forth in Section 3.11 for the avoidance of doubt, the license granted in this Section 3.5.1 shall not include or imply a right of Pfizer to use

Execution Version

any of BioNTech’s Confidential Information (that is not a BioNTech Improvement or Product Technology) outside the Field.

3.5.2Additional License To BioNTech.

3.5.2.1Without limiting any other license or sublicense granted under this Agreement and subject to the terms and conditions of this Agreement, Pfizer, effective as of the Effective Date, hereby grants to BioNTech a non-exclusive, royalty-free, fully paid-up, sublicensable license under all Pfizer Improvements that were solely or jointly invented by BioNTech Representatives to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise Exploit any products or processes outside the Field.

3.5.2.2Without limiting any other license or sublicense granted under this Agreement and subject to the terms and conditions of this Agreement, Pfizer, effective as of the Effective Date, hereby grants to BioNTech a non-exclusive, royalty-free, fully paid-up, sublicensable license under Pfizer’s interest in the Research and Development Program Technology to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise Exploit any products or processes outside the Field.

3.5.2.3For the avoidance of doubt, the licenses granted in this Section 3.5.2 shall not include or imply a right of BioNTech to use any Pfizer Confidential Information (that is not a Pfizer Improvement or Research and Development Program Technology) outside the Field, but remain subject to the obligations set forth in Section 3.11.

3.5.3The licenses granted pursuant to Section 3.5.1 and Section 3.5.2 may be sublicensed by the licensee Party pursuant to the terms of those applicable licenses, provided that (a) the sublicensing Party shall be responsible for failure by its Sublicensees to comply with the relevant terms and conditions of this Agreement applicable to such licenses and (b) [***] without BioNTech's prior consent (such consent not to be unreasonably withheld). For the avoidance of doubt, Section 3.7 shall not apply to the sublicensing of those rights licensed under this Section 3.5.

3.6Trademark Licenses. Trademark Licenses are set forth in Section 11.9.5.

3.7Sublicensees. Either Party shall have the right to grant sublicenses and, as applicable, sub-sublicenses under and subject to the rights granted to it under Sections 3.1 to 3.4 and 11.9.5 to (a) its Affiliates; (b) permitted Third Party subcontractors which such Party uses to undertake services for, or to perform its obligations under this Agreement; (c) Sublicensees in respect of Manufacturing, provided that, other than where a sublicense is required by a Governmental Authority or pursuant to a Third Party Funder agreement, the sublicensing Party shall (i) discuss the proposed use of a Third Party with the other Party, and take into account any reasonable views, objections or comments with respect to the proposed Third Party; (ii) impose industry standard obligations of confidentiality and non-use on the Third Party with respect to the other Party's Confidential Information, and limit the disclosure of that other Party's Confidential Information so far as is reasonably necessary; and (iii) not, where Pfizer is the sublicensing Party, [***] without BioNTech's prior consent (such consent not to be unreasonably withheld); and (d) distributors of the Product in the Territory; and (e) in the case of BioNTech, and subject to the restrictions

Execution Version

in Sections 3.1, 3.2, and 3.4 and the terms of Section 12 and excluding any rights under Section 11.9.5, Fosun and any of Fosun’s Affiliates pursuant to the Fosun Agreement for Commercialization in the Field outside the Territory. In respect of any and all such sublicenses (or sub-sublicenses):

3.7.1the sublicensing Party shall be responsible for failure by its Sublicensees to comply with the terms and conditions of this Agreement;

3.7.2the rights sublicensed under the sublicense may not be further sublicensed by the Sublicensee;

3.7.3the sublicensing Party shall notify the other Party in writing of any sublicenses granted to Third Parties (other than Fosun);

3.7.4in the event of a sublicense in respect of the Commercialization of Product, shall provide a copy of the relevant sublicense agreement to the other Party upon request which may be redacted to delete provisions not applicable to the calculation of Gross Profits; provided, however, that the Sublicensing Party shall not be required to provide copies of any sublicense agreement between such Sublicensing Party and its Affiliates;

3.7.5unless otherwise agreed between the Parties on a case-by-case basis, all sublicenses shall automatically terminate (and the sublicensing Party shall ensure that all sublicenses automatically terminate) upon termination (for whatever reason) or expiry of a license granted hereunder, but only to the extent necessary to terminate the sublicense in so far as it corresponds to any terminated or expired licenses granted in this Agreement; and

3.7.6in respect of Trademarks, the Party granting the sublicense shall ensure that all goodwill arising from use of the sublicensed Trademarks enures for the benefit of the Party that owns the applicable Trademark.

3.8BioNTech Current Licenses.

3.8.1Maintenance of Current Licenses. BioNTech will maintain in full effect and will perform all of its obligations in a timely manner under each of the Current Licenses. Absent Pfizer’s prior written consent (which may be provided, conditioned or withheld in Pfizer’s sole discretion), BioNTech will not terminate, modify or amend any Current License in any manner that would adversely affect any of the rights granted or that may be granted to Pfizer under this Agreement or that would impose any obligations upon Pfizer hereunder (including any increase in Third Party License Payments) that are in addition to those obligations that would exist under this Agreement based on the Current Licenses as they exist on the Effective Date or adversely affect BioNTech’s ability to perform its obligations under this Agreement. Further, BioNTech will not take any action or omit to take any action that would cause it to be in breach of any Current License or that would give rise to a right of any Current Licensor to terminate the applicable Current License.

3.8.2Communications and Performance. Notwithstanding anything to the contrary in this Agreement, BioNTech will use Commercially Reasonable Efforts to facilitate any communications between Pfizer and any Current Licensor required for Pfizer to exercise the rights granted to it pursuant to this Section 3 and will use Commercially Reasonable Efforts to cause each applicable Current Licensor to perform all of its obligations under the applicable Current License.

Execution Version

3.8.3Breach of Current License by BioNTech. If BioNTech receives notification of any actual or potential breach or otherwise becomes aware of its breach of any Current License (and if uncured, such breach could give rise to the termination of the applicable Current License), then BioNTech will immediately notify Pfizer of such breach. To the extent that any act or omission on the part of Pfizer is the cause of such breach of a Current License, Pfizer will take all actions and provide BioNTech with all cooperation necessary to cure such breach, in each case as reasonably requested by BioNTech and at Pfizer’s sole cost and expense. To the extent that Pfizer is not the cause of such breach of a Current License, BioNTech will have the first opportunity to cure such breach in accordance with a plan to be mutually agreed upon by the Parties in writing, acting reasonably (each, a “Cure Plan”). If (a) BioNTech, at any time, is not using diligent efforts to cure such breach pursuant to the applicable Cure Plan or (b) BioNTech is unable to cure such breach in accordance with the applicable Cure Plan or it becomes reasonably apparent that BioNTech will not be able to cure such breach pursuant to the applicable Cure Plan, then Pfizer may, at its election and in its sole discretion and without prejudice to its other remedies against BioNTech, act reasonably to cure such breach and BioNTech will take all actions and provide Pfizer with all cooperation to cure such breach, in each case as directed by Pfizer. Further, if Pfizer is not the cause of such breach of a Current License, then BioNTech will, at Pfizer’s sole election, (i) reimburse Pfizer for all out-of-pocket costs and expenses incurred by or on behalf of Pfizer or any of its Representatives in connection with curing such breach; or (ii) permit Pfizer, under the Agreement, to offset any such costs and expenses incurred by or on behalf of Pfizer or any of Pfizer’s Representatives in connection with curing such breach against Pfizer’s future payment obligations to BioNTech (or any of its successor or assigns) under this Agreement.

3.8.4Termination of any Current License. In the event that any Current License is terminated by the applicable Current Licensor and this Agreement, as of the effective date of such termination, has not otherwise expired or been terminated, Pfizer, to the extent permitted by such Current License (or if not permitted or addressed in such Current License, to the extent permitted by the applicable Current Licensor), will have the right without prejudice to its other remedies against BioNTech, at Pfizer’s election, to convert the sublicenses granted under this Agreement by BioNTech to Pfizer under such Current License to a direct license from the applicable Current Licensor to Pfizer on the terms and conditions contained in such Current License (with Pfizer assuming the applicable obligations of BioNTech thereunder) or such other terms and conditions as may be negotiated by Pfizer and the applicable Current Licensor; provided that Pfizer shall negotiate in good faith reasonable terms and conditions, including with respect to royalties or other payments due in connection with the Candidates or Products. In the event Pfizer enters into any such direct license with a Current Licensor pursuant to this Section 3.8.4, BioNTech will, at Pfizer’s sole election and without prejudice to its other remedies hereunder:

3.8.4.1in respect of royalties and other payments payable by Pfizer under such direct license to the Current Licensor, to the extent such royalties and payments are due in connection with the Candidates or Products hereunder, reimburse to Pfizer the difference between (a) the amount that is payable under any direct license with Pfizer and (b) the amount that would have to be reimbursed by Pfizer to BioNTech in accordance with Section 4.10.1 with respect to the Current License if the Current License had not been terminated; or

Execution Version

3.8.4.2permit Pfizer to offset any such reimbursement amounts (to the extent not reimbursed pursuant to clause (a) above) against Pfizer’s future payment obligations to BioNTech (or any of its successor or assigns) under this Agreement (including BioNTech’s share of Gross Profits) until Pfizer has fully recovered all such reimbursement amounts.

3.8.5Consents and Waivers. BioNTech represents, warrants and covenants to Pfizer that, to the extent any terms and conditions of this Agreement do not (or will not at any time during the Term) conform to any requirements relating to the grant of sublicenses under any Current License, it has obtained the irrevocable consent (or, if applicable, the waiver of any resultant conflict) from the applicable Current Licensor that is necessary to permit the activities contemplated under this Agreement, including such that BioNTech may grant the applicable sublicenses granted or to be granted hereunder and perform all of its obligations hereunder and Pfizer may exercise all of its rights and perform all of its obligations hereunder, in each case, without breaching the applicable Current License. In the event that any provision in any Current License which conflicts with this Agreement or adversely impacts the activities contemplated under this Agreement comes to the attention of either BioNTech or Pfizer or which otherwise, at any time during the Term, would cause the representation, warranty and covenant set forth in the preceding sentence to be untrue, BioNTech, in consultation with Pfizer, will obtain any and all additional required consents or waivers from the applicable Current Licensor(s) which may be necessary to align the conflicting provision(s) of the applicable Current License with this Agreement and to permit the activities contemplated by this Agreement.

3.8.6Exceptions to the Fosun Agreements. If BioNTech (as opposed to Pfizer) has breached the Fosun Agreement [***]. In addition, in respect of the Fosun Agreement (i) [***]; and (ii) [***].

3.8.7Reduction in Royalties. [***]

3.9Third Party Agreements. Subject to Section 4.10, each Party will be solely responsible for all obligations (including royalty and payment obligations) that relate to Candidates, Products, BioNTech Technology or Pfizer Technology under its or its Affiliates' own agreements with Third Parties that are in effect on or prior to the Effective Date, including the Current Licenses for which BioNTech has sole responsibility.

3.10No Implied Rights. Except as expressly provided in this Agreement, neither Party will be deemed to have granted the other Party (by implication, estoppel or otherwise) any right, title, license or other interest in or with respect to any Patent Rights, Know-How, Trademarks or other Intellectual Property Rights or information Controlled by such Party.

3.11Exclusivity.

3.11.1Mutual Exclusivity. Except if otherwise permitted by the unanimous consent of the JSC, during the Term, neither Party shall, and shall procure that its Affiliates shall not, itself or with or on behalf of a Third Party, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized or otherwise Exploit or have Exploited any [***] in the Field within the Territory, except that each Party may continue any agreement existing as of the Effective Date with a Third Party for non-clinical research within the Field with academic institutions and

Execution Version

consortia. For avoidance of doubt, the foregoing exclusivity obligation shall not apply to (a) [***]; (b) [***]; (c) [***]; or (d) [***].

3.11.2Exclusivity of the Licenses. Without prejudice to the licenses granted by BioNTech pursuant to this Section 3, BioNTech shall not, and shall procure that its Affiliates shall not, grant any license, permission, waiver, covenant not to xxx, or other right to use or Exploit any of the BioNTech Technology within the Field and within the Territory that would conflict with or erode any of Pfizer's rights hereunder.

3.11.3Exclusivity in the Product. Except pursuant to this Agreement, neither Party shall, and shall procure that its respective Affiliates shall not, itself or with or on behalf of a Third Party, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized or otherwise Exploit (a) any Candidate Controlled by BioNTech as of the Effective Date within the Field; or (b) any Candidate that, as a consequence of the Development under this Agreement, becomes Controlled by BioNTech after the Effective Date, for any field; or (c) any Product for any field or application; in each case (a), (b) and (c) other than for non-clinical research purposes, or within the Field pursuant to the Fosun Agreement.

3.12Adjustments to Commercialization Territories.

3.12.1BioNTech Territory Exit Option: BioNTech shall have the option to opt-out of Commercializing the Product in any country of the BioNTech Commercialization Territory (excluding any Additional Commitment Country which has become part of the BioNTech Commercialization Territory pursuant to Section 3.12.2), whereupon Pfizer shall take over Commercialization of the Product in any such country (the “BioNTech Territory Exit Option”). BioNTech may exercise the BioNTech Territory Exit Option, on a country by country basis, upon no less than [***] prior written notice to Pfizer, provided, however, that the Parties agree upon a transition plan within the first [***] of such notice, which plan may require BioNTech to conduct distribution, Commercialization, promotional and supply activities beyond the expiration of the [***] period, however. In the event of any such option exercise, (a) the Parties will work together to transition to Pfizer the responsibilities for distribution, Commercialization and promotion of the Product and (b) as of the option exercise effective date, the Pfizer Commercialization Territory under this Agreement shall be extended accordingly and (c) prior to Pfizer fully transitioning as the exclusive distributor and licensee in the applicable country, where the Product has already been launched, BioNTech shall ensure that the Product continues to be supplied in such country.

3.12.2Pfizer Country Exit Option: On a country by country basis in relation to [***] that obliges Commercialization of the Product in such country; (each such country under (a) and (b) being an “Additional Commitment Country”), BioNTech shall request in writing from Pfizer a decision as to whether Pfizer wishes to Commercialize in such Additional Commitment Country in accordance with the Commercialization requirements [***] of its receipt of such notice or [***] prior to the date of the planned initiation of Commercialization following full Market Authorization Approval (for clarity, not Emergency Use Authorization or any conditional Market Authorization Approval) in such Additional Commitment Country [***] If Pfizer notifies BioNTech that it wishes to Commercialize the Product in such Additional Commitment Country, then Pfizer shall Commercialize the Product in such Additional Commitment [***].

Execution Version

3.13Expansion of the Territory.

3.13.1Right of First Negotiation to Expand into Fosun Territory. If the Fosun Agreement expires or is otherwise terminated for any reason, BioNTech shall promptly (and in any event within [***] of the earlier of expiration or termination of the Fosun Agreement or BioNTech receiving notice of expiration or termination of the Fosun Agreement) notify Pfizer in writing and Pfizer shall [***] such rights to be exercised by Pfizer within [***] of Pfizer’s receipt of BioNTech’s notice provided in accordance with this Section 3.13.1.

3.13.2Election; Negotiation. If Pfizer elects to negotiate for such rights in the Fosun Territory, the Parties shall in good faith and acting reasonably exclusively negotiate for a period of no less than [***] after Pfizer’s notice of its intent to negotiate for those rights and BioNTech shall disclose to Pfizer if, at any time during such period, BioNTech is concurrently negotiating with one or more permitted Third Parties for such rights; provided, however, that BioNTech shall not be required to disclose the identity of such Third Party.

3.13.3BioNTech Negotiation [***]. Prior to exhaustion of Pfizer’s exclusive negotiation right, BioNTech shall not engage in negotiations for, or license, or grant any option to the Product for the Fosun Territory [***]. The terms and discussions around, as well as the existence of, any negotiation activities between Pfizer and BioNTech shall be confidential information of each Party which neither shall disclose to a Third Party.

3.13.4Interim Assistance in Fosun Territory. During the period from termination of the Fosun Agreement until BioNTech concludes an agreement for the commercialization of the Product in the Fosun Territory with a Third Party (and provided that neither BioNTech nor Fosun are able and willing to distribute the Product in the Fosun Territory during such time period), Pfizer shall be free but not obligated) to distribute Product in the Fosun Territory (pursuant to the Regulatory Approval held for the Product by or on behalf of BioNTech) if it believes it is necessary or desirable at such time, for public health reasons, for the Product to be made available in the Fosun Territory (which sales shall be included in the Gross Profits calculation). For clarity, Pfizer shall have no obligation to distribute or Commercialize the Product in the Fosun Territory.

4.	Payments, Funding, Financial Matters.

4.1Upfront Payment. The Parties acknowledge and agree that Pfizer made a one-time, non-refundable (without limiting Pfizer’s right to claim for damages under this Agreement) payment of Seventy-Two Million US Dollars (US $72,000,000) to BioNTech on or about 21 May 2020 (“Upfront Payment”) , which payment has been and shall be dedicated to activities to be performed under the Research and Development Plan.

4.2Equity Investment. The Parties acknowledge and agree that Pfizer and BioNTech entered into an "Investment Agreement" on 9 April 2020 in conjunction with this Agreement pursuant to which Pfizer subscribed for shares in BioNTech in consideration for an investment amount of One Hundred and Thirteen Million US Dollars (US $113,000,000) based on a price per share of US $47.53, subject to the conditions as prescribed in such Investment Agreement (“Equity Investment”).

4.3Regulatory Milestone Payment. Within the later of (a) [***] of the date upon which either BioNTech or Pfizer first obtains all Regulatory Approvals required for the Commercialization of the

Execution Version

Product in a Major Market Country in the Territory or (b) following achievement of the milestone under (a) above [***] after the Amendment Signing Date, Pfizer shall pay BioNTech a one-time, non-refundable (without limiting Pfizer’s right to claim for damages under this Agreement) milestone payment of [***] US Dollars (US $[***]) (“Regulatory Approval Milestone”).

4.4Sharing of Development Costs.

4.4.1Shared Development Costs. Except as otherwise provided herein, each Party shall bear fifty percent (50%) of all Shared Development Costs.

4.4.2BioNTech Deferred Development Costs. The Parties acknowledge and agree that from the Effective Date until December 31, 2020 (the “Deferred Payment Period”), BioNTech's share of the Shared Development Costs incurred in accordance with the binding parts of the Development Budget, Research and Development Plan and the Manufacturing Plan, and this Agreement were initially funded by way of an interest free repayable loan from Pfizer (“BioNTech Deferred Development Costs”). BioNTech shall make a payment to reimburse Pfizer the BioNTech Deferred Development Costs incurred during the Deferred Payment Period within [***] of receipt of Pfizer's invoice for the same. The Parties shall exchange reasonable documentation of all relevant Shared Development Costs in accordance with Section 4.4.4 applicable to such invoice. Pfizer may offset any BioNTech Deferred Development Costs (to the extent not reimbursed to Pfizer), against Pfizer's future payment obligations to BioNTech (or any of its successors or assigns) under this Agreement. Following the end of the Deferred Payment Period, BioNTech shall thereafter itself fund its share of the Shared Development Costs in accordance with Section 4.4.4.

4.4.3Budgeting of Shared Development Costs. The Parties shall agree on, at least once per Calendar Year, and regularly update (if required), the Development Budget through the JSC. As soon as either Party determines that it is likely to overspend on the binding part of the Development Budget that is allocated to that Party by more than [***], it shall inform the JSC accordingly, and shall only be entitled to incur such overrun costs as Shared Development Costs pursuant to Section 4.4.1 and 4.4.2 upon the JSC’s mutual consent.

4.4.4Reporting and Reconciliation. After the end of the Deferred Payment Period, all Shared Development Costs incurred in accordance with the binding parts of the Development Budget shall initially be borne by the Party incurring such costs and shall thereafter be subject to reimbursement in accordance with this Section 4.4.4. Each Party shall report to the other Party, within [***] after the end of each Pfizer US Quarter, the Shared Development Costs incurred by such Party during such Pfizer Quarter. Such report shall specify in reasonable detail all amounts included in such Shared Development Costs during such Pfizer Quarter (broken down by activity), and out-of-pocket costs shall be allocated to the extent possible to a specific activity in the applicable binding part of the Research and Development Plan. Each such report shall enable the receiving Party to compare the reported Shared Development Costs against the applicable binding part of the Development Budget previously approved by the JSC, on both a quarterly basis and a cumulative basis for each activity. The Parties shall seek to resolve any questions related to such accounting statements within [***] following receipt by each Party of the other Party’s report hereunder. Following such resolution, BioNTech shall prepare a reconciliation report for the Shared Development Costs for such Pfizer Quarter (including as against the binding parts of the Development Budget) and shall either (a) deliver an invoice to Pfizer for any amounts due to BioNTech as a result of reconciliation or (b) notify Pfizer that it should issue an invoice to

Execution Version

BioNTech for any amounts due to Pfizer as a result of reconciliation. Any such invoice from BioNTech to Pfizer shall be payable within [***] from receipt by Pfizer. Any such invoice from Pfizer to BioNTech shall be payable within [***] from receipt by Pfizer.

4.4.5Capex Costs. Notwithstanding anything else in this Agreement, each Party shall be solely responsible for its own Capex Costs and any capital expenditures required in connection with this Agreement.

4.4.6Other Costs. Except as expressly set forth otherwise in this Agreement), each Party will bear all costs and expenses it incurs in connection with its activities under this Agreement.

4.5Third Party Funding.

4.5.1Third Party Funders. Pfizer and BioNTech shall, in good faith and acting collaboratively, seek funding from one or more Third Parties for such Third Party to provide financial support to the collaboration between the Parties under this Agreement (each, a “Third Party Funder”). For each potential Third Party Funder, the Parties will agree on (a) the Party to lead the communications and discussions with such Third Party Funder (the “Lead Party”) and (b) the activities, costs or expenses for which funding support shall be sought (e.g. funding for Development costs, funding in support of a Party's Capex Costs (“Capex Funding”) or both). An initial list of potential Third Party Funders and their allocation as between the Parties is set forth in Schedule 4.5. Notwithstanding the foregoing, Pfizer shall be entitled to secure funding from, and shall be the Lead Party in discussions with [***], in the event that Pfizer, in its sole discretion [***] and BioNTech shall be entitled to secure funding from, and shall be the Lead Party in discussions with [***], in the event that BioNTech, in its sole discretion, chooses to seek funding from [***].

4.5.2Discussions with Funders. The Lead Party will lead any discussions with such Third Parties in any country, provided that the Lead Party will provide regular updates to the JSC and keep the JSC reasonably informed of the status and any developments in such discussions, and shall, at the other Party’s reasonable request, update the other Party on any such discussions. The Lead Party shall conduct any such discussions and draft and file any applications for any Third Party Funding in good faith and acting reasonably with respect to its requests for such funding. Where legally possible and unless otherwise agreed between the Parties, each application for any Third Party funding shall be made in both Parties’ name unless the Parties have agreed in advance pursuant to Section 4.5.1 that such application shall be in respect of one Party’s Capex Funding alone, in which case such application may be made in that Party's own name alone. The Lead Party shall not enter into a written agreement with any Third Party Funder without prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed) unless the Parties have agreed in advance pursuant to Section 4.5.1 that such agreement shall be in respect of that Lead Party's Capex Funding alone, in which case the Lead Party can conclude such Third Party Funder agreement without consent from the other Party. Notwithstanding the foregoing, (a) Pfizer shall be entitled to seek any funding from [***] without requiring BioNTech's consent; (b) BioNTech shall be entitled to seek any funding from [***] without requiring Pfizer's consent; and (c) neither Party shall agree as a party to any agreement with any Third Party Funder or in consequence of such agreement to commit any particular allocation of supply of Product for any country or government without the prior consent of the JCC pursuant to Section 7.4.2.5. Pfizer and BioNTech acknowledge and agree that there is no guaranty that any Lead Party will be successful

Execution Version

in securing any funding from any Third Party Funder or that any specific amount of funding will be obtained.

4.5.3Allocation of Funds and Balancing Payment. To the extent possible, any Third Party funding to the extent it relates to activities in relation to which the Parties have agreed to treat the associated Development costs as Shared Development Cost shall be shared equally between the Parties. If such sharing is not possible, a balancing adjustment shall be made in favor of the other Party to the Shared Development Costs to reflect [***] percent of such funding that that Party receives from the Third Party Funder provided that doing so does not breach any applicable Laws or the terms of such funding. Each Party shall promptly report to the other Party in writing if and when it receives any payments from any Third Party Funder funding that relates to activities, costs or expenses that are Shared Development Costs.

4.5.4Not Applicable to Loans. For the avoidance of doubt, this Section 4.5 shall not apply to any traditional loans provided by any Third Party to a Party provided that (a) such loans are repayable by the borrower Party and not, directly or indirectly, by the other Party; (b) this Agreement, any other agreement ancillary to this Agreement, the BioNTech Technology, Product Technology and Product are not provided as security for, or otherwise encumbered by way of, such loan (excluding, for clarity, any tangible assets). Each Party shall be entitled to seek any such loans from any Third Party without any obligations to the other Party.

4.5.5Documentation. To the extent the conditions agreed by the Lead Party with any Third Party Funder require the disclosure or delivery of specific documentation relating to Shared Development Costs (e.g. invoices from Third Parties or calculation of internal costs) in order to obtain funding or reimbursement for such Shared Development Costs from such Third Party Funder, upon the Lead Party’s request, the other Party will use Commercially Reasonable Efforts to provide such documentation to the Lead Party within [***] from the request, provided that the Lead Party shall pay all reasonably necessary costs and expenses of the other Party which are directly incurred in connection with provision of any documentation to the extent it is beyond the documentation or the efforts required pursuant to Section 4.4.4, provided, further, [***].

4.6Accounting Principles. Each Party shall determine Shared Development Costs using its standard accounting procedures, consistently applied and in accordance with GAAP or IFRS, as applicable (provided that the application of such procedures results, on balance, in outcomes that are fair and equitable to both Parties taking into consideration the interests of both Parties as reflected in this Agreement). All personnel costs of either Party or its Affiliates are excluded from Shared Development Costs.

4.7Commercialization Costs. Each Party will be solely responsible for the costs it incurs in Commercializing the Product within its respective Commercialization Territory and such costs shall not be included in the calculation of Gross Profits as described in Section 4.9 below.

4.8Commercialization Sales Milestones. Pfizer shall pay BioNTech the following one off Commercialization Sales Milestone Payments within [***] of the end of the Pfizer Quarter in which the annual Net Sales of the Product within the Territory pursuant to this Agreement in a Pfizer Year first achieve the relevant level described below. For the avoidance of doubt, the Parties recognize that more than one Commercialization Sales Milestone Payment may become due in any particular Pfizer Quarter or Pfizer Year; however, each of the Commercial Sales Milestones Payments set forth below shall be payable one

Execution Version

time only, regardless of the number of Pfizer Years in which the applicable Annual Net Sales Level is achieved.

Milestone	Annual Net Sales Level in the Territory (US$)	Amount to be Paid to BioNTech (US$) (each a “Commercialization Sales Milestone Payment”)
1	$[***]	$[***]
2	$[***]	$[***]
3	$[***]	$[***]
4	$[***]	$[***]
5	$[***]	$[***]
6	$[***]	$[***]

4.9Gross Profit Sharing.

4.9.1Sharing of Gross Profits. Subject to Section 4.4.2, BioNTech and Pfizer will share the Gross Profits generated through the Commercialization of the Product in the Territory pursuant to this Agreement on a fifty-fifty (50:50) basis calculated on a Pfizer Quarter basis. In reflecting that principle, it is agreed that all Product Shipping and Storage Costs incurred for Products, as well as Agreed Product Component costs incurred in acquiring or Manufacturing Agreed Product Components supplied or provided to customers in connection with Commercialization of the Product (if applicable) shall be shared on a fifty (50:50) basis.

4.9.2Calculation of Net Sales. In calculating Net Sales for the purposes of this Section 4, [***].

4.9.3Quarterly Reporting of Net Sales and Payments. Within [***] after the end of each US Pfizer Quarter, each Party (a “Reporting Party”) shall deliver to the other Party (a “Notified Party”) a report setting forth, for the most recent Pfizer Quarter, the following information, on a country-by-country and Territory-wide basis: [***].

4.9.4Manufacturing Variances and True-Up of Transfer Pricing. Each Party shall, [***].

4.9.5Quarterly Consolidated Report. Within the later of (i) [***] after exchange of all the reports and amounts pursuant to Section 4.9.3 or (ii) [***] of the end of the applicable US Pfizer Quarter, Pfizer shall prepare and provide to BioNTech a consolidated report, with respect to the applicable Pfizer Quarter, setting forth:

[***]

4.9.6Payment of Gross Profit Share. To the extent Pfizer, with respect to any Pfizer Quarter, is to make a payment to BioNTech for its Gross Profit portion as set forth in the consolidated financial report prepared pursuant to Section 4.9.5, such payment shall be made by Pfizer to BioNTech as provided in Section 4.13. To the extent BioNTech is to make a payment to Pfizer for its Gross Profit portion as set forth in the consolidated financial report prepared pursuant to Section 4.9.5, such payment shall be made by BioNTech to Pfizer as provided in Section 4.13. Such payments under this Section 4.9.6 for any Pfizer Quarter shall be made within [***] after

Execution Version

Pfizer, pursuant to Section 4.9.5, delivers to BioNTech the consolidated financial report for such Pfizer Quarter.

4.10Third Party License Payments.

4.10.1Third Party Royalties.

4.10.1.1 [***].

4.10.1.2Following the consolidated financial report for each Pfizer Quarter prepared by Pfizer and delivered to BioNTech pursuant to Section 4.9.5 above [***].

4.10.2Other Third Party License Payments. Subject to Section 3.8.4, for Third Party License Payments due under Third Party Agreements, the following rules, as applicable, shall apply:

4.10.2.1 [***];

4.10.2.2 [***]; and

4.10.2.3 [***].

4.10.2.4 [***].

4.10.3Exclusion of Certain Payments. [***].

4.11Taxes.

4.11.1Withholding Taxes. The Parties agree to use reasonable efforts to cooperate with one another and use commercially reasonable efforts to avoid or reduce, to the extent permitted by applicable Law, tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by the paying Party to the receiving Party under this Agreement (“Withholding Taxes”). If Withholding Taxes are imposed on any payment under this Agreement, the liability for such Withholding Taxes shall be the sole responsibility of the receiving Party, and the paying Party shall (a) deduct or withhold such Withholding Taxes from the payment made to the receiving Party, (b) timely pay such Withholding Taxes to the proper taxing authority, and (c) send proof of payment to the receiving Party within [***] following such payment. Each Party shall comply with (or provide the other Party with) any certification, identification or other reporting requirements that may be reasonably necessary in order for the paying Party to not withhold Withholding Taxes or to withhold Withholding Taxes at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other with commercially reasonable assistance to enable the recovery, as permitted by applicable Law, of Withholding Taxes or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing the cost of such Withholding Taxes under this Section 4.11.1 (Taxes and Withholding). Notwithstanding the foregoing, if as a result of any assignment or sublicense by the paying Party, any change in the paying Party’s tax residency, any change in the entity that originates the payment, or any failure on the part of the paying Party to comply with applicable Law with respect to Withholding Taxes (including filing or record retention requirements), Withholding Taxes are imposed that would not otherwise have been imposed (“Incremental Withholding Taxes”), then the paying Party shall be solely responsible for the amount of such Incremental

Execution Version

Withholding Taxes and shall increase the amounts payable to the receiving Party so that the receiving Party receives a sum equal to the sum which it would have received had there been no such imposition of Incremental Withholding Taxes.

4.11.2Value Added Tax. All payments between the Parties under this Agreement are exclusive of applicable statutory value added tax or similar taxes (“VAT”), if any, which shall be listed separately on each invoice. If and to the extent any VAT will become payable due to any supplies or services rendered under this Agreement and if and to the extent such VAT is to be paid by the Party providing the supply or service to the competent tax authorities, the receiving Party shall pay an amount equal to such VAT to the providing Party upon receipt of a valid invoice allowing for the recovery of such VAT.

4.11.3Taxes of Co-Entrepreneurship. If and to the extent the Parties are considered to be partners of a co-entrepreneurship for tax purposes because of their collaboration governed by this Agreement and taxes allocated to the co-entrepreneurship (e.g. German trade tax, but excluding any taxes imposed on or with respect to net income other than German trade tax) are owed by either of the Parties, such tax (as well as any related cost of reporting and preparation of relevant tax returns) shall be [***]. In deviation of the foregoing, if and to the extent such tax (including related cost) is increased or reduced by circumstances that are exclusively attributable to one of the Parties (Causing Party) (in particular due to so-called special trade tax effects), any increased tax (including related costs) shall exclusively be allocated to and be borne by the Causing Party and any saved tax shall be credited to the Causing Party. The Parties shall cooperate in good faith to agree on a mutual tax filing position for their collaboration governed by this Agreement in due course after the Effective Date. Each Party shall have the right to assign any or all of its contractual position under this Agreement to a wholly owned corporate subsidiary (“Blocker Entity”) provided that the relevant Party (i) remains secondarily liable for any liabilities of the Blocker Entity under this Agreement in respect of the contractual position assigned and (ii) shall indemnify the other Party from any taxes triggered by the transfer of such contractual position to the Blocker Entity.

4.11.4Other. Except as otherwise set forth in this Section 4.11, each Party shall be solely responsible for the payment of all Taxes imposed on such Party’s income arising directly or indirectly from the activities of the Parties under this Agreement and each Party shall be solely responsible for taxes based on, imposed on or calculated by reference to any employees employed by that Party.

4.11.5Branded Prescription Drug Fee. Under the provisions of the U.S. Patient Protection and Affordable Care Act, Pub. L. No. 111-14 (as amended), Pfizer is subject to the annual fee on prescription drug manufacturers, hereinafter referred to as the “Branded Prescription Drug Fee”. [***]

4.12Currency, Source of Payments. All amounts payable and calculations under this Agreement will be in United States dollars [***]. As applicable, all costs and expenses will be translated into United States dollars at the exchange rate used by the relevant Party for public financial accounting purposes. If, due to restrictions or prohibitions imposed by national or international authority, a given payment cannot be made as provided under this Section 4.12, the Parties will consult with a view to finding a prompt and acceptable solution. If the Parties are unable to identify a mutually acceptable solution regarding such

Execution Version

payment, then the Party owing the relevant payment may elect, in its sole discretion, to deliver such payment in the relevant jurisdiction and in the local currency of the relevant jurisdiction.

4.13Method of Payment. Except as permitted pursuant to Section 4.12, each payment hereunder will be made by electronic transfer in immediately available funds via either a bank wire transfer, an ACH (automated clearing house) mechanism, or any other means of electronic funds transfer, at the paying Party’s election, to such bank account as the receiving Party will designate in writing to the other Party within [***] of the Signing Date, and thereafter at least [***] before the payment is due. All invoice or billing related questions in relation to Pfizer should be referred to Pfizer’s Accounting Department at [***] or go to the Accounts Payable Invoice Portal at [***]. Unless otherwise specified herein, each invoice is payable within [***] of receipt of the relevant invoice.

4.14Record Keeping and Audits.

4.14.1Record Keeping. Each Party shall keep and maintain and shall cause its Affiliates to keep and maintain books and accounts of record in sufficient detail to enable the determination of [***] and any other financial provisions of or applicable to this Agreement. Such records will be maintained for up to [***] after the end of the year to which they pertain or such longer period of time required under a Current License, insofar as applicable to the rights sublicenses pursuant to such Current License.

4.14.2Right to Audit. Upon [***] prior notice from a Party (the “Auditing Party”), the other Party (the “Audited Party”) will permit an independent certified public accounting firm of nationally recognized standing selected by the Auditing Party and reasonably acceptable to the Audited Party, to examine [***] the relevant books and records of the Audited Party and its Affiliates (and where possible, its subcontractors) as may be reasonably necessary to verify the amounts reported by the Audited Party in accordance with Sections 4.4 to 4.10. An examination by the Auditing Party under this Section 4.14 will occur not more than [***] and will be limited to the pertinent books and records for any Calendar Year ending not more than [***] before the date of the request. The accounting firm will be provided access to such books and records at the Audited Party’s or its Affiliates’ facility(ies) where such books and records are normally kept and such examination will be conducted during the Audited Party’s or its Affiliates’ normal business hours. The Audited Party may require the accounting firm to sign a reasonably acceptable non-disclosure agreement before providing the accounting firm with access to the Audited Party’s or its Affiliates’ facilities or records. Upon completion of the audit, the accounting firm will provide both Pfizer and BioNTech the same written report disclosing any discrepancies in the reports submitted by the Audited Party, and, in each case, the specific details concerning any discrepancies. No other information will be provided to the Auditing Party.

4.14.3Underpayments/Overpayments. If such accounting firm concludes that there are errors in how Shared Development Costs, Third Party funding, BioNTech Deferred Development Costs, Net Sales, Gross Profits, Transfer Prices, Third Party License Payments, Expedited Milestone Refunds or Proportional Adjustments have been calculated, allocated, paid or reclaimed, then adjustments shall be made in accordance with the accounting firm's recommendations in a reconciliation of such amounts and any overpayment or underpayment by the Audited Party shall be rectified either by a refund to, or payment by, the Audited Party from or to the Auditing Party within [***] of the date the Audited Party receives such accountant’s written report. Further, if the

Execution Version

amount of any overpayment or overallocation to the Audited Party exceeds more than [***] of the amount that was properly payable due or allocated to the Audited Party, then the Audited Party will reimburse the Auditing Party for the Auditing Party’s out-of-pocket costs in connection with the audit.

4.14.4Confidentiality. Notwithstanding any provision of this Agreement to the contrary, all reports and financial information of the Audited Party or its Affiliates which are provided to or subject to review by the Auditing Party will be deemed to be Confidential Information of the Audited Party and subject to the provisions of Section 12.1.

4.15No Guaranty of Success.

4.15.1Pfizer and BioNTech acknowledge and agree that any milestone payments payable hereunder: (a) have been included in this Agreement on the basis that they are only payable or otherwise relevant if a certain Product is successfully Developed or Commercialized in accordance with the applicable milestone or event, as applicable; (b) are solely intended to allocate amounts that may be achieved upon successful Development or Commercialization of such Product as applicable, between Pfizer and BioNTech; (c) are not intended to be used as a measure of damages if this Agreement is terminated for any reason; and (d) will only be triggered, and will only be relevant as provided, in accordance with the terms and conditions of such provisions.

4.15.2Pfizer and BioNTech further acknowledge and agree that nothing in this Agreement, or in any document or presentation provided by Pfizer to BioNTech prior to the Effective Date will be construed as representing any estimate or projection of (a) the successful Development or Commercialization of any Product under this Agreement, (b) the number of Products that will or may be successfully Developed or Commercialized under this Agreement, (c) the number of countries in the Territory in which the Product will receive Regulatory Approval, (d) anticipated sales or the actual value of any Products that may be successfully Developed or Commercialized under this Agreement or (e) the damages, if any, that may be payable if this Agreement is terminated for any reason.

4.15.3Neither Party makes any representation, warranty or covenant, either express or implied, to the other Party that (a) it will successfully Develop, Manufacture, Commercialize or continue to Develop, Manufacture or Commercialize any Product in any country, (b) it will secure Regulatory Approval for the Product in any country in the Territory, (c) if Commercialized, that any Product will achieve any particular sales level, whether in any individual country or cumulatively throughout the Territory or (d) it will devote, or cause to be devoted, any level of diligence or resources to Developing, Manufacturing or Commercializing any Product in any country, or in the Territory.

4.16No Other Compensation. Other than as explicitly set forth in this Agreement, neither Party will be obligated to pay any additional fees, milestone payments, royalties or other payments of any kind to the other Party under this Agreement or any Related Agreement.

4.17Late Payment. Any payments or portions thereof due hereunder which are not paid when due will bear interest at the Contract Interest Rate, compounded annually, calculated on the number of days

Execution Version

such payment is delinquent. This Section 4.17 will in no way limit any other remedies available to either Party.

4.18No Double Counting. There will be no double counting of any payments, costs or revenue item in the calculation of any amounts under this Agreement or any Related Agreement, and to the extent a cost or expense has been included in one category or sub-category, it will not be included in another; similarly, to the extent any revenue has been taken into account in one category or sub-category it will not be taken into account in another. For clarity, [***].

5.	Research and Development Plan

5.1Scope of Development and Updating of Plans Pfizer and BioNTech will collaborate during the Term to conduct research to identify, Develop and evaluate Candidates and Products within the Field in accordance with the binding parts of the Research and Development Plan, the Development Budget, the Manufacturing Plan, and the terms and conditions set forth in this Section 5. The Research and Development Plan may be modified by agreement and approval of the JSC pursuant to Section 6, provided that the JSC shall have no right or authority to (a) modify the Research and Development Plan in a way not permitted under Section 6.3; or (b) modify the Research and Development Plan so as to amend the contractual provisions of this Agreement. The Parties acknowledge and agree that the initial [***] of each of the Research and Development Plan, the Manufacturing Plan and the Development Budget have been agreed between the Parties, the first [***] of each binding upon the Parties and the second [***] indicative but non-binding. At least [***] prior to the expiration of such initial [***] binding period, the JSC shall decide and mutually agree on the following [***] period of each of the Research and Development Plan and the Development Budget which period, upon agreement, shall be binding upon the Parties subject to Section 6.3.4. At least [***] prior to the expiration of the initial [***] period following the Effective Date, the JSC shall establish a rolling [***] process to decide on and update each of the Research and Development Plan and the Development Budget for subsequent [***] periods, each of which shall be updated by the JSC no later than [***] prior to the expiration of the then binding [***] period.

5.2Research and Development Plan. The Research and Development Plan shall (a) include a broad non-binding overview of the first [***] of the planned Development program (specifying in reasonable detail all material Development activities) to generate the preclinical, clinical, CMC, regulatory and other information required for submitting a marketing authorization application for Regulatory Approval for the Candidate or Product and to achieve such Regulatory Approval for the Candidate or Product in one or more selected country(ies) of the Territory; (b) include a more detailed and binding part of the plan for the initial binding period described in Section 5.1, which will be updated in accordance with Section 5.1; and (c) set forth those obligations assigned to each Party with respect to the performance of the Development activities contemplated by such Research and Development Plan.

5.3Allocation of Responsibilities.

5.3.1General. Each Party will use Commercially Reasonable Efforts to perform its obligations and activities identified under the binding parts of the Research and Development Plan or as allocated to it by the JSC in a professional manner in accordance with any target dates set forth in Research and Development Plan. Further, each Party will perform its obligations under the binding parts of the Research and Development Plan or as allocated to it by the JSC in compliance with all Laws applicable to its activities under the Research and Development Plan.

Execution Version

5.3.2Mutations. If and to the extent Mutations of the SARS-CoV-2 virus arise [***].

5.3.3Label Extensions. If a Party wishes to extend the label or approved indication of any Product Developed hereunder to other indications (including any outside of the Field), it may so notify the JSC. In such event, the JSC shall discuss such label extension in good faith. If the JSC agrees by unanimous consent that Development should be undertaken to support the label extension, the Parties shall include the Development activities required to be undertaken to support such label extension in the Research and Development Plan and, if appropriate, amend the Field accordingly to cover such extension. Any external cost or expense (other than Capex Cost) incurred by either Party (or its Affiliates) solely and specifically in connection with such Development activities [***].

5.3.4Subcontractors . Either Party may subcontract its responsibilities under the binding parts of the Research and Development Plan or those allocated to it by the JSC without the other Party’s prior written consent; provided that such Party shall be responsible for the management of all permitted subcontractors (which will include any Affiliate of a Party). The engagement of any Third Party subcontractor by a Party shall be in writing. The engagement of any subcontractor (whether Affiliate or Third Party) shall not relieve such Party of its obligations under this Agreement or the binding parts of the Research and Development Plan. Any agreement between the Party or its Affiliate and a subcontractor pertaining to the Research and Development Plan activities shall be consistent with the provisions of this Agreement including (a) an obligation to assign all Intellectual Property Rights generated during its performance of such Research and Development Plan to the Party free of any encumbrance such that the Party may fulfil its obligations hereunder and (b) terms and conditions under which such Third Party is obligated to preserve the confidentiality of the Research and Development Program, Research and Development Program Technology and any Confidential Information are at least as restrictive as those described in Section 12.2.1.

5.3.5Flexibility of Resources. Due to practical consequences arising from the outbreak of the virus that is the subject of the Field, it may become difficult or temporarily impossible (including as classified as a force majeure event) for a Party to fulfil all of its responsibilities under the Research and Development Plan or as allocated to it by the JSC. Accordingly, a Party, in its effort to collaborate, may therefore agree to swap, substitute or perform any of the other Party's responsibilities that were allocated to it in the Research and Development Plan or by the JSC. The JSC shall be responsible for coordinating any such changes, which must be finally approved in writing by the Parties where the change results in a Party taking on additional financial cost and responsibility.

5.3.6Personnel Matters. Each Party acknowledges and agrees that it is solely responsible for the compensation of its personnel assigned to the Research and Development Plan, and shall be responsible for withholding all national, state, local or other applicable taxes and similar items for such personnel. Each Party also shall be responsible for all other of its employer related obligations, including providing appropriate insurance coverage and employee benefits, and making all other deductions required by law affecting the gross wages of each of its employees. BioNTech personnel assigned to the Research and Development Plan activities are not nor shall they be deemed to be employees of Pfizer, and Pfizer personnel assigned to the Research and Development Plan activities are not nor shall they be deemed to be employees of BioNTech.

Execution Version

5.4Materials and Permitted Activities.

5.4.1Transfer. From time to time during the Term, Pfizer shall provide BioNTech with tangible chemical or biological materials (the “Pfizer Materials”) and BioNTech may provide Pfizer with BioNTech Materials for the other Party’s use in accordance with binding parts of the Research and Development Plan. The Party providing its Materials represents and warrants to the other Party that, as of the date of delivery of the Material (a) to the providing Party’s knowledge, such Party has the right to provide such Material to the other Party for the uses in accordance with the binding parts of the Research and Development Plan, (b) the Materials comply with any requirements set forth in the Research and Development Plan or otherwise mutually agreed between the Parties (if any) in writing and (c) to the providing Party’s knowledge, the use of the Materials authorized herein does not infringe any Third Party rights. Except as expressly set forth in the preceding sentence, the Materials are provided by the providing Party on an “as-is” basis without any representation or warranty of any type, express or implied, including any representation or warranty of merchantability or fitness for a particular purpose, each of which is hereby expressly disclaimed by the receiving Party.

5.4.2Title to Materials. All right, title and interest in and to the providing Party’s Materials (including any modifications or progeny thereof) will remain the sole and exclusive property of such Party notwithstanding the transfer to and use by other Party of the same.

5.4.3Permitted Activities. Notwithstanding anything to the contrary in this Agreement save for each Party’s exclusivity obligations and restrictions (including those at Sections 3.1 and 3.11), nothing in this Agreement shall be deemed to prevent or restrict in any way the ability of either Party or its Affiliates to conduct any activities in the Territory, which activities would be allowed under any safe harbor, research exemption, government or executive declaration of urgent public health need, or similar right available in law or equity if conducted by a Third Party.

5.4.4Return of Proprietary Materials. Upon termination or expiration of the Term, each Party receiving the other Party’s Materials hereunder shall, either destroy or return all unused Materials to the providing Party.

5.5Human Materials. To the extent a Party holds and controls Human Materials that have been collected as part of any Clinical Trial in relation to the Product or a product identical to the Product, upon the other Party's reasonable request for access to such Human Materials for purposes of obtaining Marketing Authorization Approval or other Development purposes for, in the case of Pfizer, the Product or, in the case of BioNTech, a product identical to the Product in the Fosun Territory, the Parties shall negotiate in good faith with respect to an agreement under which the Party holding and controlling such Human Materials could provide such Human Materials.

6.	Contract Governance

6.1Alliance Managers. Each Party will appoint a (i) single individual to act as the primary point of contact between the Parties to support the activities under the Research and Development Plan and the Manufacturing Plan and (ii) single individual to support matters relating to the Commercialization of, and regulatory and Compliance issues regarding pharmaceutical products (all persons under (i) and (ii) being the “Alliance Managers”). A Party's Alliance Manager for Research and Development and Manufacturing may be the same or different than the Alliance Manager for Commercialization. Each Party

Execution Version

may change its designated Alliance Managers at any time upon written notice to the other Party. The Alliance Managers will:

6.1.1act as a key point of contact between the Parties to facilitate a successful collaboration hereunder;

6.1.2use good faith efforts to attend (either in person or by telecommunications) and actively participate in all meetings of the JSC or JCC, as applicable, and as agreed by the Alliance Managers, any meetings of any RCC or any subcommittees established hereunder, but will be non-voting members at such meetings; and

6.1.3be the first point of referral for all matters of conflict resolution and bring disputes to the attention of the JSC in a timely manner.

6.2Program Directors. Each Party will appoint a program director to oversee all activities conducted under the Research and Development Plan and all activities related to Commercialization, including regulatory and Compliance activities (each, a “Program Director”). A Party may appoint a different Program Director for activities under the Research and Development Plan and activities related to Commercialization. Each Party may change its designated Program Director at any time upon written notice to the other Party. The Program Directors will coordinate the efforts of their respective Party in conducting activities under the Research and Development Plan.

6.3Joint Steering Committee.

6.3.1Composition. As of the Effective Date, the Parties will establish a Joint Steering Committee, comprised of at least [***] representatives of BioNTech (including the Alliance Manager for BioNTech) and at least [***] representatives of Pfizer (including the Alliance Manager for Pfizer). The JSC representatives for each of Pfizer and BioNTech will be referred to herein as the “Pfizer JSC Members” and the “BioNTech JSC Members” respectively.

Each Party may replace its representatives to the JSC at any time upon notice to the other Party, provided that at all times an equal number of representatives from each Party are appointed to the JSC and each Party shall be responsible for ensuring any replaced representative is fully briefed and apprised of the Research and Development Program. Each Party shall procure that its JSC representatives shall make themselves available to attend JSC meetings upon reasonable notice and in accordance with this Agreement. Each Party may invite non-voting employees and consultants to attend meetings of the JSC. All members of the JSC and any invitees of either Party described above will agree in writing to be bound to obligations of confidentiality and assignment of Intellectual Property Rights no less restrictive than those that bind the Parties under this Agreement.

6.3.2Committee Chair. The JSC will be chaired by a BioNTech JSC Member (the “JSC Chair”). BioNTech may replace the JSC Chair at any time upon notice to Pfizer. The responsibilities of the JSC Chair will be:

6.3.2.1to notify each Party at least [***] Business Days in advance of each JSC meeting;

6.3.2.2to collect and organize agenda items for each JSC meeting; and

Execution Version

6.3.2.3to prepare the written minutes of each JSC meeting and circulate such minutes for review and approval by the Parties and identify action items to be carried out by the Parties.

6.3.3Meetings. Until the initiation of a Phase I Clinical Trial or Expedited Trial Pathway, the JSC shall meet at least weekly, unless otherwise unanimously agreed. Thereafter, the JSC will meet on at least bi-weekly basis (or less or more frequently as the JSC so determines), either in-person or by audio or video teleconference. Meetings of the JSC will occur at such times and places as mutually agreed by the Parties. Any sub-committees or working groups established in accordance with Section 6.3.4 may meet via audio or video teleconference on a regular basis and in-person at such times and places as the Parties may agree. Meetings of the JSC will only occur if at least two representatives of each Party are present at the meeting or participating by teleconference or videoconference. Each Party will be responsible for, and will not be entitled to any reimbursement from the other Party with respect to, any and all personnel costs or expenses (including travel expenses) which are incurred by or on behalf of its personnel in connection with participation in any JSC meetings or sub-committee or working group meetings, or any other travel required to be undertaken by either Party’s personnel in connection with the performance of the Agreement. The JSC Chair will use good faith efforts to (a) prepare and circulate to BioNTech and Pfizer each JSC meeting agenda on or before the day prior to the scheduled date for each JSC meeting and (b) circulate for review and approval by BioNTech and Pfizer written minutes of each JSC meeting within [***] Business Days after such meeting. The Parties will agree on the minutes of each meeting promptly, but in no event later than the day before the next meeting of the JSC.

6.3.4Responsibilities. The JSC will coordinate and provide operational and strategic oversight of the Development and Manufacturing activities to be performed under the Research and Development Plan and the Manufacturing Plan by each Party and, within such scope will:

6.3.4.1review and approve all proposals of whether to seek funding from a Third Party Funder, and the terms of any proposed agreement with a Third Party Funder, which (with the exceptions specified in Section 4.5.2 for [***] and [***]) will require unanimous consent of the JSC;

6.3.4.2monitor and assess the progress of activities under the Research and Development Plan and the Manufacturing Plan;

6.3.4.3decide on the Candidates or Products that will be studied in the Clinical Trials;

6.3.4.4decide on the design of the Clinical Trials, including the protocol governing the Clinical Trials;

6.3.4.5decide on and revise and approve any revisions of the Research and Development Plan and the Development Budget (including in accordance with the mechanism described in Section 5.1 and any adjustments pursuant to Section 5.3.3 and 5.3.5), each of which shall require unanimous consent of the JSC except as expressly set forth in Section 6.4.9;

6.3.4.6discuss any Intellectual Property Rights of a Third Party which may be relevant to Candidates and Products;

Execution Version

6.3.4.7oversee the Development of Manufacturing processes relating to the Candidates or Products, establishment of Manufacturing capacity, and endorse a strategy for Manufacturing Candidates and Product for both the Clinical Trials and planned Commercialization;

6.3.4.8review and discuss all preclinical data and data arising from Clinical Trials investigating the Candidate or Product in the Territory, including adverse events;

6.3.4.9review and discuss all preclinical data and data arising from Clinical Trials under the Fosun Agreement, including adverse events;

6.3.4.10 form such other Committees and sub-committees as the JSC may deem appropriate within its area of responsibility, such as a Joint Development Committee and the like, provided that the JSC may, with unanimous consent, delegate decision-making authority (that is within the JSC's own authority) relevant to such committee’s and sub-committee’s area of expertise only;

6.3.4.11 address such other matters relating to the activities of the Parties under the Research and Development Plan as either Party may bring before the JSC, including any matters that are expressly for the JSC to decide as provided in this Agreement;

6.3.4.12 review and discuss any proposals by either Party relating to permitting a Third Party to perform research involving the Product;

6.3.4.13 agree on a Development Budget, as well as any amendments to such budgets, provided that the Development Budget and any amendments to it shall require unanimous consent of the JSC;

6.3.4.14 discuss, collaborate on and oversee any applications for Regulatory Approvals in respect of the Candidates and Products, both within and outside the Territory;

6.3.4.15 discuss, collaborate on and agree on mutations pursuant to Section 5.3.2 or any label extension pursuant to Section 5.3.3, each of which must be agreed by unanimous consent of the JSC; and

6.3.4.16attempt to resolve any disputes between the Parties with respect to (a) the performance of activities under the Research and Development Plan on an informal basis or (b) matters before the Patent Committee, in each case subject to Section 6.5.

6.3.5Limits on JSC Authority. Notwithstanding any provision of this Section 6 to the contrary, (a) each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing, (b) except with respect to modifications to the Research and Development Plan permitted as set forth in Section 6.3.4.5, the JSC will not have the power to amend this Agreement or otherwise modify or waive compliance with this Agreement in any manner and (c) neither Party will require the other Party to (i) breach any obligation or agreement that such other Party may have with or to a Third Party to the extent such obligation or agreement existed prior to the Effective Date or (ii) perform any activities that are materially different or

Execution Version

greater in scope or more costly than those provided for in the Research and Development Plan then in effect.

6.3.6JSC Term. The JSC may be dissolved upon mutual agreement between the Parties.

6.4Other Committees.

6.4.1Joint Commercialization Committee. The Parties shall establish a Joint Commercialization Committee (the “JCC”) to (a) develop and oversee strategies on a global level for the Commercialization of the Product in the Territory, including reviewing and overseeing Packaging and Labeling and establishing global pricing guidelines, and marketing and patient access programs and strategies for the Product, (b) establish and oversee the implementation of a Global Commercialization Plan and, if the JCC so elects, review and oversee any Annual Regional Commercialization Plans in accordance with Section 9.1.1, and oversee the Commercialization Activities under the collaboration, in each case ((a) and (b)), on a global and, as applicable, on a Commercialization Region basis, and (c) establish and, if appropriate, amend guidance for the appropriate Packaging Configuration that may be used by either Commercialization Party, provided that the Parties acknowledge and agree that [***]. The JCC shall be composed of [***] senior executives of each Party; provided that the total number of representatives may be changed upon mutual agreement of the Parties (so long as each Party has an equal number of representatives). One representative of each party on the JCC shall be designated by such Party to be a co-chairperson of the JCC. As part of its responsibilities, but subject to the decision making processes at Section 6.5.4 in the event agreement cannot be reached, the JCC shall also perform the following:

6.4.1.1Within each annual planning cycle, the JCC shall discuss and seek to agree on the forward-looking Gross Profit budget for the following year to be set forth in the applicable Global Commercialization Plan by reference to the following year’s profit and loss forecast [***]. Relevant items for such review and discussion shall include: [***]. Each Party shall promptly notify the JCC if it becomes aware that there is a deviation in the immediately preceding Pfizer Quarter of more than [***] of the actual Gross Profit as compared against the budget for the Gross Profit in the profit and loss forecasts pursuant to the above (a “Budget Deviation”) and specify the reason for such Budget Deviation. Following such Budget Deviation notice, the JCC shall discuss the reasons for such deviation on a Relevant Line Item by Relevant Line Item basis and seek to agree on any potential measures to be taken to address and improve the situation. In addition, from [***] onwards, the Parties shall review, each Pfizer Quarter, the profit and loss statement compared to the Gross Profit level pursuant to (i) and (ii) above for such Pfizer Quarter and such year-to-date against the equivalent Pfizer Quarter in the previous year and the equivalent year-to-date period in the previous year.

6.4.1.2The JCC shall review, discuss and agree by mutual consent all aspects relating to Product Components in any market or region, including [***].

6.4.2Regional Commercialization Committee(s). The JCC may elect, at its discretion, to establish individual regional commercialization committees for the following regions located within a Party's Commercialization Territory (or such regions as may be amended by Pfizer from time to time): [***], (each a “Commercialization Region”) in the Territory (each an “RCC”),

Execution Version

provided that [***]. Each RCC will oversee and monitor the activities of the applicable Commercializing Party for such Commercialization Region. Each RCC will review the Annual Regional Commercialization Plan for the Commercialization Region for which such RCC is responsible, provided that [***]. To the extent an RCC is not established for a Commercialization Region (i) within the Pfizer Commercialization Territory, Pfizer shall establish its own Commercialization plan for such Commercialization Region, or (ii) within the BioNTech Commercialization Territory, BioNTech shall establish its own Commercialization Plan for such Commercialization Region, provided that in each case of (i) and (ii), any such Commercialization Plan must not be inconsistent with the global positioning and the Global Commercialization Plan agreed in the JCC or pursuant to Section 6.5.4. Each RCC shall be composed of [***] representatives from each Party. One of the Pfizer representatives on each RCC established for Commercialization Regions within the Pfizer Commercialization Territory shall be designated by Pfizer to be the chairperson of such RCC and one of the BioNTech representatives of each RCC established for the Commercialization Regions within the BioNTech Commercialization Territory shall be designated by BioNTech to be the chairperson of such RCC; provided that for any RCC established for a Commercialization Region that incorporates countries in both the BioNTech Commercialization Territory and the Pfizer Commercialization Territory, the chairperson of such RCC shall be designated by the Party having more countries in its Commercialization Territory in such Commercialization Region unless the JCC elects to establish two RCC's for such Commercialization Region where each such RCC only has responsibility for countries with in either the BioNTech Commercialization Territory or the Pfizer Commercialization Territory, but not both.

6.4.3Joint Finance Committee. The Parties shall establish a Joint Finance Committee (the “JFC”) to work with the other Committees to assist in financial, forecasting, budgeting and planning matters as required, including (a) assisting the JCC and the Joint Manufacturing Committee established pursuant to this Agreement in developing the long-range forecast for commercial supply of the Products; (b) recommending and approving procedures, formats and timelines consistent with this Agreement for reporting pursuant to Sections 4.9 and 4.10 financial data and assist in resolving differences that relate to the financial terms of this Agreement; provided that no Party shall be required to make any material changes to its internal accounting and reporting systems and standards; (c) reviewing calculations of the amount of any payments to be made by the Parties (or their Affiliates) hereunder, reviewing the reconciliation of payments; (d) coordinating audits of financial data where appropriate and required or allowed by this Agreement; and (e) establishing the inter-party procedures, contracts (if necessary), and financial structure necessary to effect that economic result contemplated by this Agreement and monitoring and maintaining such structure. Furthermore, the JFC shall establish reporting procedures for the sharing of information reasonably required by the other Party for its financial reporting. Such reporting shall as a minimum include reasonable detail with respect to [***]. The JFC shall be composed of [***] representatives from each Party, wherein one representative has expertise on research and development matters and the other on commercial matters, provided that the total number of representatives may be changed upon mutual agreement of the Parties (so long as each Party has an equal number of representatives).

6.4.4Joint Manufacturing Committee. The Parties shall establish a Joint Manufacturing Committee (the “JMC”) to plan, decide on, develop, amend, revise and oversee the execution of the Manufacturing Plan, to help the Parties establish adequate Manufacturing

Execution Version

facilities, capacity and capability for the Product, to address such other matters relating to the activities of the Parties under the Manufacturing Plan as either Party may bring before it and, subject to Section 6.5, to attempt to resolve any disputes between the Parties with respect to the performance of activities under the Manufacturing Plan on an informal basis. The JMC shall agree and decide on an initial Manufacturing Plan within [***] of the Amendment Signing Date. The JMC shall work with the JCC and the JFC in respect of Manufacturing activities. The JMC shall be composed of [***] from each Party, provided that the total number of representatives may be changed upon mutual agreement of the Parties (so long as each Party has an equal number of representatives).

6.4.5Compliance Committee. Pfizer and BioNTech agree to establish a Compliance Committee (the “Compliance Committee”) promptly after the Amendment Signing Date. The Compliance Committee shall be comprised of [***] from each Party or such other number as may be mutually agreed by the Parties, provided that each Party at all times shall have an equal number of representatives on the Compliance Committee. The Compliance Committee shall report to the JCC. Subject to the terms and conditions of this Agreement, the Compliance Committee shall have overall responsibility for resolving discrepancies between the Parties’ respective compliance policies; managing compliance with corporate integrity agreements and deferred prosecution agreements (or similar agreements/settlement documents) to which either of the Parties are subject; and ensuring a process to monitor the Parties’ activities under this Agreement for compliance with all applicable Laws relating to healthcare and all Anti-Corruption Laws.

6.4.6Committee Membership – General. Each Party will ensure that the members appointed by it to serve on any Committee, including the JSC or JCC, have, as applicable: (a) the appropriate level of seniority and decision-making authority commensurate with the responsibilities of the Committee to which they are appointed; and (b) a range of expertise, as applicable, in the Commercialization of pharmaceutical or vaccine products to enable an efficient cross-functional Committee structure. If any Committee member becomes unwilling or unable to fulfil his or her duties hereunder, then the Party that appointed such member will promptly appoint a replacement by written notice to the other Party. Further, each Party may replace any of its designated Committee representatives at any time on written notice to the other Party. The chairperson or co-chairpersons, as applicable, of each Committee will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of such Committee; provided that the Committee chairperson(s) will call a meeting of the applicable Committee promptly upon the written request of the most senior representative from the other Party serving on such Committee to convene such a meeting.

6.4.7Secretary; Minutes. Each Committee will have a secretary (who need not be a voting member of such Committee), which will alternate yearly between the Parties. The hosting Party’s secretary (or designee) for a given Committee will be responsible for preparing reasonably detailed written minutes of all meetings of such Committee that reflect, without limitation, material decisions made, action items identified and unresolved matters discussed at such meetings. The initial draft of the meeting minutes for a given Committee meeting, reflecting key decisions, action items and unresolved matter, among other details, will be completed by the end of such meeting and circulated to the Committee’s members for subsequent review and approval.

Execution Version

6.4.8Meetings. Each Committee will meet at such times as it elects to do so; provided that the JCC and each RCC will meet at least once every [***], via teleconference or videoconference or otherwise (with at least [***] per calendar year being in person if feasible), or as otherwise agreed by the JCC or the relevant RCC, as applicable. Additionally, either Party may call a meeting of the JCC or any RCC at any time; provided that the requesting Party provides at least [***] prior written notice to the chair of such Committee and such notice includes a proposed agenda for such meeting. Any and each subcommittee established hereunder will establish a meeting frequency and meeting protocol necessary to coordinate and conduct the activities for which it is responsible, as mutually agreed by the Parties. Any in-person meetings of the JCC and any RCC will be held on an alternating basis between a location designated by BioNTech and Pfizer, unless otherwise agreed by the Parties. Each Party will be solely responsible for its own expenses relating to attending and participating in all Committee meetings. As appropriate, other employee representatives of the Parties may attend such meetings as non-voting participants, but no Third Party personnel may attend unless otherwise agreed by each of the Parties. All Committee meetings will be conducted in English, and all documents (including all Committee meeting minutes and Annual Regional Commercialization Plans) will be in English.

6.4.9Reporting. Each Commercializing Party will keep the JCC or applicable RCC informed of progress and results of the Commercialization Activities and Medical Activities for which such Commercializing Party is responsible through its members on such Committee at each regularly scheduled meeting thereof and as otherwise provided herein.

6.4.10No Authority to Amend or Modify. Notwithstanding anything herein to the contrary, no Committee will have any authority to amend, modify or waive compliance with this Agreement or any Related Agreement. Subject to Section 17.6, the Parties agree to periodically review the operation of the JCC and the provisions of Article 9 and mutually agree any changes which are considered necessary or appropriate in light of prevailing circumstances and to ensure the Agreement, its operation and that of the JCC continues to comply with applicable Laws

6.5Committee Decision-Making.

6.5.1Consensus Decision Making. Each Party shall procure that its respective Committee members shall act reasonably and in good faith to take action by unanimous consent of the Parties, with each Party having a single vote, irrespective of the number of Committee representatives actually in attendance, provided that at least [***] from each Party is in attendance at any meeting in which a decision is made.

6.5.2Joint Steering Committee Deadlocks. If, despite good faith efforts, the JSC is unable to reach unanimous agreement on a particular matter, within [***] after the JSC first meets to consider such matter, or such later date as may be mutually acceptable to the Parties (each such matter, a “Disputed Matter”), then:

6.5.2.1[***]; and

6.5.2.2[***]; and

6.5.2.3[***].

Execution Version

The Parties agree that the JSC will further refine the details of the decision-making rights and processes in accordance with Schedule 6.5.2 and the terms of this Agreement.

6.5.3Regional Commercialization Committees Deadlocks. All deadlocks arising in any RCC will be referred to the JCC for resolution and the JCC shall attempt to resolve such matter within ten (10) Business Days of the matter being referred to it.

6.5.4Joint Commercialization Committee Deadlocks. Either Party may elect to refer a deadlock arising in the JCC (including deadlocks referred to it by the RCC) to [***]. If [***] are not able to resolve the dispute, then:

6.5.4.1[***];

6.5.4.2[***]; and

6.5.4.3[***],

provided that [***].

6.5.5Joint Manufacturing Committee Deadlocks. All deadlocks arising from the JMC will be referred to the Parties' respective [***] for resolution and such respective [***] shall use good faith efforts to discuss and resolve such deadlock within [***] of the matter being referred to them.

6.5.6Other Deadlocks. All deadlocks arising from any other Committee described in Section 6.4 shall be referred to the JSC or JCC, depending on whether the issue subject to the deadlock is primarily related to Research and Development or Commercialization, for resolution and the JSC or JCC, as applicable, shall attempt to resolve such matter within [***] of the matter being referred to it, provided that the JSC or JCC, as applicable, may elect to consult with members of the other Committee (that is, the JCC or JSC, as applicable), or include such members in decision-making, where such matter is related to the expertise of such other Committee or its members.

6.5.7Dispute Resolution. For the avoidance of doubt Section 6.5 concerns resolution of any committee deadlocks relating to operational matters to be determined by the applicable committee, and any other dispute or deadlock, including any dispute as to questions of contractual interpretation under this Agreement, shall only be determined and resolved pursuant to Section 17.11.

7.	Manufacturing

7.1Development of Manufacture Process. BioNTech and Pfizer shall jointly Develop a scalable process for Manufacture of Candidates and Products in the Field in the Territory in accordance with the binding parts of the Research and Development Plan and the Manufacturing Plan.

7.2 Manufacture of Candidates Products. Each Party will use Commercially Reasonable Efforts to perform its obligations and activities identified under the binding parts of the Manufacturing Plan or as allocated to it by the JSC, or the JMC, once established, in a professional manner in accordance with any target dates set forth in the Manufacturing Plan. Further, each Party will perform its obligations under the binding parts of the Manufacturing Plan or as allocated to it by the JSC or the JMC, once established, in compliance with all Laws applicable to its activities under the Manufacturing Plan. Pfizer and BioNTech

Execution Version

will collaborate in the build-up of Manufacturing capacity for the Manufacturing of Candidates and Products for clinical and commercial purposes in accordance with the binding parts of the Manufacturing Plan and the terms and conditions set forth in this Section 7. The Manufacturing Plan may be modified by unanimous consent of the JSC or the JMC, once established, pursuant to Section 6. Unless otherwise agreed in the Manufacturing Plan, at a minimum Pfizer will be responsible for the build-up of its Manufacturing site(s) in the USA for quantities of Product to be agreed as part of the Manufacturing Plan and the commercial supply agreement for such site, and at a minimum BioNTech will be responsible for the extension of its Manufacturing sites in Mainz and Xxxx-Xxxxxxxxx for quantities of Product to be agreed as part of the Manufacturing Plan and the commercial supply agreement for such sites. [***] The Manufacturing Plan may also consider one or both Parties engaging Third Party contract manufacturing organizations as a source of Manufacturing. In addition, promptly after the Effective Date, the Parties will agree on a technology transfer plan and continue to perform the technology transfer that the Parties have already started prior to the Effective Date to enable Manufacturing by Pfizer. For the avoidance of doubt, to the extent the technology transferred under this Agreement is identical to the technology to be transferred pursuant to the Flu Collaboration License, the Parties shall cooperate to minimize any duplication of technology transfer efforts under the Flu Collaboration License that unreasonably would be duplicative, wasteful or unnecessary.

7.3Quality Requirements. Each Party that undertakes or subcontracts any Manufacturing activities in respect of the Candidates or Products, whether for the purposes of this Agreement, the Clinical Trials or pursuant to the commercial supply agreements shall ensure (a) that all Manufacturing activities are undertaken in accordance with (i) applicable cGMP standards, applicable Laws, and other regulatory and manufacturing good practice (including record and sample keeping, deviation reporting, testing and quality requirements and post-marketing regulatory guidelines from the FDA and the EMA); (ii) the requirements of the applicable quality agreement; and (iii) the requirements of the applicable supply agreement entered into pursuant to Section 7.4, and (b) that such Product manufactured by it is (i) in conformance with the specifications therefor in effect at the time of shipment by such Party to the other Party or to any Third Party distributor or customer, such that the Product is not, at the time of shipment from such Party to the other Party or to any distributors or customers in the Territory, adulterated or misbranded within the meaning of the FD&C Act or any analogous applicable Law outside of the United States; and (ii) in conformance, at such time of shipment by such Party, in all material respects with the certificates of analysis accompanying such Product when shipped.

7.4Manufacturing Agreements.

7.4.1Clinical Supply. Within [***] following the Effective Date, the Parties shall enter into an agreement for clinical supply, as required to ensure the Clinical Trials planned can proceed on the timelines set forth in the binding parts of the Research and Development Plan. All clinical supply of Candidates and Products shall be charged as Shared Development Costs at the Manufacturing Costs. In addition, the Parties have agreed on quality agreements with respect to such clinical supply agreement.

7.4.2Commercial Supply. Furthermore, the Parties will negotiate in good faith and mutually agree on one or more commercial supply agreement(s) and quality agreement(s) simultaneously with the negotiation of the Commercialization Terms. The commercial supply agreement(s) shall be in accordance with the following commercial terms:

Execution Version

7.4.2.1The Manufacturing Party shall be entitled to charge (i) the Transfer Price for each batch of Product delivered in accordance with the relevant commercial supply agreement, or (ii) where intermediates, drug substance or bulk drug product is supplied for Manufacturing the Product, the Manufacturing Costs (as further defined in Section 1.93) for any such intermediates, drug substance or bulk drug product, but in each case of (i) and (ii), all supplies shall be made by the Manufacturing Party on a buy/sell model. Such Transfer Price (or Manufacturing Cost) shall be invoiced by the Manufacturing Party upon delivery of the Products and shall be payable by the other Party within [***] from receipt of such invoice.

7.4.2.2The Transfer Price (or Manufacturing Cost) shall be adjusted on a yearly basis for all commercial supply agreements in accordance with relevant cost developments.

7.4.2.3The Parties will work together, subject to and observing applicable Laws, and agree the volumes of Product Materials to be purchased from Third Party suppliers for the purposes of this Agreement and to [***] of either Party to source the other Party's requirements for such Product Materials for its Manufacturing activities pursuant to this Agreement, which sourced Product Materials shall then be sold, at cost, to that other Party [***].

7.4.2.4[***].

7.4.2.5The Parties will cooperate and use Commercially Reasonable Efforts to manufacture or cause to be manufactured and continuously supply the Product for distribution and use in the Field by customers and patients in the Territory. The JCC shall determine, by mutual consent, the allocation of supplies of Product in the Territory on a fair and equitable basis, subject also to any applicable Law, export controls, any government supply obligations, supply obligations included in any Third Party Funder agreements, supply obligations pursuant to advance purchase agreements, including agreements with any Governmental Authority, as well as supplies reasonably required by BioNTech for product identical to the Product in the Fosun Territory; provided, however, that the allocation of supplies required for the purposes of this Agreement shall take precedence over supplies for other uses, which priority shall be the primary consideration for such determination. Notwithstanding the foregoing, neither Party will have liability to the other Party by virtue of any shortage or allocation.

7.4.3The supply agreements to be entered into between the Parties pursuant to Sections 7.4.1 and 7.4.2 shall include appropriate accounting mechanisms to allow for true-up payments in respect of (i) Manufacturing Costs, including to account for any xxxx up on the Manufacturing Costs of Product Materials where permitted in the definition of Manufacturing Costs or costs paid to Third Party manufacturers for the manufacture and supply of Candidates or Products or components thereof, and (ii) Manufacturing Variances.

Execution Version

7.5Allocation of Responsibilities. Section 5.3.1 and Sections 5.3.4 to 5.3.6 shall apply mutatis mutandis in respect of each Party's responsibilities under the Manufacturing Plan.

7.6Quality Audits. The Parties shall negotiate in good faith and mutually agree on appropriate and customary audit rights of the other Party and any relevant Third Party contractor of such Party with respect to manufacturing quality matters in the commercial supply agreement(s) or quality agreement(s).

8.	Development, Regulatory and Pharmacovigilance

8.1Development Matters.

8.1.1Allocation of Development and Regulatory Responsibility. The Development of Candidates and Products shall be conducted by the Parties, under the direction and oversight of the JSC (and, as applicable, the Joint Development Committee), in accordance with the applicable Research and Development Plan and Development Budget. Pursuant to the initial Research and Development Plan, the Parties shall identify a strategy for Development of the Candidates and Products in the Territory that identifies the Party that is leading the clinical Development of the Candidates or Products in a country in the Territory (the “Lead Development Party”). Notwithstanding the foregoing, the Parties have agreed that (a) Pfizer shall lead the clinical aspects of Development of Candidates and Products in the USA, and (b) BioNTech shall lead the clinical aspects of Development of Candidates and Products in the EU. BioNTech shall be the sponsor and IND/CTA holder for all Clinical Trials in the Territory, in each case, subject to a mutually agreeable strategy with respect to the Development of Candidates and Products. For any Clinical Trial for which Pfizer is the Lead Development Party (but is not the sponsor of such Clinical Trials), BioNTech shall have delegated to Pfizer operational and day-to-day Development activities, decision-making authority and responsibility for such Clinical Trial, including those activities described in Schedule 8.1.1, subject to a protocol approved by unanimous consent by the JSC. For avoidance of doubt, the Lead Development Party shall conduct its Development activities in collaboration with and with active review of the other Party.

8.1.2Appointment of Lead Development Party for Future Clinical Trials. At any time during the Term, the JSC may determine by mutual consent that additional clinical Development of the Candidate and Product are warranted and, in such event, unless otherwise agreed by the JSC, (a) Pfizer shall be the Lead Development Party for each additional Clinical Trial in the USA, (b) BioNTech shall be the Lead Development Party for each additional Clinical Trial in the EU and (c) the JSC shall mutually agree on the appointment of one of the Parties to be the Lead Development Party for each additional Clinical Trial on a Clinical Trial-by-Clinical Trial basis in a country or region in the Territory other than the USA and EU (“ROW”), and subject to the mutually agreed upon strategy.

8.1.3Clinical Trials. In respect of Clinical Trials for the Candidates or Products pursuant to this Agreement, the following shall apply:

8.1.3.1GxP Standards. Subject to Section 8.1.3.8, BioNTech as the sponsor for any Clinical Trial in respect of any Candidate or Product pursuant to this Agreement shall ensure the Clinical Trial is conducted in accordance with GxP and all applicable Laws, and will provide to the other Party any significant GxP or non-compliance issues relating to the protocol for such Clinical Trial, which arise or may be identified through monitoring,

Execution Version

8.1.3.2Monitoring Plans. A high-level strategy for monitoring Clinical Trials in respect of any Candidate or Product pursuant to this Agreement will be agreed by the JSC within [***] following the Effective Date. The Lead Development Party of the Clinical Trial will notify the other Party if there are any amendments required to such monitoring plan, and provide such other Party with an opportunity to review and comment on any such amendments, and any amendments shall only be made following approval by the JSC.

8.1.3.3Sponsor Oversight Plan. The Parties shall mutually agree on a sponsor oversight plan to set forth the accountabilities and oversight of all Clinical Trials conducted by the Lead Development Party, consistent with that certain GCP Quality Agreement, dated December 10, 2020, including Appendix D, Roles and Responsibilities.

8.1.3.4IRB/IEC Approval. BioNTech as the sponsor and Regulatory Approval holder of the Clinical Trials shall ensure that the Clinical Trial is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC), except that BioNTech shall delegate this responsibility to Pfizer for any Clinical Trial for which Pfizer is the Lead Development Party. The Lead Development Party shall provide documentation of both the initial IRB/IEC approval of the final protocol to the other Party and annual renewals of that approval if such renewals are required. To the extent a Party receives notice of any withdrawal or suspension of IRB/IEC approval during the Term, it will promptly inform the other Party.

8.1.3.5Informed Consent. BioNTech as the sponsor and Regulatory Approval holder for each applicable Clinical Trial will obtain informed consent for each Clinical Trial subject in accordance with the applicable informed consent document and applicable Law and will inform and obtain express consent from each Clinical Trial subject that the data, including Personal Data, arising from such Clinical Trial may be used in accordance with the terms of this Agreement (including its export from the European Union and its processing by Pfizer or other Third Parties in accordance with the terms of this Agreement and Law), provided however, that BioNTech shall delegate this responsibility to Pfizer for those Clinical Trials for which Pfizer is the Lead Development Party. Notwithstanding the foregoing, the Lead Development Party will share the informed consent document with the other Party for such other Party’s review and comment prior to its use in a Clinical Trial in a country in the Territory.

8.1.3.6Sponsorship. Where the Lead Development Party (or its Affiliate or designee) is not the sponsor of a Clinical Trial or Regulatory Approval holder, such Lead Development Party shall not represent to any Third Party, including any Clinical Trial subjects, that the Lead Development Party or its Affiliates are a sponsor.

8.1.3.7Reporting. BioNTech is solely responsible for any and all safety reporting and regulatory obligations associated with the conduct of the Clinical Trial for which it is the sponsor, including, but not limited to, obtaining and maintaining Regulatory Approvals for the conduct of the Clinical Trials, provided, however, that BioNTech shall delegate the safety reporting and regulatory obligations associated with the conduct of each Clinical Trial in the Territory to Pfizer subject to Section 8.3.7.

Execution Version

8.1.3.8Delegation. Notwithstanding the responsibilities of BioNTech as IND/CTA holder or sponsor of Clinical Trials, where Pfizer is the Lead Development Party for a Clinical Trial Pfizer shall conduct its activities in compliance with GxP and applicable Law with respect to each of the activities which have been delegated to Pfizer pursuant to Schedule 8.1.1.

8.2Regulatory Matters.

8.2.1Lead Regulatory Party. The JSC shall agree on a strategy to allocate operational responsibility for regulatory activities relating to each Candidate or Product to one of the Parties (the “Lead Regulatory Party”) which shall, as a default initial allocation, be by reference to the country or region where such Party is the Lead Development Party. The JSC’s initial allocation shall be that Lead Regulatory Party for regulatory activities relating to each Candidate or Product in the EU shall be BioNTech, and the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in the USA shall be Pfizer. Subject to the JSC’s mutual consent to seek Regulatory Approval in one or more countries or regions in the ROW, Pfizer shall be the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in such country or region in the ROW. If the JSC cannot agree on whether Regulatory Approval shall be sought for any country or region in the ROW, the Party that wishes to seek Regulatory Approval in such country or region shall be entitled to be the Lead Regulatory Party for regulatory activities relating to each Candidate or Product in such country or region and seek such Regulatory Approval at its own cost. The JSC may vary from the foregoing allocations by mutual consent. The other Party shall cooperate with the Lead Regulatory Party, at its reasonable request, with respect to any regulatory matters for which the Regulatory Approval holder is responsible or to whom regulatory matters have been delegated. Notwithstanding the foregoing, for matters relating to any Vaccine Technical Committee, Price Approval or reimbursement approval in a country, such matters shall be handled by the Party in whose Commercialization Territory such country is located irrespective of whether they are the Lead Regulatory Party.

8.2.2Regulatory Communications and Filings. The Lead Regulatory Party shall use Commercially Reasonable Efforts to prosecute to grant and maintain all applications for Regulatory Approvals for the Product, including any supplements or amendments thereto and all Regulatory Approvals obtained therefrom. The Lead Regulatory Party shall make all filings with the Regulatory Authority that are necessary to maintain the Regulatory Approvals for the Product in good standing, including any regulatory reporting. In accordance with Section 8.2.1, each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Unless exigent action is required with respect to a given filing before a Regulatory Authority concerning a Candidate or Product, or a material communication with a Regulatory Authority concerning the same, the Lead Regulatory Party shall provide the other Party with copies of all filings relating to such Marketing Authorization Application prior to submission within a reasonable amount of time (but not less than [***]) to allow such Party to review and comment on such filings, and the Party submitting such filing shall consider all comments and proposed revisions from the other Party in good faith prior to submission. The Lead Regulatory Party shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution or maintenance thereof, including any material communications that it receives with respect to the same. The Lead

Execution Version

Regulatory Party shall provide to the other Party copies of all final Marketing Authorization Applications and filings relating thereto that it submits within [***] from filing (unless access to such Marketing Authorization Applications or filing is reasonably required earlier in which case the Lead Regulatory Party shall make such Marketing Authorization Applications and filings available earlier than [***] to the extent reasonably possible). The foregoing provisions of this Section 8.2.2 shall also apply to material and substantive communications with Regulatory Authorities. Both Parties will cooperate with respect to any and all regulatory matters with respect to the Product, including the implementation of any of the foregoing in any country in the Territory. For the avoidance of doubt, where Pfizer is the Lead Regulatory Party, all filing, prosecution and maintenance activities to be made by Pfizer under this Section 8.2.2 shall be made in the name of BioNTech or its Affiliate, unless otherwise agreed pursuant to Section 8.2.6, and Pfizer shall submit or make available to BioNTech within [***] copies of all filings and other material correspondence submitted to any Regulatory Authority, Governmental Authority or Government Official worldwide in BioNTech’s name or on BioNTech’s behalf in connection with such Regulatory Approvals and applications therefor.

8.2.3Requests by Associations or Competitors. The JCC shall, in good faith, seek to agree and align on the types of complaints, inquiries or other requests for information with respect to the Product from any trade or industry association or any competitor that may merit standard responses. Either Party shall use such standard responses in response to any such complaint, inquiry or request on which the JCC aligns. Furthermore, either Party will promptly notify the respective other Party if it or its Affiliates receive any complaint, inquiry or request, including situations for which such standard responses are not applicable or appropriate. If such standard responses are not sufficient, where such complaint, inquiry or request relates to or primarily impacts only one Party's Commercialization Territory, such Party will have control and discretion with respect to determining the appropriate response thereto, subject to applicable Law; provided, however, that if any such complaint, inquiry or request (i) relates to the safety or efficacy of the Product, subject to the terms of the applicable Pharmacovigilance Agreement, the Party that is the applicable MA Holder will have control and discretion (having regard to the other Party's input and recommendations) with respect to determining the appropriate response thereto or (ii) relates to or impacts both Parties' Commercialization Territory, the Party in receipt of such complaint, inquiry or request shall refer it to the JCC and the JCC will have control and discretion with respect to determining the appropriate response thereto, subject to applicable Law.

8.2.4Regulatory Meetings. The Lead Regulatory Party shall consult with the other Party reasonably in advance of the date of any anticipated meeting with a Regulatory Authority relating to any Marketing Authorization Applications or Regulatory Approvals in respect of any Candidate or Product for which it is responsible and shall consider any timely and reasonable recommendations made by the other Party in preparation for such meeting. The Parties agree that the Lead Regulatory Party shall lead interactions with respect to countries or regions in the Territory for which such Party is the Lead Regulatory Party. Upon the request of the other Party, and to the extent legally permissible and not opposed by the relevant Regulatory Authority, the Lead Regulatory Party shall permit the other Party to attend any and all meetings with the applicable Regulatory Authority concerning the Candidate or Product. [***]

8.2.5Manufacturing Matters. Where a Party is the Lead Regulatory Party and responsible for preparing and maintaining the filings for Regulatory Approval, the other Party shall

Execution Version

provide all reasonable assistance to the Lead Regulatory Party in such filings, including preparation of the CMC portions of the Common Technical Document in English and supporting ancillary cGMP documents and analytical data as required to meet specific regulatory filing and approval requirements. Each Party shall promptly provide the other with copies of material written correspondence as reasonably necessary to permit each Party to comply with its relevant regulatory obligations described in the Agreement or as otherwise reasonably requested.

8.2.6Ownership of Regulatory Filings, Regulatory Approvals and Pricing and Reimbursement Approvals. The Parties shall discuss through the JSC which Party shall apply for and hold the Regulatory Approvals directed to a Candidate or Product in each country in the Territory. Notwithstanding Section 6.5.2, if despite good faith efforts, the JSC is unable to reach unanimous agreement on which Party shall apply for and hold the MAA or Marketing Authorization Approvals directed to a Candidate or Product in any country in the Territory, then BioNTech shall have final decision making authority in that respect, provided that Pfizer shall not be required to apply for and hold any MAA or Marketing Authorization Approval in a country unless Pfizer and its Affiliates are already Commercializing a Pfizer vaccine product in such country and are permitted to hold an MAA or Marketing Authorization Approval for the Product in such country. The Parties acknowledge that, unless otherwise determined pursuant to this Section 8.2.6 or required under applicable Law, all Regulatory Approvals directed to a Candidate or Product in a country in the Territory and all applications therefor shall be made and/or held in the name of and owned by BioNTech or its Affiliate. For clarity, if under the applicable Law of any country BioNTech or its Affiliate is allowed to apply for a Regulatory Approval even though, at the time of such application, BioNTech or its Affiliate does not fulfil the requirements under applicable Law to hold such Regulatory Approval in such country, BioNTech or its Affiliate shall be allowed to file such application, provided that BioNTech reasonably believes that it will fulfill all such requirements within such time period as will not unreasonably delay approval of the applicable Regulatory Approval. In addition, the following principles shall apply:

8.2.6.1Where BioNTech or its Affiliate has applied for and/or holds in its own name any MAA or Marketing Authorization Approval directed to a Candidate or Product in a given country in the Territory, it may, upon giving reasonable notice to Pfizer, elect with Pfizer's agreement to transfer to Pfizer or any of its Affiliates such Regulatory Approval (or the relevant application therefor) in such country and Pfizer or its Affiliate will not withhold its agreement to such transfer if Pfizer or any of its Affiliates is already Commercializing a Pfizer vaccine product in such country and is permitted to hold such MAA or Marketing Authorization Approval in such country.

8.2.6.2Where an MAA or Marketing Authorization Approval directed to a Candidate or Product in a given country in the Territory is held by Pfizer or its Affiliate after it has been (i) applied for or obtained by Pfizer or its Affiliate or (ii) transferred to Pfizer or its Affiliate pursuant to Section 8.2.6.1 above, BioNTech, in its sole discretion, may at any time request in writing that Pfizer transfers or transfers back, as applicable, such Regulatory Approval (or application therefor) to BioNTech or its Affiliate and, upon such written request, the Parties will mutually agree on the date of the transfer or transfer back, as applicable, of such Regulatory Approval (or application therefor) to BioNTech or its Affiliate, provided that such date shall be no later than six (6) months after BioNTech’s request and BioNTech has fulfilled all necessary requirements under applicable Law to

Execution Version

hold such Regulatory Approval (or application therefor) at the time of transfer or transfer back.

8.2.6.3Recognizing that the transfer of the foregoing responsibilities or the responsibilities described in Sections 8.2.1 and 8.2.2 and Regulatory Approvals, as the case may be, requires time, coordination and effort, the Parties will agree a reasonable transition plan for each such transfer (including specifications for the transfer period) and during the transfer period BioNTech or Pfizer, as applicable, shall continue to use Commercially Reasonable Efforts to maintain the Regulatory Approvals in good standing and continue to perform its obligations as Lead Regulatory Party or owner of the Regulatory Approval (or application therefor), unless determined otherwise in the relevant transition plan.

8.2.6.4A Party that is a Regulatory Approval holder under this Agreement shall procure that its Affiliates conduct all activities in connection with such Regulatory Approvals in accordance with this Agreement.

8.2.7Notice of Regulatory Investigation or Inquiry. If any Regulatory Authority (i) contacts a Party with respect to the alleged improper Development, Manufacture, or Commercialization of a Candidate or Product in the Territory, (ii) conducts, or gives notice of its intent to conduct, an inspection at a Party’s facilities used in the Development or Manufacturing of a Candidate or Product, or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of a Party that could reasonably be expected to adversely affect any Development, Manufacture or Commercialization Activities with respect to a Candidate or Product in the Territory, then such Party shall promptly notify the other Party of such contact, inspection or notice. The inspected Party shall provide such other Party with copies of all pertinent information and documentation issued by any such Regulatory Authority within [***] of receipt, and, to the extent practicable, the JSC or appropriate subcommittee. Such other Party shall have the right to (a) be present at any such inspection where reasonably practicable, and (b) review and comment upon in advance any responses of the inspected Party that pertain to a Candidate or Product or a Party’s activities hereunder.

8.3Pharmacovigilance and Pharmacovigilance Agreement.

8.3.1As soon as practicably possible following the Signing Date the Parties shall form a Joint Safety Committee to (a) review and approve each investigator’s brochure for the clinical Development of Candidates and Products, (b) review and approve all aggregated data Drug Safety Update Reports, annual IND reports, and other period reports to Governmental Authorities information regarding patient safety (including adverse drug) experiences that are or may be associated with Candidates or Products, (c) review, discuss and agree the outputs of each Party’s periodic Candidate and Product related benefit/risk analysis, and (d) such other patient safety-related activities as the Parties may delegate to it from time to time.

8.3.2So long as BioNTech holds the necessary INDs/CTAs/Regulatory Approvals and is acting as sponsor in a country or region in the Territory, BioNTech may initiate clinical Development of the Candidates and Products in the EU prior to the Parties entering into a pharmacovigilance agreement. In such circumstances BioNTech shall be responsible for collecting, monitoring, evaluating, sharing and reporting to applicable Governmental Authorities in the EU information regarding patient safety (including adverse drug) experiences that are or may be

Execution Version

associated with Candidates or Products. BioNTech shall be responsible for maintaining a suitable safety database.

8.3.3The Parties acknowledge and agree that they have entered into a pharmacovigilance agreement covering pharmacovigilance responsibility relating to Development Activities and shall update such agreement or enter into a new pharmacovigilance agreement with respect to Commercialization Activities (each a “Pharmacovigilance Agreement”), in each case reflecting the applicable terms set forth in Section 8.3.7 and Schedule 8.3.

8.3.4Following the filing of the IND for Candidate(s) with FDA:

8.3.4.1should BioNTech require Pfizer to take over certain activities in relation to collecting, monitoring, evaluating, sharing and reporting to applicable Governmental Authorities, but excluding Ethics Committees, information regarding patient safety (including adverse drug) experiences that are or may be associated with Candidates or Products in the EU, the Parties shall agree and execute an amendment to the Pharmacovigilance Agreement to (i) reflect the additional activities and responsibilities the Parties have agreed Pfizer will perform in the EU, and (ii) set out the procedures the Parties have agreed upon to allow for the reconciliation of BioNTech’s safety database with Pfizer’s safety database. The effectiveness of the amendment shall be conditional upon BioNTech delivering to Pfizer (x) confirmation from the relevant Governmental Authorities in the EU that they have accepted an amendment to the clinical trial protocol for any on-going clinical trial of Candidates or Product in the EU to reflect the necessary changes (as agreed with Pfizer) in responsibilities and contact information for collecting, monitoring, evaluating, sharing and reporting of information regarding patient safety (including adverse drug) experiences, and (y) written confirmation from BioNTech that it has amended the relevant clinical trial agreements to reflect the change in pharmacovigilance provider and trained the investigators on the new reporting procedures; and,

8.3.4.2BioNTech through their agreement with Fosun shall ensure that Fosun, via BioNTech, deliver to Pfizer (x) a copy of a due diligence report on Fosun’s safety data reporting system reasonably acceptable to Pfizer in terms of findings made, (y) a copy of the pharmacovigilance agreement between BioNTech and Fosun which, inter alia, provides for delivery to Pfizer of fully assessed, translated (into English) CIOMS forms for all SAEs: Death / life threatening SUSARs – 5 Business Days from Day 0 (Day 0 being receipt by Fosun from the clinical investigator), or 10 days for all other SAEs, [***] and (z) details of the quality management system used with Fosun to ensure that if late inbound reports are received BioNTech can request root cause analysis and implementation of corrective and preventive actions by Fosun. The Parties agree that prior to Fosun’s commencement of clinical activities by Fosun, BioNTech shall have entered into a written agreement with Fosun, reflecting the foregoing.

8.3.5The Pharmacovigilance Agreement and each amendment to it from time to time shall set forth the responsibilities and procedures for (i) collecting, monitoring, evaluating, sharing and reporting to applicable Governmental Authorities information regarding patient safety (including adverse drug) experiences that are or may be associated with Candidates or Products in the countries covered by that agreement and (ii) providing regulatory information to and support

Execution Version

of the other Party with regard to regulatory obligations, provided, that, each such agreement shall include the following guiding principles: acting as BioNTech’s delegate for regulatory interactions, Pfizer shall primarily control the regulatory process and regulatory interactions in the countries covered by that agreement, provided, however that the Parties shall work together collaboratively to further the purposes of the collaboration and the activities described in this Agreement. Subject to the proviso in the foregoing sentence, to the extent there is any conflict between the terms and conditions of the Pharmacovigilance Agreement (as amended from time to time) and this Agreement with respect to safety or regulatory matters, the Pharmacovigilance Agreement shall control.

8.3.6Audits. Each Party shall have the right, at its sole cost and expense, to perform audits of the other Party’s pharmacovigilance, regulatory, and environmental, health and safety activities concerning any Candidates or Products under this Agreement, including each Party’s oversight of any Third Party contracted to perform pharmacovigilance, regulatory or environmental health and safety activities as outlined in this Agreement and in compliance with applicable Laws, which audit right is exercisable once per Calendar Year (or more frequently for material cause) during the Term, provided, however, that the auditing Party shall notify the other Party of the identity of any Third Party auditor, such other Party may require such Third Party auditor to sign a customary confidentiality agreement in form and substance reasonably acceptable to such other Party and the auditing Party shall not use such Third Party auditor without the prior consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned. Upon request, BioNTech shall provide Pfizer with a copy of its latest audit report on Fosun’s pharmacovigilance activities.

8.3.7Global Safety Database and Safety Reporting. Subject to the Pharmacovigilance Agreement entered into as described in Section 8.3.3 as amended from time, Pfizer shall maintain the global safety database for the Candidates and Products pursuant to this Agreement, provided that (a) BioNTech will hold a safety database to meet its sponsor responsibilities and regulatory responsibilities in the EU and any other countries or markets in the BioNTech Commercialization Territory and to hold safety data reports received from the Fosun Territory; (b) information shall be exchanged between Pfizer and BioNTech as described in the Pharmacovigilance Agreement to ensure alignment of information between the databases; and (c) BioNTech will delegate to Pfizer its responsibilities for the collection, processing, assessment and safety reporting to Regulatory Authorities for (i) all Clinical Trial(s) conducted pursuant to this Agreement and the Research and Development Plan thereunder in the Territory upon the approval of the IND for Candidate(s) with FDA and (ii) upon Regulatory Approval of the Marketing Authorization Applications or grant of Emergency Use Authorization, adverse event and other safety information relating to the Candidates or Products. Notwithstanding the foregoing, such responsibility can only be delegated to and Pfizer can only accept this responsibility if, with respect to safety information arising from clinical trials, the Clinical Trial sites for the Candidates and Products are reporting the safety data and, with respect to safety information from Commercialization Activities and Medical Activities, BioNTech and its Affiliates are reporting the safety data, in each case, including all individual Serious Adverse Events, translated into English, to Pfizer and for so long as Pfizer has access to all safety data, including all individual Serious Adverse Events, translated into English for any and all active Clinical Trials for the Candidates and Products, including products identical to Candidates or Products conducted under the terms and conditions of the Fosun Agreement (or subsequent agreements with other development partners) and for all Commercialization Activities and Medical

Execution Version

Activities conducted by or on behalf of BioNTech to allow Pfizer to meet its regulatory obligations as Lead Regulatory Party in the Territory.

8.3.8Procedures and Training. Each Party will, at its sole cost and expense, put into place and cause its Affiliates to put into place, appropriate procedures, including the provision of adequate training to all applicable Representatives, to ensure full and timely compliance with its obligations under each of (a) this Section 8.3 and (b) the Pharmacovigilance Agreement.

8.4Product Complaints and Returns. The Parties’ rights and obligations with respect to non-conformance and returns of Products shall be governed by, as and to the extent applicable, Sections 9.3.1.2, 9.3.2.2, 9.10, 9.11, and Section 16 of this Agreement, and the applicable sections of the clinical supply agreement, the commercial supply agreement(s), any global quality agreement, any pharmacovigilance, in each case, where such agreement is related to the Product so affected. In addition, BioNTech may forward any product complaints received by it to Pfizer for further processing, reporting, closure and other related activities in the BioNTech Commercialization Territory to fulfill BioNTech’s responsibilities for complaint handling on BioNTech’s behalf in accordance with procedures that are agreed by the Parties.

8.5Clinical Trial Register. BioNTech shall, in accordance with Law and its internal policies, register, and publish the summaries and results of, Clinical Trials relating to the Candidate or Product on a clinical trial register maintained by it (or an equivalent register), or as otherwise required by Law. If Pfizer is the Lead Development Party for a Clinical Trial, Pfizer shall prepare such summaries and results in accordance with its internal policies and in a timely manner so as to allow the summaries and results to be published within the mandatory time period, and provide such summaries and results to BioNTech for review and comment. Pfizer will give reasonable consideration to any such comments. BioNTech shall publish such summaries and results on a clinical trial register maintained by it (or an equivalent register), within the mandatory time period.

8.6Regulatory Exclusivity. The JCC shall oversee the process of applying for and securing exclusivity rights that may be available under the applicable Law of countries in the Territory, including any data or market exclusivity periods such as those periods listed in the FDA's Orange Book or Purple Book (as applicable) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 (including any pediatric exclusivity extensions or other forms of regulatory exclusivity that may be available), and all international equivalents.

8.7Liability. Subject to Pfizer and its Affiliates compliance with (i) the obligations set forth in Sections 8.1.3.8 above, Pfizer and its Affiliates, employees, agents or representatives will not be liable to BioNTech or its Affiliates in respect of any act, omission, default or neglect on the part of Pfizer, its Affiliates, or their respective employees, agents or representatives in connection with the activities undertaken as a Lead Regulatory Party where such activities are undertaken in good faith, unless liability arises from Pfizer's or its Affiliates, employees, agents or representatives gross negligence or willful misconduct.

8.8Objection Right. Notwithstanding any other provision of this Section 8, where a Party is the MA Holder, it shall have the right to object to or oppose any intended action of the other Party if such objecting Party reasonably and in good faith believes the other Party’s intended action is contrary to applicable Law and carries a material risk that if such action is taken, it will result in a material negative impact on approvability of a Market Authorization Application or continued approval of a Marketing Authorization Approval for the Product or sanctions or fines from the relevant Governmental Authority. In

Execution Version

case of an objection or opposition by the MA Holder pursuant to the preceding sentence, the Parties shall promptly discuss the relevant issue in good faith and the objected or opposed intended action shall not be initiated or shall be put on hold until the Parties have reached an agreement on how to ensure compliance with applicable law.

8.9Personal Data. The Parties agree that any processing of Personal Data pursuant to this Agreement will be in their capacity as independent controllers with respect to such Personal Data. To the extent the Parties shall be required to share Personal Data in connection with this Agreement, the Parties shall enter into a legally binding written agreement governing the Parties relationship and their processing activities as required by Applicable Data Protection Law.

9.	Commercialization

9.1Annual Plans.

9.1.1Preparation of Annual Plans. The JCC shall prepare a Global Commercialization Plan (which will include a projected budget for Gross Profit for the applicable year set on a global and Major Market by Major Market basis) and will update such plan at least once per year. If the JCC agrees to establish one or more RCCs, each RCC shall prepare an Annual Regional Commercialization Plan which shall have regard to the Global Commercialization Plan's objectives and principles, and update such plan at least once per year for its respective Commercialization Region and submit the same to the JCC for review and approval solely in respect of those aspects where such local plans deviate from the Global Commercialization Plan. The Global Commercialization Plan (and updates made thereto) shall be prepared and reviewed in accordance with the timing for Pfizer’s global operations planning process, which timing shall be communicated by Pfizer to BioNTech sufficiently in advance to enable the Parties to prepare and approve the Global Commercialization Plan and updates thereto in accordance with such timing. Each Annual Regional Commercialization Plan that is to be prepared or reviewed by a RCC shall be prepared and reviewed for such year in accordance with (a) the timing for Pfizer’s operations planning process for the applicable Commercialization Region(s) within the Pfizer Commercialization Territory, which timing shall be communicated by Pfizer to BioNTech sufficiently in advance to enable the Parties to prepare and review such Annual Regional Commercialization Plan reasonably in advance of its implementation and (b) the timing for BioNTech’s operations planning process for the applicable Commercialization Region(s) within the BioNTech Commercialization Territory, which timing shall be communicated by BioNTech to Pfizer sufficiently in advance to enable the Parties to prepare and review such Annual Regional Commercialization Plan reasonably in advance of its implementation.

9.1.2Content of Commercialization Plans. The Global Commercialization Plan will include [***]. It is expected that only certain aspects of the Global Commercialization Plan shall be updated each Calendar Year, to adjust the plan for annual variations including the forecasts for Units of Product to be sold during each Calendar Quarter of the applicable year.

Execution Version

9.2Pfizer Commercialization Responsibilities. In the Pfizer Commercialization Territory, Pfizer, subject to Section 9.14 and at its own cost, shall (or shall cause its Affiliates, sublicensees or subcontractors to);

9.2.1be responsible for commercial distribution of the Product and those other activities normally undertaken by the commercial distributor of a pharmaceutical product (in each case consistent with Commercially Reasonable Efforts), including, but not limited to:

9.2.1.1rejecting or accepting and fulfilling Third Party orders for Products and selling Products;

9.2.1.2subject to Section 9.6, applying for and negotiating for pricing and reimbursement of the Product;

9.2.1.3conducting all customer contracting pertaining to the Product;

9.2.1.4consulting with BioNTech whether to implement and, if so decided by Pfizer or BioNTech, as applicable in accordance with Section 9.11, implementing any recalls or market withdrawals of the Product; and

9.2.1.5managing and responding to medical information requests;

9.2.2manage and oversee product liability claims pertaining to Products distributed by it for use by its customers or patients in the Pfizer Commercialization Territory, and be responsible for the costs and Liabilities of all product liability claims solely to the extent that the injuries underlying such claims are caused by the breach or default, negligence or intentional misconduct of Pfizer, its Affiliates or any of its or their Representatives, and shall indemnify and hold harmless BioNTech and its Affiliates, Representatives from such costs;

9.2.3be responsible for promoting and detailing the Product in each country or region, as applicable, of the Pfizer Commercialization Territory using Commercially Reasonable Efforts and in a manner not inconsistent with the strategy and Global Commercialization Plan established by the JCC and, if applicable, the Annual Regional Commercialization Plan established by any applicable RCC, provided, however, that in no event will Pfizer, its Affiliates or any of their respective sublicensees or subcontractors be required to conduct any such activity in a manner that is inconsistent with Pfizer’s or its Affiliates’ own promotion or its detailing practices, policies or procedures for Pfizer’s or its Affiliates’ other products, consistently applied;

9.2.4subject to Sections 9.5 and 10.3, be responsible for training its medical and field sales personnel;

9.2.5ensure that its sales, medical and other representatives comply with all applicable regulatory, professional and legal requirements governing Product marketing, promotion and detailing activity, including all Anti-Corruption Laws;

9.2.6subject to Section 9.5.3, ensure that promotional materials developed by Pfizer are not inconsistent with the global messaging and global positioning platform approved by the JCC in the Global Commercialization Plan and in compliance with all Pfizer policies, the relevant Regulatory Approvals and applicable Laws;

Execution Version

9.2.7comply with the standards and requirements set forth in Section 9.4.2;

9.2.8subject to the Pharmacovigilance Agreement, be responsible for maintaining the global safety database and managing pharmacovigilance reporting in accordance with the Pharmacovigilance Agreement, in each case on the behalf of the MA Holder(s);

9.2.9not actively solicit any orders for the Product from within the BioNTech Commercialization Territory;

9.2.10sell the Products in its own name and on its own account, subject to the profit sharing mechanism set forth in Section 4.9 above;

9.2.11invoice its customers and collect receivables in accordance with good industry practice, and

9.2.12ensure through an active monitoring program that its personnel and other representatives fully comply with all applicable regulatory, professional and legal requirements governing Product Commercialization Activity.

Pfizer shall not be obliged to commence its detailing and promotional efforts in a country of the Pfizer Commercialization Territory until after the Product has received a Market Authorization Approval (as opposed to an Emergency Use Authorization) and recommendations from the applicable Vaccine Technical Committee in such country. For clarity, other Commercialization Activities and Medical Activities may be conducted by Pfizer, at its sole discretion, prior to Regulatory Approval of a Product to the extent permitted by applicable Law in order to prepare for promotion, marketing and sale of Products once such Regulatory Approval is obtained and Pfizer shall not be obligated to commence any detailing and promotional efforts in violation of applicable Law.

9.3BioNTech Commercialization Responsibilities:

9.3.1General Responsibilities. BioNTech, at its own cost, shall

9.3.1.1in accordance with the Pharmacovigilance Agreement, promptly forward to Pfizer for handling all adverse event and associated safety information it or its representatives receive pertaining to the Product;

9.3.1.2be responsible for and indemnify and hold harmless Pfizer and its Affiliates, representatives, personnel and subcontractors, against the costs and Liabilities of all product liability claims, except to the extent such costs and Liabilities are the responsibility of Pfizer pursuant to Section 9.2.2;

9.3.1.3except to the extent Pfizer becomes the MA Holder for any country (including pursuant to Section 8.2.6 this Agreement), fulfill the obligations of the MA Holder and shall maintain the Regulatory Approvals for each Product and not diminish the label or indication for any Product without Pfizer’s prior consent; and

9.3.1.4ensure through an active monitoring program that its personnel and other representatives fully comply with all applicable regulatory, professional and legal requirements governing Product Commercialization Activity.

Execution Version

9.3.2BioNTech Commercialization Territory Responsibilities. In the BioNTech Commercialization Territory, BioNTech, subject to Section 9.14 and at its own cost, shall (or shall cause its Affiliates, sublicensees or subcontractors to):

9.3.2.1be responsible for commercial distribution of the Product and those other activities normally undertaken by the commercial distributor of a pharmaceutical product (in each case consistent with Commercially Reasonable Efforts), including, but not limited to

(a)

rejecting or accepting and fulfilling Third Party orders for Products and selling Products;

(b)

subject to Section 9.6, applying for and negotiating for pricing and reimbursement of the Product;

(c)

conducting all customer contracting pertaining to the Product;

(d)

consulting with Pfizer whether to implement and, if so decided by Pfizer or BioNTech, as applicable in accordance with Section 9.11, implementing any recalls or market withdrawals of the Product; and

(e)

managing and responding to medical information requests;

9.3.2.2manage and oversee product liability claims pertaining to Products distributed by it for use by its customers or patients in the BioNTech Commercialization Territory, and be responsible for the costs of all product liability claims as set forth in Section 9.3.1.2;

9.3.2.3be responsible for promoting and detailing the Product in each country or region, as applicable, of the BioNTech Commercialization Territory using Commercially Reasonable Efforts and in a manner not inconsistent with the strategy and Global Commercialization Plan established by the JCC and, if applicable, the Annual Regional Commercialization Plan established by any applicable RCC, provided, however, that in no event will BioNTech, its Affiliates or any of their respective sublicensees or subcontractors be required to conduct any such activity in a manner that is inconsistent with BioNTech’s or its Affiliates’ own promotion or its detailing practices, policies or procedures for BioNTech’s or its Affiliates’ other products, consistently applied, or if no such practices are established across multiple commercialized products, then in a manner compliant with applicable Law and consistent with established industry practices for promotion and detailing;

9.3.2.4subject to Sections 9.5 and 10.3, be responsible for training its medical and field sales personnel;

9.3.2.5ensure that its sales, medical and other representatives comply with all applicable regulatory, professional and legal requirements governing Product marketing, promotion and detailing activity, including all Anti-Corruption Laws;

Execution Version

9.3.2.6subject to Section 9.5.3, ensure that promotional materials developed by BioNTech are not inconsistent with the global messaging and global positioning platform approved by the JCC in the Global Commercialization Plan and in compliance with all BioNTech policies, the relevant Regulatory Approvals and applicable Laws;

9.3.2.7comply with the standards and requirements set forth in Section 9.4.2;

9.3.2.8not actively solicit any orders for the Product from within the Pfizer Commercialization Territory;

9.3.2.9sell the Products in its own name and on its own account, subject to the profit sharing mechanism set forth in Section 4.9 above;

9.3.2.10invoice its customers and collect receivables in accordance with good industry practice, and

9.3.2.11ensure through an active monitoring program that its personnel and other representatives fully comply with all applicable regulatory, professional and legal requirements governing Product Commercialization Activity.

BioNTech shall not be obliged to commence its detailing and promotional efforts in a country of the BioNTech Commercialization Territory until after the Product has received a Market Authorization Approval (as opposed to Emergency Use Authorization) and recommendations from the applicable Vaccine Technical Committee, if any, in or for such country. For clarity, other Commercialization Activities and Medical Activities may be conducted by BioNTech, at its sole discretion, prior to Regulatory Approval to the extent permitted by applicable Law of a Product in order to prepare for promotion, marketing and sale of Products once such Regulatory Approval is obtained and BioNTech shall not be obligated to commence any detailing and promotional efforts in violation of applicable Law.

9.4Sales Force.

9.4.1Maintenance of Sales Force. Within its respective Commercialization Territory, in each Major Market Country, the applicable Commercializing Party will use Commercially Reasonable Efforts to provide and maintain, at its respective sole cost and expense (following Regulatory Approval of the Product in such country), (a) a well-trained internal or external sales force of PSRs sufficient to promote the Product in accordance with the applicable Annual Regional Commercialization Plan, if there is one or if not, in accordance with the Global Commercialization Plan and (b) an adequate number of well-trained internal or external Sales Managers to oversee all of such Commercializing Party’s PSRs and other sales force Representatives.

9.4.2Pfizer Policies and Standards. Pfizer will ensure that during the course of its promotion of the Product in the Pfizer Commercialization Territory, its respecting Sales Managers, PSRs and other sales and promotion representatives are governed by promotional standards and are subject to policies that (a) require them to limit the claims of efficacy and safety for the Product to those which are consistent with the Pfizer Promotional Materials approved by Pfizer and the Pfizer Training Materials; (b) require such individuals to use only the Pfizer Promotional Materials approved by Pfizer; (c) do not permit such individuals to add, delete or modify claims of efficacy

Execution Version

or safety contained in such Pfizer Promotional Materials or to make any other changes in any such Pfizer Promotional Materials; (d) include the manner in which employees and other representatives should handle unsolicited requests for information related to off-label uses of the Product; and (e) are designed to ensure compliance with applicable Laws. In addition, Pfizer will ensure that its marketing, promotion and detailing of the Product will be in adherence to all applicable Laws, Anti-Corruption Laws, Party Specific Regulations, Pfizer’s Internal Compliance Codes, Professional Requirements and the applicable Annual Regional Commercialization Plan, if there is one, and any updates thereto, in each case to the extent applicable in such country. Pfizer shall provide BioNTech with access to copies of its global foundational headquarters level policies that have worldwide applicability to the promotion and Commercialization of the Product. [***]

9.4.3BioNTech Policies and Standards. BioNTech will ensure that during the course of its promotion of the Product in the BioNTech Commercialization Territory, its respecting Sales Managers, PSRs and other sales and promotion representatives are governed by promotional standards and are subject to policies that (a) require them to limit the claims of efficacy and safety for the Product to those which are consistent with the BioNTech Promotional Materials approved by BioNTech and the BioNTech Training Materials; (b) require such individuals to use only the BioNTech Promotional Materials approved by BioNTech; (c) do not permit such individuals to add, delete or modify claims of efficacy or safety contained in such BioNTech Promotional Materials or to make any other changes in any such BioNTech Promotional Materials; (d) include the manner in which employees and other representatives should handle unsolicited requests for information related to off-label uses of the Product; and (e) are designed to ensure compliance with applicable Laws. In addition, BioNTech will ensure that its marketing, promotion and detailing of the Product will be in adherence to all applicable Laws, Anti-Corruption Laws, Party Specific Regulations, BioNTech’s Internal Compliance Codes, Professional Requirements and the applicable Annual Regional Commercialization Plan, if there is one, and any updates thereto, in each case to the extent applicable in such country. At least [***] prior to Commercialization of the Product in the BioNTech Commercialization Territory, or such shorter period as may be agreed by the Compliance Committee, BioNTech shall provide Pfizer with BioNTech’s policies in relation to promotion and Commercialization of the Product for Pfizer's review and compliance audit. Within [***] after any change of such policies, BioNTech shall provide Pfizer with a copy of any changed compliance policies.

9.4.4Compliance of Personnel. If information comes to a Party’s attention that provides such Party with a reasonable basis to believe that any Sales Manager or PSR of the other Party or its Affiliates has (a) violated any applicable Law as it relates to promoting or detailing of the Product or (b) failed to comply with the terms of this Agreement in respect of its Commercialization Activities, then, with respect to either (a) or (b), such Party will have the right to (i) request that the other Party immediately assess the performance of such individual and (ii) exercise any other rights or remedies available to it under this Agreement, at law or in equity. The other Party will (A) promptly use Commercially Reasonable Efforts to evaluate and resolve such issue in accordance with its internal policies or as it may otherwise deem appropriate, (B) to the extent permitted by applicable Law, keep the first Party informed of the progress of, and information learned during, such evaluation and (C) within [***] of the first Party bringing such information to the other Party’s attention, provide the first Party, to the extent permitted by applicable Law, with a reasonably detailed written report summarizing any steps taken toward

Execution Version

resolution of the matter, unless such other Party has received an opinion from counsel that such disclosure would waive any applicable privilege attaching to information or written report.

9.5Training Materials, Promotional Materials and Other Product Information.

9.5.1Pfizer’s Training Obligations. Pfizer or its Affiliates, at its cost and risk, will develop (as necessary or desirable to address local requirements or customs and market strategies and needs) and design training materials, for use by its PSRs and Sales Managers in particular countries within the Pfizer Commercialization Territory (the “Pfizer Training Materials”). The Pfizer Training Materials shall be in compliance with applicable Law, consistent with the applicable Regulatory Approvals for the Product and, except where necessary to comply with applicable Law, not be inconsistent with the global Commercialization strategy for the Product established by the JCC as reflected in the Global Commercialization Plan. Upon BioNTech’s reasonable request, Pfizer shall provide BioNTech with access to the Pfizer Training Materials developed specifically for the Product for use in the Major Markets in the Pfizer Commercialization Territory for BioNTech to review, and Pfizer shall take into account any reasonable comments made by BioNTech in relation to such Pfizer Training Materials. Utilizing such Pfizer Training Materials, Pfizer will be responsible, at its own cost and risk, for preparing and delivering training to its PSRs and Sales Managers with respect to the Product and the detailing thereof. Such training shall occur (a) prior to the provision by such PSR or Sales Manager of any detailing or promotional activities with respect to the Product and (b) periodically thereafter in each country in the Pfizer Commercialization Territory as is consistent with Pfizer’s practices for periodic training of its Sales Managers and PSRs or as may be otherwise needed to update such training based on new information. Pfizer shall share the Pfizer Training Materials with BioNTech for BioNTech’s use, subject to Section 9.5.2 and at its sole risk, in the BioNTech Commercialization Territory; provided, however, that Pfizer shall not be liable to BioNTech for any inaccuracy or error in the Pfizer Training Materials.

9.5.2BioNTech’s Training Obligations. Utilizing the Pfizer Training Materials where applicable, BioNTech or its Affiliates, at its cost and risk, will adapt (as necessary or desirable to address local requirements or customs and market strategies and needs) and design training materials, for use in particular countries within the BioNTech Commercialization Territory (as so adapted and designed, the “BioNTech Training Materials”). BioNTech shall ensure that the BioNTech Training Materials shall be in compliance with applicable Law, consistent with the applicable Regulatory Approvals for the Product and, except where necessary to comply with applicable Law, not be inconsistent with the global Commercialization strategy for the Product established by the JCC as reflected in the Global Commercialization Plan. Utilizing such BioNTech Training Materials, BioNTech will be responsible, at its own cost and risk, for preparing and delivering training to its PSRs and Sales Managers with respect to the Product and the detailing thereof. Such training shall occur (a) prior to the provision by such PSR or Sales Manager of any detailing or promotional activities with respect to the Product and (b) periodically thereafter in each country in the BioNTech Commercialization Territory as is consistent with BioNTech’s practices for periodic training of its Sales Managers and PSRs or as may be otherwise needed to update such training based on new information.

9.5.3Promotional Materials. All written sales, promotion and advertising materials relating to the Product, and other media and materials used to promote the Product or educate the

Execution Version

public regarding the Product or any indication treated with the Product (collectively and including translations, “Promotional Materials”) will be prepared by Pfizer for the Pfizer Commercialization Territory (the “Pfizer Promotional Materials”) and by BioNTech for the BioNTech Commercialization Territory (the “BioNTech Promotional Materials”) and, Pfizer or BioNTech, as applicable, will determine, in its discretion, but subject to the requirements set forth below in this Section 9.5.3 and in Section 9.12, the content, the quantity and the method of distribution of all such Promotional Materials within its respective Commercialization Territory. All such Promotional Materials prepared by a Party shall (a) be owned (as to Copyright) by such Party; (b) not be inconsistent with the global messaging platform approved by the JCC as reflected in the Global Commercialization Plan (c) be in compliance with the applicable Regulatory Approval(s) for the Product and applicable Law, and (d) be reviewed and approved for use in a manner consistent with such Party’s normal procedures for reviewing and approving promotional materials for its other Products, consistently applied (or in the case of BioNTech in accordance with procedures consistent with applicable Laws and industry standards for review and approval of promotional materials for pharmaceutical and vaccine products), and in any event, in accordance with procedures to ensure that such Promotional Materials meet the requirements set forth in clauses (b) and (c) above. Pfizer and BioNTech shall coordinate to ensure there is consistency of approach by BioNTech of its Promotional Materials for Germany compared with Pfizer’s Promotional Materials for the rest of the EU. In connection with the performance of its Commercialization Activities in each country of the Pfizer Commercialization Territory, Pfizer will and will cause its Affiliates and Representatives, including Pfizer’s sales managers and PSRs, to use only the Pfizer Promotional Materials provided by Pfizer for use in such country and to not use such Pfizer Promotional Materials for any other purposes other than its Commercialization Activities under this Agreement. In connection with the performance of its Commercialization Activities in each country of the BioNTech Commercialization Territory, BioNTech will and will cause its Affiliates and Representatives, including BioNTech’s sales managers and PSRs, to use only the BioNTech Promotional Materials provided by BioNTech for use in such country and to not use such Pfizer Promotional Materials for any other purposes other than its Commercialization Activities under this Agreement. On an item-by-item and country-by-country basis, and upon the written request of BioNTech and with Pfizer’s prior written approval (such approval not to be unreasonably withheld or delayed), Pfizer hereby licenses BioNTech to use, reproduce, copy, modify, distribute and display such Pfizer Promotional Materials in accordance with this Agreement and compliance with applicable Law, provided that BioNTech will not use such Pfizer Promotional Materials for any other purposes other than its Commercialization Activities under this Agreement. For clarity, BioNTech may combine requests for Pfizer’s approval for the use of several items in various countries in one written request.

9.6Pricing, Reimbursement and Market Access.

9.6.1Guidelines. The JCC shall establish a global pricing strategy, launch sequencing and a range of suggested prices and any discount strategies, rebates or managed entry strategies, which price ranges and strategies may differ by region or country, for each Product in the Territory (collectively, the “Pricing and Reimbursement Guidelines”) which will be submitted by the JCC to each of the Parties as recommended but non-binding guidance. All sales of Product shall be made in accordance with the applicable Pricing and Reimbursement Guidelines [***].

Execution Version

9.6.2Pricing Meetings, Submissions & Negotiations. Subject to Section 8.2, the Commercializing Party having rights to Commercialize in a specific country or region of its Commercialization Territory will be solely responsible for conducting all meetings and negotiations with, and the preparation of all materials and submissions for, national and local Governmental Authorities, health insurance providers (e.g., managed care, sickness fund), retail and hospital pharmacies, other formulary segments (e.g., sub-national and local payors) and other Third Party payors relating to any pricing, tenders, direct procurement contracts, inclusion on formularies, coverage or reimbursement with respect to Products in each such country or region, and shall have the right to hold in its name and control all applications, registrations, licenses, authorizations, approvals required for such purposes. All such pricing meetings, submissions and negotiations shall be planned and conducted by each Party in compliance with applicable Law, Anti-Corruption Laws, applicable pharmaceutical industry guidelines, applicable Internal Compliance Codes and Party Specific Regulations.

9.7Purchase Agreements with Governmental Authorities.

9.7.1After the Amendment Signing Date, in negotiating any agreement with a Governmental Authority for such Government Authority to purchase the Product, [***] such Party will notify and promptly meet to discuss with the other Party the results of such negotiation prior to concluding and entering into such agreement.

9.7.2In any event, prior to entering into any agreement with any Government Authority in a Major Market Country after the Amendment Signing Date, for such Governmental Authority to purchase or have purchased from the Party negotiating such agreement or for such Party to otherwise supply Product to such Governmental Authority, to the extent permitted and provided the receiving Party has the necessary security and infrastructure in place as may be required by the Governmental Authority (provided that, where permitted, such security and infrastructure requirement shall be communicated to the receiving Party by the negotiating Party in writing reasonably in advance of any need for such security and infrastructure by the receiving Party), the applicable Party negotiating such agreement shall make a substantially negotiated draft version of such agreement available to the other Party for review and comment, and that other Party shall make available its comments (if any) to any such draft agreement to the Party negotiating such purchasing or supply agreement within [***] of its receipt of such draft agreement. The Party negotiating such purchasing or supply agreement shall consider the other Party’s comments in good faith when finalizing its negotiation of such purchasing or supply agreement with such Government Authority. In addition, each Party shall promptly submit to the other Party a copy of any such purchasing or supply agreement concluded with any Government Authority prior to the Amendment Signing Date to the extent permitted under such agreement (and, where required, shall use good faith efforts to obtain relevant consents of the Government Authority to allow such sharing of such agreement). Notwithstanding the provisions of Section 12.1, the Party receiving any agreements with Government Authorities that are provided pursuant to this Section 9.7, including any drafts provided hereunder, shall treat such agreements as the providing Party’s Confidential Information and shall hold such agreements, including any drafts provided hereunder, strictly confidential in perpetuity and shall only disclose those aspects of such agreements to those Representatives of the receiving Party having a need to know.

Execution Version

9.8Product Packaging Configurations. The Parties shall each provide to the JCC current information regarding their respective Product Shipping and Storage Costs associated with all current and proposed Packaging Configurations for which they are responsible. [***]

9.9Product Orders; Invoicing; Distribution and Sales. With respect to Product in each country of a Party’s Commercialization Territory, the applicable Commercializing Party will have sole control and responsibility with respect to (a) receiving orders and order processing, including, rejection or acceptance and fulfillment of orders, (b) invoicing, (c) collection and receivables, (d) distribution and (e) effecting all sales of Product in the Commercialization Territory (provided that the foregoing shall not prevent or be breached by the unsolicited supply of Product by one Party from an EU country within its Commercialization Territory to an EU country outside of its Commercialization Territory in response to an unsolicited order).

9.10Returns. With respect to Product in each country of a Party’s Commercialization Territory, the applicable Commercializing Party will have sole control and, subject to Sections 9.2.2, 9.3.1.2 and 9.3.2.2, responsibility with respect to handling all returns of the Product and destruction of non-saleable or returned Product. Any and all costs associated with returns of Product, including accruals for returns of the Product sold during the Term will be included as a deduction from gross sales in the calculation of Net Sales pursuant to Section 4.9.2.

9.11Recalls and Withdrawals. In the event that either Party believes that a recall or withdrawal of a Product is advisable in any country of the Territory, it shall promptly consult with the other Party with respect thereto. After such consultation, Pfizer will have the sole right and authority to make any decision to initiate a recall or withdrawal of the Product in any country of the Pfizer Commercialization Territory and BioNTech will have the sole right and authority to make any decision to initiate a recall or withdrawal of the Product in any country of the BioNTech Commercialization Territory, provided, however, that in each such case, with respect to (a) any lot or batch of Product manufactured by a Party, its Affiliates or any of their respective subcontractors, in the event that such Party, after consultation with the other Party, determines that such lot or batch of Product should be recalled in one or more countries of the other Party’s Commercialization Territory, it shall so notify such other Party and such other Party shall promptly institute a recall of such lot or batch of such Product, and (b) if the Party that is the MA Holder in a country in the other Party’s Commercialization Territory determines in good faith, after consultation with the other Party and its legal counsel, that a recall is required in such country by applicable Law, it shall so notify such other Party and such other Party shall promptly institute a recall. Subject to the foregoing and Sections 9.2.2, 9.3.1.2, 9.3.2.2 and 16.3, the Commercializing Party will have sole control, responsibility and discretion with respect to implementing any and all such recalls or withdrawals in each country of such Party’s Commercialization Territory, provided that where the Recall Costs are to be borne by the other Party the Commercializing Party shall use Commercially Reasonable Efforts to mitigate any such Recall Costs. The Recall Costs of any such recall or withdrawal will be borne by BioNTech, except to the extent that the recall or withdrawal of Product is attributable to the (i) breach or default of Pfizer or its Affiliates or any of its or their Representatives under this Agreement or in its Manufacturing, handling or storing of the Product that is the subject of the recall or withdrawal, or (ii) negligence or willful misconduct of Pfizer, its Affiliates or any of its or their Representatives, in which event Pfizer will if such recall or withdrawal is in a country in the Pfizer Commercialization Territory, bear or, if such recall or withdrawal is in a country in the BioNTech Commercialization Territory, reimburse BioNTech and its Affiliates for such Recall Costs. If there is any

Execution Version

recall or withdrawal, then the Commercializing Party will implement any necessary action, and the other Party will provide any and all assistance as reasonably requested by the Commercializing Party.

9.12Co-branding. As of the Amendment Signing Date, the Parties agree on the following co-branding provisions to govern the future use of the Pfizer House Xxxx and BioNTech House Xxxx:

Where permitted by applicable Law and consistent with the applicable Regulatory Approval, subject to Section 11.9.4, the Parties shall include on (a) Product Packaging and Labeling for the Product in the Territory, (b) all Promotional Materials to be distributed in the Territory by the Commercializing Party’s Sales Managers and PSRs and (c) those Medical Education Materials related solely to the Product to be distributed in the Territory by the Commercializing Party’s MSLs (the materials described in each of (a), (b) and (c), the “Commercialization Materials”), both the Pfizer House Xxxx and the BioNTech House Xxxx, with both House Marks being clearly visible to the customer and having equal prominence; provided that:

9.12.1with respect to Commercialization Materials distributed in connection with the Product Commercialized under an Emergency Use Authorization issued by the FDA or by a Regulatory Authority in reference to the Emergency Use Authorization issued by the FDA, then on a country by country basis:

(a)[***]; and

(b)[***];

9.12.2[***]

9.12.3[***].

[***]

9.13Vaccine Technical Committees. Pfizer shall have the right to seek all recommendations for use of the Product from the applicable Vaccine Technical Committees throughout the Pfizer Commercialization Territory and BioNTech shall have the sole right to seek all recommendations for use of the Product from the applicable Vaccine Technical Committees throughout the BioNTech Commercialization Territory.

9.14Diligence and Performance Standards. Each Party’s obligations to Commercialize the Product in its respective Commercialization Territory (and to undertake any Medical Activities in its respective Commercialization Territory) [***]. For clarity, [***], provided that a Party’s Commercialization Activities or Medical Activities in such country shall remain subject to this Article 9 and Article 10, including compliance with all applicable Laws, including Anti-Corruption Laws and provided further that if one Party does not actively Commercialize the Product in any such country which is part of its Commercialization Territory, the other Party may, through written notice to such Party, notify such Party that it desires to discuss taking over Commercialization in such country and, in such event, the Parties shall discuss in good faith whether such country shall be added to the Commercialization Territory of the other Party; provided that the Party that is entitled to Commercialize in such Commercialization Territory shall have no obligation to agree to add such country to the Commercialization Territory of the

Execution Version

other Party. Notwithstanding the foregoing, the Parties acknowledge the provisions of Section 4.15 and that neither Party guarantees the success of the Product.

9.15Management of Representatives. Each Party will have sole authority and responsibility for recruiting, hiring, managing, compensating (including paying for all benefits, wages, special incentives, workers’ compensation and employment taxes), disciplining, terminating the employment of and otherwise controlling the Representatives provided or engaged by or on behalf of such Party or its Affiliates for performance of its Commercialization Activities and other obligations under this Agreement; provided that all such Representatives will be, to the extent relevant to the activities to be performed by such Representatives, subject to written obligations of confidentiality and invention assignment substantially consistent with the relevant provisions of this Agreement prior to, and as a condition of, such Representatives performing any such Commercialization Activities, provided, further¸ that to the extent that ownership of all relevant inventions of such Representative vests in such Party or its Affiliates, no such written obligation of invention assignment are required. Each Party will respectively provide for the day-to-day management of its or its Affiliates’ Sales Managers, PSRs, MSLs and other Representatives involved in any Commercialization Activities, including furnishing administrative support, financial resources, equipment and supplies.

10.	Medical Affairs

10.1Global Medical Activities. The Parties shall, but only using Commercially Reasonable Efforts in accordance with its obligations pursuant to Section 9.14, undertake their respective global medical activities [***] (“Global Medical Activities”). The medical affairs section of the Global Commercialization plan will address medical strategies and guidelines; provided, however, that each Party will have final say on its own Global Medical Activities. A copy of any article or abstract that relates directly to the Product which has been published in a scientific, me

Document Metadata

Table of Contents

Amended and Restated collaboration AGREEMENT