Document:

acuitasbiontechnon_exclu

NON-EXCLUSIVE LICENSE AGREEMENT BETWEEN BIONTECH AG AND ACUITAS THERAPEUTICS INC  EXECUTION COPY COVID-19 VACCINE   NON-EXCLUSIVE LICENSE AGREEMENT  by and between  ACUITAS THERAPEUTICS, INC.  and  BIONTECH RNA PHARMACEUTICALS GMBH  dated  April 7, 2020  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 Exhibit 4.53 

 

Table of Contents  Page  1. DEFINITIONS ......................................................................................................................... 1  2. LICENSE GRANTS; TECHNOLOGY TRANSFER ............................................................. 8  2.1 Licenses by Acuitas ....................................................................................................... 8  2.2 Option to Convert Non-exclusive License ...................................................................... 8  2.3 Sublicensing Rights ....................................................................................................... 8  2.4 Technology Transfer. .................................................................................................... 9  2.5 Updates to Appendix 1.1 ............................................................................................... 9  2.6 Documents and Declaration ........................................................................................... 9  3. LICENSE LIMITATIONS ...................................................................................................... 9  4. PAYMENTS AND ROYALTIES ............................................................................................ 9  4.1 Milestone Payments ...................................................................................................... 9  4.2 Royalties ..................................................................................................................... 11  4.3 Payment Terms ........................................................................................................... 12  5. OWNERSHIP AND INVENTORSHIP OF IP...................................................................... 13  6. PATENT PROSECUTION AND MAINTENANCE ............................................................ 13  6.1 Generally .................................................................................................................... 14  6.2 Election Not to Prosecute or Maintain or Pay Patent Costs ........................................... 14  6.3 Regulatory Exclusivity Periods .................................................................................... 14  6.4 Cooperation ................................................................................................................. 15  7. PATENT ENFORCEMENT AND DEFENSE ...................................................................... 15  7.1 Notice ......................................................................................................................... 15  7.2 Enforcement and Defense ............................................................................................ 15  8. CONFIDENTIALITY............................................................................................................ 17 8.1 Confidential Information............................................................................17  8.2 Restrictions............ ....... ........................................................................17  8.3 Exceptions............................................................... ...... ......................17  8.4 Permitted Disclosures..................................................................... .......... 18  8.5 Return of Confidential Information .............................................................................. 18  8.6 Publications............................................................................ ................ 18  8.7 Terms of this License Agreement; Publicity.................................. ...................... 19  9. WARRANTIES; LIMITATIONS OF LIABILITY; INDEMNIFICATION ....................... 19  9.1 Representations and Warranties ................................................................................... 19  

 

Table of Contents  (continued)  Page  9.2 Additional Representations of Acuitas ......................................................................... 19  9.3 Disclaimers ................................................................................................................. 20  9.4 No Consequential Damages ......................................................................................... 20  9.5 Performance by Others ................................................................................................ 20  9.6 Indemnification ........................................................................................................... 21  9.7 Insurance ..................................................................................................................... 23  10. TERM AND TERMINATION .............................................................................................. 23  10.1 Term ........................................................................................................................... 23  10.2 Termination by Acuitas ............................................................................................... 23  10.3 Termination by BioNTech ........................................................................................... 24  10.4 Termination Upon Bankruptcy .................................................................................... 24  10.5 Effects of Termination ................................................................................................. 25  10.6 Survival ....................................................................................................................... 25  11. GENERAL PROVISIONS .................................................................................................... 25  11.1 Dispute Resolution ...................................................................................................... 25  11.2 Cumulative Remedies and Irreparable Harm ................................................................ 26  11.3 Relationship of Parties ................................................................................................. 26  11.4 Compliance with Law .................................................................................................. 26  11.5 Governing Law ........................................................................................................... 27  11.6 Counterparts; Facsimiles ............................................................................................. 27  11.7 Headings ..................................................................................................................... 27  11.8 Waiver of Rule of Construction ................................................................................... 27  11.9 Interpretation ............................................................................................................... 27  11.10 Binding Effect ............................................................................................................. 27  11.11 Assignment ................................................................................................................. 27  11.12 Notices ........................................................................................................................ 27  11.13 Amendment and Waiver .............................................................................................. 28  11.14 Severability ................................................................................................................. 28  11.15 Entire Agreement ........................................................................................................ 28  11.16 Force Majeure ............................................................................................................. 28  

 

List of Appendices  Appendix 1.1 Patents within the Acuitas LNP Technology as of the License Agreement Effective  Date  Appendix 1.17 Dual Improvement Patents  Appendix 1.23 Jointly Owned Patents  Appendix 1.53 Description of the Target(s)  Appendix 2.4 Technology Transfer Agreement  Appendix 9.2 Exceptions to Acuitas’ Representations and Warranties in Section 9.2  

 

1  License Agreement  This License Agreement ("License Agreement"), dated as of April 7, 2020 (the "License Agreement  Effective Date"), is made by and between Acuitas Therapeutics Inc., a British Columbia corporation  ("Acuitas"), and BioNTech RNA Pharmaceuticals GmbH, a German corporation ("BioNTech"). Each of  Acuitas and BioNTech may be referred to herein as a "Party" or together as the "Parties."  WHEREAS, Acuitas has proprietary LNP Technology (as defined below);  WHEREAS, BioNTech has expertise and intellectual property relating to mRNA Constructs (as  defined below) as well as to formulation development including non-clinical testing and GMP  manufacturing;  WHEREAS, Acuitas and BioNTech are parties to that certain Development and Option Agreement  (dated  July 10, 2017) (the "Development and Option Agreement") pursuant to which BioNTech has options  to take licenses under the Acuitas LNP Technology (as defined below) with respect to BioNTech’s mRNA  Constructs; and  WHEREAS, pursuant to the terms of the Development and Option Agreement, BioNTech has  exercised an option with respect to the Target (as defined below) and the Parties are now entering into a  licensing arrangement whereby BioNTech will have a license under the Acuitas LNP Technology to  develop and commercialize Licensed Products (as defined below) based on such Target.  NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other  good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties  hereby agree as follows:  1. Definitions. The following terms and their correlatives will have the following meanings:  1.1 "Acuitas LNP Technology" means any and all LNP Technology Controlled by Acuitas or  any of its Affiliates as of the License Agreement Effective Date or at any time during the Term, including  Acuitas' right and interest in any Technology created, conceived or reduced to practice under the  Development and Option Agreement and necessary or useful for the research, development, manufacturing  and commercialization of Licensed Products. Unless otherwise set forth herein, Acuitas LNP Technology  will exclude Jointly Owned Patents and Dual Improvement Patents.   1.2 "Acuitas Indemnitiees" has the meaning set forth in Section 9.6(a).  1.3 "Affiliate" of a person or entity means any other entity which (directly or indirectly) is  controlled by, controls or is under common control with such person or entity.  For the purposes of this  definition, the term "control" (including, with correlative meanings, the terms "controlled by" and "under  common control with") as used with respect to an entity will mean (i) in the case of a corporate entity, direct  or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the  election of directors or (ii) in the case of a non-corporate entity, direct or indirect ownership of at least fifty  percent (50%) of the equity interests with the voting power to direct the management and policies of such  entity, provided that if local Law restricts foreign ownership, control will be established by direct or indirect  ownership of the maximum ownership percentage that may, under such local Law, be owned by foreign  interests.   

 

2  1.4 [***] 1.5 "cGMP" means current Good Manufacturing Practices as specified in the U.S. C.F.R., ICH  Guideline Q7A, or equivalent Laws of an applicable Regulatory Authority at the time of manufacture.  1.6 "Calendar Quarter" means the respective periods of three (3) consecutive calendar months  ending on March 31, June 30, September 30 and December 31.  1.7 "Change of Control" with respect to Acuitas, shall be deemed to have occurred if during  the Term (i) any person or entity is or becomes the "beneficial owner", directly or indirectly, of shares of  capital stock or other interests (including partnership interests) of Acuitas then outstanding and normally  entitled (without regard to the occurrence of any contingency) to vote in the election of the directors,  managers or similar supervisory positions of Acuitas representing fifty percent (50%) or more of the total  voting power of all outstanding classes of voting stock of Acuitas or has the power, directly or indirectly,  to elect a majority of the members of the Acuitas' board of directors, or similar governing body; or (ii)  Acuitas enters into a merger, consolidation or similar transaction with another person or entity; or (iii)  Acuitas sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets  representing all or substantially all of Acuitas’ consolidated total assets to which this Agreement relates; or  (iv) the holders of capital stock of Acuitas approve a plan or proposal for the liquidation or dissolution of  Acuitas." 1.8 "Combination Product" means a Licensed Product that is combined and sold together (but  not, for avoidance of doubt, formulated together) with at least one additional active ingredient/product other  than a Licensed Product. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be "active  ingredients", except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an  active ingredient in accordance with 21 C.F.R. 210.3(b)(7) or equivalent Laws in other  jurisdictions, provided however, [***] 1.9 “Competitive Product” shall mean a product that is, or can reasonably be, used for the same  Indication as a Licensed Product.  1.10 “Indication” shall mean an individual disease or clinical condition with respect to which at  least one adequate and well controlled study is required to support inclusion of such disease or condition in  the indication statement of an FDA approved package insert for a Licensed Product.   1.11 "Confidential Information" has the meaning set forth in Section 8.1.  

 

3  1.12 "Control" or "Controlled" means, with respect to any Know-How or Patent, the possession  (whether by ownership or license, other than by a license or sublicense granted pursuant to this License  Agreement or the Development and Option Agreement) by Acuitas or its Affiliates of the ability to grant  to BioNTech a license or access to such Know-How or Patent as provided herein to such item, without  violating the terms of any agreement or other arrangement with any Third Party and without owing any  milestone, royalty or other monetary obligations to a Third Party.  1.13 "Covered Product" means a Licensed Product covered by one or more Valid Claims of the  Acuitas LNP Technology.  1.14 "Covers", with reference to (a) a Patent, means that the manufacture, development or  commercialization of a Licensed Product would infringe a Valid Claim of such Patent in the country in  which such activity occurs; and (b) Know-How, means that the manufacture, development or  commercialization of a Licensed Product incorporates or embodies such Know-How.  1.15 "Development and Option Agreement" has the meaning set forth in the Preamble.  1.16 "Disclosing Party" has the meaning set forth in Section 8.1  1.17 “Dual Improvement Patents” means the Patents listed in Appendix 1.17 hereto, as  amended from time to time.  1.18 "Field of Use" means use of Licensed Product for human therapeutic and prophylactic  applications.  1.19 "First Commercial Sale" means the first sale for use or consumption of any Licensed  Product in a country after all required Regulatory Approvals for commercial sale of such Licensed Product  have been obtained in such country.  1.20 “Fusion Protein” [***] 1.21 "Indemnification Claim Notice" has the meaning set forth in Section 9.6(c).  1.22 "Indemnified Party" has the meaning set forth in Section 9.6(c).  1.23 “Jointly Owned Patents” means the Patents listed in Appendix 1.23 hereto, as amended  from time to time.  1.24 "Know-How" means all commercial, technical, scientific and other know-how and  information, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions,  skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly  procedures, computer programs, specifications, data and results (including biological, chemical,  

 

4  pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety,  manufacturing and quality control data and know-how, including study designs and protocols), in all cases,  provided it is confidential and proprietary, and regardless of whether patentable, in written, electronic or  any other form.  1.25 "Law" or "Laws" means all laws, statutes, rules, regulations, orders, judgments, or  ordinances having the effect of law of any federal, national, multinational, state, provincial, county, city or  other political subdivision.  1.26 "License Agreement" has the meaning set forth in the Preamble.  1.27 "License Agreement Effective Date" has the meaning set forth in the Preamble.  1.28 "Licensed Product(s)" means [***] product(s) consisting of Lipid Nanoparticles (LNP) containing [***] mRNA Constructs [***] where such product is derived from, is based on, or utilizes any Acuitas LNP Technology. For the avoidance of doubt, the term “Licensed Product” in  respect of the Target [***]. 1.29 "LNP Technology" means Technology that claims, embodies or incorporates delivery  systems (and components thereof) based on or incorporating lipid nanoparticles (LNP).  1.30 "LNP Technology Patent(s)" means Patents comprised in the Acuitas LNP Technology,  including any future Patent which will become part of the Acuitas LNP Technology during the Term and  further including Acuitas' rights in the Jointly Owned Patents, unless otherwise set forth herein.  1.31 "Losses" has the meaning set forth in Section 9.6(a).  1.32 “Major Market Countries” means Canada, United States, Japan, France, Germany, Spain,  Italy, or United Kingdom.  1.33 "mRNA Construct" [***] 1.34 "mRNA Technology" means Technology that claims, embodies or incorporates expression  systems (and components thereof), based on or incorporating mRNA.  1.35 "Milestones" means the milestones payable pursuant to Section 4.  1.36 "Milestone Event" has the meaning set forth in Section 4.1.  1.37 "Milestone Payment" has the meaning set forth in Section 4.1.  

 

5  1.38 "Net Sales" means, with respect to any Licensed Product, [***] (a) [***] (b) [***] (c) [***] (d) [***] (e) [***] (f) [***] (g) [***] [***]              [***] [***] [***] 1.39 "Patent(s)" means an (i) issued patent, a patent application, and a future patent issued  from any such patent application, (ii) a future patent issued from a patent application filed in any  country worldwide which claims priority from a patent or patent application of (i), and (iii) any additions,  divisions, continuations, continuations-in-part, invention certificates, substitutions, reissues,  reexaminations, extensions, registrations, utility models, supplementary protection certificates and  renewals based on any patent or patent application under (i) or (ii), but not including any rights that  give rise to regulatory  

 

6  exclusivity periods (other than supplementary protection certificates, which will be treated as "Patents"  hereunder).  1.40 "Patent Costs" means the reasonable, documented, out-of-pocket costs and expenses paid  to outside legal counsel, and filing and maintenance expenses, actually and reasonably incurred by a Party  in prosecuting and maintaining Patents and enforcing and defending them.  1.41 "Phase 1 Study" means a human clinical trial of a Licensed Product in any country, the  primary purpose of which is the determination of safety and which may include the determination of  pharmacokinetic and/or pharmacodynamic profiles in healthy individuals or a diseased patient population.  A Phase 1 Study in a diseased patient population may include, in addition to primary determination of  safety, dose exploration and a determination of preliminary efficacy of a product in the target patient  population.  For clarity, a particular human clinical trial of a Licensed Product will not be considered both  a Phase 1 Study and a Phase 2 Study for the purposes of Milestone payments under Section 4.1.  1.42 "Phase 2 Study" means a human clinical trial of a Licensed Product in any country, and  which is: (a) a human clinical trial (other than a Phase 1 Study) in which the primary purpose is dose  exploration, dose response, duration of effect, kinetics or preliminary efficacy and safety of a product in  the target patient population, or (b) a controlled dose-ranging clinical trial to evaluate further the efficacy  and safety of such product in the target patient population and to define the optimal dosing regimen.  1.43 "Phase 3 Study" means a human clinical trial of a Licensed Product in any country, and  which is: (a) a controlled study of a product in the target patient population of the efficacy and safety of  such product which is prospectively designed to demonstrate statistically whether such product is effective  and safe for use in a particular indication in a manner sufficient to obtain Regulatory Approval to market  such product.  1.44 "Pre-Existing Restrictions" means, with respect to a Target, that (a)  [***] (“Pre-Existing Third Party Restrictions”), or (b)  [***] (“Pre-Existing Internal Restrictions”). 1.45 "Receiving Party" has the meaning set forth in Section 8.1.  1.46 "Regulatory Approval" means, with respect to a country or extra-national territory, any and  all approvals (including BLAs and MAAs), licenses, registrations or authorizations of any Regulatory  Authority necessary in order to commercially distribute, sell or market a product in such country or some  or all of such extra-national territory, including any pricing or reimbursement approvals.  1.47 "Regulatory Authority" means any national (e.g., the FDA), supra-national (e.g., the  EMA), regional, state or local regulatory agency, department, bureau, commission, council or other  governmental authority, in any jurisdiction in the world, involved in the granting of Regulatory Approval.   1.48 “ [***] Target” means the  [***] 1.49 "Royalty Term" has the meaning set forth in Section 4.2(d).  

 

7  1.50 "BioNTech Indemnitees" has the meaning set forth in Section 9.6(b).  1.51 "Solely Owned IP" has the meaning set forth in Article 5.  1.52 "Sublicensee" means any Third Party that is granted a sublicense as permitted by  Section 2.2, either directly by BioNTech or its Affiliates or indirectly by any other Sublicensee hereunder.   1.53 “Target” means the proteins described in Appendix 1.53 and includes: (a)  [***] naturally occurring human protein  [***]. 1.54 "Technology" means collectively Patents and Know-How.  1.55 "Term" has the meaning set forth in Section 10.1.  1.56 "Territory" means worldwide.  1.57 "Third Party" means any person or entity other than BioNTech, Acuitas and their respective  Affiliates.  1.58 "Third Party Claims" has the meaning set forth in Section 9.6(a).  1.59 “Vaccine” means any product primarily intended (i) to elicit an adaptive immune  response in the recipient against a specific disease-causing organism or malignancy as the result of  presentation of antigen(s) associated with the disease-causing organism or malignancy; or (ii) to provide  passive immune protection against a specific disease-causing organism.   1.60 “Vaccine Target” means Covid-19 Target as described in Appendix 1.53.  1.61 "Valid Claim" means, with respect to a particular country, any claim of (i) an issued and  unexpired Patent; or (ii) a pending Patent claim,  [***] 

 

8  2. License Grants; Technology Transfer. 2.1 Licenses by Acuitas. Subject to the terms and conditions of this License Agreement,  Acuitas hereby grants to BioNTech and its Affiliates (i) a non-exclusive, non-transferrable license, with the  right to sublicense only as permitted by Section 2.3(b), under the Acuitas LNP Technology, to develop,  have developed, make, have made, use and have used, sell, offer for sale, have sold and import and have  imported Licensed Products in the Field of Use in the Territory and (ii) an exclusive, non-transferrable  license, with the right to sublicense only as permitted by Section 2.3(b), under the Jointly Owned Program  Patents, and any Dual Improvement Patents owned by Acuitas, to develop, have developed, make, have  made, use and have used, sell, offer for sale, have sold and import and have imported Licensed Products  within the scope of allowed and/or issued claims within any Major Market Country (whether or not  expired) within the BioNTech mRNA Technology in the Field of Use in the Territory.  [***] 2.2 Option to Convert Non-exclusive License.   BioNTech will have a limited option  to convert the non-exclusive license granted pursuant to Section 2.1 to an exclusive license.  BioNTech  will notify Acuitas and the Escrow Agent in writing of its desire to exercise the exclusive license  option (“Conversion Option Notice”) and pay to Acuitas an escrow fee of  [***] dollars (U.S.$ [***]).  The Escrow Agent - on behalf of Acuitas - will review the Conversion Option Notice provided by  BioNTech hereunder to determine whether or not any such proposed Target is on the Restricted Target  List as of the date of such Option Conversion Notice.  If the Target is subject to Pre-existing  Restrictions, the Escrow Agent will notify BioNTech that the license set forth in Section 2.1 may not be  converted to an exclusive license. If the Target is not subject to Pre-existing Restrictions, the Escrow  Agent will notify BioNTech that the license set forth in Section 2.1 may be converted to an exclusive  license upon BioNTech’s delivery of a signed Exclusive License Agreement in the form attached  hereto as Exhibit 2.2 and payment of a conversion fee equal to (the difference between the  nonexclusive and exclusive option fee under the Development and Option Agreement ([***] dollars  (U.S.$ [***])) plus (the difference between any milestone fees paid under the nonexclusive license prior  to the Conversion Option Notice and the milestone fees for such events under an exclusive license).  2.3 Sublicensing Rights.  (a) Transfer.  The license granted in Section 2.1 [and option set forth in Section 2.2] is transferable only upon a permitted assignment of this License Agreement in accordance with Section 11.11.  (b) BioNTech Sublicenses.  The licenses granted in Section 2.1 may be sublicensed (with the right to sublicense through multiple tiers), in full or in part, by BioNTech, its Affiliates or  Sublicensees to Third Parties provided, that for any sublicense to Third Parties:  (i) Each sublicense will be in writing and on terms consistent with and subject to the  terms of this License Agreement,  (ii) BioNTech will provide Acuitas with a copy of any sublicense agreement with a Sublicensee within [***] days of execution thereof, which sublicense agreement may be redacted as 

 

necessary to protect commercially sensitive information and shall be treated as BioNTech Confidential  Information hereunder;  (iii) BioNTech will be responsible for any and all obligations of such Sublicensee as if such Sublicensee were BioNTech hereunder; and  (iv) Any sublicense granted by BioNTech to any rights licensed to it hereunder shall terminate immediately upon the termination of the license from Acuitas to BioNTech and its  Affiliates with respect to such rights, provided that such sublicensed rights shall not terminate if, as of the  effective date of such termination pursuant to Sections 10.2, 10.3(a) or 10.4, a Sublicensee is not in  material default of its obligations under its sublicense agreement, and within  [***] days of such termination and a written notice by Acuitas and disclosure of this License Agreement to the Sublicensee,  the Sublicensee agrees in writing to be bound directly to Acuitas under a license agreement  substantially similar to this License Agreement with respect to the rights sublicensed hereunder,  substituting such Sublicensee for BioNTech.  (c) Subcontractors.  For clarity purposes, BioNTech is entitled to engage contract  research organizations and contract manufacturing organizations for the development and manufacture of  Licensed Products on behalf of BioNTech. To the extent such contract organizations require a license  to perform such subcontracted activities under applicable Laws, BioNTech is entitled to grant a limited  license without an obligation to meet the conditions of Section 2.2 (b)(ii) and (iv).  2.4 Technology Transfer. After the License Agreement Effective Date Acuitas will conduct  a single full transfer of Acuitas LNP Technology to BioNTech and/or its designee(s) (which designee(s)  may be an Affiliate or a Third Party cGMP manufacturer) as required for the applicable transferee of the  then-current process. The technology transfer activities, the rights and obligations of the  Parties, the reimbursement of Acuitas for the technology transfer activities, and the rights and  licenses to any Technology generated in the course of the technology transfer will be as set forth in the  Technology Transfer Agreement becoming effective on the License Agreement Effective Date and  included in Appendix 2.4.  2.5 Updates to Appendix 1.1.  Acuitas shall notify BioNTech at least once every  [***] months of Patents that are added to the Acuitas LNP Technology following the License Agreement  Effective Date or any Patents that have been abandoned or discontinued in accordance with the terms of  this License Agreement. Appendix 1.1 shall be automatically updated to include any such added or deleted  Patents.   2.6 Documents and Declarations. Acuitas shall execute all documents, give all declarations  regarding the licenses granted hereunder and reasonably cooperate with BioNTech to the extent  such documents, declarations and/or cooperation are required for the recording or registration of the  licenses granted hereunder at the various patent offices in the Territory for the benefit of BioNTech, its  Affiliates or their Sublicensees.  3. License Limitations. No licenses or other rights are granted by Acuitas hereunder to use any  trademark, trade name, trade dress or service mark owned or otherwise Controlled by Acuitas or any of its  Affiliates. All licenses and other rights are or shall be granted only as expressly provided in this  License Agreement, and no other licenses or other rights is or shall be created or granted by either Party  hereunder by implication, estoppel or otherwise. 4. Payments and Royalties. 4.1 Milestone Payments.  BioNTech will make 9 milestone payments (each, a "Milestone  Payment") to Acuitas upon the first occurrence of each of the milestone events (each, a "Milestone Event")  by a Licensed Product as set forth below in this Section 4.1. BioNTech will notify Acuitas of the  

 

10  achievement of each Milestone Event within  [***] business days of such achievement. Each Milestone Payment will be payable to Acuitas by BioNTech within  [***] days of the achievement of the specified Milestone Event and such payments when owed or paid will be non-refundable and non-creditable. If one  or more of the Milestone Events set forth below are not achieved or not required for any reason, the payment  for such skipped Milestone Event will be due at the same time as the payment for the next achieved  Milestone Event.   Milestone Event Milestone Payment For Covered  Products   [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***] 

 

11   [***] 4.2 Royalties.  (a) Royalty.  Subject to the remainder of this Section 4.2, on a country-by-country basis and a Licensed Product-by-Licensed Product basis,  (i) [***] BioNTech will pay to Acuitas a royalty of  [***]% Net Sales.  [***] (b) Third Party Royalty Payments.  If BioNTech or its Affiliate or Sublicensee, in its  reasonable judgment, considers it necessary or useful to obtain a license from any Third Party that Covers a  Licensed Product in order to develop, manufacture or commercialize such Licensed Product the amount of  BioNTech’s royalty obligations under Sections 4.1(a) will be reduced by [***] percent ([***]%) of the  amount of the royalty payments made to such Third Party ("Third Party Royalty Payments"), provided,  however, [***] For avoidance of doubt, Third Party Royalty Payments will include payments by  BioNTech in connection with Acuitas sublicenses under Section 2.2.  (c) [***] (d) Term. The royalty term ("Royalty Term") shall expire on a country-by- country and Licensed Product-by-Licensed Product basis, on the last to occur of (i) expiration of the last to expire  Valid Claim in the Acuitas LNP Technology that, but for the license described herein from Acuitas to  BioNTech for the applicable Licensed Product, is infringed by the making, using or sale of such Licensed  Product, (ii) expiration of any period of data exclusivity, market exclusivity or supplemental  protection certificates covering the Licensed Product in such country; and (iii)  [***] years after First Commercial Sale of Licensed Product in such country, provided  [***]. For the avoidance of doubt, upon exhaustion of the obligation to pay Royalties to Acuitas as set forth above the continued use of Acuitas  Know-How comprised in the LNP Technology for the development, manufacture and/or sale of the  Licensed Product shall not, in and of itself, obligate BioNTech to pay further royalties to Acuitas.  Thereafter, BioNTech's license under Section 2.1 will become irrevocable, fully paid-up and royalty-free  on a country-by-country and Licensed Product-by-Licensed Product basis.   

 

12  (e) [***] 4.3 Payment Terms.  (a) Manner of Payment.  All payments to be made by BioNTech hereunder will be  made in U.S. dollars by wire transfer to such bank account as Acuitas may designate.  (b) Records and Audits. BioNTech shall keep, and shall cause each of its Affiliates and  Sublicensees, as applicable, to keep adequate books and records of accounting for the purpose of  calculating all royalties payable to Acuitas hereunder.  For the  [***] years next following the end of the  calendar year to which each shall pertain, such books and records of accounting (including those of  BioNTech’s Affiliates) shall be kept at each of their principal places of business and shall be open for  inspection at reasonable times and upon reasonable notice by an independent certified accountant  selected by Acuitas, and which is reasonably acceptable to BioNTech, for the sole purpose of  inspecting the royalties due to Acuitas under this License Agreement. In no event shall such  inspections be conducted hereunder more frequently than once every  [***] months. Such accountant  must have executed and delivered to BioNTech and its Affiliates, a confidentiality agreement as  reasonably requested by BioNTech, which shall include provisions limiting such accountant’s disclosure  to Acuitas to only the results and basis for such results of such inspection.  The results of such  inspection, if any, shall be binding on both Parties.  Any underpayments shall be paid by BioNTech  within  [***] days of notification of the results of such inspection. Any overpayments shall be fully  creditable against amounts payable in subsequent payment periods. Acuitas shall pay for such  inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any  calendar year shown by such inspection of more than  [***] percent ([***]%) of the amount paid,  BioNTech shall reimburse Acuitas for any reasonable out-of-pocket costs of such accountant.  (c) Reports and Royalty Payments.  For as long as royalties are due under Section  4.2, BioNTech shall furnish to Acuitas a written report for each Calendar Quarter, showing the amount of  Net Sales of Licensed Products and royalty due for such Calendar Quarter. Reports shall be provided  within  [***] ([***]) days of the end of the Calendar Quarter for Net Sales generated by BioNTech  and its Affiliates, and within  [***] ([***]) days of the end of the Calendar Quarter for Net Sales  generated by Sublicensees. Royalty payments for each Calendar Quarter shall be due at the same time  as the last such written report for the Calendar Quarter. The report shall include, at a minimum, the  following information for the applicable Calendar Quarter, each listed by Licensed Product and by country  of sale: (i)  [***] (ii)  [***] (iii)  [***] (iv)  [***] and (v)  [***].  All such reports shall be treated as  Confidential Information of BioNTech.  [***]. 

 

13  (d) Currency Exchange.  With respect to Net Sales invoiced in U.S. dollars, the Net  Sales and the amounts due to Acuitas hereunder will be expressed in U.S. dollars. With respect to Net Sales  invoiced in a currency other than U.S. dollars, payments will be calculated based on standard methodologies  employed by BioNTech or its Affiliates or Sublicensees for consolidation purposes for the Calendar Quarter  for which remittance is made for royalties.  (e) Withholding Taxes.  BioNTech may withhold from payments due to Acuitas  amounts for payment of any withholding tax that is required by Law to be paid to any taxing authority with  respect to such payments.  BioNTech will provide Acuitas all relevant documents and correspondence, and  will also provide to Acuitas any other cooperation or assistance on a reasonable basis as may be necessary  to enable Acuitas to claim exemption from such withholding taxes and to receive a refund of such  withholding tax or claim a foreign tax credit.  BioNTech will give proper evidence from time to time as to  the payment of any such tax. The Parties will cooperate with each other in seeking deductions under any  double taxation or other similar treaty or agreement from time to time in force. Such cooperation may include  BioNTech making payments from a single source in the U.S., where possible. Apart from any such permitted  withholding and those deductions expressly included in the definition of Net Sales, the amounts payable by  BioNTech to Acuitas hereunder will not be reduced on account of any taxes, charges, duties or other levies.\  (f) Taxes on Income.   Except as otherwise set forth in this Section 4.3, 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.  (g) Blocked Payments.  In the event that, by reason of applicable law in any country, it  becomes impossible or illegal for BioNTech or its Affiliates or Sublicensees to transfer, or have transferred  on its behalf, payments owed to Acuitas hereunder, BioNTech will promptly notify Acuitas of the conditions  preventing such transfer and such payments will be deposited in local currency in the relevant country to the  credit of Acuitas in a recognized banking institution designated by Acuitas or, if none is designated  by Acuitas within a period of  [***] days, in a recognized banking institution selected by BioNTech or its  Affiliate or Sublicensee, as the case may be, and identified in a written notice given to Acuitas.  (h) Interest Due.  If any payment due to Acuitas under this License Agreement is  overdue (and is not subject to a good faith dispute), then BioNTech will pay interest thereon (before  and after any judgment) at an annual rate of the lesser of  [***] percent ([***]%) above the prime rate as  reported in The Wall Street Journal, Eastern Edition, and [***], such interest to run from the date upon  which payment of such sum became due until payment thereof in full together with such interest.  (i) Mutual Convenience of the Parties.  The royalty and other payment obligations  set forth hereunder have been agreed to by the Parties for the purpose of reflecting and advancing their  mutual convenience, including the ease of calculating and paying royalties and other amounts to Acuitas.  5. Ownership and Inventorship of IP.  As between the Parties, each Party will own and retain all right, title and interest in and to any and all Know-How and Patents arising therefrom that are discovered, created, conceived, developed or reduced to practice solely by or on behalf of such Party under or in connection with this License Agreement ("Solely Owned IP").  Subject to the licenses hereunder and the other terms and conditions of this License Agreement or any other agreement between the Parties, each Party will be solely responsible for the prosecution and maintenance, and the enforcement and defense, of any Patents within its Solely Owned IP. 6. Patent Prosecution and Maintenance. 

 

14  6.1 Generally.  As between the Parties and subject to Section 6.2 below, Acuitas (or its Third  Party licensor, if any) will have the sole right, at its sole costs, to prosecute and maintain Acuitas LNP  Technology Patents. Upon filing, Acuitas will provide BioNTech with copies of all applications for all such  LNP Technology Patents, and will keep BioNTech timely updated about patent applications intended for  grant. If BioNTech deems it necessary to file a divisional application before grant of the patent but Acuitas  elects not to file such a divisional application, BioNTech will have the right to request the filing on its own  costs under the provisions of Section 6.2(a). The Parties will enter into a joint patent prosecution and  maintenance agreement with respect to prosecution and maintenance any and all Jointly Owned Patents and  the Parties will share equally all costs in connection with such efforts.   6.2 Election Not to Prosecute or Maintain or Pay Patent Costs.  (a) By Acuitas. If Acuitas elects not (i) to file, prosecute or maintain any LNP Technology Patents (including filing a divisional application for any LNP Technology Patents)for which it is responsible  under Section 6.1 in any particular country before the applicable filing deadline or continue such activities  once filed in a particular country, or (ii) to pay the Patent Costs associated with prosecution or maintenance  of any such LNP Technology Patents then in each such case Acuitas will so notify BioNTech, promptly in  writing and in good time to enable Acuitas to meet any deadlines by which an action must be taken to  preserve such LNP Technology Patent in such country, if BioNTech so requests.  Upon receipt of each such  notice by Acuitas, BioNTech will have the right, but not the obligation, to notify Acuitas in writing on a  timely basis that Acuitas should continue the prosecution and/or maintenance and/or file divisional  application of such LNP Technology Patent in the respective country, and thereafter, Acuitas would  prosecute and maintain such LNP Technology Patent in such country at the sole direction of BioNTech,  Acuitas would make available to BioNTech all documentation and correspondence with respect to such  Acuitas LNP Technology Patent, and BioNTech would compensate the reasonable Patent Costs incurred  by Acuitas in connection with such efforts, i.e., Patent Costs which Acuitas would not have had incurred if  it had elected not to file, prosecute or maintain the respective Acuitas LNP Technology Patent. BioNTech’s  license to such Acuitas LNP Technology Patent hereunder under Section 2.1 will be, irrevocable and royalty  free, and such Acuitas LNP Technology Patent will thereafter no longer be part of the Acuitas LNP  Technology in such country for purposes of this License Agreement.  BioNTech is entitled to discontinue  the payment of Patent Costs for any LNP Technology Patents at any time, provided that it will so notify  Acuitas in writing in time for such discontinuance.  (b) By BioNTech. If BioNTech elects not (i) to file, prosecute or maintain any Jointly Owned Patents for which it is responsible under Section 6.1 in any particular country before the applicable filing  deadline or continue such activities once filed in a particular country, or (ii) to pay the Patent Costs  associated with prosecution or maintenance of any Jointly Owned Patents then in each such case BioNTech  will so notify Acuitas, promptly in writing and in good time to enable BioNTech to meet any deadlines by  which an action must be taken to preserve such Jointly Owned Patent in such country at Acuitas' expense,  if Acuitas so requests. Upon receipt of each such notice by BioNTech, Acuitas will have the right, but not  the obligation, to notify BioNTech in writing on a timely basis that BioNTech should transfer the  prosecution or maintenance of such Jointly Owned Patent to Acuitas and at Acuitas' sole expense and such  LNP Technology Patent will thereafter no longer be part of the Acuitas LNP Technology in such country  for purposes of this License Agreement. Acuitas is entitled to discontinue the payment of Patent Costs for  any Jointly Owned Patents at any time, provided that it will so notify BioNTech in writing in time for such  discontinuance.  6.3 Regulatory Exclusivity Periods. With respect to any Patent listings required for any  regulatory exclusivity periods for Licensed Products the Parties will discuss and seek to reach mutual  agreement, subject to Applicable Law, on which Acuitas LNP Technology Patents to list. Except where  required under Applicable Law, without the written consent of BioNTech, Acuitas will not apply for, and  

 

15  is not authorized under this Agreement to apply for, any Patent listings required for any regulatory  exclusivity periods for any Licensed Product. For the avoidance of doubt, Acuitas is not restricted from  applying for any Patent listings required for any regulatory exclusivity periods for any product but the  Licensed Products.  6.4 Cooperation.  Each Party will reasonably cooperate with the other Party in those activities  involving the Acuitas LNP Technology Patents set forth in Sections 6.1 to 6.3.  Such cooperation includes  promptly executing all documents, or requiring inventors, subcontractors, employees and consultants and  agents of BioNTech and Acuitas and their respective Affiliates and Sublicensees to execute all documents,  as reasonable and appropriate so as to enable such activities in respect of any such Acuitas LNP Technology  Patents in any country.  7. Patent Enforcement and Defense. 7.1 Notice.  To the extent not in breach of an obligation of confidentiality, each Party will  promptly notify, in writing, the other Party upon learning of any actual or suspected infringement of any  Acuitas LNP Technology Patents by a Third Party, or of any claim of invalidity, unenforceability, or non- infringement of any Acuitas LNP Technology Patents, and will, along with such notice, supply the other  Party with any evidence in its possession pertaining thereto.  7.2 Enforcement and Defense.  (a) Enforcement.  As between the Parties, Acuitas (or its Third Party licensor, or licensee if any) will have the first right, but not the obligation, to seek to abate any infringement of the  Acuitas LNP Technology Patents by a Third Party, or to file suit against any such Third Party for such  infringement provided that (i) Acuitas shall bear all the expense of such suit or abatement of infringement,  and (ii) BioNTech shall have the first right but not the obligation to take action or bring suit against such  Third party infringer with respect to: (A) Jointly Owned Patents; and/or (B) any other LNP Technology  Patents that, on the date of first notice of such infringement, are necessary or useful for the research,  development, manufacturing and commercialization of Licensed Product but not necessary or useful for the  research, development, manufacturing and commercialization of any LNP-comprising product that is  exclusively licensed or optioned to a Third Party or is under late stage development by Acuitas; provided  that BioNTech shall bear all the expense of such suit or abatement of infringement. If the Party first  responsible for such enforcement elects not to take action or to bring suit to prosecute such infringement or  to continue such action or suit, it shall notify the other Party of such election within [***] days after become aware of or receipt of the notice of the infringement or after the election to stop any such action or  suit. If after the expiration of the  [***] days period (or, if earlier, the date upon which the responsible Party provides written notice that it does not plan to bring such action) the responsible Party has  neither obtained a discontinuance of infringement nor filed suit against any such Third Party infringer of  such Patent, then (i) in the case of an election by Acuitas (or its Third Party licensor, or licensee if any) not  to prosecute an infringement of an LNP Technology Patent, BioNTech shall have the right, but not the  obligation, to take action or bring suit against such Third Party infringer of such Patents, provided the  infringement is with respect to a product related to the Target(s) being the subject of this License  Agreement, and further provided that BioNTech shall bear all the expenses of such suit and (ii) in the  case of a BioNTech election not to prosecute an infringement of a Jointly Owned Patents or LNP  Technology Patent, Acuitas shall have the right, but not the obligation, to take action or bring suit against  such Third Party infringer of such Patents, provided that Acuitas shall bear all the expenses of such suit.   (b) Defense.  As between the Parties, Acuitas (or is Third Party licensor or licensee, if any) will have the first right, but not the obligation, at its sole costs, to defend against a declaratory judgment  action or other action challenging any Acuitas LNP Technology Patents, other than: (i) Jointly Owned  

 

16  Patents; and (ii) any other LNP Technology Patents that, on the date of first notice of such action, are not  necessary or useful for the research, development, manufacturing and commercialization of any LNP- comprising product that is exclusively licensed or optioned to a Third Party or is under Late Stage  Development by Acuitas, and as between the Parties, BioNTech will have the first right, but not the  obligation, at its sole costs, to defend against a declaratory judgment action or other action challenging  Jointly Owned Patents and/or such other LNP Technology Patents. If the Party first responsible for such  defense does not take steps to defend within a commercially reasonably time, or elects not to continue any  such defense (in which case it will promptly provide notice thereof to the other Party), then (i) in the case  of an election by Acuitas (or its Third Party licensor, or licensee if any) not to defend an LNP Technology  Patent, BioNTech shall have the right, but not the obligation, to take defend any LNP Technology Patents  that cover Licensed Product and no other product licensed or optioned by Acuitas to a Third Party or  commercialized by Acuitas provided that BioNTech shall bear all the expenses of such suit and (ii) in the  case of a BioNTech election not to defend the Jointly Owned Patents, Acuitas shall have the right, but not  the obligation, to take action or bring suit to defend such Patents, provided that Acuitas shall bear all the  expenses of such suit.   (c) Notwithstanding the foregoing, any response to a Third Party infringer's counterclaim of invalidity or unenforceability of any Acuitas LNP Technology Patents shall be controlled by the Party who  controls the relevant enforcement proceeding pursuant to Section 7.2 (a) unless otherwise mutually agreed  by the Parties.  (d) Withdrawal, Cooperation and Participation.  With respect to any infringement or defensive action identified above in this Section 7.2 which may be controlled by either BioNTech or  Acuitas:  (i) If the controlling Party ceases to pursue or withdraws from such action, it will promptly notify the other Party (in good time to enable the other Party to meet any deadlines by which any action must be taken to preserve any rights in such infringement or defensive action) and such other Party may substitute itself for the withdrawing Party, shall be granted the right and standing to sue in the other Party's name, and proceed under the terms and conditions of this Section 7.2. (ii) The non-controlling Party will cooperate with the Party controlling any such action (as may be reasonably requested by the controlling Party), including (A) providing access to relevant documents and other evidence, (B) making its and its Affiliates and licensees and Sublicensees and all of their respective employees, subcontractors, consultants and agents available at reasonable business hours and for reasonable periods of time, but only to the extent relevant to such action, and (C) if necessary, by being joined as a party, subject for this clause (C) to the controlling Party agreeing to indemnify such non-controlling Party for its involvement as a named party in such action and paying those Patent Costs incurred by such Party in connection with such joinder.  The Party controlling any such action will keep the other Party updated with respect to any such action, including providing copies of all documents received or filed in connection with any such action. (iii) Each Party will have the right to participate or otherwise be involved in any such action controlled by the other Party, in each case at the participating (i.e., non-controlling) Party’s  sole cost and expense.  If a Party elects to so participate or be involved, the controlling Party will  provide the participating Party and its counsel with an opportunity to consult with the controlling  Party and its counsel regarding the prosecution of such action (including reviewing the contents of  any correspondence, legal papers or other documents related thereto), and the controlling Party will  

 

17  take into account reasonable requests of the participating Party regarding such enforcement or  defense.  (e) Settlement.  Neither Party will settle or consent to an adverse judgment in any action described in this Section 7.2 and controlled by such Party, including any judgment which affects the scope,  validity or enforcement of any Acuitas LNP Technology Patents involved therewith, without the prior  written consent of the other Party (such consent not to be unreasonably withheld or delayed).  (f) Damages.  Unless otherwise agreed by the Parties, all monies recovered upon the final judgment or settlement of any action which may be controlled by either BioNTech or Acuitas and described  in Section 7.2(a) or 7.2(b) in each case will be used first to reimburse the controlling Party, and thereafter  the non-controlling Party, for each of their out-of-pocket costs and expenses relating to the action, with the  balance of any such recovery to be divided as follows:  (i) To the extent such recovery reflects lost profits damages, BioNTech will retain  such lost profits recovery, less the amount of royalties payable to Acuitas by treating such  lost profits recovery as "Net Sales" hereunder; and (ii) To the extent such recovery reflects reasonable royalty damages,  [***]  percent ([***]%) to the Party controlling the action and  [***] percent ([***]%) to the other  Party. 8. Confidentiality. 8.1 Confidential Information.  Each Party ("Disclosing Party") may disclose to the other  Party ("Receiving Party"), and Receiving Party may acquire during the course and conduct of activities  under this License Agreement, certain proprietary or confidential information of Disclosing Party in  connection with this License Agreement.  The term "Confidential Information" means all information of  any kind, whether in written, oral, graphical, machine-readable or other form, whether or not marked as  confidential or proprietary, that are disclosed or made available by or on behalf of the Disclosing Party to  the Receiving Party in connection with this License Agreement.  8.2 Restrictions.  During the Term and for  [***] years thereafter, Receiving Party will keep all Disclosing Party’s Confidential Information in confidence with the same degree of care with  which Receiving Party holds its own confidential information, but in no event less than reasonable care.   Receiving Party will not use Disclosing Party’s Confidential Information except for in  connection with the performance of its obligations and exercise of its rights under this License  Agreement.  Receiving Party has the right to disclose Disclosing Party’s Confidential Information  without Disclosing Party’s prior written consent to Receiving Party’s Affiliates, and each of their  employees, subcontractors, consultants and agents who have a need to know such Confidential  Information in order to perform their obligations and exercise their rights under this License  Agreement and who are under written obligation to comply with the restrictions on use and  disclosure that are no less restrictive than those set forth in this Section 8.2. Receiving Party  assumes responsibility for such entities and persons maintaining Disclosing Party’s Confidential  Information in confidence and using same only for the purposes described herein.  8.3 Exceptions.  Receiving Party’s obligation of nondisclosure and the limitations upon  the right to use the Disclosing Party’s Confidential Information will not apply to a specific portion  of the Disclosing Party’s Confidential Information to the extent that Receiving Party can demonstrate  that such portion: (i) was known to Receiving Party or any of its Affiliates prior to the time of  disclosure by the Disclosing Party without obligation of confidentiality; (ii) is or becomes public  knowledge through no fault or omission of Receiving Party or any of its Affiliates; (iii) is obtained  on a non-confidential basis by  

 

18  Receiving Party or any of its Affiliates from a Third Party who to Receiving Party’s knowledge is lawfully  in possession thereof and under no obligation of confidentiality to Disclosing Party; or (iv) has been  independently developed by or on behalf of Receiving Party or any of its Affiliates without the aid,  application or use of Disclosing Party’s Confidential Information.  8.4 Permitted Disclosures.  Receiving Party may disclose Disclosing Party’s Confidential  Information to the extent (and only to the extent) such disclosure is reasonably necessary in the following  instances:  (a) in order and to the extent required to comply with applicable Law (including any securities Law or regulation or the rules of a securities exchange) or with a legal, regulatory or  administrative proceeding;  (b) in connection with prosecuting or defending litigation, and filing, prosecuting and enforcing LNP Technology Patents in connection with Receiving Party’s rights and obligations pursuant to  this License Agreement; and  (c) to acquirers or permitted assignees; investment bankers, investors and lenders, including potential acquirers, assignees, investment bankers, and lenders;  (d) in the case of BioNTech, to (i) subcontractors; or (ii) potential licensees or collaboration partners, but in case (ii) only such information that is reasonably necessary or useful for the  potential licensee or partner to evaluate the applicable Licensed Product, and LNP/Licensed Product  manufacturing processes, but excluding the particular chemical structure and formulation of any LNPs  (which excluded information may be disclosed to such potential licensee or partner upon Acuitas’ prior  written consent);  provided that (1) where reasonably possible, Receiving Party will notify Disclosing Party of Receiving  Party’s intent to make any disclosure pursuant to subsections (a) and (b) sufficiently prior to making such  disclosure so as to allow Disclosing Party adequate time to take whatever action it may deem appropriate  to protect the confidentiality of the information to be disclosed, and (2) with respect to subsections (c) and  (d), each of those entities are required to comply with the restrictions on use and disclosure in Section 8.2  (other than investment bankers, investors and lenders, which must be bound prior to disclosure by  commercially reasonable obligations of confidentiality).  8.5 Return of Confidential Information. Upon expiry or earlier termination of this License  Agreement, upon written request of a Party (such request, if made, to be made within  [***] months of such expiry or termination) the other Party will destroy or return (as shall be specified in such request) to  the requesting Party all copies of the Confidential Information of the requesting Party; provided that the  Party may retain: (i) one copy of such Confidential Information for record-keeping purposes, for the sole  purpose of ensuring compliance with this Agreement; (ii) any copies of such Confidential Information as  is required to be retained under applicable Law; (iii) any copies of such Confidential Information as is  necessary or useful for such Party to exercise a right or fulfill an obligation under another License  Agreement, if any, or as set forth in this License Agreement; and (iv) any copies of any computer records  and files containing Confidential Information that have been created by such Party’s routine  archiving/backup procedures.  8.6 Publications.  Notwithstanding anything in this License Agreement to the contrary,  BioNTech is permitted to publish the results of its development under this License Agreement, provided,  however, that it will not disclose Acuitas Confidential Information in any publication by BioNTech of the  

 

19  results of any Licensed Product development by BioNTech without Acuitas’ prior written consent, which  will not be unreasonably withheld, conditioned or delayed.  8.7 Terms of this License Agreement; Publicity.  The Parties agree that the existence and  terms of the Parties’ relationship and this License Agreement will be treated as Confidential Information of  both Parties, and thus may be disclosed only as permitted by Section 8.4.  Except as required by Law, each  Party agrees not to issue any press release or public statement disclosing information relating to the  existence of this License Agreement or the transactions contemplated hereby or the terms hereof without  the prior written consent of the other Party.  9. Warranties; Limitations of Liability; Indemnification. 9.1 Representations and Warranties. Each Party represents and warrants to the other as of  the License Agreement Effective Date that:  (a) it is a corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated,  (b) it has the legal right and power to enter into this License Agreement, to extend the rights and licenses granted or to be granted to the other in this License Agreement, and to fully perform its  obligations hereunder,  (c) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this License Agreement and the performance of its obligations hereunder and  (d) this License Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance  with its terms.  9.2 Additional Representations of Acuitas.  Except as set forth on Appendix 9.2, Acuitas  hereby represents and warrants to BioNTech as of the License Agreement Effective Date as follows:  (a) Impairment. Neither Acuitas nor any of its Affiliates has entered into any agreement or otherwise licensed, granted, assigned, transferred, conveyed or otherwise encumbered or disposed of any  right, title or interest in or to any of its assets, including any intellectual property rights including Know- How, that would in any way conflict with or impair the scope of any rights or licenses granted to BioNTech  hereunder, including under any of the agreements which Acuitas has identified to BioNTech prior to the  License Agreement Effective Date.  (b) Patents.  Appendix 1.1 sets forth a complete and accurate list of all LNP Technology Patents.  Acuitas Controls, and will Control during the Term, the LNP Technology Patents listed on  Appendix 1.1 and the Know-How within the Acuitas LNP Technology, and is entitled to grant the licenses  specified herein.  To Acuitas’ knowledge, the LNP Technology Patents have been procured or are being  procured from the respective patent offices in accordance with applicable Law.  None of the LNP  Technology Patents is or has been involved in any opposition, cancellation, interference, reissue or  reexamination proceeding, and to Acuitas’ knowledge as of the License Agreement Effective Date, no  Acuitas LNP Technology is the subject of any judicial, administrative or arbitral order, award, decree,  injunction, lawsuit, proceeding or stipulation. Neither Acuitas nor any of its Affiliates has received any  notice alleging that the LNP Technology Patents are invalid or unenforceable, or challenging Acuitas’  ownership of or right to use any such rights before the Effective Date.  

 

20  (c) Entire LNP Technology. The Acuitas LNP Technology licensed to BioNTech under this License Agreement comprises all Technology Controlled by Acuitas which is required to develop,  manufacture and commercialize the Licensed Products.  (d) Encumbrances. Acuitas and its Affiliates are not subject to any payment obligations to Third Parties as a result of the execution or performance of this License Agreement.  Until the License  Agreement Effective Date, neither Acuitas nor any of its Affiliates has granted any license or security  interests on the Acuitas LNP Technology, and the Acuitas LNP Technology as licensed hereby is free and  clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien or charge of  any kind.    (e) Defaults. The execution, delivery and performance by Acuitas of this License Agreement and the consummation of the transactions contemplated hereby will not result in any violation of, conflict  with, result in a breach of or constitute a default under any understanding, contract or agreement to which  Acuitas is a party or by which it is bound, including each of the agreements which Acuitas has identified to  BioNTech prior to the License Agreement Effective Date, in each case as would reasonably be expected to  have a material adverse effect on the rights granted to BioNTech hereunder.  (f) Litigation. There is no action, suit, proceeding or investigation pending or, to the knowledge of Acuitas, currently threatened in writing against or affecting Acuitas that questions the validity  of this License Agreement or the right of Acuitas to enter into this License Agreement or consummate the  transactions contemplated hereby or that relates to the Acuitas LNP Technology.  (g) Infringement.  Neither Acuitas nor any of its Affiliates has received any notice of any claim, nor does Acuitas or its Affiliates have any knowledge of any basis for any claim, that any Patent,  Know-How or other intellectual property owned or controlled by a Third Party would be infringed or  misappropriated by the practice of any Acuitas LNP Technology in connection with the production, use,  research, development, manufacture or commercialization of any Licensed Product.  (h) Third Party Infringement.  To Acuitas’ knowledge, no Third Party is infringing or has infringed any Patent within the Acuitas LNP Technology or is misappropriating or has misappropriated  any Know-how within the Acuitas LNP Technology.  9.3 Disclaimers.  Without limiting the respective rights and obligations of the Parties expressly  set forth herein, each Party specifically disclaims any guarantee that any Licensed Product will be successful,  in whole or in part. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS LICENSE  AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTY OF  ANY KIND UNDER THIS LICENSE AGREEMENT, EITHER EXPRESS OR IMPLIED.  9.4 No Consequential Damages.  NOTWITHSTANDING ANYTHING IN THIS LICENSE  AGREEMENT OR OTHERWISE, NEITHER PARTY WILL BE LIABLE TO THE OTHER OR ANY  THIRD PARTY WITH RESPECT TO ANY SUBJECT MATTER OF THIS LICENSE AGREEMENT  FOR ANY INDIRECT, PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES; PROVIDED THAT  THIS SECTION 9.4 WILL NOT APPLY TO BREACHES OF A PARTY’S OBLIGATIONS OR UNDER  ARTICLE NINE OR THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER  SECTION 9.6.  9.5 Performance by Others.  The Parties recognize that each Party may perform some or all  of its obligations under this License Agreement through Affiliates and permitted subcontractors provided,  however, that each Party will remain responsible and liable for the performance by its Affiliates and  

 

21  permitted subcontractors and will cause its Affiliates and permitted subcontractors to comply with the  provisions of this License Agreement in connection therewith.  9.6 Indemnification.  (a) Indemnification by BioNTech.  BioNTech will indemnify Acuitas, its Affiliates and their  respective directors, officers, employees, Third Party licensors and agents, and their respective successors,  heirs and assigns (collectively, "Acuitas Indemnitees"), and defend and hold each of them harmless, from  and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees  and expenses) (collectively, "Losses") in connection with any and all suits, investigations, claims or demands  of Third Parties (collectively, "Third Party Claims") against the Acuitas Indemnitees to the extent arising  from or occurring as a result of: (i) the breach by BioNTech of any provision of this License Agreement; (ii)  any negligence or willful misconduct on the part of any BioNTech Indemnitee; or (iii) the development or  commercialization by or on behalf of BioNTech or any of its Affiliates or Sublicensees of Licensed Product  other than if related to an LNP component thereof, except in each case (i)-(iii) to the extent arising from or  occurring as a result of the negligence or willful misconduct on the part of an Acuitas Indemnitee or Acuitas’  breach of this License Agreement.  (b) Indemnification by Acuitas.  Acuitas will indemnify BioNTech, its Affiliates and their  respective directors, officers, employees and agents, and their respective successors, heirs and assigns  (collectively, "BioNTech Indemnitees"), and defend and hold each of them harmless, from and against any  and all Losses in connection with any and all Third Party Claims against BioNTech Indemnitees to the extent  arising from or occurring as a result of: (i) the breach by Acuitas of any provision of this License  Agreement; or (ii) any negligence or willful misconduct on the part of any Acuitas Indemnitee, or (iii)  [***]. (c) Notice of Claim.  All indemnification claims provided for in Sections 9.6(a) and 9.6(b)  will be made solely by such Party to this License Agreement (the "Indemnified Party").  The Indemnified  Party will promptly notify the indemnifying Party (an "Indemnification Claim Notice") of any Losses  or the discovery of any fact upon which the Indemnified Party intends to base a request for indemnification  under Section 9.6(a) and 9.6(b), but in no event will the indemnifying Party be liable for any Losses  that result from any delay in providing such notice.  Each Indemnification Claim Notice must contain a  description of the claim and the nature and estimated amount of such Loss (to the extent that the nature and  amount of such Loss is known at such time).  The Indemnified Party will furnish promptly to the  indemnifying Party copies of all papers and official documents received in respect of any Losses and Third  Party Claims.  (d) Defense, Settlement, Cooperation and Expenses. (i) Control of Defense.  At its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within  [***] days after the indemnifying Party’s receipt of an Indemnification Claim Notice.  The assumption of  the defense of a Third Party Claim by the indemnifying Party will not be construed  as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party  in respect of the Third Party Claim, nor will it constitute a waiver by the indemnifying Party of  any defenses it may assert against the Indemnified Party’s claim for indemnification.  Upon  assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel  in the defense of the  

 

22  Third Party Claim any legal counsel selected by the indemnifying Party (the indemnifying Party  will consult with the Indemnified Party with respect to such counsel and a possible conflict of  interest of such counsel retained by the indemnifying Party).  In the event the indemnifying Party  assumes the defense of a Third Party Claim, the Indemnified Party will immediately deliver to the  indemnifying Party all original notices and documents (including court papers) received by the  Indemnified Party in connection with the Third Party Claim.  In the event that it is ultimately  determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the  Indemnified Party from and against the Third Party Claim, the Indemnified Party will reimburse  the indemnifying Party for any and all costs and expenses (including reasonable attorneys’ fees and  costs of suit) and any Third Party Claims incurred by the indemnifying Party in its defense of the  Third Party Claim.  (ii) Right to Participate in Defense.  Without limiting Section 9.6(d)(i), any  Indemnified Party will be entitled to participate in, but not control, the defense of such Third Party  Claim and to employ counsel of its choice for such purpose; provided, however, that such  employment will be at the Indemnified Party’s own cost and expense unless (i) the indemnifying  Party has failed to assume the defense and employ counsel in accordance with Section 9.6(d)(i) (in  which case the Indemnified Party will control the defense) or (ii) the interests of the Indemnified  Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to  prohibit the representation by the same counsel of both Parties under applicable Law, ethical rules  or equitable principles, in which case the indemnifying Party will assume one hundred percent  (100%) of any such costs and expenses of counsel for the Indemnified Party.  (iii) Settlement.  With respect to any Third Party Claims that relate solely to the payment of money damages in connection with a Third Party Claim and that will not result in the  Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affecting  the business of the Indemnified Party in any manner, and as to which the indemnifying Party will  have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the  indemnifying Party will have the sole right to agree to the entry of any judgment, enter into any  settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole  discretion, will deem appropriate.  With respect to all other Losses in connection with Third Party  Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in  accordance with Section 9.6(d)(i), the indemnifying Party will have authority to agree to the entry  of any judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains  the prior written consent of the Indemnified Party (such consent not to be unreasonably withheld,  delayed or conditioned).  The indemnifying Party will not be liable for any settlement or other  disposition of a Loss by an Indemnified Party that is reached without the prior written consent of  the indemnifying Party.  Regardless of whether the indemnifying Party chooses to defend or  prosecute any Third Party Claim, no Indemnified Party will admit any liability with respect to or  settle, compromise or discharge, any Third Party Claim without the prior written consent of the  indemnifying Party, such consent not to be unreasonably withheld, delayed or conditioned.  (iv) Cooperation.  Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party will, and will cause each other indemnified  party to, cooperate in the defense or prosecution thereof and will furnish such records, information  and testimony, provide such witnesses and attend such conferences, discovery proceedings,  hearings, trials and appeals as may be reasonably requested in connection therewith, at the  indemnifying Party’s expense.  Such cooperation will include access during normal business hours  afforded to the indemnifying Party to, and reasonable retention by the Indemnified Party of, records  and information that are reasonably relevant to such Third Party Claim, and making indemnified  parties and other employees and agents available on a mutually convenient basis to provide  

 

23  additional information and explanation of any material provided hereunder, and the indemnifying  Party will reimburse the Indemnified Party for all its reasonable out-of-pocket costs and expenses  in connection therewith.  (v) Costs and Expenses.  Except as provided above in this Section 9.6(d), the costs and expenses, including attorneys’ fees and expenses, incurred by the Indemnified Party in connection  with any claim will be reimbursed on a Calendar Quarter basis by the indemnifying Party, without  prejudice to the indemnifying Party’s right to contest the Indemnified Party’s right to  indemnification and subject to refund in the event the indemnifying Party is ultimately held not to  be obligated to indemnify the Indemnified Party.  9.7 Insurance.  Each Party will maintain at its sole cost and expense, an adequate liability  insurance or self-insurance program (including product liability insurance) to protect against potential  liabilities and risk arising out of activities to be performed under this License Agreement, and any agreement  related hereto and upon such terms (including coverages, deductible limits and self-insured retentions) as  are customary in the respective industry of such Party for the activities to be conducted by such Party under  this License Agreement.  Subject to the preceding sentence, such liability insurance or self-insurance  program will insure against all types of liability, including personal injury, physical injury or property  damage arising out of the manufacture, sale, use, distribution or marketing of Licensed Product.  The  coverage limits set forth herein will not create any limitation on a Party’s liability to the other under this  License Agreement.  10. Term and Termination. 10.1 Term.  This License Agreement will commence as of the License Agreement Effective  Date and, unless sooner terminated in accordance with the terms hereof or by mutual written consent, will  continue on a Licensed Product-by-Licensed Product and a country-by-country basis, until there are no more  payments owed to Acuitas in such country (the longest such period of time hereunder, the "Term").  Upon  there being no more such payments hereunder in such country, the license contained in Section 2.1 will  become fully paid up and will remain in effect with respect to such Licensed Product in such country.  10.2 Termination by Acuitas.  (a) Breach.  Acuitas will have the right to terminate this License Agreement in full upon delivery of written notice to BioNTech in the event of any material breach by BioNTech of any terms and  conditions of this License Agreement, provided that such breach has not been cured within  [***] days after written notice thereof is given by Acuitas to BioNTech specifying the nature of the alleged breach.  (b) Disputed Breach.  If BioNTech disputes in good faith the existence or materiality of a breach specified in a notice provided in accordance with Section 10.2(a), and BioNTech provides Acuitas  notice of such dispute within such  [***] -day period, then Acuitas shall not have the right to terminate this License Agreement under Section 10.2(a) unless and until it is finally determined, in accordance with  Section 11.1, that BioNTech has materially breached this License Agreement and that BioNTech fails  to cure such breach within  [***] days following such decision.  It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this License Agreement shall remain in effect  and the Parties shall continue to perform all of their respective obligations hereunder. During the pendency  of any such dispute, BioNTech shall pay to Acuitas all Acuitas Milestone payments and royalty payments  set forth herein.  

 

24  10.3 Termination by BioNTech.  (a) Breach.  BioNTech will have the right to terminate this License Agreement in full upon delivery of written notice to Acuitas in the event of any material breach by Acuitas of any terms  and conditions of this License Agreement, provided that such breach has not been cured within  [***] days after written notice thereof is given by BioNTech to Acuitas specifying the nature of the alleged breach.   (b) Discretionary Termination.  BioNTech will have the right (i) to terminate this License Agreement in full at its discretion for any reason by delivering written notice to Acuitas, such termination  to be effective  [***] days following the date of such notice. (c) Alternative to Termination Under Section 10.3(a).  If BioNTech has the right to terminate this License Agreement under Section 10.3(a) as a result of a material breach by Acuitas (including following  expiration of all applicable cure periods thereunder) that fundamentally impairs the value of BioNTech’s  rights hereunder with respect to the Licensed Target, then BioNTech may, in lieu of exercising such  termination right, elect by written notice to Acuitas before the end of such applicable cure period to have  this License Agreement continue in full force and effect for the Term, provided that the following will  apply:  [***]. 10.4 Termination Upon Bankruptcy.  All rights and licenses granted under or pursuant to  this License Agreement by Acuitas are, and will otherwise be deemed to be, for purposes of Section  65.11(7) of the Bankruptcy and Insolvency Act, R.S.C. 1985, c. B-3 and Section 32(6) of the  Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36 (the “Insolvency Legislation”), a grant of  “right to use intellectual property” as used in the Insolvency Legislation.  The Parties agree that  BioNTech and its Affiliates and Sublicensees, as licensees of such rights under this License Agreement,  will retain and may fully exercise all of their rights and elections under the Insolvency Legislation subject  to the payment of amounts provided for herein.  Without limiting BioNTech’s rights under the  Insolvency Legislation, if Acuitas becomes insolvent or makes an assignment for the benefit of its  creditors or there is filed by or against the Acuitas any bankruptcy, receivership, reorganization or similar  proceeding (an “Insolvency Event”) pursuant to or under the Insolvency Legislation or otherwise,  BioNTech shall be entitled to a copy of any and all such intellectual property and all embodiments of  such intellectual property, and the same, if not in the possession of Acuitas, shall be promptly delivered to  it (i) before this License Agreement is rejected by or on behalf of Acuitas, within  [***] days after BioNTech’s written request, unless Acuitas, or its trustee or receiver, elects within  [***] days to continue to perform all of its obligations under this License Agreement, or (ii) after any rejection of this License  Agreement by or on behalf of Acuitas, if not previously delivered as provided under clause (i) above.   All rights of the Parties under this Section 10.4(b) and under Section 65.11(7) of the Bankruptcy and  Insolvency Act, R.S.C. 1985, c. B-3 and Section 32(6) of the Companies’ Creditors Arrangement Act are  in addition to and not in substitution of any and all other rights, powers, and remedies that each party may  have under this License Agreement, the Insolvency Legislation, and any other 

 

25  applicable Laws.  BioNTech shall have the right to perform the obligations of Acuitas hereunder with respect  to such intellectual property, but neither such provision nor such performance by BioNTech shall release  Acuitas from any such obligation or liability for failing to perform it.  10.5  Effects of Termination.  Upon termination (but not expiration pursuant to Section 10.1)  of this License Agreement for any reason:  (a) Cessation of Rights.  Except as otherwise expressly provided herein, including in Sections 8.5, 10.3(c) and 10.5(b), all rights and licenses granted by Acuitas to BioNTech in Section 2.1 will terminate.  (b) Sell Off. Notwithstanding the termination of BioNTech's licenses and other rights under  this License Agreement, BioNTech shall retain the right to distribute, sell or otherwise dispose of its existing  inventory of the Licensed Products, in each case that is intended for distribution, sale or disposition in the  Territory, for a period of not more than  [***] months following the date of the effective termination, as  though this License Agreement had not been terminated, and such distribution, sale or other disposition  shall not constitute infringement of the Patents or other intellectual property or proprietary rights of  Acuitas or its Affiliates. BioNTech's right to distribute, sell or otherwise dispose of its existing inventory of  the Licensed Products pursuant to this Section 10.5 (b) shall be subject to BioNTech's continuing  obligation to pay royalties with respect to the Net Sales.  10.6 Survival.  In addition to the termination consequences set forth in Section 10.5, the  following provisions will survive termination or expiration of this License Agreement: Articles 1 and 8 and  Sections 4.4, 5.1, 9.3, 9.4, 9.6, 9.7, 10.4, 10.5, 10.6, 11.1, 11.2, 11.5, 11.7, 11.8, 11.9, 11.10, 11.11 and 11.12.  Termination or expiration of this License Agreement will not relieve the Parties of any liability or obligation  which accrued hereunder prior to the effective date of such termination or expiration nor preclude either  Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any  breach of this License Agreement nor prejudice either Party’s right to obtain performance of any obligation.  All other rights and obligations will terminate upon expiration of this License Agreement.  11. General Provisions. 11.1 Dispute Resolution. (a) Disputes.  Disputes arising under or in connection with this License Agreement will be  resolved pursuant to this Section 11.1; provided, however, that in the event a dispute cannot be resolved  without an adjudication of the rights or obligations of a Third Party (other than any BioNTech Indemnitees  or Acuitas Indemnitees identified in Section 9.6), the dispute procedures set forth Sections 11.1(c)  and 11.1(c) will be inapplicable as to such dispute.  (b) Dispute Escalation.  In the event of a dispute between the Parties, the Parties will first  attempt in good faith to resolve such dispute by negotiation and consultation between themselves.  In  the event that such dispute is not resolved on an informal basis within  [***] days, any Party may, by  written notice to the other, have such dispute referred to each Party’s  [***], who will attempt in good faith  to resolve such dispute by negotiation and consultation for a  [***] day period following receipt of such  written notice  (c) Dispute Resolution.  In the event the  [***] of the Parties are not able to resolve such  dispute as set forth above, the Parties agree to try to solve such dispute amicably by mediation. The  Parties shall conduct a mediation procedure according to the Mediation Rules of the World Intellectual  Property Organization (WIPO) in effect on the date of the commencement of the mediation  

 

26  proceedings. The location of the mediation proceedings will be London, England. The number of  mediators will be   [***]. The language of the mediation proceedings will be English. If the dispute has not  been settled pursuant to the said rules within  [***] days following the filing of a request for mediation or  within such other period as the Parties may agree in writing, either Party may submit the dispute to final  and binding arbitration. Any dispute relating to the validity performance, construction or  interpretation of this Agreement, which cannot be resolved amicably between the Parties after following  the procedure set forth in this Section 11.1, shall be submitted to arbitration in accordance with the  Arbitration Rules of WIPO in effect on the date of the commencement of the arbitration proceedings.  The location of the arbitration proceedings will be London, England. The number of arbitrators will  be  [***]. The language of the arbitration proceeding will be English. The decision of the arbitrators  shall be final and binding upon the Parties (absent manifest error on the part of the arbitrator(s)) and  enforceable in any court of competent jurisdiction.   (d) Injunctive Relief.  Notwithstanding the dispute resolution procedures set forth in this  Section 11.1, in the event of an actual or threatened breach hereunder, the aggrieved Party may seek equitable  relief (including restraining orders, specific performance or other injunctive relief) in any court or other  forum, without first submitting to any dispute resolution procedures hereunder.  (e) Tolling.  The Parties agree that all applicable statutes of limitation and time-based defenses  (such as estoppel and laches) will be tolled while the dispute resolution procedures set forth in this  Section 11.1 are pending, and the Parties will cooperate in taking all actions reasonably necessary to achieve  such a result.  (f) Prevailing Party.  The prevailing Party in any arbitration under Section 11.1(c) or any  other suit related to this License Agreement will be entitled to recover from the losing Party all out-of-pocket  fees, costs and expenses (including those of attorneys, professionals and accountants and all those arising  from appeals and investigations) incurred by the prevailing Party in connection with such arbitration or suit.  11.2 Cumulative Remedies and Irreparable Harm.  All rights and remedies of the Parties  hereunder will be cumulative and in addition to all other rights and remedies provided hereunder or available  by agreement, at Law or otherwise.  Each Party acknowledges and agrees that breach of any of the terms or  conditions of this License Agreement may cause irreparable harm and damage to the other and that such  damage may not be ascertainable in money damages and that as a result thereof the non-breaching Party may  be entitled to seek from a court equitable or injunctive relief restraining any breach or future violation of the  terms contained herein by the breaching Party without the necessity of proving actual damages or posting  bond.  Such right to equitable relief is in addition to whatever remedies either Party may be entitled to as a  matter of Law or equity, including money damages.  11.3 Relationship of Parties.  Nothing in this License Agreement is intended or will be deemed  to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties.  No  Party will incur any debts or make any commitments for the other, except to the extent, if at all, specifically  provided therein.  There are no express or implied third party beneficiaries hereunder (except for BioNTech  Indemnitees and Acuitas Indemnitees for purposes of Section 9.6).  For clarity, BioNTech does not grant to  Acuitas any rights or licenses under this License Agreement to any BioNTech technology or intellectual  property rights.  11.4 Compliance with Law.  Each Party will perform or cause to be performed any and all of  its obligations or the exercise of any and all of its rights hereunder in good scientific manner and in  compliance with all applicable Law.  

 

27  11.5 Governing Law.  This License Agreement will be governed by and construed in  accordance with the Laws of England and Wales, without respect to its conflict of Laws rules, provided that  any dispute relating to the scope, validity, enforceability or infringement of any Patents or Know-How will  be governed by, and construed and enforced in accordance with, the substantive Laws of the jurisdiction in  which such Patents or Know-How apply.  11.6 Counterparts; Facsimiles.  This License Agreement may be executed in one or more  counterparts, each of which will be deemed an original, and all of which together will be deemed to be one  and the same instrument.  Facsimile or PDF execution and delivery of this License Agreement by either  Party will constitute a legal, valid and binding execution and delivery of this License Agreement by such  Party.  11.7 Headings.  All headings in this License Agreement are for convenience only and will not  affect the meaning of any provision hereof.  11.8 Waiver of Rule of Construction.  Each Party has had the opportunity to consult with  counsel in connection with the review, drafting and negotiation of this License Agreement.  Accordingly,  the rule of construction that any ambiguity in this License Agreement will be construed against the drafting  party will not apply.  11.9 Interpretation.  Whenever any provision of this License Agreement uses the term  "including" (or "includes"), such term will be deemed to mean "including without limitation" (or "includes  without limitations").  "Herein," "hereby," "hereunder," "hereof" and other equivalent words refer to this  License Agreement as an entirety and not solely to the particular portion of this License Agreement in which  any such word is used.  All definitions set forth herein will be deemed applicable whether the words defined  are used herein in the singular or the plural.  Unless otherwise provided, all references to Sections and  Appendices in this License Agreement are to Sections and Appendices of this License Agreement.  References to any Sections include Sections and subsections that are part of the related Section.   11.10 Binding Effect.  This License Agreement will inure to the benefit of and be binding upon  the Parties, their Affiliates, and their respective lawful successors and assigns.  11.11 Assignment.  This License Agreement may not be assigned by either Party, nor may either  Party delegate its obligations or otherwise transfer licenses or other rights created by this License Agreement,  except as expressly permitted hereunder or otherwise without the prior written consent of the other Party,  which consent will not be unreasonably withheld; provided that either Party may assign this License  Agreement without such consent to an Affiliate or to its successor in connection with sale of all or  substantially all of its assets or business or that portion of its business pertaining to the subject matter of this  License Agreement (whether by merger, consolidation or otherwise).  11.12 Notices.  All notices, requests, demands and other communications required or permitted to be given pursuant to this License Agreement will be in writing and will be deemed to have been duly  given upon the date of receipt if delivered by hand, recognized international overnight courier, or registered  or certified mail, return receipt requested, postage prepaid to the following addresses:  If to BioNTech:   BioNTech SE  An der Goldgrube 12  D-5513 Mainz Germany Attention:  [***] -   

 

28  If to Acuitas:  Acuitas Therapeutics Inc.  6190 Agronomy Road, Suite 405  Vancouver, B.C.  Canada V6T 1Z3  Attention:  [***] With a copy to: McCarthy Tetrault LLP  Suite 2400 745 Thurlow Street  Vancouver, B.C.  Canada V6E 0C5  Attention:  [***] Either Party may change its designated address by notice to the other Party in the manner provided  in this Section 11.12.  11.13 Amendment and Waiver.  This License Agreement may be amended, supplemented, or  otherwise modified only by means of a written instrument signed by both Parties; provided that any unilateral  undertaking or waiver made by one Party in favor of the other will be enforceable if undertaken in a writing  signed by the Party to be charged with the undertaking or waiver.  Any waiver of any rights or failure to act  in a specific instance will relate only to such instance and will not be construed as an agreement to waive  any rights or fail to act in any other instance, whether or not similar.  11.14 Severability.  In the event that any provision of this License Agreement will, for any  reason, be held to be invalid or unenforceable in any respect, such invalidity or unenforceability will not  affect any other provision hereof, and the Parties will negotiate in good faith to modify the License  Agreement to preserve (to the extent possible) their original intent.  11.15 Entire Agreement.  This License Agreement together with the Development and Option  Agreement and any other license agreements entered into during the Term pursuant to the Development and  Option Agreement are the sole agreement with respect to the subject matter hereof and supersedes all other  agreements and understandings between the Parties with respect to same.  11.16 Force Majeure.  Neither Acuitas nor BioNTech will be liable for failure of or delay in  performing obligations set forth in this License Agreement (other than any obligation to pay monies when  due), and neither will be deemed in breach of such obligations, if such failure or delay is due to natural  disasters or any causes reasonably beyond the control of Acuitas or BioNTech; provided that the Party  affected will promptly notify the other of the force majeure condition and will exert reasonable efforts to  eliminate, cure or overcome any such causes and to resume performance of its obligations as soon as  possible.  [Remainder of this Page Intentionally Left Blank]  

 

Signature Page to License Agreement  WITNESS WHEREOF, the Parties have caused this License Agreement to be executed by their  respective duly authorized officers as of the License Agreement Effective Date.  ACUITAS THERAPEUTICS INC.  By:  (Signature)  Name:  Title:  Date:  BIONTECH  RNA PHARMACEUTICALS GMBH  By:  (Signature)  Name:  Title:  Date:  Thomas Madden President & CEO April 7, 2020 T.  D.  Madden   

 

Appendix 1.1   [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***] 

 

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Appendix 1.17  [***] 

 

Appendix 1.23  [***]  

 

Appendix 1.53  [***]   [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***] 

 

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[***] 

 

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Appendix 2.4  [***]  

 

Appendix 9.2  Exceptions to Acuitas’ Representations and Warranties in Section 9.2redactionofannex8-pfizer

SENSITIVE  EUROPEAN COMMISSION  Directorate-General for Health and Food Safety PURCHASE AGREEMENT (“PA”)1 for the further development, production,  purchasing options and supply of COVID-19 Vaccines for EU Member  States  NUMBER — SANTE/2021/03/020  1. The European Commission, acting on behalf and in the name of the Member States set out in Annex III (hereinafter referred to as “Participating Member States”),2: being represented for the purposes of the signature of this PA by Ms Stella Kyriakides,  Commissioner of Health and Food Safety  on the one part and  2. Pfizer Inc. Incorporated in Delaware (Registration Number 0383418) with its registered address at 235  East 42nd Street  10017 New York City, NY (UNITED STATES)  appointed as the leader of the group by the members of the group that submitted the joint tender  (hereinafter referred to as “Pfizer”)  and  BioNTech Manufacturing GmbH  Registered with the commercial register of the lower court (Amtsgericht) of Mainz, Germany  under HRB 47548, with its registered address at An der Goldgrube 12  55131 MAINZ, GERMANY  (hereinafter referred to as “BioNTech”)  1 This PA is based on the agreement between the Commission and the Member States as approved by Commission Decision C(2020)  4192 final on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and  related procedures.  2 As provided for in Article 4(5)(b) of Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support  within the Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under  Regulation (EU) 2016/369, and amending its provisions taking into account the COVID‐19 outbreak.  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 Exhibit 4.54 

 

2    as a member of the group (collectively ‘the Contractor’), represented for the purposes of the  signature of this PA which has the form of a framework contract by [***]  on the other part,    HAVE AGREED      to the special conditions and the general conditions of this PA and the following Annexes  and Attachments:  Annex I – Model for Vaccine Order Form  Annex II – Agreement between the Commission and Member States on procuring Covid-19  vaccines on behalf of the Member States and related procedures, annexed to the Commission  Decision C(2020) 4192 final of 18 June 2020  Annex III – Participating Member States  Annex IV – Subcontractors   Annex V – Participating Contractor Affiliates  Attachment 1 – Specifications  Attachment 2 – Delivery Documentation  Attachment 3 – Delivery Specification  Attachment 4 – Labelling and Packaging Specifications  Attachment 5 – Return and Disposal of Product Materials  which form an integral part of this PA.     [***]  [***]  [***]  [***]      For any other proposed amendments, the parties will discuss the impact thereof in good faith  and any such shall require the written prior approval of the Commission and the Participating  Member States, not to be unreasonably withheld or delayed.     

 

3    This PA sets out:  1. the procedure and conditions by which the Participating Member States will pay  for the services and/or supplies from the Contractor;  2. the provisions that apply to any Vaccine Order Form which the Participating  Member States and the Contractor may conclude under this PA; and  3. the obligations of the parties during and after the duration of this PA.  All documents issued by the Contractor (end-user agreements, general terms and conditions,  etc.) except its tender are held inapplicable, unless explicitly mentioned in the special  conditions of this PA. In all circumstances, in the event of contradiction between this PA and  documents issued by the Contractor, this PA prevails, regardless of any provision to the  contrary in the Contractor’s documents.    

 

4    Table of Content    TABLE OF CONTENT .......................................................................................................................... 4  I. SPECIAL CONDITIONS .......................................................................................................... 5  I.1 Order of Priority of Provisions ..................................................................................... 5  I.2 Definitions .................................................................................................................... 5  I.3 Subject Matter ............................................................................................................... 9  I.4 Entry into force and duration of the PA ...................................................................... 10  I.5 Implementation of the PA ........................................................................................... 11  I.6 Supply of the Vaccine ................................................................................................. 11  I.7 Prices ........................................................................................................................... 17  I.8 Payment Arrangements ............................................................................................... 17  I.9 Communication Details .............................................................................................. 18  I.10 Project management .................................................................................................... 19  I.11 Exploitation of the results of the PA ........................................................................... 19  I.12 Indemnification ........................................................................................................... 19  I.13 Applicable Law and Settlement of Disputes ............................................................... 19  I.14 Other Special Conditions ............................................................................................ 19  II. GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SERVICES ...... 21  II.1 Definitions .................................................................................................................. 21  II.2 Roles and responsibilities in the event of a joint tender ............................................. 21  II.3 Severability ................................................................................................................. 21  II.4 Provision of services and supplies .............................................................................. 21  II.5 Communication between the parties ........................................................................... 21  II.6 Liability ....................................................................................................................... 22  II.7 Conflict of interest and professional conflicting interests .......................................... 23  II.8 Representations and warranties ................................................................................... 24  II.9 Confidentiality ............................................................................................................ 25  II.10 Announcements and publicity..................................................................................... 26  II.11 Processing of personal data ......................................................................................... 27  II.12 Subcontracting ............................................................................................................ 27  II.13 Amendments ............................................................................................................... 27  II.14 Assignment ................................................................................................................. 27  II.15 Force majeure ............................................................................................................. 28  II.16 Suspension of the implementation of the PA .............................................................. 28  II.17 Termination of the PA ................................................................................................ 29  II.18 Invoices, value added tax and e-invoicing .................................................................. 30  

 

5    II.19 Payments and guarantees ............................................................................................ 31  II.20 Recovery ..................................................................................................................... 32  II.21 Checks and audits ....................................................................................................... 32  II.22 Relationship of the parties .......................................................................................... 33  II.23 Waiver ......................................................................................................................... 34  II.24 Further documents ...................................................................................................... 34  II.25 Headings ..................................................................................................................... 34  II.26 Electronic Delivery and Storage ................................................................................. 34  II.27 Entire Agreement ........................................................................................................ 34  II.28 Costs ........................................................................................................................... 34  ANNEX I: VACCINE ORDER FORM .................................................................................................. 6  ANNEX II: AGREEMENT BETWEEN THE COMMISSION AND MEMBER STATES ON  PROCURING COVID-19 VACCINES ON BEHALF OF THE MEMBER STATES AND  RELATED PROCEDURES, ANNEXED TO THE COMMISSION DECISION C(2020)  4192 FINAL OF 18 JUNE 2020 .............................................................................................. 12  ANNEX III: PARTICIPATING MEMBER STATES ......................................................................... 17  ANNEX IV: SUBCONTRACTORS .................................................................................................... 18  ANNEX V – PARTICIPATING CONTRACTOR AFFILIATES ....................................................... 19  IN ADDITION, ANY CONTRACTOR AFFILIATE WHICH IS INVOLVED IN THE SALE OR  DISTRIBUTION OF PRODUCT WHICH IS RESOLD OR DONATED BY A  PARTICIPATING MEMBER STATE SHALL BE DEEMED TO BE A PARTICIPATING  CONTRACTOR AFFILIATE.ATTACHMENT 1: SPECIFICATIONS ................................ 19  ATTACHMENT 2: DELIVERY DOCUMENTATION ...................................................................... 19  ATTACHMENT 3: DELIVERY SPECIFICATION............................................................................ 19  ATTACHMENT 4 : LABELLING AND PACKAGING SPECIFICATIONS .................................... 19  ATTACHMENT 5: RETURN AND DISPOSAL OF PRODUCT MATERIALS ............................... 19            

 

  I. SPECIAL CONDITIONS   I.1 ORDER OF PRIORITY OF PROVISIONS  If there is any conflict between different provisions in this PA, the following rules must be  applied:  (a) The provisions set out in the special conditions and Article II.6 of the general  conditions (Liability) take precedence over those in the other parts of the PA.  (b) The other provisions set out in the general conditions take precedence over  those in the Annexes and Attachments.  (c) The provisions set out in the PA take precedence over those in the Vaccine  Order Forms.  I.2 DEFINITIONS  The following definitions shall apply to this PA:  ‘Additional Order’: has the meaning set forth in Article I.6.2;  ‘Additional Product’: has the meaning set forth in Article I.6.2;  ‘Affiliate’: means in relation to a body corporate, any other entity which directly or indirectly  Controls, is Controlled by, or is under direct or indirect common Control of that body corporate  from time to time;  ‘Authorisation’: means a Conditional Marketing Authorisation and/or Marketing  Authorisation that permits the Products to be placed on the market in the European Economic  Area;  “Commission Experts” means up to three (3) clinical expert individuals employed by, or  advising, the Commission in connection with the COVID-19 pandemic, such individuals to be  identified by the Commission and communicated to Contractor promptly following the  Effective Date (it being understood that if Contractor expresses a reasonable objection to the  identity of one or more Commission Experts, the Commission will suggest (an) alternative  expert(s));   ‘Conditional Marketing Authorisation’: means a conditional marketing authorisation  granted by the European Commission, as amended or varied from time to time, as referred to  in Article 14-a of Regulation (EC) No 726/2004;  ‘Confidential Information’: means any information disclosed to or obtained by one party to  the other party, either directly or indirectly, or which the disclosing party indicates in writing  at the time of disclosure to, or receipt by, the recipient is to be considered confidential or  proprietary, or which such recipient knows or ought reasonably to know is information of a  

 

  confidential or proprietary nature, including the terms of this PA and any Vaccine Order Form.  Confidential Information shall not include any information (i) the receiving party can prove  was known to it prior to the date of disclosure; (ii) the receiving party can prove was lawfully  obtained from a third party without any obligation of confidentiality; (iii) is or becomes part  of the public domain other than through any act or omission of the receiving party; or (iv) is  independently developed by the receiving party without use of or reference to the disclosing  party’s Confidential Information, as evidenced by the receiving party’s records;  ‘Conflict of interest’: a situation where the impartial and objective Implementation of the PA  by the Contractor is compromised for reasons involving family, emotional life, political or  national affinity, economic interest, any other direct or indirect personal interest, or any other  shared interest with the Commission, the Participating Member State or any third party related  to the subject matter of the PA;  ‘Contracted Doses’: has the meaning set forth in Article I.6.2;  ‘Control’: means the possession by a person or an entity, directly or indirectly, of the power  to direct or cause the direction of the management and policies of the other person or entity  (whether through the ownership of voting shares, by contract or otherwise) and "Controls"  and "Controlled" shall be interpreted accordingly;  “COVAX Facility” means the COVID-19 Vaccines Global Access procurement initiative  led by Gavi, UNICEF, the Vaccine Alliance, the World Health Organization (WHO) and the  Coalition for Epidemic Preparedness Innovations (CEPI), for the procurement and delivery  of doses of approved vaccine for COVID-19;  ‘Delivery Price’: has the meaning set forth in Article I.8.2;  ‘Delivery Schedule’: has the meaning set forth in Article I.6.3, as such may be modified by  agreement of the parties pursuant to the provisions in Articles I.6.2 and I.6.3;  ‘Effective Date’: has the meaning set forth in Article I.4.1;  ‘Force majeure’: any unforeseeable, exceptional situation or event beyond the reasonable  control of the parties that prevents either of them from fulfilling any of their obligations under  the PA,[***].  ‘Formal notification’ (or ‘formally notify’): form of communication between the parties made  in writing by mail or email, which provides the sender with compelling evidence that the  message was delivered to the specified recipient;  ‘Fraud’: an act or omission committed in order to make an unlawful gain for the perpetrator  or another by causing a loss to the Union's financial interests, and relating to: i) the use or  presentation of false, incorrect or incomplete statements or documents, which has as its effect  the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the  non-disclosure of information in violation of a specific obligation, with the same effect or iii)  

 

  the misapplication of such funds or assets for purposes other than those for which they were  originally granted, which damages the Union's financial interests, it being understood that the  Union’s financial interests are impacted within the framework of  this PA as the Union is  engaging resources into the coordination and preparation of the PA, resulting from Decision  C(2020) 4192 final of 18 June 2020 which approved the agreement with Member States on  procuring COVID-19 vaccines on behalf of the Member States (“the Decision”), this agreement  being based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 March 2016 on the provision  of emergency support within the Union3   (“the ESI Regulation”) ;  ‘Good Manufacturing Practice’: means the current practices for manufacture required by  the standards, rules, principles and guidelines set out in Directive 2001/83/EC (as amended by  Directive 2004/27/EC), Directive 2017/1572, Directive 2003/94/EC and EudraLex - Volume  4 of the Rules Governing Medicinal Products in the EU entitled “EU Guidelines to Good  Manufacturing Practice Medicinal Products for Human and Veterinary Use”;  ‘Implementation of the PA’: the purchase of services or supplies envisaged in the PA through  the signature and performance of Vaccine Order Forms;  ‘Indemnified Persons’: has the meaning set forth in Article 0;  ‘Irregularity’: any infringement of a provision of Union law resulting from an act or omission  by the Contractor within the meaning of Article 1(2) of the Council (EC, Euratom) Regulation  2988/95 of 18 December 1995 on the protection of the European Communities financial  interests (in OJ 23.12.95, L 312/1) , which has, or would have, the effect of prejudicing the  Union’s budget, it being understood that the Union’s financial interests are impacted within the  framework of this PA, as the Union is engaging resources into the coordination and preparation  of the PA, resulting from the Decision which approved the agreement with Member States on  procuring COVID-19 vaccines on behalf of the Member States, this agreement being based on  Article 4(5)(b) of the ESI Regulation;  [***]  “Key Supply/ies”: means those critical components, services and other critical input items  required for the development, production and supply of the Vaccine pursuant to this PA, for  which a delay in their supply is capable of materially adversely affecting the timely  performance of the Contractor’s delivery obligations under this PA.   [***]  [***]  ‘Latent Defect’: means a defect causing the Product to not conform to the applicable  Specifications which could not have been detected by the Participating Member State, its  designee, or their personnel at delivery through visual inspection;    3   OJ L 70, 16.3.2016, p.1, as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support  under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID‐19 outbreak, OJ L 117, 15.4.2020,  p. 3.  

 

  ‘Law(s)’: means, collectively, all applicable supranational, national and local laws, common  laws, statutes, ordinances, codes, rules, regulations, orders, decrees or other pronouncements  of any government, administrative or judicial authority having the effect of law;  ‘Losses’: has the meaning set forth in Article 0;  ‘Marketing Authorisation’: means the marketing authorisation (other than Conditional  Marketing Authorisation), in respect of the Product granted by the European Commission, as  amended or varied from time to time, that allows the Product to be placed on the market in the  European Economic Area according to applicable Law;  “New Countries”: has the meaning set forth in Article I.6.3;  ‘Non-Complying Product’: has the meaning set forth in Article I.6.14;  “Non-EU Key Supply/ies”: means Key Supply/ies for which, at the time of production of  the Vaccine pursuant to this PA, no supplier exists in the European Union that could provide  the component, service and other input item from the territory of the EU. [***]  ‘Notification’ (or ‘notify’): form of communication between the parties made in writing  including by electronic means;  ‘Participating Contractor Affiliate’: means an Affiliate of Pfizer or BioNTech as  identified in Annex V;  “PMS Experts” means, in relation to each Participating Member State, one (1) clinical expert  employed by, or advising, such Participating Member State in connection with the COVID-19  pandemic, the identity of such individual to be communicated by the Commission to Contractor  promptly following the Effective Date (it being understood that if Contractor expresses a  reasonable objection to the identity of a PMS Expert, the relevant Participating Member State  will suggest an alternative expert);  [***]‘Product’: means the Vaccine;  ‘Product Materials’: means all packaging materials and components needed for delivery of  the Product;  ‘Professional conflicting interest’: a situation in which the Contractor’s previous or ongoing  professional activities affect its capacity to implement the PA or to perform a Vaccine Order  Form to an appropriate quality standard;  ‘Record’: means books, documents, and other data, of all matters relating to performance of  obligations under this PA;  

 

  ‘Related person’: any natural or legal person who is a member of the administrative,  management or supervisory body of the Contractor, or who has powers of representation,  decision or control with regard to the Contractor;  [***][***]‘Specifications’: means the specifications for the manufacture, testing and testing  procedures, and supply of the Product as set out in Attachment 1 (Specifications), and as such  specifications may be amended, supplemented or otherwise modified by the Contractor and  communicated to the Commission;  ‘Taxes’: has the meaning set forth in Article II.17.1;  ‘Term’: means the term of the PA set out in Article I.4.2 of the PA;   ‘Thermal Shipper’: has the meaning set forth in Article I.6.8;   ‘Third Party Claim’: has the meaning set forth in Article 0.  ‘Vaccine’: the medicinal product, being BNT162b2, a nucleoside-modified messenger RNA  (mRNA) vaccine that encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S)  for which Authorisation has been granted, [***].  ‘Vaccine IP Rights’: has the meaning set forth in Article I.11;  ‘Vaccine Order Form”: has the meaning set forth in Article I.5.2; and  [***]Except where the context expressly requires otherwise, (a) the use of any gender herein  shall be deemed to encompass references to either or both genders, and the use of the singular  shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and  “including” shall be deemed to be followed by the phrase “without limitation", (c) the word  “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any  definition of or reference to any agreement, instrument or other document herein shall be  construed as referring to such agreement, instrument or other document as from time to time  amended, supplemented or otherwise modified (subject to any restrictions on such  amendments, supplements or modifications set forth herein), (e) any reference herein to any  person shall be construed to include the person's successors and assigns, (f) the words “herein”,  “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this PA  in its entirety and not to any particular provision hereof, (g) all references herein to Articles,  Annexes or Attachments shall be construed to refer to Articles, Annexes or Attachments of this  PA, and references to this PA include all Annexes and Attachments hereto, (h) the word  “notice” means notice in writing or by email (whether or not specifically stated) and shall  include notices, consents, approvals and other written communications contemplated under this  PA, (i) provisions that require that a party or parties “agree”, “consent” or “approve” or the like  shall require that such agreement, consent or approval be specific and in writing, whether by  written agreement, letter, approved minutes or otherwise (including e-mail), (j) references to  any specific law, rule or regulation, or article, section or other division thereof, shall be deemed  to include the then-current amendments thereto or any replacement or successor law, rule or  regulation thereof.  I.3 SUBJECT MATTER  The subject of the call for tenders SANTE/2021/03/020 is securing the purchase of certain  vaccine doses for the Participating Member States.  

 

  Following the Decision, taken in accordance with Article 4(5)(b) of the ESI Regulation, the  Commission is running procurement procedures on behalf of Participating Member States, with  a view to signing EU-level Advance Purchase Agreements and Purchase Agreements with  vaccine manufacturers.   An APA between the Parties was signed on 20 November 2020 (“APA”). Subsequently, a PA  between the Parties was signed on 17 February 2021 (“PA.1”).  In compliance with Article 164(l)(d) as well as Annex I, Points 11.1(b)(ii) and 11.1(c) of the  Financial Regulation, the Commission launched on 9 April 2021 a negotiated procedure  without prior publication of a contract notice for the procurement of additional doses of  vaccines. This procedure was justified by the need to urgently secure an exceptionally high  amount of additional doses of vaccines to address the pandemic within a reasonable period of  time, as well as by the absence of competition for technical reasons. This PA is for such  additional doses, and while it is organised following the Decision, it is entirely separate from  the APA and from the PA.1 between the Parties.  In view of its importance, this PA will be approved for signature on behalf and in the name of  the Participating Member States by a separate individual Commission decision.  The Conditional Marketing Authorisation for the Vaccine was granted on 21 December 2020.  The Commission, on behalf of the Participating Member States, wishes to purchase the Vaccine  through this PA to ensure the availability in the European Union of sufficient vaccine doses to  address the pandemic [***].  On the basis of this PA, the European Commission commissions the Contractor to commit to  produce and deliver 900 million doses of the Vaccine which shall be ordered by the  Participating Member States (via specific Vaccine Order Forms) at the price and conditions,  including timeframe, agreed under this PA, with the option to obtain a further 900 million doses  of the Vaccine subject to the conditions set out in this PA.  The Contractor or a Participating Contractor Affiliate shall supply to the Participating Member  States the agreed doses of the Vaccine pursuant to the Vaccine Order Forms.   The Vaccine Order Forms shall be signed by the Contractor and shall incorporate by reference  this PA.  I.4 ENTRY INTO FORCE AND DURATION OF THE PA  I.4.1 The PA enters into force on the date on which the last party signs it (“Effective Date”).  I.4.2 The PA is concluded for a period of thirty six (36) months with effect from the Effective  Date (“Term”).  I.4.3 Contractor and the Participating Member States may not sign any Vaccine Order Form  after the PA expires.  I.4.4 The PA continues to apply to such Vaccine Order Forms after its expiry. [***].  

 

  I.4.5 Renewal of the PA   The PA will expire automatically at the end of the Term, unless it is extended in mutual written  agreement between the parties. For the avoidance of doubt, if the exercise of the Additional  Order involves delivery of doses beyond the Term, the parties shall agree to a renewal until the  end of the last month for which deliveries of the Additional Order are foreseen in the relevant  delivery schedule. This renewal process will be repeated until all doses have been delivered.   Renewal does not change or postpone any existing obligations.  I.5 IMPLEMENTATION OF THE PA   I.5.1 Period of provision of the supplies  The period for the provision of the supplies starts to run as foreseen in Article I.6.3.   I.5.2 Implementation of the PA  The PA shall be implemented following signature between the Commission and the Contractor  as follows:  The Contractor agrees to supply an initial total number of 900 million Vaccine doses to  Participating Member States collectively, upon their order, in accordance with this PA and the  respective Vaccine Order Forms.  The Participating Member States shall place orders for supplies of 900 million Vaccine doses  in total in accordance with the allocation communicated by the Commission to the Contractor  pursuant to Article I.6.3, by sending the Contractor a completed copy of Annex I (“Vaccine  Order Form”) in paper format or emailed pdf [***]. This Vaccine Order Form shall be signed  by an authorised representative of the Participating Member State and the Contractor.  [***] the Contractor must send back to the Participating Member States the duly signed and  dated Vaccine Order Form in paper format or emailed pdf.  I.6 SUPPLY OF THE VACCINE  I.6.1 General  During the term of this PA, the Contractor shall supply or have supplied the Product to the  relevant Participating Member States, and the Participating Member States shall purchase the  Product, subject to and in accordance with the terms and conditions of this PA.  I.6.2 Product supply  At the Effective Date, the Commission orders 900 million doses (“Contracted Doses”) of the  Product on behalf of the Participating Member States. The Contracted Doses shall be delivered  by the Contractor to the Participating Member States in accordance with the allocation provided  by the Commission and according to the schedule and in the quantities [***] as set out in the  Delivery Schedule.     The Additional Order    

 

  The parties acknowledge that the Commission may wish to place an additional binding order  (the “Additional Order”) for a maximum of up to 900 million doses of the Vaccine, to be  exercised (unless otherwise agreed by the parties) in minimum tranches of [***]). Vaccine to  be supplied pursuant to an Additional Order will be “Additional Product”. [***].   The parties also agree that such Additional Order may be placed by the Commission only after  (i) the Contractor confirms whether the doses are available (if the request is for more than the  minimum Additional Order volume of [***]) and when they can be delivered (ii) the  Commission confirms the required allocation between Participating Member States and (iii)  the Contractor confirms the delivery schedule which shall be based on the allocation provided  (and which shall not commence earlier than [***] ).   All Additional Orders must be placed by the Commission by [***] .  The Participating Member States participating in one or more tranches of the Additional Order  shall be obliged to send an additional Vaccine Order Form for each tranche of the Additional  Order in which they participate. All terms and conditions included in this PA, in particular  those included in Article I.6.3 with regard to Deliveries, [***] , shall apply mutatis mutandis  to the Additional Order.   The Commission shall communicate to the Contractor the allocation of the Contracted Doses  supplied pursuant to the initial order and any Additional Product among the Participating  Member States.    Resale and Donation  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]  [***]      I.6.3 Supply mechanism  The supply under this PA shall in principle come from [***], and shall incorporate RNA  produced at [***]manufacturing sites, including, [***] sites operated by the following sub- contractors:    [***]  [***]  [***]  [***]  [***]      

 

  The parties acknowledge that Contractor is not obliged to use all these sites provided it has  sufficient capacity.    Recognising the urgency of the public health crisis and the necessity to hasten/enable supply,  (1) the Commission and Participating Member States shall make best reasonable efforts, where  appropriate in collaboration with the European Medicines Agency, to expedite any relevant  and outstanding authorisations required for supply to commence from the Contractor’s  controlled manufacturing sites [***]; [***]     Delivery  The Contracted Doses shall be delivered by the Contractor to the Participating Member States  in accordance with the allocation provided by the Commission and according to the schedule  and in the quantities [***] as set out in the following table (the “Delivery Schedule”):  [***]  [***]    Within [***] following the Effective Date, the Commission shall communicate to the  Contractor a table how to allocate the 900 million Vaccine doses amongst the Participating  Member States. Each Participating Member State shall have a commitment to purchase the  number of Vaccine doses as set out in such allocation table and, to operationalise the ordering  of the Vaccine, each Participating Member State will enter into a Vaccine Order Form per  Article I.5.2. Each Vaccine Order Form will specify in particular the number of doses that the  Participating Member State will purchase from the above-mentioned allocation table, the price  of all Vaccine doses pursuant to Article I.7, and the liability and indemnification undertakings  by the Participating Member State (which will be incorporated by reference from the PA into  the Vaccine Order Form). For the avoidance of doubt, the Contractor shall have no obligation  to supply any Vaccine doses to any Participating Member State where there is not a Vaccine  Order Form, including provisions related to liability and indemnity (which will be incorporated  by reference from the PA into the Vaccine Order Form executed by the Participating Member  State and the Contractor). It is agreed that the Contractor may discharge its obligations under  the Vaccine Order Form acting with one or more Participating Contractor Affiliates.  The Delivery Schedule and logistics will be further refined into a [***] schedule by the  Contractor in accordance with provisions below, after the execution of the Vaccine Order Form  for that Participating Member State.   To operationalise the Vaccine Order Forms, [***].  For the avoidance of doubt, the Delivery Schedule is firm and no adjustments can be made  without the written agreement of the parties. This is without prejudice to the ability of the  Contractor to accelerate supply [***] .    [***]  [***]  [***]  [***]  .  

 

      I.6.4 Manufacturing  The Contractor warrants that [***].   The Contractor confirms that it is in possession of all necessary manufacturing authorisations  to undertake the manufacturing of the Vaccine.   The Contractor also warrants that, [***].  For the purpose of fulfilling its obligation to manufacture the Vaccine , the Contractor shall, in  principle, procure all Key Supplies [***] .  For each such Key Supply including, in particular, Non-EU Key Supplies, the Contractor  commits that it will have in place, when producing the Vaccine doses covered by this PA, an  effective supply management system [***].   I.6.5 Legal and regulatory filings and requests  The Contractor shall ensure that all Product is properly labelled and packaged in accordance  with the provisions of Article I.6.8 and Good Manufacturing Practice and in accordance with  the applicable EU legislation on information on packaging (Title V of Directive 2001/83/EC).    Notwithstanding the above, [***]the Contractor shall comply with all conditions (in the  relevant timescales) set out in the Authorisation (where applicable), subject to any exemption,  exception or waiver of requirements for the Product granted or permitted by the Participating  Member State (including but not limited to serialization).  I.6.6 [***]  I.6.7 Waiver    [***]  [***]  .  I.6.8 Packaging, labelling and shipping  At the date of execution of this PA, the Vaccine is expected to be supplied in a thermal shipping  box in accordance with Attachment 4 (Labelling and Packaging Specifications) (“Thermal  Shipper”). [***]. The costs of packaging, packing materials, addressing, labelling, loading and  delivery to the agreed Participating Member States’ delivery point of the Vaccine [***].  All deliveries shall be accompanied by the documentation specified in Attachment 2 (Delivery  Documentation) (which may be updated from time to time by the Contractor upon notice to the  Commission), and shall be in accordance with, and subject to, the delivery specification set  forth in Attachment 3 (Delivery Specification). The Product shall be labelled and packaged in  

 

  accordance with the packaging specifications set forth in Attachment 4 (Labelling and  Packaging Specifications).   Final specifications including package size and labels will be communicated to the  Commission and to the Participating Member States prior to delivery. All specifications shall  be consistent with any conditions set out in the Authorisation and applicable Law.  I.6.9 Storage, transport and product acceptance      [***].  Final storage specifications, based on the Authorisation received, will be communicated to the  Participating Member State prior to delivery.   [***]  [***]  I.6.10 Delivery  The Contractor will deliver the doses ordered by each of the Participating Member States to  one or more locations selected by the Participating Member State in accordance with the  procedure set out in this Article I.6.10 and the Vaccine Order Form. [***]. For the avoidance  of doubt, the Participating Member States shall bear all costs and expenses for operating these  distribution hubs and for use of the Vaccine, including, but not limited to, those for storage and  distribution of the Vaccine after delivery, local duties and local QA testing.  The Participating Member States must have all appropriate facilities and personnel in place to  enable the timely receipt of delivered doses. The duly authorised representative of the  Participating Member State shall sign to confirm receipt of delivery (the current proposed  format of which is as set out in Attachment 2 (Delivery Documentation)). The person signing  for receipt must ensure the contents of the delivery match the accompanying shipping  documentation proof of receipt.  The Contractor shall deliver the Product [***] to the location agreed pursuant to this Article  I.6.10.   The Contractor  and the Participating Member State shall agree the location(s) for delivery of  shipments of the Product; provided that (i) each location meets the requirements set forth in  Attachment 3 (Delivery Specification), and (ii) all locations which are additional to those  approved in advance by the Contractor prior to the Effective Date shall be agreed upon by the  Contractor and the Participating Member State [***].   All shipments of Product [***] or such other amount as notified to the Commission from time  to time by the Contractor in accordance with the terms of this PA.   I.6.11 Product handling  Upon delivery of the Product, the Participating Member State shall store and handle the Product  in the manner set forth in the Specifications set forth in Attachment 1 (Specifications), the  

 

  instructions in Attachment 3 (Delivery Specification) and the instructions provided by the  Contractor to ensure stability and integrity of the Product.   The Participating Member States shall be solely responsible and liable for the proper storage,  handling, distribution, transportation, administration, use and disposal of the Product in their  [***] following delivery of the Product to the Participating Member State or its designee.  Without prejudice to the generality of the foregoing, the Participating Member States shall  ensure that: (a) recipients of the Product shall follow the return and disposal instructions in  Attachment 5 (Return and Disposal of Product Materials) when disposing of open and unused  Product and its packaging components; and (b) such return and disposal complies with Laws  regarding pharmaceutical waste, medical waste, or hazardous waste, as appropriate.  Participating Member States shall be responsible for and shall ensure that any equipment used  to deliver the Product, for example [***] are stored in an appropriate clean and secure location  to protect and maintain the functionality of such equipment (in controlled conditions, with no  exposure to weather or pests, etc). Within [***] of receipt of the Product, subject to Article  I.6.14, the Participating Member State shall take the necessary measures to enable the  collection by the Contractor of all such equipment, including [***] in accordance with the  Contractor’s instructions, consistent with the provisions of Attachment 5 (Return and Disposal  of Product Materials).  The Contractor may provide Safety Data Sheets and other agreed information to Participating  Member States [***]. .   I.6.12 Title to Product and risk of loss    [***]  I.6.13 Quality tests and checks    [***]  .  I.6.14 Rejection of Product; Disposal of rejected shipments  A Participating Member State must visually inspect the Product [***] following the  instructions set out in Attachment 3 (Delivery Specification) and may reject any specific  delivery of the Product or doses therein that does not conform [***] (“Non-Complying  Product”) by providing notice to Pfizer Customer Service following an agreed protocol:[***].   Without prejudice to the right to refer the matter to the dispute resolution procedure set out in  Article I.1 and the provision on [***] , replacement of Non-Complying Product [***]. The  provisions of this Article I.6.14 shall survive termination or expiration of this PA.  I.6.15 Maintenance and retention of Records  Each party shall maintain [***] with respect to its activities under this PA as required by Laws.  The Participating Member State will maintain a quality system for receipt, inspection, storage,  traceability to further delivery points, and recall activities. If the Participating Member State  

 

  does not have a quality system for the activities defined, the Contractor may share details of a  proposed quality system for the Participating Member State’s compliance.    I.6.16 Diversion issues  All Product delivered to a Participating Member State shall be: (a) stored securely by the  Participating Member State; and (b) without prejudice to Article I.6.2, distributed by the  Participating Member State in a secure manner appropriate to the transportation route and  destination, in each case (a) and (b) to guard against and deter theft, diversion, tampering,  substitution (with, for example, counterfeits) or unauthorised resale or export out of the  Participating Member State, and to protect and preserve the integrity and efficacy of the  Product. [***]   I.7 PRICES  The price of the Vaccine to the Commission and the Participating Member States for the 900  million Contracted Doses and any Additional Order will be [***]   I.8 PAYMENT ARRANGEMENTS  I.8.1 [***]  I.8.2 [***]Delivery Price  The Delivery Price for the Contracted Doses and any Additional Order is to be paid by the  Participating Member State to the Participating Contractor Affiliate [***]..   [***]  [***]The Participating Contractor Affiliate may claim the payment of the Delivery Price in  accordance with this Article I.8.2. The Participating Contractor Affiliate must send an invoice  in paper format or emailed pdf for payment of the balance due under a Vaccine Order Form for  each provision of supplies to the Participating Member States.  Invoices shall be established by the Participating Contractor Affiliate for a given order of  supplies and for an identified delivery scheduled within the Vaccine Order Form.  The  Participating Contractor Affiliate may not send an invoice to a Participating Member State  before it receives from the Participating Member State [***]in respect of which such invoice  is established, which [***] .  The Participating Contractor Affiliate must send an invoice in paper format or emailed pdf or  by electronic systems for payment due under the Vaccine Order Form accompanied by the  following:    - [***]  Each invoice must contain the following information:  - Name of the Participating Member State concerned  - PA and Vaccine Order Form number/reference  - Order reference  -  Billing address  - Product [***]  

 

  - Quantity [***]  - [***] reference and date  - Price  - Any applicable taxes, transportation charges or other charges provided for in the   Vaccine Order Form  -  The ship-to destination  -  [***]  - Participating Contractor Affiliate name and bank account.  The Participating Member States must approve the submitted documents or deliverables as  conforming to the above requirements and pay [***]. Any payment which falls due on a date  which is not a business day may be made on the next succeeding business day. Any dispute by  a Participating Member State of an invoice shall be provided to the Participating Contractor  Affiliate in writing (along with substantiating documentation and a reasonably detailed  description of the dispute) [***]. A Participating Member State will be deemed to have  accepted all invoices for which the Participating Contractor Affiliate does not receive timely  notification of disputes, and shall pay all undisputed amounts due under such invoices within  the period set forth in this Article I.8.2. The parties shall seek to resolve all such disputes  expeditiously and in good faith.  In addition to all other remedies available under this PA or at Law, if a Participating Member  State fails to pay any undisputed amounts when due under this PA, the Contractor [***].  The Commission and the Participating Member States shall not, and acknowledge that they  will have no right, under this PA, any Vaccine Order Form, any order, any other agreement,  document or Law, to withhold, offset, recoup or debit any amounts owed (or to become due  and owing) to the Participating Contractor Affiliate, against any other amount owed (or to  become due and owing) to it by the Contractor or an Affiliate.    [***]  [***]  I.8.3 Bank account  Payments by the Commission must be made to [***]:[***][***][***][***][***]  I.9 COMMUNICATION DETAILS  For the purpose of this PA, communications must be sent to the following addresses:  If to the Commission:  European Commission  Directorate-General for Health and Food Safety  E-mail: SANTE-PROCUREMENT@ec.europa.eu     If to a Participating Member State  – See details in Vaccine Order Form  

 

  By derogation from this Article I.9, different contact details for the Commission, the  Participating Member States or the Contractor may be provided in Vaccine Order Form.  I.10 PROJECT MANAGEMENT  Pfizer, BioNTech and the Commission will each nominate a project manager that will be the  sole contact point for and responsible for managing the overall relationship between the parties.  Each Participating Member State shall in addition appoint an expert to work on PA  implementation at Participating Member State level. Project meetings with the Commission  and Participating Member State experts will be held regularly on a timeframe to be determined  following execution of the PA to report, amongst other things, on progress of clinical studies,  licensing activities, manufacturing status, forecast and deliveries. Details specific to each  Participating Member State such as logistics and payments shall be handled directly by the  respective Participating Member State experts.  I.11 EXPLOITATION OF THE RESULTS OF THE PA  The Commission acknowledges and agrees [***] (collectively, the “Vaccine IP Rights”).  [***] . All rights not expressly granted by the Contractor hereunder are reserved by the  Contractor.  I.12 INDEMNIFICATION   The Commission, on behalf of the Participating Member States, declares that the use of  Vaccines produced under this PA will happen under epidemic conditions requiring such  use, and that the administration of Vaccines will therefore be conducted under the sole  responsibility of the Participating Member States. [***] .  I.13 APPLICABLE LAW AND SETTLEMENT OF DISPUTES   I.13.1 This PA shall be governed by the laws of Belgium.  [***]  I.14 OTHER SPECIAL CONDITIONS  The Contractor shall keep the Commission and the Participating Member States informed about  [***] during the pharmacovigilance or vaccine monitoring programmes in relation to the  Vaccines which are the object of this PA [***].     SIGNATURES  For the Contractor,   [***][***][***].     For the Commission, on behalf and in the  name of the Participating Member States,  [forename/surname/position]      

 

  Signature:   Signature:   Done at [place], [date]  Done at [place], [date]  In duplicate in English.       

 

  II. GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT   II.1 DEFINITIONS  All definitions are contained in Article I.2 or in the relevant provisions of this PA.   II.2 ROLES AND RESPONSIBILITIES IN THE EVENT OF A JOINT TENDER  In the event of a joint tender submitted by a group of economic operators and where the group  does not have legal personality or legal capacity, one member of the group is appointed as  leader of the group.  II.3 SEVERABILITY  Each provision of this PA is severable and distinct from the others. If a provision is or becomes  illegal, invalid or unenforceable to any extent, it must be severed from the remainder of the  PA. This does not affect the legality, validity or enforceability of any other provisions of the  PA, which continue in full force and effect. The illegal, invalid or unenforceable provision  must be replaced by a legal, valid and enforceable substitute provision which corresponds as  closely as possible with the actual intent of the parties under the illegal, invalid or  unenforceable provision. The replacement of such a provision must be made in good faith  between the parties. The PA must be interpreted as if it had contained the substitute provision  as from its entry into force.  II.4 PROVISION OF SERVICES AND SUPPLIES  II.4.1 All periods specified in the PA are calculated in calendar days, unless otherwise  specified.  II.4.2 The Contractor must immediately inform the Commission of any changes in the  exclusion situations as declared, according to Article 137 (1) of Regulation (EU)  2018/1046.  II.5 COMMUNICATION BETWEEN THE PARTIES  II.5.1 Form and means of communication  Any formal notification under the PA must:  (a) be made in writing in paper or electronic format in the language of the contract;  (b) bear the PA number and, if applicable, the Vaccine Order Form number;  (c) be made using the relevant communication details set out in Article I.9; and  (d) be sent by mail or email.  If a party requests written confirmation of an e-mail within a reasonable time, the other party  must provide an original signed paper version of the communication as soon as possible.  The parties agree that any communication made by email has full legal effect and is admissible  as evidence in judicial proceedings.  

 

  II.5.2 Date of communications by mail and email  Any communication is deemed to have been made when the receiving party receives it, unless  this PA refers to the date when the communication was sent.  E-mail is deemed to have been received by the receiving party on the day of dispatch of that e- mail, provided that it is sent to the e-mail address indicated in Article I.9. The sending party  must be able to prove the date of dispatch. In the event that the sending party receives a non- delivery report, it must make every effort to ensure that the other party actually receives the  communication by email or mail. In such a case, the sending party is not held in breach of its  obligation to send such communication within a specified deadline.  Mail sent to the Commission or the Participating Member State is deemed to have been  received on the date on which the department responsible referred to in Article I.9 registers it.  Formal notifications are considered to have been received by the receiving party on the date of  receipt indicated in the proof received by the sending party that the message was delivered to  the specified recipient.  II.6 LIABILITY  II.6.1 During the term of this PA, [***].  II.6.2 [***].  II.6.3 The Commission and the Participating Member States shall [***]to mitigate both (1)  the damages that would otherwise be recoverable from the other or the Contractor  pursuant to this PA and the Vaccine Order Forms, and (2) any costs, fees, expenses or  losses that may be incurred by the Commission or the Participating Member State, or  for which the Contractor may be responsible, under this PA and/or any Vaccine Order  Form, by taking appropriate and reasonable actions to reduce or limit the amount of  such damages, costs, fees, expenses or losses.  II.6.4 Limits on liability  (i) Taking into account the unprecedented nature of the current COVID-19  situation and the exceptional circumstances under which the Vaccine shall be  delivered, the parties explicitly agree that [***].  (ii) [***].  (iii) The Contractor shall not be liable for any breach or non-compliance of this PA  solely and exclusively towards the Participating Member State or any third  parties acting on its behalf, whenever that Participating Member State or third  parties acting on its behalf acted in breach of the Participating Member State’s  obligations under this PA or any Vaccine Order Form;  (iv) The aggregate liability of the Contractor and its Affiliates towards the  Commission arising out of or relating to this PA and/or the Vaccine Order  Forms (whether arising contractually or extra-contractually), shall not exceed  [***].  

 

  (v) The liability of the Contractor and its Affiliates towards the Participating  Member States arising out of or relating to this PA and/or any Vaccine Order  Form concluded with a Participating Member State (whether arising  contractually or extra contractually), shall not exceed [***].  (vi) [***].  II.6.5 No limitation of liability  Nothing in this PA excludes or limits the liability of either party for:  [***]  II.6.6 Waiver of sovereign immunity   Each Participating Member State represents that it has adequate statutory or regulatory  authority and adequate funding appropriation to undertake and completely fulfil the  indemnification obligations pursuant to Article I.12 of this PA.    II.6.7 Recall  In the event of a recall of the Vaccine, [***].  II.7 CONFLICT OF INTEREST AND PROFESSIONAL CONFLICTING INTERESTS  II.7.1 The Contractor must take all the necessary measures to prevent any situation of conflict  of interest or professional conflicting interest.  II.7.2 The Contractor must notify the Commission in writing as soon as possible of any  situation that could constitute a conflict of interest or a professional conflicting interest  during the Implementation of the PA. The Contractor must immediately take action to  rectify the situation.  The Commission may do any of the following:  (a) verify that the Contractor’s action is appropriate;  (b) require the Contractor to take further action within a specified deadline;  (c) decide not to award a Vaccine Order Form to the Contractor.  II.7.3 The Contractor must pass on all the relevant obligations in writing to:   (a) its personnel which is directly involved in the performance of this PA;  (b) any natural person with the power to represent it or take decisions on its behalf;  (c) third parties involved in the Implementation of the PA, including  subcontractors.  The Contractor must also ensure that the persons referred to above are not placed in a situation  which could give rise to conflicts of interest.  

 

  II.8 Representations and warranties  II.8.1 Mutual representations and warranties  The parties each represent and warrant to each other the following:  (i) Organization and authority. They have full right, power and authority to enter  into this PA and to perform their respective obligations under this PA;  (ii) No conflicts or violations. The execution and delivery of this PA by such party  and the performance of such party’s obligations hereunder (i) do not conflict  with or violate any laws existing as of the date of entry into force of the PA and  applicable to such party and (ii) do not and will not conflict with, violate, breach  or constitute a default under, and are not prohibited or materially restricted by,  any [***] contractual obligations of such party; [***]; and  (iii) Valid execution. Such party is duly authorised to execute and deliver this PA,  and the person executing this PA on behalf of such party is duly authorised to  execute and bind such party to the terms set forth herein.  The above warranties shall also be given by the Participating Member States in respect  of the Vaccine Orders Forms and their obligations contained therein.  II.8.2 Warranties of either party  The Contractor warrants to the Commission and the Participating Member States that:     [***]  [***]  In the event of any breach of the Contractor’s warranties or undertakings relating to the  Vaccine, the Commission’s and the Participating Member States’ [***].   The Commission and the Participating Member State warrant that the PA is awarded and each  Vaccine Order Form is concluded in accordance with applicable Laws.  [***].  II.8.3 Anti-bribery/anti-corruption  The parties represent and warrant that, beyond the mutual consideration set forth in this PA,  neither they nor their agents have provided or requested, or will provide or request, any  additional incentive or benefit to or from the other party or its agents to induce either party to  enter into this PA or perform any part of this PA.  The Contractor has not made, and will not make, in the performance of this PA directly or  indirectly any payment, offer, promise, or authorisation of payment of money or anything of  value to a government official, political party, candidate for political office, or any other  person, and has not sought and will not seek improperly or corruptly to influence any  government official, political party, candidate for political office, or any other person, in order  to gain an improper business advantage.  

 

  II.8.4 No other warranty  Except to the extent set out expressly in this PA, all conditions, warranties or other terms which  might have effect between the parties or be implied or incorporated into this PA (whether by  statute, common law or otherwise) are hereby excluded to the fullest extent permitted by  applicable Law. [***].  II.9 CONFIDENTIALITY  II.9.1 Neither the Commission, a Participating Member State nor the Contractor shall, at any  time, without the disclosing party’s prior written consent, disclose to any third party  any of the other party’s Confidential Information.  II.9.2 The Commission, the Participating Member State and the Contractor shall:  (a) use such Confidential Information solely for the purposes for which it was  provided;  (b) take all reasonable precautions to prevent any unauthorised use or disclosure;  (c) not disclose or distribute any Confidential Information to any third party  except as and to the extent authorised in writing to do so by the disclosing  party.  II.9.3 The receiving party shall be permitted to disclose Confidential Information that is  required or requested to be disclosed by a governmental authority pursuant to applicable  law in connection with any other legal or administrative proceeding, provided that it (i)  notifies the disclosing party of any such disclosure requirement or request as soon as  practicable and (ii) furnishes only that portion of the Confidential Information which,  in the opinion of the receiving party or their legal counsel, is responsive to such  requirement or request and (iii) asks the court or other public body, if applicable, to  treat the Confidential Information as confidential.  II.9.4 The receiving party shall disclose Confidential Information only to such of its  representatives who have a need to know such Confidential Information to fulfil its  obligations under this PA; provided, however, before any disclosure of Confidential  Information, the receiving party shall bind its representatives receiving such  Confidential Information to a written agreement of confidentiality at least as restrictive  as contained in this PA; and prior to any disclosure, the receiving party shall instruct its  representatives of the confidential nature of, and to maintain the confidentiality of, the  Confidential Information. The receiving party shall be responsible for all actions of its  representatives, including any breach of the terms hereof, regardless of whether or not  such representatives remain employed or in contractual privity with the receiving party.  II.9.5 Notwithstanding the foregoing, in all cases, [***] the Contractor may disclose  Confidential Information to their Affiliates without prior written consent of the  Participating Member States.  II.9.6 The confidentiality obligations set out in this Article II.9 are binding on the  Commission, the Participating Member State and the Contractor during the  Implementation of the PA and for as long as the information or documents remain  confidential unless:  

 

  (a) the disclosing party agrees to release the receiving party from the  confidentiality obligation earlier;  (b) the Confidential Information or documents become public through other  means than a breach of the confidentiality obligation;  (c) the applicable Law requires the disclosure of the Confidential Information or  documents.  II.9.7 The Contractor must obtain from any natural person with the power to represent it or  take decisions on its behalf, as well as from third parties involved in the Implementation  of the PA a commitment that they will comply with this Article. At the request of the  Commission, the Contractor must provide a document providing evidence of this  commitment.  II.9.8 Neither this PA nor the performance by either party hereunder shall transfer to the  receiving party any proprietary right, title, interest or claim in or to any of the disclosing  party’s Confidential Information (including, but not limited to, any intellectual property  rights subsisting therein) or be construed as granting a license in its Confidential  Information.  II.9.9 The provisions of this Article II.9 shall survive the termination or expiration of this PA  for [***], except with respect to any information that constitutes a trade secret (as  defined by the applicable Law), in which case the recipient of such information will  continue to be bound by its obligations under this Article II.9 for so long as such  information continues to constitute a trade secret, but in no event for a period of less  than [***] specified above.  II.9.10 The Contractor acknowledges that the Commission is subject to requirements laid down  under Regulation (EC) 1049/2001.The Commission commits that it will consult with  the Contractor on any disclosure request concerning documents containing Confidential  Information as provided for in Article 4(4) of said Regulation.  II.10 ANNOUNCEMENTS AND PUBLICITY  The parties shall consult together on the timing, contents and manner of any press release  relating to the execution of this PA. Other than the foregoing, no party shall make, or permit  any person to make, any public announcement concerning the existence, subject matter or terms  of this PA or a Vaccine Order Form, the wider transactions contemplated by them, or the  relationship between the parties, without the prior written consent of the other party (such  consent not to be unreasonably withheld or delayed), except (i) as required by law, any  governmental or regulatory authority (including, without limitation, any relevant securities  exchange), any court or other authority of competent jurisdiction; or (ii) on terms that are  consistent and do not go further than the matters covered in any agreed press release. For  clarity, unless consent is granted pursuant to this Article II.10, no announcement or disclosure  will [***].  A party shall not use the name, trade name, service marks, trademarks, trade dress or logos of  the other party in publicity releases, advertising or any other publication, without the other  party’s prior written consent in each instance, provided, however, that consent is granted for  public announcements pursuant to above sub-clause (ii) in this Article II.10.  

 

  II.11 PROCESSING OF PERSONAL DATA   II.11.1 Processing of personal data by the Commission  Any personal data included in or relating to the PA, including its implementation, shall be  processed in accordance with Regulation (EU) 2018/1725. Such data shall be processed solely  for the purposes of the implementation, management and monitoring of the PA by the data  controller. For the purpose of this provision, the data controller for the Commission shall be  the Director-General of the European Commission’s Directorate-General for Health and Food  Safety. The data protection notice is available at https://ec.europa.eu/info/data-protection- public-procurement-procedures_en.   The Contractor or any other person whose personal data is processed by the data controller in  relation to this PA has specific rights as a data subject under Chapter III (Articles 14-25) of  Regulation (EU) 2018/1725, in particular the right to access, rectify or erase their personal data  and the right to restrict or, where applicable, the right to object to processing or the right to data  portability.  Should the Contractor or any other person whose personal data is processed in relation to this  PA have any queries concerning the processing of its personal data, it shall address itself to the  data controller. They may also address themselves to the Data Protection Officer of the data  controller. They have the right to lodge a complaint at any time to the European Data Protection  Supervisor.  II.11.2 Processing of personal data by the Contractor  The processing of personal data by the Contractor shall meet the requirements of Regulation  (EU) 2016/679 and be processed solely for the purposes set out by the controller.  II.12 SUBCONTRACTING  II.12.1 The Contractor may not subcontract and have the PA implemented by third parties  beyond the third parties already mentioned in its tender [***].  II.12.2 In the case of subcontracting, the Contractor remains bound by its contractual  obligations and is solely responsible for the Implementation of the PA.  II.12.3 The Contractor must ensure that the subcontract does not affect the rights of the  Commission and the Participating Member States under this PA.  II.13 [***]AMENDMENTS  II.13.1 Any amendment to the PA or a Vaccine Order Form must be made in writing before all  contractual obligations have been fulfilled. A Vaccine Order Form does not constitute  an amendment to the PA.  II.13.2 No amendment can make changes to the PA or a Vaccine Order Form that might alter  the initial conditions of the procurement procedure or result in unequal treatment of  tenderers or contractors.  II.14 ASSIGNMENT  

 

  Neither this PA nor any interest hereunder will be assignable by a party without the prior  written consent of the other party, except as follows: [***]. Neither this PA nor any interest  hereunder will be assignable by a party without the prior written consent of the other party,  except as follows: Force majeure  II.14.1 If a party is affected by Force majeure, it must immediately notify the other party,  stating the nature of the circumstances, their likely duration and foreseeable effects.  II.14.2 A party is not liable for any delay or failure to perform its obligations under the PA or  Vaccine Order Form if that delay or failure is a result of Force majeure. [***].  II.14.3 The parties must take all necessary measures to limit any damage due to Force majeure  and shall use commercially reasonable efforts to avoid or minimize the delay in  performance of their respective obligations affected by Force majeure.    II.15 SUSPENSION OF THE IMPLEMENTATION OF THE PA  II.15.1 Suspension by the Contractor  If the Contractor or a Participating Contractor Affiliate is affected by Force majeure, it may  suspend the provision of the services under a Vaccine Order Form.  The Contractor or the Participating Contractor Affiliate must immediately notify the  Commission of the suspension. The notification must include a description of the Force  majeure and state when the Contractor or the Participating Contractor Affiliate expects to  resume the provision of services.  The Contractor or the Participating Contractor Affiliate must notify the Commission as soon as  it is able to resume performance of the Vaccine Order Form, unless the Commission has already  terminated the PA or the Vaccine Order Form.  II.15.2 Suspension by the Commission or the Participating Member State  Pursuant to the Financial Regulation, the Commission or the Participating Member State may  suspend the Implementation of the PA or performance of a Vaccine Order Form or any part of  it:  (a) if the procedure for awarding the PA or a Vaccine Order Form or the Implementation  of the PA proves to have been subject to Irregularities, Fraud (in the sense of the  Financial Regulation) or breach of obligations;  (b) in order to verify whether the presumed Irregularities, Fraud (in the sense of the  Financial Regulation) or breach of obligations have actually occurred.  The Commission or the Participating Member State in question must formally notify the  Contractor of the suspension and the reasons for it. Suspension takes effect on the date of  formal notification, or at a later date if the formal notification so provides.  The Commission or the Participating Member State in question must notify the Contractor as  soon as the verification is completed whether:  

 

  (a) it is lifting the suspension; or  (b) it intends to terminate the PA or a Vaccine Order Form under Article II.16.1, (f) or (i).  The Contractor is not entitled to compensation for suspension of any part of the PA or a Vaccine  Order Form. For the avoidance of doubt, the Contractor shall not be under any obligation to  deliver any Contracted Doses or the Additional Order during the suspension period, and the  Delivery Schedule shall be adjusted to take into account the period of such suspension. Equally  for the avoidance of doubt, the Contractor shall complete the delivery of any Contracted Doses  or Additional Order that were already in transit on the date of the formal notification or at the  later date indicated in the formal notification.  II.16 TERMINATION OF THE PA  II.16.1 Grounds for termination by the Commission  The Commission may terminate the PA or the Participating Member State may terminate any  on-going Vaccine Order Form (depending on whether the event affects the PA or the Vaccine  Order Form) solely in the following circumstances:  (a) [***].  (b) if the Contractor does not implement the PA or perform the Vaccine Order Form in  accordance with material aspects of the PA or the Vaccine Order Form (as applicable)  or is otherwise in material breach of another substantial contractual obligation;   (c) [***].  (d) if the Contractor or any person that assumes unlimited liability for the debts of the  Contractor is in one of the situations provided for in points (a) and (b) of Article 136(1)  of the Financial Regulation5;  (e) if the Contractor or any Related person is in one of the situations provided for in points  (c) to (h) of Article 136(1) or Article 136(2) of the Financial Regulation;  (f) if the procedure for awarding the PA or the Implementation of the PA proves to have  been subject to Irregularities, Fraud (in the sense of the Financial Regulation) or breach  of obligations;  (g) if the Contractor is in a situation that does constitute a Conflict of interest or a  Professional conflicting interest which would have a material adverse impact on the  performance of the PA;  (h) in case of a change regarding the exclusion situations listed in Article 136 of Regulation  (EU) 2018/1046 that calls into question the decision to award the contract;  (i) [***].  II.16.2 Grounds for termination by the Contractor  The Contractor may terminate the PA or any on-going Vaccine Order Form solely in the  following circumstances:  (a) if the Commission or the Participating Member State does not implement the PA or  does not perform the Vaccine Order Form in accordance with material aspects of the    5   Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules  applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No  1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision  No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, OJ L 193 of 30.7.2018, p.1 https://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1544791836334&uri=CELEX:32018R1046  

 

  PA or the Vaccine Order Form (as applicable) or is otherwise in material breach of  another substantial contractual obligation, [***].    II.16.3 Procedure for termination  A party must formally notify the other party of its intention to terminate the PA or a Vaccine  Order Form and the grounds for termination.  The other party has [***]following the date of receipt to submit observations, including the  measures it has taken or will take to continue fulfilling its contractual obligations. Failing that,  the decision to terminate becomes enforceable the day after the time limit for submitting  observations has elapsed in the event the grounds giving rise to termination have not been  cured.  If the other party submits observations, the party intending to terminate must formally notify it.   II.16.4 Effects of termination  [***] of the date of termination, the Contractor must submit any invoice required for services  that were provided before the date of termination.   The termination or expiration of this PA shall not affect the survival and continuing validity of  Articles I.1, I.2, I.4, I.6.2 (so far as it concerns resale and donation), I.6.7, I.6.9, I.6.11, I.6.12,  I.6.14, I.6.16, I.7 to I.9, I.11 to I.14, II.3, II.5, II.6, II.8.2, II.8.4, II.9 to II.11, II.15, II.17.4, II.18  to II.28, Attachment 3 (Delivery Specification) and Attachment 5 (Return and Disposal of  Product Materials) or of any other provision which is expressly or by implication intended to  continue in force after such termination or expiration.  Expiry or termination of this PA for any reason shall be without prejudice to either party’s  other rights and remedies or to any accrued rights and liabilities as the date of such expiry or  termination; [***].  II.17 INVOICES, VALUE ADDED TAX AND E-INVOICING   II.17.1 Invoices and value added tax  Invoices must contain the Contractor’s or the Participating Contractor Affiliate’s (or leader’s  in the case of a joint tender) identification data, the amount, the currency and the date, as well  as the PA reference and reference to the Vaccine Order Form.  Invoices must indicate the place of taxation of the Contractor or the Participating Contractor  Affiliate (or leader in the case of a joint tender) for value added tax (VAT) purposes and must  specify separately amounts not including VAT and amounts including VAT.  It is understood and agreed between the parties that any prices stated under this PA and Vaccine  Order Form are exclusive of any VAT or similar tax and all other taxes which are incurred as  a result of manufacturing and supplying the Product (including custom duties, levies and  charges and all local taxes) (“Taxes”), which shall be added thereon as applicable.  Where  Taxes are properly chargeable on any amounts payable under this PA or Vaccine Order Form,  the party making the payment will pay the amount of Taxes, as specified on the invoice, in  accordance with the laws and regulations of the country in which the Taxes are chargeable.    

 

    [***]  II.18 PAYMENTS AND GUARANTEES   II.18.1 Date of payment  The date of payment is deemed to be the date on which [***]   II.18.2 Currency  Payments are made in euros or, for non-Eurozone countries, the local functional currency of  the Participating Member State. For non-Eurozone countries, the Vaccine Order Form shall set  forth the Delivery Price in the local functional currency converted from euro at the exchange  rate existing one (1) day prior to the Effective Date of the PA as of 4:00pm London time  published in Bloomberg FX Fixings (BFIX), such rates being found via Bloomberg or the  website www.bloomberg.com/markets/currencies/fx-fixings.    II.18.3 Costs of transfer  The costs of the transfer are borne as follows:  (a) the Commission or the Participating Member State in question bears the costs of  dispatch charged by its bank;  (b) the Contractor or the Participating Contractor Affiliate bears the costs of receipt  charged by its bank;  (c) the party causing repetition of the transfer bears the costs for repeated transfer.  II.18.4 Suspension of the time allowed for payment  The Commission or the Participating Member State in question may suspend the payment  periods specified in Article I.8 at any time by notifying the Contractor or the Participating  Contractor Affiliate (or leader in the case of a joint tender) that its invoice cannot be processed.   [***]   [***]   [***]   .  Suspension takes effect on the date the Commission or the Participating Member State in  question sends the notification. The remaining payment period resumes from the date on which  the requested information or revised documents are received or the necessary further  verification, including on-the-spot checks, is carried out. [***] .   II.18.5 Interest on late payment  On expiry of the payment periods specified in Article I.8, the Contractor or the Participating  Contractor Affiliate (or leader in the case of a joint tender) is entitled to interest on late payment  at the higher of (a) the rate applied by the European Central Bank for its main refinancing  operations in euros (the reference rate) [***] (or such centralized bank reference rate set forth  

 

  in the Vaccine Order Form) and (b) [***] The reference rate is the rate in force, as published  in the C series of the Official Journal of the European Union, on the first day of the month in  which the payment period ends.  Suspension of the payment period as provided for in Article II.18.4 is not considered as giving  rise to late payment.  Interest on late payment covers the period running from the day following the due date for  payment up to and including the date of payment as defined in Article II.18.1.  II.19 RECOVERY  II.19.1 Recovery procedure  In all cases where the recovery procedure as described in the Financial Regulation applies, the  parties shall follow the procedure set out in this Article.  Before recovery, the Commission or the Participating Member State in question must formally  notify the Contractor of its intention to recover the amount it claims, specifying the amount  due and the reasons for recovery and inviting the Contractor to make any observations [***] .  If no observations have been submitted or if, despite the observations submitted, the  Commission or the Participating Member State in question decides to pursue the recovery  procedure, it must confirm recovery by formally notifying a debit note to the Contractor,  specifying the date of payment. The Contractor must pay in accordance with the provisions  specified in the debit note.  If the Contractor does not pay by the due date, the Commission or the Participating Member  State in question may, after informing the Contractor in writing, recover the amounts due:  (a) by offsetting them against any amounts owed to the Contractor by the Commission or  the Participating Member State in question;  (b) by taking legal action.  II.19.2 Interest on late payment  If the Contractor does not honour the obligation to pay the amount due by the date set by the  Commission or the Participating Member State in question, the amount due bears interest at  the rate indicated in Article II.18.5. Interest on late payments will cover the period starting on  the day after the due date for payment and ending on the date when the Commission or the  Participating Member State in question receives the full amount owed.  Any partial payment is first entered against charges and interest on late payment and then  against the principal amount.  II.20 CHECKS AND AUDITS  II.20.1 The Commission and the European Anti-Fraud Office may check or require an audit on  the Implementation of the PA. This may be carried out either by OLAF’s own staff or  by any outside body authorised to do so on its behalf, provided that the auditor may not  be a competitor of the Contractor.  

 

  Such checks and audits may be initiated at any moment during business hours during  the provision of the services and up to [***]  starting from the payment of the balance  of the last specific contract issued under this PA.   The audit procedure is initiated on the date of receipt of the relevant letter sent by the  Commission. Audits are carried out on a confidential basis.  II.20.2 The Contractor must keep all original documents stored on any appropriate medium,  including digitised originals if authorised under national law, for a period of [***]  starting from the payment of the balance of the last specific contract issued under this  PA.  II.20.3 The Contractor must grant the appropriate right of access to sites and premises where  the PA is implemented, [***] , needed to conduct such checks and audits. The  Contractor must ensure that the information is readily available at the moment of the  check or audit and, if so requested, that information is handed over in an appropriate  format. The auditor must, insofar possible, comply with all applicable and reasonable  security measures notified to Commission by the Contractor subject to this not creating  any material obstacles for the performance of the auditor’s tasks.  II.20.4 On the basis of the findings made during the audit, a provisional report is drawn up.  The Commission or its authorised representative must send it to the Contractor, who  has [***] following the date of receipt to submit observations. The Contractor must  receive the final report within [***] following the expiry of the deadline to submit  observations.  On the basis of the final audit findings, the Participating Member State in question may  recover all or part of the payments made in accordance with Article II.19 and may take  any other measures which it considers necessary.  II.20.5 In accordance with Council Regulation (Euratom, EC) No 2185/96 of 11 November  1996 concerning on-the-spot checks and inspection carried out by the Commission in  order to protect the European Communities’ financial interests against fraud and other  irregularities and Regulation (EU, Euratom) No 883/2013 of the European Parliament  and of the Council of 11 September 2013 concerning investigations conducted by the  European Anti-Fraud Office, the European Anti-Fraud Office may carry out  investigations, including on the spot checks and inspections, to establish whether there  has been fraud, corruption or any other illegal activity under the contract affecting the  financial interests of the Union. Findings arising from an investigation may lead to  criminal prosecution under national law.  The investigations may be carried out at any moment during the provision of the  services and up to [***] starting from the payment of the balance of the last specific  contract issued under this PA.  II.20.6 The Court of Auditors and the European Public Prosecutor’s Office established by  Council Regulation (EU) 2017/19398 (‘the EPPO’) have the same rights as the  Commission, particularly right of access, for the purpose of checks, audits and  investigations.  II.21 RELATIONSHIP OF THE PARTIES  

 

  The relationship hereby established between the Contractor and the Commission is solely that  of independent contractors. Neither party has authority to act or make any agreements or  representations on behalf of the other party. This PA is not intended to create, and shall not be  construed as creating, between the parties, the relationship of principal and agent, employer  and employee, joint venturers, co-partners, or any other such relationship, the existence of  which is expressly denied.  II.22 WAIVER  A waiver by any party of any term or condition of this PA in any instance shall not be deemed  or construed to be a waiver of such term or condition for the future, or of any subsequent breach  thereof. All remedies specified in this PA shall be cumulative and in addition to any other  remedies provided at Law or in equity, except where expressly otherwise agreed.  II.23 FURTHER DOCUMENTS  Each party hereto agrees to execute such further documents and take such further steps as may  be reasonably necessary or desirable to effectuate the purposes of this PA.  II.24 HEADINGS  Headings of Articles or other parts of this PA are included herein for convenience of reference  only and shall not constitute a part of this PA or change the meaning of this PA.  II.25 ELECTRONIC DELIVERY AND STORAGE  Delivery of a signed PA by reliable electronic means, including facsimile or email (with receipt  electronically confirmed), shall be an effective method of delivery of the executed PA. This  PA may be stored by electronic means and either an original or an electronically stored copy  of this PA can be used for all purposes, including in any proceeding to enforce the rights or  obligations of the parties to this PA.  II.26 ENTIRE AGREEMENT  This PA, together with any Annexes and Attachments, which are hereby incorporated by  reference, constitute the entire agreement of the parties with respect to its subject matter and  merges and supersedes all prior discussions and writings with respect to thereto.   II.27 COSTS  Each party will bear its own legal costs in preparing and concluding this PA.    

 

  ANNEX I: VACCINE ORDER FORM    This Vaccine Order Form is submitted by:    [The Government of [•]] (the “Participating Member State”), represented for the  purposes of signing this Vaccine Order Form by [forename, surname, function, department  of authorising officer],    to:    Pfizer Inc, incorporated in Delaware (Registration Number 0383418) with its registered  address at 235 East 42nd Street, 10017 New York City, NY (UNITED STATES)  (“Pfizer”);  and  BioNTech Manufacturing GmbH, registered with the commercial register of the lower  court (Amstgericht) of Mainz, Germany under HRB 47548, with its registered address at  An ger Goldgrube 12, 55131 Mainz, Germany (“BioNTech”),  (Pfizer and BioNTech together the “Contractor”, represented for the purposes of signing  this Vaccine Order Form by [***] ).    The Participating Member State and Contractor are together referred to as the “Parties” and  each individually as a “Party”.    WHEREAS  ⎯ Contractor and the European Commission, acting on behalf of and in the name of the  Participating Member States, entered into a Purchase Agreement for the purchase and  supply of Contractor’s Vaccine for EU Member States dated [•] 2021 (the “PA”), the  terms of which are binding on the Participating Member States and must be read in  conjunction with this Vaccine Order Form.    The PA provides that each Participating Member State will submit to Contractor a  Vaccine Order Form through which Contractor shall make available and deliver to the  relevant Participating Member State a proportion of the Contracted Doses or  Additional Order as applicable, in accordance with the allocation provided by the  Commission pursuant to Article I.6.3 of the PA and at the price and conditions as set  out in the PA.     ⎯ In accordance with Article I.5.2 and I.6.2 of the PA, the Participating Member State  hereby places its order for its full allocated portion of the Contracted Doses or  Additional Order (as applicable).  

 

  Article I  Subject matter    1. This Vaccine Order Form is submitted by the Participating Member State to Contractor  in accordance with the terms of the PA, and forms an integral part of the PA.  The  terms and conditions of the PA are incorporated into this Vaccine Order Form by  reference. In the event of contradiction between this Vaccine Order Form and the PA,  the terms of the PA prevail regardless of any provision to the contrary. Any capitalised  terms in this Vaccine Order Form will have the meaning attributed to them in the  definitions list included in Article I.2 of the PA.  2.     This Vaccine Order Form relates to the order for the Participating Member State’s full  allocated portion of the Contracted Doses or the relevant Additional Order (as  applicable) as set out in the allocation provided by the Commission to Contractor  pursuant to Article I.6.2 of the PA.  The submission of this signed Vaccine Order  Form by the Participating Member State to Contractor constitutes a binding order by  the Participating Member State for the purchase of its full allocated portion of the  Contracted Doses or the relevant Additional Order (as applicable) in accordance with  the details set out in the Appendix to this Vaccine Order Form       3. By signature of this Vaccine Order Form, the undersigned Participating Member State  warrants to Contractor that:    a it is irrevocably and unconditionally bound by the terms of the PA (as  concluded by the Commission on behalf and in the name of the Participating  Member States), including the indemnification obligations and the liability,  limitation of liability and exclusions terms set out therein;    b the provisions of the PA are enforceable against it in accordance with its  terms;    c it shall indemnify the Indemnified Persons in accordance with Article  I.12 (Indemnification) of the PA;  d it has full right, power and authority to enter into this Vaccine Order  Form and to perform its respective obligations under it;  e the person executing this Vaccine Order Form is duly authorized to  execute and bind the undersigned Participating Member State to the terms set  forth herein and incorporated by reference.    4. [***] .  5.     

 

  The Participating Member State represents and warrants that all necessary  permissions and approvals have been or will be obtained prior to the time for  performance by the Participating Member State, to authorise performance of all of the  obligations contained herein.    6. Any change to the Appendix to this Vaccine Order Form requires to be agreed by the  parties in writing or by email.      Article II  Delivery, Supply    1. Delivery Address.  The Delivery Address(es) for the Participating Member State is as  set out in the Appendix to this Vaccine Order Form.         2. Supply of the Products    The Contractor shall supply the Products as further described in the PA: [Note:  Include any additional details concerning the supply here.]    Article III  Invoices; Notices    1. Invoice and Payments.  Contractor shall invoice the Participating Member State in  accordance with the terms of the PA.  All payments to Contractor or its designated  Affiliate shall be made in accordance with the terms of the PA.    Payment shall be made in the currency set out in the Appendix to this Vaccine Order  Form.    2. Notice.  Any notice given under this Vaccine Order Form must a) be made in writing  in English in paper or electronic format; b) bear the PA number and the number of this  Vaccine Order Form; c) be made using the relevant communication details set out in  the Appendix to this Vaccine Order Form with respect to the Participating Member  State and Contractor (as applicable); d) be sent by mail and email:     Article IV.   Entry into Force and Duration    1. This Vaccine Order Form shall enter into force on the date of signature by the Parties  and will remain into force until termination of the PA, or if the PA expires, until the last  delivery of Product [***] .  

 

    Article V.  Applicable Law and Settlement of Disputes    1. For the avoidance of doubt, Article I.13 (Applicable Law and Settlement of Disputes)  of the PA shall apply to any dispute arising out of the implementation of or in  connection with this Vaccine Order Form and the Participating Member State  irrevocably agrees to be bound by the provisions set out therein.      

 

  Appendix     Order Details    a. Participating Member State will purchase [insert amount] number of doses of  [Contracted Doses] [Additional Order] of the Vaccine, on the basis of the  following delivery schedule:     [***]    b. The price of [Contracted Doses] [Additional Order] is [***] .  The total amount payable by the Participating Member State for the [Contracted  Doses] [Additional Order] is [insert amount], [***] .  c. The Delivery Address(es) are as follows:  [insert]  d. Payment shall be made in the following currency pursuant to the provisions of  Article II.19.2 of the PA: [to be completed].  e. Details for notices  Participating Member State:  [Name of Participating Member State]  [Full official address of Participating Member State]  [Full name of addressee physical person (contact person)]  [Function of addressee physical person (contact person)]  E-mail: [complete email of addressee physical person (contact person)]    Contractor:  [Add details]          (Signature page follows)   

 

  SIGNATURES    For the Participating Member State,  [forename/surname/position]    Signature:_____________________  Done at [place], [date]        For acceptance of the Vaccine Order Form,  Contractor,  [***] Signature: _______________________  Done at [place], [date]        The invoice will be paid only once the Contractor has returned the signed Vaccine Order Form.       

 

  ANNEX II: AGREEMENT BETWEEN THE COMMISSION AND MEMBER STATES ON PROCURING  COVID-19 VACCINES ON BEHALF OF THE MEMBER STATES AND RELATED PROCEDURES, ANNEXED  TO THE COMMISSION DECISION C(2020) 4192 FINAL OF 18 JUNE 2020    Agreement    Preamble    Having regard to Article 4(5)(b) of Council regulation (EU) 2016/369 on the provision of emergency  support within the Union1as amended by Council regulation (EU) 2020/521 of 14 April 2020 activating  the emergency support under regulation (EU) 2016/369, and amending  its  provisions  taking  into   account  the  COVID-19 outbreak (hereinafter “ESI” or “ESI regulation    ***    The European Commission (“the Commission”)    and    The following Member States: (XXX), hereinafter referred to as “the Participating Member States”    Together referred to as “the Parties”    Agree on the Following:    Article 1: Objective and mandate of the Commission    On  the basis  of  the  present  agreement,  the  Commission  is  mandated  to  conclude,  on behalf of  the Participating Member States, Advance Purchase Agreements (“APA”) with vaccine  manufacturers   with  the  objective  to  procure  vaccines  for  the  purposes  of combatting the COVID 19 pandemic at  Union level.    The Annex to this agreement sets out the negotiating directives for this purpose.    Article 2: Acquisition of vaccine doses    It is the Participating Member States, and not the Commission, that shall acquire vaccine doses  from   the  manufacturers  on  the  basis  of  the  APAs  unless  otherwise  agreed.  All relevant vaccination  policies shall therefore remain matters for the Participating Member States.     Article 3: APAs containing a right to acquire vaccine doses    Where the Commission concludes an APA in conformity with the present agreement that provides  the   right  for  the  Participating  Member  States  to  acquire  vaccine  doses,  the  use of  such a  right  shall   take  place  by  means  of  the  conclusion  of  contracts  between  the Participating Member States and  the vaccine manufacturers. There shall be no obligation for any Participating Member State to conclude  such a contract on the basis of the APA. The APA shall contain a clause to this end.     Article 4: APAs containing an obligation to acquire vaccine doses    Where  the  Commission  intends  to  conclude,  in  conformity  with  the  present  agreement, an   APA    containing   an   obligation   to   acquire   vaccine   doses,   it   shall   inform   the Participating   Member    States   of   such   intention   and   the   detailed   terms.   In   case   a Participating Member State does  

 

  not agree with the conclusion of an APA containing an obligation  to  acquire  vaccine  doses  or  its   terms,  it  has  the  right  to  opt  out  by  explicit notification  to  the  Commission  within  5  working   days  after  the  Commission  has communicated  its  intention  to  conclude  the  APA.  All  Participating   Member  States  not having opted out within the period of 5 working days are deemed to have authorised  the Commission  to  negotiate  and  conclude  the  APA  with  the  vaccine  manufacturer  in  their name  and on their behalf.     Article 5: The legally binding nature of APAs    Once  concluded,  the  terms  of  the  APA  shall  be  legally  binding  on  the  Participating Member  States, except for those who have exercised their right to opt out.    Article 6: Responsibility and liability    The   present   Agreement   regulates   only   the   division   of   potential   liability   and indemnification  between the Commission and the Participating Member States.  It does not regulate the extent to or the  conditions under which potential liability of the vaccine manufacturer may be taken over or indemnified  under the APAs.     The  Commission  shall  be  exclusively  responsible  for  the  procurement  process  and  the conclusion  of APAs including any liability arising out of the conduct of the negotiations.      Participating Member States acquiring a vaccine shall be responsible for the deployment and  use  of   the  vaccines  under  their  national  vaccination  strategies,  and  shall  bear  any liability  associated   with  such  use  and  deployment.  This shall extend to and include any indemnification of vaccine  manufacturers under the terms and conditions of the relevant APA for liability related to the use and  deployment of vaccines normally borne by such manufacturer.    Article 7: Obligation not to negotiate separately    By  signing  the  present  Agreement,  the  Participating  Member  States  confirm  their participation in  the procedure and agree not to launch their own procedures for advance purchase of that vaccine with  the same manufacturers.    In  case    an  APA  containing  an  obligation  to  acquire  vaccine  doses  has  been  concluded with a  specific manufacturer, the Member States having made use of the opt-out provided under   the   present    Agreement   can   enter into   separate   negotiations   with   the   same manufacturer after the APA  under the present Agreement has been signed.    Annex    Initial considerations    A  permanent  solution  to  the  COVID-19  crisis  is  most  likely  to  be  brought  about  by  the  development  and  deployment of  a  safe  and  effective  vaccine  against  the  virus.  Every month   gained  in  the  deployment  of  a  vaccine  will  save  many  lives,  many  jobs  and billions of euros.    Therefore, it is the objective of the present Agreement that the EU takes steps to secure sufficient  supplies of a safe and effective vaccine for Member States.     Structure and purpose of the procurement    Work   on   a   COVID-19   vaccine   is   challenging   for   many   reasons:   the   shortened development   timeframe,  the  large  upfront  costs  for  manufacturers,  the  high  failure  rate during   clinical   trials.    If   vaccine   producers   follow   their   usual   practice   of   making investments in production capacity  

 

  only when they are sure of a viable product, this will result  in  considerably  longer  waiting  times  for   a  vaccine.  Investments need to be made now in order to ensure that vaccines are being produced at the  scale required as early as possible.    Under  the  present  agreement,  this  challenge  will  be  addressed  through  concluding  EU-level   Advance  Purchase  Agreements  (“APA”)  with  vaccine  manufacturers   when necessary,  to  secure   access  to  vaccine  candidates  where  they  are  successful,  including up-front EU financing to de-risk  essential investments to increase the speed and scale of manufacturing  successful  vaccines.  Funding  for the up-front payments will come from the Emergency Support Instrument (ESI).    The Parties understand that developing a safe and effective vaccine is a highly complex process and the  risk of failure in any such venture is very high. Therefore, the aim is to put  in  place APAs  with  a   number  of  manufacturers  of  leading  vaccine  candidates,  to maximise the chances of having access  to at least one successful vaccine.    The Commission will invite all vaccine manufacturers to manifest interest. In general, the Commission   will  give priority  to  negotiating  specific  APAs  with  those  manufacturers that (a) have entered or   have firm plans to enter clinical trials still in 2020, (b) have the capacity  to  develop  a  successful   vaccine  and  (c)  have  a  proven  capacity  to  produce  at scale already in 2021.     Process and governance    In order to run the procurement centrally and efficiently, the European Commission will set  up  a   steering  board  for  the  process  subject  to  Article  6  of  the  present  Agreement.  It will  be  co- chaired  by  the  European  Commission  and  a  Participating  Member  State  with experience in the  negotiations and production capacities for vaccines. The steering board will  include  senior  officials   from  all  Participating  Member  States  to  assist  and  provide guidance throughout the evaluation  process.     The  co-chairs  of  the  steering  board  will  propose  a  team  of  a  limited  number  of  experts with   relevant  experience  for  the  ongoing  negotiations  from  six  Participating  Member States with  production capacities for vaccines. These experts will join with the European Commission  in  a   negotiation  team  (“joint  negotiation  team”),  which  will  work  on  a continuous  basis  as  one  unit.   That  joint  negotiation  team  will  start  work  immediately building  on  previous  contacts  with   individual  companies  by  the  European  Commission and  Participating  Member  States.  In  order   to  launch  negotiations  with  a  specific manufacturer,  there  needs  to  be  support  from  at  least  four   Participating  Member  States. The  joint  negotiation  team  will  make  its  best  effort  to  take  the   advice  of  the steering board  into  account  in  the  negotiations  and  will  report  back  to  the  steering   board  on  a regular basis on the progress made in negotiating with individual companies.     For compliance with the applicable rules, all members of the steering board and the joint negotiation   team  will  obtain  the  status  of  experts  associated  to  the  procurement  process as  provided  in  the   Financial  Regulation.  Given  their  access  to  highly  sensitive  business information,  all  those   members  will  be  required  to  sign  strict  confidentiality  and  no-conflict-of-interest agreements.    Assisted by the steering board, the European Commission will then decide which of the resulting APAs  should be concluded, in particular if financing under ESI is insufficient to finance all relevant packages.   The  Commission  will  only  consider  those  APAs  for financing  where  at  least  four  Participation   Member  States  have  expressed  agreement. Before  making  any  final  decisions,  the  Commission   will  seek  independent  scientific advice on the state of progress and the available  data on quality,  safety  and efficacy for the vaccine candidate in question.     Should  financing  under  ESI  be  insufficient,  Participating  Member  States  can  decide  to top up  ESI funding to make up the gap to finance all packages. In such a case where there are opportunities to  conclude further APAs but money  from ESI is no longer sufficient, Participating  Member  States  will   

 

  have  the  opportunity  to  express  their  interest  in  such opportunities.   If   at   least   four   Participating    Member States   express   interest,   those Participating Member States will make use of the possibility  of a voluntary contribution to ESI to the required amount allowing the Commission to proceed with  signing the APA only  on  behalf  of  those  Member  States  that  have  expressed  interest  and   contributed  the funds to ESI.    For  full  transparency,  the  European  Commission  will  report  to  the  IPCR  at  least  once every two  weeks on overall progress more generally.    Advanced Purchase Agreements and conditions    To  conclude  APAs,  the  joint  negotiating  team  will  negotiate  funding  packages  with individual   vaccine  producers  in  return  for  the  right  to  buy  a  specific  number  of  vaccine doses in a given  timeframe and at a certain price.     As outlined in the present Agreement, the European Commission also has the possibility to conclude  APAs including an obligation to procure the vaccine if it becomes available, where  the  conditions   (notably  the  pricing)  of  those  APAs  make  this  worthwhile  and  in line  with  the  conditions  in   the  present  Agreement.  If  in  such  a  case  the  distinction between  upfront  payments  and  purchase   price  is  difficult  to  draw,  the  Commission  will share  the  total  cost  related  to  the  vaccine   purchase  but  will  in  any  case  contribute  no more than 50% of the total cost.     Funding  provided  up  front  will  be  considered  as  an  advance  payment  for  any  eventual purchase   by  Member  States,  thus  reducing  the  amount  that  Member  States  will  have  to pay when eventually  purchasing that vaccine.     The  up-front  payments  under  the  APAs  shall  be  used  by  manufacturers  to  de-risk  the necessary   investments  related  to  both  vaccine  development  and  clinical  trials,  and  the preparation of the at- scale production capacity along the entire vaccine production value chain  in  the  EU  required  for  a   rapid  deployment  of  millions  of  doses  of  an  eventual vaccine.  The  relevant  payments  should  be   structured  according  to  the  need  of  the manufacturer, but subject to the state of the vaccine  development, in particular relying on transparency  of  the  associated  clinical  data  and  its assessment,   at  the  time  of  payment. This is in order to avoid obligations to pay in situations where the development  work has shown a vaccine candidate likely to be unsuccessful.    The  purchase  price  of  the  vaccine,  as  well  as  the  amount  of  funding  provided up  front will  take   into  account  a  transparent  estimation  of  production  costs  (supported  by independent audits where  available), as well as the resources already granted from other public sources. Under the APA, the  manufacturer can be asked to provide ex post proof supported by independent audits concerning the  activities financed by these payments.     The aim of the negotiation is to conclude APAs with individual companies under the best possible  conditions. These APAs should specify details with respect to:     a) Payments  to  be  made,  such  as  payment  amounts,  payment  schedules,  type  of payments  requested  and  the use of those payments related to de-risk investment, financing  clinical   trials,  providing  working  capital  and  scaling-up  production capacity;  b) Delivery details of the vaccine if successful, such as price per person immunised (or   alternatively,  number  of  doses  required  per  person  immunised  and  price  per dose),  quantity of doses to be delivered and delivery timeline following approval;     and    c) Any other relevant conditions, such as production capacity built or used in the EU or  liability arrangements.   

 

    For  liability  arrangements,  the  joint  negotiation  team  will  make  its  best  effort  to  limit what  is   required  by  individual  companies  for  the  purpose  of  indemnification  to  be included in the terms  and conditions of the APA.    The  APAs  will  contain  provisions  to  clarify  the  law  applicable  to  both  the  APA  and resulting   purchase  orders  as  well  as  the  competent  courts.  The  Participating  Member States agree that each  APA negotiated by the Commission on their behalf with a vaccine manufacturer will have the same  applicable law for all Participating Member States, and that  the  courts  corresponding  to  that   applicable  law  will  be  competent  to  hear  disputes arising from that APA.    When  taking  a  decision  to  finance  individual  APAs,  the  European  Commission,  in consultation   with  the  steering  board,  will  take  into  account  the  following  elements:  any available data on  quality, safety and efficacy of the vaccine at time of negotiation of the contract,  speed  of  delivery  at   scale,  cost,  risk-sharing,  diversification  of  technologies, capacity  to  supply  through  development   of  production  capacity  within  the  EU,  possible flexible  future  use  of  any  capacity  funded,   engagement  at  an  early  stage  with  EU regulators with the intention to apply for an EU marketing  authorisation for the candidate vaccine(s), commitment to supply vulnerable countries.     The  procedure  outlined  above  complies  with  the  ESI  Regulation  and  the  Financial Regulation.   The  latter  is  aligned  to  the  European  procurement  Directives,  which  also provide  the  basis  for   national  procurement  rules.  Participating  Member  States  may  rely on the procedure run by the  European Commission to directly purchase vaccines from the manufacturers  as  and when  any  of  the   vaccines  becomes  available  based  on  the conditions  laid  down  in  the  APA.  Access to vaccine  doses will be allocated to Participating Member States according to the population distribution key.    In  the  negotiations  with  the  pharmaceutical  industry  under  the  present  Agreement,  the Commission   will  promote  a  Covid-19  vaccine  as  a  global  public  good.  This  promotion will  include  access   for  low  and  middle  income  countries  to  these  vaccines  in  sufficient quantity and at low prices.  The Commission will seek to promote related questions with the pharmaceutical industry regarding  intellectual property sharing, especially when such IP  has  been  developed  with  public  support,  in   order  to  these  objectives.  Any  vaccines available  for  purchase  under  the  APAs  concluded  but   not  needed  and  purchased  by Participating Member States can be made available to the global  solidarity effort.   

 

      ANNEX III: PARTICIPATING MEMBER STATES  Federal Republic of Germany  French Republic  Italian Republic  Kingdom of Spain  Republic of Austria  Hellenic Republic  Republic of Cyprus  Republic of Malta  Kingdom of Denmark  Kingdom of Sweden  Republic of Finland  Ireland  Portuguese Republic  Kingdom of Belgium  Grand Duchy of Luxembourg  Kingdom of the Netherlands  Republic of Poland  Romania  Republic of Bulgaria  Republic of Slovenia  Republic of Croatia  Czech Republic  Hungary  Slovak Republic  Republic of Lithuania  Republic of Latvia  Republic of Estonia     

 

ANNEX IV: SUBCONTRACTORS  [***] [***] [***] [***] 

 

  ANNEX V – PARTICIPATING CONTRACTOR AFFILIATES    Country Participating Contractor Affiliate  Germany BioNTech Europe GmbH  France Pfizer SAS  Italy Pfizer S.r.l.  Spain Pfizer S.L.U.  Austria Pfizer Corporation Austria GmbH  Greece Pfizer Hellas SA  Cyprus Pfizer Export B.V.   Malta Pfizer Export B.V.   Denmark Pfizer ApS  Sweden Pfizer Innovations AB  Finland Pfizer Finland Oy  Ireland Pfizer Healthcare Ireland  Portugal Pfizer Biofarmacêutica Sociedade Unipessoal, Lda  Belgium Pfizer SA  Luxembourg Pfizer Luxembourg S.A.R.L.  Netherlands Pfizer B.V.  Poland Pfizer Export B.V. and Trading Polska sp. z o.o.  Romania Pfizer Romania SRL  Bulgaria Pfizer Export B.V.  Slovenia Pfizer Export B.V.  Croatia Pfizer Export B.V.  Czech Republic Pfizer, spol. s r.o.  Hungary Pfizer Gyógyszerkereskedelmi Kft.  Slovakia Pfizer Export B.V.  Lithuania Pfizer Export B.V.  Latvia Pfizer Export B.V.  Estonia Pfizer Export B.V.    In addition, any Contractor Affiliate which is involved in the sale or distribution of Product  which is resold or donated by a Participating Member State shall be deemed to be a  Participating Contractor Affiliate.

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