Advance Purchase Agreement BioNTech Pfizer

EU-Impfvertrag mit BioNTech Pfizer vom 20.11.2020 zurück

/ 104
PDF herunterladen
SANTE/2020/C3/043 - 512.838335 SENSITIVE EUROPEAN COMMISSION Directorate-General for Health and Food Safety ADVANCE PURCHASE AGREEMENT ("APA") 1 for the development, production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member States SANTE/2020/C3/043 - S12.838335 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 APA 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 Ander Goldgrube 12, 55131 MAINZ, GERMANY (hereinafter referred to as "BioNTech") as a member of the group (collectively 'the Contractor'), represented for the purposes of the signature of this APA which has the form of a framework contract by Nanette Cocero, President of Vaccines, Pfizer Inc. on the other part, This APA is based on the agreement between the Commission and the Member States as approved by Commission Decision C(2020) 4192 final on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures. 2 As provided for in Article 4(5)(b) of Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak. 1
1

SANTE/2020/C3/043 - 512.838335 SENSITIVE HAVE AGREED to the special conditions and the general conditions of this APA 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 APA. The full content of the Attachments will be provided as soon as possible after Authorisation has been obtained and prior to the first shipment and may be updated by the Contractor and communicated to the Participating Member States from time to time, it being understood that any changes made will be of a practical nature and will not materially alter the risk, cost or liability of the parties. In case any substantial amendments are sought to be made, the parties will discuss the impact thereof in good faith. This APA sets out: 1.      the procedure and conditions by which the Commission and 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 APA; and 3.      the obligations of the parties during and after the duration of this APA. 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 APA. In all circumstances, in the event of contradiction between this APA and documents issued by the Contractor, this APA prevails, regardless of any provision to the contrary in the Contractor's documents. 2
2

SANTE/2020/C3/043 - 512.838335 SENSITIVE TabJe of Content TABLE OF CONTENT .......................................................................................................................... 3 I.     SPECIAL CONDITIONS .......................................................................................................... 5 1.1      Order of Priority of Provisions ..................................................................................... 5 1.2      Definitions .................................................................................................................... 5 1.3      Subject Matter ............................................................................................................... 9 1.4      Entry into force and duration of the APA ................................................................... 10 1.5      Implementation of the APA ........................................................................................ 11 1.6      Supply of the Vaccine ................................................................................................. 11 1.7      Prices ........................................................................................................................... 20 1.8      Payment Arrangements ............................................................................................... 20 1.9      Communication Details .............................................................................................. 23 1.10     Project management .................................................................................................... 23 1.11     Exploitation of the results of the APA ........................................................................ 23 1.12     Indemnification ........................................................................................................... 24 I. 13    Applicable Law and Settlement of Disputes ............................................................... 26 1.14     Other Special Conditions ............................................................................................ 27 II.    GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SERVICES ...... 29 11.1     Definitions .................................................................................................................. 29 11.2     Roles and responsibilities in the event of a joint tender ............................................. 29 11.3     Severability ................................................................................................................. 29 11.4     Provision of services and supplies .............................................................................. 29 11.5     Communication between the parties ........................................................................... 29 11.6     Liability ....................................................................................................................... 30 II. 7    Conflict of interest and professional conflicting interests .......................................... 32 11.8     Representations and warranties ................................................................................... 33 11.9     Confidentiality ............................................................................................................ 34 11.10    Announcements and publicity..................................................................................... 36 11.11    Processing of personal data ......................................................................................... 36 11.12    Subcontracting ............................................................................................................ 37 11.13    Amendments ............................................................................................................... 37 11.14    Assignment ................................................................................................................. 37 11.15    Force majeure ............................................................................................................. 38 11.16    Suspension of the implementation of the APA ........................................................... 38 11.17    Termination of the APA ............................................................................................. 39 3
3

SANTE/2020/C3/043 - 512.838335 SENSITIVE II.18    Invoices, value added tax and e-invoicing .................................................................. 41 II.19    Payments and guarantees ............................................................................................ 42 II.20    Recovery ..................................................................................................................... 43 II.21    Checks and audits ....................................................................................................... 44 II.22    Relationship of the parties .......................................................................................... 45 II.23    Waiver ......................................................................................................................... 45 II.24    Further documents ...................................................................................................... 45 II.25    Headings ..................................................................................................................... 45 II.26    Electronic Delivery and Storage ................................................................................. 45 II.27    Entire Agreement ........................................................................................................ 46 II.28    Costs ........................................................................................................................... 46 ANNEX I: MODEL FOR VACCINE ORDER FORM ........................................................................ 47 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 .............................................................................................. 52 ANNEX III: PARTICIPATING MEMBER STATES ......................................................................... 57 ANNEX IV: SUBCONTRACTORS .................................................................................................... 58 ANNEX V - PARTICIPATING CONTRACTOR AFFILIATES ....................................................... 59 ATTACHMENT 1: SPECIFICATION ................................................................................................ 60 ATTACHMENT 2: DELIVERY DOCUMENTATION ...................................................................... 73 ATTACHMENT 3: DELIVERY SPECIFICATION ............................................................................ 74 ATTACHMENT 4: LABELLING AND PACKAGING SPECIFICATIONS .................................. 103 ATTACHMENT 5: RETURN AND DISPOSAL OF PRODUCT MATERIALS ............................. 104 4
4

SANTE/2020/C3/043 - 512.838335 SENSITIVE I.     SPECIAL CONDITIONS 1.1     ORDER OF PRIORITY OF PROVISIONS If there is any conflict between different provisions in this APA, the following rules must be applied: (a)     The provisions set out in the special conditions and Article 11.6 of the general conditions (Liability) take precedence over those in the other parts of the APA. (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 APA take precedence over those in the Vaccine Order Forms. 1.2     DEFINITIONS The following definitions shall apply to this APA: 'Additional Order': has the meaning set forth in Article 1.6.2; 'Additional Product': has the meaning set forth in Article 1.6.2; 'Adjusted Delivery Schedule': has the meaning set forth in Article I.6.3(ii); 'Advance Payment': has the meaning set forth in Article 1.8.1 '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; 'Best Reasonable Efforts': means, with respect to the efforts to be expended by the Contractor to achieve the objective, the activities and degree of effort that a similarly situated party (with respect to size, resources and assets) in the pharmaceutical industry would use to accomplish a similar objective in similar circumstances, in particular taking into account the following factors: current urgency of the COVID-19 crisis and the Contractor's desire to address the crisis; the COVID-19 vaccine landscape; the novelty, safety and efficacy of the Vaccine; the costs, liabilities and any external and internal resources reasonably necessary or useful to achieve the relevant objective; the specific challenges of developing, manufacturing and supplying this novel Vaccine; and all other relevant risks, uncertainties, limitations and challenges. The Commission acknowledges and agrees, and Best Reasonable Efforts does not 5
5

SANTE/2020/C3/043 - 512.838335 SENSITIVE require, that the Contractor be obliged to take any action prejudicial to the Contractor to meet such "Best Reasonable Efforts" standard, and the Contractor in turn acknowledges and shares the Commission's desire that the Vaccine be made available to help address the pandemic; 'Conditional Marketing Authorisation': means a conditional marketing authorisation granted by the European Commission 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 APA 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 APA by the Contractor is compromised for reasons involving family, emotional life, political or national affinity, economic interest, any other direct or indirect personal interest, or any other shared interest with the Commission, the Participating Member State or any third party related to the subject matter of the APA; 'Contracted Doses': has the meaning set forth in Article 1.6.2; '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; 'Delivery Price': has the meaning set forth in Article 1.8.2; 'Delivery Schedule': means the Interim Delivery Schedule or the Adjusted Delivery Schedule, as applicable; 'Effective Date': has the meaning set forth in Article 1.4.1; '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 APA, such as acts of God, natural disasters, flood, severe storm, earthquake, civil 6
6

SANTE/2020/C3/043 - 512.838335 SENSITIVE disturbance, lockout, riot, order of any court or administrative body, embargo, acts of government (other than the Commission or a Participating Member State), war (whether or not declared), acts of terrorism or the impact on a party of an outbreak of any disease or an epidemic or pandemic or other similar causes subject to the clarification set out below. The situation or event must not be attributable to error or negligence on the part of the parties or on the part of the subcontractors and must prove to be inevitable despite their exercising due diligence. Defaults of service, defects in equipment or material or delays in making them available, labour disputes, strikes and financial difficulties may not be invoked as Force majeure, unless they stem directly from a relevant case of Force majeure. For the avoidance of doubt, (i) failure to make payment cannot be qualified as Force majeure and (ii) the parties agree that, although the current COVID-19 crisis is in itself no longer an 'unforeseeable' situation, it may still result in circumstances which are unforeseeable and beyond the reasonable control of the parties and therefore within the definition of Force majeure; '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 under this APA only by reason of the Advance Payment; '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 APA': the purchase of services or supplies envisaged in the APA through the signature and performance ofVaccine Order Forms; 'Indemnified Persons': has the meaning set forth in Article 1.12.1; 'Interim Delivery Schedule': has the meaning set forth in Article 1.6.3; '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 under this APA only by reason of the Advance Payment; 7
7

SANTE/2020/C3/043 - 512.838335 SENSITIVE 'Latent Defect': means a defect causing the Product to not conform to the applicable Specifications that the relevant Participating Member State can show was present at the time of delivery of the Product and which could not have been detected by the Participating Member State, its designee, or their personnel at delivery through visual inspection; '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 I.12.1; '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; 'Non-Complying Product': has the meaning set forth in Article I.6.14; '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; '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 APA 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 APA; '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.18.1; 8
8

SANTE/2020/C3/043 - 512.838335 SENSITIVE 'Term': means the term of the APA set out in Article 1.4.2 of the APA; 'Thermal Shipper': has the meaning set forth in Article 1.6.8; 'Third Party Claim': has the meaning set forth in Article 1.12.4. 'Vaccine': BNT162b2, a nucleoside-modified messenger RNA (modRNA) vaccine that encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S) for which a rolling submission for BNT162b2 has been initiated with the European Medicines Agency; 'Vaccine IP Rights': has the meaning set forth in Article Error! Reference source not f ound.; and 'Vaccine Order Form: has the meaning set forth in Article 1.5.21.3. 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 APA 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 APA, and references to this APA 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 APA, (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), G) 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. 1.3     SUBJECT MATTER The subject of the call for tenders SANTE/2020/C3/043 is securing the purchase of certain vaccine doses for the Participating Member States. By Decision C(2020) 4192 final of 18 June 2020, the Commission approved the agreement with Member States on procuring COVID-19 vaccines on behalf of the Member States ("the Decision"). This agreement is based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 9
9

SANTE/2020/C3/043 - 512.838335 SENSITIVE March 2016 on the provision of emergency support within the Union3 ("the ESI Regulation") which provides that the Commission may grant emergency support in the form of procurement on behalf of the Member States based on an agreement between the Commission and Member States. In order to implement such action, the Commission is running procurement procedures on behalf of Participating Member States, with a view to signing EU-level AP As with vaccine manufacturers. In view of its importance, this APA will be approved for signature on behalf and in the name of the Participating Member States by a separate individual Commission decision. The Contractor is currently in Phase 3 clinical development of the Vaccine and is using its Best Reasonable Efforts to secure Authorisation of such vaccine candidate by the Commission, expected at the earliest in December 2020. The Commission, on behalf of the Participating Member States, wishes to purchase the Vaccine during the pandemic period through this APA. It acknowledges that the clinical development might not be successful or regulatory approval may not be obtained and subsequently an authorised Vaccine may not be available. On the basis of this APA, the European Commission commissions the Contractor to commit to produce and deliver in priority 200 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 APA. In case the Contractor succeeds to develop a safe and effective Vaccine according to the terms laid down in this APA, the Contractor or an Affiliate of the Contractor 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 APA. 1.4     ENTRY INTO FORCE AND DURATION OF THE APA I.4.1   The APA enters into force on the date on which the last party signs it ("Effective Date"). I.4.2   The APA is concluded for a period of 24 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 APA expires. The APA continues to apply to such Vaccine Order Forms after its expiry. The services relating to such Vaccine Order Forms must be performed no later than six months after the expiry of the APA. 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. 10
10

Zur nächsten Seite