ADVANCE PURCHASE AGREEMENT (“APA”)1 for the development, production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member

SENSITIVE

SANTE/2020/C3/043 - SI2.838335

SENSITIVE

SANTE/2020/C3/043 - SI2.838335

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 - SI2.838335

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”),¹:

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 An der 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.

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.

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; ^{1 2}

Table 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

1.13    Applicable Law and Settlement of Disputes...............................................................26

1.14    Other Special Conditions............................................................................................27

II.    GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SERVICES......29

II. 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

11.7    Conflict of interest and professional conflicting interests..........................................32

11.8    Representations and warranties...................................................................................33

11.9    Confidentiality............................................................................................................34

II. 10    Announcements and publicity.....................................................................................36

II. 11    Processing of personal data.........................................................................................36

II. 12    Subcontracting............................................................................................................37

II. 13    Amendments...............................................................................................................37

II. 14    Assignment.................................................................................................................37

II. 15    Force majeure.............................................................................................................38

II. 16    Suspension of the implementation of the APA...........................................................38

II. 17    Termination of the APA.............................................................................................39

II. 18    Invoices, value added tax and e-invoicing..................................................................41

II. 19    Payments and guarantees............................................................................................42

11.20    Recovery.....................................................................................................................43

11.21    Checks and audits.......................................................................................................44

11.22    Relationship of the parties..........................................................................................45

11.23    Waiver.........................................................................................................................45

11.24    Further documents......................................................................................................45

11.25    Headings.....................................................................................................................45

11.26    Electronic Delivery and Storage.................................................................................45

11.27    Entire Agreement........................................................................................................46

11.28    Costs...........................................................................................................................46

ANNEX I: MODEL FOR VACCINE ORDER FORM........................................................................47