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SANTE/2020/C3/043 - SI2.838335
 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 - 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”),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 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 
 
 
on the other part, 
1  
This APA is based on the agreement between the Commission and the Member States as approved by Commission Decision 
C(2020) 4192 final on approving the agreement with Member States on procuring Covid-19 vaccines on behalf of the Member 
States and related procedures. 
2  
As provided for in Article 4(5)(b) of Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support 
within the Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under 
Regulation (EU) 2016/369, and amending its provisions taking into account the COVID- 19 outbreak. 


SANTE/2020/C3/043 - SI2.838335
 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, 
 
 
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. 


SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
Table of Content 
 
TABLE OF CONTENT .......................................................................................................................... 3 
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 APA ................................................................... 10 
I.5 
Implementation of the APA ........................................................................................ 11 
I.6 
Supply of the Vaccine ................................................................................................. 11 
I.7 
Prices ........................................................................................................................... 20 
I.8 
Payment Arrangements ............................................................................................... 20 
I.9 
Communication Details .............................................................................................. 23 
I.10 
Project management .................................................................................................... 23 
I.11 
Exploitation of the results of the APA ........................................................................ 23 
I.12 
Indemnification ........................................................................................................... 24 
I.13 
Applicable Law and Settlement of Disputes ............................................................... 26 
I.14 
Other Special Conditions ............................................................................................ 27 
II. 
GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SERVICES ...... 29 
II.1 
Definitions .................................................................................................................. 29 
II.2 
Roles and responsibilities in the event of a joint tender ............................................. 29 
II.3 
Severability ................................................................................................................. 29 
II.4 
Provision of services and supplies .............................................................................. 29 
II.5 
Communication between the parties ........................................................................... 29 
II.6 
Liability ....................................................................................................................... 30 
II.7 
Conflict of interest and professional conflicting interests .......................................... 32 
II.8 
Representations and warranties ................................................................................... 33 
II.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 

 

SANTE/2020/C3/043 - SI2.838335 
 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 
 
 
 
 
 

 

SANTE/2020/C3/043 - SI2.838335
 SENSITIVE 
I.
SPECIAL CONDITIONS
I.1 
ORDER OF PRIORITY OF PROVISIONS
If there is any conflict between different provisions in this APA, the following rules must be 
applied: 
(a)
The provisions set out in the special conditions and Article II.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.
I.2 
DEFINITIONS
The following definitions shall apply to this APA: 
‘Additional Order’: has the meaning set forth in Article I.6.2; 
‘Additional Product’: has the meaning set forth in Article I.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 I.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,
 
 
 
 
 
 
 
 
 


SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
 
 

‘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 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; 
‘Delivery Price’: has the meaning set forth in Article I.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 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 APA, such as acts of God, natural disasters, flood, severe storm, earthquake, civil 

 

SANTE/2020/C3/043 - SI2.838335 
 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 of Vaccine Order Forms; 
‘Indemnified Persons’: has the meaning set forth in Article I.12.1; 
‘Interim Delivery Schedule’: has the meaning set forth in Article I.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; 

 

SANTE/2020/C3/043 - SI2.838335 
 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; 

 

SANTE/2020/C3/043 - SI2.838335
 SENSITIVE 
‘Term’: means the term of the APA set out in Article I.4.2 of the APA; 
‘Thermal Shipper’: has the meaning set forth in Article I.6.8;  
‘Third Party Claim’: has the meaning set forth in Article I.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  I.11; and
‘Vaccine Order Form: has the meaning set forth in Article I.5.2I.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), (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/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 


SANTE/2020/C3/043 - SI2.838335 
 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 APAs 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. 
I.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. 
                                                      
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. 
10 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
I.4.4  Renewal of the APA  
The APA will expire automatically at the end of the Term, unless it is extended in mutual 
written agreement between the parties. Renewal does not change or postpone any existing 
obligations. 
I.5 
IMPLEMENTATION OF THE APA  
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 APA 
The APA shall be implemented following signature between the Commission and the 
Contractor as follows: 
In order to guarantee the right of the Participating Member States to acquire Vaccine doses in 
a given timeframe and at a certain price and conditions, the Commission will pay the Advance 
Payment.  
The Contractor shall use Best Reasonable Efforts to build manufacturing capacity or utilise 
existing capacity to be capable of manufacturing and supplying the Product to the Commission 
in accordance with the provisions of this APA. 
The Contractor agrees to supply an initial total number of 200 million Vaccine doses to 
Participating Member States collectively, upon their order, in accordance with this APA and 
the respective Vaccine Order Forms. 
The Participating Member States shall place orders for supplies of 200 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 within 10 business days following the 
Commission communicating the allocation. This Vaccine Order Form shall be signed by an 
authorised representative of the Participating Member State and the Contractor. 
Within 10 business days of receipt of the Vaccine Order Form from a Participating Member 
State, 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  Creation of the Vaccine 
During the term of this APA, and subject to the successful development and authorisation of 
the Vaccine as set out in this APA, the Contractor shall use Best Reasonable Efforts to 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 APA. 
 
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SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
(vi) 
In the event the Contractor is unable to deliver the full amount of the Contracted 
Doses by 
, the Commission and the Contractor will have the right 
to terminate the APA.  
For the avoidance of doubt, the Participating Member States will not have the right to terminate 
the Vaccine Order Forms in scenarios (iii), (v) or (vi) above in the event that the Commission 
has not exercised its right to terminate the APA.   
If the Vaccine is successfully developed and obtains Authorisation in the foreseen time-line 
(between 15 December 2020 and 15 August 2021), the Contractor shall use Best Reasonable 
Efforts to ensure that the doses are supplied in accordance with the Interim Delivery Schedule, 
or if applicable, the Adjusted Delivery Schedule. Allocations shall be made pursuant to Article 
I.6.3(iv) in case of insufficient supply to deliver the full amount of Contracted Doses. 
Within 20 days following the Effective Date, the Commission shall communicate to the 
Contractor a table how to allocate the 200 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 the above-mentioned allocation table and to sign a Vaccine Order Form to 
this effect as set out below.  
To operationalise the ordering of the Vaccine, each Participating Member State will enter into 
a Vaccine Order Form. 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 APA into the Vaccine Order Form). Deliveries of doses to each Participating Member State 
shall be done on a pro-rata basis throughout the delivery period. 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 APA 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. 
I.6.4  Manufacturing 
The Contractor confirms that it is in possession of all necessary manufacturing authorisations 
to undertake the manufacturing of the Vaccine.  
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, prior to delivery, the Contractor shall comply with all conditions 
(in the relevant timescales) set out in the Authorisation (where applicable), subject to any 
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SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
 
I.9 
COMMUNICATION DETAILS 
For the purpose of this APA, communications must be sent to the following addresses: 
If to the Commission: 
European Commission 
Directorate-General for Health and Food Safety 
E-mail: xxxxxxxxxxxxxxxxx@xx.xxxxxx.xx  
If to a Participating Member State  – See details in Vaccine Order Form 
If to Pfizer: 
 
 

 
 
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 APA 
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 APA 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 APA4 
The Commission acknowledges and agrees that the Contractor shall be the sole owner of all 
intellectual property rights generated during the development, manufacture, and supply of the 
Vaccine or otherwise related to the Vaccine, including all know-how (collectively, the 
“Vaccine IP Rights”). 
 
                                                      
4  
This article must be adapted with care. In particular where the FWC is in essence only a licence on pre-existing materials (with no 
actual production of new materials specifically for the Union), as is the case for instance for a subscription contract to a database 
service provider, this article must be adapted accordingly. All information is in the Explanatory note on IPR on: 
http://myintracomm.ec.testa.eu/budgweb/EN/imp/procurement/Documents/ipr-note-en.pdf.  
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SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
(a) 
In the event of a dispute arising under this APA or the Vaccine Order Forms, as 
applicable, between the parties, the parties shall first refer such dispute to 
informal dispute resolution discussions between their respective 
representatives. The Contractor or the Commission on behalf of itself or of the 
Participating Member States may initiate such informal dispute resolution by 
sending written notice of the dispute to the other party, and, within twenty (20) 
days of such notice, the representatives shall meet and attempt to resolve the 
dispute by good faith negotiations. 
(b) 
The Commission, the Participating Member States and the Contractor each 
irrevocably submit to the exclusive jurisdiction of the courts located in Brussels, 
Belgium to settle any dispute or claim which may arise under or in connection 
with this APA or the legal relationships established by this APA or any Vaccine 
Order Form. 
I.14  OTHER SPECIAL CONDITIONS 
The Contractor shall keep the Commission and the Participating Member States informed about 
any significant safety signal detected during the pharmacovigilance or vaccine monitoring 
programmes in relation to the Vaccines which are the object of this APA 
 
from notifying the European Medicines Agency. 
(Signature page follows) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
27 
 



SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
II. 
GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT 
FOR SERVICES 
II.1 
DEFINITIONS 
All definitions are contained in Article I.2 
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 APA is severable and distinct from the others. If a provision is or 
becomes illegal, invalid or unenforceable to any extent, it must be severed from the remainder 
of the APA. This does not affect the legality, validity or enforceability of any other provisions 
of the APA, which continue in full force and effect. The illegal, invalid or unenforceable 
provision must be replaced by a legal, valid and enforceable substitute provision which 
corresponds as closely as possible with the actual intent of the parties under the illegal, invalid 
or unenforceable provision. The replacement of such a provision must be made in good faith 
between the parties. The APA 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 APA 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 communication of information, notices or documents under the APA must: 
(a) 
be made in writing in paper or electronic format in the language of the contract; 
(b) 
bear the APA number and, if applicable, the Vaccine Order Form number; 
(c) 
be made using the relevant communication details set out in Article I.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. 
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SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
(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 APA or a Vaccine Order Form under Article II.17.1, (f) or 
(i). 
The Contractor is not entitled to compensation for suspension of any part of the APA or a 
Vaccine Order Form. For the avoidance of doubt, the Contractor shall not be under any 
obligation to deliver any Contracted Doses 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 that 
were already in transit on the date of the formal notification or at the later date indicated in the 
formal notification. 
II.17  TERMINATION OF THE APA 
II.17.1 Grounds for termination by the Commission 
The Commission may terminate the APA or the Participating Member State may terminate any 
on-going Vaccine Order Form (depending on whether the event affects the APA or the Vaccine 
Order Form) solely in the following circumstances: 
(a) 
in the event any of the circumstances referred to in Articles I.6.3(iii),  I.6.3(v) or 
I.6.3(vi) occur; 
(b) 
if the Contractor does not implement the APA or perform the Vaccine Order Form in 
accordance with material aspects of the APA or the Vaccine Order Form (as applicable) 
or is otherwise in material breach of another substantial contractual obligation;  
(c) 
if the  Contractor repeatedly refuse to sign Vaccine Order Forms without cause. 
Termination of three or more Vaccine Order Forms in these circumstances also 
constitutes grounds for termination of the APA; 
(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; 
                                                      
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 
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SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
II.20.2 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.19.5. 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.21  CHECKS AND AUDITS 
II.21.1 The Commission and the European Anti-Fraud Office may check or require an audit on 
the Implementation of the APA. This may be carried out either by OLAF’s own staff 
or by any outside body authorised to do so on its behalf, 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 five years starting from the payment of the 
balance of the last specific contract issued under this APA.  
The audit procedure is initiated on the date of receipt of the relevant letter sent by the 
Commission. Audits are carried out on a confidential basis. 
II.21.2 The Contractor must keep all original documents stored on any appropriate medium, 
including digitised originals if authorised under national law, for a period of five years 
starting from the payment of the balance of the last specific contract issued under this 
APA. 
II.21.3 The Contractor must grant the appropriate right of access to sites and premises where 
the APA 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.21.4 On the basis of the findings made during the audit, a provisional report is drawn up. 
The Commission or its authorised representative must send it to the Contractor, who 
has 30 days following the date of receipt to submit observations. The Contractor must 
receive the final report within 60 days following the expiry of the deadline to submit 
observations. 
On the basis of the final audit findings, the Commission or the Participating Member 
State in question may recover all or part of the payments made in accordance with 
Article II.20 and may take any other measures which it considers necessary. 
44 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
II.21.5 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 five years starting from the payment of the balance of the last specific 
contract issued under this APA. 
II.21.6 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.22  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 APA 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.23  WAIVER 
A waiver by any party of any term or condition of this APA 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 APA shall be cumulative and in addition to any other 
remedies provided at Law or in equity, except where expressly otherwise agreed. 
II.24  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 APA. 
II.25  HEADINGS 
Headings of Articles or other parts of this APA are included herein for convenience of reference 
only and shall not constitute a part of this APA or change the meaning of this APA. 
II.26  ELECTRONIC DELIVERY AND STORAGE 
Delivery of a signed APA by reliable electronic means, including facsimile or email (with 
receipt electronically confirmed), shall be an effective method of delivery of the executed APA. 
45 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
This APA may be stored by electronic means and either an original or an electronically stored 
copy of this APA can be used for all purposes, including in any proceeding to enforce the rights 
or obligations of the parties to this APA. 
II.27  ENTIRE AGREEMENT 
This APA, 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.28  COSTS 
Each party will bear its own legal costs in preparing and concluding this APA.
 
 
46 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
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: 
 
[Add details for Contractor] 
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 an Advance Purchase Agreement for the 
purchase and supply of Contractor’s Vaccine for EU Member States dated [•] 2020 (the 
APA”), the terms of which are binding on the Participating Member States and must 
be read in conjunction with this Vaccine Order Form. 
 
  The APA 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 APA and at the price and conditions as set out in the 
APA.  
 
  In accordance with Article I.5.2 of the APA, the [name of 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 [name of the Participating Member State] to 
Contractor in accordance with the terms of the APA, and forms an integral part of the 
APA.  The terms and conditions of the APA are incorporated into this Vaccine Order 
Form by reference. In the event of contradiction between this Vaccine Order Form and 
the APA, the terms of the APA 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 APA. 
47 
 





SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
Contractor: [Add details] 
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 APA, or if the APA expires, until the 
last delivery of Product which in any event must take place within 6 months of such 
expiry. 
 
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 APA 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.  
 
 
(Signature page follows) 
 
50 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
SIGNATURES 
 
For the Participating Member State
[forename/surname/position] 
 
Signature:_____________________ 
Done at [place], [date
 
 
 
 
For acceptance of the Vaccine Order Form, 
[Contractor], 
[forename/surname/position
 
Signature: _______________________ 
Done at [place], [date
 
 
The invoice will be paid only once the Contractor has returned the signed Vaccine Order Form. 
 
 
 
51 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
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   
52 
 

SANTE/2020/C3/043 - SI2.838335 
 SENSITIVE 
 
 
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 
 
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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  
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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; 
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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. 
 
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ANNEX III: PARTICIPATING MEMBER STATES 
Germany 
France 
Italy 
Spain 
Austria 
Greece 
Cyprus 
Malta 
Denmark 
Sweden 
Finland 
Ireland 
Portugal 
Belgium 
Luxembourg 
Netherlands 
Poland 
Romania 
Bulgaria 
Slovenia 
Croatia 
Czech Republic 
Hungary 
Slovakia 
Lithuania 
Latvia 
Estonia 
 
 
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 SENSITIVE 
 
 
ANNEX V Ʌ 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 Hellas SA 
Malta 
Pfizer Hellas SA 
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 BV 
Poland 
Pfizer 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 PFE, spol. s r.o. 
After 1/12  shall be merged into 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. 
 
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deleted as they are fully protected by 
Article 4(2) first indent of Regulation 
(EC) No 1049/2001