SANTE/2020/C3/043 - SI2.838335
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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.
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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.
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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
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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
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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,
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;
‘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
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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;
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‘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;
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‘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
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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.
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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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(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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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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(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)
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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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(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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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.
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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.
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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.
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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.
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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)
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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.
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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
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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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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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Article 4(2) first indent of Regulation
(EC) No 1049/2001