on the one part, and
Moderna Netherlands B.V.,
Claude Debussylaan 7, 1082MC Amsterdam (The Netherlands)
VAT number: NL863079015B01,
and
Moderna Biotech Spain S.L,
Julian Camarillo 31, 28037 Madrid (Spain)
VAT number: ESB88625314
(the
), represented for the purposes of the signature of this contract
HERA/2023/ CPN/0011
by the authorised
,
on the other part.
HAVE AGREED
to the special conditions, the general conditions for framework contracts for supplies and
the following annexes:
Annex I
Tender specifications
Annex II
tender
Annex III
Model for specific contracts
Annex IV
Model for reporting
which form an integral part of this framework contract (the
This FWC sets out:
1. the procedure by which the contracting authorities may order supplies from the
contractor;
2. the provisions that apply to any specific contract which the contracting
authorities and the contractor may conclude under this FWC; and
3. the obligations of the parties during and after the duration of this FWC.
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 FWC. In all circumstances, in the event of contradiction between this FWC and
documents issued by the contractor, this FWC prevails, regardless of any provision to the
3
TABLE OF CONTENT
I.
SPECIAL CONDITIONS ...................................................................................................................... 7
I.1.
ORDER OF PRIORITY OF PROVISIONS........................................................................................... 7
I.2.
SUBJECT MATTER ...................................................................................................................... 7
I.3.
ENTRY INTO FORCE AND DURATION OF THE FWC ........................................................................ 8
I.4.
APPOINTMENT OF THE CONTRACTOR AND IMPLEMENTATION OF THE FWC............................... 8
I.4.1.
Appointment of the contractor ............................................................................................................. 8
I.4.2.
Period of provision of the supplies ...................................................................................................... 8
I.4.3.
Implementation of the FWC ................................................................................................................ 9
I.4.4.
Delivery ............................................................................................................................................. 12
I.4.5 Donations/Resale .............................................................................................................................................. 13
I.4.6. Reporting ......................................................................................................................................................... 13
I.5.
PRICES .................................................................................................................................... 13
I.5.1.
Maximum amount of the FWC and maximum prices ....................................................................... 13
I.5.2.
Price revision index ........................................................................................................................... 14
I.6.
PAYMENT ARRANGEMENTS ..................................................................................................... 14
I.6.1.
Pre-financing ..................................................................................................................................... 14
I.6.2.
Interim payments ............................................................................................................................... 14
I.6.3.
Payment delivery instalments ............................................................................................................ 14
I.6.4.
Performance guarantee ...................................................................................................................... 15
I.6.5.
Retention money guarantee ............................................................................................................... 15
I.7.
BANK ACCOUNT ...................................................................................................................... 15
I.8.
COMMUNICATION DETAILS ..................................................................................................... 16
I.9.
PROCESSING OF PERSONAL DATA ............................................................................................ 20
I.9.1
Processing of personal data by the contracting authority .................................................................. 20
I.9.2
Processing of personal data by the contractor ................................................................................... 20
I.10.
INVOICE AND VALUE ADDED TAX ........................................................................................... 20
I.11.
APPLICABLE LAW AND SETTLEMENT OF DISPUTES ................................................................. 20
I.12.
JOINT PROCUREMENT FWC ................................................................................................... 21
I.13.
OTHER SPECIAL CONDITIONS ................................................................................................. 21
SIGNATURES ................................................................................................................................................... 28
II.
GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SUPPLIES ...................... 29
II.1.
DEFINITIONS ............................................................................................................................ 29
II.2.
ROLES AND RESPONSIBILITIES IN THE EVENT OF A JOINT TENDER ....................................... 31
II.3.
SEVERABILITY ......................................................................................................................... 31
II.4.
DELIVERY OF SUPPLIES ............................................................................................................ 32
II.5.
COMMUNICATION BETWEEN THE PARTIES ................................................................................ 36
II.6.
LIABILITY ................................................................................................................................ 38
II.7.
CONFLICT OF INTEREST AND PROFESSIONAL CONFLICTING INTERESTS .................................... 38
II.8.
CONFIDENTIALITY ................................................................................................................... 39
II.9.
PROCESSING OF PERSONAL DATA ............................................................................................. 40
II.10.
SUBCONTRACTING ................................................................................................................... 42
II.11.
AMENDMENTS ......................................................................................................................... 42
4
II.13.
FORCE MAJEURE ..................................................................................................................... 43
II.14.
LIQUIDATED DAMAGES ............................................................................................................ 43
II.15.
REDUCTION IN PRICE ............................................................................................................... 44
II.16.
SUSPENSION OF THE IMPLEMENTATION OF THE FWC ............................................................... 45
II.17.
TERMINATION OF THE FWC ....................................................................................................... 46
II.18.
INVOICES, VALUE ADDED TAX AND E-INVOICING ...................................................................... 48
II.19.
PRICE REVISION ....................................................................................................................... 49
II.20.
PAYMENTS AND GUARANTEES ................................................................................................. 50
II.21.
RECOVERY .......................................................................................................................... 52
II.22.
CHECKS AND AUDITS ............................................................................................................... 53
II.23.
INTELLECTUAL PROPERTY........................................................................................................ 54
ANNEX I (TENDER SPECIFICATION IN A SEPARATE ATTACHMENT) ........................................................... 56
ANNEX II OFFER (THE TECHNICAL OFFER IS IN A SEPARATE ATTACHMENT) ............................................ 56
ANNEX III SPECIFIC CONTRACT ........................................................................................................... 60
ANNEX IV MODEL OF REPORTING ........................................................................................................ 64
5
I. SPECIAL CONDITIONS
I.1. ORDER OF PRIORITY OF PROVISIONS
If there is any conflict between different provisions in this FWC, the following rules must be
applied:
The provisions set out in the special conditions take precedence over those in the other parts of
the FWC.
The provisions set out in the general conditions take precedence over those in the specific
contract (Annex III).
The provisions set out in the specific contract (Annex III) take precedence over those in the
other annexes.
The provisions set out in the tender specifications (Annex I) take precedence over those in the
tender (Annex II).
The provisions set out in the FWC take precedence over those in the specific contracts.
For the avoidance of doubt, a conflict in this sense is not given if for a specific topic (e.g., place
of delivery) any of the contracting authorities and the contractor explicitly agree in the specific
contract on a solution which is different than the situation or solution as described in this FWC.
I.2. SUBJECT MATTER
The subject matter of the FWC is the supply of up to 146 000 000 (one hundred and forty-six
million) doses of the latest approved mRNA COVID-19 vaccine with EU Marketing
authorisation.
This volume is an estimate only and there is no commitment as to the exact quantity to be
ordered. The actual volumes will depend on the quantities which the contracting authorities
order through specific contracts. The ordering mechanism is defined in article 1.4.3.1.
The vaccines supplied under this contract will be labelled in accordance with the applicable EU
legislation and/or
according
to the applicable national legislation of the contracting authorities.
The contractor may confirm with contracting authorities whether full or partial exemptions
apply to the obligation that the labelling and the package leaflet must be in the official
language(s) as per Article 63(3) of Directive 2001/83/EC.
6
I.3. ENTRY INTO FORCE AND DURATION OF THE FWC
I.3.1 The FWC enters into force on the date on which the last party signs it.
I.3.2 The Implementation of the FWC cannot start before its entry into force.
I.3.3 The FWC is concluded for a period of 24 months with effect from the date of its entry
into force.
I.3.4 The parties may not sign any specific contract after the expiry of the FWC.
The FWC continues to apply to such specific contracts after its expiry or termination.
The supplies relating to such specific contracts must be delivered no later than six (6)
months after the expiry of the FWC. The conditions set out in the FWC continue to apply
to such specific contracts after the expiry of the FWC. At the end of this period, all
remaining specific contracts are automatically terminated.
I.3.5 The suspension of the Implementation of the FWC or a specific contract due to Force
Majeure as provided for in Article II.16 will
I.3.6 If, after the end of the FWC, one party continues to perform its obligations without
opposition from the other party, such performance is not and cannot be construed as a
renewal of the FWC.
I.3.7
Renewal of the FWC
For the avoidance of doubt, a renewal of the FWC in the sense of this Article I.3.7 does
not imply the conclusion of a new FWC but only the extension of the initial duration of
the FWC.
I.4. APPOINTMENT OF THE CONTRACTOR AND IMPLEMENTATION OF THE FWC
I.4.1. Appointment of the contractor
The contracting authority appoints the contractor within this FWC for the subject matter set out in
Article I.2.
I.4.2. Period of provision of the supplies
The period for the provision of the supplies starts to run from the date indicated in the specific
contract.
7
I.4.3. Implementation of the FWC
I.4.3.1 Ordering mechanism
Contracting authorities will be able to order vaccine doses throughout the duration of the
framework contract by signing specific contracts with the contractor.
The Commission will consult the contracting authorities on a
basis (or other timeframe
to be determined), and the Commission will communicate to the contractor through an email the
estimated demand per country (initial notice).
Within
calendar days of the
initial notice, the contractor shall respond by
providing an estimate of available amounts of vaccine and indicate the Delivery Schedule for
these quantities.
The Commission will consult the contracting authorities and will communicate to the contractor
The contractor shall formally confirm the receipt and the acceptance or rejection of the final
notice
Once confirmed
, the contractor and the contracting authorities will proceed
with the signature of a specific contract to order the quantities
The contracting authorities may order supplies
by sending the contractor
specific contract (following the model available in Annex III) by e-mail. Within
(unless agreed differently by the contracting parties in writing), following the
reception of the specific contract by e-mail, the contractor must either:
- send back to the contracting authority the specific contract duly signed and dated by
way of a scanned copy by e-mail; or
- send a valid explanation of why it cannot accept the order
8
9
I.4.3.2 Adapted variant vaccine
The contractor shall ensure that the vaccine is adapted to the relevant variants for the European
Union population and ensure availability of adapted vaccines in accordance with the most recent
recommendations on the need for updating the strain composition of COVID-19
vaccines.
The contractor shall notify the contracting authorities through Commission without undue delay
in case (a) an application for Marketing authorization (including through an update of an
existing authorization) of such adapted variant vaccine has been submitted to EMA and (b)
authorization for such adapted variant vaccine has been granted.
As soon as reasonably possible after the contractor notifies the contracting authorities it has
applied for a Marketing authorisation for an adapted variant vaccine, the parties will discuss and
agree in good faith any modifications necessary to the Delivery Schedule of ongoing specific
contracts subject to the delivery terms referred to in point 1.4.3.1.
10
I.4.4. Delivery
The contractor will deliver the supplies at the locations in the contracting authorities, as stated in
specific contracts, between the relevant contracting authority and the contractor or as otherwise
agreed in writing or by email between the contracting authority and the contractor during the
performance of the contract (according to Delivery at Place (DAP); Incoterms® 2020).1
Upon delivery at the agreed location, the contracting authority shall be ready to
physically receive the products and ensure proper storage conditions.
The deadline for delivery for quantities is determined based on the delivery proposed and
accepted during the ordering mechanism. Upon signature by both parties of a specific contract,
the contractor will ship and deliver the products within the timing defined in the delivery
schedule.
1
These terms are for sale on the website http://www.iccwbo.org/incoterms/
11
I.4.5 Donations/Resale
The contracting authority shall be entitled to re-sell and/or donate any of the vaccines supplied on
a basis of this FWC and subsequent specific contracts to a contracting authority within the
meaning of this FWC.
. No resale shall take place at a price higher than the purchase price as agreed
in the contract.
I.4.6. Reporting
During the duration of this FWC, if applicable, in the deadline of thirty (30) calendar days after
the end of each quarter, the contractor will report to the lead contracting authority (Commission)
on the specific contracts signed per each contracting authority for the previous quarter, using a
template provided in Annex IV. The reports are considered as Confidential information between
the contractor and the lead contracting authority (Commission), in the meaning of Article II.8 of
this FWC, and this referred Article will apply to such reports.
I.5. PRICES
I.5.1. Maximum amount of the FWC and maximum prices
The price per dose (net, plus VAT if applicable) is specified in Annex II.
For clarity, the contractor has no obligation to provide more supplies than
over
the duration of the FWC, unless mutually agreed to.
The net price charged for the vaccine, excluding VAT, supplied under a specific contract must
reflect the price stated in this FWC.
2 This maximum ceiling is based on the maximum number of doses that can be ordered throughout the duration
of the framework contract, multiplied by the highest price per dose. This ceiling is subject to an amendment
depending on the indexed price that will be applicable for the additional quantities as per art. I.4.3.2 and I.5.2
12
I.5.2. Price revision index
I.6. PAYMENT ARRANGEMENTS
I.6.1. Pre-financing
Pre-financing is not applicable to this FWC.
I.6.2. Interim payments
Interim payment is not applicable to this contract.
I.6.3. Payment delivery instalments
1. The contractor may claim the payment for each delivery instalment, in accordance with
Article II.20.
13
I.6.4. Performance guarantee
Performance guarantee is not applicable to this FWC.
I.6.5. Retention money guarantee
Retention money guarantee is not applicable to this FWC.
I.7. BANK ACCOUNT
member) bank account. The bank account details shall be indicated in the specific contracts
between the relevant contracting authority and the contractor.
14
I.9. PROCESSING OF PERSONAL DATA
I.9.1 Processing of personal data by the contracting authority
For the purpose of Article I.9.1:
(a) the data controller3 is Head of Unit HERA.3 of the European
Directorate- General Health Emergency Preparedness and Response authority;
(b) the data protection notice is available at https://ec.europa.eu/info/data-protection-
public-procurement-procedures en.
I.9.2 Processing of personal data by the contractor
Article I.9.2 is not applicable to this framework contract.
I.10. INVOICE AND VALUE ADDED TAX
This Article complements Article II.18.1 (Invoices and VAT).
The Commission is exempt from all taxes and duties, including VAT, in accordance with
Articles 3 and 4 of the Protocol on the privileges and immunities of the European Union.
The contracting authority, which is not an EU institution, shall be subject to VAT, pursuant to their
respective national law.
For the contracting authority that is not an EU institution, if according to its national law it is
exempt from VAT, the contractor must complete the necessary formalities with the relevant
authorities to ensure that the supplies and services required for Implementation of the FWC are
exempt from VAT.
Each contracting authority shall provide their respective local VAT registration number to the
contractor upon the placing of each new order (to support VAT exemption for intra-community
cross border transactions). For avoidance of doubt, if a contracting authority does not provide
its local VAT registration number to the contractor upon the placing of each new order, the
contractor will add VAT to the respective invoice.
I.11. APPLICABLE LAW AND SETTLEMENT OF DISPUTES
The FWC is governed by Union law, complemented, where necessary, by the law of Belgium.
The application of the United Nations Convention on Contracts for the International Sales of
Goods (CISG) is excluded.
3 Regulation (EU) 2018/1725 of 23 October 2018 on the protection of natural persons with regard to the processing of personal data
by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No
45/2001 and Decision No 1247/2002/EC, OJ L 295/39, 21.11.2018, https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32018R1725&from=EN
19
The courts of Belgium shall have exclusive jurisdiction over any dispute regarding the validity,
interpretation, performance or termination of the FWC or a specific contract.
Nothing in this article shall be construed as preventing any party from seeking immediate
injunctive relief or any other interim remedy where such relief is necessary to protect that
I.12. JOINT PROCUREMENT FWC
I.12.1 This FWC signed by the Commission in the name and on behalf of all the other
contracting authorities constitutes a bilateral legal commitment between each contracting
authority and the contractor. Each contracting authority is responsible for the implementation
of its FWC through the signature of specific contracts with the contractor; and each contracting
authority is responsible for the particular specific contracts it awards.
I.12.2 If the contractor has a complaint about the conclusion, performance or termination of a
specific contract, the contractor remains bound by its obligations under the FWC and other
specific contracts.
I.13. OTHER SPECIAL CONDITIONS
The following articles are added to the General Conditions:
Article II.4.101 QUALITY REQUIREMENTS AFTER DELIVERY
II.4.10.1 ¹ After the delivery of supplies by the contractor in accordance with Article I.4.4 of
20
this FWC, the contracting authority will be responsible for ensuring the quality of the products
in relation to the labelled storage conditions and any other instructions given by the contractor,
during storage, handling and transportation.
II.4.10.2 ¹ The contracting authority will ensure product is distributed to authorised customers
(including research Institutions), and documented evidence of traceability to those authorised
customers is maintained.
II.4.10.3
.
II.4.10.4 ¹ In the event that a product recall or product withdrawal is considered by the
contracting authority or the contractor, such party shall notify the other party prior to proceeding
with any action. The contracting authority and contractor shall cooperate fully and without
delay, regarding any proposed recall or product withdrawal, as well as in relation to any falsified
product or field correction, or corrective or preventive action that may be required.
II.4.10.5 ¹
, the contracting authorities shall submit to the Commission and to
the contractor and whenever it is deemed necessary or requested by contractor (e.g. when
purchases occur), a written report on the actual use of products in the given country. The report
shall include the number of patients with the number of administered vaccines, the indication
(pre- or post-exposure), administration route, when possible, the age range and gender
distribution of the patients who have received the product and if applicable its use in pregnant
or breast-feeding women.
. Any information that is exchanged
between the parties pursuant to this provision shall be in compliance with applicable personal
data, privacy and patient right protection requirements.
Article II.15¹ Reduction in price (REPLACES IN ITS ENTIRETY ARTICLE II.15.1 and
ARTICLE II.15.2 OF THE GENERAL CONDITIONS)
21
Article II.10.1¹ Subcontracting
By derogation to provision II.10.1, the contractor may use a subcontractor not mentioned in its
tender upon prior written approval to the Commission and provided the subcontractor has been
approved by the EMA. The contractor will be responsible for the subcontractor and shall cause
such subcontractor to be bound by the same obligations as the ones set forth herein, including
those pertaining to confidentiality.
The following articles in the General Conditions are replaced by the new provisions,
deleted or added as stated below:
The original Article II.4.8 is deleted:
The original Article II.4.8 is hereby deleted and will not be replaced by any new provisions.
The original Article II.4.11 is replaced with the following provision:
II.4.11 Certificate of compliance
Each delivery must be accompanied with the consignment note referred to in Article II.4.10.
(d), the certificate of compliance and the Marketing Information Form. These documents can
be provided electronically.
The original Article II.4.12 (c) is replaced with the following provision:
c) be distributed in accordance with EU GDP until the point of delivery to the relevant
contracting authority.
If, for reasons attributable to the contractor, the contracting authority is unable to accept the
supplies, the contractor must be notified in writing at the latest by the deadline for declaring
product complaints in as specified in Article II.4.13.
22
The original Article II.4.13 (a) (ii), (b) and (c) is replaced with the following provision:
The original Article II.4.14 (b) is replaced with the following provision:
The original Article II.4.15 is deleted:
The original Article II.4.15 is hereby deleted and will not be replaced by any new provisions.
II.6.5
If the contractor is composed of two or more economic operators (i.e. who
submitted a joint tender), they are all jointly and severally liable to the contracting authority for
the Implementation of the FWC.
II.6.6 Except in case of Force Majeure, the contracting authority is liable for any loss or
damage caused to the contractor during or as a consequence of the implementation of the FWC
resulting from a breach attributable to contracting authority, including in the event of non-
payment or failure to accept deliveries, but only to an amount not exceeding the total amount
of the specific contract. However, if the loss or damage was caused by willful misconduct or
gross negligence of the contracting authority, a Related Person, its Personnel or its
subcontractors, contracting authority is liable for the whole amount of the damage or loss.
The original Article II.8.1 is replaced with the following provision:
The contracting authority and the contractor must treat with confidentiality any information or
documents, in any format, disclosed in writing or orally relating to the Implementation of the
24
FWC (and identified in writing as confidential unless it is clear from the context and other
factors that the documents or discussions are confidential).
The original Article II.8.2 (c) is replaced with the following provision:
(c) not disclose directly or indirectly, Confidential Information or documents to third parties
without the prior written agreement of the other party (unless such third parties need this
Confidential Information contained in this contract to perform activities under this agreement
and agree to comply with this Article or are subject to substantially similar confidentiality
obligations as provided in this Article).
The original Article II.8.3 (c) is replaced with the following provision:
(c) the law requires the disclosure of the Confidential information or documents (including
securities laws or as required by the stock exchange rules of the contractor or any of its Affiliates).
The following new Article II.12.2 is added:
By way of derogation from the provision of Article II.12.1 the contractor will have the right to
extend the rights, licenses, and obligations granted or imposed under this FWC or any specific
contract to one or more of its Affiliates subject to prior written notification to the Commission
or contracting authority.
The original Article II.14.1 II.14.2 is replaced with the following provision:
II. 14.1.
Delay in delivery
25
II. 14.2.
Procedure
The original Article II.17 is amended with the following provisions:
The following provision to the end of Article II.17.1 is added:
The following provision to the end of Article II.17.2 is added:
26
The original Article II.17.4 is replaced with the following provision:
The original Article II.18.2 is replaced with the following provision:
SIGNATURES
For the contractor,
For the Commission; and in the name and
on behalf of all the other contracting
authorities,
Signature:
Signature:
Done at [place], [date]
Done at [place], [date]
In duplicate in English.
27
II.
GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR
SUPPLIES
II.1. DEFINITIONS
For the purpose of this FWC, the following definitions (indicated in italics in the text) apply:
means, with respect to each party, any corporation, firm, partnership or other entity
or person which directly or indirectly controls or is controlled by or is under common control with
the named party. For purposes of this definition,
(including, with correlative meaning,
the terms
control
shall be presumed to exist if one
of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of
at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors of
such corporate entity or any direct or indirect parent of such corporate entity, and (b) in the case of non-
corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the
power to direct the management and policies of such non-corporate entities;
: the internal system(s) used by the parties to process electronic invoices;
failure by the contractor to fulfil one or more of its contractual
obligations;
: any information or document received by either
party from the other or accessed by either party in the context of the implementation of the
Contract, that any of the parties has identified in writing as confidential. The technical, scientific
and commercial sections included in Annex II of this contract, as well as the unit prices and any
other pricing info included in Article I.5 of this FWC, or in any Annexes of this FWC (except
the total value of this FWC) are considered confidential. Confidential information may not
include information that its owner has made publicly available without any breach;
of
: a situation where the impartial and objective Implementation of the FWC
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 contracting authority or any third party related to the subject matter of
the FWC;
: the quantities and delivery schedule attached to each specific contract
pursuant to the terms of the FWC, that specifies the quantities of vaccines to be delivered to the
relevant contracting authority under such specific contract, including the dates of delivery, as
may be updated from time to time by an agreement of the parties;
(electronic data interchange): a message created and exchanged through the
electronic transfer, from computer to computer, of commercial and administrative data using an
agreed standard;
-
: the service-oriented communication platform that provides a series of web services
and allows the exchange of standardised electronic messages and documents between the
parties. This is done either through web services, with a machine-to-machine connection
Supplier portal). The Platform may be used to exchange electronic documents (e-documents)
such as electronic requests for supplies, electronic specific contracts, and electronic delivery of
the certificate of conformity or electronic invoices between the parties;
M
: any unforeseeable, exceptional situation or event beyond the control of the
28
parties that prevents either of them from fulfilling any of their obligations under the FWC. 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, defects in equipment or material or delays in making them available, labor
disputes, strikes and financial difficulties may not be invoked as Force Majeure, unless they stem
directly from a relevant case of Force Majeure;
(or
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;
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;
Good Distribution Practice / EU GDP all applicable Good Distribution Practices, as
determined in accordance with applicable provisions of Directive 2001/83/EC, current and in
force at the applicable time, including: the Guidelines of 5 November 2013 on Good
Distribution Practice of medicinal products for human use (2013/C 343/01); and Guidelines of
19 March 2015 on principles of Good Distribution Practice of active substances for medicinal
products for human use (2015/C 95/01) and the relevant applicable laws in any relevant country,
each as may be amended and applicable from time to time;
Good Manufacturing Practice / EU GMP
medicinal products set up in the Directive 2001/83/EC, as last amended, Directive 2017/1572
and guidelines published on a basis of Article 47 of Directive 2001/83/EC in the EudraLex
Volume 4 of the Rules Governing Medicinal Products of Human and Veterinary Use;
: the purchase of supplies envisaged in the FWC through the
signature and performance of specific contracts;
Initial quantities has the meaning set forth in Article I.2,
means (a) any processes, trade secrets, inventions, industrial models,
designs, methodologies, drawings, discoveries, result, materials, formulae, procedures,
techniques, clinical data or technical or other information or data, manufacturing, engineering
and technical drawings, including proprietary rights in any of the foregoing, and (b) registered
trademarks, trade mark applications, unregistered marks, trade dress, copyrights, know-how,
patents, patent applications, and any and all provisional, divisions, continuations, continuations
in part, extensions, substitutions, renewals, registrations, revalidations, reissues or additions,
including certificates of supplementary protection, of or to any of the aforesaid patents and
patent applications, and all foreign counterparts of any, or to any, of the aforesaid patents and
patent applications.
: the guideline document which lays down the technical
specifications, message standards, security standards, checks of syntax and semantics, etc. to
facilitate machine-to-machine connection. This document is updated on a regular basis;
Marketing
: the approval under the relevant provisions of Regulation (EC)
29
726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union
procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency, by the European Commission
necessary for placing on the market of the vaccine in the territory of the European Union,
including conditional marketing authorisation in accordance with Article 14a of Regulation
(EC) 726/2004 and as amended;
including by electronic means;
: the execution of tasks and delivery of the purchased
supplies by the contractor to the contracting authority;
: persons employed directly or indirectly or contracted by the contractor to
implement the FWC;
professional activities affect its capacity to implement the FWC or to perform a specific contract
to an appropriate quality standard,
: 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;
: a document from the contracting authority requesting that the
contractors in a multiple FWC with re-opening of competition provide a specific tender for
supplies whose terms are not entirely defined under the FWC;
: a contract concluded between a given contracting authority and the
contractor under the FWC, implementing it and specifying details of a supply to be provided;
: the e-PRIOR portal, which allows the contractor to exchange electronic
business documents, such as invoices, through a graphical user interface.
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 a legal personality or legal capacity, one member of the group is appointed as
leader of the group.
II.3. SEVERABILITY
Each provision of this FWC 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 FWC. This does not affect the legality, validity or enforceability of any other provisions
of the FWC, 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 accordance
with Article II.11. The FWC must be interpreted as if it had contained the substitute provision
30
as from its entry into force.
II.4. DELIVERY OF SUPPLIES
II.4.1 Signature of the FWC does not oblige the contracting authority to enter into a specific contract.
II.4.2. The contractor must comply with the minimum requirements provided for in the tender specifications.
This includes compliance with applicable obligations under environmental, social and labor law established
by Union law, national law and collective agreements or by the international environmental, social and labor
law provisions listed in Annex X to Directive 2014/24/EU, compliance with data protection obligations
resulting from Regulation (EU) 2016/679 and Regulation (EU) 2018/1725; and Regulation (EU, Euratom)
2018/10464 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.
II.4.3 All periods specified in the FWC are calculated in calendar days, unless otherwise specified.
II.4.4 The contractor must not present itself as a representative of the contracting authority and must
inform third parties that it is not part of the European public service.
II.4.5 The contractor is responsible for the Personnel who perform the contract and exercises its authority
over its Personnel without interference by the contracting authority. The contractor must inform its personnel
that: (a) they may not accept any direct instructions from the contracting authority; and
(b) their participation in providing the supplies does not result in any employment or contractual
relationship with the contracting authority.
II.4.6 The contractor must ensure that the Personnel implementing the FWC and any future replacement
Personnel possess the professional qualifications and experience required to provide the supplies, as the
case may be on the basis of the selection criteria set out in the tender specifications.
II.4.7
Personnel who:
(a) does not have the expertise required to provide the supplies; or
(b) has caused disruption at the premises of the contracting authority.
The contractor bears the cost of replacing its Personnel and is responsible for any delay in providing the
supplies resulting from the replacement of Personnel. Before deciding to replace a member of Personnel,
the contractor should first give him the opportunity to present observations.
II.4.8 The contractor must record and report to the contracting authority any problem that affects its ability
to deliver the supplies. The report must describe the problem, state when it started and what action the
contractor is taking to resolve it.
II.4.9 The contractor must immediately inform the contracting authority of any changes in the exclusion
situations as declared, according to Article 137 (1) of the Financial Regulation.
II.4.10 Delivery
4 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1544791836334&uri=CELEX:32018R1046
31
a)
Time allowed for delivery.
The time allowed for delivery is calculated in accordance with Article I.4.
b)
Date, time and place of delivery.
The relevant contracting authority must be notified in writing of the exact date of delivery within the period
indicated in Article I.4. All deliveries must be made at the agreed place of delivery during the hours indicated
in Article I.4.
c)
Notwithstanding the applicable Incoterm set out in Article I.4.4, the contractor must bear all costs and
risks involved in delivering the supplies to the place of delivery. Proof of delivery. Each delivery
instalment must be accompanied by a consignment note in duplicate, duly signed and dated by the
contractor or its carrier, giving the FWC number and particulars of the supplies delivered, and
confirming the compliance with conditions required by good distribution practice, necessary to ensure
the consistent quality of the product. One copy of the consignment note must be countersigned by the
contracting authority and returned to the contractor or to its carrier.
d) Consignment note
Each delivery must be accompanied by a consignment note in duplicate, duly signed and dated by the
contractor or its carrier, giving the specific contract number and particulars of the supplies delivered. One
copy of the consignment note must be countersigned by the contracting authority and returned to the
contractor or to its carrier.
II.4.11 Certificate of conformity
Signature of the consignment note by the contracting authority, as provided for in point (c) of Article II.4.10
is simply an acknowledgment of the fact that the delivery took place and in no way implies conformity of
the supplies with the specific contract.
Conformity of the supplies delivered must be evidenced by the signature of a certificate to this effect by the
contracting authority no later than one month after the date of delivery, unless otherwise specified in the
special conditions or in the tender specifications.
Conformity must be declared only where the conditions laid down in the FWC and in the specific contract
are satisfied and the supplies conform to the tender specifications.
If, for reasons attributable to the contractor, the contracting authority is unable to accept the supplies, the
contractor must be formally notified at the latest by the deadline for conformity.
II.4.12 Conformity of the supplies delivered with the FWC
The vaccines delivered by the contractor to the contracting authority must be in conformity in quantity,
quality, price and packaging with the FWC and the relevant specific contract.
Contractor warrants that the vaccines supplied under each specific contract shall:
a)
Comply with the Tender Specifications (minimum requirements);
b) be manufactured in accordance with EU GMP; and
32
c)
be distributed in accordance with EU GDP until the point delivery to the relevant contracting authority.
Conformity of the supplies delivered must be evidenced by the signature of a certificate to this effect by the
contracting authority no later than one month after the date of delivery, unless otherwise specified in the
special conditions or in the tender specifications.
Conformity must be declared only where the conditions laid down in the FWC are satisfied and the supplies
conform to the tender specifications.
If, for reasons attributable to the contractor, the contracting authority is unable to accept the supplies, the
contractor must be notified in writing at the latest by the deadline for conformity.
II.4.13
Remedies
If a contracting authority considers that any delivery instalment supplied by contractor does not comply with
the Contract, in particular with the Article I.4 and Article II.4.4, the following procedure applies:
a) such contracting authority will give contractor written notice of such alleged non- compliance including
the reasons therefor, in reasonable detail including the nature and basis, and any other relevant information,
and, if requested by contractor, will provide sufficient samples of such vaccines to contractor for
confirmatory testing:
(i)
in the case of non-compliance readily discoverable by a customary inspection of such vaccines
on delivery, within five (5) working days after delivery with working days having to be
interpreted as business days in the respective jurisdiction of the contracting authority; or
(ii) in the case of non-compliance which cannot be readily discoverable by a customary inspection
of such vaccines following delivery, within two (2) working days after such non-compliance
becomes known, or might reasonably be expected to become known, to such contracting
authority, but in any event not later than sixty (60) days after delivery
b) Contractor will evaluate such vaccines (including testing of samples provided by such contracting
authority, if applicable) and notify such contracting authority within twenty (20) working days after
ntracting authority
that it disagrees that there is a non-compliance and such contracting authority does not accept
efforts to resolve the issue amicably. If such disagreement is not resolved within five (5) working days
after one party notifies the other party in writing of the disagreement and requesting resolution,
contractor and such contracting authority will refer the dispute for final settlement to an independent
testing laboratory mutually acceptable to contractor and such contracting authority. The costs of the
testing laboratory will be borne by such contracting authority or by contractor, depending upon whether
a non-compliance is established, or not, by the independent testing laboratory, and in case of non-
compliance which party is deemed responsible for the non-compliance as determined in the final written
conclusion of the testing laboratory with respect to the root cause of the non-compliant vaccines; and
c) if a non-compliance is deemed attributable to contractor (either upon agreement of the parties or final
determination pursuant to subsection (b) above as applicable), contractor shall, at its sole discretion,
within twenty (20) working days either (i) supply such contracting authority with an equivalent
replacement quantity of conforming vaccines; or (ii) issue a credit note to refund such contracting
authority the amounts paid by such contracting authority relating to the nonconforming Product in
question.
In case of non-compliance by the contractor with a Delivery Schedule, Article II.15 will apply.
II.4.14 General provisions concerning supplies
(a) Packaging
33
The supplies must be packaged according to the tender specifications in a way that facilitates storage in the
conditions required to maintain the quality of the products.
Each shipment must be clearly labelled with the following information:
-
name of contracting authority and address for delivery;
-
name of contractor;
-
description of contents;
-
date of delivery;
-
number and date of Contract;
-
EC code number of article, when applicable.
(b) Guarantee
The supplies must be guaranteed by the contractor against all defects in manufacture or materials for their
remaining shelf-life, unless provision is made for a longer period in the tender specifications.
The contractor must guarantee that any permits and licenses required for manufacturing and selling the
supplies have been obtained.
The contractor must replace at its own expense, within a reasonable time and without any significant
inconvenience to the contracting authority, taking account of the nature of the supplies and the purpose for
which they are required by the contracting authority, any items which become damaged or defective in the
course of normal use during the guarantee period.
The contractor is responsible for any conformity defect which exists at the time of delivery, even if this
defect does not appear until a later date.
The contractor is also responsible for any conformity defect which occurs after delivery and is ascribable to
non-compliance with its obligations, including failure to provide a guarantee that, for a certain period,
supplies used for the purposes for which they are normally used or for a specific purpose will preserve their
qualities or characteristics as specified.
If part of an item is replaced, the replacement part must be guaranteed under the same terms and conditions
for a further period of the same duration as that specified above.
If a defect is found to originate in a systematic flaw in design, the contractor must replace or modify all
identical parts incorporated in the other supplies that are part of the order, even though they may not have
been the cause of any incident. In this case, the guarantee period must be extended as stated above.
II.4.15 If the contractor fails to deliver the supply in accordance with the FWC or a specific contract or if it
fails to deliver the supply in accordance with the expected quality levels specified in the tender
specifications, the contracting authority may, even if these failings constitute a breach that could
trigger Article II.17.1, without prior notice of default to the contractor or judicial intervention being
required, decide to have these obligations performed by a third party, at the
expense. The
contracting authority shall formally notify the contractor of its decision to have the contractor
substituted and the grounds for this substitution.
Any such substitution does not affect the
damages under Article II.18 that the substitution would not cover.
34
II.5. COMMUNICATION BETWEEN THE PARTIES
II.5.1. Form and means of communication
Any communication of information, notices or documents under the FWC must:
(a) be made in writing in paper or electronic format in the language of the contract;
(b) bear the FWC number and, if applicable, the specific contract number;
(c) be made using the relevant communication details set out in Article I.8; and
(d) be sent by mail, email or, for the documents specified in the special conditions, via e-
PRIOR.
If a party requests written confirmation of an e-mail within a reasonable time, the other party
must provide an original signed paper version of the communication as soon as possible.
The parties agree that any communication made by email has full legal effect and is admissible
as evidence in judicial proceedings.
II.5.2. Date of communications by mail and email
Any communication is deemed to have been made when the receiving party receives it, unless
this FWC contract refers to the date when the communication was sent.
E-mail is deemed to have been received by the receiving party on the day of dispatch of that e-
mail, provided that it is sent to the e-mail address indicated in Article I.8. The sending party
must be able to prove the date of dispatch. In the event that the sending party receives a non-
delivery report, it must make every effort to ensure that the other party actually receives the
communication by email or mail. In such a case, the sending party is not held in breach of its
obligation to send such communication within a specified deadline.
Mail sent to the contracting authority is deemed to have been received by the contracting
authority on the date on which the department responsible referred to in Article I.8 registers it.
Formal notifications are considered to have been received by the receiving party on the date of
receipt indicated in the proof received by the sending party that the message was delivered to
the specified recipient.
II.5.3. Submission of e-documents via e-PRIOR
If provided for in the special conditions, the exchange of electronic documents (e-documents)
such as specific contracts and invoices between the parties is automated through the use of the
e-PRIOR platform. This platform provides two possibilities for such exchanges: either through
web services (machine-to-machine connection) or through a web application (the Supplier
portal).
The contracting authority takes the necessary measures to implement and maintain electronic
systems that enable the Supplier portal to be used effectively.
In the case of machine-to-machine connection, a direct connection is established between the
implement and maintain electronic systems that enable the machine-to-machine connection to
be used effectively. The electronic systems are specified in the Interface control document. The
contractor (or leader in the case of a joint tender) must take the necessary technical measures to
35
set up a machine-to-machine connection and at its own cost.
If communication via the Supplier portal or via the web services (machine-to-machine
connection) is hindered by factors beyond the control of one party, it must notify the other
immediately and the parties must take the necessary measures to restore this communication.
If it is impossible to restore the communication within two working days, one party must notify
the other that alternative means of communication specified in Article II.5.1 will be used until
the Supplier portal or the machine-to-machine connection is restored.
When a change in the Interface control document requires adaptations, the contractor (or leader
in the case of a joint tender) has up to six months from receipt of the Notification to implement
this change. This period can be shortened by mutual agreement of the parties. This period does
not apply to urgent measures required by the security policy of the contracting authority to
ensure integrity, confidentiality and non-repudiation of information and the availability of e-
PRIOR, which must be applied immediately.
II.5.4. Validity and date of e-documents
The parties agree that any e-document, including related attachments exchanged via e-PRIOR:
(a) is considered as equivalent to a paper document;
(b) is deemed to be the original of the document;
(c) is legally binding on the parties once an e-PRIOR authorised person has performed the
-PRIOR and has full legal effect; and
(d) constitutes evidence of the information contained in it and is admissible as evidence in
judicial proceedings.
The parties expressly waive any rights to contest the validity of such a document solely on the
grounds that communications between the parties occurred through e-PRIOR or that the
document has been signed through e-PRIOR. If a direct connection is established between the
-
document, sent as mentioned in the Interface control document, qualifies as an EDI message.
If the e-document is dispatched through the Supplier portal, it is deemed to have been legally
issued or sent when the contractor (or leader in the case of a joint tender) is able to successfully
submit the e-document without any error messages. The generated PDF and XML document
for the e-document are considered as proof of receipt by the contracting authority.
In the event that an e-document is dispatched using a direct connection established between the
pa
-document is deemed to have been legally issued or sent when its
When using the Supplier portal, the contractor (or leader in the case of a joint tender) can
download the PDF or XML message for each e-document for one year after submission. After
this period, copies of the e-documents are no longer available for automatic download from the
Supplier portal.
II.5.5. Authorised persons in e-PRIOR
The contractor submits a request for each person who needs to be assigned the role of
in
e-PRIOR. These persons are identified by means of the European Communication
36
Authentication Service (ECAS) and authorized to access and perform actions in e-PRIOR
within the permissions of the user roles that the contracting authority has assigned to them.
User roles enabling these e-PRIOR authorised persons to sign legally binding documents such
as specific tenders or specific contracts are granted only upon submission of supporting
documents proving that the authorised person is empowered to act as a legal representative of
the contractor.
II.6. LIABILITY
II. 6.I The contracting authority is not liable for any damage or loss caused by the contractor, including any
damage or loss to third parties during or as a consequence of the performance of the contract.
II.6.2 If required by the relevant applicable legislation, the contractor must take out an insurance policy
against risks and damage or loss relating to the Implementation of the FWC. It must also take out
supplementary insurance as reasonably required by standard practice in the industry. Upon request,
the contractor must provide evidence of insurance coverage to the contracting authority.
II.6.3 Except in case of Force Majeure, the contractor is liable for any loss or damage caused to the
contracting authority during or as a consequence of Implementation of the FWC resulting from a
breach attributable to the contractor, including in the event of subcontracting, but only to an amount
not exceeding three times the total amount of the contract. However, if the damage or loss is caused
by the gross negligence or willful misconduct of the contractor, a Related Person, its Personnel or its
subcontractors, as well as in the case of an action brought against the contracting authority by a third
party for breach of its Intellectual Property rights, the contractor is liable for the whole amount of the
damage or loss.
II.6.4 If a third party brings any action against the contracting authority in connection with the
Implementation of the FWC, the contractor must assist the contracting authority in the legal
proceedings, including by intervening in support of the contracting authority upon request.
e third party is established and that such liability is
caused by the contractor during or as a consequence of the Implementation of the FWC, Article II.6.3
applies. In that case, the limitations of liability foreseen in Article II.6.3 do not apply.
II.6.5 If the contractor is composed of two or more economic operators (i.e. who submitted a joint tender),
they are all jointly and severally liable to the contracting authority for the Implementation of the
FWC.
II.6.6 The contracting authority is not liable for any loss or damage caused to the contractor during or as a
consequence of Implementation of the FWC, unless the loss or damage was caused by willful
misconduct or gross negligence of the contracting authority.
II.7. CONFLICT OF INTEREST AND PROFESSIONAL CONFLICTING
INTERESTS
II.7.1 The contractor must take all the necessary measures to prevent any situation of Conflict
of interest or Professional conflicting interest.
II.7.2 The contractor must notify the contracting authority in writing as soon as possible of
any situation that could constitute a Conflict of interest or a Professional conflicting
37
interest during the Implementation of the FWC. The contractor must immediately take
action to rectify the situation.
The contracting authority may do any of the following:
(a) verify that the
is appropriate;
(b) require the contractor to take further action within a specified deadline;
(c) decide not to award any specific contract to the contractor until the situation has been rectified.
II.7.3 The contractor must pass on all the relevant obligations in writing to:
(a) its Personnel;
(b) any Related Person;
(c) third parties involved in the Implementation of the FWC, including subcontractors.
The contractor must also ensure that the persons referred to above are not placed in a
situation which could give rise to conflicts of interest.
II.8. CONFIDENTIALITY
II.8.1. The contracting authority and the contractor must treat with confidentiality any
information or documents, in any format, disclosed in writing or orally relating to the
Implementation of the FWC .
II.8.2. Each party must:
(a) not use Confidential information or documents for any purpose other than to perform
its obligations under the FWC or a specific contract without the prior written
agreement of the other party;
(b) ensure the protection of such Confidential information or documents with the same
level of protection as its own Confidential information or documents, and in any case
with due diligence;
(c) not disclose directly or indirectly, Confidential information or documents to third
parties without the prior written agreement of the other party.
II.8.3 The confidentiality obligation set out in this Article are binding on the contracting
authority and the contractor during the Implementation of the FWC and for as long as
the information or documents remain confidential unless:
(a) the disclosing party agrees to release the receiving party from the confidentiality
obligation earlier;
(b) the Confidential information or documents become public through other means than a
breach of the confidentiality obligation,
(c) the applicable law requires the disclosure of the Confidential information or documents.
II.8.4 The contractor must obtain from any Related Person and its Personnel, as well as from,
as well as from third parties involved in the Implementation of the FWC a written
commitment that they will comply with this Article. At the request of the contracting
38
authority, the contractor must provide a document providing evidence of this
commitment.
II.8.5 The contracting authority is entitled to make available (any part of) the Confidential
information or documents to its staff and the staff of other Union institutions, agencies
and bodies, as well to other persons and entities working for the contracting authority or
cooperating with it. This includes other contractors or subcontractors and their
Personnel, who need to know the same for the Implementation of the FWC, who know
they must treat it confidentially and who are bound by confidentiality obligations that
in this section.
II.9. PROCESSING OF PERSONAL DATA
II.9.1 Processing of personal data by the contracting authority
Any personal data included in or relating to the FWC, including its implementation, shall be
processed in accordance with Regulation (EU) No 2018/1725. Such data shall be processed
solely for the purposes of the implementation, management and monitoring of the FWC by the
data controller.
The contractor or any other person whose personal data is processed by the data controller in
relation to this FWC has specific rights as a data subject under Chapter III (Articles 14-25) of
Regulation (EU) No 2018/1725, in particular the right to access, rectify or erase their personal
data and the right to restrict or, where applicable, the right to object to processing or the right
to data portability.
Should the contractor or any other person whose personal data is processed in relation to this
FWC have any queries concerning the processing of its personal data, it shall address itself to
the data controller. They may also address themselves to the Data Protection Officer of the data
controller. They have the right to lodge a complaint at any time to the European Data Protection
Supervisor.
Details concerning the processing of personal data are available in the data protection notice
referred to in Article I.9.
II.9.2 Processing of personal data by the contractor
The processing of personal data by the contractor shall meet the requirements of Regulation
(EU) No 2018/1725 and be processed solely for the purposes set out by the controller.
respond to requests for exercising rights of person whose personal data is processed in relation
to this FWC as laid down in Chapter III (Articles 14-25) of Regulation (EU) No 2018/1725.
The contractor shall inform without delay the controller about such requests.
The contractor may act only on documented written instructions and under the supervision of
the controller, in particular with regard to the purposes of the processing, the categories of data
that may be processed, the recipients of the data and the means by which the data subject may
exercise its rights.
The contractor shall grant Personnel access to the data to the extent strictly necessary for the
implementation, management and monitoring of the FWC. The contractor must ensure that
Personnel authorized to process personal data has committed itself to confidentiality or is under
39
appropriate statutory obligation of confidentiality in accordance with the provisions of Article
II.8.
The contractor shall adopt appropriate technical and organizational security measures, giving
due regard to the risks inherent in the processing and to the nature, scope, context and purposes
of processing, in order to ensure, in particular, as appropriate:
(a) the pseudonymization and encryption of personal data;
(b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of
processing systems and services;
(c) the ability to restore the availability and access to personal data in a timely manner in
the event of a physical or technical incident;
(d) a process for regularly testing, assessing and evaluating the effectiveness of technical
and organizational measures for ensuring the security of the processing;
(e) measures to protect personal data from accidental or unlawful destruction, loss,
alteration, unauthorized disclosure of or access to personal data transmitted, stored or
otherwise processed.
The contractor shall notify relevant personal data breaches to the controller without undue delay
and at the latest within 48 hours after the contractor becomes aware of the breach. In such cases,
the contractor shall provide the controller with at least the following information:
(a) nature of the personal data breach including where possible, the categories and
approximate number of data subjects concerned and the categories and approximate
number of personal data records concerned;
(b) likely consequences of the breach;
(c) measures taken or proposed to be taken to address the breach, including, where
appropriate, measures to mitigate its possible adverse effects.
The contractor shall immediately inform the data controller if, in its opinion, an instruction
infringes Regulation (EU) 2018/1725, Regulation (EU) 2016/679, or other Union or Member
State data protection provisions as referred to in the tender specifications.
The contractor shall assist the controller for the fulfilment of its obligations pursuant to Article
33 to 41 under Regulation (EU) 2018/1725 to:
(a) ensure compliance with its data protection obligations regarding the security of the
processing, and the confidentiality of electronic communications and directories of
users;
(b) notify a personal data breach to the European Data Protection Supervisor;
(c) communicate a personal data breach without undue delay to the data subject, where
applicable;
(d) carry out data protection impact assessments and prior consultations as necessary.
The contractor shall maintain a record of all data processing operations carried on behalf of the
controller, transfers of personal data, security breaches, responses to requests for exercising
rights of people whose personal data is processed and requests for access to personal data by
third parties.
The contracting authority is subject to Protocol 7 of the Treaty on the Functioning of the
European Union on the privileges and immunities of the European Union, particularly as
regards the inviolability of archives (including the physical location of data and services as set
out in Article I.9.2) and data security, which includes personal data held on behalf of the
contracting authority in the premises of the contractor or subcontractor.
40
The contractor shall notify the contracting authority without delay of any legally binding request
for disclosure of the personal data processed on behalf of the contracting authority made by any
national public authority, including an authority from a third country. The contractor may not
give such access without the prior written authorization of the contracting authority.
The duration of processing of personal data by the contractor will not exceed the period referred
to in Article II.22.2. Upon expiry of this period, the contractor shall, at the choice of the
controller, return, without any undue delay in a commonly agreed format, all personal data
processed on behalf of the controller and the copies thereof or shall effectively delete all
personal data unless Union or national law requires a longer storage of personal data.
For the purpose of Article II.10, if part or all of the processing of personal data is subcontracted
to a third party, the contractor shall pass on the obligations referred to in Articles I.9.2 and II.9.2
in writing to those parties, including subcontractors. At the request of the contracting authority,
the contractor shall provide a document providing evidence of this commitment.
II.10. SUBCONTRACTING
II.10.1 The contractor must not subcontract and have the FWC implemented by third parties
beyond the third parties already mentioned in its tender without prior written
authorization from the contracting authority.
II.10.2 Even if the contracting authority authorizes subcontracting, the contractor remains
bound by its contractual obligations and is solely responsible for the Implementation
of the FWC.
II.10.3 The contractor must ensure that the subcontract does not affect the rights of the
contracting authority under this FWC, particularly those under Articles II.8 and II.22.
II.10.4 The contracting authority may request the contractor to replace a subcontractor found
to be in a situation provided for in points (d) and (e) of Article II.17.1. The contractor
bears the costs of such replacement.
II.11. AMENDMENTS
II.11.1 Any amendment to the FWC or a specific contract must be made in writing before all
contractual obligations have been fulfilled. A specific contract does not constitute an
amendment to the FWC. Any acceptance or payment by the contracting authority of
an invoice referring to the general terms and conditions of the contractor does not
constitute a valid amendment to the FWC or to a specific contract and does not make
these general terms and conditions applicable to the FWC or a specific contract.
II.11.2 Any amendment must not make changes to the FWC or a specific contract that might
alter the initial conditions of the procurement procedure or result in unequal treatment
of tenderers or contractors.
II.12. ASSIGNMENT of the contract to a third-party
II.12.1 The contractor must not assign any of the rights and obligations arising from the FWC
or a specific contract.
By way of exception to the preceding clause, in duly justified exceptional
circumstances, rights and / or obligations arising from the FWC and/or a specific
41
contract may be assigned with the prior written authorization of the contracting
authority. This authorization shall be granted or not at the discretion of the contracting
exceptional circumstances on which it is based and provide the identity of the intended
assignee. The contracting authority may request additional information.
Any right or obligation assigned by the contractor without authorization mentioned in
the preceding clause is not enforceable against the contracting authority. Accordingly,
the assignor will remain jointly and severally bound with the assignee vis-à-vis the
contracting authority.
II.13. FORCE MAJEURE
II.13.1 If a party is affected by Force Majeure, it must immediately notify the other party,
stating the nature of the circumstances, their likely duration and foreseeable effects.
II.13.2 A party is not liable for any delay or failure to perform its obligations under the FWC
or a specific contract if that delay or failure is a result of Force Majeure. If the contractor
is unable to fulfil its contractual obligations owing to Force Majeure, it has the right to
remuneration only for the supplies actually delivered and which obtain a certificate of
conformity.
II.13.3 The parties must take all necessary measures to limit any damage due to Force Majeure.
Force Majeure either suspends the Implementation of the FWC as provided for in Article II.16
or leads to the termination of the FWC as provided for in Article II.17. The effects of the
suspension of the FWC due to Force Majeure on the duration is laid down in Article I.3.5.
II.14. LIQUIDATED DAMAGES
II.14.1. Delay in delivery
If the contractor fails to perform its contractual obligations within the applicable time limits set
out in this FWC, the contracting authority may claim liquidated damages for each day of delay
using the following formula:
0.3 x (V/d)
where:
V is the price of the relevant purchase or supply;
d is the duration specified in the relevant specific contract for delivery of the relevant purchase
or supply or, failing that, the period between the date specified in Article I.4.2 and the date of
delivery or performance specified in the relevant specific contract, expressed in days.
Liquidated damages for delay in delivery may be imposed together with a reduction in price
under the conditions laid down in Article II.15 or a substitution of the contractor under the
conditions laid down in Article II.4.15.
Any claim for liquidated damages does not affect (a) the
liability for damages that
nor (c) the
that the contracting authority may have under the FWC or a specific contract.
42
II.14.2. Procedure
The contracting authority must formally notify the contractor of its intention to apply liquidated
damages and the corresponding calculated amount.
The contractor has 30 days following the date of receipt to submit observations. Failing that,
the decision becomes enforceable the day after the time limit for submitting observations has
elapsed.
If the contractor submits observations, the contracting authority, taking into account the relevant
observations, must notify the contractor:
(c) of the withdrawal of its intention to apply liquidated damages; or
(d) of its final decision to apply liquidated damages and the corresponding amount.
II.14.3. Nature of liquidated damages
The parties expressly acknowledge and agree that any amount payable under this Article is not
a penalty and in view of all the circumstances including the legitimate interest of the contracting
authority for a timely delivery to fulfil its mission of public services, represents a reasonable
estimate of fair compensation for the damage that may be incurred by the contracting authority
due to failure to provide the supplies within the applicable time limits set out in this FWC or in
a specific contract.
II.14.4. Claims and liability
Any claim for liquidated damages does not affect the
actual or potential liability or
the contracting
II.15. REDUCTION IN PRICE
II.15.1. Quality standards
If the contractor fails to deliver the supply in accordance with the FWC or a specific contract
th the expected
authority may, even if these failings constitute a breach that could trigger Article II.17.1, reduce
the price. The price reduction will be directly proportional to the difference, upon the time of the
signature of the FWC, between the value of the unperformed obligations or low-quality delivery
and the value of the agreed supply. This includes in particular cases where the contracting
authority cannot approve a document or deliver a certificate of conformity for supply as defined
in Article I.6 after the contractor has submitted the required additional information, correction
or new supply.
A reduction in price may be imposed together with liquidated damages under the conditions of
Article II.14.
rights under Article II.17 for damages that the reduction in price would not cover or any other
right or remedy that the contracting authority may have under the FWC or a specific contract.
43
II.15.2. Procedure
The contracting authority must formally notify the contractor of its intention to reduce payment
and the corresponding calculated amount.
The contractor has 30 days following the date of receipt to submit observations. Failing that,
the decision becomes enforceable the day after the time limit for submitting observations has
elapsed.
If the contractor submits observations, the contracting authority, taking into account the relevant
observations, must notify the contractor:
(a) of the withdrawal of its intention to reduce payment; or
(b) of its final decision to reduce payment and the corresponding amount.
II.15.3. Claims and liability
Any
II.16. SUSPENSION OF THE IMPLEMENTATION OF THE FWC
II.16.1. Suspension by the contractor
If the performance of the contract is affected by Force Majeure, the contractor may suspend the
Performance of a specific contract.
The contractor must immediately notify the contracting authority of the suspension. The
Notification must include a description of the Force Majeure and state when the contractor
expects to resume the performance of the contract.
The contractor must notify the contracting authority as soon as it is able to resume performance
of the specific contract, unless the contracting authority has already terminated the FWC or the
specific contract.
The contracting authority is not entitled to compensation for the suspension of any part of the
FWC or a specific contract, in the event of Force Majeure.
II.16.2. Suspension by the contracting authority
The contracting authority may suspend the Implementation of the FWC or Performance of a
specific contract or any part of it:
in case of Force Majeure affecting the Implementation of the FWC or the Performance of a
specific contract;
(a) if the procedure for awarding the FWC or a specific contract or the Implementation
of the FWC proves to have been subject to irregularities, Fraud or Breach of
obligations;
(b) in order to verify whether the presumed irregularities, Fraud or Breach of obligations
have actually occurred.
The contracting authority 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
44
notification so provides.
The contracting authority 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 FWC or a specific contract under Article II.17.1(f) or (j).
The contractor is not entitled to compensation for the suspension of any part of the FWC or a
specific contract.
The contracting authority may in addition suspend the time allowed for payments in accordance
with Article II.20.7.
II.17. TERMINATION OF THE FWC
II.17.1. Grounds for termination by the contracting authority
The lead contracting authority may terminate the FWC, or a contracting authority may terminate on-
going specific contract, concluded between this contracting authority and the contractor, in the following
circumstances:
(a) if provision of the supplies under an on-going specific contract has not actually started
within thirty (30) calendar days of the scheduled date and the contracting authority
considers that the new date proposed, if any, is unacceptable, taking into account Article
II.11.2 (for the purpose of this litra (a), a contracting authority may terminate the specific
contract affected by the delayed supply on the conditions set out just above, however,
such delayed supply with respect to a specific contract shall not entitle the lead
contracting authority to terminate the FWC, unless it concerns three or more specific
contracts where litra (c) would be applicable);
(b) if the contractor is unable, through its own fault, to obtain any permit or license required
for Implementation of the FWC;
(c) if the contractor fails to implement the FWC or to perform the specific contract in
accordance with the tender specifications or Request for supplies or is materially in
breach of another substantial contractual obligation or repeatedly refuses to sign specific
contracts. Termination of three or more specific contracts in these circumstances also
constitutes grounds for termination of the FWC;
(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 Regulation6;
(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 to Article 136(2) of the Financial Regulation.
(f) if the procedure for awarding the FWC or the Implementation of the FWC prove to have
been subject to irregularities, Fraud or Breach of obligations;
(g) if the contractor does not comply with applicable obligations under environmental,
social and labor law established by Union law, national law, collective agreements or
45
by the international environmental, social and labor law provisions listed in Annex X to
Directive 2014/24/EU;
(h) if the contractor is in a situation that could constitute a Conflict of interest or a
Professional conflicting interest as referred to in Article II.7 and does not rectify the situation;
(i)
financial, technical, organizational or ownership
situation is likely to substantially affect the Implementation of the FWC or substantially
modify the conditions under which the FWC was initially awarded or a change regarding
the exclusion situations listed in Art 136 of Regulation (EU) 2018/10465 that calls into
question the decision to award the contract or the contractor becomes subject to
restrictive measures hindering the Implementation of the FWC;
(j) in the event of Force Majeure, where either resuming implementation is impossible or
the necessary ensuing amendments to the FWC or a specific contract would mean that
the tender specifications are no longer fulfilled or result in unequal treatment of
tenderers or contractors;
(k) if the needs of the contracting authority change and it no longer requires new supplies
under the FWC; in such cases ongoing specific contracts remain unaffected;
(l) if the contractor is in breach of the data protection obligations resulting from Article
II.9.2;
(m) if the contractor does not comply with the applicable data protection obligations
resulting from Regulation (EU) 2016/679.
(n) if it is manifest that, at a later date and before such breach becomes effective, the
contractor will materially fail to implement the FWC or to perform the specific contract
in accordance with the tender specifications or request for specific contract or will be
materially in breach of another contractual obligation or will repeatedly refuse to sign
specific contracts, unless the contractor provides the contracting authority with
sufficient assurances of its future performance.
II.17.2. Grounds for termination by the contractor
The contractor may terminate the FWC or any on-going specific contract if the contracting
authority materially fails to comply with its obligations, in particular the obligation to
provide the information needed for the contractor to implement the FWC or to perform a
specific contract as provided for in the tender specifications.
The contractor may also terminate the FWC or any on-going specific contract in the event of Force
Majeure, where resuming implementation is impossible.
II.17.3. Procedure for termination
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
46
A party must formally notify the other party of its intention to terminate the FWC or a specific
contract and the grounds for termination.
The other party has 30 days following the date of receipt to submit observations, including the
measures it has taken or will take to continue fulfilling its contractual obligations. Failing that,
the decision to terminate becomes enforceable the day after the time limit for submitting
observations has elapsed and provided the ground for termination has not been remedied.
If the other party submits observations, the party intending to terminate must formally notify it
either of the withdrawal of its intention to terminate or of its final decision to terminate.
In the cases referred to in points (a) to (d), (g) to (i), (k) to (n) of Article II.17.1 and in Article
II.17.2, the date on which the termination takes effect must be specified in the Formal
notification.
In the cases referred to in points (e), (f) and (j) of Article II.17.1, the termination takes effect on
the day following the date on which the contractor receives Notification of termination.
In addition, at the request of the contracting authority and regardless of the grounds for
termination, the contractor must provide all necessary assistance, including information,
documents and files, to allow the contracting authority to complete, continue or transfer the
delivery of the supplies to a new contractor or internally, without interruption or adverse effect
on the quality or continuity of delivery of the supplies. The parties may agree to draw up a
transition plan detailing the
unless such plan is already detailed in other
contractual documents or in the tender specifications. The contractor must provide such
assistance at no additional cost, except if it can demonstrate that it requires substantial additional
resources or means, in which case it must provide an estimate of the costs involved and the
parties will negotiate an arrangement in good faith.
II.17.4. Effects of termination
The contractor is liable for damage incurred by the contracting authority as a result of the
termination of the FWC or a specific contract, including the additional cost of appointing and
contracting another contractor to provide or complete the supplies, except if the damage is a
result of a termination in accordance with Article II.17.1(j), (k) or (l) or in Article II.17.2. The
contracting authority may claim compensation for such damage.
The contractor is not entitled to compensation for any loss resulting from the termination of the
FWC or a specific contract, including loss of anticipated profits, unless the loss was caused by
the situation specified in Article II.17.2.
The contractor must take all appropriate measures to minimise costs, prevent damage and cancel
or reduce its commitments.
Within sixty (60) calendar days of the date of termination, the contractor must submit any report
and any invoice required for supplies that were provided before the date of termination.
In the case of joint tenders, the contracting authority may terminate the FWC or a specific
contract with each member of the group separately on the basis of points (d), (e), (g), (m) and
(n) of Article II.17.1, under the conditions set out in Article II.11.2.
II.18. INVOICES, VALUE ADDED TAX AND E-INVOICING
47
II.18.1. Invoices and value added tax
data, the amount, the currency and the date, as well as the FWC reference and reference to the
specific contract.
Invoices must indicate the place of taxation of the contractor (or leader in the case of a joint
tender) for value added tax (VAT) purposes and must specify separately amounts not including
VAT and amounts including VAT.
The Commission is exempt from all taxes and duties, including VAT, in accordance with
Articles 3 and 4 of Protocol 7 of the Treaty on the Functioning of the European Union on the
privileges and immunities of the European Union.
The contractor (or leader in the case of a joint tender) must complete the necessary formalities
with the relevant authorities to ensure that the supplies and services required for Implementation
of the FWC are exempt from taxes and duties, including VAT.
II.18.2. E-invoicing
If provided for in the special conditions, the contractor (or leader in the case of a joint tender)
submits invoices in electronic format if the conditions regarding electronic signature specified
by Directive 2006/112/EC on VAT are fulfilled, i.e. using a qualified electronic signature or
through electronic data interchange.
Reception of invoices by standard format (pdf) or email is not accepted.
II.19. PRICE REVISION
If a price revision index is provided in Article I.5.2, this Article applies to it.
Prices are fixed and not subject to revision during the first year of the FWC.
At the beginning of the second and every following year of the FWC, each price may be revised
upwards or downwards at the request of one of the parties.
A party may request a price revision in writing no later than three months before the anniversary
date of entry into force of the FWC. The other party must acknowledge the request within 14
days of receipt.
At the anniversary date, the contracting authority must communicate the final index for the
month in which the request was received, or failing that, the last provisional index available for
that month. The contractor establishes the new price on this basis and communicates it as soon
as possible to the contracting authority for verification.
The contracting authority purchases on the basis of the prices in force at the date on which the
specific contract enters into force.
The price revision is calculated using the following formula:
Pr = Po x (Ir/Io)
48
where: Pr = revised price;
Po = price in the tender;
Io = index for the month in which the FWC enters into force;
Ir = index for the month in which the request to revise prices is received.
II.20. PAYMENTS AND GUARANTEES
II.20.1. Date of payment
The date of payment is deemed to be the date on which the contracting authority's account is
debited.
II.20.2. Currency
Payments are made in euros, unless another currency is provided for in Article I.7.
II.20.3. Conversion
The contracting authority makes any conversion between the euro and another currency at the
daily euro exchange rate published in the Official Journal of the European Union, or failing that,
at the monthly accounting exchange rate, as established by the European Commission and
published on the website indicated below, applicable on the day when it issues the payment
order.
The contractor makes any conversion between the euro and another currency at the monthly
accounting exchange rate, established by the Commission and published on the website
indicated below, applicable on the date of the invoice.
II.20.4. Costs of transfer
The costs of the transfer are borne as follows:
(a) the contracting authority bears the costs of dispatch charged by its bank;
(b) the contractor bears the costs of receipt charged by its bank;
(c) the party causing repetition of the transfer bears the costs for repeated transfer.
II.20.5. Pre-financing, performance and money retention guarantees
If, as provided for in Article I.6, a financial guarantee is required for the payment of pre-
financing, as performance guarantee or as money retention guarantee, it must fulfil the following
conditions:
(a) the financial guarantee is provided by a bank, or a financial institution approved by the
contracting authority or, at the request of the contractor and with the agreement of the
contracting authority, by a third party;
(b) the guarantee shall have the effect of making the bank or financial institution or the third
party provide irrevocable collateral security or stand as first-call guarantor of the
contractor's obligations without requiring that the contracting authority has recourse against
the principal debtor (the contractor).
49
The contractor bears the cost of providing such a guarantee.
Pre-financing guarantees must remain in force until the pre-financing is cleared against interim
payments or payment of the balance. Where the payment of the balance takes the form of a debit
note, the pre-financing guarantee must remain in force for three months after the debit note is
sent to the contractor. The contracting authority must release the guarantee within the following
month.
Performance guarantees cover compliance with substantial contractual obligations until the
contracting authority has given its final approval for the supply. The performance guarantee
must not exceed 10 % of the total price of the specific contract. The contracting authority must
release the guarantee fully after the final certificate of conformity of the supply has been
delivered, as provided for in the specific contract.
Retention money guarantees cover full delivery of the supplies in accordance with the specific
contract, including during the contract liability period and until their final certificate of
conformity has been delivered by the contracting authority. The retention money guarantee
must not exceed 10 % of the total price of the specific contract. The contracting authority must
release the guarantee after the expiry of the contract liability period as provided for in the
specific contract.
The contracting authority must not request a retention money guarantee for a specific contract
when it has requested a performance guarantee.
II.20.6. Interim payments and payment of the balance
The contractor (or leader in the case of a joint tender) must send an invoice for interim payment,
as provided for in Article I.6 or in the tender specifications or in the specific contract.
The contractor (or leader in the case of a joint tender) must send an invoice for payment of the
balance within 60 days of the end of the period of provision of the supplies, as provided for in
Article I.6, in the tender specifications or in the specific contract.
Payment of the invoice and approval of documents does not imply recognition of the regularity,
authenticity, completeness and correctness of the declarations and information they contain.
Payment of the balance may take the form of recovery.
II.20.7. Suspension of the time allowed for payment
The contracting authority may suspend the payment periods specified in Article I.6 at any time
by notifying the contractor (or leader in the case of a joint tender) that its invoice cannot be
processed. The reasons the contracting authority may cite for not being able to process an
invoice are:
(a)
because it does not comply with the FWC;
(b)
because the contractor has not produced the appropriate supplies or documents; or
(c)
because the contracting authority has observations on the supplies or documents
submitted with the invoice.
(d)
because it is manifest that, at a later date and before such breach becomes effective, the
contractor will materially fail to implement the FWC or to perform the specific contract in
50
accordance with the tender specifications or request for specific contract or will be in material
breach of another contractual obligation or will repeatedly refuse to sign specific contracts,
unless the contractor provides the contracting authority with sufficient assurances of its future
performance.
The contracting authority must notify the contractor (or leader in the case of a joint tender) as
soon as possible of any such suspension, giving the reasons for it. In cases b) and c) referred
above, the contracting authority shall notify the contractor (or leader in case of a joint tender)
the time limits to submit additional information or corrections or a new version of the documents
or deliverables if the contracting authority requires it.
Suspension takes effect on the date the contracting authority sends the Notification. The
remaining payment period resumes from the date on which the requested information or revised
documents are received or the necessary further verification, including on-the-spot checks, is
carried out. Where the suspension period exceeds two months, the contractor (or leader in the
case of a joint tender) may request the contracting authority to justify the continued suspension.
Where the payment periods have been suspended following rejection of a document referred to
in the first paragraph of this Article and the new document produced is also rejected, the
contracting authority reserves the right to terminate the specific contract in accordance with
Article II.17.1(c).
II.20.8. Interest on late payment
On expiry of the payment periods specified in Article I.6, the contractor (or leader in the case
of a joint tender) is entitled to interest on late payment at the rate applied by the European
Central Bank for its main refinancing operations in euros (the reference rate) plus eight points.
The reference rate is the rate in force, as published in the C series of the Official Journal of the
European Union, on the first day of the month in which the payment period ends.
Suspension of the payment period as provided for in Article II.20.7 is not considered as giving
rise to late payment.
Interest in late payment covers the period running from the day following the due date for
payment up to and including the date of payment as defined in Article II.20.1.
However, when the calculated interest is EUR 200 or less, it must be paid to the contractor (or
leader in the case of a joint tender) only if it requests it within two months of receiving late
payment.
II.21. RECOVERY
II.21.1 If an amount is to be recovered under the terms of the FWC, the contractor must repay
the contracting authority the amount in question.
II.21.2
Recovery procedure
Before recovery, the contracting authority must formally notify the contractor of its intention to
recover the amount it claims, specifying the amount due and the reasons for recovery and
inviting the contractor to make any observations within 30 days of receipt.
If no observations have been submitted or if, despite the observations submitted, the contracting
authority decides to pursue the recovery procedure, it must confirm recovery by formally
notifying a debit note to the contractor, specifying the date of payment. The contractor must pay
51
in accordance with the provisions specified in the debit note.
If the contractor does not pay by the due date, the contracting authority may, after informing
the contractor in writing, recover the amounts due:
(a) by offsetting them against any amounts owed to the contractor by the Union or by the
European Atomic Energy Community or by an executive agency when it implements
the Union budget;
(b) by calling in a financial guarantee if the contractor has submitted one to the contracting
authority;
(c) by taking legal action.
II.21.3 Interest on late payment
If the contractor does not honor the obligation to pay the amount due by the date set by the
contracting authority in the debit note, the amount due bears interest at the rate indicated in
Article II.20.8. 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 contracting authority 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.21.4
Recovery rules in the case of joint tender
If the contract is signed by a group (joint tender), the group is jointly and severally liable under
the conditions set out in Article II.6 (liability). The contracting authority shall send the debit
note first to the leader of the group.
If the leader does not pay by the due date the whole amount, and if the amount due cannot be
offset or can only be offset partially in accordance with Article II.21.2 (a), then the contracting
authority may claim the amount still due to any other member or members of the group by
respectively notifying them with a debit note in conformity with the provisions laid down in
Article II.21.2.
II.22. CHECKS AND AUDITS
II.22.1 The contracting authorities may check or require an audit on the Implementation of the
FWC. This may be carried out by any outside body authorized to do so on its behalf.
Such checks and audits may be initiated at any moment during
business hours) the provision of the supplies and up to five years starting from the
payment of the balance of the last specific contract issued under this FWC.
The audit procedure is initiated on the date of receipt of the relevant letter sent by the
contracting authority. Audits are carried out on a confidential basis.
II.22.2 The contractor must keep all original documents stored on any appropriate medium,
including digitized originals if authorized under national law, for a period of five years
starting from the payment of the balance of the last specific contract issued under this
FWC.
52
II.22.3
authorized by the contracting authority the appropriate right of access to sites and
premises where the FWC is implemented and to all the information, including
information in electronic format, 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.
II.22.4 On the basis of the findings made during the audit, a provisional report is drawn up.
The contracting authority or its authorized 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 contracting authority may recover all or
part of the payments made in accordance with Article II.21 and may take any other
measures which it considers necessary.
II.22.5 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
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.
Investigations may be carried out at any moment during the performance of the
contract and up to five years starting from the payment of the balance of the last
specific contract issued under this FWC.
II.22.6
Council Regulation (EU) 2017/19396
contracting authority, particularly right of access, for the purpose of checks, audits and
investigations.
II.22.7 The costs associated with the audit shall be borne by the contracting authority, unless
the audit reveals a breach of the FWC by the contractor, in which case the costs shall be
borne by the contractor.
II.23. INTELLECTUAL PROPERTY
Contracting authority acknowledges and agrees that contractor (or its Affiliates) will be the sole
owner of all Intellectual Property rights generated during the development, manufacture, and
supply of the supplies or otherwise related to the supplies, including all know-how (collectively,
the "Product IP Rights"). The contractor shall be entitled to exclusively exploit any such Product
IP Rights. Except as expressly set forth in this FWC, contractor does not grant contracting
authority by implication, estoppel or otherwise, any right, title, license or interest in the Product
6 Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the
53
IP Rights. All rights not expressly granted by the contractor are reserved by the contractor.
54
7 Pursuant price revision index under I.5.2 section of the FWC
9 Exceptionally until June 30st for 2024 only.
55
10
and MDV. The reservation can be adapted to the volume that needs to be reserved.
56
12
57
58
ANNEX III SPECIFIC CONTRACT
Model for specific contracts
SPECIFIC CONTRACT
No [complete]
implementing framework contract No HERA/XX
[Please select the relevant contracting authority:
European Commission
1.
[forename, surname, function, department of authorising officer],
OR: Contracting authority from participating country
1. [Name of the Country
[VAT registration number if applicable],
represented for the purposes of signing this specific contract by [forename, surname, function,
department of authorising officer],
and
2. [Please select the relevant group member of the joint tender that represents the contractor
for this specific contract:
[Full
official
name]
[Official legal form]
[Statutory registration number or ID or passport number]
[Full official address]
[VAT registration number]
for this specific contract appointed as representative of the group by the members of the group
that submitted the joint tender
3.[Full official name]
[Official legal form]
[Statutory registration number or ID or passport number]
[Full official address]
[VAT registration number]
[repeat these data as many times as there are contractors in case of joint tender and continue
numbering]
(collectively "the contractor"), represented for the purposes of signing this specific contract by
[forename, surname and function of legal representative,]
59
HAVE AGREED
ARTICLE 1. SUBJECT MATTER
1.1
This specific contract implements framework contract (FWC) No XXX, signed by the parties
on [complete date of signature of the FWC].
1.2
In accordance with the provisions set out in the FWC and in this specific contract and
[its][their] annex[es], which form an integral part of it:
the contracting authority will purchase and the contractor will supply the following [XXX]
quantities of XXX as follows [specify if Initial quantities or additional quantities/insert
date/delivery location]:
[In addition, the contracting authority reserves the following number of vaccines [insert quantites/ initial
delivery timelines for reserved doses ] :
[The contracting authority shall ensure that the receiving warehouse(s) shall enter into a Quality
Agreement with the contractor in the format attached promptly following entry into this specific contract
and in any case in a timely manner prior to first shipment of Product]
.
ARTICLE 2. ENTRY INTO FORCE AND DURATION
2.1
This specific contract enters into force on the date on which the last party signs it.
2.2
The performance of the contract starts from [the date of entry into force of this specific
contract] [insert date].
2.3
The performance of the contract must not exceed [complete] [days] [months]. The parties may
extend the duration by written agreement before it elapses and before expiry of the FWC.
ARTICLE 3. PRICE
3.1
The price payable under this specific contract is EUR [amount in figures and in words].
[The maximum amount covering all purchases under this specific contract is EUR [amount in
figures and in words]].
ARTICLE 4. BANK ACCOUNT
insert local
currency], identified as follows:
Name of bank:
Full address of branch:
Exact denomination of account holder: Full
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account number including bank codes:
IBAN code:
ARTICLE 5. DELIVERY
[Location for delivery and any other delivery arrangements]
FWC conditions of December 2018
ARTICLE 6: LABELLING AND PACKAGE LEAFLET
[Where applicable, details of full or partial exemptions to the obligation that the labelling and the
package leaflet must be in the official language(s) as per Article 63(3) of Directive 2001/83/EC.]
ARTICLE 7: COMMUNICATION DETAILS
For the purpose of this specific contract, communications must be sent to the following addresses:
Contracting authority:
[name of the person: forename, surname, position]
[name of the organisation and address of the organisation]
[phone and email]
Contractor:
[Full name] [Function] [Company name] [Full official address]
E-mail: [complete]
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ARTICLE 8: PERFORMANCE GUARANTEE
Performance guarantee is not applicable to this specific contract.
ARTICLE 9: RETENTION MONEY GUARANTEE
Retention money guarantee is not applicable to this specific contract.
[Annexes]
Signatures
For the contractor,
For
the
contracting
[Company name/forename/surname/function]
authority,
[forename/surname/function]
signature:
signature:
Done at [place], [date]
Done at [place], [date]
In duplicate in English
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