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Tender specifications
TABLE OF CONTENTS
1. SCOPE AND DESCRIPTION OF THE PROCUREMENT ...................................... 4
1.1. Contracting authority: who is the buyer? ............................................................. 4
1.2. Subject: what is this call for tenders about?......................................................... 5
1.3. Description: what do we want to buy through this call for tenders?.................... 5
1.3.1 Detailed characteristics of the purchase and deliverables ................................. 5
1.3.2 Minimum requirements ..................................................................................... 6
1.3.3 Other provisions related to performance of the APA........................................ 8
1.3.3.1
Contact point ....................................................................................... 8
1.3.3.2
Meetings .............................................................................................. 8
1.3.3.3
Reports................................................................................................. 8
1.3.3.4
Quality control..................................................................................... 9
1.3.3.5
Document and change management.................................................... 9
1.3.3.6
Inspections and audits ......................................................................... 9
1.3.3.7
Working languages............................................................................ 10
1.4. Place of performance: where will the contract be performed?........................... 10
1.5. Nature of the contract: how will the contract be implemented? ........................ 10
1.6. Volume and value of the contract: how much do we plan to buy? .................... 10
1.7. Duration of the contract: how long do we plan to use the contract?.................. 11
1.8. Electronic exchange system: can exchanges under the contract be automated? 11
2. GENERAL INFORMATION ON TENDERING..................................................... 12
2.1. Legal basis: what are the rules?.......................................................................... 12
2.2. Rules on access to procurement: who may submit a tender?............................. 12
2.3. Ways to submit a tender: how can economic operators organise themselves
to submit a tender? .......................................................................................... 13
2.3.1. Joint tenders..................................................................................................... 13
2.3.2. Subcontracting................................................................................................. 14
2.3.3. Entities on whose capacities the tenderer relies to fulfil the selection
criteria.............................................................................................................. 15
3. EVALUATION AND AWARD ............................................................................... 17
3.1. Exclusion criteria................................................................................................ 17
3.2. Selection criteria................................................................................................. 18
3.2.1. Legal and regulatory capacity ......................................................................... 19
3.2.2. Economic and financial capacity..................................................................... 19
3.2.3. Technical and professional capacity ............................................................... 20
3.3. Compliance with the minimum requirements of the Tender specifications....... 22
3.4. Negotiation......................................................................................................... 23
3.5. Award criteria..................................................................................................... 23
3.6. Award ................................................................................................................. 27
4. FORM AND CONTENT OF THE TENDER .......................................................... 28
4.1. Form of the tender: how to submit the tender? .................................................. 28
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4.2. Content of the tender: what documents to submit with the tender? ................... 28
The tenders can be negotiated in accordance with section 2.1 of the tender
specifications................................................................................................... 29
4.3. Signature policy: how can documents be signed?.............................................. 29
4.4. Confidentiality of tenders: what information and under what conditions can
be disclosed? ................................................................................................... 29
APPENDIX: LIST OF REFERENCES ............................................................................ 31
ANNEXES ........................................................................................................................ 32
Annex 1. List of documents to be submitted with the tender or during the
procedure......................................................................................................... 33
Annex 2. Declaration on Honour on exclusion and selection criteria....................... 38
Annex 3. Power of attorney....................................................................................... 44
Annex 4. List of identified subcontractors ................................................................ 46
Annex 5.1. Commitment letter by an identified subcontractor ................................. 47
Annex 5.2. Commitment letter by an entity on whose capacities is being relied ..... 48
Annex 6. Financial offer form................................................................................... 49
Annex 7. Agreement between the Commission and Member States on procuring
Covid-19 vaccines on behalf of the Member States and related procedures,
as approved by the Commission Decision C(2020) 4192 final of 18 June
2020................................................................................................................. 49
Annex 8. Draft ADVANCE PURCHASE AGREEMENT (“APA”) for the
development, production, priority-purchasing options and supply of a
successful COVID-19 vaccine for EU Member States .................................. 49
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1. SCOPE AND DESCRIPTION OF THE PROCUREMENT
1.1. Contracting authority: who is the buyer?
This call for tenders is launched and managed by the European Commission referred to as the
Contracting authority for the purposes of this call for tender.
The contract with the winning tenderer (“Contractor”) shall be concluded by the European
Commission on behalf and in the name of the following EU Member States (hereinafter
referred to as “the Contracting authorities”):
Republic of Austria (AT)
Kingdom of Belgium (BE)
Republic of Bulgaria (BG)
Republic of Croatia (HR)
Republic of Cyprus (CY)
Czech Republic (CZ)
Kingdom of Denmark (DK)
Republic of Estonia (EE)
Republic of Finland (FI)
French Republic (FR)
Federal Republic of Germany (DE)
Hellenic Republic (EL)
Hungary (HU)
Ireland (IE)
Italian Republic (IT)
Republic of Latvia (LV)
Republic of Lithuania (LT)
Grand Duchy of Luxembourg (LU)
Republic of Malta (MT)
Kingdom of the Netherlands (NL)
Republic of Poland (PL)
Portuguese Republic (PT)
Romania (RO)
Republic of Slovakia (SK)
Republic of Slovenia (SI)
Kingdom of Spain (ES)
Kingdom of Sweden (SE)
The contract is divided in two parts or stages (“steps”), the first one aims at financing the
development of a safe and effective COVID-19 vaccine in exchange of guaranteeing the right
to acquire vaccine doses. The second stage is the production and supply by the Contractor of
vaccine doses following requests by the Commission or individual orders placed by the
participating Member States. In this second stage, the Commission acts as a central
purchasing body for the Member States, that is as intermediary by awarding a contract that
may be used by the Member States.
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1.2. Subject: what is this call for tenders about?
The subject of this tender is financing the research, development and manufacturing of a
COVID-19 vaccine in accordance with the applicable legislation, and securing the purchase of
certain vaccine doses for the participating Member States.
The first stage will include a pre-financing in the form of one or several up-front payments to
de-risk essential investments to increase the speed and scale of manufacturing of vaccines and
secure rights for the participating Member States to purchase vaccine doses at a specified
price and conditions.
The development of an effective and safe COVID-19 vaccine will save many lives, jobs and
billions of euros. Conversely, to the normal practice, where vaccine producers make
investments in their production capacity only when they are sure of a viable product, given
the current situation of global emergency, investments need to be made now in order to ensure
that vaccines will be produced at the scale required as early as possible.
This APA is not exclusive, and different tender procedures to secure vaccines may be
launched by the Commission.
In the second stage, through EU-level APAs, the participating Member States would secure
supplies from vaccine contractors where the vaccines are successful during clinical trials. To
this end, it is necessary to conclude a contract aiming at getting record-time results in the
research and development of a safe and effective vaccine against COVID-19. In this context,
the up-front financing of part of the vaccine manufacturer’s costs for vaccine development,
clinical trials and preparation of at-scale production capacity, would de-risk essential
investments and increase the speed and scale of manufacturing successful vaccines, while
providing the European Union with a major advantage to ensure supply of vaccines for EU
citizens. Therefore, in order to maximise the chances of having access to one or several
successful vaccines, the Commission may launch several tender procedures with several
manufacturers of leading vaccine candidates.
This call for tenders is not divided into lots.
1.3. Description: what do we want to buy through this call for tenders?
1.3.1 Detailed characteristics of the purchase and deliverables
The conditions for the up-front financing of research, development and manufacturing of a
safe and effective vaccine for COVID-19 and increase of its production capacity in exchange
of the right to buy vaccine doses will be negotiated with an individual company with the
objective of supplying the participating Member States. They aim at ensuring that in case of
success, the successful vaccine manufacturers produce the capacity required for rapid
deployment of millions of doses of a safe and effective vaccine in the EU.
The European Commission will conclude the APA with the selected vaccine producer to
ensure proper research and development of a rapid vaccine solution, as well as an increase of
their production capacities with the aim to benefit immediately from the results. APAs are
divided in two different stages or “steps”:
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I. The first step (step I) of the APA consists in the development by the Contractor of a
COVID-19 vaccine:
In order to support the manufacturers with the clinical trials and enhance the Contractor’s
capacity to produce a vaccine, the Contracting authority (the European Commission) will
make a pre-financing in the form of an “up-front” payment according to the terms defined in
the APA.
In exchange of the amount paid, the Contractor commits to produce, and supply in priority an
agreed timeframe vaccine doses if and/or when requested by the Contracting authority or by
the participating Member States. In addition, the Contractor might allow using the production
capacities funded by the upfront payments made by the Contracting authority by other
producers of successful vaccine(s) should its own vaccine candidate prove to be unsuccessful.
II. The second step (step II) entails the following:
-
If the first step is successful according to the terms and conditions specified above, the
Contractor shall deliver the agreed vaccine doses under the terms specified in the agreed
contract. Those terms may provide for delivery to the recipient Member States
following a request of the Contracting authority or following purchase orders by the
recipient Member States themselves.
-
1.3.2 Minimum requirements
The subject of this tender is the development and production of a COVID-19 vaccine in
accordance with the applicable legislation. As the development phase of the vaccine has not
yet been finalized at the moment of the launch of this call for tenders, it is likely that the
certain minimum requirements of the product cannot be evaluated before the APA signature.
However, the tender shall commit to the following minimum requirements:
a) Technical requirements for vaccine characteristics
1 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for
the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,
(OJ L 136, 30.4.2004, p. 1).).
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- Pharmaceutical formula: suspension for injection (preferably)
- Injectable (preferably)
- Primary packaging in single doses or multi-dose vials (preferably max 10 doses per
vial)
- The minimum requirements regarding the information on the packaging in
accordance with the European law (prospect with adverse reactions, etc.)
- Manufacturing in compliance with the principles of good manufacturing practice
for medicinal products irrespective of the final destination of the medicinal
products.
Compliance with these requirements is mandatory and cannot be subject to any assumptions,
limitations, conditions, or reservations on the part of the tenderer. The Contractor will provide
evidence of compliance with the applicable minimum requirements to the Contracting
authority from the moment the vaccine is ready for production.
b) Regulatory requirements
The Contractor shall demonstrate compliance with all relevant legislation and regulatory
requirements and fulfil necessary licencing requirements particular to the supply of vaccines
in the European Union.
The Contractor shall hold a marketing authorisation for a COVID-19 vaccine ahead of placing
on the EU market. The vaccine shall be manufactured, controlled and distributed in
compliance with Directive 2001/83/EC of the European Parliament and of the Council on the
Community code relating to medicinal products for human use.
During the course of the contract, the Contractor enables the Contracting authorities to carry
out a GMP/GDP-inspection at all times. The Contractor shall provide full cooperation during
these inspections as long as the inspections are related to this tender. The costs of the
inspection are for the account of the Contracting authorities, unless the inspection results in
proof of default. In the latter case, all costs are for the account of the Contractor.
c) Other requirements that might be used to guide the purchase of the vaccine
2 Includes both clinical and pre-clinical immunogenicity data
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NB: Requirements in Table 1 are only indicatory in case purchase orders are placed before the
Contractor receives the EU Marketing authorization (or the necessary authorisation to place
the product on the market of one or more Member States). The requirements listed in the table
cannot be considered as any replacement of the European Medicines Agency’s (EMA)
requirements for COVID-19 vaccine assessment and the EU marketing authorization.
1.3.3 Other provisions related to performance of the APA
1.3.3.1 Contact point
The European Commission will designate a contact point for the overall management of the
APA. Each participating Member State will designate a contact point for the management of
the specific contracts/order forms, if any.
The Contractor will designate a single contact point for the management of the APA and all
specific contracts/order forms.
1.3.3.2 Meetings
Monitoring meetings, e.g. contract implementation monitoring meetings and delivery
progress monitoring meetings of the APA will be held according to the APA. Authorised
senior representatives of the Contractor that have the authority to make decisions regarding
the contract shall attend the meeting.
The costs of attendance of its own representatives for those meetings must be born
exclusively by the Contractor.
1.3.3.3 Reports
The Contractor will send reports (e.g., contract implementation monitoring reports;
3 It is a critical aspect but it is understood that data will not be available by end of 2020
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periodical updates of the production and delivery; periodical performance and delivery
progress monitoring reports; updates on progress made in terms of clinical development of
the vaccine; interim and final results of clinical studies of the vaccine; progress on the build-
up of manufacturing capacities; updates on progress; challenges and opportunities, updates
on establishment of the supply chain, delivery plans for all Member States, other relevant
information on the vaccine, any relevant information for the establishment of the vaccination
strategies, etc.) to the European Commission in English by electronic mail as defined in the
APA.
All costs related to the Contractor's management obligations under the APA must be borne
exclusively by the Contractor and included in the financial offer. The European Commission
and the participating Member States will not reimburse any expenses incurred in relation to
these tasks and obligations.
1.3.3.4 Quality control
The Contractor must have a comprehensively designed and implemented system for the
investigation and documentation of any quality issue in line with Chapters 6 (Quality Control)
and Chapter 8 (Complaints, Quality defects and Product Recalls) of the EU Good
Manufacturing Practices.
Any quality issue detected by, reported to and/or recorded by the Contractor that might
eventually affect the quality and/or supply of the product, shall be reported to the Contracting
authority within 7 calendar days. To follow-up, the Contractor shall communicate to the
Contracting authority a documented proof that the reported quality issues have been processed
and completed according to relevant national legislation.
1.3.3.5 Document and change management
The Contractor must have a document management process and procedures related to this
contract. Records are retained according to regulatory requirements, including release,
reference samples, and shipping documentation. The Contracting authority [or the
participating Member State should the APA contain a right and not an obligation of the
participating Member States to acquire the vaccines] retains shipping documentation at the
disposal of the competent authorities.
The Contractor must have a management system for follow-up, review, implementation and
evaluation of changes related to this contract.
1.3.3.6 Inspections and audits
During the duration of the contract, the Contracting authority [or the participating Member
State in accordance with the APA or specific contracts/order forms] reserves a right to carry
out inspections, audits or to request from the Contractor any document demonstrating that the
latter meets any contractual requirement as defined in the APA.
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1.3.3.7 Working languages
All the communication and documents related to carrying out this contract are in English,
unless mutually agreed differently by the parties.
1.4. Place of performance: where will the contract be performed?
The research, development and production will be performed in the Contractor’s premises
(unless outsourced). Once a suitable vaccine has been developed, vaccine doses will be
delivered to the locations indicated by the Commission, in accordance with the provisions of
the APA, or indicated by the participating Member States in the relevant specific
contracts/order forms signed by them. The signature of a specific contract/order form entails
the acceptance of the APA terms.
1.5. Nature of the contract: how will the contract be implemented?
The contract (APA) is divided in two parts or stages (“steps”), the first one aims at financing
the development and manufacturing of a safe and effective vaccine in exchange of the right to
acquire vaccine doses. The second step covers the production and delivery of the vaccine
doses to the place of delivery indicated by the Commission or/and the purchase of the
vaccines via individual orders placed by the participating Member States.
The signature of an APA does not necessarily impose an obligation on the Contracting
authority or the participating Member States to conclude specific contracts/vaccine order
forms with an APA Contractor.
The APA is to be concluded with the vaccine manufacturer. The selected manufacturer must
a) not be in an exclusion situation, (b) satisfy the selection and award criteria, and (c) submit a
tender that complies with the tender specifications.
1.6. Volume and value of the contract: how much do we plan to buy?
A desired number of vaccine doses is indicated in the financial offer (Annex 6). Tenderers
will indicate the proposed number of vaccine doses in the financial offer. Yet, the final
estimated volume number of a vaccine doses for the whole duration of the APA can be further
negotiated and included in the APA accordingly.
Should the vaccine be successful, the Contractor will make available the minimum number of
vaccine doses agreed within the agreed timeline and price. For APAs containing an obligation
of participating Member States to acquire vaccines, the Commission or the participating
Member States will indicate to the Contractor the volume per participating Member State and
the place of delivery in the conditions laid down in the APA. For APAs containing a right and
not an obligation of the participating Member States to acquire the vaccines, the participating
Member States will order through specific contracts/order forms on the basis of a population
distribution key and their needs.
The APA ceiling shall be determined by the total amount of the successful tenderer's financial
offer for the overall estimated volume of upfront costs and purchases, corresponding to the
maximum duration of the APA, possibly increased by a reserve of 10% to cover unforeseen
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needs of the Contracting authorities.
1.7. Duration of the contract: how long do we plan to use the contract?
The APA(s) for guaranteeing the right of participating Member States to purchase vaccine
doses against the coverage of part of the vaccine manufacturer’s upfront costs and the
subsequent supplies of vaccine doses, resulting from the award of this call for tenders will be
.
1.8. Electronic exchange system: can exchanges under the contract be automated?
For all exchanges with the Contractor during the implementation of the contract as well as for
future possible subsequent proceedings for the purposes of EDES (European Union's Early
Detection and Exclusion System) the Contracting authority may use an electronic exchange
system meeting the requirements of Article 148 of 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. At the request of the Contracting authority the use of such a
system shall become mandatory for the Contractor(s) at no additional cost for the Contracting
authority. Details on specifications, access, terms and conditions of use will be provided in
advance.
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2. GENERAL INFORMATION ON TENDERING
2.1. Legal basis: what are the rules?
This call for tenders is governed by the provisions of 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 (the Financial Regulation)4 and Council Regulation (EU)
2016/369 on the provision of emergency support within the Union5, as amended by Council
Regulation (EU) 2020/5216 (Article 4(5)(b) in particular). With the purpose of launching this
call for tenders, an agreement was concluded between the Commission and Member States on
procuring Covid-19 vaccines on behalf of the Member States. This agreement was approved by
Commission Decision C(2020) 4192 final of 18 June 2020 (see Annex 7).
The Contracting authority has chosen to award the contract resulting from this call for tenders
through a negotiated procedure without prior publication of a contract notice pursuant to Article
164(1)(d) and (4) of the Financial Regulation and point 11.1(c) of Annex I to the Financial
Regulation.
The Contracting authority may negotiate the tenders in order to improve their content or to
adapt them to the requirements set out in the procurement documents. The negotiation process
is described further in section 3.4.
2.2. Rules on access to procurement: who may submit a tender?
Participation in this call for tenders is open on equal terms to all legal persons which have been
invited to submit a tender as follows:
- Legal persons coming within the scope of the Treaties;
- Legal persons established in a third country, which has a special agreement with the
European Union in the field of public procurement on the conditions laid down in that
agreement. Where the Agreement on Government Procurement7 concluded within the
World Trade Organisation applies, the participation to this call for tenders is open to all legal
persons established in the countries that have ratified this Agreement, on the conditions laid
down therein.
The rules on access to procurement do not apply to subcontractors. Subcontracting may not be
used with the intent to circumvent the rules on access to procurement.
4
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 30.07.2018, p.1).
5
OJ L 70, 16.3.2016, p. 1.
6
Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and
amending its provisions taking into account the COVID-19 outbreak, OJ L 117, 15.4.2020, p. 3.
7 https://www.wto.org/english/tratop E/gproc e/gp gpa e.htm.
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To enable the Contracting authority to verify the access, each tenderer must indicate its
country of establishment (and in case of joint tender – the country of establishment of each
group member) and must present the supporting evidence normally acceptable under the law
of that country/-ies. The same document(s) could be used to prove country/-ies of
establishment and the delegation(s) of the authorisation to sign as described in Section 4.3.
For tenderers established in the United Kingdom:
Please be aware that following the entry into force of the EU-UK Withdrawal Agreement* on 1
February 2020 and in particular Articles 127(6), 137 and 138, the references to natural or legal
persons residing or established in a Member State of the European Union are to be understood as
including natural or legal persons residing or established in the United Kingdom. UK entities,
which have been invited to submit a tender, are therefore eligible to participate under this call.
* Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland
from the European Union and the European Atomic Energy Community.
2.3. Ways to submit a tender: how can economic operators organise themselves to
submit a tender?
Only economic operators invited can submit a tender. In principle, only invited economic
operators may submit a tender. However, an invited economic operator may form a joint
tender with other economic operators (including economic operators who were invited and/or
economic operators who were not directly invited). In this case, the tender may be submitted
by the leader of the consortium in accordance with Section 2.4.1.
In order to fulfil the selection criteria set out in Section 3.2, the tenderer can rely on the
capacities of subcontractors or other entities (not subcontractors).
The role of each entity involved in a tender (hereafter referred to as involved entity) must be
clearly specified: sole tenderer, member of a group or Group leader, subcontractor or an entity on
whose capacities the tenderer relies to fulfil the selection criteria8. This applies also where the
involved entities belong to the same economic group.
2.3.1. Joint tenders
A joint tender is a tender, which is submitted by a group (with or without legal form) of
economic operators regardless of the link they have between them. The group as a whole is
considered a tenderer9.
All members of the group assume joint and several liability towards the Contracting authority
and the participating Member States for the performance of the contract as a whole.
8
Such an entity is not considered a subcontractor, see Section 2.4.3.
9
References to tenderer or tenderers in this document shal be understood as covering both sole tenderers and groups of economic
operators submitting a joint tender.
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Group members must appoint a Group leader and a single point of contact authorised to act on
their behalf in connection with the submission of the tender and all relevant questions,
clarification requests, notifications, etc., that may be received during the evaluation, award
and until the APA signature. The model power of attorney attached in Annex 3 is to be used.
The joint tender must clearly indicate the role and tasks of each member and of the Group leader
who will act as the Contracting authority's contact point for the APA's administrative or financial
aspects and operational management. The Group leader will have full authority to bind the group
and each of its members during APA execution. If the joint tender is successful, the Contracting
authority shall sign the APA with the Group leader, authorised by the other members to sign the
APA on their behalf via power of attorney drawn up in the model attached in Annex 3.
Changes in the composition of the group during the procurement procedure (after the submission
deadline and before the APA signature) shall lead to rejection of the tender except in case of a
merger or takeover of a member of the group (universal succession), provided that the new entity
has access to procurement (see Section 2.2) and is not in an exclusion situation, (see Section
3.1).
In any case the selection criteria must be still fulfilled by the group and the terms of the
originally submitted tender may not be altered substantially, i.e. all the tasks assigned to the
former entity must be taken over by the new entity member of the group, the change must not
make the tender non-compliant with the Tender specifications, and the evaluation of award
criteria of the originally submitted tender may not be modified.
2.3.2. Subcontracting
Subcontracting is the situation where the Contractor enters into legal commitments with other
economic operators, which will perform part of the contract on its behalf. The Contractor
retains full liability towards the Contracting authority for performance of the contract as a
whole.
The following shall not be considered subcontracting:
a) Use of workers posted to the Contractor by another company owned by the same
group and established in a Member State (“intra-group posting” as defined by Article
1, 3, (b) of Directive 96/71/EC concerning the posting of workers in the framework of
the provision of services).
b) Use of workers hired out to the Contractor by a temporary employment undertaking or
placement agency established in a Member State (“hiring out of workers” as defined
by Article 1, 3, (c) of Directive 96/71/EC concerning the posting of workers in the
framework of the provision of services).
c) Use of workers temporarily transferred to the Contractor from an undertaking
established outside the territory of a Member State and that belongs to the same group
(“intra-corporate transfer” as defined by Article 3, (b) of Directive 2014/66/EU on the
conditions of entry and residence of third-country nationals in the framework of an
intra-corporate transfer) .
d) Use of staff without employment contract (“self-employed persons working for the
Contractor”), without the tasks of the self-employed persons being particular well-
defined parts of the contract.
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e) Use of suppliers and/or transporters by the Contractor, in order to perform the contract
at the place of performance, unless the economic activities of the suppliers and/or the
transporting services are within the subject of this call for tender (see Section 1.3).
f) Performance of part of the contract by members of an EEIG (European Economic
Interest Grouping), when the EEIG is itself a Contractor or a group member.
The persons mentioned in points a), b), c) and d) above will be considered as “personnel” of
the Contractor as defined in the contract.
All contractual tasks may be subcontracted unless procurement documents expressly reserve
the execution of certain critical tasks to the sole tenderer itself, or in case of a joint tender, to a
member of the group.
By filling in the form available in Annex 4, tenderers are required to give an indication of the
proportion of the contract that they intend to subcontract, as well as to identify and describe
briefly the envisaged contractual roles/tasks of subcontractors meeting any of these conditions
(hereafter referred to as identified subcontractors):
on whose capacities the tenderer relies upon to fulfil the selection criteria as described
under Section 3.2;
whose individual share of the contract, known at the time of submission, is above 10
% .
Any such subcontractor must provide the tenderer with a commitment letter drawn up in the
model attached in Annex 5.1 and signed by its authorised representative.
Changes concerning subcontractors identified in the tender (withdrawal/replacement of a
subcontractor, additional subcontracting) during the procurement procedure (after the
submission deadline and before the APA signature) require the prior written approval of the
Contracting authority subject to the following verifications:
any new subcontractor is not in an exclusion situation;
the tenderer still fulfils the selection criteria and the new subcontractor fulfils the
selection criteria applicable to it individually, if any;
the terms of the originally submitted tender are not altered substantially, i.e. all the
tasks assigned to the former subcontractor are taken over by another involved entity,
the change does not make the tender non-compliant with the Tender specifications,
and the evaluation of award criteria of the originally submitted tender is not modified.
Subcontracting to subcontractors identified in a tender that was accepted by the Contracting
authority and resulted in a signed APA, is considered authorised.
2.3.3. Entities on whose capacities the tenderer relies to fulfil the selection criteria
In order to fulfil the selection criteria a tenderer may also rely on the capacities of other
entities, regardless of the legal nature of the links it has with them. It must in that case prove
that it will have at its disposal the resources necessary for the performance of the APA by
producing a commitment letter in the model attached in Annex 5.2, signed by the authorised
representative of such an entity, and the supporting evidence that those other entities have the
respective resources.
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3. EVALUATION AND AWARD
The evaluation of the tenders that comply with the submission conditions will consist of the
following elements:
Check if the tenderer has access to procurement (see Section 2.2);
Verification of administrative compliance (if the tender is drawn up in one of the
official EU languages and signed by duly authorised representative(-s) of the
tenderer);
Verification of non-exclusion of tenderers on the basis of the exclusion criteria set out
in the Financial Regulation;
Selection of tenderers on the basis of selection criteria;
Verification of compliance with the minimum requirements defined in the Tender
specifications;
Evaluation of tenders on the basis of the award criteria.
The Contracting authority will evaluate the abovementioned elements in the order that it
considers to be the most appropriate. If the evaluation of one or more elements demonstrates
that there are grounds for rejection, the tender will be rejected and will not be subjected to
further full evaluation. The unsuccessful tenderers will be informed of the ground for
rejection without being given feedback on the non-assessed content of their tenders. Only
tenderer(s) for whom the verification of all elements did not reveal grounds for rejection can
be awarded the APA.
The evaluation will be based on the information and evidence contained in the tenders and, if
applicable, on additional information and evidence provided at the request of the Contracting
authority during the procedure. If any of the declarations or information provided proves to be
false, the Contracting authority may impose administrative sanctions (exclusion or financial
penalties) on the entity providing the false declarations/information.
For the purposes of the evaluation related to exclusion and selection criteria, the Contracting
authority may also refer to publicly available information, in particular evidence that it can
access on a national database free of charge.
3.1. Exclusion criteria
The objective of the exclusion criteria is to assess whether the tenderer is in any of the
exclusion situations listed in Article 136(1) of the Financial Regulation.
As evidence of non-exclusion the tenderer needs to submit with its tender a Declaration on
Honour10 in the model available in Annex 2.11 The declaration must be signed by an
authorised representative of the entity providing the declaration.
10
The European Single Procurement Document (ESPD) may not be used yet in European Commission's calls for tenders.
11
Unless the same declaration has already been submitted for the purposes of another award procedure of the European
Commission, the situation has not changed, and the time elapsed since the issuing date of the declaration does not exceed one
year.
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The initial verification of non-exclusion of tenderers will be done on the basis of the
submitted declarations and consultation of the European Union's Early Detection and
Exclusion System (EDES). The documents mentioned as supporting evidence in the
Declaration on Honour, need to be provided whenever requested and where this is necessary
to ensure the proper conduct of the procedure within a deadline given by the Contracting
authority12.
Annex 1 specifies which of the involved entities participating in a tender need to provide the
Declaration on Honour and, when requested by the Contracting authority, the supporting
evidence.
Please note that a request for evidence in no way implies that the tenderer has been
successful.
3.2. Selection criteria
The objective of the selection criteria is to assess whether the tenderer has the legal,
regulatory, economic, financial, technical and professional capacity to perform the APA.
The selection criteria for this call for tenders, including the minimum levels of capacity, the
basis for assessment and the evidence required, are specified in the following subsections.
The tender submitted by the tenderer not meeting the minimum levels of capacity will be
rejected.
When submitting its tender the tenderer shall declare on honour that it fulfils the selection
criteria for the call for tender. The model Declaration on Honour available in Annex 2 shall
be used.
The initial assessment of whether a tenderer fulfils the selection criteria will be done on the
basis of the submitted declaration(s).
The subsections below specify for which selection criteria evidence must be provided with the
tender or may be requested later, at any time during the procurement procedure13. In any case,
12
The obligation to provide the supporting evidence will be waived in the following situations:
-
if the same documents have already been provided in a previous award procedure of the European Commission, have
been issued no more than one year before the date of their request by the Contracting authority and are still valid at that
date;
-
if such evidence can be accessed by the Contracting Authority on a national database free of charge, in which case the
economic operator shal provide the Contracting authority with the internet address of the database and, if needed, the
necessary identification data to retrieve the document;
-
if there is a material impossibility to provide such evidence.
13
The obligation to provide the supporting evidence will be waived in the following situations:
-
if the same documents have already been provided in a previous award procedure of the European Commission, have
been issued no more than one year before the date of their request by the Contracting authority and are still valid at that
date;
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3.4. Negotiation
In accordance with Section 2.1 of the tender specifications, tenders can be negotiated.
The tenderer shall submit its first offer within the deadline indicated in the Invitation to
tender. Details concerning the submission of the tenders are provided in the Invitation to
tender.
The Commission may negotiate the offer submitted (as well as any successive offer) with the
tenderer, in order to adapt it to the procurement documents and/or to find the best commercial
offer.
Negotiations will be conducted in an iterative way, based on the successive tenders submitted
for each negotiation round. The Commission also reserves the right to award a contract on the
basis of the initial tender without negotiation.
The negotiation may not modify the minimum requirements nor the exclusion, selection and
award criteria specified in the procurement documents. A contrario, negotiations may address
the technical and financial conditions of the tender as well as non-substantial aspects of the
conditions of the contract.
3.5. Award criteria
The objective of the award criteria is to evaluate the tenders with a view to choosing the most
economically advantageous tender.
Tenders will be evaluated on the basis of the following award criteria:
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applicable VAT system, it is the tenderer's responsibility to contact his or her national
authorities to clarify the way in which the European Union is exempt from VAT.
The tenders can be negotiated in accordance with section 2.1 of the tender specifications.
4.3. Signature policy: how can documents be signed?
Where a document needs to be signed, the signature must be either hand-written, a qualified
electronic signature or an advanced electronic signature based on a qualified certificate as
defined in Regulation (EU) No 910/2014 on electronic identification and trust services for
electronic transactions in the internal market (the eIDAS Regulation).
For hand-written signatures see Section 1 of the Invitation to tender.
All documents must be signed by the duly authorised representatives.
For the following documents, when signed by representatives, tenderers must provide
evidence for the delegation of the authorisation to sign:
-
The Declaration on Honour of the tenderer (in case of joint tender – the Declarations
on Honour of all group members) attached in Annex 2;
-
The price schedule in PDF format attached in Annex 6;
-
If applicable:
o in the case of joint tender, the power(s) of attorney drawn up using the model
attached in Annex 3;
o in case of subcontracting, the Commitment letter(s) by identified
subcontractor (s) attached in Annex 5.1;
o in case of a third party making economic and financial and/or technical and
professional resources available to the tenderer, the Commitment letter(s) by
entity(s) on whose capacities is(are) being relied attached in Annex 5.2.
The delegation of the authorisation to sign on behalf of the signatories (including, in the case
of proxy(-ies), the chain of authorisations) must be evidenced by appropriate written evidence
(copy of the notice of appointment of the persons authorised to represent the legal entity in
signing contracts (together or alone), or a copy of the publication of such appointment if the
legislation which applies to signatory requires such publication or a power of attorney). A
document that the Contracting authority can access on a national database free of charge does
not need to be submitted if the Contracting authority is provided with the exact internet link
and, if applicable, the necessary identification data to retrieve the document.
4.4. Confidentiality of tenders: what information and under what conditions can be
disclosed?
Once the Contracting authority has opened a tender, it becomes its property and shall be
treated confidentially, subject to the following:
For the purposes of evaluating the tender and, if applicable, implementing the
contract, performing audits, benchmarking, etc., the Contracting authority is entitled to
make available (any part of) the tender to its staff and the staff of other Union
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APPENDIX: LIST OF REFERENCES
Award criteria
See Section 3.4
Contracting authority
See Section 1.1
Entities on whose capacities See Section 2.4.3
the tenderer relies to fulfil the
selection criteria
EU Validation services
See Section 2.3
EU Grants and Tenders Rules on Legal Entity Validation,
LEAR appointment and Financial Capacity assessment
Exclusion criteria
See Section 3.1
Financial Regulation
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
Group leader
See Section 2.4.1
Identified subcontractors
See Section 2.4.2
Involved entities
See Section 2.4
Joint tender
See Section 2.4.1
Participating entities
See Section 1.1
Participant Register
See Section 2.3
https://ec.europa.eu/info/funding-
tenders/opportunities/portal/screen/how-to-
participate/participant-
registerhttps://ec.europa.eu/info/funding-
tenders/opportunities/portal/screen/how-to-
participate/participant- -
Selection criteria
See Section 3.2
Sole tenderer
See Section 2.4
Subcontracting/subcontractor
See Section 2.4.2
Treaties
The EU Treaties:
https://europa.eu/european-union/law/treaties en
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ANNEXES
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Annex 2. Declaration on Honour on exclusion and selection criteria
Declaration
on
honour
on
exclusion criteria and selection criteria
The undersigned [insert name of the signatory of this form], representing:
(only for natural persons) (only for legal persons) the following legal person:
himself or herself
ID or passport number:
Full official name:
Official legal form:
(‘the person’)
Statutory registration number:
Full official address:
VAT registration number:
(‘the person’)
The person is not required to submit the declaration on exclusion criteria if the same declaration
has already been submitted for the purposes of another award procedure of the same Contracting
authority24, provided the situation has not changed, and that the time that has elapsed since the
issuing date of the declaration does not exceed one year.
In this case, the signatory declares that the person has already provided the same declaration on
exclusion criteria for a previous procedure and confirms that there has been no change in its
situation:
Date of the declaration
Full reference to previous procedure
I – Situation of exclusion concerning the person
(1) declares that the above-mentioned person is in one of the following
YES
NO
situations:
(a) it is bankrupt, subject to insolvency or winding-up procedures, its assets are
being administered by a liquidator or by a court, it is in an arrangement with
creditors, its business activities are suspended or it is in any analogous situation
arising from a similar procedure provided for under Union or national law;
24 The same EU institution, agency, body or office.
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the selection criteria for which a consolidated asseessment will be
made as provided in the tender specifications.
VIII – Evidence for selection
The signatory declares that the above-mentioned person is able to provide the necessary
supporting documents listed in the relevant sections of the tender specifications and which are
not available electronically upon request and without delay.
The person is not required to submit the evidence if it has already been submitted for another
procurement procedure of the same Contracting authority26. The documents must have been
issued no more than one year before the date of their request by the Contracting authority and
must still be valid at that date.
The signatory declares that the person has already provided the documentary evidence for a
previous procedure and confirms that there has been no change in its situation:
Document
Full reference to previous procedure
Insert as many lines as necessary.
The above-mentioned person must immediately inform the Contracting authority of any changes
in the situations as declared.
The above-mentioned person may be subject to rejection from this procedure and to
administrative sanctions (exclusion or financial penalty) if any of the declarations or information
provided as a condition for participating in this procedure prove to be false.
Full name
Date
Signature
26 The same institution of agency.
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Annex 3. Power of attorney
Call for tenders SANTE/2020/C3/087 - for the development, production, priority-purchasing
options and supply of COVID-19 Vaccines for EU Member States
POWER OF ATTORNEY
The undersigned:
– Signatory (Name, Function, Company, Registered address, VAT Number)
having the legal capacity required to act on behalf of his/her company,
HEREBY AGREES TO THE FOLLOWING:
1) To submit a joint tender as a member of a group of tenderers (the Group), constituted by
Company 1, Company 2, Company N (Group members), and led by Company 1 (Group
leader), in accordance with the conditions specified in the Tender specifications and the
terms specified in the tender to which this Power of attorney is attached.
2) If the Contracting authority awards the contract resulting from this call for tenders to the
Group on the basis of the joint tender to which this power of attorney is attached, all Group
members shall be considered parties to the contract in accordance with the following
conditions:
(a) All Group members shall be jointly and severally liable towards the Contracting authority
for the performance of the contract.
(b) All Group members shall comply with the terms and conditions of the contract and
ensure the proper delivery of their respective share of the services and/or supplies subject
to the contract.
3) Payments by the Contracting authority related to the services and/or supplies subject to the
Contract shall be made through the bank account of the Group leader: [Provide details on
bank, address, account number]. Payment to the Group leader discharges the Contracting
authority from its payment obligation vis a vis other Group members.
4) The Group members grant to the Group leader all the necessary powers to act on their behalf
in the submission of the tender and the conclusion of the contract, including:
(a) The Group leader shall submit the tender on behalf of all Group members and indicate
the name and e-mail address of an individual - single point of contact authorised to
communicate officially with the Contracting authority in connection with the submitted
tender on behalf of all Group members, including in connection with all relevant
questions, clarification requests, notifications, etc., that may be received during the
evaluation, award and until the contract signature.
(b) The Group leader shall sign any contractual documents — including the contract, and
amendments thereto — and issue any invoices related to the performance of the contract
on behalf of all Group members.
(c) The Group leader shall act as a single contact point with the Contracting authority in the
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delivery of the services and/or supplies subject to the contract. It shall co-ordinate the
delivery of the services and/or supplies by the Group to the Contracting authority, and
shall see to a proper administration of the contract.
Any modification to the present Power of attorney shall be subject to the Contracting authority’s
express approval. This Power of attorney shall expire when all the contractual obligations of the
Group have ceased to exist. The parties cannot terminate it before that date without the
Contracting authority’s consent.
Place and date:
Name (in capital letters), function, company and signature:
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Annex 5.1. Commitment letter by an identified subcontractor
[Letterhead, if any]
EUROPEAN COMMISSION
Call for tenders Ref. SANTE/2020/C3/087
Attn:
[Insert date]
Commitment letter by identified subcontractor
I, the undersigned,
Name:
Function:
Company:
Registered address:
VAT Number:
having the legal capacity required to act on behalf of the company [insert name of the entity]
hereby confirm that our company agrees to participate as subcontractor in the offer of
Done at:
Name:
Position:
Signature:
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Annex 5.2. Commitment letter by an entity on whose capacities is being relied
[Letterhead, if any]
EUROPEAN COMMISSION
Call for tenders Ref. SANTE/2020/C3/087
Attn:
[Insert date]
Commitment letter by an entity on whose capacity is being relied
I, the undersigned,
Name:
Function:
Company:
Registered address:
VAT Number:
having the legal capacity required to act on behalf of the company [insert name of the entity]
hereby confirm that our company authorises the [insert name of the tenderer] to rely on its
financial and economic capacity in order to meet the minimum levels required for the Call
for tenders SANTE/2020/C3/087 - for the development, production, priority-purchasing
options and supply of COVID-19 Vaccines for EU Member States.
Done at:
Name:
Position:
Signature:
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Annex 6. Financial offer form
To submit an offer, this form must be filled-in electronically using the file "Annex 6 Price
schedule.xlsx", printed and signed.
NB: If the contract will be awarded, information from this price schedule might be used in the
APA.
Annex 7. Agreement between the Commission and Member States on procuring
Covid-19 vaccines on behalf of the Member States and related procedures,
as approved by the Commission Decision C(2020) 4192 final of 18 June
2020
Annex 8. Draft ADVANCE PURCHASE AGREEMENT (“APA”) for the
development, production, priority-purchasing options and supply of a
successful COVID-19 vaccine for EU Member States
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