Council Regulation (EC) No 73/2008 of 20 December 2007 setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (Text with EEA relevance)
Date: 2007-12-20
Institutions: Council of the European Union
Subjects: EU programme, EU research policy, innovation, joint venture, legal status, medicinal product, pharmaceutical industry

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COUNCIL REGULATION (EC) No 73/2008

of 20 December 2007

setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on
Innovative Medicines

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 171 and 172 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the European Economic and
Social Committee (1),

Whereas:

(1) Decision No 1982/2006/EC of the European Parliament
and of the Council of 18 December 2006 concerning the
Seventh Framework Programme of the European Commu-
nity for research, technological development and demon-
stration activities (2007-2013) (2) (hereinafter referred to as
for a
the Seventh Framework Programme) provides
Community contribution for the establishment of long-
term public private partnerships in the form of
Joint
Technology Initiatives which could be
implemented
through Joint Undertakings within the meaning of
Article 171 of the Treaty. These Joint Technology Initiatives
result from the work of European Technology Platforms,
already set up under the Sixth Framework Programme, and
cover selected aspects of research in their field. They should
combine private sector investment and European public
funding, including funding from the Seventh Framework
Programme.

(2) Council Decision/2006/971/EC of 19 December 2006
imple-
concerning the specific programme ‘Cooperation’
menting the Seventh Framework Programme of
the
European Community for research, technological develop-
ment and demonstration activities (2007 to 2013) (3)
(hereinafter referred as the Specific Programme Cooper-
ation) underlines the need for ambitious pan-European
public private partnerships to accelerate the development of
major technologies, large research actions at Community
level including, in particular, Joint Technology Initiatives.

(3)

(4)

(5)

(6)

(7)

The Lisbon Growth and Jobs Agenda underscores the need
to develop favourable conditions for investment in knowl-
edge and innovation in Europe to boost competitiveness,
growth and jobs in the Community.

In its conclusions of 13 March 2003, of 22 September
2003 and of 24 September 2004, the Council highlighted
the importance of further developing actions following the
including the development of new
3 % Action Plans,
initiatives aimed at
intensifying cooperation between
industry and the public sector in funding research to
enhance trans-national public-private links.

In its conclusions of 4 December 2006 and of 19 February
2007, the Competitiveness Council and in its conclusions
invited the
of 9 March 2007 the European Council
Commission to present proposals for the setting up of
Joint Technology Initiatives for such initiatives that have
reached an appropriate stage of preparedness.

The European Federation of Pharmaceutical Industries and
Associations (hereinafter referred to as EFPIA) took the lead
in establishing the European Technology Platform on
Innovative Medicines under the Sixth Framework Pro-
gramme. It developed a Strategic Research Agenda, based
on an extensive consultation with public and private
stakeholders. The Strategic Research Agenda described the
research bottlenecks in the drug development process and
recommends the scientific direction for a Joint Technology
Initiative on Innovative Medicines.

The Joint Technology Initiative on Innovative Medicines
responds to the Commission Communication of 1 July
2003 ‘A Stronger European-based Pharmaceutical Industry
for the Benefit of the Patient — A Call for Action’ and in
to the recommendation regarding access to
particular
innovative medicines to secure the development of a
competitive innovative-based industry. This Communica-
tion was a response to the Report ‘Stimulating Innovation
and Improving the EU Science Base’ adopted on 7 May
2002 by the High Level Group on innovation and provision
of medicines — G10 Medicines. This Joint Technology
Initiative also responds to the Commission Communication
of 23 January 2002 ‘Life Sciences and Biotechnology — a
strategy for Europe (2002)’.

(1) Opinion delivered on 24 October 2007 (not yet published in the

Official Journal).

(2) OJ L 412, 30.12.2006, p. 1.
(3) OJ L 400, 30.12.2006, p. 86, corrected by OJ L 54, 22.2.2007, p. 30.

(8)

The Joint Technology Initiative on Innovative Medicines
also replies to the need for action as identified in the Report
January 2006. This
‘Creating an Innovative Europe’ of

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report identifies pharmaceuticals as a key strategic area and
it stresses the need for the Joint Technology Initiative on
Innovative Medicines at European level.

activities. Such research activities should respect funda-
mental ethical principles applicable in the Seventh Frame-
work Programme.

(9)

The Joint Technology Initiative on Innovative Medicines
should be a public private partnership aiming at increasing
investments in the biopharmaceutical sector in Europe in
the Members States and countries associated within the
Seventh Framework Programme. It should provide socio-
economic benefits for European citizens, contribute to the
health of European citizens, increase the competitiveness of
Europe and help to establish Europe as the most attractive
place for biopharmaceutical research and development.

(10) The objective of

the Joint Technology Initiative on
Innovative Medicines should be to foster collaboration
between all stakeholders such as industry, public authorities
(including regulators), organisations of patients, academia
and clinical centres. The Joint Technology Initiative on
Innovative Medicines should define a commonly agreed
referred to as Research
research agenda (hereinafter
Agenda) closely following the recommendations of
the
Strategic Research Agenda developed by the European
Technology Platform on Innovative Medicines which
identified efficacy, safety, knowledge management and
training as important areas.

(11) The Joint Technology Initiative on Innovative Medicines
should propose a coordinated approach to overcome
identified research bottlenecks in the drug development
process, and to support pre-competitive pharmaceutical
research and development,
to accelerate the
development of safe and more effective medicines for
patients. In the present context ‘pre-competitive pharma-
ceutical research and development’ should be understood as
research on the tools and methodologies used in the drug
development process.

in order

(12) The Joint Technology Initiative on Innovative Medicines
should deliver new approaches, methods and technologies,
improve knowledge management of research results and
data, and support the training of professionals. To this end,
is necessary to set up a Joint Undertaking for the
it
implementation of
the Joint Technology Initiative on
Innovative Medicines (hereinafter referred to as the IMI
Joint Undertaking) as a legal entity.

(13) The objective of

the IMI

Joint Undertaking should be
achieved through support of research activities by pooling
resources from the public and private sectors. To this end,
the IMI Joint Undertaking should be capable of organising
competitive calls for proposals for supporting the research

(14) The IMI Joint Undertaking should be set up for a period up
to 31 December 2017 to ensure the appropriate manage-
ment of research activities initiated but not concluded
during the Seventh Framework Programme (2007 to
2013).

(15) The IMI Joint Undertaking should be a body set up by the
Community and discharge for the implementation of its
budget should be given by the European Parliament, on the
recommendation of
in accordance with
the Council,
Council Regulation (EC, Euratom) No 1605/2002 of
25 June 2002 on the Financial Regulation applicable to
the European Communities (hereinafter
the budget of
referred to as the Financial Regulation) (1) taking however
into account the specificities resulting from the nature of
joint technology initiatives as public-private partnerships
and in particular from the private sector contribution to the
budget.

(16) Founding members of the IMI Joint Undertaking should be

the Community and EFPIA.

(17) EFPIA is a non-profit organisation representing the research
based pharmaceutical industry in Europe. The aim of EFPIA
is to ensure and promote the technological and economic
development of the pharmaceutical
industry in Europe.
EFPIA is open for membership to national associations of
research-based pharmaceutical companies, as well as
directly to research-based pharmaceutical companies.
It
applies general principles of openness and transparency for
membership ensuring a wide industrial involvement.

(18) The IMI
members.

Joint Undertaking should be open to new

(19) The rules for organisation and operation of the IMI Joint
Undertaking should be laid down in the Statutes of the IMI
Joint Undertaking as part of this Regulation.

(20) A letter of commitment concerning the Statutes of the IMI
Joint Undertaking has been signed by EFPIA and its research
based pharmaceutical companies that are members of
EFPIA.

(21) The research activities should be covered by funding from
the Community and at least on an equal level by resources
from the research based pharmaceutical companies that are
members of EFPIA. Further financing options may be

(1) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation
(EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

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available, inter alia, from the European Investment Bank, in
particular through the Risk-Sharing Finance Facility devel-
oped jointly with the EIB and the Commission pursuant to
Annex III to Decision/2006/971/EC.

(22) The running costs of the IMI Joint Undertaking should be

covered in equal amount by EFPIA and the Community.

recover funds lost, wrongly paid or incorrectly used in
accordance with Council Regulation (EC, Euratom)
No 2988/95 of 18 December 1995 on the protection of
the European Communities financial interests (3), Council
Regulation (Euratom, EC) No 2185/96 of 11 November
1996 concerning on-the-spot checks and inspections
carried out by the Commission in order to protect the
European Communities' financial
interests against fraud
irregularities (4), and the Regulation (EC)
and other
No 1073/1999 of the European Parliament and of the
Council of 25 May 1999 concerning investigations
concluded by the European Anti-Fraud Office (OLAF) (5).

(23) To ensure an equal partnership,

the research based
pharmaceutical companies that are members of EFPIA
activities should not be eligible to receive financial support
from the IMI Joint Undertaking.

(28)

(24) The IMI Joint Undertaking should adopt,

In order

in accordance
with the Financial Regulation and subject to prior consent
of the Commission, specific financial rules which take into
account its specific operating needs arising, in particular,
from the need to combine Community and private funding
to support research and development activities in an
to ensure a
efficient and timely manner.
the
harmonised treatment between the participants of
Joint Undertaking research activities and those of
the
indirect actions of the Seventh Framework Programme, it is
appropriate that value added tax should not be an eligible
cost for Community funding, in accordance with Regula-
tion (EC) No 1906/2006 of the European Parliament and of
the Council of 18 December 2006 laying down the rules
for the participation of undertakings, research centres and
universities
the Seventh Framework
Programme and for the dissemination of research results
(2007-2013) (1).

in actions under

(25) The need to ensure stable employment conditions and
equal treatment of staff, and in order to attract specialised
scientific and technical staff of the highest calibre, requires
the application of the Staff Regulations of officials of the
European Communities and the Conditions of Employment
of other servants of the European Communities laid down
in Regulation (EC, Euratom, ECSC) No 259/68 of
the
Council (2) to all staff recruited by the IMI Joint Under-
taking.

(26) As a body possessing legal personality,

Joint
Undertaking should be accountable for its actions. As
regards the resolution of disputes in contractual matters, it
should be possible that the contracts concluded by the Joint
the
Undertaking provide that
European Communities has jurisdiction.

the Court of

Justice of

the IMI

In order to facilitate the setting up of
Joint
Undertaking, the Commission should be responsible for the
establishment and initial operation of
Joint
Undertaking until
the operational capacity to
it has
implement its own budget.

the IMI

the IMI

(29) The IMI

Joint Undertaking should be established in
Brussels, Belgium. A host agreement should be concluded
between the IMI Joint Undertaking and Belgium concerning
office accommodation, privileges and immunities and other
Joint
support
Undertaking.

to be provided by Belgium to the IMI

(30) Since the objective of this Regulation, namely the establish-
ment of the IMI Joint Undertaking, cannot be sufficiently
achieved by the Member States due to the trans-national
nature of the great research challenge identified, which
requires the pooling of complementary knowledge and
financial resources across the sectors and borders and can
therefore be better achieved at Community level,
the
Community may adopt measures, in accordance with the
principle of subsidiarity as set our in Article 5 of the Treaty.
In accordance with the principle of proportionality, as set
out in that Article, this Regulation does not go beyond
what is necessary in order to achieve this objective,

HAS ADOPTED THIS REGULATION:

Article 1

Establishment of a Joint Undertaking

(27) Appropriate measures should be taken to prevent irregula-
rities and fraud and the necessary steps should be taken to

1. A Joint Undertaking for the implementation of the Joint
Technology Initiative on Innovative Medicines is hereby set up
for a period up to 31 December 2017 (hereinafter referred to as
IMI Joint Undertaking).

(1) OJ L 391, 30.12.2006, p. 1.
(2) OJ L 56, 4.3.1968, p. 1. Regulation as last amended by Regulation

(EC, Euratom) No 337/2007 (OJ L 90, 30.3.2007, p. 1).

(3) OJ L 312, 23.12.1995, p. 1.
(4) OJ L 292, 15.11.1996, p. 2.
(5) OJ L 136, 31.5.1999, p. 1.

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2. The seat of the IMI Joint Undertaking shall be located in
Brussels, Belgium.

Article 5

Community contribution

Article 2

Objectives

‘Health’ of

The IMI Joint Undertaking shall contribute to the implementa-
tion of the Seventh Framework Programme and in particular the
Theme
the Specific Programme Cooperation
implementing the Seventh Framework Programme. It shall have
the objective of significantly improving the efficiency and
effectiveness of the drug development process with the long-
term aim that the pharmaceutical sector produce more effective
and safer innovative medicines. In particular it shall:

(a)

(b)

(c)

(d)

‘pre-competitive pharmaceutical

support
research and
in the Member States and countries asso-
development’
ciated with the Seventh Framework Programme via a
coordinated approach to overcome the identified research
bottlenecks in the drug development process;

support the implementation of the research priorities as set
out by the Research Agenda of
the Joint Technology
Initiative on Innovative Medicines (hereinafter referred to as
‘Research Activities’), notably by awarding grants following
competitive calls for proposals;

ensure complementarity with other activities of the Seventh
Framework Programme;

be a public-private partnership aiming at increasing the
research investment in the biopharmaceutical sector in the
Members States and countries associated to the Seventh
Framework Programme by pooling resources and fostering
collaboration between the public and private sectors;

(e)

promote the involvement of small and medium-sized
enterprises (SME) in its activities, in line with the objectives
of the Seventh Framework Programme.

Article 3

Legal status

The IMI Joint Undertaking shall be a Community body and shall
have legal personality. In each of the Member States of the
European Community, it shall enjoy the most extensive legal
capacity accorded to legal persons under the laws of those States.
in particular, acquire or dispose of movable and
It may,
immovable property and may be a party to legal proceedings.

Article 4

Statutes

The Statutes of the IMI Joint Undertaking, as set out in the Annex
hereto, shall constitute an integral part of this Regulation and are
hereby adopted.

1. The maximum Community contribution to the IMI Joint
Undertaking covering running costs and Research Activities shall
be EUR 1 000 million. The contribution shall be paid from the
appropriation in the general budget of the European Union
allocated to the ‘Health’
the Specific Programme
theme of
Cooperation implementing the Seventh Framework Programme
according to the provisions of Article 54(2)(b) of the Financial
Regulation.

2. The arrangements for the Community financial contribution
shall be established by means of a general agreement and annual
financial agreements to be concluded between the Commission,
on behalf of the Community, and the IMI Joint Undertaking.

3. The Community contribution to the IMI Joint Undertaking
for the funding of
the Research Activities shall be granted
following open and competitive calls for proposals.

Article 6

Financial rules

in accordance with Article 185(1) of

1. The IMI Joint Undertakings shall adopt specific financial
rules
the Financial
from Commission Regulation
Regulation. They may depart
(EC, Euratom) No 2343/2002 (1) on the framework Financial
Regulation for the bodies referred to in Article 185 of the
Financial Regulation where the specific operating needs of the
IMI Joint Undertaking so require and subject to prior consent of
the Commission.

2. The IMI Joint Undertaking shall have its own internal audit
capability.

Article 7

Staff

1. The Staff Regulations of Officials of the European Commu-
nities, the Conditions of Employment of Other Servants of the
European Communities and the rules adopted jointly by the
institutions of the European Communities for the purpose of
applying these Staff Regulations and Conditions of Employment
shall apply to the staff of the IMI Joint undertaking and its
Executive Director.

2. Without prejudice to paragraph 3 of
this Article and
Article 6(3) of the Statutes, the IMI Joint Undertaking shall
exercise the powers conferred on the appointing authority by the
Staff Regulations of Officials of the European Communities and
on the authority empowered to conclude contracts by the
Conditions of Employment of Other Servants of the European
Communities in respect of its staff.

(1) OJ L 357, 31.12.2002, p. 72.

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in agreement with the
3. The Governing Board shall,
Commission, adopt
the necessary implementing measures
referred to in Article 110 of the Staff Regulations of Officials
of the European Communities, and the Conditions of Employ-
ment of Other Servants of the European Communities.

4. The staff resources shall be determined in the establishment
plan of the IMI Joint Undertaking that will be set out in its
annual budget.

the IMI

5. The staff of
Joint Undertaking shall consist of
temporary agents and contract agents engaged for a fixed period
that may be renewed no more than once for a fixed period. The
total period of engagement shall not exceed seven years and shall
not in any case exceed the lifetime of the Joint Undertaking.

(c)

(d)

in actions brought against
including decisions of
provided for in Articles 230 and 232 of the Treaty;

Joint Undertaking,
its bodies, under the conditions

the IMI

in disputes related to compensation for damage caused by
the staff of the IMI Joint Undertaking in the performance of
their duties.

2.
For any matter not covered by this Regulation or by other
acts of Community law, the law of the State where the seat of the
IMI Joint Undertaking is located shall apply.

6. All cost related to the staff shall be borne by the IMI Joint
Undertaking.

Report, evaluation and discharge

Article 11

Article 8

Privileges and immunities

The Protocol on the Privileges and Immunities of the European
Communities shall apply to the IMI Joint Undertaking and its
staff.

Article 9

Liability

1. The contractual liability of the IMI Joint Undertaking shall be
governed by the relevant contractual provisions and by the law
applicable to the agreement or contract in question.

In the case of non-contractual

Joint
2.
Undertaking shall,
in accordance with the general principles
common to the laws of the Member States, make good any
damage caused by its staff in the performance of their duties.

the IMI

liability,

3. Any payment by the IMI Joint Undertaking in respect of the
liability referred to in paragraphs 1 and 2 and the costs and
expenses incurred in connection therewith shall be considered as
expenditure of the IMI Joint Undertaking and shall be covered by
the resources of the IMI Joint Undertaking.

4. The IMI Joint Undertaking shall be solely responsible for
meeting its obligations.

Article 10

Jurisdiction of the Court of Justice and applicable law

1. The Court of Justice shall have jurisdiction:

(a)

in any dispute between the Members which relates to the
subject matter of
the Statutes
referred to in Article 4;

this Regulation and/or

(b)

pursuant to any arbitration clause contained in agreements
and contracts concluded by the IMI Joint Undertaking;

1. The Commission shall present to the European Parliament
and to the Council an annual report on the progress achieved by
the IMI Joint Undertaking. This report shall contain details of
implementation including number of proposals
submitted,
number of proposals selected for funding, type of participants,
including SMEs, and country statistics.

2. By 31 December 2010, as well as by 31 December 2013,
the Commission shall carry out interim evaluations of the IMI
Joint Undertaking with the assistance of independent experts on
the basis of terms of reference established after consultation of
the IMI Joint Undertaking. These evaluations shall cover the
quality and efficiency of the IMI Joint Undertaking and progress
towards the objectives set. The Commission shall communicate
the conclusions thereof, accompanied by its observations and,
where appropriate, proposals to amend this Regulation, includ-
ing the possible early termination of the IMI Joint Undertaking,
to the European Parliament and the Council.

3. Not
the Joint
later than six months after the end of
Undertaking, the Commission shall conduct a final evaluation of
the IMI Joint Undertaking with the assistance of independent
experts. The results of the final evaluation shall be presented to
the European Parliament and to the Council.

4. Discharge for the implementation of the budget of the IMI
Joint Undertaking shall be given by the European Parliament,
upon recommendation of the Council,
in accordance with a
procedure provided for by the financial rules of the IMI Joint
Undertaking referred to in Article 6.

Article 12

Protection of the financial interests of the Members and
anti-fraud measures

1. The IMI Joint Undertaking shall ensure that the financial
interests of its Members are adequately protected by carrying out
or by allowing the carrying out of appropriate internal and
external controls.

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In case of

irregularities committed by the IMI

Joint
2.
Undertaking or its staff, the Members shall reserve the right to
recover amount unduly spent or to reduce or suspend any
subsequent contribution to the IMI Joint Undertaking.

Parliament, Council and Commission documents (3) shall apply
to documents held by the IMI Joint Undertaking.

For the purposes of combating fraud, corruption and other

3.
illegal acts, Regulation (EC) No 1073/1999 shall apply.

2. The IMI
arrangements for
2001 by 7 August 2008.

Joint Undertaking shall adopt

the practical
implementing Regulation (EC) No 1049/

4. The IMI Joint Undertaking shall carry out on-the-spot checks
and financial audits among the participants of the Research
Activities funded by the IMI Joint Undertaking.

3. Decisions taken by the IMI Joint Undertaking pursuant to
Article 8 of Regulation (EC) No 1049/2001 may form the
subject of a complaint to the Ombudsman or of an action before
the Court of
the conditions laid down in
Justice, under
Articles 195 and 230 of the Treaty respectively.

5. The Commission and/or the Court of Auditors may,
if
necessary, carry out on-the-spot checks among the recipients of
the IMI Joint Undertaking's funding and the agents responsible
for allocating it. To that end, the IMI Joint Undertaking shall
ensure that grant agreements and contracts provide for the right
of the Commission and/or the Court of Auditors to carry out the
the detection of
appropriate controls and,
irregularities, to impose dissuasive and proportionate penalties.

in the event of

6. The European Anti-Fraud Office (OLAF) established by
Commission Decision 1999/352/EC, ECSC, Euratom (1) shall
enjoy the same powers in respect of the IMI Joint Undertaking
and its staff as it enjoys in respect of Commission departments.
it shall
As soon as the IMI Joint Undertaking is established,
accede to the Interinstitutional Agreement of 25 May 1999
between the European Parliament,
and the
Commission of the European Communities concerning internal
investigations by the European Anti-fraud Office (OLAF) (2). The
IMI Joint Undertaking shall adopt the necessary measures needed
to facilitate internal investigations conducted by OLAF.

the Council

Article 13

Confidentiality

Article 15

Intellectual property

The IMI Joint Undertaking shall adopt distinct rules governing
the protection, use and dissemination of research results based
on the principles of Regulation (EC) 1906/2006 as set out in
Article 22 of the Statutes which ensure that, where appropriate,
intellectual property generated in Research Activities under this
Regulation is protected, and that research results are used and
disseminated.

Article 16

Preparatory actions

1. The Commission shall be responsible for the establishment
and initial operation of the IMI Joint Undertaking until the IMI
Joint Undertaking has the operational capacity to implement its
own budget. It shall carry out, in accordance with Community
law, all necessary actions in collaboration with other Founding
Members and the involvement of the Governing Board.

Without prejudice to Article 14, the IMI Joint Undertaking shall
ensure the protection of sensitive information, the disclosure of
its Members or of
which could damage the interests of
participants in the activities of the IMI Joint Undertaking.

2.
For that purpose, until such time as the Executive Director
takes up his/her duties following his/her appointment by the
Governing Board in accordance with Article 6(3) of the Statutes,
the Commission may assign a limited number of its officials,
including one to fulfil the functions of the Executive Director, on
an interim basis.

Article 14

Transparency

1. Regulation (EC) No 1049/2001 of the European Parliament
and of the Council of 30 May 2001 regarding access to European

3. The interim Executive Director may authorise all payments
covered by the credits provided in the budget of the IMI Joint
Undertaking once approved by the Governing Board and may
following the
conclude contracts,
adoption of the IMI Joint Undertaking establishment plan. The
Commission authorising officer may authorise all payments
covered by the credits provided in the general budget of the IMI
Joint Undertaking.

including staff contracts

(1) OJ L 136, 31.5.1999, p. 20.
(2) OJ L 136, 31.5.1999, p. 15.

(3) OJ L 145, 31.5.2001, p. 43.

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Article 17

Support from the host State

A host agreement shall be concluded between the IMI Joint
Undertaking and Belgium concerning office accommodation,
privileges and immunities and other support to be provided by
Belgium to the IMI Joint Undertaking.

Article 18

Entry into force

This Regulation shall enter into force on the third day following
its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2007.

For the Council

The President

F. NUNES CORREIA

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STATUTES OF THE JOINT UNDERTAKING FOR THE IMPLEMENTATION OF THE JOINT TECHNOLOGY
INITIATIVE ON INNOVATIVE MEDICINES

ANNEX

Article 1

Tasks and activities

Article 2

Members

the
The main tasks and activities of
implementation of
the Joint Technology Initiative on Innovative
Medicines (hereinafter referred to as IMI Joint Undertaking) shall be
the following:

the Joint Undertaking for

1. The founding members of the IMI Joint Undertaking (hereinafter
referred to as Founding Members) shall be:

(a)

the European Community, represented by the Commission; and,

to ensure the establishment and sustainable management of the
Joint Technology Initiative on ‘Innovative Medicines’;

(b)

(a)

(b)

(c)

to define and carry out the annual implementation plan referred to
in Article 18 via calls for project;

to regularly review and make any necessary adjustments to the
Research Agenda of the Joint Technology Initiative on Innovative
Medicines in light of scientific developments occurring during its
implementation;

(d)

to mobilise the public and private sector resources needed;

(e)

to establish and develop close and long-term cooperation between
the Community,
industry and the other stakeholders such as
regulatory bodies, patients organisations, academia and clinical
centres, as well as cooperation between industry and academia;

(f)

to facilitate coordination with national and international activities
in this area;

(g)

to undertake communication and dissemination activities;

(h)

(i)

(j)

to communicate and interact with the Member States and the
countries associated within the Seventh Framework Programme via
a group specifically established for
this purpose (hereinafter
referred to as IMI States Representatives Group);

to organise at least an annual meeting (hereinafter referred to as a
Stakeholder Forum) with interest groups to ensure openness and
transparency of the Research Activities of the IMI Joint Under-
taking with its stakeholders;

to notify legal entities that have concluded a grant agreement
(hereinafter referred to as Grant Agreement) with the IMI Joint
Undertaking of the potential borrowing opportunities from the
European Investment Bank, in particular the Risk Sharing Finance
Facility set up under the Seventh Framework Programme;

upon acceptance of the Statutes of the IMI Joint Undertaking, the
European Federation of Pharmaceutical Industries and Associations
(hereinafter referred to as EFPIA) a non-profit association registered
under Swiss law (registration number 4749) with its permanent
office in Brussels, Belgium. EFPIA operates as a representative
organisation of the Pharmaceutical Industry in Europe.

2.
Provided that they contribute to the funding to achieve the objectives
of the IMI Joint Undertaking as described in Article 2 of the Regulation
and accept the Statutes of the IMI Joint Undertaking, any legal entity
supporting directly or indirectly research and development in a Member
State or in a country associated to the Seventh Framework Programme
may apply to become a Member of the IMI Joint Undertaking.

3. The Founding Members and new members
paragraphs 1 and 2 are hereinafter referred to as ‘Members’.

referred to in

Article 3

Accession and changes to membership

1. Any application for new membership shall be addressed to the
Governing Board.

2. Decisions of the Governing Board on accession of any other legal
entity shall be made taking into account the relevance and potential
added value of the applicant for the achievement of the objectives of the
IMI Joint Undertaking. For any application for new membership, the
Commission shall provide timely information to the Council on the
assessment and, where applicable, on the decision of the Governing
Board.

3. Any Member may terminate its membership of
Joint
Undertaking. The termination shall become effective and irrevocable six
months after notification to the other Members following which the
former Member shall be discharged from any obligations others than
those approved by the IMI Joint Undertaking prior to the membership
termination.

the IMI

4. Membership of the IMI Joint Undertaking may not be transferred to
a third party unless the prior agreement of the Governing Board is given.

(k)

to publish information on the projects, including the name of the
participants and the amount of the financial contribution of the
IMI Joint Undertaking per participant;

Article 4

Bodies

(l)

to ensure the efficiency of
‘Innovative Medicines’;

the Joint Technology Initiative on

1. The bodies IMI Joint Undertaking shall be:

— the Governing Board,

(m)

to carry out any other activity needed to achieve the objectives
referred to in Article 2 of the Regulation.

— the Executive Director,

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— the Scientific Committee.

(f)

approve the annual activity report, including the corresponding
expenditure;

In case a specific task is not assigned to one of the bodies, the

2.
Governing Board shall be the competent one.

(g)

approve the annual accounts and the balance-sheet;

3. The IMI
Joint Undertaking shall be supported by two external
advisory bodies: the IMI States Representatives Group and Stakeholder
Forum.

Article 5

Governing Board

1. Composition, voting rights and decision taking

(h)

(i)

approve, as appropriate. any change to the Research Agenda
recommended by the Scientific Committee;

approve the guidelines on evaluation and selection of project
proposals as proposed by the Executive Office;

(j)

approve the list of selected project proposals;

Each Member of the IMI Joint Undertaking shall be represented in
the Governing Board by a maximum of five representatives;

(k)

appoint, dismiss or
replace the Executive Director, provide
guidance and direction to the Executive Director, and monitor
the Executive Director's performance;

the Founding Members shall have five votes each in the Governing
Board;

(l)

approve the organisational structure of the Executive Office based
on recommendations of the Executive Director;

the voting right of any new Member shall be determined in
proportion to its contribution towards the total contributions to
the activities of the IMI Joint Undertaking;

(m)

(n)

the financial

adopt
accordance with Article 6 of the Regulation;

rules of

the IMI

Joint Undertaking in

approve the internal rules and procedures of
Joint
Undertaking, including the Intellectual Property Policy in line with
the principles set out in Article 22;

the IMI

(a)

(b)

(c)

(d)

the vote of each Member shall be indivisible;

(e)

(f)

(g)

the Governing Board shall make decisions by a three-quarters
majority and shall require the positive vote by the Founding
Members;

the chairperson of the Governing Board shall be a representative of
the Founding Members, serving on a rotating basis;

the representatives of the Members shall not be personally liable
for actions undertaken in their capacity as representatives on the
Governing Board.

2. The role and tasks

The Governing Board shall have overall responsibility for the operations
of the IMI Joint Undertaking and shall oversee the implementation of its
activities.

The Governing Board shall in particular:

(a)

(b)

(c)

(d)

assess the application(s) and decide changes in membership in
accordance with Article 3;

decide on the termination of the membership in the IMI Joint
Undertaking of any Member which does not fulfil its obligations
the Treaty ensuring
without prejudice to the provisions of
compliance with Community law;

approve the annual
corresponding expenditure estimates;

implementation plan proposal and the

approve the annual budget proposal, including the staff establish-
ment plan;

(o)

adopt its rules of procedure in accordance with paragraph 3;

(p)

(q)

(r)

approve the initiatives to amend the Statutes in accordance with
Article 23;

assign any task not specifically allocated to one of the other bodies
of the IMI Joint Undertaking;

adopt practical arrangements for implementing Regulation (EC)
No 1049/2001 as referred to in Article 14 of the Regulation;

(s)

supervise the overall activities of the IMI Joint Undertaking.

3. Rules of procedure

(a)

The Governing Board shall meet at least twice a year. Extraordinary
meetings shall be convened at the request of one of the Members
or at the request of the Executive Director. The meetings shall
normally take place at the seat of the IMI Joint Undertaking;

(b) Unless otherwise decided in particular cases, the Executive Director

shall participate in the meetings;

(c)

The chairman of the IMI States Representatives Group shall have
the right
the Governing Board as an
observer;

to attend meetings of

(d)

The chairman of the Scientific Committee shall participate by
invitation of the Governing Board, as relevant to the agenda;

(e)

approve the calls for proposals;

(e) Observers and/or other experts may be invited by the Governing
Board to attend meetings as and when relevant to the agenda.

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Article 6

Executive Director

(l) manage invitations for tenders for IMI Joint Undertaking goods/
services requirements according to the financial rules of the IMI
Joint Undertaking;

1. The Executive Director shall be the chief executive responsible for
the day-to-day management of the IMI Joint Undertaking in accordance
with the decisions of the Governing Board. In that context, he/she shall
regularly inform as well as respond to any specific ad hoc requests for
information from the Governing Board and the Scientific Committee.
The Director shall exercise, in respect of the staff, the powers laid down
in Article 7(2) of the Regulation.

2. The Executive Director shall be the legal representative of the IMI
Joint Undertaking. He/she shall perform his/her tasks with complete
independence, and shall be accountable to the Governing Board.

3. The Executive Director shall be appointed by the Governing Board
for a period of three years following a call for expressions of interest
published in the Official
the European Union and in other
periodicals or on Internet sites. After an evaluation of the Director's
performance, the Governing Board may extend the term of office once
for a further period of not more than four years.

Journal of

4. The Executive Director shall in particular:

(a)

be responsible for the communication activities related to the IMI
Joint Undertaking;

(b) manage appropriately the public and private funds;

(c)

(d)

(e)

(f)

(g)

(h)

(i)

recommend to the Governing Board, arrangements and guidelines
for evaluation and selection of the project proposals for approval.
These guidelines shall include procedures, composition, duties of
the peer review committees that evaluate the project proposals and
the rules for dissemination of research results;

supervise the management of the launch of the calls for project
proposals, the evaluation and selection of the project proposals, the
negotiation of the selected project proposals, the follow-up of the
project proposals and the administration of the grants, including
the coordination of the funded research activities;

be in charge of
appropriate accounting system;

the establishment and management of

the

provide the Governing Board and the Scientific Committee with
relevant documentation and logistical support;

prepare the annual
corresponding expenditure estimates;

implementation plan proposal and the

prepare the annual budget proposal, including the staff establish-
ment plan;

prepare the annual activity report, including the corresponding
expenditure;

(j)

prepare the annual accounts and the balance-sheet;

(m) prepare the calls for proposals;

(n)

perform tasks entrusted or delegated to it by the Governing Board;

(o)

(p)

submit to the Governing Board any change to the Research Agenda
as recommended by the Scientific Committee;

submit to the Governing Board his/her proposal(s) concerning the
organisation structure of the Executive Office and organise, direct
and supervise the staff of the IMI Joint Undertaking;

(q)

convene meetings of the Governing Board;

(r)

(s)

(t)

call the annual meeting of the Stakeholder Forum, to ensure
openness and transparency of
Joint
Undertaking with its stakeholders;

the activities of

the IMI

attend as appropriate the meetings of the Governing Board, of the
Scientific Committee and of the Stakeholder Forum as observer;

if appropriate, set up scientific ad hoc/subsidiary bodies/commit-
tees decided by the Governing Board and gather experts scientific
advice;

(u)

provide to the Governing Board any other information that may be
requested;

(v)

be responsible for risk assessment and risk management;

(w)

(x)

propose to the Governing Board any insurance that it may be
necessary for the IMI Joint Undertaking to take out in order to
meet its obligations;

for

responsible

concluding Grant Agreements

be
the
implementation of the Research Activities, and service and supply
contracts necessary for the operations of the IMI Joint Undertaking
as referred to in Article 12.

for

5. The Executive Director shall be supported by the staff of
Executive Office.

the

Article 7

Scientific Committee

1. The Scientific Committee is an advisory body to the Governing
Board and shall conduct its activities in close liaison and with the support
of the Executive Office.

2. The Scientific Committee shall consist of no more than 15 members.

(k)

prepare any other information that may be requested by the
Governing Board;

3. The members shall reflect a balanced representation of expertise
from academia, patient organisations, industry and regulatory bodies.
Collectively, the Scientific Committee members shall have the scientific

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4.2.2008

competencies and expertise covering the complete drug development
process needed to make strategic science-based recommendations
regarding the IMI Joint Undertaking.

4. The Governing Board shall establish the specific criteria and
selection process for the composition of the Scientific Committee and
shall appoint its members from a list proposed by the IMI States
Representatives Group.

5. A chairperson shall be elected by consensus of
Committee from among its members.

the Scientific

6. The Scientific Committee shall have the following tasks:

(a)

(b)

(c)

advise on the continued relevance of the Research Agenda and
recommend any amendments;

advise on the scientific priorities for the annual implementation
plan proposal;

advise the Governing Board and the Executive Director on the
scientific achievements described in the annual activity report;

(d)

advise on the composition of the peer review committees.

(f)

(g)

advise on the changes to the call and the evaluation process and
intellectual property rules of the IMI Joint Undertaking;

inform the IMI Joint Undertaking on relevant activities ongoing at
national level.

3. The IMI States Representative Group shall meet at least bi-annually
and shall be convened by the Executive Director. Extraordinary meetings
can be convened to deal with specific matters of major relevance to IMI
Joint Undertaking activities. These meetings shall be called by the
Executive Director either on his/her own initiative or upon request from
IMI States Representatives Group. The IMI States Representatives Group
may issue, on its own initiative, recommendations to the IMI Joint
Undertaking. The IMI Joint Undertaking shall
inform the IMI States
the follow up it has given to such
Representatives Group of
recommendations.

The Executive Director shall attend the meetings of
Representatives Group.

the IMI States

The IMI States Representative Group shall adopt its rules of procedure.

Article 9

Stakeholder Forum

7. The Scientific Committee shall meet at least once a year and shall be
convened by the chairperson.

1. The Stakeholder Forum shall be a meeting opened to all stakeholders
and convened at least once a year by the Executive Director.

8. The Scientific Committee may, with the agreement of
the
chairperson, invite non-member persons to participate in its meetings
for advice.

2. The Stakeholder Forum shall be informed on the activities of the IMI
Joint Undertaking and shall be invited to provide comments.

Article 8

IMI States Representatives Group

Article 10

Internal auditing function

1. Composition

The IMI States Representative Group shall consist of one representative of
each Member State and of each country associated to the Framework
Programme. It shall elect a chairperson among its members.

2. Role and tasks

The IMI States Representative Group shall have an advisory role for the
IMI Joint Undertaking and shall act as an interface between the IMI Joint
respective
Undertaking and the relevant stakeholders within their
countries. It shall in particular:

The functions entrusted by Article 185(3) of the Financial Regulation to
the Commission's internal auditor shall be carried out under
the
responsibility of the Governing Board, which shall make appropriate
Joint
provision taking into account the size and scope of
Undertaking.

the IMI

Article 11

Sources of financing

1. All resources of the IMI Joint Undertaking and its activities shall be
devoted to the objectives provided for in Article 2 of the Regulation.

(a)

(b)

advise on the annual scientific priorities, including the synergies
with the Framework Programme;

2. The resources of the IMI Joint Undertaking entered to its budget
shall be composed of:

facilitate the dissemination of information related to the calls for
stakeholders within their own countries;

(a) Members' financial contributions;

(c)

be informed on the outcome of the evaluation process;

(d)

provide an opinion on the update of the Research Agenda;

(b)

any revenue generated by the IMI Joint Undertaking;

(c)

any other financial contributions, resources and revenues.

(e)

advise on the activities of the IMI Joint Undertaking;

Any interest yielded by the contributions paid by its Members shall be
considered to be revenue of the IMI Joint Undertaking.

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3. The running costs of the IMI Joint Undertaking shall be financed by
its Members:

Joint Undertaking shall
2. The IMI
the implementation,
for
mechanisms
concluded Grant Agreements.

set up the procedures and
supervision and control of

(a)

The Founding Members shall contribute on an equal level, each of
them with an amount not exceeding 4 % of the total financial
contribution by the Community to the IMI Joint Undertaking. If
part of the contribution from the Community is not used, it may
be available for Research Activities referred to in paragraph 4;

(b) Any other member shall contribute in proportion to its total

contribution towards the Research Activities.

4. The Research Activities shall be jointly funded through:

(a)

non-monetary contributions (hereinafter referred to as contribu-
tions in kind) by the research based pharmaceutical companies that
(such as personnel,
are members of EFPIA, with resources
equipment, consumables, etc.) at
to the financial
contribution of the Community;

least equal

(b)

a matching financial contribution of the Community from the
Seventh Framework Programme entered to the budget of the IMI
Joint Undertaking;

(c)

contributions from members referred to in Article 2(2).

Contributions in kind shall be subject to an evaluation. The methodology
for evaluating contributions in kind shall be defined in the internal rules
and procedures of the IMI Joint Undertaking, in compliance with its
financial rules and based on the Rules of Participation of the Seventh
Framework Programme. Contributions in kind shall be verified by an
independent auditor.

5. The participating research based pharmaceutical companies that are
members of EFPIA shall not be eligible to receive any financial support
from the IMI Joint Undertaking for any activity.

Should any Member of

6.
Joint Undertaking, or any
the IMI
participating research based pharmaceutical company that is a member
its commitments concerning its agreed
of EFPIA,
contributions, the Executive Director shall convene a meeting of the
Governing Board to decide:

to meet

fail

in the case of a defaulting Member, whether its membership should
be terminated, or if any other measures should be taken until it has
been met its obligations; or

(a)

(b)

3. The Grant Agreement shall:

(a)

(b)

set up the appropriate arrangements for the implementation of the
research activities;

set up the appropriate financial arrangements and the rules relating
to intellectual property rights on the basis of the principles as set
out in Article 22;

(c)

govern the relationship between the selected consortium and the
IMI Joint Undertaking.

4. The Project Agreement shall be concluded between the members of
a consortium:

(a)

to set up the appropriate arrangements for the implementation of
the Grant Agreement;

(b)

to govern the relationship between the participants in a project.

5. Any legal entity carrying out activities relevant to the objectives of
the IMI Joint Undertaking in a Member State or country associated to the
Seventh Framework Programme shall be eligible for participating in a
project. Any other legal entities may participate if so agreed by the
Governing Board.

6. Apart from the contribution to the running costs as set out in
Article 11(3), the Community contribution to the IMI Joint Undertaking
shall be used for the implementation of the Research Activities. The
upper funding limits of such Community financial contribution shall
comply with those laid down by the Rules for Participation of the
Seventh Framework Programme. The following legal entities are eligible
for such funding:

(a) micro, small and medium-sized enterprises within the meaning of
Commission Recommendation 2003/361/EC of 6 May 2003
concerning the definition of micro, small and medium-sized
enterprises (1);

(b)

(c)

legal entities established as non-profit public bodies under national
law (2);

intergovernmental organisations, which have legal personality
under international public law, as well as any specialised agencies
set up by such intergovernmental organisations;

in the case of a defaulting participating research based pharma-
ceutical company that is a member of EFPIA, which appropriate
measures should be taken.

(d)

legal entities established under Community law;

7. The IMI Joint Undertaking shall own all assets generated by it or
transferred to it for the fulfilment of its objectives provided for in
Article 2 of the Regulation.

(e)

legal entities established as non-profit organisations which carry
out research or technological development as one of their main
objectives;

Article 12

(f)

secondary and higher education establishments;

Research activities, Grant Agreements and Project Agreements

(g)

non-profit qualified patients organisations.

1. The IMI
Joint Undertaking shall support prospective research
activities following open and competitive calls for project proposals,
independent evaluation, and the conclusion of Grant Agreements and
Project Agreements.

(1) O J L 124, 20.5.2003, p. 36.
(2)

For the purpose of the Regulation, ‘non-profit public bodies’ include those that
may make profit but are not permitted to distribute such profits otherwise
than in the furtherance of public interest purposes and which carry out
scientific and technological research among their main activities.

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In order to be considered eligible for Community funding, costs
the research activities shall be

7.
incurred in the implementation of
exclusive of value added tax.

Article 18

Planning and reporting

Article 13

Financial commitments

1. The Annual Implementation Plan shall describe the activities of IMI
Joint Undertaking planned for the coming year and the corresponding
expenditure estimates. Once approved by the Governing Board, a
publishable version of the Annual Implementation Plan shall be made
publicly available.

The financial commitments of the IMI Joint Undertaking shall not exceed
the amount of financial resources available or committed to its budget by
its Members.

Article 14

Financial revenues

Except when the IMI
to
Article 24, any excess revenue over expenditure shall not be paid to the
Members of the IMI Joint Undertaking.

Joint Undertaking is wound up pursuant

Article 15

Financial year

The financial year shall correspond to the calendar year.

Article 16

Financial implementation

The Executive Director shall
Undertaking.

implement the budget of the IMI Joint

Article 17

Financial reporting

1.
Every year, the Executive Director shall present to the Governing
Board a preliminary draft Annual Budget Plan containing a forecast of
annual expenditure for the following two years. Within this forecast, the
estimates of revenue and expenditure for the first of those two years shall
be drawn up in such detail as is necessary for the internal budgetary
procedure of each Member regarding its financial contributions to the
IMI Joint Undertaking. The Executive Director shall supply the Governing
Board with all supplementary information needed for this purpose.

2. The members of the Governing Board shall communicate to the
Executive Director their comments on the preliminary draft Annual
Budget Plan and in particular on the estimates of resources and
expenditure for the following year.

3. Taking into account the comments received from the members of
the Governing Board, the Executive Director shall prepare the draft
Annual Budget Plan for the following year and submit
to the
Governing Board for approval.

it

4. The Annual Budget Plan and the annual implementation plan for a
particular year shall be adopted by the Governing Board of the IMI Joint
Undertaking by the end of the previous year.

5. Within two months after the closure of each financial year, the
annual accounts and balance sheets for the preceding year shall be
submitted by the Executive Director to the Governing Board for approval.
The Annual Accounts and balance sheets for the preceding year shall be
submitted to the Court of Auditors and the Commission.

Implementation Plan for

2. An Annual Activity Report shall present progress made by the IMI
Joint Undertaking in each calendar year, in particular in relation to the
Annual
shall also include
information on the performed Research Activities and the participation
of SMEs in them as well as on other activities during the previous year
and the corresponding expenditure. The expenditure shall be based on
Members'
from
contributions as well as
participating research based pharmaceutical companies that are members
of EFPIA.

contributions

that year.

financial

It

The Annual Activity Report shall be presented by the Executive Director
together with the Annual Accounts and balance sheets. Once approved
by the Governing Board, the Annual Activity Report shall be made
public.

Article 19

Service and supply contracts

for

Joint Undertaking shall

the procedures and
The IMI
mechanisms
supervision and control of
concluded service and supply contracts concluded where necessary for
the operations of the IMI Joint Undertaking, according to the provisions
of its financial rules.

the implementation,

set up all

Article 20

Liability of Members, insurance

1. The financial liability of the Members for the debts of the IMI Joint
Undertaking is limited to their contribution already made for the running
costs as set out in Article 11(3).

2. The IMI Joint Undertaking shall take out and maintain appropriate
insurance.

Article 21

Conflict of interests

The IMI Joint Undertaking shall avoid any conflict of interest in the
implementation of its activities.

Article 22

Intellectual property policy

1. The IMI Joint Undertaking shall adopt its general rules governing the
intellectual property policy of the IMI Joint Undertaking that will be
incorporated in the grant agreements and project agreements.

2. The objective of the intellectual property policy of the IMI Joint
Undertaking is to promote knowledge creation,
together with its
disclosure and exploitation, to achieve fair allocation of rights, to reward
innovation, and to achieve a broad participation of private and public
entities (including, but not
limited to, participating research based
pharmaceutical companies that are members of EFPIA, academic groups
and small and medium-sized enterprises) in projects.

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3. The intellectual property policy shall reflect the following principles:

(a)

(b)

in a project shall remain the owner of

Each participant
the
intellectual property that it introduces into a project, and shall
remain the owner of the intellectual property that it generates in a
project unless otherwise mutually agreed in writing by the
participants in a project. The terms and conditions of access
rights and licenses with regard to the intellectual property
introduced into or generated by participants in a project, shall be
defined in the Grant Agreement and the Project Agreement of the
project concerned;

Participants in a project shall undertake to disseminate and allow
the use of the results and the intellectual property generated by the
project concerned under terms and conditions defined in the Grant
Agreement and the Project Agreement taking into account the
protection of intellectual property rights, confidentiality obliga-
tions and legitimate interests of the owners.

Article 23

Amendments to the Statutes

1. Any Member of the IMI Joint Undertaking may take an initiative to
the Governing Board for the amendment of these Statutes.

Article 24

Winding up

1. At the end of the period provided for in Article 1 of the Regulation,
or following an amendment pursuant to Article 11(2) of the Regulation,
the IMI Joint Undertaking shall be wound up.

2. The winding up procedure shall be automatically triggered if one of
the Founding Members terminates its membership of the IMI
Joint
Undertaking.

3.
For the purpose of conducting the proceedings in winding up of the
IMI Joint Undertaking, the Governing Board shall appoint one or more
liquidators, who shall comply with the decisions of the Governing Board.

4. When the IMI Joint Undertaking is being wound up, it shall return to
the host state any physical support item made available by the host state
in accordance with the host agreement.

5. When any physical support item has been dealt with as provided in
paragraph 4, any further assets shall be used to cover the liabilities of the
IMI Joint Undertaking and the expenditures relating to its winding up.
Any surplus or deficit shall be distributed among or met by the Members
existing at the time of the winding up in proportion of their actual
contribution to the IMI Joint Undertaking. Any surplus distributed to the
Community shall be returned to the Commission budget.

2. The initiatives referred to in paragraph 1 as approved by the
Governing Board shall be submitted as draft amendments to the
Commission who shall adopt them, as appropriate.

6. Remaining assets, debts or liabilities shall be distributed to the
Members existing at the time of the winding up in proportion to their
actual contribution to the IMI Joint Undertaking.

3. However, any amendment affecting the essential elements of these
Statutes and in particular amendments to Articles 2, 3, 5, 6, 11, 12, 20,
23 and 24 thereof shall be adopted in accordance with Article 172 of the
Treaty.

7. An ad hoc procedure shall be set up to ensure the appropriate
management of any Grant Agreement referred to in Article 12 and
service and supply contract referred to in Article 19, with duration
longer than the duration of the IMI Joint Undertaking.