ANNEX

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

Article 1

Tasks and activities

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

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

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

(c)	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)	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);

(i)	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 Undertaking with its stakeholders;

(j)

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;

(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;

(l)	to ensure the efficiency of the Joint Technology Initiative on ‘Innovative Medicines’;

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

Article 2

Members

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,

(b)

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 referred to in paragraphs 1 and 2 are hereinafter referred to as ‘Members’.

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 the IMI 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.

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.

Article 4

Bodies

1.   The bodies IMI Joint Undertaking shall be:

—	the Governing Board,

—	the Executive Director,

—	the Scientific Committee.

2.   In case a specific task is not assigned to one of the bodies, the Governing Board shall be the competent one.

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

Composition, voting rights and decision taking

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

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

(c)	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;

(d)	the vote of each Member shall be indivisible;

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

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

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

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

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

(c)	approve the annual implementation plan proposal and the corresponding expenditure estimates;

(d)	approve the annual budget proposal, including the staff establishment plan;

(e)	approve the calls for proposals;

(f)	approve the annual activity report, including the corresponding expenditure;

(g)	approve the annual accounts and the balance-sheet;

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

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

(j)	approve the list of selected project proposals;

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

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

(m)	adopt the financial rules of the IMI Joint Undertaking in accordance with Article 6 of the Regulation;

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

(o)	adopt its rules of procedure in accordance with paragraph 3;

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

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

(r)	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.

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 to attend meetings of the Governing Board as an observer;

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

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

Article 6

Executive Director

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 Journal of 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.

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)

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;

(d)

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;

(e)	be in charge of the establishment and management of the appropriate accounting system;

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

(g)	prepare the annual implementation plan proposal and the corresponding expenditure estimates;

(h)	prepare the annual budget proposal, including the staff establishment plan;

(i)	prepare the annual activity report, including the corresponding expenditure;

(j)	prepare the annual accounts and the balance-sheet;

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

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

(m)	prepare the calls for proposals;

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

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

(p)	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)	call the annual meeting of the Stakeholder Forum, to ensure openness and transparency of the activities of the IMI Joint Undertaking with its stakeholders;

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

(t)	if appropriate, set up scientific ad hoc/subsidiary bodies/committees 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)	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;

(x)	be responsible for concluding Grant Agreements for 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.

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

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.

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 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 the Scientific Committee from among its members.

6.   The Scientific Committee shall have the following tasks:

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

(b)	advise on the scientific priorities for the annual implementation plan proposal;

(c)	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.

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

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

Article 8

IMI States Representatives Group

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.

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 Undertaking and the relevant stakeholders within their respective countries. It shall in particular:

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

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

(c)	be informed on the outcome of the evaluation process;

(d)	provide an opinion on the update of the Research Agenda;

(e)	advise on the activities of the IMI Joint Undertaking;

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

(g)	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 Representatives Group of the follow up it has given to such recommendations.

The Executive Director shall attend the meetings of the IMI States Representatives Group.

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

Article 9

Stakeholder Forum

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

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

Article 10

Internal auditing function

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 provision taking into account the size and scope of the IMI Joint Undertaking.

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.

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

(a)	Members' financial contributions;

(b)	any revenue generated by the IMI Joint Undertaking;

(c)	any other financial contributions, resources and revenues.

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

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

(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 contributions in kind) by the research based pharmaceutical companies that are members of EFPIA, with resources (such as personnel, equipment, consumables, etc.) at least equal to the financial contribution of the Community;

(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.

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

(a)	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

(b)	in the case of a defaulting participating research based pharmaceutical company that is a member of EFPIA, which appropriate measures should be taken.

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.

Article 12

Research activities, Grant Agreements and Project Agreements

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.

2.   The IMI Joint Undertaking shall set up the procedures and mechanisms for the implementation, supervision and control of concluded Grant Agreements.

3.   The Grant Agreement shall:

(a)	set up the appropriate arrangements for the implementation of the research activities;

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

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

(d)	legal entities established under Community law;

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

(f)	secondary and higher education establishments;

(g)	non-profit qualified patients organisations.

7.   In order to be considered eligible for Community funding, costs incurred in the implementation of the research activities shall be exclusive of value added tax.

Article 13

Financial commitments

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 Joint Undertaking is wound up pursuant to Article 24, any excess revenue over expenditure shall not be paid to the Members of the IMI Joint Undertaking.

Article 15

Financial year

The financial year shall correspond to the calendar year.

Article 16

Financial implementation

The Executive Director shall implement the budget of the IMI Joint Undertaking.

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 it to the Governing Board for approval.

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.

Article 18

Planning and reporting

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.

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 Implementation Plan for that year. It 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' financial contributions as well as contributions from participating research based pharmaceutical companies that are members of EFPIA.

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

The IMI Joint Undertaking shall set up all the procedures and mechanisms for the implementation, 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.

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.

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

(a)

Each participant in a project shall remain the owner of 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;

(b)

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 obligations 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.

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.

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.

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.

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.

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.

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(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.