# L_2014169EN.01005401.xml

| 7.6.2014 | EN | Official Journal of the European Union | L 169/54 |
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7.6.2014

EN

Official Journal of the European Union

L 169/54

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COUNCIL REGULATION (EU) No 557/2014

of 6 May 2014

establishing the Innovative Medicines Initiative 2 Joint Undertaking

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 187 and the first paragraph of Article 188 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Parliament,

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

Whereas:

| (1) | Public-private partnerships in the form of Joint Technology Initiatives were initially provided for in Decision No 1982/2006/EC of the European Parliament and of the Council (1). |
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(1)

Public-private partnerships in the form of Joint Technology Initiatives were initially provided for in Decision No 1982/2006/EC of the European Parliament and of the Council (1).

| (2) | Council Decision 2006/971/EC (2) identified specific public-private partnerships to be supported, including a public-private partnership on Innovative Medicines Joint Technology Initiative between the Union and the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’). |
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(2)

Council Decision 2006/971/EC (2) identified specific public-private partnerships to be supported, including a public-private partnership on Innovative Medicines Joint Technology Initiative between the Union and the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’).

| (3) | Commission Communication entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’ (the ‘Europe 2020 Strategy’), endorsed by the European Parliament and the Council, emphasises the need to develop favourable conditions for investment in knowledge and innovation so as to achieve smart, sustainable and inclusive growth in the Union. |
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(3)

Commission Communication entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’ (the ‘Europe 2020 Strategy’), endorsed by the European Parliament and the Council, emphasises the need to develop favourable conditions for investment in knowledge and innovation so as to achieve smart, sustainable and inclusive growth in the Union.

| (4) | Regulation (EU) No 1291/2013 of the European Parliament and of the Council (3) established Horizon 2020 — The Framework Programme for Research and Innovation (2014-2020) (‘Horizon 2020’). Horizon 2020 aims to achieve a greater impact with respect to research and innovation by combining Horizon 2020 and private sector funds in public-private partnerships in key areas where research and innovation can contribute to the Union’s wider competitiveness goals, leverage private investment and help tackle societal challenges. Those partnerships should be based on a long-term commitment, including a balanced contribution from all partners, be accountable for the achievement of their objectives and be aligned with the Union’s strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective and efficient and give the opportunity to a wide range of stakeholders active in their specific areas to participate. In accordance with Regulation (EU) No 1291/2013, Union involvement in those partnerships may take the form of financial contributions to joint undertakings established on the basis of Article 187 of the Treaty on the Functioning of the European Union under Decision No 1982/2006/EC. |
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(4)

Regulation (EU) No 1291/2013 of the European Parliament and of the Council (3) established Horizon 2020 — The Framework Programme for Research and Innovation (2014-2020) (‘Horizon 2020’). Horizon 2020 aims to achieve a greater impact with respect to research and innovation by combining Horizon 2020 and private sector funds in public-private partnerships in key areas where research and innovation can contribute to the Union’s wider competitiveness goals, leverage private investment and help tackle societal challenges. Those partnerships should be based on a long-term commitment, including a balanced contribution from all partners, be accountable for the achievement of their objectives and be aligned with the Union’s strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective and efficient and give the opportunity to a wide range of stakeholders active in their specific areas to participate. In accordance with Regulation (EU) No 1291/2013, Union involvement in those partnerships may take the form of financial contributions to joint undertakings established on the basis of Article 187 of the Treaty on the Functioning of the European Union under Decision No 1982/2006/EC.

| (5) | In accordance with Regulation (EU) No 1291/2013 and Council Decision 2013/743/EU (4), further support should be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision 2013/743/EU. |
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(5)

In accordance with Regulation (EU) No 1291/2013 and Council Decision 2013/743/EU (4), further support should be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision 2013/743/EU.

| (6) | The Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI Joint undertaking’) set up by Council Regulation (EC) No 73/2008 (5) has demonstrated the effective mobilisation of resources by bringing together several partners from the pharmaceutical industry, academia, small and medium-sized enterprises (‘SMEs’), patient organisations and regulators. |
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(6)

The Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI Joint undertaking’) set up by Council Regulation (EC) No 73/2008 (5) has demonstrated the effective mobilisation of resources by bringing together several partners from the pharmaceutical industry, academia, small and medium-sized enterprises (‘SMEs’), patient organisations and regulators.

| (7) | The IMI Joint Undertaking has also stepped up cooperation between stakeholders in the health research and innovation field by allowing access to other partners’ expertise and increasing the collaboration between the pharmaceutical industry and other stakeholders in the Union by developing comprehensive research agendas and horizontal policy coordination. No other European or national programme has enabled cross-company collaboration within the pharmaceutical sector on the scale that has been achieved by the Joint Technology Initiative on Innovative Medicines. The interim evaluation of the IMI Joint Undertaking underlined that it enables mutual learning and provides an opportunity to improve the reciprocal understanding of the stakeholders, thus benefiting all parties, and that it has significantly contributed to the transition towards an open innovation model in biopharmaceutical research. |
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(7)

The IMI Joint Undertaking has also stepped up cooperation between stakeholders in the health research and innovation field by allowing access to other partners’ expertise and increasing the collaboration between the pharmaceutical industry and other stakeholders in the Union by developing comprehensive research agendas and horizontal policy coordination. No other European or national programme has enabled cross-company collaboration within the pharmaceutical sector on the scale that has been achieved by the Joint Technology Initiative on Innovative Medicines. The interim evaluation of the IMI Joint Undertaking underlined that it enables mutual learning and provides an opportunity to improve the reciprocal understanding of the stakeholders, thus benefiting all parties, and that it has significantly contributed to the transition towards an open innovation model in biopharmaceutical research.

| (8) | Research related to the future of medicine should be undertaken in areas where combination of societal, public health and biomedical industry competitiveness goals requires the pooling of resources and fostering collaboration between the public and private sectors, with the involvement of SMEs. The scope of the initiative should be expanded to cover all areas of life science research and innovation of public health interest, as identified by the World Health Organisation report on priority medicines for Europe and the World, which has been updated in 2013. The initiative should consequently seek to involve a broader range of partners, including mid-caps, from different sectors, such as biomedical imaging, medical information technology, diagnostic and animal health industries. A wider participation would help to advance the development of new approaches and technologies for the prevention, diagnosis and treatment of diseases with high impact on public health. |
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(8)

Research related to the future of medicine should be undertaken in areas where combination of societal, public health and biomedical industry competitiveness goals requires the pooling of resources and fostering collaboration between the public and private sectors, with the involvement of SMEs. The scope of the initiative should be expanded to cover all areas of life science research and innovation of public health interest, as identified by the World Health Organisation report on priority medicines for Europe and the World, which has been updated in 2013. The initiative should consequently seek to involve a broader range of partners, including mid-caps, from different sectors, such as biomedical imaging, medical information technology, diagnostic and animal health industries. A wider participation would help to advance the development of new approaches and technologies for the prevention, diagnosis and treatment of diseases with high impact on public health.

| (9) | A new joint undertaking should be established for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI2 Joint Undertaking’) and should replace and succeed the IMI Joint Undertaking. The IMI2 Joint Undertaking should seek to foster the capacity of smaller actors such as research organisations, universities and SMEs for participating in open innovation models and to promote the involvement of SMEs in its activities, in line with its objectives. |
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(9)

A new joint undertaking should be established for the implementation of the Joint Technology Initiative on Innovative Medicines (‘IMI2 Joint Undertaking’) and should replace and succeed the IMI Joint Undertaking. The IMI2 Joint Undertaking should seek to foster the capacity of smaller actors such as research organisations, universities and SMEs for participating in open innovation models and to promote the involvement of SMEs in its activities, in line with its objectives.

| (10) | The continuation of this initiative should also take into account the experience acquired from the operations of the IMI Joint Undertaking including the results of its interim evaluation and stakeholders’ recommendations and should be implemented using a structure and rules that are more fit for its purpose in order to enhance efficiency and ensure simplification at operational level. To that effect, the IMI2 Joint Undertaking should adopt financial rules specific to its needs in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6). |
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(10)

The continuation of this initiative should also take into account the experience acquired from the operations of the IMI Joint Undertaking including the results of its interim evaluation and stakeholders’ recommendations and should be implemented using a structure and rules that are more fit for its purpose in order to enhance efficiency and ensure simplification at operational level. To that effect, the IMI2 Joint Undertaking should adopt financial rules specific to its needs in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6).

| (11) | The Members other than the Union of the IMI2 Joint Undertaking have agreed to pursue the research activities in the area of activities of the IMI2 Joint Undertaking within a structure better adapted to the nature of a public-private partnership. It is appropriate that the Members other than the Union of the IMI2 Joint Undertaking accept the Statutes contained in the Annex to this Regulation by means of a letter of endorsement. |
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(11)

The Members other than the Union of the IMI2 Joint Undertaking have agreed to pursue the research activities in the area of activities of the IMI2 Joint Undertaking within a structure better adapted to the nature of a public-private partnership. It is appropriate that the Members other than the Union of the IMI2 Joint Undertaking accept the Statutes contained in the Annex to this Regulation by means of a letter of endorsement.

| (12) | As a means to further develop the IMI2 Joint Undertaking’s objectives, membership should also be open to other legal entities. Moreover, legal entities interested in supporting the IMI2 Joint Undertaking’s objectives in their specific areas of research should be offered the possibility to become Associated Partners of the IMI2 Joint Undertaking. |
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(12)

As a means to further develop the IMI2 Joint Undertaking’s objectives, membership should also be open to other legal entities. Moreover, legal entities interested in supporting the IMI2 Joint Undertaking’s objectives in their specific areas of research should be offered the possibility to become Associated Partners of the IMI2 Joint Undertaking.

| (13) | It should be possible for any eligible institution to become a participant or a coordinator in the selected projects. |
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(13)

It should be possible for any eligible institution to become a participant or a coordinator in the selected projects.

| (14) | To achieve its objectives, the IMI2 Joint Undertaking should provide financial support to participants mainly in the form of grants following open and competitive calls for proposals. |
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(14)

To achieve its objectives, the IMI2 Joint Undertaking should provide financial support to participants mainly in the form of grants following open and competitive calls for proposals.

| (15) | The participants should be fully informed about applicable legal and procedural conditions, including those laid down on the basis of Article 1(3) of Regulation (EU) No 1290/2013 of the European Parliament and of the Council (7), especially regarding eligibility for funding and the exploitation and dissemination of results. Those conditions should be consistent and reasonable and should ensure equitable and fair treatment of participants regarding ownership of and access to the results generated within the IMI2 Joint Undertaking’s projects. |
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(15)

The participants should be fully informed about applicable legal and procedural conditions, including those laid down on the basis of Article 1(3) of Regulation (EU) No 1290/2013 of the European Parliament and of the Council (7), especially regarding eligibility for funding and the exploitation and dissemination of results. Those conditions should be consistent and reasonable and should ensure equitable and fair treatment of participants regarding ownership of and access to the results generated within the IMI2 Joint Undertaking’s projects.

| (16) | The contributions from the Members other than the Union should relate to the administrative costs of the IMI2 Joint Undertaking and, together with the contributions from the Associated Partners for their specific area of research, to the co-financing required to carry out research and innovation actions supported by the IMI2 Joint Undertaking. |
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(16)

The contributions from the Members other than the Union should relate to the administrative costs of the IMI2 Joint Undertaking and, together with the contributions from the Associated Partners for their specific area of research, to the co-financing required to carry out research and innovation actions supported by the IMI2 Joint Undertaking.

| (17) | Participation in indirect actions funded by the IMI2 Joint Undertaking should comply with Regulation (EU) No 1290/2013. The IMI2 Joint Undertaking should, moreover, ensure consistent application of those rules based on relevant measures adopted by the Commission. |
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(17)

Participation in indirect actions funded by the IMI2 Joint Undertaking should comply with Regulation (EU) No 1290/2013. The IMI2 Joint Undertaking should, moreover, ensure consistent application of those rules based on relevant measures adopted by the Commission.

| (18) | The IMI2 Joint Undertaking should also use electronic means managed by the Commission to ensure openness and transparency and facilitate participation. Therefore, the calls for proposals launched by the IMI2 Joint Undertaking should also be published on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. Moreover, relevant data on, inter alia, proposals, applicants, grants and participants should be made available by the IMI2 Joint Undertaking for inclusion in Horizon 2020 reporting and dissemination electronic systems managed by the Commission, in an appropriate format and with the periodicity corresponding to the Commission’s reporting obligations. |
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(18)

The IMI2 Joint Undertaking should also use electronic means managed by the Commission to ensure openness and transparency and facilitate participation. Therefore, the calls for proposals launched by the IMI2 Joint Undertaking should also be published on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission. Moreover, relevant data on, inter alia, proposals, applicants, grants and participants should be made available by the IMI2 Joint Undertaking for inclusion in Horizon 2020 reporting and dissemination electronic systems managed by the Commission, in an appropriate format and with the periodicity corresponding to the Commission’s reporting obligations.

| (19) | The Union financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 1268/2012 (8). |
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(19)

The Union financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 1268/2012 (8).

| (20) | For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with Regulation (EU) No 1291/2013. |
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(20)

For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. Audits of recipients of Union funds under this Regulation should be carried out in compliance with Regulation (EU) No 1291/2013.

| (21) | The financial interests of the Union and of the other Members of the IMI2 Joint Undertaking should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012. |
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(21)

The financial interests of the Union and of the other Members of the IMI2 Joint Undertaking should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012.

| (22) | The Commission’s internal auditor should exercise the same powers over the IMI2 Joint Undertaking as those exercised in respect of the Commission. |
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(22)

The Commission’s internal auditor should exercise the same powers over the IMI2 Joint Undertaking as those exercised in respect of the Commission.

| (23) | In view of the specific nature and the current status of the joint undertakings, and to ensure continuity with the Seventh Framework Programme, the joint undertakings should continue to be subject to a separate discharge. By way of derogation from Articles 60(7) and 209 of Regulation (EU, Euratom) No 966/2012, discharge for the implementation of the budget of the IMI2 Joint Undertaking should therefore be given by the European Parliament on the recommendation of the Council. Hence, the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012 should not apply to the Union financial contribution to the IMI2 Joint Undertaking but they should be aligned to the extent possible to the ones foreseen for bodies under Article 208 of Regulation (EU, Euratom) No 966/2012. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors. |
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(23)

In view of the specific nature and the current status of the joint undertakings, and to ensure continuity with the Seventh Framework Programme, the joint undertakings should continue to be subject to a separate discharge. By way of derogation from Articles 60(7) and 209 of Regulation (EU, Euratom) No 966/2012, discharge for the implementation of the budget of the IMI2 Joint Undertaking should therefore be given by the European Parliament on the recommendation of the Council. Hence, the reporting requirements set out in Article 60(5) of Regulation (EU, Euratom) No 966/2012 should not apply to the Union financial contribution to the IMI2 Joint Undertaking but they should be aligned to the extent possible to the ones foreseen for bodies under Article 208 of Regulation (EU, Euratom) No 966/2012. The auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the Court of Auditors.

| (24) | The IMI2 Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner to its appropriate bodies as well as promoting its activities, including information and dissemination activities to the wider public. The rules of procedure of the bodies of the IMI2 Joint Undertaking should be made publicly available. |
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(24)

The IMI2 Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner to its appropriate bodies as well as promoting its activities, including information and dissemination activities to the wider public. The rules of procedure of the bodies of the IMI2 Joint Undertaking should be made publicly available.

| (25) | The Scientific Panel for Health was set up by Horizon 2020 as a science-led stakeholder platform, in order to elaborate scientific input, to provide a coherent scientific focused analysis of research and innovation bottlenecks and opportunities related to the Horizon 2020 societal challenge on health, demographic change and well-being, to contribute to the definition of its research and innovation priorities and to encourage Union-wide scientific participation. Through active cooperation with stakeholders, it helps to build capabilities and to foster knowledge-sharing and stronger collaboration across the Union in that field. The IMI2 Joint Undertaking should, therefore, collaborate and exchange information with the Scientific Panel for Health, where appropriate. |
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(25)

The Scientific Panel for Health was set up by Horizon 2020 as a science-led stakeholder platform, in order to elaborate scientific input, to provide a coherent scientific focused analysis of research and innovation bottlenecks and opportunities related to the Horizon 2020 societal challenge on health, demographic change and well-being, to contribute to the definition of its research and innovation priorities and to encourage Union-wide scientific participation. Through active cooperation with stakeholders, it helps to build capabilities and to foster knowledge-sharing and stronger collaboration across the Union in that field. The IMI2 Joint Undertaking should, therefore, collaborate and exchange information with the Scientific Panel for Health, where appropriate.

| (26) | Horizon 2020 should contribute to the closing of the research and innovation divide within the Union by promoting synergies with the European Structural and Investment Funds (ESIF). Therefore the IMI2 Joint Undertaking should seek to develop close interactions with the ESIF, which can specifically help to strengthen local, regional and national research and innovation capabilities in the area of the IMI2 Joint Undertaking and underpin smart specialisation efforts. |
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(26)

Horizon 2020 should contribute to the closing of the research and innovation divide within the Union by promoting synergies with the European Structural and Investment Funds (ESIF). Therefore the IMI2 Joint Undertaking should seek to develop close interactions with the ESIF, which can specifically help to strengthen local, regional and national research and innovation capabilities in the area of the IMI2 Joint Undertaking and underpin smart specialisation efforts.

| (27) | The IMI Joint Undertaking was set up for a period up to 31 December 2017. The IMI2 Joint Undertaking should provide continued support to the Innovative Medicines research programme by implementing the remaining actions initiated under Regulation (EC) No 73/2008 in accordance with that Regulation. The transition from the IMI Joint Undertaking to the IMI2 Joint Undertaking should be aligned and synchronised with the transition from the Seventh Framework programme to Horizon 2020 to ensure optimal use of the funding available for research. In the interest of legal certainty and clarity, Regulation (EC) No 73/2008 should therefore be repealed and transitional provisions should be set out. |
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(27)

The IMI Joint Undertaking was set up for a period up to 31 December 2017. The IMI2 Joint Undertaking should provide continued support to the Innovative Medicines research programme by implementing the remaining actions initiated under Regulation (EC) No 73/2008 in accordance with that Regulation. The transition from the IMI Joint Undertaking to the IMI2 Joint Undertaking should be aligned and synchronised with the transition from the Seventh Framework programme to Horizon 2020 to ensure optimal use of the funding available for research. In the interest of legal certainty and clarity, Regulation (EC) No 73/2008 should therefore be repealed and transitional provisions should be set out.

| (28) | Given the aim of Horizon 2020 to achieve greater simplification and coherence, all calls for proposals by the IMI2 Joint Undertaking should take into account the duration of Horizon 2020. |
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(28)

Given the aim of Horizon 2020 to achieve greater simplification and coherence, all calls for proposals by the IMI2 Joint Undertaking should take into account the duration of Horizon 2020.

| (29) | Since the objective of this Regulation, namely establishment of the IMI2 Joint Undertaking in order to strengthen industrial research and innovation across the Union cannot be sufficiently achieved by the Member States but can rather, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. 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 that objective, |
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(29)

Since the objective of this Regulation, namely establishment of the IMI2 Joint Undertaking in order to strengthen industrial research and innovation across the Union cannot be sufficiently achieved by the Member States but can rather, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. 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 that objective,

HAS ADOPTED THIS REGULATION:

Article 1

Establishment

1.   For the implementation of the Joint Technology Initiative on Innovative Medicines, a joint undertaking within the meaning of Article 187 of the Treaty on the Functioning of the European Union (‘IMI2 Joint Undertaking’), is established for a period until 31 December 2024. In order to take into account the duration of Horizon 2020, calls for proposals by the IMI2 Joint Undertaking shall be launched at the latest by 31 December 2020. In duly justified cases calls for proposals may be launched by 31 December 2021.

2.   The IMI2 Joint Undertaking shall replace and succeed the IMI Joint Undertaking, established by Regulation (EC) No 73/2008.

3.   The IMI2 Joint Undertaking shall be a body entrusted with the implementation of a public-private partnership referred to in Article 209 of Regulation (EU, Euratom) No 966/2012.

4.   The IMI2 Joint Undertaking shall have legal personality. In each of the Member States, it shall have the most extensive legal capacity accorded to legal persons under the laws of those Member States. It may, in particular, acquire or dispose of movable and immovable property and may be party to legal proceedings.

5.   The seat of the IMI2 Joint Undertaking shall be located in Brussels, Belgium.

6.   The Statutes of the IMI2 Joint Undertaking are set out in the Annex.

Article 2

Objectives

The IMI2 Joint Undertaking shall have the following objectives:

| (a) | to support, in accordance with Article 25 of Regulation (EU) No 1291/2013, the development and implementation of pre-competitive research and of innovation activities of strategic importance to the Union’s competitiveness and industrial leadership or to address specific societal challenges in particular as described in parts II and III of Annex I to Decision 2013/743/EU, and in particular the challenge to improve European citizens’ health and well-being; |
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(a)

to support, in accordance with Article 25 of Regulation (EU) No 1291/2013, the development and implementation of pre-competitive research and of innovation activities of strategic importance to the Union’s competitiveness and industrial leadership or to address specific societal challenges in particular as described in parts II and III of Annex I to Decision 2013/743/EU, and in particular the challenge to improve European citizens’ health and well-being;

| (b) | to contribute to the objectives of the Joint Technology Initiative on Innovative Medicines, in particular to:






  (i) | increase the success rate in clinical trials of priority medicines identified by the World Health Organisation; |
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(b)

to contribute to the objectives of the Joint Technology Initiative on Innovative Medicines, in particular to:

(i)

increase the success rate in clinical trials of priority medicines identified by the World Health Organisation;

| (ii) | where possible, reduce the time to reach clinical proof of concept in medicine development, such as for cancer, immunological, respiratory, neurological and neurodegenerative diseases; |
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(ii)

where possible, reduce the time to reach clinical proof of concept in medicine development, such as for cancer, immunological, respiratory, neurological and neurodegenerative diseases;

| (iii) | develop new therapies for diseases for which there is a high unmet need, such as Alzheimer’s disease and limited market incentives, such as antimicrobial resistance; |
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(iii)

develop new therapies for diseases for which there is a high unmet need, such as Alzheimer’s disease and limited market incentives, such as antimicrobial resistance;

| (iv) | develop diagnostic and treatment biomarkers for diseases clearly linked to clinical relevance and approved by regulators; |
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(iv)

develop diagnostic and treatment biomarkers for diseases clearly linked to clinical relevance and approved by regulators;

| (v) | reduce the failure rate of vaccine candidates in phase III clinical trials through new biomarkers for initial efficacy and safety checks; |
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(v)

reduce the failure rate of vaccine candidates in phase III clinical trials through new biomarkers for initial efficacy and safety checks;

| (vi) | improve the current drug development process by providing support for the development of tools, standards and approaches to assess efficacy, safety and quality of regulated health products. |
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(vi)

improve the current drug development process by providing support for the development of tools, standards and approaches to assess efficacy, safety and quality of regulated health products.

Article 3

Union financial contribution

1.   The Union financial contribution to the IMI2 Joint Undertaking, including EFTA appropriations, to cover administrative costs and operational costs shall be up to EUR 1 638 000 000 and shall consist of the following:

| (a) | up to EUR 1 425 000 000 to match the contribution of European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), or its constituent entities or their affiliated entities; |
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(a)

up to EUR 1 425 000 000 to match the contribution of European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), or its constituent entities or their affiliated entities;

| (b) | up to EUR 213 000 000 to match additional contributions from other Members, Associated Partners, or from their constituent entities or their affiliated entities. |
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(b)

up to EUR 213 000 000 to match additional contributions from other Members, Associated Partners, or from their constituent entities or their affiliated entities.

The contribution of the Union shall be paid from the appropriations in the general budget of the Union allocated to Horizon 2020 Specific Programme implementing Horizon 2020 in accordance with point (c)(iv) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 for bodies referred to in Article 209 of that Regulation.

2.   The arrangements for the Union financial contribution shall be set out in a delegation agreement and annual transfer of funds agreements to be concluded between the Commission, on behalf of the Union, and the IMI2 Joint Undertaking.

3.   The delegation agreement referred to in paragraph 2 of this Article shall address the elements set out in Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and in Article 40 of the Delegated Regulation (EU) No 1268/2012 as well as, inter alia, the following:

| (a) | the requirements for the IMI2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU; |
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(a)

the requirements for the IMI2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU;

| (b) | the requirements for the IMI2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU; |
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(b)

the requirements for the IMI2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU;

| (c) | the specific performance indicators related to the functioning of the IMI2 Joint Undertaking; |
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(c)

the specific performance indicators related to the functioning of the IMI2 Joint Undertaking;

| (d) | the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission; |
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(d)

the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

| (e) | provisions for the publication of calls for proposals of the IMI2 Joint Undertaking also on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission; |
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(e)

provisions for the publication of calls for proposals of the IMI2 Joint Undertaking also on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;

| (f) | the use of and changes to human resources, in particular the recruitment by function group, grade and category, the reclassification exercise and any changes to the number of staff members. |
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(f)

the use of and changes to human resources, in particular the recruitment by function group, grade and category, the reclassification exercise and any changes to the number of staff members.

Article 4

Contributions of Members other than the Union and of Associated Partners

1.   EFPIA shall make or arrange for its constituent entities or their affiliated entities to make contributions of at least EUR 1 425 000 000. Other Members other than the Union and Associated Partners shall make, or arrange for their constituent entities or their affiliated entities to make, the contributions corresponding to the amounts they have committed when becoming a Member or an Associated Partner.

2.   The contributions referred to in paragraph 1 of this Article shall consist of contributions to the IMI2 Joint Undertaking as set out in Article 13(2), point (b) of Article 13(3) and point (c) of Article 13(3) of the Statutes. In-kind contributions consisting of costs incurred in third countries other than countries associated to Horizon 2020 shall be justified and relevant to the objectives set out in Article 2 of this Regulation, and shall not exceed 30 % of the eligible costs at the level of the IMI2 programme, incurred by the Members other than the Union and by the Associated Partners.

3.   The Members other than the Union and Associated Partners shall report each year by 31 January to the Governing Board of the IMI2 Joint Undertaking on the value of the contributions referred to in paragraph 2 made in each of the previous financial years. The States Representatives Group shall also be informed thereof in a timely manner.

4.   For the purpose of valuing the contributions referred to in point (b) of Article 13(3) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where the entity is established, and to the applicable International Accounting Standards and International Financial Reporting Standards. The costs shall be certified by an independent external auditor appointed by the entity concerned. The valuation method may be verified by the IMI2 Joint Undertaking should there be any uncertainty arising from the certification. In case of remaining uncertainties, it may be audited by the IMI2 Joint Undertaking.

5.   The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the IMI2 Joint Undertaking or trigger the winding up procedure referred to in Article 21(2) of the Statutes if those Members and Associated Partners, their constituent entities or their affiliated entities do not contribute, contribute only partially or contribute late with regard to the contributions referred to in paragraph 2 of this Article.

Article 5

Financial rules

Without prejudice to Article 12 of this Regulation, the IMI2 Joint Undertaking shall adopt its specific financial rules in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 110/2014 (9).

9

Article 6

Staff

1.   The Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (10) (hereinafter ‘Staff Regulations’ and ‘Conditions of Employment’) and the rules adopted jointly by the institutions of the Union for the purpose of applying Staff Regulations and Conditions of Employment shall apply to the staff of the IMI2 Joint Undertaking.

2.   The Governing Board shall exercise, with respect to the staff of the IMI2 Joint Undertaking, the powers conferred by the Staff Regulations on the Appointing Authority and the powers conferred by the Conditions of Employment on the authority empowered to conclude contract (hereinafter ‘the appointing authority powers’).

The Governing Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation may be suspended. The Executive Director shall be authorised to sub-delegate those powers.

Where exceptional circumstances so require, the Governing Board may by decision temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subsequent sub-delegation of those powers by the latter. In such cases the Governing Board shall exercise the appointing authority powers itself or shall delegate them to one of its members or to a staff member of the IMI2 Joint Undertaking other than the Executive Director.

3.   The Governing Board shall adopt appropriate implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations.

4.   The staff resources shall be determined in the staff establishment plan of the IMI2 Joint Undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents, in line with its annual budget.

5.   The staff of the IMI2 Joint Undertaking shall consist of temporary staff and contract staff.

6.   All costs related to the staff shall be borne by the IMI2 Joint Undertaking.

Article 7

Seconded national experts and trainees

1.   The IMI2 Joint Undertaking may make use of seconded national experts and trainees not employed by the IMI2 Joint Undertaking. The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff as referred to in Article 6(4) in line with the annual budget.

2.   The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the IMI2 Joint Undertaking and on the use of trainees.

Article 8

Privileges and Immunities

The Protocol No 7 on the privileges and immunities of the European Union, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, shall apply to the IMI2 Joint Undertaking and its staff.

Article 9

Liability of the IMI2 Joint Undertaking

1.   The contractual liability of the IMI2 Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question.

2.   In the case of non-contractual liability, the IMI2 Joint 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.

3.   Any payment by the IMI2 Joint Undertaking in respect of the liability referred to in paragraphs 1 or 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the IMI2 Joint Undertaking and shall be covered by its resources.

4.   The IMI2 Joint Undertaking shall be solely responsible for meeting its obligations.

Article 10

Jurisdiction of the Court of Justice of the European Union and applicable law

1.   The Court of Justice of the European Union shall have jurisdiction:

| (a) | pursuant to any arbitration clause contained in agreements or contracts concluded by the IMI2 Joint Undertaking or in its decisions; |
| --- | --- |

(a)

pursuant to any arbitration clause contained in agreements or contracts concluded by the IMI2 Joint Undertaking or in its decisions;

| (b) | in disputes relating to compensation for damage caused by the staff of the IMI2 Joint Undertaking in the performance of their duties; |
| --- | --- |

(b)

in disputes relating to compensation for damage caused by the staff of the IMI2 Joint Undertaking in the performance of their duties;

| (c) | in any dispute between the IMI2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment. |
| --- | --- |

(c)

in any dispute between the IMI2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment.

2.   Regarding any matter not covered by this Regulation or by other Union legal acts, the law of the State where the seat of the IMI2 Joint Undertaking is located shall apply.

Article 11

Evaluation

1.   By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the IMI2 Joint Undertaking. The Commission shall prepare a report on that evaluation which includes conclusions of the evaluation and observations by the Commission. The Commission shall send that report to the European Parliament and to the Council by 31 December 2017. The results of the interim evaluation of the IMI2 Joint Undertaking shall be taken into account in the in-depth assessment and in the interim evaluation referred to in Article 32 of Regulation (EU) No 1291/2013.

2.   On the basis of the conclusions of the interim evaluation referred to in paragraph 1 of this Article the Commission may act in accordance with Article 4(5) or take any other appropriate action.

3.   Within six months after the winding up of the IMI2 Joint Undertaking, but no later than two years after the triggering of the winding up procedure referred to in Article 21 of the Statutes, the Commission shall conduct a final evaluation of the IMI2 Joint Undertaking. The results of that final evaluation shall be presented to the European Parliament and to the Council.

Article 12

Discharge

By way of derogation from Article 60(7) and Article 209 of Regulation (EU, Euratom) No 966/2012, the discharge for the implementation of the budget of the IMI2 Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council in accordance with the procedure provided for in the financial rules of the IMI2 Joint Undertaking.

Article 13

Ex post audits

1.   Ex post audits of expenditure on indirect actions shall be carried out by the IMI2 Joint Undertaking in accordance with Article 29 of Regulation (EU) No 1291/2013 as part of Horizon 2020 indirect actions.

2.   The Commission may decide to carry out the audits referred to in paragraph 1 itself of those participants which have received funding from the IMI2 Joint Undertaking. In such cases, it shall do so in accordance with the applicable rules, in particular the provisions of Regulations (EU, Euratom) No 966/2012, (EU) No 1290/2013 and (EU) No 1291/2013.

Article 14

Protection of the financial interests of the Members

1.   The IMI2 Joint Undertaking shall grant Commission staff and other persons authorised by the IMI2 Joint Undertaking or the Commission, as well as the Court of Auditors, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits.

2.   The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (11) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (12), with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with an agreement, decision or contract funded under this Regulation.

3.   Without prejudice to paragraphs 1 and 2 agreements, decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering:

| (a) | the IMI2 Joint Undertaking and OLAF to conduct audits and investigations, for the purposes described in paragraphs 1 and 2, in accordance with their respective competences; and |
| --- | --- |

(a)

the IMI2 Joint Undertaking and OLAF to conduct audits and investigations, for the purposes described in paragraphs 1 and 2, in accordance with their respective competences; and

| (b) | the Commission and the Court of Auditors to conduct audits, for the purposes described in paragraphs 1 and 2, of the recipients of funding from the IMI2 Joint Undertaking, in accordance with their respective competences. |
| --- | --- |

(b)

the Commission and the Court of Auditors to conduct audits, for the purposes described in paragraphs 1 and 2, of the recipients of funding from the IMI2 Joint Undertaking, in accordance with their respective competences.

4.   The IMI2 Joint Undertaking shall ensure that the financial interests of its Members are adequately protected by carrying out or commissioning appropriate internal and external controls.

5.   The IMI2 Joint Undertaking shall accede to the Inter-institutional Agreement of 25 May 1999 between the European Parliament, the Council and the Commission concerning internal investigations by the European Anti-fraud Office (OLAF) (13). The IMI2 Joint Undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF.

Article 15

Confidentiality

Without prejudice to Article 16, the IMI2 Joint Undertaking shall ensure the protection of sensitive information the disclosure of which could damage the interests of its Members or of participants in the activities of the IMI2 Joint Undertaking.

Article 16

Transparency

1.   Regulation (EC) No 1049/2001 of the European Parliament and of the Council (14) shall apply to documents held by the IMI2 Joint Undertaking.

2.   The IMI2 Joint Undertaking Governing Board may adopt the practical arrangements for implementing Regulation (EC) No 1049/2001.

3.   Without prejudice to Article 10 of this Regulation, decisions taken by the IMI2 Joint Undertaking pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman under the conditions laid down in Article 228 of the Treaty on the Functioning of the European Union.

Article 17

Rules for participation and dissemination

Regulation (EU) No 1290/2013 shall apply to the actions funded by the IMI2 Joint Undertaking. In accordance with that Regulation, the IMI2 Joint Undertaking shall be considered as a funding body and shall provide financial support to indirect actions as set out in Article 1 of the Statutes.

Article 18

Support from the host State

An administrative agreement may be concluded between the IMI2 Joint Undertaking and the State where its seat is located concerning privileges and immunities and other support to be provided by that State to the IMI2 Joint Undertaking.

Article 19

Repeal and transitional provisions

1.   Regulation (EC) No 73/2008 is repealed.

2.   Without prejudice to paragraph 1, actions initiated under Regulation (EC) No 73/2008 and financial obligations related to those actions shall continue to be governed by that Regulation until their completion.

The actions arising from calls for proposals provided for in annual implementation plans adopted under Regulation (EC) No 73/2008 shall also be regarded as actions initiated under that Regulation.

The interim evaluation referred to in Article 11(1) of this Regulation shall include a final evaluation of the IMI Joint Undertaking under Regulation (EC) No 73/2008.

3.   This Regulation shall not affect the rights and obligations of staff engaged under Regulation (EC) No 73/2008.

The employment contracts of staff referred to in the first subparagraph may be renewed under this Regulation in accordance with the Staff Regulations and Conditions of Employment.

The Executive Director appointed on the basis of Regulation (EC) No 73/2008 shall, for the remaining period of term of office, be assigned to the functions of the Executive Director as provided for in this Regulation with effect from 27 June 2014. The other conditions of contract shall remain unchanged.

4.   Unless otherwise agreed between the Members of the IMI Joint Undertaking pursuant to Regulation (EC) No 73/2008, all rights and obligations including assets, debts or liabilities of the Members of the IMI Joint Undertaking pursuant to Regulation (EC) No 73/2008 shall be transferred to the Members of the IMI2 Joint Undertaking pursuant to this Regulation.

5.   Any unused appropriations under Regulation (EC) No 73/2008 shall be transferred to the IMI2 Joint Undertaking.

Article 20

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 6 May 2014.

For the Council

The President

G. STOURNARAS

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(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 Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1).

1

(2)  Council Decision 2006/971/EC of 19 December 2006 concerning the Specific Programme ‘Cooperation’ implementing the Seventh Framework programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 400 30.12.2006, p. 86).

2

(3)  Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104).

3

(4)  Council Decision 2013/743/EU of 3 December 2013 establishing the Specific Programme implementing Horizon 2020 (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965).

4

(5)  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 (OJ L 30, 4.2.2008, p. 38).

5

(6)  Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

6

(7)  Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in ‘Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)’ and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81).

7

(8)  Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p. 1).

8

(9)  Commission Delegated Regulation (EU) No 110/2014 of 30 September 2013 on the model financial regulation for public-private partnership bodies referred to in Article 209 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 38, 7.2.2014, p. 2).

9

(10)  Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1).

10

(11)  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 and other irregularities (OJ L 292, 15.11.1996, p. 2).

11

(12)  Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).

12

(13)  
  OJ L 136, 31.5.1999, p. 15.

13

(14)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

14

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ANNEX

STATUTES OF THE INNOVATIVE MEDICINES INITIATIVE 2 JOINT UNDERTAKING

Article 1

Tasks

The IMI2 Joint Undertaking shall carry out the following tasks:

| (a) | mobilise the public and private sector resources needed to achieve the objectives of the IMI2 Joint Undertaking; |
| --- | --- |

(a)

mobilise the public and private sector resources needed to achieve the objectives of the IMI2 Joint Undertaking;

| (b) | regularly review and make any necessary adjustments to the Strategic Research Agenda of the IMI2 Joint Undertaking in light of scientific developments occurring during its implementation; |
| --- | --- |

(b)

regularly review and make any necessary adjustments to the Strategic Research Agenda of the IMI2 Joint Undertaking in light of scientific developments occurring during its implementation;

| (c) | establish and develop close and long-term cooperation between the Union, other Members, Associated Partners, and the other stakeholders such as other industries, regulatory bodies, patient organisations, academia and clinical centres, as well as cooperation between industry and academia; |
| --- | --- |

(c)

establish and develop close and long-term cooperation between the Union, other Members, Associated Partners, and the other stakeholders such as other industries, regulatory bodies, patient organisations, academia and clinical centres, as well as cooperation between industry and academia;

| (d) | facilitate coordination with European, national and international activities in this area, and to communicate and interact with the Member States and the countries associated with Horizon 2020; |
| --- | --- |

(d)

facilitate coordination with European, national and international activities in this area, and to communicate and interact with the Member States and the countries associated with Horizon 2020;

| (e) | effectively support pre-competitive research and innovation in life sciences mainly through grants; if clinical trials are necessary, priority shall be given to phases I and II; phases III and IV shall be funded in justified cases where it is demonstrated that unmet medical needs exist, and if they are either non-competitive or pre-competitive; |
| --- | --- |

(e)

effectively support pre-competitive research and innovation in life sciences mainly through grants; if clinical trials are necessary, priority shall be given to phases I and II; phases III and IV shall be funded in justified cases where it is demonstrated that unmet medical needs exist, and if they are either non-competitive or pre-competitive;

| (f) | define and carry out the IMI2 Joint Undertaking annual work plan mainly through competitive calls for proposals; |
| --- | --- |

(f)

define and carry out the IMI2 Joint Undertaking annual work plan mainly through competitive calls for proposals;

| (g) | initiate competitive calls for proposals and any other necessary procedure for funding, evaluate proposals, award funding to projects according to the applicable rules, within the limits of available funds; |
| --- | --- |

(g)

initiate competitive calls for proposals and any other necessary procedure for funding, evaluate proposals, award funding to projects according to the applicable rules, within the limits of available funds;

| (h) | publish information on the projects, including participating entities and the amount of the financial contribution of the IMI2 Joint Undertaking per participant; |
| --- | --- |

(h)

publish information on the projects, including participating entities and the amount of the financial contribution of the IMI2 Joint Undertaking per participant;

| (i) | engage in information, communication, exploitation and dissemination activities by applying mutatis mutandis Article 28 of the Regulation (EU) No 1291/2013, including making the detailed information on results from calls for proposals available and accessible in a common Horizon 2020 e-database; |
| --- | --- |

(i)

engage in information, communication, exploitation and dissemination activities by applying mutatis mutandis Article 28 of the Regulation (EU) No 1291/2013, including making the detailed information on results from calls for proposals available and accessible in a common Horizon 2020 e-database;

| (j) | liaise with a broad range of stakeholders including research organisations and universities; |
| --- | --- |

(j)

liaise with a broad range of stakeholders including research organisations and universities;

| (k) | organise regular communication, including at least one annual meeting with interest groups and with its stakeholders via the Stakeholder Forum to ensure openness and transparency of the research activities of the IMI2 Joint Undertaking; |
| --- | --- |

(k)

organise regular communication, including at least one annual meeting with interest groups and with its stakeholders via the Stakeholder Forum to ensure openness and transparency of the research activities of the IMI2 Joint Undertaking;

| (l) | any other task needed to achieve the objectives referred to in Article 2 of this Regulation. |
| --- | --- |

(l)

any other task needed to achieve the objectives referred to in Article 2 of this Regulation.

Article 2

Members and Associated Partners

| 1. | The Members of the IMI2 Joint Undertaking shall be:






  (a) | the Union, represented by the Commission; |
| --- | --- | --- |

1.

(a)

the Union, represented by the Commission;

| (b) | upon acceptance of these Statutes by means of a letter of endorsement, the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’). |
| --- | --- |

(b)

upon acceptance of these Statutes by means of a letter of endorsement, the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’).

| 2. | Provided that it contributes to the funding referred to in Article 13 of these Statutes to achieve the objectives of the IMI2 Joint Undertaking set out in Article 2 of this Regulation and accepts these Statutes, any legal entity that directly or indirectly supports research and innovation in a Member State or in a country associated with Horizon 2020 may apply to become a Member of the IMI2 Joint Undertaking. |
| --- | --- |

2.

| 3. | Constituent entities of a Member are the entities that constitute each Member of the IMI2 Joint Undertaking other than the Union, according to that Member’s Statutes. |
| --- | --- |

3.

| 4. | Upon acceptance of these Statutes by means of a letter of endorsement, any legal entity other than a Member or a constituent entity of a Member or any affiliated entity of either, supporting the objectives of the IMI2 Joint Undertaking in its specific area of research, in a Member State or in a country associated with Horizon 2020, may apply to become an Associated Partner of the IMI2 Joint Undertaking. The letter of endorsement shall detail the scope of the association in terms of content, activities and duration. |
| --- | --- |

4.

| 5. | Associated Partners shall contribute in the same manner as Members other than the Union to the IMI2 Joint Undertaking’s operational costs, in accordance with Article 13 of these Statutes.
  The letter of endorsement shall detail the Associated Partners’ contribution to IMI2 Joint Undertaking, that the Union will match, in accordance with Articles 3 and 4 of this Regulation. |
| --- | --- |

5.

The letter of endorsement shall detail the Associated Partners’ contribution to IMI2 Joint Undertaking, that the Union will match, in accordance with Articles 3 and 4 of this Regulation.

Article 3

Changes to membership and to association

| 1. | Any application to become a Member or an Associated Partner of the IMI2 Joint Undertaking shall be addressed to the Governing Board. In the case of application to become a Member, the application shall be accompanied by a proposal to adapt the composition of the Governing Board. |
| --- | --- |

1.

| 2. | The Governing Board shall assess the application taking into account the relevance and the potential added value of the applicant for the achievement of the objectives of the IMI2 Joint Undertaking and shall decide on the application. |
| --- | --- |

2.

| 3. | Any Member or Associated Partner may terminate its membership of or association to the IMI2 Joint Undertaking. The termination shall become effective and irrevocable six months after notification to the other Members and Associated Partners. As of then, the former Member or Associated Partner shall be discharged from any obligations other than those approved or incurred by the IMI2 Joint Undertaking prior to terminating the membership or association. |
| --- | --- |

3.

| 4. | Membership of or association to the IMI2 Joint Undertaking may not be transferred to a third party without the prior agreement of the Governing Board. |
| --- | --- |

4.

| 5. | Upon any change to membership or association pursuant to this Article, the Commission shall immediately publish on its website an updated list of Members and Associated Partners of the IMI2 Joint Undertaking together with the date of such change. |
| --- | --- |

5.

Article 4

Bodies of the IMI2 Joint Undertaking

| 1. | The bodies of the IMI2 Joint Undertaking shall be:






  (a) | the Governing Board; |
| --- | --- | --- |

1.

(a)

the Governing Board;

| (b) | the Executive Director; |
| --- | --- |

(b)

the Executive Director;

| (c) | the Scientific Committee; |
| --- | --- |

(c)

the Scientific Committee;

| (d) | the States Representatives Group; |
| --- | --- |

(d)

the States Representatives Group;

| (e) | the Stakeholder Forum. |
| --- | --- |

(e)

the Stakeholder Forum.

| 2. | The Scientific Committee, the States Representatives Group and the Stakeholder Forum shall be advisory bodies of the IMI2 Joint Undertaking. |
| --- | --- |

2.

Article 5

Composition of the Governing Board

The Governing Board shall be composed of five representatives per Member.

Article 6

Functioning of the Governing Board

| 1. | Without prejudice to paragraph 2, each Member shall have a percentage out of 100 voting rights corresponding to the percentage of its contribution to the IMI2 Joint Undertaking.
  The Union shall hold 50 % of the voting rights. The voting rights of the Union shall be indivisible. Each Member may allocate its voting rights among its representatives in the Governing Board. The Members shall use their best efforts to achieve consensus. Failing consensus, the Governing Board shall take its decisions by a majority of at least 75 % of all votes including the votes of those who are absent.
  The chairperson of the Governing Board shall be appointed on a rotating annual basis by the Union and the other Members, in turn. |
| --- | --- |

1.

The Union shall hold 50 % of the voting rights. The voting rights of the Union shall be indivisible. Each Member may allocate its voting rights among its representatives in the Governing Board. The Members shall use their best efforts to achieve consensus. Failing consensus, the Governing Board shall take its decisions by a majority of at least 75 % of all votes including the votes of those who are absent.

The chairperson of the Governing Board shall be appointed on a rotating annual basis by the Union and the other Members, in turn.

| 2. | The Governing Board shall hold its ordinary meetings at least twice a year. It may hold extraordinary meetings at the request of any Member or at the request of the chairperson. The meetings of the Governing Board shall be convened by its chairperson and shall normally take place at the seat of the IMI2 Joint Undertaking.
  The Executive Director shall take part in the deliberations, but shall have no voting rights.
  The Governing Board shall invite any Associated Partner to take part in deliberations of the Governing Board for those points on the agenda that concern its association. Associated Partners shall have no voting rights.
  The chairperson of the States Representatives Group shall attend meetings of the Governing Board and take part in the deliberations but shall have no voting rights.
  The chairperson of the Scientific Committee shall have the right, whenever issues falling within its tasks are discussed, to attend meetings of the Governing Board as an observer and take part in its deliberations, but shall have no voting rights.
  The Governing Board may invite, on a case-by-case basis, other persons to attend its meetings as observers, in particular representatives of regional authorities within the Union. |
| --- | --- |

2.

The Executive Director shall take part in the deliberations, but shall have no voting rights.

The Governing Board shall invite any Associated Partner to take part in deliberations of the Governing Board for those points on the agenda that concern its association. Associated Partners shall have no voting rights.

The chairperson of the States Representatives Group shall attend meetings of the Governing Board and take part in the deliberations but shall have no voting rights.

The chairperson of the Scientific Committee shall have the right, whenever issues falling within its tasks are discussed, to attend meetings of the Governing Board as an observer and take part in its deliberations, but shall have no voting rights.

The Governing Board may invite, on a case-by-case basis, other persons to attend its meetings as observers, in particular representatives of regional authorities within the Union.

| 3. | The representatives of the Members shall not be personally liable for actions they have undertaken in their capacity as representatives on the Governing Board. |
| --- | --- |

3.

| 4. | The Governing Board shall adopt its own rules of procedure. |
| --- | --- |

4.

Article 7

Tasks of the Governing Board

| 1. | The Governing Board shall have overall responsibility for the strategic orientation and the operations of the IMI2 Joint Undertaking and shall supervise the implementation of its activities. |
| --- | --- |

1.

| 2. | The Commission, within its role in the Governing Board, shall seek to ensure coordination between the activities of the IMI2 Joint Undertaking and the relevant activities of Horizon 2020 with a view to promoting synergies when identifying priorities covered by collaborative research. |
| --- | --- |

2.

| 3. | The Governing Board shall in particular carry out the following tasks:






  (a) | assess, accept or reject applications for a membership or association in accordance with Article 3 of these Statutes; |
| --- | --- | --- |

3.

(a)

assess, accept or reject applications for a membership or association in accordance with Article 3 of these Statutes;

| (b) | decide on the termination of the membership or association in the IMI2 Joint Undertaking of any Member or Associated Partner that does not fulfil its obligations; |
| --- | --- |

(b)

decide on the termination of the membership or association in the IMI2 Joint Undertaking of any Member or Associated Partner that does not fulfil its obligations;

| (c) | adopt the financial rules of the IMI2 Joint Undertaking in accordance with Article 5 of this Regulation; |
| --- | --- |

(c)

adopt the financial rules of the IMI2 Joint Undertaking in accordance with Article 5 of this Regulation;

| (d) | adopt the annual budget of the IMI2 Joint Undertaking, including the corresponding staff establishment plan indicating the number of temporary posts by function group and by grade as well as the number of contract staff and seconded national experts expressed in full-time equivalents; |
| --- | --- |

(d)

adopt the annual budget of the IMI2 Joint Undertaking, including the corresponding staff establishment plan indicating the number of temporary posts by function group and by grade as well as the number of contract staff and seconded national experts expressed in full-time equivalents;

| (e) | exercise the appointing authority powers with respect to the staff, in accordance with Article 6(2) of this Regulation; |
| --- | --- |

(e)

exercise the appointing authority powers with respect to the staff, in accordance with Article 6(2) of this Regulation;

| (f) | appoint, dismiss, extend the term of office of, provide guidance to and monitor the performance of the Executive Director; |
| --- | --- |

(f)

appoint, dismiss, extend the term of office of, provide guidance to and monitor the performance of the Executive Director;

| (g) | approve the organisational structure of the Programme Office upon recommendation of the Executive Director; |
| --- | --- |

(g)

approve the organisational structure of the Programme Office upon recommendation of the Executive Director;

| (h) | adopt the annual work plan and the corresponding expenditure estimates, proposed by the Executive Director in close cooperation with advisory groups, after having consulted the Scientific Committee and the States Representatives Group; |
| --- | --- |

(h)

adopt the annual work plan and the corresponding expenditure estimates, proposed by the Executive Director in close cooperation with advisory groups, after having consulted the Scientific Committee and the States Representatives Group;

| (i) | approve the annual activity report, including the corresponding expenditure; |
| --- | --- |

(i)

approve the annual activity report, including the corresponding expenditure;

| (j) | arrange, as appropriate, for the establishment of an internal audit capability of the IMI2 Joint Undertaking; |
| --- | --- |

(j)

arrange, as appropriate, for the establishment of an internal audit capability of the IMI2 Joint Undertaking;

| (k) | approve the calls for proposals as well as, where appropriate, the related rules for submission, evaluation, selection, award and evaluation review procedures, proposed by the Executive Director in close cooperation with advisory groups; |
| --- | --- |

(k)

approve the calls for proposals as well as, where appropriate, the related rules for submission, evaluation, selection, award and evaluation review procedures, proposed by the Executive Director in close cooperation with advisory groups;

| (l) | approve the list of proposals selected for funding; |
| --- | --- |

(l)

approve the list of proposals selected for funding;

| (m) | establish the IMI2 Joint Undertaking’s communications policy upon recommendation of the Executive Director; |
| --- | --- |

(m)

establish the IMI2 Joint Undertaking’s communications policy upon recommendation of the Executive Director;

| (n) | where appropriate, establish implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 6(3) of this Regulation; |
| --- | --- |

(n)

where appropriate, establish implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 6(3) of this Regulation;

| (o) | where appropriate, establish rules on the secondment of national experts to the IMI2 Joint Undertaking and on the use of trainees in accordance with Article 7 of this Regulation; |
| --- | --- |

(o)

where appropriate, establish rules on the secondment of national experts to the IMI2 Joint Undertaking and on the use of trainees in accordance with Article 7 of this Regulation;

| (p) | where appropriate, set up advisory groups in addition to the bodies of the IMI2 Joint Undertaking; |
| --- | --- |

(p)

where appropriate, set up advisory groups in addition to the bodies of the IMI2 Joint Undertaking;

| (q) | where appropriate, submit to the Commission a request to amend this Regulation proposed by a Member of the IMI2 Joint Undertaking; |
| --- | --- |

(q)

where appropriate, submit to the Commission a request to amend this Regulation proposed by a Member of the IMI2 Joint Undertaking;

| (r) | be responsible for any task which is not specifically allocated to a particular body of the IMI2 Joint Undertaking; it may assign such tasks to any of those bodies. |
| --- | --- |

(r)

be responsible for any task which is not specifically allocated to a particular body of the IMI2 Joint Undertaking; it may assign such tasks to any of those bodies.

Article 8

Appointment, dismissal or extension of the term of office of the Executive Director

| 1. | The Executive Director shall be appointed by the Governing Board from a list of candidates proposed by the Commission, following an open and transparent selection procedure. The Commission shall associate the representation from the other Members of the IMI2 Joint Undertaking in the selection procedure as appropriate.
  In particular, an appropriate representation from the other Members of the IMI2 Joint Undertaking shall be ensured at the pre-selection stage of the selection procedure. For that purpose, the Members other than the Union shall appoint by common accord a representative as well as an observer on behalf of the Governing Board. |
| --- | --- |

1.

In particular, an appropriate representation from the other Members of the IMI2 Joint Undertaking shall be ensured at the pre-selection stage of the selection procedure. For that purpose, the Members other than the Union shall appoint by common accord a representative as well as an observer on behalf of the Governing Board.

| 2. | The Executive Director shall be a member of staff and shall be engaged as a temporary agent of the IMI2 Joint Undertaking under point (a) of Article 2 of the Conditions of Employment.
  For the purpose of concluding the contract of the Executive Director, the IMI2 Joint Undertaking shall be represented by the chairperson of the Governing Board. |
| --- | --- |

2.

For the purpose of concluding the contract of the Executive Director, the IMI2 Joint Undertaking shall be represented by the chairperson of the Governing Board.

| 3. | The term of office of the Executive Director shall be three years. By the end of that period, the Commission associating the Members other than the Union as appropriate shall undertake an assessment of the performance of the Executive Director and the IMI2 Joint Undertaking’s future tasks and challenges. |
| --- | --- |

3.

| 4. | The Governing Board, acting on a proposal from the Commission which takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once, for a period of no more than four years. |
| --- | --- |

4.

| 5. | An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period. |
| --- | --- |

5.

| 6. | The Executive Director may be dismissed only upon a decision of the Governing Board acting on a proposal from the Commission associating the Members other than the Union as appropriate. |
| --- | --- |

6.

Article 9

Tasks of the Executive Director

| 1. | The Executive Director shall be the chief executive responsible for the day-to-day management of the IMI2 Joint Undertaking in accordance with the decisions of the Governing Board. |
| --- | --- |

1.

| 2. | The Executive Director shall be the legal representative of the IMI2 Joint Undertaking. The Executive Director shall be accountable to the Governing Board. |
| --- | --- |

2.

| 3. | The Executive Director shall implement the budget of the IMI2 Joint Undertaking. |
| --- | --- |

3.

| 4. | The Executive Director shall in particular carry out the following tasks in an independent manner:






  (a) | prepare and submit for adoption to the Governing Board the draft annual budget, including the corresponding staff establishment plan indicating the number of temporary posts in each grade and function group and the number of contract staff and seconded national experts expressed in full-time equivalents; |
| --- | --- | --- |

4.

(a)

prepare and submit for adoption to the Governing Board the draft annual budget, including the corresponding staff establishment plan indicating the number of temporary posts in each grade and function group and the number of contract staff and seconded national experts expressed in full-time equivalents;

| (b) | prepare in close cooperation with advisory groups and submit for adoption to the Governing Board the annual work plan and the corresponding expenditure estimates; |
| --- | --- |

(b)

prepare in close cooperation with advisory groups and submit for adoption to the Governing Board the annual work plan and the corresponding expenditure estimates;

| (c) | submit for opinion to the Governing Board the annual accounts; |
| --- | --- |

(c)

submit for opinion to the Governing Board the annual accounts;

| (d) | prepare and submit for approval to the Governing Board the annual activity report, including the information on corresponding expenditure; |
| --- | --- |

(d)

prepare and submit for approval to the Governing Board the annual activity report, including the information on corresponding expenditure;

| (e) | submit for approval to the Governing Board the list of proposals selected for funding; |
| --- | --- |

(e)

submit for approval to the Governing Board the list of proposals selected for funding;

| (f) | inform the States Representatives Group and the Scientific Committee regularly of all matters relevant to their advisory role; |
| --- | --- |

(f)

inform the States Representatives Group and the Scientific Committee regularly of all matters relevant to their advisory role;

| (g) | sign individual grant agreements and decisions; |
| --- | --- |

(g)

sign individual grant agreements and decisions;

| (h) | sign procurement contracts; |
| --- | --- |

(h)

sign procurement contracts;

| (i) | implement the IMI2 Joint Undertaking’s communications policy; |
| --- | --- |

(i)

implement the IMI2 Joint Undertaking’s communications policy;

| (j) | organise, direct and supervise the operations and the staff of the IMI2 Joint Undertaking within the limits of the delegation by the Governing Board as provided for in Article 6(2) of this Regulation; |
| --- | --- |

(j)

organise, direct and supervise the operations and the staff of the IMI2 Joint Undertaking within the limits of the delegation by the Governing Board as provided for in Article 6(2) of this Regulation;

| (k) | establish and ensure the functioning of an effective and efficient internal control system and report any significant change to it to the Governing Board; |
| --- | --- |

(k)

establish and ensure the functioning of an effective and efficient internal control system and report any significant change to it to the Governing Board;

| (l) | ensure that risk assessment and risk management are performed; |
| --- | --- |

(l)

ensure that risk assessment and risk management are performed;

| (m) | take any other measures needed for assessing the progress of the IMI2 Joint Undertaking towards achieving its objectives; |
| --- | --- |

(m)

take any other measures needed for assessing the progress of the IMI2 Joint Undertaking towards achieving its objectives;

| (n) | perform any other tasks entrusted or delegated to the Executive Director by the Governing Board. |
| --- | --- |

(n)

perform any other tasks entrusted or delegated to the Executive Director by the Governing Board.

| 5. | The Executive Director shall set up a Programme Office for the execution, under his/her responsibility, of all support tasks arising from this Regulation. The Programme Office shall be composed of the staff of the IMI2 Joint Undertaking and shall in particular carry out the following tasks:






  (a) | provide support in establishing and managing an appropriate accounting system in accordance with the financial rules of the IMI2 Joint Undertaking; |
| --- | --- | --- |

5.

(a)

provide support in establishing and managing an appropriate accounting system in accordance with the financial rules of the IMI2 Joint Undertaking;

| (b) | manage the calls for proposals as provided for in the annual work plan and administer the grant agreements and decisions, including their coordination; |
| --- | --- |

(b)

manage the calls for proposals as provided for in the annual work plan and administer the grant agreements and decisions, including their coordination;

| (c) | provide to the Members and to the other bodies of the IMI2 Joint Undertaking all relevant information and support necessary for them to perform their duties as well as responding to their specific requests; |
| --- | --- |

(c)

provide to the Members and to the other bodies of the IMI2 Joint Undertaking all relevant information and support necessary for them to perform their duties as well as responding to their specific requests;

| (d) | act as the secretariat of the bodies of the IMI2 Joint Undertaking and provide support to advisory groups set up by the Governing Board. |
| --- | --- |

(d)

act as the secretariat of the bodies of the IMI2 Joint Undertaking and provide support to advisory groups set up by the Governing Board.

Article 10

Scientific Committee

| 1. | The Scientific Committee shall consist of no more than 11 members appointed for a renewable period of two years. It shall elect a chairperson from among its members for the period of two years.
  Additional experts may be appointed if necessary for specific ad-hoc tasks and limited duration. They shall be selected following the same procedure as that applicable to the permanent members of the Scientific Committee. |
| --- | --- |

1.

Additional experts may be appointed if necessary for specific ad-hoc tasks and limited duration. They shall be selected following the same procedure as that applicable to the permanent members of the Scientific Committee.

| 2. | The members of the Scientific Committee shall reflect a balanced representation of worldwide recognised experts from academia, industry and regulatory bodies. Collectively, the members of the Scientific Committee shall have the necessary scientific competencies and expertise covering the technical domain needed to make strategic science-based recommendations to the IMI2 Joint Undertaking. |
| --- | --- |

2.

| 3. | The Governing Board shall establish the specific criteria and selection process for the composition of the Scientific Committee and shall appoint its members. The Governing Board shall take into consideration the potential candidates proposed by the States Representatives Group. |
| --- | --- |

3.

| 4. | The Scientific Committee shall carry out the following tasks:






  (a) | advise on the scientific priorities to be included in the Strategic Research Agenda taking into account related activities in Horizon 2020; |
| --- | --- | --- |

4.

(a)

advise on the scientific priorities to be included in the Strategic Research Agenda taking into account related activities in Horizon 2020;

| (b) | advise on the scientific priorities to be addressed in the annual work plans; |
| --- | --- |

(b)

advise on the scientific priorities to be addressed in the annual work plans;

| (c) | advise on the scientific achievements described in the annual activity report. |
| --- | --- |

(c)

advise on the scientific achievements described in the annual activity report.

| 5. | The Scientific Committee shall meet at least twice a year. The meetings shall be convened by its chairperson. |
| --- | --- |

5.

| 6. | The Scientific Committee may, with the agreement of the chairperson, invite other persons to attend its meetings. |
| --- | --- |

6.

| 7. | The Scientific Committee shall adopt its own rules of procedure. |
| --- | --- |

7.

Article 11

States Representatives Group

| 1. | The States Representatives Group shall consist of one representative of each Member State and of each country associated to Horizon 2020. It shall elect a chairperson from among its members. |
| --- | --- |

1.

| 2. | The States Representatives Group shall meet at least twice a year. The meetings shall be convened by its chairperson. The chairperson of the Governing Board and the Executive Director or their representatives shall attend the meetings.
  The chairperson of the States Representatives Group may invite other persons to attend its meetings as observers, in particular representatives of regional authorities within the Union and representatives of SME associations. |
| --- | --- |

2.

The chairperson of the States Representatives Group may invite other persons to attend its meetings as observers, in particular representatives of regional authorities within the Union and representatives of SME associations.

| 3. | The States Representatives Group shall be consulted and, in particular, review information and provide opinions on the following matters:






  (a) | programme progress of the IMI2 Joint Undertaking and achievement of its targets, including the information on calls and proposals evaluation process; |
| --- | --- | --- |

3.

(a)

programme progress of the IMI2 Joint Undertaking and achievement of its targets, including the information on calls and proposals evaluation process;

| (b) | updating of strategic orientation; |
| --- | --- |

(b)

updating of strategic orientation;

| (c) | links to Horizon 2020; |
| --- | --- |

(c)

links to Horizon 2020;

| (d) | annual work plans; |
| --- | --- |

(d)

annual work plans;

| (e) | involvement of SMEs. |
| --- | --- |

(e)

involvement of SMEs.

| 4. | The States Representatives Group shall also provide information to, and act as an interface with, the IMI2 Joint Undertaking on the following matters:






  (a) | the status of relevant national or regional research and innovation programmes and identification of potential areas of cooperation, including deployment, to allow synergies and avoid overlaps; |
| --- | --- | --- |

4.

(a)

the status of relevant national or regional research and innovation programmes and identification of potential areas of cooperation, including deployment, to allow synergies and avoid overlaps;

| (b) | specific measures taken at national level or regional level with regard to dissemination events, dedicated technical workshops and communication activities. |
| --- | --- |

(b)

specific measures taken at national level or regional level with regard to dissemination events, dedicated technical workshops and communication activities.

| 5. | The States Representatives Group may issue, on its own initiative, recommendations or proposals to the Governing Board on technical, managerial and financial matters as well as on annual plans, in particular when those matters affect national or regional interests.
  The Governing Board shall inform without undue delay the States Representatives Group of the follow up it has given to such recommendations or proposals, or it shall give reasons if they are not followed up. |
| --- | --- |

5.

The Governing Board shall inform without undue delay the States Representatives Group of the follow up it has given to such recommendations or proposals, or it shall give reasons if they are not followed up.

| 6. | The States Representatives Group shall receive information on a regular basis, among others on the participation in indirect actions funded by the IMI2 Joint Undertaking, on the outcome of each call and project implementation, on justifications for activities referred to in Article 4(2) of this Regulation, on synergies with other relevant Union programmes, and on the execution of the IMI2 Joint Undertaking budget. |
| --- | --- |

6.

| 7. | The States Representatives Group shall adopt its own rules of procedure. |
| --- | --- |

7.

Article 12

Stakeholder Forum

| 1. | The Stakeholder Forum shall be open to all public and private stakeholders, international interest groups from Member States, associated countries as well as from other countries. |
| --- | --- |

1.

| 2. | The Stakeholder Forum shall be informed of the activities of the IMI2 Joint Undertaking and shall be invited to provide comments. |
| --- | --- |

2.

| 3. | The meetings of the Stakeholder Forum shall be convened by the Executive Director. |
| --- | --- |

3.

Article 13

Sources of financing

| 1. | The IMI2 Joint Undertaking shall be jointly funded by the Union, the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities through financial contributions paid in instalments and contributions consisting of the costs incurred by them in implementing indirect actions and that are not reimbursed by the IMI2 Joint Undertaking. |
| --- | --- |

1.

| 2. | The administrative costs of the IMI2 Joint Undertaking shall not exceed EUR 85 200 000 and shall be covered through financial contributions divided equally on an annual basis between the Union and the Members other than the Union. If part of the contribution for administrative costs is not used, it may be made available to cover the operational costs of the IMI2 Joint Undertaking. |
| --- | --- |

2.

| 3. | The operational costs of the IMI2 Joint Undertaking shall be covered through the following contributions:






  (a) | a financial contribution by the Union; |
| --- | --- | --- |

3.

(a)

a financial contribution by the Union;

| (b) | in kind contributions by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities, consisting of the costs incurred by them in implementing indirect actions, and in relation to advisory groups, if foreseen in the annual work plan, less the contribution of the IMI2 Joint Undertaking and any other Union financial contribution to those costs; |
| --- | --- |

(b)

in kind contributions by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities, consisting of the costs incurred by them in implementing indirect actions, and in relation to advisory groups, if foreseen in the annual work plan, less the contribution of the IMI2 Joint Undertaking and any other Union financial contribution to those costs;

| (c) | financial contributions by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities, which may be made in addition to, or instead of point (b). |
| --- | --- |

(c)

financial contributions by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities, which may be made in addition to, or instead of point (b).

| 4. | The resources of the IMI2 Joint Undertaking entered in its budget shall be composed of the following contributions:






  (a) | Members’ financial contributions to the administrative costs; |
| --- | --- | --- |

4.

(a)

Members’ financial contributions to the administrative costs;

| (b) | Members’ and Associated Partners’ financial contributions to the operational costs; |
| --- | --- |

(b)

Members’ and Associated Partners’ financial contributions to the operational costs;

| (c) | any revenue generated by the IMI2 Joint Undertaking; |
| --- | --- |

(c)

any revenue generated by the IMI2 Joint Undertaking;

| (d) | other financial contributions, resources and revenues. |
| --- | --- |

(d)

other financial contributions, resources and revenues.

Any interest yielded by the contributions paid to the IMI2 Joint Undertaking by its Members and Associated Partners shall be considered to be its revenue.

| 5. | All resources of the IMI2 Joint Undertaking and its activities shall be devoted to the objectives set out in Article 2 of this Regulation. |
| --- | --- |

5.

| 6. | The IMI2 Joint Undertaking shall own all assets generated by it or transferred to it for the achievement of its objectives. |
| --- | --- |

6.

| 7. | Except when the IMI2 Joint Undertaking is wound up, any excess revenue over expenditure shall not be paid to the Members of the IMI2 Joint Undertaking. |
| --- | --- |

7.

Article 14

Financial commitments

The financial commitments of the IMI2 Joint Undertaking shall not exceed the amount of financial resources available or committed to its budget by its Members and Associated Partners.

Article 15

Financial year

The financial year shall run from 1 January to 31 December.

Article 16

Operational and financial planning

| 1. | The Executive Director shall submit for adoption to the Governing Board a draft annual work plan, which shall include a detailed plan of the research and innovation activities, the administrative activities and the corresponding expenditure estimates for the coming year. The draft work plan shall also include the estimated value of the contributions to be made in accordance with point (b) of Article 13(3) of the Statutes. |
| --- | --- |

1.

| 2. | The annual work plan for a particular year shall be adopted by the end of the previous year. The annual work plan shall be made publicly available. |
| --- | --- |

2.

| 3. | The Executive Director shall prepare the draft annual budget for the following year and submit it to the Governing Board for adoption. |
| --- | --- |

3.

| 4. | The annual budget for a particular year shall be adopted by the Governing Board by the end of the previous year. |
| --- | --- |

4.

| 5. | The annual budget shall be adapted in order to take into account the amount of the Union financial contribution as set out in the Union budget. |
| --- | --- |

5.

Article 17

Operational and financial reporting

| 1. | The Executive Director shall report annually to the Governing Board on the performance of the duties of the Executive Director in accordance with the financial rules of the IMI2 Joint Undertaking.
  Within two months of the closure of each financial year, the Executive Director shall submit to the Governing Board for approval an annual activity report on the progress made by the IMI2 Joint Undertaking in the previous calendar year, in particular in relation to the annual work plan for that year. The annual activity report shall include, inter alia, information on the following matters:






  (a) | research, innovation and other actions carried out and the corresponding expenditure; |
| --- | --- | --- |

1.

Within two months of the closure of each financial year, the Executive Director shall submit to the Governing Board for approval an annual activity report on the progress made by the IMI2 Joint Undertaking in the previous calendar year, in particular in relation to the annual work plan for that year. The annual activity report shall include, inter alia, information on the following matters:

(a)

research, innovation and other actions carried out and the corresponding expenditure;

| (b) | proposals submitted, including a breakdown by participant type, including SMEs, and by country; |
| --- | --- |

(b)

proposals submitted, including a breakdown by participant type, including SMEs, and by country;

| (c) | the actions selected for funding, including a breakdown by participant type, including SMEs, and by country and indicating the contribution of the IMI2 Joint Undertaking to the individual participants and actions. |
| --- | --- |

(c)

the actions selected for funding, including a breakdown by participant type, including SMEs, and by country and indicating the contribution of the IMI2 Joint Undertaking to the individual participants and actions.

| 2. | Once approved by the Governing Board, the annual activity report shall be made publicly available. |
| --- | --- |

2.

| 3. | By 1 March of the following financial year, the accounting officer of the IMI2 Joint Undertaking shall send the provisional accounts to the Commission’s accounting officer and the Court of Auditors.
  By 31 March of the following financial year, the IMI2 Joint Undertaking shall send the report on the budgetary and financial management to the European Parliament, the Council and the Court of Auditors.
  On receipt of the Court of Auditors’ observations on the IMI2 Joint Undertaking’s provisional accounts pursuant to Article 148 of Regulation (EU, Euratom) No 966/2012, the accounting officer of the IMI2 Joint Undertaking shall draw up the IMI2 Joint Undertaking’s final accounts and the Executive Director shall submit them to the Governing Board for an opinion.
  The Governing Board shall deliver an opinion on the IMI2 Joint Undertaking’s final accounts.
  The Executive Director shall, by 1 July of the following financial year, send the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Governing Board’s opinion.
  The final accounts shall be published in the Official Journal of the European Union by 15 November of the following financial year.
  The Executive Director shall provide the Court of Auditors with a reply to its observations made in its annual report by 30 September. The Executive Director shall also submit that reply to the Governing Board.
  The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year in question, in accordance with Article 165(3) of Regulation (EU, Euratom) No 966/2012. |
| --- | --- |

3.

By 31 March of the following financial year, the IMI2 Joint Undertaking shall send the report on the budgetary and financial management to the European Parliament, the Council and the Court of Auditors.

On receipt of the Court of Auditors’ observations on the IMI2 Joint Undertaking’s provisional accounts pursuant to Article 148 of Regulation (EU, Euratom) No 966/2012, the accounting officer of the IMI2 Joint Undertaking shall draw up the IMI2 Joint Undertaking’s final accounts and the Executive Director shall submit them to the Governing Board for an opinion.

The Governing Board shall deliver an opinion on the IMI2 Joint Undertaking’s final accounts.

The Executive Director shall, by 1 July of the following financial year, send the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Governing Board’s opinion.

The final accounts shall be published in the Official Journal of the European Union by 15 November of the following financial year.

The Executive Director shall provide the Court of Auditors with a reply to its observations made in its annual report by 30 September. The Executive Director shall also submit that reply to the Governing Board.

The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year in question, in accordance with Article 165(3) of Regulation (EU, Euratom) No 966/2012.

Article 18

Internal audit

The Commission’s internal auditor shall exercise the same powers over the IMI2 Joint Undertaking as those exercised in respect of the Commission.

Article 19

Liability of Members and insurance

| 1. | The financial liability of the Members for the debts of the IMI2 Joint Undertaking shall be limited to their contributions already made to the administrative costs. |
| --- | --- |

1.

| 2. | The IMI2 Joint Undertaking shall take out and maintain appropriate insurance. |
| --- | --- |

2.

Article 20

Conflict of interest

| 1. | The IMI2 Joint Undertaking, its bodies and staff shall avoid conflict of interest in the implementation of their activities. |
| --- | --- |

1.

| 2. | The IMI2 Joint Undertaking Governing Board shall adopt rules for the prevention and management of conflicts of interest in respect of its Members, Associated Partners, bodies and staff. Those rules shall contain provisions intended to avoid conflict of interest in respect of the representatives of the Members serving in the Governing Board. |
| --- | --- |

2.

Article 21

Winding up

| 1. | The IMI2 Joint Undertaking shall be wound up at the end of the period laid down in Article 1 of this Regulation. |
| --- | --- |

1.

| 2. | In addition to paragraph 1, the winding up procedure shall be automatically triggered if the Union or all other Members withdraw from the IMI2 Joint Undertaking. |
| --- | --- |

2.

| 3. | For the purpose of conducting the proceedings to wind up the IMI2 Joint Undertaking, the Governing Board shall appoint one or more liquidators, who shall comply with the decisions of the Governing Board. |
| --- | --- |

3.

| 4. | When the IMI2 Joint Undertaking is being wound up, its assets shall be used to cover its liabilities and the expenditure relating to its winding up. Any surplus shall be distributed among the Members at the time of the winding up in proportion to their financial contributions to the IMI2 Joint Undertaking. Any such surplus distributed to the Union shall be returned to the Union budget. |
| --- | --- |

4.

| 5. | An ad hoc procedure shall be set up to ensure the appropriate management of any agreement concluded or decision adopted by the IMI2 Joint Undertaking as well as any procurement contract with a duration longer than the duration of the IMI2 Joint Undertaking. |
| --- | --- |

5.

---