EN Official Journal of the European Union L 169/54

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).

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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).

(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.

(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.

(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.

(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.

(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,

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;

(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; (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; (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.

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;

(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;

(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;

(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;

(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).

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;

(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.

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

(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.

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

(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).

(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).

(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).

(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).

(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).

(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).

(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).

(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).

(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).

(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).

(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).

(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).

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

(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).