76 Amendments of Michèle RIVASI related to 2013/0240(NLE)
Amendment 63 #
Proposal for a Regulation
Title 1
Title 1
Proposal for a COUNCIL REGULATION on the Innovative MedicinTherapies Initiative 2 Joint Undertaking (Text with EEA relevance) (Adopting this amendment would necessitate corresponding changes throughout the wholeOr. en text.)
Amendment 64 #
Proposal for a Regulation
Citation 1 a (new)
Citation 1 a (new)
Having regard to Article 168 (5), Article 183 and 184 of the Treaty
Amendment 65 #
Proposal for a Regulation
Recital 2
Recital 2
(2) Council Decision No 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)8[1] 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 (hereinafter ‘EFPIA’)involving close cooperation of stakeholders including industry, research organisations, patients, academia and clinicians. __________________ 8 OJ L 400 30.12.2006, p. 86
Amendment 69 #
Proposal for a Regulation
Recital 5
Recital 5
(5) In accordance with Decision (EU) No …/2013 of the Council of … 2013 establishing the Specific Programme implementing Horizon 2020 (2014-2020)11 further support shouldmay be provided to joint undertakings established under Decision No 1982/2006/EC under the conditions specified in Decision (EU) No […]/2013.. __________________ 11 OJ … [H2020 SP] OJ … [H2020 SP]
Amendment 71 #
Proposal for a Regulation
Recital 8
Recital 8
(8) Research related to the future of medicinetherapies shall be undertaken in areas where combination of societal, public health and biomedical industry competitiveness goals requires 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 allrelevant areas of public health, life science research and innovation taking into account the need for prevention of diseases as well as the relevant social aspects. The areas would be of public health interest, as identified by the World Health Organisation including in the report on priority medicines for Europe and the World, which is currently being updated with the new version expected to be released in 2013by Member States public health institutions. The initiative should consequently seek to involve a broader range of partners, including mid-caps, from differentfrom different public and private sectors (e.g. biomedical imaging, medical information technology, phytotherapy, phagotherapy, nutrition, diagnostic and/or animal health industries) and adopt a multidisciplinary approach allowing synergies between biomedical sciences, other natural sciences and social sciences. A wider participation would help to advance the development of new approaches and technologies for the understanding the lifestyle and environmental determinants, prevention, diagnosis and treatment of diseases with high impact on public health.
Amendment 73 #
Proposal for a Regulation
Recital 9
Recital 9
(9) The continuationevolving 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' recommendations14 and be implemented using a more fit-for-purpose structure and rules in order to enhance efficiency and ensure simplification at operational level. To this effect, the Innovative Medicines Initiative 2 (hereinafter ‘'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 the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union15 , and by broadening its objectives from medicines to wider encompassing concept of therapies. The IMI Joint Undertaking should therefore continue as and the Innovative Therapies Initiative (hereinafter "ITI"). __________________ 15 OJ L 298 26.10.2012, p. 1. 14 http://ec.europa.eu/research/consultations/li fe_science_h2020/consultation_en.htm Or. en (The amendment changing IMI2 to ITI should apply throughout the text.)
Amendment 75 #
Proposal for a Regulation
Recital 10
Recital 10
(10) The private Members to the IMI2TI Joint Undertaking have to expressed in writing their agreement to pursue the research activities in the area of the IMI2TI Joint Undertaking within a structure better adapted to the nature of a public-private partnership. It is appropriate that the private-sector Members to the IMI2TI Joint Undertaking accept the Statutes contained in the Annex by means of a letter of endorsement.
Amendment 76 #
Proposal for a Regulation
Recital 11
Recital 11
(11) As a means to further develop IMI2TI Joint Undertaking's objectives, membership should be open to otherany legal entities. Moreover, legal entities established in the Union. Legal entities established in the Union or in countries associated to the framework programme and interested in supporting IMI2TI Joint Undertaking's objectives in their specific areas of research should be offered the possibility to become Associated PartnMembers in the IMI2TI Joint Undertaking.
Amendment 77 #
Proposal for a Regulation
Recital 13
Recital 13
(13) Contributions from the private Members should relate to the administrative costs of the IMI2TI Joint Undertaking and, together with the Associated Partners for their specific area of research, to the co- financing required to carry out research and innovation actions supported by the IMI2TI Joint Undertaking.
Amendment 82 #
Proposal for a Regulation
Recital 19
Recital 19
Amendment 84 #
Proposal for a Regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) The ITI Joint Undertaking should operate in a transparent way, providing all relevant available information to its bodies and making publicly available information related to its functioning including the draft agendas and minutes of the meeting of the Governing Board and Scientific Committee. In addition, Members of the Governing Board, the Scientific Committee and the Executive director should publish and keep updated their full declaration of professional activities and financial interests.
Amendment 86 #
Proposal for a Regulation
Recital 20
Recital 20
(20) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty on European Union, the objectives of the IMI2TI Joint Undertaking in strengthening industrial research and innovation across the Union canmay not be sufficiently achieved by the Member States and can therefore, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved by the Union. This Regulation confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose.
Amendment 94 #
Proposal for a Regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. For the implementation of the Joint Technology Initiative on Innovative MedicinTherapies, a joint undertaking within the meaning of Article 187 of the Treaty (hereinafter ‘''IMI2TI Joint Undertaking'’'), is established for a period from 1 January 2014 until 31 December 2024.
Amendment 96 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – introductory part
Article 2 – paragraph 1 – point b – introductory part
(b) to contribute to the objectives ofimplementation of public policy objectives in the field of Health through the Joint Technology Initiative on Innovative MedicinTherapies, in particular to:
Amendment 98 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point i
Article 2 – paragraph 1 – point b – point i
i) increase the success rate in clinical trials of priority medicines and therapies identified by the World Health Organisation and public health institutes in the European Union;
Amendment 100 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point ii
Article 2 – paragraph 1 – point b – point ii
ii) reduce the time to reach clinical proof of concept in medicinetherapies development, such as for immunological, respiratory, neurological and neurodegenerative diseases;
Amendment 104 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point iii
Article 2 – paragraph 1 – point b – point iii
iii) develop new therapies for diseases for which there is a high unmet need, such as Alzheimer's disease, poverty related diseases and neglected diseases, and limited market incentives, such as antimicrobial resistance; , including through the development of prevention and therapies;
Amendment 105 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point iv
Article 2 – paragraph 1 – point b – point iv
iv) support the develop diagnostic and treatment biomarkers for diseases clearly linked to clinical relevance and approved by regulators; phase III and IV of clinical trials shall not be supported;
Amendment 106 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point v
Article 2 – paragraph 1 – point b – point v
Amendment 108 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point vi a (new)
Article 2 – paragraph 1 – point b – point vi a (new)
via) Contribute to the development of open innovation models for needs driven research beyond the project level, throughout the whole ITI JU;
Amendment 109 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point vi b (new)
Article 2 – paragraph 1 – point b – point vi b (new)
vib) Reinforce the capacity of smaller actors such as research organisation, universities and SMEs for participating in open innovation models;
Amendment 110 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point vi c (new)
Article 2 – paragraph 1 – point b – point vi c (new)
vic) Aim at delivering available and affordable therapies in alignment with EU objectives and priorities in health R&D as established in Horizon 2020.
Amendment 111 #
Proposal for a Regulation
Article 2 – paragraph 1 – point b – point vi d (new)
Article 2 – paragraph 1 – point b – point vi d (new)
vid) Coordinate with initiatives resulting from the WHO Consultative Expert Working Group (CEWG) process on financing and coordination of R&D and its implementation, in particular through demonstration projects;
Amendment 115 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – introductory part
Article 3 – paragraph 1 – subparagraph 1 – introductory part
The maximum Union contribution, including EFTA appropriations, to the IMI2 Joint Undertaking to cover administrative costs and operational costs shall be EUR 1 725000 million which shall consist of the following:match the contributions of the Members.
Amendment 117 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point a
Article 3 – paragraph 1 – subparagraph 1 – point a
Amendment 120 #
Proposal for a Regulation
Article 3 – paragraph 1 – subparagraph 1 – point b
Article 3 – paragraph 1 – subparagraph 1 – point b
Amendment 125 #
Proposal for a Regulation
Article 4 – title
Article 4 – title
Contributions of Members other than the Union and of Associated Partners
Amendment 126 #
Proposal for a Regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. EFPIA shall make or arrange for its constituent entities or their affiliated entities toMembers other than the Union shall make contributions of at least EUR 1 50750 million. Other Members other than the Union or Associated Partners shall make, or arrange for their constituent entities or their affiliated entities, or arrange for their constituent or affiliated entities established in the Union, or in Associated countries to Horizon 2020, to make, the contributions corresponding to the amounts they have committed when becoming a Member or an Associated Partner.
Amendment 127 #
Proposal for a Regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The contribution referred to in paragraph 1 shall consist of contributions to the IMI2TI Joint Undertaking as laid down in Clause 13(2), Clause 13(3)(b) and Clause 13(3)(c) of the Statutes contained in the Annex. In- kind contributions from entities established in third countries other than Associated Countries to Horizon 2020 shall not be accounted for as in-kind contributions referred to in paragraph 1.
Amendment 128 #
Proposal for a Regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
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.
Amendment 129 #
Proposal for a Regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the IMI2TI Joint Undertaking or trigger the winding up procedure referred to in Clause 21(2) of the Statutes contained in the Annex if those Members and Associated Partners, their constituent entities or their affiliated entitiee public objectives of the funding are not fulfilled by the Joint Undertaking and if Members do not contribute, contribute only partially or contribute late with regard to the contributions referred to in paragraph 2.
Amendment 138 #
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. By 31 DecemberJuly 2017 the Commission shall conduct an interim evaluation of the IMI2 Joint Undertaking. The Commission shall communicate the conclusions thereof, accompanied by its observations, to the European Parliament and to the Council by 30 Juneanuary 2018.
Amendment 145 #
Proposal for a Regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The IMI2 Joint Undertaking Governing Board may adopt practical arrangements for implementing Regulation (EC) No 1049/2001. In particular, all documents related to the meeting of the Governing Board, Member States Representative Group and Scientific Committee shall be made public (including agendas and minutes of the meetings).
Amendment 146 #
Proposal for a Regulation
Article 16 – paragraph 3 a (new)
Article 16 – paragraph 3 a (new)
3 a. Members of the Governing Board, of the Scientific Committee and the Executive Director shall make publicly available and keep updated a declaration of full professional activities, of financial interests and of conflict of interests. The declarations shall contain the following information : (a) the person occupation and his/her membership of boards or committees of private companies, non-governmental organisations and associations; (b) holdings in companies or partnerships where there are potential public policy implications or where that holding gives the person significant influence over the affairs;
Amendment 149 #
Proposal for a Regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
As a general rule, the ITI Joint Undertaking shall apply the rules for dissemination and exploitation established in Horizon 2020. In addition it shall develop binding guidelines to ensure: - open access to research results after the conclusion of the projects, including access to data relating to clinical trials, including negative and positive results; - management of intellectual property and licensing practices designed to ensure a widest and affordable access to end products; Attention shall be paid to ensure that smaller actors such as research organisation, universities and SMEs can successfully participate in open innovation models;
Amendment 152 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point a
Annex 1 – part 1 – paragraph 1 – point a
(a) to mobilise the public and private sector resources needed to achieve the objectives of IMI2 Joint Undertakinglead the development of the Strategic Research Agenda of the joint undertaking following consultation of the ITI Members, its advisory bodies and stakeholders;
Amendment 155 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point c
Annex 1 – part 1 – paragraph 1 – point c
(c) to 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, research organisations such as product development partnerships, academia and clinical centres, civil society organisations as well as cooperation between industry and academia;
Amendment 159 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point e
Annex 1 – part 1 – paragraph 1 – point e
(e) to effectively support pre-competitive research and innovation in health related life sciences mainly through grants; phase III and IV of clinical trials shall not be supported;
Amendment 161 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point h
Annex 1 – part 1 – paragraph 1 – point h
(h) information, communication, exploitation and dissemination activities by applying mutatis mutandis the provisions of Article 22 of the Regulation (EU) No […]/2013 [the Horizon 2020 Framework Programme]; including binding guidelines for ensuring open access to research results after the conclusion of the project and intellectual property management and licensing ensuring widest and affordable access to the end products
Amendment 162 #
Proposal for a Regulation
Annex 1 – part 1 – paragraph 1 – point i
Annex 1 – part 1 – paragraph 1 – point i
(i) to organise a meeting at least annually with interest groups to ensure openness and transparency of the research activities of the IMI2 Joint Undertaking with its stakeholder through regular communication and at least an annual meeting with interest groups;
Amendment 163 #
Proposal for a Regulation
Annex 1 – part 2
Annex 1 – part 2
2. Members and Associated Partners
Amendment 165 #
Proposal for a Regulation
Annex 1 – part 2 – point 1 – point b
Annex 1 – part 2 – point 1 – point b
(b) upon acceptance of these Statutes by means of a letter of endorsement, the European Federation of Pharmaceutical Industries and Associations (hereinafter ‘'EFPIA'’).any legal entity represented individually or by an association;
Amendment 166 #
Proposal for a Regulation
Annex 1 – part 2 – point 3
Annex 1 – part 2 – point 3
3. Upon acceptance of these Statutes by means of a letter of endorsement, any legal entity other than a Member or aits 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 the Horizon 2020 Framework Programme, may apply to join IMI2 as an Associated Partneror affiliated entities which are established in a Member State or in a country associated with the Horizon 2020 Framework Programme, supporting the objectives of the ITI Joint Undertaking in its specific area of research, may apply to join ITI. The letter of endorsement shall detail the scope of the association in terms of content, of activities and duration.
Amendment 168 #
Proposal for a Regulation
Annex 1 – part 2 – point 4 – introductory part
Annex 1 – part 2 – point 4 – introductory part
4. Associated Partners shall contribute like Members other than the Union to the IMI2 Joint Undertaking's operational costs, in accordance with Clause 13 of these StatutesThe letter of endorsement shall detail the contribution to ITI Joint Undertaking and that the Union will match, in accordance with Articles 3 and 4 of this Regulation.
Amendment 169 #
Proposal for a Regulation
Annex 1 – part 2 – point 4 – paragraph 1
Annex 1 – part 2 – point 4 – paragraph 1
Amendment 170 #
Proposal for a Regulation
Annex 1 – part 3
Annex 1 – part 3
3. Changes to membership and to association
Amendment 171 #
Proposal for a Regulation
Annex 1 – part 3 – point 1
Annex 1 – part 3 – point 1
1. Any application for becoming a Member or an Associated Partner to the IMI2TI Joint Undertaking shall be addressed to the Governing Board, accompanied in the case of application for becoming a Member by a proposal to adapt the composition of the Governing Board set out in Clause 5.
Amendment 175 #
Proposal for a Regulation
Annex 1 – part 3 – point 3
Annex 1 – part 3 – point 3
3. Any Member or Associated Partner may terminate its membership 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 IMI2TI Joint Undertaking prior to terminating the membership or participation.
Amendment 177 #
Proposal for a Regulation
Annex 1 – part 4 – point 1 – point b a (new)
Annex 1 – part 4 – point 1 – point b a (new)
(ba) the Industry Group
Amendment 178 #
Proposal for a Regulation
Annex 1 – part 4 – point 2
Annex 1 – part 4 – point 2
2. The Industry Group, the Scientific Committee, the States Representatives Group and the Stakeholder ForumGroup shall be advisory bodies to the IMI2TI Joint Undertaking.
Amendment 179 #
Proposal for a Regulation
Annex 1 – part 5 – paragraph 1
Annex 1 – part 5 – paragraph 1
The Governing Board shall be composed of 512 representatives per Member, distributed as following: 3 from the Industry Group, 3 from the Commission, 1 from Member States Representative Group, 3 from the Scientific Committee, and 2 from the Stakeholder Group.
Amendment 180 #
Proposal for a Regulation
Annex 1 – part 6 – point 1 – introductory part
Annex 1 – part 6 – point 1 – introductory part
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 Undertakingrepresentative of the Governing Board shall have one vote.
Amendment 181 #
Proposal for a Regulation
Annex 1 – part 6 – point 1 – paragraph 1
Annex 1 – part 6 – point 1 – paragraph 1
The Commission shall hold 50% of the voting rights. The vote of the Commission shall be indivisible. Each Member may allocate its voting rights among its representatives in of 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 not in attendance.
Amendment 182 #
Proposal for a Regulation
Annex 1 – part 6 – point 1 – paragraph 2
Annex 1 – part 6 – point 1 – paragraph 2
The chairperson of the Governing Board shall be appointed on a rotatingan annual basis by each the Union and the other Members, in turn.
Amendment 183 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – introductory part
Annex 1 – part 6 – point 2 – introductory part
2. The Governing Board shall hold its ordinary meetings at least twice a year. It may hold extraordinary meetings at the request of any Memberrepresentative 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 IMI2TI Joint Undertaking. The draft agenda, final agenda and minutes of the meetings shall be published on the ITI website.
Amendment 184 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – paragraph 2
Annex 1 – part 6 – point 2 – paragraph 2
The Governing Board shall invite any Associated PartnMember to take part in its deliberations for those points on the agenda that concern its association. Associated Partners shall have no voting rights.
Amendment 186 #
Proposal for a Regulation
Annex 1 – part 6 – point 2 – paragraph 3
Annex 1 – part 6 – point 2 – paragraph 3
The chairperson of the States Representatives Group shall attendhave a seat in the Governing Board, attend the meetings of the Governing Board as an observernd have voting rights.
Amendment 190 #
Proposal for a Regulation
Annex 1 – part 7 – point 2 – point b
Annex 1 – part 7 – point 2 – point b
(b) decide on the termination of the membership or association in the IMI2TI Joint Undertaking of any Member or Associated Partner that does not fulfil its obligations;
Amendment 206 #
Proposal for a Regulation
Annex 1 – part 10 – point 1 – introductory part
Annex 1 – part 10 – point 1 – introductory part
1. The Scientific Committee shall consist of no more than 715 members appointed for a renewable period of one year. It shall elect a chairperson from amongst its members for one year and three members of the Governing Board.
Amendment 209 #
Proposal for a Regulation
Annex 1 – part 10 – point 2
Annex 1 – part 10 – point 2
2. The members of the Scientific Committee shall reflect a balanced representation of world-wide recognized independent experts from academia, industry and regulatory bodiesclinicians and medical profession. Collectively, the Scientific Committee members shall have the necessary scientific competencies and expertise covering the technical domain needed to make strategic science-based recommendations to the IMI2 Joint Undertaking.
Amendment 211 #
Proposal for a Regulation
Annex 1 – part 10 – point 4 – point -a (new)
Annex 1 – part 10 – point 4 – point -a (new)
(-a) advise on the priorities of the Strategic Research agenda
Amendment 214 #
Proposal for a Regulation
Annex 1 – part 10 – point 4 a (new)
Annex 1 – part 10 – point 4 a (new)
Amendment 215 #
Proposal for a Regulation
Annex 1 – part 10 – point 5
Annex 1 – part 10 – point 5
5. The Scientific Committee shall meet at least ontwice a year. The meetings shall be convened by its chairperson. The draft agenda, final agenda and minutes of the meetings shall be published on the ITI website.
Amendment 218 #
Proposal for a Regulation
Annex 1 – part 11 – point 1
Annex 1 – part 11 – point 1
1. The IMI2TI Member States Representatives Group shall consist of one representative of each Member State and of each country associated to the Horizon 2020 Framework Programme. It shall elect a chairperson from amongst its members, who shall have a seat as a representative in the Governing Board.
Amendment 219 #
Proposal for a Regulation
Annex 1 – part 11 – point 2 – introductory part
Annex 1 – part 11 – point 2 – introductory part
2. The States Representatives Group shall meet at least ontwice 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 draft agenda, final agenda and minutes of the meetings shall be published on the ITI website.
Amendment 221 #
Proposal for a Regulation
Annex 1 – part 11 – point 2 – paragraph 1
Annex 1 – part 11 – point 2 – paragraph 1
The chairperson of the States Representatives Group may invite other persons to attend its meetings as observers, in particular representatives of regional authorities of the Union and representatives of SME associations, representatives of civil society organisations and representatives of patients organisations.
Amendment 224 #
Proposal for a Regulation
Annex 1 – part 12
Annex 1 – part 12
12. Stakeholder ForumCommittee
Amendment 225 #
Proposal for a Regulation
Annex 1 – part 12 – point 1
Annex 1 – part 12 – point 1
1. The Stakeholder ForumCommittee shall be open to all public and private stakeholders, international interest groups from Member States, and associated countries as well as from other countrie. It shall include representatives of patients organisations, healthcare provider's organisations, and other civil society organisations. It shall elect two representatives of the governing board among its members.
Amendment 227 #
Proposal for a Regulation
Annex 1 – part 12 – point 2
Annex 1 – part 12 – point 2
2. The Stakeholder ForumCommittee shall be informed of the activities of the IMI2TI Joint Undertaking and shall be invited to provide comments including on the priorities of the Strategic Research Agenda.
Amendment 228 #
Proposal for a Regulation
Annex 1 – part 12 – point 3
Annex 1 – part 12 – point 3
3. The meetings of the Stakeholder ForumCommittee shall be convened by the Executive Directoat least once a year.
Amendment 229 #
Proposal for a Regulation
Annex 1 – part 13 – point 3 – point b
Annex 1 – part 13 – point 3 – point b
(b) in kind contributions by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliated entities established in the Union or associated countries to Horizon 2020, consisting of the costs incurred by them in implementing indirect actions, and in relation to advisory bodies referred to in Clause 7(2)(q) if foreseen in the annual work plan, less the contribution of the IMI2 Joint Undertaking and any other Union contribution to those costs;
Amendment 230 #
Proposal for a Regulation
Annex 1 – part 13 – point 3 – point c
Annex 1 – part 13 – point 3 – point c
(c) a financial contribution by the Members other than the Union and the Associated Partners, or their constituent entities or their affiliatedor their constituent entities, which may be made in addition to, or instead of point (b).
Amendment 231 #
Proposal for a Regulation
Annex 1 – part 13 – point 4 – point b
Annex 1 – part 13 – point 4 – point b
(b) Members' and Associated Partners' financial contributions to the operational costs;
Amendment 232 #
Proposal for a Regulation
Annex 1 – part 14 – paragraph 1
Annex 1 – part 14 – paragraph 1
Financial commitments of the IMI2TI Joint Undertaking shall not exceed the amount of financial resources available or committed to its budget by its Members and Associated Partners.
Amendment 240 #
Proposal for a Regulation
Annex 1 – part 20 – point 2
Annex 1 – part 20 – point 2
2. The IMI2TI Joint Undertaking Governing Board mayshall adopt rules for the prevention and management of conflicts of interest in respect of its Members, Associated Partners, bodies and staff. In those rules, provision shall be made to avoid conflict of interest for the representatives of the Members servserving the Governing Board and the Scientific Committee. In particular those rules shall clarify the details to be published ing the Governing Boarddeclaration of full professional activities, of financial interests and of conflict of interests.
Amendment 243 #
Proposal for a Regulation
Annex 1 – part 21 – point 1
Annex 1 – part 21 – point 1
1. The IMI2TI Joint Undertaking shall be wound up at the end of the period in Article 1 of this Regulation or if evaluation demonstrates that the objectives of the undertaking are not fulfilled.