Statutes of the European Research Infrastructure for Imaging Technologies in Biological and Biomedical Sciences — Euro-BioImaging European Research Infrastructure Consortium (Euro-BioImaging ERIC)

(2019/C 377/01)

Euro-BioImaging ERIC Statutes

PREAMBLE

The Euro-BioImaging Members and Euro-BioImaging Observers,

RECOGNISING that life-sciences and biomedical research are critical to tackling the European grand challenges such as health, demographic change and wellbeing, food security, sustainable agriculture, marine and maritime research, and the bio-economy and inclusive, innovative and secure societies;

RECOGNISING that new imaging technologies are revolutionising the life sciences and the understanding of health and disease;

RECOGNISING that the demand from life science researchers to access innovative imaging technologies, training, image data storage and analysis is constantly increasing;

RECOGNISING that it is imperative that European life scientists maintain a lead in these developments so that their discoveries continue to drive innovation and provide knowledge;

RECOGNISING that the construction and operation of the Euro-BioImaging ERIC is a means by which Europe will realise the full potential of the technical revolution in the life sciences and enable its best scientists to have access to cutting-edge imaging technologies and services provided by the best experts in the field;

RECOGNISING that effective access to the Euro-BioImaging ERIC data and technology must be granted to the research community, in particular to researchers from EU Member States and from associated countries;

RECOGNISING that the distributed structure of the Euro-BioImaging ERIC will strengthen the European Research Area and contribute to the mobility of knowledge and the dissemination and optimisation of research and technological development within Europe;

DESIRING to further strengthen the international position of European states and organisations in research, and to intensify scientific cooperation across disciplinary and national boundaries;

RECOGNISING that the biological and medical imaging communities have synergistic capabilities and complementary goals;

RECOGNISING that the Euro-BioImaging ERIC shall pursue synergies with other research infrastructures; and

RECOGNISING that the financial sustainability of the Euro-BioImaging ERIC is essential to achieve the abovementioned objectives,

HAVE AGREED AS FOLLOWS:

CHAPTER 1

ESSENTIAL ELEMENTS

Article 1 Tasks and activities 1. Euro-BioImaging ERIC’s principal task shall be to establish and operate a distributed research imaging infrastructure across Europe that provides open access to innovative biological and medical imaging technologies for researchers. Euro-BioImaging ERIC aims as well to provide expert, image data and training services for performing cutting-edge research using imaging technologies. 2. In pursuit of its principal task, and in accordance with the provisions of these Statutes and in execution of the five-year Euro-BioImaging Strategic Plan, Euro-BioImaging ERIC shall, in particular, carry out the following activities: (a) open physical access to imaging infrastructure; (b) advanced expertise and services for technology users; (c) training for technology users, facility staff and technology experts; (d) data analysis and storage support for user-generated image data; (e) open virtual access to image analysis software and image data repositories of public interest; (f) high-quality standards for image acquisition, training and data management; (g) European-level coordination and integration activities for the scientific imaging communities; (h) any other activity necessary to fulfil its principal task. 3. Euro-BioImaging ERIC may also carry out other activities, such as: (a) promotion of Euro-BioImaging ERIC; (b) implementation of technological developments related to the services; (c) joint development activities through a coordinated, long-term development programme involving collaboration among Euro-BioImaging Nodes and user groups including industry; (d) knowledge transfer to industry and policymakers; (e) promoting the resources of Euro-BioImaging ERIC for education and training purposes; (f) collaborating and interoperating with research infrastructures in related and complementary fields. 4. Euro-BioImaging ERIC shall pursue its principal task on a non-economic basis. Euro-BioImaging ERIC may carry out limited ancillary economic activities, either directly or indirectly, provided that those activities are compatible with the principal task of Euro-BioImaging ERIC and with the activities necessary for achieving that task and that they do not jeopardise the achievement thereof. Any income generated by those limited ancillary economic activities shall be used by Euro-BioImaging ERIC to further its purposes.

Article 2 Statutory seat 1. Euro-BioImaging ERIC shall be a distributed research infrastructure with its statutory seat located in Finland. 2. European Molecular Biology Laboratory shall host the community-specific section for biological imaging and manage image data (Bio-Hub) and Italy shall host the community-specific section for medical imaging and manage image data (Med-Hub). 3. The statutory seat, the Bio-Hub and the Med-Hub shall form the Euro-BioImaging Hub. 4. Euro-BioImaging ERIC shall be linked through service level agreements to Euro-BioImaging Nodes located in or at Euro-BioImaging ERIC Members.

Article 3 Name A European research infrastructure called ‘the European Research Infrastructure for Imaging Technologies in Biological and Biomedical Sciences’ is set up as a European Research Infrastructure Consortium (ERIC) under Council Regulation (EC) No 723/2009 (1) and named ‘Euro-BioImaging European Research Infrastructure Consortium’ or ‘Euro-BioImaging ERIC’.

Article 4 Duration and the procedure for the winding-up 1. Euro-BioImaging ERIC shall exist for an indefinite period, but may be wound up in accordance with the procedure laid down in paragraphs 2 to 3. 2. The winding-up of Euro-BioImaging ERIC shall be decided by the Euro-BioImaging Board by a two-thirds majority. 3. Assets remaining after payment of Euro-BioImaging ERIC debts shall be apportioned among the Euro-BioImaging ERIC Members and Observers in proportion to their accumulated contribution to Euro-BioImaging ERIC, unless otherwise agreed by the Euro-BioImaging Board.

Article 5 Liability 1. Euro-BioImaging ERIC shall be liable for its debts. Euro-BioImaging ERIC shall not be liable for liabilities arising in Euro-BioImaging Nodes. 2. The Euro-BioImaging ERIC Members’ financial liability for the debts of Euro-BioImaging ERIC shall be limited to their respective contributions. 3. Euro-BioImaging ERIC shall take appropriate insurance to cover the risks specific to the operation of the Euro-BioImaging ERIC.

Article 6 Access policy for users 1. Effective access to Euro-BioImaging ERIC services, including physical access to all imaging technologies, training and expertise, shall be provided based on the scientific merit and technical feasibility of the proposed user research project. 2. The Euro-BioImaging Board shall approve access rules governing the procedures and criteria for the access to Euro-BioImaging ERIC services, taking into account the principles of the European Charter for Access to Research Infrastructures. 3. Image data administered by Euro-BioImaging ERIC will, as far as legally permitted, be available and openly accessible to any researchers, scientific institutions and other stakeholders, in line with the FAIR principles. Use and collection of data shall be subject to the relevant statutory provisions of data privacy.

Article 7 Scientific Evaluation Policy The activities of Euro-BioImaging ERIC shall be evaluated annually by the Euro-BioImaging Scientific Advisory Board.

Article 8 Dissemination Policy 1. Euro-BioImaging ERIC shall be a facilitator of research and shall as a general rule encourage access as open as possible to research data, subject to the conditions established in the Euro-BioImaging ERIC dissemination policy. 2. Euro-BioImaging ERIC shall request researchers to make their research results publicly available and offer to make results available through Euro-BioImaging ERIC. The use of Euro-BioImaging ERIC services or infrastructure, or both, shall be acknowledged in publications. 3. Euro-BioImaging ERIC shall use several channels to reach the target audiences, including web portal, newsletter, workshops, presence in conferences, articles in magazines and daily newspapers.

Article 9 Intellectual Property Rights Policy 1. Subject to the terms of any contract between Euro-BioImaging ERIC and the users, intellectual property rights created by users of the Euro-BioImaging ERIC shall be owned by those users. 2. Euro-BioImaging ERIC may own intellectual property rights entirely or partly created, obtained or developed by Euro-BioImaging ERIC under the conditions established in the Euro- BioImaging intellectual property rights policy.

Article 10 Employment Policy The selection procedures, recruitment and employment for the Euro-BioImaging Hub office shall be transparent, non-discriminatory and respect equal opportunities.

Article 11 Procurement Policy Euro-BioImaging ERIC shall treat procurement candidates and tenders equally and without discrimination. Euro-BioImaging ERIC procurement policy shall respect the principles of transparency, non-discrimination and competition. Detailed rules on procurement procedures and criteria shall be set out in the implementing procurement policy.

CHAPTER 2

GENERAL PROVISIONS

Article 12 Definitions For the purposes of these Statutes, the following definitions shall apply: (a) ‘Euro-BioImaging’: Pan-European research infrastructure providing open user access to a broad range of state-of-the-art imaging technologies for the life sciences, including biological and biomedical imaging. (b) ‘Euro-BioImaging ERIC’: Legal entity set up pursuant to Article 3. (c) ‘Euro-BioImaging ERIC Member’: Entity listed in Article 16(1) (i.e. EU Member States, associated countries, third countries other than associated countries and intergovernmental organisations) which has become a member of Euro-BioImaging ERIC upon successful completion of the application procedure in accordance with Article 16(2). (d) ‘Euro-BioImaging ERIC Member Country’: Euro-BioImaging ERIC Member which is a country (i.e. EU Member State, associated country or third country). (e) ‘Euro-BioImaging ERIC Observer’: Entity listed in Article 16(1) that is not (yet) in a position to join as Euro-BioImaging ERIC Member and that has successfully applied for observership status to the Euro-BioImaging Board. (f) ‘Euro-BioImaging Hub’: Coordinating center of Euro-BioImaging ERIC, composed of the Statutory Seat, the Bio-Hub and the Med-Hub. (g) ‘Statutory Seat’: Finland, country hosting Euro-BioImaging ERIC, as provided for in Article 8 of Regulation (EC) No 723/2009. (h) ‘Bio-Hub’: Part of the Euro-BioImaging Hub hosted by EMBL and charged with the coordination and support activities of the Euro-BioImaging Hub for user access and training in biological imaging and image data management. It is composed of the Section Director of the Bio-Hub and its staff. It is the community-specific section for biological imaging. (i) ‘Med-Hub’: Part of the Euro-BioImaging Hub hosted by Italy and charged with the coordination and support activities of the Euro-BioImaging Hub for user access and training in medical imaging and image data management. It is composed of the Section Director of the Med-Hub and its staff. It is the community-specific section for medical imaging. (j) ‘Euro-BioImaging Node’: A national or international research institute, or network of institutes, located in or at a Euro-BioImaging ERIC Member, which has entered into a service level agreement with Euro-BioImaging ERIC, upon the fulfillment of the conditions and procedures established by the Euro-BioImaging Board. (k) ‘Euro-BioImaging Board’: Euro-BioImaging ERIC’s governing body provided for in Article 29. (l) ‘Euro-BioImaging Directorate’: Euro-BioImaging ERIC’s executive body provided for in Article 30. (m) ‘Euro-BioImaging SAB’: Euro-BioImaging Scientific Advisory Board, Advisory Body provided for in Article 31. (n) ‘Euro-BioImaging Panel of Nodes’: Advisory Body provided for in Article 32. (o) ‘EBIB Advisory Panel’: Euro-BioImaging Industry Board Advisory Panel, Advisory Body provided for in Article 33. (p) ‘Advisory Bodies’: Euro-BioImaging SAB, Euro-BioImaging Panel of Nodes, EBIB Advisory Panel and any other advisory governance body, with no decision-making power, subsequently created by the Euro-BioImaging Board. (q) ‘Euro-BioImaging Hub Office’: Office of staff supporting the Euro-BioImaging Directorate, provided for in Article 14. (r) ‘Simple Majority’: Vote carrying more than half of the votes cast. (s) ‘Two-thirds Majority’: Vote carrying a majority of two thirds of the Euro-BioImaging ERIC Members present or represented and voting. (t) ‘Three-fourths Majority’: Vote carrying a majority of three fourths of the Euro-BioImaging ERIC Members present or represented and voting. (u) ‘EMBL’: European Molecular Biology Laboratory, intergovernmental organisation with the privileges and immunities recognised under its constituting documents and international law; host of the Bio-Hub. (v) ‘Euro-BioImaging Financial Plan’: A five-year estimate of the value and timing of financial resources required to realise the Euro-BioImaging Strategic Plan. (w) ‘Euro-BioImaging Strategic Plan’: A five-year strategic plan adopted by the Euro-BioImaging Board to fulfill the purpose and goals of Euro-BioImaging ERIC, including scientific, technological and administrative matters. (x) ‘Rules of Procedure of the Euro-BioImaging Board’: Rules governing the organisation and operation of the Euro-BioImaging Board, adopted by it in accordance with Article 29(8)(i). (y) ‘Contribution(s)’: Monetary and in-kind contributions to Euro-BioImaging ERIC as decided by the Euro-BioImaging Board in accordance with the provisions of Chapter 5. (z) ‘In-kind Contribution(s)’: Contributions that are not monetary, in accordance with Article 26. (aa) ‘ELSI’: Ethical, Legal and Social Implications.

Article 13 Organisational Structure 1. The specific tasks of each section of the Euro-BioImaging Hub shall be defined in an internal policy, upon proposal by the Euro-BioImaging Directorate. This internal policy shall be adopted at the first meeting of the Euro-BioImaging Board. 2. The internal policy referred to in the paragraph above shall be developed in accordance with the following principles: (a) Each section of the Euro-BioImaging Hub shall carry out specific tasks for which it has the leading expertise and can provide the best service. (b) General data services shall be hosted by EMBL. (c) In general, the Statutory Seat shall be responsible for the overall coordination and administration of Euro-BioImaging ERIC, notwithstanding that the Bio-Hub and the Med-Hub shall support the Statutory Seat in the overall tasks which require community-specific implementation. (d) In general, the Bio-Hub and the Med-Hub shall be responsible for coordination and support of community specific activities of the infrastructure. 3. Tasks and activities carried out by each section of the Euro-BioImaging Hub, including employment, shall be governed by the laws and regulations of the country or of the international organisation in which those activities are carried out. 4. The Statutory Seat, Bio-Hub and Med-Hub shall not be required to advance funds and therefore the performance of the tasks allocated to them is subject to the provision of sufficient funds from the Euro-BioImaging ERIC budget and an appropriate Euro-BioIMaging Financial Plan.

Article 14 Euro-BioImaging Hub Office 1. The Euro-BioImaging Hub Office shall assist the Euro-BioImaging Directorate in the implementation of their tasks and in the overall coordination and administration of Euro-BioImaging ERIC. 2. The Euro-BioImaging Hub Office staff working in Finland is employed by the appropriate legal entity at the Statutory Seat or by the Euro-BioImaging ERIC. They shall be appointed by, dismissed by and report to the Director-General. 3. The Euro-BioImaging Hub Office staff working at EMBL shall be employed by the Bio-Hub host. They shall be appointed by, dismissed by and report to the Section Director of the Bio-Hub. 4. The Euro-BioImaging Hub Office staff working in Italy shall be employed by the appropriate legal entity at the Med-Hub host or by Euro-BioImaging ERIC. They shall be appointed by, dismissed by and report to the Section Director of the Med-Hub.

Article 15 Working language The working language of Euro-BioImaging ERIC shall be English.

CHAPTER 3

MEMBERSHIP AND OBSERVERSHIP

Article 16 Membership and admission of new Euro-BioImaging ERIC Members 1. Membership of the Euro-BioImaging ERIC shall be open to: (a) EU Member States; (b) associated countries; (c) third countries other than associated countries; and (d) intergovernmental organisations. 2. Entities listed in paragraph 1 wishing to become a Euro-BioImaging ERIC Member need to put forward an application to the Euro-BioImaging Board, which must satisfy the following conditions for admission: (a) the application shall describe how the applicant will contribute to the Euro-BioImaging ERIC’s tasks and activities described in Chapter 1 and how it will fulfil its obligations referred to in Chapter 4. In particular, an applicant must have shown, to the satisfaction of the Euro-BioImaging Board, that it has the means and sustained commitment to do the following: (i) make Contributions to the Euro-BioImaging ERIC; and (ii) abide by and participate in the governance arrangements of the Euro-BioImaging ERIC in accordance with these statutes; (b) the application shall also contain a declaration of adherence to the Statutes, the Rules of Procedure of the Euro-BioImaging Board, internal policies and the decisions of the Euro-BioImaging ERIC’s governance bodies. 3. The written application shall be submitted to the Chair of the Euro-BioImaging Board and shall be subject to approval by the Euro-BioImaging Board. The Chair of the Euro-BioImaging Board shall inform the applicant about admittance or refusal. 4. Euro-BioImaging ERIC shall at all times have at least one EU Member State as a Euro-BioImaging ERIC Member and at least two other Euro-BioImaging ERIC Members which are either EU Member States or associated countries.The list of Euro-BioImaging ERIC Members is set out in Annex I. 5. If at any time membership of Euro-BioImaging ERIC is not compliant with paragraph 4 above Euro-BioImaging ERIC shall be wound up. 6. If at any time EU Member States and associated countries cease to jointly hold the majority of votes in the Euro-BioImaging Board, Euro-BioImaging ERIC shall be wound up. In order to avoid the winding-up of Euro-BioImaging ERIC, the Euro-BioImaging ERIC Members may agree to a prioritisation of the votes of the EU Member States or associated countries, so that they continue to jointly hold the majority of votes in the Euro-BioImaging Board.

Article 17 Observership and admission of new Euro-BioImaging ERIC Observers 1. Entities listed in Article 16(1), who are not (yet) in a position to join as Euro-BioImaging ERIC Members, may apply for observership. The application for admission as a Euro-BioImaging ERIC Observer shall contain a declaration of adherence to the Statutes, the Rules of Procedure of the Euro-BioImaging Board, internal policies and the decisions of the Euro-BioImaging ERIC’s governance bodies. The application shall be submitted to the Chair of the Euro-BioImaging Board in writing and shall be approved by the Euro-BioImaging Board. The Chair of the Euro-BioImaging Board shall inform the applicant about admittance — including the set of conditions related thereto — or refusal. 2. Euro-BioImaging Observers are not Euro-BioImaging ERIC Members and shall have only those rights and obligations as set out for Euro-BioImaging ERIC Observers in the Statutes and/or the Rules of Procedure of the Euro-BioImaging Board or internal policies. Euro-BioImaging ERIC Observers shall have the right to participate, without voting rights, in the Euro-BioImaging Board meetings according to conditions decided by the Euro-BioImaging Board. The rights and obligations of the Euro-BioImaging ERIC Observers may be amended by the Euro-BioImaging Board. 3. The list of Euro-BioImaging ERIC Observers is set out in Annex I. 4. The level of annual Contribution that Euro-BioImaging ERIC Observers shall be required to make is provided for in Article 24(4).

Article 18 Duration of Membership or Observership and withdrawal 1. Euro-BioImaging ERIC Members may not withdraw within the first five years of their membership. After the five-year period, any Euro-BioImaging ERIC Member may withdraw by giving a one-year notice of withdrawal in writing to the Chair of the Euro-BioImaging Board. The withdrawal shall only become effective on 31st December following the end of the one-year notice period. 2. Euro-BioImaging ERIC Observers shall be admitted for a three-year period, renewable by the Euro-BioImaging Board for three-year periods following a request by the relevant Euro-BioImaging ERIC Observer. 3. A Euro-BioImaging ERIC Observer may end its observership by giving a one-year notice of withdrawal in writing to the Chair of the Euro-BioImaging Board. The withdrawal shall only become effective on 31 December following the end of the one-year notice period. 4. Any withdrawing Euro-BioImaging ERIC Member or ending observership Euro-BioImaging ERIC Observer shall not be entitled to reclaim the Contributions they provided to Euro-BioImaging ERIC and shall remain liable to make all Contributions that were due while it was a Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer, including any unpaid Contributions of the first five years of membership. The withdrawal or ending shall not take effect until the withdrawing Euro-BioImaging ERIC Member or ending observership Euro-BioImaging ERIC Observer has fulfilled its obligations. 5. The Euro-BioImaging Board shall record formally in writing the withdrawal and its consequences for Euro-BioImaging ERIC. 6. The withdrawal of a Euro-BioImaging ERIC Member automatically entails the withdrawal of its Euro-BioImaging Nodes from the Euro-BioImaging ERIC.

Article 19 Suspension of rights of Euro-BioImaging ERIC Members If a Euro-BioImaging ERIC Member owes Contributions equalling or exceeding the amount of the Contributions due from that Euro-BioImaging ERIC Member for the preceding year, its voting rights in the Euro-BioImaging Board shall be automatically suspended.

Article 20 Termination of membership or observership 1. Without prejudice to the Euro-BioImaging Board’s power to suspend the rights of a Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer, the Euro-BioImaging Board may terminate a membership or observership if the following conditions are met: (a) the Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer is in material breach of its obligations under the Statutes, or has caused, or threatens to cause a serious disruption to the operations of Euro-BioImaging ERIC. A Euro-BioImaging ERIC Member in arrears of its Contribution payment for the two preceding financial years shall be deemed to cause a serious disruption in the sense of the Statutes; (b) the Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer was provided with ample opportunity to present its defence to the Euro-BioImaging Board and was heard by the Euro-BioImaging Board; and (c) the Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer has failed to rectify any such breach within three months as stipulated by the Euro-BioImaging Board through written notice. 2. A Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer whose membership or observership is terminated shall not be entitled to claim any compensation or goodwill value, nor reimbursement of any Contribution made in respect of the financial year during which the termination takes effect, nor with respect to any of the preceding years. They shall neither be exempt from the payment of any Contribution due to the Euro-BioImaging ERIC budget — including the Contributions for the full financial year in which the termination takes effect — neither in whole nor in part. Any unpaid Contributions, including any unpaid Contributions for the first five years of membership, shall be paid promptly upon confirmation of the termination of the membership or observership. 3. Any outstanding obligations of the Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer shall be fulfilled promptly upon confirmation of the termination of the membership or observership. 4. The termination of a Euro-BioImaging Membership automatically entails the withdrawal of that Member Euro-BioImaging Nodes from Euro-BioImaging ERIC.

CHAPTER 4

RIGHTS AND OBLIGATIONS OF EURO-BIOIMAGING ERIC MEMBERS AND OBSERVERS

Article 21 Rights and obligations of Euro-BioImaging ERIC Members 1. Without prejudice to other rights set out in the Statutes, the Rules of Procedure of the Euro-BioImaging Board, internal policies, resolutions of the Euro-BioImaging Board or applicable laws, each Euro-BioImaging ERIC Member has a right to: (a) participate through its delegates in the Euro-BioImaging Board meetings, with the right to vote on the items listed in Article 29(8). (b) elect and be elected for the governance bodies of the Euro-BioImaging ERIC through its delegates; (c) appoint representing public entities under the terms provided for in the ERIC Regulation; (d) propose Euro-BioImaging Nodes through its delegates, upon the successful completion of the procedure approved by the Euro-BioImaging Board; (e) ensure a right for its research community to use the services provided by the Euro-BioImaging Hub and Euro-BioImaging Nodes, on the terms established, inter alia, in the Euro-BioImaging ERIC access policy. (f) Purchase goods and services to be provided in kind for the official and exclusive use of Euro-BioImaging ERIC which are solely for the non-economic activities of the Euro-BioImaging ERIC (and accounted as such in the Euro-BioImaging ERIC accounts). 2. Without prejudice to other obligations set out in the Statutes, the Rules of Procedure of the Euro-BioImaging Board, internal policies, resolutions of the Euro-BioImaging Board or applicable laws, each Euro-BioImaging ERIC Member shall have the obligation to: (a) make its Contribution according to Article 24; (b) bear the financial liability for the debts of Euro-BioImaging ERIC within the limits of its respective Contribution, as set out in Article 5; (c) appoint delegates as set out in Article 29(4), and empower them with the full authority to vote on all issues raised during the Euro-BioImaging Board’s deliberations included in the agenda and in those submitted for approval through written procedure; (d) abide by the decisions of the Euro-BioImaging ERIC governance bodies; (e) cooperate to ensure that the services in its respective Euro-BioImaging Nodes abide by Euro-BioImaging standards; and (f) make its best endeavours to support its Euro-BioImaging Nodes in accordance with national policies and the decisions of the Euro-BioImaging Board, inter alia, by making investments in infrastructure where appropriate.

Article 22 Rights and obligations of Euro-BioImaging ERIC Observers 1. Rights of Euro-BioImaging ERIC Observers shall include: (a) the right to attend the Euro-BioImaging Board without a vote; (b) the right for its research community to participate in the activities identified by the Euro-BioImaging Board; (c) the right to appoint representing public entities in accordance with the ERIC Regulation; (d) the right to withdraw from Euro-BioImaging ERIC, on the terms set out in Article 18. 2. Each Euro-BioImaging ERIC Observer shall: (a) provide Contributions in accordance with Article 24(4); (b) bear the financial liability for the debts of Euro-BioImaging ERIC within the limits of its respective Contribution, as set out in Article 5; (c) appoint delegates as set out in Article 29(4); and (d) abide by the decisions of the Euro-BioImaging ERIC bodies.

CHAPTER 5

FINANCE AND CONTRIBUTION MODEL

Article 23 Resources The resources of Euro-BioImaging ERIC shall consist of the following: (a) Contributions made in accordance with Article 24(1) and 24(2); (b) grants; and (c) other resources within limits and under terms approved by the Euro-BioImaging Board (such as but not limited to goods and services in the sense of Article 21(1)(f).

Article 24 Contributions 1. Euro-BioImaging ERIC Member Countries shall be jointly responsible for ensuring that the Euro-BioImaging ERIC activities are sufficiently funded and for maintaining a positive cash balance in their annual Contributions. 2. Euro-BioImaging ERIC Member Countries shall make annual Contributions to the Euro-BioImaging ERIC budget in accordance with the Euro-BioImaging Financial Plan, as provided for in Article 25. 3. EMBL as launching Euro-BioImaging ERIC Member and intergovernmental organisation shall contribute in kind as specified in Annex II. Contributions by other intergovernmental organisations shall be decided by the Euro-BioImaging Board on a case-by-case basis. 4. Euro-BioImaging ERIC Observers shall pay 30 % of the Contribution which they would have to pay if they were a Euro-BioImaging ERIC Member. 5. In addition to the Contribution provided for under Article 25(2), Euro-BioImaging ERIC Members hosting the Statutory Seat, the Bio-and Med-Hub shall provide space for the coordination activities of the Euro-BioImaging Hub described in Article 13(2) in accordance with the scale foreseen for basic operation. Support and infrastructure costs incurred by the Euro-BioImaging Hub hosts shall be recovered from the Euro-BioImaging ERIC budget.

Article 25 Financial planning and calculation of Contributions 1. Every five years the Euro-BioImaging Directorate shall submit a draft Financial Plan to the Euro-BioImaging Board for consideration and approval. The Financial Plan sets out the basis for each Euro-BioImaging Member Country’s Contributions in this five year period and the maximum agreed budget for Euro-BioImaging ERIC for the same period. The Financial Plan shall be based on the Euro-BioImaging Strategic Plan. 2. Contributions shall be calculated once at the beginning of every Euro-BioImaging Financial Plan. Each Euro-BioImaging ERIC Member Country`s annual Contribution shall be composed of two parts: (a) a fixed amount, representing 40 % of the total annual Euro-BioImaging ERIC Member Country Contributions; (b) a variable amount, representing 60 % of the total annual Euro-BioImaging ERIC Member Country Contributions, based on the average Euro-BioImaging ERIC Member Country nominal gross domestic product during the three preceding calendar years for which statistical information from Eurostat (or from the International Monetary Fund as regards countries not included in Eurostat statistics) is available. 3. Without prejudice to Article 26, Contributions shall be calculated and paid in Euro. 4. In case of accession, withdrawal or termination of Euro-BioImaging ERIC Members during a n ongoing Euro-BioImaging Financial Plan, the Contributions of the remaining Euro-BioImaging ERIC Members shall remain unchanged.

Article 26 Nature of Contributions 1. Annual Contributions to the Euro-BioImaging ERIC budget shall be by default monetary Contributions. 2. The Euro-BioImaging Board may approve In-Kind Contributions proposed by a Euro-BioImaging ERIC Member or Euro-BioImaging ERIC Observer, subject to the procedure and criteria set in the In-Kind Contribution policy approved by the Euro-BioImaging Board provided that the Euro-BioImaging ERIC shall have sufficient financial resources to face its financial engagements according to the five-year Euro-BioImaging Financial Plan and the Euro-BioImaging Strategic Plan. 3. In-Kind Contributions must be quantifiable and auditable, providing the Euro-BioImaging ERIC with the equivalent value as a monetary Contribution. Their declared value shall be evaluated by a committee of experts, which shall take into account its current resource structure and the possible coordination costs created. 4. The internal policy on In-Kind Contributions shall establish the maximum percentage of In-Kind Contributions allowed. 5. Where In-Kind Contributions consist of assets, a separate agreement between the respective Euro-BioImaging ERIC Member or Observer and Euro-BioImaging ERIC shall be concluded in order to clarify ownership rights and other relevant matters. 6. Where In-Kind Contributions consist of secondment of local staff to Euro-BioImaging ERIC, the Euro-BioImaging Board shall approve selection criteria for the relevant position. The Euro-BioImaging Board shall only approve such In- Kind Contribution if the specific criteria are satisfied.

Article 27 Budgetary principles, accounts and audit 1. The financial year of Euro-BioImaging ERIC shall begin on 1 January and end on 31 December of each year. 2. The Euro-BioImaging Directorate shall present for approval by the Euro-BioImaging Board a budget for the following year no later than 1 October. 3. The accounts of Euro-BioImaging ERIC shall be accompanied by a report on budgetary and financial management of the financial year. 4. Euro-BioImaging ERIC shall be subject to the requirements of the law of the country where it has its Statutory Seat as regards preparation, filing, auditing and publication of accounts.

Article 28 Tax and excise duty exemptions 1. VAT exemptions based on Articles 143(1)(g) and 151(1)(b) of Council Directive 2006/112/EC (2) and in accordance with Articles 50 and 51 of Council Implementing Regulation (EU) No 282/2011 (3), shall be applied to purchases of goods and services by the Euro-BioImaging ERIC and by a Euro-BioImaging ERIC Member in the meaning of Chapters 3 and 4 of the Statutes which are for the official and exclusive use by the Euro-BioImaging ERIC, provided that such purchase is made solely for the non-economic activities of the Euro-BioImaging ERIC in line with its activities. VAT exemptions shall be limited to purchases exceeding the value of EUR 300. 2. Excise duty exemptions based on Article 12 of Council Directive 2008/118/EC (4), shall be limited to purchases by Euro-BioImaging ERIC which are for the official and exclusive use by Euro-BioImaging ERIC, provided that such purchase is made solely for the non-economic activities of Euro-BioImaging ERIC in line with its activities and that the purchase exceeds the value of EUR 300. 3. Purchases by staff members shall not be covered by the exemptions.

CHAPTER 6

GOVERNANCE

Article 29 Euro-BioImaging Board 1. The Euro-BioImaging Board shall be the governing body of Euro-BioImaging ERIC. 2. The Euro-BioImaging Board shall be composed of representatives of Euro-BioImaging ERIC Members and Observers. 3. Each Euro-BioImaging ERIC Member shall have one indivisible vote. Euro-BioImaging ERIC Observers may attend Euro-BioImaging Board meetings without the right to vote. 4. Each Euro-BioImaging ERIC Member and Observer shall appoint up to three delegates, who may be accompanied by advisers. Members of the Advisory Bodies shall not be nominated as delegates. 5. Any Euro-BioImaging ERIC Member or Observer may be represented in the Euro-BioImaging ERIC by a public entity, including regions or private entities with a public service mission, of its own choosing and appointed according to its own rules and procedures. Such Euro-BioImaging ERIC Members or Observers shall inform the Chair of the Euro-BioImaging Board of any changes to the representing entity, termination of its mandate, or of any changes to the specific rights and obligations delegated to the representing entity. 6. The Euro-BioImaging Board shall meet at least twice a year. The meetings of the Euro-BioImaging Board shall be convened by the Chair. An extraordinary meeting of the Euro-BioImaging Board may be requested by at least 50 % of the Euro-BioImaging ERIC Members. 7. A quorum of two-thirds of Euro-BioImaging ERIC Members shall be required for having a valid Euro-BioImaging Board meeting. If the quorum is not met, a second meeting shall be convened as soon as possible following a new invitation, with the same agenda. In the second meeting, the quorum shall be considered met if 50 % of Euro-BioImaging ERIC Members are present. 8. The Euro-BioImaging Board shall be responsible for the overall direction and supervision of Euro-BioImaging ERIC. In particular, the Euro-BioImaging Board shall: (a) approve the entry of an interested entity as a new Euro-BioImaging ERIC Member, by a Two-thirds Majority; (b) approve applications to become an Euro-BioImaging ERIC Observer and the renewal of observership status, by a Two-thirds Majority; (c) decide on the termination of the membership or observership of a Euro-BioImaging ERIC Member or Observer, under the conditions established in Article 20, by a Three-fourths Majority; (d) adopt the Euro-BioImaging Strategic Plan, by a Three-fourths Majority; (e) approve the Euro-BioImaging Financial Plan, by a Three-fourths Majority; (f) approve the Euro-BioImaging budget annually, by a Three-fourths Majority; (g) approve the annual audited accounts as well as the accompanying report on the budgetary and financial management for the preceding financial year, by a Two-thirds Majority; (h) adopt proposals for amendments of the Statutes, by a Three-fourths Majority; (i) establish or amend the Rules of Procedure of the Euro-BioImaging Board, by a Two-thirds Majority; (j) establish or amend the Euro-BioImaging internal policies, including those referred to in Chapter 1 and 7, by a Two-thirds Majority; (k) approve terms of reference of Advisory Bodies, by a Two-thirds Majority; (l) approve criteria and procedure for proposal, evaluation and approval of Euro-BioImaging Nodes, by a Two-thirds Majority; (m) decide to enter into, terminate, renew or not to renew a service level agreement with a Euro-BioImaging Node, by a Two-thirds Majority; (n) appoint and dismiss the Director-General and the Section Directors, by a Two-thirds Majority; (o) appoint the Chair and Vice-chair(s) of the Euro-BioImaging Board, by a Two-thirds Majority; (p) appoint members of Advisory Bodies, by a Simple Majority; (q) establish and eliminate additional Advisory Bodies besides those regulated in these statutes, committees and working groups as it deems necessary for the proper functioning and achievement of Euro-BioImaging ERIC goals, by a Two-thirds Majority; (r) approve reports, by a Simple Majority; (s) approve the winding up of the Euro-BioImaging ERIC, by a Three-fourths Majority; and (t) decide upon any other matters that are necessary to fulfil the task of Euro-BioImaging ERIC, by a Two-thirds Majority.

Article 30 Euro-BioImaging Directorate 1. The Euro-BioImaging Directorate shall be the executive body of Euro-BioImaging ERIC. It shall be composed of the Director-General, who shall be the legal representative of Euro-BioImaging ERIC, a Section Director of the Bio-Hub and a Section Director of the Med-Hub. Together with the two Section Directors, the Director-General will represent Euro-BioImaging ERIC and promote the research infrastructure at the national and international level. 2. The Euro-BioImaging Board shall appoint and dismiss the Director-General and the Section Directors for a fixed period. 3. The Section Directors shall work closely as a management team with the Director-General to prepare and implement Euro-BioImaging ERIC tasks indicated in Article 1, in particular those that require community-specific implementation. The Director-General shall take decisions affecting the overall infrastructure in a non-community specific manner after consultation with and input from the Section Directors. Decisions that affect only one community shall be taken by the Director-General jointly with the respective Section Director. 4. The Euro-BioImaging Directorate shall carry out the day-to-day management of Euro-BioImaging ERIC and shall be responsible for the implementation of the decisions by the Euro-BioImaging Board, including but not limited to: (a) preparing the Euro-BioImaging Strategic Plan, for which it will seek the advice of the Euro-BioImaging Panel of Nodes and the Euro-BioImaging SAB, execute and supervise it; (b) preparing and executing the Euro-BioImaging Financial Plan; (c) proposing each year no later than 1 October a budget showing detailed estimates of the projected income and expenditure of Euro-BioImaging ERIC for the following financial year; (d) preparing the annual financial accounts of Euro-BioImaging ERIC; (e) preparing and negotiating service level agreements with Euro-BioImaging Nodes; (f) attending the meetings of the Euro-BioImaging Board in a non-voting capacity; (g) preparing the agenda for the Euro-BioImaging Board meetings and prepare the deliberations of the Euro-BioImaging Board; (h) informing the Euro-BioImaging Board about all relevant matters related to Euro-BioImaging that would either require a decision or acknowledgement; (i) managing, appointing and dismissing the Euro-BioImaging Hub Office staff as provided for in Article 14; and (j) preparing the annual activity report for the European Commission as provided for in Article 36.

Article 31 Euro-BioImaging Scientific Advisory Board (Euro-BioImaging SAB) 1. The Euro-BioImaging SAB will oversee the scientific, ethical, technical and management quality of the Euro-BioImaging ERIC activities at the Euro-BioImaging Hub and Euro-BioImaging Nodes and provide advice related thereto to the Euro-BioImaging Board and Euro-BioImaging Directorate. 2. The Euro-BioImaging SAB shall be composed of highly qualified, internationally recognised scientists and ethical experts selected on the basis of their competence in all aspects of the activities of the Euro-BioImaging ERIC. The Euro-BioImaging SAB members shall be appointed in their own right and not as representatives of the Euro-BioImaging ERIC Members. 3. The Euro-BioImaging Directorate, after consultation with Euro-BioImaging ERIC Members, shall propose a list of candidates from which Euro-BioImaging SAB members shall be appointed by the Euro-BioImaging Board. 4. The Euro-BioImaging Board shall approve terms of reference for the Euro-BioImaging SAB. The Euro-BioImaging SAB shall establish its own rules of procedure.

Article 32 Euro-BioImaging Panel of Nodes 1. The Euro-BioImaging Panel of Nodes shall give advice to the Euro-BioImaging Directorate in relation to Euro-BioImaging activities. 2. The Euro-BioImaging Panel of Nodes shall be composed of representatives of Euro-BioImaging Nodes. 3. The Euro-BioImaging Board shall approve terms of reference for the Euro-BioImaging Panel of Nodes. The Euro-BioImaging Panel of Nodes shall establish its own rules of procedure.

Article 33 Euro-BioImaging Industry Board Advisory Panel (EBIB Advisory Panel) 1. The EBIB Advisory Panel shall provide advice to the Euro-BioImaging Directorate on any industry relevant needs or initiatives that Euro-BioImaging should address. 2. The EBIB Advisory Panel shall be composed of highly qualified experts from relevant companies. 3. The Euro-BioImaging Board shall approve terms of reference for the EBIB Advisory Panel. The EBIB Advisory Panel shall establish its own rules of procedure.

CHAPTER 7

MISCELLANEOUS

Article 34 ELSI policy The Euro-BioImaging Board shall adopt an ELSI policy which shall govern the activities of the Euro-BioImaging ERIC. Its application shall be evaluated by the Euro-BioImaging SAB.

Article 35 Data Policy 1. Generally Open Source and Open Access principles shall be favoured. 2. Euro-BioImaging ERIC shall provide guidance (including via website) to users to ensure that research undertaken using material made accessible through Euro-BioImaging ERIC shall be undertaken within a framework that recognises the rights of data owners and privacy of individuals. 3. Euro-BioImaging ERIC shall ensure that users agree to the terms and conditions governing access and that suitable security arrangements are in place regarding internal storage and handling. 4. Euro-BioImaging ERIC shall define arrangements for investigating allegations of security breaches and confidentiality disclosures regarding research data.

Article 36 Reporting to the European Commission 1. Euro-BioImaging ERIC shall produce an annual activity report, containing in particular the scientific, operational and financial aspects of its activities. The report shall be approved by the Euro-BioImaging Board and transmitted to the European Commission and relevant public authorities within six months from the end of the corresponding financial year. This report shall be made publicly available on the Euro-BioImaging ERIC website. 2. Euro-BioImaging ERIC shall inform the European Commission of any circumstances which threaten to seriously jeopardise the achievement of Euro-BioImaging ERIC tasks or hinder Euro-BioImaging ERIC from fulfilling requirements laid down in Regulation (EC) No 723/2009.

Article 37 Applicable law The internal functioning of Euro-BioImaging ERIC shall be governed: (a) by Union law, in particular Regulation (EC) No 723/2009 and the decisions referred to in Articles 6(1)(a) and 12(1) of the Regulation; (b) by the law of the State where Euro-BioImaging ERIC has its Statutory Seat in the case of matters not, or only party, regulated by acts referred to in point (a); and (c) by these statutes and their implementing rules.

Article 38 Disputes 1. The Euro-BioImaging ERIC and the Euro-BioImaging ERIC Members shall endeavour to settle disputes amicably. 2. The Court of Justice of the European Union shall have jurisdiction over litigation among Euro-BioImaging ERIC Members and/or Euro-BioImaging Observers in relation to Euro-BioImaging ERIC, between Euro-BioImaging ERIC Members and/or Euro-BioImaging ERIC Observers and Euro-BioImaging ERIC and over any litigation to which the Union is a party. 3. Union legislation on jurisdiction shall apply to disputes between Euro-BioImaging ERIC and third parties. In cases not covered by Union legislation, the law of the State where Euro-BioImaging ERIC has its Statutory Seat shall determine the competent jurisdiction for the resolution of such disputes. 4. As an exception, for the EMBL, such disputes must — if they cannot be settled amicably — be referred to arbitration. The Permanent Court of Arbitration Optional Rules for Arbitration Involving International Organisations and States in force at the date of entry into force of the Commission Implementing Decision setting up the Euro-BioImaging ERIC will apply. The appointing authority will be the Secretary-General of the Permanent Court of Arbitration following a written request submitted by either party.

Article 39 Privileges and immunities Nothing in the Statutes may be interpreted as a waiver of any privileges or immunities accorded to the EMBL by its constituent documents or international law.

Article 40 Consolidated Statutes and availability The Statutes shall be kept up to date and publicly available on Euro-BioImaging ERIC website and at the Statutory Seat.

Article 41 Setting-up provisions 1. A first meeting of the Euro-BioImaging Board shall be called by the State where Euro-BioImaging ERIC has its Statutory Seat as soon as possible after the Commission decision setting up Euro-BioImaging ERIC takes effect. The Rules of Procedure of the Euro-BioImaging Board shall be adopted in this meeting in accordance with the voting rules laid down in Article 29(8)(i). 2. Before the first meeting is held and no later than forty-five calendar days after the Commission decision setting up Euro-BioImaging ERIC takes effect, the relevant State shall notify the founding Euro-BioImaging ERIC Members and Observers of any specific urgent legal action that needs to be taken on behalf of the Euro-BioImaging ERIC. Unless a founding Euro-BioImaging ERIC Member objects within five working days after being notified, the legal action shall be carried out by a person duly authorised by the relevant State.

(1) Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC) (OJ L 206, 8.8.2009, p. 1).

(2) Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

(3) Council Implementing Regulation (EU) No 282/2011 of 15 March 2011 laying down implementing measures for Directive 2006/112/EC on the common system of value added tax (OJ L 77, 23.3.2011, p. 1).

(4) Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty and repealing Directive 92/12/EEC (OJ L 9, 14.1.2009, p. 12).