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EP PerMed- Consortium Agreement Consortium Agreement for co-funded European Partnerships European Partnership for Personalised Medicine (EP PerMed) (Based on DESCA – Model Consortium Agreement for Horizon Europe, version 1.1, November 2022)  EP PerMed- Consortium Agreement Change Records Version Date Changes version 1 22 September 2023 Initial draft for co-funded European Partnerships for Personalised Medicine (EP PerMed) in Horizon Europe version 2 11 January 2024 Final version 19 February 2024  EP PerMed- Consortium Agreement Table of contents 1 Definitions ...................................................................................................................................... 10 1.1 Definitions............................................................................................................................... 10 1.2 Additional Definitions .............................................................................................................. 10 1.3 Applicable Documents.............................................................................................................. 12 2 Purpose .......................................................................................................................................... 12 3 Entry into force, duration and termination ..................................................................................... 12 3.1 Entry into force ........................................................................................................................ 12 3.2 Duration and termination .......................................................................................................... 12 3.3 Survival of rights and obligations .............................................................................................. 13 4 Responsibilities of Parties ............................................................................................................... 13 4.1 General principles .................................................................................................................. 13 4.2 Specific responsibilities for Affiliated Entities ............................................................................ 14 4.3 Specific responsibilities for Associated Partner(s) - AP ............................................................... 14 4.4 Breach..................................................................................................................................... 15 4.5 Involvement of third parties ....................................................................................................... 15 4.6 Specific responsibilities regarding data protection ....................................................................... 15 5 Liability towards each other ........................................................................................................... 16 5.1 No warranties ........................................................................................................................... 16 5.2 Limitations of contractual liability .............................................................................................. 16 5.3 Damage caused to third parties ................................................................................................... 16 5.4 Force Majeure .......................................................................................................................... 16 6 Governance structure ..................................................................................................................... 17 6.1 General structure ...................................................................................................................... 17 6.2 General operational procedures for all Consortium Bodies ............................................................ 18 6.2.1 Representation in meetings .................................................................................................... 18 6.2.2 Preparation and organisation of meetings ................................................................................ 18 6.2.3 Voting rules and quorum ....................................................................................................... 20 6.2.4 Veto rights ........................................................................................................................... 22 6.2.5 Minutes of meetings ............................................................................................................. 22 6.3 Firewall for meetings regarding any EP PerMed calls (on-site, online or hybrid) ........................... 22 7 Specific operational procedures for the Consortium Bodies ............................................................ 22 7.1 General Assembly .................................................................................................................... 22 7.1.1 Members ............................................................................................................................. 23 7.1.2 Decisions ............................................................................................................................. 23 7.2 Coordination Unit .................................................................................................................... 24 3 / 106  EP PerMed- Consortium Agreement 7.2.1 Members ............................................................................................................................. 24 7.2.2 Minutes of meetings ............................................................................................................. 24 7.2.3 Tasks .................................................................................................................................. 24 7.3 Extended General Assembly ..................................................................................................... 24 7.3.1 Members ............................................................................................................................. 24 7.3.2 Tasks .................................................................................................................................. 25 7.4 Call Steering Committee ........................................................................................................... 25 7.4.1 Members ............................................................................................................................. 25 7.4.2 Mandate .............................................................................................................................. 25 7.4.3 Tasks .................................................................................................................................. 25 7.5 Call Secretariat ........................................................................................................................ 26 7.6 Coordinator ............................................................................................................................. 26 8 Financial provisions........................................................................................................................ 27 8.1 General Principles .................................................................................................................... 27 8.1.1 Distribution of the EC Financial Contributions ......................................................................... 27 8.1.2 Funding Principles ............................................................................................................... 28 8.1.3 Financial Consequences of the termination of the participation of a Party ................................. 28 8.2 Payments ................................................................................................................................. 28 8.2.1 General Principles ................................................................................................................ 28 8.2.2 Withholding of Payments ...................................................................................................... 29 8.2.3 Budgeting ............................................................................................................................ 29 8.2.4 Justifying costs .................................................................................................................... 30 8.2.5 Payment schedule ................................................................................................................. 30 8.2.6 Reserve fund ........................................................................................................................ 31 8.2.7 Excess payments .................................................................................................................. 32 8.2.8 Revenue .............................................................................................................................. 32 8.2.9 Costs of Certificates on the Financial Statements .................................................................... 32 8.3 Reporting ................................................................................................................................ 32 8.3.1 Reporting to the Granting Authority (Periodic Report) ............................................................ 32 4 / 106  EP PerMed- Consortium Agreement 8.3.2 Reporting to the Coordinator (Internal Report) ........................................................................ 33 8.4 Insufficient EC Financial Contribution ....................................................................................... 33 8.4.1 Cost monitoring system ........................................................................................................ 33 8.4.2 Regular trainings on cost reporting ........................................................................................ 33 8.4.3 Less EC Financial Contribution than foreseen for the Joint Transnational Calls (category D1) .... 33 8.4.4 Less EC Financial Contribution than foreseen for Consortium Budget than foreseen in the Consortium Plan .............................................................................................................................. 34 8.4.5 No EU Financial Contribution ............................................................................................... 35 8.5 Budget flexibility ..................................................................................................................... 35 9 Call Implementation ....................................................................................................................... 36 9.1 Selection process: ..................................................................................................................... 36 9.1.1 Central scientific evaluation (Step 1) ...................................................................................... 36 9.1.2 Central scientific evaluation (Step 2) ...................................................................................... 36 9.2 Use of EC share for support of third party of Transnational Projects (JTCs) .................................. 36 9.3 Ranking List ............................................................................................................................ 37 9.4 Conflicts of interest/ information Barrier .................................................................................... 37 9.4.1 Conflicts of interest .............................................................................................................. 38 9.4.2 Information Barrier .............................................................................................................. 38 9.5 Contractual obligations towards the Granting Authority on selection ............................................ 38 9.6 Contractual obligations for projects funded in the Joint Calls ....................................................... 39 10 Results ............................................................................................................................................ 40 10.1 Ownership of Results ............................................................................................................... 40 10.2 Joint ownership ........................................................................................................................ 40 10.3 Transfer of Results ................................................................................................................... 40 10.4 Dissemination .......................................................................................................................... 41 10.4.1 Dissemination of own (including jointly owned) Results ..................................................... 41 10.4.2 Dissemination of another Party’s unpublished Results or Background .................................. 41 10.4.3 Cooperation obligations .................................................................................................... 42 10.4.4 Use of names, logos or trademarks ..................................................................................... 42 11 Access Rights .................................................................................................................................. 42 11.1 Background included ................................................................................................................ 42 11.2 General Principles .................................................................................................................... 42 11.3 Access Rights for implementation ............................................................................................. 42 5 / 106  EP PerMed- Consortium Agreement 11.4 Access Rights for Exploitation .................................................................................................. 43 11.4.1 Access Rights to Results ................................................................................................... 43 11.4.2 Access Rights to Background ............................................................................................ 43 11.4.3 Requests .......................................................................................................................... 43 11.5 Access Rights for entities under the same control ........................................................................ 43 11.6 Additional Access Rights .......................................................................................................... 43 11.7 Access Rights for Parties entering or leaving the consortium........................................................ 44 11.7.1 New Parties entering the consortium .................................................................................. 44 11.7.2 Parties leaving the consortium ........................................................................................... 44 11.8 Specific Provisions for Access Rights to Software ...................................................................... 44 12 Non-disclosure of information ........................................................................................................ 44 12.1 Confidential Information........................................................................................................... 44 12.2 Approach................................................................................................................................. 44 12.3 Range ...................................................................................................................................... 45 12.4 Exception ................................................................................................................................ 45 12.5 Handling ................................................................................................................................. 45 12.6 Unauthorised disclosure ............................................................................................................ 45 12.7 Disclosure of Confidential Information for compliance with applicable laws and regulations .......... 46 12.8 Confidentiality in Transnational Projects .................................................................................... 46 13 Data management ........................................................................................................................... 46 14 Miscellaneous ................................................................................................................................. 46 14.1 Attachments, inconsistencies and severability ............................................................................. 46 14.2 No representation, partnership or agency .................................................................................... 46 14.3 Formal and written notices ........................................................................................................ 47 14.4 Assignment and amendments .................................................................................................... 47 14.5 Mandatory national law ............................................................................................................ 47 14.6 Language................................................................................................................................. 47 14.7 Applicable law ......................................................................................................................... 47 14.8 Settlement of disputes ............................................................................................................... 47 14.8.1 Amicable solution within the consortium............................................................................ 47 14.8.2 Dispute resolution ............................................................................................................ 48 15 Signatures ...................................................................................................................................... 49 Appendix: Attachment 1: Background Included .................................................................................................... 103 Attachment 2: Accession document ...................................................................................................... 104 6 / 106  EP PerMed- Consortium Agreement CONSORTIUM AGREEMENT THIS CONSORTIUM AGREEMENT is based upon Regulation (EU) No 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation (2021-2027), laying down its rules for participation and dissemination (hereinafter referred to as “Horizon Europe Regulation”), and the European Commission’s General Model Grant Agreement and its Annexes, and is made on November 1st 2023, hereinafter referred to as the Effective Date. BETWEEN: Short name - Participant organisation name N° Role Legal address DLR – Deutsches Zentrum für Luft- und Raumfahrt 1 (Co) COR LINDER HOEHE, 51147, KOELN, DE ANR – Agence National de la Recherche 2 86 RUE REGNAULT, 75013, PARIS, FR BEN VLO-EWI – Vlaams Gewest - VLAIO Flanders Innovation & Entrepreneurship - Flemish 3 Government AVENUE DU PORT 88, 1000, BRUSSEL, BE BEN IACS – (Instituto Aragones De Ciencias De La Salud - Health Sciences Institute in Aragon) 4 AVENIDA SAN JUAN BOSCO 13, 50009, ZARAGOZA, ES BEN TLS – Fondazione Toscana Life Sciences 5 VIA FIORENTINA 1, 53100, SIENA, IT BEN RCN – The Research Council of Norway 6 DRAMMENSVEIEN 288, 0283, OSLO, NO BEN IT-MoH – Ministero Della Salute 7 Via Giorgio Ribotta 5, 00144, ROMA, IT BEN ISCIII – Instituto de Salud Carlos III 8 MONFORTE DE LEMOS 5, 28029, MADRID, ES BEN SFI – Science Foundation Ireland 9 THREE PARK PLACE, HATCH STREET UPPER, D002FX65, DUBLIN, IE BEN SMWK – Saxon State Ministry for Science, Culture and Tourism 10 WIGARDSTRASSE 17, 01097, Dresden, DE BEN FTELE - Fondazione Telethon Ets 11 VIA VARESE 16/B, 00185, ROMA, IT BEN FRRB - Fondazione Regionale per la Ricerca Biomedica 12 PIAZZA CITTA DI LOMBARDIA 1, 20124, MILANO, IT BEN FWF - Fonds zur Förderung der wissenschaftlichen Forschung 13 GEORG-COCH-PLATZ 2, 1010, WIEN, AT BEN HRB - Health Research Board 14 67 72 LOWER MOUNT STREET, D02 H638, DUBLIN, IE BEN LMT - Lietuvos mokslo taryba, (Research Council of Lithuania) 15 Gedimino 3, LT-01103, Vilnius, LT BEN CSO-MOH - Chief Scientist Office – Ministry of Health 16 YIRMIYAHU 39, 9101002, JERUSALEM, IL BEN ETAG - Sihtasutus Eesti Teadusagentuur 17 SOOLA 8, 51004, TARTU, EE BEN TUBITAK – TURKIYE BILIMSEL VE TEKNOLOJIK ARASTIRMA KURUMU 18 Ataturk Bulvari 221, 06100, ANKARA, TR BEN EITH - EIT Health eV 19 MIES-VAN-DER-ROHE-STRASSE 1 C, 80807, MUNCHEN, DE BEN 19.1 EITH BENE AE 19.2 EIHT SCAN AE VINNOVA - VINNOVA Sweden´s Innovation Agency 20 MASTER SAMUELSG 56, 10158, STOCKHOLM, SE BEN NCBR - National Centre for Research and Development 21 UL. CHMIELNA 69, 00-801, WARSZAWA, PL BEN AICIB - Agency for Clinical Research and Biomedical Innovation 22 RUA DE SANTA CATARINA 1288, 4000-447, PORTO, PT BEN 7 / 106  EP PerMed- Consortium Agreement FCT - Fundação para a Ciência e a Tecnologia 23 AVENIDA D CARLOS I 126, 1249 074, LISBOA, PT BEN ZonMw - Zorgonderzoek Nederland ZON 24 Laan Van Nieuw Oost Indie 334, 2593 CE, DEN HAAG, NL BEN FNR - Fonds National de la Recherche 25 2 AVENUE DE L'UNIVERSITE, 4365, ESCH-SUR-ALZETTE, LU BEN RT - Regione Toscana – Tuscany Region 26 Palazzo Strozzi Sacrati - Piazza del Duomo 10, 50122, FIRENZE, IT BEN SPW EER – Service Public De Wallonie 27 Place de la Wallonie 1, 5100, Namur, BE BEN FRS-FNRS - Fonds De La Recherche Scientifique- FNRS 28 RUE D'EGMONT 5, 1000, BRUXELLES, BE BEN DS-CAT - Departament De Salut - Generalitat De Catalunya 29 Trav. de les Corts (Pavelló Ave Maria) 131-159, 08028, BARCELONA, ES BEN CFN - Comunidad Foral de Navarra 30 AVENIDA CARLOS III 2, 31002, PAMPLONA, ES BEN MoSAE – Sotsiaalministeerium 31 Suur-Ameerika 1, 10122, TALLINN, EE BEN FWO - Fonds voor Wetenschappelijk Onderzoek-Vlaanderen 32 LEUVENSEWEG 38, 1000, BRUSSEL, BE BEN BFRK - Innovaatiorahoituskeskus Business Finland 33 PO BOX 69, 00101, HELSINKI, FI BEN 33.1 BFOY - Business Finland Oy AE SRC Swedish Research Council 34 BOX 1035, 101 38, STOCKHOLM, SE BEN AKA - Academy of Finland 35 HAKANIEMENRANTA 6, 00531, HELSINKI, FI BEN BBMRI-ERIC - Biobanking an Biomolecular Resources Research Infrastructure - European 36 Research Infrastructure Consortium NEUE STIFTINGTALSTRASSE 2/B/6, 8010, GRAZ, AT BEN IFD - Innovation Fund Denmark 37 OSTERGADE 26 A, 1100, KOBENHAVN K, DK BEN NKFIH - National Research, Development and Innovation Office 38 KETHLY ANNA TER 1, 1077, BUDAPEST, HU BEN LZP - Latvian Council of Science 39 SMILSU IELA 8, 1050, RIGA, LV BEN DRCT - Direção Regional da Ciência e Tecnologia / Regional Directorate of Science and 40 Technology LARGO PRIOR DO CRATO, 9700-157, PONTA DELGADA, PT BEN CCDRC - Comissão de Coordenação e Desenvolvimento Regional do Centro 41 RUA BERNARDIM RIBEIRO 80, 3000-069, COIMBRA, PT BEN RANNIS - The Icelandic Centre for Research 42 BORGARTUNI 30, 105, REYKJAVIK, IS BEN MUR - Ministero dell/Università e della Ricerca 43 Via Michele Carcani 61, 00153, Roma, IT BEN DPTO Salud – Departamento De Salud Gobierno Vasco 44 Donostia-San Sebastián, 1, 01010, VITORIA-GASTEIZ, ES BEN BIOEF - Basque Foundation for Health Innovation and Research 44.1 AE UEFISCDI - Unitatea executiva pentru finantarea invatamantului superior a cercetarii 45 dezvoltarii si inovarii STR D I MENDELEEV 21-25, 010362, BUCURESTI, RO BEN BMG - Bundesministerium für Gesundheit 46 ROCHUSTRASSE 1, 53123, BONN, DE BEN BMBF - Bundesministerium für Bildung und Forschung 47 Heinemannstrasse 2, 53175, BONN, DE BEN BMBWF AT - Bundesministerium für Bildung, Wissenschaft und Forschung 48 MINORITENPLATZ 5, 1010, VIENNA, AT BEN FIO – FONDS INNOVEREN EN ONDERNEMEN 49 BOULEVARD DU ROI ALBERT II 35, 1030, BRUXELLES, BE BEN 8 / 106  EP PerMed- Consortium Agreement (hereinafter, jointly or individually, referred to as „Coordinator”/“Beneficiaries”/“Affiliated Entities” or “Parties”) and INNOSUISSE - SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG 50 EINSTEINSTRASSE 2, 3003, BERN Switzerland AP (hereinafter referred to as “Associated Partner”, – the Associated Partner is also included in the term “Parties” (see above)) relating to the Action entitled European Partnership for Personalised Medicine in short EP PerMed hereinafter referred to as “EP PerMed”. WHEREAS: The Parties, having considerable experience in the field concerned, have submitted a proposal for the EP PerMed to the European Commission1 as part of Horizon Europe – the Framework Programme for Research and Innovation (2021-2027) and the following framework programme. The Parties wish to specify or supplement binding commitments among themselves in addition to the provisions of the specific Grant Agreement (GA) to be signed by the Parties and the European Commission (hereinafter “Grant Agreement” or “GA”). The Parties are aware that this Consortium Agreement is based upon the DESCA Model Consortium Agreement for Horizon Europe. NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS: 1 It is expected that the European Commission (EC) will act as the Granting Authority. 9 / 106  EP PerMed- Consortium Agreement 1 Definitions 1.1 Definitions Words beginning with a capital letter shall have the meaning defined either herein or in the Horizon Europe Regulation or in the Grant Agreement including its Annexes. 1.2 Additional Definitions Annual Work Pro- Annual Work Programme means the description of the upcoming activities and the re- gramme - AWP lated agreed budget on the yearly bases along the Consortium Plan jointly developed by the responsible Parties and agreed by the General Assembly. Each AWP is a deliverable of the Consortium Plan and has to be approved by the European Health and Digital Ex- ecutive Agency (HaDEA). Affiliated Entity (AE) Entity affiliated to a beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/10466 which participate in the action with similar rights and ob- ligations as the beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). Associated Partner Associated Partners which participate in the action, but without the right to charge (AP) costs or claim contributions. Beneficiary (BEN) The signatories of the Grant Agreement (either directly or through an accession form). Consortium Body Consortium Body means any management body described in the governance struc- ture (chapter 6) of this Consortium Agreement. Consortium Budget The Consortium Budget is the part A, C and E of the Annex 2 of GA budget categories planned for administrative and management activities in Work Package (WP) 1 till WP 5. Consortium Plan Consortium Plan means the Description of the Action (Annex 1 of the Grant Agree- ment) and the related agreed EC Financial Contribution (Annex 2 of the Grant Agree- ment) as first defined in the Grant Agreement and which may be updated by official amendments. Coordinator (COR) The Coordinator is the legal entity and beneficiary acting as the intermediary be- tween the Consortium and the Granting Authority. Defaulting Party Defaulting Party means a Party which the General Assembly has identified to be in breach of this Consortium Agreement and/or the Grant Agreement as specified in 4.4 of this Consortium Agreement. EC Financial Contribu- EC Financial Contribution max. €100,575,465.38 is the financial contribution tion of the European Commission to EP PerMed (Annex 2 of Grant Agreement). It is composed of the Consortium Budget and the EC share for support of third parties EC share for support of EC share for support of third party is the difference between EC Financial third parties Contribution and the Consortium Budget. 10 / 106  EP PerMed- Consortium Agreement EP PerMed Budget EP PerMed Budget is the estimated Project Cost €335,251,551.24 Expert Panel Expert Panel is the board of independent experts evaluating proposals of the Joint Calls. Funding Organisation Funding Organisation is a national or regional organisation responsible for provid- ing the national/regional share of funding for the Transnational Projects. Granting Authority Granting Authority is the European Commission via HaDEA and it is the body awarding the EC Financial Contribution for EP PerMed. Highly Detrimental Sit- Highly Detrimental Situation means a situation that leads to the reduction of more uation than EUR 1,000,000 of the EC share for support of third parties per annual Joint Transnational Call. Joint Transnational Joint Transnational Calls mean the co-funded calls for collaborative proposals in Per- Calls - JTC sonalised Medicine which are organised annually by all Funding Organisations par- ticipating in the respective JTC and represent the main objective of EP PerMed. Member A member is a person or a group of people in a specific committee and are always defined separately in the respective chapters. Needed Needed means: For the implementation of EP PerMed: Access Rights are Needed if, without the grant of such Access Rights, carry- ing out the tasks assigned to the recipient Party would be technically or le- gally impossible, significantly delayed, or require significant additional fi- nancial or human resources. For Exploitation of own Results: Access Rights are Needed if, without the grant of such Access Rights, the Exploitation of own Results would be technically or legally impossible. Party An entity becomes a Party to this Consortium Agreement upon signature of this Con- sortium Agreement by a duly authorised representative. The terms "party" and "parties" are always used in the context of the respective chapter. Software Software means sequences of instructions to carry out a process in, or convertible into, a form executable by a computer and fixed in any tangible medium of expres- sion. Transnational Consor- Transnational Consortium/Project is a consortium/project selected for funding un- tium/Project der a Joint Call of EP PerMed. 11 / 106  EP PerMed- Consortium Agreement 1.3 Applicable Documents For the sake of clarity, the following documents, listed from more general to the more specific, are part of the Co- funded Action and apply to this Consortium Agreement: - The Horizon Europe Regulation; - The terms party and parties are always used in the context of the respective chapter. (Text with EEA relevance); - Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and the free movement of such data - All and any information and provision provided by the European Commission during the award proce- dure; - the Grant Agreement. 2 Purpose The purpose of this Consortium Agreement is to specify with respect to EP PerMed the relationship among the Parties, in particular concerning the organisation of the work between the Parties, the management of EP PerMed and the rights and obligations of the Parties concerning inter alia liability, Access Rights, dispute resolution, financial provisions and call implementation. For the avoidance of doubt, this Consortium Agreement is limited to EP PerMed. The consortia of the Transnational Projects under EP PerMed have to execute separate consortium agreements in accordance with their specific needs. 3 Entry into force, duration and termination 3.1 Entry into force An entity becomes a Party to this Consortium Agreement upon signature of this Consortium Agreement by a duly authorised representative. This Consortium Agreement shall have effect from the Effective Date identified at the beginning of this Consortium Agreement. An entity becomes a new Party to the Consortium Agreement upon signature of the accession document (Attachment 2) by the new Party and the Coordinator. Such accession shall have effect from the date identified in the accession document. A Party which has not yet signed this Consortium Agreement shall neither be entitled to vote nor to receive any EC Financial contribution. 3.2 Duration and termination This Consortium Agreement shall continue in full force and effect until complete fulfilment of all obligations undertaken by the Parties under the Grant Agreement and under this Consortium Agreement. 12 / 106  EP PerMed- Consortium Agreement However, this Consortium Agreement or the participation of one or more Parties to it may be terminated in accordance with the terms of this Consortium Agreement. If - the Grant Agreement is not signed by the European Commission or a Party, or - the Grant Agreement is terminated, or - a Party's participation in the Grant Agreement is terminated, this Consortium Agreement shall automatically terminate in respect of the affected Party/ies, subject to the provisions surviving the expiration or termination under 3.3 of this Consortium Agreement. If a Beneficiary’s or Affiliated Entity`s participation in the Grant Agreement is terminated, the terminating Party shall do its utmost to limit the consequences for EP PerMed. Wherever possible, it shall honour its commitments in funding the running projects under EP PerMed calls. If an Associated Partner´s participation in EP PerMed is terminated, its participation in this Consortium Agreement may be terminated subject to the provisions surviving the expiration or termination under this Consortium Agreement (chapter 4.2 and chapter 3.3). 3.3 Survival of rights and obligations The provisions relating to Access Rights, Dissemination, confidentiality, for the time period mentioned therein, as well as for liability, applicable law, settlement of disputes of this Consortium Agreement shall survive the expiration or termination of this Consortium Agreement. Termination shall not affect any rights or obligations of a Party leaving EP PerMed incurred prior to the date of termination, unless otherwise agreed between the General Assembly and the leaving Party. This includes the obligation to provide all necessary input, deliverables and documents for the period of its participation. 4 Responsibilities of Parties 4.1 General principles Each Party undertakes to take part in the efficient implementation of EP PerMed, and to cooperate, perform and fulfil, promptly and on time, all of its obligations under the Grant Agreement and this Consortium Agreement as may be reasonably required from it and in a manner of good faith as prescribed by Belgian law. Each Party undertakes to notify promptly the Granting Authority and the other Parties, in accordance with the governance structure of this Consortium Agreement, of any significant information, fact, problem or delay likely to affect EP PerMed. Each Party shall promptly provide all information reasonably required by a Consortium Body or by the Coordinator to carry out its tasks and shall responsibly manage the access of its employees to the EU Funding & Tenders Portal. Each Party shall take reasonable measures to ensure the accuracy of any information or materials it supplies to the other Parties. 13 / 106  EP PerMed- Consortium Agreement 4.2 Specific responsibilities for Affiliated Entities - AE Entities Affiliated to a Beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/1046, participate in the action as Affiliated Entities with similar rights and obligations as the Beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). They do not become party to the Grant Agreement (do not sign the GA) but they are part of the consortium. They are therefore de facto treated like beneficiaries (have their own financial statement, must provide their own Certificate on Financial Statement (CFS), must contribute to the technical report, must submit deliverables, etc.). As defined in article 8 of the Grant Agreement, Affiliated Entities can charge costs and contributions to the action under the same conditions as the Beneficiaries and must implement the action tasks attributed to them in Annex 1 “description of Action” of the Grant Agreement in accordance with Article 11 of the Grant Agreement on Proper implementation of the action. Their costs and contributions will be considered for the calculation of the grant. All the obligations of the Beneficiaries under the Grant Agreement (as stipulated in its article 8) and relevant obligations of Parties under this Consortium Agreement also apply to their Affiliated Entities. Breaches by Affiliated Entities will be handled in the same manner as breaches by Beneficiaries. 4.3 Specific responsibilities for Associated Partner(s) - AP For the avoidance of doubt, the Associated Partner(s) do(es) not sign the Grant Agreement and do(es) not receive funding from the Granting Authority and therefore do(es) not have a right to charge costs or claim contributions from the Granting Authority. Associated Partner(s) must ensure its/their own funding for the implementation of EP PerMed. However, certain terms and conditions of the Grant Agreement and its Annexes are applicable to the Associated Partner(s). The Coordinator will share a copy of the signed Grant Agreement and information on any amendments with the Associated Partner(s). The Associated Partner(s) hereby commit(s) to implement EP PerMed tasks attributed to it/them in Annex 1 of the Grant Agreement. In addition, the Associated Partner(s) hereby commit(s) especially to the following articles of the Grant Agreement and related regulations of Annex 5: - Proper implementation of the action (Article 11) - Conflicts of interest (Article 12) - Confidentiality and security (Article 13) - Ethics and values (Article 14) - Visibility (Article 17.2) - Specific rules for carrying out the action (Article 18) - Information obligations (Article 19) - Record-keeping (Article 20) The Associated Partner(s) support(s) the Beneficiaries regarding their exploitation, dissemination and Open Science obligations and commit(s) to contribute to the technical and continuous reporting during and after the implementation of EP PerMed. Furthermore, the Associated Partner(s) hereby explicitly agree to cooperate with and grant access to bodies according to Article 25 of the Grant Agreement (the Granting Authority, the European Anti-Fraud Office (OLAF), the European Public Prosecutor’s Office (EPPO), the European Court of Auditors (ECA)), so that these bodies can carry out checks, reviews, audits and investigations also towards the Associated Partner(s). 14 / 106  EP PerMed- Consortium Agreement Any Associated Partner from a non-EU-country undertakes to comply additionally with any other obligation arising from Art. 10.1 of the Grant Agreement. In case of termination or being declared a Defaulting Party, an Associated Partner shall, within the limits specified in chapter 5.2 of this Consortium Agreement, bear any reasonable and justifiable costs occurring to the other Parties for performing this Associated Partners tasks and the costs for additional efforts necessary to implement EP PerMed Moreover, an Associated Partner is obliged to indemnify the other Parties for any claim of the Granting Authority against them, caused by this Associated Partner´s actions or omissions during Grant Agreement preparation, EP PerMed implementation or after EP PerMed end. Regarding such claims the Associated Partner´s special liability is limited to the amount of its total budget as indicated in Annex 1 of the Grant Agreement. Should the Associated Partner(s) be obliged to sign a separate agreement concerning its funding for the EP PerMed, it is the responsibility of the Associated Partner to ensure such agreement is not in conflict with this Consortium Agreement. Furthermore, there will be separated agreements for each JTCs in which AP is joining concerning the assigned budget to the JTC, the evaluation of the call and the funding of the respective third parties. 4.4 Breach In the event that the General Assembly identifies a breach by a Party of its obligations under this Consortium Agreement or the Grant Agreement (e.g. improper implementation of EP PerMed), the Coordinator or, if the Coordinator is in breach of its obligations, the Party appointed by the General Assembly, will give formal notice to such Party requiring that such breach will be remedied within 30 calendar days from the date of receipt of the written notice by the Party. If such breach is substantial and is not remedied within that period or is not capable of remedy, the General Assembly may decide to declare the Party to be a Defaulting Party and to decide on the consequences thereof which may include termination of its participation. 4.5 Involvement of third parties A Party that enters into a subcontract or otherwise involves third parties (including but not limited to Affiliated Entities or other Participants) in EP PerMed remains responsible for carrying out its relevant part of EP PerMed and for such third party’s compliance with the provisions of this Consortium Agreement and of the Grant Agreement. Such Party has to ensure that the involvement of third parties does not affect the rights and obligations of the other Parties under this Consortium Agreement and the Grant Agreement. 4.6 Specific responsibilities regarding data protection Where necessary, the Parties shall cooperate in order to enable one another to fulfil legal obligations arising under applicable data protection laws (the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and relevant national data protection law applicable to said Party) within the scope of the performance and administration of EP PerMed and of this Consortium Agreement. In particular, the Parties shall, where necessary, conclude a separate data processing, data sharing and/or joint controller agreement before any data processing or data sharing takes place. 15 / 106  EP PerMed- Consortium Agreement 5 Liability towards each other 5.1 No warranties In respect of any information or materials (including Results and Background) supplied by one Party to another under EP PerMed, no warranty or representation of any kind is made, given or implied as to the sufficiency or fitness for purpose nor as to the absence of any infringement of any proprietary rights of third parties. Therefore, - the recipient Party shall in all cases be entirely and solely liable for the use to which it puts such infor- mation and materials, and - no Party granting Access Rights shall be liable in case of infringement of proprietary rights of a third party resulting from any other Party (or its entities under the same control) exercising its Access Rights. However, each Party shall promptly inform the other Party/ies of any claims of third parties that come to their knowledge. 5.2 Limitations of contractual liability No Party shall be responsible to any other Party for any indirect or consequential loss or similar damage such as, but not limited to, loss of profit, loss of revenue or loss of contracts, except in case of breach of confidentiality. A Party’s general aggregate liability towards the other Parties collectively shall be limited to the Beneficiary’s share of the total costs of the Project as identified in Annex 2 of the Grant Agreement and in case of Associated Partners to the amount of its total budget as indicated in Annex 1 of the Grant Agreement. A Party’s liability shall not be limited under either of the two foregoing paragraphs to the extent such damage was caused by a wilful act or gross negligence or to the extent that such limitation is not permitted by law. 5.3 Damage caused to third parties Each Party shall be solely liable for any loss, damage or injury to third parties resulting from the performance of the said Party’s obligations by it or on its behalf under this Consortium Agreement or from its use of Results or Background. 5.4 Force Majeure No Party shall be considered to be in breach of this Consortium Agreement if it is prevented from fulfilling its obligations under the Consortium Agreement by Force Majeure. Each Party will notify the General Assembly of any Force Majeure without undue delay. If the consequences of Force Majeure for EP PerMed are not overcome within six weeks after such notice, the transfer of tasks - if any - shall be decided by the General Assembly. 16 / 106  EP PerMed- Consortium Agreement 6 Governance structure 6.1 General structure The organisational structure of the consortium shall comprise the following Consortium Bodies: General Assembly The General Assembly (GeA), consisting of 1-2 representatives per EP PerMed (GeA) participant (beneficiaries, affiliated entities and associate partner) and the EC. The GeA is the formal decision-making body of EP PerMed. It discusses and decides about the strategy and major orientation of EP PerMed, priorities and actions to be supported, evolutions in EP PerMed’s membership, contractual issues and alloca- tion of implementation budget among the various WPs and activities among part- ners. It will meet at least once a year, preferably twice. It is chaired by the Coordi- nator of EP PerMed and a vice-chair elected from the GeA. The vice-chair election (period, procedure etc.) will be defined in the Rules of Procedure after the start of EP PerMed. The Rules of Procedure will be developed in agreement with the GeA. Any major contractual changes regarding the Consortium Agreement, that are de- cided by the GeA will be made in writing and signed by the authorised representa- tive of each organisation. Extended General As- The Extended General Assembly (ExtGeA) includes the GeA and additionally the sembly (ExtGeA) International Consortium for Personalised Medicine (ICPerMed) members and thus will include and utilise an international PM perspective and collaboration. The ExtGeA will discuss and advice EP PerMed activities and decide on joint activities of ICPerMed and EP PerMed. Coordination Unit (CU) The Coordination Unit (CU) drives the operational activities, preparing decisions to be made by the GeA. Composed of the Coordinator, the WP Leads and the EC, the CU will ensure an effective coordination, alignment and management of the overall activities. Whereas crucial strategic decisions will be made by the GeA, more general decisions (on a day-by-day basis) will be made by the CU. Details on 17 / 106  EP PerMed- Consortium Agreement the nature of these decisions are defined in this CA and in the Rules of Procedure, which will be developed in the beginning of EP PerMed’s runtime. Coordinator (COR) The Coordinator is the legal entity acting as the intermediary between the Parties and the Granting Authority. The Coordinator shall, in addition to its responsibilities as a Party, perform the tasks assigned to it as described in the Grant Agreement and this Consortium Agreement. Call Steering Commit- The Call Steering Committees (CSC) support the JTCs, which are the main activity tees (CSC) in EP PerMed. The CSC develop and implement the seven Joint Transnational Calls. Therefore, specific committees will be created for each joint call, since EP PerMed is devoted to schemes of variable geometry. The decisions for each JTC will be taken among the respective CSC. The CSC gathers one representative per organisation financially contributing to the given JTC. Joint Call Secretariat The Joint Call Secretariat is the body taking care of the coordination of manage- (JCS) ment activities of a given JTC. External EP PerMed The external EP PerMed advisory bodies (Advisory Board, Stakeholder Forum, advisory bodies each Call Advisory Board) will be defined and established. 6.2 General operational procedures for all Consortium Bodies 6.2.1 Representation in meetings Any Party which is appointed to take part in a Consortium Body shall designate one representative (hereinafter referred to as "Member"). Any Member: − should be present or represented at any meeting of such Consortium Body, − may appoint a substitute or a proxy to attend and vote at any meeting of such Consortium Body, and shall participate in a cooperative manner in the meetings of such Consortium Body. 6.2.2 Preparation and organisation of meetings 6.2.2.1 Convening meetings The chairperson of a Consortium Body shall convene meetings of that Consortium Body. Ordinary meeting Extraordinary meeting Extended General Assembly At least once a year At any time upon request of the (ExtGeA) Coordination Unit or 1/3 of the Members of the Extended General Assembly General Assembly (GeA) At least once a year At any time upon request of the Coordination Unit or 1/3 of the Members of the General Assembly 18 / 106  EP PerMed- Consortium Agreement Coordination Unit At least quarterly (incl. on-site At any time upon request of any meeting and online meetings) Member of the Coordination Unit Call Steering Committees (CSC) Usually twice per JTC (on-site or At any time upon request of the online) JCS or 1/3 of the CSC 6.2.2.2 Notice of a meeting The chairperson of a Consortium Body shall give written notice of a meeting to each Member of that Consortium Body as soon as possible and no later than the minimum number of days preceding the meeting as indicated below. The minimum number of days also apply to the case that the quorum is not reached and the chairperson of a Consortium Body has to convene another meeting (see 6.2.2.1). Ordinary meeting Extraordinary meeting Extended General Assembly 45 calendar days 15 calendar days General Assembly 45 calendar days 15 calendar days Coordination Unit 20 calendar days 15 calendar days Call Steering Committee 30 calendar days 15 calendar days 6.2.2.3 Sending the agenda The chairperson of a Consortium Body shall prepare and send each Member of that Consortium Body an agenda no later than the minimum number of days preceding the meeting as indicated below. Ordinary meeting Extraordinary meeting Extended General Assembly 14 calendar days 7 calendar days General Assembly 14 calendar days 7 calendar days Coordination Unit 4 calendar days 4 calendar days Call Steering Committee 7 calendar days 7 calendar days 6.2.2.4 Adding agenda items Any agenda item requiring a decision by the Members of a Consortium Body must be identified as such on the agenda. Any Member of a Consortium Body may add an item to the original agenda by written notice to all of the other Members of that Consortium Body up to the minimum number of days preceding the meeting as indicated below. 19 / 106  EP PerMed- Consortium Agreement Ordinary meeting Extraordinary meeting Extended General Assembly 7 calendar days 7 calendar days General Assembly 7 calendar days 7 calendar days Coordination Unit 3 calendar days 3 calendar days Call Steering Committee 5 calendar days 5 calendar days During a meeting the Members of a Consortium Body present or represented can unanimously agree to add a new item to the original agenda. 6.2.2.5 Forms of meetings and decisions Meetings of each Consortium Body may also be held by tele- or videoconference, or other telecommunication means or other telecommunication means that allow for the proper identification of the attending Members. Decisions may also be taken via online voting tools, provided the online vote duly observes the principles of fairness, transparency, proper documentation and confidentiality as required to ensure the same degree of reliability than a vote in a physical meeting. The chairperson shall inform the Parties of the tool to be used for online voting in due time before the vote to make sure they have sufficient technical access and opportunity to cast their vote. Any decision may also be taken without a meeting if a the chairperson circulates to all Members of a Consortium Body a suggested decision with a deadline for responses of at least 10 calendar days after receipt by a Member, and b the decision is agreed by two-thirds (2/3) of the votes cast, provided that at least two-thirds (2/3) of the Members entitled to vote answer the decision request (either by casting their vote or by notifying their abstention). Abstentions thus count towards reaching the minimum participation, and their notification should be mentioned in the voting request sent by the chairperson). The chairperson shall inform all the Members of the outcome of this vote. A veto according to 6.2.4 of this Consortium Agreement may be submitted up to 15 calendar days after receipt of this information by the Member. The decision will be binding after the chairperson sends a notification to all Members of that Consortium Body. The Coordinator will keep records of the votes and make them available to the Members on request. 6.2.3 Voting rules and quorum Each Consortium Body shall not deliberate and decide validly in meetings unless half (1/2) of its Members are present or represented (quorum). If the quorum is not reached, the chairperson of the Consortium Body shall convene an extraordinary meeting in which a decision is taken even if less than the quorum of Members is present or represented. For voting rules and quorum of decisions without a meeting, see 6.2.2.5 20 / 106  EP PerMed- Consortium Agreement The voting rules are: Voting rights Extended General - one vote for each EP PerMed Beneficiary/the Coordinator Assembly (ExtGeA) - one vote for each ICPerMed-Member, who is not an EP PerMed Beneficiary - one vote for each EP PerMed Associated Partner - one vote for the EC General Assembly - one vote for each EP PerMed Beneficiary/the Coordinator (GeA) - one vote for the EC - the votes will be weighted with regard to number of EP PerMed beneficiar- ies per country2 Coordination Unit (CU) - one vote for Coordinator/WP 1 (DLR) - one vote per WP 2 to 5 representative - one vote for the EC Voting regarding the EC share to the third parties: Call Steering Committees (CSC) - one vote per representative from each EP PerMed Beneficiary financially contributing to the given joint call Voting regarding all other decisions: - one vote per representative from each organisation financially contributing to the given joint call If two Parties act as an “institutional couple”, i.e. if they come from the same country and manage the same research budget, they shall share one vote. A Defaulting Party shall not vote. The linked Beneficiary with all his Affiliated Entities has only one vote in all decision bodies of EP PerMed. Each Consortium Body shall strive to make decisions by consensus. If consensus cannot be achieved, decisions shall be taken by a majority of two-thirds (2/3) of the votes cast. 2 If for example there are three beneficiaries located in the same country, their votes will be weighted by 1/3 each. European organizations incl. their AE (like the EC), that are not associated with a certain country, will have one vote each. 21 / 106  EP PerMed- Consortium Agreement 6.2.4 Veto rights A Party which can show that its own work, time for performance, costs, liabilities, intellectual property rights or other legitimate interests would be severely affected by a decision of that Consortium Body may exercise a veto with respect to the corresponding decision or relevant part of the decision. When the decision is foreseen on the original agenda, a Party may veto such a decision during the meeting only. When a decision has been taken on a new item added to the agenda before or during the meeting, a Party may veto such decision during the meeting or within 15 calendar days after receipt of the draft minutes of the meeting by the Party. When a decision has been taken without a meeting, a Party may veto such decision within 15 calendar days after receipt of the written notice from the chairperson of the outcome of the vote by the Party. In case of exercise of veto, the Parties shall make every effort to resolve the matter which occasioned the veto to the general satisfaction of all Parties. A Party may neither veto decisions relating to its identification to be in breach of its obligations nor to its identification as a Defaulting Party. The Defaulting Party may not veto decisions relating to its participation and termination in the consortium or the consequences of them. A Party requesting to leave the consortium may not veto decisions relating thereto. 6.2.5 Minutes of meetings The chairperson of a Consortium Body shall produce minutes of each meeting which shall be the formal record of all decisions taken. He / She shall send the draft minutes to all Members of that Consortium Body within 15 calendar days of the meeting. The minutes shall be considered as accepted if, within 15 calendar days from receipt, no Member of that Consortium Body has sent an objection by written notice to the chairperson with respect to the accuracy of the draft of the minutes by written notice. The chairperson shall send the accepted minutes to all the Members of that Consortium Body and to the Coordinator, who shall retain copies of them. 6.3 Firewall for meetings regarding any EP PerMed calls (on-site, online or hybrid) EP PerMed parties that are not funders and/or are eligible to apply for calls of EP PerMed will not participate in the Call Steering Committee/s (CSCs) or the Joint Call Secretariats (JCSs). They will further not participate in meetings (or dedicated sessions of meetings) of the Coordination Unit, General Assembly and Extended General Assembly when confidential information about the Joint Transnational Calls (JTC) or other calls are discussed or if confidential information about call-related topics are provided. They are not eligible to vote in decisions with regard to the calls or the evaluation process. 7 Specific operational procedures for the Consortium Bodies 7.1 General Assembly In addition to the rules described in 6.2, the following rules apply: 22 / 106  EP PerMed- Consortium Agreement 7.1.1 Members The General Assembly shall consist of 1-2 representative of each Party (hereinafter “General Assembly Member”). Each General Assembly Member shall be deemed to be duly authorised to deliberate, negotiate and decide on all matters listed in 7.1.2. of this Consortium Agreement. The Coordinator and an elected vice-chair shall chair all meetings of the General Assembly, unless decided otherwise in a meeting of the General Assembly. The Parties agree to abide by all decisions of the General Assembly. This does not prevent the Parties from exercising their veto rights, according to 6.2.4, or from submitting a dispute to resolution in accordance with the provisions of 14.8. Regarding unanimity or majority decisions, only General Assembly Members with voting rights regarding the item are considered. 7.1.2 Decisions The General Assembly is responsible for the overall direction and follow-up of EP PerMed. The following decisions shall be taken by the General Assembly: Content, finances and intellectual property rights − Delegation of (minor) decisions to the Coordination Unit − Proposals for changes to Consortium Plan (Annexes 1 and 2 of the Grant Agreement) to be agreed by the Granting Authority; − Develop and agree on the upcoming Annual Work Programmes and related (annual) budgets on a yearly basis; − Foreseen updates of the Strategic Research and Innovation Agenda (SRIA) − Additions or modifications to all Attachments of this Consortium Agreement; − Use of the reserve fund; − Decisions related to a Highly Detrimental Situation; − Decisions related to a conflict of interests; − Settlement of disputes. Appointments − Appointment of Members of the Advisory Board; − Appointment of the Joint Call Secretariats; − Appointment of GeA vice-chair. Evolution of the consortium − Entry/withdrawal of a Party to/from EP PerMed and approval of the settlement on the conditions of the accession/withdrawal of such a Party; − Decisions related to the termination of a Party’s participation in the Co-fund Action (including handling of additional costs, if any); − Identification of a breach by a Party of its obligations under this Consortium Agreement or the Grant Agreement and the remedies to be performed by such Party; − Declaration of a Party to be a Defaulting Party and the remedies to be performed by such Party (including termination of such Party’s participation in EP PerMed); − Steps to be taken for litigation purposes and the coverage of litigation costs in case of joint claims of a Party/Parties against another Party/other Parties; − Proposal to the Granting Authority for a change of the Coordinator; − Proposal to the Granting Authority for suspension of all or part of EP PerMed; − Proposal to the Granting Authority for termination of EP PerMed and the Consortium Agreement. 23 / 106  EP PerMed- Consortium Agreement 7.2 Coordination Unit In addition to the rules described in 6.2, the following rules apply: 7.2.1 Members The Coordination Unit shall consist of the Coordinator, the Work Package Leads and the EC. The Coordinator shall chair all meetings of the Coordination Unit, unless decided otherwise in a meeting of the Coordination Unit. 7.2.2 Minutes of meetings Minutes of Coordination Unit meetings, once accepted, can be consulted by the General Assembly Members for information. 7.2.3 Tasks The Coordination Unit shall: − prepare the meetings, propose decisions and prepare the agenda of the General Assembly meetings according to chapter 7.1.2.; − seek a consensus among the Parties; − be responsible for the proper execution and implementation of the decisions of the General Assembly; − monitor the effective and efficient implementation of EP PerMed; − collect information at least every 12 months on the progress of EP PerMed, examine that information to assess the compliance of EP PerMed with the Consortium Plan and, if necessary, propose modifications of the Consortium Plan to the General Assembly; − support the Coordinator in preparing meetings with the Granting Authority and in preparing related data and deliverables; − prepare the content and timing of press releases and joint publications by the consortium or proposed by the Granting Authority in respect of the procedures in article 17 of the Grant Agreement and its Annex 5, chapter “Communication, Dissemination, Open Science and Visibility” and of chapter 10 of this Consortium Agreement; − in the case of abolished tasks as a result of a decision of the General Assembly, advise the General Assembly on ways to rearrange tasks and budgets of the Parties concerned. Such rearrangement shall take into consideration any prior legitimate commitments which cannot be cancelled; 7.3 Extended General Assembly In addition to the rules described in 6.2, the following rules apply: 7.3.1 Members The Extended General Assembly shall consist of one representative of each Party (hereinafter “General Assembly Member”) and all ICPerMed members. A chair elected by the Extended General Assembly shall chair all meetings of the Extended General Assembly, unless decided otherwise in a meeting of the Extended General Assembly. 24 / 106  EP PerMed- Consortium Agreement 7.3.2 Tasks The Extended General Assembly shall: − Connect EP PerMed with additional European and international countries and therewith support the alignment of the Co-fund activities with activities undertaken at the European and international levels. − Propose, discuss, decide on and develop strategic joint ICPerMed and EP PerMed activities (e.g. events and policy papers). 7.4 Call Steering Committee In addition to the rules described in 6.2, the following rules apply: 7.4.1 Members The Call Steering Committee is composed of one mandated representative from each Funding Organisation participating in a given Joint Call (hereinafter “CSC Members”). 7.4.2 Mandate A Call Steering Committee will be set up for each Joint Call, acting as the decision-making body for all aspects related to the practical implementation and follow-up of the concerned Joint Call. The mandate of the Call Steering Committee starts with the preparation of the development of the concept of the respective call and ends with the finalisation of selection list of the respective JTC. 7.4.3 Tasks The Call Steering Committee shall: − Develop and approve the Call Memorandum of Understanding and the text of the Call Announcement; − Agree on the general eligibility of partners in Transnational Projects for funding based on the Joint Call and national/regional eligibility rules; − Provide names of potential reviewers/experts to the Expert Panel and to the Call Secretariat; − Appoint the Members of the Expert Panel; − Decide on which projects to invite to step 2, based on the evaluation made by the Expert Panel (if applicable); − Decide on which proposals to recommend for funding based on and not deviating from the Ranking List established by the Expert Panel; − Re-evaluate the rules for the use of the EC Financial Contribution for the Transnational Projects, if necessary. Decisions regarding the Joint Call(s): − Setup of timelines for the Joint Call(s); − Approval of the text and topics; − Guidelines and rules for participation in the Joint Call(s); − Agreement on the Transnational Projects to be funded, according to the Ranking List; − Financial decision in case a Funding Organisation has no funds for the national/regional share in a Transnational Project (i.e. decision about how to replace and/or fund the final recipients of the Transnational Project). 25 / 106  EP PerMed- Consortium Agreement 7.5 Call Secretariat In addition to the rules described in 6.2, the following rules apply: 7.5.1 Members The Joint Call Secretariats will be appointed by the General Assembly. 7.5.2 Tasks The Joint Call Secretariat is responsible for leading the coordination and management activities regarding the Joint Call. In particular, the Joint Call Secretariat shall: − prepare a list with suggestions for fundable proposals for the Joint Call and give a funding recommendation to the Call Steering Committee; − handle the proposition of the Call Steering Committee for names of potential external reviewers; − prepare a template concerning potential situations of conflicts of interests and a declaration to be confirmed by the external experts. 7.6 Coordinator The Coordinator shall be the intermediary between the Parties and the Granting Authority and shall perform all tasks assigned to it as described in the Grant Agreement and in this Consortium Agreement. 7.6.1 Tasks In particular, the Coordinator shall be responsible for: − monitoring the progress of EP PerMed in collaboration with the Coordination Unit; − monitoring compliance by the Parties with their obligations under this Consortium Agreement and the Grant Agreement; − convening and chairing General Assembly and Coordination Unit meetings and support the Call Secretariats; − keeping the contact list of Members of the Consortium Bodies and other contact persons updated and available; − collecting, reviewing to verify consistency and submitting reports, other deliverables (including financial statements and related certifications) and specific requested documents to the Granting Authority; − transmitting documents and information related to EP PerMed to any external party concerned; − administering the EC Financial Contribution and fulfilling the financial tasks described in chapter 7; − establishing a cost monitoring system and providing the General Assembly with the results of this cost assessment; − providing, upon request, the Parties with official copies or originals of documents that are in the sole possession of the Coordinator when such copies or originals are necessary for the Parties to present claims; − handling conflicts of interests; − providing a copy of the Grant Agreement and its Annexes to the Associated Partners; − handling and advising on the settlement of disputes; − developing Rules of Procedure for the EP PerMed consortium bodies (including a non-disclosure agreement with each member of the Advisory Board). If one or more of the Parties is late in submission of any EP PerMed deliverable, the Coordinator may nevertheless submit the other ’Parties’ EP PerMed deliverables and all other documents required by the Grant Agreement to the Granting Authority in time. 26 / 106  EP PerMed- Consortium Agreement If the Coordinator fails in his/her coordination tasks, the General Assembly may propose to the Granting Authority to change the Coordinator. The Coordinator shall not be entitled to act or to make legally binding declarations on behalf of any other Party or of the consortium, unless explicitly stated otherwise in the Grant Agreement or this Consortium Agreement. The Coordinator shall not enlarge its role beyond the tasks specified in this Consortium Agreement and in the Grant Agreement. 8 Financial provisions Chapter 8 of the Consortium Agreement applies to all Beneficiaries and Affiliated Entities. Chapter 8 does not apply to Associated Partners. 8.1 General Principles As presented in Annex 2 of the Grant Agreement, the EC Financial Contribution consists of the contribution to direct costs and the related indirect costs. Each Beneficiary shall make their best efforts to match their regional/national funding budget with the expected success of their respective research communities. In addition, the Beneficiary and Affiliated Entity will undertake all possible efforts to ensure the best possible use of all available EP PerMed budget. All provisions included in this chapter apply to the Affiliated Entities in the same way that they apply to the Beneficiaries, except if there is a specific mention for Affiliated Entities. The Beneficiaries must ensure that their Affiliated Entities respect the obligations stipulated in this chapter (i.e. by signing a contract with them). The provisions of this chapter do not apply to the Associated Partners. Associated Partners agree to cover their entire costs from their own funds. 8.1.1 Distribution of the EC Financial Contributions The EC Financial Contribution to EP PerMed shall be distributed by the Coordinator according to: - the Consortium Plan - the Description of Action (Annex 1 of the Grant Agreement) and budget (Annex 2 of the Grant Agreement) and respective amendments, - the Annual Work Programme, - the approval of reports by the Granting Authority, and - the provisions of payment in 8.2. A Beneficiary shall only be able to receive funds after having duly signed the Consortium Agreement and the Accession Form to the Grant Agreement. The Affiliated Entities linked to a Beneficiary shall only be able to receive funds after the beneficiary he is linked to has duly signed the Consortium Agreement and the Accession Form to the Grant Agreement. A Beneficiary that involves Affiliated Entities should conclude a written contract with those Affiliated Entities that ensures compliance with the provisions of the Grant Agreement and the Consortium Agreement. A Beneficiary and Affiliated Entity shall be funded only for its tasks carried out in accordance with the Description of Action, the valid Annual Work Programme with respective amendments and the Consortium Plan. Each Beneficiary and Affiliated Entity is responsible for the management and payment of its subcontractors and must ensure that they meet the obligations stipulated in the Grant Agreement – Art.6.2. B and Art. 9.3. Justifying Costs towards the Granting Authority. 27 / 106  EP PerMed- Consortium Agreement In accordance with its own usual accounting and management principles and practices, each Beneficiary shall be solely responsible for justifying its costs (and those of its Affiliated Entities, if any) with respect to the EP PerMed towards the Granting Authority. Neither the Coordinator nor any of the other Beneficiaries and Affiliated Entities shall be in any way liable or responsible for such justification of costs towards the Granting Authority. 8.1.2 Funding Principles Each Beneficiary and Affiliated that spends less than its allocated share of the budget as set out in the Consortium Plan will be funded in accordance with its actual duly justified eligible costs only. Each Beneficiary and Affiliated that spends more than its allocated share of the budget as set out in the Consortium Plan will be funded only in respect of duly justified eligible costs up to an amount not exceeding that share, unless otherwise agreed by the Coordination Unit. Specific funding principles related to the funding of Transnational Projects selected in the Joint Transnational Calls are defined under chapter 9.2. 8.1.3 Financial Consequences of the termination of the participation of a Party A Beneficiary and Affiliated Entity leaving the consortium shall refund to the Coordinator any payments it has received except the amount of contribution accepted by the Granting Authority or another contributor to the Co- funded Action or consortium. In addition, a Defaulting Party shall, within the limits specified in 5.2 of this Consortium Agreement, bear any reasonable and justifiable additional costs occurring to the other Beneficiaries and Affiliated Entities in order to perform the leaving Party´s task and necessary additional efforts to fulfil them as a consequence of the Party leaving the consortium. The General Assembly should agree on a procedure regarding additional costs which are not covered by the Defaulting Party or the Mutual Insurance Mechanism. 8.2 Payments 8.2.1 General Principles Payments to Beneficiaries are the exclusive task of the Coordinator. Related banking and transaction costs are borne by the receiving Beneficiary. Payments to the Affiliated Entity are paid to the affiliated Beneficiaries. In particular, the Coordinator shall: − notify the Beneficiary concerned promptly of the date and composition of the amount transferred to its bank account, giving the relevant references, − perform diligently its tasks in the proper administration of any funds and in maintaining financial accounts, and − undertake to keep the EC Financial Contribution separated from its normal business accounts, its own assets and property, except if the Coordinator is a Public Body or is not entitled to do so due to statutory legislation. Beneficiary will have to provide to the Coordinator in order to receive the payments a Financial Identification Form (FIF), completed and signed both by the account holder and bank of the Beneficiary, submitted via PT-Open. With reference to article 22 of the Grant Agreement, no Party shall before the end of the EP PerMed receive more than its allocated share of the maximum grant amount less the amounts retained by the Granting Authority for the Mutual Insurance Mechanism. Considering the Reserve Fund (5 %) specified in chapter 8.2.6, the coordinator shall apply those limits and stop payments to each Party for which 80% of its maximum grant amount (Annex 2 28 / 106  EP PerMed- Consortium Agreement of the Grant Agreement) is paid, considering the coordinator’s financial availability of the maximum EC Financial Contribution received previously by the Granting Authority. This limit could be increased up to 85%, once that the Reserve Fund is treated as part of the EC Financial Contribution, as set up in chapter 8.2.6, if there is EC Financial Contribution available. 8.2.2 Withholding of Payments The Coordinator is entitled to withhold any payments due to a Beneficiary (also for its Affiliated Entity, if any) identified by the General Assembly to be in breach of its obligations under this Consortium Agreement or the Grant Agreement or to a Beneficiary/ Affiliated Entity which has not yet signed this Consortium Agreement. The Coordinator is entitled to recover any payments already paid to a Defaulting Party except the costs already claimed by the Defaulting Party and accepted by the Granting Authority. The Coordinator is equally entitled to withhold payments to a Defaulting Party when this is suggested by or agreed with the Granting Authority. If a Beneficiary (also for its Affiliated Entity, if any) has received more EC Financial Contribution than it actually needed and then it was approved by the Granting Authority during the reporting periods, the Coordinator is entitled to offset or to withhold payments of the following interim payment or the final payment or to recover the surplus from that Beneficiary (also for its Affiliated Entity, if any). 8.2.3 Budgeting The Consortium Budget will be listed in the actual version of Annex 2 of the Grant Agreement. The Consortium Budget shall be valued in accordance with the usual accounting and management principles and practices of the respective Parties. Costs will be reimbursed to the Beneficiary and Affiliated Entity as follows: A Beneficiary and Affiliated Entity shall be reimbursed only for its tasks carried out in accordance with Annex 1 to GA. This means that there will be no reimbursement for costs related to additional efforts by any Beneficiary and Affiliated Entity that go beyond Annex 1 to GA. The EC Funding Contribution should be used for reimbursement according to the following prioritisation: 1st) covering 100% of the Consortium Budget (part A, C and E of the Annex 2 of GA budget categories planned for activities in WP 1 till WP 5); 2nd) EC share for support of third party in relation to part D of the Annex 2 of GA of Transnational Projects (JTCs); 3rd) additional calls according Annex 1 of the Grant Agreement. The Coordinator shall design a financial reporting scheme (chapter 8.3) that includes the data needed from each Beneficiary and Affiliated Entity to trigger an early warning on the balance of EC Financial Contribution. Should the EC Financial Contribution funds received from the Granting Authority not be enough to cover the agreed annual reimbursements to Beneficiaries and Affiliated Entities or the distribution of funds after new instalments from the Granting Authority, the Coordinator shall work out a plan to postpone payments and to adapt the Consortium Plan in order to prevent additional costs from running up as best as possible until the next instalment. In case of any disagreements, the Coordinator shall convene a meeting of the General Assembly, where an agreement shall be attempted. If no solution can be found, the rules for settlement of disputes (chapter 14.8) shall be followed. 29 / 106  EP PerMed- Consortium Agreement 8.2.4 Justifying costs The costs of each Beneficiary and Affiliated Entity are calculated according to its involvement in EP PerMed based on the following cost categories as defined in Horizon Europe (Article 6 of GA): a) Personnel costs b) Subcontracting costs c) Purchase costs d) Costs for Financial Support to Third Parties e) Indirect costs The total budget of EP PerMed per Beneficiary and Affiliated Entity can be found in respective Annex 2 to the Grant Agreement. Justifying costs towards the Granting Authority: In accordance with its own usual accounting and management principles and practices, each Beneficiary and Affiliated Entity shall be solely responsible for justifying its costs with respect to EP PerMed towards the Granting Authority. Neither the Coordinator nor any of the other Beneficiaries and Affiliated Entities shall be in any way liable or responsible for such justification of costs towards the Granting Authority. Justifying costs towards the General Assembly: The costs of each Beneficiary and Affiliated Entity assigned within a certain Annual Work Programme shall be reported to the General Assembly on an annual basis using the respective cost categories as defined in the Annex 2 of the Grant Agreement. 8.2.5 Payment schedule The payment schedule, which contains the transfer of payments to the Beneficiaries (in according with Article 8.2.1), will be handled according to the following: The Beneficiaries and Affiliated Entities agree that the funding of costs included in the Consortium Plan will be divided in payments according the Annual Work Programme and according the selection lists of the Call Steering Committee (CSC) for each Joint Transnational Call. All payments will be made subject to the approval of the reported costs towards the Granting Authority in the Periodic Reports. All payments will be handled as it was stated in chapter 8.2.1. In the General Assembly, if necessary, according to the updated table showing the new overall budget for the EP PerMed, the General Assembly representatives will decide if there is a need to make adjustment payments. a) Payments according the Annual Work Programme and the internal financial reporting: 60 % - according the planned costs of the respective AWP; - payable at the beginning of the respective AWP. 30 / 106  EP PerMed- Consortium Agreement 40 % (approximatly) - after the Coordinator has received and assessed the internal financial report; - if a Beneficiary and Affiliated Entity requires further payments before the end of the respective AWP, the respective Beneficiary and Affiliated Entity can provide the internal report to the coordinator and receive the payment earlier; - the Coordinator will notify payment within 60 days after approval of the internal report. Payments to Beneficiaries can be combined, if needed. b) Payments according the selection list of the CSC for each Joint Transnational Call: 50 % - according the joint selection list of the funded projects of the respective Joint Transnational Call (JTC). 50 % - after the financial completion of the funded projects of the respective JTC. The support to the Transnational Projects shall be paid by the respective Funding Organisation. The Coordinator shall not transfer any funds directly to the Transnational Projects. c) Payment of the Balance 100 % - on receipt of the payment of the balance, and after the amounts to be recovered under this Consortium Agreement or the Grant Agreement are transferred to the Coordinators bank account; - if recovery under this Consortium Agreement or the Grant Agreement is needed, the payment has to be done within 14 calendar days from the Coordinator’s request for recovery; - open payments will only be paid out after all refunded claims have been received by the Coordinator. 8.2.6 Reserve fund The Beneficiaries and Affiliated Entities have agreed to create a Reserve Fund of 5% of all amounts of the EC Financial Contribution received, which will be used to cover additional costs encountered while implementing the Consortium Plan or in case of less EC Financial Contribution than foreseen (chapter 8.4). Any Beneficiary/Affiliated Entity may apply for this reserve fund during a meeting of the General Assembly in order to implement an activity. The Beneficiary/Affiliated Entity shall present this activity and the budget required from the reserve funds to implement this activity. The General Assembly decides whether this Beneficiary/Affiliated Entity may implement this activity with the help of the agreed budget. In case the Reserve Fund is not used during the EP PerMed duration, it will be treated as part of the EC Financial Contribution, if there is EC Financial Contribution available. If there is an urgent need, the Reserve Fund can be dissolved early, the Coordination Unit will consult the General Assembly on final decision. 31 / 106  EP PerMed- Consortium Agreement 8.2.7 Excess payments A Beneficiary (in according with Article 8.2.1) has received excess payment a if the payment received from the Coordinator exceeds the amount declared or b if a Beneficiary has received payments but, within the last year of the EP PerMed, its real EP PerMed costs fall significantly behind the costs it would be entitled to according to the Consortium Plan. In case a Beneficiary has received excess payment, it has to inform the Coordinator and return the relevant amount to the Coordinator without undue delay. In case no refund takes place within 30 days upon request for return of excess payment from the Coordinator, the Beneficiary is in substantial breach of the Consortium Agreement. Amounts which are not refunded by a breaching Beneficiary and which are not due to the Granting Authority, shall be apportioned by the Coordinator to the remaining Beneficiaries pro rata according to their share of total costs of the EP PerMed as identified in the Consortium Plan, until recovery from the breaching Beneficiary is possible. 8.2.8 Revenue In case a Beneficiary/Affiliated Entity earns any revenue that is deductible from the total funding as set out in the Consortium Plan, the deduction is only directed toward the Beneficiary and Affiliated Entity earning such revenue. The other Beneficiaries/Affiliated Entities’ financial share of the budget shall not be affected by one Beneficiary/Affiliated Entity’s revenue. In case the relevant revenue is more than the allocated share of the Beneficiary/Affiliated Entity as set out in the Consortium Plan, the Beneficiary/Affiliated Entity shall reimburse the funding reduction suffered by other Beneficiaries/Affiliated Entities. 8.2.9 Costs of Certificates on the Financial Statements The audit costs with regard to the Certificate on the Financial Statements are eligible. The budget is located at the Coordinator. Each Beneficiary and Affiliated Entity shall cover the costs (audit costs) for its own mandatory Certificate on the Financial Statements by itself. The budget for the costs for the audit will then be distributed by the Coordinator, according to the actual costs per Beneficiary and Affiliated Entity that were audited. 8.3 Reporting 8.3.1 Reporting to the Granting Authority (Periodic Report) The Beneficiaries and Affiliated Entities must report to the Granting Authority their use of the different types of costs (personnel costs, subcontracting costs, purchase costs and other costs categories) as defined in the Consortium Plan for the different activities implemented by the EP PerMed. They must report as well their costs of providing financial support to third parties (costs related to the funding of transnational research projects within the Joint Transnational Calls). To be considered eligible, the costs must meet the criteria defined in article 6 of the Grant Agreement. The Reporting obligations toward the Granting Authority are detailed in article 20 of the Grant Agreement. All Beneficiaries and Affiliated Entities agree to use the tool “PT-Open” (see chapter 8.3.2 below) in advance for preparing the Periodic Report towards the Granting Authority. 32 / 106  EP PerMed- Consortium Agreement 8.3.2 Reporting to the Coordinator (Internal Report) In order to monitor carefully the advancement and financial aspects of the EP PerMed, internal reports will be submitted by each Beneficiaries and Affiliated Entities to the Coordinator. These internal reports will be requested on a yearly basis, additional to the Periodic Reports. To collect this information, the Coordinator will use the tool “PT-Open” (www.ptopen.eu), a controlling tool developed and owned by the Coordinator. All agree to use the provided tool and to report their actual costs incurred. Internal reports have to be submitted within 30 days following the end of each reporting period and if requested by the Coordinator. The Coordinator will approve the reports and may – in relevant cases – request individual evidence or justifications. If an internal report is not approved by the Coordinator, the decision must be ratified by the Coordination Units. 8.4 Insufficient EC Financial Contribution In the unlikely case that the EC Financial Contribution is not sufficient to contribute to the costs of the EP PerMed as foreseen, the Beneficiaries and Affiliates Entities agree to use the procedure described in the following paragraphs. For the avoidance of doubt, nothing in this Agreement shall be deemed to require a Beneficiary and Affiliated Entity to breach any mandatory statutory national law under which the Beneficiary and Affiliated Entity is operating or to raise its national commitment to pay for financial gaps as described below. 8.4.1 Cost monitoring system The EC Financial Contribution is based on actual costs. According to the Grant Agreement a reimbursement of 30% for all direct and indirect costs foreseen in the Consortium Plan will be awarded by the Granting Authority. If these costs are less than foreseen in the Grant Agreement, the EC Financial Contribution will be less as well and funding gaps might appear. In order to avoid such situations, the Coordinator, shall establish a cost monitoring system, which shall allow for an overview of the budget available for reimbursement and for a cost assessment to plan the consequences of a potentially low leverage of EC Financial Contribution, especially related to the Joint Calls. The Coordinator shall provide the General Assembly with the results of this costs assessment and deliver an early warning, should a scenario of severe reduction of EC Financial Contribution arise in comparison with the numbers foreseen in the Consortium Plan, so that appropriate changes of activities, delays or cancellation of payments can be discussed. The respective decisions shall then be taken by the General Assembly considering the obligation of the Consortium, as agreed upon in the Grant Agreement, to fulfil the Consortium Plan in a reasonable manner and in compliance with the relevant clauses of this Consortium Agreement. 8.4.2 Regular trainings on cost reporting Each Beneficiary and Affiliated Entity shall ensure that the employees working for EP PerMed are fully aware of and follow the rules. These employees shall attend trainings on cost reporting on a regular basis. 8.4.3 Less EC Financial Contribution than foreseen for the Joint Transnational Calls (category D1) The following cases might occur: Case 1: Reduction in EC Financial Contribution due to Transnational Projects reporting less eligible costs than foreseen in the national/regional funding contracts 33 / 106  EP PerMed- Consortium Agreement The funding of Transnational Projects resulting from the Joint Transnational Calls leverages EC Financial Contribution when reported according to the Grant Agreement. If the eligible costs reported in the national funding contracts are less than foreseen, this may in turn lead to a reduction in the EC Financial Contribution. The reason for such a decrease in the eligible costs may lie in poor planning on the part of the consortium running the Transnational Project or in unforeseen circumstances, such as the bankruptcy of one of the project partners. Yet the reduction in the EC Financial Contribution may have a negative effect on the budget situation of the whole EP PerMed Consortium. In case of a bankruptcy, the affected Call-specific Consortia shall endeavor to mitigate the situation as appropriate or compatible with the funding regulations of the affected Funding Partner, e.g. by allowing the respective Transnational Projects to exchange the defaulting project partner. If the effective costs are less than foreseen and the respective Funding Partner already received EC Financial Contribution for the full amount leveraged by the national funding contracts, the respective Funding Beneficiaries and Affiliated Entities shall return the excess EC Financial Contribution without unjustified delay to the Coordinator. Funding Partners from countries outside the Euro-zone shall convert their reported costs according to the rules laid down in Article 21.3 of the Grant Agreement. If the above-mentioned is not sufficient, the affected Call Steering Committee shall come up with a proposal of how any potential loss can be reduced to a minimum, and bring it before the General Assembly for a decision. The members of the respective Call-specific Consortium may decide to voluntarily increase their contribution in case that the available EC Financial Contribution or another Funding Partner does not provide sufficient funding. Case 2: A Funding Partner has to revoke after the ranking lists were fixed, but before the national funding contracts for the Transnational Projects could be signed The determination of the ranking lists resulting from the proposal evaluation constitutes the final step of the full- proposal stage of the Joint Transnational Calls. If at this stage, which is before the national funding contracts for the successful proposals could be signed, a Funding Partner has to revoke and cannot fund their respective national share of the potential Transnational Projects of the Joint Call, the Chairperson of the CSC shall enact the following steps: (1) A meeting shall be convened of the Call Steering Committee affected by this situation, in order to discuss the possibility to replace the respective proposers of the concerned Transnational Projects with eligible stakeholders from other countries and fund those replacements. The Funding Partners shall be free to consider this option in line with their respective national regulations. (2) If a replacement is not possible and a funding gap appears, all Funding Partners involved in the respective Call Steering Committee shall come together and deliberate, how, or whether at all the funding gap – and thus, the financing of the project partners, whose funding had been revoked – could be covered by re-dimensioning the prospective Transnational Projects. (3) If the situation occurs at a time where the costs for implementing the Consortium Plan cannot be fully reimbursed and the funding gap closed by rearranging or reducing the distribution of the EC Financial Contribution, the Funding Partners shall resort to the procedures laid down at the beginning of chapter 8.4. 8.4.4 Less EC Financial Contribution than foreseen for Consortium Budget than foreseen in the Consortium Plan Each Beneficiary and Affiliated Entity shall attempt to contribute to the Consortium Plan as expected. If the contribution foreseen is not possible, the respective Beneficiary and Affiliated Entity shall immediately inform the 34 / 106  EP PerMed- Consortium Agreement Coordinator, who shall suggest a mitigation strategy to the General Assembly. This might include budget shifts among the Beneficiaries and Affiliated Entities or the involvement of new Beneficiaries and Affiliated Entities. In case that the Consortium Budget is lower than foreseen in the Consortium Plan the EC Financial Contribution will be lower as well. The EC Financial Contribution is related to the budget committed to the Joint Transnational Calls by the Funding Partners as well as to the way in which the Beneficiaries and Affiliated Entities uphold their respective commitments for the specified activities indicated in the Consortium Plan. If a Beneficiary and Affiliated Entity reduces its commitments regarding its indicated budget for the Joint Transnational Calls or its provision of resources (personnel or funding) for the Consortium Plan, the possible leverage of the EC Financial Contribution will be lower and a funding gap might appear with regard to the execution of the Consortium Plan. In this case, the Coordinator together with the EP PerMed Coordination Unit shall come up with a proposal to the General Assembly about which sources of funding to use (e.g. the reserve fund) in order to mitigate the funding gap. This proposal and the actions arising from it shall be discussed and decided upon in the General Assembly. 8.4.5 No EU Financial Contribution In the unlikely case that the EP PerMed is terminated and the availability of the EC Financial Contribution is either reduced or completely cancelled by the Granting Authority, the Coordinator shall convene a meeting of the General Assembly, where an agreement shall be attempted on how to equally distribute any loss in proportion to the size of the costs incurred and commitments made. The liabilities of all Parties shall be limited in accordance with the rules established in chapter 5.2. a) In case that enough EC Financial Contribution has already been made available by the Granting Authority to establish the Reserve Fund, this Reserve Fund and all the remaining EC Financial Contribution shall be used in line with its pre-determined purpose to cover the costs incurred in the execution of the Consortium Plan up to the time of termination and in compliance with national legislations. Any contractual funding commitments established by the Funding Partners up to the time of the termination that include co-funding from the EC Financial Contribution shall be honoured in the same way. b) In case that EC Financial Contribution has been made available before termination, but that it is not enough to cover both the Consortium Budget incurred until then and the funding commitments established that include potential EC Financial Contribution, the prioritisation laid out in chapter 8.2.3 shall be applied and the process towards finding a solution shall be followed as outlined at the beginning of this chapter. c) In case that no EC Financial Contribution is available whatsoever, the same principles shall be followed as described in the previous paragraph 8.4.5 b of this chapter. All Parties acting in this consortium in conjunction with a Funding Organisation are required to come to an agreement with their Funding Organisations on their respective national or regional levels regarding how to approach the situations explained above. By signing this Consortium Agreement all Parties confirm that such a national or regional agreement is in place on their respective sides and that the provisions of this chapter can be followed. 8.5 Budget flexibility Budget transfers and modifications are allowed between Parties and between costs categories without an amendment to the Grant Agreement provided that the work is implemented as stipulated in the Description of Action (Annex 1 to the Grant Agreement) and within any other limits set out in article 5.5 of the Grant Agreement. As a prior step to implementing the mentioned transfers without amendment, the Coordination should inform the European Commission authorised officer and obtain written validation of such a course of action by the latter. 35 / 106  EP PerMed- Consortium Agreement The Coordination Unit shall be informed in due time of all budget transfers. Budget transfers shall always be duly justified and approved by the Parties directly concerned. Budget transfers are possible as follows, after validation by the task leads concerned, the work package leads concerned, and the Coordinator: - Budget transfers for activities implemented according to the Consortium Plan; - Budget transfers for activities implemented according to the AWP; - Budget transfers from one AWP to an other AWP; - Budget transfers within the budget of one Party; - Between different activities in which the Party is involved; - Budget transfers from one Beneficiary to its Affiliated Entity and between its Affiliated Entities. 9 Call Implementation 9.1 Selection process: 9.1.1 Central scientific evaluation (Step 1) A single international peer review shall be accomplished after the regional/national and transnational eligibility checks to evaluate the submitted proposals. Only those proposals which are eligible according to transnational rules shall be evaluated. At least three independent experts shall evaluate each proposal. The result of the peer review shall be a Ranking List of proposals suggested for submitting a proposal in step 2. Limited oversubscription in step 1: The Parties shall make their best efforts to match their regional/national funding budget with the expected success of their respective research communities. The selected proposals should not exceed the proposed total individual regional/national budget of the Joint Call by more than three times for Beneficiaries and two times for funding organisations from countries which are not eligible for receive EC contribution. 9.1.2 Central scientific evaluation (Step 2) The proposal selection in step 2 shall be implemented following the rules indicated in Annex 5 of the Grant Agreement, chapter “Specific rules for Co-funded Partnerships”. A single international peer review shall be implemented. Only those step 2 proposals which are eligible shall be evaluated. The Expert Panel shall rank proposals according to the programme’s evaluation criteria. At least three independent experts shall evaluate each step 2 proposal. The result of the peer review shall be a list of step 2 proposals suggested for funding (i.e. Ranking List). The selection procedure must be followed by an independent expert observer, who must write a report. 9.2 Share of the EC contribution used to support third parties in Transnational Projects (JTCs) The Parties agree that the share (percentage) of the EC contribution used to support third parties receiving financial support by Parties through JTCs is revised in each AWP and the respective MoU. In addition: - The EC Financial Contribution will be used to fund the participation of patient organisations in joint transnational calls (dedicated budget 10.5 Mio € within WP2). 36 / 106  EP PerMed- Consortium Agreement - approximately 5 Mio. Euro from the EC financial contribution will be used to fund third parties in dedicated calls such as for specific calls of WP 3, 4 and 5 (see Annex 1 of the GA and the respective AWP). The Parties agree to fund as many Transnational Projects as possible following the Ranking List at least within the limits of their indicative commitment for a given call. When the Ranking List of projects recommended for funding is set up, the main goal should be first to explore all funding solutions to unblock situations at regional/national level (i.e. regional/national funding organisations shall make all reasonable efforts to match national funding with the success of their respective research communities). The EC share for support of third party for Transnational Projects shall be used in the most efficient way possible. The Parties thus agree that they will not insist on an equal share of it. The EC share for support of third party for Transnational Projects for each Party shall be limited to the Party’s respective financial contribution to the Joint Call. A Funding Organisation shall not receive more than 20% of the EC share for support of third party in a specific JTC. The Parties agree to use a mixed mode financing system to compensate cases where participating Funding Organisations have exhausted their budget at different points in the Ranking List. A minimum of 40 % EC share for support of third party for Transnational Projects will be used for proportional topping-up of the national/regional funding of the respective Parties. The remaining part of the EC share for support of third party for Transnational Projects will be reserved for financial balancing purposes. If more than 60 % of the EC share for support of third party for Transnational Projects is needed for balancing purposes in order to maximise the number of Transnational Projects that can be funded, this percentage may be further increased by a decision of organisations eligible for EC share for support of third party in the Call Steering Committee. The Call Steering Committee may re-evaluate the rules for using the EC share for support of third party for Transnational Projects, if needed. 9.3 Ranking List Based on the ranking of the Expert Panel, and considering the available budgets of the Funding Organisations and the EC share for support of third party, the Call Secretariat will propose a funding recommendation to the Call Steering Committee, considering that it is a requirement of EP PerMed to follow the Ranking List as suggested. The Call Steering Committee shall agree on the Ranking List based on the suggestion by the Call Secretariat. Projects with scores below the thresholds given in the text of the Joint Call will not be funded even if there is regional/national funding available. Adaption of the thresholds for specific JTC are possible by the respective CSC. 9.4 Conflicts of interest/ Information Barrier Parties and their representatives cannot be Beneficiary of competitive activities implemented in the context of EP PerMed. In particular, they cannot participate in proposals submitted to the Transnational calls for research proposals, unless they have been listed and allowed to do so in the Grant Agreement and Attachment 3 of this CA. Beneficiaries that are not listed may not apply for funding under EP PerMed’s Joint Transnational calls. Each organisation allowed to apply to the Joint Transnational Calls has indicated in the Grant Agreement and Attachment 3 their individual measures to mitigate the Conflicts of Interest, including but not limited to staff separation and Information barriers (chapter 9.4.2). In order to further avoid conflict of interests, Parties have also agreed to the setting up of “Firewalls”. Parties that may apply to Transnational calls for research proposals cannot participate in the WP 2 dedicated to the preparation, implementation or follow-up of the calls, nor have access to any information pertaining to these activities. This may require to organise meetings in compartmentalised sessions, in order to separate topics and discussions. 37 / 106  EP PerMed- Consortium Agreement 9.4.1 Conflicts of interest All Parties (CSC members and Reviewers) must report a potential Conflict of interest to the CSC. All staff involved in the action shall be required to disclose any conflict of interest to the Coordinator, who will handle the case and take adequate measures. • Parties applying in a joint call Parties agree to a compartmentalised organisation and governance. This means that Parties that may apply to co- funded Joint Calls (or other competitive activities supported by EP PerMed) may not participate in work packages and tasks dedicated to the preparation, implementation and monitoring of said activities. Neither may they access any information pertaining to the implementation of these work packages and tasks. A list of Parties allowed to apply to the Joint Calls is included in the Grant Agreement and Attachment 3. Parties that are not listed may not apply for funding under EP PerMed’s Joint Calls. Each Parties allowed to apply to the Joint Calls has indicated in the Grant Agreement and Attachment 3 their individual measures to mitigate the Conflicts of Interest, including but not limited to staff separation and Information barriers (chapter 9.4.2). For transparency, these Parties will also be listed in the relevant Call texts. • Conflict of interests in evaluation Each Party agrees that, in order to avoid any conflict of interest within the Joint calls developed in EP PerMed, it will not be involved in the evaluation process (including the appointment of the international panel of independent experts), if the Party or its Affiliated Entities plan to respond themselves to this call. In selecting the experts for the evaluation, the CSC shall endeavour to avoid any possible conflicts of interest. The Call Secretariat shall prepare a template concerning potential conflicts of interest and a declaration, which has to be confirmed by each expert involved in the evaluation of the Joint Calls. 9.4.2 Information Barrier If Parties or departments of Parties might apply in a joint activity, they must set up “information barriers” to avoid the technical possibility for Parties with a conflict of interest (see above) to access emails, documents or any information received by the staff involved with the preparation of documents to be used in the award procedure (e.g. Call, evaluation etc.) as well as internal guidance and control standards clearly prohibiting sharing such information within the organisation. The Information Barrier therefore prevents any possible Conflict of Interests and prevents Parties from accessing information regarding the preparation, implementation and follow up of calls. This includes compartmentalising discussion themes during meetings of relevant governing bodies (see chapter 6.3 and Attachment 3 of this CA). 9.5 Contractual obligations towards the Granting Authority on selection The Funding Organisations shall provide to the Coordinator within 10 days after the end of the selection process a formal and duly signed commitment on availability of funds for their selected projects. After the end of the selection process, the Coordinator shall submit to the Granting Authority the following: (a) the ranking list(s) of the projects; (b) the evaluation observers' report on the evaluation; 38 / 106  EP PerMed- Consortium Agreement (c) the joint selection list of the projects to be funded, and (d) from each Funding Organisation participating in the respective Joint Call, a formal and duly signed commitment on availability of funds for the selected projects. The Coordinator will furthermore submit to the Granting Authority after the end of the selection process information on each project selected for funding, including data on each participant and abstracts of the project proposal, in a format specified by the Granting Authority, for publication and evaluation purposes. This information will be updated at the end of EP PerMed (information on each Funded Project, including data on each participant and overview on the results). The Funding Organisations shall inform their final recipients in funding contracts that the above-mentioned data will be submitted to the Granting Authority. 9.6 Contractual obligations for projects funded in the Joint Calls The Parties acting as Funding Organisations for projects selected for funding in the Joint Calls agree to oblige their final recipients in funding contracts to the following: • to have a signed a consortium agreement latest 6 months after the start of the project at least addressing the following topics: o Internal organisation and management of the consortium o Intellectual property arrangements o Settlement of internal disputes • to prepare popular science summaries of the project contents for EP PerMed activities and publications (e.g. for brochures, [digital] newsletters, the website) • to take part in, and contribute with project presentations and/or posters to the foreseen events of EP PerMed • to prepare short annual scientific reports and one final scientific report according to standardised templates, to respond to up to two in-depth monitoring activities (mid-term and final) and to participate in monitoring survey after the projects have ended to measure project progress, project output and contribution to overall Co-fund Action aims • to provide the information on their projects, including data on each participant and abstracts of the project proposal, in a format specified by the Granting Authority, for publication and evaluation purposes • to follow the obligations of the EU- Grant Agreement Avoiding conflict of interest (see Article 12) Confidentiality and security obligations (see Article 13) Ethics (see Article 14) Give visibility to the EU funding as appropriate (see Article 17.2) Respect specific rules for the action implementation (see Article 18) 39 / 106  EP PerMed- Consortium Agreement Information obligations (see Article 19) Record-keeping (see Article 20) • to ensure that the bodies mentioned in Article 25 (e.g. Granting Authority, the European Court of Auditors (ECA), the European Anti-Fraud Office (OLAF)) have the right to carry out checks, reviews, audits and investigations on the final recipients, and in particular to audit the payments received. If access is denied by the final recipient, the costs will be rejected. 10 Results For the avoidance of doubt, the term “Results” in this chapter refers to the Results generated by the consortium of EP PerMed and does not include the results generated by Projects funded by the Joint Calls. 10.1 Ownership of Results Results are owned by the Party that generates them. 10.2 Joint ownership Joint ownership is governed by Grant Agreement Article 16.4 and its Annex 5, chapter “Ownership of results”, with the following additions: Unless otherwise agreed: − each of the joint owners shall be entitled to use their jointly owned Results for non-commercial research and teaching activities on a royalty-free basis, and without requiring the prior consent of the other joint owner(s). − each of the joint owners shall be entitled to otherwise Exploit the jointly owned Results and to grant non-exclusive licenses to third parties (without any right to sub-license), if the other joint owners are given: (a) at least 45 calendar days advance notice; and (b) fair and reasonable compensation. The joint owners shall agree on all protection measures and the division of related cost in advance. 10.3 Transfer of Results Each Party may transfer ownership of its own Results, including its share in jointly owned Results, following the procedures of the Grant Agreement Article 16.4 and its Annex 5, Section Transfer and licensing of results, sub- section “Transfer of ownership”. The Parties waive their right to prior notice and their right to object to such a transfer of ownership of results to identified third parties according to the Grant Agreement Article 16.4 and its Annex 5, Section Transfer of licensing of results, sub-section “Transfer of ownership”, 3rd paragraph. The transferring Party shall make reasonable efforts to inform the other Parties of such transfer as soon as practicable, however, not later than at the time of the transfer and shall ensure that the rights of the other Parties under the Consortium Agreement and the Grant Agreement will not be affected by such transfer. 40 / 106  EP PerMed- Consortium Agreement The Parties recognise that in the framework of a merger or an acquisition of an important part of its assets, it may be impossible under applicable EU and national laws on mergers and acquisitions for a Party to give at least 45 calendar days prior notice for the transfer as foreseen in the Grant Agreement. The obligations above apply only for as long as other Parties still have - or still may request - Access Rights to the Results. 10.4 Dissemination For the avoidance of doubt, the confidentiality obligations set out in chapter 12 apply to all dissemination activities described in this chapter 10.4 as far as Confidential Information is involved. 10.4.1 Dissemination of own (including jointly owned) Results During EP PerMed and for a period of 1 year after the end of EP PerMed, the dissemination of own Results by one or several Parties including but not restricted to publications and presentations, shall be governed by the procedure of article 17.4 of the Grant Agreement and its Annex 5, section “Dissemination”, subject to the following provisions: Prior notice of any planned publication shall be given to the other Parties at least 45 calendar days before the publication. Any objection to the planned publication shall be made in accordance with the Grant Agreement by written notice to the Coordinator and to the Party or Parties proposing the dissemination within 30 calendar days after receipt of the notice. If no objection is made within the time limit stated above, the publication is permitted. An objection is justified if a the protection of the objecting Party's Results or Background would be adversely affected, or b the objecting Party's legitimate interests in relation to its Results or Background would be significantly harmed, or c the proposed publication includes Confidential Information of the objecting Party. The objection has to include a precise request for necessary modifications. If an objection has been raised the involved Parties shall discuss how to overcome the justified grounds for the objection on a timely basis (for example by amendment to the planned publication and/or by protecting information before publication) and the objecting Party shall not unreasonably continue the opposition if appropriate measures are taken following the discussion. The objecting Party can request a publication delay of not more than 90 calendar days from the time it raises such an objection. After 90 calendar days the publication is permitted, provided that the objections of the objecting Party have been addressed. 10.4.2 Dissemination of another Party’s unpublished Results or Background A Party shall not include in any dissemination activity another Party's Results or Background without obtaining the owning Party's prior written approval, unless they are already published. 41 / 106  EP PerMed- Consortium Agreement 10.4.3 Cooperation obligations The Parties undertake to cooperate to allow the timely submission, examination, publication and defence of any dissertation or thesis for a degree that includes their Results or Background subject to the confidentiality and publication provisions agreed in this Consortium Agreement. 10.4.4 Use of names, logos or trademarks Nothing in this Consortium Agreement shall be construed as conferring rights to use in advertising, publicity or otherwise the name of the Parties or any of their logos or trademarks without their prior written approval. 11 Access Rights For the avoidance of doubt, this chapter refers to the Access Rights of the consortium of EP PerMed and does not include the background/results of the Funded Projects. 11.1 Background included In Attachment 1, the Parties have identified and agreed on the Background for EP PerMed and have also, where relevant, informed each other that Access to specific Background is subject to legal restrictions or limits. Anything not identified in Attachment 1 shall not be the object of Access Right obligations regarding Background. Any Party may add additional own Background to Attachment 1 during EP PerMed provided they give written notice to the other Parties. However, approval of the General Assembly is needed should a Party wish to modify or withdraw its Background in Attachment 1. 11.2 General Principles Each Party shall implement its tasks in accordance with the Consortium Plan and shall bear sole responsibility for ensuring that its acts within EP PerMed do not knowingly infringe third party property rights. Any Access Rights granted exclude any rights to sublicense unless expressly stated otherwise. Access Rights shall be free of any administrative transfer costs. Access Rights are granted on a non-exclusive basis. Results and Background shall be used only for the purposes for which Access Rights to it have been granted. All requests for Access Rights shall be made in writing. The granting of Access Rights may be made conditional on the acceptance of specific conditions aimed at ensuring that these rights will be used only for the intended purpose and that appropriate confidentiality obligations are in place. The requesting Party must show that the Access Rights are Needed. 11.3 Access Rights for implementation Access Rights to Results and Background Needed for the performance of the own work of a Party under EP PerMed shall be granted on a royalty-free basis, unless otherwise agreed for Background in Attachment 1. 42 / 106  EP PerMed- Consortium Agreement 11.4 Access Rights for Exploitation 11.4.1 Access Rights to Results Access Rights to Results if Needed for Exploitation of a Party's own Results shall be granted on Fair and Reasonable conditions. Access rights to Results for internal research and for teaching activities shall be granted on a royalty-free basis. 11.4.2 Access Rights to Background Access Rights to Background if Needed for Exploitation of a Party’s own Results, shall be granted on Fair and Reasonable conditions. 11.4.3 Requests A request for Access Rights may be made up to 12 months after the end of EP PerMed or, in the case of 11.7.2, after the termination of the requesting Party’s participation in EP PerMed. 11.5 Access Rights for entities under the same control Entities under the same control have Access Rights under the conditions of the Grant Agreement article 16.4 and its Annex 5, section "Access rights to results and background”, sub-section “Access rights for entities under the same control”. Such Access Rights must be requested by the entity under the same control from the Party that holds the Background or Results. Alternatively, the Party granting the Access Rights may individually agree with the Party requesting the Access Rights to have the Access Rights include the right to sublicense to the latter's entity under the same control. Access Rights to an entity under the same control shall be granted on Fair and Reasonable conditions and upon written bilateral agreement. Entities under the same control which obtain Access Rights in return fulfil all confidentiality obligations accepted by the Parties under the Grant Agreement or this Consortium Agreement as if such entities were Parties. Access Rights may be refused to entities under the same control if such granting is contrary to the legitimate interests of the Party which owns the Background or the Results. Access Rights granted to any entity under the same control are subject to the continuation of the Access Rights of the Party with whom it is under the same control, and shall automatically terminate upon termination of the Access Rights granted to such Party. Upon cessation of the status as an entity under the same control, any Access Rights granted to such former entity under the same control shall lapse. Further arrangements with entities under the same control may be negotiated in separate agreements. 11.6 Additional Access Rights For the avoidance of doubt any grant of Access Rights not covered by the Grant Agreement or this Consortium Agreement shall be at the absolute discretion of the owning Party and subject to such terms and conditions as may be agreed between the owning and receiving Parties. 43 / 106  EP PerMed- Consortium Agreement 11.7 Access Rights for Parties entering or leaving the consortium 11.7.1 New Parties entering the consortium As regards Results developed before the accession of the new Party, the new Party will be granted Access Rights on the conditions applying for Access Rights to Background. 11.7.2 Parties leaving the consortium Access Rights granted to a leaving Party: - Defaulting Party Access Rights granted to a Defaulting Party and such Party's right to request Access Rights shall cease immediately upon receipt by the Defaulting Party of the formal notice of the decision of the General Assembly to terminate its participation in the consortium. - Non-defaulting Party A non-defaulting Party leaving voluntarily and with the other Parties' consent shall have Access Rights to the Results developed until the date of the termination of its participation. It may request Access Rights within the period of time specified in 11.4.3. Access Rights to be granted by any leaving Party: Any Party leaving EP PerMed shall continue to grant Access Rights pursuant to the Grant Agreement and this Consortium Agreement as if it had remained a Party for the whole duration of EP PerMed. 11.8 Specific Provisions for Access Rights to Software For the avoidance of doubt, the general provisions for Access Rights provided for in this chapter 11 are applicable also to Software. Parties’ Access Rights to Software do not include any right to receive source code or object code ported to a certain hardware platform or any right to receive respective Software documentation in any particular form or detail, but only as available from the Party granting the Access Rights. 12 Non-disclosure of information 12.1 Confidential Information All information in whatever form or mode of communication, which is disclosed by a Party (the “Disclosing Party”) to any other Party (the “Recipient”) in connection with EP PerMed during its implementation and which has been explicitly marked as “confidential” at the time of disclosure, or when disclosed orally has been identified verbally or in writing as confidential at the time of disclosure or has been confirmed and designated in writing within 15 calendar days from oral disclosure at the latest as confidential information by the Disclosing Party, or is commonly regarded as confidential or proprietary in the life sciences industry, is “Confidential Information”. 12.2 Approach The Recipients hereby undertake in addition and without prejudice to any commitment on non-disclosure under the Grant Agreement, for a period of 5 years after the final payment of the Granting Authority or end of EP PerMed activities, whichever is later: − not to use Confidential Information otherwise than for the purpose for which it was disclosed; 44 / 106  EP PerMed- Consortium Agreement − not to disclose Confidential Information without the prior written consent by the Disclosing Party; − to ensure that internal distribution of Confidential Information by a Recipient shall take place on a strict need-to-know basis; and − to return to the Disclosing Party, or destroy, on request all Confidential Information that has been disclosed to the Recipients including all copies thereof and to delete all information stored in a machine-readable form to the extent practically possible. The Recipients may keep a copy to the extent it is required to keep, archive or store such Confidential Information because of compliance with applicable laws and regulations or for the proof of on-going obligations provided that the Recipient complies with the confidentiality obligations herein contained with respect to such copy. 12.3 Range The Recipients shall be responsible for the fulfilment of the above obligations on the part of their employees or third parties involved in EP PerMed and shall ensure that they remain so obliged, as far as legally possible, during and after the end of EP PerMed and/or after the termination of the contractual relationship with the employee or third party. 12.4 Exception The above shall not apply for disclosure or use of Confidential Information, if and in so far as the Recipient can show that: − the Confidential Information has become or becomes publicly available by means other than a breach of the Recipient’s confidentiality obligations; − the Disclosing Party subsequently informs the Recipient that the Confidential Information is no longer confidential; − the Confidential Information is communicated to the Recipient without any obligation of confidentiality by a third party who is to the best knowledge of the Recipient in lawful possession thereof and under no obligation of confidentiality to the Disclosing Party; − the disclosure or communication of the Confidential Information is foreseen by provisions of the Grant Agreement; − the Confidential Information, at any time, was developed by the Recipient completely independently of any such disclosure by the Disclosing Party; − the Confidential Information was already known to the Recipient prior to disclosure, or − the Recipient is required to disclose the Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, subject to the provisions in 12.7 hereunder. 12.5 Handling The Recipient shall apply the same degree of care with regard to the Confidential Information disclosed within the scope of EP PerMed as with its own confidential and/or proprietary information, but in no case less than reasonable care. 12.6 Unauthorised disclosure Each Recipient shall promptly inform the relevant Disclosing Party by written notice of any unauthorised disclosure, misappropriation or misuse of Confidential Information after it becomes aware of such unauthorised disclosure, misappropriation or misuse. 45 / 106  EP PerMed- Consortium Agreement 12.7 Disclosure of Confidential Information for compliance with applicable laws and regulations If any Recipient becomes aware that it will be required, or is likely to be required, to disclose Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, it shall, to the extent it is lawfully able to do so, prior to any such disclosure according to the described approach in chapter 12.2. the Disclosing Party will be notified. 12.8 Confidentiality in Transnational Projects The content of the proposals received under the Joint Call is deemed to be confidential, except of the lists of applications and lists of Funded Projects. This obligation shall survive the expiration or termination of the Consortium Agreement. 13 Data management Appropriate and secure use of materials and data of Transnational Projects will be enabled according to the application of common standards. Data management guidelines will be developed by the Lead of WP 2 in month 12 and will be applied in the Joint Call. The collected data will be protected and secured, in order to avoid a malevolent use of it. 14 Miscellaneous 14.1 Attachments, inconsistencies and severability This Consortium Agreement consists of this core text and: − Attachment 1 (Background included) − Attachment 2 (Accession document) − Attachment 3 (Conflicts of Interest/Information Barrier in Call implementation) In case the terms of this Consortium Agreement are in conflict with the terms of the Grant Agreement, the terms of the latter shall prevail. In case of conflicts between the attachments and the core text of this Consortium Agreement, the latter shall prevail. Should any provision of this Consortium Agreement become invalid, illegal or unenforceable, it shall not affect the validity of the remaining provisions of this Consortium Agreement. In such a case, the Parties concerned shall be entitled to request that a valid and practicable provision be negotiated that fulfils the purpose of the original provision. 14.2 No representation, partnership or agency Except as otherwise provided in 7.6.1, no Party shall be entitled to act or to make legally binding declarations on behalf of any other Party or of the consortium. Nothing in this Consortium Agreement shall be deemed to constitute a joint venture, agency, partnership, interest grouping or any other kind of formal business grouping or entity between the Parties. 46 / 106  EP PerMed- Consortium Agreement 14.3 Formal and written notices Any notice to be given under this Consortium Agreement shall be addressed to the recipients as listed in the most current address list kept by the Coordinator. Any change of persons or contact details shall be immediately communicated to the Coordinator by written notice. The address list shall be accessible to all Parties. Formal notices: If it is required in this Consortium Agreement (4.4 and 14.4) that a formal notice, consent or approval shall be given, such notice shall be signed by an authorised representative of a Party and shall either be served personally or sent by mail with recorded delivery with acknowledgement of receipt. Written notice: Where written notice is required by this Consortium Agreement, this is fulfilled also by other means of communication such as e-mail with acknowledgement of receipt. 14.4 Assignment and amendments Except as set out in 10.3, no rights or obligations of the Parties arising from this Consortium Agreement may be assigned or transferred, in whole or in part, to any third party without the other Parties’ prior formal approval. Amendments and modifications to the text of this Consortium Agreement not explicitly listed in 7.1.2 require a separate written agreement to be signed between all Parties. 14.5 Mandatory national law Nothing in this Consortium Agreement shall be deemed to require a Party to breach any mandatory statutory law under which the Party is operating. 14.6 Language This Consortium Agreement is drawn up in English, which language shall govern all documents, notices, meetings, arbitral proceedings and processes relative thereto. 14.7 Applicable law This Consortium Agreement shall be construed in accordance with and governed by the laws of Belgium excluding its conflict of law provisions. 14.8 Settlement of disputes 14.8.1 Amicable solution within the consortium The Parties shall endeavour to settle their disputes amicably. In case of a conflict of opinion which cannot be solved within the respective Consortium Body or between the respective Consortium Bodies, the Coordinator shall be approached for advice. The Coordinator may decide to seek a decision of the General Assembly in order to come to a solution. If the Coordinator is involved in the conflict, WP Lead 2 should take over this role. 47 / 106  EP PerMed- Consortium Agreement 14.8.2 Dispute resolution Should the attempts to settle the dispute within the consortium fail to bring about a full agreement between the Parties, the Consortium will try to solve it through the following method of dispute resolution. All disputes arising out of or in connection with this Consortium Agreement, which cannot be solved amicably, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules. The place of arbitration shall be Brussels if not otherwise agreed by the conflicting Parties. The award of the arbitration will be final and binding upon the Parties. If this method is not applicable for a Parties, nothing in this Consortium Agreement shall limit the Parties' right to seek injunctive relief in any applicable competent court. 48 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. Deutsches Zentrum für Luft- und Raumfahrt e. V. (COO) Name(s) Title(s) Date 49 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P02) Agence Nationale de la Recherche (BEN) Name(s) Title(s) Date 50 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P03) VLAAMSE GVLAAMSE GEWESTEWEST (BEN) Name(s) Title(s) Date 51 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P04) IACS – (Instituto Aragones De Ciencias De La Salud - Health Sciences Institute in Aragon) (BEN) Name(s) Title(s) Date 52 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P05) Fondazione Toscana Life Sciences (BEN) Name(s) Title(s) Date 53 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P06) The Research Council of Norway (BEN) Name(s) Title(s) Date 54 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P07) MINISTERO DELLA SALUTE (BEN) Name(s) Title(s) Date 55 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P08) Instituto de Salud Carlos III (BEN) Name(s) Title(s) Date 56 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P09) Science Foundation Ireland (BEN) Name(s) Title(s) Date 57 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P10) Saxon State Ministry for Science, Culture and Tourism (BEN) Name(s) Title(s) Date 58 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P11) Fondazione Telethon ETS (BEN) Name(s) Title(s) Date 59 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P12) Fondazione Regionale per la Ricerca Biomedica (BEN) Name(s) Title(s) Date 60 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P13) Fonds zur Förderung der wissenschaftlichen Forschung (BEN) Name(s) Title(s) Date 61 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P14) Health Research Board (BEN) Name(s) Title(s) Date 62 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P15) Lietuvos mokslo taryba (Research Council of Lithuania) (BEN) Name(s) Title(s) Date 63 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P16) Medical Research & Development Fund for Health Services (BEN) Name(s) Title(s) Date 64 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P17) ETAG - Sihtasutus Eesti Teadusagentuur (BEN) Name(s) Title(s) Date 65 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P18) The Scientific and Technological Research Council of Turkey (BEN) Name(s) Title(s) Date 66 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P19) EIT Health e.V. (BEN) Name(s) Title(s) Date 67 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P19.1) EIT Health BENE (AE) Name(s) Title(s) Date 68 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P19.2) EIT Health SCAN (AE) Name(s) Title(s) Date 69 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P20) VINNOVA Sweden´s Innovation Agency (BEN) Name(s) Title(s) Date 70 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P21) National Centre for Research and Development (BEN) Name(s) Title(s) Date 71 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P22) Agency for Clinical Research and Biomedical Innovation (BEN) Name(s) Title(s) Date 72 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P23) Fundação para a Ciência e a Tecnologia (BEN) Name(s) Title(s) Date 73 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P24) Zorgonderzoek Nederland ZON (BEN) Name(s) Title(s) Date 74 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P25) Fonds National de la Recherche (BEN) Name(s) Title(s) Date 75 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P26) Regione Toscana (BEN) Name(s) Title(s) Date 76 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P27) SERVICE PUBLIC DE WALLONIE (BEN) Name(s) Title(s) Date 77 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P28) FONDS DE LA RECHERCHE SCIENTIFIQUE- FNRS (BEN) Name(s) Title(s) Date 78 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P29) DEPARTAMENT DE SALUT - GENERALITAT DE CATALUNYA (BEN) Name(s) Title(s) Date 79 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P30) Comunidad Foral de Navarra (BEN) Name(s) Title(s) Date 80 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P31) Sotsiaalministeerium Estonia (BEN) Name(s) Title(s) Date 81 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P32) FONDS VOOR WETENSCHAPPELIJK ONDERZOEK-VLAANDEREN - FONDS WETENSCHAPPELIJK ONDERZOEK - VLAANDEREN FWO (BEN) Name(s) Title(s) Date 82 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P33) Innovaatiorahoituskeskus Business Finland (BEN) Name(s) Title(s) Date 83 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P33.1) Business Finland Oy (AE) Name(s) Title(s) Date 84 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P34) Swedish Research Council (BEN) Name(s) Title(s) Date 85 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P35) Academy of Finland (BEN) Name(s) Title(s) Date 86 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P36) Biobanking an Biomolecular Resources Research Infrastructure - European Research Infrastructure Consortium (BEN) Name(s) Title(s) Date 87 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P37) Innovation Fund Denmark (BEN) Name(s) Title(s) Date 88 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P38) National Research, Development and Innovation Office (BEN) Name(s) Title(s) Date 89 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P39) Latvian Council of Science (BEN) Name(s) Title(s) Date 90 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P40) Regiao Autónoma dos Acores (BEN) Name(s) Title(s) Date 91 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P41) Comissão de Coordenação e Desenvolvimento Regional do Centro (BEN) Name(s) Title(s) Date 92 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P42) The Icelandic Centre for Research (BEN) Name(s) Title(s) Date 93 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P43) Ministry of Economy and Finance Revolving Fund Community Policies (BEN) Name(s) Title(s) Date 94 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P44) DEPARTAMENTO DE SALUD GOBIERNO VASCO (BEN) Name(s) Title(s) Date 95 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P44.1) Basque Foundation for Health Research and Innovation (BIOEF) (AE) Name(s) Title(s) Date 96 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P45) UNITATEA EXECUTIVA PENTRU FINANTAREA INVATAMANTULUI SUPERIOR A CERCETARII DEZVOLTARII SI INOVARII (BEN) Name(s) Title(s) Date 97 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P46) Federal Ministry of Health (BMG) (BEN) Name(s) Title(s) Date 98 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P47) Bundesministerium für Bildung und Forschung (BMBF) (BEN) Name(s) Title(s) Date 99 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P48) Bundesministerium für Bildung, Wissenschaft und Forschung (BMBWF AT) (BEN) Name(s) Title(s) Date 100 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P49) FONDS INNOVEREN EN ONDERNEMEN (BEN) Name(s) Title(s) Date 101 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P50) INNOSUISSE (AF) Name(s) Title(s) Date 102 / 106  EP PerMed- Consortium Agreement Appendix Attachment 1: Background Included According to the Grant Agreement (Article 16.1) Background is defined as “data, know-how or information (…) that is (…) needed to implement the Action or exploit the results”. Because of this need, Access Rights have to be granted in principle, but Parties must identify and agree amongst them on the Background for EP PerMed. This is the purpose of this attachment. PARTY 1 As to [NAME OF THE PARTY], it is agreed between the Parties that, to the best of their knowledge, [insert the relevant option here]. [Option 1] the following Background is hereby identified and agreed upon for EP PerMed. Specific limitations and/or conditions, shall be as mentioned hereunder: Background description Specific restrictions and/or Specific restrictions and/or conditions for implementation conditions for Exploitation (Article 16.4 Grant Agreement and (Article 16.4 Grant Agreement its Annex 5, chapter “Access rights and its Annex 5, chapter to results and background”, sub- “Access rights to results and section “Access rights to background”, sub-section background and results for “Access rights for exploiting the implementing the Action”) results”) This represents the status at the time of signature of this Consortium Agreement. [Option 2] no data, know-how or information of [NAME OF THE PARTY] is Needed by another Party for implementation of EP PerMed (Article 16.1 and its Annex 5 Grant Agreement, chapter “Access rights to results and background”, sub-section “Access rights to background and results for implementing the action”) or Exploitation of that other Party’s Results (Article 16.1 and its Annex 5 Grant Agreement, chapter “Access rights to results and background”, sub-section “Access rights for exploiting the results”). This represents the status at the time of signature of this Consortium Agreement. [Same for PARTY 2, PARTY 3, etc] 103 / 106  EP PerMed- Consortium Agreement Attachment 2: Accession document ACCESSION of a new Party to [ACRONYM OF THE CO-FUND ACTION] Consortium Agreement, version xx, [DATE] [OFFICIAL NAME OF THE NEW PARTY AS IDENTIFIED IN THE GRANT AGREEMENT] hereby consents to become a Party to the Consortium Agreement identified above and accepts all the rights and obligations of a Party starting [DATE]. [OFFICIAL NAME OF THE COORDINATOR AS IDENTIFIED IN THE GRANT AGREEMENT] hereby certifies that the consortium has accepted in the meeting held on [DATE] the accession of [THE NAME OF THE NEW PARTY] to the consortium starting [DATE]. This accession document has been done in 2 originals to be duly signed by the undersigned authorised representatives. [DATE] [PLACE] [NAME OF THE NEW PARTY] Signature(s) Name(s) Title(s) [DATE] [PLACE] [NAME OF THE COORDINATOR] Signature(s) Name(s) Title(s) 104 / 106  EP PerMed- Consortium Agreement Attachment 3: Conflicts of Interest and Information Barrier in Call implementation Possibility to fund members of the consortiums through the Financial Support to Third Parties When implementing financial support to third parties in co-funded partnerships, the beneficiaries must avoid any conflict of interest and comply with the principles of transparency, non-discrimination and sound financial management. EP PerMed partners will not be allowed to participate as potential applicants (coordinators or partners) in JTCs. However, under exceptional circumstances there could be (under the current constellation of the EP PerMed consortium) some beneficiary that could participate in calls. These partners are the following: ISCIII, BBMRI, TUBITAK. As the EP PerMed is open for additional organisations joining the EP PerMed consortium, there might be additional concerned organisation in the future. The process to follow for avoiding conflict of interest will consist in identifying for each call the potential partners that could apply, send to the JCS the necessary information to confirm that there is not conflict of interest and request a written approval. The organisation could not apply until it has received a positive answer by the JCS. The criteria for not having conflict of interest are: • EP PerMed partner and the corresponding third parties belong to an independent department • EP PerMed partner and the corresponding third parties have independent management structure • The third parties must be eligible to receive funds from the corresponding EP PerMed partner and have no connections to the internal mechanisms In addition, the following information is important: - BBMRI-ERIC will be mainly involved within WP5 activities and may participate to other activities within WP3 and WP4 of the EP PerMed. BBMRI-ERIC is a pan-European federated research infrastructure under the ERIC legal framework. BBMRI-ERIC will not be involved in the EP PerMed management or implemen- tation of the calls themselves. BBMRI National Nodes and their biobanks as well as other research centers may apply for some of the calls under EP PerMed. The BBMRI National Nodes, their biobanks and research centers are located across BBMRI-ERIC 23 member and observer countries and one international organisa- tion; they are not operated under the ERIC legal framework. - EITH will be involved in the conceptualisation and design of many calls (in WP2 only those related to RITC), as well as in the management and implementation of some (fast-track validation grants under WP3). EITH and its affiliates are not eligible to act as a beneficiary for the latter (which are aimed at innovators such as research organisations and hospitals) and will refrain from acting as a beneficiary for the former. This will preclude conflicts of interest and ensure working in full transparency. - FTELE acts both as a research funding organisation as well as research performing organisation. FTELE runs 2 research institutes: The Telethon Institute for Genetics and Medicine (TIGEM) based in Pozzuoli (Naples) which is fully owned by FTELE and the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) based in Milan and which is a joint-venture with the San Raffaele University Hospital. Both institutes perform re- search in the field of PM and may apply to the EP PerMed joint call under FTELE legal entity. To prevent any potential conflict of interest and to create a "firewall" between the FTELE involved in the EP PerMed and the researchers who may apply to EP PerMed call, the following measures will be implemented: - FTELE will be deeply involved in WP3 and partially in WP1 (to promote the synergies with the EU partnership on Rare Diseases) and WP5. FTELE team will not be involved in the management or implementation of the calls themselves nor in the discussion on the priorities for the calls. - Despite focusing only on the above mention WPs, FTELE team involved in EP PerMed will not include any researcher who may apply to the calls. FTELE team involved in the project is based in FTELE offices in Milan, away from the hospital that hosts SR-TIGET and belongs to 2 offices 105 / 106  EP PerMed- Consortium Agreement (Public Affairs and Business Development) that do not perform any lab research activity. - IACS (Institute for Health Sciences in Aragon) is the entity that promotes research, innovation and knowledge brokering in biomedicine and health sciences for the Aragon Regional Health System. IACS carries out its activity with the expectation of contributing to high quality care in the public health system, supporting inno- vation, research of excellence and benchmark training, as well as supporting the creation of wealth and eco- nomic growth. IACS will be deeply involved in WP3 and WP4. IACS will not be involved in the management or implementation of the project calls themselves. In the event that its own researchers (understood as re- searchers hired by the institution) would like to apply to a project call, IACS would not participate in the management and implementation of the call, but also not in the discussions for the proposal and design of the topic. - ISCIII is a public research organisation that also manages the National Health Strategic Research Action. ISCIII launches yearly competitive calls for projects, contracts, fellowships, networks, R&D platforms and independent clinical trials. Both missions (research performing and funding activities) are separated physi- cally in different campuses and they are managed by completely different structures (Underdirectorates). - TUBITAK, in addition to being a funding organisation, has various research institutes including a health- related institute, namely the TUBİTAK Marmara Research Centre Life Sciences Institute. This institute may want to apply to some calls under EP PerMed. However, these institutes are not directly linked to where the project will be carried out, which is the International cooperation department under the TUBITAK Presidency which is located in a different city in addition to having different managers. The institutions are normally eligible to receive funds from TUBITAK and have no connections to the internal mechanisms. 106 / 106 EP PerMed- Consortium Agreement Consortium Agreement for co-funded European Partnerships European Partnership for Personalised Medicine (EP PerMed) (Based on DESCA – Model Consortium Agreement for Horizon Europe, version 1.1, November 2022)  EP PerMed- Consortium Agreement Change Records Version Date Changes version 1 22 September 2023 Initial draft for co-funded European Partnerships for Personalised Medicine (EP PerMed) in Horizon Europe version 2 11 January 2024 Final version 19 February 2024  EP PerMed- Consortium Agreement Table of contents 1 Definitions ...................................................................................................................................... 10 1.1 Definitions............................................................................................................................... 10 1.2 Additional Definitions .............................................................................................................. 10 1.3 Applicable Documents.............................................................................................................. 12 2 Purpose .......................................................................................................................................... 12 3 Entry into force, duration and termination ..................................................................................... 12 3.1 Entry into force ........................................................................................................................ 12 3.2 Duration and termination .......................................................................................................... 12 3.3 Survival of rights and obligations .............................................................................................. 13 4 Responsibilities of Parties ............................................................................................................... 13 4.1 General principles .................................................................................................................. 13 4.2 Specific responsibilities for Affiliated Entities ............................................................................ 14 4.3 Specific responsibilities for Associated Partner(s) - AP ............................................................... 14 4.4 Breach..................................................................................................................................... 15 4.5 Involvement of third parties ....................................................................................................... 15 4.6 Specific responsibilities regarding data protection ....................................................................... 15 5 Liability towards each other ........................................................................................................... 16 5.1 No warranties ........................................................................................................................... 16 5.2 Limitations of contractual liability .............................................................................................. 16 5.3 Damage caused to third parties ................................................................................................... 16 5.4 Force Majeure .......................................................................................................................... 16 6 Governance structure ..................................................................................................................... 17 6.1 General structure ...................................................................................................................... 17 6.2 General operational procedures for all Consortium Bodies ............................................................ 18 6.2.1 Representation in meetings .................................................................................................... 18 6.2.2 Preparation and organisation of meetings ................................................................................ 18 6.2.3 Voting rules and quorum ....................................................................................................... 20 6.2.4 Veto rights ........................................................................................................................... 22 6.2.5 Minutes of meetings ............................................................................................................. 22 6.3 Firewall for meetings regarding any EP PerMed calls (on-site, online or hybrid) ........................... 22 7 Specific operational procedures for the Consortium Bodies ............................................................ 22 7.1 General Assembly .................................................................................................................... 22 7.1.1 Members ............................................................................................................................. 23 7.1.2 Decisions ............................................................................................................................. 23 7.2 Coordination Unit .................................................................................................................... 24 3 / 106  EP PerMed- Consortium Agreement 7.2.1 Members ............................................................................................................................. 24 7.2.2 Minutes of meetings ............................................................................................................. 24 7.2.3 Tasks .................................................................................................................................. 24 7.3 Extended General Assembly ..................................................................................................... 24 7.3.1 Members ............................................................................................................................. 24 7.3.2 Tasks .................................................................................................................................. 25 7.4 Call Steering Committee ........................................................................................................... 25 7.4.1 Members ............................................................................................................................. 25 7.4.2 Mandate .............................................................................................................................. 25 7.4.3 Tasks .................................................................................................................................. 25 7.5 Call Secretariat ........................................................................................................................ 26 7.6 Coordinator ............................................................................................................................. 26 8 Financial provisions........................................................................................................................ 27 8.1 General Principles .................................................................................................................... 27 8.1.1 Distribution of the EC Financial Contributions ......................................................................... 27 8.1.2 Funding Principles ............................................................................................................... 28 8.1.3 Financial Consequences of the termination of the participation of a Party ................................. 28 8.2 Payments ................................................................................................................................. 28 8.2.1 General Principles ................................................................................................................ 28 8.2.2 Withholding of Payments ...................................................................................................... 29 8.2.3 Budgeting ............................................................................................................................ 29 8.2.4 Justifying costs .................................................................................................................... 30 8.2.5 Payment schedule ................................................................................................................. 30 8.2.6 Reserve fund ........................................................................................................................ 31 8.2.7 Excess payments .................................................................................................................. 32 8.2.8 Revenue .............................................................................................................................. 32 8.2.9 Costs of Certificates on the Financial Statements .................................................................... 32 8.3 Reporting ................................................................................................................................ 32 8.3.1 Reporting to the Granting Authority (Periodic Report) ............................................................ 32 4 / 106  EP PerMed- Consortium Agreement 8.3.2 Reporting to the Coordinator (Internal Report) ........................................................................ 33 8.4 Insufficient EC Financial Contribution ....................................................................................... 33 8.4.1 Cost monitoring system ........................................................................................................ 33 8.4.2 Regular trainings on cost reporting ........................................................................................ 33 8.4.3 Less EC Financial Contribution than foreseen for the Joint Transnational Calls (category D1) .... 33 8.4.4 Less EC Financial Contribution than foreseen for Consortium Budget than foreseen in the Consortium Plan .............................................................................................................................. 34 8.4.5 No EU Financial Contribution ............................................................................................... 35 8.5 Budget flexibility ..................................................................................................................... 35 9 Call Implementation ....................................................................................................................... 36 9.1 Selection process: ..................................................................................................................... 36 9.1.1 Central scientific evaluation (Step 1) ...................................................................................... 36 9.1.2 Central scientific evaluation (Step 2) ...................................................................................... 36 9.2 Use of EC share for support of third party of Transnational Projects (JTCs) .................................. 36 9.3 Ranking List ............................................................................................................................ 37 9.4 Conflicts of interest/ information Barrier .................................................................................... 37 9.4.1 Conflicts of interest .............................................................................................................. 38 9.4.2 Information Barrier .............................................................................................................. 38 9.5 Contractual obligations towards the Granting Authority on selection ............................................ 38 9.6 Contractual obligations for projects funded in the Joint Calls ....................................................... 39 10 Results ............................................................................................................................................ 40 10.1 Ownership of Results ............................................................................................................... 40 10.2 Joint ownership ........................................................................................................................ 40 10.3 Transfer of Results ................................................................................................................... 40 10.4 Dissemination .......................................................................................................................... 41 10.4.1 Dissemination of own (including jointly owned) Results ..................................................... 41 10.4.2 Dissemination of another Party’s unpublished Results or Background .................................. 41 10.4.3 Cooperation obligations .................................................................................................... 42 10.4.4 Use of names, logos or trademarks ..................................................................................... 42 11 Access Rights .................................................................................................................................. 42 11.1 Background included ................................................................................................................ 42 11.2 General Principles .................................................................................................................... 42 11.3 Access Rights for implementation ............................................................................................. 42 5 / 106  EP PerMed- Consortium Agreement 11.4 Access Rights for Exploitation .................................................................................................. 43 11.4.1 Access Rights to Results ................................................................................................... 43 11.4.2 Access Rights to Background ............................................................................................ 43 11.4.3 Requests .......................................................................................................................... 43 11.5 Access Rights for entities under the same control ........................................................................ 43 11.6 Additional Access Rights .......................................................................................................... 43 11.7 Access Rights for Parties entering or leaving the consortium........................................................ 44 11.7.1 New Parties entering the consortium .................................................................................. 44 11.7.2 Parties leaving the consortium ........................................................................................... 44 11.8 Specific Provisions for Access Rights to Software ...................................................................... 44 12 Non-disclosure of information ........................................................................................................ 44 12.1 Confidential Information........................................................................................................... 44 12.2 Approach................................................................................................................................. 44 12.3 Range ...................................................................................................................................... 45 12.4 Exception ................................................................................................................................ 45 12.5 Handling ................................................................................................................................. 45 12.6 Unauthorised disclosure ............................................................................................................ 45 12.7 Disclosure of Confidential Information for compliance with applicable laws and regulations .......... 46 12.8 Confidentiality in Transnational Projects .................................................................................... 46 13 Data management ........................................................................................................................... 46 14 Miscellaneous ................................................................................................................................. 46 14.1 Attachments, inconsistencies and severability ............................................................................. 46 14.2 No representation, partnership or agency .................................................................................... 46 14.3 Formal and written notices ........................................................................................................ 47 14.4 Assignment and amendments .................................................................................................... 47 14.5 Mandatory national law ............................................................................................................ 47 14.6 Language................................................................................................................................. 47 14.7 Applicable law ......................................................................................................................... 47 14.8 Settlement of disputes ............................................................................................................... 47 14.8.1 Amicable solution within the consortium............................................................................ 47 14.8.2 Dispute resolution ............................................................................................................ 48 15 Signatures ...................................................................................................................................... 49 Appendix: Attachment 1: Background Included .................................................................................................... 103 Attachment 2: Accession document ...................................................................................................... 104 6 / 106  EP PerMed- Consortium Agreement CONSORTIUM AGREEMENT THIS CONSORTIUM AGREEMENT is based upon Regulation (EU) No 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation (2021-2027), laying down its rules for participation and dissemination (hereinafter referred to as “Horizon Europe Regulation”), and the European Commission’s General Model Grant Agreement and its Annexes, and is made on November 1st 2023, hereinafter referred to as the Effective Date. BETWEEN: Short name - Participant organisation name N° Role Legal address DLR – Deutsches Zentrum für Luft- und Raumfahrt 1 (Co) COR LINDER HOEHE, 51147, KOELN, DE ANR – Agence National de la Recherche 2 86 RUE REGNAULT, 75013, PARIS, FR BEN VLO-EWI – Vlaams Gewest - VLAIO Flanders Innovation & Entrepreneurship - Flemish 3 Government AVENUE DU PORT 88, 1000, BRUSSEL, BE BEN IACS – (Instituto Aragones De Ciencias De La Salud - Health Sciences Institute in Aragon) 4 AVENIDA SAN JUAN BOSCO 13, 50009, ZARAGOZA, ES BEN TLS – Fondazione Toscana Life Sciences 5 VIA FIORENTINA 1, 53100, SIENA, IT BEN RCN – The Research Council of Norway 6 DRAMMENSVEIEN 288, 0283, OSLO, NO BEN IT-MoH – Ministero Della Salute 7 Via Giorgio Ribotta 5, 00144, ROMA, IT BEN ISCIII – Instituto de Salud Carlos III 8 MONFORTE DE LEMOS 5, 28029, MADRID, ES BEN SFI – Science Foundation Ireland 9 THREE PARK PLACE, HATCH STREET UPPER, D002FX65, DUBLIN, IE BEN SMWK – Saxon State Ministry for Science, Culture and Tourism 10 WIGARDSTRASSE 17, 01097, Dresden, DE BEN FTELE - Fondazione Telethon Ets 11 VIA VARESE 16/B, 00185, ROMA, IT BEN FRRB - Fondazione Regionale per la Ricerca Biomedica 12 PIAZZA CITTA DI LOMBARDIA 1, 20124, MILANO, IT BEN FWF - Fonds zur Förderung der wissenschaftlichen Forschung 13 GEORG-COCH-PLATZ 2, 1010, WIEN, AT BEN HRB - Health Research Board 14 67 72 LOWER MOUNT STREET, D02 H638, DUBLIN, IE BEN LMT - Lietuvos mokslo taryba, (Research Council of Lithuania) 15 Gedimino 3, LT-01103, Vilnius, LT BEN CSO-MOH - Chief Scientist Office – Ministry of Health 16 YIRMIYAHU 39, 9101002, JERUSALEM, IL BEN ETAG - Sihtasutus Eesti Teadusagentuur 17 SOOLA 8, 51004, TARTU, EE BEN TUBITAK – TURKIYE BILIMSEL VE TEKNOLOJIK ARASTIRMA KURUMU 18 Ataturk Bulvari 221, 06100, ANKARA, TR BEN EITH - EIT Health eV 19 MIES-VAN-DER-ROHE-STRASSE 1 C, 80807, MUNCHEN, DE BEN 19.1 EITH BENE AE 19.2 EIHT SCAN AE VINNOVA - VINNOVA Sweden´s Innovation Agency 20 MASTER SAMUELSG 56, 10158, STOCKHOLM, SE BEN NCBR - National Centre for Research and Development 21 UL. CHMIELNA 69, 00-801, WARSZAWA, PL BEN AICIB - Agency for Clinical Research and Biomedical Innovation 22 RUA DE SANTA CATARINA 1288, 4000-447, PORTO, PT BEN 7 / 106  EP PerMed- Consortium Agreement FCT - Fundação para a Ciência e a Tecnologia 23 AVENIDA D CARLOS I 126, 1249 074, LISBOA, PT BEN ZonMw - Zorgonderzoek Nederland ZON 24 Laan Van Nieuw Oost Indie 334, 2593 CE, DEN HAAG, NL BEN FNR - Fonds National de la Recherche 25 2 AVENUE DE L'UNIVERSITE, 4365, ESCH-SUR-ALZETTE, LU BEN RT - Regione Toscana – Tuscany Region 26 Palazzo Strozzi Sacrati - Piazza del Duomo 10, 50122, FIRENZE, IT BEN SPW EER – Service Public De Wallonie 27 Place de la Wallonie 1, 5100, Namur, BE BEN FRS-FNRS - Fonds De La Recherche Scientifique- FNRS 28 RUE D'EGMONT 5, 1000, BRUXELLES, BE BEN DS-CAT - Departament De Salut - Generalitat De Catalunya 29 Trav. de les Corts (Pavelló Ave Maria) 131-159, 08028, BARCELONA, ES BEN CFN - Comunidad Foral de Navarra 30 AVENIDA CARLOS III 2, 31002, PAMPLONA, ES BEN MoSAE – Sotsiaalministeerium 31 Suur-Ameerika 1, 10122, TALLINN, EE BEN FWO - Fonds voor Wetenschappelijk Onderzoek-Vlaanderen 32 LEUVENSEWEG 38, 1000, BRUSSEL, BE BEN BFRK - Innovaatiorahoituskeskus Business Finland 33 PO BOX 69, 00101, HELSINKI, FI BEN 33.1 BFOY - Business Finland Oy AE SRC Swedish Research Council 34 BOX 1035, 101 38, STOCKHOLM, SE BEN AKA - Academy of Finland 35 HAKANIEMENRANTA 6, 00531, HELSINKI, FI BEN BBMRI-ERIC - Biobanking an Biomolecular Resources Research Infrastructure - European 36 Research Infrastructure Consortium NEUE STIFTINGTALSTRASSE 2/B/6, 8010, GRAZ, AT BEN IFD - Innovation Fund Denmark 37 OSTERGADE 26 A, 1100, KOBENHAVN K, DK BEN NKFIH - National Research, Development and Innovation Office 38 KETHLY ANNA TER 1, 1077, BUDAPEST, HU BEN LZP - Latvian Council of Science 39 SMILSU IELA 8, 1050, RIGA, LV BEN DRCT - Direção Regional da Ciência e Tecnologia / Regional Directorate of Science and 40 Technology LARGO PRIOR DO CRATO, 9700-157, PONTA DELGADA, PT BEN CCDRC - Comissão de Coordenação e Desenvolvimento Regional do Centro 41 RUA BERNARDIM RIBEIRO 80, 3000-069, COIMBRA, PT BEN RANNIS - The Icelandic Centre for Research 42 BORGARTUNI 30, 105, REYKJAVIK, IS BEN MUR - Ministero dell/Università e della Ricerca 43 Via Michele Carcani 61, 00153, Roma, IT BEN DPTO Salud – Departamento De Salud Gobierno Vasco 44 Donostia-San Sebastián, 1, 01010, VITORIA-GASTEIZ, ES BEN BIOEF - Basque Foundation for Health Innovation and Research 44.1 AE UEFISCDI - Unitatea executiva pentru finantarea invatamantului superior a cercetarii 45 dezvoltarii si inovarii STR D I MENDELEEV 21-25, 010362, BUCURESTI, RO BEN BMG - Bundesministerium für Gesundheit 46 ROCHUSTRASSE 1, 53123, BONN, DE BEN BMBF - Bundesministerium für Bildung und Forschung 47 Heinemannstrasse 2, 53175, BONN, DE BEN BMBWF AT - Bundesministerium für Bildung, Wissenschaft und Forschung 48 MINORITENPLATZ 5, 1010, VIENNA, AT BEN FIO – FONDS INNOVEREN EN ONDERNEMEN 49 BOULEVARD DU ROI ALBERT II 35, 1030, BRUXELLES, BE BEN 8 / 106  EP PerMed- Consortium Agreement (hereinafter, jointly or individually, referred to as „Coordinator”/“Beneficiaries”/“Affiliated Entities” or “Parties”) and INNOSUISSE - SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG 50 EINSTEINSTRASSE 2, 3003, BERN Switzerland AP (hereinafter referred to as “Associated Partner”, – the Associated Partner is also included in the term “Parties” (see above)) relating to the Action entitled European Partnership for Personalised Medicine in short EP PerMed hereinafter referred to as “EP PerMed”. WHEREAS: The Parties, having considerable experience in the field concerned, have submitted a proposal for the EP PerMed to the European Commission1 as part of Horizon Europe – the Framework Programme for Research and Innovation (2021-2027) and the following framework programme. The Parties wish to specify or supplement binding commitments among themselves in addition to the provisions of the specific Grant Agreement (GA) to be signed by the Parties and the European Commission (hereinafter “Grant Agreement” or “GA”). The Parties are aware that this Consortium Agreement is based upon the DESCA Model Consortium Agreement for Horizon Europe. NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS: 1 It is expected that the European Commission (EC) will act as the Granting Authority. 9 / 106  EP PerMed- Consortium Agreement 1 Definitions 1.1 Definitions Words beginning with a capital letter shall have the meaning defined either herein or in the Horizon Europe Regulation or in the Grant Agreement including its Annexes. 1.2 Additional Definitions Annual Work Pro- Annual Work Programme means the description of the upcoming activities and the re- gramme - AWP lated agreed budget on the yearly bases along the Consortium Plan jointly developed by the responsible Parties and agreed by the General Assembly. Each AWP is a deliverable of the Consortium Plan and has to be approved by the European Health and Digital Ex- ecutive Agency (HaDEA). Affiliated Entity (AE) Entity affiliated to a beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/10466 which participate in the action with similar rights and ob- ligations as the beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). Associated Partner Associated Partners which participate in the action, but without the right to charge (AP) costs or claim contributions. Beneficiary (BEN) The signatories of the Grant Agreement (either directly or through an accession form). Consortium Body Consortium Body means any management body described in the governance struc- ture (chapter 6) of this Consortium Agreement. Consortium Budget The Consortium Budget is the part A, C and E of the Annex 2 of GA budget categories planned for administrative and management activities in Work Package (WP) 1 till WP 5. Consortium Plan Consortium Plan means the Description of the Action (Annex 1 of the Grant Agree- ment) and the related agreed EC Financial Contribution (Annex 2 of the Grant Agree- ment) as first defined in the Grant Agreement and which may be updated by official amendments. Coordinator (COR) The Coordinator is the legal entity and beneficiary acting as the intermediary be- tween the Consortium and the Granting Authority. Defaulting Party Defaulting Party means a Party which the General Assembly has identified to be in breach of this Consortium Agreement and/or the Grant Agreement as specified in 4.4 of this Consortium Agreement. EC Financial Contribu- EC Financial Contribution max. €100,575,465.38 is the financial contribution tion of the European Commission to EP PerMed (Annex 2 of Grant Agreement). It is composed of the Consortium Budget and the EC share for support of third parties EC share for support of EC share for support of third party is the difference between EC Financial third parties Contribution and the Consortium Budget. 10 / 106  EP PerMed- Consortium Agreement EP PerMed Budget EP PerMed Budget is the estimated Project Cost €335,251,551.24 Expert Panel Expert Panel is the board of independent experts evaluating proposals of the Joint Calls. Funding Organisation Funding Organisation is a national or regional organisation responsible for provid- ing the national/regional share of funding for the Transnational Projects. Granting Authority Granting Authority is the European Commission via HaDEA and it is the body awarding the EC Financial Contribution for EP PerMed. Highly Detrimental Sit- Highly Detrimental Situation means a situation that leads to the reduction of more uation than EUR 1,000,000 of the EC share for support of third parties per annual Joint Transnational Call. Joint Transnational Joint Transnational Calls mean the co-funded calls for collaborative proposals in Per- Calls - JTC sonalised Medicine which are organised annually by all Funding Organisations par- ticipating in the respective JTC and represent the main objective of EP PerMed. Member A member is a person or a group of people in a specific committee and are always defined separately in the respective chapters. Needed Needed means: For the implementation of EP PerMed: Access Rights are Needed if, without the grant of such Access Rights, carry- ing out the tasks assigned to the recipient Party would be technically or le- gally impossible, significantly delayed, or require significant additional fi- nancial or human resources. For Exploitation of own Results: Access Rights are Needed if, without the grant of such Access Rights, the Exploitation of own Results would be technically or legally impossible. Party An entity becomes a Party to this Consortium Agreement upon signature of this Con- sortium Agreement by a duly authorised representative. The terms "party" and "parties" are always used in the context of the respective chapter. Software Software means sequences of instructions to carry out a process in, or convertible into, a form executable by a computer and fixed in any tangible medium of expres- sion. Transnational Consor- Transnational Consortium/Project is a consortium/project selected for funding un- tium/Project der a Joint Call of EP PerMed. 11 / 106  EP PerMed- Consortium Agreement 1.3 Applicable Documents For the sake of clarity, the following documents, listed from more general to the more specific, are part of the Co- funded Action and apply to this Consortium Agreement: - The Horizon Europe Regulation; - The terms party and parties are always used in the context of the respective chapter. (Text with EEA relevance); - Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and the free movement of such data - All and any information and provision provided by the European Commission during the award proce- dure; - the Grant Agreement. 2 Purpose The purpose of this Consortium Agreement is to specify with respect to EP PerMed the relationship among the Parties, in particular concerning the organisation of the work between the Parties, the management of EP PerMed and the rights and obligations of the Parties concerning inter alia liability, Access Rights, dispute resolution, financial provisions and call implementation. For the avoidance of doubt, this Consortium Agreement is limited to EP PerMed. The consortia of the Transnational Projects under EP PerMed have to execute separate consortium agreements in accordance with their specific needs. 3 Entry into force, duration and termination 3.1 Entry into force An entity becomes a Party to this Consortium Agreement upon signature of this Consortium Agreement by a duly authorised representative. This Consortium Agreement shall have effect from the Effective Date identified at the beginning of this Consortium Agreement. An entity becomes a new Party to the Consortium Agreement upon signature of the accession document (Attachment 2) by the new Party and the Coordinator. Such accession shall have effect from the date identified in the accession document. A Party which has not yet signed this Consortium Agreement shall neither be entitled to vote nor to receive any EC Financial contribution. 3.2 Duration and termination This Consortium Agreement shall continue in full force and effect until complete fulfilment of all obligations undertaken by the Parties under the Grant Agreement and under this Consortium Agreement. 12 / 106  EP PerMed- Consortium Agreement However, this Consortium Agreement or the participation of one or more Parties to it may be terminated in accordance with the terms of this Consortium Agreement. If - the Grant Agreement is not signed by the European Commission or a Party, or - the Grant Agreement is terminated, or - a Party's participation in the Grant Agreement is terminated, this Consortium Agreement shall automatically terminate in respect of the affected Party/ies, subject to the provisions surviving the expiration or termination under 3.3 of this Consortium Agreement. If a Beneficiary’s or Affiliated Entity`s participation in the Grant Agreement is terminated, the terminating Party shall do its utmost to limit the consequences for EP PerMed. Wherever possible, it shall honour its commitments in funding the running projects under EP PerMed calls. If an Associated Partner´s participation in EP PerMed is terminated, its participation in this Consortium Agreement may be terminated subject to the provisions surviving the expiration or termination under this Consortium Agreement (chapter 4.2 and chapter 3.3). 3.3 Survival of rights and obligations The provisions relating to Access Rights, Dissemination, confidentiality, for the time period mentioned therein, as well as for liability, applicable law, settlement of disputes of this Consortium Agreement shall survive the expiration or termination of this Consortium Agreement. Termination shall not affect any rights or obligations of a Party leaving EP PerMed incurred prior to the date of termination, unless otherwise agreed between the General Assembly and the leaving Party. This includes the obligation to provide all necessary input, deliverables and documents for the period of its participation. 4 Responsibilities of Parties 4.1 General principles Each Party undertakes to take part in the efficient implementation of EP PerMed, and to cooperate, perform and fulfil, promptly and on time, all of its obligations under the Grant Agreement and this Consortium Agreement as may be reasonably required from it and in a manner of good faith as prescribed by Belgian law. Each Party undertakes to notify promptly the Granting Authority and the other Parties, in accordance with the governance structure of this Consortium Agreement, of any significant information, fact, problem or delay likely to affect EP PerMed. Each Party shall promptly provide all information reasonably required by a Consortium Body or by the Coordinator to carry out its tasks and shall responsibly manage the access of its employees to the EU Funding & Tenders Portal. Each Party shall take reasonable measures to ensure the accuracy of any information or materials it supplies to the other Parties. 13 / 106  EP PerMed- Consortium Agreement 4.2 Specific responsibilities for Affiliated Entities - AE Entities Affiliated to a Beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/1046, participate in the action as Affiliated Entities with similar rights and obligations as the Beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). They do not become party to the Grant Agreement (do not sign the GA) but they are part of the consortium. They are therefore de facto treated like beneficiaries (have their own financial statement, must provide their own Certificate on Financial Statement (CFS), must contribute to the technical report, must submit deliverables, etc.). As defined in article 8 of the Grant Agreement, Affiliated Entities can charge costs and contributions to the action under the same conditions as the Beneficiaries and must implement the action tasks attributed to them in Annex 1 “description of Action” of the Grant Agreement in accordance with Article 11 of the Grant Agreement on Proper implementation of the action. Their costs and contributions will be considered for the calculation of the grant. All the obligations of the Beneficiaries under the Grant Agreement (as stipulated in its article 8) and relevant obligations of Parties under this Consortium Agreement also apply to their Affiliated Entities. Breaches by Affiliated Entities will be handled in the same manner as breaches by Beneficiaries. 4.3 Specific responsibilities for Associated Partner(s) - AP For the avoidance of doubt, the Associated Partner(s) do(es) not sign the Grant Agreement and do(es) not receive funding from the Granting Authority and therefore do(es) not have a right to charge costs or claim contributions from the Granting Authority. Associated Partner(s) must ensure its/their own funding for the implementation of EP PerMed. However, certain terms and conditions of the Grant Agreement and its Annexes are applicable to the Associated Partner(s). The Coordinator will share a copy of the signed Grant Agreement and information on any amendments with the Associated Partner(s). The Associated Partner(s) hereby commit(s) to implement EP PerMed tasks attributed to it/them in Annex 1 of the Grant Agreement. In addition, the Associated Partner(s) hereby commit(s) especially to the following articles of the Grant Agreement and related regulations of Annex 5: - Proper implementation of the action (Article 11) - Conflicts of interest (Article 12) - Confidentiality and security (Article 13) - Ethics and values (Article 14) - Visibility (Article 17.2) - Specific rules for carrying out the action (Article 18) - Information obligations (Article 19) - Record-keeping (Article 20) The Associated Partner(s) support(s) the Beneficiaries regarding their exploitation, dissemination and Open Science obligations and commit(s) to contribute to the technical and continuous reporting during and after the implementation of EP PerMed. Furthermore, the Associated Partner(s) hereby explicitly agree to cooperate with and grant access to bodies according to Article 25 of the Grant Agreement (the Granting Authority, the European Anti-Fraud Office (OLAF), the European Public Prosecutor’s Office (EPPO), the European Court of Auditors (ECA)), so that these bodies can carry out checks, reviews, audits and investigations also towards the Associated Partner(s). 14 / 106  EP PerMed- Consortium Agreement Any Associated Partner from a non-EU-country undertakes to comply additionally with any other obligation arising from Art. 10.1 of the Grant Agreement. In case of termination or being declared a Defaulting Party, an Associated Partner shall, within the limits specified in chapter 5.2 of this Consortium Agreement, bear any reasonable and justifiable costs occurring to the other Parties for performing this Associated Partners tasks and the costs for additional efforts necessary to implement EP PerMed Moreover, an Associated Partner is obliged to indemnify the other Parties for any claim of the Granting Authority against them, caused by this Associated Partner´s actions or omissions during Grant Agreement preparation, EP PerMed implementation or after EP PerMed end. Regarding such claims the Associated Partner´s special liability is limited to the amount of its total budget as indicated in Annex 1 of the Grant Agreement. Should the Associated Partner(s) be obliged to sign a separate agreement concerning its funding for the EP PerMed, it is the responsibility of the Associated Partner to ensure such agreement is not in conflict with this Consortium Agreement. Furthermore, there will be separated agreements for each JTCs in which AP is joining concerning the assigned budget to the JTC, the evaluation of the call and the funding of the respective third parties. 4.4 Breach In the event that the General Assembly identifies a breach by a Party of its obligations under this Consortium Agreement or the Grant Agreement (e.g. improper implementation of EP PerMed), the Coordinator or, if the Coordinator is in breach of its obligations, the Party appointed by the General Assembly, will give formal notice to such Party requiring that such breach will be remedied within 30 calendar days from the date of receipt of the written notice by the Party. If such breach is substantial and is not remedied within that period or is not capable of remedy, the General Assembly may decide to declare the Party to be a Defaulting Party and to decide on the consequences thereof which may include termination of its participation. 4.5 Involvement of third parties A Party that enters into a subcontract or otherwise involves third parties (including but not limited to Affiliated Entities or other Participants) in EP PerMed remains responsible for carrying out its relevant part of EP PerMed and for such third party’s compliance with the provisions of this Consortium Agreement and of the Grant Agreement. Such Party has to ensure that the involvement of third parties does not affect the rights and obligations of the other Parties under this Consortium Agreement and the Grant Agreement. 4.6 Specific responsibilities regarding data protection Where necessary, the Parties shall cooperate in order to enable one another to fulfil legal obligations arising under applicable data protection laws (the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and relevant national data protection law applicable to said Party) within the scope of the performance and administration of EP PerMed and of this Consortium Agreement. In particular, the Parties shall, where necessary, conclude a separate data processing, data sharing and/or joint controller agreement before any data processing or data sharing takes place. 15 / 106  EP PerMed- Consortium Agreement 5 Liability towards each other 5.1 No warranties In respect of any information or materials (including Results and Background) supplied by one Party to another under EP PerMed, no warranty or representation of any kind is made, given or implied as to the sufficiency or fitness for purpose nor as to the absence of any infringement of any proprietary rights of third parties. Therefore, - the recipient Party shall in all cases be entirely and solely liable for the use to which it puts such infor- mation and materials, and - no Party granting Access Rights shall be liable in case of infringement of proprietary rights of a third party resulting from any other Party (or its entities under the same control) exercising its Access Rights. However, each Party shall promptly inform the other Party/ies of any claims of third parties that come to their knowledge. 5.2 Limitations of contractual liability No Party shall be responsible to any other Party for any indirect or consequential loss or similar damage such as, but not limited to, loss of profit, loss of revenue or loss of contracts, except in case of breach of confidentiality. A Party’s general aggregate liability towards the other Parties collectively shall be limited to the Beneficiary’s share of the total costs of the Project as identified in Annex 2 of the Grant Agreement and in case of Associated Partners to the amount of its total budget as indicated in Annex 1 of the Grant Agreement. A Party’s liability shall not be limited under either of the two foregoing paragraphs to the extent such damage was caused by a wilful act or gross negligence or to the extent that such limitation is not permitted by law. 5.3 Damage caused to third parties Each Party shall be solely liable for any loss, damage or injury to third parties resulting from the performance of the said Party’s obligations by it or on its behalf under this Consortium Agreement or from its use of Results or Background. 5.4 Force Majeure No Party shall be considered to be in breach of this Consortium Agreement if it is prevented from fulfilling its obligations under the Consortium Agreement by Force Majeure. Each Party will notify the General Assembly of any Force Majeure without undue delay. If the consequences of Force Majeure for EP PerMed are not overcome within six weeks after such notice, the transfer of tasks - if any - shall be decided by the General Assembly. 16 / 106  EP PerMed- Consortium Agreement 6 Governance structure 6.1 General structure The organisational structure of the consortium shall comprise the following Consortium Bodies: General Assembly The General Assembly (GeA), consisting of 1-2 representatives per EP PerMed (GeA) participant (beneficiaries, affiliated entities and associate partner) and the EC. The GeA is the formal decision-making body of EP PerMed. It discusses and decides about the strategy and major orientation of EP PerMed, priorities and actions to be supported, evolutions in EP PerMed’s membership, contractual issues and alloca- tion of implementation budget among the various WPs and activities among part- ners. It will meet at least once a year, preferably twice. It is chaired by the Coordi- nator of EP PerMed and a vice-chair elected from the GeA. The vice-chair election (period, procedure etc.) will be defined in the Rules of Procedure after the start of EP PerMed. The Rules of Procedure will be developed in agreement with the GeA. Any major contractual changes regarding the Consortium Agreement, that are de- cided by the GeA will be made in writing and signed by the authorised representa- tive of each organisation. Extended General As- The Extended General Assembly (ExtGeA) includes the GeA and additionally the sembly (ExtGeA) International Consortium for Personalised Medicine (ICPerMed) members and thus will include and utilise an international PM perspective and collaboration. The ExtGeA will discuss and advice EP PerMed activities and decide on joint activities of ICPerMed and EP PerMed. Coordination Unit (CU) The Coordination Unit (CU) drives the operational activities, preparing decisions to be made by the GeA. Composed of the Coordinator, the WP Leads and the EC, the CU will ensure an effective coordination, alignment and management of the overall activities. Whereas crucial strategic decisions will be made by the GeA, more general decisions (on a day-by-day basis) will be made by the CU. Details on 17 / 106  EP PerMed- Consortium Agreement the nature of these decisions are defined in this CA and in the Rules of Procedure, which will be developed in the beginning of EP PerMed’s runtime. Coordinator (COR) The Coordinator is the legal entity acting as the intermediary between the Parties and the Granting Authority. The Coordinator shall, in addition to its responsibilities as a Party, perform the tasks assigned to it as described in the Grant Agreement and this Consortium Agreement. Call Steering Commit- The Call Steering Committees (CSC) support the JTCs, which are the main activity tees (CSC) in EP PerMed. The CSC develop and implement the seven Joint Transnational Calls. Therefore, specific committees will be created for each joint call, since EP PerMed is devoted to schemes of variable geometry. The decisions for each JTC will be taken among the respective CSC. The CSC gathers one representative per organisation financially contributing to the given JTC. Joint Call Secretariat The Joint Call Secretariat is the body taking care of the coordination of manage- (JCS) ment activities of a given JTC. External EP PerMed The external EP PerMed advisory bodies (Advisory Board, Stakeholder Forum, advisory bodies each Call Advisory Board) will be defined and established. 6.2 General operational procedures for all Consortium Bodies 6.2.1 Representation in meetings Any Party which is appointed to take part in a Consortium Body shall designate one representative (hereinafter referred to as "Member"). Any Member: − should be present or represented at any meeting of such Consortium Body, − may appoint a substitute or a proxy to attend and vote at any meeting of such Consortium Body, and shall participate in a cooperative manner in the meetings of such Consortium Body. 6.2.2 Preparation and organisation of meetings 6.2.2.1 Convening meetings The chairperson of a Consortium Body shall convene meetings of that Consortium Body. Ordinary meeting Extraordinary meeting Extended General Assembly At least once a year At any time upon request of the (ExtGeA) Coordination Unit or 1/3 of the Members of the Extended General Assembly General Assembly (GeA) At least once a year At any time upon request of the Coordination Unit or 1/3 of the Members of the General Assembly 18 / 106  EP PerMed- Consortium Agreement Coordination Unit At least quarterly (incl. on-site At any time upon request of any meeting and online meetings) Member of the Coordination Unit Call Steering Committees (CSC) Usually twice per JTC (on-site or At any time upon request of the online) JCS or 1/3 of the CSC 6.2.2.2 Notice of a meeting The chairperson of a Consortium Body shall give written notice of a meeting to each Member of that Consortium Body as soon as possible and no later than the minimum number of days preceding the meeting as indicated below. The minimum number of days also apply to the case that the quorum is not reached and the chairperson of a Consortium Body has to convene another meeting (see 6.2.2.1). Ordinary meeting Extraordinary meeting Extended General Assembly 45 calendar days 15 calendar days General Assembly 45 calendar days 15 calendar days Coordination Unit 20 calendar days 15 calendar days Call Steering Committee 30 calendar days 15 calendar days 6.2.2.3 Sending the agenda The chairperson of a Consortium Body shall prepare and send each Member of that Consortium Body an agenda no later than the minimum number of days preceding the meeting as indicated below. Ordinary meeting Extraordinary meeting Extended General Assembly 14 calendar days 7 calendar days General Assembly 14 calendar days 7 calendar days Coordination Unit 4 calendar days 4 calendar days Call Steering Committee 7 calendar days 7 calendar days 6.2.2.4 Adding agenda items Any agenda item requiring a decision by the Members of a Consortium Body must be identified as such on the agenda. Any Member of a Consortium Body may add an item to the original agenda by written notice to all of the other Members of that Consortium Body up to the minimum number of days preceding the meeting as indicated below. 19 / 106  EP PerMed- Consortium Agreement Ordinary meeting Extraordinary meeting Extended General Assembly 7 calendar days 7 calendar days General Assembly 7 calendar days 7 calendar days Coordination Unit 3 calendar days 3 calendar days Call Steering Committee 5 calendar days 5 calendar days During a meeting the Members of a Consortium Body present or represented can unanimously agree to add a new item to the original agenda. 6.2.2.5 Forms of meetings and decisions Meetings of each Consortium Body may also be held by tele- or videoconference, or other telecommunication means or other telecommunication means that allow for the proper identification of the attending Members. Decisions may also be taken via online voting tools, provided the online vote duly observes the principles of fairness, transparency, proper documentation and confidentiality as required to ensure the same degree of reliability than a vote in a physical meeting. The chairperson shall inform the Parties of the tool to be used for online voting in due time before the vote to make sure they have sufficient technical access and opportunity to cast their vote. Any decision may also be taken without a meeting if a the chairperson circulates to all Members of a Consortium Body a suggested decision with a deadline for responses of at least 10 calendar days after receipt by a Member, and b the decision is agreed by two-thirds (2/3) of the votes cast, provided that at least two-thirds (2/3) of the Members entitled to vote answer the decision request (either by casting their vote or by notifying their abstention). Abstentions thus count towards reaching the minimum participation, and their notification should be mentioned in the voting request sent by the chairperson). The chairperson shall inform all the Members of the outcome of this vote. A veto according to 6.2.4 of this Consortium Agreement may be submitted up to 15 calendar days after receipt of this information by the Member. The decision will be binding after the chairperson sends a notification to all Members of that Consortium Body. The Coordinator will keep records of the votes and make them available to the Members on request. 6.2.3 Voting rules and quorum Each Consortium Body shall not deliberate and decide validly in meetings unless half (1/2) of its Members are present or represented (quorum). If the quorum is not reached, the chairperson of the Consortium Body shall convene an extraordinary meeting in which a decision is taken even if less than the quorum of Members is present or represented. For voting rules and quorum of decisions without a meeting, see 6.2.2.5 20 / 106  EP PerMed- Consortium Agreement The voting rules are: Voting rights Extended General - one vote for each EP PerMed Beneficiary/the Coordinator Assembly (ExtGeA) - one vote for each ICPerMed-Member, who is not an EP PerMed Beneficiary - one vote for each EP PerMed Associated Partner - one vote for the EC General Assembly - one vote for each EP PerMed Beneficiary/the Coordinator (GeA) - one vote for the EC - the votes will be weighted with regard to number of EP PerMed beneficiar- ies per country2 Coordination Unit (CU) - one vote for Coordinator/WP 1 (DLR) - one vote per WP 2 to 5 representative - one vote for the EC Voting regarding the EC share to the third parties: Call Steering Committees (CSC) - one vote per representative from each EP PerMed Beneficiary financially contributing to the given joint call Voting regarding all other decisions: - one vote per representative from each organisation financially contributing to the given joint call If two Parties act as an “institutional couple”, i.e. if they come from the same country and manage the same research budget, they shall share one vote. A Defaulting Party shall not vote. The linked Beneficiary with all his Affiliated Entities has only one vote in all decision bodies of EP PerMed. Each Consortium Body shall strive to make decisions by consensus. If consensus cannot be achieved, decisions shall be taken by a majority of two-thirds (2/3) of the votes cast. 2 If for example there are three beneficiaries located in the same country, their votes will be weighted by 1/3 each. European organizations incl. their AE (like the EC), that are not associated with a certain country, will have one vote each. 21 / 106  EP PerMed- Consortium Agreement 6.2.4 Veto rights A Party which can show that its own work, time for performance, costs, liabilities, intellectual property rights or other legitimate interests would be severely affected by a decision of that Consortium Body may exercise a veto with respect to the corresponding decision or relevant part of the decision. When the decision is foreseen on the original agenda, a Party may veto such a decision during the meeting only. When a decision has been taken on a new item added to the agenda before or during the meeting, a Party may veto such decision during the meeting or within 15 calendar days after receipt of the draft minutes of the meeting by the Party. When a decision has been taken without a meeting, a Party may veto such decision within 15 calendar days after receipt of the written notice from the chairperson of the outcome of the vote by the Party. In case of exercise of veto, the Parties shall make every effort to resolve the matter which occasioned the veto to the general satisfaction of all Parties. A Party may neither veto decisions relating to its identification to be in breach of its obligations nor to its identification as a Defaulting Party. The Defaulting Party may not veto decisions relating to its participation and termination in the consortium or the consequences of them. A Party requesting to leave the consortium may not veto decisions relating thereto. 6.2.5 Minutes of meetings The chairperson of a Consortium Body shall produce minutes of each meeting which shall be the formal record of all decisions taken. He / She shall send the draft minutes to all Members of that Consortium Body within 15 calendar days of the meeting. The minutes shall be considered as accepted if, within 15 calendar days from receipt, no Member of that Consortium Body has sent an objection by written notice to the chairperson with respect to the accuracy of the draft of the minutes by written notice. The chairperson shall send the accepted minutes to all the Members of that Consortium Body and to the Coordinator, who shall retain copies of them. 6.3 Firewall for meetings regarding any EP PerMed calls (on-site, online or hybrid) EP PerMed parties that are not funders and/or are eligible to apply for calls of EP PerMed will not participate in the Call Steering Committee/s (CSCs) or the Joint Call Secretariats (JCSs). They will further not participate in meetings (or dedicated sessions of meetings) of the Coordination Unit, General Assembly and Extended General Assembly when confidential information about the Joint Transnational Calls (JTC) or other calls are discussed or if confidential information about call-related topics are provided. They are not eligible to vote in decisions with regard to the calls or the evaluation process. 7 Specific operational procedures for the Consortium Bodies 7.1 General Assembly In addition to the rules described in 6.2, the following rules apply: 22 / 106  EP PerMed- Consortium Agreement 7.1.1 Members The General Assembly shall consist of 1-2 representative of each Party (hereinafter “General Assembly Member”). Each General Assembly Member shall be deemed to be duly authorised to deliberate, negotiate and decide on all matters listed in 7.1.2. of this Consortium Agreement. The Coordinator and an elected vice-chair shall chair all meetings of the General Assembly, unless decided otherwise in a meeting of the General Assembly. The Parties agree to abide by all decisions of the General Assembly. This does not prevent the Parties from exercising their veto rights, according to 6.2.4, or from submitting a dispute to resolution in accordance with the provisions of 14.8. Regarding unanimity or majority decisions, only General Assembly Members with voting rights regarding the item are considered. 7.1.2 Decisions The General Assembly is responsible for the overall direction and follow-up of EP PerMed. The following decisions shall be taken by the General Assembly: Content, finances and intellectual property rights − Delegation of (minor) decisions to the Coordination Unit − Proposals for changes to Consortium Plan (Annexes 1 and 2 of the Grant Agreement) to be agreed by the Granting Authority; − Develop and agree on the upcoming Annual Work Programmes and related (annual) budgets on a yearly basis; − Foreseen updates of the Strategic Research and Innovation Agenda (SRIA) − Additions or modifications to all Attachments of this Consortium Agreement; − Use of the reserve fund; − Decisions related to a Highly Detrimental Situation; − Decisions related to a conflict of interests; − Settlement of disputes. Appointments − Appointment of Members of the Advisory Board; − Appointment of the Joint Call Secretariats; − Appointment of GeA vice-chair. Evolution of the consortium − Entry/withdrawal of a Party to/from EP PerMed and approval of the settlement on the conditions of the accession/withdrawal of such a Party; − Decisions related to the termination of a Party’s participation in the Co-fund Action (including handling of additional costs, if any); − Identification of a breach by a Party of its obligations under this Consortium Agreement or the Grant Agreement and the remedies to be performed by such Party; − Declaration of a Party to be a Defaulting Party and the remedies to be performed by such Party (including termination of such Party’s participation in EP PerMed); − Steps to be taken for litigation purposes and the coverage of litigation costs in case of joint claims of a Party/Parties against another Party/other Parties; − Proposal to the Granting Authority for a change of the Coordinator; − Proposal to the Granting Authority for suspension of all or part of EP PerMed; − Proposal to the Granting Authority for termination of EP PerMed and the Consortium Agreement. 23 / 106  EP PerMed- Consortium Agreement 7.2 Coordination Unit In addition to the rules described in 6.2, the following rules apply: 7.2.1 Members The Coordination Unit shall consist of the Coordinator, the Work Package Leads and the EC. The Coordinator shall chair all meetings of the Coordination Unit, unless decided otherwise in a meeting of the Coordination Unit. 7.2.2 Minutes of meetings Minutes of Coordination Unit meetings, once accepted, can be consulted by the General Assembly Members for information. 7.2.3 Tasks The Coordination Unit shall: − prepare the meetings, propose decisions and prepare the agenda of the General Assembly meetings according to chapter 7.1.2.; − seek a consensus among the Parties; − be responsible for the proper execution and implementation of the decisions of the General Assembly; − monitor the effective and efficient implementation of EP PerMed; − collect information at least every 12 months on the progress of EP PerMed, examine that information to assess the compliance of EP PerMed with the Consortium Plan and, if necessary, propose modifications of the Consortium Plan to the General Assembly; − support the Coordinator in preparing meetings with the Granting Authority and in preparing related data and deliverables; − prepare the content and timing of press releases and joint publications by the consortium or proposed by the Granting Authority in respect of the procedures in article 17 of the Grant Agreement and its Annex 5, chapter “Communication, Dissemination, Open Science and Visibility” and of chapter 10 of this Consortium Agreement; − in the case of abolished tasks as a result of a decision of the General Assembly, advise the General Assembly on ways to rearrange tasks and budgets of the Parties concerned. Such rearrangement shall take into consideration any prior legitimate commitments which cannot be cancelled; 7.3 Extended General Assembly In addition to the rules described in 6.2, the following rules apply: 7.3.1 Members The Extended General Assembly shall consist of one representative of each Party (hereinafter “General Assembly Member”) and all ICPerMed members. A chair elected by the Extended General Assembly shall chair all meetings of the Extended General Assembly, unless decided otherwise in a meeting of the Extended General Assembly. 24 / 106  EP PerMed- Consortium Agreement 7.3.2 Tasks The Extended General Assembly shall: − Connect EP PerMed with additional European and international countries and therewith support the alignment of the Co-fund activities with activities undertaken at the European and international levels. − Propose, discuss, decide on and develop strategic joint ICPerMed and EP PerMed activities (e.g. events and policy papers). 7.4 Call Steering Committee In addition to the rules described in 6.2, the following rules apply: 7.4.1 Members The Call Steering Committee is composed of one mandated representative from each Funding Organisation participating in a given Joint Call (hereinafter “CSC Members”). 7.4.2 Mandate A Call Steering Committee will be set up for each Joint Call, acting as the decision-making body for all aspects related to the practical implementation and follow-up of the concerned Joint Call. The mandate of the Call Steering Committee starts with the preparation of the development of the concept of the respective call and ends with the finalisation of selection list of the respective JTC. 7.4.3 Tasks The Call Steering Committee shall: − Develop and approve the Call Memorandum of Understanding and the text of the Call Announcement; − Agree on the general eligibility of partners in Transnational Projects for funding based on the Joint Call and national/regional eligibility rules; − Provide names of potential reviewers/experts to the Expert Panel and to the Call Secretariat; − Appoint the Members of the Expert Panel; − Decide on which projects to invite to step 2, based on the evaluation made by the Expert Panel (if applicable); − Decide on which proposals to recommend for funding based on and not deviating from the Ranking List established by the Expert Panel; − Re-evaluate the rules for the use of the EC Financial Contribution for the Transnational Projects, if necessary. Decisions regarding the Joint Call(s): − Setup of timelines for the Joint Call(s); − Approval of the text and topics; − Guidelines and rules for participation in the Joint Call(s); − Agreement on the Transnational Projects to be funded, according to the Ranking List; − Financial decision in case a Funding Organisation has no funds for the national/regional share in a Transnational Project (i.e. decision about how to replace and/or fund the final recipients of the Transnational Project). 25 / 106  EP PerMed- Consortium Agreement 7.5 Call Secretariat In addition to the rules described in 6.2, the following rules apply: 7.5.1 Members The Joint Call Secretariats will be appointed by the General Assembly. 7.5.2 Tasks The Joint Call Secretariat is responsible for leading the coordination and management activities regarding the Joint Call. In particular, the Joint Call Secretariat shall: − prepare a list with suggestions for fundable proposals for the Joint Call and give a funding recommendation to the Call Steering Committee; − handle the proposition of the Call Steering Committee for names of potential external reviewers; − prepare a template concerning potential situations of conflicts of interests and a declaration to be confirmed by the external experts. 7.6 Coordinator The Coordinator shall be the intermediary between the Parties and the Granting Authority and shall perform all tasks assigned to it as described in the Grant Agreement and in this Consortium Agreement. 7.6.1 Tasks In particular, the Coordinator shall be responsible for: − monitoring the progress of EP PerMed in collaboration with the Coordination Unit; − monitoring compliance by the Parties with their obligations under this Consortium Agreement and the Grant Agreement; − convening and chairing General Assembly and Coordination Unit meetings and support the Call Secretariats; − keeping the contact list of Members of the Consortium Bodies and other contact persons updated and available; − collecting, reviewing to verify consistency and submitting reports, other deliverables (including financial statements and related certifications) and specific requested documents to the Granting Authority; − transmitting documents and information related to EP PerMed to any external party concerned; − administering the EC Financial Contribution and fulfilling the financial tasks described in chapter 7; − establishing a cost monitoring system and providing the General Assembly with the results of this cost assessment; − providing, upon request, the Parties with official copies or originals of documents that are in the sole possession of the Coordinator when such copies or originals are necessary for the Parties to present claims; − handling conflicts of interests; − providing a copy of the Grant Agreement and its Annexes to the Associated Partners; − handling and advising on the settlement of disputes; − developing Rules of Procedure for the EP PerMed consortium bodies (including a non-disclosure agreement with each member of the Advisory Board). If one or more of the Parties is late in submission of any EP PerMed deliverable, the Coordinator may nevertheless submit the other ’Parties’ EP PerMed deliverables and all other documents required by the Grant Agreement to the Granting Authority in time. 26 / 106  EP PerMed- Consortium Agreement If the Coordinator fails in his/her coordination tasks, the General Assembly may propose to the Granting Authority to change the Coordinator. The Coordinator shall not be entitled to act or to make legally binding declarations on behalf of any other Party or of the consortium, unless explicitly stated otherwise in the Grant Agreement or this Consortium Agreement. The Coordinator shall not enlarge its role beyond the tasks specified in this Consortium Agreement and in the Grant Agreement. 8 Financial provisions Chapter 8 of the Consortium Agreement applies to all Beneficiaries and Affiliated Entities. Chapter 8 does not apply to Associated Partners. 8.1 General Principles As presented in Annex 2 of the Grant Agreement, the EC Financial Contribution consists of the contribution to direct costs and the related indirect costs. Each Beneficiary shall make their best efforts to match their regional/national funding budget with the expected success of their respective research communities. In addition, the Beneficiary and Affiliated Entity will undertake all possible efforts to ensure the best possible use of all available EP PerMed budget. All provisions included in this chapter apply to the Affiliated Entities in the same way that they apply to the Beneficiaries, except if there is a specific mention for Affiliated Entities. The Beneficiaries must ensure that their Affiliated Entities respect the obligations stipulated in this chapter (i.e. by signing a contract with them). The provisions of this chapter do not apply to the Associated Partners. Associated Partners agree to cover their entire costs from their own funds. 8.1.1 Distribution of the EC Financial Contributions The EC Financial Contribution to EP PerMed shall be distributed by the Coordinator according to: - the Consortium Plan - the Description of Action (Annex 1 of the Grant Agreement) and budget (Annex 2 of the Grant Agreement) and respective amendments, - the Annual Work Programme, - the approval of reports by the Granting Authority, and - the provisions of payment in 8.2. A Beneficiary shall only be able to receive funds after having duly signed the Consortium Agreement and the Accession Form to the Grant Agreement. The Affiliated Entities linked to a Beneficiary shall only be able to receive funds after the beneficiary he is linked to has duly signed the Consortium Agreement and the Accession Form to the Grant Agreement. A Beneficiary that involves Affiliated Entities should conclude a written contract with those Affiliated Entities that ensures compliance with the provisions of the Grant Agreement and the Consortium Agreement. A Beneficiary and Affiliated Entity shall be funded only for its tasks carried out in accordance with the Description of Action, the valid Annual Work Programme with respective amendments and the Consortium Plan. Each Beneficiary and Affiliated Entity is responsible for the management and payment of its subcontractors and must ensure that they meet the obligations stipulated in the Grant Agreement – Art.6.2. B and Art. 9.3. Justifying Costs towards the Granting Authority. 27 / 106  EP PerMed- Consortium Agreement In accordance with its own usual accounting and management principles and practices, each Beneficiary shall be solely responsible for justifying its costs (and those of its Affiliated Entities, if any) with respect to the EP PerMed towards the Granting Authority. Neither the Coordinator nor any of the other Beneficiaries and Affiliated Entities shall be in any way liable or responsible for such justification of costs towards the Granting Authority. 8.1.2 Funding Principles Each Beneficiary and Affiliated that spends less than its allocated share of the budget as set out in the Consortium Plan will be funded in accordance with its actual duly justified eligible costs only. Each Beneficiary and Affiliated that spends more than its allocated share of the budget as set out in the Consortium Plan will be funded only in respect of duly justified eligible costs up to an amount not exceeding that share, unless otherwise agreed by the Coordination Unit. Specific funding principles related to the funding of Transnational Projects selected in the Joint Transnational Calls are defined under chapter 9.2. 8.1.3 Financial Consequences of the termination of the participation of a Party A Beneficiary and Affiliated Entity leaving the consortium shall refund to the Coordinator any payments it has received except the amount of contribution accepted by the Granting Authority or another contributor to the Co- funded Action or consortium. In addition, a Defaulting Party shall, within the limits specified in 5.2 of this Consortium Agreement, bear any reasonable and justifiable additional costs occurring to the other Beneficiaries and Affiliated Entities in order to perform the leaving Party´s task and necessary additional efforts to fulfil them as a consequence of the Party leaving the consortium. The General Assembly should agree on a procedure regarding additional costs which are not covered by the Defaulting Party or the Mutual Insurance Mechanism. 8.2 Payments 8.2.1 General Principles Payments to Beneficiaries are the exclusive task of the Coordinator. Related banking and transaction costs are borne by the receiving Beneficiary. Payments to the Affiliated Entity are paid to the affiliated Beneficiaries. In particular, the Coordinator shall: − notify the Beneficiary concerned promptly of the date and composition of the amount transferred to its bank account, giving the relevant references, − perform diligently its tasks in the proper administration of any funds and in maintaining financial accounts, and − undertake to keep the EC Financial Contribution separated from its normal business accounts, its own assets and property, except if the Coordinator is a Public Body or is not entitled to do so due to statutory legislation. Beneficiary will have to provide to the Coordinator in order to receive the payments a Financial Identification Form (FIF), completed and signed both by the account holder and bank of the Beneficiary, submitted via PT-Open. With reference to article 22 of the Grant Agreement, no Party shall before the end of the EP PerMed receive more than its allocated share of the maximum grant amount less the amounts retained by the Granting Authority for the Mutual Insurance Mechanism. Considering the Reserve Fund (5 %) specified in chapter 8.2.6, the coordinator shall apply those limits and stop payments to each Party for which 80% of its maximum grant amount (Annex 2 28 / 106  EP PerMed- Consortium Agreement of the Grant Agreement) is paid, considering the coordinator’s financial availability of the maximum EC Financial Contribution received previously by the Granting Authority. This limit could be increased up to 85%, once that the Reserve Fund is treated as part of the EC Financial Contribution, as set up in chapter 8.2.6, if there is EC Financial Contribution available. 8.2.2 Withholding of Payments The Coordinator is entitled to withhold any payments due to a Beneficiary (also for its Affiliated Entity, if any) identified by the General Assembly to be in breach of its obligations under this Consortium Agreement or the Grant Agreement or to a Beneficiary/ Affiliated Entity which has not yet signed this Consortium Agreement. The Coordinator is entitled to recover any payments already paid to a Defaulting Party except the costs already claimed by the Defaulting Party and accepted by the Granting Authority. The Coordinator is equally entitled to withhold payments to a Defaulting Party when this is suggested by or agreed with the Granting Authority. If a Beneficiary (also for its Affiliated Entity, if any) has received more EC Financial Contribution than it actually needed and then it was approved by the Granting Authority during the reporting periods, the Coordinator is entitled to offset or to withhold payments of the following interim payment or the final payment or to recover the surplus from that Beneficiary (also for its Affiliated Entity, if any). 8.2.3 Budgeting The Consortium Budget will be listed in the actual version of Annex 2 of the Grant Agreement. The Consortium Budget shall be valued in accordance with the usual accounting and management principles and practices of the respective Parties. Costs will be reimbursed to the Beneficiary and Affiliated Entity as follows: A Beneficiary and Affiliated Entity shall be reimbursed only for its tasks carried out in accordance with Annex 1 to GA. This means that there will be no reimbursement for costs related to additional efforts by any Beneficiary and Affiliated Entity that go beyond Annex 1 to GA. The EC Funding Contribution should be used for reimbursement according to the following prioritisation: 1st) covering 100% of the Consortium Budget (part A, C and E of the Annex 2 of GA budget categories planned for activities in WP 1 till WP 5); 2nd) EC share for support of third party in relation to part D of the Annex 2 of GA of Transnational Projects (JTCs); 3rd) additional calls according Annex 1 of the Grant Agreement. The Coordinator shall design a financial reporting scheme (chapter 8.3) that includes the data needed from each Beneficiary and Affiliated Entity to trigger an early warning on the balance of EC Financial Contribution. Should the EC Financial Contribution funds received from the Granting Authority not be enough to cover the agreed annual reimbursements to Beneficiaries and Affiliated Entities or the distribution of funds after new instalments from the Granting Authority, the Coordinator shall work out a plan to postpone payments and to adapt the Consortium Plan in order to prevent additional costs from running up as best as possible until the next instalment. In case of any disagreements, the Coordinator shall convene a meeting of the General Assembly, where an agreement shall be attempted. If no solution can be found, the rules for settlement of disputes (chapter 14.8) shall be followed. 29 / 106  EP PerMed- Consortium Agreement 8.2.4 Justifying costs The costs of each Beneficiary and Affiliated Entity are calculated according to its involvement in EP PerMed based on the following cost categories as defined in Horizon Europe (Article 6 of GA): a) Personnel costs b) Subcontracting costs c) Purchase costs d) Costs for Financial Support to Third Parties e) Indirect costs The total budget of EP PerMed per Beneficiary and Affiliated Entity can be found in respective Annex 2 to the Grant Agreement. Justifying costs towards the Granting Authority: In accordance with its own usual accounting and management principles and practices, each Beneficiary and Affiliated Entity shall be solely responsible for justifying its costs with respect to EP PerMed towards the Granting Authority. Neither the Coordinator nor any of the other Beneficiaries and Affiliated Entities shall be in any way liable or responsible for such justification of costs towards the Granting Authority. Justifying costs towards the General Assembly: The costs of each Beneficiary and Affiliated Entity assigned within a certain Annual Work Programme shall be reported to the General Assembly on an annual basis using the respective cost categories as defined in the Annex 2 of the Grant Agreement. 8.2.5 Payment schedule The payment schedule, which contains the transfer of payments to the Beneficiaries (in according with Article 8.2.1), will be handled according to the following: The Beneficiaries and Affiliated Entities agree that the funding of costs included in the Consortium Plan will be divided in payments according the Annual Work Programme and according the selection lists of the Call Steering Committee (CSC) for each Joint Transnational Call. All payments will be made subject to the approval of the reported costs towards the Granting Authority in the Periodic Reports. All payments will be handled as it was stated in chapter 8.2.1. In the General Assembly, if necessary, according to the updated table showing the new overall budget for the EP PerMed, the General Assembly representatives will decide if there is a need to make adjustment payments. a) Payments according the Annual Work Programme and the internal financial reporting: 60 % - according the planned costs of the respective AWP; - payable at the beginning of the respective AWP. 30 / 106  EP PerMed- Consortium Agreement 40 % (approximatly) - after the Coordinator has received and assessed the internal financial report; - if a Beneficiary and Affiliated Entity requires further payments before the end of the respective AWP, the respective Beneficiary and Affiliated Entity can provide the internal report to the coordinator and receive the payment earlier; - the Coordinator will notify payment within 60 days after approval of the internal report. Payments to Beneficiaries can be combined, if needed. b) Payments according the selection list of the CSC for each Joint Transnational Call: 50 % - according the joint selection list of the funded projects of the respective Joint Transnational Call (JTC). 50 % - after the financial completion of the funded projects of the respective JTC. The support to the Transnational Projects shall be paid by the respective Funding Organisation. The Coordinator shall not transfer any funds directly to the Transnational Projects. c) Payment of the Balance 100 % - on receipt of the payment of the balance, and after the amounts to be recovered under this Consortium Agreement or the Grant Agreement are transferred to the Coordinators bank account; - if recovery under this Consortium Agreement or the Grant Agreement is needed, the payment has to be done within 14 calendar days from the Coordinator’s request for recovery; - open payments will only be paid out after all refunded claims have been received by the Coordinator. 8.2.6 Reserve fund The Beneficiaries and Affiliated Entities have agreed to create a Reserve Fund of 5% of all amounts of the EC Financial Contribution received, which will be used to cover additional costs encountered while implementing the Consortium Plan or in case of less EC Financial Contribution than foreseen (chapter 8.4). Any Beneficiary/Affiliated Entity may apply for this reserve fund during a meeting of the General Assembly in order to implement an activity. The Beneficiary/Affiliated Entity shall present this activity and the budget required from the reserve funds to implement this activity. The General Assembly decides whether this Beneficiary/Affiliated Entity may implement this activity with the help of the agreed budget. In case the Reserve Fund is not used during the EP PerMed duration, it will be treated as part of the EC Financial Contribution, if there is EC Financial Contribution available. If there is an urgent need, the Reserve Fund can be dissolved early, the Coordination Unit will consult the General Assembly on final decision. 31 / 106  EP PerMed- Consortium Agreement 8.2.7 Excess payments A Beneficiary (in according with Article 8.2.1) has received excess payment a if the payment received from the Coordinator exceeds the amount declared or b if a Beneficiary has received payments but, within the last year of the EP PerMed, its real EP PerMed costs fall significantly behind the costs it would be entitled to according to the Consortium Plan. In case a Beneficiary has received excess payment, it has to inform the Coordinator and return the relevant amount to the Coordinator without undue delay. In case no refund takes place within 30 days upon request for return of excess payment from the Coordinator, the Beneficiary is in substantial breach of the Consortium Agreement. Amounts which are not refunded by a breaching Beneficiary and which are not due to the Granting Authority, shall be apportioned by the Coordinator to the remaining Beneficiaries pro rata according to their share of total costs of the EP PerMed as identified in the Consortium Plan, until recovery from the breaching Beneficiary is possible. 8.2.8 Revenue In case a Beneficiary/Affiliated Entity earns any revenue that is deductible from the total funding as set out in the Consortium Plan, the deduction is only directed toward the Beneficiary and Affiliated Entity earning such revenue. The other Beneficiaries/Affiliated Entities’ financial share of the budget shall not be affected by one Beneficiary/Affiliated Entity’s revenue. In case the relevant revenue is more than the allocated share of the Beneficiary/Affiliated Entity as set out in the Consortium Plan, the Beneficiary/Affiliated Entity shall reimburse the funding reduction suffered by other Beneficiaries/Affiliated Entities. 8.2.9 Costs of Certificates on the Financial Statements The audit costs with regard to the Certificate on the Financial Statements are eligible. The budget is located at the Coordinator. Each Beneficiary and Affiliated Entity shall cover the costs (audit costs) for its own mandatory Certificate on the Financial Statements by itself. The budget for the costs for the audit will then be distributed by the Coordinator, according to the actual costs per Beneficiary and Affiliated Entity that were audited. 8.3 Reporting 8.3.1 Reporting to the Granting Authority (Periodic Report) The Beneficiaries and Affiliated Entities must report to the Granting Authority their use of the different types of costs (personnel costs, subcontracting costs, purchase costs and other costs categories) as defined in the Consortium Plan for the different activities implemented by the EP PerMed. They must report as well their costs of providing financial support to third parties (costs related to the funding of transnational research projects within the Joint Transnational Calls). To be considered eligible, the costs must meet the criteria defined in article 6 of the Grant Agreement. The Reporting obligations toward the Granting Authority are detailed in article 20 of the Grant Agreement. All Beneficiaries and Affiliated Entities agree to use the tool “PT-Open” (see chapter 8.3.2 below) in advance for preparing the Periodic Report towards the Granting Authority. 32 / 106  EP PerMed- Consortium Agreement 8.3.2 Reporting to the Coordinator (Internal Report) In order to monitor carefully the advancement and financial aspects of the EP PerMed, internal reports will be submitted by each Beneficiaries and Affiliated Entities to the Coordinator. These internal reports will be requested on a yearly basis, additional to the Periodic Reports. To collect this information, the Coordinator will use the tool “PT-Open” (www.ptopen.eu), a controlling tool developed and owned by the Coordinator. All agree to use the provided tool and to report their actual costs incurred. Internal reports have to be submitted within 30 days following the end of each reporting period and if requested by the Coordinator. The Coordinator will approve the reports and may – in relevant cases – request individual evidence or justifications. If an internal report is not approved by the Coordinator, the decision must be ratified by the Coordination Units. 8.4 Insufficient EC Financial Contribution In the unlikely case that the EC Financial Contribution is not sufficient to contribute to the costs of the EP PerMed as foreseen, the Beneficiaries and Affiliates Entities agree to use the procedure described in the following paragraphs. For the avoidance of doubt, nothing in this Agreement shall be deemed to require a Beneficiary and Affiliated Entity to breach any mandatory statutory national law under which the Beneficiary and Affiliated Entity is operating or to raise its national commitment to pay for financial gaps as described below. 8.4.1 Cost monitoring system The EC Financial Contribution is based on actual costs. According to the Grant Agreement a reimbursement of 30% for all direct and indirect costs foreseen in the Consortium Plan will be awarded by the Granting Authority. If these costs are less than foreseen in the Grant Agreement, the EC Financial Contribution will be less as well and funding gaps might appear. In order to avoid such situations, the Coordinator, shall establish a cost monitoring system, which shall allow for an overview of the budget available for reimbursement and for a cost assessment to plan the consequences of a potentially low leverage of EC Financial Contribution, especially related to the Joint Calls. The Coordinator shall provide the General Assembly with the results of this costs assessment and deliver an early warning, should a scenario of severe reduction of EC Financial Contribution arise in comparison with the numbers foreseen in the Consortium Plan, so that appropriate changes of activities, delays or cancellation of payments can be discussed. The respective decisions shall then be taken by the General Assembly considering the obligation of the Consortium, as agreed upon in the Grant Agreement, to fulfil the Consortium Plan in a reasonable manner and in compliance with the relevant clauses of this Consortium Agreement. 8.4.2 Regular trainings on cost reporting Each Beneficiary and Affiliated Entity shall ensure that the employees working for EP PerMed are fully aware of and follow the rules. These employees shall attend trainings on cost reporting on a regular basis. 8.4.3 Less EC Financial Contribution than foreseen for the Joint Transnational Calls (category D1) The following cases might occur: Case 1: Reduction in EC Financial Contribution due to Transnational Projects reporting less eligible costs than foreseen in the national/regional funding contracts 33 / 106  EP PerMed- Consortium Agreement The funding of Transnational Projects resulting from the Joint Transnational Calls leverages EC Financial Contribution when reported according to the Grant Agreement. If the eligible costs reported in the national funding contracts are less than foreseen, this may in turn lead to a reduction in the EC Financial Contribution. The reason for such a decrease in the eligible costs may lie in poor planning on the part of the consortium running the Transnational Project or in unforeseen circumstances, such as the bankruptcy of one of the project partners. Yet the reduction in the EC Financial Contribution may have a negative effect on the budget situation of the whole EP PerMed Consortium. In case of a bankruptcy, the affected Call-specific Consortia shall endeavor to mitigate the situation as appropriate or compatible with the funding regulations of the affected Funding Partner, e.g. by allowing the respective Transnational Projects to exchange the defaulting project partner. If the effective costs are less than foreseen and the respective Funding Partner already received EC Financial Contribution for the full amount leveraged by the national funding contracts, the respective Funding Beneficiaries and Affiliated Entities shall return the excess EC Financial Contribution without unjustified delay to the Coordinator. Funding Partners from countries outside the Euro-zone shall convert their reported costs according to the rules laid down in Article 21.3 of the Grant Agreement. If the above-mentioned is not sufficient, the affected Call Steering Committee shall come up with a proposal of how any potential loss can be reduced to a minimum, and bring it before the General Assembly for a decision. The members of the respective Call-specific Consortium may decide to voluntarily increase their contribution in case that the available EC Financial Contribution or another Funding Partner does not provide sufficient funding. Case 2: A Funding Partner has to revoke after the ranking lists were fixed, but before the national funding contracts for the Transnational Projects could be signed The determination of the ranking lists resulting from the proposal evaluation constitutes the final step of the full- proposal stage of the Joint Transnational Calls. If at this stage, which is before the national funding contracts for the successful proposals could be signed, a Funding Partner has to revoke and cannot fund their respective national share of the potential Transnational Projects of the Joint Call, the Chairperson of the CSC shall enact the following steps: (1) A meeting shall be convened of the Call Steering Committee affected by this situation, in order to discuss the possibility to replace the respective proposers of the concerned Transnational Projects with eligible stakeholders from other countries and fund those replacements. The Funding Partners shall be free to consider this option in line with their respective national regulations. (2) If a replacement is not possible and a funding gap appears, all Funding Partners involved in the respective Call Steering Committee shall come together and deliberate, how, or whether at all the funding gap – and thus, the financing of the project partners, whose funding had been revoked – could be covered by re-dimensioning the prospective Transnational Projects. (3) If the situation occurs at a time where the costs for implementing the Consortium Plan cannot be fully reimbursed and the funding gap closed by rearranging or reducing the distribution of the EC Financial Contribution, the Funding Partners shall resort to the procedures laid down at the beginning of chapter 8.4. 8.4.4 Less EC Financial Contribution than foreseen for Consortium Budget than foreseen in the Consortium Plan Each Beneficiary and Affiliated Entity shall attempt to contribute to the Consortium Plan as expected. If the contribution foreseen is not possible, the respective Beneficiary and Affiliated Entity shall immediately inform the 34 / 106  EP PerMed- Consortium Agreement Coordinator, who shall suggest a mitigation strategy to the General Assembly. This might include budget shifts among the Beneficiaries and Affiliated Entities or the involvement of new Beneficiaries and Affiliated Entities. In case that the Consortium Budget is lower than foreseen in the Consortium Plan the EC Financial Contribution will be lower as well. The EC Financial Contribution is related to the budget committed to the Joint Transnational Calls by the Funding Partners as well as to the way in which the Beneficiaries and Affiliated Entities uphold their respective commitments for the specified activities indicated in the Consortium Plan. If a Beneficiary and Affiliated Entity reduces its commitments regarding its indicated budget for the Joint Transnational Calls or its provision of resources (personnel or funding) for the Consortium Plan, the possible leverage of the EC Financial Contribution will be lower and a funding gap might appear with regard to the execution of the Consortium Plan. In this case, the Coordinator together with the EP PerMed Coordination Unit shall come up with a proposal to the General Assembly about which sources of funding to use (e.g. the reserve fund) in order to mitigate the funding gap. This proposal and the actions arising from it shall be discussed and decided upon in the General Assembly. 8.4.5 No EU Financial Contribution In the unlikely case that the EP PerMed is terminated and the availability of the EC Financial Contribution is either reduced or completely cancelled by the Granting Authority, the Coordinator shall convene a meeting of the General Assembly, where an agreement shall be attempted on how to equally distribute any loss in proportion to the size of the costs incurred and commitments made. The liabilities of all Parties shall be limited in accordance with the rules established in chapter 5.2. a) In case that enough EC Financial Contribution has already been made available by the Granting Authority to establish the Reserve Fund, this Reserve Fund and all the remaining EC Financial Contribution shall be used in line with its pre-determined purpose to cover the costs incurred in the execution of the Consortium Plan up to the time of termination and in compliance with national legislations. Any contractual funding commitments established by the Funding Partners up to the time of the termination that include co-funding from the EC Financial Contribution shall be honoured in the same way. b) In case that EC Financial Contribution has been made available before termination, but that it is not enough to cover both the Consortium Budget incurred until then and the funding commitments established that include potential EC Financial Contribution, the prioritisation laid out in chapter 8.2.3 shall be applied and the process towards finding a solution shall be followed as outlined at the beginning of this chapter. c) In case that no EC Financial Contribution is available whatsoever, the same principles shall be followed as described in the previous paragraph 8.4.5 b of this chapter. All Parties acting in this consortium in conjunction with a Funding Organisation are required to come to an agreement with their Funding Organisations on their respective national or regional levels regarding how to approach the situations explained above. By signing this Consortium Agreement all Parties confirm that such a national or regional agreement is in place on their respective sides and that the provisions of this chapter can be followed. 8.5 Budget flexibility Budget transfers and modifications are allowed between Parties and between costs categories without an amendment to the Grant Agreement provided that the work is implemented as stipulated in the Description of Action (Annex 1 to the Grant Agreement) and within any other limits set out in article 5.5 of the Grant Agreement. As a prior step to implementing the mentioned transfers without amendment, the Coordination should inform the European Commission authorised officer and obtain written validation of such a course of action by the latter. 35 / 106  EP PerMed- Consortium Agreement The Coordination Unit shall be informed in due time of all budget transfers. Budget transfers shall always be duly justified and approved by the Parties directly concerned. Budget transfers are possible as follows, after validation by the task leads concerned, the work package leads concerned, and the Coordinator: - Budget transfers for activities implemented according to the Consortium Plan; - Budget transfers for activities implemented according to the AWP; - Budget transfers from one AWP to an other AWP; - Budget transfers within the budget of one Party; - Between different activities in which the Party is involved; - Budget transfers from one Beneficiary to its Affiliated Entity and between its Affiliated Entities. 9 Call Implementation 9.1 Selection process: 9.1.1 Central scientific evaluation (Step 1) A single international peer review shall be accomplished after the regional/national and transnational eligibility checks to evaluate the submitted proposals. Only those proposals which are eligible according to transnational rules shall be evaluated. At least three independent experts shall evaluate each proposal. The result of the peer review shall be a Ranking List of proposals suggested for submitting a proposal in step 2. Limited oversubscription in step 1: The Parties shall make their best efforts to match their regional/national funding budget with the expected success of their respective research communities. The selected proposals should not exceed the proposed total individual regional/national budget of the Joint Call by more than three times for Beneficiaries and two times for funding organisations from countries which are not eligible for receive EC contribution. 9.1.2 Central scientific evaluation (Step 2) The proposal selection in step 2 shall be implemented following the rules indicated in Annex 5 of the Grant Agreement, chapter “Specific rules for Co-funded Partnerships”. A single international peer review shall be implemented. Only those step 2 proposals which are eligible shall be evaluated. The Expert Panel shall rank proposals according to the programme’s evaluation criteria. At least three independent experts shall evaluate each step 2 proposal. The result of the peer review shall be a list of step 2 proposals suggested for funding (i.e. Ranking List). The selection procedure must be followed by an independent expert observer, who must write a report. 9.2 Share of the EC contribution used to support third parties in Transnational Projects (JTCs) The Parties agree that the share (percentage) of the EC contribution used to support third parties receiving financial support by Parties through JTCs is revised in each AWP and the respective MoU. In addition: - The EC Financial Contribution will be used to fund the participation of patient organisations in joint transnational calls (dedicated budget 10.5 Mio € within WP2). 36 / 106  EP PerMed- Consortium Agreement - approximately 5 Mio. Euro from the EC financial contribution will be used to fund third parties in dedicated calls such as for specific calls of WP 3, 4 and 5 (see Annex 1 of the GA and the respective AWP). The Parties agree to fund as many Transnational Projects as possible following the Ranking List at least within the limits of their indicative commitment for a given call. When the Ranking List of projects recommended for funding is set up, the main goal should be first to explore all funding solutions to unblock situations at regional/national level (i.e. regional/national funding organisations shall make all reasonable efforts to match national funding with the success of their respective research communities). The EC share for support of third party for Transnational Projects shall be used in the most efficient way possible. The Parties thus agree that they will not insist on an equal share of it. The EC share for support of third party for Transnational Projects for each Party shall be limited to the Party’s respective financial contribution to the Joint Call. A Funding Organisation shall not receive more than 20% of the EC share for support of third party in a specific JTC. The Parties agree to use a mixed mode financing system to compensate cases where participating Funding Organisations have exhausted their budget at different points in the Ranking List. A minimum of 40 % EC share for support of third party for Transnational Projects will be used for proportional topping-up of the national/regional funding of the respective Parties. The remaining part of the EC share for support of third party for Transnational Projects will be reserved for financial balancing purposes. If more than 60 % of the EC share for support of third party for Transnational Projects is needed for balancing purposes in order to maximise the number of Transnational Projects that can be funded, this percentage may be further increased by a decision of organisations eligible for EC share for support of third party in the Call Steering Committee. The Call Steering Committee may re-evaluate the rules for using the EC share for support of third party for Transnational Projects, if needed. 9.3 Ranking List Based on the ranking of the Expert Panel, and considering the available budgets of the Funding Organisations and the EC share for support of third party, the Call Secretariat will propose a funding recommendation to the Call Steering Committee, considering that it is a requirement of EP PerMed to follow the Ranking List as suggested. The Call Steering Committee shall agree on the Ranking List based on the suggestion by the Call Secretariat. Projects with scores below the thresholds given in the text of the Joint Call will not be funded even if there is regional/national funding available. Adaption of the thresholds for specific JTC are possible by the respective CSC. 9.4 Conflicts of interest/ Information Barrier Parties and their representatives cannot be Beneficiary of competitive activities implemented in the context of EP PerMed. In particular, they cannot participate in proposals submitted to the Transnational calls for research proposals, unless they have been listed and allowed to do so in the Grant Agreement and Attachment 3 of this CA. Beneficiaries that are not listed may not apply for funding under EP PerMed’s Joint Transnational calls. Each organisation allowed to apply to the Joint Transnational Calls has indicated in the Grant Agreement and Attachment 3 their individual measures to mitigate the Conflicts of Interest, including but not limited to staff separation and Information barriers (chapter 9.4.2). In order to further avoid conflict of interests, Parties have also agreed to the setting up of “Firewalls”. Parties that may apply to Transnational calls for research proposals cannot participate in the WP 2 dedicated to the preparation, implementation or follow-up of the calls, nor have access to any information pertaining to these activities. This may require to organise meetings in compartmentalised sessions, in order to separate topics and discussions. 37 / 106  EP PerMed- Consortium Agreement 9.4.1 Conflicts of interest All Parties (CSC members and Reviewers) must report a potential Conflict of interest to the CSC. All staff involved in the action shall be required to disclose any conflict of interest to the Coordinator, who will handle the case and take adequate measures. • Parties applying in a joint call Parties agree to a compartmentalised organisation and governance. This means that Parties that may apply to co- funded Joint Calls (or other competitive activities supported by EP PerMed) may not participate in work packages and tasks dedicated to the preparation, implementation and monitoring of said activities. Neither may they access any information pertaining to the implementation of these work packages and tasks. A list of Parties allowed to apply to the Joint Calls is included in the Grant Agreement and Attachment 3. Parties that are not listed may not apply for funding under EP PerMed’s Joint Calls. Each Parties allowed to apply to the Joint Calls has indicated in the Grant Agreement and Attachment 3 their individual measures to mitigate the Conflicts of Interest, including but not limited to staff separation and Information barriers (chapter 9.4.2). For transparency, these Parties will also be listed in the relevant Call texts. • Conflict of interests in evaluation Each Party agrees that, in order to avoid any conflict of interest within the Joint calls developed in EP PerMed, it will not be involved in the evaluation process (including the appointment of the international panel of independent experts), if the Party or its Affiliated Entities plan to respond themselves to this call. In selecting the experts for the evaluation, the CSC shall endeavour to avoid any possible conflicts of interest. The Call Secretariat shall prepare a template concerning potential conflicts of interest and a declaration, which has to be confirmed by each expert involved in the evaluation of the Joint Calls. 9.4.2 Information Barrier If Parties or departments of Parties might apply in a joint activity, they must set up “information barriers” to avoid the technical possibility for Parties with a conflict of interest (see above) to access emails, documents or any information received by the staff involved with the preparation of documents to be used in the award procedure (e.g. Call, evaluation etc.) as well as internal guidance and control standards clearly prohibiting sharing such information within the organisation. The Information Barrier therefore prevents any possible Conflict of Interests and prevents Parties from accessing information regarding the preparation, implementation and follow up of calls. This includes compartmentalising discussion themes during meetings of relevant governing bodies (see chapter 6.3 and Attachment 3 of this CA). 9.5 Contractual obligations towards the Granting Authority on selection The Funding Organisations shall provide to the Coordinator within 10 days after the end of the selection process a formal and duly signed commitment on availability of funds for their selected projects. After the end of the selection process, the Coordinator shall submit to the Granting Authority the following: (a) the ranking list(s) of the projects; (b) the evaluation observers' report on the evaluation; 38 / 106  EP PerMed- Consortium Agreement (c) the joint selection list of the projects to be funded, and (d) from each Funding Organisation participating in the respective Joint Call, a formal and duly signed commitment on availability of funds for the selected projects. The Coordinator will furthermore submit to the Granting Authority after the end of the selection process information on each project selected for funding, including data on each participant and abstracts of the project proposal, in a format specified by the Granting Authority, for publication and evaluation purposes. This information will be updated at the end of EP PerMed (information on each Funded Project, including data on each participant and overview on the results). The Funding Organisations shall inform their final recipients in funding contracts that the above-mentioned data will be submitted to the Granting Authority. 9.6 Contractual obligations for projects funded in the Joint Calls The Parties acting as Funding Organisations for projects selected for funding in the Joint Calls agree to oblige their final recipients in funding contracts to the following: • to have a signed a consortium agreement latest 6 months after the start of the project at least addressing the following topics: o Internal organisation and management of the consortium o Intellectual property arrangements o Settlement of internal disputes • to prepare popular science summaries of the project contents for EP PerMed activities and publications (e.g. for brochures, [digital] newsletters, the website) • to take part in, and contribute with project presentations and/or posters to the foreseen events of EP PerMed • to prepare short annual scientific reports and one final scientific report according to standardised templates, to respond to up to two in-depth monitoring activities (mid-term and final) and to participate in monitoring survey after the projects have ended to measure project progress, project output and contribution to overall Co-fund Action aims • to provide the information on their projects, including data on each participant and abstracts of the project proposal, in a format specified by the Granting Authority, for publication and evaluation purposes • to follow the obligations of the EU- Grant Agreement Avoiding conflict of interest (see Article 12) Confidentiality and security obligations (see Article 13) Ethics (see Article 14) Give visibility to the EU funding as appropriate (see Article 17.2) Respect specific rules for the action implementation (see Article 18) 39 / 106  EP PerMed- Consortium Agreement Information obligations (see Article 19) Record-keeping (see Article 20) • to ensure that the bodies mentioned in Article 25 (e.g. Granting Authority, the European Court of Auditors (ECA), the European Anti-Fraud Office (OLAF)) have the right to carry out checks, reviews, audits and investigations on the final recipients, and in particular to audit the payments received. If access is denied by the final recipient, the costs will be rejected. 10 Results For the avoidance of doubt, the term “Results” in this chapter refers to the Results generated by the consortium of EP PerMed and does not include the results generated by Projects funded by the Joint Calls. 10.1 Ownership of Results Results are owned by the Party that generates them. 10.2 Joint ownership Joint ownership is governed by Grant Agreement Article 16.4 and its Annex 5, chapter “Ownership of results”, with the following additions: Unless otherwise agreed: − each of the joint owners shall be entitled to use their jointly owned Results for non-commercial research and teaching activities on a royalty-free basis, and without requiring the prior consent of the other joint owner(s). − each of the joint owners shall be entitled to otherwise Exploit the jointly owned Results and to grant non-exclusive licenses to third parties (without any right to sub-license), if the other joint owners are given: (a) at least 45 calendar days advance notice; and (b) fair and reasonable compensation. The joint owners shall agree on all protection measures and the division of related cost in advance. 10.3 Transfer of Results Each Party may transfer ownership of its own Results, including its share in jointly owned Results, following the procedures of the Grant Agreement Article 16.4 and its Annex 5, Section Transfer and licensing of results, sub- section “Transfer of ownership”. The Parties waive their right to prior notice and their right to object to such a transfer of ownership of results to identified third parties according to the Grant Agreement Article 16.4 and its Annex 5, Section Transfer of licensing of results, sub-section “Transfer of ownership”, 3rd paragraph. The transferring Party shall make reasonable efforts to inform the other Parties of such transfer as soon as practicable, however, not later than at the time of the transfer and shall ensure that the rights of the other Parties under the Consortium Agreement and the Grant Agreement will not be affected by such transfer. 40 / 106  EP PerMed- Consortium Agreement The Parties recognise that in the framework of a merger or an acquisition of an important part of its assets, it may be impossible under applicable EU and national laws on mergers and acquisitions for a Party to give at least 45 calendar days prior notice for the transfer as foreseen in the Grant Agreement. The obligations above apply only for as long as other Parties still have - or still may request - Access Rights to the Results. 10.4 Dissemination For the avoidance of doubt, the confidentiality obligations set out in chapter 12 apply to all dissemination activities described in this chapter 10.4 as far as Confidential Information is involved. 10.4.1 Dissemination of own (including jointly owned) Results During EP PerMed and for a period of 1 year after the end of EP PerMed, the dissemination of own Results by one or several Parties including but not restricted to publications and presentations, shall be governed by the procedure of article 17.4 of the Grant Agreement and its Annex 5, section “Dissemination”, subject to the following provisions: Prior notice of any planned publication shall be given to the other Parties at least 45 calendar days before the publication. Any objection to the planned publication shall be made in accordance with the Grant Agreement by written notice to the Coordinator and to the Party or Parties proposing the dissemination within 30 calendar days after receipt of the notice. If no objection is made within the time limit stated above, the publication is permitted. An objection is justified if a the protection of the objecting Party's Results or Background would be adversely affected, or b the objecting Party's legitimate interests in relation to its Results or Background would be significantly harmed, or c the proposed publication includes Confidential Information of the objecting Party. The objection has to include a precise request for necessary modifications. If an objection has been raised the involved Parties shall discuss how to overcome the justified grounds for the objection on a timely basis (for example by amendment to the planned publication and/or by protecting information before publication) and the objecting Party shall not unreasonably continue the opposition if appropriate measures are taken following the discussion. The objecting Party can request a publication delay of not more than 90 calendar days from the time it raises such an objection. After 90 calendar days the publication is permitted, provided that the objections of the objecting Party have been addressed. 10.4.2 Dissemination of another Party’s unpublished Results or Background A Party shall not include in any dissemination activity another Party's Results or Background without obtaining the owning Party's prior written approval, unless they are already published. 41 / 106  EP PerMed- Consortium Agreement 10.4.3 Cooperation obligations The Parties undertake to cooperate to allow the timely submission, examination, publication and defence of any dissertation or thesis for a degree that includes their Results or Background subject to the confidentiality and publication provisions agreed in this Consortium Agreement. 10.4.4 Use of names, logos or trademarks Nothing in this Consortium Agreement shall be construed as conferring rights to use in advertising, publicity or otherwise the name of the Parties or any of their logos or trademarks without their prior written approval. 11 Access Rights For the avoidance of doubt, this chapter refers to the Access Rights of the consortium of EP PerMed and does not include the background/results of the Funded Projects. 11.1 Background included In Attachment 1, the Parties have identified and agreed on the Background for EP PerMed and have also, where relevant, informed each other that Access to specific Background is subject to legal restrictions or limits. Anything not identified in Attachment 1 shall not be the object of Access Right obligations regarding Background. Any Party may add additional own Background to Attachment 1 during EP PerMed provided they give written notice to the other Parties. However, approval of the General Assembly is needed should a Party wish to modify or withdraw its Background in Attachment 1. 11.2 General Principles Each Party shall implement its tasks in accordance with the Consortium Plan and shall bear sole responsibility for ensuring that its acts within EP PerMed do not knowingly infringe third party property rights. Any Access Rights granted exclude any rights to sublicense unless expressly stated otherwise. Access Rights shall be free of any administrative transfer costs. Access Rights are granted on a non-exclusive basis. Results and Background shall be used only for the purposes for which Access Rights to it have been granted. All requests for Access Rights shall be made in writing. The granting of Access Rights may be made conditional on the acceptance of specific conditions aimed at ensuring that these rights will be used only for the intended purpose and that appropriate confidentiality obligations are in place. The requesting Party must show that the Access Rights are Needed. 11.3 Access Rights for implementation Access Rights to Results and Background Needed for the performance of the own work of a Party under EP PerMed shall be granted on a royalty-free basis, unless otherwise agreed for Background in Attachment 1. 42 / 106  EP PerMed- Consortium Agreement 11.4 Access Rights for Exploitation 11.4.1 Access Rights to Results Access Rights to Results if Needed for Exploitation of a Party's own Results shall be granted on Fair and Reasonable conditions. Access rights to Results for internal research and for teaching activities shall be granted on a royalty-free basis. 11.4.2 Access Rights to Background Access Rights to Background if Needed for Exploitation of a Party’s own Results, shall be granted on Fair and Reasonable conditions. 11.4.3 Requests A request for Access Rights may be made up to 12 months after the end of EP PerMed or, in the case of 11.7.2, after the termination of the requesting Party’s participation in EP PerMed. 11.5 Access Rights for entities under the same control Entities under the same control have Access Rights under the conditions of the Grant Agreement article 16.4 and its Annex 5, section "Access rights to results and background”, sub-section “Access rights for entities under the same control”. Such Access Rights must be requested by the entity under the same control from the Party that holds the Background or Results. Alternatively, the Party granting the Access Rights may individually agree with the Party requesting the Access Rights to have the Access Rights include the right to sublicense to the latter's entity under the same control. Access Rights to an entity under the same control shall be granted on Fair and Reasonable conditions and upon written bilateral agreement. Entities under the same control which obtain Access Rights in return fulfil all confidentiality obligations accepted by the Parties under the Grant Agreement or this Consortium Agreement as if such entities were Parties. Access Rights may be refused to entities under the same control if such granting is contrary to the legitimate interests of the Party which owns the Background or the Results. Access Rights granted to any entity under the same control are subject to the continuation of the Access Rights of the Party with whom it is under the same control, and shall automatically terminate upon termination of the Access Rights granted to such Party. Upon cessation of the status as an entity under the same control, any Access Rights granted to such former entity under the same control shall lapse. Further arrangements with entities under the same control may be negotiated in separate agreements. 11.6 Additional Access Rights For the avoidance of doubt any grant of Access Rights not covered by the Grant Agreement or this Consortium Agreement shall be at the absolute discretion of the owning Party and subject to such terms and conditions as may be agreed between the owning and receiving Parties. 43 / 106  EP PerMed- Consortium Agreement 11.7 Access Rights for Parties entering or leaving the consortium 11.7.1 New Parties entering the consortium As regards Results developed before the accession of the new Party, the new Party will be granted Access Rights on the conditions applying for Access Rights to Background. 11.7.2 Parties leaving the consortium Access Rights granted to a leaving Party: - Defaulting Party Access Rights granted to a Defaulting Party and such Party's right to request Access Rights shall cease immediately upon receipt by the Defaulting Party of the formal notice of the decision of the General Assembly to terminate its participation in the consortium. - Non-defaulting Party A non-defaulting Party leaving voluntarily and with the other Parties' consent shall have Access Rights to the Results developed until the date of the termination of its participation. It may request Access Rights within the period of time specified in 11.4.3. Access Rights to be granted by any leaving Party: Any Party leaving EP PerMed shall continue to grant Access Rights pursuant to the Grant Agreement and this Consortium Agreement as if it had remained a Party for the whole duration of EP PerMed. 11.8 Specific Provisions for Access Rights to Software For the avoidance of doubt, the general provisions for Access Rights provided for in this chapter 11 are applicable also to Software. Parties’ Access Rights to Software do not include any right to receive source code or object code ported to a certain hardware platform or any right to receive respective Software documentation in any particular form or detail, but only as available from the Party granting the Access Rights. 12 Non-disclosure of information 12.1 Confidential Information All information in whatever form or mode of communication, which is disclosed by a Party (the “Disclosing Party”) to any other Party (the “Recipient”) in connection with EP PerMed during its implementation and which has been explicitly marked as “confidential” at the time of disclosure, or when disclosed orally has been identified verbally or in writing as confidential at the time of disclosure or has been confirmed and designated in writing within 15 calendar days from oral disclosure at the latest as confidential information by the Disclosing Party, or is commonly regarded as confidential or proprietary in the life sciences industry, is “Confidential Information”. 12.2 Approach The Recipients hereby undertake in addition and without prejudice to any commitment on non-disclosure under the Grant Agreement, for a period of 5 years after the final payment of the Granting Authority or end of EP PerMed activities, whichever is later: − not to use Confidential Information otherwise than for the purpose for which it was disclosed; 44 / 106  EP PerMed- Consortium Agreement − not to disclose Confidential Information without the prior written consent by the Disclosing Party; − to ensure that internal distribution of Confidential Information by a Recipient shall take place on a strict need-to-know basis; and − to return to the Disclosing Party, or destroy, on request all Confidential Information that has been disclosed to the Recipients including all copies thereof and to delete all information stored in a machine-readable form to the extent practically possible. The Recipients may keep a copy to the extent it is required to keep, archive or store such Confidential Information because of compliance with applicable laws and regulations or for the proof of on-going obligations provided that the Recipient complies with the confidentiality obligations herein contained with respect to such copy. 12.3 Range The Recipients shall be responsible for the fulfilment of the above obligations on the part of their employees or third parties involved in EP PerMed and shall ensure that they remain so obliged, as far as legally possible, during and after the end of EP PerMed and/or after the termination of the contractual relationship with the employee or third party. 12.4 Exception The above shall not apply for disclosure or use of Confidential Information, if and in so far as the Recipient can show that: − the Confidential Information has become or becomes publicly available by means other than a breach of the Recipient’s confidentiality obligations; − the Disclosing Party subsequently informs the Recipient that the Confidential Information is no longer confidential; − the Confidential Information is communicated to the Recipient without any obligation of confidentiality by a third party who is to the best knowledge of the Recipient in lawful possession thereof and under no obligation of confidentiality to the Disclosing Party; − the disclosure or communication of the Confidential Information is foreseen by provisions of the Grant Agreement; − the Confidential Information, at any time, was developed by the Recipient completely independently of any such disclosure by the Disclosing Party; − the Confidential Information was already known to the Recipient prior to disclosure, or − the Recipient is required to disclose the Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, subject to the provisions in 12.7 hereunder. 12.5 Handling The Recipient shall apply the same degree of care with regard to the Confidential Information disclosed within the scope of EP PerMed as with its own confidential and/or proprietary information, but in no case less than reasonable care. 12.6 Unauthorised disclosure Each Recipient shall promptly inform the relevant Disclosing Party by written notice of any unauthorised disclosure, misappropriation or misuse of Confidential Information after it becomes aware of such unauthorised disclosure, misappropriation or misuse. 45 / 106  EP PerMed- Consortium Agreement 12.7 Disclosure of Confidential Information for compliance with applicable laws and regulations If any Recipient becomes aware that it will be required, or is likely to be required, to disclose Confidential Information in order to comply with applicable laws or regulations or with a court or administrative order, it shall, to the extent it is lawfully able to do so, prior to any such disclosure according to the described approach in chapter 12.2. the Disclosing Party will be notified. 12.8 Confidentiality in Transnational Projects The content of the proposals received under the Joint Call is deemed to be confidential, except of the lists of applications and lists of Funded Projects. This obligation shall survive the expiration or termination of the Consortium Agreement. 13 Data management Appropriate and secure use of materials and data of Transnational Projects will be enabled according to the application of common standards. Data management guidelines will be developed by the Lead of WP 2 in month 12 and will be applied in the Joint Call. The collected data will be protected and secured, in order to avoid a malevolent use of it. 14 Miscellaneous 14.1 Attachments, inconsistencies and severability This Consortium Agreement consists of this core text and: − Attachment 1 (Background included) − Attachment 2 (Accession document) − Attachment 3 (Conflicts of Interest/Information Barrier in Call implementation) In case the terms of this Consortium Agreement are in conflict with the terms of the Grant Agreement, the terms of the latter shall prevail. In case of conflicts between the attachments and the core text of this Consortium Agreement, the latter shall prevail. Should any provision of this Consortium Agreement become invalid, illegal or unenforceable, it shall not affect the validity of the remaining provisions of this Consortium Agreement. In such a case, the Parties concerned shall be entitled to request that a valid and practicable provision be negotiated that fulfils the purpose of the original provision. 14.2 No representation, partnership or agency Except as otherwise provided in 7.6.1, no Party shall be entitled to act or to make legally binding declarations on behalf of any other Party or of the consortium. Nothing in this Consortium Agreement shall be deemed to constitute a joint venture, agency, partnership, interest grouping or any other kind of formal business grouping or entity between the Parties. 46 / 106  EP PerMed- Consortium Agreement 14.3 Formal and written notices Any notice to be given under this Consortium Agreement shall be addressed to the recipients as listed in the most current address list kept by the Coordinator. Any change of persons or contact details shall be immediately communicated to the Coordinator by written notice. The address list shall be accessible to all Parties. Formal notices: If it is required in this Consortium Agreement (4.4 and 14.4) that a formal notice, consent or approval shall be given, such notice shall be signed by an authorised representative of a Party and shall either be served personally or sent by mail with recorded delivery with acknowledgement of receipt. Written notice: Where written notice is required by this Consortium Agreement, this is fulfilled also by other means of communication such as e-mail with acknowledgement of receipt. 14.4 Assignment and amendments Except as set out in 10.3, no rights or obligations of the Parties arising from this Consortium Agreement may be assigned or transferred, in whole or in part, to any third party without the other Parties’ prior formal approval. Amendments and modifications to the text of this Consortium Agreement not explicitly listed in 7.1.2 require a separate written agreement to be signed between all Parties. 14.5 Mandatory national law Nothing in this Consortium Agreement shall be deemed to require a Party to breach any mandatory statutory law under which the Party is operating. 14.6 Language This Consortium Agreement is drawn up in English, which language shall govern all documents, notices, meetings, arbitral proceedings and processes relative thereto. 14.7 Applicable law This Consortium Agreement shall be construed in accordance with and governed by the laws of Belgium excluding its conflict of law provisions. 14.8 Settlement of disputes 14.8.1 Amicable solution within the consortium The Parties shall endeavour to settle their disputes amicably. In case of a conflict of opinion which cannot be solved within the respective Consortium Body or between the respective Consortium Bodies, the Coordinator shall be approached for advice. The Coordinator may decide to seek a decision of the General Assembly in order to come to a solution. If the Coordinator is involved in the conflict, WP Lead 2 should take over this role. 47 / 106  EP PerMed- Consortium Agreement 14.8.2 Dispute resolution Should the attempts to settle the dispute within the consortium fail to bring about a full agreement between the Parties, the Consortium will try to solve it through the following method of dispute resolution. All disputes arising out of or in connection with this Consortium Agreement, which cannot be solved amicably, shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules. The place of arbitration shall be Brussels if not otherwise agreed by the conflicting Parties. The award of the arbitration will be final and binding upon the Parties. If this method is not applicable for a Parties, nothing in this Consortium Agreement shall limit the Parties' right to seek injunctive relief in any applicable competent court. 48 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P02) Agence Nationale de la Recherche (BEN) Name(s) Thierry DAMERVAL Title(s) President & CEO Date 22/04/2024 50 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P03) VLAAMSE GVLAAMSE GEWESTEWEST (BEN) Name(s) Title(s) Date 51 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P04) IACS – (Instituto Aragones De Ciencias De La Salud - Health Sciences Institute in Aragon) (BEN) Name: Elena Gonzalvo Suñer Title: Executive Director Date: that of electronic signature 52 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P05) Fondazione Toscana Life Sciences (BEN) Name(s) Title(s) Date 53 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P24) Zorgonderzoek Nederland ZON (BEN) Name(s) Merik Seven Title(s) Director international programs Date 09-04-2024 74 / 106 DocuSign Envelope ID: 9D34890E-6FC8-43BA-B426-A4862B8EE2FC EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P25) Fonds National de la Recherche (BEN) Name(s) Andreea Monnat Title(s) Acting Secretary General Date 21st March 2024 75 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P33) Innovaatiorahoituskeskus Business Finland (BEN) Ws) Bate If « A. Oli 83/106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P33.1) Business Finland Oy (AE) Name(s) Teija Lahti-Nuuttila A Titie(s) Executive Director Date 10.04.2024 84/106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P38) National Research, Development and Innovation Office (BEN) Name(s) Title(s) Date 89 / 106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P48) Bundesministerium für Bildung, Wissenschaft und Forschung (BMBWF AT) (BEN) Name(s) Hemma BAUER Title(s) Head ofDepartment - Life Sciences and Animal Affairs Date 13June2024 ^TK^ /\ ^•^ 100/106  EP PerMed- Consortium Agreement 15 Signatures AS WITNESS: The Parties have caused this Consortium Agreement to be duly signed by the undersigned authorised representatives in separate signature pages the day and year first above written. (P50) INNOSUISSE (AE) Name(s) Title(s) Date 102 / 106  EP PerMed- Consortium Agreement Appendix Attachment 1: Background Included According to the Grant Agreement (Article 16.1) Background is defined as “data, know-how or information (…) that is (…) needed to implement the Action or exploit the results”. Because of this need, Access Rights have to be granted in principle, but Parties must identify and agree amongst them on the Background for EP PerMed. This is the purpose of this attachment. PARTY 1 As to [NAME OF THE PARTY], it is agreed between the Parties that, to the best of their knowledge, [insert the relevant option here]. [Option 1] the following Background is hereby identified and agreed upon for EP PerMed. Specific limitations and/or conditions, shall be as mentioned hereunder: Background description Specific restrictions and/or Specific restrictions and/or conditions for implementation conditions for Exploitation (Article 16.4 Grant Agreement and (Article 16.4 Grant Agreement its Annex 5, chapter “Access rights and its Annex 5, chapter to results and background”, sub- “Access rights to results and section “Access rights to background”, sub-section background and results for “Access rights for exploiting the implementing the Action”) results”) This represents the status at the time of signature of this Consortium Agreement. [Option 2] no data, know-how or information of [NAME OF THE PARTY] is Needed by another Party for implementation of EP PerMed (Article 16.1 and its Annex 5 Grant Agreement, chapter “Access rights to results and background”, sub-section “Access rights to background and results for implementing the action”) or Exploitation of that other Party’s Results (Article 16.1 and its Annex 5 Grant Agreement, chapter “Access rights to results and background”, sub-section “Access rights for exploiting the results”). This represents the status at the time of signature of this Consortium Agreement. [Same for PARTY 2, PARTY 3, etc] 103 / 106  EP PerMed- Consortium Agreement Attachment 2: Accession document ACCESSION of a new Party to [ACRONYM OF THE CO-FUND ACTION] Consortium Agreement, version xx, [DATE] [OFFICIAL NAME OF THE NEW PARTY AS IDENTIFIED IN THE GRANT AGREEMENT] hereby consents to become a Party to the Consortium Agreement identified above and accepts all the rights and obligations of a Party starting [DATE]. [OFFICIAL NAME OF THE COORDINATOR AS IDENTIFIED IN THE GRANT AGREEMENT] hereby certifies that the consortium has accepted in the meeting held on [DATE] the accession of [THE NAME OF THE NEW PARTY] to the consortium starting [DATE]. This accession document has been done in 2 originals to be duly signed by the undersigned authorised representatives. [DATE] [PLACE] [NAME OF THE NEW PARTY] Signature(s) Name(s) Title(s) [DATE] [PLACE] [NAME OF THE COORDINATOR] Signature(s) Name(s) Title(s) 104 / 106  EP PerMed- Consortium Agreement Attachment 3: Conflicts of Interest and Information Barrier in Call implementation Possibility to fund members of the consortiums through the Financial Support to Third Parties When implementing financial support to third parties in co-funded partnerships, the beneficiaries must avoid any conflict of interest and comply with the principles of transparency, non-discrimination and sound financial management. EP PerMed partners will not be allowed to participate as potential applicants (coordinators or partners) in JTCs. However, under exceptional circumstances there could be (under the current constellation of the EP PerMed consortium) some beneficiary that could participate in calls. These partners are the following: ISCIII, BBMRI, TUBITAK. As the EP PerMed is open for additional organisations joining the EP PerMed consortium, there might be additional concerned organisation in the future. The process to follow for avoiding conflict of interest will consist in identifying for each call the potential partners that could apply, send to the JCS the necessary information to confirm that there is not conflict of interest and request a written approval. The organisation could not apply until it has received a positive answer by the JCS. The criteria for not having conflict of interest are: • EP PerMed partner and the corresponding third parties belong to an independent department • EP PerMed partner and the corresponding third parties have independent management structure • The third parties must be eligible to receive funds from the corresponding EP PerMed partner and have no connections to the internal mechanisms In addition, the following information is important: - BBMRI-ERIC will be mainly involved within WP5 activities and may participate to other activities within WP3 and WP4 of the EP PerMed. BBMRI-ERIC is a pan-European federated research infrastructure under the ERIC legal framework. BBMRI-ERIC will not be involved in the EP PerMed management or implemen- tation of the calls themselves. BBMRI National Nodes and their biobanks as well as other research centers may apply for some of the calls under EP PerMed. The BBMRI National Nodes, their biobanks and research centers are located across BBMRI-ERIC 23 member and observer countries and one international organisa- tion; they are not operated under the ERIC legal framework. - EITH will be involved in the conceptualisation and design of many calls (in WP2 only those related to RITC), as well as in the management and implementation of some (fast-track validation grants under WP3). EITH and its affiliates are not eligible to act as a beneficiary for the latter (which are aimed at innovators such as research organisations and hospitals) and will refrain from acting as a beneficiary for the former. This will preclude conflicts of interest and ensure working in full transparency. - FTELE acts both as a research funding organisation as well as research performing organisation. FTELE runs 2 research institutes: The Telethon Institute for Genetics and Medicine (TIGEM) based in Pozzuoli (Naples) which is fully owned by FTELE and the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) based in Milan and which is a joint-venture with the San Raffaele University Hospital. Both institutes perform re- search in the field of PM and may apply to the EP PerMed joint call under FTELE legal entity. To prevent any potential conflict of interest and to create a "firewall" between the FTELE involved in the EP PerMed and the researchers who may apply to EP PerMed call, the following measures will be implemented: - FTELE will be deeply involved in WP3 and partially in WP1 (to promote the synergies with the EU partnership on Rare Diseases) and WP5. FTELE team will not be involved in the management or implementation of the calls themselves nor in the discussion on the priorities for the calls. - Despite focusing only on the above mention WPs, FTELE team involved in EP PerMed will not include any researcher who may apply to the calls. FTELE team involved in the project is based in FTELE offices in Milan, away from the hospital that hosts SR-TIGET and belongs to 2 offices 105 / 106  EP PerMed- Consortium Agreement (Public Affairs and Business Development) that do not perform any lab research activity. - IACS (Institute for Health Sciences in Aragon) is the entity that promotes research, innovation and knowledge brokering in biomedicine and health sciences for the Aragon Regional Health System. IACS carries out its activity with the expectation of contributing to high quality care in the public health system, supporting inno- vation, research of excellence and benchmark training, as well as supporting the creation of wealth and eco- nomic growth. IACS will be deeply involved in WP3 and WP4. IACS will not be involved in the management or implementation of the project calls themselves. In the event that its own researchers (understood as re- searchers hired by the institution) would like to apply to a project call, IACS would not participate in the management and implementation of the call, but also not in the discussions for the proposal and design of the topic. - ISCIII is a public research organisation that also manages the National Health Strategic Research Action. ISCIII launches yearly competitive calls for projects, contracts, fellowships, networks, R&D platforms and independent clinical trials. Both missions (research performing and funding activities) are separated physi- cally in different campuses and they are managed by completely different structures (Underdirectorates). - TUBITAK, in addition to being a funding organisation, has various research institutes including a health- related institute, namely the TUBİTAK Marmara Research Centre Life Sciences Institute. This institute may want to apply to some calls under EP PerMed. However, these institutes are not directly linked to where the project will be carried out, which is the International cooperation department under the TUBITAK Presidency which is located in a different city in addition to having different managers. The institutions are normally eligible to receive funds from TUBITAK and have no connections to the internal mechanisms. 106 / 106