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THCS Consortium Agreement, version 0.4, 25/01/2023 Consortium Agreement EUROPEAN PARTNERSHIP ON TRANSFORMING HEALTH AND CARE SYSTEMS (THCS) 1 THCS Consortium Agreement, version 0.4, 25/01/2023 Table of Contents Consortium Agreement ................................................................................................................................ 1 1. Definitions ............................................................................................................................................. 8 2. Purpose ................................................................................................................................................ 12 3. Entry into force, amendments, duration and termination ........................................................... 12 4. Responsibilities of Parties ............................................................................................................... 13 5. Liability towards each other ............................................................................................................. 15 6. Governance structure ....................................................................................................................... 15 7. Financial provisions .......................................................................................................................... 26 8. Results ................................................................................................................................................. 34 9. Access Rights ..................................................................................................................................... 38 10. Non-disclosure of information ......................................................................................................... 40 11. Miscellaneous ..................................................................................................................................... 42 12. Signatures ........................................................................................................................................... 44 Attachment 1: Background included ...................................................................................................... 94 Attachment 2: Accession document ..................................................................................................... 105 Attachment 3: List of Affiliated Entities ............................................................................................... 106 Attachment 4: Non-Disclosure Agreement .......................................................................................... 107 2 THCS Consortium Agreement, version 0.4, 25/01/2023 History of changes Version Date Changes Version 0 05/10/2022 Initial draft Version 0.1 31/10/2022 Specific provisions concerning art. 7 were included Version 0.2 10/11/2022 Updated draft including information on the Parties and amended text based on comments received by the Parties Version 0.3 15/12/2022 Updated draft including information on Attachment 1 and amendments to arts. 6 and 7 to add clarity on specific rules and procedures Version 0.4 25/01/2022 Updated draft including amendments to the Parties undersigning the Agreement, to art. 7, and specific provisions for Associated Partners (art. 4.2). Remarks This Consortium Agreement is created for THCS and will be a complement to the General Model Grant Agreement (MGA) under Horizon Europe applied to the European Partnership on Transforming Health and Care Systems. The Horizon Europe DESCA (Development of a Simplified Consortium Agreement) model was used to draft the document and it was adapted to address the features of THCS as DESCA models are created for projects which will be governed by a Horizon Europe Model Grant Agreement (MGA), i.e. notably “Research and Innovation Actions” and “Innovation Actions”. For the sake of clarity and, to comply with article 9 of the Grant Agreement, which states that the Beneficiaries must ensure that their relevant contractual obligations also apply to the Associated Partners, the latter shall also sign this Consortium Agreement. 3 THCS Consortium Agreement, version 0.4, 25/01/2023 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 on the European Commission’s General Model Grant Agreement and its Annexes, and is made on January 1st, 2023, hereinafter referred to as the Effective Date BETWEEN: - MINISTERO DELLA SALUTE (IT MOH), PIC number 999531942, established in Viale Giorgio Ribotta 5 – 00144 Roma, Italy, the Coordinator - MINISTERO DELL’UNIVERSITA E DELLA RICERCA (MUR), PIC number 894763406, established in Largo Antonio Ruberti 1 – 00153 Roma, Italy - REGIONE TOSCANA (RT), PIC number 998823842, established in Piazza Duomo 10 – 50122 Firenze, Italy - UNIVERSITA CATTOLICA DEL SACRO CUORE (UCSC), PIC number 99915771, established in Largo Agostino Gemelli 1 – 20123 Milano, Italy - OSTERREICHISCHE FORSCHUNGSFORDERUNGSGESELLSCHAFT MBH (FFG), PIC number 999507207, established in Sensengasse 1 – 1090 Wien, Austria - BUNDESMINISTERIUM FUER KLIMASCHUTZ, UMWELT, ENERGIE, MOBILITAET, INNOVATION UND TECHNOLOGIE (BMK), PIC number 999633695, established in Radetzkystraße 2 – 1030 Wien, Austria - FONDS INNOVEREN EN ONDERNEMEN (FIO), PIC number 919917349, established in Koning Albert II laan 35 bus 12 – 1030 Brusells, Belgium - MINISTERE DE LA COMMUNAUTE FRANÇAISE DE BELGIQUE (FWB), PIC number 949522719, established in Rue A. Lavallée 1 – 1080 Brussels, Belgium - FONDS DE LA RECHERCHE SCIENTIFIQUE- FNRS (F.R.S.- FNRS), PIC number 999540381, established in Rue d’Egmont 5 – 1000 Brussels, Belgium - SUOMEN AKATEMIA (AKA), PIC number 999517586, established in Hakaniemenranta 6 – 00531 Helsinki, Finland - TAMPEREEN KORKEAKOULUSAATIO SR (TAU), PIC number 902999288, established in Kalevantie 4 - 33014 Tampere, Finland - TERVEYDEN JA HYVINVOINNIN LAITOS (THL), PIC number 996697893, established in Mannerheimintie 166 – 00271 Helsinki, Finland - AGENCE NATIONALE DE LA RECHERCHE (ANR), PIC number 998711613, established in Avenue Daumesnil 50 – 75012 Paris, France - MINISTERE DE LA SANTE ET DE LA PREVENTION (FR MOH), PIC number 998887377, established in Avenue Duquesne 14 – 75350 Paris, France - GENIKI GRAMMATIA EREVNAS KAI KAINOTOMIAS (GSRI), PIC number 999827016, established in Mesogeion Avenue 14-18 – 11521 Athens, Greece - RANNSOKNAMIDSTOD ISLANDS (RANNIS), PIC number 999547268, established in Borgartún 30 – 105 Reykjavik, Iceland - THE HEALTH RESEARCH BOARD (HRB), PIC number 999546686, established in Grattan House, Lower Mount Street 67-72 - D02 H638 Dublin 2, Ireland - MINISTRY OF HEALTH (CSO MOH), PIC number 999596156, established in Yirmiyahu st. 39 – 9101010 Jerusalem, Israel - LATVIJAS ZINATNES PADOME (LZP), PIC number 999546589, established in Smilsu iela 8 – 1050 Riga, Latvia - LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA (SAM), PIC number 933839468, established in Vilniaus g. 33 – 01506 Vilnius, Lithuania 4 THCS Consortium Agreement, version 0.4, 25/01/2023 - LIETUVOS MOKSLO TARYBA (LMT), PIC number 997808446, established in Gedimino pr. 3 – 01103 Vilnius, Lithuania - NEDERLANDSE ORGANISATIE VOOR WETENSCHAPPELIJK ONDERZOEK (NWO), PIC number 999663862, established in Laan van Nieuw Oost-Indië 300 - 2593 CE Den Haag, The Netherlands - ZORGONDERZOEK NEDERLAND ZON (ZonMw), PIC number 999544164, established in Laan van Nieuw Oost-Indië 338 - 2593 CE Den Haag, The Netherlands - NORGES FORSKNINGSRAD (RCN), PIC number 999460453, established in Drammensveien 288 – 0283 Oslo, Norway - NARODOWE CENTRUM BADAN I ROZWOJU (NCBR), PIC number 999519720, established in Chmielna 69 – 00-801 Warsaw, Poland - AICIB - AGÊNCIA DE INVESTIGAÇÃO CLÍNICA E INOVAÇÃO BIOMÉDICA (AICIB), PIC number 892687606, established in Rua De Santa Catarina 1288 – 4000-447 Porto, Portugal - FUNDACAO PARA A CIENCIA E A TECNOLOGIA (FCT), PIC number 999543970, established in Av. D. Carlos I, 126 – 1249-074 Lisboa, Portugal - COMISSÃO DE COORDENACAO E DESENVOLVIMENTO REGIONAL DO CENTRO (CCDRC), PIC number 955664468, established in Rua Bernardim Ribeiro 80 – 3000-069 Coimbra, Portugal - UNIVERSITATEA BABES BOLYAI (UBB), PIC number 999860578, established in M. Kogălniceanu 1 – 400084 Cluj-Napoca, Romania - MINISTERSTVO ZDRAVOTNICTVA SLOVENSKEJ REPUBLIKY (MOH SR), PIC number 999825173, established in Limbova 2 - 83752 Bratislava, Slovakia - SLUZBA VLADE REPUBLIKE SLOVENIJE ZA DIGITALNO PREOBRAZBO (ODT), PIC number 887090900, established in Davčna ulica 1 – 1000 Ljubljana, Slovenia - MINISTRSTVO ZA ZDRAVJE (SI MOH), PIC number 975180383, established in Štefanova ulica 5 – 1000 Ljubljana, Slovenia - AGENCIA ESTATAL DE INVESTIGACION (AEI), PIC number 911508128, established in Torrelaguna 58 bis – 28027 Madrid, Spain - FUNDACION INSTITUTO DE INVESTIGACION MARQUES DE VALDECILLA (IDIVAL), PIC number 946556944, established in Avda Cardenal Herrera Oria – 39011 Santander, Spain - CONSEJERÍA DE SALUD Y CONSUMO DE LA JUNTA DE ANDALUCÍA (CSCJA), PIC number 950939307, established in Edif Arena 1 Avda de la Innovación s/n – 41020 Sevilla, Spain - INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD (IACS), PIC number 998462032, established in Centro de Investigación Biomédica de Aragón (CIBA) - Avda. San Juan Bosco, 13, planta 1 – 50009 Zaragoza, Spain - FORSKINGSRADET FOR HALSA ARBETSLIVOCH VALFARD (FORTE), PIC number 998908814, established in Ringvagen 100 – 10064 Stockholm, Sweden - VERKET FOR INNOVATIONSSYSTEM (VINNOVA), PIC number 999618757, established in Master Samuelsgatan 56 – 10158 Stockholm, Sweden - FUNDACION PARA EL FOMENTO EN ASTURIAS DE LA INVESTIGACION CIENTIFICA APLICADA Y TECNOLOGIA (FICYT), PIC number 999791514, established in Cabo Noval 11, 1ºC – 33007 Oviedo, Spain - AGENZIA REGIONALE PER LA SALUTE ED IL SOCIALE (ARESS), PIC number 951003618, established in Lungomare Nazario Sauro 33 – 70121 Bari, Italy - INSTITUTO DE SALUD CARLOS III (ISCIII), PIC number 999507886, established in Avenida Monforte de Lemos 5 – 28029 Madrid, Spain - MINISTRY FOR EDUCATION, SPORT, YOUTH, RESEARCH AND INNOVATION (MEYR), PIC number 947567102, established in Great Siege Road – VLT2000 Floriana, Malta - STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG (NIVEL), PIC number 998294125, established in Otterstraat 118-124 – 3513CR Utrecht, The Netherlands 5 THCS Consortium Agreement, version 0.4, 25/01/2023 - SOTSIAALMINISTEERIUM (MSA), PIC number 998429731, established in Suur-Ameerika 1 – 10122 Tallin, Estonia - SIHTASUTUS EESTI TEADUSAGENTUUR (ETAg), PIC number 998483760, established in Soola street 8 – 51004 Tartu, Estonia - INNOVATIONSFONDEN (IFD), PIC number 939076692, established in Europahuset, Europaplads 2- 4 – 8000 Aarhus C, Denmark - DEPARTAMENTO DE SALUD GOBIERNO VASCO (DPTO SALUD), PIC number 918233041, established in Donostia-San Sebastián 1 – Vitoria-Gasteiz, Spain - ASOCIACIÓN INSTITUTO DE INVESTIGACIÓN EN SERVICIOS DE SALUD-KRONIKGUNE (KRONIKGUNE), PIC number 955006420, established in Ronda de Azkue 1 – 48902 Barakaldo, Spain - UNITATEA EXECUTIVA PENTRU FINANTAREA INVATAMANTULUI SUPERIOR A CERCETARII DEZVOLTARII SI INOVARII (UEFISCDI), PIC number 972130024, established in Mendeleev 21-25 – 010362 Bucharest, Romania hereinafter jointly or individually referred to as “Beneficiaries” or “Beneficiary” AND - FEDERAL OFFICE OF PUBLIC HEALTH (FOPH), PIC number 888590132, established in Schwarzenburgstrasse 157 – 3003 Bern, Switzerland, Associated Partner - SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG (INNOSUISSE), PIC number 906868230, established in Einsteinstrasse 2 – 3003 Bern, Switzerland, Associated Partner - SCHWEIZERISCHER NATIONALFONDS ZUR FORDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG (SNSF), PIC number 999540575, established in Wildhainweg 3 – 3001 Bern, Switzerland, Associated Partner - SCOTTISH GOVERNMENT (SG), PIC number 998850032, established in St Andrew’s House-Regent Road 2 – EH1 3DG Edinburgh, United Kingdom, Associated Partner - THE NHS CONFEDERATION (NHSC), PIC number 892794888, established in Smith Square 18 - SW1P 3HZ London, United Kingdom, Associated Partner - AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ), PIC number 919244654, established in Fishers Lane 5600 – 20857 Rockville, United States, Associated Partner - HEALTH DATA RESEARCH UK (HDR UK), PIC number 892849596, established in Euston Road 215 - NW12BE London, United Kingdom, Associated Partner hereinafter jointly or individually referred to as “Associated Partners” or “Associated Partner” the Beneficiaries and the Associated Partners being hereinafter, jointly or individually, referred to as “Parties” or “Party” relating to the Action entitled EUROPEAN PARTNERSHIP ON TRANSFORMING HEALTH AND CARE SYSTEMS in short THCS hereinafter referred to as “Project” WHEREAS: The Parties, including their Affiliated Entities, having considerable experience in the field concerned, have submitted a proposal for the Project to the Granting Authority as part of Horizon Europe – the Framework Programme for Research and Innovation (2021-2027). Their Project proposal was selected for funding and the Parties entered into the Grant Agreement preparation phase with the Granting Authority, aiming at adapting the Model Grant Agreement for Horizon Europe (MGA- HEU), provided as part of the call conditions, to the Project. 6 THCS Consortium Agreement, version 0.4, 25/01/2023 At the end of the Grant Agreement preparation phase, the Coordinator was requested to sign the ensuing Grant Agreement on behalf of the other Beneficiaries, which afterwards acceded to this Grant Agreement by signing an accession form. Several Parties, being Associated Partners and not Beneficiaries, didn’t sign the Grant Agreement. Therefore, for the proper implementation of the Project, the Parties, including their Affiliated Entities, wish to specify or supplement binding commitments among themselves in addition to the provisions of the specific Grant Agreement to be signed by the Beneficiaries of the Project and the Granting Authority (hereinafter “Grant Agreement”). The Parties acknowledge that they are responsible for the compliance of their Affiliated Entities with the relevant EU provisions (Grant Agreement and its annexes) and this Consortium Agreement. The Parties are aware that this Consortium Agreement is based upon the DESCA model consortium agreement for Horizon Europe and has been adapted to THCS. NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS: ----------------------- PART LEFT INTENTIONNALLY IN BLANK ------------------------- 7 THCS Consortium Agreement, version 0.4, 25/01/2023 1. Definitions and applicable documents 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 Access Right Access Right means the right to use Results or Background, as detailed in Sections 8 and 9 of this Consortium Agreement. Advisory Board “Innovators” The Advisory Board “Innovators” is the THCS Consortium Body which shall ensure that the Partnership will maintain a strong European and international dimension and be linked with key policies and networks at European and international level. Annual Work Plan The Annual Work Plan is the description of the action and the related agreed budget for a given year of THCS as agreed by the Project Consortium and the Granting Authority and attached to the Grant Agreement in Annex 1 ‘Description of the action’. Background Background means any Data, know-how or information — whatever its form or nature (tangible or intangible), including any rights such as copyrights or other intellectual or industrial property rights pertaining to such information — that is held by Parties, including their Affiliated Entities or other Third Parties, prior to their accession to the Consortium Agreement, and which is Needed for carrying out THCS activities or for exploiting Results of THCS, and which is listed in Attachment I to this Consortium Agreement. Call Steering Committee Call Steering Committee is the THCS Consortium Body composed by the Research and Innovation Funding Organisations (RFOs) funding a dedicated Joint Transnational Call. Each Joint Transnational Call will set up a Call Steering Committee (CSC). The CSC acts as the decision-making body for the implementation of the dedicated Joint Transnational Call. Communication Promotion of the Project and of its Results to the general public – including EU citizens, civil society and mass media - through the use of an accessible language. Communication aims at creating public awareness and enhances the visibility of the Project Results, the consortium and the research programme. Consortium Agreement Consortium Agreement means the present core text, its attachments, and any subsequent amendments thereto. Consortium Body Consortium Body means any management body described in the Governance Structure section of this Consortium Agreement. Contact Persons Contact Persons are those persons identified by the Parties who should receive communications concerning THCS and whose names were indicated during the submission of the THCS proposal. From time to time, by written request to the Coordinating Team, each Party may add or substitute Contact Persons to be included on the THCS mailing list. Coordinator The Beneficiary who signs the Grant Agreement on behalf of the consortium together with the Granting Authority. The Coordinator must: (i) monitor that the action is implemented properly (see Article 11 of the Grant Agreement), (ii) act as the intermediary for all communications between the Participants and the Granting Authority, (iii) distribute the payments received from the Granting Authority to the other Beneficiaries. 8 THCS Consortium Agreement, version 0.4, 25/01/2023 Coordinating Team The Coordinating Team is composed of the project managers who support the THCS Coordinator in the overall day-to-day management of THCS. In particular, the Coordinating Team implements the overall management and coordination of THCS. Data Data means any information or data generated and used in the framework of THCS. Data shall include personal data as defined by 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 repealing Directive 95/46/EC (General Data Protection Regulation). Data Management Plan A document that outlines from the start of the Project the main aspects of the lifecycle of research outputs, notably including Data. This includes their provenance, organisation and curation, as well as adequate provisions for their access based on FAIR (Findable, Accessible, Interoperable, Reusable) principles, preservation, sharing, and eventual deletion, both during and after THCS. 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 Section 4.2 of this Consortium Agreement. Description of Action The Description of Action is the general work plan for THCS as defined in the Grant Agreement, Annex 1. Dissemination The public disclosure of the Results by appropriate means, other than resulting from protecting or exploiting the Results, including by scientific publications in any medium. EU Top-Up The EU-Top-Up is the financial contribution of the Granting Authority to the Transnational Projects funded within the Joint Transnational Call. Exploitation The use of Results in further research and innovation activities other than those covered by the action concerned, including among other things, commercial exploitation such as developing, creating, manufacturing and marketing a product or process, creating and providing a service, or in standardization activities. Force Majeure Force majeure’ means any situation or event that: - prevents either Party, including its Affiliated Entities, from fulfilling their obligations under THCS, - was unforeseeable, exceptional and beyond the Parties’, including their Affiliated Entities, control, - was not due to error or negligence on their part (or on the part of other Parties, including their Affiliated Entities, involved in the action), a - proves to be inevitable in spite of exercising all due diligence. The following cannot be invoked as force majeure: - any default of a service, defect in equipment or material or delays in making them available, unless they stem directly from a relevant case of Force Majeure, - labour disputes or strikes, or - financial difficulties. Funding Agency Board The Funding Agency Board is the THCS Consortium Body composed by all Research and Innovation Funding Organisations, that are either Beneficiaries either Associated Partners in THCS, which is in charge of the decision on the topic of each Joint Transnational Call in accordance with Section 6.3.3 of this Consortium Agreement. General Assembly The General Assembly is the THCS Consortium Body in charge of making most relevant key decisions of the Partnership in accordance with Section 6.3.1 of this Consortium Agreement. Grant Agreement Grant Agreement means the multi-beneficiary Grant Agreement concluded between the Granting Authority 9 THCS Consortium Agreement, version 0.4, 25/01/2023 and the Coordinator, to which other Beneficiaries access through signing accession forms under the Horizon Europe Programme for the conduct and financing of THCS. Granting Authority The body who awards the grant to THCS, namely the European Commission, and signs the Grant Agreement together with the Coordinator. Internal Funding Rules Internal Funding Rules means the internal rules of the THCS consortium by which eligible costs originated by THCS are reimbursed by the Granting Authority under the Grant Agreement, as defined in Section 7.4 of the Consortium Agreement. Joint Results Joint Results means Results developed under THCS jointly by two or more Parties, including their Affiliated Entities, or other Third Parties and whose characteristics are such that it is not possible to establish the respective contribution of each Party or separate the intellectual contribution of each of the said entities in order to request or obtain intellectual property rights separately. Joint Transnational Call (JTC) Joint Transnational Call (JTC) means a call for collaborative transnational proposals within THCS, which is organized jointly by JTC Research and Innovation Funding Organisations. Joint Call Secretariat The Joint Call Secretariat acts as a central office in charge of organising the operative steps involved in a Joint Transnational Call. Depending on the experience and expected workload this Joint Call Secretariat could be composed of representatives from RFOs that are participating in the call. Mixed funding model In this model, each participating funding organisation will fund its own successful participants. Funding will not be available from one participating funding organisation for successful participants from other participating funding organisations so there is no cross-border funding involved. In this model, the EU top-up funding is used (partially) to close the gaps of funding within the ranking list (i.e. project participants for which no more national/regional funding is available). An agreed share of top-up funding is to be allocated to fill these funding gaps irrespective of nationality. National Mirror Groups Countries involved in THCS will be invited to establish National Mirror Groups (NMG) reflecting the health and care policy, research and innovation sectors at a national and if applicable at a regional level, thus ensuring that specificities of the Health and Care Systems of the Countries involved in the Partnership are properly addressed in the activities. Needed Needed means: - For the implementation of THCS: Access Rights are Needed if, without the grant of such Access Rights, carrying out the tasks assigned to the recipient Party, including its Affiliated Entities, would be technically or legally impossible, significantly delayed, or require significant additional financial or human resources. - For Exploitation of own Results: Access Rights are Needed if, without the granting of such Access Rights, the Exploitation of own Results would be technically or legally impossible. Object code Object code generally refers to the output, a compiled file, which is produced when the Source Code is compiled with a C compiler. The object code file contains a sequence of machine-readable instructions that is processed by the CPU in a computer. Parties The legal entities identified in the Consortium Agreement and having signed the Consortium Agreement, and any new legal entity having acceded to the Consortium Agreement in accordance with its relevant provisions. Partnership European Partnerships bring the European Commission and private and/or public partners together to address some of Europe’s most pressing challenges through concerted research and innovation initiatives. They are a key implementation tool of Horizon Europe, and contribute significantly to achieving the EU’s political priorities. 10 THCS Consortium Agreement, version 0.4, 25/01/2023 THCS Partnership is composed by all Beneficiaries of THCS Grant Agreement, their Affiliated Entities and the Associated Partners listed in the THCS Grant Agreement. Research and Innovation Funding Organisation Research and Innovation Funding Organisation (RFO) means a national or a regional legal entity responsible for providing the national share of funding for a Project selected within a THCS Joint Transnational Call. Research Performing Organisation Research Performing Organisation (RPO) means a legal entity, including a public body, that is established as a non-profit organization and whose main objective is carrying out academic teaching, research or technological development. Results Results means any tangible or intangible effect of the action, such as Data, know-how or information whatever its form or nature, whether or not it can be protected, as well as any rights attached to it, including intellectual property rights, produced within THCS, including, concepts, methods, schemes for quality assurance and quality control, Data, and interpretation of Data, but excluding Background. Software Software means a package or entity of coded sequences of instructions to carry out an algorithm-driven process by a computer-processor controlled system. Source code Source code is the set of instructions and statements written by a programmer using a computer programming language. It contains declarations, instructions, functions, loops and other statements, which act as instructions for the program on how to function. This code is later translated into machine language by a compiler. The translated code is referred to as object code. Strategic Board The Strategic Board is the THCS Consortium Body responsible for the oversight and strategic guidance of the Partnership. This body takes strategic decisions/proposals for the management of the Partnership in accordance with Section 6.3.2 of this Consortium Agreement. Third Parties Third Parties can be defined as any entity/person who is not in a THCS Consortium Body, i.e. that is not a Beneficiary, Affiliated Entity or Associated Partner, and is not bound by rules of confidentiality under THCS. These rules are e.g., stipulated in the Grant Agreement, Consortium Agreement, collaboration agreements and confidentiality agreements. Subcontractors are included in this definition. 1.3. Applicable documents For sake of clarity, the following documents apply to this Consortium Agreement, including its Annexes: - Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (…) (“Financial Regulation”); - The Horizon Europe Regulation; - Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe – the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (Text with EEA relevance); - All and any information and provision provided by the Granting Authority during the award procedure, either publicly (call conditions, including pertaining call documentation) or to the Applicants; - The Grant Agreement signed by and between the Coordinator and the Granting Authority, including its Annexes. The Parties hereby acknowledge having access to and to abide to the provisions set forth by the above-listed documents. Should any Party seek access to one or several of the above-listed documents, it shall contact the Coordinator. 11 THCS Consortium Agreement, version 0.4, 25/01/2023 2. Purpose The purpose of this Consortium Agreement is to specify with respect to THCS the relationship among the Parties, including their Affiliated Entities, in particular concerning the organisation of the work between them, the management of the Partnership and the rights and obligations of the Parties, including their Affiliated Entities, concerning inter alia liability, Access Rights and dispute resolution. 3. Entry into force, amendments, 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. 3.2. Amendments Any amendments and modifications to the articles and text of this Consortium Agreement require a separate written agreement to be signed by all Parties. Any modifications to any attachment of this agreement will not require a separate written agreement to be signed by all Parties. The attachments will be modified or updated, if required, and adopted, by the General Assembly once a year. The Parties are responsible for consulting their Affiliated Entities on suggested Amendments or modifications to this Consortium Agreement prior to their adoption by the General Assembly. All Parties, including their Affiliated Entities, will receive notice of updated documents (Consortium Agreement and/or its attachments) once these are adopted by the General Assembly. 3.3. Duration and termination This Consortium Agreement shall continue in full force and effect until complete fulfilment of all obligations undertaken by the Parties, including their Affiliated Entities, under the Grant Agreement and under this Consortium Agreement. This includes amendments regarding any extension of THCS approved by the Granting Authority as well. This Consortium Agreement may be terminated automatically, in whole or in part, upon a unanimous decision of the General Assembly. Unless otherwise agreed in writing by the Parties or otherwise expressly specified in this Consortium Agreement, the Consortium Agreement will be terminated automatically in the event of a decision by the Granting Authority to no longer provide financing for the Partnership. However, the participation of one or more Parties, including their Affiliated Entities, may be terminated in accordance with the terms of this Consortium Agreement, if - the Grant Agreement is not signed by the Granting Authority or a Beneficiary, or - the Grant Agreement is terminated, or - a Party's participation in the Grant Agreement is terminated. In any of these events, this Consortium Agreement shall automatically terminate in respect of the affected Party/ies, subject to the provisions surviving the expiration or termination under Section 3.4 of this Consortium Agreement. A non-defaulting Party including its Affiliated Entities, may withdraw from THCS at any time (“withdrawing Party”) with a prior notice that solidly motivates the withdrawal (e.g. change of mandate of a Party due to national political decision...). In the case a withdrawing Party has Affiliated Entities, suitable arrangements for the concerned Affiliated Entities must be found prior to withdrawing from THCS. The Coordinator must be notified sixty (60) calendar days prior to the withdrawal through written notice. The Coordinator, shall immediately inform the Consortium and the Granting Authority. The costs incurred by the withdrawing Party prior to the withdrawal remain eligible in accordance with the provisions described in section 7. 12 THCS Consortium Agreement, version 0.4, 25/01/2023 3.4. Survival of rights and obligations The provisions relating to sections 8, 9 and 10 of this Consortium Agreement, for the time period mentioned therein, as well as for liability, applicable law and settlement of disputes shall survive the termination of this Consortium Agreement. Termination shall not affect any rights or obligations of a Party, withdrawing from THCS, incurred prior to the date of termination, unless otherwise agreed between the General Assembly and the withdrawing Party. This includes the obligation to provide all input, deliverables and documents for the period of its participation. 4. Responsibilities of Parties 4.1. General principles Each Party, including its Affiliated Entities, undertakes to take part in the efficient implementation of THCS, as described in article 11 of the Grant Agreement, and to cooperate, perform and fulfil, promptly and on time, all of its obligations under THCS, 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, in accordance with the governance structure of THCS, any significant information, fact, problem or delay likely to affect THCS. Each Party shall promptly provide all information reasonably required by a Consortium Body or by the Coordinator to carry out its tasks. Each Party shall take reasonable measures to ensure the accuracy of any information or materials it supplies to the other Parties. 4.2. Specific responsabilities for Associated Partners 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 the Project. 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 the Project 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 the Project. 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). 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 section 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 the Project. 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, Project implementation or after Project end. Regarding such claims the Associated Partner´s 13 THCS Consortium Agreement, version 0.4, 25/01/2023 special liability is limited to once 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 Project, it is the responsibility of the Associated Partner to ensure such agreement is not in conflict with this Consortium Agreement. 4.3. Breach In accordance with the Grant Agreement, breaches by Affiliated Entities will be dealt with in the same way as breaches by Beneficiaries. In the event that the General Assembly identifies a breach by a Party itself of its obligations under this Consortium Agreement or the Grant Agreement or by one of its Affiliated Entities, of improper implementation of THCS, 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 Defaulting and to decide on the consequences thereof, which may include termination of its participation. If a Beneficiary is Defaulting, the General Assembly will find suitable arrangements for the concerned Affiliated Entities. The obligations in this Consortium Agreement regarding the Parties and their participation in THCS will terminate if: - The General Assembly declares the Party as Defaulting and terminates its participation; - The Party withdraws from THCS; - Any event described in Section 3.3 of this Consortium Agreement take place; - The Party to which an Affiliated Entity is affiliated is Defaulting and no suitable solution is found for the concerned Affiliated Entity. 4.4. Involvement of Third Parties and/or Affiliated Entities A Party that enters into a subcontract or otherwise involves Third Parties and/or Affiliated Entities in THCS remains responsible for carrying out its relevant part of THCS and for such Third Parties and/or Affiliated Entities’ compliance with the provisions of this Consortium Agreement and of the Grant Agreement. Such Party has to ensure that the involvement of Third Parties and/or Affiliated Entities does not affect the rights and obligations of the other Parties under this Consortium Agreement and the Grant Agreement. To that end, it is good practice for a Party that involves Affiliated Entities or Third Parties to conclude a written contract with those Affiliated Entities or Third Parties that ensures compliance with the provisions of the Grant Agreement and this Consortium Agreement, and to inform the Coordinator accordingly of the conclusion of this contract. In the case an Affiliated Entity enters into a subcontract or otherwise involves Third Parties in THCS, the Affiliated Entity remains responsible for carrying out its relevant part of THCS and must comply with the above provisions concerning the conclusion of a written contract with those Third Parties and inform the Coordinator accordingly. 4.5. Specific responsibilities regarding data protection The Parties, including their Affiliated Entities, shall process personal data in accordance with all applicable laws including without limitation to EU General Data Protection Regulation and national data protection laws, all as updated from time to time. Where necessary, the Parties, including their Affiliated Entities, shall cooperate in order to enable one another to fulfill 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 – GDPR – and relevant national data protection law applicable to said Party) within the scope of the performance and administration of THCS 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. 14 THCS Consortium Agreement, version 0.4, 25/01/2023 5. Liability towards each other 5.1. No warranties In respect of any information or materials (incl. Results and Background) supplied by one Party to another under THCS, 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 information 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. 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, provided such damage was not caused by a wilful act. A Party’s aggregate liability towards the other Parties collectively shall be limited to once: - for a Beneficiary or an Affiliated Entity, the concerned Beneficiary’s or Affiliated Entity’s share of the total costs of THCS as identified in Annex 2 of the Grant Agreement; and. - for an Associated Partner, the concerned Associated Partner’s total estimated costs as identified in Annex 1 of 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 Coordinator and the General Assembly of any Force Majeure without undue delay. If the consequences of Force Majeure for the Project are not overcome within 6 weeks after such notice, the transfer of tasks - if any - shall be decided by the General Assembly. 5.5. Compliance Subject to the foregoing liability exclusions and limitation, each Party, including its Affiliated Entities, shall be legally accountable to ensure that its work in THCS complies fully with all applicable local, national, European and international laws, regulations and guidelines which are effective during the period of THCS, including those governing health and safety, Data protection, and where relevant, the use of human or animal subjects and good clinical practice (including national legislation implementing the Parliament’s Directive 2001/20/EC on good clinical practice). In this regard, each Party, including its Affiliated Entities, shall follow the confidentiality rules in accordance with Section 10 of this Consortium Agreement. 6. Governance structure The governance of the Partnership includes both a strategic and an operational level, and a link between them, a coordination-level. 15 THCS Consortium Agreement, version 0.4, 25/01/2023 6.1. General structure The organisational structure of THCS shall comprise the following Bodies. - The General Assembly, the body in charge of making most relevant key decisions of the Partnership.It is composed by representatives from all Parties. - The Strategic Board, the body responsible for the oversight and strategic guidance of the Partnership. This body takes strategic decisions/proposals for the management of the Partnership. It is composed by THCS WP Leaders. - The Funding Agency Board, composed by all Research and Innovation Funding Organisations involved in the Partnership, as the body in charge of the decision on the topic of each Joint Transnational Call based on the priorities identified in the Strategic Research and Innovation Agenda (SRIA) and the Annual Work Plan. - The Advisory Board “Innovators” composed by experts and a representative group of stakeholders at European level that cover the entire health and care system, demand side. It shall ensure that the Partnership will both maintain a strong European and international dimension and be linked with key policies and networks at European and international level. - Countries involved in THCS will be invited to establish National Mirror Groups (NMG) reflecting the health and care policy, research and innovation sectors at a national and if applicable at a regional level, thus ensuring that specificities of the Health and Care Systems of the Countries involved in the Partnership are properly addressed in the activities. The organisational structure of THCS shall also comprise the following functions: - The Coordinator as the legal entity acting as the intermediary between the Parties, including their Affiliated Entities, and the Granting Authority. The Coordinator is responsible for the scientific and administrative management of the Programme. The Coordinator is supported by the Coordinating Team for the administrative management and by the Strategic Board for the scientific management. The Coordinator, in addition to its responsibilities as a Party, shall perform with the support of the Coordinating Team the tasks assigned to it as described in the Grant Agreement and this Consortium Agreement. - The Work Package (WP) leaders are responsible for the proper implementation of the obligations of their respective WP, coordination and interaction within their respective WP, as well as across the WPs. - The Task leaders and co-leaders are responsible for the proper implementation of the obligations of their respective tasks. - The Call Steering Committee is composed by the Research and Innovation Funding Organisations (RFOs) funding a dedicated Joint Transnational Call. Each Joint Transnational Call will set up a Call Steering 16 THCS Consortium Agreement, version 0.4, 25/01/2023 Committee (CSC). The CSC acts as the decision-making body for the implementation of the dedicated Joint Transnational Call. - The Joint Call Secretariat acts as a central office in charge of organising the operative steps involved in a Joint Transnational Call. Depending on the experience and expected workload this Joint Call Secretariat could be composed of representatives from RFOs that are participating in the call. - Countries that will establish National Mirror Groups will be invited to appoint a National Mirror Group Representative. National Mirror Group Representatives shall contribute to build a long-term THCS programme by building a long-term network, for the exchange of information, expertise and best practices, bringing together experts and activities and ensuring that they are coordinated, feed their needs into THCS, contribute to the objectives, and learn from the work performed within THCS through peer learning. 6.2. General operational procedures for all Consortium Bodies In case of any discrepancy between the provisions under this article and the Terms of Reference of each Governance Body to be defined and endorsed by the General Assembly at the start of the Partnership, the latter shall prevail. 6.2.1 Representation in meetings and meetings attendance Any member of a Consortium Body (hereinafter referred to as "Member"): - should be present or represented at any meeting of such Consortium Body by a fully mandated representative; - the fully mandated representative shall be duly authorised to decide on all matters relating to the Consortium Body; - may appoint a substitute or a proxy or mandate another representative to attend and provide opinion at any meeting; - shall participate in a cooperative manner in the meetings. In case of experts accompanying the Consortium Body representative to a meeting, if appropriate, the Consortium Body representative has to provide notice to the Coordinating Team at least five (5) calendar days ahead of the meeting with the details of the expert and in what capacity the expert is attending the meeting. For physical meetings, the Coordinating Team will strive to accommodate these requests, but participation may be limited due to room capacity constraints. In case of virtual meetings, the Coordinating Team can refuse this request under specific conditions, including conflict of interest or confidentiality aspects. If an invited expert does not belong to an institution involved in THCS, the signature of a Confidentiality Agreement and, if relevant, a Declaration of interest shall be required by the Coordinator prior to receiving any documents and/or attending the meetings. For Consortium Body meetings, for all THCS Parties, including their Affiliated Entities, travel costs shall be covered by THCS through its organisation’s daily travel and subsistence allowance. No travel costs will be covered by THCS for any additional persons or national experts accompanying the representatives of institutions involved in THCS, nor for the European Commission representatives, who do not receive payment for travel costs. 6.2.2 Preparation and organisation of meetings Convening meetings The Coordinator shall convene meetings of the Consortium Bodies, as described in the tables below, if not otherwise provided in the following specific operation procedures of the respective Consortium Bodies. Ordinary meeting Extraordinary meeting General Assembly At least twice a year At any time upon request of the Strategic Board or 1/3 of the Members of the General Assembly Strategic Board At least bi-monthly At any time upon request of any Member of the Strategic Board Funding Agencies Board At least twice a year At any time upon request of 1/3 of the Members of the Funding Agency Board Other bodies will also provide input into THCS and have regular meetings. 17 THCS Consortium Agreement, version 0.4, 25/01/2023 Ordinary meeting Extraordinary meeting Advisory Board “Innovators” At least twice a year As required by decision of the Strategic Board National Mirror Groups At least once a year As required by decision of the Strategic Board Representatives Meetings of each Consortium Body may also be held by tele- or videoconference, or other telecommunication means. Unless due to exceptional circumstances or Force majeure, for the General Assembly and the Strategic Board, one physical meeting will be organised by year. Notice of a meeting Unless otherwise provided for in the following specific operation procedures of the respective Consortium Bodies, the Coordinator shall give notice in writing of a meeting to each Contact Person of that Consortium Body as soon as possible and no later than the minimum number of days preceding the meeting as indicated below. Ordinary meeting Extraordinary meeting General Assembly 45 calendar days 30 calendar days Strategic Board 14 calendar days 7 calendar days Funding Agency Board 30 calendar days 7 calendar days Sending the agenda Unless otherwise provided for in the rules of procedure of the respective Consortium Body, the Coordinator shall prepare and send to each Contact Person of that Consortium Body a written (original) agenda no later than the minimum number of days preceding the meeting as indicated below. Ordinary meeting Extraordinary meeting General Assembly 20 calendar days 15 calendar days Strategic Board 7 calendar days 5 calendar days Funding Agency Board 15 calendar days 5 calendar days 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. Ordinary meeting Extraordinary meeting General Assembly 10 calendar days 7 calendar days Strategic Board 2 calendar days 2 calendar days Funding Agency Board 7 calendar days 2 calendar days During a meeting any additional item to the original agenda shall be approved by the majority. Entry into force of decisions Decisions will only be binding once the relevant part of the minutes has been accepted according to Section Error! Reference source not found.. Decisions without a meeting Any decision may also be taken without a meeting if: a) the Coordinator invites all Members of the Consortium Body to vote a suggested decision through a written/online consultation with a deadline for responses of at least 10 calendar days after receipt by a Party and b) the decision is agreed by the defined majority (see Section 6.2.3). 18 THCS Consortium Agreement, version 0.4, 25/01/2023 The Coordinator shall inform all the Parties of the outcome of the vote. Objections to the outcome of the vote shall be submitted up to 15 calendar days to the Coordinator after notification of the decision. Without any objection received within this period, the decision/outcome of the vote shall be considered as accepted. In cases of severe dispute, the Coordinator shall refer the decision to a regular or extraordinary meeting as appropriate. The decisions will be binding after the Coordinator sends to all Members of the Consortium Body a written notification of this acceptance. 6.2.3 Voting rules and quorum Each Consortium Body shall not deliberate and decide validly in meetings unless two-thirds (2/3) of its Members are present or represented (quorum). If the quorum is not reached, the Coordinator or the chairperson of the Consortium Body shall convene another ordinary meeting within 25 calendar days. If in this meeting the quorum is not reached once more, the chairperson shall convene an extraordinary meeting, which shall be entitled to decide even if less than the quorum of Members is present or represented. Each Member of a Consortium Body present or represented in the meeting shall have one vote. A Party, which the General Assembly has declared according to Section Error! Reference source not found.3 to be a Defaulting Party may not vote. Decisions shall be taken by a majority of two-thirds (2/3) of the votes cast. 6.2.4 Minutes of meetings Unless otherwise provided for in section 6.3, the chairperson of each Consortium Body shall produce, if needed with the support of the Coordinating Team, written minutes of each meeting, which shall be the formal record of all decisions taken. The chairperson shall then make, if needed with the support of the Coordinating Team, the draft minutes available to all Members of the Consortium Body within ten calendar days of the meeting. The minutes shall be considered as accepted if, within 15 calendar days from receipt, no Party has sent an objection to the chairperson with respect to the accuracy of the draft minutes by written notice. The chairperson shall send the accepted minutes to all the Members, and to the Coordinator, who shall retain copies of them. Excluding confidential information, all minutes of Consortium Body meetings will be published and shared with THCS Parties, including their Affiliated Entities. Decisions will only be binding once the relevant part of the minutes has been accepted as accurately reflecting the decisions taken in the meeting. 6.3. Specific operational procedures for the Consortium Bodies 6.3.1 General Assembly In addition to the rules described in Section 6.2, the following rules shall apply: Members The General Assembly shall consist of one principal representative of each Party (hereinafter General Assembly Member). In order to ensure co-ordination, equality and stability in the knowledge of the THCS and its oversight, a principal representative and a permanent alternate will be appointed, both duly authorised to deliberate, negotiate and decide on all matters related to the General Assembly. Each organisation that is a member of the General Assembly can also provide additional Contact Persons. Chair The General Assembly should elect one Chair and Vice Chair that will rotate, unless decided otherwise in a meeting of the General Assembly. Observers and invited experts The members of the Advisory Board “Innovators” may be invited as observers to the General Assembly meetings as considered appropriate. The General Assembly can invite external experts to its meetings as considered appropriate. The Health and Digital Executive Agency (HaDEA) and EC Services are invited as observers to the General 19 THCS Consortium Agreement, version 0.4, 25/01/2023 Assembly meetings. Tasks The General Assembly manages the contractual implementation of THCS both on the scientific and administrative level. The General Assembly shall: - Propose amendments to the Consortium Agreement, to be signed by the Parties, upon proposal by the Management Board; - Prepare and decide on proposals of amendments to Annexes 1 and 2 of the Grant Agreement to be agreed by the Granting Authority upon proposal by the Management Board; - Approve the Annual Work Plans and associated budgets before submission to the Granting Authority; - Approve the annual internal funding rates upon proposal by the Funding Agency Board; - Approve the annual internal THCS budget; - Approve of the achievement of the most significant milestones; - Approve updates to the Strategic Research and Innovation Agenda (SRIA); - Approve the adoption of key strategic documents such as the THCS Communication, Dissemination and Exploitation Plan, the THCS Data Management, the Monitoring & Evaluation Framework; - Decide on an entry of a new Party to THCS and approve the settlement on the conditions of new Parties; - Decide a withdrawal of a Party, including its Affiliated Entities, from THCS and approve the settlement on the conditions of the withdrawal; - Identify and decide on a breach by a Party, including its Affiliated Entities, of its obligations under this Consortium Agreement or the Grant Agreement; - Declare and decide on a Party, including its Affiliated Entities, to be a Defaulting Party; - Terminate and decide on Defaulting Party’s contribution in THCS and measures relating thereto; - Prepare and decide on proposal to the Granting Authority for a change of the Coordinator; - Prepare and decide on proposal to the Granting Authority for suspension of all or part of THCS; - Prepare and decide on proposal to the Granting Authority for termination of THCS and the Consortium Agreement; - Approve nominations for the Advisory Board “Innovators”. Decisions The General Assembly shall be free to act on its own initiative to formulate proposals and take decisions in accordance with the procedures set out herein. In addition, all proposals made by the Strategic Board shall also be considered and decided upon by the General Assembly. In case the General Assembly decides it cannot take a decision or when the General Assembly and the Strategic Board agree that the delegation will help the consortium in its daily management, the General Assembly may delegate this decision to the Strategic Board. The delegation shall specify the subject matter to be decided by the Strategic Board. Consensus on all matters among the Parties shall be sought. If consensus cannot be reached, the following voting procedure is foreseen: - Only General Assembly Members present at the meeting shall be entitled to vote, even if several Contact Persons’ are present; - Countries should have equal representivity in the General Assembly. Each country shall have three votes. Hence, if a country is represented by more than three organisations, at country level three voting General Assembly Members should be identified. Each country will decide how to organise the three votes, potentially organising an ad hoc consultation to represent other Parties, including their Affiliated Entites, as needed. If the three voting General Assembly Members for a particular country have to be changed, this will have to be announced at least one week before a General Assembly meeting and this composition can then not be changed. - A decision shall be accepted if at least two-third (2/3) of the General Assembly Members’ votes cast are in favour of the decision. In case the above condition is not fulfilled, then a second voting round shall be organized in another session, in order to give the opportunity to slightly change what is being voted after the decision item has been modified, based on the discussions held during the initial session. In this case, if the quorum of 2/3 of the votes cast in 20 THCS Consortium Agreement, version 0.4, 25/01/2023 favour of the decision is not reached once more, a decision could be accepted with a second vote in the same session if 51% of the General Assembly Members’ votes cast are in favour of the decision. The Parties agree to abide by all decisions of the General Assembly. This does not prevent the Parties from exercising their veto rights, or from submitting a dispute to resolution in accordance with the provisions of Settlement of disputes in Section Error! Reference source not found.. Veto rights The following veto rights apply to the decision of the General Assembly. A Party which can show that a decision is in contradiction with proven essential rules, obligations or values from its institution, national agreement with Affiliated Entities or country (e.g. obligations with regard to national law) 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, including telephone or video conferences. In case of force majeure, a Party may veto such a decision as well within 15 calendar days after the draft minutes of the meeting are sent. When a decision has been taken on a new item added to the agenda before the meeting, a Party may veto such decision during the meeting and within 15 calendar days after the draft minutes of the meeting are sent. When a decision has been taken without a meeting, a Party may veto such decision within 15 calendar days after written notification by the Coordinator of the outcome of the vote. In case of exercise of veto, the General Assembly shall make every effort to resolve the matter which occasioned the veto to the general satisfaction of all. If no agreement can be achieved, the Party that has exercised a veto right may consider opting-out for the concerned decision. 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. Declaration of interests It is important for THCS to be as upfront and transparent as possible to ensure that THCS meets the high standards of impartiality and objectivity expected by EU citizens in a public- public partnership. It is therefore crucial to put in place a process for preventing risks of conflicts of interest that could erode public trust and the uptake of THCS outputs. In this regard, considering that one of the tasks of the General Assembly is the approval of the Annual Work Plans and the related budgets, the Research Performing Organizations (RPOs) involved in THCS that are potentially interested in submitting a proposal under JTCs launched by THCS and whose topic is indicated from time to time in the Annual Work Plan - will not take part to meetings dedicated to the approval of the Annual Work Plans and won’t receive preparatory and full drafts for revisions/comments. RPOs may only be involved in key meetings supporting the Annual Work Plan brainstorming phase when needed and upon the decision of the Research and Innovation Funding Organisations. For sake of clarity, RPOs are not involved in the three THCS Work-Packages related to the funding of Joint Transnational Calls. In particular, the concerned RPOs are the following: Istituto Superiore di Sanità (ISS), Università Cattolica del Sacro Cuore (UCSC), Tampereen Korkeakoulusaatio Sr (TAU), Terveyden Ja Hyvinvoinnin Laitos (THL), Institut National de la Santé et de la Recherche Médicale (INSERM), Universitatea Babes Bolyai (UBB), University Hospital Martin (UHM), Nacionalni Institut Za Javno Zdravje (NIJZ), Instituto Aragonés de Ciencias de la Salud (IACS), Stichting Nederlands Instituut Voor Onderzoek Van De Gezondheidszorg (NIVEL) and Asociación Instituto de Investigación en Servicios de Salud-KRONIKGUNE (KRONIKGUNE). 6.3.2 Strategic Board In addition to the rules described in Section 6.2, the following rules shall apply: Members The Strategic Board shall consist of the Coordinator who can be represented by members of the THCS coordinating team and WPs 4 to 10 leaders. 21 THCS Consortium Agreement, version 0.4, 25/01/2023 The EC Services will also join the Strategic Board and inform and endorse priorities to be discussed. Membership in the Strategic Board will cease upon resignation by a member or a decision of the General Assembly. If a Strategic Board principal representative has not attended two Strategic Board meetings in person or online and has not been substituted by a competent and fully mandated substitute, the Coordinator informs the General Assembly, which shall decide on a renewal of the membership in the Strategic Board or a replacement. In order to ensure coordination, equality and stability in the knowledge of THCS and its oversight, one principal representative and one permanent deputy, both duly authorised to deliberate, negotiate and decide on all matters relating to the Strategic Board shall be nominated. Each organisation part of the Strategic Board can also provide other Contact Persons”. Observers and invited experts If considered appropriate, other Parties, including their Affiliated Entities, with roles relevant for the implementation of the Partnership may be invited as observers to the Strategic Board meetings. Chair The Coordinator or, if absent, his/her Deputy shall chair all meetings of the Strategic Board, unless decided otherwise by a majority of two-thirds. Tasks The Strategic Board members commit themselves to undertake their tasks in an unbiased way. The Strategic Board is the operational body that supports the Coordinator in the day-to-day implementation of the Grant Agreement based on the Description of Action and Annual Work Plans. The Strategic Board shall also ensure the coherence and the integration of all the WPs and tasks of THCS; it ensures cross-cutting discussion and synergies. The Strategic Board shall: - propose all operational decisions required for the implementation of THCS; - collaborate with all Parties of the Consortium for the planning, implementation and reporting of THCS; - propose, when required, amendments to the Grant Agreement for approval by the General Assembly; - prepare the next Annual Work Plan and its corresponding budget; - report the progress in the periodic reports for approval by the General Assembly; - quality-check and approve deliverables before submission to the Granting Authority; - monitor the effective and efficient implementation of THCS and contribute, in collaboration with the Coordinating Team, to the monitoring and reporting on the implementation indicators - prepare the meetings, propose decisions and prepare the agenda of the General Assembly according to Section 6.3.1 - support the Coordinator in preparing meetings with the Granting Authority and in preparing related data and deliverables; - execute and implement the decisions of the General Assembly; - monitor the creation of Results and their ownership and any protection measures, - monitor and actively participate in the communication and dissemination and exploitation measures of THCS Results, 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 of the Grant Agreement Article 29; - ensure strategic alignment with other EU Partnerships, especially IHI. In the case of abolished activities as a result of a decision of the General Assembly, the Strategic Board shall advise the General Assembly on ways to rearrange activities and budgets of the Parties concerned. Such rearrangement shall take into consideration the legitimate commitments taken prior to the decisions, which cannot be cancelled. Decisions Each WP leader organisation principal representative for WPs 4 to 10 has one vote as well as the Coordinator and EC Services have. Consensus on all matters shall be sought. If consensus is not reached, decisions shall be taken by a majority of two-thirds (2/3) of the votes cast. 22 THCS Consortium Agreement, version 0.4, 25/01/2023 Veto Rights The Coordinator or, if absent, his/her Deputy, may exercise a veto with respect to a decision or a relevant part of a decision if the decision or a relevant part of the decision is in contradiction to the Grant Agreement and the Consortium Agreement. Declaration of interests It is important for THCS to be as upfront and transparent as possible to ensure that THCS meets the high standards of impartiality and objectivity expected by EU citizens in a public- public partnership. It is therefore crucial to put in place a process for preventing risks of conflicts of interest that could erode public trust and the uptake of THCS outputs. In this regard, considering that one of the tasks of the Strategic Board is the preparation of the Annual Work Plans and the related budget, the WP4 Leader (THL) - which is a Research Performing Organization potentially interested in submitting a proposal under JTCs launched by THCS and whose topic is indicated from time to time in the Annual Work Plan - will take part into the Strategic Board with a representative who will not be allowed to participate to JTCs and who will sign a Confidentiality Agreement. 6.3.3 Funding Agency Board In addition to the rules described in Section 6.2, the following rules shall apply: Members The Funding Agency Board shall consist of one principal representative of each Research and Innovation Funding Organisation Party of this Agreement.. In order to ensure co-ordination, equality and stability in the knowledge of the THCS and its oversight, a principal representative and a permanent alternate will be appointed, both duly authorised to deliberate, negotiate and decide on all matters related to the Funding Agency Board. Each Research and Innovation Funding Organisation that is a member of the Funding Agency Board can also provide additional Contact Persons. Observers and invited experts If considered appropriate, other Parties with roles relevant for the implementation of the Partnership may be invited as observers to the Funding Agency Board meetings. Chair The Coordinator or, if absent, his/her Deputy shall chair all meetings of the Funding Agency Board, unless decided otherwise by a majority of two-thirds. Tasks The Funding Agency Board members commit themselves to undertake their tasks in an unbiased way. The Funding Agency Board will be in charge of the decision on the topic of each Joint Transnational Call based on the priorities identified in the Strategic Research and Innovation Agenda and the Annual Work Plan. For such purpose, the priority topics identified by the Strategic Board will be presented to the Funding Agency Board that will share comments and make the final decision on a first topic description. The Funding Agency Board will be in charge of defining the THCS internal funding rates, i.e. the internal distribution of the 30% EC co-fund, according to the starting points and principles set out in art. 7.3 as well as of participating in the construction of the THCS internal budget. The Funding Agency Board shall also be involved in the definition of indicators and development of monitoring procedures related to JTCs. Decisions Each principal representative has one vote. Consensus on all matters shall be sought. If consensus is not reached, decisions shall be taken by a majority of two-thirds (2/3) of the votes cast. 23 THCS Consortium Agreement, version 0.4, 25/01/2023 6.3.4 Other THCS Bodies a. Advisory Board “Innovators” In addition to the rules described in Article 6.2, the following rules apply. Members The Advisory Board “Innovators” will include experts and representative group of stakeholders at European level that cover the entire health and care system, demand side, and are not participating in THCS. A list of possible Members will be identified by the Coordinating Team in cooperation with the Strategic Board at the beginning of the Partnership and shared with the General Assembly for approval. Chair The Chair will be elected by the Advisory Board “Innovators” members. Tasks The Advisory Board “Innovators” will ensure that the Partnership will maintain a strong European and international dimension and be linked with key policies and networks at European and international level. Through the Advisory Board collaboration with key experts and networks is aimed to offer reflections on the strategic orientation and the identification of synergies. The Advisory Board will provide advice on and contribute to: - the Science to Policy Dialogue; - the identification of synergies & collaborations; - ensure an adequate monitoring and evaluation of the Partnership performance by providing insight on selected key strategic deliverables such as e.g,. the Annual Work Plans, the dissemination and communication plan, the sustainability report, etc. Declaration of interests It is important for THCS to be as upfront and transparent as possible to ensure that THCS meets the high standards of impartiality and objectivity expected by EU citizens in a public- public partnership. It is therefore crucial to put in place a process for preventing risks of conflicts of interest that could erode public trust and the uptake of THCS outputs. In this regard, Members of the Advisory Board “Innovators” will be requested to disclose any potential conflict of interest, especially as regards the Annual Work Plans since these include the topic of JTCs. Members of the Advisory Board “Innovators” will be also requested to undersign a Non-Disclosure Agreement. b. National Mirror Groups In addition to the rules described in Article 6.2, the following rules apply. The Coordinating Team will propose standard Terms of Reference for the functioning of NMG, but it will be up to each NMG to establish their own procedures depending on the national ecosystem. Members National Mirror Groups (NMG) should involve decision makers, research and innovation funding bodies and relevant national stakeholders and experts. If applicable, existing regional and local networks should be also involved to include the perspective of the regional and local instances. Therefore, NMGs shall be constituted as much as possible by actors representing most of the stakeholders from the National/Regional/Local Health and Care and Research and Innovation systems Countries participating in the Partnership will be strongly advised to constitute NMG, bringing together the stakeholders better reflecting the different contexts. The Coordinating team will share guidance for the definition of the NMG at the beginning of the Partnership but the creation and composition will be at the discretion of each participating country. Countries that will establish National Mirror Groups will be invited to appoint a National Mirror Group Representative. National Mirror Group Representatives shall contribute to build a long-term THCS programme by building a long-term network, for the exchange of information, expertise and best practices, bringing together experts and activities and ensuring that they are coordinated, feed their needs into THCS, contribute to the objectives, and learn from the work performed within THCS through peer learning. 24 THCS Consortium Agreement, version 0.4, 25/01/2023 Tasks Although not mandatory, it is expected that the establishment of NMG will ensure that national activities, strategies, and needs are taken into account when selecting and implementing Partnership activities, and in particular those requesting co-development and co-creation approaches, and when designing the Partnership Annual Work Plans. NMG should also support the dissemination of the Partnership activities/results, thus contributing to the impact maximisation of the Partnership. NMG shall be consulted through agreed procedures: a) to contribute with their feedback to the design of the Partnership Annual Work Plans, although carefully respecting the necessary rules to avoid any conflict of interest; b) to support the assessment of needs for research, development and innovation (RDI) and capacity building; c) to better understand the barriers and difficulties that might hinder implementation of new solutions and findings, in an ecosystem wide approach; d) to support funded projects by giving feedback and input, and possibly connecting them to relevant additional stakeholders; e) to help identifying key practices that might benefit from additional in-kind implementation support through the Partnership (involving practices in workshops, study visits, webinars, etc.); f) to help stimulating national and regional stakeholders to follow the implementation of funded projects, participate where possible in key events to maximise the impact; g) to ensure a wider Dissemination and Exploitation of the results at National and regional level. The aforementioned support will be provided by NMGs mainly through the use of national resources and in-kind contributions of all partners involved in the Consortium. 6.4. Coordinator 6.4.1 Role of the 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. 6.4.2 Responsibilities In particular, the Coordinator shall be responsible for: - monitoring compliance by the Parties with their obligations under this Consortium Agreement and the Grant Agreement; - keeping the address list of Members and other Contact Persons updated and available; - ensuring smooth operation of the Partnership: work plan maintenance, monitoring progress, analysing Results, identification of problems and consequences for future work progress; - 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 connected with the Project to any other Parties, including their Affiliated Entities, concerned; - administering the financial contribution of the Granting Authority and fulfilling the financial tasks described in Section Error! Reference source not found.; - providing, upon request, the Parties, including their Affiliated Entities, 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, including their Affiliated Entities, to present claims. If one or more of the Parties is late in submission of any Project deliverable, the Coordinator may nevertheless submit the other ’Parties’ Project deliverables and all other documents required by the Grant Agreement to the Granting Authority in time. 6.4.3 Change of Coordinator If the Coordinator fails in its coordination tasks, the General Assembly may propose to the Granting Authority to change the Coordinator. 6.4.4 Declarations of 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. 25 THCS Consortium Agreement, version 0.4, 25/01/2023 6.4.5 Scope of action of the Coordinator The Coordinator shall not enlarge its role beyond the tasks specified in this Consortium Agreement and in the Grant Agreement. 6.4.6 Coordinating Team The overall executive management is implemented by the Coordinator supported by Project managers in the coordinating body. The Coordinator and Project managers constitute the THCS Coordinating Team. They will ensure, with the General Assembly, the compliance of THCS and its Parties with the EU provisions (Grant Agreement and its annexes) and the Consortium Agreement. The Coordinating Team will guide Parties, including their Affiliated Entities, on Horizon Europe rules and provisions, whenever relevant. Governance procedures creating an efficient network spanning all Parties, including their Affiliated Entities, of THCS will be set up and followed to ensure a smooth functioning of the Partnership. As described in the Work Package 2 “Coordination and Management”, the main activities of this task entail the management of the consortium and internal communication. The Coordinating Team also assists and facilitates the work of the Strategic Board and the Coordinator for executing the decisions of the General Assembly as well as the day- to-day management of the Partnership. 6.5. New Partners entering the consortium The consortium remains open to the integration of additional entities or countries that want to join and contribute to THCS with their knowledge and resources, including financial ones, provided that they can bring both the required expertise and co-funding. Any new entities from already participating countries willing to participate in THCS must fill in an application form in which they must describe their expertise, specify the WPs and tasks in which they would like to contribute, an estimation of the budget dedicated to financial support to third parties (if applicable), and justify their capacities to perform work that enters into the scope of THCS. The application forms must be completed at least 6 months before the submission of an Annual Work Plan to allow the integration of potential new partners in this Annual Work Plan. The Strategic Board evaluates the submitted application forms and submit a decision memo to the Coordinator in order to decide on the integration of the new applicants into the THCS Consortium and overall Work Plan. The Coordinator then informs the applicants and their country institution(s) already involved in the THCS about the decision of the Strategic Board and the subsequent follow-up. For new countries, the same process applies. However, relevant entities from new countries wishing to join have the opportunity to take part to the meetings of the General Assembly as guests. They will introduce themselves and any activities related to the Partnership and how they wish to contribute. The relevant organisations willing to participate in THCS then fill in the application form for evaluation by the Strategic Board for a potential integration into the workflow and in the THCS next Annual Work Plans. The Coordinating Team will assist potential new Partners in understanding the Partnership and in establishing the adequate involvement of the country’s organisations in the different boards and structures. The approval of the General Assembly will be sought for a new country’s integration into the Partnership and on the conditions of the accession of such a new country. After approval of the integration of a new Party in THCS by the THCS boards including the Strategic Board and the General Assembly, the Coordinator must submit a request for amendment of the Grant Agreement in accordance with Article 39 of the Grant Agreement. New Parties must assume the rights and obligations under this Consortium Agreement with effect from the date of their accession. 7. Financial provisions All provisions included in this section 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 section (i.e. by signing a contract with them). For the sake of clarity all provisios included in tis section do not apply to the Associated Partners. All Beneficiaries agree that provisions included in this section shall reflect the principles of equal treatment, collaboration, mutual support among Countries and efficient use of resources that will drive THCS, aiming at 26 THCS Consortium Agreement, version 0.4, 25/01/2023 reaching the full potential of R&I capacities across Europe and promoting an inclusive approach (European Research Area priorities), 7.1. General Principles 7.1.1 Distribution of Financial Contribution The financial contribution of the Granting Authority to THCS shall be distributed by the Coordinator according to: - the Description of Action (Annex 1 of the Grant Agreement) and the Annual Work Plan and amendments - the internal version of the THCS total budget table (following the structure of the Annex 2 of the Grant Agreement) approved annually by the General Assembly - the approval of reports by the Granting Authority, and - the Internal Funding Rules of Section 7.3 and the provisions of payment in Section 7.6 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 this Beneficiary has duly signed the Consortium Agreement and the Accession Form to the Grant Agreement. As a reminder, it is good practice for a Beneficiary that involves Affiliated Entities to conclude a written contract with those Affiliated Entities that ensures compliance with the provisions of the Grant Agreement and the Consortium Agreement. A Beneficiary or an Affiliated Entity shall be funded only for its tasks carried out in accordance with the Description of Action and the valid Annual Work Plan with respective amendments. Each Beneficiary 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. 7.1.2 Justifying Costs In accordance with its own usual accounting and management principles and practices and with article 6 of the Grant Agreement, each Beneficiary and Affiliated Entity shall be solely responsible for justifying its costs with respect to THCS towards the Granting Authority. Neither the Coordinator nor any of the other Beneficiaries or Affiliated Entities shall be in any way liable or responsible for such justification of costs towards the Granting Authority. 7.1.3 Funding Principles A Beneficiary or an Affiliated Entity, that spends less than its allocated share of the budget as set out in the last validated by the General Assembly version of the THCS total budget table will be funded in accordance with its actual duly justified eligible costs only. A Beneficiary or an Affiliated Entity that spends more than its allocated share of the budget as set out in the last validated by the General Assembly version of the THCS total budget table will be funded only in respect of duly justified eligible costs up to an amount not exceeding that share. 7.1.4 Return of excess payments; receipts Excess Payment A Beneficiary or Affiliated Entity has received excess payment if, at the end of THCS, the payments received from the Coordinator exceeds the amount of the EU contribution, calculated by applying the internal rates on the total costs declared by a Beneficiary or Affiliated Entity and accepted by the Granting Authority. In case a Beneficiary or Affiliated Entity has received excess payment, the Coordinator shall send a request to the Beneficiary or Affiliated Entity to return the relevant amount to the Coordinator without undue delay. In case no refund takes place within 45 calendar days upon request for return of excess payment from the Coordinator, the Beneficiary or Affiliated Entity is in substantial breach of the Consortium Agreement. Amounts which are not refunded by a breaching Beneficiary or Affiliated Entity and which are not due to the Granting Authority, shall be apportioned by the Coordinator to the remaining Parties following a procedure agreed by the General Assembly, until recovery from the breaching Beneficiary or Affiliated Entity is possible. In this connection, the remaining Parties shall not be treated disadvantageously among each other. 27 THCS Consortium Agreement, version 0.4, 25/01/2023 Revenue In case a Beneficiary or an Affiliated Entity earns any revenue that is deductible from the total funding as set out in the updated internal version of the THCS budget table, approved annually by the General Assembly, and in the Description of Action, the deduction is only directed toward the Beneficiary or the Affiliated Entity earning such income. The other Beneficiaries or an Affiliated Entities’ financial share of the budget shall not be affected by one Beneficiary or an Affiliated Entity’s revenue. In case the relevant revenue is more than the allocated share of the Beneficiary or the Affiliated Entity as set out in the last validated by the General Assembly version of the THCS total budget table, the Beneficiary or the Affiliated Entity concerned shall reimburse the funding reduction. 7.1.5 Financial Consequences of the termination of the participation of a Beneficiary or an Affiliated Entity A Beneficiary or an Affiliated Entity leaving the consortium shall refund to the Coordinator all payments it has received except the amount of contribution accepted by the Granting Authority or another contributor. In addition, a Defaulting Beneficiary or Affiliated Entity shall, within the limits specified in Article 5.2, bear any reasonable and justifiable additional costs occurring to the other Beneficiaries or Affiliated Entities in order to perform the leaving Party’s task and necessary additional efforts to fulfil them as a consequence of the Beneficiary or Affiliated Entity leaving the Consortium. The General Assembly should agree on a procedure regarding additional costs which are not covered by the Defaulting Beneficiary or Affiliated Entity or the Mutual Insurance Mechanism. 7.2. Budgeting The budget set out in the internal version of the THCS budget table, approved annually by the General Assembly, as well as the annual budget set out in accordance with the Annual Work Plan shall be valued in accordance with the usual accounting and management principles and practices of the respective Beneficiaries and Affiliated Entities. Associated Partners agree to cover the costs arising from their involvement in the THCS activities from their own funds. 7.3. Internal funding and budgeting rules Each Beneficiary and Affiliated Entity agrees to 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 of the Grant Agreement. 7.3.1 Justifying costs The costs of each Beneficiary and Affiliated Entity are calculated according to its involvement in THCS based on the following cost categories: a) Personnel costs (actual costs) b) Subcontracting costs c) Other direct costs – Travel and subsistence d) Other direct costs – Purchase of other goods, works and services e) Financial Support to Third Parties f) Indirect costs The initial global budget of THCS per co-funded Partner is set out in Annex 2 of the Grant Agreement. 7.3.2 Internal funding rates Whereas the overall EU funding rate of the Programme is 30% of the actual eligible costs, submitted and duly justified by the Beneficiaries or Affiliated Entities and accepted by the Granting Authority, the Beneficiaries and Affiliated Entities agree to use different internal funding rates for the activities included in the Description of Action. The Coordinator will be responsible for distributing the received funding to the Beneficiaries and Affiliated Entities according to the internal funding rates. The Beneficiaries and the Affiliated Entities agree that the 30% EU co-fund related to Direct Costs, and in particular to Personnel Costs, Subcontracting Costs, and Purchase Costs, and Indirect Costs as set out in Annex 2 to Grant Agreement will be allocated to them in order to ensure the implementation of activities set out in Annex 1 to Grant Agreement. 28 THCS Consortium Agreement, version 0.4, 25/01/2023 The Beneficiaries and the Affiliated Entities agree that the internal redistribution of the 30% EU co-fund related to Financial Support to Third Parties (cash contribution to Joint Transnational Calls) shall be based on the following: - THCS is a co-fund action, where the EU resources are complementary to national/institutional resources. - The said EU co-funding will be re-distributed on the basis of the actual activities that will be implemented and the actual costs that will be incurred. - Funding re-distribution policy should give priority to key strategic activities and costs that are considered necessary for THCS implementation. The Beneficiaries and the Affiliated Entities, therefore agree to define the internal funding rates according to the following starting points: - 30% EU co-fund related to Direct Costs, and in particular to Personnel Costs, Subcontracting Costs, and Purchase Costs, and Indirect Costs as set out in Annex 2 to Grant Agreement will be allocated to Beneficiaries and Affiliated Entities in order to ensure the implementation of activities set out in Annex 1 to Grant Agreement. - Full or hight support – within the limit of yearly available funds – to costs needed for Partnership Implementation: logistics for THCS Meetings and workshops, subcontracting needed for THCS Activities, reimbursement for stakeholders/experts. - Full or hight support – withing the limit of yearly available funds – to travel and accomodation costs strictly related to THCS meetings, These will not include national travels for internal purposes (i.e. travels for funded projects financial audit). - Full or high support – within the limit of yearly available funds – to Joint Call Secretariat and WP Leaders: key activities provided by some Partners for the whole consortium benefit. - Full or high support – within the limit of yearly available funds – to Research Organisations to carry out strategic activities in which they have responsibilities for the whole consortium benefit. - Ensure a EU co-fund on the amount that will be actually claimed for Financial Support to Third Parties. - Ensure that the redistribution of EU co-fund is considering all activities implemented. Internal funding rates should be re-evaluated annually and decided upon by the General Assembly for the upcoming year. in parallel with the decisions on the Annual Work Plan and the Annual Internal Budget, to ensure sustainability of THCS, in accordance with the EU Top-Up available. 7.3.3 Internal budget construction In any case a Beneficiary, including its Affiliated Entities, can receive more than one its share of the Maximum Grant as set out in Annex 2 to Grant Agreement. The budget should be used for reimbursement according to the following prioritization. Firstly, the EU co-fund should be used to cover administrative and management activities of THCS (implementation costs). The remaining part should be dedicated to co-fund Transnational Research and Innovation Projects. The Beneficiaries and the Affiliated Entities, agree with the following general principles. Implementation costs The Beneficiaries and the Affiliated Entities agree to apply different co-funding rates to THCS activities. They notably agree to use lower co-funding rates for the funding of transnational research projects selected in the co-funded joint transnational calls and the funding of THCS monitoring activities at national level to be able to use higher co-funding rates for the implementation of THCS activities. In particular: - Subcontracting, travel and accomodation and purchase costs that are mandatory for the implementation of the THCS will be co-funded at 100%; - Joint Call Secretariat is considered a key service for the whole THCS and therefore all efforts shall be made to fully cover the personnel costs associated (up to 100%); - THCS should also try to provide higher support to key strategic activities (up to 100%), including:  Activities related to coordination and management (WP2)  Leadership roles/Partners that are taking major responsibilities (WP, task leaders and co-leaders should be supported on the activities where they have responsiblity roles)  Knowledge/expertise made available to THCS that, alternatively, needs to be purchased outside the Consortium (i.e. Expertise of Research Performing Organisations to deliver training under WP10 - Knowledge Hub to support the transferability of good practices) - All other costs not indicated above will be co-funded at 30% 29 THCS Consortium Agreement, version 0.4, 25/01/2023 Co-funding of Transnational Research and Innovation Projects The Parties agree with the following general principles: - The EU Top-Up funding for each EU-eligible Research and Innovation Funding Organisation participating in a co-funded Call will be predominantly allocated according to the Research and Innovation Funding Organisation’s respective actual financial contribution to the concerned co-funded call. - The EU-eligible Research and Innovation Funding Organisations agree to use the Granting Authority contribution, following the allocation of the implementation costs, for Transnational research projects as a Mixed funding mode composed of: I. Reimbursement: up to 50%-70% of the EU Top-Up for each JTC will be distributed among eligible Research and Innovation Funding Organisations, on a fixed reimbursement rate (pro-rata), proportionally to each respective actual contribution (just-retour reimbursement). II. Gap filling: up to 30%-50% of the EU Top-Up for each JTC may be used for Gap filling or a "flexibility" common pot that will be used to close the gaps of funding within the ranking list. Research and Innovation Funding Organisations first have to fulfil their budget commitments for a given Co-funded Call indicated in the concerned Call Memorandum of Understanding before they are allowed to get money from the common pot. A Research and Innovation Funding Organization cannot receive more than 15% of the Gap filling. The total EU Top-Up received by a single Research and Innovation Funding Organisation shall not exceed the respective national/regional contribution provided to research projects. The Call Steering Committee (CSC) will be able to adjust the redistribution of EU Top-Up between a virtual (pro-rata) and real (“flexibility”) common pot during the CSC funding meeting. An annual internal estimated budget will be constructed each year in accordance/in parallel with the elaboration of the Annual Work Plan and taking into consideration the starting points and general principles set out in Articles 7.3.2 and 7.3.3, respectively. 7.4. Budget flexibility The reference budget for the budget transfers is the latest version of the THCS internal total budget table. During the preparation of the first version of the internal total budget table, budget transfers may concern only the 1st Annual Work Plan budget. Budget transfers and modifications are allowed between Beneficiaries and/or Affiliated Entities 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 art. 5.5 of the Grant Agreement. The process and approval procedure are defined below. The Coordinating Team shall be informed of all budget transfers. Budget transfers shall always be duly justified and approved by the Beneficiaries or Affiliated Entities directly concerned. Budget transfers between Beneficiaries and/or Affiliated Entities are possible as follows: - Budget transfers for activities implemented during the whole THCS duration (7 years): validation by the task leaders concerned, the Work package leaders concerned, and the Coordinator. - Budget transfers in the budget of one Beneficiary and/or Affiliated Entity: - Between different activities in which the partner is involved: validation by the task leaders concerned, the Work Package leaders concerned, and the Coordinator. 7.5. Insufficient financial contribution of the Granting Authority In the unlikely case that the EU Financial Contribution is not sufficient to contribute to the costs of THCS in the planned way, the Beneficiaries, including their Affiliated Entities, agree to start without unjustified delay a discussion on the subject using the procedure described in the following paragraphs. For the avoidance of doubt, nothing in this Agreement shall be deemed to require a Beneficiary to breach any mandatory statutory national law under which the Beneficiary is operating or to raise its national commitment to pay for financial gaps as described below. The EU Financial Contribution for the Joint Transnational Calls is based on actual costs. According to the Grant Agreement a reimbursement of 30% for all direct and indirect costs foreseen in its Annex 2 will be awarded by the Granting Authority. If these costs are less than planned in the Grant Agreement, the EU Financial Contribution will be less as well. In order to avoid such situations, as set out in art. 7.6 the THCS Coordinating Team shall establish a cost monitoring system, which shall allow for an overview at all times of 30 THCS Consortium Agreement, version 0.4, 25/01/2023 the budget available for reimbursements and for a cost assessment of the consequences of a potentially low leverage of EU Financial Contribution, especially around the annual Joint Transnational Calls. 7.5.1 Less EU Financial Contribution than foreseen for the Joint Transnational Calls The following cases might occur: 1) Reduction in EU Financial Contribution due to Transnational Projects reporting less eligible costs than foreseen in the national funding contracts The funding of Transnational Projects resulting from the Joint Transnational Calls leverages EU 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 EU 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 Beneficiaries, including its Affiliated Entities. Yet the reduction in the EU Financial Contribution may have a negative effect on the budget situation of the whole THCS Consortium. In case of a bankruptcy the affected Call-specific Consortia shall endeavour to mitigate the situation as appropriate or compatible with the funding regulations of the affected Research and Innovation Funding Organisation, 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 Research and Innovation Funding Organisationalready received EU Financial Contribution for the full amount leveraged by the national funding contracts, the respective Research and Innovation Funding Organisation shall return the excess EU Financial Contribution without unjustified delay to the Coordinating Team. Research and Innovation Funding Organisations 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. 2) A Research and Innovation Funding Organisation 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 Research and Innovation Funding Organisation has to revoke and cannot fund their respective national share of the potential Transnational Projects of the Joint Call, the Coordinator 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 Research and Innovation Funding Organisations 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 Research and Innovation Funding Organisations 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 activities set out in Annex 1 to Grant Agreement cannot be fully reimbursed and the funding gap closed by rearranging or reducing the distribution of the EU Financial Contribution, the Research and Innovation Funding Organisations shall resort to the procedures laid down at the beginning of Section 7.5. 7.5.2 Fewer eligible direct costs than foreseen in the Annex 2 to Grant Agreement In case that the actual amount of eligible direct costs is lower than foreseen in the Annex 2 to Grant Agreement the EU Financial Contribution will be lower as well. The actual amount of eligible direct costs is related to the budget committed to the Joint Transnational Calls by the Research and Innovation Funding Organisations as well as to the way in which the Beneficiaries and the Affiliated Entities uphold their respective commitments for the specified activities indicated in the Annex 1 to Grant Agreement. If a Beneficiary and/or an Affiliated Entity reduces its commitments regarding its indicated budget for the Joint Transnational Calls or its provision of resources (personnel or funding) for the activities set out in Annex 1 to Grant Agreement, the possible leverage of the EU Financial Contribution will be lower and a funding gap might 31 THCS Consortium Agreement, version 0.4, 25/01/2023 appear with regard to the execution of the Annex 1 to Grant Agreement. In this case, the Coordinator together with the Funding Agency Board shall come up to the General Assembly with a proposal to mitigate the funding gap. This proposal and the actions arising from it shall be discussed and decided upon in the General Assembly. 7.5.3 No EU Financial Contribution In the unlikely case that the THCS is terminated and the availability of the EU 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 Benefciaries and Affiliated Entities shall be limited in accordance with the rules established in Section 5.2. a. In case that enough EU Financial Contribution has already been made available by the Granting Authority all the remaining EU Financial Contribution shall be used in line with its pre-determined purpose to cover the costs incurred in the execution of the activities set out in Annex 1 to Grant Agreement up to the time of termination and in compliance with national legislations. Any contractual funding commitments established by the Research and Innovation Funding Organisations up to the time of the termination that include co- funding from the EU Financial Contribution shall be honoured in the same way. b. In case that EU Financial Contribution has been made available before termination, but that it is not enough to cover both the Implementation Costs incurred until then and the funding commitments established that include potential EU Financial Contribution, the prioritisation laid out in Section 7.3 shall be applied and the process towards finding a solution shall be followed as outlined at the beginning of this section. c. In case that no EU Financial Contribution is available whatsoever, the same principles shall be followed as described in the previous paragraph 7.5.3 b of this section). 7.6. Methodology for the monitoring of the budget The overall THCS budget will be monitored by the Coordination Team. In addition, the technical oriented monitoring of the resources will be done by the Coordination Team in accordance with the respective WP and Task leaders. If a reporting period, as stated in the Grant Agreement, exceeds 12 months, an internal financial reporting will be implemented by the Coordination Team in order to allow the Beneficiaries and the Affiliated Entities to monitor their budget at least every 12 months. The internal financial reporting aims also to monitor the THCS budget at regular basis (at least once per year) on the Partnership level, to flag and to resolve any problems before the reporting to the Granting Authority. The Coordinating shall provide the General Assembly with the results of this costs assessment and deliver an early warning, should a scenario of a severe reduction of EU Financial Contribution (art. 7.5) arise in comparison with the numbers foreseen in the Grant Agreement, so that appropriate changes of activities or delays of payments can be discussed taking into account the obligation of the Consortium, as agreed upon in the Grant Agreement, to fulfil the Consortium Plan in a reasonable manner. The Beneficiaries and the Affiliated Entities shall submit their internal financial reports to the Coordinator in the two months following the end of the internal reporting period. 7.7. Payments 7.7.1 Principles Payments to Beneficiaries are the exclusive tasks of the Coordinator. In particular, the Coordinator shall: - notify the Beneficiary concerned promptly (article 7.b.iii of the Grant Agreement) of the date and composition of the amount transferred to its bank account, giving the relevant references. The Coordinator will transfer to a Beneficiary the amounts due to the Beneficiary and to its Affiliated Entities. The Beneficiary is responsible to transfer the amounts due to its Affiliated Entities according to the information provided by the Coordinator (table with the payment amounts for all Beneficiaries and all Affiliated Entities). The table with the payment amounts will be sent by the Coordinator to all Beneficiaries and all Affiliated Entities at least 7 calendar days prior to the bank transfer. During this time period, the Beneficiaries can inform the Coordinator about any request for modification of the amounts to be paid to them and/or to their Affiliated Entities. All requests for modification of the amounts to be paid must be in accordance with the section 7 of this Consortium Agreement. - perform diligently its tasks in the proper administration of any funds and in maintaining financial accounts. 32 THCS Consortium Agreement, version 0.4, 25/01/2023 7.7.2 Payment limitation With reference to Articles 22.3.1 and 22.3.3 of the Grant Agreement, no Beneficiary or Affiliated Entity shall before the end of the Partnership receive more than its allocated share of the maximum grant amount from which the amounts retained by the Granting Authority for the Mutual Insurance Mechanism and for the final payment have been deducted. Therefore, the Coordinator shall apply the same limits and stop payments to each Beneficiary and Affiliated Entity for which 85% of its maximum grant amount (according to the up to date and validated by the General Assembly internal total budget table) is paid. 7.7.3 Payment Strategy The payment schedule, which contains the transfer of pre-financing, interim and final payments to Beneficiaries, will be handled according to the following: Initial pre-financing An initial pre-financing will be paid to Beneficiaries, for the Beneficiaries and their Affiliated Entities, without unjustified delay after receipt of the initial EU pre-financing from the Granting Authority. Additional pre-financings If a need is identified by the consortium and/or by the Coordinator (i.e. if a very important amount of funds sent by the Granting Authority to the Coordinator but not yet distributed to the Beneficiaries or Affiliated Entities is remaining on the Coordinator’s account for THCS), additional pre-financings may be paid to Beneficiaries (for the Beneficiaries and/or their Affiliated Entities). The calculation of the amounts due, the schedule and modalities shall be proposed by the Coordinator and validated by the General Assembly. The payment limitation stipulated in Art. 7.6.2 applies. Interim payments Interim payments shall be transferred to Beneficiaries, for the Beneficiaries and their Affiliated Entities, after reception of the funds from the Granting Authority, without unjustified delay. The interim payments shall reimburse the EU contribution calculated on the basis of the eligible costs incurred by each Beneficiary and their Affiliated Entities during the corresponding reporting period and the internal funding rates. The amount due to each Beneficiary and its Affiliated Entities is calculated as follows: - Step 1: Calculation of the total EU contribution for each Beneficiary and their Affiliated Entities by taking the costs accepted by the Granting Authority for the corresponding reporting period and applying the internal funding rates; - Step 2: Minus the Beneficiary and their Affiliated Entities’s cashflow; cashflow means the EU contribution received but not yet used by the Beneficiary and their Affiliated Entities; - Step 3: Checking that the total amount of pre-financing and interim payments transferred from the Coordinator’s account to the Beneficiary and their Affiliated Entities shall not exceed 85% of the maximum grant amount set out in Article 7.6.2 of this Consortium Agreement. The interim payment shall be distributed to a Beneficiary and their Affiliated Entities provided that: - the Beneficiary and their Affiliated Entities have contributed to the relevant deliverables and reports for the previous periods and that such deliverables and reports have been accepted by the Granting Authority; - the Beneficiary and their Affiliated Entities have reported and justified its receipts and costs as required by the Coordinator for the previous periods and that the Financial Statement of such Participant has been accepted in all or part by the Granting Authority; - the Beneficiary or Affiliated Entity is not a Defaulting Beneficiary or Affiliated Entity. - In case a Beneficiary or Affiliated Entity does not fulfil the conditions for the Interim payment, such Beneficiary or Affiliated Entity shall not receive any further financial contribution of the Granting Authority until such conditions are met, unless the General Assembly decides otherwise. 7.7.4 Final Payment The final payment shall be distributed to Beneficiaries, for the Beneficiaries and their Affiliated Entities, after receipt from the Granting Authority without unjustified delay. The amount due to each Beneficiary and their Affiliated Entities is calculated in the following steps: 33 THCS Consortium Agreement, version 0.4, 25/01/2023 - Step1: Calculation of the total EU contribution for each Beneficiary and their Affiliated Entities by taking the total eligible costs declared by each Beneficiary and their Affiliated Entities and accepted by the Granting Authority and applying the internal funding rates. - Step 2: Minus the EU financial contribution already received by the Beneficiary and their Affiliated Entities. As specified in Article 7.1.3 of the present Consortium Agreement, the final payment shall be limited to the maximum grant amount of each Beneficiary and their Affiliated Entities as indicated in the last version of the THCS internal total budget table validated by the General Assembly. - Step 3: Reduction due to the no-profit rule, according to the Grant Agreement. - Step 4: Reduction due to improper implementation or breach of other obligations, according to art. 28 of the Grant Agreement. If the balance is positive, it will be paid to the Beneficiary and their Affiliated Entities. If the balance is negative, it will be recovered. 7.7.5 Adjustment payments At each General Assembly meeting, if necessary, according to the updated table showing the new overall budget for the Partnership, the General Assembly principal representatives will decide if there is a need to make adjustment payments. 7.7.6 Payment retention and recovery The Coordinator is entitled to withhold any payments due to a Beneficiary and Affiliated Entity identified by a responsible Consortium Body to be in breach of its obligations under this Consortium Agreement or the Grant Agreement, or to a Beneficiary (and its Affiliated Entities), which has not yet signed this Consortium Agreement. The Coordinator is entitled to recover any payments already paid to a Defaulting Beneficiary or Affiliated Entity except the costs already claimed by the Defaulting Beneficiary or Affiliated Entity and accepted by the Granting Authority. The Coordinator is equally entitled to withhold payments to a Beneficiary or Affiliated Entity when this is suggested by or agreed with the Granting Authority. 8. Results 8.1. Ownership of Results generated within THCS Results generated within THCS are owned by the Party, including its Affiliated Entity that generates them. 8.2. Joint ownership Joint ownership is governed by Grant Agreement Article 16.4 and its Annex 5, Section Ownership of results, with the following additions. In case of joint ownership, the joint owners shall make their best efforts to establish a joint-ownership agreement regarding the allocation and terms of exercising such joint ownership as soon as possible and within a maximum of six (6) months as from the date on which the respective Results have been generated. Unless otherwise agreed in the joint ownership agreement: - each of the joint owners shall always 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. The Parties, including their Affiliated Entities, must indicate the owner(s) of the Results (Results ownership list) in the final periodic report. 8.3. Exploitation of Results As per Annex 5 of the Grant Agreement, all Parties, including their Affiliated Entities, which have received funding under the grant, must — up to four years after the end of the action — use their best efforts to exploit their Results directly or to have them exploited indirectly by another entity, in particular through transfer or licensing. If, despite a Party’s best efforts, the Results are not exploited within one year after the end of the action, each 34 THCS Consortium Agreement, version 0.4, 25/01/2023 Party must (unless otherwise agreed in writing with the granting authority) use the Horizon Results Platform 1 to find interested parties to exploit the Results. If Results are incorporated in a standard, the Parties, including their Affiliated Entities, must (unless otherwise agreed with the Granting Authority or unless it is impossible) ask the standardisation body to include the funding statement (see Article 17 of the Grant Agreement) in (information related to) the standard. 8.4. Transfer of Results 8.4.1 Transferring ownership Each Party, including its Affiliated Entities, 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, including their Affiliated Entities, must ensure that obligations under the Consortium Agreement regarding their Results are passed on to the new owner and that this new owner has the obligation to pass them on in any subsequent transfer. 8.4.2 Informing of the transfer The transferring Party shall, however, at the time of the transfer, inform the other Parties of such 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. The other Parties, including their Affiliated Entities, may object within 30 calendar days of receiving notification (or less if agreed in writing), if they can show that the transfer would adversely affect their Access Rights. In this case, the transfer may not take place until agreement has been reached between the Parties concerned. 8.4.3 Granting licenses The Parties, including their Affiliated Entities, may grant licenses to their own Results (or otherwise give the right to exploit them), including on an exclusive basis, provided this does not affect compliance with their obligations. Exclusive licences for Results may be granted only if all the other Parties concerned have waived their Access Rights. 8.4.4 Specific cases of mergers or acquisitions 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. 8.4.5 Application of the obligations The obligations above apply only for as long as other Parties, including their Affiliated Entities, still have - or still may request - Access Rights to the Results. 8.5. Open science research data management Subject to confidentiality obligations and applicable data protection rules, each Party, including its Affiliated Entities, must manage the digital research data it generates (Data) or uses in THCS responsibly, in line with the FAIR principles (‘findability’, ‘accessibility’, ‘interoperability’ and ‘reusability’). The THCS Data Management Plan is a deliverable in the THCS work plan and its updates will be distributed to all Parties, including their Affiliated Entities, along with the Partnership Management Plan for good operating procedures including guidelines, templates and summary of the Consortium Agreement rules. All Parties, including their Affiliated Entities, shall respect the requirements set out in these documents. The management and protection of data produced outside THCS will follow the boundaries set by the ethical and legal frameworks under which those data were originally collected. Whenever possible and applicable, the Parties will make use of or build further on existing sustainable FAIR data management solutions, i.e., those offered or adopted by the EC, Member States, the EOSC, and/or EC or Member State supported research infrastructures or research consortia. All Parties, including their Affiliated Entities, will take all of the following actions: 1 Horizon Results Platform (europa.eu) 35 THCS Consortium Agreement, version 0.4, 25/01/2023 - contribute to the Data Management Plan (and regularly update it). The Data Management Plan will consist of generic parts that are applicable to all Data, and specific parts that are applicable to specific subsets or types of Data. Each Party, including its Affiliated Entities, is responsible that management of the Data it generates and/or uses, is properly and timely addressed in the Data Management Plan, and will provide the necessary inputs to that extent. Each Party, including its Affiliated Entities, has the responsibility to timely bring to the attention any issue that may impede adherence to it. Each Party, including its Affiliated Entities, will update parts of the Data Management Plan that specifically pertain to the Data it generates and/or uses, without delay, whenever significant changes arise. This includes, but is not limited to: the generation of new data, changes in data access provisions or curation policies, attainment of tasks (e.g., datasets deposited in a repository, etc.), changes in relevant practices (e.g., new innovation potential, decision to file for a patent). The consecutive Data Management Plan deliverables will be delivered as non- restricted, public deliverables under Creative Commons Attribution International Public License (CC BY). However, parts of the Data Management Plan may be excluded from this public deliverable if there are reasons (legitimate interests or other constraints) to do so. - as soon as possible and within the deadlines set out in the Data Management Plan, deposit the data it has generated in a trusted repository, unless the applicable legislation prevents such deposit. Trusted repository is further specified in the EU Grants - AGA – Annotated Model Grant Agreement. This does not entail that data must be made open. Data includes raw data, to the extent technically feasible, but especially if it is crucial to enable reanalysis, reproducibility and/or data reuse. Deposition of data must take place at the latest by the end of the project. In exceptional cases in which specific constraints apply (e.g. security rules), deposition can be delayed beyond the end of the project. Data underpinning a scientific publication should be deposited at the latest at the time of publication, and in line with standard community practices. - as soon as possible and within the deadlines set out in the Data Management Plan, ensure open access - via the repository - to the deposited data, under the latest available version of CC BY or Creative Commons Public Domain Dedication (CC 0) or a license with equivalent rights, following the principle ‘as open as possible as closed as necessary’, unless providing open access would in particular: a) be against the Party’s, including its Affiliated Entities, legitimate interests, including regarding commercial exploitation, or b) be contrary to any other constraints, in particular the EU competitive interests or the Parties’, including their Affiliated Entities, obligations under this Agreement; if open access is not provided (to some or all data), this must be justified in the Data Management Plan. - provide information via the repository about any research output or any other tools and instruments needed to re-use or validate the data. - provide and deposit metadata for all deposited Data in line with the FAIR principles, in machine-actionable format, using methods, procedures and tools specified in the Data Management Plan. Metadata should follow a standardised format, in line with community standards, and provide rich information on the Data, at least about the following: datasets (description, date of deposit, author(s), venue and embargo); Horizon Europe or Euratom funding; grant project name, acronym and number; licensing terms; persistent identifiers for the dataset, the authors involved in the action, and, if possible, for their organisations and the grant. Where applicable, the metadata must include persistent identifiers for related publications and other research outputs. The metadata must be open under a Creative Common Public Domain Dedication (CC 0) or equivalent (to the extent legitimate interests or constraints are safeguarded), Each Party, including its Affiliated Entities, is responsible for the assurance of quality, accuracy, and integrity and control of its Data, using where applicable methods, procedures and tools provided for that purpose by the Partnership and/or specified in the Data Management Plan. 8.6. Dissemination For the avoidance of doubt, the confidentiality obligations set out in Section 10 apply to all dissemination activities described in this Section 8.6 as far as Confidential Information is involved. 8.6.1 Dissemination of own (including jointly owned) Results Dissemination During the Project and for a period of 1 year after the end of the Project, the dissemination of own Results by one or several Parties, including their Affiliated Entities, referring but not restricted to publications and 36 THCS Consortium Agreement, version 0.4, 25/01/2023 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, including their Affiliated Entities, at least 21 calendar days before the publication, together with sufficient information on the Results it will disseminate. 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(ies), including its/their Affiliated Entities, proposing the dissemination within 15 calendar days after receipt of the notice. If no objection is made within the time limit stated above, the publication is permitted. Objections to dissemination An objection is justified if: a) the protection of the objecting Party's, including its Affiliated Entities, Results or Background would be adversely affected, or b) the objecting Party's, including its Affiliated Entities, 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, including its Affiliated Entities. The objection has to include a precise request for necessary modifications. If an objection has been raised, the involved Parties, including their Affiliated Entities, 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, including its Affiliated Entities, shall not unreasonably continue the opposition if appropriate measures are taken following the discussion. Open access The Parties, including their Affiliated Entities, must ensure open access to peer-reviewed scientific publications relating to their Results in accordance with the Grant Agreement. In particular, they must ensure that: - at the latest at the time of publication, a machine-readable electronic copy of the published version, or the final peer-reviewed manuscript accepted for publication, is deposited in a trusted repository for scientific publications - immediate open access is provided to the deposited publication via the repository, under the latest available version of the Creative Commons Attribution International Public License (CC BY) or a license with equivalent rights; for monographs and other long-text formats, the license may exclude commercial uses and derivative works (e.g. CC BY-NC, CC BY-ND) and - information is given via the repository about any research output or any other tools and instruments needed to validate the conclusions of the scientific publication. The Parties, including their Affiliated Entities, (or authors) must retain sufficient intellectual property rights to comply with the open access requirements. Metadata of deposited publications must be open under a Creative Common Public Domain Dedication (CC 0) or equivalent, in line with the FAIR principles (in particular machine-actionable) and provide information at least about the following: publication (author(s), title, date of publication, publication venue); Horizon Europe or Euratom funding; funding from the national government (if applicable); grant project name, acronym and number; licensing terms; persistent identifiers for the publication, the authors involved in the action and, if possible, for their organisations and the grant. Where applicable, the metadata must include persistent identifiers for any research output or any other tools and instruments needed to validate the conclusions of the publication. Authors should ensure open access that grants online access free of charge for any user. Only publication fees in full open access venues for peer-reviewed scientific publications are eligible for reimbursement. Acknowledgment of EU support Unless otherwise agreed with the granting authority, communication activities of the Parties, including their Affiliated Entities, related to the action (including media relations, conferences, seminars, information material, such as brochures, leaflets, posters, presentations, etc., in electronic form, via traditional or social media, etc.), 37 THCS Consortium Agreement, version 0.4, 25/01/2023 dissemination activities and any infrastructure, equipment, vehicles, supplies or major result funded by the grant must acknowledge EU support and display the European flag (emblem) and funding statement. The emblem must remain distinct and separate and cannot be modified by adding other visual marks, brands or text. Any communication or dissemination activity related to the action must use factually accurate information. Moreover, it must indicate the following disclaimer (translated into local languages where appropriate): “Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or [name of the granting authority]. Neither the European Union nor the granting authority can be held responsible for them.” Acknowledgment of further support in the case of Associated Partners Acknowledgment of further support e.g. by national funding agencies or ministries needs to be acknowledged as laid down in the respective agreements. This applies to any communication or dissemination related to the action involving Participants receiving such support. Moreover, it must indicate the following disclaimer: “Also funded by the [name of the additional funding organisation]. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect the official views of the [respective funding agency].” 8.6.2 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. Parties shall ensure that this obligation is extended to their Affiliated Entities. 8.6.3 Cooperation obligations The Parties, including their Affiliated Entities, undertake to cooperate to allow the timely submission, examination, publication and, presentation 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. 8.6.4 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, including their Affiliated Entities, or any of their logos or trademarks without their prior written approval. 9. Access Rights 9.1. Background included 9.1.1. Background included In Attachment 1, the Parties have identified and agreed on the Background for the Project 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. 9.1.2. Adding or modifying Background Any Parties, including their Affiliated Entities, may add further own Background to Attachment 1 during THCS by written notice to the Coordinator, who will inform the General Assembly and update Attachment 1. However, approval of the General Assembly is needed should a Party, including its Affiliated Entities, wish to modify or withdraw its Background in Attachment 1. For the sake of clarity, should a Background be withdrawn, unless decided otherwise by the General Assembly, after discussion of the reasons for the withdrawal, the Access Rights related to such Background already granted shall remain. Any possibility to further Access Rights to such withdrawn Background shall not be possible to request after the withdrawal. 9.1.3. Ownership of Background The Parties, including their Affiliated Entities, must give each other access to the Background identified as needed for implementing the action, subject to any specific rules in Annex 5 of the Grant Agreement. 38 THCS Consortium Agreement, version 0.4, 25/01/2023 If Background is subject to rights of a Third Party, the Participant concerned must ensure that it is able to comply with its obligations under the Consortium Agreement. Background held by a Party, including its Affiliated Entities, will remain the property of that Party, regardless of the property rights claimed with respect to Results developed in THCS, and notwithstanding the use of such Background to develop Results in THCS. For the sake of clarity, each Party, including its Affiliated Entities, shall list its Background related to THCS before the start of THCS in Attachment 1 of this Consortium Agreement, and communicate additional Background during the execution of THCS in writing to the Coordinator for subsequent inclusion in an update of Attachment 1. 9.2. General Principles 9.2.1. Implementation of the tasks Each Party, including its Affiliated Entities, shall implement its tasks in accordance with the Description of Action and Annual Work Plan and shall bear sole responsibility for ensuring that its acts within THCS do not knowingly infringe other Parties, including their Affiliated Entities, property rights. All Access Rights shall be subject to applicable laws and regulations and, in the case of personal data included in the Results or Data, subject to the applicable ethics approvals and, if and where required, the informed consents and/or an additional agreement in accordance with Section 4.4. 9.2.2. Sublicenses Any Access Rights granted expressly exclude any rights to sublicense to Third Parties unless expressly stated otherwise. 9.2.3. Administrative transfer costs Access Rights shall be free of any administrative transfer costs. 9.2.4. Granting Access Rights Access Rights are granted on a non-exclusive basis. 9.2.5. Use of Results and Background Results and Background shall be used only for the purposes for which Access Rights to it have been granted. 9.2.6. Requests for Access Rights 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, including its Affiliated Entities, must show that the Access Rights are needed. 9.2.7. Extending obligations to Affiliated Entities, Represented Associated Partners and other Third Parties Parties shall ensure in their contracts with their Affiliated Entities and other Third Parties that the obligations of the present section are extended to such entities. 9.2.8. Defaulting Party If a Party, including its Affiliated Entities, defaults on its obligations, the General Assembly may agree that this Participant no longer has Access Rights. 9.2.9. Access Rights for implementation Without prejudice to Article 9.2.6, Access Rights to Results and Background Needed for the performance of the own work of a Party, including its Affiliated Entities, under THCS shall be granted - on a royalty-free basis - unless otherwise agreed for Background in Attachment 1. 9.2.10. Access Rights for Exploitation The Parties, including their Affiliated Entities, must grant each other access — under fair and reasonable 39 THCS Consortium Agreement, version 0.4, 25/01/2023 conditions — to Background and Results needed for exploiting their Results, unless the Party that holds the Background has informed the other Parties, including their Affiliated Entities, in Attachment 1 that access to its Background is subject to restrictions and unless there are specific conditions regarding the Access Rights to Results. Requests for access must be made — unless agreed otherwise in writing — up to one year after the end of the action Access Rights to Results for non-commercial research activities and for teaching activities shall be granted on a royalty-free basis. 9.3. 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, including its Affiliated Entities, and subject to such terms and conditions as may be agreed between the owning and receiving Parties, including their Affiliated Entities. 9.4. Access Rights for Parties entering or leaving the consortium 9.4.1. 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 same conditions as when applying for Access Rights to Background. New Parties will have to give Access Rights to other Parties, based on the conditions of the Consortium Agreement, and complete Attachment 1. 9.4.2. Parties leaving the consortium Defaulting Party Access Rights granted to a Defaulting Partyand such Participant’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 Section 9.2.10. Access Rights to be granted by any leaving Party Any Party leaving THCS 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 THCS. However, following a hearing amongst the remaining Parties, the General Assembly may decide that such Access Rights will not be necessary. 9.5. Specific Provisions for Access Rights to Software For the avoidance of doubt, the general provisions for Access Rights provided for in this Section 9 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. 10. Non-disclosure of information 10.1. Confidential information Parties, including their Affiliated Entities, shall not divulge to Third Parties any confidential information that they have received for which confidential treatment has been requested and is justified, unless legally obliged. For the avoidance of doubt, Associated Partners acknowledge and consent to be bound by obligations under Article 13 (confidentiality and security) of the Grant Agreement, the specific rules on confidentiality and security 40 THCS Consortium Agreement, version 0.4, 25/01/2023 set out in Annex 5 and all provisions included in this section, in the same way that they apply to Beneficiaries. All information in whatever form or mode of communication, which is disclosed by a Party, including its Affiliated Entities, (the “disclosing Party”) to any other Party, including its Affiliated Entities, (the “recipient Party”) in connection with THCS during its implementation and which has been explicitly marked as “confidential” at the time of disclosure, or when disclosed orally has been identified as confidential at the time of disclosure and has been confirmed and designated in writing within 15 calendar days from oral disclosure at the latest as confidential information by the “disclosing Party, is “confidential information”. 10.2. Confidentiality obligations Each “recipient Party” hereby undertakes in addition and without prejudice to any commitment on non- disclosure under the Grand Agreement, for a period of 5 years after the end of THCS: - not to use confidential information otherwise than for the purpose for which it was disclosed; - 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 Party” 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 a “recipient Party” including all copies thereof and to delete all information stored in a machine-readable form to the extent practically possible. Each “recipient Party” 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 comply with the confidentiality obligations herein contained with respect to such copy for the confidentiality period agreed above (5 years after the end of THCS). Each “recipient Party” shall be responsible for the fulfilment of the above obligations on the part of their employees or Third Parties involved in THCS and shall ensure that they remain so obliged, as far as legally possible, during and after the end of THCS and/or after the termination of the contractual relationship with the employee or Third Parties. 10.3. Exceptions The above shall not apply for disclosure or use of confidential information, if and in so far as the “recipient Parties” can show that: - the confidential information has become or becomes publicly available by means other than a breach of the “recipient Party’s” confidentiality obligations; - the “disclosing Party” subsequently informs the “recipient Party” that the confidential information is no longer confidential; - the confidential information is communicated to the “recipient Party” without any obligation of confidentiality by a Third Party who is to the best knowledge of the “recipient Party” 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 Participant” prior to disclosure, or - the “recipient Party” 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 provision of Sections 10.6 and 10.7 hereunder. 10.4. Reasonable care The “recipient Party” shall apply the same degree of care with regard to the confidential information disclosed within the scope of THCS as with its own confidential and/or proprietary information, but in no case less than reasonable care. 10.5. Unauthorised disclosure Each Party, including its Affiliated Entities, shall promptly advise the other “disclosing Party” in writing of any unauthorised disclosure, misappropriation or misuse of confidential information after it becomes aware of such unauthorised disclosure, misappropriation or misuse. 41 THCS Consortium Agreement, version 0.4, 25/01/2023 10.6. Notifications If any Party, including its Affiliated Entities, 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: - notify the Coordinator, - notify the “disclosing Party” immediately, and - comply with the “disclosing Party’s” reasonable instructions to protect the confidentiality of the information. 10.7. Extending obligations to Affiliated Entities and other Third Parties Parties shall ensure in their contracts with their Affiliated Entities and other Third Parties that the obligations of the present section are extended to such entities. 10.8. Confidentiality agreements If an entity/a person which is not a THCS Consortium Body Participant requires and is given access to THCS confidential information, a confidentiality agreement shall be signed by the Coordinator (who represents the THCS Consortium), and the entity/the person. It shall be concluded before any confidential information on THCS will be exchanged, and its terms and conditions shall be no less strict than those of this Consortium Agreement. The Parties will be notified of such a request no later than 5 working days after its receipt and will be given a 7 working days’ notice to object to the request. The Parties will be notified immediately if such a Third Party is granted access and will at the same time be given access to the Confidentiality Agreement. This does not apply if the information has to be compulsorily disclosed. 10.9. Code of conduct The Parties. including their Affiliated Entities, agree to follow the code of conduct (core principles) concerning the Representation of THCS and THCS external public communication specified below and to operate at the highest standards of ethics and transparency. Members of THCS Consortium Bodies do not act on an individual basis; they sit in an institutional capacity, representing their country/region and Affiliated Entities views and the higher authorities nominating them are responsible for ensuring that they do not have conflicts of interest. The following core principles have to be respected: - Ethics: the Parties, including their Affiliated Entities, commit to meet the highest ethical standards. In particular, they shall accomplish their functions in THCS with diligence, integrity, honesty, fairness, accountability and discretion, taking into account the public interest. They shall act impartially, avoiding any situation liable to give rise to conflicts of interest (including potentially leveraged gifts and hospitality). - Representation of THCS: Keeping in mind the public character of their function as THCS Consortium Body members, they shall conduct themselves in a way that maintains and promotes the public's trust in THCS’s governance structure and refrain from any practice detrimental to the reputation and interests neither of the Consortium Body nor of THCS. - External public communication: If communicating on a matter on which the Consortium Body has taken a position, each Member shall represent the views of the Consortium Body respecting the intended collegial approach sought in THCS. Members are free to give their own personal view but shall make clear that this does not necessarily represent the view of the Consortium Body. - Confidentiality: the Parties, including their Affiliated Entities, are bound to the confidentiality obligations stated above in articles 10.1, 10.2 and 10.3. - Conflict of interest: For the avoidance of doubt, Associated Partners acknowledge and consent to be bound by obligations under Article 12 (conflict of interest) of the Grant Agreement and all provisions included in this section, in the same way that they apply to Beneficiaries. 11. Miscellaneous 11.1. Attachments, inconsistencies and severability This Consortium Agreement consists of this core text and: - Attachment 1 (Background included) - Attachment 2 (Accession document) 42 THCS Consortium Agreement, version 0.4, 25/01/2023 - Attachment 3 (List of Affiliated Entities) - Attachment 4: (Non-Disclosure Agreement2) 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, including their Affiliated Entities, shall be entitled to request that a valid and practicable provision be negotiated that fulfils the purpose of the original provision. 11.2. No representation, partnership or agency Except as otherwise provided in this Consortium Agreement, no Party, including its Affiliated Entities, shall be entitled to act or to make legally binding declarations on behalf of any other Party, including its Affiliated Entities, 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 or their Affiliated Entities or other subcontractors. 11.3. Formal and written notices and other communication Any notice to be given under this Consortium Agreement shall be addressed in writing to the addresses and recipients as listed in the most current address list kept by the Coordinator. Any change of persons or contact details shall be notified immediately by the respective Party, or Affiliated Entity, to the Coordinator. The address list shall be accessible to all Parties, including their Affiliated Entities. Formal notice: If it is required in this Consortium Agreement that a formal notice, consent or approval shall be given (for section 4.2 Breach, 9.2.8 Defaulting Party and 11.4 Assignment), such notice shall be signed by an authorised representative of a Party and shall either be served personally or sent by postal mail with recorded 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. Other communication: Other communication between the Parties may also be effected by other means such as e- mail with acknowledgement of receipt, which fulfils the conditions of written form. 11.4. Assignment Except as set out in Section 8.5 no rights or obligations of the Parties, including their Affiliated Entities, 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 (as defined in section 12.3). 11.5. Mandatory national law Nothing in this Consortium Agreement shall be deemed to require a Party, including its Affiliated Entities, to breach any mandatory statutory law under which the Party, including its Affiliated Entities, is operating. 11.6. Language This Consortium Agreement is drawn up in English, which language shall govern all documents, notices, meetings, arbitral proceedings and processes relative thereto. 11.7. Applicable law This Consortium Agreement shall be construed in accordance with and governed by the laws of Belgium excluding its conflict of law provisions. 2 Only for use by the Coordinator - IT MOH – according to the provisions set forth in Articles 6 and 8 of the Consortium Agreement 43 THCS Consortium Agreement, version 0.4, 25/01/2023 11.8. Settlement of disputes The Parties, including their Affiliated Entities, shall endeavor to settle their disputes amicably. The Parties agree that any dispute, controversy or claim arising under, out of or relating to this Consortium Agreement and any subsequent amendments of this Consortium Agreement, including, without limitation, its formation, validity, binding effect, interpretation, performance, breach or termination (a "Dispute") which cannot be solved amicably, shall first be submitted by the Parties to the Work Package Leader concerned. The Coordination Team may be involved in the conflict resolution if requested by the Work Package Leader. If the Coordinator is involved in the conflict, another Party selected jointly by the General Assembly should take over this role. All disputes arising out of or in connection with this Consortium Agreement, which cannot be solved amicably through the above mechanism, shall be finally settled by the courts of Brussels. 12. 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. ----------------------- PART LEFT INTENTIONNALLY IN BLANK ------------------------- 44 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTERO DELLA SALUTE (IT MOH) Signature(s) Name(s) Title(s) Date 45 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTERO DELL’UNIVERSITA E DELLA RICERCA (MUR) Signature(s) Name(s) Title(s) Date 46 THCS Consortium Agreement, version 0.4, 25/01/2023 REGIONE TOSCANA (RT) Signature(s) Name(s) Title(s) Date 47 THCS Consortium Agreement, version 0.4, 25/01/2023 UNIVERSITA CATTOLICA DEL SACRO CUORE (UCSC) Signature(s) Name(s) Title(s) Date 48 THCS Consortium Agreement, version 0.4, 25/01/2023 OSTERREICHISCHE FORSCHUNGSFORDERUNGSGESELLSCHAFT MBH (FFG) Signature(s) Name(s) Title(s) Date 49 THCS Consortium Agreement, version 0.4, 25/01/2023 BUNDESMINISTERIUM FUER KLIMASCHUTZ, UMWELT, ENERGIE, MOBILITAET, INNOVATION UND TECHNOLOGIE (BMK) Signature(s) Name(s) Title(s) Date 50 THCS Consortium Agreement, version 0.4, 25/01/2023 FONDS INNOVEREN EN ONDERNEMEN (FIO) Signature(s) Name(s) Title(s) Date 51 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTERE DE LA COMMUNAUTE FRANÇAISE DE BELGIQUE (FWB) Signature(s) Name(s) Title(s) Date 52 THCS Consortium Agreement, version 0.4, 25/01/2023 FONDS DE LA RECHERCHE SCIENTIFIQUE- FNRS (F.R.S.- FNRS) Signature(s) Name(s) Title(s) Date 53 THCS Consortium Agreement, version 0.4, 25/01/2023 SUOMEN AKATEMIA (AKA) Signature(s) Name(s) Title(s) Date 54 THCS Consortium Agreement, version 0.4, 25/01/2023 TAMPEREEN KORKEAKOULUSAATIO SR (TAU) Signature(s) Name(s) Title(s) Date 55 THCS Consortium Agreement, version 0.4, 25/01/2023 TERVEYDEN JA HYVINVOINNIN LAITOS (THL) Signature(s) Name(s) Title(s) Date 56 THCS Consortium Agreement, version 0.4, 25/01/2023 AGENCE NATIONALE DE LA RECHERCHE (ANR) Signature(s) Name(s) Title(s) Date 57 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTERE DE LA SANTE ET DE LA PREVENTION (FR MOH) Signature(s) Name(s) Title(s) Date 58 THCS Consortium Agreement, version 0.4, 25/01/2023 GENIKI GRAMMATIA EREVNAS KAI KAINOTOMIAS (GSRI) Signature(s) Name(s) Title(s) Date 59 THCS Consortium Agreement, version 0.4, 25/01/2023 RANNSOKNAMIDSTOD ISLANDS (RANNIS) Signature(s) Name(s) Title(s) Date 60 THCS Consortium Agreement, version 0.4, 25/01/2023 THE HEALTH RESEARCH BOARD (HRB) Signature(s) Name(s) Title(s) Date 61 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTRY OF HEALTH (CSO MOH) Signature(s) Name(s) Title(s) Date 62 THCS Consortium Agreement, version 0.4, 25/01/2023 LATVIJAS ZINATNES PADOME (LZP) Signature(s) Name(s) Title(s) Date 63 THCS Consortium Agreement, version 0.4, 25/01/2023 LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA (SAM) Signature(s) Name(s) Title(s) Date 64 THCS Consortium Agreement, version 0.4, 25/01/2023 LIETUVOS MOKSLO TARYBA (LMT) Signature(s) Name(s) Title(s) Date 65 THCS Consortium Agreement, version 0.4, 25/01/2023 NEDERLANDSE ORGANISATIE VOOR WETENSCHAPPELIJK ONDERZOEK (NWO) Signature(s) Name(s) Title(s) Date 66 THCS Consortium Agreement, version 0.4, 25/01/2023 ZORGONDERZOEK NEDERLAND ZON (ZonMw) Signature(s) Name(s) Title(s) Date 67 THCS Consortium Agreement, version 0.4, 25/01/2023 NORGES FORSKNINGSRAD (RCN) Signature(s) Name(s) Title(s) Date 68 THCS Consortium Agreement, version 0.4, 25/01/2023 NARODOWE CENTRUM BADAN I ROZWOJU (NCBR) Signature(s) Name(s) Title(s) Date 69 THCS Consortium Agreement, version 0.4, 25/01/2023 AICIB - AGÊNCIA DE INVESTIGAÇÃO CLÍNICA E INOVAÇÃO BIOMÉDICA (AICIB) Signature(s) Name(s) Title(s) Date 70 THCS Consortium Agreement, version 0.4, 25/01/2023 FUNDACAO PARA A CIENCIA E A TECNOLOGIA (FCT) Signature(s) Name(s) Title(s) Date 71 THCS Consortium Agreement, version 0.4, 25/01/2023 COMISSÃO DE COORDENACAO E DESENVOLVIMENTO REGIONAL DO CENTRO (CCDRC) Signature(s) Name(s) Title(s) Date 72 THCS Consortium Agreement, version 0.4, 25/01/2023 UNIVERSITATEA BABES BOLYAI (UBB) Signature(s) Name(s) Title(s) Date 73 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTERSTVO ZDRAVOTNICTVA SLOVENSKEJ REPUBLIKY (MOH SR) Signature(s) Name(s) Title(s) Date 74 THCS Consortium Agreement, version 0.4, 25/01/2023 SLUZBA VLADE REPUBLIKE SLOVENIJE ZA DIGITALNO PREOBRAZBO (ODT) Signature(s) Name(s) Title(s) Date 75 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTRSTVO ZA ZDRAVJE (SI MOH) Signature(s) Name(s) Title(s) Date 76 THCS Consortium Agreement, version 0.4, 25/01/2023 AGENCIA ESTATAL DE INVESTIGACION (AEI) Signature(s) Name(s) Title(s) Date 77 THCS Consortium Agreement, version 0.4, 25/01/2023 FUNDACION INSTITUTO DE INVESTIGACION MARQUES DE VALDECILLA (IDIVAL) Signature(s) Name(s) Title(s) Date 78 THCS Consortium Agreement, version 0.4, 25/01/2023 CONSEJERÍA DE SALUD Y CONSUMO DE LA JUNTA DE ANDALUCÍA (CSCJA) Signature(s) Name(s) Title(s) Date 79 THCS Consortium Agreement, version 0.4, 25/01/2023 INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD (IACS) Signature(s) Name(s) Title(s) Date 80 THCS Consortium Agreement, version 0.4, 25/01/2023 FORSKINGSRADET FOR HALSA ARBETSLIVOCH VALFARD (FORTE) Signature(s) Name(s) Title(s) Date 81 THCS Consortium Agreement, version 0.4, 25/01/2023 VERKET FOR INNOVATIONSSYSTEM (VINNOVA) Signature(s) Name(s) Title(s) Date 82 THCS Consortium Agreement, version 0.4, 25/01/2023 FUNDACION PARA EL FOMENTO EN ASTURIAS DE LA INVESTIGACION CIENTIFICA APLICADA Y TECNOLOGIA (FICYT) Signature(s) Name(s) Title(s) Date 83 THCS Consortium Agreement, version 0.4, 25/01/2023 AGENZIA REGIONALE PER LA SALUTE ED IL SOCIALE (ARESS) Signature(s) Name(s) Title(s) Date 84 THCS Consortium Agreement, version 0.4, 25/01/2023 INSTITUTO DE SALUD CARLOS III (ISCIII) Signature(s) Name(s) Title(s) Date 85 THCS Consortium Agreement, version 0.4, 25/01/2023 MINISTRY FOR EDUCATION, SPORT, YOUTH, RESEARCH AND INNOVATION (MEYR) Signature(s) Name(s) Title(s) Date 86 THCS Consortium Agreement, version 0.4, 25/01/2023 STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG (NIVEL) Signature(s) Name(s) Title(s) Date 87 THCS Consortium Agreement, version 0.4, 25/01/2023 SOTSIAALMINISTEERIUM (MSA) Siia pane oma allkiri käsitsi. Maarjo Mändmaa Secretary General Date 88 THCS Consortium Agreement, version 0.4, 25/01/2023 SIHTASUTUS EESTI TEADUSAGENTUUR (ETAg) Signature(s) Name(s) Title(s) Date 89 THCS Consortium Agreement, version 0.4, 25/01/2023 INNOVATIONSFONDEN (IFD) Signature(s) Name(s) Title(s) Date 90 THCS Consortium Agreement, version 0.4, 25/01/2023 DEPARTAMENTO DE SALUD GOBIERNO VASCO (DPTO SALUD) Signature(s) Name(s) Title(s) Date 91 THCS Consortium Agreement, version 0.4, 25/01/2023 ASOCIACIÓN INSTITUTO DE INVESTIGACIÓN EN SERVICIOS DE SALUD-KRONIKGUNE (KRONIKGUNE) Signature(s) Name(s) Title(s) Date 92 THCS Consortium Agreement, version 0.4, 25/01/2023 UNITATEA EXECUTIVA PENTRU FINANTAREA INVATAMANTULUI SUPERIOR A CERCETARII DEZVOLTARII SI INOVARII (UEFISCDI) Signature(s) Name(s) Title(s) Date 93 THCS Consortium Agreement, version 0.4, 25/01/2023 FEDERAL OFFICE OF PUBLIC HEALTH (FOPH) Signature(s) Name(s) Title(s) Date 94 THCS Consortium Agreement, version 0.4, 25/01/2023 SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG (INNOSUISSE) Signature(s) Name(s) Title(s) Date 95 THCS Consortium Agreement, version 0.4, 25/01/2023 SCHWEIZERISCHER NATIONALFONDS ZUR FORDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG (SNSF) Signature(s) Name(s) Title(s) Date 96 THCS Consortium Agreement, version 0.4, 25/01/2023 SCOTTISH GOVERNMENT (SG) Signature(s) Name(s) Title(s) Date 97 THCS Consortium Agreement, version 0.4, 25/01/2023 THE NHS CONFEDERATION (NHSC) Signature(s) Name(s) Title(s) Date 98 THCS Consortium Agreement, version 0.4, 25/01/2023 AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ) Signature(s) Name(s) Title(s) Date 99 THCS Consortium Agreement, version 0.4, 25/01/2023 HEALTH DATA RESEARCH UK (HDR UK) Signature(s) Name(s) Title(s) Date 100 THCS Consortium Agreement, version 0.4, 25/01/2023 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 the Project. This is the purpose of this attachment. As to MINISTERO DELLA SALUTE is agreed between the Parties that, to the best of their knowledge, the following Background is hereby identified and agreed upon for the Project. Specific limitations and/or conditions, shall be as mentioned hereunder: Describe Specific restrictions and/or conditions Specific restrictions and/or Background for implementation (Article 16.4 Grant conditions for Exploitation (Article Agreement and its Annex 5, Section 16.4 Grant Agreement and its “Access rights to results and Annex 5, Section “Access rights to background”, sub-section “Access results and background”, sub- rights to background and results for section “Access rights for implementing the Action”) exploiting the results”) Electronic Proposal Access Rights to the Source and Object Subject to the license agreement and Submission Code of the Electronic Proposal Submission the license conditions of Consortium System System are expressly excluded. of Bioengineering and Informatics Copyright owner is the Consortium of (CBIM). Bioengineering and Informatics (CBIM). Therefore, usage beyond access to the Electronic Proposal Submission System as a user would be subject to a license granted by the Consortium of Bioengineering and Informatics (CBIM). This represents the status at the time of signature of this Consortium Agreement. As to: - MINISTERO DELL’UNIVERSITA E DELLA RICERCA - REGIONE TOSCANA - UNIVERSITA CATTOLICA DEL SACRO CUORE - OSTERREICHISCHE FORSCHUNGSFORDERUNGSGESELLSCHAFT MBH - BUNDESMINISTERIUM FUER KLIMASCHUTZ, UMWELT, ENERGIE, MOBILITAET, INNOVATION UND TECHNOLOGIE - FONDS INNOVEREN EN ONDERNEMEN - MINISTERE DE LA COMMUNAUTE FRANÇAISE DE BELGIQUE - FONDS DE LA RECHERCHE SCIENTIFIQUE- FNRS - SUOMEN AKATEMIA - TAMPEREEN KORKEAKOULUSAATIO SR - TERVEYDEN JA HYVINVOINNIN LAITOS - AGENCE NATIONALE DE LA RECHERCHE - MINISTERE DE LA SANTE ET DE LA PREVENTION - GENIKI GRAMMATIA EREVNAS KAI KAINOTOMIAS - RANNSOKNAMIDSTOD ISLANDS - THE HEALTH RESEARCH BOARD - MINISTRY OF HEALTH - LATVIJAS ZINATNES PADOME 101 THCS Consortium Agreement, version 0.4, 25/01/2023 - LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA - LIETUVOS MOKSLO TARYBA - NEDERLANDSE ORGANISATIE VOOR WETENSCHAPPELIJK ONDERZOEK - ZORGONDERZOEK NEDERLAND ZON - NORGES FORSKNINGSRAD - NARODOWE CENTRUM BADAN I ROZWOJU - AICIB - AGÊNCIA DE INVESTIGAÇÃO CLÍNICA E INOVAÇÃO BIOMÉDICA - FUNDACAO PARA A CIENCIA E A TECNOLOGIA - COMISSÃO DE COORDENACAO E DESENVOLVIMENTO REGIONAL DO CENTRO - UNIVERSITATEA BABES BOLYAI - MINISTERSTVO ZDRAVOTNICTVA SLOVENSKEJ REPUBLIKY - SLUZBA VLADE REPUBLIKE SLOVENIJE ZA DIGITALNO PREOBRAZBO - MINISTRSTVO ZA ZDRAVJE - AGENCIA ESTATAL DE INVESTIGACION - FUNDACION INSTITUTO DE INVESTIGACION MARQUES DE VALDECILLA - CONSEJERÍA DE SALUD Y CONSUMO DE LA JUNTA DE ANDALUCÍA - INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD - FORSKINGSRADET FOR HALSA ARBETSLIVOCH VALFARD - VERKET FOR INNOVATIONSSYSTEM - FUNDACION PARA EL FOMENTO EN ASTURIAS DE LA INVESTIGACION CIENTIFICA APLICADA Y TECNOLOGIA - AGENZIA REGIONALE PER LA SALUTE ED IL SOCIALE - INSTITUTO DE SALUD CARLOS III - MINISTRY FOR EDUCATION, SPORT, YOUTH, RESEARCH AND INNOVATION - STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG - SOTSIAALMINISTEERIUM - SIHTASUTUS EESTI TEADUSAGENTUUR - INNOVATIONSFONDEN - DEPARTAMENTO DE SALUD GOBIERNO VASCO - ASOCIACIÓN INSTITUTO DE INVESTIGACIÓN EN SERVICIOS DE SALUD-KRONIKGUNE - UNITATEA EXECUTIVA PENTRU FINANTAREA INVATAMANTULUI SUPERIOR A CERCETARII DEZVOLTARII SI INOVARII - FEDERAL OFFICE OF PUBLIC HEALTH - SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG - SCHWEIZERISCHER NATIONALFONDS ZUR FORDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG - SCOTTISH GOVERNMENT - THE NHS CONFEDERATION - AGENCY FOR HEALTHCARE RESEARCH AND QUALITY - HEALTH DATA RESEARCH UK it is agreed between the Parties that, to the best of their knowledge no data, know-how or information of - MINISTERO DELL’UNIVERSITA E DELLA RICERCA - REGIONE TOSCANA - UNIVERSITA CATTOLICA DEL SACRO CUORE - OSTERREICHISCHE FORSCHUNGSFORDERUNGSGESELLSCHAFT MBH 102 THCS Consortium Agreement, version 0.4, 25/01/2023 - BUNDESMINISTERIUM FUER KLIMASCHUTZ, UMWELT, ENERGIE, MOBILITAET, INNOVATION UND TECHNOLOGIE - FONDS INNOVEREN EN ONDERNEMEN - MINISTERE DE LA COMMUNAUTE FRANÇAISE DE BELGIQUE - FONDS DE LA RECHERCHE SCIENTIFIQUE- FNRS - SUOMEN AKATEMIA - TAMPEREEN KORKEAKOULUSAATIO SR - TERVEYDEN JA HYVINVOINNIN LAITOS - AGENCE NATIONALE DE LA RECHERCHE - MINISTERE DE LA SANTE ET DE LA PREVENTION - GENIKI GRAMMATIA EREVNAS KAI KAINOTOMIAS - RANNSOKNAMIDSTOD ISLANDS - THE HEALTH RESEARCH BOARD - MINISTRY OF HEALTH - LATVIJAS ZINATNES PADOME - LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA - LIETUVOS MOKSLO TARYBA - NEDERLANDSE ORGANISATIE VOOR WETENSCHAPPELIJK ONDERZOEK - ZORGONDERZOEK NEDERLAND ZON - NORGES FORSKNINGSRAD - NARODOWE CENTRUM BADAN I ROZWOJU - AICIB - AGÊNCIA DE INVESTIGAÇÃO CLÍNICA E INOVAÇÃO BIOMÉDICA - FUNDACAO PARA A CIENCIA E A TECNOLOGIA - COMISSÃO DE COORDENACAO E DESENVOLVIMENTO REGIONAL DO CENTRO - UNIVERSITATEA BABES BOLYAI - MINISTERSTVO ZDRAVOTNICTVA SLOVENSKEJ REPUBLIKY - SLUZBA VLADE REPUBLIKE SLOVENIJE ZA DIGITALNO PREOBRAZBO - MINISTRSTVO ZA ZDRAVJE - AGENCIA ESTATAL DE INVESTIGACION - FUNDACION INSTITUTO DE INVESTIGACION MARQUES DE VALDECILLA - CONSEJERÍA DE SALUD Y CONSUMO DE LA JUNTA DE ANDALUCÍA - INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD - FORSKINGSRADET FOR HALSA ARBETSLIVOCH VALFARD - VERKET FOR INNOVATIONSSYSTEM - FUNDACION PARA EL FOMENTO EN ASTURIAS DE LA INVESTIGACION CIENTIFICA APLICADA Y TECNOLOGIA - AGENZIA REGIONALE PER LA SALUTE ED IL SOCIALE - INSTITUTO DE SALUD CARLOS III - MINISTRY FOR EDUCATION, SPORT, YOUTH, RESEARCH AND INNOVATION - STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG - SOTSIAALMINISTEERIUM - SIHTASUTUS EESTI TEADUSAGENTUUR - INNOVATIONSFONDEN - DEPARTAMENTO DE SALUD GOBIERNO VASCO 103 THCS Consortium Agreement, version 0.4, 25/01/2023 - ASOCIACIÓN INSTITUTO DE INVESTIGACIÓN EN SERVICIOS DE SALUD-KRONIKGUNE - UNITATEA EXECUTIVA PENTRU FINANTAREA INVATAMANTULUI SUPERIOR A CERCETARII DEZVOLTARII SI INOVARII - FEDERAL OFFICE OF PUBLIC HEALTH - SCHWEIZERISCHE AGENTUR FUR INNOVATIONSFORDERUNG - SCHWEIZERISCHER NATIONALFONDS ZUR FORDERUNG DER WISSENSCHAFTLICHEN FORSCHUNG - SCOTTISH GOVERNMENT - THE NHS CONFEDERATION - AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ) - HEALTH DATA RESEARCH UK (HDR UK) is Needed by another Party for implementation of the Project (Article 16.1 and its Annex 5 Grant Agreement, Section “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, Section “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. 104 THCS Consortium Agreement, version 0.4, 25/01/2023 Attachment 2: Accession document ACCESSION of a new Party to THCS Consortium Agreement, version […, YYYY-MM-DD] [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]. MINISTERO DELLA SALUTE 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 and Place] [INSERT NAME OF THE NEW PARTY] Signature(s) Name(s) Title(s) [Date and Place] MINISTERO DELLA SALUTE Signature(s) Name(s) Title(s) 105 THCS Consortium Agreement, version 0.4, 25/01/2023 Attachment 3: List of Affiliated Entities For MINISTERO DELLA SALUTE (IT MOH), Italy Affiliated Entity 1: ISTITUTO SUPERIORE DI SANITA’ (ISS) Address: Viale Regina Elena n. 299 – 00161 Roma Affiliated Entity 2 AZIENDA ULSS N. 4 VENETO ORIENTALE (PROMIS) Address: Piazza De Gasperi n. 5 - 30027 San Donà di Piave (VE) For FONDS INNOVEREN EN ONDERNEMEN (FIO), Belgium Affiliated Entity 1: VLAAMSE GEWEST (VLAIO) Address: Avenue du Port n. 88 – 1000 Brussel For MINISTERE DES AFFAIRES SOCIALES ET DE LA SANTE (FR MOH), France Affiliated Entity 1: INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) Address: Rue de Tolbiac n. 101 – 75654 Paris For MINISTERSTVO ZDRAVOTNICTVA SLOVENSKEJ REPUBLIKYE (MOH SR), Slovakia Affiliated Entity 1: UNIVERSITY HOSPITAL MARTIN (UHM) Address: Kollárova n. 2 – 036 59 Martin For MINISTRSTVO ZA ZDRAVJE (SI MOH), Slovenia Affiliated Entity 1: NACIONALNI INSTITUT ZA JAVNO ZDRAVJE (NIJZ) Address: Trubarjeva Cesta n. 2 – 1000 Ljubljana For CONSEJERIA DE SALUD y CONSUMO DE LA JUNTA DE ANDALUCIA (CSCJA), Spain Affiliated Entity 1: FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD M.P. (FPS) Address: Avenida Americo Vespucio n. 15 Edif. S2 – 41092 Sevilla FOR DEPARTAMENTO DE SALUD GOBIERNO VASCO (DPTO SALUD), Spain Affiliated Entity 1 FUNDACIÓN VASCA DE INNOVACIÓN E INVESTIGACIÓN SANITARIAS (BIOEF) Address: Torre Bec, Azkue Kalea n. 1 – 48902 Barakaldo 106 THCS Consortium Agreement, version 0.4, 25/01/2023 Attachment 4: Non-Disclosure Agreement3 EUROPEAN PARTNERSHIP ON TRANSFORMING HEALTH AND CARE SYSTEMS CONFIDENTIAL DISCLOSURE AGREEMENT This confidentiality agreement (hereinafter "Confidentiality Agreement") is entered into between: A) MINISTERO DELLA SALUTE as Coordinator of the European Partnership on Transforming Health and Care Systems (the Disclosing Party), and B) _____________________________________ who has signed this Confidentiality Agreement in his capacity of appointed member of the Advisory Board “Innovators” of the European Partnership on Transforming Health and Care Systems (the Receiving Party). (Hereinafter also, each individually, Party, and jointly, Parties). 1. Purpose. In order to ensure a proper implementation of the European Partnership on Transforming Health and Care Systems (THCS) and of its activities, within the scope of the Advisory Board “Innovators” which is extensively outlined in the corresponding Terms of Reference that are attached to this Agreement, the Parties must exchange information of a confidential nature ("Confidential Information" as defined in Article 2 below) and would like to ensure that it remains confidential. Each Party may, as the Partnership progresses, provide technical and/or scientific information to the other Party and they may want this information to be treated as confidential under the terms and conditions set out below, 2. "Confidential Information". "Confidential Information" includes any information, and/or documentation, and/or material and/or instrument and/or research and development program provided by either Party, or furthermore acquired by one of the Parties, directly or indirectly, by any means (for example, paper copies or electronic form), clearly declared as "confidential", "proprietary", or similar phraseology that indicates the privileged and/or confidential nature of the information. The confidential nature of the information may also regard studies and analyses prepared by one Party, on the basis of Confidential Information provided by the other Party. All oral information must be treated as confidential, as must any information regarding any third party. Information that does not qualify as Confidential Information includes information that: (I) was in the public domain prior to the transfer of the same information from one Party to the other or information that has become publicly available without violating this Confidentiality Agreement; (II) has become available after being published by one Party to the other for reasons not attributable to the receiving Party; (III) was available to the receiving Party prior to the communication, as can be demonstrated by the date of communication on previous documents; (IV) is legitimately obtained by one of the Parties from a third party who has no obligation of confidentiality; (V) was developed independently by the receiving Party without use or reference to information from the communicating Party, as can be demonstrated by documents and other evidence in possession of the receiving Party; or (VI) was delivered by one Party to a Judicial or Administrative Authority in compliance with laws or regulations, or as required by the same Judicial or Administrative Authority, in which case the receiving Party shall promptly notify the communicating Party, in writing, prior to such disclosure or, if this is not possible, immediately following the disclosure of the information, as well as the method of disclosure in such a way as to limit its dissemination as much as possible. 3. Non-use and non-disclosure. Each Party agrees not to use the Confidential Information for purposes other than those allowed in paragraph 1 above, either directly and/or indirectly. 3 Only for use of the Coordinator according to the provisions set forth in Articles 6 and 8 of the Consortium Agreement 107 THCS Consortium Agreement, version 0.4, 25/01/2023 Each Party agrees to not disclose Confidential Information to third parties or employees and/or different types of third-party coworkers, except when these third parties or their employees and/or different types of third-party co-workers are directly involved in the analysis of the project or as consultants to a Party. If it is mandatory that a third party be involved in carrying out any of the activities listed above in paragraph 1, the Party requesting this involvement must require these third parties to sign a confidentiality agreement with content that reflects the obligations of and is similar to this Confidentiality Agreement. Employees and/or co-workers of either Party and/or employees and/or co-workers of audit companies responsible for auditing financial statements of either Party are not considered third parties. The receiving Party has the right to disclose Confidential Information to its consultants. If there is unlawful disclosure of Confidential Information by these consultants, or by members of the governing bodies of each of the Parties, the liability for damages will be the responsibility of the receiving Party. 4. Maintaining Confidentiality. Each Party will take reasonable measures to protect the confidentiality of and prevent the dissemination of Confidential Information received under the terms of this Confidentiality Agreement. When handling Confidential Information received from the other Party, each Party should use the same means they use for their own confidential documents and ensure that all persons who have access to the Confidential Information are bound to confidentiality. Each Party must assess, through normal standards of reason and diligence, which must be measured based on the nature and type of information processed and/or received, the methods used for the protection of the confidentiality of restricted and sensitive information. If this assessment reveals that the methods used for the protection of Confidential Information are inadequate for the nature and type of information received and processed, the Party will be required to take measures that, according to normal standards of reason and diligence, are sufficient to safeguard the confidentiality of the type of information received. Failure to do so will result in liability for all damages caused to the other Party, as a result of the disclosure of Confidential Information received by the other Party. 5. Limitations. Neither obligation nor commitment nor right, even of an additional pre-contractual nature, with respect to what is contained in this Confidentiality Agreement arises on either Party, as a result of signing this Confidentiality Agreement. Where each Party has the right to unilaterally terminate this Agreement at their own discretion, the ceasing Party continue to be required to respect the terms and conditions of this Confidentiality Agreement with respect to any Confidential Information acquired during execution of the activities described in paragraph 1 above for a period equal to 12 (twelve) months, effective from the date of signing of this Confidentiality Agreement. No additional obligation may arise from this Confidentiality Agreement for the Parties as a result of the termination of assignments related to THCS. 6. Invalidity. The declaration of nullity or invalidity of one or more provisions contained in this Confidentiality Agreement does not determine the invalidity or nullity of the Confidentiality Agreement as a whole or of the remaining provisions contained herein, which must be interpreted in such a way as to yield economic and substantial effects similar as much as possible to those arising from the original text of the Confidentiality Agreement. 7. Return of materials. All Confidential Information communicated by one Party to the other, in any material form, and all copies owned by the other Party, remain property of the communicating Party and must be returned or destroyed promptly upon written request from the communicating Party. Nevertheless, the obligation to preserve the confidentiality of the content as stated in the last part of paragraph 5 above remains binding. 8. Amendments. Any amendment to this Confidentiality Agreement must be made in writing and be approved by appropriate undersigning by both Parties. 9. Termination. The duration of this Confidentiality Agreement is of 84 months from the date of its undersigning by both Parties. 108 THCS Consortium Agreement, version 0.4, 25/01/2023 10. Remedies. The receiving Party acknowledges that every violation of the provisions contained in this Confidentiality Agreement may cause irreparable damage to the Disclosing Party, reserving the right to claim monetary reparation, and any other legal remedy provided for from time to time by current regulation. 11. Applicable Law and Jurisdiction. The Parties agree that this Agreement and all disputes arising hereunder shall be governed by the existing laws in Belgium. The Parties shall endeavor to amicably settle any disputes arising out of or in connection with the performance of this Agreement. If an amicable settlement cannot be reached, the parties may apply to the competent jurisdiction according to the above-mentioned principle. This document constitutes the complete agreement between the Parties with respect to Confidential Information. The Parties acknowledge and agree to the terms and conditions contained in this Confidentiality Agreement, as evidenced by the signatures appearing below. 109