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Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 EUROPEAN COMMISSION Directorate-General for Communications Networks, Content and Technology CNECT.H – Digital Society, Trust and Cybersecurity H.3 – eHealth, Well-Being and Ageing GRANT AGREEMENT Project 101194865 — B1MGplus PREAMBLE This Agreement (‘the Agreement’) is between the following parties: on the one part, the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and on the other part, 1. ‘the coordinator’: EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL), PIC 999988230, established in Meyerhofstrasse 1, HEIDELBERG 69117, Germany, and the following other beneficiaries, if they sign their ‘accession form’ (see Annex 3 and Article 40): 2. PNED GIE (LNDS), PIC 885395049, established in 6 AVENUE DES HAUTS-FOURNEAUX, ESCH-SUR-ALZETTE 4362, Luxembourg, 3. INSTITUTO NACIONAL DE SAUDE DR. RICARDO JORGE (INSA), PIC 998308190, established in AVENIDA PADRE CRUZ, LISBOA 1649-016, Portugal, 4. STICHTING HEALTH-RI (HEALTH-RI), PIC 887782025, established in JAARBEURSPLEIN 6, UTRECHT 3521 AL, Netherlands, 5. NATIONALT GENOM CENTER (NGC), PIC 886250880, established in ORESTADS BOULEVARD 5, BYG. 208, COPENHAGEN 2300, Denmark, 6. CONSORCIO PARA LA EXPLOTACION DEL CENTRO NACIONAL DE ANALISIS GENOMICO (CNAG), PIC 882802433, established in C BALDIRI 1 REIXAC 4, BARCELONA 08028, Spain, 7. BARCELONA SUPERCOMPUTING CENTER CENTRO NACIONAL DE SUPERCOMPUTACION (BSC), PIC 999655520, established in CALLE JORDI GIRONA 31, BARCELONA 08034, Spain, 1 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 8. UPPSALA UNIVERSITET (UU), PIC 999985029, established in VON KRAEMERS ALLE 4, UPPSALA 751 05, Sweden, 9. INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM), PIC 999997833, established in RUE DE TOLBIAC 101, PARIS 75654, France, 10. CONSIGLIO NAZIONALE DELLE RICERCHE (CNR), PIC 999979500, established in PIAZZALE ALDO MORO 7, ROMA 00185, Italy, 11. SMARTEX SRL SOCIETA' DI PRODOTTI E SERVIZI GIURIDICI INTERDISCIPLINARI (SLEX), PIC 925521039, established in VIA MAZZINI 60 B, S.GIULIANO TERME 56017, Italy, 12. INSTITUTO DE SALUD CARLOS III (ISCIII), PIC 999507886, established in MONFORTE DE LEMOS 5, MADRID 28029, Spain, 13. ASSOCIACAO BIP4DAB (Biodata.pt), PIC 889852005, established in RUA DA QUINTA GRANDE 6, OEIRAS 2780-156, Portugal, 14. EBERHARD KARLS UNIVERSITAET TUEBINGEN (EKUT), PIC 999991916, established in GESCHWISTER-SCHOLL-PLATZ, TUEBINGEN 72074, Germany, 15. KAROLINSKA INSTITUTET (KI), PIC 999978530, established in Nobels Vag 5, STOCKHOLM 17177, Sweden, 16. SOTSIAALMINISTEERIUM (MSAE), PIC 998429731, established in Suur-Ameerika 1, TALLINN 10122, Estonia, 17. BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE (BfArM), PIC 998293931, established in KURT GEORG KIESINGER ALLEE 3, BONN 53175, Germany, 18. SCIENSANO (Sciensano), PIC 906160809, established in JULIETTE WYTSMANSTRAAT 14, ELSENE 1050, Belgium, 19. INSTITUTUL DE CERCETARE-DEZVOLTARE IN GENOMICA (GRDI), PIC 881344232, established in STR DIONISIE LUPU 37 SECTOR 2, BUCURESTI 020021, Romania, 20. HELSINGIN YLIOPISTO (UH), PIC 999994535, established in FABIANINKATU 33, HELSINGIN YLIOPISTO 00014, Finland, Unless otherwise specified, references to ‘beneficiary’ or ‘beneficiaries’ include the coordinator and affiliated entities (if any). If only one beneficiary signs the grant agreement (‘mono-beneficiary grant’), all provisions referring to the ‘coordinator’ or the ‘beneficiaries’ will be considered — mutatis mutandis — as referring to the beneficiary. The parties referred to above have agreed to enter into the Agreement. By signing the Agreement and the accession forms, the beneficiaries accept the grant and agree to implement the action under their own responsibility and in accordance with the Agreement, with all the obligations and terms and conditions it sets out. 2 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 The Agreement is composed of: Preamble Terms and Conditions (including Data Sheet) Annex 1 Description of the action1 Annex 2 Estimated budget for the action Annex 2a Additional information on unit costs and contributions (if applicable) Annex 3 Accession forms (if applicable)2 Annex 3a Declaration on joint and several liability of affiliated entities (if applicable)3 Annex 4 Model for the financial statements Annex 5 Specific rules (if applicable) 1 Template published on Portal Reference Documents. 2 Template published on Portal Reference Documents. 3 Template published on Portal Reference Documents. 3 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 TERMS AND CONDITIONS TABLE OF CONTENTS GRANT AGREEMENT.................................................................................................................................................... 1 PREAMBLE........................................................................................................................................................................1 TERMS AND CONDITIONS...........................................................................................................................................4 DATASHEET...................................................................................................................................................................... 9 CHAPTER 1 GENERAL..............................................................................................................................................15 ARTICLE 1 — SUBJECT OF THE AGREEMENT ..................................................................................... 15 ARTICLE 2 — DEFINITIONS........................................................................................................................15 CHAPTER 2 ACTION................................................................................................................................................. 16 ARTICLE 3 — ACTION................................................................................................................................. 16 ARTICLE 4 — DURATION AND STARTING DATE...................................................................................16 CHAPTER 3 GRANT...................................................................................................................................................16 ARTICLE 5 — GRANT...................................................................................................................................16 5.1 Form of grant......................................................................................................................................16 5.2 Maximum grant amount..................................................................................................................... 17 5.3 Funding rate........................................................................................................................................17 5.4 Estimated budget, budget categories and forms of funding.............................................................. 17 5.5 Budget flexibility................................................................................................................................17 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS......................................18 6.1 General eligibility conditions............................................................................................................. 18 6.2 Specific eligibility conditions for each budget category................................................................... 19 6.3 Ineligible costs and contributions...................................................................................................... 23 6.4 Consequences of non-compliance...................................................................................................... 24 CHAPTER 4 GRANT IMPLEMENTATION............................................................................................................ 24 SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS........................................................................................................................................ 24 ARTICLE 7 — BENEFICIARIES................................................................................................................... 24 ARTICLE 8 — AFFILIATED ENTITIES....................................................................................................... 26 ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION................................................... 26 9.1 Associated partners.............................................................................................................................26 9.2 Third parties giving in-kind contributions to the action.................................................................... 27 9.3 Subcontractors.....................................................................................................................................27 4 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 9.4 Recipients of financial support to third parties..................................................................................28 ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS....................................................................... 28 10.1 Non-EU participants......................................................................................................................... 28 10.2 Participants which are international organisations...........................................................................28 10.3 Pillar-assessed participants............................................................................................................... 29 SECTION 2 RULES FOR CARRYING OUT THE ACTION...........................................................................31 ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION............................................................ 31 11.1 Obligation to properly implement the action................................................................................... 31 11.2 Consequences of non-compliance.................................................................................................... 31 ARTICLE 12 — CONFLICT OF INTERESTS.............................................................................................. 31 12.1 Conflict of interests.......................................................................................................................... 31 12.2 Consequences of non-compliance.................................................................................................... 32 ARTICLE 13 — CONFIDENTIALITY AND SECURITY............................................................................ 32 13.1 Sensitive information........................................................................................................................32 13.2 Classified information...................................................................................................................... 33 13.3 Consequences of non-compliance.................................................................................................... 33 ARTICLE 14 — ETHICS AND VALUES...................................................................................................... 33 14.1 Ethics.................................................................................................................................................33 14.2 Values................................................................................................................................................ 33 14.3 Consequences of non-compliance.................................................................................................... 33 ARTICLE 15 — DATA PROTECTION.......................................................................................................... 34 15.1 Data processing by the granting authority....................................................................................... 34 15.2 Data processing by the beneficiaries............................................................................................... 34 15.3 Consequences of non-compliance.................................................................................................... 34 ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE................................................................................ 35 16.1 Background and access rights to background..................................................................................35 16.2 Ownership of results.........................................................................................................................35 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes...................................35 16.4 Specific rules on IPR, results and background................................................................................ 36 16.5 Consequences of non-compliance.................................................................................................... 36 ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY............................................ 36 17.1 Communication — Dissemination — Promoting the action........................................................... 36 17.2 Visibility — European flag and funding statement......................................................................... 37 17.3 Quality of information — Disclaimer..............................................................................................37 5 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 17.4 Specific communication, dissemination and visibility rules............................................................38 17.5 Consequences of non-compliance.................................................................................................... 38 ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION............................................... 38 18.1 Specific rules for carrying out the action........................................................................................ 38 18.2 Consequences of non-compliance.................................................................................................... 38 SECTION 3 GRANT ADMINISTRATION......................................................................................................... 38 ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS.................................................................... 38 19.1 Information requests......................................................................................................................... 38 19.2 Participant Register data updates..................................................................................................... 38 19.3 Information about events and circumstances which impact the action............................................38 19.4 Consequences of non-compliance.................................................................................................... 39 ARTICLE 20 — RECORD-KEEPING............................................................................................................ 39 20.1 Keeping records and supporting documents.................................................................................... 39 20.2 Consequences of non-compliance.................................................................................................... 40 ARTICLE 21 — REPORTING........................................................................................................................ 40 21.1 Continuous reporting........................................................................................................................ 40 21.2 Periodic reporting: Technical reports and financial statements....................................................... 40 21.3 Currency for financial statements and conversion into euros..........................................................41 21.4 Reporting language...........................................................................................................................42 21.5 Consequences of non-compliance.................................................................................................... 42 ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE................. 42 22.1 Payments and payment arrangements.............................................................................................. 42 22.2 Recoveries.........................................................................................................................................42 22.3 Amounts due.....................................................................................................................................43 22.4 Enforced recovery.............................................................................................................................48 22.5 Consequences of non-compliance.................................................................................................... 48 ARTICLE 23 — GUARANTEES....................................................................................................................49 23.1 Prefinancing guarantee..................................................................................................................... 49 23.2 Consequences of non-compliance.................................................................................................... 49 ARTICLE 24 — CERTIFICATES................................................................................................................... 49 24.1 Operational verification report (OVR).............................................................................................50 24.2 Certificate on the financial statements (CFS).................................................................................. 50 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC).................................. 50 24.4 Systems and process audit (SPA).....................................................................................................51 24.5 Consequences of non-compliance.................................................................................................... 51 6 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS..................................................................................................................................... 51 25.1 Granting authority checks, reviews and audits................................................................................ 51 25.2 European Commission checks, reviews and audits in grants of other granting authorities..............52 25.3 Access to records for assessing simplified forms of funding.......................................................... 53 25.4 OLAF, EPPO and ECA audits and investigations........................................................................... 53 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations.................................................................................................................... 53 25.6 Consequences of non-compliance.................................................................................................... 54 ARTICLE 26 — IMPACT EVALUATIONS................................................................................................... 55 26.1 Impact evaluation............................................................................................................................. 55 26.2 Consequences of non-compliance.................................................................................................... 55 CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE.................................................................................. 55 SECTION 1 REJECTIONS AND GRANT REDUCTION.................................................................................55 ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS...........................................................55 27.1 Conditions......................................................................................................................................... 55 27.2 Procedure.......................................................................................................................................... 55 27.3 Effects............................................................................................................................................... 55 ARTICLE 28 — GRANT REDUCTION........................................................................................................ 56 28.1 Conditions......................................................................................................................................... 56 28.2 Procedure.......................................................................................................................................... 56 28.3 Effects............................................................................................................................................... 56 SECTION 2 SUSPENSION AND TERMINATION............................................................................................56 ARTICLE 29 — PAYMENT DEADLINE SUSPENSION............................................................................. 56 29.1 Conditions......................................................................................................................................... 56 29.2 Procedure.......................................................................................................................................... 57 ARTICLE 30 — PAYMENT SUSPENSION...................................................................................................57 30.1 Conditions......................................................................................................................................... 57 30.2 Procedure.......................................................................................................................................... 58 ARTICLE 31 — GRANT AGREEMENT SUSPENSION..............................................................................58 31.1 Consortium-requested GA suspension............................................................................................. 58 31.2 EU-initiated GA suspension.............................................................................................................59 ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION......................................... 60 32.1 Consortium-requested GA termination............................................................................................ 60 32.2 Consortium-requested beneficiary termination................................................................................ 61 32.3 EU-initiated GA or beneficiary termination.................................................................................... 62 7 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS............... 65 ARTICLE 33 — DAMAGES...........................................................................................................................65 33.1 Liability of the granting authority....................................................................................................65 33.2 Liability of the beneficiaries............................................................................................................ 66 ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES....................................... 66 SECTION 4 FORCE MAJEURE.......................................................................................................................... 66 ARTICLE 35 — FORCE MAJEURE.............................................................................................................. 66 CHAPTER 6 FINAL PROVISIONS...........................................................................................................................66 ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES...............................................................66 36.1 Forms and means of communication — Electronic management................................................... 66 36.2 Date of communication.................................................................................................................... 67 36.3 Addresses for communication.......................................................................................................... 67 ARTICLE 37 — INTERPRETATION OF THE AGREEMENT.....................................................................67 ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES..........................................................68 ARTICLE 39 — AMENDMENTS.................................................................................................................. 68 39.1 Conditions......................................................................................................................................... 68 39.2 Procedure.......................................................................................................................................... 68 ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES........................................... 69 40.1 Accession of the beneficiaries mentioned in the Preamble............................................................. 69 40.2 Addition of new beneficiaries.......................................................................................................... 69 ARTICLE 41 — TRANSFER OF THE AGREEMENT................................................................................. 69 ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY.................................................................................................................................69 ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES.............................................. 70 43.1 Applicable law..................................................................................................................................70 43.2 Dispute settlement............................................................................................................................ 70 ARTICLE 44 — ENTRY INTO FORCE.........................................................................................................70 8 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 DATA SHEET 1. General data Project summary: Project summary The EU Member States’ initiative 1+ Million Genomes (1+MG) aims to enable secure access to genomic and corresponding clinical data across Europe, supporting research, health policy and personalised healthcare. This initiative follows a two-staged roadmap, via the Beyond 1M Genomes and European Genomic Data Infrastructure projects, alongside 1+MG Working Groups and National Mirror Groups. The Genome of Europe project will build a European network of national genomic reference cohorts. B1MGplus aims to support the scale up and sustainability of 1+MG by supporting Member States’ to create a federated European genomics data infrastructure based on a European Digital Infrastructure Consortium (EDIC). It will also facilitate the uptake of genomics into healthcare delivery and public health policy, while developing the guidelines for meta-data standards and data quality assurance within the 1+MG Framework. B1MGplus activities include: -Preparation of Genome EDIC: drafting of legal and policy documents for operational readiness, supporting GDI Pillar I for long-term sustainability, setting up risk management frameworks and stakeholder interaction plans -Facilitating strategic orientation of the 1+MG initiative -Facilitating the uptake of genomics for healthcare: promoting awareness and engagement of public health professionals, encouraging the maturity assessment of genomics in healthcare systems, creating a citizens' hub for disseminating information on genomics, supporting the demonstration of the economic impact of genomics medicine on healthcare -Developing data standards, ontologies, and sequencing practices to ensure that data made available is 1+MG-ready B1MGplus advances the 1+MG initiative, fostering genomic medicine and personalised healthcare. This project will contribute to unlocking the promise of genomics for healthcare and public health, creating unprecedented opportunities in cancer, common and rare diseases, infectious diseases and pharmacogenomics. Keywords: – 1+MG, GENOME EDIC, EUROPEAN GENOMIC INFRASTRUCTURE, EHDS, PERSONALISED MEDICINE Project number: 101194865 Project name: Beyond 1 Million Genomes Plus Project acronym: B1MGplus Call: DIGITAL-2024-CLOUD-DATA-AI-06 Topic: DIGITAL-2024-CLOUD-DATA-AI-06-GENOME Type of action: DIGITAL Coordination and Support Actions Granting authority: European Commission-EU Grant managed through EU Funding & Tenders Portal: Yes (eGrants) Project starting date: fixed date: 1 February 2025 Project end date: 31 January 2028 Project duration: 36 months Consortium agreement: Yes 2. Participants List of participants: Total Max grant N° Role Short name Legal name Ctry PIC eligible costs amount (BEN and AE) 1 COO ELIXIR / EMBL EUROPEAN MOLECULAR BIOLOGY LABORATORY DE 999988230 354 986.97 354 986.97 (IO) 2 BEN LNDS PNED GIE LU 885395049 441 184.57 441 184.57 9 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Total Max grant N° Role Short name Legal name Ctry PIC eligible costs amount (BEN and AE) 3 BEN INSA INSTITUTO NACIONAL DE SAUDE DR. RICARDO PT 998308190 155 643.15 155 643.15 JORGE 4 BEN HEALTH-RI STICHTING HEALTH-RI NL 887782025 27 356.42 27 356.42 5 BEN NGC NATIONALT GENOM CENTER DK 886250880 304 402.43 304 402.43 6 BEN CNAG CONSORCIO PARA LA EXPLOTACION DEL CENTRO ES 882802433 41 183.86 41 183.86 NACIONAL DE ANALISIS GENOMICO 7 BEN BSC BARCELONA SUPERCOMPUTING CENTER CENTRO ES 999655520 14 225.34 14 225.34 NACIONAL DE SUPERCOMPUTACION 8 BEN UU UPPSALA UNIVERSITET SE 999985029 18 602.37 18 602.37 9 BEN INSERM INSTITUT NATIONAL DE LA SANTE ET DE LA FR 999997833 76 399.04 76 399.04 RECHERCHE MEDICALE 10 BEN CNR CONSIGLIO NAZIONALE DELLE RICERCHE IT 999979500 77 592.77 77 592.77 11 BEN SLEX SMARTEX SRL SOCIETA' DI PRODOTTI E SERVIZI IT 925521039 188 759.35 188 759.35 GIURIDICI INTERDISCIPLINARI 12 BEN ISCIII INSTITUTO DE SALUD CARLOS III ES 999507886 41 541.98 41 541.98 13 BEN Biodata.pt ASSOCIACAO BIP4DAB PT 889852005 12 255.68 12 255.68 14 BEN EKUT EBERHARD KARLS UNIVERSITAET TUEBINGEN DE 999991916 7 560.32 7 560.32 15 BEN KI KAROLINSKA INSTITUTET SE 999978530 38 796.39 38 796.39 16 BEN MSAE SOTSIAALMINISTEERIUM EE 998429731 22 879.92 22 879.92 17 BEN BfArM BUNDESINSTITUT FUR ARZNEIMITTEL UND DE 998293931 26 742.08 26 742.08 MEDIZINPRODUKTE 18 BEN Sciensano SCIENSANO BE 906160809 111 614.23 111 614.23 19 BEN GRDI INSTITUTUL DE CERCETARE-DEZVOLTARE IN RO 881344232 27 853.81 27 853.81 GENOMICA 20 BEN UH HELSINGIN YLIOPISTO FI 999994535 10 419.32 10 419.32 21 AP UL UNIVERZA V LJUBLJANI SI 999923240 0.00 0.00 22 AP UHEI RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG DE 999987648 0.00 0.00 23 AP MU Masarykova univerzita CZ 999880657 0.00 0.00 24 AP HDIR HELSEDIREKTORATET NO 974772304 0.00 0.00 25 AP RBI RUDER BOSKOVIC INSTITUTE HR 999875031 0.00 0.00 26 AP VUHSK VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LT 991636530 0.00 0.00 LIGONINE SANTAROS KLINIKOS 27 AP UiB UNIVERSITETET I BERGEN NO 999974456 0.00 0.00 28 AP VINNOVA VERKET FOR INNOVATIONSSYSTEM SE 999618757 0.00 0.00 29 AP OOI Orszagos Onkologiai Intezet HU 991549909 0.00 0.00 30 AP UNISR UNIVERSITA VITA-SALUTE SAN RAFFAELE IT 999854467 0.00 0.00 31 AP SIB SIB SWISS INSTITUTE OF BIOINFORMATICS CH 999629815 0.00 0.00 32 AP MESR MINISTERE DE LA RECHERCHE ET DE LU 905655827 0.00 0.00 L'ENSEIGNEMENT SUPERIEUR 33 AP CERTH ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS EL 998802502 0.00 0.00 ANAPTYXIS 34 AP CRG FUNDACIO CENTRE DE REGULACIO GENOMICA ES 999544455 0.00 0.00 35 AP LBMC LATVIJAS BIOMEDICINAS PETIJUMU UN STUDIJU LV 998836646 0.00 0.00 CENTRS 36 AP IGG ISTITUTO GIANNINA GASLINI IT 999448037 0.00 0.00 Total 2 000 000.00 2 000 000.00 Coordinator: 10 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 – EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) 3. Grant Maximum grant amount, total estimated eligible costs and contributions and funding rate: Total eligible costs Funding rate Maximum grant amount Maximum grant amount (BEN and AE) (%) (Annex 2) (award decision) 2 000 000.00 100 2 000 000.00 2 000 000.00 Grant form: Budget-based Grant mode: Action grant Budget categories/activity types: - A. Personnel costs - A.1 Employees, A.2 Natural persons under direct contract, A.3 Seconded persons - A.4 SME owners and natural person beneficiaries - B. Subcontracting costs - C. Purchase costs - C.1 Travel and subsistence - C.2 Equipment - C.3 Other goods, works and services - D. Other cost categories - D.2 Internally invoiced goods and services - E. Indirect costs Cost eligibility options: - Standard supplementary payments - Average personnel costs (unit cost according to usual cost accounting practices) - Limitation for subcontracting - Travel and subsistence: - Travel: Actual costs - Accommodation: Actual costs - Subsistence: Actual costs - Equipment: depreciation only - Indirect cost flat-rate: 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any) - VAT: Yes - Other ineligible costs Budget flexibility: Yes (no flexibility cap) 4. Reporting, payments and recoveries 4.1 Continuous reporting (art 21) 11 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Deliverables: see Funding & Tenders Portal Continuous Reporting tool 4.2 Periodic reporting and payments Reporting and payment schedule (art 21, 22): Reporting Payments Deadline Reporting periods Type Deadline Type (time to pay) RP No Month from Month to 30 days from entry into force/10 days before starting date/ Initial prefinancing financial guarantee (if required) – whichever is the latest 1 1 18 Periodic report 60 days after end Interim payment 90 days from of reporting period receiving periodic report 2 19 36 Periodic report 60 days after end Final payment 90 days from of reporting period receiving periodic report Prefinancing payments and guarantees: Prefinancing payment Prefinancing guarantee Guarantee Type Amount Division per participant amount Prefinancing 1 (initial) 1 600 000.00 n/a 1 - ELIXIR / EMBL n/a 2 - LNDS n/a 3 - INSA n/a 4 - HEALTH-RI n/a 5 - NGC n/a 6 - CNAG n/a 7 - BSC n/a 8 - UU n/a 9 - INSERM n/a 10 - CNR n/a 11 - SLEX n/a 12 - ISCIII n/a 13 - Biodata.pt n/a 14 - EKUT n/a 15 - KI n/a 16 - MSAE n/a 17 - BfArM n/a 18 - Sciensano n/a 19 - GRDI n/a 20 - UH n/a Reporting and payment modalities (art 21, 22): Mutual Insurance Mechanism (MIM): No 12 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Restrictions on distribution of initial prefinancing: The prefinancing may be distributed only if the minimum number of beneficiaries set out in the call condititions (if any) have acceded to the Agreement and only to beneficiaries that have acceded. Interim payment ceiling (if any): 90% of the maximum grant amount No-profit rule: Yes Late payment interest: ECB + 3.5% Bank account for payments: DE19672800510465251408 Conversion into euros: Double conversion Reporting language: Language of the Agreement 4.3 Certificates (art 24): Certificates on the financial statements (CFS): Conditions: Schedule: only at final payment, if threshold is reached Standard threshold (beneficiary-level): - financial statement: requested EU contribution to costs ≥ EUR 325 000.00 4.4 Recoveries (art 22) First-line liability for recoveries: Beneficiary termination: Beneficiary concerned Final payment: Coordinator After final payment: Beneficiary concerned Joint and several liability for enforced recoveries (in case of non-payment): Limited joint and several liability of other beneficiaries — up to the maximum grant amount of the beneficiary Joint and several liability of affiliated entities — n/a 5. Consequences of non-compliance, applicable law & dispute settlement forum Applicable law (art 43): Standard applicable law regime: EU law + law of Belgium Special applicable law regime: – EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL): general principles governing the law of international organisations and the general rules of international law Dispute settlement forum (art 43): Standard dispute settlement forum: 13 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 EU beneficiaries: EU General Court + EU Court of Justice (on appeal) Non-EU beneficiaries: Courts of Brussels, Belgium (unless an international agreement provides for the enforceability of EU court judgements) Special dispute settlement forum: – EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL): Arbitration 6. Other Specific rules (Annex 5): Yes Standard time-limits after project end: Confidentiality (for X years after final payment): 5 Record-keeping (for X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Reviews (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Audits (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Extension of findings from other grants to this grant (no later than X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Impact evaluation (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) 14 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 CHAPTER 1 GENERAL ARTICLE 1 — SUBJECT OF THE AGREEMENT This Agreement sets out the rights and obligations and terms and conditions applicable to the grant awarded for the implementation of the action set out in Chapter 2. ARTICLE 2 — DEFINITIONS For the purpose of this Agreement, the following definitions apply: Actions — The project which is being funded in the context of this Agreement. Grant — The grant awarded in the context of this Agreement. EU grants — Grants awarded by EU institutions, bodies, offices or agencies (including EU executive agencies, EU regulatory agencies, EDA, joint undertakings, etc.). Participants — Entities participating in the action as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties. Beneficiaries (BEN) — The signatories of this Agreement (either directly or through an accession form). Affiliated entities (AE) — Entities affiliated to a beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/10464 which participate in the action with similar rights and obligations as the beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). Associated partners (AP) — Entities which participate in the action, but without the right to charge costs or claim contributions. Purchases — Contracts for goods, works or services needed to carry out the action (e.g. equipment, consumables and supplies) but which are not part of the action tasks (see Annex 1). Subcontracting — Contracts for goods, works or services that are part of the action tasks (see Annex 1). In-kind contributions — In-kind contributions within the meaning of Article 2(36) of EU Financial 4 For the definition, see Article 187 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 (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (‘EU Financial Regulation’) (OJ L 193, 30.7.2018, p. 1): “affiliated entities [are]: (a) entities that form a sole beneficiary [(i.e. where an entity is formed of several entities that satisfy the criteria for being awarded a grant, including where the entity is specifically established for the purpose of implementing an action to be financed by a grant)]; (b) entities that satisfy the eligibility criteria and that do not fall within one of the situations referred to in Article 136(1) and 141(1) and that have a link with the beneficiary, in particular a legal or capital link, which is neither limited to the action nor established for the sole purpose of its implementation”. 15 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Regulation 2018/1046, i.e. non-financial resources made available free of charge by third parties. Fraud — Fraud within the meaning of Article 3 of EU Directive 2017/13715 and Article 1 of the Convention on the protection of the European Communities’ financial interests, drawn up by the Council Act of 26 July 19956, as well as any other wrongful or criminal deception intended to result in financial or personal gain. Irregularities — Any type of breach (regulatory or contractual) which could impact the EU financial interests, including irregularities within the meaning of Article 1(2) of EU Regulation 2988/957. Grave professional misconduct — Any type of unacceptable or improper behaviour in exercising one’s profession, especially by employees, including grave professional misconduct within the meaning of Article 136(1)(c) of EU Financial Regulation 2018/1046. Applicable EU, international and national law — Any legal acts or other (binding or non-binding) rules and guidance in the area concerned. Portal — EU Funding & Tenders Portal; electronic portal and exchange system managed by the European Commission and used by itself and other EU institutions, bodies, offices or agencies for the management of their funding programmes (grants, procurements, prizes, etc.). CHAPTER 2 ACTION ARTICLE 3 — ACTION The grant is awarded for the action 101194865 — B1MGplus (‘action’), as described in Annex 1. ARTICLE 4 — DURATION AND STARTING DATE The duration and the starting date of the action are set out in the Data Sheet (see Point 1). CHAPTER 3 GRANT ARTICLE 5 — GRANT 5.1 Form of grant The grant is an action grant8 which takes the form of a budget-based mixed actual cost grant (i.e. a 5 Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). 6 OJ C 316, 27.11.1995, p. 48. 7 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 8 For the definition, see Article 180(2)(a) EU Financial Regulation 2018/1046: ‘action grant’ means an EU grant to finance “an action intended to help achieve a Union policy objective”. 16 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 grant based on actual costs incurred, but which may also include other forms of funding, such as unit costs or contributions, flat-rate costs or contributions, lump sum costs or contributions or financing not linked to costs). 5.2 Maximum grant amount The maximum grant amount is set out in the Data Sheet (see Point 3) and in the estimated budget (Annex 2). 5.3 Funding rate The funding rate for costs is 100% of the action’s eligible costs. Contributions are not subject to any funding rate. 5.4 Estimated budget, budget categories and forms of funding The estimated budget for the action is set out in Annex 2. It contains the estimated eligible costs and contributions for the action, broken down by participant and budget category. Annex 2 also shows the types of costs and contributions (forms of funding)9 to be used for each budget category. If unit costs or contributions are used, the details on the calculation will be explained in Annex 2a. 5.5 Budget flexibility The budget breakdown may be adjusted — without an amendment (see Article 39) — by transfers (between participants and budget categories), as long as this does not imply any substantive or important change to the description of the action in Annex 1. However: - changes to the budget category for volunteers (if used) always require an amendment - changes to budget categories with lump sums costs or contributions (if used; including financing not linked to costs) always require an amendment - changes to budget categories with higher funding rates or budget ceilings (if used) always require an amendment - addition of amounts for subcontracts not provided for in Annex 1 either require an amendment or simplified approval in accordance with Article 6.2 - other changes require an amendment or simplified approval, if specifically provided for in Article 6.2 - flexibility caps: not applicable. 9 See Article 125 EU Financial Regulation 2018/1046. 17 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS In order to be eligible, costs and contributions must meet the eligibility conditions set out in this Article. 6.1 General eligibility conditions The general eligibility conditions are the following: (a) for actual costs: (i) they must be actually incurred by the beneficiary (ii) they must be incurred in the period set out in Article 4 (with the exception of costs relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (iii) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (iv) they must be incurred in connection with the action as described in Annex 1 and necessary for its implementation (v) they must be identifiable and verifiable, in particular recorded in the beneficiary’s accounts in accordance with the accounting standards applicable in the country where the beneficiary is established and with the beneficiary’s usual cost accounting practices (vi) they must comply with the applicable national law on taxes, labour and social security and (vii) they must be reasonable, justified and must comply with the principle of sound financial management, in particular regarding economy and efficiency (b) for unit costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the units must: - be actually used or produced by the beneficiary in the period set out in Article 4 (with the exception of units relating to the submission of the final periodic report, which may be used or produced afterwards; see Article 21) - be necessary for the implementation of the action and (iii) the number of units must be identifiable and verifiable, in particular supported by records and documentation (see Article 20) (c) for flat-rate costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 18 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 (ii) the costs or contributions to which the flat-rate is applied must: - be eligible - relate to the period set out in Article 4 (with the exception of costs or contributions relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (d) for lump sum costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the work must be properly implemented by the beneficiary in accordance with Annex 1 (iii) the deliverables/outputs must be achieved in the period set out in Article 4 (with the exception of deliverables/outputs relating to the submission of the final periodic report, which may be achieved afterwards; see Article 21) (e) for unit, flat-rate or lump sum costs or contributions according to usual cost accounting practices (if any): (i) they must fulfil the general eligibility conditions for the type of cost concerned (ii) the cost accounting practices must be applied in a consistent manner, based on objective criteria, regardless of the source of funding (f) for financing not linked to costs (if any): the results must be achieved or the conditions must be fulfilled as described in Annex 1. In addition, for direct cost categories (e.g. personnel, travel & subsistence, subcontracting and other direct costs) only costs that are directly linked to the action implementation and can therefore be attributed to it directly are eligible. They must not include any indirect costs (i.e. costs that are only indirectly linked to the action, e.g. via cost drivers). 6.2 Specific eligibility conditions for each budget category For each budget category, the specific eligibility conditions are as follows: Direct costs A. Personnel costs A.1 Costs for employees (or equivalent) are eligible as personnel costs if they fulfil the general eligibility conditions and are related to personnel working for the beneficiary under an employment contract (or equivalent appointing act) and assigned to the action. They must be limited to salaries, social security contributions, taxes and other costs linked to the remuneration, if they arise from national law or the employment contract (or equivalent appointing act) and be calculated on the basis of the costs actually incurred, in accordance with the following method: 19 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 {daily rate for the person multiplied by number of day-equivalents worked on the action (rounded up or down to the nearest half-day)}. The daily rate must be calculated as: {annual personnel costs for the person divided by 215}. The number of day-equivalents declared for a person must be identifiable and verifiable (see Article 20). The total number of day-equivalents declared in EU grants, for a person for a year, cannot be higher than 215. The personnel costs may also include supplementary payments for personnel assigned to the action (including payments on the basis of supplementary contracts regardless of their nature), if: - it is part of the beneficiary’s usual remuneration practices and is paid in a consistent manner whenever the same kind of work or expertise is required - the criteria used to calculate the supplementary payments are objective and generally applied by the beneficiary, regardless of the source of funding used. If the beneficiary uses average personnel costs (unit cost according to usual cost accounting practices), the personnel costs must fulfil the general eligibility conditions for such unit costs and the daily rate must be calculated: - using the actual personnel costs recorded in the beneficiary’s accounts and excluding any costs which are ineligible or already included in other budget categories; the actual personnel costs may be adjusted on the basis of budgeted or estimated elements, if they are relevant for calculating the personnel costs, reasonable and correspond to objective and verifiable information and - according to usual cost accounting practices which are applied in a consistent manner, based on objective criteria, regardless of the source of funding. A.2 and A.3 Costs for natural persons working under a direct contract other than an employment contract and costs for seconded persons by a third party against payment are also eligible as personnel costs, if they are assigned to the action, fulfil the general eligibility conditions and: (a) work under conditions similar to those of an employee (in particular regarding the way the work is organised, the tasks that are performed and the premises where they are performed) and (b) the result of the work belongs to the beneficiary (unless agreed otherwise). They must be calculated on the basis of a rate which corresponds to the costs actually incurred for 20 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 the direct contract or secondment and must not be significantly different from those for personnel performing similar tasks under an employment contract with the beneficiary. A.4 The work of SME owners for the action (i.e. owners of beneficiaries that are small and medium- sized enterprises10 not receiving a salary) or natural person beneficiaries (i.e. beneficiaries that are natural persons not receiving a salary) may be declared as personnel costs, if they fulfil the general eligibility conditions and are calculated as unit costs in accordance with the method set out in Annex 2a. B. Subcontracting costs Subcontracting costs for the action (including related duties, taxes and charges, such as non- deductible or non-refundable value added tax (VAT)) are eligible, if they are calculated on the basis of the costs actually incurred, fulfil the general eligibility conditions and are awarded using the beneficiary’s usual purchasing practices — provided these ensure subcontracts with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. Subcontracting may cover only a limited part of the action. The tasks to be subcontracted and the estimated cost for each subcontract must be set out in Annex 1 and the total estimated costs of subcontracting per beneficiary must be set out in Annex 2 (or may be approved ex post in the periodic report, if the use of subcontracting does not entail changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants; ‘simplified approval procedure’). C. Purchase costs Purchase costs for the action (including related duties, taxes and charges, such as non-deductible or non-refundable value added tax (VAT)) are eligible if they fulfil the general eligibility conditions and are bought using the beneficiary’s usual purchasing practices — provided these ensure purchases with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. C.1 Travel and subsistence Purchases for travel, accommodation and subsistence must be calculated as follows: 10 For the definition, see Commission Recommendation 2003/361/EC: micro, small or medium-sized enterprise (SME) are enterprises - engaged in an economic activity, irrespective of their legal form (including, in particular, self- employed persons and family businesses engaged in craft or other activities, and partnerships or associations regularly engaged in an economic activity) and - employing fewer than 250 persons (expressed in ‘annual working units’ as defined in Article 5 of the Recommendation) and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. 21 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 - travel: on the basis of the costs actually incurred and in line with the beneficiary’s usual practices on travel - accommodation: on the basis of the costs actually incurred and in line with the beneficiary’s usual practices on travel - subsistence: on the basis of the costs actually incurred and in line with the beneficiary’s usual practices on travel . C.2 Equipment Purchases of equipment, infrastructure or other assets used for the action must be declared as depreciation costs, calculated on the basis of the costs actually incurred and written off in accordance with international accounting standards and the beneficiary’s usual accounting practices. Only the portion of the costs that corresponds to the rate of actual use for the action during the action duration can be taken into account. Costs for renting or leasing equipment, infrastructure or other assets are also eligible, if they do not exceed the depreciation costs of similar equipment, infrastructure or assets and do not include any financing fees. C.3 Other goods, works and services Purchases of other goods, works and services must be calculated on the basis of the costs actually incurred. Such goods, works and services include, for instance, consumables and supplies, promotion, dissemination, protection of results, translations, publications, certificates and financial guarantees, if required under the Agreement. D. Other cost categories D.2 Internally invoiced goods and services Costs for internally invoiced goods and services directly used for the action may be declared as unit cost according to usual cost accounting practices, if and as declared eligible in the call conditions, if they fulfil the general eligibility conditions for such unit costs and the amount per unit is calculated: - using the actual costs for the good or service recorded in the beneficiary’s accounts, attributed either by direct measurement or on the basis of cost drivers, and excluding any cost which are ineligible or already included in other budget categories; the actual costs may be adjusted on the basis of budgeted or estimated elements, if they are relevant for calculating the costs, reasonable and correspond to objective and verifiable information and - according to usual cost accounting practices which are applied in a consistent manner, based on objective criteria, regardless of the source of funding. ‘Internally invoiced goods and services’ means goods or services which are provided within the 22 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 beneficiary’s organisation directly for the action and which the beneficiary values on the basis of its usual cost accounting practices. Indirect costs E. Indirect costs Indirect costs will be reimbursed at the flat-rate of 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any). Contributions Not applicable 6.3 Ineligible costs and contributions The following costs or contributions are ineligible: (a) costs or contributions that do not comply with the conditions set out above (Article 6.1 and 6.2), in particular: (i) costs related to return on capital and dividends paid by a beneficiary (ii) debt and debt service charges (iii) provisions for future losses or debts (iv) interest owed (v) currency exchange losses (vi) bank costs charged by the beneficiary’s bank for transfers from the granting authority (vii) excessive or reckless expenditure (viii) deductible or refundable VAT (including VAT paid by public bodies acting as public authority) (ix) costs incurred or contributions for activities implemented during grant agreement suspension (see Article 31) (x) in-kind contributions by third parties (b) costs or contributions declared under other EU grants (or grants awarded by an EU Member State, non-EU country or other body implementing the EU budget), except for the following cases: (i) Synergy actions: not applicable (ii) if the action grant is combined with an operating grant11 running during the same period 11 For the definition, see Article 180(2)(b) of EU Financial Regulation 2018/1046: ‘operating grant’ means an EU grant to finance “the functioning of a body which has an objective forming part of and supporting an EU policy”. 23 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 and the beneficiary can demonstrate that the operating grant does not cover any (direct or indirect) costs of the action grant (c) costs or contributions for staff of a national (or regional/local) administration, for activities that are part of the administration’s normal activities (i.e. not undertaken only because of the grant) (d) costs or contributions (especially travel and subsistence) for staff or representatives of EU institutions, bodies or agencies (e) other : (i) country restrictions for eligible costs: not applicable (ii) costs or contributions declared specifically ineligible in the call conditions. 6.4 Consequences of non-compliance If a beneficiary declares costs or contributions that are ineligible, they will be rejected (see Article 27). This may also lead to other measures described in Chapter 5. CHAPTER 4 GRANT IMPLEMENTATION SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS ARTICLE 7 — BENEFICIARIES The beneficiaries, as signatories of the Agreement, are fully responsible towards the granting authority for implementing it and for complying with all its obligations. They must implement the Agreement to their best abilities, in good faith and in accordance with all the obligations and terms and conditions it sets out. They must have the appropriate resources to implement the action and implement the action under their own responsibility and in accordance with Article 11. If they rely on affiliated entities or other participants (see Articles 8 and 9), they retain sole responsibility towards the granting authority and the other beneficiaries. They are jointly responsible for the technical implementation of the action. If one of the beneficiaries fails to implement their part of the action, the other beneficiaries must ensure that this part is implemented by someone else (without being entitled to an increase of the maximum grant amount and subject to an amendment; see Article 39). The financial responsibility of each beneficiary in case of recoveries is governed by Article 22. The beneficiaries (and their action) must remain eligible under the EU programme funding the grant for the entire duration of the action. Costs and contributions will be eligible only as long as the beneficiary and the action are eligible. The internal roles and responsibilities of the beneficiaries are divided as follows: 24 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 (a) Each beneficiary must: (i) keep information stored in the Portal Participant Register up to date (see Article 19) (ii) inform the granting authority (and the other beneficiaries) immediately of any events or circumstances likely to affect significantly or delay the implementation of the action (see Article 19) (iii) submit to the coordinator in good time: - the prefinancing guarantees (if required; see Article 23) - the financial statements and certificates on the financial statements (CFS) (if required; see Articles 21 and 24.2 and Data Sheet, Point 4.3) - the contribution to the deliverables and technical reports (see Article 21) - any other documents or information required by the granting authority under the Agreement (iv) submit via the Portal data and information related to the participation of their affiliated entities. (b) The coordinator must: (i) monitor that the action is implemented properly (see Article 11) (ii) act as the intermediary for all communications between the consortium and the granting authority, unless the Agreement or granting authority specifies otherwise, and in particular: - submit the prefinancing guarantees to the granting authority (if any) - request and review any documents or information required and verify their quality and completeness before passing them on to the granting authority - submit the deliverables and reports to the granting authority - inform the granting authority about the payments made to the other beneficiaries (report on the distribution of payments; if required, see Articles 22 and 32) (iii) distribute the payments received from the granting authority to the other beneficiaries without unjustified delay (see Article 22). The coordinator may not delegate or subcontract the above-mentioned tasks to any other beneficiary or third party (including affiliated entities). However, coordinators which are public bodies may delegate the tasks set out in Point (b)(ii) last indent and (iii) above to entities with ‘authorisation to administer’ which they have created or which are controlled by or affiliated to them. In this case, the coordinator retains sole responsibility for the payments and for compliance with the obligations under the Agreement. 25 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Moreover, coordinators which are ‘sole beneficiaries’12 (or similar, such as European research infrastructure consortia (ERICs)) may delegate the tasks set out in Point (b)(i) to (iii) above to one of their members. The coordinator retains sole responsibility for compliance with the obligations under the Agreement. The beneficiaries must have internal arrangements regarding their operation and co-ordination, to ensure that the action is implemented properly. If required by the granting authority (see Data Sheet, Point 1), these arrangements must be set out in a written consortium agreement between the beneficiaries, covering for instance: - the internal organisation of the consortium - the management of access to the Portal - different distribution keys for the payments and financial responsibilities in case of recoveries (if any) - additional rules on rights and obligations related to background and results (see Article 16) - settlement of internal disputes - liability, indemnification and confidentiality arrangements between the beneficiaries. The internal arrangements must not contain any provision contrary to this Agreement. ARTICLE 8 — AFFILIATED ENTITIES Not applicable ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION 9.1 Associated partners The following entities which cooperate with a beneficiary will participate in the action as ‘associated partners’: - UNIVERZA V LJUBLJANI (UL), PIC 999923240 - RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG (UHEI), PIC 999987648 - Masarykova univerzita (MU), PIC 999880657 - HELSEDIREKTORATET (HDIR), PIC 974772304 - RUDER BOSKOVIC INSTITUTE (RBI), PIC 999875031 - VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LIGONINE SANTAROS KLINIKOS (VUHSK), PIC 991636530 12 For the definition, see Article 187(2) EU Financial Regulation 2018/1046: “Where several entities satisfy the criteria for being awarded a grant and together form one entity, that entity may be treated as the sole beneficiary, including where it is specifically established for the purpose of implementing the action financed by the grant.” 26 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 - UNIVERSITETET I BERGEN (UiB), PIC 999974456 - VERKET FOR INNOVATIONSSYSTEM (VINNOVA), PIC 999618757 - Orszagos Onkologiai Intezet (OOI), PIC 991549909 - UNIVERSITA VITA-SALUTE SAN RAFFAELE (UNISR), PIC 999854467 - SIB SWISS INSTITUTE OF BIOINFORMATICS (SIB), PIC 999629815 - MINISTERE DE LA RECHERCHE ET DE L'ENSEIGNEMENT SUPERIEUR (MESR), PIC 905655827 - ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS (CERTH), PIC 998802502 - FUNDACIO CENTRE DE REGULACIO GENOMICA (CRG), PIC 999544455 - LATVIJAS BIOMEDICINAS PETIJUMU UN STUDIJU CENTRS (LBMC), PIC 998836646 - ISTITUTO GIANNINA GASLINI (IGG), PIC 999448037 Associated partners must implement the action tasks attributed to them in Annex 1 in accordance with Article 11. They may not charge costs or contributions to the action and the costs for their tasks are not eligible. The tasks must be set out in Annex 1. The beneficiaries must ensure that their contractual obligations under Articles 11 (proper implementation), 12 (conflict of interests), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping) also apply to the associated partners. The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the associated partners. 9.2 Third parties giving in-kind contributions to the action Other third parties may give in-kind contributions to the action (i.e. personnel, equipment, other goods, works and services, etc. which are free-of-charge), if necessary for the implementation. Third parties giving in-kind contributions do not implement any action tasks. They may not charge costs or contributions to the action and the costs for the in-kind contributions are not eligible. The third parties and their in-kind contributions should be set out in Annex 1. 9.3 Subcontractors Subcontractors may participate in the action, if necessary for the implementation. Subcontractors must implement their action tasks in accordance with Article 11. The costs for the subcontracted tasks (invoiced price from the subcontractor) are eligible and may be charged by the 27 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 beneficiaries, under the conditions set out in Article 6. The costs will be included in Annex 2 as part of the beneficiaries’ costs. The beneficiaries must ensure that their contractual obligations under Articles 11 (proper implementation), 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping) also apply to the subcontractors. The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the subcontractors. 9.4 Recipients of financial support to third parties If the action includes providing financial support to third parties (e.g. grants, prizes or similar forms of support), the beneficiaries must ensure that their contractual obligations under Articles 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping)also apply to the third parties receiving the support (recipients). The beneficiaries must also ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the recipients. ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS 10.1 Non-EU participants Participants which are established in a non-EU country (if any) undertake to comply with their obligations under the Agreement and: - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use qualified external auditors which are independent and comply with comparable standards as those set out in EU Directive 2006/43/EC13 - for the controls under Article 25: to allow for checks, reviews, audits and investigations (including on-the-spot checks, visits and inspections) by the bodies mentioned in that Article (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.). Special rules on dispute settlement apply (see Data Sheet, Point 5). 10.2 Participants which are international organisations Participants which are international organisations (IOs; if any) undertake to comply with their obligations under the Agreement and: 13 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 28 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use either independent public officers or external auditors which comply with comparable standards as those set out in EU Directive 2006/43/EC - for the controls under Article 25: to allow for the checks, reviews, audits and investigations by the bodies mentioned in that Article, taking into account the specific agreements concluded by them and the EU (if any). For such participants, nothing in the Agreement will be interpreted as a waiver of their privileges or immunities, as accorded by their constituent documents or international law. Special rules on applicable law and dispute settlement apply (see Article 43 and Data Sheet, Point 5). 10.3 Pillar-assessed participants Pillar-assessed participants (if any) may rely on their own systems, rules and procedures, in so far as they have been positively assessed and do not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries. ‘Pillar-assessment’ means a review by the European Commission on the systems, rules and procedures which participants use for managing EU grants (in particular internal control system, accounting system, external audits, financing of third parties, rules on recovery and exclusion, information on recipients and protection of personal data; see Article 154 EU Financial Regulation 2018/1046). Participants with a positive pillar assessment may rely on their own systems, rules and procedures, in particular for: - record-keeping (Article 20): may be done in accordance with internal standards, rules and procedures - currency conversion for financial statements (Article 21): may be done in accordance with usual accounting practices - guarantees (Article 23): for public law bodies, prefinancing guarantees are not needed - certificates (Article 24): - certificates on the financial statements (CFS): may be provided by their regular internal or external auditors and in accordance with their internal financial regulations and procedures - certificates on usual accounting practices (CoMUC): are not needed if those practices are covered by an ex-ante assessment and use the following specific rules, for: - recoveries (Article 22): in case of financial support to third parties, there will be no recovery if the participant has done everything possible to retrieve the undue amounts from the third party 29 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 receiving the support (including legal proceedings) and non-recovery is not due to an error or negligence on its part - checks, reviews, audits and investigations by the EU (Article 25): will be conducted taking into account the rules and procedures specifically agreed between them and the framework agreement (if any) - impact evaluation (Article 26): will be conducted in accordance with the participant’s internal rules and procedures and the framework agreement (if any) - grant agreement suspension (Article 31): certain costs incurred during grant suspension are eligible (notably, minimum costs necessary for a possible resumption of the action and costs relating to contracts which were entered into before the pre-information letter was received and which could not reasonably be suspended, reallocated or terminated on legal grounds) - grant agreement termination (Article 32): the final grant amount and final payment will be calculated taking into account also costs relating to contracts due for execution only after termination takes effect, if the contract was entered into before the pre-information letter was received and could not reasonably be terminated on legal grounds - liability for damages (Article 33.2): the granting authority must be compensated for damage it sustains as a result of the implementation of the action or because the action was not implemented in full compliance with the Agreement only if the damage is due to an infringement of the participant’s internal rules and procedures or due to a violation of third parties’ rights by the participant or one of its employees or individual for whom the employees are responsible. Participants whose pillar assessment covers procurement and granting procedures may also do purchases, subcontracting and financial support to third parties (Article 6.2) in accordance with their internal rules and procedures for purchases, subcontracting and financial support. Participants whose pillar assessment covers data protection rules may rely on their internal standards, rules and procedures for data protection (Article 15). The participants may however not rely on provisions which would breach the principle of equal treatment of applicants or beneficiaries or call into question the decision awarding the grant, such as in particular: - eligibility (Article 6) - consortium roles and set-up (Articles 7-9) - security and ethics (Articles 13, 14) - IPR (including background and results, access rights and rights of use), communication, dissemination and visibility (Articles 16 and 17) - information obligation (Article 19) - payment, reporting and amendments (Articles 21, 22 and 39) - rejections, reductions, suspensions and terminations (Articles 27, 28, 29-32) 30 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 If the pillar assessment was subject to remedial measures, reliance on the internal systems, rules and procedures is subject to compliance with those remedial measures. Participants whose assessment has not yet been updated to cover (the new rules on) data protection may rely on their internal systems, rules and procedures, provided that they ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subject - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the personal data. Participants must inform the coordinator without delay of any changes to the systems, rules and procedures that were part of the pillar assessment. The coordinator must immediately inform the granting authority. Pillar-assessed participants that have also concluded a framework agreement with the EU, may moreover — under the same conditions as those above (i.e. not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries) — rely on the provisions set out in that framework agreement. SECTION 2 RULES FOR CARRYING OUT THE ACTION ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION 11.1 Obligation to properly implement the action The beneficiaries must implement the action as described in Annex 1 and in compliance with the provisions of the Agreement, the call conditions and all legal obligations under applicable EU, international and national law. 11.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 12 — CONFLICT OF INTERESTS 12.1 Conflict of interests 31 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 The beneficiaries must take all measures to prevent any situation where the impartial and objective implementation of the Agreement could be compromised for reasons involving family, emotional life, political or national affinity, economic interest or any other direct or indirect interest (‘conflict of interests’). They must formally notify the granting authority without delay of any situation constituting or likely to lead to a conflict of interests and immediately take all the necessary steps to rectify this situation. The granting authority may verify that the measures taken are appropriate and may require additional measures to be taken by a specified deadline. 12.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the beneficiary may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 13 — CONFIDENTIALITY AND SECURITY 13.1 Sensitive information The parties must keep confidential any data, documents or other material (in any form) that is identified as sensitive in writing (‘sensitive information’) — during the implementation of the action and for at least until the time-limit set out in the Data Sheet (see Point 6). If a beneficiary requests, the granting authority may agree to keep such information confidential for a longer period. Unless otherwise agreed between the parties, they may use sensitive information only to implement the Agreement. The beneficiaries may disclose sensitive information to their personnel or other participants involved in the action only if they: (a) need to know it in order to implement the Agreement and (b) are bound by an obligation of confidentiality. The granting authority may disclose sensitive information to its staff and to other EU institutions and bodies. It may moreover disclose sensitive information to third parties, if: (a) this is necessary to implement the Agreement or safeguard the EU financial interests and (b) the recipients of the information are bound by an obligation of confidentiality. The confidentiality obligations no longer apply if: (a) the disclosing party agrees to release the other party (b) the information becomes publicly available, without breaching any confidentiality obligation 32 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 (c) the disclosure of the sensitive information is required by EU, international or national law. Specific confidentiality rules (if any) are set out in Annex 5. 13.2 Classified information The parties must handle classified information in accordance with the applicable EU, international or national law on classified information (in particular, Decision 2015/44414 and its implementing rules). Deliverables which contain classified information must be submitted according to special procedures agreed with the granting authority. Action tasks involving classified information may be subcontracted only after explicit approval (in writing) from the granting authority. Classified information may not be disclosed to any third party (including participants involved in the action implementation) without prior explicit written approval from the granting authority. Specific security rules (if any) are set out in Annex 5. 13.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 14 — ETHICS AND VALUES 14.1 Ethics The action must be carried out in line with the highest ethical standards and the applicable EU, international and national law on ethical principles. Specific ethics rules (if any) are set out in Annex 5. 14.2 Values The beneficiaries must commit to and ensure the respect of basic EU values (such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities). Specific rules on values (if any) are set out in Annex 5. 14.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). 14 Commission Decision 2015/444/EC, Euratom of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 33 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Such breaches may also lead to other measures described in Chapter 5. ARTICLE 15 — DATA PROTECTION 15.1 Data processing by the granting authority Any personal data under the Agreement will be processed under the responsibility of the data controller of the granting authority in accordance with and for the purposes set out in the Portal Privacy Statement. For grants where the granting authority is the European Commission, an EU regulatory or executive agency, joint undertaking or other EU body, the processing will be subject to Regulation 2018/172515. 15.2 Data processing by the beneficiaries The beneficiaries must process personal data under the Agreement in compliance with the applicable EU, international and national law on data protection (in particular, Regulation 2016/67916). They must ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subjects - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the data. The beneficiaries may grant their personnel access to personal data only if it is strictly necessary for implementing, managing and monitoring the Agreement. The beneficiaries must ensure that the personnel is under a confidentiality obligation. The beneficiaries must inform the persons whose data are transferred to the granting authority and provide them with the Portal Privacy Statement. 15.3 Consequences of non-compliance 15 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 16 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 (‘GDPR’) (OJ L 119, 4.5.2016, p. 1). 34 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS —ACCESS RIGHTS AND RIGHTS OF USE 16.1 Background and access rights to background The beneficiaries must give each other and the other participants access to the background identified as needed for implementing the action, subject to any specific rules in Annex 5. ‘Background’ means any data, know-how or information — whatever its form or nature (tangible or intangible), including any rights such as intellectual property rights — that is: (a) held by the beneficiaries before they acceded to the Agreement and (b) needed to implement the action or exploit the results. If background is subject to rights of a third party, the beneficiary concerned must ensure that it is able to comply with its obligations under the Agreement. 16.2 Ownership of results The granting authority does not obtain ownership of the results produced under the action. ‘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. 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes The granting authority has the right to use non-sensitive information relating to the action and materials and documents received from the beneficiaries (notably summaries for publication, deliverables, as well as any other material, such as pictures or audio-visual material, in paper or electronic form) for policy, information, communication, dissemination and publicity purposes — during the action or afterwards. The right to use the beneficiaries’ materials, documents and information is granted in the form of a royalty-free, non-exclusive and irrevocable licence, which includes the following rights: (a) use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) (b) distribution to the public (in particular, publication as hard copies and in electronic or digital format, publication on the internet, as a downloadable or non-downloadable file, broadcasting by any channel, public display or presentation, communicating through press information services, or inclusion in widely accessible databases or indexes) 35 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 (c) editing or redrafting (including shortening, summarising, inserting other elements (e.g. meta-data, legends, other graphic, visual, audio or text elements), extracting parts (e.g. audio or video files), dividing into parts, use in a compilation) (d) translation (e) storage in paper, electronic or other form (f) archiving, in line with applicable document-management rules (g) the right to authorise third parties to act on its behalf or sub-license to third parties the modes of use set out in Points (b), (c), (d) and (f), if needed for the information, communication and publicity activity of the granting authority (h) processing, analysing, aggregating the materials, documents and information received and producing derivative works. The rights of use are granted for the whole duration of the industrial or intellectual property rights concerned. If materials or documents are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Where applicable, the granting authority will insert the following information: “© – [year] – [name of the copyright owner]. All rights reserved. Licensed to the [name of granting authority] under conditions.” 16.4 Specific rules on IPR, results and background Specific rules regarding intellectual property rights, results and background (if any) are set out in Annex 5. 16.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY 17.1 Communication — Dissemination — Promoting the action Unless otherwise agreed with the granting authority, the beneficiaries must promote the action and its results by providing targeted information to multiple audiences (including the media and the public), in accordance with Annex 1 and in a strategic, coherent and effective manner. Before engaging in a communication or dissemination activity expected to have a major media impact, the beneficiaries must inform the granting authority. 36 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 17.2 Visibility — European flag and funding statement Unless otherwise agreed with the granting authority, communication activities of the beneficiaries 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.), 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 (translated into local languages, where appropriate): The emblem must remain distinct and separate and cannot be modified by adding other visual marks, brands or text. Apart from the emblem, no other visual identity or logo may be used to highlight the EU support. When displayed in association with other logos (e.g. of beneficiaries or sponsors), the emblem must be displayed at least as prominently and visibly as the other logos. For the purposes of their obligations under this Article, the beneficiaries may use the emblem without first obtaining approval from the granting authority. This does not, however, give them the right to exclusive use. Moreover, they may not appropriate the emblem or any similar trademark or logo, either by registration or by any other means. 17.3 Quality of information — Disclaimer 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): 37 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 “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.” 17.4 Specific communication, dissemination and visibility rules Specific communication, dissemination and visibility rules (if any) are set out in Annex 5. 17.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION 18.1 Specific rules for carrying out the action Specific rules for implementing the action (if any) are set out in Annex 5. 18.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. SECTION 3 GRANT ADMINISTRATION ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS 19.1 Information requests The beneficiaries must provide — during the action or afterwards and in accordance with Article 7 — any information requested in order to verify eligibility of the costs or contributions declared, proper implementation of the action and compliance with the other obligations under the Agreement. The information provided must be accurate, precise and complete and in the format requested, including electronic format. 19.2 Participant Register data updates The beneficiaries must keep — at all times, during the action or afterwards — their information stored in the Portal Participant Register up to date, in particular, their name, address, legal representatives, legal form and organisation type. 19.3 Information about events and circumstances which impact the action The beneficiaries must immediately inform the granting authority (and the other beneficiaries) of any of the following: 38 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 (a) events which are likely to affect or delay the implementation of the action or affect the EU’s financial interests, in particular: (i) changes in their legal, financial, technical, organisational or ownership situation (including changes linked to one of the exclusion grounds listed in the declaration of honour signed before grant signature) (ii) linked action information: not applicable (b) circumstances affecting: (i) the decision to award the grant or (ii) compliance with requirements under the Agreement. 19.4 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 20 — RECORD-KEEPING 20.1 Keeping records and supporting documents The beneficiaries must — at least until the time-limit set out in the Data Sheet (see Point 6) — keep records and other supporting documents to prove the proper implementation of the action in line with the accepted standards in the respective field (if any). In addition, the beneficiaries must — for the same period — keep the following to justify the amounts declared: (a) for actual costs: adequate records and supporting documents to prove the costs declared (such as contracts, subcontracts, invoices and accounting records); in addition, the beneficiaries’ usual accounting and internal control procedures must enable direct reconciliation between the amounts declared, the amounts recorded in their accounts and the amounts stated in the supporting documents (b) for flat-rate costs and contributions (if any): adequate records and supporting documents to prove the eligibility of the costs or contributions to which the flat-rate is applied (c) for the following simplified costs and contributions: the beneficiaries do not need to keep specific records on the actual costs incurred, but must keep: (i) for unit costs and contributions (if any): adequate records and supporting documents to prove the number of units declared (ii) for lump sum costs and contributions (if any): adequate records and supporting documents to prove proper implementation of the work as described in Annex 1 (iii) for financing not linked to costs (if any): adequate records and supporting documents 39 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 to prove the achievement of the results or the fulfilment of the conditions as described in Annex 1 (d) for unit, flat-rate and lump sum costs and contributions according to usual cost accounting practices (if any): the beneficiaries must keep any adequate records and supporting documents to prove that their cost accounting practices have been applied in a consistent manner, based on objective criteria, regardless of the source of funding, and that they comply with the eligibility conditions set out in Articles 6.1 and 6.2. Moreover, the following is needed for specific budget categories: (e) for personnel costs: time worked for the beneficiary under the action must be supported by declarations signed monthly by the person and their supervisor, unless another reliable time-record system is in place; the granting authority may accept alternative evidence supporting the time worked for the action declared, if it considers that it offers an adequate level of assurance (f) additional record-keeping rules: not applicable The records and supporting documents must be made available upon request (see Article 19) or in the context of checks, reviews, audits or investigations (see Article 25). If there are on-going checks, reviews, audits, investigations, litigation or other pursuits of claims under the Agreement (including the extension of findings; see Article 25), the beneficiaries must keep these records and other supporting documentation until the end of these procedures. The beneficiaries must keep the original documents. Digital and digitalised documents are considered originals if they are authorised by the applicable national law. The granting authority may accept non-original documents if they offer a comparable level of assurance. 20.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 21 — REPORTING 21.1 Continuous reporting The beneficiaries must continuously report on the progress of the action (e.g. deliverables, milestones, outputs/outcomes, critical risks, indicators, etc; if any), in the Portal Continuous Reporting tool and in accordance with the timing and conditions it sets out (as agreed with the granting authority). Standardised deliverables (e.g. progress reports not linked to payments, reports on cumulative expenditure, special reports, etc; if any) must be submitted using the templates published on the Portal. 21.2 Periodic reporting: Technical reports and financial statements 40 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 In addition, the beneficiaries must provide reports to request payments, in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2): - for additional prefinancings (if any): an additional prefinancing report - for interim payments (if any) and the final payment: a periodic report. The prefinancing and periodic reports include a technical and financial part. The technical part includes an overview of the action implementation. It must be prepared using the template available in the Portal Periodic Reporting tool. The financial part of the additional prefinancing report includes a statement on the use of the previous prefinancing payment. The financial part of the periodic report includes: - the financial statements (individual and consolidated; for all beneficiaries/affiliated entities) - the explanation on the use of resources (or detailed cost reporting table, if required) - the certificates on the financial statements (CFS) (if required; see Article 24.2 and Data Sheet, Point 4.3). The financial statements must detail the eligible costs and contributions for each budget category and, for the final payment, also the revenues for the action (see Articles 6 and 22). All eligible costs and contributions incurred should be declared, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Amounts that are not declared in the individual financial statements will not be taken into account by the granting authority. By signing the financial statements (directly in the Portal Periodic Reporting tool), the beneficiaries confirm that: - the information provided is complete, reliable and true - the costs and contributions declared are eligible (see Article 6) - the costs and contributions can be substantiated by adequate records and supporting documents (see Article 20) that will be produced upon request (see Article 19) or in the context of checks, reviews, audits and investigations (see Article 25) - for the final periodic report: all the revenues have been declared (if required; see Article 22). Beneficiaries will have to submit also the financial statements of their affiliated entities (if any). In case of recoveries (see Article 22), beneficiaries will be held responsible also for the financial statements of their affiliated entities. 21.3 Currency for financial statements and conversion into euros The financial statements must be drafted in euro. Beneficiaries with general accounts established in a currency other than the euro must convert the 41 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 costs recorded in their accounts into euro, at the average of the daily exchange rates published in the C series of the Official Journal of the European Union (ECB website), calculated over the corresponding reporting period. If no daily euro exchange rate is published in the Official Journal for the currency in question, they must be converted at the average of the monthly accounting exchange rates published on the European Commission website (InforEuro), calculated over the corresponding reporting period. Beneficiaries with general accounts in euro must convert costs incurred in another currency into euro according to their usual accounting practices. 21.4 Reporting language The reporting must be in the language of the Agreement, unless otherwise agreed with the granting authority (see Data Sheet, Point 4.2). 21.5 Consequences of non-compliance If a report submitted does not comply with this Article, the granting authority may suspend the payment deadline (see Article 29) and apply other measures described in Chapter 5. If the coordinator breaches its reporting obligations, the granting authority may terminate the grant or the coordinator’s participation (see Article 32) or apply other measures described in Chapter 5. ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE 22.1 Payments and payment arrangements Payments will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). They will be made in euro to the bank account indicated by the coordinator (see Data Sheet, Point 4.2) and must be distributed without unjustified delay (restrictions may apply to distribution of the initial prefinancing payment; see Data Sheet, Point 4.2). Payments to this bank account will discharge the granting authority from its payment obligation. The cost of payment transfers will be borne as follows: - the granting authority bears the cost of transfers charged by its bank - the beneficiary bears the cost of transfers charged by its bank - the party causing a repetition of a transfer bears all costs of the repeated transfer. Payments by the granting authority will be considered to have been carried out on the date when they are debited to its account. 22.2 Recoveries 42 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Recoveries will be made, if — at beneficiary termination, final payment or afterwards — it turns out that the granting authority has paid too much and needs to recover the amounts undue. The general liability regime for recoveries (first-line liability) is as follows: At final payment, the coordinator will be fully liable for recoveries, even if it has not been the final recipient of the undue amounts. At beneficiary termination or after final payment, recoveries will be made directly against the beneficiaries concerned. Beneficiaries will be fully liable for repaying the debts of their affiliated entities. In case of enforced recoveries (see Article 22.4): - the beneficiaries will be jointly and severally liable for repaying debts of another beneficiary under the Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4) - affiliated entities will be held liable for repaying debts of their beneficiaries under the Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4). 22.3 Amounts due 22.3.1 Prefinancing payments The aim of the prefinancing is to provide the beneficiaries with a float. It remains the property of the EU until the final payment. For initial prefinancings (if any), the amount due, schedule and modalities are set out in the Data Sheet (see Point 4.2). For additional prefinancings (if any), the amount due, schedule and modalities are also set out in the Data Sheet (see Point 4.2). However, if the statement on the use of the previous prefinancing payment shows that less than 70% was used, the amount set out in the Data Sheet will be reduced by the difference between the 70% threshold and the amount used. Prefinancing payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.2 Amount due at beneficiary termination — Recovery In case of beneficiary termination, the granting authority will determine the provisional amount due for the beneficiary concerned. Payments (if any) will be made with the next interim or final payment. The amount due will be calculated in the following step: 43 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Step 1 — Calculation of the total accepted EU contribution Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the beneficiary for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of the beneficiary), taking into account requests for a lower contribution to costs and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’ for the beneficiary. The balance is then calculated by deducting the payments received (if any; see report on the distribution of payments in Article 32), from the total accepted EU contribution: {total accepted EU contribution for the beneficiary minus {prefinancing and interim payments received (if any)}}. If the balance is positive, the amount will be included in the next interim or final payment to the consortium. If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount due, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered and ask this amount to be paid to the coordinator (confirmation letter). The amounts will later on also be taken into account for the next interim or final payment. 22.3.3 Interim payments Interim payments reimburse the eligible costs and contributions claimed for the implementation of the action during the reporting periods (if any). Interim payments (if any) will be made in accordance with the schedule and modalities set out the Data Sheet (see Point 4.2). Payment is subject to the approval of the periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The interim payment will be calculated by the granting authority in the following steps: Step 1 — Calculation of the total accepted EU contribution 44 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Step 2 — Limit to the interim payment ceiling Step 1 — Calculation of the total accepted EU contribution The granting authority will calculate the ‘accepted EU contribution’ for the action for the reporting period, by first calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions from beneficiary termination (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the interim payment ceiling The resulting amount is then capped to ensure that the total amount of prefinancing and interim payments (if any) does not exceed the interim payment ceiling set out in the Data Sheet (see Point 4.2). Interim payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.4 Final payment — Final grant amount — Revenues and Profit — Recovery The final payment (payment of the balance) reimburses the remaining part of the eligible costs and contributions claimed for the implementation of the action (if any). The final payment will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). Payment is subject to the approval of the final periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The final grant amount for the action will be calculated in the following steps: Step 1 — Calculation of the total accepted EU contribution Step 2 — Limit to the maximum grant amount Step 3 — Reduction due to the no-profit rule Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the action for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the total accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, CFS 45 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the maximum grant amount If the resulting amount is higher than the maximum grant amount set out in Article 5.2, it will be limited to the latter. Step 3 — Reduction due to the no-profit rule If the no-profit rule is provided for in the Data Sheet (see Point 4.2), the grant must not produce a profit (i.e. surplus of the amount obtained following Step 2 plus the action’s revenues, over the eligible costs and contributions approved by the granting authority). ‘Revenue’ is all income generated by the action, during its duration (see Article 4), for beneficiaries that are profit legal entities. If there is a profit, it will be deducted in proportion to the final rate of reimbursement of the eligible costs approved by the granting authority (as compared to the amount calculated following Steps 1 and 2 minus the contributions). The balance (final payment) is then calculated by deducting the total amount of prefinancing and interim payments already made (if any), from the final grant amount: {final grant amount minus {prefinancing and interim payments made (if any)}}. If the balance is positive, it will be paid to the coordinator. The final payment (or part of it) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to recover, the final grant amount, the amount to be recovered and the reasons why - requesting observations within 30 days of receiving notification. 46 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and date for payment. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 22.3.5 Audit implementation after final payment — Revised final grant amount — Recovery If — after the final payment (in particular, after checks, reviews, audits or investigations; see Article 25) — the granting authority rejects costs or contributions (see Article 27) or reduces the grant (see Article 28), it will calculate the revised final grant amount for the beneficiary concerned. The beneficiary revised final grant amount will be calculated in the following step: Step 1 — Calculation of the revised total accepted EU contribution Step 1 — Calculation of the revised total accepted EU contribution The granting authority will first calculate the ‘revised accepted EU contribution’ for the beneficiary, by calculating the ‘revised accepted costs’ and ‘revised accepted contributions’. After that, it will take into account grant reductions (if any). The resulting ‘revised total accepted EU contribution’ is the beneficiary revised final grant amount. If the revised final grant amount is lower than the beneficiary’s final grant amount (i.e. its share in the final grant amount for the action), it will be recovered in accordance with the following procedure: The beneficiary final grant amount (i.e. share in the final grant amount for the action) is calculated as follows: {{total accepted EU contribution for the beneficiary divided by total accepted EU contribution for the action} multiplied by final grant amount for the action}. The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and the date for payment. Recoveries against affiliated entities (if any) will be handled through their beneficiaries. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 47 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 22.4 Enforced recovery If payment is not made by the date specified in the debit note, the amount due will be recovered: (a) by offsetting the amount — without the coordinator or beneficiary’s consent — against any amounts owed to the coordinator or beneficiary by the granting authority. In exceptional circumstances, to safeguard the EU financial interests, the amount may be offset before the payment date specified in the debit note. For grants where the granting authority is the European Commission or an EU executive agency, debts may also be offset against amounts owed by other Commission services or executive agencies. (b) by drawing on the financial guarantee(s) (if any) (c) by holding other beneficiaries jointly and severally liable (if any; see Data Sheet, Point 4.4) (d) by holding affiliated entities jointly and severally liable (if any, see Data Sheet, Point 4.4) (e) by taking legal action (see Article 43) or, provided that the granting authority is the European Commission or an EU executive agency, by adopting an enforceable decision under Article 299 of the Treaty on the Functioning of the EU (TFEU) and Article 100(2) of EU Financial Regulation 2018/1046. The amount to be recovered will be increased by late-payment interest at the rate set out in Article 22.5, from the day following the payment date in the debit note, up to and including the date the full payment is received. Partial payments will be first credited against expenses, charges and late-payment interest and then against the principal. Bank charges incurred in the recovery process will be borne by the beneficiary, unless Directive 2015/236617 applies. For grants where the granting authority is an EU executive agency, enforced recovery by offsetting or enforceable decision will be done by the services of the European Commission (see also Article 43). 22.5 Consequences of non-compliance 22.5.1 If the granting authority does not pay within the payment deadlines (see above), the beneficiaries are entitled to late-payment interest at the rate applied by the European Central Bank (ECB) for its main refinancing operations in euros (‘reference rate’), plus the rate specified in the Data Sheet (Point 4.2). The reference rate is the rate in force on the first day of the month in which the payment deadline expires, as published in the C series of the Official Journal of the European Union. If the late-payment interest is lower than or equal to EUR 200, it will be paid to the coordinator only on request submitted within two months of receiving the late payment. 17 Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). 48 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Late-payment interest is not due if all beneficiaries are EU Member States (including regional and local government authorities or other public bodies acting on behalf of a Member State for the purpose of this Agreement). If payments or the payment deadline are suspended (see Articles 29 and 30), payment will not be considered as late. Late-payment interest covers the period running from the day following the due date for payment (see above), up to and including the date of payment. Late-payment interest is not considered for the purposes of calculating the final grant amount. 22.5.2 If the coordinator breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the coordinator may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 23 — GUARANTEES 23.1 Prefinancing guarantee If required by the granting authority (see Data Sheet, Point 4.2), the beneficiaries must provide (one or more) prefinancing guarantee(s) in accordance with the timing and the amounts set out in the Data Sheet. The coordinator must submit them to the granting authority in due time before the prefinancing they are linked to. The guarantees must be drawn up using the template published on the Portal and fulfil the following conditions: (a) be provided by a bank or approved financial institution established in the EU or — if requested by the coordinator and accepted by the granting authority — by a third party or a bank or financial institution established outside the EU offering equivalent security (b) the guarantor stands as first-call guarantor and does not require the granting authority to first have recourse against the principal debtor (i.e. the beneficiary concerned) and (c) remain explicitly in force until the final payment and, if the final payment takes the form of a recovery, until five months after the debit note is notified to a beneficiary. They will be released within the following month. 23.2 Consequences of non-compliance If the beneficiaries breach their obligation to provide the prefinancing guarantee, the prefinancing will not be paid. Such breaches may also lead to other measures described in Chapter 5. ARTICLE 24 — CERTIFICATES 49 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 24.1 Operational verification report (OVR) Not applicable 24.2 Certificate on the financial statements (CFS) If required by the granting authority (see Data Sheet, Point 4.3), the beneficiaries must provide certificates on their financial statements (CFS), in accordance with the schedule, threshold and conditions set out in the Data Sheet. The coordinator must submit them as part of the periodic report (see Article 21). The certificates must be drawn up using the template published on the Portal, cover the costs declared on the basis of actual costs and costs according to usual cost accounting practices (if any), and fulfil the following conditions: (a) be provided by a qualified approved external auditor which is independent and complies with Directive 2006/43/EC18 (or for public bodies: by a competent independent public officer) (b) the verification must be carried out according to the highest professional standards to ensure that the financial statements comply with the provisions under the Agreement and that the costs declared are eligible. The certificates will not affect the granting authority's right to carry out its own checks, reviews or audits, nor preclude the European Court of Auditors (ECA), the European Public Prosecutor’s Office (EPPO) or the European Anti-Fraud Office (OLAF) from using their prerogatives for audits and investigations under the Agreement (see Article 25). If the costs (or a part of them) were already audited by the granting authority, these costs do not need to be covered by the certificate and will not be counted for calculating the threshold (if any). 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC) Beneficiaries which use unit, flat rate or lump sum costs or contributions according to usual costs accounting practices (if any) may submit to the granting authority, for approval, a certificate on the methodology stating that their usual cost accounting practices comply with the eligibility conditions under the Agreement. The certificate must be drawn up using the template published on the Portal and fulfil the following conditions: (a) be provided by a qualified approved external auditor which is independent and complies with Directive 2006/43/EC19 (or for public bodies: by a competent independent public officer) (b) the verification must be carried out according to the highest professional standards to ensure that the methodology for declaring costs according to usual accounting practices complies with the provisions under the Agreement. 18 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 19 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 50 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 If the certificate is approved, amounts declared in line with this methodology will not be challenged subsequently, unless the beneficiary concealed information for the purpose of the approval. 24.4 Systems and process audit (SPA) Not applicable 24.5 Consequences of non-compliance If a beneficiary does not submit a certificate on the financial statements (CFS) or the certificate is rejected, the accepted EU contribution to costs will be capped to reflect the CFS threshold. If a beneficiary breaches any of its other obligations under this Article, the granting authority may apply the measures described in Chapter 5. ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS 25.1 Granting authority checks, reviews and audits 25.1.1 Internal checks The granting authority may — during the action or afterwards — check the proper implementation of the action and compliance with the obligations under the Agreement, including assessing costs and contributions, deliverables and reports. 25.1.2 Project reviews The granting authority may carry out reviews on the proper implementation of the action and compliance with the obligations under the Agreement (general project reviews or specific issues reviews). Such project reviews may be started during the implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiary concerned and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent, outside experts. If it uses outside experts, the coordinator or beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The coordinator or beneficiary concerned must cooperate diligently and provide — within the deadline requested — any information and data in addition to deliverables and reports already submitted (including information on the use of resources). The granting authority may request beneficiaries to provide such information to it directly. Sensitive information and documents will be treated in accordance with Article 13. The coordinator or beneficiary concerned may be requested to participate in meetings, including with the outside experts. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including to the outside experts) and must ensure that information requested is readily available. 51 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the review findings, a project review report will be drawn up. The granting authority will formally notify the project review report to the coordinator or beneficiary concerned, which has 30 days from receiving notification to make observations. Project reviews (including project review reports) will be in the language of the Agreement, unless otherwise agreed with the granting authority (see Data Sheet, Point 4.2). 25.1.3 Audits The granting authority may carry out audits on the proper implementation of the action and compliance with the obligations under the Agreement. Such audits may be started during the implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the beneficiary concerned and will be considered to start on the date of the notification. The granting authority may use its own audit service, delegate audits to a centralised service or use external audit firms. If it uses an external firm, the beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The beneficiary concerned must cooperate diligently and provide — within the deadline requested — any information (including complete accounts, individual salary statements or other personal data) to verify compliance with the Agreement. Sensitive information and documents will be treated in accordance with Article 13. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including for the external audit firm) and must ensure that information requested is readily available. Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the audit findings, a draft audit report will be drawn up. The auditors will formally notify the draft audit report to the beneficiary concerned, which has 30 days from receiving notification to make observations (contradictory audit procedure). The final audit report will take into account observations by the beneficiary concerned and will be formally notified to them. Audits (including audit reports) will be in the language of the Agreement, unless otherwise agreed with the granting authority (see Data Sheet, Point 4.2). 25.2 European Commission checks, reviews and audits in grants of other granting authorities Where the granting authority is not the European Commission, the latter has the same rights of checks, reviews and audits as the granting authority. 52 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 25.3 Access to records for assessing simplified forms of funding The beneficiaries must give the European Commission access to their statutory records for the periodic assessment of simplified forms of funding which are used in EU programmes. 25.4 OLAF, EPPO and ECA audits and investigations The following bodies may also carry out checks, reviews, audits and investigations — during the action or afterwards: - the European Anti-Fraud Office (OLAF) under Regulations No 883/201320 and No 2185/9621 - the European Public Prosecutor’s Office (EPPO) under Regulation 2017/1939 - the European Court of Auditors (ECA) under Article 287 of the Treaty on the Functioning of the EU (TFEU) and Article 257 of EU Financial Regulation 2018/1046. If requested by these bodies, the beneficiary concerned must provide full, accurate and complete information in the format requested (including complete accounts, individual salary statements or other personal data, including in electronic format) and allow access to sites and premises for on-the-spot visits or inspections — as provided for under these Regulations. To this end, the beneficiary concerned must keep all relevant information relating to the action, at least until the time-limit set out in the Data Sheet (Point 6) and, in any case, until any ongoing checks, reviews, audits, investigations, litigation or other pursuits of claims have been concluded. 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations 25.5.1 Consequences of checks, reviews, audits and investigations in this grant Findings in checks, reviews, audits or investigations carried out in the context of this grant may lead to rejections (see Article 27), grant reduction (see Article 28) or other measures described in Chapter 5. Rejections or grant reductions after the final payment will lead to a revised final grant amount (see Article 22). Findings in checks, reviews, audits or investigations during the action implementation may lead to a request for amendment (see Article 39), to change the description of the action set out in Annex 1. Checks, reviews, audits or investigations that find systemic or recurrent errors, irregularities, fraud or breach of obligations in any EU grant may also lead to consequences in other EU grants awarded under similar conditions (‘extension to other grants’). 20 Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18/09/2013, p. 1). 21 Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15/11/1996, p. 2). 53 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Moreover, findings arising from an OLAF or EPPO investigation may lead to criminal prosecution under national law. 25.5.2 Extension from other grants Results of checks, reviews, audits or investigations in other grants may be extended to this grant, if: (a) the beneficiary concerned is found, in other EU grants awarded under similar conditions, to have committed systemic or recurrent errors, irregularities, fraud or breach of obligations that have a material impact on this grant and (b) those findings are formally notified to the beneficiary concerned — together with the list of grants affected by the findings — within the time-limit for audits set out in the Data Sheet (see Point 6). The granting authority will formally notify the beneficiary concerned of the intention to extend the findings and the list of grants affected. If the extension concerns rejections of costs or contributions: the notification will include: (a) an invitation to submit observations on the list of grants affected by the findings (b) the request to submit revised financial statements for all grants affected (c) the correction rate for extrapolation, established on the basis of the systemic or recurrent errors, to calculate the amounts to be rejected, if the beneficiary concerned: (i) considers that the submission of revised financial statements is not possible or practicable or (ii) does not submit revised financial statements. If the extension concerns grant reductions: the notification will include: (a) an invitation to submit observations on the list of grants affected by the findings and (b) the correction rate for extrapolation, established on the basis of the systemic or recurrent errors and the principle of proportionality. The beneficiary concerned has 60 days from receiving notification to submit observations, revised financial statements or to propose a duly substantiated alternative correction method/rate. On the basis of this, the granting authority will analyse the impact and decide on the implementation (i.e. start rejection or grant reduction procedures, either on the basis of the revised financial statements or the announced/alternative method/rate or a mix of those; see Articles 27 and 28). 25.6 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. 54 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ARTICLE 26 — IMPACT EVALUATIONS 26.1 Impact evaluation The granting authority may carry out impact evaluations of the action, measured against the objectives and indicators of the EU programme funding the grant. Such evaluations may be started during implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiaries and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent outside experts. The coordinator or beneficiaries must provide any information relevant to evaluate the impact of the action, including information in electronic format. 26.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the granting authority may apply the measures described in Chapter 5. CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE SECTION 1 REJECTIONS AND GRANT REDUCTION ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS 27.1 Conditions The granting authority will — at beneficiary termination, interim payment, final payment or afterwards — reject any costs or contributions which are ineligible (see Article 6), in particular following checks, reviews, audits or investigations (see Article 25). The rejection may also be based on the extension of findings from other grants to this grant (see Article 25). Ineligible costs or contributions will be rejected. 27.2 Procedure If the rejection does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the rejection, the amounts and the reasons why. The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the rejection (payment review procedure). If the rejection leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 27.3 Effects 55 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 If the granting authority rejects costs or contributions, it will deduct them from the costs or contributions declared and then calculate the amount due (and, if needed, make a recovery; see Article 22). ARTICLE 28 — GRANT REDUCTION 28.1 Conditions The granting authority may — at beneficiary termination, final payment or afterwards — reduce the grant for a beneficiary, if: (a) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (see Article 25). The amount of the reduction will be calculated for each beneficiary concerned and proportionate to the seriousness and the duration of the errors, irregularities or fraud or breach of obligations, by applying an individual reduction rate to their accepted EU contribution. 28.2 Procedure If the grant reduction does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the reduction, the amount to be reduced and the reasons why. The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the reduction (payment review procedure). If the grant reduction leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 28.3 Effects If the granting authority reduces the grant, it will deduct the reduction and then calculate the amount due (and, if needed, make a recovery; see Article 22). SECTION 2 SUSPENSION AND TERMINATION ARTICLE 29 — PAYMENT DEADLINE SUSPENSION 29.1 Conditions 56 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 The granting authority may — at any moment — suspend the payment deadline if a payment cannot be processed because: (a) the required report (see Article 21) has not been submitted or is not complete or additional information is needed (b) there are doubts about the amount to be paid (e.g. ongoing audit extension procedure, queries about eligibility, need for a grant reduction, etc.) and additional checks, reviews, audits or investigations are necessary, or (c) there are other issues affecting the EU financial interests. 29.2 Procedure The granting authority will formally notify the coordinator of the suspension and the reasons why. The suspension will take effect the day the notification is sent. If the conditions for suspending the payment deadline are no longer met, the suspension will be lifted — and the remaining time to pay (see Data Sheet, Point 4.2) will resume. If the suspension exceeds two months, the coordinator may request the granting authority to confirm if the suspension will continue. If the payment deadline has been suspended due to the non-compliance of the report and the revised report is not submitted (or was submitted but is also rejected), the granting authority may also terminate the grant or the participation of the coordinator (see Article 32). ARTICLE 30 — PAYMENT SUSPENSION 30.1 Conditions The granting authority may — at any moment — suspend payments, in whole or in part for one or more beneficiaries, if: (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant. If payments are suspended for one or more beneficiaries, the granting authority will make partial 57 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 payment(s) for the part(s) not suspended. If suspension concerns the final payment, the payment (or recovery) of the remaining amount after suspension is lifted will be considered to be the payment that closes the action. 30.2 Procedure Before suspending payments, the granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to suspend payments and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. At the end of the suspension procedure, the granting authority will also inform the coordinator. The suspension will take effect the day after the confirmation notification is sent. If the conditions for resuming payments are met, the suspension will be lifted. The granting authority will formally notify the beneficiary concerned (and the coordinator) and set the suspension end date. During the suspension, no prefinancing will be paid to the beneficiaries concerned. For interim payments, the periodic reports for all reporting periods except the last one (see Article 21) must not contain any financial statements from the beneficiary concerned (or its affiliated entities). The coordinator must include them in the next periodic report after the suspension is lifted or — if suspension is not lifted before the end of the action — in the last periodic report. ARTICLE 31 — GRANT AGREEMENT SUSPENSION 31.1 Consortium-requested GA suspension 31.1.1 Conditions and procedure The beneficiaries may request the suspension of the grant or any part of it, if exceptional circumstances — in particular force majeure (see Article 35) — make implementation impossible or excessively difficult. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the suspension takes effect; this date may be before the date of the submission of the amendment request and - the expected date of resumption. The suspension will take effect on the day specified in the amendment. Once circumstances allow for implementation to resume, the coordinator must immediately request 58 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 another amendment of the Agreement to set the suspension end date, the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the amendment. This date may be before the date of the submission of the amendment request. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during grant suspension are not eligible (see Article 6.3). 31.2 EU-initiated GA suspension 31.2.1 Conditions The granting authority may suspend the grant or any part of it, if: (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (c) other: (i) linked action issues: not applicable (ii) additional GA suspension grounds: not applicable. 31.2.2 Procedure Before suspending the grant, the granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to suspend the grant and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. The suspension will take effect the day after the confirmation notification is sent (or on a later date specified in the notification). 59 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Once the conditions for resuming implementation of the action are met, the granting authority will formally notify the coordinator a lifting of suspension letter, in which it will set the suspension end date and invite the coordinator to request an amendment of the Agreement to set the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the lifting of suspension letter. This date may be before the date on which the letter is sent. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during suspension are not eligible (see Article 6.3). The beneficiaries may not claim damages due to suspension by the granting authority (see Article 33). Grant suspension does not affect the granting authority’s right to terminate the grant or a beneficiary (see Article 32) or reduce the grant (see Article 28). ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION 32.1 Consortium-requested GA termination 32.1.1 Conditions and procedure The beneficiaries may request the termination of the grant. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the consortium ends work on the action (‘end of work date’) and - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. The termination will take effect on the termination date specified in the amendment. If no reasons are given or if the granting authority considers the reasons do not justify termination, it may consider the grant terminated improperly. 32.1.2 Effects The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). 60 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Improper termination may lead to a grant reduction (see Article 28). After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.2 Consortium-requested beneficiary termination 32.2.1 Conditions and procedure The coordinator may request the termination of the participation of one or more beneficiaries, on request of the beneficiary concerned or on behalf of the other beneficiaries. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the opinion of the beneficiary concerned (or proof that this opinion has been requested in writing) - the date the beneficiary ends work on the action (‘end of work date’) - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. If the termination concerns the coordinator and is done without its agreement, the amendment request must be submitted by another beneficiary (acting on behalf of the consortium). The termination will take effect on the termination date specified in the amendment. If no information is given or if the granting authority considers that the reasons do not justify termination, it may consider the beneficiary to have been terminated improperly. 32.2.2 Effects The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a second request for amendment (see Article 39) with other amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. 61 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the second request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the second request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). Improper termination may lead to a reduction of the grant (see Article 31) or grant termination (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.3 EU-initiated GA or beneficiary termination 32.3.1 Conditions The granting authority may terminate the grant or the participation of one or more beneficiaries, if: (a) one or more beneficiaries do not accede to the Agreement (see Article 40) (b) a change to the action or the legal, financial, technical, organisational or ownership situation of a beneficiary is likely to substantially affect the implementation of the action or calls into question the decision to award the grant (including changes linked to one of the exclusion grounds listed in the declaration of honour) (c) following termination of one or more beneficiaries, the necessary changes to the Agreement (and their impact on the action) would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (d) implementation of the action has become impossible or the changes necessary for its continuation would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (e) a beneficiary (or person with unlimited liability for its debts) is subject to bankruptcy 62 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 proceedings or similar (including insolvency, winding-up, administration by a liquidator or court, arrangement with creditors, suspension of business activities, etc.) (f) a beneficiary (or person with unlimited liability for its debts) is in breach of social security or tax obligations (g) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has been found guilty of grave professional misconduct (h) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed fraud, corruption, or is involved in a criminal organisation, money laundering, terrorism-related crimes (including terrorism financing), child labour or human trafficking (i) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) was created under a different jurisdiction with the intent to circumvent fiscal, social or other legal obligations in the country of origin (or created another entity with this purpose) (j) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.) (k) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 25) (l) despite a specific request by the granting authority, a beneficiary does not request — through the coordinator — an amendment to the Agreement to end the participation of one of its affiliated entities or associated partners that is in one of the situations under points (d), (f), (e), (g), (h), (i) or (j) and to reallocate its tasks, or (m) other: (i) linked action issues: not applicable (ii) additional GA termination grounds: not applicable. 32.3.2 Procedure Before terminating the grant or participation of one or more beneficiaries, the granting authority will send a pre-information letter to the coordinator or beneficiary concerned: 63 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 - formally notifying the intention to terminate and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the termination and the date it will take effect (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. For beneficiary terminations, the granting authority will — at the end of the procedure — also inform the coordinator. The termination will take effect the day after the confirmation notification is sent (or on a later date specified in the notification; ‘termination date’). 32.3.3 Effects (a) for GA termination: The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the last open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. If the grant is terminated for breach of the obligation to submit reports, the coordinator may not submit any report after termination. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). Termination does not affect the granting authority’s right to reduce the grant (see Article 28) or to impose administrative sanctions (see Article 34). The beneficiaries may not claim damages due to termination by the granting authority (see Article 33). After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. (b) for beneficiary termination: The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial 64 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a request for amendment (see Article 39) with any amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS ARTICLE 33 — DAMAGES 33.1 Liability of the granting authority The granting authority cannot be held liable for any damage caused to the beneficiaries or to third parties as a consequence of the implementation of the Agreement, including for gross negligence. The granting authority cannot be held liable for any damage caused by any of the beneficiaries or other participants involved in the action, as a consequence of the implementation of the Agreement. 65 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 33.2 Liability of the beneficiaries The beneficiaries must compensate the granting authority for any damage it sustains as a result of the implementation of the action or because the action was not implemented in full compliance with the Agreement, provided that it was caused by gross negligence or wilful act. The liability does not extend to indirect or consequential losses or similar damage (such as loss of profit, loss of revenue or loss of contracts), provided such damage was not caused by wilful act or by a breach of confidentiality. ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES Nothing in this Agreement may be construed as preventing the adoption of administrative sanctions (i.e. exclusion from EU award procedures and/or financial penalties) or other public law measures, in addition or as an alternative to the contractual measures provided under this Agreement (see, for instance, Articles 135 to 145 EU Financial Regulation 2018/1046 and Articles 4 and 7 of Regulation 2988/9522). SECTION 4 FORCE MAJEURE ARTICLE 35 — FORCE MAJEURE A party prevented by force majeure from fulfilling its obligations under the Agreement cannot be considered in breach of them. ‘Force majeure’ means any situation or event that: - prevents either party from fulfilling their obligations under the Agreement, - was unforeseeable, exceptional situation and beyond the parties’ control, - was not due to error or negligence on their part (or on the part of other participants involved in the action), and - proves to be inevitable in spite of exercising all due diligence. Any situation constituting force majeure must be formally notified to the other party without delay, stating the nature, likely duration and foreseeable effects. The parties must immediately take all the necessary steps to limit any damage due to force majeure and do their best to resume implementation of the action as soon as possible. CHAPTER 6 FINAL PROVISIONS ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES 36.1 Forms and means of communication — Electronic management 22 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 66 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 EU grants are managed fully electronically through the EU Funding & Tenders Portal (‘Portal’). All communications must be made electronically through the Portal, in accordance with the Portal Terms and Conditions and using the forms and templates provided there (except if explicitly instructed otherwise by the granting authority). Communications must be made in writing and clearly identify the grant agreement (project number and acronym). Communications must be made by persons authorised according to the Portal Terms and Conditions. For naming the authorised persons, each beneficiary must have designated — before the signature of this Agreement — a ‘legal entity appointed representative (LEAR)’. The role and tasks of the LEAR are stipulated in their appointment letter (see Portal Terms and Conditions). If the electronic exchange system is temporarily unavailable, instructions will be given on the Portal. 36.2 Date of communication The sending date for communications made through the Portal will be the date and time of sending, as indicated by the time logs. The receiving date for communications made through the Portal will be the date and time the communication is accessed, as indicated by the time logs. Formal notifications that have not been accessed within 10 days after sending, will be considered to have been accessed (see Portal Terms and Conditions). If a communication is exceptionally made on paper (by e-mail or postal service), general principles apply (i.e. date of sending/receipt). Formal notifications by registered post with proof of delivery will be considered to have been received either on the delivery date registered by the postal service or the deadline for collection at the post office. If the electronic exchange system is temporarily unavailable, the sending party cannot be considered in breach of its obligation to send a communication within a specified deadline. 36.3 Addresses for communication The Portal can be accessed via the Europa website. The address for paper communications to the granting authority (if exceptionally allowed) is the official mailing address indicated on its website. For beneficiaries, it is the legal address specified in the Portal Participant Register. ARTICLE 37 — INTERPRETATION OF THE AGREEMENT The provisions in the Data Sheet take precedence over the rest of the Terms and Conditions of the Agreement. Annex 5 takes precedence over the Terms and Conditions; the Terms and Conditions take precedence over the Annexes other than Annex 5. Annex 2 takes precedence over Annex 1. 67 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES In accordance with Regulation No 1182/7123, periods expressed in days, months or years are calculated from the moment the triggering event occurs. The day during which that event occurs is not considered as falling within the period. ‘Days’ means calendar days, not working days. ARTICLE 39 — AMENDMENTS 39.1 Conditions The Agreement may be amended, unless the amendment entails changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants. Amendments may be requested by any of the parties. 39.2 Procedure The party requesting an amendment must submit a request for amendment signed directly in the Portal Amendment tool. The coordinator submits and receives requests for amendment on behalf of the beneficiaries (see Annex 3). If a change of coordinator is requested without its agreement, the submission must be done by another beneficiary (acting on behalf of the other beneficiaries). The request for amendment must include: - the reasons why - the appropriate supporting documents and - for a change of coordinator without its agreement: the opinion of the coordinator (or proof that this opinion has been requested in writing). The granting authority may request additional information. If the party receiving the request agrees, it must sign the amendment in the tool within 45 days of receiving notification (or any additional information the granting authority has requested). If it does not agree, it must formally notify its disagreement within the same deadline. The deadline may be extended, if necessary for the assessment of the request. If no notification is received within the deadline, the request is considered to have been rejected. An amendment enters into force on the day of the signature of the receiving party. An amendment takes effect on the date of entry into force or other date specified in the amendment. 23 Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time-limits (OJ L 124, 8/6/1971, p. 1). 68 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES 40.1 Accession of the beneficiaries mentioned in the Preamble The beneficiaries which are not coordinator must accede to the grant by signing the accession form (see Annex 3) directly in the Portal Grant Preparation tool, within 30 days after the entry into force of the Agreement (see Article 44). They will assume the rights and obligations under the Agreement with effect from the date of its entry into force (see Article 44). If a beneficiary does not accede to the grant within the above deadline, the coordinator must — within 30 days — request an amendment (see Article 39) to terminate the beneficiary and make any changes necessary to ensure proper implementation of the action. This does not affect the granting authority’s right to terminate the grant (see Article 32). 40.2 Addition of new beneficiaries In justified cases, the beneficiaries may request the addition of a new beneficiary. For this purpose, the coordinator must submit a request for amendment in accordance with Article 39. It must include an accession form (see Annex 3) signed by the new beneficiary directly in the Portal Amendment tool. New beneficiaries will assume the rights and obligations under the Agreement with effect from the date of their accession specified in the accession form (see Annex 3). Additions are also possible in mono-beneficiary grants. ARTICLE 41 — TRANSFER OF THE AGREEMENT In justified cases, the beneficiary of a mono-beneficiary grant may request the transfer of the grant to a new beneficiary, provided that this would not call into question the decision awarding the grant or breach the principle of equal treatment of applicants. The beneficiary must submit a request for amendment (see Article 39), with - the reasons why - the accession form (see Annex 3) signed by the new beneficiary directly in the Portal Amendment tool and - additional supporting documents (if required by the granting authority). The new beneficiary will assume the rights and obligations under the Agreement with effect from the date of accession specified in the accession form (see Annex 3). ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY The beneficiaries may not assign any of their claims for payment against the granting authority to 69 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 any third party, except if expressly approved in writing by the granting authority on the basis of a reasoned, written request by the coordinator (on behalf of the beneficiary concerned). If the granting authority has not accepted the assignment or if the terms of it are not observed, the assignment will have no effect on it. In no circumstances will an assignment release the beneficiaries from their obligations towards the granting authority. ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES 43.1 Applicable law The Agreement is governed by the applicable EU law, supplemented if necessary by the law of Belgium. Special rules may apply for beneficiaries which are international organisations (if any; see Data Sheet, Point 5). 43.2 Dispute settlement If a dispute concerns the interpretation, application or validity of the Agreement, the parties must bring action before the EU General Court — or, on appeal, the EU Court of Justice — under Article 272 of the Treaty on the Functioning of the EU (TFEU). For non-EU beneficiaries (if any), such disputes must be brought before the courts of Brussels, Belgium — unless an international agreement provides for the enforceability of EU court judgements. For beneficiaries with arbitration as special dispute settlement forum (if any; see Data Sheet, Point 5), the dispute will — in the absence of an amicable settlement — be settled in accordance with the Rules for Arbitration published on the Portal. If a dispute concerns administrative sanctions, offsetting or an enforceable decision under Article 299 TFEU (see Articles 22 and 34), the beneficiaries must bring action before the General Court — or, on appeal, the Court of Justice — under Article 263 TFEU. For grants where the granting authority is an EU executive agency (see Preamble), actions against offsetting and enforceable decisions must be brought against the European Commission (not against the granting authority; see also Article 22). ARTICLE 44 — ENTRY INTO FORCE The Agreement will enter into force on the day of signature by the granting authority or the coordinator, depending on which is later. 70 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 SIGNATURES For the coordinator For the granting authority [--TGSMark#signature-999988230_75_210--] [--TGSMark#signature-service_75_210--] Virginia OTON with ECAS id notonvir signed in the Participant Portal Signed by Mikaela FARR-DAVID with ECAS id farrdmi as an authorised on 13/03/2025 at 09:15:14 (transaction id SigId-1587-OGGMp1bX0z representative on 13-03-2025 09:33:43 (transaction id SigId-1807-QD zZ3BMlzT1mxJSoyFzMI7kvwTp2nPIfJMdAfIOP17IkaKZT9wqOVqKksZ DiKzkdzxh3leV3r1FC26BktVUSi86UxTczKMIzffBZXQNB2XQKUDegDf4 H82QGJd6i7LvznTW42qIm-yntOf97TTHqEoxWy94AED4-T61wL0SCd uh7LoDsnnJUfoho92i4n1RNLN7wy-yntOf97TTHqEoxWy94AED4-QUW SGmRVSY3mAaQw6E1pzx5UvW8khtbCV108hgRQkm1HtiOyXJzcsUzl zWhY40UQKAmGkvNHvNPQaHEQBHOiluDVXNwwLKTYnRPGNlZ7nHzj jo7EwY4BOrzr6uTQb185zJuGt). Timestamp by third party at P3SDZWeSOFzvdLdVnigZ0BwcE2xAhrEm) 2025.03.13 09:15:22 CET 2025.03.13 09:33:48 CET 71  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 1 Digital Europe Programme (DIGITAL) Description of the action (DoA) Part A Part B Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 DESCRIPTION OF THE ACTION (PART A) COVER PAGE Part A of the Description of the Action (DoA) must be completed directly on the Portal Grant Preparation screens. PROJECT Grant Preparation (General Information screen) — Enter the info. Project number: 101194865 Project name: Beyond 1 Million Genomes Plus Project acronym: B1MGplus Call: DIGITAL-2024-CLOUD-DATA-AI-06 Topic: DIGITAL-2024-CLOUD-DATA-AI-06-GENOME Type of action: DIGITAL-CSA Service: CNECT/H/03 Project starting date: fixed date: 1 February 2025 Project duration: 36 months TABLE OF CONTENTS Project summary ......................................................................................................................................................3 List of participants .................................................................................................................................................. 3 List of work packages .............................................................................................................................................6 Staff effort ............................................................................................................................................................. 15 List of deliverables ................................................................................................................................................17 List of milestones (outputs/outcomes) .................................................................................................................. 28 List of critical risks ............................................................................................................................................... 31 Project reviews ...................................................................................................................................................... 33 2 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 PROJECT SUMMARY Project summary Grant Preparation (General Information screen) — Provide an overall description of your project (including context and overall objectives, planned activities and main achievements, and expected results and impacts (on target groups, change procedures, capacities, innovation etc)). This summary should give readers a clear idea of what your project is about. Use the project summary from your proposal. The EU Member States’ initiative 1+ Million Genomes (1+MG) aims to enable secure access to genomic and corresponding clinical data across Europe, supporting research, health policy and personalised healthcare. This initiative follows a two-staged roadmap, via the Beyond 1M Genomes and European Genomic Data Infrastructure projects, alongside 1+MG Working Groups and National Mirror Groups. The Genome of Europe project will build a European network of national genomic reference cohorts. B1MGplus aims to support the scale up and sustainability of 1+MG by supporting Member States’ to create a federated European genomics data infrastructure based on a European Digital Infrastructure Consortium (EDIC). It will also facilitate the uptake of genomics into healthcare delivery and public health policy, while developing the guidelines for meta-data standards and data quality assurance within the 1+MG Framework. B1MGplus activities include: -Preparation of Genome EDIC: drafting of legal and policy documents for operational readiness, supporting GDI Pillar I for long-term sustainability, setting up risk management frameworks and stakeholder interaction plans -Facilitating strategic orientation of the 1+MG initiative -Facilitating the uptake of genomics for healthcare: promoting awareness and engagement of public health professionals, encouraging the maturity assessment of genomics in healthcare systems, creating a citizens' hub for disseminating information on genomics, supporting the demonstration of the economic impact of genomics medicine on healthcare -Developing data standards, ontologies, and sequencing practices to ensure that data made available is 1+MG-ready B1MGplus advances the 1+MG initiative, fostering genomic medicine and personalised healthcare. This project will contribute to unlocking the promise of genomics for healthcare and public health, creating unprecedented opportunities in cancer, common and rare diseases, infectious diseases and pharmacogenomics. LIST OF PARTICIPANTS PARTICIPANTS Grant Preparation (Beneficiaries screen) — Enter the info. Number Role Short name Legal name Country PIC 1 COO ELIXIR / EMBL EUROPEAN MOLECULAR BIOLOGY DE 999988230 LABORATORY 2 BEN LNDS PNED GIE LU 885395049 3 BEN INSA INSTITUTO NACIONAL DE SAUDE DR. PT 998308190 RICARDO JORGE 4 BEN HEALTH-RI STICHTING HEALTH-RI NL 887782025 5 BEN NGC NATIONALT GENOM CENTER DK 886250880 6 BEN CNAG CONSORCIO PARA LA EXPLOTACION ES 882802433 3 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 PARTICIPANTS Grant Preparation (Beneficiaries screen) — Enter the info. Number Role Short name Legal name Country PIC DEL CENTRO NACIONAL DE ANALISIS GENOMICO 7 BEN BSC BARCELONA SUPERCOMPUTING ES 999655520 CENTER CENTRO NACIONAL DE SUPERCOMPUTACION 8 BEN UU UPPSALA UNIVERSITET SE 999985029 9 BEN INSERM INSTITUT NATIONAL DE LA SANTE ET DE LA FR 999997833 RECHERCHE MEDICALE 10 BEN CNR CONSIGLIO NAZIONALE DELLE RICERCHE IT 999979500 11 BEN SLEX SMARTEX SRL SOCIETA' DI PRODOTTI E IT 925521039 SERVIZI GIURIDICI INTERDISCIPLINARI 12 BEN ISCIII INSTITUTO DE SALUD CARLOS III ES 999507886 13 BEN Biodata.pt ASSOCIACAO BIP4DAB PT 889852005 14 BEN EKUT EBERHARD KARLS UNIVERSITAET DE 999991916 TUEBINGEN 15 BEN KI KAROLINSKA INSTITUTET SE 999978530 16 BEN MSAE SOTSIAALMINISTEERIUM EE 998429731 17 BEN BfArM BUNDESINSTITUT FUR ARZNEIMITTEL UND DE 998293931 MEDIZINPRODUKTE 18 BEN Sciensano SCIENSANO BE 906160809 19 BEN GRDI INSTITUTUL DE CERCETARE-DEZVOLTARE RO 881344232 IN GENOMICA 20 BEN UH HELSINGIN YLIOPISTO FI 999994535 21 AP UL UNIVERZA V LJUBLJANI SI 999923240 22 AP UHEI RUPRECHT-KARLS-UNIVERSITAET DE 999987648 HEIDELBERG 23 AP MU Masarykova univerzita CZ 999880657 24 AP HDIR HELSEDIREKTORATET NO 974772304 25 AP RBI RUDER BOSKOVIC INSTITUTE HR 999875031 26 AP VUHSK VIESOJI ISTAIGA VILNIAUS UNIVERSITETO LT 991636530 LIGONINE SANTAROS KLINIKOS 27 AP UiB UNIVERSITETET I BERGEN NO 999974456 28 AP VINNOVA VERKET FOR INNOVATIONSSYSTEM SE 999618757 29 AP OOI Orszagos Onkologiai Intezet HU 991549909 30 AP UNISR UNIVERSITA VITA-SALUTE SAN RAFFAELE IT 999854467 31 AP SIB SIB SWISS INSTITUTE OF BIOINFORMATICS CH 999629815 32 AP MESR MINISTERE DE LA RECHERCHE ET DE LU 905655827 L'ENSEIGNEMENT SUPERIEUR 4 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 PARTICIPANTS Grant Preparation (Beneficiaries screen) — Enter the info. Number Role Short name Legal name Country PIC 33 AP CERTH ETHNIKO KENTRO EREVNAS KAI EL 998802502 TECHNOLOGIKIS ANAPTYXIS 34 AP CRG FUNDACIO CENTRE DE REGULACIO ES 999544455 GENOMICA 35 AP LBMC LATVIJAS BIOMEDICINAS PETIJUMU UN LV 998836646 STUDIJU CENTRS 36 AP IGG ISTITUTO GIANNINA GASLINI IT 999448037 5 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 LIST OF WORK PACKAGES Work packages Grant Preparation (Work Packages screen) — Enter the info. Work Work Package name Lead Beneficiary Effort Start End Deliverables Package No (Person- Month Month Months) WP1 Project coordination and support to 1+MG 1 - ELIXIR / EMBL 19.85 1 36 D1.1 – Project handbook initiative D1.2 – Data management plan D1.3 – Project communication plan D1.4 – Project communication plan review D1.5 – Project handbook review D1.6 – Final evaluation or project handbook and comunication plan WP2 Genome EDIC establishment 2 - LNDS 114.00 1 36 D2.1 – Report on legal framework D2.2 – Recommendations on ethical and legal implementation D2.3 – Draft ROPA for operations D2.4 – Policy toolset D2.5 – Legal documents tool set D2.6 – Use case report D2.7 – Sustainability report D2.8 – Cybersecurity compliance report D2.9 – Risk management standard framework D2.10 – Acceptance criteria Initial report D2.11 – Quality assurance and risk management framework D2.12 – Risk management implementation plan WP3 1+MG Healthcare Implementation & Health 3 - INSA 78.97 1 36 D3.1 – Webinar on the analysis of the Economics mapping exercise of genomic medicine programs from all countries D3.2 – Tutorial and webinar for the 6 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Work packages Grant Preparation (Work Packages screen) — Enter the info. Work Work Package name Lead Beneficiary Effort Start End Deliverables Package No (Person- Month Month Months) genomics in healthcare Maturity Level Model available D3.3 – Report on citizens engagement D3.4 – Scope of a project aiming at developing a standardised approach to measure economic impact of WGS D3.5 – Recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems WP4 1+MG Data requirements 4 - HEALTH-RI 30.10 1 36 D4.1 – Update of the recommendation of whole genome sequencing D4.2 – Recommendations for long-read whole genome sequencing D4.3 – Phenotype data model D4.4 – Genotype data model D4.5 – Terms of use / ELSI metadata D4.6 – Metadata model for data analysis provenance D4.7 – Updated version of the data models, standards and ontologies part of the 1+MG framework 7 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Work package WP1 – Project coordination and support to 1+MG initiative Work Package Number WP1 Lead Beneficiary 1 - ELIXIR / EMBL Work Package Name Project coordination and support to 1+MG initiative Start Month 1 End Month 36 Objectives The primary aim of this WP is to ensure the efficient and effective implementation of the project activities. Additionally, the project coordination will closely support the 1+MG activities, either as part of the 1+MG Group or within the framework of the genome EDIC once it is established.This will ensure that project activities are aligned with the needs of the 1+MG initiative, according to the resources available in the project. O1.1 Project Mobilisation (Task 1.1) O1.2 Project monitoring, coordination and support to1+MG (Task 1.2) O1.3 Project communication strategy and support to 1+MG (Task 1.3) O1.4 Project stakeholder management and support to 1+MG stakeholder forum (Task 1.4) Work package leaders: Serena Scollen, Nikki Coutts, Juan Arenas (ELIXIR Hub) Description Project mobilisation: The coordination team (ELIXIR Hub) will ensure early engagement of project participants by activating project boards and WPs. In addition, connections with relevant EU initiatives and EC-funded projects will be established (e.g. GDI, GoE, THEDAS2, QUANTUM). This task includes setting up the project repository and implementing communication and monitoring tools. Participants: ELIXIR Coordination monitoring and support: The coordination team will actively engage in all project activities to ensure the successful delivery of both the project and the 1+MG initiative roadmap, maximising their impact. The relevant project bodies will be chaired by the coordination team who will also support 1+MG initiative bodies, as indicated in the section ‘consortium management and decision-making’. The ELIXIR PMO will monitor project delivery including deliverables, milestones and use of the assigned resources. Change management will also fall under the ELIXIR PMO responsibilities, carried out in close collaboration with the Management Board. Details about monitoring activities are already presented in section 2.2 under project management, quality assurance, and monitoring and evaluation strategy. The coordinator will support the governance of the 1+MG initiative (with governance responsibilities held by the EC) and will be responsible for presenting project activities to the 1+MG Group. The coordinator will ensure that feedback from the 1+MG Group and EC reviewers is addressed. Participants: ELIXIR Project communication strategy: The project communications team, in close collaboration with the WP leaders, especially those in WP3, will develop, implement and monitor the project communication strategy to support the communication of the 1+MG initiative. Key components include creating B1MGplus project branding, a website, templates, social media channels and a quarterly newsletter. The team will also define the target audience and establish metrics to measure success (refer to section x.x under dissemination and communication of the project and its results). All project participants will adhere to the Communication Strategy, which will be managed and monitored by the ELIXIR Hub communications team. Participants: ELIXIR Stakeholder involvement: WP1 will support the other work packages (WPs) by facilitating the involvement of the 1+MG Stakeholder Forum. This includes contributing to the organisation and management of activities tailored to engage various stakeholder groups effectively. Participants: ELIXIR Work package WP2 – Genome EDIC establishment Work Package Number WP2 Lead Beneficiary 2 - LNDS 8 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Work Package Name Genome EDIC establishment Start Month 1 End Month 36 Objectives This WP will provide input to the GDI Project and the Genome EDIC that is to be set up to support the EDIC in becoming operational. The work will provide the foundation (i.e. content creation) for the negotiations of member countries in the GDI Pillar I on the data governance and governance implementation, sustainability and business model as well as the input into the development of the IT infrastructure. The work will be limited to cover a minimum viable product that allows the Genome EDIC to become operational but not cover any future developments yet as these plans will be too volatile during the lifetime of the project and the provided funds not sufficient to cover additional scenarios. O2.1 Address legal and ethical questions related to the EDIC operations (Task 2.1) O2.2 Set up a framework of policies that guide the EDIC operations (Task 2.2) O2.3 Set up a framework of legal documents governing the relationships of EDIC with various actors (Task 2.3) O2.4 Provide input for the sustainability framework (Task 2.4) O2.5 Quality assurance and risk management framework (Task 2.5) Work package leaders: Regina Becker (LNDS), Bruno Rodrigues (MESR), Giovanni Comandè (SLEX) Description Task 2.1: ELSI framework: In this task we will analyse the ethical and legal challenges and enablers when implementing a cross- border data infrastructure for secondary use of health and genomic data according to a joint data governance. We will investigate in particular the challenges associated with the creation of a genomic data space that is intended to become a subspace of the European Health Data Space (EHDS). As the 1+MG EDIC will be created and needs to receive its mandate independent of the EHDS, the legal basis for data inclusion as well as all the operations and related activities such as the data governance for data reuse beyond research and including also healthcare and public health purposes will be considered. Also additional elements relevant for the ethical, legal and operational aspects such as the reporting of incidental findings, a continued access for research integrity etc. must be solved for the EDIC. While some work on the legal basis was done already in the B1MG project and the GDI project, the considerations were largely limited to the data sharing for research and only the main operations, not taking into account a wider scope of secondary use and activities that go beyond the data sharing. Establishing a processing record of processing activities (ROPA) for all the processing related to the operations based on modelled workflows will help to identify potential issues. In addition, the EHDS Regulation should be considered in investigating the possibility and utility to become an authorised participant in the EHDS. We will also explore the potential conditions for such integration that may be further specified in implementing acts and defining the most appropriate ways to and operationalise the EDIC’s participation in the HealthData@EU infrastructure. The results will be translated into an adaptation of previous considerations and new aspects such as concrete recommendations on non-discrimination principles. The analyses in this task also give input into ELSI related metadata. The definition of metadata models to capture relevant and actionable information related to ethical and legal aspects will be pursued in WP4. This task will feed relevant content into this development. The analysis of the ethical and legal situation performed in this task will lead to interpretations and recommendations that will be shared with relevant stakeholders such as the 1+MG ELSI Working Group, other projects and initiatives (e.g. EUCAIM, Joint Action TEHDAS2), the Commission, data protection authorities and others as sparring partners for feedback. To the extent feasible the proposed solutions might be experimented in the form of a regulatory sandbox involving the appropriate Authorities. Participants: LNDS(BEN), SLEX(BEN), MESR(AP) Task 2.2: Policy framework: The GDI project has foreseen a path that leads to the creation of the EDIC, which includes the statutes. However, to become operational, a policy framework is also needed to govern the various aspects of the operations of the EDIC. The statutes defined in the GDI will provide for the main elements of activities, responsibilities and decision making on a top-level requiring the actual drafting of implementing rules. The policy framework will foresee the rules of procedure of how decisions are made, the role and functioning of the various committees supporting the EDIC decision making bodies and implement the governance and data governance in suitable documents to guide the functioning of the EDIC. We will build on task 2.1 as well as on the work done in the B1MG project on the 1+MG data governance for research and extend it for other secondary use purposes. We will take up the analysis of task 2.1 on the European Health Data Space and adapt existing work where necessary. We aim to stay as close as possible to the procedures agreed in 9 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 the EHDS. For the governance of the EDIC itself, we intend to build on the experience of research infrastructures, data infrastructures and other relevant entities. The recommendations will be discussed with the Pillar I working group of governmental representatives in the GDI project that also doubles as the EDIC Working Group of the 1+MG and, if the EDIC itself is created, the EDIC general assembly. The outcome of the discussions with Pillar I / the EDIC Working Group will be fed back into this task for translation into formalised policy documents. Participants: LNDS(BEN), NGC(BEN), ISCIII(BEN) Task 2.3: Legal document framework: Once the governance and data governance are finally decided, the relationship between the various actors needs to be translated into standard legal documents enabling binding commitments and regulating the rights and obligations of all the entities to the extent that they are not provided for in the statutes. This includes among others data providers, IT infrastructure providers designated by the Member Countries, National Coordination Points as well as service providers contracted for central services. Relevant input for the content will further be provided by task 2.1. These legal documents will address the needs of the procurement policy of the EDIC (including with data providers and with the entities providing the national services for the EDIC) as it may be determined based on the task 2.1 and 2.2. Special attention will be given to the situation where an actor is located outside the European Economic Area and to the fostering of data altruism under the existing regulatory framework. The result of this task will provide the EDIC with the legal documents tool set (contracts, regulations,..) needed to allow the envisaged operations Participants: SLEX(BEN) Task 2.4: Sustainability framework: The EDIC must respond to real needs. An exploration of user needs will provide information of such real needs. The demand both in content and in frequency should provide guidance for the EDIC in terms of infrastructure, legal, ethical and financial requirements. An exploration of such needs will be done to derive from real life experience and actual cost incurred. The result is a quantitative and qualitative analysis of user needs. Such needs analysis will be complemented with exemplary stories and also success stories incurred in relevant countries already engaged in genomic medicine. In addition, fictional use case stories will be described that can illustrate the unique selling points of 1+MG to provide information to be used with various stakeholders. The vested interest of the various stakeholders from research funders to the healthcare sector, from health insurances to industry, from governments to citizens will be explored. Within this task, we will organise focused workshops with relevant task forces and working groups, including patient and citizen representative feedback groups. Also onsite visits at relevant infrastructure providers may be foreseen. Meetings will be complemented with structured interviews of relevant stakeholders. These activities will provide basic input into the policies, the development of membership models, related membership fees, user models and potential user fees of the EDIC, which are channelled into the design of the EDIC and its business model. Participants: CNR(BEN), NGC(BEN), ISCIII(BEN), UHEI(AP), MU(AP), HDIR(AP), RBI(AP), VUHSK(AP), Vinnova (AP), OOI(AP), LBMC(AP) Task 2.5: Quality assurance and risk management framework The entire framework laid out in the GDI project, including contractual, policies, and data governance as envisaged in Pillar I and technical implementation as envisaged in Pillar II requires the formulation of acceptance criteria (ea. Reliability, risk management, DPdDD etc.) in order to transfer the pre- production GDI tools and workflows towards production in the EDIC. These criteria and the risk management approach must be defined by the Genome EDIC as the responsible controller under the GDPR for the operations, i.e. the disclosure to the user. The end goal is to ensure that the EDIC is in a position to do a DPIA, based on validated documentation and commonly applied quality and risk management standards. This requires defining exactly what different roles are: Data provider, compute provider, DAC, etc. and what elements of the 1+MG EDIC operations require a DPIA and/or a consultation of data protection authorities. This includes all risks with regard to the data protection principles. Based on use cases, we model relevant scenarios to identify critical points in the operations. It requires describing in sequence diagrams exactly how these actors communicate on an API level, describing the flow of data and accesses between actors in the infrastructure, to implement a given use-case. It also entails defining the risk management framework and standards that the platform must adhere to in production. These activities will guide the second half of the GDI project product implementation tracks ensuring that transitioning from development into production will be as smooth as possible. Depending on progress of the WP and establishment of the EDIC a DPIA should be conducted as soon as the framework is in place. T2.5 will also identify and map the cybersecurity compliance needs for the GDI. Participants: CNR(BEN), NGC(BEN), ISCIII(BEN), UHEI(AP), MU(AP), HDIR(AP), RBI(AP), VUHSK(AP), Vinnova (AP), OOI(AP), LBMC(AP) 10 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Work package WP3 – 1+MG Healthcare Implementation & Health Economics Work Package Number WP3 Lead Beneficiary 3 - INSA Work Package Name 1+MG Healthcare Implementation & Health Economics Start Month 1 End Month 36 Objectives O3.1 To bridge implementation gaps on genomics in healthcare systems across Europe, through mapping, self- assessment and benchmarking using the 1+MG Maturity Level Model (MLM) structure (Tasks 3.1, 3.2) O3.2 To document the implementation of genomic medicine in national healthcare systems, facilitating sharing of experiences across countries and informing policy makers (Task 3.3) O3.3 To promote the awareness, literacy level and education of citizens, health professionals and policy makers on genomic medicine across Europe (Task 3.1 and Task 3.4) O3.4 To contribute to implementation of WGS and other genetic tests in healthcare, by informing policy makers and decision-makers on how to measure and model its economic impact, supporting the right decisions and legitimising budget allocation. (Task 3.5) Work package leaders: Astrid Vicente (INSA), Lene Cividanes (NGC), Inês Amado (Inserm), Frédérique Nowak (Inserm) Description Task 3.1: A network of public health and health professionals to support genomic medicine: INSA, INSERM, MSAE, GRDI To optimise the societal impact of the 1+MG Initiative and the upcoming Genome EDIC, it is imperative for health authorities at both European and national levels to comprehend the benefits of genomic medicine for their populations. This understanding is pivotal for countries to allocate their limited healthcare resources towards genomic medicine effectively. Likewise, it is essential for health professionals, who will be main users of the evolving tools and infrastructure for genomic medicine, to fully understand the potential benefits. We will therefore seek to connect a network of health authorities, public health experts, and health professionals with the 1+MG Initiative, aiming to bridge the gap between scientific and technical advancements in genomic medicine, and their practical applications in healthcare. We will establish and engage with this network, increasing awareness, identifying challenges and unmet needs, and collaboratively devising impactful solutions for the advancement and sustainability of the Genome EDIC in healthcare systems. To achieve this objective, we will collaborate with NMGs, national genomic and personalised medicine programmes, and European networks and initiatives, to raise awareness among national health authorities, and engage policymakers, public health experts and health professionals in this network. To guarantee an active cooperation from the network participants, we will organise regular meetings (in person and online) to discuss critical issues concerning the implementation of genomic medicine in healthcare. The topics of these meetings will follow the MLM domain structure, and in each meeting we will launch a structured discussion of one or more specific relevant challenges, seeking to understand the participants' perspectives on gaps and solutions. These meetings will facilitate a deeper understanding of the challenges and requirements from a public health perspective, elucidate the necessary actions for decision-makers at the national level, and lead to the collaborative formulation of actionable recommendations for the EDIC. We will endeavour on bringing into this network multiple relevant professional profiles and medical specialities that are not yet aware of or taking full advantage of the potential of genomics in clinical practice. Seeking a wider dissemination, we will host online workshops targeting health authorities, public health experts, and health professionals, particularly those who may not be experts in genomics but are potential decision-makers and/or end-users in need of additional information on genomic medicine and healthcare. Participants: INSA(BEN), GRDI(BEN), MSAE(BEN), UL(AP) Task 3.2: Leveraging the 1+MG MLM for adoption of Genomics in Healthcare INSA, INSERM, MSAE Understanding the strengths and challenges of healthcare systems across Europe in genomic practices is essential for ensuring equitable access to the promising potential of Personalised Medicine for all European citizens. Our objective is to promote and support the utilisation of the 1+MG MLM to facilitate adoption of genomics in healthcare by more countries across Europe and globally, and bridge gaps in healthcare systems through assessment, planning, and 11 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 recommendations. As the field progresses and healthcare systems improve their maturity levels in genomic practice, it is anticipated that new challenges will emerge, requiring dynamic adaptations of the MLM as needed. The overall task will be supported by the network of public health professionals established in Task 1 and the expertise from the 1+MG National Mirror Groups. We will leverage this network to expand the usage of the MLM tools to assess the maturity of genomic practices in more regional and national healthcare systems. For this we will conduct dissemination sessions with the network of public health professionals, and facilitate maturity assessments upon request from countries or regions, and advocate for the adoption of the MLM benchmarking tool. For this purpose we will develop a tutorial, and videotape a webinar with key information. Regular analysis and dissemination of outcomes will inform recommendations for planning and investments across Europe, with a specific emphasis on achieving uniform adoption of genomic medicine within healthcare systems to promote equity. Given that the 1+MG MLM was designed to be a dynamic tool that incorporates novel developments over time, if suggested by experts in the network we will evaluate the relevance and possibility to incorporate new dimensions that capture novel aspects aligned with emerging developments in genomic medicine implementation. Participants: INSA(BEN), MSAE(BEN) Task 3.3: Mapping and sharing successful practices for genomic medicine in healthcare systems INSERM, INSA, Genomic medicine maturity varies across European countries, and solutions for specific challenges have been previously developed, which can serve as best practices for less mature countries. Mapping and disseminating these best practices will facilitate faster development and implementation of genomics in healthcare in a consistent manner across Europe, both for providing better diagnosis and treatment, but also for prevention.This effort not only promotes equity in access to genomic medicine but also addresses domains that are typically less developed and identifies capacity building actions. In this task, we will conduct a mapping exercise to document the implementation of genomic medicine in national healthcare systems, both for diagnosis and treatment, but also for prevention. Following the Maturity Level Model structure, we will collect information through the NMGs in a structured way in order to enable efficient benchmarking between countries. An annual review of this mapping exercise will be conducted in order to monitor the rollout of genomic medicine in healthcare systems across Europe. Individual results will be released on the 1+MG implementation framework website. A webinar will be organized to present to stakeholders the results of the mapping exercise of genomic medicine programs. A synthesis of the results, with good practice identifications and gaps analysis will contribute to recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems. The goal is to facilitate sharing of experiences across countries, learn from each other and provide valuable insights to policy makers, with the aim of identifying and disseminating good practices that can help reduce disparities in healthcare implementation of genomic medicine across Europe. Participants: INSA(BEN), INSERM(BEN) Task 3.4: Patient and citizen hub: Sciensano, BfArM, GRDI, INSA Patients and citizens are the starting point (data origin) and the end point (improve their wellbeing) of genomic medicine. Therefore, it is crucial to create awareness, gather data in a citizen and/or patient centred way and implement and develop genomic technologies in line with societal values. An impressive body of informational materials has been developed or is under development in many national and international projects, including the GDI, CAN.HEAL, GoE, DNADEBATE, DNAdialogue, Your DNA Your Say, SIENNA genomics, genomeDE, EOSC4Cancer, PROPHET and others. However, these materials are not sufficiently broadly disseminated and are not adapted to specific audiences. In this task, we will focus on bringing these materials together, adapting them upon demand (e.g. translations, cultural adaptations, simplification, …) and disseminating them through existing networks (national mirror groups, patient organisations, civil society groups, educational system, traditional and social media, etc.). The focus of the content will be on the benefits and risks of implementing genomic technologies in healthcare systems (data use, common good, privacy protection, …) and the role of citizens and patients (consent, data solidarity, …). Another content topic will be to provide the scientific background and information on genomic medicine to empower and educate the public so that they can make informed choices. This will include testimonials from people who have already gained experience with genomic medicine. Additionally, specific topics will be addressed based on informational needs expressed by disseminating networks (EBCP mirror groups, TEHDAS, teacher’s hubs, patient organisations, …). Dissemination activities will be aligned with existing initiatives: 1) in-person examples include classes and projects in high schools, theme days of patient/ civil society organisations, lectures, panels, discussion days, … 2) online examples include publications in newsletters, social media content (e.g. cartoons, infographics) and a dedicated information hub. This hub will bring together materials that are created in different projects and grow organically as this content is adapted for specific audiences. The citizen information hub will bring together already existing materials including videos, cartoons, infographics, testimonies, etc. in a layered fashion (organised by topic, easy start and option to learn more), with informational blogs that encourage comments (which would be then be answered by organising into an FAQ section). Participants: INSA(BEN), Sciensano(BEN), BfArM(BEN), UL(AP) 12 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Task 3.5: Health Economics: NGC, KI, MSAE, GRDI, INSA It is crucial to establish the evidence base for the health impact and economic implications of genomics to inform decision takers and policy makers on how to measure economic impact and cost-effectiveness of WGS (and other comprehensive genetic tests) in healthcare. Clinical evidence and economic models are prerequisites for decision making and legitimization of budget allocation when deciding under what circumstances and how genetic tests should be integrated into routine medical care and public health programs. However, we only have very limited data as well as models measuring the economic impact of genomics. In this task we will focus on knowledge sharing across countries through meetings, mapping of existing work and identifying possible use cases for pilot models for HTA’s. The work will be carried out in close collaboration with experts from the field. Organise two face-to-face meetings of HTA experts and national representatives. Based on the work initiated in B1MG together with the HEOR WG in 1+ MG experts will continue the evaluation of existing experiences and models for cost- effectiveness to determine whether the use of WGS provides a sufficient economic incentive compared to other health interventions and identify relevant use-cases. Continue the mapping exercise started by the B1MG to identify relevant information on existing experiences; both in form of existing titles/reviews as well as overviews of studies/projects on economic evaluation of WGS or secondary other comprehensive genetic tests already carried out. Identify existing use cases where WGS has been used (preferably in health care) within a well described disease area and with access to relevant data on clinical evidence and costs. Based on the relevant use cases, agree on one or more use cases for development of an initial pilot model (decision tree) to be tested in a number of MS’s to help estimate economic impact of implementation of WGS (or other comprehensive tests) in healthcare. By revealing the cost implications of genome sequencing in health care, where resources are limited and healthcare providers must make informed decisions about how to distribute resources to benefit a large number of patients, MS can take informed decisions and drive innovation to reduce costs and improve efficacy in health care systems. However, we still need to carry out more research to determine situations and settings where the use of WGS is cost-effective in healthcare and in a larger societal perspective to be able to make informed decisions and when relevant achieve cost reductions in national healthcare systems. Therefore, based on the mapping exercises, the pilot decision tree and proved clinical evidence for genetic testing in healthcare, will scope a cross border project aiming at developing a standardised approach (model) to measure economic impact of WGS through a standardised framework with room for national and case-specific adaptation. Overall, the health economic task will focus on scoping models for cost-effectiveness of WGS to provide crucial insights that can help MSs understand the value of WGS in healthcare and enable them to make relevant decisions for the benefit of the patients and foster more efficient and effective healthcare solutions. Participants: INSA(BEN), NGC(BEN), KI(BEN), GRDI(BEN), MSAE(BEN) Work package WP4 – 1+MG Data requirements Work Package Number WP4 Lead Beneficiary 4 - HEALTH-RI Work Package Name 1+MG Data requirements Start Month 1 End Month 36 Objectives O4.1 Review and update the sequencing guidelines part of the 1+MG framework (Task 4.1) O4.2 Review and update the data models, standards and ontologies of the 1+MG framework (Task 4.2) O4.3 Extending and improving metadata, quality and utility of 1+MG data and software (Task 4.3 & Task 4.4 & Task 4.5) Work package leaders: Jeroen Belien (HRI), Ivo Gut (CNAG), Alfonso Valencia, Salvador Capella-Gutierrez (BSC), Bengt Persson (UU) Description Task 4.1: Review and update the sequencing guidelines part of the 1+MG framework. In this task we will review best practices for sequencing whole genomes and exomes using short-read sequencing 13 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 technologies and keep up to date the recommendations for this type of sequencing and the appropriate data analysis. We will also establish documentation for best practices of long-read whole genome sequencing and appropriate data analysis. Participants: CNAG(BEN), EKUT(BEN) Task 4.2: Review and update the data models, standards and ontologies of the 1+MG framework In task 4.2 we will review, update and extend the current frameworks on (meta)data models, standards and ontologies of the 1+MG overall framework. With focus on the phenotypic and clinical data, we will organise monthly meetings between the 1+MG WG3, GDI WP6 (data linkage and harmonisation), GDI WP7 (use cases), and GDI task 8.2 to step by step arrive at harmonisation of domain data models, ontologies used, modelling of the metadata (e.g. to optimise findability (based on DCAT-AP v3 and upcoming extensions like Health (as product from HealthData@EU WP6) as well as quality labels (from QUANTUM project) and discovery), as well as on alignment of different standards, of the established/confirmed phenotypic part of the minimal datasets of the 1+MG use case WGs. Additionally, we will experiment in incorporating phenotype data derived from EHRs, registries, and questionnaires for comprehensive data integration. With focus on the genotypic data, we will organise monthly meetings (1+MG WG3 & WG4 & GDI relevant experts, e.g. from WP6 and WP8 task 8.2) to step by step arrive at harmonisation of domain data models, ontologies used, modelling of the metadata, as well as on alignment of different standards, of the established/confirmed genotypic part of the minimal datasets of the 1+MG use case WGs. Work in task 4.2 will be coordinated with TEHDAS2 WP5, where requirements for data holders are defined, and TEHDAS WP6, where procedures for making data available are defined. Participants: Health-RI(BEN), BSC(BEN), UU(BEN), BioData.pt(BEN), UH(BEN), CRG(AP) Task 4.3: Metadata to achieve reproducible, transparent and reusable results from running 1+MG journeys. With a focus on the metadata that are necessary to achieve reproducible, transparent and reusable results when executing 1+MG workflows, we will organise regular meetings between relevant 1+MG WGs, and GDI WPs to step by step arrive at harmonised metadata and data management of provenance of the 1+MG workflow, on “terms of use” and other ELSI- related information, based on access levels, and the generation and accessibility of metadata throughout the complete data life cycle from data characterisation for inclusion (e.g. vulnerabilities of data subjects) to relevant information on users that may influence data use within the 1+MG framework. Most of these metadata depend on legal and ethical boundaries as set by the future EDIC as well as data protection requirements, and this task will therefore align with WP2 task 2.1 for the legal framework, which will cover the relevant information that needs to be coded. Interaction will also take place with task 2.2 where policies related to metadata capture and use across the data life cycle will be touched upon. By co-organising monthly meetings with the GDI (meta)data squad activities (WP6 and more), various metadata will be (further) defined and implemented to oversee the generation and accessibility of metadata throughout the complete user workflow. We will also look at best practices for Data management in close collaboration with the GDI and GoE projects. Data management in 1+MG needs to be appropriate for collection of data generated in GoE. Participants: Health-RI(BEN), BSC(BEN), UU(BEN), ISCIII(BEN), BioData.pt(BEN), EKUT(BEN), SIB(AP), CERTH(AP), CRG(AP), UiB(AP), UNISR(AP) Task 4.4: Project Mobilisation: Sustainability and quality of software and its associated metadata In task 4.4 we will elaborate on the different aspects of software and its associated metadata quality, its readiness and maturation as a mechanism towards the inclusion of reference implementations into the 1+MG landscape. Beyond specific software implementations, this task will investigate existing standards in order to guarantee interoperability of different software components originating from International efforts like ELIXIR and the GA4GH (Global Alliance for Genomic and Health). The output of this task is particularly important for building a sustainable software stack that can be deployed nationally. Another aspect to be considered is the existing (and needed) standards for enabling reproducible and replicable federated analysis of the data made available through the infrastructure. Careful consideration of those standards, developed elsewhere, is essential to enable optimal use of associated computational capacities which in turn should contribute to faster and more efficient analysis and reduced environmental impact Participants: Health-RI(BEN), BSC(BEN), UU(BEN), ISCIII(BEN), BioData.pt(BEN), EKUT(BEN), SIB(AP), CERTH(AP), CRG(AP), UiB(AP), UNISR(AP) 14 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 STAFF EFFORT Staff effort per participant Grant Preparation (Work packages - Effort screen) — Enter the info. Participant WP1 WP2 WP3 WP4 Total Person-Months 1 - ELIXIR / EMBL 19.85 19.85 2 - LNDS 35.67 35.67 3 - INSA 24.64 24.64 4 - HEALTH-RI 2.05 2.05 5 - NGC 18.59 13.02 31.61 6 - CNAG 8.55 8.55 7 - BSC 2.42 2.42 8 - UU 2.05 2.05 9 - INSERM 8.93 8.93 10 - CNR 12.09 12.09 11 - SLEX 32.07 32.07 12 - ISCIII 5.58 1.12 6.70 13 - Biodata.pt 2.05 2.05 14 - EKUT 1.93 1.93 15 - KI 5.58 5.58 16 - MSAE 4.65 4.65 17 - BfArM 2.98 2.98 18 - Sciensano 11.96 11.96 19 - GRDI 5.21 5.21 15 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Staff effort per participant Grant Preparation (Work packages - Effort screen) — Enter the info. Participant WP1 WP2 WP3 WP4 Total Person-Months 20 - UH 0.93 0.93 21 - UL 2.00 2.00 22 - UHEI 1.00 1.00 23 - MU 1.00 1.00 24 - HDIR 1.00 1.00 25 - RBI 1.00 1.00 26 - VUHSK 1.00 1.00 27 - UiB 1.00 1.00 28 - VINNOVA 1.00 1.00 29 - OOI 1.00 1.00 30 - UNISR 1.00 1.00 31 - SIB 2.00 2.00 32 - MESR 1.00 1.00 33 - CERTH 2.00 2.00 34 - CRG 3.00 3.00 35 - LBMC 1.00 1.00 36 - IGG 1.00 1.00 Total Person-Months 19.85 114.00 78.97 30.10 242.92 16 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 LIST OF DELIVERABLES Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D1.1 Project handbook WP1 1 - ELIXIR / EMBL R — Document, report PU - Public 6 D1.2 Data management plan WP1 1 - ELIXIR / EMBL DMP — Data PU - Public 6 Management Plan D1.3 Project communication plan WP1 1 - ELIXIR / EMBL R — Document, report PU - Public 6 D1.4 Project communication plan review WP1 1 - ELIXIR / EMBL R — Document, report PU - Public 16 D1.5 Project handbook review WP1 1 - ELIXIR / EMBL R — Document, report PU - Public 16 D1.6 Final evaluation or project handbook and WP1 1 - ELIXIR / EMBL R — Document, report PU - Public 34 comunication plan D2.1 Report on legal framework WP2 2 - LNDS R — Document, report PU - Public 20 D2.2 Recommendations on ethical and legal WP2 2 - LNDS R — Document, report PU - Public 36 implementation D2.3 Draft ROPA for operations WP2 2 - LNDS R — Document, report PU - Public 18 D2.4 Policy toolset WP2 2 - LNDS R — Document, report PU - Public 24 D2.5 Legal documents tool set WP2 11 - SLEX R — Document, report PU - Public 24 D2.6 Use case report WP2 12 - ISCIII R — Document, report PU - Public 4 D2.7 Sustainability report WP2 10 - CNR R — Document, report PU - Public 24 17 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D2.8 Cybersecurity compliance report WP2 11 - SLEX R — Document, report PU - Public 6 D2.9 Risk management standard framework WP2 5 - NGC R — Document, report PU - Public 12 D2.10 Acceptance criteria Initial report WP2 5 - NGC R — Document, report PU - Public 12 D2.11 Quality assurance and risk management WP2 5 - NGC R — Document, report SEN - Sensitive 36 framework D2.12 Risk management implementation plan WP2 5 - NGC R — Document, report SEN - Sensitive 36 D3.1 Webinar on the analysis of the mapping WP3 9 - INSERM R — Document, report PU - Public 24 exercise of genomic medicine programs from all countries D3.2 Tutorial and webinar for the genomics in WP3 3 - INSA R — Document, report PU - Public 10 healthcare Maturity Level Model available D3.3 Report on citizens engagement WP3 18 - Sciensano R — Document, report PU - Public 36 D3.4 Scope of a project aiming at developing a WP3 5 - NGC R — Document, report PU - Public 36 standardised approach to measure economic impact of WGS D3.5 Recommendations for the EDIC on WP3 3 - INSA R — Document, report PU - Public 36 implementation and sustainability of genomic medicine in healthcare systems D4.1 Update of the recommendation of whole WP4 6 - CNAG R — Document, report PU - Public 12 genome sequencing 18 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D4.2 Recommendations for long-read whole WP4 6 - CNAG R — Document, report PU - Public 24 genome sequencing D4.3 Phenotype data model WP4 4 - HEALTH-RI R — Document, report PU - Public 36 D4.4 Genotype data model WP4 4 - HEALTH-RI R — Document, report PU - Public 36 D4.5 Terms of use / ELSI metadata WP4 8 - UU R — Document, report PU - Public 36 D4.6 Metadata model for data analysis WP4 7 - BSC R — Document, report PU - Public 36 provenance D4.7 Updated version of the data models, WP4 4 - HEALTH-RI R — Document, report PU - Public 36 standards and ontologies part of the 1+MG framework 19 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable D1.1 – Project handbook Deliverable Number D1.1 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Project handbook Type R — Document, report Dissemination Level PU - Public Due Date (month) 6 Work Package No WP1 Description Guide to the project process, assets and tools Deliverable D1.2 – Data management plan Deliverable Number D1.2 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Data management plan Type DMP — Data Management Dissemination Level PU - Public Plan Due Date (month) 6 Work Package No WP1 Description Data management plan for the management of the project Deliverable D1.3 – Project communication plan Deliverable Number D1.3 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Project communication plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 6 Work Package No WP1 Description Communication plan Deliverable D1.4 – Project communication plan review Deliverable Number D1.4 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Project communication plan review Type R — Document, report Dissemination Level PU - Public Due Date (month) 16 Work Package No WP1 Description Review of project communication plan 20 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable D1.5 – Project handbook review Deliverable Number D1.5 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Project handbook review Type R — Document, report Dissemination Level PU - Public Due Date (month) 16 Work Package No WP1 Description Review of the project handbook Deliverable D1.6 – Final evaluation or project handbook and comunication plan Deliverable Number D1.6 Lead Beneficiary 1 - ELIXIR / EMBL Deliverable Name Final evaluation or project handbook and comunication plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 34 Work Package No WP1 Description Review of the project handbook and communication plan Deliverable D2.1 – Report on legal framework Deliverable Number D2.1 Lead Beneficiary 2 - LNDS Deliverable Name Report on legal framework Type R — Document, report Dissemination Level PU - Public Due Date (month) 20 Work Package No WP2 Description Analysis of the legal framework of the Genome EDIC's operations considering relevant legislation such as GDPR, DGA, EHDS etc. Deliverable D2.2 – Recommendations on ethical and legal implementation Deliverable Number D2.2 Lead Beneficiary 2 - LNDS Deliverable Name Recommendations on ethical and legal implementation Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP2 Description Translation of the analysis of the legal analysis and the ethical framework into concrete recommendations for the data governance 21 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable D2.3 – Draft ROPA for operations Deliverable Number D2.3 Lead Beneficiary 2 - LNDS Deliverable Name Draft ROPA for operations Type R — Document, report Dissemination Level PU - Public Due Date (month) 18 Work Package No WP2 Description Records of service provision processing activities as required by the GDPR Deliverable D2.4 – Policy toolset Deliverable Number D2.4 Lead Beneficiary 2 - LNDS Deliverable Name Policy toolset Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP2 Description Providing Genome EDIC with policies relevant for its operations and implementation of governance, derived from requirements given from GDI Deliverable D2.5 – Legal documents tool set Deliverable Number D2.5 Lead Beneficiary 11 - SLEX Deliverable Name Legal documents tool set Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP2 Description Collection of contracts and other legal documents for the operations and overarching governance Deliverable D2.6 – Use case report Deliverable Number D2.6 Lead Beneficiary 12 - ISCIII Deliverable Name Use case report Type R — Document, report Dissemination Level PU - Public Due Date (month) 4 Work Package No WP2 Description Quantitative user needs analysis and qualitative needs based on stories derived from best practices experiences of relevant countries and illustrations of unique selling points of 1+MG 22 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable D2.7 – Sustainability report Deliverable Number D2.7 Lead Beneficiary 10 - CNR Deliverable Name Sustainability report Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP2 Description Report on conclusions drawn from various stakeholder events and interviews on membership, user and cost models Deliverable D2.8 – Cybersecurity compliance report Deliverable Number D2.8 Lead Beneficiary 11 - SLEX Deliverable Name Cybersecurity compliance report Type R — Document, report Dissemination Level PU - Public Due Date (month) 6 Work Package No WP2 Description Assessment of the consequences of cybersecurity law on the setup of the Genome EDIC's IT infrastructure Deliverable D2.9 – Risk management standard framework Deliverable Number D2.9 Lead Beneficiary 5 - NGC Deliverable Name Risk management standard framework Type R — Document, report Dissemination Level PU - Public Due Date (month) 12 Work Package No WP2 Description Overarching risk management principles for the EDIC Deliverable D2.10 – Acceptance criteria Initial report Deliverable Number D2.10 Lead Beneficiary 5 - NGC Deliverable Name Acceptance criteria Initial report Type R — Document, report Dissemination Level PU - Public Due Date (month) 12 Work Package No WP2 Description Full set of acceptance criteria for IT platform 23 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable D2.11 – Quality assurance and risk management framework Deliverable Number D2.11 Lead Beneficiary 5 - NGC Deliverable Name Quality assurance and risk management framework Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP2 Description Definition of the EDIC's risk management framework building on the acceptance criteria, enabling a DPIA and deployment of products in production Deliverable D2.12 – Risk management implementation plan Deliverable Number D2.12 Lead Beneficiary 5 - NGC Deliverable Name Risk management implementation plan Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP2 Description Implementation plan for the risk management system based on framework, acceptance criteria and documentation Deliverable D3.1 – Webinar on the analysis of the mapping exercise of genomic medicine programs from all countries Deliverable Number D3.1 Lead Beneficiary 9 - INSERM Deliverable Name Webinar on the analysis of the mapping exercise of genomic medicine programs from all countries Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP3 Description A webinar will be organized to present to stakeholders the results of the mapping exercise of genomic medicine programs Deliverable D3.2 – Tutorial and webinar for the genomics in healthcare Maturity Level Model available Deliverable Number D3.2 Lead Beneficiary 3 - INSA Deliverable Name Tutorial and webinar for the genomics in healthcare Maturity Level Model available Type R — Document, report Dissemination Level PU - Public Due Date (month) 10 Work Package No WP3 Description 24 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 A tutorial and a videotaped webinar to facilitate dissemination of the Maturity Level Model for Genomics in Healthcare Deliverable D3.3 – Report on citizens engagement Deliverable Number D3.3 Lead Beneficiary 18 - Sciensano Deliverable Name Report on citizens engagement Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP3 Description Citizen engagement report on gathered informational materials and dissemination activities Deliverable D3.4 – Scope of a project aiming at developing a standardised approach to measure economic impact of WGS Deliverable Number D3.4 Lead Beneficiary 5 - NGC Deliverable Name Scope of a project aiming at developing a standardised approach to measure economic impact of WGS Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP3 Description Scope of a project aiming at developing a standardised approach to measure economic impact of WGS, including report on existing publications, projects, use-cases and HTA’s of WGS Deliverable D3.5 – Recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems Deliverable Number D3.5 Lead Beneficiary 3 - INSA Deliverable Name Recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP3 Description Collection of recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems at multiple levels, resulting from the conclusions from all WP3 tasks: awareness and education of policy makers and health professionals, challenges and best practices in genomic medicine programs, citizens and patients awareness and literacy, health economic models. Deliverable D4.1 – Update of the recommendation of whole genome sequencing Deliverable Number D4.1 Lead Beneficiary 6 - CNAG 25 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable Name Update of the recommendation of whole genome sequencing Type R — Document, report Dissemination Level PU - Public Due Date (month) 12 Work Package No WP4 Description Update of the recommendation of whole genome sequencing Deliverable D4.2 – Recommendations for long-read whole genome sequencing Deliverable Number D4.2 Lead Beneficiary 6 - CNAG Deliverable Name Recommendations for long-read whole genome sequencing Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP4 Description Recommendations for long-read whole genome sequencing Deliverable D4.3 – Phenotype data model Deliverable Number D4.3 Lead Beneficiary 4 - HEALTH-RI Deliverable Name Phenotype data model Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description A harmonised set of minimal datasets for phenotypic data per use case and a union sunflower model for the combined 1+MG datasets Deliverable D4.4 – Genotype data model Deliverable Number D4.4 Lead Beneficiary 4 - HEALTH-RI Deliverable Name Genotype data model Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description A harmonised set of minimal datasets for genotypic data per use case and a union sunflower model for the combined 1+MG datasets Deliverable D4.5 – Terms of use / ELSI metadata Deliverable Number D4.5 Lead Beneficiary 8 - UU 26 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Deliverable Name Terms of use / ELSI metadata Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description A harmonised metadata schema on terms of use/ ELSI metadata that as an extension will be added/merged to the sunflower metadata model based on DCAT-AP Deliverable D4.6 – Metadata model for data analysis provenance Deliverable Number D4.6 Lead Beneficiary 7 - BSC Deliverable Name Metadata model for data analysis provenance Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description Provide a list of metadata requirements and standards matching them to capture data analysis provenance so results can be reproduced and replicated Deliverable D4.7 – Updated version of the data models, standards and ontologies part of the 1+MG framework Deliverable Number D4.7 Lead Beneficiary 4 - HEALTH-RI Deliverable Name Updated version of the data models, standards and ontologies part of the 1+MG framework Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description The current technical section of the 1+MG framework on data models, standards and ontologies has been updated with results obtained, c.q. progress made within timeframe of this project 27 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 LIST OF MILESTONES Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 1 M1.1 Project Mobilised WP1 1 - ELIXIR / EMBL Boards and WPs have been formalised and work 3 has started, connection established with target project. Milestone published in Zenodo 2 M1.2 Project website goes live WP1 1 - ELIXIR / EMBL Project website is live 3 3 M1.3 First stakeholders event WP1 1 - ELIXIR / EMBL Stakeholder event has taken place Statistic of 9 participation are published in the website 4 M1.4 Second stakeholders event WP1 1 - ELIXIR / EMBL Stakeholder event has taken place. Statistic of 21 participation are published in the website 5 M1.5 Third stakeholders event WP1 1 - ELIXIR / EMBL Stakeholder event has taken place. Statistic of 33 participation are published in the website 6 M2.1 Overview of policies WP2 2 - LNDS List and scope of policies that are necessary for 6 operations. Report 7 M2.2 Overview of legal documents required WP2 11 - SLEX List and scope of contracts and other legal 6 documents that are necessary for operations. Report 8 M2.3 Initial risk management framework WP2 5 - NGC The overarching risk framework for the EDIC 6 defined and applied risk management standards. Report 9 M2.4 Acceptance criteria v1 WP2 5 - NGC Formulation of quality and risk management 9 acceptance criteria - version one based on initial findings. Report 10 M2.5 Description of node roles WP2 5 - NGC Describing functional roles for the node within 12 the delivery system of the EDIC at API level. Report 28 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 11 M2.6 Acceptance criteria v2 WP2 5 - NGC Second iteration of acceptance criteria. Report 15 12 M2.7 API sequence diagram WP2 5 - NGC Diagram depicting interaction between node roles 18 at API level. Workflow diagram 13 M2.8 Data Protection Impact Assessment list WP2 2 - LNDS Overview of elements with regard to the Genome 24 EDIC's operations that will require a DPIA and/ or a consultation of the supervisory authorities. Report 14 M2.9 Initial policy toolset WP2 2 - LNDS Draft Policy Toolset. Report 24 15 M2.10 Initial legal documents tool set WP2 11 - SLEX Draft legal documents toolset as a living 24 document. Report 16 M2.11 Regulatory Sandbox Workshop WP2 2 - LNDS Workshop with data protection authorities on 8 legal interpretations for secondary use. Report 17 M2.12 Regulatory Sandbox Workshop WP2 2 - LNDS Workshop with data protection authorities on 20 legal interpretations for secondary use. Report 18 2.13 Regulatory Sandbox Workshop WP2 2 - LNDS Workshop with data protection authorities on 32 legal interpretations for secondary use. Report 19 M2.14 Stakeholder engagement plan for WP2 10 - CNR Strategy on involvement of stakeholders on 3 sustainability the business models envisaged and planning of events. Report 20 M3.1 Guideline for data collection available WP3 9 - INSERM Methodology for collection of information on 8 national genomic programmes across europe. Protocol 21 M3.2 Meetings with the network of public WP3 3 - INSA Public health and health professionals from 30 health and health professionals on topics signatory countries agreement to participate in relevant for implementation of genomics in the network, and first in person meeting with the healthcare concluded 29 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 1+MG Implementation in Healthcare Working Group concluded. Meeting report 22 M3.3 First meeting of health economics WP3 5 - NGC First in person meeting of the experts from 9 working group concluded the Health Economics and Outcomes Research 1+MG Working Group with other relevant experts concluded. Meeting report 23 M3.4 Creation of a Citizens hub WP3 18 - Sciensano Citizen information hub, bringing together 12 already existing materials in a layered fashion, with informational blogs that encourage comments. First version of citizen hub is live 24 M3.5 Second meeting of health economics WP3 5 - NGC Second in person meeting of the experts from 30 working group concluded the Health Economics and Outcomes Research Working Group with other relevant experts concluded. Meeting report 25 M4.1 Phenotype data model v1 WP4 4 - HEALTH-RI A first version of the consensus phenotype data 18 model to be used in 1+MG and for GoE data. Report and v1 consensus phenotype model 26 M4.2 Genotype data model v1 WP4 4 - HEALTH-RI A first version of the consensus genotype data 18 model to be used in 1+MG and for GoE data. Report and v1 consensus genotype model 27 M4.3 Terms of use/ELSI metadata v1 WP4 8 - UU A first version of the consensus terms of use/ELSI 12 metadata model to be used in 1+MG and for GoE data. Report and v1 terms of use/ELSI metadata model 28 M4.4 Terms of use/ELSI metadata v2 WP4 8 - UU A second version of the consensus terms of use/ 18 ELSI metadata model to be used in 1+MG and for GoE data. Report and v2 terms of use/ELSI metadata model 30 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 29 M3.5 Metadata for reproducible and WP4 12 - ISCIII Initial collection of the available mechanisms 14 replicable data analysis for capture data analysis provenance through community-driven standards. Report 30 M4.6 Indicators to evaluate software content WP4 7 - BSC Initial collection of indicators for evaluating the 18 and metadata quality software quality and of its associated metadata. Report and demonstrator LIST OF CRITICAL RISKS Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) 1 Limited funding available could have an impact on WP2, WP3, WP4, Establish connections with ongoing and new initiatives, RIs, and projects that support the the project outcomes. To deliver against the full WP1 initiative to align efforts and outputs. 1+MG ambition there are still gaps for which no Seek the support of the 1+MG MS group to increase national funding for key expertise. funding is available for e.g. proficiency testing as a Highlight gaps to the EC at various governance meetings. specific example. 2 Delayed creation of the Genome EDIC resulting in WP2 Interactions with GDI Pillar I to get reliable positions at least on the most critical elements temporary decision, potentially leading to shifting for the development work. targets for the entire legal and policy framework. 3 The EHDS will set up requirements which make it WP2 The Genome EDIC may decide not to join as it does not depend on the EHDS. The impossible for the Genome EDIC in its envisaged national implementation could still be designed to serve both the EDIC and the EHDS as setup to join 31 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) the infrastructure requirements are likely higher for the EDIC due to our aim for very high standards. 4 The EDIC as a legal instrument will not provide WP2 Luxembourg as a host country could be explored to provide or complement any necessary a legal basis for the operations, which is the basis legislation as Luxembourg may be able to pass laws fairly quickly if needed. assumption for most of the tasks in WP2. 5 Lack of stakeholder engagement, in particular from WP3, WP1 Materials will be brought together into a 'Hub' for future reference once more engagement is healthcare or citizens necessary. Dissemination to these groups will be targeted at this stage 6 Health economic model experience and relevant WP3 Use MSs who are most keep to test the models to estimate economic impact of WGS data is kept at a national level and not shared implementation 7 Other initiatives are not willing to share progress WP4 Project experts engaged across multiple projects. Make value clear to all. openly 8 Insufficient interest from countries in carrying out WP3 Engage with NMGs to understand the reasons and work towards meeting countries needs a maturity assessment of genomics implementation regarding the process, the indicators or any other reported issues in healthcare systems, as well as mapping exercise, using the 1+MG Maturity Level Model 9 Higher than expected engagement from public WP3 Seek other effective solutions for online meetings and additional funding sources at the health and other health professionals in the planned national levels network, together with insufficient funding prevents in person meetings with wide European country representation 32 Project: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 PROJECT REVIEWS Project Reviews Grant Preparation (Reviews screen) — Enter the info. Review Timing Location Comments No (month) RV1 18 TBC Technical review and financial RV2 24 TBC Technical review RV3 36 TBC Final Technical review and financial 33  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 IMPORTANT NOTICE What is the Application Form? The Application Form is the template for EU grants applications; it must be submitted via the EU Funding & Tenders Portal before the call deadline. The Form consists of 2 parts: • Part A contains structured administrative information • Part B is a narrative technical description of the project. Part A is generated by the IT system. It is based on the information that you enter into the Portal Submission System screens. Part B needs to be uploaded as PDF (+ annexes) in the Submission System. The templates to use are available there. How to prepare and submit it? The Application Form must be prepared by the consortium and submitted by a representative. Once submitted, you will receive a confirmation. Character and page limits: ∙ page limit normally 70 pages (unless otherwise provided in the Call document) ∙ supporting documents can be provided as an annex and do not count towards the page limit ∙ minimum font size — Arial 9 points ∙ page size: A4 ∙ margins (top, bottom, left and right): at least 15 mm (not including headers & footers). Please abide by the formatting rules. They are NOT a target! Keep your text as concise as possible. Do not use hyperlinks to show information that is an essential part of your application. If you attempt to upload an application that exceeds the specified limit, you will receive an automatic warning asking you to shorten and re-upload your application. For applications that are not shortened, the excess pages will be made invisible and thus disregarded by the evaluators. Please do NOT delete any instructions in the document. The overall page limit has been raised to ensure equal treatment of all applicants. This document is tagged. Be careful not to delete the tags; they are needed for the processing.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 TECHNICAL DESCRIPTION (PART B) COVER PAGE PROJECT Project name: Beyond 1 Million Genomes Plus Project acronym: B1MGplus Coordinator contact: Serena SCOLLEN, ELIXIR Hub TABLE OF CONTENTS TECHNICAL DESCRIPTION (PART B) COVER PAGE PROJECT SUMMARY 1. RELEVANCE 1.1 Objectives and activities 1.2 Contribution to long-term policy objectives, policies and strategies — Synergies 1.3 Digital technology supply chain 1.4 Financial obstacles 2. IMPLEMENTATION 2.1 Maturity 1+MG initiative maturity Maturity towards the legal requirements and establishment of the Genome EDIC Maturity towards the 1+MG Healthcare Implementation and Health Economics Maturity towards 1+MG data requirements Maturity on project coordination and support to 1+MG initiative 2.2 Implementation plan and efficient use of resources Implementation plan WP1 - Project coordination and support to the 1+MG initiative implementation plan WP2 - Project coordination and support to the 1+MG initiative implementation plan WP3 - Healthcare Implementation and Heath Economics implementation plan WP4 - 1+MG Data requirements implementation plan Project management, quality assurance and monitoring and evaluation strategy Cost effectiveness and financial management Critical risks and risk management strategy 2.3 Capacity to carry out the proposed work Consortium cooperation and division of roles Outside resources (subcontracting, seconded staff, etc) Consortium management and decision-making 3. IMPACT 3.1 Expected outcomes and deliverables — Dissemination and communication Expected outcomes and deliverables Dissemination and communication of the project and its results 3.2 Competitiveness and benefits for society Competitiveness and benefits for the society 3.3 Environmental sustainability and contribution to European Green Deal goals Environmental sustainability and contribution to European Green Deal goals 4. WORK PLAN, WORK PACKAGES, ACTIVITIES, RESOURCES AND TIMING 4.1 Work plan Work plan 4.2 Work packages, activities, resources and timing Work Package 1 - Project coordination and support to 1+MG initiative  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Work Package 2 - Genome EDIC establishment Work Package 3 - 1+MG Healthcare Implementation & Health Economics Work Package 4 - 1+MG Data requirements Staff effort Subcontracting Purchases and equipment Other cost categories Timetable 5.1 Ethics 5.2 Security 6. DECLARATIONS Double funding Financial support to third parties (if applicable) ANNEXES #@APP-FORM-DEP@# #@PRJ-SUM-PS@# [This document is tagged. Do not delete the tags; they are needed for the processing.] PROJECT SUMMARY Project summary See Abstract (Application Form Part A). #§PRJ-SUM-PS§# #@REL-EVA-RE@# #@PRJ-OBJ-PO@# 1. RELEVANCE 1.1 Objectives and activities Objectives and activities Describe how the project is aligned with the objectives and activities as described in the Call document. How does the project address the general objectives and themes and priorities of the call? What is the project’s contribution to the overall Digital Europe Programme objectives? B1MGplus will coordinate and support key and specific areas to establish the sustainable operation and uptake of the European Genomic Data Infrastructure to realise the EU Member States’ initiative 1+ Million Genomes (1+MG) (see Box 1). These areas will complement the currently funded 1+MG implementation projects and the work carried out by the 1+MG Working Groups and National Mirror Groups. The creation of a sustainable federated infrastructure for genomic data will allow many more people, including health professionals and researchers, to benefit from the secure access of genomic and other linked health data. This project will contribute towards the broader ambitions to unlock the promise of genomics for healthcare and public health purposes for citizens and society, creating unprecedented opportunities for personalised health in the areas of cancer, common and rare diseases, infectious diseases and pharmacogenomics. Genomics can enable more accurate and timely diagnostics, boost prevention, and make more efficient use of valuable resources through the development of more targeted personalised medicines, therapies, and interventions. Accurate genomic profiling of individual patients will be an important contribution to promote a shift of medical practice towards disease prevention. In the long run, genomic data analysis has the potential to improve the effectiveness, accessibility, efficiency, sustainability and resilience of health systems in the European Union. Box 1. Background to the 1+MG initiative The European 1+Million Genomes (1+MG) Initiative1 aims to enable personalised medicine and health through a shared framework and infrastructure for securely accessing and integrating high-quality genomic data and other health data across borders. Since its inception in 2018, the initiative has gained support from 25 EU countries, the UK and Norway. The initiative promises to enhance prevention, patient care and treatment outcomes and positions Europe at the forefront of genomics research and patient-centred healthcare. The approach to fulfil this coordination and support action has been endorsed by the 1+MG Member State representatives who have been involved in delivering the 1+MG initiative ambitions and implementation projects since their inception (see Figure 1). The B1MGplus consortium is composed of experts from the: 1 https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 1. 1+MG Member States’ (representatives and national experts) 2. 1+MG Coordination Group (CG) 3. 1+MG Working Groups 4. EC funded 1+MG initiative implementation projects from the different phases of the roadmap: a. design and testing phase of the 1+MG roadmap (Beyond 1M Genomes (B1MG)) b. scale up and sustainability (European Genomic Data Infrastructure project (GDI) and Genome of Europe (GoE)) projects. The B1MGplus consortium will support the scale up and sustainability phase and build upon and support the current and past projects. Experts within the consortium are also engaged in other projects focusing on developing principles and infrastructures for the secondary use of health and genomic data. Key initiatives include the European Federation of Cancer Images (EUCAIM), the European Health Data Space (EHDS) and projects such as the Joint Action Towards the European Health Data Space part 2 (TEHDAS2), and the Healthdata@EU pilot. The overlap of experts across these projects ensures synergies, and effective addressing of challenges, thereby preventing duplication of effort. Figure 1 1+MG initiative implementation projects. Support to the implementation of the 1+MG 2023–2027 roadmap This project aims to advance the implementation of the 1+MG 2023–2027 roadmap 2 (Figure 2) by addressing specific requirements outlined in the call text (the currently underfunded areas of the roadmap) and delivering or supporting the five implementation tracks of the 1+MG 2023-27 roadmap. More specifically, the objective is to: ● Support the preparatory work for the creation and for the operation of an EDIC3 ● Facilitate strategic orientation of the 1+MG initiative ● Support expert work to enable the uptake of genomics for healthcare and public health purposes ● Address data aspects of the 1+MG Framework. 2 https://digital-strategy.ec.europa.eu/en/news/1million-genomes-initiative-new-roadmap-adopted-scale-and- sustainability-phase 3 1+MG MSs’ representatives endorse establishing an EDIC to operate and maintain the European GDI. This is the preferred option for the sustainability of the initiative and data infrastructure.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Figure 2 The 1+MG Roadmap 2023–2027 outlines activities and goals to develop and implement the 1+MG Framework, engage with stakeholders and advance personalised medicine approaches across Europe. The roadmap has five implementation tracks interlinking with use cases covering various data and disease areas. Implementation tracks: (1) 1+MG Framework (2) 1+MG European Federated Genomics Data Infrastructure (3) 1+MG proof accessible data (4) National Mirror Groups (5) Contribution, alignment and integration with EHDS-2, other European projects and initiatives. Use cases: Synthetic data, Genome of Europe, rare diseases, cancer, complex diseases, infectious diseases. To do this, the project will be structured in key areas: Preparatory work for the creation and operation of the Genome European Digital Infrastructure Consortium (EDIC) With reference to the legal and ethical perspectives, this line of activities is transversal to all implementation tracks of the 1+MG 2023–2027 Roadmap yet it will impact more significantly Tracks 2,4,5. Notably, track 2 focuses on establishing and expanding the 1+MG data infrastructure and envisions the creation of a common European legal entity by 2027 to ensure long-term sustainability (Figure 2). Beyond the design of a secure infrastructure, the legal and ethical aspects also need to consider the changing legal landscape determined by the increasing number of EU directives and regulations (e.g. European Health Data Space, Data Governance Act, NIS2 Directive). To ensure legal compliance of the operations, a comprehensive framework of legal, policy, quality and risk management documents needs to be established. This effort will be informed by input from the GDI project, including consideration of the statutes of the EDIC, which are currently under development. Simultaneously, new considerations will be fed into the GDI decision making process for adoption by the Pillar I that also serves as the official Genome EDIC Working Working Group. The B1MGplus consortium will therefore connect its activities with those of GDI Pillar I (Long-term sustainability), where the EDIC Working Group (WG) and the 1+MG MS representatives are working together via a dedicated GDI Task Force to establish the Genome EDIC, a legal framework, by 2025. As such, B1MGplus will provide the support required to make progress towards an operational EDIC (initially to GDI Pillar I and then the EDIC once it is established). Considering it possible that a common European legal entity would be established already during the first phase of B1MGplus, special attention will be given initially to the careful drafting of the establishing statute already envisaging its implementing rules. To this end B1MGplus Work Package 2 - Genome EDIC establishment wil:: ● Before M12: ○ Will have set up working groups and task forces, as needed ○ Will have contributed to the drafting of the Statute to attach to the EC Decision to establish the EDIC also by highlighting the needed implementing policies and rules not already considered in the Decision ○ Expanded the research done on the data governance for data reuse in research towards other applications such as healthcare reuse, quality management and policy making, linking it to the legal and the policy frameworks ○ Held one or more workshops (according to needs) with National ELSI experts and regulatory sandbox workshops with data protection authorities ○ Defined an overview of the needed policies to be implemented ○ Defined an overview of the needed legal documents to be implemented ○ Analysed user needs to make suggestions for a minimum viable product as initial services to be provided and analysed success stories relevant for the Genome EDIC to illustrate its potential impact for stakeholder buy-in to support sustainability ○ Laid the first foundation for a risk management framework ○ Defined a stakeholder interaction plan for sustainability ● Before M24: ○ Will have finalised the first draft of the legal framework of the Genome EDIC's operations considering relevant legislation such as GDPR, DGA, EHDS with a focus to leverage the synergies among the involved legal rules ○ Drafted the legal documents toolset ○ Drafted the policy toolset ○ Gained an overview of stakeholder positions on the sustainability considerations developed in the GDI Pillar I ○ Agreed on acceptance criteria from a risk management point of view for IT infrastructure to be integrated into the Genome EDIC ○ Supported the Genome EDIC with an analysis of its DPIA needs and supported it with input from regulatory sandbox meetings ● Before M36: ○ Will have finalised the the legal framework of the Genome EDIC's operations setting the appropriate connections and synergies with the EHDS ○ Completed the planned legal documents toolset ○ Completed the planned policy toolset ○ Defined a risk management framework for the IT infrastructure and a corresponding implementation plan Facilitating and supporting the 1+MG initiative strategically to enable the uptake of genomics for healthcare and public health purposes  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 These activities will support Track 4 of the 1+MG 2023–2027 Roadmap to promote national engagements, contributions and alignment (Figure 2). Building on the healthcare implementation outputs of B1MG and health economics outcomes research 4, and aligning actions being developed in GDI toward healthcare professionals and citizens, we will support the leadership of the 1+MG WGs in Healthcare Implementation and Health Economics of genomics to make decisive progress in demonstrating the impact of 1+MG on healthcare. In this regard B1MGplus Work Package 3 - 1+MG Healthcare Implementation & Health Economics will: ● Before M12: ○ Build a network of public health and health professionals, working together to bridge the gap between the genomic data available and its full usability for healthcare ○ Build on recommendations from GDI to promote basic and lifelong education of health professionals on genomic medicine ○ Build a toolbox to facilitate the use of the Maturity Level Model developed in the B1MG project for healthcare systems self-assessment of genomic implementation ○ Develop a guideline for mapping of genomic initiatives and best practices at the national and regional levels ○ Create a citizens Hub for dissemination of relevant information material on genomics and health ○ Organise an expert meeting with health economics experts to scope a standardised approach to measure economic impact of WGS ● Before M24: ○ Publish and disseminate a Policy Brief targeting decision makers on the potential and main challenges and solutions of the genomic data infrastructure usage in healthcare ○ Publish best practices identified in the mapping exercise that can be shared by member states ○ Report on existing publication, projects, use cases and Health Technology Assessment (HTA) of Whole Genome Sequencing (WGS) ● Before M36: ○ Draft actionable recommendations on implementation and sustainability of genomics in healthcare systems ○ Report on gaps, challenges, needs and actions for implementation of genomics in healthcare ○ Report on MLM outcomes and benchmarking with additional countries ○ Develop a decision tree or other preliminary model for health economics Data requirements constituting the 1+MG Framework The objectives and activities in this area all support track 1 of the 1+MG 2023–2027 Roadmap to develop and maintain the 1+MG Framework (Figure 2). The 1+MG Framework is the main outcome of the B1MG project. It is a web portal bringing together the specific recommendations, guidelines, and best practices agreed upon in the 1+MG Initiative to realise its ambition for secure access to genomics and health data across Europe. By 2027, the Framework will be: ● Widely adopted nationally, with guidance tailored to facilitate national implementation ● Updated to reflect implementation developments and new countries joining Outputs from this area will directly feed into track 2 ‘Establishing and expanding the 1+MG data infrastructure’ and track 3 ‘Generating accessible 1+MG-ready data’. For track 2, the frameworks are required for the technical infrastructure to be further established and operational. For track 3, the aims by 2027 are to have high quality, 1+MG-ready whole genome sequences generated and linked at a national level. Data will be generated at a large scale via the Genome of Europe (GoE) and other parallel projects. These data will be used to test and demonstrate the value of the 1+MG infrastructure. The data frameworks produced by B1MGplus will provide guidance towards making data 1+MG-ready in terms of semantic interoperability, data quality and metadata standards. More specifically, B1MGplus will coordinate further development of the 1+MG data frameworks including the metadata model, data standards, ontologies and the establishment of sequencing practices. This effort will be connected with ongoing projects such as GDI Pillar II and Pillar III, QUANTUM and TEHDAS2, aiming to extend and improve metadata, quality and utility of 1+MG data and software. The harmonisation of existing and developing minimal datasets will enhance semantic interoperability. Datasets lacking metadata such as quality, genotype, terms of use, ELSI or metadata that can aid discovery and 1+MG journey provenance will be systematically defined and accompanying metadata schemas will be developed. Furthermore, B1MGplus will expand quality requirements to include software components, ensuring that proposed software stacks adhere to existing best practices during development. Ongoing projects such as EOSC-EVERSE will provide an overall framework for software development best practices. Additional metadata mechanisms will be considered to complement data transformation,enabling optimal data reuse. This includes leveraging community-driven standards like RO-Crate, initially proposed in EOSC-Life and further developed in ongoing EU-funded projects like BY-COVID, EOSC4Cancer and EuroScienceGateway. In this regard B1MGplus Work Package 4 - 1+MG Data requirements will provide the 1+MG initiative with: ● Before M12: ○ The initial harmonised minimal datasets including cardinalities and conformance ○ Version 1 of terms of use and ELSI metadata items, in close collaboration with WP2 ○ An initial definition of 1+MG journey provenance metadata items ○ An initial definition of software quality metrics for the software stack supporting data management and mobilisation. ● Before M24: ○ Version 1 of the (minimal) dataset models for both phenotype and genotype ○ Version 2 of the metadata schema for the terms of use and ELSI metadata, in close collaboration with WP2 ○ Version 1 of metadata schema for the 1+MG journey provenance metadata, including data transformation. 4 https://framework.onemilliongenomes.eu/genomics-into-healthcare  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ● Before M36: ○ Version 2 of the (minimal) dataset models for both phenotype and genotype ○ Version 3 of the metadata schema for the terms of use and ELSI metadata, in close collaboration with WP2 ○ Version 2 of metadata schema for the 1+MG journey provenance metadata ○ A set of software quality indicators to evaluate the maturity of software components needed for managing data and metadata within the 1+MG journey. Alignment with other European initiatives All of the above areas will also ensure progress for Track 5 ‘Aligning with European Health Data Space and other European initiatives’ of the 1+MG 2023–2027 Roadmap, which states that interoperability and integration across European initiatives and projects is necessary to realise genomic medicine implementation. Examples include the European Health Data Space, the European Cancer Image Initiative, European Virtual Human Twins initiative, future cancer data hubs, the Cancer Mission actions, and the European Partnerships for Rare Diseases, Personalised Medicine, and Transforming Health and Care Systems. B1MGplus will work to coordinate collaboration between relevant European initiatives and projects to achieve interoperability and integration where possible. Ideally, initiatives managing genomic data will adopt 1+MG Framework components, or at a minimum be interoperable. [1] https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes [2] https://ec.europa.eu/newsroom/dae/redirection/document/86449 [3] https://ec.europa.eu/newsroom/dae/redirection/document/99974 [4] https://b1mg-project.eu [5] https://gdi.onemilliongenomes.eu [6] https://github.com/GenomicDataInfrastructure #@COM-PLE-CP@# 1.2 Contribution to long-term policy objectives, policies and strategies — Synergies Contribution to long-term policy objectives, policies and strategies — Synergies Describe how the project contributes to long-term policy objectives of the call’s domain/area and to the relevant policies and strategies, and how it is based on a sound needs analysis in line with the activities at European and national level. What challenge does the project aim to address? The objectives should be specific, measurable, achievable, relevant and time-bound within the duration of the project. B1MGplus will make contributions towards the creation, operation and realisation of a sustainable federated infrastructure for genomic data for healthcare and research. B1MGplus will significantly contribute to the implementation of several EU- level policies, ranging from healthcare and disease-specific policies to those focussed on digital and data areas. B1MGplus will support Member States’ work, outlining a sustainability roadmap and enabling the creation and operation of an EDIC for the 1+MG initiative in line with the Decision (EU) 2022/2481 of the European Parliament and of the Council of 14 December 2022 establishing the Digital Decade Policy Programme 2030. A summary of policy objectives from the call text is below, with references to relevant, common, and overarching EU-level policies and strategies, briefly outlining how the B1MGplus project will contribute. The activities will be monitored and indicators will be tracked by referring to the activities outlined in section 1.1 (before M12, M24 and M36). Legal and ethical enablers Addressed by B1MGplus: Supporting the Genome EDIC WG and the 1+MG Member States on the establishment of the EDIC by carrying out the field work required to generate high quality landscape and scoping documents necessary for the compliance framework beyond the legal creation of an EDIC. These documents will drive EDIC to become operational and offer compliant access to health and genomic data, covering legal, policy, quality and security aspects of data provision. WP2 will research the legal setup and perform a detailed analysis of all operations of the EDIC with regard to its legal qualification. This analysis will be complemented by a scrutiny of the regulatory framework beyond the GDPR. The consequences will be considered for the establishment of the legal basis through the EDIC implementing act or other legal documents. In addition, recommendations given around the data protection by design and default analysis during the B1MG project, currently adopted by GDI Pillar I, will be captured and translated into policies constructing a risk management framework. Key results: ● A record of processing activities that captures the legitimacy of EDIC and the corresponding safeguards ● A number of documents that can be fed back to the GDI Pillar I and/or the EDIC for discussion and/or adoption to provide legal tools and policies to govern the operations for suitable and specific safeguards to ensure the protection of the rights and freedoms of the data subjects whose data are included in the EDIC for secondary use. ● A framework that can guide the implementation of national IT infrastructure to ensure the quality and the security of workflows, tools and platforms. EHDS Regulation and operationalise the EDIC’s participation in the HealthData@EU infrastructure Addressed by B1MGplus: WP2 will analyse the EHDS Regulation and will seek close exchange with relevant projects and stakeholders to investigate the conditions for a participation in the HealthData@EU infrastructure, to give recommendations on the alignment of its policies, tools, security measures and IT framework with the requirements of the EHDS. Key results: ● An analysis of the model how the EDIC could join the EHDS, its relationship with the various stakeholders and the conditions and opportunities of such participation  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ● Information on the practical consequences of the participation in the HealthData@EU infrastructure Implementation for healthcare and public health purposes, Addressed by B1MGplus: ● Engaging public health professionals, and policy makers, in the discussion of benefits and challenges of adopting genomics in healthcare systems for clinical practice and public health policies ● Documenting the implementation of genomic medicine practices in national healthcare systems ● Promoting the awareness, literacy level and education of citizens on genomic medicine across Europe. WP3 will provide a framework of reference for genomics in healthcare that supports the decision making process, facilitating the definition of mid and long term targets and the path for genomics implementation, incorporating the feedback received from B1MG and the 1+MG experts. Key results: ● Mapping of gaps, challenges, unmet needs and solutions from the perspective of public health and healthcare professionals, healthcare systems and national genomic healthcare implementation programmes ● Recommendations for the EDIC on the uptake and implementation of genomics for healthcare and public health ● A citizen’s hub for dissemination of genomic medicine, promoting citizens and patients awareness, literacy and trust Health economic models and health policy Addressed by B1MGplus: The project will map existing studies on health economy and health technology assessments related to whole genome sequencing and other comprehensive genetic tests in healthcare. Building on the collected best practices, and together with experts in the field, the project will develop decision trees to be tested in national settings to guide decision making related to genomics in healthcare. The long term impact of the work is the scoping of a project on economic impact of genomic medicine in healthcare to support future prioritisation in healthcare, policy makers and decisions on investment in genomic medicine. Key results: ● Overview of literature and existing studies on health economy and health technology assessments related to WGS and other comprehensive genetic tests in healthcare ● Decision trees tested in national settings ● Scoping of a project on economic impact of genomic medicine in healthcare Implementation and equity in access to genomics medicine, Addressed by B1MGplus: Enhancing the 1+MG MLM for the implementation of genomics medicine in healthcare systems with updated domains and indicators, promoting its use and benchmarking by more healthcare systems. This will provide an homogeneous assessment framework that will foster the alignment of optimisation aims in healthcare systems across Europe, closing gaps, reducing asymmetries and ensuring a path towards equity of access to personalised medicine for all Europeans. Key results: ● Updated 1+MG MLM incorporating novel dimensions aligned with emerging developments in genomic medicine ● Benchmarking of the MLM by healthcare systems across europe Frameworks for 1+MG data/metadata standards’ maintenance and data Addressed by B1MGplus: Expand the 1+MG Framework to fully define the 1+MG minimal metadata model, data standards, ontologies and quality criteria providing accessibility and maintenance, ensuring continuous alignment and support of 1+MG data use for research, innovation and policy making. Key results: ● ● Phenotype data model ● Genotype data model ● Terms of use/ELSI metadata ● Software quality indicators for components to be incorporated into the 1+MG journey. ● Data/metadata provenance models. Due to the limited budget available for B1MGplus as a coordination and support action, the consortium, as in B1MG, will execute an implementation plan that builds on the connection to relevant initiatives and projects to facilitate the delivery of the goals listed above (see section 2.2). #§COM-PLE-CP§# 1.3 Digital technology supply chain Digital technology supply chain Explain to what extent the project would reinforce and secure the digital technology supply chain in the EU. This criterion might not be applicable to all topics — for details refer to the Call document. Not applicable 1.4 Financial obstacles Financial obstacles Describe to what extent the project can overcome financial obstacles such as the lack of market finance. This criterion might not be applicable to all topics — for details refer to the Call document.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Not applicable #§PRJ-OBJ-PO§# #§REL-EVA-RE§# #@QUA-LIT-QL@# #@MAT-URI-MU@# 2. IMPLEMENTATION 2.1 Maturity Maturity Explain the maturity of the project, i.e. the state of preparation and the readiness to start the implementation of the proposed activities. The activities outlined in B1MGplus build upon the developments of the 1+MG initiative and 1+MG implementation projects. The recommendations from B1MG have been outlined (shown in boxes) and considered for the B1MGplus implementation plans. While these recommendations may not always be applicable, they are fully noted for clarity. As an example, for the legal requirements, it has been decided by Member States that the model will be an EU-law enabled common genomic data space rather than building on national law. A further example is the MLM which has been validated in 8 countries and is not deemed unvalidated. As the consortium is formed of 1+MG and national experts, activities outlined can start immediately. Most of the experts have been involved in the development of recommendations, guidelines and technical outputs, as well as the 1+MG 2023–2027 roadmap, that have already been endorsed by the 1+MG Group. In the following sections the maturity of the 1+MG initiative and areas pertinent for the project objectives are discussed. 1+MG initiative maturity The 1+MG initiative was established in 2018 by 13 countries. Since then the initiative has progressed through the design and testing phase (1+MG Roadmap 2020–2022) and has embarked on a scale up and sustainability phase (1+MG Roadmap 2023– 2027). There are now 27 countries directly participating via (1) Member States representatives in the 1+MG Working Group (2) EU experts across the 12 1+MG Working Groups and (3) National experts via National Mirror Groups. B1MGplus would be the fourth EC funded project directly supporting the initiative. The previous CSA has completed (B1MG, 2020-23) but two projects are ongoing (GDI, 2022–26) and the (GoE5 2024–28). The initiative, via national and EC funding, has developed the governance and built strategic and technical capacity to fully absorb the task required for the success of the scale up and sustainability phase. The technical capability in particular has built upon MS funded activities conducted by ELIXIR in the last 10 years. Maturity towards the legal requirements and establishment of the Genome EDIC As part of the GDI Pillar I work with the Member States representatives in the project, which largely serve also as the EDIC WG, a Task Force has been started for the legal establishment of the Genome EDIC in 2025. While it is not expected to be fully operational in the initial years, its establishment will be critical for garnering, depositing and accessing genomic and health data through the Genome EDIC once operational. It is also envisaged that the Genome EDIC will become an Authorised Participant in the EHDS. The Genome EDIC will then have contractual capacity to guide the deployment and operations, to receive further support for the activities and to demonstrate through quick-wins the direct and added value for healthcare in addition to the opportunities for research, innovation and policy making. B1MGplus will facilitate the decision making process towards the Genome EDIC implementation by providing input to find solutions for legal challenges, by providing convincing arguments for the Member States engagement based on health economics studies and by providing support for sustainability analyses. Once the EDIC is established, B1MGplus will continue supporting the EDIC by taking the necessary steps and compiling a document framework to support the implementation of the operational framework required to move into full operations. The progress made by the initiative and the implementation projects: B1MG has defined an initial framework with the focus on research reuse. GDI is negotiating with member country representatives to create an EDIC. B1MGplus will complement the effort by addressing elements not yet covered in B1MG and will feed them into the negotiations of the GDI Pillar I and the EDIC Working Group to allow the Genome EDIC to define its operations. Recommendations from the B1MG review - for consideration in B1MGplus activities ● The translation of ELSI recommendations to technical infrastructure needs to be further developed. In particular, when aiming for federated, decentralised approaches for data sharing, data access governance and requirements related to consent and transparency need to be focused on. While the plan for centralised Data Access Committees (DACs) seems to be beneficial, its feasibility might be challenging and contingency plans should be foreseen. ● Future work should better address the variations among EU countries in implementing GDPR regulations regarding the secondary use of health and genetic data, as well as the establishment of a unified ethico-legal framework. ● A consistent and mature sustainability plan needs to be formulated and pursued in follow-up projects to ensure that the created value of B1MG is efficiently maintained. The sustainability plan should also address economic models. 5 EC funding decision pending at the time of writing this proposal with the GoE now moved into the Grant Agreement Preparation phase.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Maturity towards the 1+MG Healthcare Implementation and Health Economics As part of the B1MG project activities the 1+MG Maturity Level Model 6 was developed providing a framework for self assessment of healthcare systems (and clinical institutions) for the deployment of genomics medicine as a crucial component to make significant progress on the implementation of Personalized Medicine practices. The MLM was successfully tested by eight different countries. The B1MG reviewers, the 1+MG initiative members, as well as the European Commission (the EC Innovation Radar selected the 1+MG as a key innovation) have already made recommendations to make this a more useful global tool by enabling the benchmarking of EU and non EU healthcare systems, and helping them on decision making process on the next steps based on their own circumstances and priorities. B1MGplus will provide the necessary continuity to the team involved in the MLM to bring it to the next stage. It will engage with public health and health professionals, and policy makers, to increase their awareness and gather their perspectives on how genomics can be leveraged for better healthcare. It will further build on the MLM framework to map national and regional genomic initiatives, highlighting the best practices, challenges and solutions that may be shared across Europe. It will also build on key challenges on health professional education, citizen and patient awareness, as previously identified in the MLM pilot in eight countries, to develop actions that will improve these indicators, including recommendations and sharing of citizen literacy activities from other initiatives and projects. On the Health Economics side, and as part of the work carried out in B1MG, it is evident that there is a clear gap of sound and useful health economics models that can demonstrate and support the investment decisions across healthcare systems. Still the work in B1MG was useful to analyse the landscape and to set the scene to make progress in this area. Recommendations from the B1MG review - for consideration in B1MGplus activities ● The MLM is still not sufficiently elaborated when applied for making an assessment of the relevant maturity levels and effectively use the results. So far, the validation of the model is limited. ● The sustainability plan should also address economic models. ● The approach on how to assess health economics for genomics in specific use cases or in general remains to be still investigated. Maturity towards 1+MG data requirements As part of 1+MG working groups activities (WG3 “Data standards” and WG4 “Good Sequencing Practice”) and via the B1MG and GDI projects, significant progress has been made and will continue to be made in building consensus on the 1+MG Minimal metadata model, data standards, ontologies and best practices for sequencing. Additionally, these efforts focus on requirements for data/metadata provenance and software, which are critical to ensure reproducibility of results. Still the coordination of these activities, that take part in parallel projects and initiatives, to establish data standards (e.g. GDI, TEHDAS, Healthdata@EU, QUANTUM, GoE) require additional work. Activities also need to be extended to incorporate software management and quality aspects required to ensure the reproducibility of results connecting to relevant activities (e.g. ELIXIR-STEERS, EVERSE). A robust proficiency testing framework is key, in which facilities can periodically participate to validate their performance. The framework also allows the testing of new sequencing approaches, pipelines and data analytical methods being tackled in GDI and EUCAIM. Special attention will be paid by the B1MGplus consortium to the final recommendation received from the B1MG reviewers in collaboration with other 1+MG implementation projects GDI and GoE. Recommendations from the B1MG review - for consideration in B1MGplus activities ● Follow-up projects should employ unified semantics for data and metadata models across its use cases including harmonising and extending the proposed data models. Approaches for managing longitudinal data of a particular patient should be investigated and established. In addition, scalability of the models should be taken into account. ● Existing tools and standards should be leveraged to establish proper metadata management enabling efficient search. Specific attention should be given to the metadata required for defining access to data and overall, for the privacy framework, to allow for implementation. ● The systematic implementation of standards and alignment with other relevant initiatives and regulations should be pursued in follow up projects like GDI to properly capitalise on the investments and facilitate sustainability. Maturity on project coordination and support to 1+MG initiative Since 2020, the ELIXIR Hub has been a neutral broker role for the 1+MG initiative. As the coordinator of the B1MG and GDI projects, ELIXIR has collaborated with institutions nominated by 1+MG member states representatives to implement the 1+MG ambition through EC funded activities. In this dynamic environment, coordination is crucial to maintain alignment of funded projects with the evolving initiative. The initiative is approaching a significant transition point: the data infrastructure is being deployed, the legal entity (Genome EDIC) is being established, and the initial specific data collection (Genome of Europe) is about to commence. Simultaneously, the EHDS will begin its implementation phase and EC partnerships (e.g. precision medicine, rare diseases) and missions (e.g. cancer) are being launched. In this context, having a coordination and support team is essential. This team will navigate the complex landscape, ensuring alignment of activities across related initiatives and projects, maximising synergies, and facilitating implementation. They will also engage relevant stakeholders, building on the 1+MG Stakeholder Forum established by the B1MG project, to ensure cohesive progress towards the initiative's goals. Recommendations from the B1MG review - for consideration in B1MGplus activities ● Streamlining the stakeholder engagement and citizen engagement activities on the European level will be needed. ● Concrete measures to implement the input from the stakeholder engagement should be foreseen. #§MAT-URI-MU§# #@CON-MET-CM@# #@PRJ-MGT-PM@# #@FIN-MGT-FM@# #@RSK-MGT-RM@# 2.2 Implementation plan and efficient use of resources 6 https://framework.onemilliongenomes.eu/genomics-into-healthcare  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Implementation plan Show that the implementation work plan is sound by explaining the rationale behind the proposed work packages and how they contribute to achieve the objectives of the project. Explain the coherence between the objectives, activities, planned resources and project management processes. Show how the project integrates, builds on and follows up on any pre-existing work or EU funded projects. Provide details (including architecture and deliverables) about pre-existing technical solutions. The B1MGplus project will support the 1+MG initiative in the journey to: (a) establishing the legal entity that will operationalise the ambition of the initiative (b) make progress on the implementation of genomics into healthcare, promoting awareness and engaging health professionals, public health policy makers and citizens (c) demonstrating the return of investment through development of health economic models (d) establish the metadata model, data standards and quality aspects required for high quality data to follow into the genomic data infrastructure and to be made accessible All of these areas will progress the implementation of genomics and personalised medicine across Europe. The implementation work plan has been organised into four work packages that are tightly linked to the above themes plus the required coordination, support and monitoring of the project's activities (Figure 3). The four WPs will also connect to the 1+MG initiative and the GDI implementation projects to ensure mutual progress in ongoing activities. Inputs from the 1+MG governance, 1+MG WGs and GDI activities will be taken into consideration by the WPs as they develop activities and outputs (left side). The project deliverable outputs will then be brought to the decision making bodies of the 1+MG (and the Genome EDIC when established) for verification, validation and adoption (right side). Figure 3. B1MGplus project and governance structure. The CSA project will be structured into four WPs that work towards the main outcomes. The WPs will report progress to the General Assembly (via the coordinator) and the 1+MG external monitoring and advice bodies that will be updated as part of their regular meetings and provide advice and direction to the project. Additional details in sections Consortium management and decision-making and 4.1 Work plan. WP1 - Project coordination and support to the 1+MG initiative implementation plan Acting as coordinator and neutral broker, ELIXIR will lead WP1 providing: ● Coordination and support required across all project activities ● Monitoring of the technical and financial aspects ● Facilitation of the stakeholder engagement - crucial for each WP, but in particular WP3 to establish the networks of experts required for healthcare implementation and economics. This will be achieved through organising events and leveraging established connections with other initiatives and the GDI project. Table 1. Anticipated WP1 interaction with 1+MG initiative and 1+MG implementation projects B1MGplus GDI GoE 1+MG Communication Cross dissemination and joint Cross dissemination and joint Cross dissemination and outreach meetings meetings and joint meetings Stakeholders Alignment/joint stakeholders Alignment/joint stakeholders Alignment/joint management meeting to maximise synergies meeting to maximise synergies. stakeholders meeting 2025-Q3/Q4, 2026-Q3/Q4 Dates to be confirmed. with GDI/GoE. Table 2. Anticipated WP1 interaction with related projects and initiatives  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Projects & Initiatives Relationship with B1MGplus EUCAIM Collaboration and support on establishment of Genome EDIC and EUCAIM EDIC EHDS Collaboration and support on discussion around the interrelation between Genome EDIC and EHDS across topics relevant for all WPs TEHDAS2 B1MGplus will look to provide inputs and advice to align initiatives and avoid duplication of funding or resources seeking the establishment of interoperable governance and infrastructures WP2 - Project coordination and support to the 1+MG initiative implementation plan WP2 led by LNDS (LU) will produce the documentation required by the EDIC WG established as part of the GDI Pillar to make progress toward the establishment of the Genome EDIC. WP2 will inform and seek advice from the 1+MG Group and the EDIC WG and form the Genome EDIC once it is established. Table 3. Anticipated WP2 interaction with 1+MG initiative and 1+MG implementation projects B1MGplus GDI GoE 1+MG Draft EDIC WG and Task Force in Pillar I will Would follow and B1MGplus will seek recommendations make use of B1MGplus outputs for implements agreements feedback and advice. data governance discussion with the governmental to make GoE data It benefits from the policies for EDIC representatives to decide on the respective available. previous and ongoing establishment data governance policy. On the other hand, Work in GoE on contributions of the B1MGPlus builds on the data governances preparing for actual data nominated national that were adopted in GDI (based on the inclusion may influence ELSI experts. work in B1MG) to derive the policies based the policies and provide on chosen data governance. The process new insights and lessons may be interactive with the work on the learnt, in particular on policies leading to proposals for changes in information and consent. the data governance and vv. It will further benefit from building on the ethical policy recommendations developed in B1MG. Risk management Pillar II in GDI can use the risk management Will benefit from the B1MGplus will seek framework (RMF) framework to tune the IT infrastructure reassurance provided by feedback and advice deployment according to the needs of the the (RMF) Genome EDIC Sustainability GDI develops sustainability plans, which Will benefit from the B1MGplus will seek recommendations B1MGplus will discuss with stakeholders sustainability plan feedback and advice and feed back the lessons learnt to support ensuring access to GoE GDI in developing a sustainable business data model. B1MGPlus can build on the sustainability work that was performed in B1MG and also the use case discussions that were kick- started through use case workshops in the definition of user needs. Legal document and GDI, through the Pillar I/EDIC Working Some of the legal B1MGplus will seek policy framework, Group, will establish requirements based on analysis will also be feedback and advice. ROPA and DPIA its chosen (data) governance, which needs beneficial for the GoE B1MGPlus will benefit guidance to be made actionable in a legally compliant project. Conversely, GoE from and reuse the way (this will be the task of B1MGplus). The can provide practical legal analyses drafts prepared by B1MGplus will be feedback to enhance the performed by B1MG submitted to the GDI Pillar I/EDIC Working overall framework and by the ELSI Group for discussion and adoption. developed in WP2 Working Group of 1+MG. Table 4. Anticipated WP2 interaction with related projects and initiatives Projects & Relationship with B1MGplus Initiatives  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 GoE As the first 1+MG genome generating project, GoE will feed back experiences and implementation documents that can be utilised by B1MGplus EUCAIM As a parallel EDIC, EUCAIM will act as sparring partner and we will be able to learn mutually and act synergistically on solving challenges around legal analyses and risk management strategies TEHDAS2 TEHDAS2 will prepare the implementing acts of the Commission for the EHDS. B1MGplus will seek alignment on overlapping principles such as transparency and other data subject rights. EHDS The EHDS with its implementing acts will establish a framework of requirements relevant to integrating the Genome EDIC into the EHDS. This may also support sustainability It may also as Member States are likely to pursue a synergistic model where IT infrastructure is shared for both EHDS and Genome EDIC. WP3 - Healthcare Implementation and Heath Economics implementation plan Lead by INSA (PT), WP3 will be focused on supporting and making decisive progress on the work of 1+MG WG6 (Healthcare implementation) and WG7 (Health economics) Table 5. Anticipated WP3 interaction with 1+MG initiative and 1+MG implementation projects B1MGplus GDI GoE 1+MG Network of public The GDI project will The GoE WP5 is co-led The participants of the 1+MG Healthcare health and develop a set of by Beneficiary INSA, implementation Working Group will overlap healthcare recommendations for and will be analysing with this network, and provide support for professionals training and education of genetic variant the identification of public health and other healthcare professionals, distribution across health professionals in their countries to which the B1MGplus European populations contribute to the network activities. This network of health with diverse network will contribute to a better professionals will work on ancestralities for understanding of the current situation in to disseminate and clinically relevant genes. Europe, and will lead to the elaboration of implement in signatory This analysis will be recommendations on healthcare countries. extremely important to implementation on the multiple topics provide equity in covered by the 1+MG Maturity Level genomic medicine for all Model. It will also promote the use of this populations of Europe. model for maturity assessment by other This network may healthcare systems, as well as the provide advice on how definition of novel dimensions that reflect the clinically relevant progress in genomic medicine findings, for instance for implementation in healthcare systems actionable disease genes or pharmacogenes, can be efficiently disseminated and used in clinical care. Health Economics Participants of the 1+MG Health Models Economics and Outcomes Research will provide support to the activities developed in Task 3.5 to develop Health Economics Models for genomics. Communication The GDI project will Communication material 1+MG on Healthcare implementation with citizens and develop a general produced by GoE can activities on citizen and patient literacy and patients guidance, resources and be contributed to the communication, will align and/or provide actions plan to tackle B1MG Communication examples of communication initiatives in outreach and Hub. signatory countries that can be of dissemination to citizens relevance to the Communication hub and patients, which will be developed by B1MGplus. contributed to the Communication hub developed by B1MGplus Meetings The B1MGplus meetings planned in Task 3.1 and Task 3.5 will be carried out jointly with 1+MG Working Groups on Healthcare  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Implementation and Health Economics. Table 6. Anticipated WP3 interaction with related projects and initiatives Projects & Initiatives Relationship with B1MGplus EUCAIM Beneficiary INSA participates in the EUCAIM EDIC Working Group. TEHDAS2 Will benefit from the Healthcare implementation and Health economics outputs to guide the introduction of genomics data into EHDS EHDS Will benefit from the Healthcare implementation and Health economics outputs for the introduction of genomics data into EHDS ICPERMED ICPerMed activities from the Working Groups on Policy and Strategy and on Internationalisation can be aligned with WP3 regarding the use of the 1+MG Maturity Level Model and Health Economics at the European and global level. WP4 - 1+MG Data requirements implementation plan WP4, led by HRI (NL), will build on the efforts of related partner projects to expand the 1+MG Framework on metadata models, data standards, ontologies and data quality. The primary task of this WP will be to coordinate across already funded activities (GDI, GoE, TEHDAS2, QUANTUM) thereby freeing resources for other key aspects to make high-quality data accessible and useful. Table 7. Anticipated WP4 interaction with 1+MG and 1+MG implementation projects B1MGplus GDI GoE 1+MG Data standards Alignment with data Alignment with data Alignment with the “technical (Coordination) management activities in WP6, management activities in oriented” WG3, WG4 and use case activities in WP7 as WP4 for GoE relevant WG5 and the 1+MG use case well as semantic interoperability standards from GDI/1+MG working groups. Feedback on work in task 8.2. We will will be re-used in GoE. 1+MG standards will be continue with the collaborative Feedback from GoE on communicated as well as monthly TCs with the 1+MG these standards will be coordinated by B1MGplus. WG3 and GDI task 8.2 provided to the B1MGplus Existing framework members to continuously work team to be incorporated in documents, under guidance of on the continuous work by the (coordinated by) B1MGplus, extending/updating/maintaining 1+MG WG3 and other will be updated collaboratively the harmonised minimal relevant 1+MG WGs by the related projects (e.g. dataset, the related metadata GDI, GoE). schemas (e.g. to submit datasets, ELSI related metadata in close collaboration with 1+MG WG2 and B1MGplus WP2). Sequencing qualities Implementation as part of Alignment with WG4 activities the sequencing of 100K on Good sequencing data subjects practices. representative of the EU population. Table 8. Anticipated WP4 interaction with related projects and initiatives Projects & Initiatives Relationship with B1MGplus XpanDH XpanDH-EEHRxF: European Electronic Health Record Exchange Format. XpanDH is mobilising and building capacity to ensure the widespread adoption of the European Electronic Health Records Exchange Format (EEHRxF) across Europe. Guidelines, implementations and other relevant results are used as input for the 1+MG metadata models, data standards and ontologies such that re-use of data from health(care) will be optimal and prevent re-inventing wheels as well as mis-matches in formats and standards used which require additional mappings which could  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 result in loss or interpretation of information. Besides WP4, also WP3 might have interactions with this myHealth@EU related project. HealthData@EU WP6 defines the Health DCAT-AP extension which is a mandatory part of the 1+MG initiative metadata schemas for catalogues. Health-RI is involved in the Dutch Geonovum expert working group on the Dutch implementation and maintenance of all DCAT-APs. Dependencies: First draft is being reviewed by SEMIC Q1/Q2 2024. Official release is expected in 2026. Metadata schemas based on DCAT-AP will only then be able to be adapted and used, expected implementation therefore not earlier then Q3/Q4 2026. QUANTUM Data(set) quality, data(set) utility and data maturity (organisation); partner Health-RI Dependencies: Quality and utility labels for 1+MG initiative metadata schemas will be provided by this project. The QUANTUM project started in Q1 2024 and currently has set out various surveys to gather relevant information from data holders in the consortium to help us understand their data scopes and uses, as well as current data quality practices. A Delphi exercise is yet to start to gather expert insights and achieve consensus on dimensions for the data quality and utility label. Expected official metadata items for DCAT-AP extensions are not expected before 2026. EUCAIM UU is a beneficiary in EUCAIM working on interoperability with GDI. BSC is another beneficiary of EUCAIM working on federated learning aspects and the evaluation of software and AI models for their use within the project. TEHDAS2 Data standards and Access models; Partner UU Dependencies: Draft guidelines for data description expected to be ready by December 2024. Guidelines for data holders on data description ready by July 2025.Guidelines for data holders on making personal and nonpersonal electronic health data available for reuse ready by February 2026. Guidelines for Health Data Access Bodies on collaboration with other Parties ready by October 2026. EOSC-EVERSE BSC is part of this EOSC related project with a strong participation in the research software development best practices WP where indicators and metrics for software quality and its associated metadata are expected to be generated. Associated partner CERTH is the coordinator of this project, which will reinforce the joint work between both projects. ELIXIR-STEERS WP2 and WP3 work on software best practices and FAIR methodology. Several partners of WP4 are also in ELIXIR-STEERS, facilitating knowledge transfer between the projects. ELSI requirements implementation plan With regard to their respective research activities involving human participants (interviews, workshops, meetings and consultations), WP2 led by LNDS (LU), WP3 led by INSA (PT), and WP4 led by HRI (NL) will ensure that if any ethics approvals or other authorisations are required, they will be obtained before the commencement of the relevant activities, and that appropriate informed consent processes will be in place, when necessary. All personal data collected in the context of these activities will be processed according to applicable legislation, including the EU General Data Protection Regulation. Additional details are provided in section 5.1 Ethics Project management, quality assurance and monitoring and evaluation strategy Describe the measures planned to ensure that the project implementation is of high quality and completed in time. Describe the methods to ensure good quality of monitoring, planning and control activities. Describe the evaluation methods and indicators (quantitative and qualitative) to monitor and verify the outreach and coverage of the activities and results. The indicators proposed to measure progress should be specific, measurable, achievable, relevant and time-bound. The selection of the consortium is discussed in section 2.3 Capacity to carry out the proposed work Project monitoring The coordinator, as part of WP1 activities, will take responsibility for the technical delivery of the project supported by the WP leaders and all project participants. Monitoring activities will include: use of resources (every six months), opportunities, risks,  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 issues (reviewed periodically according to their criticality), and the timely execution (deliverables and milestones) supported by a quality control process. Additional monitoring and control activities will be carried out by the Management Board (coordinator and WP leaders) via monthly meetings and annual general assemblies to ensure a successful delivery. Monitoring at this frequency will ensure any deviations are identified promptly in order to be addressed and corrected. The project coordinator will, at least once per year, make recommendations to the General Assembly if adjustments in the project work plan and/or resource allocation are needed to deliver the expected project results. Quality assurance and measuring progress The project coordinator will be responsible, with input from all participants, for the establishment and execution of quality assurance processes for project deliverables and milestones, which will be clearly defined in the project handbook. As part of these processes, named reviewers will be nominated by the Work Package leaders who will be responsible for reviewing all public project deliverables and milestones. All project deliverables and milestones will be made available under CC-BY licence and shared with the 1+MG Stakeholders via supported by the GDI project. Deliverables of relevance to the 1+MG Initiative will be shared with the 1+MG Group. Call KPIs to be monitored The following KPIs are defined in the call text and will be monitored as part of the project activities during the Management Board meetings (see section Consortium management and decision-making) ● Number and type of events with private and public stakeholders promoting the implementation of genomics in research, healthcare and public health policy. ○ Within the budget limitation, the expectation is to host at least one virtual open event per year for WP2, WP3, WP4 and a physical event co-located with B1MGplus GA (the day before) or another 1+MG Implementation project (e.g. GDI, GoE) ● Number of countries using the Maturity Level Model to assess the implementation of genomics in healthcare ○ At least countries committed to being part of Genome EDIC and those who aim to be operational or in deployment at the end of GDI (12). [Please note that, although this is what we are aiming for, we cannot guarantee the achievement of this goal, as the decision on this by countries is outside the influence of B1MGplus partners]. ● Number of countries covered by the project’s evidence-base on the economic aspects of genomic implementation in healthcare ○ At least countries participating actively in 1+MG WG7 and WP3 of GDI, including all the countries participating in this CSA. B1MGplus - rules for utilisation of event Budget ● Expected meetings (minimum) ○ 1 Kick-off, including WP meetings (2 days event) ○ 3 virtual WP2, WP3, WP4 events (at least 1 per year) ○ 1 F2F GA co-located to include WP2,WP3,WP4 events the day before (2 days event) Note: Additional events will be considered with MB approval. ● Rules for allocation of physical events ○ Where possible, preferences to be given to locations offering low travel and accommodations costs, free venues and/or taking on part of the cost of the event organisation ○ Where possible, hybrid participation should be enabled ○ Those beneficiaries participating in GDI / GoE or future implementation projects could use their budget on those projects to join and contribute to B1MGplus. All projects are funded to support 1+MG implementation - note: we are already doing it to connect and contribute to related projects, but we will check with the EC ○ Beneficiaries only involved in B1MGplus (no other 1+MG projects) would be expected to cover their travel cost from their current budget, which can be redistributed between PC and ODC as needed. ○ To maximise the resources, funding for external experts will be limited (applying updated B1MG rules) ■ €450 for attending 1 day (no accommodation), ■ €650 for attending 2 days (1-night accommodation), ■ €900 for attending 3 days (2-night accommodation) ■ Number of external not funded experts expecting to attend in person per WP meeting <= 6 ○ We ask WP leaders to consider which external experts are required to join the carefully ○ Coordination will update the MB on the utilisation of the events budget. The monitoring of communication and dissemination activities is detailed in Dissemination and communication of the project and its results Cost effectiveness and financial management Describe the measures adopted to ensure that the proposed results and objectives will be achieved in the most cost-effective way.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Indicate the arrangements adopted for the financial management of the project and, in particular, how the financial resources will be allocated and managed within the consortium. Do NOT compare and justify the costs of each work package, but summarize briefly why your budget is cost effective. The budget has been distributed based on the call text requirements and after consideration of synergies with other projects where activities can be aligned. The largest drivers for the cost allocation are around the establishment of the Genome EDIC (WP2) and Healthcare Implementation and Health economics (WP3). WP2 is tasked with conducting landscape research to provide solid recommendations for advancing the implementation of the Genome EDIC. This involves an in-depth analysis of the situation across EU countries and to contemplate regulatory, governance, financial, operational and ELSI aspects. WP3 encompasses both Healthcare implementation and Health economics, reflecting their strong interconnection. Significant progress in these areas is essential in the short to mid-term, as they will provide critical content and guidance for implementation. Along with WP2 outputs, these efforts will inform the decision-making process for establishing the Genome EDIC. This will enable Member States' representatives in GDI Pillar I to agree on a common approach before countries can make formal commitments to participate in the Genome EDIC. Overview of costs distribution The budget has been allocated among Beneficiaries to coordinate activities, achieve milestones and to produce the specified project deliverables. A group of participants, nominated by 1+MG Member States representatives or the WP leaders before the submission, will join as associated partners. This arrangement allows them to contribute to discussions, bring key expertise and ensure equal opportunities for countries involved or interested in joining 1+MG. This inclusive approach will enable these countries to participate in key activities coordinated by this action. The requested budget (€2M) is distributed as follows; 87.1% (€1,741,658.88-) of the total budget is allocated to Personnel Costs (PC), 6.35% (€127,500.00) to Other Direct Costs (ODC) and the remaining 6.55% (€130,841.12) to Indirect Costs (IC). No subcontracting costs have been identified as required at the time of submission. The coordinator holds a budget to organise project WP and workshops meetings and to reimburse unfunded experts to attend relevant meetings where their inputs would be required according to their own institution rules and in alignment with the grant agreement requirements. Details on major cost items are described in the purchases and equipment section. Funded activities in B1MGplus - justification for associated costs WP1 Project coordination and support to 1+MG initiative Activities funded under Work Package 1 - Project coordination and support to 1+MG initiative include project management and coordination, communications activities, stakeholder management, and ongoing support to the 1+MG initiative and its working groups and boards. WP1 has also budgeted for ‘Other Direct Costs’ to support the organisation of project-level meetings, WP- level meetings, travel to events, and the reimbursement of travel costs for external experts when their inputs are required at project-level meetings (all travel budget is held by the coordinator). WP2 Genome EDIC establishment Activities budgeted are described in Work Package 2 - Genome EDIC establishment, in addition: ● Task 2.1 ○ M2.11-2.13: Regulatory Sandbox Workshop / LNDS, SLEX ○ D2.1 Report on legal framework / LNDS, SLEX ○ D2.2 Recommendations on ethical and legal implementation / LNDS, SLEX ○ D2.3 Draft ROPA for operations / LNDS Comment: LNDS is the lead partner and responsible for the milestones and deliverables for this task encompassing a comprehensive scope of open legal questions, analysis of legal framework and community discussions. This involves monthly meetings with nominated national 1+MG ELSI experts as well as annual F2F full-day workshops and workshops with data protection authorities. SLEX contributes to the regulatory sandboxes, the analysis of the regulatory framework, in particular related to cybersecurity and will contribute to the recommendations on ethical and legal implementation derived from the other tasks. ● Task 2.2 ○ M2.1 Overview of policies / LNDS ○ M2.9 Initial policy toolset / LNDS, ISCIII ○ D2.5 Policy toolset / LDNS, ISCIII, NGC LNDS will contribute policies related to data inclusion, data access, data use and data retention including the information of data subjects, the overall communication policy and the policies related to results from data use. ISCIII will contribute general policies related to the overall governance, such as the terms of reference of the general assembly, the establishment of committees, decision making in these committees, and equal opportunity policies. NGC will contribute policies related to the risk management and quality requirements. ● Task 2.3 ○ M2.2 Overview of legal documents required / SLEX ○ M2.10 Initial legal documents tool set / SLEX ○ D2.6 Legal documents tool set / SLEX  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Comment: LNDS has currently no funds in this task due to the budget constraints but will participate nevertheless. ● Task 2.4 ○ M2.14 Stakeholder engagement plan for sustainability / CNR ○ D2.7 Use case report / ISCIII ○ D2.8 Sustainability report / CNR, NGC ● Task 2.5 ○ M2.3 Initial risk management framework / NGC ○ M2.4 Acceptance criteria V1 / NGC ○ M2.5 Description of node roles / NGC ○ M2.6 Acceptance criteria V2 / NGC ○ M2.7 API sequence diagram / NGC ○ M2.8 Data Protection Impact Assessment list / LNDS, SLEX ○ D2.9 Cybersecurity compliance report / SLEX ○ D2.10 Risk management standard framework / NGC ○ D2.11 Acceptance criteria Initial report / NGC ○ D2.12 Quality assurance and risk management framework / NGC ○ D2.13 Risk management implementation plan / NGC Comment: Due to the budget constraints, NGC is underfunded in this task. However, this work is crucial for the EDIC to become operational, we were unable to reduce or postpone the work envisaged and NGC is committed to deliver on the task. ● Travel budget (held by the Coordinator) ○ Assumption of ca. 2800 EUR for each participant per year to participate in the GA, the F2F workshops and other relevant events / task forces. ○ Budget per workshop under the budget LNDS is calculated based on: ■ 350 EUR per expert travel cost for a 1 day meeting ■ 100 EUR per expert catering & venue cost for a 1 day meeting ■ 25 participants per workshop (number may be higher though according to experience) ● Other cost ○ Ongoing discussions on the legal instrument of the EDIC have demonstrated that it may be required to obtain external legal advice. We would therefore like to reserve a certain budget to be prepared for such a need. WP3 1+MG Healthcare Implementation & Health Economics Activities budgeted are described in Work Package 3 - 1+MG Healthcare Implementation & Health Economics, in addition: ● Task 3.1 ○ M3.2 Meetings with the network of public health and health professionals on topics relevant for implementation of genomics in healthcare concluded/ INSA, GRDI ○ D3.5 Recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems INSA, INSERM, NGC, Sciensano ● Task 3.2 ○ D3.2 Tutorial and webinar for the genomics in healthcare Maturity Level Model available/ INSA, MSAE ● Task 3.3 ○ M3.1 Guideline for data collection available INSERM, INSA ● Task 3.4 ○ M3.4 Creation of a Citizens hub Sciensano, BfArM, INSA ○ D3.3 Report on citizens engagement Sciensano, BfArM ● Task 3.5 ○ M3.3 First meeting of health economics working group concluded / NGC, GRDI ○ M3.5 Second meeting of the network of public health and health professionals concluded NGC, MSAE ○ D3.4 Scope of a project aiming at developing a standardised approach to measure economic impact of WGS / NGC, KI, GRDI, INSA ● Travel budget (held by the Coordinator) ○ In person meetings of WP participants and experts, including experts from the 1+MG WG6 and WG7, are envisaged for Task 3.1 (two meetings with approximately 25 participants, two half days each) and Task 3.5 (two meetings with approximately 25 participants, two half days each). These will be conducted back to back, as it is likely that there will be an overlap of participants and thus savings in travel costs. ○ Note: Distribution of the travel budget hosted by the coordinator would be agreed upon with the MB on a case basis, with the decisions being taken by the coordinator if agrement can’t be reached ● Other costs ○ Budget will be necessary for professional design of material included in the Toolbox for promotion of MLM use, including a video and a webinar. WP4 1+MG Data requirements Activities funded are described in Work Package 4 - 1+MG Data requirements. Activities that have been identified as required to fulfil the call ambition but which have not been included due to deviation of project total cost from the indicative budget for this topic.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 WP1 Project coordination and support to 1+MG initiative Currently the elaboration of recommendations and guidance for the establishment of public private partnership, although relevant and necessary for the evolution of the Genome EDIC, hasn’t been prioritised and therefore is not included in the WP1 nor in WP2 activities. The focus has been centred towards focussing on the establishment and readiness for first operations of the EDIC. WP2 Genome EDIC establishment Due to the extensive scope of activities involved in WP2 for establishing the Genome EDIC, we have encountered challenges in securing adequate resources for the coordination. This shortfall has the potential to impact the quality of the outcomes, as highlighted as a critical risk for the project. Critical risks and risk management strategy Describe critical risks, uncertainties or difficulties related to the implementation of your project, and your measures/strategy for addressing them. Indicate for each risk (in the description) the impact and the likelihood that the risk will materialise (high, medium, low), even after taking into account the mitigating measures. Note: Uncertainties and unexpected events occur in all organisations, even if very well-run. The risk analysis will help you to predict issues that could delay or hinder project activities. A good risk management strategy is essential for good project management. Description of risk (indicate level of (i) likelihood, # WP Proposed risk-mitigation measures and (ii) severity: Low/Medium/High) Limited funding available could have an impact on the Establish connections with ongoing and new initiatives, project outcomes. To deliver against the full 1+MG RIs, and projects that support the initiative to align efforts ambition there are still gaps for which no funding is 1, 2, and outputs. 1 available for e.g. proficiency testing as a specific 3, 4 Seek the support of the 1+MG MS group to increase example. national funding for key expertise. Highlight gaps to the EC at various governance meetings. Impact: High Likelihood: High Delayed creation of the Genome EDIC resulting in temporary decision, potentially leading to shifting targets Interactions with GDI Pillar I to get reliable positions at 2 for the entire legal and policy framework. 2 least on the most critical elements for the development work. Impact: Medium Likelihood: Medium The EHDS will set up requirements which make it The Genome EDIC may decide not to join as it does not impossible for the Genome EDIC in its envisaged setup depend on the EHDS. The national implementation could 3 to join 2 still be designed to serve both the EDIC and the EHDS as the infrastructure requirements are likely higher for the Impact: Low Likelihood: Medium EDIC due to our aim for very high standards. The EDIC as a legal instrument will not provide a legal Contact with the Commission will be sought to remedy the basis for the operations, which is the basis assumption situation. Also Luxembourg as a host country could be 4 for most of the tasks in WP2. 2 explored to provide or complement any necessary legislation as Luxembourg may be able to pass laws fairly Impact: High Likelihood: Medium quickly if needed. Lack of stakeholder engagement, in particular from Materials will be brought together into a 'Hub' for future healthcare or citizens 5 1, 3 reference once more engagement is necessary. Dissemination to these groups will be targeted at this stage Impact: Low Likelihood: Medium Health economic model experience and relevant data is kept at a national level and not shared Use MSs who are most keep to test the models to estimate 6 3 economic impact of WGS implementation Impact: Low Likelihood: Low Other initiatives are not willing to share progress openly Project experts engaged across multiple projects. Make 7 4 value clear to all. Impact: Low Likelihood: Low Insufficient interest from countries in carrying out a maturity assessment of genomics implementation in Engage with NMGs to understand the reasons and work 8 healthcare systems, as well as mapping exercise, using 3 towards meeting countries needs regarding the process, the 1+MG Maturity Level Model Impact: Medium the indicators or any other reported issues Likelihood: medium Higher than expected engagement from public health and other health professionals in the planned network, Seek other effective solutions for online meetings and 9 together with insufficient funding prevents in person 3 additional funding sources at the national levels meetings with wide European country representation Impact:low Likelihood: low  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 #§CON-MET-CM§# #§PRJ-MGT-PM§# #§FIN-MGT-FM§# #§RSK-MGT-RM§# #@CON-SOR-CS@# 2.3 Capacity to carry out the proposed work Consortium cooperation and division of roles Describe the participants (Beneficiaries, Affiliated Entities and Associated Partners, if any) and explain how they will work together to implement the project. How will they bring together the necessary expertise? How will they complement each other? In what way does each of the participants contribute to the project? Show that each has a valid role and adequate resources to fulfil that role. Note: When building your consortium you should think of organisations that can help you reach objectives and solve problems. Details on the governance can be found in the Consortium management and decision-making section. The B1MGplus consortium was established after consultations with 1+MG Member States representatives. The aim has been to bring together critical experts from various 1+MG bodies. Experts have been drawn from 1+MG bodies and Working Groups, as well as 1+MG implementation projects (B1MG, GDI, GoE) and other relevant projects and initiatives. This structure facilitates a synergistic link across different activities, ensuring comprehensive and coordinated efforts in line with the scope of the call. Selecting partners: During the consortium build process, three meetings were held with the 1+MG Member State representatives on February 29th, March 14th & May 3rd. These meetings were aimed at discussing the project plans, gathering feedback, gaining endorsement for the approach, and outlining the partners selection process. Member States had the opportunity to nominate institutions as Beneficiaries or Associated partners and approve the selection of WP leaders. Due to the limitation of funding, the number of Beneficiaries has been limited. The selected Beneficiaries will be responsible for coordinating activities across the initiative, partner projects and producing the concrete outputs for implementation. An unusually large number of Associated Partners have been included to ensure that key entities can be involved in discussions without drawing on resources for delivering the outcomes of the project. The following Beneficiaries and Affiliated Entities have joined the consortium according to their expertise and relevance to attain the project objectives: WP leads: ● ELIXIR (IOEI, COO): As an International Organisation of European Interest has been driving the advancement of research infrastructure services for Life Science funded by Member States and the European Commission. ELIXIR has been supporting 1+MG Activities and was nominated by the Member States representatives to coordinate B1MG and the European Genomic Data Infrastructure and is also involved in GoE. The PI of B1MGplus is also the chair of the biweekly 1+MG Coordination Group that discusses strategy, developed the 1+MG roadmap and reports to the 1+MG governance group. ○ B1MGplus: Leading WP1 and supporting all other WPs ● LNDS (LU, BEN) (formerly UNILU): is leading the 1+MG WG2, GDI Pillar I and the Task Force to accelerate the establishment of the Genome EDIC, and has previously led B1MG WP2 ○ B1MGplus: Leading WP2 and supporting all other WPs ● INSA (PT, BEN): was leading B1MG WP5 ‘Delivering personalised medicine cross-borders: implementation in Healthcare systems and Societal impact, participates in GDI Pillars I and II and is co-lead of 1+MG WG7 Healthcare implementation (with INSERM, FR). Co-leads GoE WP on Use cases and pilot studies. ○ B1MGplus: Leading WP3 and supporting all other WPs ● Health-RI (NL, BEN): was leading B1MG WP1 (stakeholder engagement) and WP3 Data quality guidelines and standards ○ B1MGplus: Leading WP4 and supporting all other WPs Co-leads or contributors ● NGC (DK, BEN): Leading 1+MG WG6, participating in GDI Pillars I & II ○ B1MGplus: Co-leading WP3; participating in WP2 ● CNAG (ES, BEN): is leading 1+MG WG4 Best Sequencing Practices, co-lead B1MG WP3 , and participating in GDI Pillar II on the implementation of the 1+MG Infrastructure ○ B1MGplus: Co-leading WP4 ● BSC (ES, BEN): lead of GDI pillar III ○ B1MGplus: Co-leading in WP4 ● UU (SE, BEN): Representing NBIS, the National Bioinformatics Infrastructure in Sweden; lead of B1MG WP3, co-lead GDI pillar II; co-lead 1+MG WG5 Infrastructure, and lead GoE WP4 ○ B1MGplus: Co-leading in WP4 ● INSERM (FR, BEN): co-lead of 1+MG WG7 Healthcare implementation (with PT), participating in GoE and leading the 2025 French Genomic Medicine Initiative ○ B1MGplus: Co-leading in WP3 ● CNR (FR, BEN): Participating in GDI Pillar II , participated in B1MG WP4 ○ B1MGplus: Participating in WP2 ● SLEX (IT, BEN): Has had long standing involvement in the legal work in the 1+MG WG2 ELSI and has significant expertise in the processes related to the establishing of other research infrastructures. ○ Participating in: WP2 as a co-lead ● ISCIII (ES, BEN): Participating in GDI Pillars I & III , co-led B1MG WP6  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ○ B1MGplus: Participating in WP2 and WP4 ● BioData.pt (PT, BEN): Participating in GDI Pillar II , ○ B1MGplus: Participating in WP4 ● EKUT (DE, BEN): Participating in GDI Pillar II & III , active in 1+MG WG12 ○ B1MGplus: Participating in WP4 ● KI (SE, BEN): Representing GMS, Genomic Medicine Sweden, aiming at translating innovation in genomics into clinical practice and implementing a sustainable infrastructure for precision medicine in Sweden ○ B1MGplus: Participating in WP3 ● MSAE (EE, BEN): AP in GDI, member of the 1+MG Group ○ B1MGplus: Participating in WP3 ● BfArM (DE, BEN): As platform holder in the German genome sequencing model project , BfArM will be responsible for facilitating knowledge-generating health care based on genomic medicine. ○ B1MGplus: Participating in WP3 ● Sciensano (BE, BEN): Participating in GDI Pillars I, II & III ○ B1MGplus: Participating in WP3 ● GRDI (RO, BEN): Helping to implement the ROGEN project "Development of Genomic Research in Romania" ○ B1MGplus: Participating in WP3 ● UH (FI, BEN): Linked to CSC who led B1MG WP5 and co-lead GDI Pillar II ○ B1MGplus: Participating in WP4 Associated Partners are joining to provide input to the discussions in the different WPs as such all of them are entering the consortium to contribute in kind and therefore no r costs are declared. Associated Partners ● SIB (representing Switzerland) will contribute to the activities in WP4. SIB, an Associated Partner, will receive funding from SERI under Swiss participation rules in Digital Europe. SIB will work on WP4 tasks 4.4 and 4.5 dedicating 2PMs in total with 1PM funded by SERI and 1PM provided in-kind (EUR 12,500 per PM including overheads). ● UH (FI): will contribute to the activities in WP4 ● UL (SI): will contribute to the activities in WP3 ● UHEI (DE): will contribute to the activities in WP2 ● MU (CZ): will contribute to the activities in WP2 ● HDIR (NO): will contribute to the activities in WP2 ● RBI (HR): will contribute to the activities in WP2 ● VUHSK (LT): will contribute to the activities in WP2 ● UiB (NO): will contribute to the activities in WP4 ● Vinnova (SE): will contribute to the activities in WP2 ● OOI (HU): will contribute to the activities in WP2 ● UNISR (IT): will contribute to the activities in WP4 ● MESR (LU): will co-lead and contribute to the activities in WP2 ● CERTH (GR): will contribute to the activities in WP4 ● CRG (ES): will contribute to the activities in WP4 ● LBMC (LV): will contribute to the activities in WP2 ● IGG (IT): will contribute to the activities in WP2 Organisat Name ion Function/Role/tasks/professional profile and expertise Serena is Head of Human Genomics and Translational Data at the ELIXIR Hub. Serena is the coordinator of the GDI project, a €4oM Digital Europe project and the completed B1MG project, a €4M EU H2020 Coordination and Support Action that are aligned with the 1+ Million Genomes Initiative (1+MG) and co-chairs the 1+MG coordination group. Among other projects she has previously been the project lead for the IMI FAIRplus project, an €8.3M collaboration that sets out to improve data Serena sharing and reuse in life science research. She is on the Scientific Advisory Board for Nxera, Health- ELIXIR Scollen RI, IHI BigPicture and the European Board for Movement Heath 2030. In addition, she is on the leadership team of the Genomics in Health Implementation Forum. Prior to joining ELIXIR, she was a Director within the Human Genetics and Computational Biomedicine group at Pfizer. Earlier in her career, she worked within the Toxicogenomics group at GlaxoSmithKline. She gained postdoctoral experience at the University of Cambridge and Imperial College London and a PhD from the University of Cambridge, with a focus on the genetic susceptibility to disease. Regina Becker is an “ELSI Fellow” at the Luxembourg National Data Service, which will become Luxembourg’s competent body under the DGA. Previously Regina had the role as Strategy Coordinator and lead for ELSI in the Luxembourg Node of the bioinformatics research infrastructure ELIXIR. She was involved in interpreting data protection legislation as well as practical data protection Regina concepts by design and default for many years. She leads the national GDPR working group for public LNDS Becker research and chairs also the ELSI Working Group of the governmental 1+Million Genome (1+MG) Initiative, that aims to make genomes and accompanying health data systematically available for cross-border secondary use in a harmonised fashion. In the deployment project related to 1+MG, she leads the sustainability pillar. She participated in the legal implementation of the GDPR in Luxembourg.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Astrid M. Vicente is a senior researcher in biomedical sciences and public health at the National Institute of Health Doutor Ricardo Jorge, in Lisbon, Portugal, where she heads the Department of Health Promotion and Non-Communicable Disease Prevention. She is Associate Professor at the Faculty of Sciences, University of Lisbon. She brings together expertise in genomics and in public health to the field of Personalised Medicine, particularly concerning the implementation of genomics in healthcare systems, and on strategies that promote equitable access to Personalised Medicine for all. Astrid INSA She represents the Ministry of Health of Portugal in the 1Million Genomes Initiative, where she is a Vicente member of the Coordination Group and co-leads the WG on Healthcare Implementation. Previously she co-led the B1MG WP on Societal Impact and Healthcare implementation, and she is involved in the Genome Data Infrastructure and the Genome of Europe projects. She served two consecutive terms as elected Vice-Chair of the International Consortium for Personalised Medicine (ICPerMed), and is currently leader of the Working Group on Policy and Strategy. Astrid Vicente is also coordinating the development of the National Strategy for Genomic Medicine in Portugal. Dr. Jeroen Beliën is a computer scientist (medical/clinical informatics) and associate professor at the Department of Pathology at Amsterdam UMC. He at the same time is senior project leader architecture at Health-RI. He brings key expertise in data and research management, as well as in (local, regional, and (inter)national) research infrastructures. He is/was co-lead for several IT projects amongst which setting up a translational research IT infrastructure within Amsterdam UMC as well as (inter)nationally, Jeroen Health-RI e.g. Health-RI (lead architect), CTO of https://trait.health-ri.nl/), the Dutch Techcentre for Lifesciences Beliën (https://www.dtls.nl/ ), project lead of the Dutch COVID-19 Health data portal, joined project lead of the ZonMw FAIR data services, as well as workgroup lead of common standards & minimal datasets for clinical & phenotypic data and co-lead of the H2020 CSA B1MG project, the Digital Europa implementation project Genomic Data Infrastructure, and the recently started HDAB-NL (Health Data Access Body). More info see LinkedIn. Lene Cividanes is head of Research and International Collaboration at the Danish National Genome Lene NGC Center. Lene is responsible for the Danish participation in 1+ Million Genomes (GDI, GoE, Mirror Cividanes Group and heading WG 6 on health economics). Ivo is the director of the Centro Nacional de Análisis Genómico (CNAG), one of the largest genome sequencing centers in Europe, with a staff of 100. He is the principal investigator of 10 ongoing EU- funded projects including B1MG, GDI, 3TR and EJP RD, and he was the coordinator of the FP7 RD- Ivo Gut CNAG Connect which developed an integrated platform for genome phenome analysis of rare disease data. He chairs the 1+MG Technology working group, as well as the Spanish network of sequencing centers (IMPaCT-Medicina Genómica). Alfonso Valencia, Ph.D. in Biochemistry and Molecular, is ICREA Research Professor and Director of the Life Sciences Department at the Barcelona Supercomputing Centre (BSC), Director of the Spanish National Bioinformatics Institute (INB) and head of the Spanish Node of the European Bioinformatics Alfonso Infrastructure ELIXIR. He leads the IMPaCT Data initiative in Spain to implement analytical methods BSC Valencia for genomic and medical data for research. He participates in European projects in this field, e.g. PerMedCoE, EOSC4Cancer, BY-COVID, Oncologics, iPC Pediatric Cure, and is also a member of the B1+MG initiative. He is Co-Executive Editor of Bioinformatics and he has published more than 450 articles with an h-index of 97 (Scopus profile). Bengt Persson is the Head of Node ELIXIR Sweden and Director of NBIS (National Bioinformatics Infrastructure Sweden; https://nbis.se) hosted by UU. He is MD, PhD and Professor of bioinformatics Bengt at UU and WG-5 co-lead in the EU 1 million genomes initiative. 186 publications, 19651 citations UU Persson (Google Scholar), h-index 61 (Google Scholar), i10-index 151 (Google Scholar). Research areas: protein structural calculations of consequences of mutations, functional assignments of protein families, and gene expression in different types of heart failure. Frédérique Nowak is the coordinator of the 2025 French Genomic Medicine Initiative, a national initiative for integrating genomic medicine in routine practice. She co-chairs the 1+MG WG7 on Health Implementation and is a member of the Task Force EDIC. After a master in bioengineering from the Ecole Centrale of Paris, she started her career at the Institut Gustave Roussy, where she got a PhD in Molecular Pharmacology. After her PhD, she joined Genset, a biotechnology company, where she has Frédérique been project manager for innovative projects in high-throughput molecular cytogenetics. Then, she INSERM Nowak was responsible for a R&D team at the Serono Genetics Institute of the Serono pharmaceutical company. In 2006, she joined the Institut National du Cancer (INCa), the health and science agency in charge of cancer control in France, where she was the Head of the Biology, Technology Transfer and Innovations Department. She was more particularly in charge of the coordination of the INCa’s precision oncology programs. In 2019, she joined Inserm to be the deputy coordinator of the 2025 French Genomic Medicine Initiative, before becoming its coordinator in 2021. Dr. Francesca De Leo is a senior technologist at the CNR-IBIOM and a contract teacher at the University of Bari, specializing in life science management. With an extensive educational background, Francesca she holds a degree in Biological Sciences and a PhD in Biochemistry and Molecular Biology. Since CNR De Leo 2005, Dr. De Leo has been actively engaged in the management, dissemination, and exploitation of research results. Dr. De Leo participated in the Executive Masters in Management of Research Infrastructures (EMMRI-RITRAIN) at Bicocca University of Milan, completing in March 2023. Since  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 2019, Dr. De Leo has served as the Industry, Communication, and Impact Manager for ELIXIR-IT, representing the Italian node at the European level. Her role involves coordinating impact and industry activities for the ELIXIR-Europe Work Programme 2024-2028. She is also the scientific lead for the ELIXIR-IT enhancement project "ELIXIR x NextGenerationIT" (IR000010) under the National Recovery and Resilience Plan (PNRR). She is a recognized expert evaluator for the European Commission, the Italian Ministries of Research (MUR) and Economic Development (ex MISE), as well as regional bodies such as the Apulian and Piemonte Regions. Her academic contributions include approximately thirty papers, boasting an h-index of 16 on Scopus and over 1200 citations. Full Professor of Private Comparative Law at Scuola Superiore S. Anna Pisa, Italy. PhD. SSSA, LLM Harvard Law School, Founder and Director of the LIDER-LAB (www.lider-lab.it). Attorney at law (Pisa since 1995); (New York Bar since 1997). Mediator mediation trainer. He has taught in and visited numerous universities in the world. Scientific director of many research projects funded by MIUR, CNR, ESF, EU, the Canadian Ministry of Giovanni SLEX Foreign Affairs Public Administrations, public and private companies and organizations. Main current Comande projects: LEADs -Legality Attentive Data Scientists (PI) H2020-MSCA-ITN-2020; SoBigData++: European Integrated Infrastructure for Social Mining and Big Data Analytics; INFRAIA-H2020- EU.1.4.1.2. (task Leader) - Predictive Jurisprudence, (PI) Scuola Superiore Sant’Anna. Author of 6 monographs, editor of 15 collective works, published more than 200 articles and notes in major law reviews, and chapters to collective publications in Italian, English French and Spanish. Isabel Cuesta, PhD, is the Head Scientist and Unit leader of Bioinformatics Unit (BUISCIII, https://github.com/BU-ISCIII/). She was trained in microbiology and infectious diseases, obtaining her doctorate and later specializing Isabel in Bioinformatics. Cuesta De ISCIII She is a member of the European initiative 1+Million Genome as the coordinator of the National Mirror La Plaza Working Group (NMG) of WP11 Infectious Diseases/ Covid19. She is co-leader of the Elixir Pathogen Data Focus Group https://elixir-europe.org/focus-groups/pathogen-data. She is participating in GoE, GDI, RELECOV and EU-WISH. Inês is the Executive Director of BioData.pt and deputy HoN of ELIXIR Portugal. She has been involved in working groups that define tools, standards, and ontologies, using biological test cases, following ELIXIR's vision of providing researchers in academia and industry with continuous access to Inês biological information. To her, the theme of data sharing and knowledge exchange has become more BioData.pt Chaves and more important therefore, she is working on the development of the National and European Bioinformatics Infrastructure envisioning open data and science. Moreover, she is collaborating in the development of controlled vocabulary and standards. Skilled in Bioinformatics, Molecular Biology, Biotechnology, and Proteomics. Prof. Riess, MD, is full professor for Medical Genetics and Director of the Institute of Medical Genetics and Applied Genomics. He is also founder and acting director of the Rare Disease Center Tübingen. He has more than 20 years of experience in clinical genetics and research of genetically caused disorders. He currently is and has been coordinator of numerous international, European and national funded consortia such as EUROSCA, MEFOPA, TECHGENE, RATstream, Neuromics, and SOLVE- Olaf Riess EKUT RD (together with Holm Graessner). He is also PI and spokesperson of one of four DFG funded NGS Competence Centers in Germany. OR serves in numerous advisory boards such as the rare disease working group of the 1+MG project, and to the Ministry of Health on the implementation of genome diagnostics into the health care system (genomDE). From 2016 to 2017 he served as President of the European Society of Human Genetics (ESHG), and from June 2021 to March 2023 as President of the German Human Genetics Society. Published >500 papers. Richard Rosenquist Brandell, MD, PhD, is Professor of Clinical Genetics at Karolinska Institutet, and Senior Physician at Karolinska University Hospital, Stockholm, Sweden. He is also Director of Richard Genomic Medicine Sweden, a national infrastructure for implementing precision medicine. Richard is KI Rosenquist part of the 1+MG WG for cancer and part of the Swedish National Mirror group. Richard and his team have made outstanding contributions to our understanding of the onset and evolution of chronic lymphocytic leukemia (CLL), the most common leukemia, by utilizing cutting‐edge molecular tools. Raili Sillart is adviser in the Innovation Unit at the Ministry of Social Affairs, also participating in 1+MG Raili Sillart MSAE and GDI Britta Haenisch is head of the Research Division at the Federal Institute for Drugs and Medical Devices. She is Professor of Pharmacoepidemiology at the University of Bonn. Britta Haenisch is involved in the implementation of the genome sequencing model project in Germany enabling the Britta BfArM implementation of comprehensive diagnostics and therapy finding using genome sequencing into Haenisch routine healthcare and making the data available for research. As platform holder in the model project , BfArM will be responsible for facilitating knowledge-generating health care based on genomic medicine. Wannes Van Hoof is head of the unit ethics and citizen engagement in the cancer center of Wannes Sciensano Sciensano. He has a PhD in bioethics and coordinated several national and international citizen Van Hoof engagement initiatives on ethical, legal and societal aspects of the use of genomics and data  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 technologies in the health care system. Octavian Bucur, MD, PhD is the General Director of the Genomics Research and Development Institute in Bucharest, Romania. Octavian is a Romanian Representative to the 1+ Million Genomes Octavian (1+MG) Initiative and responsible for the Romanian participation in the Genome of Europe, and 1+MG GRDI Bucur WG 1. With over a decade research experience at Harvard Medical School in Boston, USA, Octavian is now back to Romania to help in the implementation of the ROGEN project "Development of Genomic Research in Romania" (2024-2029). Dr. Markus Perola MD, PhD, is a Research Professor at the Finnish Institute of Health and Welfare (THL), Finland. Dr Perola will lead the Task 6.1. Data reception focusing on the synthetic datasets and participate in the Task 7.1 Profiling of the European population (Genome of Europe). He is leading a research team focusing on the genomics and other omics in relevance to common human traits and personalised medicine. He also is the Chief Scientific Officer of the THL biobank, the largest population-based biobank in Finland. He is the vice-director of the Clinical and Molecular Metabolism Markus UH Research Program, Faculty of Medicine, University of Helsinki. He is a member of the FinnGen Study Perola Scientific Committee and the PI of the P6-Genomics to Healthcare and COVIDprog – studies. He is the president of the Ethical Board of the Helsinki University hospital and a member of European Society of Human Genetics Public and Professional Policy Committee. His publication list includes over 400 original articles, and he is listed in the Clarivate Analytics Highly Cited Scientists. Dr. Perola is also a Consultant in Public Health Medicine and a practising physician in Haartman Hospital, HUS Helsinki University Hospital. Outside resources (subcontracting, seconded staff, etc) If you do not have all skills/resources in-house, describe how you intend to get them (contributions of members, partner organisations, subcontracting, etc.) and for which role/tasks/professional profile/expertise If there is subcontracting, please also complete the table in section 4. use of subcontracting not anticipated Consortium management and decision-making Explain the management structures and decision-making mechanisms within the consortium. Describe how decisions will be taken and how regular and effective communication will be ensured. Describe methods to ensure planning and control. Note: The concept (including organisational structure and decision-making mechanisms) must be adapted to the complexity and scale of the project. The B1MGplus project and governance structure is shown in Figure 3. This structure is designed to facilitate the implementation of the 1+MG initiative during the transition to the Genome EDIC establishment, ensuring coordination with relevant bodies and alignment with the initiative's evolving needs. Note: The consortium composition is discussed in section 2.3 Capacity to carry out the proposed work The General Assembly (GA), chaired by the project coordinator, is the ultimate decision-making body of the project. It consists of representatives from the beneficiaries, who are voting members, and Associated Partners, who are non-voting members. The General Assembly will meet at least once a year, and decisions will typically require a ⅔ majority, with each beneficiary having one vote. The entities represented in the General Assembly are deployed across the four Work Packages (WPs), with the WP Leaders and the coordinator forming the Management Board. The ELIXIR Hub, represented by Serena Scollen, Head of Human Genomics and Translational Data, will serve as the Project Coordinator. Acting as an intermediary between the project participants and the Funding Authority, the project coordinator oversees project implementation, overall reporting, and financial management. The coordinator also makes recommendations to the General Assembly when changes to the project plans are necessary. Supporting the coordinator is the Management Board, which includes the EMBL-ELIXIR Hub (comprising the PMO, External Relations, Technical Team, and Legal Services) and the WP leaders to execute the project plans. The Management Board brings the coordinator and WP leaders together to oversee the project’s technical delivery, addressing issues, risk and opportunities. They recommend actions as needed, which are then discussed and presented to the General Assembly for approval when applicable, such as in cases of significant impact on project implementation including the addition of new parties or significant changes to tasks. Relations with the external monitoring and advice bodies The coordinator, along with leaders from the four WPs, will present the project's progress to various relevant bodies and groups involved in the initiative and the 1+MG implementation projects. This process is illustrated in Figure 3. The collaborative leadership in each WP described below ensures effective communication of WP progress during planned meetings and facilitates the integration of expert inputs and advice from each group. These insights are either acted upon within the WP or escalated to the Management Board if significant changes to the implementation are necessary.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 WP4 1+MG Data Requirements activities are co-led by leaders of the 1+MG WG3 (Common standards and minimal dataset for clinical and phenotyping data), WG4 (Good sequencing practice), WG5 (Federated, secure, interoperable and privacy- respecting framework and access governance), and the GDI Pillar II (1+MG Infrastructure) and GDI Pillar III (Innovation solutions). WP3 Healthcare implementation and Health economics activities are co-led by leaders of the 1+MG WG7 (Healthcare implementation) and WG6 (Health economics). WP2 Genome EDIC implementation activities are led by the leaders of the 1+MG WG2 (Ethical, legal and societal issues), GDI Pillar I (Long term sustainability) and the Task Force created for the establishment of the EDIC. WP1 Project coordination and support to the 1+MG initiative activities are led by the 1+MG Coordination Group Chair and the GDI coordinator (Serena Scollen). Should the Genome EDIC be established before or during the project’s duration it will receive briefings from the coordinator and leads of WP1 and WP2. This will enable it to provide advice and direction to WP1. Decision making and escalation process Decisions pertaining solely to WP activities will be made within the respective WP during their regular meetings, the frequency of which determined by each WP. Decisions that impact two or more WPs or have the potential to deviate from the implementation plan should be escalated by the WP Leaders to the Management Board. If deemed necessary, the Management Board will then bring these decisions to the General Assembly. Any participant in the project can approach their WP leader or the coordinator to highlight risks or issues, which, if relevant, will then be escalated to the Management Board. Subsequently, the coordinator will bring these topics to the General Assembly when input or a decision is required. Decisions adopted by the General Assembly that necessitate an amendment to the Grant Agreement will be brought by the coordinator to the EC Project Officer assigned to the project. #§CON-SOR-CS§# #§QUA-LIT-QL§# #@IMP-ACT-IA@# #@COM-DIS-VIS-CDV@# 3. IMPACT 3.1 Expected outcomes and deliverables — Dissemination and communication Expected outcomes and deliverables Define and explain the extent to which the project will achieve the expected impacts listed in Call document. Expected impact extracted from the call text and how it will be achieved …Enabling the creation and operation of an EDIC on genomics… To reach the outcome: B1MGplus will establish a close collaboration with GDI Pillar I where the EDIC WG and the 1+MG Member States are represented. In Pillar I, decisions on the documents to be presented to member countries for the constitution of the EDIC will be taken. To that end, a Task Force has been established to drive the legal establishment of the EDIC, preferably already early in 2025. B1MGplus will support the process of the creation of the EDIC by providing input on legal challenges and potential ways to deal with them. Once created, the Genome EDIC will still have to work towards becoming operational. The legal document, policy, quality and risk management framework need to be defined to allow a compliant implementation of the data sharing of the highly sensitive data of 1+MG. Sustainable operations have to be defined, where the EDIC will start from a reduced scope of operations that is viable enough to convince funders from relevant ministries to invest (minimum viable product). Responsibilities: WP2 to produce the working document required by GDI Pillar I and the EDIC. Target audience: GDI Pillar I (EDIC WG and Taskforce) and 1+MG Group Means of verification: EDIC establishment, implementation of minimum operations (minimum viable product). …uptake of genomics and implementation of the European genomic data infrastructure not only for research, but also in the contexts of healthcare delivery and public health policy.… To reach the outcome: B1MGplus will build on the outcomes from B1MG on healthcare implementation, creating a network that will bring in the perspectives of public health experts and a wider range of health professionals from the National Mirror Groups to the 1+MG Initiative to make further progress. The 1+MG MLM will be used as a framework of discussions seeking a way forward for broader uptake of genomics in healthcare and for mapping activities, and will be improved to accommodate progress in the field. At the same time the WP3 work in Health Economics will lead to a better understanding of how to model economic impact of genomic medicine, supporting policy decisions on investment. Overall WP3 activities will impact the work of healthcare professionals to leverage the EDIC in clinical practice, and the awareness of policy makers, providing evidence to support strategy and investment decisions on adoption of genomics in healthcare systems Responsibilities: WP3 to produce evidence supporting decision makers and health professionals on the way forward for genomic medicine Target audience: Healthcare systems, policy makers, health professionals, and the 1+MG Initiative Means of verification: WP3 deliverables …ensure public trust in genomics, enable broad uptake by healthcare professionals,...  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 To reach the outcome: B1MGplus will align with the limited activities planned in GDI on the topic of healthcare professionals' educational needs, to promote the dissemination and implementation of survey oriented GDI recommendations. B1MGplus will further leverage the wide range of informational material directed at citizens and patients developed by many initiatives related to genomics in health to create a citizens informational Hub. The Citizen’s Hub will promote the wider dissemination of these materials, with a significant impact in educating and empowering the public to make better informed choices regarding genomic medicine and their health. Responsibilities: WP3 to create the Citizens Hub and promote wide dissemination of materials Target audience: Patients and citizens Means of verification: WP3 Deliverables …alignment of the future EDIC with the European Health Data Space (EHDS).... To reach the outcome: The B1MGplus coordination (WP1) and WP2 will work to align the Genome EDIC with the EHDS and allow to join as an authorised participant by drafting working documents for the EDIC that align with EHDS implementation and by taking an active role on EHDS related activities. Responsibilities: WP1 and WP2 Target audience: EHDS, 1+MG MS, European Commission, relevant projects such as JA TEHDAS2 Means of verification: Policies, legal documents and quality / risk management recommendations that meet requirements for inclusion (unless conditions influence the operations of the EDIC in a way that could make joining not feasible) … the implementation of data-related guidelines constituting the 1+MG Framework, in particular regarding (meta)data standards and data quality assurance…. To reach the outcome: B1MGplus will coordinate and align the work on (meta)data standards as well as quality and utility aspects of involved (meta)data resulting in practical (implementation) guidelines as part of the 1+MG framework. Responsibilities: all WPs Target audience: Data holders, data brokers/FAIRifiers, data users Means of verification: Harmonised minimal datasets for use cases of 1+MG including metadata schemas facilitating findability, searchability, discovery and usage of 1+MG (data) resources. Updated 1+MG framework on data models, standards and ontologies Dissemination and communication of the project and its results If relevant, describe the communication and dissemination activities, activities (target groups, main messages, tools, and channels) which are planned in order to promote the activities/results and maximise the impact. The aim is to inform and reach out to society and show the activities performed, and the use and the benefits the project will have for citizens Clarify how you will reach the target groups, relevant stakeholders, policymakers and the general public and explain the choice of the dissemination channels. Describe how the visibility of EU funding will be ensured. In case your proposal is selected for funding, you will have to provide a more detailed plan for these activities (dissemination and communication plan), within 6 months after grant signature. This plan will have to be periodically updated; in line with the project progress. The project’s dissemination and communication activities (Table 1) will target a range of stakeholders, listed below. The project Communications & Dissemination Strategy (due M6) will outline key audiences, messages and channels and will be regularly evaluated and updated. Activities will build on those of B1MG, GDI and 1+MG, ensuring that stakeholders can understand the relationship between these complementary efforts. A distinct project logo and branding guidelines will be developed by external contractors, complementing the existing logo and branding guidelines for the 1+MG initiative. This will include a funding acknowledgement ensuring visibility of EU funding on all materials and outputs (slides, posters, deliverables, pre-prints, publications, technical reports). Key stakeholders Relevant European projects and initiatives: 1+MG Group and WGs, Genome EDIC, GDI , EHDS + HealthData@EU + TEHDAS2 + XpanDH, GoE, EUCAIM , ICPERMED, QUANTUM, European Cancer Image Initiative, the Cancer Mission actions, future cancer data hubs, European Virtual Human Twins Initiative, European Partnership for Rare Diseases, Personalised Medicine and Transforming Health and Care Systems National genomic and personalised medicine programmes International initiatives - GA4GH Technical, scientific and clinical experts from: hospitals (especially healthcare professionals), research institutes, biobanks, research agencies, research infrastructures Public and private stakeholders necessary for creating the EDIC Public administrations (national, regional and local level), including: policy makers, health authorities, public health boards, health economists, research and health funders  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Genomic medicine educators Citizens (including patients) Key messages B1MGplus supports the 1+MG initiative to advance data-driven healthcare solutions to benefit citizens of Europe. Through the removal of barriers, this endeavour will boost the economic competitiveness of individual Member States, and hence Europe as a whole, placing the Union in a global leadership position. B1MGplus is enabling ○ creation and operation of a sustainable EDIC on genomics, ensuring alignment with the European Health Data Space (EHDS) ○ implementation of data-related guidelines constituting the 1+MG Framework, in particular (meta)data standards and data quality assurance ○ benchmarking through self-assessment of gaps in national implementation of genomic medicine in healthcare systems and the sharing of experiences across countries ○ improved awareness, literacy level and education of citizens, health professionals and policy makers on genomic medicine across Europe ○ increased understanding of healthcare economics in genomic medicine to inform policy decisions Table 1 Project dissemination and communication activities Activity Audience Channels Responsibility Create and share project All stakeholders, including citizens Website, social media, Task 1.3 branding based on 1+MG newsletter, slides, posters, branding deliverables, pre-prints, publications, technical reports Build and maintain project All stakeholders, including citizens Project website Task 1.3 website Build social media audience All stakeholders, including citizens Twitter/X, LinkedIn Task 1.3 through engaging content Post news and press All stakeholders, including citizens Project website Task 1.3 releases Create and disseminate a All stakeholders, including citizens Project newsletter Task 1.3 quarterly project newsletter Present the project at Relevant European projects and Posters & presentations (shared All WPs scientific conferences and initiatives, scientific and technical via Zenodo), publications (open stakeholder meetings and experts access) publish in peer review journals Organise and disseminate Target stakeholders (different for Zoom, newsletter, social media WP1 output from annual 1+MG each Forum) Stakeholder Forum Disseminate Policy tool set National and European 1+MG Framework website, Task 2.2 (with policymakers, 1+MG Group, GDI, meetings with 1+MG Group and support from Task new EDIC GDI 1.3) Disseminate Legal National and European legal 1+MG Framework website, Task 2.3 (with documents tool set experts, 1+ MG Group, GDI, new meetings with 1+MG Group and support from Task EDIC GDI 1.3) Disseminate National and European legal 1+MG Framework website, Task 2.1 (with Recommendations on experts, 1+ MG Group, GDI, new meetings with 1+MG Group and support from Task ethical and legal EDIC, EHDS, EUCAIM, EC, GDI 1.3) implementation TEHDAS2, DPAs Disseminate Quality GDI, 1+MG Group, new EDIC 1+MG Framework website, Task 2.5 (with assurance and risk meetings with 1+MG Group and support from Task management framework GDI 1.3) Engagement with network of Health authorities, public health Meetings and presentations (in Task 3.1 health authorities, public experts, and health professionals person and online) health experts, and health via national genomic and professionals, linking with personalised medicine programmes, B1MG initiative and European networks and initiatives including EHDS  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Policy Brief for genomic Genomic medicine education Social media, direct mail, project Task 3.1 (with medicine education with decision makers website, newsletter support from Task recommendation, targeting 1.3) decision makers (education) Tutorial and webinar to on Network of health authorities, public Online tutorial and webinar (also Task 3.2 1+MG Maturity Level Model health experts, and health recorded for 1+MG Framework), professionals newsletter Map of the implementation 1+MG Group, GDI, policymakers, 1+MG Framework website, Task 3.3 of genomic medicine in healthcare professionals meetings with 1+MG Group and national healthcare systems GDI, health professional network Creation of Patient and Patients and citizens Project website (or bespoke Task 3.4 (with citizen hub website), dissemination through support from Task social media, project website, 1.3) newsletter, direct emails Report on scoping a project Health economists, 1+MG, GDI, 1+MG Framework website, Task 3.5 to develop a standardised public administrations, meetings with 1+MG Group and approach to measure policymakers, funders GDI economic impact of WGS Recommendations on EDIC, 1+MG, GDI 1+MG Framework website, Task 3.3 implementation and meetings with 1+MG Group, sustainability of genomic GDI, future EDIC medicine in healthcare systems. Recommendations for long- EDIC, 1+MG, GDI 1+MG Framework website, Task 4.1 read whole genome meetings with 1+MG Group, sequencing GDI, future EDIC Proficiency testing scheme EDIC, 1+MG, GDI 1+MG Framework website, Task 4.1 on short-read NGS meetings with 1+MG Group, GDI, future EDIC Proficiency testing scheme EDIC, 1+MG, GDI 1+MG Framework website, Task 4.1 on short-read exome meetings with 1+MG Group, sequencing GDI, future EDIC Phenotype data model EDIC, 1+MG, GDI 1+MG Framework website, Task 4.2 meetings with 1+MG Group, GDI, future EDIC Genotype data model EDIC, 1+MG, GDI 1+MG Framework website, Task 4.2 meetings with 1+MG Group, GDI, future EDIC Terms of use/ELSI EDIC, 1+MG, GDI 1+MG Framework website, Task 4.4 metadata meetings with 1+MG Group, GDI, future EDIC B1MGplus targets three key stakeholder groups who are critical to the successful implementation of genomic medicine – citizens (including patients), healthcare professionals and policy makers. Building trust, awareness and acceptance amongst citizens and patients is important as citizens are both the providers of data and the ultimate beneficiaries of genomic medicine. Activities will build on citizen engagement tasks in GDI and B1MG, including addressing gaps identified in the MLM. The work will be led by WP3 with specific tasks, aiming to reach out to society as a whole, showing how EU funding contributes to tackling societal challenges. This is supported by project communication channels (website, social media, newsletter) developed in WP1. Messaging will be tailored and delivered in such a way so as to ensure and maintain a high level of awareness, acceptance and trust and provide opportunities for feedback and dialogue. The group “healthcare professionals” includes clinical geneticists, oncologists, medical doctors from other specialties (including family doctors, cardiologists, paediatricians, neurologists and others with potential to use genomics in clinical practice but less specific knowledge), nurses, pharmacists, genetic counsellors, clinical scientists, clinical bioinformaticians and data analysts. Genomic medicine will significantly change the landscape of clinical care and healthcare professions will be major players in these changes. It is therefore important to work closely with healthcare professionals to improve awareness and improve education. This will be achieved through tasks in WP3, and will build on work in GDI and B1MG to understand the attitudes and needs of healthcare professionals and address identified gaps for improved awareness and education. Policy makers include officials at the European (e.g. DG RTD, DG SANTE, DG CONNECT), national (e.g. Ministry of Health, Ministry of Science) and regional levels (e.g. Local Health Authorities). Policy makers benefit from access to high quality data for use in decision making and are motivated to improve the efficiency and effectiveness of healthcare provision. It is important to inform policy makers of the benefits of genomic medicine, the investments involved and the policy implications. Engagement  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 with policy makers will be addressed in WP3 through targeted tasks, including creating a network of public health experts, with a goal of identifying and disseminating good practices. Building on work in GDI and B1MG and addressing gaps identified in the MLM, including health economic modelling, B1MGplus will provide a framework of reference to support the decision making process and the definition of mid and long term targets for genomic medicine implementation. #§COM-DIS-VIS-CDV§# 3.2 Competitiveness and benefits for society Competitiveness and benefits for the society Describe the extent to which the project will strengthen competitiveness and bring important benefits for society B1MGplus actively supports the ambitious goals of the 1+MG initiative, aiming to deliver significant societal benefits and enhance Europe's competitiveness. By uniting 27 countries under a common vision, the initiative seeks to establish a cross- border federated network of national genome collections and other relevant data. This network holds the promise of revolutionising healthcare in Europe through data-driven solutions that benefit its citizens and health systems. Genomic data analysis has the potential to improve the effectiveness, accessibility, efficiency, sustainability and resilience of health systems in the European Union. By eliminating barriers to collaboration, this pan-European initiative not only enhances the economic competitiveness of individual Member States but also positions Europe as a global leader in genomics. No one country or institute can achieve these goals alone due to the scale of data required. It is imperative to align across countries to ensure the smooth operation of the genomics infrastructure for reasons ranging from defining minimum guidelines for ELSI or data, through to being able to access diverse data on different ethnicities that could not be generated at scale by one country alone. As outlined in the 1+MG initiative roadmap for 2023–2027, genomics holds immense potential to transform healthcare delivery. It enables more accurate and timely diagnostics, proactive prevention strategies, and the development of more targeted personalised treatments and interventions. This paradigm shift in medical practice can significantly improve health outcomes and the quality of life for EU citizens, particularly those affected by rare diseases, cancers, common complex diseases, and infectious diseases. To expedite the scientific and medical breakthroughs it is essential to establish a continuous loop between healthcare and research (Figure 4) that doesn’t currently exist in many countries. The creation of a federated infrastructure for genomic data facilitates secure data sharing among healthcare professionals and researchers, paving the way for more personalised approaches to healthcare delivery. This infrastructure fosters data-driven innovation and the emergence of new markets for health-related services, products, and medicines, driving economic growth and job creation. Figure 4. The flow and relationships required to maximise the benefits that genomics can bring to citizens and society. Genomic and affiliated phenotypic/clinical data generated by healthcare will be of huge value, increasing research and discoveries that aid in our understanding of disease prediction and treatment. Research findings can then be fed into healthcare practice. B1MGplus specifically supports progress in key areas: 1. Supporting Sustainable Infrastructure: Assisting Member States in transitioning implementation projects into a more sustainable infrastructure (EDIC). 2. Healthcare Implementation: Driving national-level efforts to generate high-impact data that will feed into the genomic infrastructure. 3. Genomic Literacy: Promoting genomic literacy to empower individuals and enhance the competence of healthcare professionals. 4. Data Management: Ensuring data aspects are handled with utmost efficiency and security. In summary, the societal benefits of B1MGplus include ensuring that genomic health data is available under robust access policies, safeguarding digital sovereignty, and maximising the potential of genomics to improve health outcomes and drive innovation in healthcare. Through these efforts, B1MGplus contributes to a healthier, more competitive, and innovative Europe.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 3.3 Environmental sustainability and contribution to European Green Deal goals Environmental sustainability and contribution to European Green Deal goals Describe the extent to which the project will contribute to environmental sustainability and in particular to European Green Deal goals This might not be applicable to all topics — for details refer to the Call document. Not applicable #§IMP-ACT-IA§#  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 #@WRK-PLA-WP@# 4. WORK PLAN, WORK PACKAGES, ACTIVITIES, RESOURCES AND TIMING 4.1 Work plan Work plan Provide a brief description of the overall structure of the work plan (list of work packages or graphical presentation (Pert chart or similar)). The overall structure of the project is presented in Figure 3 and the implementation plan is described in the ‘Implementation plan’ section. The WPs are designed to address the requirements and ambition of the call text, organised into three main activity areas: Genome EDIC establishment (WP2), Healthcare implementation and health economics (WP3) and 1+MG Data Requirements (WP4). Coordination and support are provided by WP1. All activities are closely connected to the 1+MG Initiative, WGs and the Genome EDIC WG (supported by GDI) ensuring continuous alignment with the initiative’s goals. While all WPs are essential for establishing an operational Genome EDIC, there is a particularly strong dependency between WP2 and WP3. The health economics aspects, which are crucial for facilitating the decision-making process for the 1+MG member states (27 countries) to join the Genome EDIC. 4.2 Work packages, activities, resources and timing Work packages This section concerns a detailed description of the project activities. Group your activities into work packages. A work package means a major sub-division of the project. For each work package, enter an objective (expected outcome) and list the activities, milestones and deliverables that belong to it. The grouping should be logical and guided by identifiable outputs. Projects should normally have a minimum of 2 work packages. WP1 should cover the management and coordination activities (meetings, coordination, project monitoring and evaluation, financial management, progress reports, etc) and all the activities which are cross-cutting and therefore difficult to assign to another specific work package (do not try splitting these activities across different work packages). WP2 and further WPs should be used for the other project activities. You can create as many work packages as needed by copying WP1. For very simple projects, it is possible to use a single work package for the entire project (WP1 with the project acronym as WP name). Work packages covering financial support to third parties ( only allowed if authorised in the Call document) must describe the conditions for implementing the support (for grants: max amounts per third party; criteria for calculating the exact amounts, types of activity that qualify (closed list), persons/categories of persons to be supported and criteria and procedures for giving support; for prizes: eligibility and award criteria, amount of the prize and payment arrangements). Enter each activity/milestone/output/outcome/deliverable only once (under one work package). Ensure consistency with the detailed budget table/calculator (if applicable). (n/a for prefixed Lump Sum Grants) Objectives List the specific objectives to which the work package aims to achieve. Activities and division of work (WP description) Provide a concise overview of the work (planned tasks). Be specific and give a short name and number for each task. Show who is participating in each task: Coordinator (COO), Beneficiaries (BEN), Affiliated Entities (AE), Associated Partners (AP), indicating in bold the task leader. Add information on other participants’ involvement in the project e.g. subcontractors, in-kind contributions. Note:  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 In-kind contributions: In-kind contributions for free are cost-neutral, i.e. cannot be declared as cost. Please indicate the in-kind contributions that are provided in the context of the work package. The Coordinator remains fully responsible for the coordination tasks, even if they are delegated to someone else. Coordinator tasks cannot be subcontracted. If there is subcontracting, please also complete the table below. Milestones and deliverables (outputs/outcomes) Milestones are control points in the project that help to chart progress (e.g. completion of a key deliverable allowing the next phase of the work to begin). Use them only for major outputs in complex projects, otherwise leave the section empty. Please limit the number of milestones by work package. Means of verification are how you intend to prove that a milestone has been reached. If appropriate, you can also refer to indicators. Deliverables are project outputs which are submitted to show project progress (any format). Refer only to major outputs. Do not include minor sub-items, internal working papers, meeting minutes, etc. Limit the number of deliverables to max 10-15 for the entire project. You may be asked to further reduce the number during grant preparation. For deliverables such as meetings, events, seminars, trainings, workshops, webinars, conferences, etc., enter each deliverable separately and provide the following in the 'Description' field: invitation, agenda, signed presence list, target group, number of estimated participants, duration of the event, report of the event, training material package, presentations, evaluation report, feedback questionnaire. For deliverables such as manuals, toolkits, guides, reports, leaflets, brochures, training materials etc., add in the ‘Description’ field: format (electronic or printed), language(s), approximate number of pages and estimated number of copies of publications (if any). For each deliverable you will have to indicate a due month by when you commit to upload it in the Portal. The due month of the deliverable cannot be outside the duration of the work package and must be in line with the timeline provided below. Month 1 marks the start of the project and all deadlines should be related to this starting date. The labels used mean: Public — fully open ( automatically posted online on the Project Results platforms) Sensitive — limited under the conditions of the Grant Agreement EU classified — RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444. For items classified under other rules (e.g. national or international organisation), please select the equivalent EU classification level. Work Package 1 - Project coordination and support to 1+MG initiative Work Package 1: Project coordination and support to 1+MG initiative Duration: M1 - M36 Lead Beneficiary ELIXIR Objectives The primary aim of this WP is to ensure the efficient and effective implementation of the project activities. Additionally, the project coordination will closely support the 1+MG activities, either as part of the 1+MG Group or within the framework of the genome EDIC once it is established.This will ensure that project activities are aligned with the needs of the 1+MG initiative, according to the resources available in the project. ● O1.1 Project Mobilisation (Task 1.1) ● O1.2 Project monitoring, coordination and support to1+MG (Task 1.2) ● O1.3 Project communication strategy and support to 1+MG (Task 1.3) ● O1.4 Project stakeholder management and support to 1+MG stakeholder forum (Task 1.4) Work package leaders: Serena Scollen, Nikki Coutts, Juan Arenas (ELIXIR Hub) Activities and division of work (WP description) Task name: Description / Participants: (Name, Role (see 2.3), Subcontracting / In-kind)  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Project mobilisation: The coordination team (ELIXIR Hub) will ensure early engagement of project participants by activating project boards and WPs. In addition, connections with relevant EU initiatives and EC-funded projects will be established (e.g. GDI, GoE, THEDAS2, QUANTUM). This task includes setting up the project repository and implementing communication and monitoring tools. Participants: ELIXIR Coordination monitoring and support: The coordination team will actively engage in all project activities to ensure the successful delivery of both the project and the 1+MG initiative roadmap, maximising their impact. The relevant project bodies will be chaired by the coordination team who will also support 1+MG initiative bodies, as indicated in the section ‘consortium management and decision-making’. The ELIXIR PMO will monitor project delivery including deliverables, milestones and use of the assigned resources. Change management will also fall under the ELIXIR PMO responsibilities, carried out in close collaboration with the Management Board. Details about monitoring activities are already presented in section 2.2 under project management, quality assurance, and monitoring and evaluation strategy. The coordinator will support the governance of the 1+MG initiative (with governance responsibilities held by the EC) and will be responsible for presenting project activities to the 1+MG Group. The coordinator will ensure that feedback from the 1+MG Group and EC reviewers is addressed. Participants: ELIXIR Project communication strategy: The project communications team, in close collaboration with the WP leaders, especially those in WP3, will develop, implement and monitor the project communication strategy to support the communication of the 1+MG initiative. Key components include creating B1MGplus project branding, a website, templates, social media channels and a quarterly newsletter. The team will also define the target audience and establish metrics to measure success (refer to section x.x under dissemination and communication of the project and its results). All project participants will adhere to the Communication Strategy, which will be managed and monitored by the ELIXIR Hub communications team. Participants: ELIXIR Stakeholder involvement: WP1 will support the other work packages (WPs) by facilitating the involvement of the 1+MG Stakeholder Forum. This includes contributing to the organisation and management of activities tailored to engage various stakeholder groups effectively. Participants: ELIXIR Lead # Milestone Name WP Description Due Means of Verification Beneficiary Boards and WPs have been formalised and work has MS1.1 Project Mobilised WP1 ELIXIR M03 Milestone published in Zenodo started, connection established with target project. MS1.2 Project website goes live WP1 ELIXIR Project website is live M03 Project website is live MS1.3 First stakeholders event WP1 ELIXIR Stakeholder event has taken place M09 Statistic of participation are published in the website MS1.4 Second stakeholders event WP1 ELIXIR Stakeholder event has taken place M21 Statistic of participation are published in the website MS1.5 Third stakeholders event WP1 ELIXIR Stakeholder event has taken place M33 Statistic of participation are published in the website Lead Dissemination # Deliverable Name WP Type Due Description Beneficiary Level D1.1 Project handbook WP1 ELIXIR R PU M06 Guide to the project process, assets and tools D1.2 Data management plan WP1 ELIXIR DMP PU M06 Data management plan for the management of the project D1.3 Project communication plan WP1 ELIXIR R PU M06 Communication plan D1.4 Project communication plan review WP1 ELIXIR R PU M16 Review of project communication plan D1.5 Project handbook review WP1 ELIXIR R PU M16 Review of the project handbook Final evaluation or project handbook and D1.6 WP1 ELIXIR R PU M34 Review of the project handbook and communication plan communication plan Estimated budget — Resources Participant Costs  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 D.1 Financial C.3 Other goods, support to D.2 Internally B. C.1 Travel and C.2 works and third invoiced goods and E. Indirect A) personel Subcontracting subsistence Equipment services parties services costs Total costs ELIXIR(COO) 19.85 €231,763.51 €0.00 €100,000.00 €23,223.45 €354,986.96 Total 19.85 €231,763.51 €0.00 €100,000.00 .0 €0.00 €0.00 €0.00 €23,223.45 €354,986.96 Work Package 2 - Genome EDIC establishment Work Package 2: Genome EDIC establishment Duration: M1 - M36 Lead Beneficiary LNDS Objectives This WP will provide input to the GDI Project and the Genome EDIC that is to be set up to support the EDIC in becoming operational. The work will provide the foundation (i.e. content creation) for the negotiations of member countries in the GDI Pillar I on the data governance and governance implementation, sustainability and business model as well as the input into the development of the IT infrastructure. The work will be limited to cover a minimum viable product that allows the Genome EDIC to become operational but not cover any future developments yet as these plans will be too volatile during the lifetime of the project and the provided funds not sufficient to cover additional scenarios. ● O2.1 Address legal and ethical questions related to the EDIC operations (Task 2.1) ● O2.2 Set up a framework of policies that guide the EDIC operations (Task 2.2) ● O2.3 Set up a framework of legal documents governing the relationships of EDIC with various actors (Task 2.3) ● O2.4 Provide input for the sustainability framework (Task 2.4) ● O2.5 Quality assurance and risk management framework (Task 2.5) Work package leaders: Regina Becker (LNDS), Bruno Rodrigues (MESR), Giovanni Comandè (SLEX) Activities and division of work Tas Task name: Description / Participants: (Name, Role (see 2.3), Subcontracting / In-kind) k ELSI framework: In this task we will analyse the ethical and legal challenges and enablers when implementing a cross-border data infrastructure for secondary use of health and genomic data according to a joint data governance. We will investigate in particular the challenges associated with the creation of a genomic data space that is intended to become a subspace of the European Health Data Space (EHDS). As the 1+MG EDIC will be created and needs to receive its mandate independent of the EHDS, the legal basis for data inclusion as well as all the operations and related activities such as the data governance for data reuse beyond research and including also healthcare and public health purposes 2.1 will be considered. Also additional elements relevant for the ethical, legal and operational aspects such as the reporting of incidental findings, a continued access for research integrity etc. must be solved for the EDIC. While some work on the legal basis was done already in the B1MG project and the GDI project, the considerations were largely limited to the data sharing for research and only the main operations, not taking into account a wider scope of secondary use and activities that go beyond the data sharing. Establishing a processing record of processing activities (ROPA) for all the processing related to the operations based on modelled workflows will help to identify potential issues. In addition, the EHDS Regulation should be considered in investigating the possibility and utility to become an authorised participant in the EHDS. We will also explore the potential conditions for such  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 integration that may be further specified in implementing acts and defining the most appropriate ways to and operationalise the EDIC’s participation in the HealthData@EU infrastructure. The results will be translated into an adaptation of previous considerations and new aspects such as concrete recommendations on non-discrimination principles. The analyses in this task also give input into ELSI related metadata. The definition of metadata models to capture relevant and actionable information related to ethical and legal aspects will be pursued in WP4. This task will feed relevant content into this development. The analysis of the ethical and legal situation performed in this task will lead to interpretations and recommendations that will be shared with relevant stakeholders such as the 1+MG ELSI Working Group, other projects and initiatives (e.g. EUCAIM, Joint Action TEHDAS2), the Commission, data protection authorities and others as sparring partners for feedback. To the extent feasible the proposed solutions might be experimented in the form of a regulatory sandbox involving the appropriate Authorities. Participants: LNDS(BEN), SLEX(BEN), MESR(AP) Policy framework: The GDI project has foreseen a path that leads to the creation of the EDIC, which includes the statutes. However, to become operational, a policy framework is also needed to govern the various aspects of the operations of the EDIC. The statutes defined in the GDI will provide for the main elements of activities, responsibilities and decision making on a top-level requiring the actual drafting of implementing rules. The policy framework will foresee the rules of procedure of how decisions are made, the role and functioning of the various committees supporting the EDIC decision making bodies and implement the governance and data governance in suitable documents to guide the functioning of the EDIC. We will build on task 2.1 as well as on the work done in the B1MG project on the 1+MG data governance for research and extend it for other secondary use purposes. We will 2.2 take up the analysis of task 2.1 on the European Health Data Space and adapt existing work where necessary. We aim to stay as close as possible to the procedures agreed in the EHDS. For the governance of the EDIC itself, we intend to build on the experience of research infrastructures, data infrastructures and other relevant entities. The recommendations will be discussed with the Pillar I working group of governmental representatives in the GDI project that also doubles as the EDIC Working Group of the 1+MG and, if the EDIC itself is created, the EDIC general assembly. The outcome of the discussions with Pillar I / the EDIC Working Group will be fed back into this task for translation into formalised policy documents. Participants: LNDS(BEN), NGC(BEN), ISCIII(BEN) Legal document framework: Once the governance and data governance are finally decided, the relationship between the various actors needs to be translated into standard legal documents enabling binding commitments and regulating the rights and obligations of all the entities to the extent that they are not provided for in the statutes. This includes among others data providers, IT infrastructure providers designated by the Member Countries, National Coordination Points as well as service providers contracted for central services. Relevant input for the content will further be provided by task 2.1. These legal documents will address the needs of the procurement policy of the EDIC (including with data providers 2.3 and with the entities providing the national services for the EDIC) as it may be determined based on the task 2.1 and 2.2. Special attention will be given to the situation where an actor is located outside the European Economic Area and to the fostering of data altruism under the existing regulatory framework. The result of this task will provide the EDIC with the legal documents tool set (contracts, regulations,..) needed to allow the envisaged operations Participants: SLEX(BEN) Sustainability framework: The EDIC must respond to real needs. An exploration of user needs will provide information of such real needs. The demand both in content and in frequency should provide guidance for the EDIC in terms of infrastructure, legal, ethical and financial requirements. An exploration of such needs will be done to derive from real life experience and actual cost incurred. The result is a quantitative and qualitative analysis of user needs. Such needs analysis will be complemented with exemplary stories and also success stories incurred in relevant countries already engaged in genomic medicine. In addition, fictional use case stories will be described that can illustrate the unique selling points of 1+MG to provide information to be used with various stakeholders. 2.4 The vested interest of the various stakeholders from research funders to the healthcare sector, from health insurances to industry, from governments to citizens will be explored. Within this task, we will organise focused workshops with relevant task forces and working groups, including patient and citizen representative feedback groups. Also onsite visits at relevant infrastructure providers may be foreseen. Meetings will be complemented with structured interviews of relevant stakeholders. These activities will provide basic input into the policies, the development of membership models, related membership fees, user models and potential user fees of the EDIC, which are channelled into the design of the EDIC and its business model. Participants: CNR(BEN), NGC(BEN), ISCIII(BEN), UHEI(AP), MU(AP), HDIR(AP), RBI(AP), VUHSK(AP), Vinnova (AP), OOI(AP), LBMC(AP) Quality assurance and risk management framework The entire framework laid out in the GDI project, including contractual, policies, and data governance as envisaged in Pillar I and technical implementation as envisaged in Pillar II requires the formulation of acceptance criteria (ea. Reliability, risk management, DPdDD etc.) in order to transfer the pre- 2.5 production GDI tools and workflows towards production in the EDIC. These criteria and the risk management approach must be defined by the Genome EDIC as the responsible controller under the GDPR for the operations, i.e. the disclosure to the user. The end goal is to ensure that the EDIC is in a position to do a DPIA, based on validated documentation and commonly applied quality and risk management standards. This requires defining exactly what different roles are: Data provider, compute provider, DAC, etc. and what elements  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 of the 1+MG EDIC operations require a DPIA and/or a consultation of data protection authorities. This includes all risks with regard to the data protection principles. Based on use cases, we model relevant scenarios to identify critical points in the operations. It requires describing in sequence diagrams exactly how these actors communicate on an API level, describing the flow of data and accesses between actors in the infrastructure, to implement a given use-case. It also entails defining the risk management framework and standards that the platform must adhere to in production. These activities will guide the second half of the GDI project product implementation tracks ensuring that transitioning from development into production will be as smooth as possible. Depending on progress of the WP and establishment of the EDIC a DPIA should be conducted as soon as the framework is in place. T2.5 will also identify and map the cybersecurity compliance needs for the GDI. Participants: CNR(BEN), NGC(BEN), ISCIII(BEN), UHEI(AP), MU(AP), HDIR(AP), RBI(AP), VUHSK(AP), Vinnova (AP), OOI(AP), LBMC(AP) Milestones and deliverables (outputs/outcomes) Lead # Milestone Name WP Description Due Means of Verification Beneficiary MS2.1 Overview of policies WP2 LNDS List and scope of policies that are necessary for operations M06 Report List and scope of contracts and other legal documents that are necessary for MS2.2 Overview of legal documents required WP2 SLEX M06 Report operations The overarching risk framework for the EDIC defined and applied risk management MS2.3 Initial risk management framework WP2 NGC M06 Report standards Formulation of quality and risk management acceptance criteria - version one based MS2.4 Acceptance criteria v1 WP2 NGC M09 Report on initial findings Describing functional roles for the node within the delivery system of the EDIC at MS2.5 Description of node roles WP2 NGC M12 Report API level MS2.6 Acceptance criteria v2 WP2 NGC Second iteration of acceptance criteria M15 Report MS2.7 API sequence diagram WP2 NGC Diagram depicting interaction between node roles at API level M18 Workflow diagram Overview of elements with regard to the Genome EDIC's operations that will require MS2.8 Data Protection Impact Assessment list WP2 LNDS M24 Report a DPIA and/or a consultation of the supervisory authorities MS2.9 Initial policy toolset WP2 LNDS Draft Policy Toolset M24 Report MS2.10 Initial legal documents tool set WP2 SLEX Draft legal documents toolset as a living document M24 Report MS2.11 Regulatory Sandbox Workshop WP2 LNDS Workshop with data protection authorities on legal interpretations for secondary use M08 Report MS2.12 Regulatory Sandbox Workshop WP2 LNDS Workshop with data protection authorities on legal interpretations for secondary use M20 Report MS2.13 Regulatory Sandbox Workshop WP2 LNDS Workshop with data protection authorities on legal interpretations for secondary use M32 Report Stakeholder engagement plan for Strategy on involvement of stakeholders on the business models envisaged and MS2.14 WP2 CNR M03 Report sustainability planning of events Lead Dissemination # Deliverable Name WP Type Due Description Beneficiary Level  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Analysis of the legal framework of the Genome EDIC's operations considering relevant D2.1 Report on legal framework WP2 LNDS R PU M20 legislation such as GDPR, DGA, EHDS etc. Recommendations on ethical and Translation of the analysis of the legal analysis and the ethical framework into concrete D2.2 WP2 LNDS R PU M36 legal implementation recommendations for the data governance D2.3 Draft ROPA for operations WP2 LNDS R PU M18 Records of service provision processing activities as required by the GDPR Providing Genome EDIC with policies relevant for its operations and implementation of D2.5 Policy toolset WP2 LNDS R PU M24 governance, derived from requirements given from GDI Collection of contracts and other legal documents for the operations and overarching D2.6 Legal documents tool set WP2 SLEX R PU M24 governance Quantitative user needs analysis and qualitative needs based on stories derived from D2.7 Use case report WP2 ISCIII R PU M04 best practices experiences of relevant countries and illustrations of unique selling points of 1+MG Report on conclusions drawn from various stakeholder events and interviews on D2.8 Sustainability report WP2 CNR R PU M24 membership, user and cost models Assessment of the consequences of cybersecurity law on the setup of the Genome D2.9 Cybersecurity compliance report WP2 SLEX R PU M06 EDIC's IT infrastructure Risk management standard D2.1 WP2 NGC R PU M12 Overarching risk management principles for the EDIC framework D2.11 Acceptance criteria Initial report WP2 NGC R PU M12 Full set of acceptance criteria for IT platform Quality assurance and risk Definition of the EDIC's risk management framework building on the acceptance criteria, D2.12 WP2 NGC R SEN M36 management framework enabling a DPIA and deployment of products in production Risk management implementation Implementation plan for the risk management system based on framework, acceptance D2.13 WP2 NGC R SEN M36 plan criteria and documentation Estimated budget — Resources Participant Costs C.3 Other D.1 Financial D.2 Internally B. C.1 Travel and C.2 goods, works support to third invoiced goods E. Indirect A) personnel Subcontracting subsistence Equipment and services parties and services costs Total costs LNDS(BEN) 35.67 €392,322.03 €0.00 €0.00 €20,000.00 €28,862.54 €441,184.57 SLEX(BEN) 32.07 €176,410.61 €0.00 €12,348.74 €188,759.35 CNR(BEN) 12.09 €72,516.61 €0.00 €5,076.16 €77,592.78 NGC(BEN) 18.59 €167,308.97 €0.00 €11,711.63 €179,020.60 MSAE(BEN) 0 €0.00 €0.00 €0.00 €0.00 ISCIII(BEN) 5.58 €32,334.25 €0.00 €2,263.40 €34,597.65  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 MESR(AP) 1 €0.00 €0.00 €0.00 €0.00 UHEI(AP) 1 €0.00 €0.00 €0.00 €0.00 MU(AP) 1 €0.00 €0.00 €0.00 €0.00 HDIR(AP) 1 €0.00 €0.00 €0.00 €0.00 RBI(AP) 1 €0.00 €0.00 €0.00 €0.00 VUHSK(AP) 1 €0.00 €0.00 €0.00 €0.00 Vinnova (AP) 1 €0.00 €0.00 €0.00 €0.00 OOI(AP) 1 €0.00 €0.00 €0.00 €0.00 LBMC(AP) 1 €0.00 €0.00 €0.00 €0.00 IGG(AP) 1 €0.00 €0.00 €0.00 €0.00 Total 114.00 €840,892.47 €0.00 €0.00 €0.00 €20,000.00 €0.00 €0.00 €60,262.47 €921,154.95 Work Package 3 - 1+MG Healthcare Implementation & Health Economics Work Package 3: 1+MG Healthcare Implementation & Health Economics Duration: M1 - M36 Lead Beneficiary INSA Objectives ● O3.1 To bridge implementation gaps on genomics in healthcare systems across Europe, through mapping, self-assessment and benchmarking using the 1+MG Maturity Level Model (MLM) structure (Tasks 3.1, 3.2) ● O3.2 To document the implementation of genomic medicine in national healthcare systems, facilitating sharing of experiences across countries and informing policy makers (Task 3.3) ● O3.3 To promote the awareness, literacy level and education of citizens, health professionals and policy makers on genomic medicine across Europe (Task 3.1 and Task 3.4) ● O3.4 To contribute to implementation of WGS and other genetic tests in healthcare, by informing policy makers and decision-makers on how to measure and model its economic impact, supporting the right decisions and legitimising budget allocation. (Task 3.5) Work package leaders: Astrid Vicente (INSA), Lene Cividanes (NGC), Inês Amado (Inserm), Frédérique Nowak (Inserm) Activities and division of work Tas Task name: Description / Participants: (Name, Role )) k A network of public health and health professionals to support genomic medicine: INSA, INSERM, MSAE, GRDI To optimise the societal impact of the 1+MG Initiative and the upcoming Genome EDIC, it is imperative for health authorities at both European and national levels to comprehend the benefits of genomic medicine for their populations. This understanding is pivotal for countries to allocate their limited healthcare resources towards genomic medicine effectively. 3.1 Likewise, it is essential for health professionals, who will be main users of the evolving tools and infrastructure for genomic medicine, to fully understand the potential benefits. We will therefore seek to connect a network of health authorities, public health experts, and health professionals with the 1+MG Initiative, aiming to bridge the gap between scientific and technical advancements in genomic medicine, and their practical applications in healthcare. We will establish and engage with this network, increasing awareness, identifying challenges and unmet needs, and collaboratively devising impactful solutions for the advancement and sustainability of the Genome EDIC in healthcare systems.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 To achieve this objective, we will collaborate with NMGs, national genomic and personalised medicine programmes, and European networks and initiatives, to raise awareness among national health authorities, and engage policymakers, public health experts and health professionals in this network. To guarantee an active cooperation from the network participants, we will organise regular meetings (in person and online) to discuss critical issues concerning the implementation of genomic medicine in healthcare. The topics of these meetings will follow the MLM domain structure, and in each meeting we will launch a structured discussion of one or more specific relevant challenges, seeking to understand the participants' perspectives on gaps and solutions. These meetings will facilitate a deeper understanding of the challenges and requirements from a public health perspective, elucidate the necessary actions for decision-makers at the national level, and lead to the collaborative formulation of actionable recommendations for the EDIC. We will endeavour on bringing into this network multiple relevant professional profiles and medical specialities that are not yet aware of or taking full advantage of the potential of genomics in clinical practice. Seeking a wider dissemination, we will host online workshops targeting health authorities, public health experts, and health professionals, particularly those who may not be experts in genomics but are potential decision-makers and/or end-users in need of additional information on genomic medicine and healthcare. Participants: INSA(BEN), GRDI(BEN), MSAE(BEN), UL(AP) Leveraging the 1+MG MLM for adoption of Genomics in Healthcare INSA, INSERM, MSAE Understanding the strengths and challenges of healthcare systems across Europe in genomic practices is essential for ensuring equitable access to the promising potential of Personalised Medicine for all European citizens. Our objective is to promote and support the utilisation of the 1+MG MLM to facilitate adoption of genomics in healthcare by more countries across Europe and globally, and bridge gaps in healthcare systems through assessment, planning, and recommendations. As the field progresses and healthcare systems improve their maturity levels in genomic practice, it is anticipated that new challenges will emerge, requiring dynamic adaptations of the MLM as needed. The overall task will be supported by the network of public health professionals established in Task 1 and the expertise from the 1+MG National Mirror Groups. We will leverage this network to expand the usage of the MLM tools to assess the maturity of genomic practices in more regional and national healthcare systems. For this we will conduct dissemination 3.2 sessions with the network of public health professionals, and facilitate maturity assessments upon request from countries or regions, and advocate for the adoption of the MLM benchmarking tool. For this purpose we will develop a tutorial, and videotape a webinar with key information. Regular analysis and dissemination of outcomes will inform recommendations for planning and investments across Europe, with a specific emphasis on achieving uniform adoption of genomic medicine within healthcare systems to promote equity. Given that the 1+MG MLM was designed to be a dynamic tool that incorporates novel developments over time, if suggested by experts in the network we will evaluate the relevance and possibility to incorporate new dimensions that capture novel aspects aligned with emerging developments in genomic medicine implementation. Participants: INSA(BEN), MSAE(BEN) Mapping and sharing successful practices for genomic medicine in healthcare systems INSERM, INSA, Genomic medicine maturity varies across European countries, and solutions for specific challenges have been previously developed, which can serve as best practices for less mature countries. Mapping and disseminating these best practices will facilitate faster development and implementation of genomics in healthcare in a consistent manner across Europe, both for providing better diagnosis and treatment, but also for prevention.This effort not only promotes equity in access to genomic medicine but also addresses domains that are typically less developed and identifies capacity building actions. In this task, we will conduct a mapping exercise to document the implementation of genomic medicine in national healthcare systems, both for diagnosis and treatment, but also for 3.3 prevention. Following the Maturity Level Model structure, we will collect information through the NMGs in a structured way in order to enable efficient benchmarking between countries. An annual review of this mapping exercise will be conducted in order to monitor the rollout of genomic medicine in healthcare systems across Europe. Individual results will be released on the 1+MG implementation framework website. A webinar will be organized to present to stakeholders the results of the mapping exercise of genomic medicine programs. A synthesis of the results, with good practice identifications and gaps analysis will contribute to recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems. The goal is to facilitate sharing of experiences across countries, learn from each other and provide valuable insights to policy makers, with the aim of identifying and disseminating good practices that can help reduce disparities in healthcare implementation of genomic medicine across Europe. Participants: INSA(BEN), INSERM(BEN). Patient and citizen hub: Sciensano, BfArM, GRDI, INSA Patients and citizens are the starting point (data origin) and the end point (improve their wellbeing) of genomic medicine. Therefore, it is crucial to create awareness, gather data in a citizen and/or patient centred way and implement and develop genomic technologies in line with societal values. An impressive body of informational materials has been developed or is under development in many national and international projects, including the GDI, CAN.HEAL, GoE, DNADEBATE, DNAdialogue, Your DNA Your Say, SIENNA genomics, genomeDE, EOSC4Cancer, PROPHET and others. However, these materials are not sufficiently broadly disseminated and are not adapted to specific audiences. In this task, we will 3.4 focus on bringing these materials together, adapting them upon demand (e.g. translations, cultural adaptations, simplification, …) and disseminating them through existing networks (national mirror groups, patient organisations, civil society groups, educational system, traditional and social media, etc.). The focus of the content will be on the benefits and risks of implementing genomic technologies in healthcare systems (data use, common good, privacy protection, …) and the role of citizens and patients (consent, data solidarity, …). Another content topic will be to provide the scientific background and information on genomic medicine to empower and educate the public so that they can make informed choices. This will include testimonials from people who have already gained experience with genomic medicine. Additionally, specific topics will be addressed based on informational needs expressed  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 by disseminating networks (EBCP mirror groups, TEHDAS, teacher’s hubs, patient organisations, …). Dissemination activities will be aligned with existing initiatives: 1) in-person examples include classes and projects in high schools, theme days of patient/civil society organisations, lectures, panels, discussion days, … 2) online examples include publications in newsletters, social media content (e.g. cartoons, infographics) and a dedicated information hub. This hub will bring together materials that are created in different projects and grow organically as this content is adapted for specific audiences. The citizen information hub will bring together already existing materials including videos, cartoons, infographics, testimonies, etc. in a layered fashion (organised by topic, easy start and option to learn more), with informational blogs that encourage comments (which would be then be answered by organising into an FAQ section). Participants: INSA(BEN), Sciensano(BEN), BfArM(BEN), UL(AP) Health Economics: NGC, KI, MSAE, GRDI, INSA It is crucial to establish the evidence base for the health impact and economic implications of genomics to inform decision takers and policy makers on how to measure economic impact and cost-effectiveness of WGS (and other comprehensive genetic tests) in healthcare. Clinical evidence and economic models are prerequisites for decision making and legitimization of budget allocation when deciding under what circumstances and how genetic tests should be integrated into routine medical care and public health programs. However, we only have very limited data as well as models measuring the economic impact of genomics. In this task we will focus on knowledge sharing across countries through meetings, mapping of existing work and identifying possible use cases for pilot models for HTA’s. The work will be carried out in close collaboration with experts from the field. Organise two face-to-face meetings of HTA experts and national representatives. Based on the work initiated in B1MG together with the HEOR WG in 1+ MG experts will continue the evaluation of existing experiences and models for cost-effectiveness to determine whether the use of WGS provides a sufficient economic incentive compared to other health interventions and identify relevant use-cases. Continue the mapping exercise started by the B1MG to identify relevant information on existing experiences; both in form of existing titles/reviews as well as overviews of studies/projects on economic evaluation of WGS or secondary other comprehensive genetic tests already carried out. 3.5 Identify existing use cases where WGS has been used (preferably in health care) within a well described disease area and with access to relevant data on clinical evidence and costs. Based on the relevant use cases, agree on one or more use cases for development of an initial pilot model (decision tree) to be tested in a number of MS’s to help estimate economic impact of implementation of WGS (or other comprehensive tests) in healthcare. By revealing the cost implications of genome sequencing in health care, where resources are limited and healthcare providers must make informed decisions about how to distribute resources to benefit a large number of patients, MS can take informed decisions and drive innovation to reduce costs and improve efficacy in health care systems. However, we still need to carry out more research to determine situations and settings where the use of WGS is cost-effective in healthcare and in a larger societal perspective to be able to make informed decisions and when relevant achieve cost reductions in national healthcare systems. Therefore, based on the mapping exercises, the pilot decision tree and proved clinical evidence for genetic testing in healthcare, will scope a cross border project aiming at developing a standardised approach (model) to measure economic impact of WGS through a standardised framework with room for national and case-specific adaptation. Overall, the health economic task will focus on scoping models for cost-effectiveness of WGS to provide crucial insights that can help MSs understand the value of WGS in healthcare and enable them to make relevant decisions for the benefit of the patients and foster more efficient and effective healthcare solutions. Participants: INSA(BEN), NGC(BEN), KI(BEN), GRDI(BEN), MSAE(BEN) Milestones and deliverables (outputs/outcomes) Lead # Milestone Name WP Description Due Means of Verification Beneficiary Methodology for collection of information on national MS3.1 Guideline for data collection available WP3 INSERM M08 Protocol genomic programmes across europe Public health and health professionals from signatory Meetings with the network of public health and health countries agreement to participate in the network, and first MS3.2 professionals on topics relevant for implementation of WP3 INSA Meeting report in person meeting with the 1+MG Implementation in genomics in healthcare concluded Healthcare Working Group concluded First meeting of health economics working group First in person meeting of the experts from the Health MS3.3 WP3 NGC M09 Meeting report concluded Economics and Outcomes Research 1+MG Working  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Group with other relevant experts concluded Citizen information hub, bringing together already existing MS3.4 Creation of a Citizens hub WP3 Sciensano materials in a layered fashion, with informational blogs M12 that encourage comments First version of citizen hub is live Second in person meeting of the experts from the Health Second meeting of health economics working group MS3.5 WP3 NGC Economics and Outcomes Research Working Group with M30 Meeting report concluded other relevant experts concluded Lead Dissemination # Deliverable Name WP Type Due Description Beneficiary Level Webinar on the analysis of the mapping A webinar will be organized to present to stakeholders the results of the D3.1 exercise of genomic medicine programs from WP3 INSERM R PU M24 mapping exercise of genomic medicine programs all countries Tutorial and webinar for the genomics in A tutorial and a videotaped webinar to facilitate dissemination of the Maturity D3.2 WP3 INSA R PU M10 healthcare Maturity Level Model available Level Model for Genomics in Healthcare Citizen engagement report on gathered informational materials and D3.3 Report on citizens engagement WP3 Sciensano R PU M36 dissemination activities Scope of a project aiming at developing a Scope of a project aiming at developing a standardised approach to measure D3.4 standardised approach to measure economic WP3 NGC R PU M36 economic impact of WGS, including report on existing publications, projects, impact of WGS use-cases and HTA’s of WGS Collection of recommendations for the EDIC on implementation and sustainability of genomic medicine in healthcare systems at multiple levels, Recommendations for the EDIC on resulting from the conclusions from all WP3 tasks: awareness and education of D3.5 implementation and sustainability of genomic WP3 INSA R PU M36 policy makers and health professionals, challenges and best practices in medicine in healthcare systems genomic medicine programs, citizens and patients awareness and literacy, health economic models. Estimated budget — Resources Participant Costs D.1 Financial D.2 Internally B. C.1 Travel and C.2 C.3 Other goods, support to third invoiced goods E. Indirect A) personel Subcontracting subsistence Equipment works and services parties and services costs Total costs INSA(BEN) 24.64 €137,960.89 €0.00 €0.00 €7,500.00 €10,182.26 €155,643.15 NGC(BEN) 13.02 €117,179.28 €0.00 €8,202.55 €125,381.83 INSERM(BEN) 8.93 €71,400.97 €0.00 €4,998.07 €76,399.04  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Sciensano(BEN) 11.96 €104,312.36 €0.00 €7,301.87 €111,614.22 KI(BEN) 5.58 €36,258.31 €0.00 €2,538.08 €38,796.39 GRDI(BEN) 5.21 €26,031.60 €0.00 €1,822.21 €27,853.82 MSAE(BEN) 4.65 €21,383.10 €0.00 €1,496.82 €22,879.92 BfArM(BEN) 2.98 €24,992.60 €0.00 €1,749.48 €26,742.08 UL(AP) 2 €0.00 €0.00 €0.00 €0.00 Total 79.0 €539,519.11 €0.00 €0.00 €0.00 €7,500.00 €0.00 €0.00 €38,291.34 €585,310.45 Work Package 4 - 1+MG Data requirements Work Package 4: 1+MG Data requirements Duration: M1 - M36 Lead Beneficiary Health-RI Objectives ● O4.1 Review and update the sequencing guidelines part of the 1+MG framework (Task 4.1) ● O4.2 Review and update the data models, standards and ontologies of the 1+MG framework (Task 4.2) ● O4.3 Extending and improving metadata, quality and utility of 1+MG data and software (Task 4.3 & Task 4.4) Work package leaders: Jeroen Belien (HRI), Ivo Gut (CNAG), Alfonso Valencia, Salvador Capella-Gutierrez (BSC), Bengt Persson (UU) Activities and division of work Task Task name: Description / Participants: (Name, Role ) Review and update the sequencing guidelines part of the 1+MG framework. In this task we will review best practices for sequencing whole genomes and exomes using short-read sequencing technologies and keep up to date the recommendations for this type 4.1 of sequencing and the appropriate data analysis. We will also establish documentation for best practices of long-read whole genome sequencing and appropriate data analysis. Participants: CNAG(BEN), EKUT(BEN) Review and update the data models, standards and ontologies of the 1+MG framework In task 4.2 we will review, update and extend the current frameworks on (meta)data models, standards and ontologies of the 1+MG overall framework. With focus on the phenotypic and clinical data, we will organise monthly meetings between the 1+MG WG3, GDI WP6 (data linkage and harmonisation), GDI WP7 (use cases), and GDI task 8.2 to step by step arrive at harmonisation of domain data models, ontologies used, modelling of the metadata (e.g. to optimise findability (based on DCAT-AP v3 and upcoming extensions like Health (as product from HealthData@EU WP6) as well as quality labels (from QUANTUM project) and discovery), as well as on alignment of different standards, of the established/confirmed 4.2 phenotypic part of the minimal datasets of the 1+MG use case WGs. Additionally, we will experiment in incorporating phenotype data derived from EHRs, registries, and questionnaires for comprehensive data integration. With focus on the genotypic data, we will organise monthly meetings (1+MG WG3 & WG4 & GDI relevant experts, e.g. from WP6 and WP8 task 8.2) to step by step arrive at harmonisation of domain data models, ontologies used, modelling of the metadata, as well as on alignment of different standards, of the established/confirmed genotypic part of the minimal datasets of the 1+MG use case WGs. Work in task 4.2 will be coordinated with TEHDAS2 WP5, where requirements for data holders are defined, and TEHDAS WP6, where procedures for making data available are defined. Participants: Health-RI(BEN), BSC(BEN), UU(BEN), BioData.pt(BEN), UH(BEN), CRG(AP) Metadata to achieve reproducible, transparent and reusable results from running 1+MG journeys. 4.3 With a focus on the metadata that are necessary to achieve reproducible, transparent and reusable results when executing 1+MG workflows, we will organise regular meetings between relevant 1+MG WGs, and GDI WPs to step by step arrive at harmonised metadata and data management of provenance of the 1+MG workflow, on “terms of use” and other ELSI-  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 related information, based on access levels, and the generation and accessibility of metadata throughout the complete data life cycle from data characterisation for inclusion (e.g. vulnerabilities of data subjects) to relevant information on users that may influence data use within the 1+MG framework. Most of these metadata depend on legal and ethical boundaries as set by the future EDIC as well as data protection requirements, and this task will therefore align with WP2 task 2.1 for the legal framework, which will cover the relevant information that needs to be coded. Interaction will also take place with task 2.2 where policies related to metadata capture and use across the data life cycle will be touched upon. By co-organising monthly meetings with the GDI (meta)data squad activities (WP6 and more), various metadata will be (further) defined and implemented to oversee the generation and accessibility of metadata throughout the complete user workflow. We will also look at best practices for Data management in close collaboration with the GDI and GoE projects. Data management in 1+MG needs to be appropriate for collection of data generated in GoE. Participants: Health-RI(BEN), BSC(BEN), UU(BEN), ISCIII(BEN), BioData.pt(BEN), EKUT(BEN), SIB(AP), CERTH(AP), CRG(AP), UiB(AP), UNISR(AP) Project Mobilisation: Sustainability and quality of software and its associated metadata In task 4.4 we will elaborate on the different aspects of software and its associated metadata quality, its readiness and maturation as a mechanism towards the inclusion of reference implementations into the 1+MG landscape. Beyond specific software implementations, this task will investigate existing standards in order to guarantee interoperability of different software components originating from International efforts like ELIXIR and the GA4GH (Global Alliance for Genomic and Health). The output of this task is particularly important for 4.4 building a sustainable software stack that can be deployed nationally. Another aspect to be considered is the existing (and needed) standards for enabling reproducible and replicable federated analysis of the data made available through the infrastructure. Careful consideration of those standards, developed elsewhere, is essential to enable optimal use of associated computational capacities which in turn should contribute to faster and more efficient analysis and reduced environmental impact Participants: Health-RI(BEN), BSC(BEN), UU(BEN), ISCIII(BEN), BioData.pt(BEN), EKUT(BEN), SIB(AP), CERTH(AP), CRG(AP), UiB(AP), UNISR(AP) Milestones and deliverables (outputs/outcomes) Lead # Milestone Name WP Description Due Means of Verification Beneficiary A first version of the consensus phenotype data model to be used in MS4.1 Phenotype data model v1 WP4 Health-RI M18 Report and v1 consensus phenotype model 1+MG and for GoE data. A first version of the consensus genotype data model to be used in MS4.2 Genotype data model v1 WP4 Health-RI M18 Report and v1 consensus genotype model 1+MG and for GoE data. A first version of the consensus terms of use/ELSI metadata model Report and v1 terms of use/ELSI metadata MS4.3 Terms of use/ELSI metadata v1 WP4 UU M12 to be used in 1+MG and for GoE data. model A second version of the consensus terms of use/ELSI metadata Report and v2 terms of use/ELSI metadata MS4.4 Terms of use/ELSI metadata v2 WP4 UU M18 model to be used in 1+MG and for GoE data. model Metadata for reproducible and Initial collection of the available mechanisms for capture data MS4.5 WP4 ISCIII M14 Report replicable data analysis analysis provenance through community-driven standards Indicators to evaluate software Initial collection of indicators for evaluating the software quality and MS4.6 WP4 BSC M18 Report and demonstrator content and metadata quality of its associated metadata Lead Dissemination # Deliverable Name WP Type Due Description Beneficiary Level Update of the recommendation of D4.1 WP4 CNAG R PU M12 Update of the recommendation of whole genome sequencing whole genome sequencing Recommendations for long-read whole D4.2 WP4 CNAG R PU M24 Recommendations for long-read whole genome sequencing genome sequencing A harmonised set of minimal datasets for phenotypic data per use case and a union D4.3 Phenotype data model WP4 Health-RI R PU M36 sunflower model for the combined 1+MG datasets  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 A harmonised set of minimal datasets for genotypic data per use case and a union D4.4 Genotype data model WP4 Health-RI R PU M36 sunflower model for the combined 1+MG datasets A harmonised metadata schema on terms of use/ ELSI metadata that as an extension D4.5 Terms of use / ELSI metadata WP4 UU R PU M36 will be added/merged to the sunflower metadata model based on DCAT-AP Metadata model for data analysis Provide a list of metadata requirements and standards matching them to capture data D4.6 WP4 BSC R PU M36 provenance analysis provenance so results can be reproduced and replicated Updated version of the data models, The current technical section of the 1+MG framework on data models, standards and D4.7 standards and ontologies part of the WP4 Health-RI R PU M36 ontologies has been updated with results obtained, c.q. progress made within timeframe 1+MG framework of this project Estimated budget — Resources Participant Costs C.3 Other D.1 Financial B. C.1 Travel and C.2 goods, works support to third D.2 Internally invoiced E. Indirect A) personel Subcontracting subsistence Equipment and services parties goods and services costs Total costs Health-RI(BEN) 2.05 €25,566.75 €0.00 €0.00 €1,789.67 €27,356.43 CNAG(BEN) 8.55 €38,489.59 €0.00 €2,694.27 €41,183.86 BSC(BEN) 2.42 €13,294.71 €0.00 €930.63 €14,225.34 UU(BEN) 2.05 €17,385.39 €0.00 €1,216.98 €18,602.37 ISCIII(BEN) 1.12 €6,490.03 €0.00 €454.30 €6,944.33 BioData.pt(BEN) 2.05 €11,453.91 €0.00 €801.77 €12,255.68 EKUT(BEN) FUNDED 0.93 €7,065.72 €0.00 €494.60 €7,560.32  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 EKUT(BEN) UNFUNDED 1 €0.00 €0.00 €0.00 UH(BEN) 0.93 €9,737.68 €0.00 €681.64 €10,419.32 SIB(AP) 2 €0.00 €0.00 €0.00 €0.00 CERTH(AP) 2 €0.00 €0.00 €0.00 €0.00 CRG(AP) 3 €0.00 €0.00 €0.00 €0.00 UiB(AP) 1 €0.00 €0.00 €0.00 €0.00 UNISR(AP) 1 €0.00 €0.00 €0.00 €0.00 Total 30.10 €129,483.78 €0.00 €0.00 €0.00 €0.00 €0.00 €0.00 €9,063.86 €138,547.65  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Staff effort Staff effort per work package Fill in the summary on work package information and effort per work package Lead Start End WP # Work Package Title Lead PMs Participant # Month Month 1 Project coordination and support to 1+MG initiative 1 ELIXIR 1 36 19.85 2 Genome EDIC establishment 2 LNDS 1 36 114.00 3 1+MG Healthcare Implementation & Health Economics 3 INSA 1 36 78.97 4 1+MG Data requirements 4 Health-RI 1 36 30.10 Total Person-Months 242.92 Staff effort per participant Fill in the effort per work package and Beneficiary/Affiliated Entity. Please indicate the number of person/months over the whole duration of the planned work. Identify the work-package leader for each work package by showing the relevant person/month figure in bold Participant WP1 WP2 WP3 WP4 Total PMs 1. ELIXIR(COO) 19.85 .0 .0 .0 19.85 2. LNDS(BEN) .0 35.67 .0 .0 35.67 3. INSA(BEN) .0 .0 24.64 .0 24.64 4. Health-RI(BEN) .0 .0 .0 2.05 2.05 5. NGC(BEN) .0 18.59 13.02 .0 31.61 6. CNAG(BEN) .0 .0 .0 8.55 8.55 7. BSC(BEN) .0 .0 .0 2.42 2.42 8. UU(BEN) .0 .0 .0 2.05 2.05 9. INSERM(BEN) .0 .0 8.93 .0 8.93 10. CNR(BEN) .0 12.09 .0 .0 12.09 11. SLEX(BEN) .0 32.07 .0 .0 32.07 12. ISCIII(BEN) .0 5.58 .0 1.12 6.70 13. BioData.pt(BEN) .0 .0 .0 2.05 2.05 14. EKUT(BEN) .0 .0 .0 1.0 1.0 FUNDED 14. EKUT(BEN) .0 .0 .0 .93 .93 UNFUNDED 15. KI(BEN) .0 .0 5.58 .0 5.58 16. MSAE(BEN) .0 .0 4.65 .0 4.65 17. BfArM(BEN) .0 .0 2.98 .0 2.98 18. Sciensano(BEN) .0 .0 11.96 .0 11.96 19. GRDI(BEN) .0 .0 5.21 .0 5.21 20. UH(BEN) .0 .0 .0 .93 .93 21. UL(AP) .0 .0 2.0 .0 2.0 22. UHEI(AP) .0 1.0 .0 .0 1.0 46  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 23. MU(AP) .0 1.0 .0 .0 1.0 24. HDIR(AP) .0 1.0 .0 .0 1.0 25. RBI(AP) .0 1.0 .0 .0 1.0 26. VUHSK(AP) .0 1.0 .0 .0 1.0 27. UiB(AP) .0 .0 .0 1.0 1.0 28. Vinnova (AP) .0 1.0 .0 .0 1.0 29. OOI(AP) .0 1.0 .0 .0 1.0 30. UNISR(AP) .0 .0 .0 1.0 1.0 31. SIB(AP) .0 .0 .0 2.0 2.0 32. MESR(AP) .0 1.0 .0 .0 1.0 33. CERTH(AP) .0 .0 .0 2.0 2.0 34. CRG(AP) .0 .0 .0 3.0 3.0 36. LBMC(AP) .0 1.0 .0 .0 1.0 37. IGG(AP) .0 1.0 .0 .0 1.0 Total 19.85 114.0 78.97 30.10 242.92 Subcontracting Subcontracting Give details on subcontracted project tasks (if any) and explain the reasons why (as opposed to direct implementation by the Beneficiaries/Affiliated Entities). Subcontracting — Subcontracting means the implementation of ‘action tasks’, i.e. specific tasks which are part of the EU grant and are described in Annex 1 of the Grant Agreement. Note: Subcontracting concerns the outsourcing of a part of the project to a party outside the consortium. It is not simply about purchasing goods or services. We normally expect that the participants have sufficient operational capacity to implement the project activities themselves. Subcontracting should therefore be exceptional. Include only subcontracts that comply with the rules (i.e. best value for money and no conflict of interest; no subcontracting of coordinator task No applicable Purchases and equipment Purchase costs (travel and subsistence, equipment and other goods works and services) Details for major cost items (needed if costs declared under ‘purchase costs’ are higher than 15% of the claimed personnel costs). Start with the most expensive cost items, down to the 15% threshold. Participant 1: ELIXIR Costs Cost item name Category WPs Explanations (EUR) 1 Kick-off (including WP meetings) ~70 participants (approx 10,000 EUR as additional funding provided by host partner) Travel and Project meetings 1 1 F2F General Assembly with associated WP meetings (2 €40,000.00 Subsistence day event, ~70 participants approx 30,000 EUR), 3 virtual WP2, WP3 & WP4 events (1 per year). Other Goods, Reimbursement of external experts invited to project Reimbursement works & 1 meetings (incl. WP/WG workshops). Additional events will €60,000.00 services be organised with MB approval Total €100,000.00 Total purchase costs > 15% (all participants) €100,000.00 Remaining purchase costs < 15% (all participants) €27,500.00 47  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Total purchase costs (all participants) €127,500.00 Equipment with full-cost option For calls where full-capitalised costs are exceptionally eligible for listed equipment (see Call document), indicate below the equipment items for which you request the full-cost option, and justify your request. Ensure consistency with the budget details provided in the previous table. Not applicable Other cost categories Other cost categories (financial support to third parties, internally invoiced goods and services, etc) Complete the table below for each participant that would like to declare costs under other costs categories (e.g. financial support and internally invoiced goods and services), irrespective of the percentage of personnel costs. Not applicable Timetable Timetable (projects of more than 2 years) Fill in cells in beige to show the duration of activities. Repeat lines/columns as necessary. Note: Use actual, calendar years and quarters. In the timeline you should indicate the timing of each activity per WP. You may add additional columns if your project is longer than 6 years. YEAR 1 YEAR 2 YEAR 3 Activity Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Task 1.1 Project mobilisation X X Task 1.2 Coordination monitoring and support X X X X X X X X X X X X Task 1.3 Project communication strategy X X X X X X X X X X X Task 1.4 Stakeholder involvement X X X X X X X X X X X Task 2.1 ELSI framework X X X X X X X X X X X X Task 2.2 Policy framework X X X X X X X X X X X Task 2.3 Contractual framework X X X X X X X X X X X X Task 2.4 Sustainability framework X X X X X X X X X X X X Task 2.5 Risk management and quality framework X X X X X X X X X X X X Task 3.1 Network of health professionals to support genomic medicine X X X X X X X X X X X X Task 3.2 Adoption of genomics in Healthcare leveraging the 1+MG MLM X X X X X X X X X X X X Task 3.3 Successful practices for genomic medicine in healthcare systems X X X X X X X X X X X X Task 3.4 Patient and citizen hub X X X X X X X X X X X X Task 3.5 Health Economics X X X X X X X X X X X X Task 4.1 Review and update the sequencing guidelines part of the 1+MG framework X X X X X X X X X X X 48 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Task 4.2 Review and update the data models, standards and ontologies of the 1+MG framework X X X X X X X X X X X Task 4.3 Metadata to achieve reproducible, transparent and reusable results from running 1+MG journeys. X X X X X X X X X X X Task 4.4 Sustainability and quality of software and its associated metadata X X X X X X X X X X X #§WRK-PLA-WP§# #@ETH-ICS-EI@# 5. OTHER 5.1 Ethics Ethics If the Call document contains a section on ethics, the ethics issues and measures you intend to take to solve/avoid them must be described in Part A. See Application Form Part A. Humans: This project will involve human participants in activities that employ social sciences and humanities methodologies, such as interviews and workshops. Specifically: In the context of WP2, focused workshops with relevant task forces and working groups, including patient and citizen representative feedback groups are envisaged. In addition, structured interviews of relevant stakeholders, including research funders, representatives of the healthcare sector, health insurance companies, industry, governments, and citizens, are planned. In the context of WP3, a network of health authorities, public health experts, and health professionals will be established. This network will be connected with the 1+MG Initiative to bridge the gap between scientific and technical advancements in genomic medicine, and their practical applications in healthcare. The activities of this network will include a series of meetings to discuss critical issues concerning the implementation of genomic medicine in healthcare, and online workshops targeting health authorities, public health experts, and health professionals, aiming to ensure wider dissemination. Furthermore, WP3 will have access to personal data (contact information and affiliation) collected in the context of surveys conducted by the GDI project, in order to align with the activities on the topic of healthcare professionals' educational needs. In the context of WP4, a series of meetings and consultations with internal and external to the project experts will take place. These activities aim to harmonise domain data models, ontologies used, modelling of the metadata, quality labels and align different standards of the established/confirmed phenotypic part of the minimal datasets of the 1+MG use case WGs, focusing on phenotypic, clinical and genotypic data. All activities described above are not expected to confer any risks to participants. The project will ensure that if any ethics approvals or other authorisations are required, they will be obtained before the commencement of the relevant activities, and that appropriate informed consent processes will be in place, when necessary. Personal data: Personal data that will be collected in the activities described above include contact information of research participants and affiliations. All personal data will be processed according to applicable legislation, including the EU General Data Protection Regulation. Non-EU countries: Partners from Switzerland and Norway are involved in this project. Their participation does not raise any ethics concern. #§ETH-ICS-EI§# #@SEC-URI-SU@# 5.2 Security Security The security issues and the measures you intend to take to solve/avoid them must be described in Part A. Note: Beneficiaries must ensure that their projects are not subject to national/third country security requirements that could affect the implementation or put into question the award of the grant (e.g. technology restrictions, national security classification, etc). No applicable 49 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 #§SEC-URI-SU§# #@DEC-LAR-DL@# 6. DECLARATIONS Double funding Information concerning other EU grants Please note that there is a strict prohibition of double funding from the EU budget (except under EU Synergies YES/NO actions). We confirm that to our best knowledge none of the projects under the action plan as a whole or in parts have benefitted from any other EU grant (including EU funding managed by authorities in EU Member States or other YES funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. We confirm that to our best knowledge none of the projects under the action plan as a whole or in parts are (nor will be) submitted for any other EU grant (including EU funding managed by authorities in EU Member States YES or other funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. Financial support to third parties (if applicable) No applicable #§DEC-LAR-DL§# ANNEXES LIST OF ANNEXES Standard List of previous projects (annex 4 to Part B) 50  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 HISTORY OF CHANGES Part A GAP Section Change General Information Start date set to 1st February 2025 Financial Beneficiary information # & Short Name Budgetary change Justification 1 - ELIXIR Reduction to A.1 Personnel Costs (PC), to As per EC ESR recommendations: reduction in €231,763.52 resources for project management, Tasks 1.1, 1.3 Increase to Other Direct Costs: & 1.4 C.1 Travel and Subsistence Costs, to €40,000.00 Other Direct Costs increased, as all travel costs are C.3 Other goods, works & services, to now held by the Coordinator (overall project €60,000.00 reduction in Other Direct Costs from €459,800.00 to Reduction in E. Indirect Costs, to €23,223.45 €100,000.00) Therefore, reduction in Total Costs, to €354,986.97 7.4% overall reduction to costs, to bring in line with project costs of €2M 2 - LNDS Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €392,322.03 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 7.4% overall reduction to costs, to bring in line with Reduction in E. Indirect Costs, to €28,862.54 project costs of €2M Therefore, reduction in Total Costs, to €441,184.57 3 - INSA Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €137,960.89 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 20% reduction Reduction in E. Indirect Costs, to €10,182.26 in resources in Tasks 3.1, 3.2, 3.3 & 3.4 Therefore, reduction in Total Costs, to €155,643.15 7.4% overall reduction to costs, to bring in line with project costs of €2M 4- Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs HEALTH-RI €25,566.75 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 80% reduction Reduction in E. Indirect Costs, to €1,789.67 in resources in Task 4.5 Therefore, reduction in Total Costs, to €27,356.42 7.4% overall reduction to costs, to bring in line with project costs of €2M 5 - NGC Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €284,488.25 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 7.4% overall reduction to costs, to bring in line with Reduction in E. Indirect Costs, to €19,914.18 project costs of €2M Therefore, reduction in Total Costs, to €304,402.43 51 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 6 - CNAG Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €38,489.59 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: reduction in Reduction in E. Indirect Costs, to €2,694.27 resources in Task 4.3 (100%) & Task 4.5 (80%) Therefore, reduction in Total Costs, to €41,183.86 7.4% overall reduction to costs, to bring in line with project costs of €2M 7 - BSC Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €13,294.71 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 80% reduction Reduction in E. Indirect Costs, to €930.63 in resources in Task 4.5 Therefore, reduction in Total Costs, to €14,225.34 7.4% overall reduction to costs, to bring in line with project costs of €2M 8 - UU Reduction to A.1 Personnel Costs (PC), to As per EC ESR recommendations: 80% reduction €17,385.39 in resources in Task 4.5 Reduction in E. Indirect Costs, to €1,216.98 Therefore, reduction in Total Costs, to 7.4% overall reduction to costs, to bring in line with €18,602.37 project costs of €2M 9 - INSERM Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €71,400.97 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: reduction in Reduction in E. Indirect Costs, to €4,998.07 resources in WP3, Tasks 3.1 & 3.3 (20%) Therefore, reduction in Total Costs, to €76,399.04 7.4% overall reduction to costs, to bring in line with project costs of €2M 10 - CNR Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €72,516.61 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 7.4% overall reduction to costs, to bring in line with Reduction in E. Indirect Costs, to €5,076.16 project costs of €2M Therefore, reduction in Total Costs, to €77,592.77 11 - SLEX Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €176,410.61 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 7.4% overall reduction to costs, to bring in line with Reduction in E. Indirect Costs, to €12,348.74 project costs of €2M Therefore, reduction in Total Costs, to €188,759.35 12 - ISCIII Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €38,824.28 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 80% reduction Reduction in E. Indirect Costs, to €2,717.70 in resources in Task 4.5 Therefore, reduction in Total Costs, to €41,541.98 7.4% overall reduction to costs, to bring in line with project costs of €2M 52 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 13 - Reduction to A.1 Personnel Costs (PC), to As per EC ESR recommendations: 80%reduction in BioData.pt €11,453.91 resources in Task 4.5 Reduction in E. Indirect Costs, to €801.77 Therefore, reduction in Total Costs, to 7.4% overall reduction to costs, to bring in line with €12,255.68 project costs of €2M Removed as Beneficiary Research activities for IMGAG must go through EKUT (central grants office). Therefore, EKUT has been changed from AP to Beneficiary and budget/effort (€7,560.32, 0.93PM in WP4) previously allocated to IMGAG will now sit with EKUT. EKUT will also still contribute 1PM to WP4 14 - IMGAG UNFUNDED Budget previously allocated to IMGAG: Reduction to A.1 Personnel Costs (PC), to As per EC ESR recommendations: 100% reduction €7,065.72 in resources in Task 4.3 Reduction in E. Indirect Costs, to €494.60 Therefore, reduction in Total Costs, to 7.4% overall reduction to costs, to bring in line with 14 - EKUT €7,560.32 project costs of €2M 15 - KI Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €36,258.31 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 7.4% overall reduction to costs, to bring in line with Reduction in E. Indirect Costs, to €2,538.08 project costs of €2M Therefore, reduction in Total Costs, to €38,796.39 16 - MSAE Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €21,383.10 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 20% reduction Reduction in E. Indirect Costs, to €1,496.82 in resources in Tasks 3.1 & 3.2 Therefore, reduction in Total Costs, to €22,879.92 7.4% overall reduction to costs, to bring in line with project costs of €2M 17 - BfArM Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €24,992.60 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 20% reduction Reduction in E. Indirect Costs, to €1,749.48 in resources in Task 3.4 Therefore, reduction in Total Costs, to €26,742.08 7.4% overall reduction to costs, to bring in line with project costs of €2M 18 - Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs Sciensano €104,312.36 are now held by the Coordinator Reduction to C.1 Travel and Subsistence Costs, to €0 As per EC ESR recommendations: 20% reduction Reduction in E. Indirect Costs, to €7,301.87 in resources in Task 3.4 Therefore, reduction in Total Costs, to €111,614.23 7.4% overall reduction to costs, to bring in line with project costs of €2M 19 - GDRI Reduction to A.1 Personnel Costs (PC), to Reduction in C.1 Travel costs, as all travel costs €26,031.60 are now held by the Coordinator Reduction to C.1 Travel and Subsistence 53  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Costs, to €0 As per EC ESR recommendations: 20%reduction in Reduction in E. Indirect Costs, to €1,822.21 resources in Task 3.1 Therefore, reduction in Total Costs, to €27,853.81 7.4% overall reduction to costs, to bring in line with project costs of €2M 20 - UH Reduction to A.1 Personnel Costs (PC), to 7.4% overall reduction to costs, to bring in line with €9,737.68 project costs of €2M Reduction in E. Indirect Costs, to €681.64 Therefore, reduction in Total Costs, to €10,419.32 Associated 36 - IGG Removal of AP EKUT EKUT now added as a Beneficiary (see above) Partners 36 - IGG Addition of new AP: Short name: IGG Long name: ISTITUTO GIANNINA GASLINI PIC: 999448037 PI: Domenico Coviello PMs: 1PM in WP2 Reinforcement of expertise in WP2 Work WP PM change Justification Packages WP1 Beneficiary 1. ELIXIR: Reduction in PM from As per EC ESR recommendations: reduction in 27PM to 19.85PM resources for project management in WP1, Tasks Updated PMs: 1.1, 1.3 & 1.4 Task 1.1: 0PM Task 1.2: 16.25PM % reduction to costs, to bring in line with project Task 1.3: 1.8PM costs of €2M Task 1.4: 1.8PM No change to scope WP2 Beneficiary 2. LNDS: Reduction in PM from % reduction to costs, to bring in line with project 38.5PM to 35.67PM costs of €2M Updated PMs: Task 2.1: 18.07PM Changes to Deliverables, see below. Task 2.2: 14.82PM Task 2.5: 2.78PM Beneficiary 5. NGC: Reduction in PM from % reduction to costs, to bring in line with project 20PM to 18.59PM costs of €2M Updated PMs: Task 2.2: 0.93PM Changes to Deliverables, see below. Task 2.4: 0.93PM Task 2.5: 16.73PM Beneficiary 10. CNR: Reduction in PM from % reduction to costs, to bring in line with project 13PM to 12.09PM costs of €2M Updated PMs: Task 2.4: 12.09PM Changes to Deliverables, see below. 54 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Beneficiary 11. SLEX: Reduction in PM from % reduction to costs, to bring in line with project 34.5PM to 32.07PM costs of €2M Updated PMs: Task 2.1: 5.11PM Changes to Deliverables, see below. Task 2.3: 20.45PM Task 2.5: 6.51PM Beneficiary 12. ISCIII: Reduction in PM from % reduction to costs, to bring in line with project 6PM to 5.58PM costs of €2M Updated PMs: Task 2.2: 2.79PM Changes to Deliverables, see below. Task 2.4: 2.79PM WP3 Update to WP Task descriptions WP descriptions amended, following changes to budget, Deliverables & Milestones. Correction to Lead Author on Deliverables Lead authors corrected for D3.1 & D3.2 Beneficiary 3. INSA: Reduction in PM from As per EC ESR recommendations: 20% reduction 33PM to 24.64PM in resources in Tasks 3.1, 3.2, 3.3 & 3.4 Updated PMs: Task 3.1: 11.95PM % reduction to PMs (due to % reduction in costs, to Task 3.2: 5.97PM bring in line with project costs of €2M) Task 3.3: 5.22PM Task 3.4: 0.75PM Reduction to Task work: Task 3.5: 0.75PM Task 3.1 - Removal of D3.1 Policy Brief on genomic medicine implementation from a public health perspective; Task 3.2 - Removal of D3.3 Report on 1+MG MLM update; Task 3.3 - Removal of D3.2 Report on the mapping of European genomic medicine programmes; the mapping work will contribute to D3.6 Beneficiary 5. NGC: Reduction in PM from % reduction to PMs (due to % reduction in costs, to 14PM to 13.02PM bring in line with project costs of €2M) Updated PMs: Task 3.5: 13.02PM 55 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Beneficiary 9. INSERM: Reduction in PM from As per EC ESR recommendations: reduction in 12PM to 8.93PM resources in Tasks 3.1 & 3.3 Updated PMs: Task 3.1: 1.49PM % reduction to PMs (due to % reduction in costs, to Task 3.3: 7.44PM bring in line with project costs of €2M) Reduction to Task work: Task 3.1 - Removal of D3.1 Policy Brief on genomic medicine implementation from a public health perspective; Task 3.3 - Removal of D3.2 Report on the mapping of European genomic medicine programmes; the mapping work will contribute to D3.6 Beneficiary 15. KI: Reduction in PM from 6PM % reduction to PMs (due to % reduction in costs, to to 5.58PM bring in line with project costs of €2M) Updated PMs: Task 3.5: 5.58PM Beneficiary 16. MSAE: Reduction in PM from As per EC ESR recommendations: reduction in 6PM to 4.65PM resources in Tasks 3.1 & 3.2 Updated PMs: Task 3.1: 2.33PM % reduction to PMs (due to % reduction in costs, to Task 3.2: 1.55PM bring in line with project costs of €2M) Task 3.5: 0.77PM Reduction to Task work: Task 3.1 - Removal of D3.1 Policy Brief on genomic medicine implementation from a public health perspective; Task 3.2 - Removal of D3.3 Report on 1+MG MLM update; Beneficiary 17. BfArM: Reduction in PM from As per EC ESR recommendations: reduction in 4PM to 2.98PM resources in Task 3.4 Updated PMs: Task 3.4: 2.98PM % reduction to PMs (due to % reduction in costs, to bring in line with project costs of €2M) Reduction to Task work: Task 3.4 - Removal of MS3.5 Beneficiary 18. SCIENSANO: Reduction in PM As per EC ESR recommendations: reduction in from 15PM to 11.96PM resources in Task 3.4 Updated PMs: Task 3.4: 11.96PM % reduction to PMs (due to % reduction in costs, to bring in line with project costs of €2M) Reduction to Task work: Task 3.4 - Removal of MS3.5 Beneficiary 19. GRDI: Reduction in PM from As per EC ESR recommendations: reduction in 6PM to 5.21PM resources in Task 3.1 Updated PMs: Task 3.1: 1.74PM % reduction to PMs (due to % reduction in costs, to Task 3.5: 3.47PM bring in line with project costs of €2M) Reduction to Task work: Task 3.1 - Removal of D3.1 Policy Brief on genomic 56 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 medicine implementation from a public health perspective WP4 Update to WP Task descriptions As per EC ESR recommendations: Removal of Task 4.3. WP descriptions amended, following changes to budget, Deliverables & Milestones. Task 4.1: Replacement of IMGAG with EKUT Research activities for IMGAG must go through Tasks, 4.3 & 4.4: Addition of EKUT as BEN; EKUT (central grants office). Therefore, EKUT has removal of EKUT as AP been changed from AP to Beneficiary and budget/effort (€7,560.32, 0.93PM in WP4) previously allocated to IMGAG will now sit with EKUT. EKUT will also still contribute 1PM to WP4 UNFUNDED Beneficiary 4. Health-RI: Reduction in PM As per EC ESR recommendations: reduction in from 3PM to 2.05PM resources in Task 4.5 Updated PMs: Task 4.2: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.4: 0.93PM bring in line with project costs of €2M) Task 4.5: 0.19PM Reduction to Task work: Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 Beneficiary 6. CNAG: Reduction in PM from As per EC ESR recommendations: reduction in 19PM to 8.55PM resources in Tasks 4.3 & 4.5 Updated PMs: Task 4.1: 8.36PM % reduction to PMs (due to % reduction in costs, to Task 4.3: 0PM bring in line with project costs of €2M) Task 4.5: 0.19PM Reduction to Task work: Task 4.3 - Removal of Task; Removal of D4.3, D4.4 & D4.5 Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 Beneficiary 7. BSC: Reduction in PM from As per EC ESR recommendations: reduction in 5PM to 2.42PM resources in Task 4.5 Updated PMs: Task 4.2: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.4: 0.93PM bring in line with project costs of €2M) Task 4.5: 0.56PM Reduction to Task work: Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 57  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Beneficiary 8. UU: Reduction in PM from 3PM As per EC ESR recommendations: reduction in to 2.05PM resources in Task 4.5 Updated PMs: Task 4.2: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.4: 0.93PM bring in line with project costs of €2M) Task 4.5: 0.19PM Reduction to Task work: Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 Beneficiary 12. ISCIII: Reduction in PM from As per EC ESR recommendations: reduction in 2PM to 1.12PM resources in Task 4.5 Updated PMs: Task 4.4: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.5: 0.19PM bring in line with project costs of €2M) Reduction to Task work: Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 Beneficiary 13. BioData.pt: Reduction in PM As per EC ESR recommendations: 80% reduction from 3PM to 2.05PM in resources in Task 4.5 Updated PMs: Task 4.2: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.4: 0.93PM bring in line with project costs of €2M) Task 4.5: 0.19PM Reduction to Task work: Task 4.5 - Removal of software quality aspects of the Task; Removal of D4.9 & M4.5 Beneficiary 14. IMGAG: Reduction in PM from As per EC ESR recommendations: 100% reduction 2PM to 0.93PM in resources in Task 4.3 Updated PMs: Task 4.1: 0.93PM % reduction to PMs (due to % reduction in costs, to Task 4.3: 0PM bring in line with project costs of €2M) Reduction to Task work: Task 4.3 - Removal of Task; Removal of D4.3, D4.4 & D4.5 Beneficiary 20. UH: Reduction in PM from % reduction to PMs (due to % reduction in costs, to 1PM to 0.93PM bring in line with project costs of €2M) Updated PMs: Task 4.2: 0.93PM Deliverable WP Changes to Deliverables Justification s 58 Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 WP3 Removal of Deliverables: Reduction of WP3 budget for Tasks 3.1, 3.2, 3.3 & 3.4 D3.1 - Policy Brief on genomic medicine implementation from a public health D3.1 will be removed - the planned policy brief will perspective (M24) be replaced by a webinar (with associated report) and outputs will contribute to D3.5 (which will have an updated title to reflect this). D3.2 - Report on the mapping of European genomic medicine programs (M24) D3.2 removed due to budget reduction D3.3 - Report on 1+MG MLM update (M30) D3.3 removed due to budget reduction Addition of Deliverables: (new) D3.1 - Webinar on the analysis of the Added mapping exercise of genomic medicine programs from all countries’ (M24) Added (previous Milestone M3.4 upgraded to a (new) D3.2 Tutorial and webinar for the Deliverable) genomics in healthcare Maturity Level Model available (M10) Renumbering of Deliverables: D3.3 Citizen engagement report on gathered Renumbered from D3.4 to D3.3 informational materials and dissemination activities (M36) Renumbered from D3.5 to D3.4 D3.4 Scope of a project aiming at developing a standardised approach to measure economic impact of WGS (M36) Renumbered from D3.6 to D3.5 D3.5 Recommendations for the EDIC and policy makers on implementation and sustainability of genomic medicine in healthcare systems (Collection of recommendations for the EDIC and policy makers on implementation and sustainability of genomic medicine in healthcare systems at multiple levels, resulting from the conclusions from all WP3 tasks) (M36) WP4 Removal of Deliverables: D4.3, D4.4, D4.5 & Removed due to reduction of WP4 budget for D4.9 Tasks 4.3 & 4.5 D4.3 ISO17043 accredited platform as proficiency testing provider (M12) D4.4 Proficiency testing scheme on short-read NGS (M24) D4.5 Proficiency testing scheme on short-read exome sequencing (M36) D4.9 Software stack maturity level (M33) 59  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Renumbering of Deliverables: Renumbering due to removal of Deliverables (see above) D4.3 Phenotype data model (M36) Renumbered from D4.6 to D4.3 D4.4 Genotype data model (M36) Renumbered from D4.7 to D4.4 D4.5 Terms of use / ELSI metadata (M36) Renumbered from D4.8 to D4.5 D4.6 Metadata model for data analysis provenance (M36) Renumbered from D4.10 to D4.6 D4.7 Updated version of the data models, Renumbered from D4.11 to D4.7 standards and ontologies part of the 1+MG framework (M36) Milestones WP Changes to Milestones Justification WP2 Removal of Milestones: The milestones were related to D2.1 and D2.2 – the M2.1 - Workshop with national ELSI experts milestones are the community input on the (M03) recommendations worked out and then distilled in M2.2 - Workshop with national ELSI experts these deliverables. Some input may also relevant (M15) for other deliverables. M2.3 - Workshop with national ELSI experts (M27) We will aim instead to get some feedback from shorter working group meetings that we will organise. Renumbering of Milestones: Due to removal of M2.1 - M2.3 above M2.4 -> M2.1 M2.5 -> M2.2 etc WP3 Changes to Milestones: Reduction of WP3 budget for Tasks 3.1, 3.2, 3.3 & 3.4 M3.2 & M3.6 combined to make new M3.2: (new) M3.2 - Meetings with the network of public health and health professionals on topics relevant for implementation of genomics in healthcare concluded (M30) Conversion of M3.4 to a Deliverable (new D3.2 - see 'Changes to Deliverables' section above) Renumbering of Milestones: Due to changes to Milestones (row above) M3.5 -> M3.4 M3.6 -> M3.5 WP4 Removal of Milestones: 80% Reduction of budget for Task 4.5 M4.5 - Software Development Best practices (M09) 60  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Renumbering of Milestones: Due to changes to Milestones (row above) M4.6 -> M4.5 M4.7 -> M4.6 Part B Section Page Change # 1.2 Contribution to long- 8 Removal of text related to Task 4.3 term policy objectives, policies and strategies — Synergies 2.2 Implementation plan 12 Addition of text to reflect re-use of outputs from other related projects and efficient use of resources: Table 3. Anticipated WP2 interaction with 1+MG initiative and 1+MG implementation projects 2.2 Implementation plan 13 Addition of text to reflect re-use of outputs from other related projects and efficient use of resources: Table 5. Anticipated WP3 interaction with 1+MG initiative and 1+MG implementation projects 2.2 Implementation plan 14 Addition of text to reflect re-use of outputs from other related projects and efficient use of resources: Table 7. Anticipated WP4 interaction with 1+MG and 1+MG implementation projects 2.2 Implementation plan 16 ‘Call KPIs to be monitored’: and efficient use of Section updated with increased detail, including rules for utilisation of event budget. resources: Project management, quality assurance and monitoring and evaluation strategy 2.2 Implementation plan 17 Changed to figures related to requested budget: and efficient use of resources: Requested budget: €2M Cost effectiveness and Personnel Costs: €1,741,658.88 (87% of budget) financial management - Other Direct Costs (ODC): €127,500.00 (6.35% of budget) Overview of costs Indirect Costs (IC): €130,841.12 (6.55% of budget) distribution Travel budget (ODC) to be held by the Coordinator (€100,000.00) 61  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 2.2 Implementation plan 17-18 Removal of Milestones M2.1 - M2.3 and subsequent renumbering of following and efficient use of Milestones resources: Cost effectiveness and Removal of PMs per Deliverable/Milestone (PM allocation per Beneficiary updated later financial management - in the document) WP2 Genome EDIC establishment 2.2 Implementation plan 18 Relevant Deliverables and Milestones per Task updated. and efficient use of resources: Removal of PMs per Deliverable/Milestone (PM allocation per Beneficiary updated later Cost effectiveness and in the document). financial management - WP3 1+MG Healthcare Update to travel budget text. Implementation & Health Economics 2.3 Capacity to carry out 21 IMGAG changed to EKUT the proposed work: Research activities for IMGAG must go through EKUT (central grants office). Therefore, Co-leads or contributors EKUT has been changed from AP to Beneficiary and budget/effort (€7,560.32, 0.93PM in WP4) previously allocated to IMGAG will now sit with EKUT. EKUT will also still contribute 1PM to WP4 UNFUNDED 2.3 Capacity to carry out 21 EKUT removed as AP the proposed work: Co-leads or contributors 2.3 Capacity to carry out 21 New Associated Partner (AP) added the proposed work: Co-leads or contributors IGG (IT) will contribute to WP2 4.2 Work packages, 34 Update to budget table activities, resources and timing: Work Package 1 - Project coordination and support to 1+MG initiative 4.2 Work packages, 36-38 Updates to Milestone, Deliverable and Budget tables activities, resources and timing: Work Package 2 - Genome EDIC establishment 4.2 Work packages, 38-42 Updates to Milestone, Deliverable, Budget and Task Description tables activities, resources and timing: Work Package 3 - 1+MG Healthcare Implementation & Health Economics 4.2 Work packages, 42-45 Update to 'Activities and division of work' table - Removal of Task 4.3 and subsequent activities, resources and renumbering of following Tasks timing: Work Package 4 - 1+MG Updates to Milestone, Deliverable and Budget tables Data requirements 62  Call: [DIGITAL-2024-CLOUD-DATA-AI-06-GENOME] — [Beyond 1 Million Genomes Plus (B1MGplus)] Associated with document Ref. Ares(2025)1939456 - 11/03/2025 4.2 Work packages, 46-47 Updates to the following tables: activities, resources and timing: 'Staff effort per work package' Staff effort 'Staff effort per participant' 'Purchase costs (travel and subsistence, equipment and other goods works and services)' [due to reduction of travel budget and reallocation of remaining budget to ELIXIR] 4.2 Work packages, 48 Update to table to reflect removal of original Task 4.3 activities, resources and timing: Timetable History of Changes 51-62 Addition of History of Changes table 63  Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 ANNEX 2 ESTIMATED BUDGET FOR THE ACTION Estimated eligible1 costs (per budget category) Estimated EU contribution2 Direct costs Indirect costs EU contribution to eligible costs Maximum B. Total costs Maximum EU Requested EU grant amount6 A. Personnel costs Subcontracting C. Purchase costs D. Other cost categories E. Indirect costs 3 Funding rate %4 contribution5 contribution costs A.1 Employees (or equivalent) A.4 SME owners B. Subcontracting C.1 Travel and C.2 Equipment C.3 Other goods, D.1 Financial D.2 Internally E. Indirect costs and natural person subsistence works and support to third invoiced goods A.2 Natural persons under direct beneficiaries services parties and services contract A.3 Seconded persons Unit costs (usual Unit costs (usual Forms of funding Actual costs accounting Unit costs7 Actual costs Actual costs Actual costs Actual costs Actual costs accounting Flat-rate costs8 practices) practices) e = flat-rate * (a1 + a2 + a3 + f=a+b+ a1 a2 a3 b c1 c2 c3 d1 d2 U g = f * U% h m b + c1 + c2 + c+d+e c3 + d1 + d2) 1 - ELIXIR / EMBL 231 763.52 0.00 0.00 0.00 40 000.00 0.00 60 000.00 0.00 0.00 23 223.45 354 986.97 100 354 986.97 354 986.97 354 986.97 2 - LNDS 392 322.03 0.00 0.00 0.00 0.00 0.00 20 000.00 0.00 0.00 28 862.54 441 184.57 100 441 184.57 441 184.57 441 184.57 3 - INSA 137 960.89 0.00 0.00 0.00 0.00 0.00 7 500.00 0.00 0.00 10 182.26 155 643.15 100 155 643.15 155 643.15 155 643.15 4 - HEALTH-RI 25 566.75 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 789.67 27 356.42 100 27 356.42 27 356.42 27 356.42 5 - NGC 284 488.25 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 19 914.18 304 402.43 100 304 402.43 304 402.43 304 402.43 6 - CNAG 38 489.59 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 2 694.27 41 183.86 100 41 183.86 41 183.86 41 183.86 7 - BSC 13 294.71 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 930.63 14 225.34 100 14 225.34 14 225.34 14 225.34 8 - UU 17 385.39 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 216.98 18 602.37 100 18 602.37 18 602.37 18 602.37 9 - INSERM 71 400.97 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 4 998.07 76 399.04 100 76 399.04 76 399.04 76 399.04 10 - CNR 72 516.61 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 5 076.16 77 592.77 100 77 592.77 77 592.77 77 592.77 11 - SLEX 176 410.61 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 12 348.74 188 759.35 100 188 759.35 188 759.35 188 759.35 12 - ISCIII 38 824.28 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 2 717.70 41 541.98 100 41 541.98 41 541.98 41 541.98 13 - Biodata.pt 11 453.91 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 801.77 12 255.68 100 12 255.68 12 255.68 12 255.68 14 - EKUT 7 065.72 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 494.60 7 560.32 100 7 560.32 7 560.32 7 560.32 15 - KI 36 258.31 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 2 538.08 38 796.39 100 38 796.39 38 796.39 38 796.39 16 - MSAE 21 383.10 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 496.82 22 879.92 100 22 879.92 22 879.92 22 879.92 17 - BfArM 24 992.60 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 749.48 26 742.08 100 26 742.08 26 742.08 26 742.08 18 - Sciensano 104 312.36 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 7 301.87 111 614.23 100 111 614.23 111 614.23 111 614.23 19 - GRDI 26 031.60 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 822.21 27 853.81 100 27 853.81 27 853.81 27 853.81 20 - UH 0.00 9 737.68 0.00 0.00 0.00 0.00 0.00 0.00 0.00 681.64 10 419.32 100 10 419.32 10 419.32 10 419.32 21 - UL 22 - UHEI 23 - MU 24 - HDIR 25 - RBI 26 - VUHSK 27 - UiB 28 - VINNOVA 29 - OOI Page 1 of 2  Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with DIGITAL MGAAres(2025)1939456 document Ref. — Multi & Mono:-v1.0 11/03/2025 Estimated eligible1 costs (per budget category) Estimated EU contribution2 Direct costs Indirect costs EU contribution to eligible costs Maximum B. Total costs Maximum EU Requested EU grant amount6 A. Personnel costs Subcontracting C. Purchase costs D. Other cost categories E. Indirect costs 3 Funding rate %4 contribution5 contribution costs A.1 Employees (or equivalent) A.4 SME owners B. Subcontracting C.1 Travel and C.2 Equipment C.3 Other goods, D.1 Financial D.2 Internally E. Indirect costs and natural person subsistence works and support to third invoiced goods A.2 Natural persons under direct beneficiaries services parties and services contract A.3 Seconded persons Unit costs (usual Unit costs (usual Forms of funding Actual costs accounting Unit costs7 Actual costs Actual costs Actual costs Actual costs Actual costs accounting Flat-rate costs8 practices) practices) e = flat-rate * (a1 + a2 + a3 + f=a+b+ a1 a2 a3 b c1 c2 c3 d1 d2 U g = f * U% h m b + c1 + c2 + c+d+e c3 + d1 + d2) 30 - UNISR 31 - SIB 32 - MESR 33 - CERTH 34 - CRG 35 - LBMC 36 - IGG Σ consortium 1 731 921.20 9 737.68 0.00 0.00 40 000.00 0.00 87 500.00 0.00 0.00 130 841.12 2 000 000.00 2 000 000.00 2 000 000.00 2 000 000.00 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 The consortium remains free to decide on a different internal distribution of the EU funding (via the consortium agreement; see Article 7). 3 Indirect costs already covered by an operating grant (received under any EU funding programme) are ineligible (see Article 6.3). Therefore, a beneficiary/affiliated entity that receives an operating grant during the action duration cannot declare indirect costs for the year(s)/reporting period(s) covered by the operating grant, unless they can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please immediately contact us via the EU Funding & Tenders Portal for details. 4 See Data Sheet for the funding rate(s). 5 This is the theoretical amount of the EU contribution to costs, if the reimbursement rate is applied to all the budgeted costs. This theoretical amount is then capped by the 'maximum grant amount'. 6 The 'maximum grant amount' is the maximum grant amount decided by the EU. It normally corresponds to the requested grant, but may be lower. 7 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 8 See Data Sheet for the flat-rate. Page 2 of 2  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 2a ADDITIONAL INFORMATION ON UNIT COSTS AND CONTRIBUTIONS SME owners/natural person beneficiaries without salary See Additional information on unit costs and contributions (Annex 2a and 2b) 1 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES PNED GIE (LNDS), PIC 885395049, established in 6 AVENUE DES HAUTS-FOURNEAUX, ESCH-SUR-ALZETTE 4362, Luxembourg, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-885395049_75_210--] Bert Verdonck with ECAS id n006uvw4 signed in the Participant Portal on 14/03/2025 at 12:24:59 (transaction id SigId-4027-GRsVzX ocnFECy9qZk6NEaVWqQ7p3ghKS8yX2GApdoBR5joHuYXuMJTtbO0i qW4yknIDcSLGPKhlgn1qrmXTdZm-rS0vSrmBGYCzVfEjLzbIwE0-sg2 O2I1tykb49uwYozGr0cbFhwSPsvRRwBzUijzR2AWQFu9pxNXfiuTtZe pbaFx0dbU2vqycVMFpYlgCMrp1ce0). Timestamp by third party at 2025.03.14 12:25:03 CET 1 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUTO NACIONAL DE SAUDE DR. RICARDO JORGE (INSA), PIC 998308190, established in AVENIDA PADRE CRUZ, LISBOA 1649-016, Portugal, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-998308190_75_210--] Fernando ALMEIDA with ECAS id npjomanu signed in the Participant Portal on 13/03/2025 at 10:51:07 (transaction id SigId-2776-xw8StRu 2QACXggseGk6bxFKZJCYkziS1vpIH3Hdd3Bgp2Xu2q8kSrpsSdKR0l6z dB0L1DtLj8Elnb80IxucQit-yntOf97TTHqEoxWy94AED4-Rp0zp9SOzZT bmrcWozvfYSKwDWzuqNuebVSqLobIgPjc3zmm6Bt2zbEPGp56iUpH 30bLnI7pJGolDLMAuoMpxyRG). Timestamp by third party at 2025.03.13 10:51:10 CET 2 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES STICHTING HEALTH-RI (HEALTH-RI), PIC 887782025, established in JAARBEURSPLEIN 6, UTRECHT 3521 AL, Netherlands, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-887782025_75_210--] Janneke Timmerman with ECAS id n00gm3t9 signed in the Participant Portal on 13/03/2025 at 09:46:18 (transaction id SigId-1950-t47GRJKT nDze0ab6EA5vGCW3cRWvr4wICRXt4jA0F6XQt9iEfXFOk6pWhin4HtMR T947VwWmuSBTZhie7BmzjK-yntOf97TTHqEoxWy94AED4-URjXfwbhu HweU5aM2GLckssrGkdYeZAMgTtnRYK5BeFiMI1Hkqmml5AgO9c2kO g9BxrXSzbNRHRKSCAJ2DPwyu). Timestamp by third party at 2025.03.13 09:46:21 CET 3 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES NATIONALT GENOM CENTER (NGC), PIC 886250880, established in ORESTADS BOULEVARD 5, BYG. 208, COPENHAGEN 2300, Denmark, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-886250880_75_210--] Lene Cividanes with ECAS id n0036ojx signed in the Participant Portal on 14/03/2025 at 11:44:38 (transaction id SigId-3458-THozI7 eRNfbzIL7QL9frYj50aTCBOnfDJpgPtqnEX41ck22JxbTczWPquXHLog 3inE9yPuu6zrum93VXuj7Q1tO-rS0vSrmBGYCzVfEjLzbIwE0-UKibl9e x6I9hCMWE0hjjNOriu1gy3Jvw9Au9UMIkmpBBg6czKt9l60uxen8zvi kWgCetA0OJN6yhzW9quWwxo1W). Timestamp by third party at 2025.03.14 11:44:41 CET 4 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES CONSORCIO PARA LA EXPLOTACION DEL CENTRO NACIONAL DE ANALISIS GENOMICO (CNAG), PIC 882802433, established in C BALDIRI 1 REIXAC 4, BARCELONA 08028, Spain, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-882802433_75_210--] Ivo Gut with ECAS id n00cuok2 signed in the Participant Portal on 14/03/2025 at 10:33:26 (transaction id SigId-2418-0gQbppuGaew KKeHda8VoWzUzTARnAH7jOdGJbN3DJ1F2NWuHFAU2nuLFZvJPZU Q8RLilQKRzJ2ePQ1fKaEkzHWq-rS0vSrmBGYCzVfEjLzbIwE0-3SZwH mDZhiQ3ngr309rKxnhc62PLUczTJaOty6jDIXzs1oHt6cFUmzpscXJF py9It8wbHspwzTFaDXMgwHebzQa). Timestamp by third party at 2025.03.14 10:33:30 CET 5 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES BARCELONA SUPERCOMPUTING CENTER CENTRO NACIONAL DE SUPERCOMPUTACION (BSC), PIC 999655520, established in CALLE JORDI GIRONA 31, BARCELONA 08034, Spain, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999655520_75_210--] Mateo VALERO with ECAS id nvalerme signed in the Participant Portal on 14/03/2025 at 10:33:10 (transaction id SigId-2412-ED0F wjonZ1IqXijiI0qQOWk5zdTbBzNJePE0r8N1spVeqy9rl7zWhYTzjHXK vkxSzrvFWJJyO9RV0qa97ct9SLC-rS0vSrmBGYCzVfEjLzbIwE0-MZMT HzeiWZvyGFXEyVGHGNjzhg2KzOaJ3F5P8sOcmH3PXPQwTNXoifIlV 3CIazVqbApWiAzlnfcv1bUS6yztYicG). Timestamp by third party at 2025.03.14 10:33:16 CET 6 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES UPPSALA UNIVERSITET (UU), PIC 999985029, established in VON KRAEMERS ALLE 4, UPPSALA 751 05, Sweden, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999985029_75_210--] Charlotte PLATZER-BJORKMAN with ECAS id nplatcha signed in the Participant Portal on 13/03/2025 at 10:55:36 (transaction id SigId- 2821-VUHc3C1EV62lwZ4xQmIOiYCFMu4KzwnuwA6Wr7sBQEiDGOAkv 4CW9g0fYgkWBYQXcyN2iQtah2GEUs0wRgInLe- yntOf97TTHqEoxWy94AED4-J81zzyFzhGcw4gMzrARzdhW39gdcVhYBy GYpUwfhVgRWvZRGUxc2e4hoQuHciGaeJh5zPR3mJ5NY2bG8Sax24Pd 0). Timestamp by third party at 2025.03.13 10:55:40 CET 7 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM), PIC 999997833, established in RUE DE TOLBIAC 101, PARIS 75654, France, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999997833_75_210--] 8 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES CONSIGLIO NAZIONALE DELLE RICERCHE (CNR), PIC 999979500, established in PIAZZALE ALDO MORO 7, ROMA 00185, Italy, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999979500_75_210--] 9 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SMARTEX SRL SOCIETA' DI PRODOTTI E SERVIZI GIURIDICI INTERDISCIPLINARI (SLEX), PIC 925521039, established in VIA MAZZINI 60 B, S.GIULIANO TERME 56017, Italy, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-925521039_75_210--] GIOVANNI COMANDE' with ECAS id ncomagio signed in the Participant Portal on 13/03/2025 at 15:44:57 (transaction id SigId- 6348-eoehiAxHW4WId10cE3kyKmzdlN8SQzzYb6HzHF56clx1gGulrVGK ZUkRubK1SdBT9gC661zpZzkynAmisr1zuIQG- yntOf97TTHqEoxWy94AED4-O7Ero9vzMhOO5TDIzGwqKzS7Of3zluON KzrSvbJHsW4E4eC3Km7i5Lam3TnhzGgUzzjsrH2jfoiVjH3zJP6MS3Bu0). Timestamp by third party at 2025.03.13 15:45:00 CET 10 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUTO DE SALUD CARLOS III (ISCIII), PIC 999507886, established in MONFORTE DE LEMOS 5, MADRID 28029, Spain, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999507886_75_210--] 11 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES ASSOCIACAO BIP4DAB (Biodata.pt), PIC 889852005, established in RUA DA QUINTA GRANDE 6, OEIRAS 2780-156, Portugal, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-889852005_75_210--] Adelino CANARIO with ECAS id ncanarad signed in the Participant Portal on 13/03/2025 at 14:19:43 (transaction id SigId-5195-oXnSJZZ KzlKXGdb0LY6nJvgVG4p0NDWcYGNK3bxN2MwZ0NGeHCHFIDRDk9 TvxAQn928uvqIjzOEhX16wpKHfmO-yntOf97TTHqEoxWy94AED4-VX KElzcNaAsQCAwrR3ADxDzQtnnJP4scdrJzJpRlZ6nYfwQ3NN6PTM1n5 2jMCtZGZ6pgKowhL3AzyiQPKPT7TW4). Timestamp by third party at 2025.03.13 14:19:46 CET 12 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES EBERHARD KARLS UNIVERSITAET TUEBINGEN (EKUT), PIC 999991916, established in GESCHWISTER-SCHOLL-PLATZ, TUEBINGEN 72074, Germany, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999991916_75_210--] Elisabeth BAIER with ECAS id nfrankel signed in the Participant Portal on 13/03/2025 at 09:52:40 (transaction id SigId-2033-LpPRto zhoKkjQCovypiqIkl3EZOVPJ6KdNTzpeHAlbVzTdjf5ds9Ynqut3gGRLh JB6CbQqwBtUIHCY2YeNhJOzm-yntOf97TTHqEoxWy94AED4-VEb1d m8MUJ1fHOqsHkI103XAm8fn4K1GzZhl0zYAKee3b9t9ij4Gzxuy0uAt AtAsHLSndJDzV6L2kMLhQzzOHyBW). Timestamp by third party at 2025.03.13 09:52:43 CET 13 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES KAROLINSKA INSTITUTET (KI), PIC 999978530, established in Nobels Vag 5, STOCKHOLM 17177, Sweden, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999978530_75_210--] Bjorn KULL with ECAS id nkulbjor signed in the Participant Portal on 14/03/2025 at 14:09:39 (transaction id SigId-5095-tnyAIdYzHxf wBn6iFbzjh6nvGlBPizzaQUtnIAUcenBEAzZ25tHbU6di4E1pnOjYp 60pm2xuaR3Xs5fkeIizl3em-rS0vSrmBGYCzVfEjLzbIwE0-0zce7qAh B4SizjLQrxCoaM5Hj2e74A8XVjBDN1oWjq72NQdpVzRh65zkFuUP zwllLlUfMls5qAvG7oyazkyZRhLW). Timestamp by third party at 2025.03.14 14:09:43 CET 14 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SOTSIAALMINISTEERIUM (MSAE), PIC 998429731, established in Suur-Ameerika 1, TALLINN 10122, Estonia, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-998429731_75_210--] 15 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE (BfArM), PIC 998293931, established in KURT GEORG KIESINGER ALLEE 3, BONN 53175, Germany, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-998293931_75_210--] 16 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SCIENSANO (Sciensano), PIC 906160809, established in JULIETTE WYTSMANSTRAAT 14, ELSENE 1050, Belgium, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-906160809_75_210--] Christian Léonard with ECAS id n0033s99 signed in the Participant Portal on 13/03/2025 at 10:08:05 (transaction id SigId-2243-9srpI8 PNOzLAmk7fj2dBzUO4MMwDFZuCvPSbfHZczsXr9zug7EGwvURQE nOrSMrdNY0EYFLFbqP4VpiGRfw0lI0-yntOf97TTHqEoxWy94AED4-Z iX8fifzzrzPg2jezceMj9cK59rJ7ppzZtMa7vNWw7xAa0zGy7mk0fIzZaz WOJCRgdO0wBvSr34G7h3gYfNIopBg). Timestamp by third party at 2025.03.13 10:08:07 CET 17 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUTUL DE CERCETARE-DEZVOLTARE IN GENOMICA (GRDI), PIC 881344232, established in STR DIONISIE LUPU 37 SECTOR 2, BUCURESTI 020021, Romania, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-881344232_75_210--] 18 Grant Agreement number: 101194865 — B1MGplus — DIGITAL-2024-CLOUD-DATA-AI-06 Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES HELSINGIN YLIOPISTO (UH), PIC 999994535, established in FABIANINKATU 33, HELSINGIN YLIOPISTO 00014, Finland, hereby agrees to become beneficiary in Agreement No 101194865 — B1MGplus (‘the Agreement’) between EUROPEAN MOLECULAR BIOLOGY LABORATORY (ELIXIR / EMBL) and the European Union (‘EU’), represented by the European Commission (‘European Commission’ or ‘granting authority’), and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this accession form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and terms and conditions it sets out. SIGNATURE For the beneficiary [--TGSMark#signature-999994535_75_210--] 19  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 4 DIGITAL EUROPE MGA — MULTI + MONO FINANCIAL STATEMENT FOR [PARTICIPANT NAME] FOR REPORTING PERIOD [NUMBER] 1 2 Eligible costs (per budget category) EU contribution Revenues Direct costs Indirect costs EU contribution to eligible costs Total requested EU Income generated by the Total costs contribution action 2 3 4 Requested EU A. Personnel costs B. Subcontracting costs C. Purchase costs D. Other cost categories E. Indirect costs Funding rate % Maximum EU contribution contribution [OPTION for PAC A.4 SME owners and C.3 Other goods, works and D.X Financial support to D.2 Internally invoiced Grants for A.1 Employees (or equivalent) natural person B. Subcontracting C.1 Travel and subsistence C.2 Equipment Procurement: D.3 E. Indirect costs services third parties goods and services beneficiaries PAC procurement costs] A.2 Natural persons under direct contract A.3 Seconded persons Unit costs (usual 5 Unit costs (usual 6 Forms of funding Actual costs Unit costs Actual costs Actual costs Actual costs Actual costs Actual costs [ Actual costs] Flat-rate costs accounting practices) accounting practices) e= f= a1 a2 a3 b c1 c2 c3 d1a d2 [ d3] flat-rate * (a1 + a2 + a3 + b + U g = f*U% h m (i) n a+b+c+d+e c1 + c2 + c3 + d1a + d2 [ + d3] ) XX – [short name beneficiary/affiliated entity] The beneficiary/affiliated entity hereby confirms that: The information provided is complete, reliable and true. The costs and contributions declared are eligible (see Article 6). The costs and contributions can be substantiated by adequate records and supporting documentation that will be produced upon request or in the context of checks, reviews, audits and investigations (see Articles 19, 20 and 25). For the last reporting period: that all the revenues have been declared (see Article 22). i Please declare all eligible costs and contributions, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Only amounts that were declared in your individual financial statements can be taken into account lateron, in order to replace costs/contributions that are found to be ineligible. 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 If you have also received an EU operating grant during this reporting period, you cannot claim indirect costs - unless you can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please contact us immediately via the Funding & Tenders Portal for details. 3 See Data Sheet for the reimbursement rate(s). 4 This is the theoretical amount of EU contribution to costs that the system calculates automatically (by multiplying the reimbursement rates by the costs declared). The amount you request (in the column 'requested EU contribution') may be less. 5 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 6 See Data Sheet for the flat-rate.  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 ANNEX 5 SPECIFIC RULES CONFIDENTIALITY AND SECURITY (— ARTICLE 13) Sensitive information with security recommendation Sensitive information with a security recommendation must comply with the additional requirements imposed by the granting authority. Before starting the action tasks concerned, the beneficiaries must have obtained all approvals or other mandatory documents needed for implementing the task. The documents must be kept on file and be submitted upon request by the coordinator to the granting authority. If they are not in English, they must be submitted together with an English summary. For requirements restricting disclosure or dissemination, the information must be handled in accordance with the recommendation and may be disclosed or disseminated only after written approval from the granting authority. EU classified information If EU classified information is used or generated by the action, it must be treated in accordance with the security classification guide (SCG) and security aspect letter (SAL) set out in Annex 1 and Decision 2015/4441 and its implementing rules — until it is declassified. Deliverables which contain EU classified information must be submitted according to special procedures agreed with the granting authority. Action tasks involving EU classified information may be subcontracted only with prior explicit written approval from the granting authority and only to entities established in an EU Member State or in a non-EU country with a security of information agreement with the EU (or an administrative arrangement with the Commission). EU classified information may not be disclosed to any third party (including participants involved in the action implementation) without prior explicit written approval from the granting authority. ETHICS (— ARTICLE 14) Ethics Actions involving activities raising ethics issues must be carried out in compliance with: - ethical principles 1 Commission Decision 2015/444/EC, Euratom of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 1  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 and - applicable EU, international and national law, including the EU Charter of Fundamental Rights and the European Convention for the Protection of Human Rights and Fundamental Freedoms and its Supplementary Protocols. The beneficiaries must pay particular attention to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of persons, the right to non-discrimination, the need to ensure protection of the environment and high levels of human health protection. Before the beginning of an action task raising an ethical issue, the beneficiaries must have obtained all approvals or other mandatory documents needed for implementing the task, notably from any (national or local) ethics committee or other bodies such as data protection authorities. The documents must be kept on file and be submitted upon request by the coordinator to the granting authority. If they are not in English, they must be submitted together with an English summary, which shows that the documents cover the action tasks in question and includes the conclusions of the committee or authority concerned (if any). INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE (— ARTICLE 16) Definitions Access rights — Rights to use results or background. Dissemination — The public disclosure of the results by appropriate means, other than resulting from protecting or exploiting the results, including by scientific or professional publications in any medium. Exploit(ation) — The use of results in further innovation and deployment 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 standardisation activities. Fair and reasonable conditions — Appropriate conditions, including possible financial terms or royalty-free conditions, taking into account the specific circumstances of the request for access, for example the actual or potential value of the results or background to which access is requested and/or the scope, duration or other characteristics of the exploitation envisaged. List of background — Background free from restrictions The beneficiaries must, where industrial and intellectual property rights (including rights of third parties) exist prior to the Agreement, establish a list of these pre-existing industrial and intellectual property rights, specifying the rights owners. The coordinator must — before starting the action — submit this list to the granting authority. 2  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 Where the call conditions restrict participation or control due to security or EU strategic autonomy reasons, background that is subject to control or other restrictions by a country (or entity from a country) which is not one of the eligible countries or target countries set out in the call conditions and that impact the results (i.e. would make the results subject to control or restrictions) must not be used and must be explicitly excluded in the list of background — unless otherwise agreed with the granting authority. Results free from restrictions Where the call conditions restrict participation or control due to security or EU strategic autonomy reasons, the beneficiaries must ensure that the results of the action are not subject to control or other restrictions by a country (or entity from a country) which is not one of the eligible countries or target countries set out in the call conditions — unless otherwise agreed with the granting authority. Ownership of results Results are owned by the beneficiaries that generate them (unless the consortium agreement specifies another ownership regime). Protection of results The beneficiaries must adequately protect their results — for an appropriate period and with appropriate territorial coverage — if protection is possible and justified, taking into account all relevant considerations, including the prospects for commercial exploitation, legitimate interests of the other beneficiaries and any other legitimate interests. Exploitation of results Beneficiaries must — up to four years after the end of the action (see Data Sheet, Point 1) — use their best efforts to exploit their results directly or to have them exploited indirectly by another entity, in particular through transfer or licensing. Where the call conditions restrict participation or control due to security or EU strategic autonomy reasons (and unless otherwise agreed with the granting authority), the beneficiaries must produce a significant amount of products, services or processes that incorporate results of the action or that are produced through the use of results of the action in the eligible countries or target countries set out in the call conditions. Where the call conditions impose moreover a first exploitation obligation, the first exploitation must also take place in the eligible countries or target countries set out in the call conditions. The beneficiaries must ensure that these obligations also apply to their affiliated entities, associated partners, subcontractors and recipients of financial support to third parties. Transfers and licensing of results Where the call conditions restrict participation or control due to security or EU strategic autonomy reasons, the beneficiaries may not transfer ownership of their results or grant licences to third parties which are established in countries which are not eligible countries or target countries set out in the call conditions (or are controlled by such countries or entities 3  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 from such countries) — unless they have requested and received prior approval by the granting authority. The request must: - identify the specific results concerned - describe in detail the new owner or licensee and the planned or potential exploitation of the results and - include a reasoned assessment of the likely impact of the transfer or license on the security interests or EU strategic autonomy. The granting authority may request additional information. The beneficiaries must ensure that their obligations under the Agreement are passed on to the new owner or licensee and that this new owner or licensee has the obligation to pass them on in any subsequent transfer. Access rights — Additional rights of use Rights of use of the granting authority on results for information, communication, publicity and dissemination purposes The granting authority also has the right to exploit non-sensitive results of the action for information, communication, dissemination and publicity purposes, using any of the following modes: - use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) - distribution to the public in hard copies, in electronic or digital format, on the internet including social networks, as a downloadable or non-downloadable file - editing or redrafting (including shortening, summarising, changing, correcting, cutting, inserting elements (e.g. meta-data, legends or other graphic, visual, audio or text elements), extracting parts (e.g. audio or video files), dividing into parts or use in a compilation) - translation(including inserting subtitles/dubbing)in all official languages of EU - storage in paper, electronic or other form - archiving in line with applicable document-management rules - the right to authorise third parties to act on its behalf or sub-license to third parties, including if there is licensed background, any of the rights or modes of exploitation set out in this provision - processing, analysing, aggregating the results and producing derivative works 4  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 - disseminating the results in widely accessible databases or indexes (such as through ‘open access’ or ‘open data’ portals or similar repositories, whether free of charge or not). The beneficiaries must ensure these rights of use for the whole duration they are protected by industrial or intellectual property rights. If results are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Access rights for the granting authority and EU institutions, bodies, offices or agencies to results for policy purposes The beneficiaries must grant access to their results — on a royalty-free basis — to the granting authority, other EU institutions, bodies, offices or agencies, for developing, implementing and monitoring EU policies or programmes. Such access rights are limited to non-commercial and non-competitive use. Access rights for the granting authority to results in case of a public emergency If requested by the granting authority in case of a public emergency, the beneficiaries must grant non-exclusive, world-wide licences to third parties — under fair and reasonable conditions — to use the results to address the public emergency. Access rights for third parties to ensure continuity and interoperability Where the call conditions impose continuity or interoperability obligations, the beneficiaries must make the results produced in the framework of the action available to the public (freely accessible on the Internet under open source licences). COMMUNICATION, DISSEMINATION AND VISIBILITY (— ARTICLE 17) Communication and dissemination plan The beneficiaries must provide a detailed communication and dissemination plan, setting out the objectives, key messaging, target audiences, communication channels, social media plan, planned budget and relevant indicators for monitoring and evaluation. Dissemination of results The beneficiaries must disseminate their results as soon as feasible, in a publicly available format, subject to any restrictions due to the protection of intellectual property, security rules or legitimate interests. They must upload the public project results to the Digital Europe Project Results platform, available through the Funding & Tenders Portal. In addition, where the call conditions impose additional dissemination obligations, they must also comply with those. Additional communication activities 5  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 The beneficiaries must engage in the following additional communication activities: - present the project (including project summary, coordinator contact details, list of participants, European flag and funding statement and special logo and project results) on the beneficiaries’ websites or social media accounts SPECIFIC RULES FOR CARRYING OUT THE ACTION (— ARTICLE 18) Implementation in case of restrictions due to security or EU strategic autonomy Where the call conditions restrict participation or control due to security or EU strategic autonomy reasons, the beneficiaries must ensure that none of the entities that participate as affiliated entities, associated partners, subcontractors or recipients of financial support to third parties are established in countries which are not eligible countries or target countries set out in the call conditions (or are controlled by such countries or entities from such countries) — unless otherwise agreed with the granting authority. The beneficiaries must moreover ensure that any cooperation with entities established in countries which are not eligible countries or target countries set out in the call conditions (or are controlled by such countries or entities from such countries) does not affect the security interests or EU strategic autonomy and avoids potential negative effects over security of supply of inputs critical to the action. Specific rules for PAC Grants for Procurement When implementing innovative procurements in PAC Grants for Procurement, the beneficiaries must respect the following conditions: - avoid any conflict of interest and comply with the principles of transparency, non- discrimination, equal treatment, sound financial management, proportionality and competition rules - assign the ownership of the intellectual property rights under the contracts to the contractors (unless there are exceptional overriding public interests which are duly justified in Annex 1), with the right of the buyers to access results — on a royalty-free basis — for their own use and to grant (or to require the contractors to grant) non- exclusive licences to third parties to exploit the results for them — under fair and reasonable conditions — without any right to sub-license - allow for all communications to be made in English (and any additional languages chosen by the beneficiaries) - ensure that prior information notices, contract notices and contract award notices contain information on the EU funding and a disclaimer that the EU is not participating as contracting authority in the procurement - allow for the award of multiple procurement contracts within the same procedure (multiple sourcing) - for procurements involving classified information: apply the security rules set out in Annex 5 mutatis mutandis to the contractors and the background and results of the contracts 6  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 - where the call conditions restrict participation or control due to security or EU strategic autonomy reasons: apply the restrictions set out in Annex 5 mutatis mutandis to the contractors and the results under the contracts - where the call conditions impose a place of performance obligation: ensure that the part of the activities that is subject to the place of performance obligation is performed in the eligible countries or target countries set out in the call conditions - to ensure reciprocal level of market access: where the WTO Government Procurement Agreement (GPA) does not apply, ensure that the participation in tendering procedures is open on equal terms to bidders from EU Member States and all countries with which the EU has an agreement in the field of public procurement under the conditions laid down in that agreement, including all Horizon Europe associated countries. Where the WTO GPA applies, ensure that tendering procedures are also open to bidders from states that have ratified this agreement, under the conditions laid down therein. Specific rules for Grants for Financial Support When implementing financial support to third parties in Grants for Financial Support, the beneficiaries must respect the following conditions: - avoid any conflict of interest and comply with the principles of transparency, non- discrimination and sound financial management - for the selection procedure and criteria: - publish open calls widely (including on the Funding & Tenders Portal and the beneficiaries’ websites) - keep open calls open for at least two months - inform recipients of call updates (if any) and the outcome of the call (list of selected projects, amounts and names of selected recipients) Specific rules for JU actions JU actions must contribute to the long-term implementation of the JU partnership, including the JU Strategic Research and Innovation Agenda, the JU objectives and the exploitation of research and innovation results. Moreover, when implementing JU actions, the members and contributing partners of the Joint Undertaking must fulfil their obligations regarding contributions to the Joint Undertaking: - the description of the action in Annex 1 must include, for beneficiaries, affiliated entities, associated partners or other participants or third parties which are members or contributing partners, the estimated contributions to the action, i.e.: - in-kind contributions to operational activities (‘IKOP’; if applicable) - in-kind contributions to additional activities linked to the action (‘IKAA’; if applicable) - financial contributions (‘FC’; if applicable) 7  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 - the contributions must be reported during the implementation of the action in the Portal Continuous Reporting tool - at the end of the action, the members and contributing partners that have not received funding under the grant must ensure that financial and in-kind contributions of EUR 430 000 or more (see Article 21) are supported by statements of contributions (CS) and certificates on the statements of contributions (CCS) which fulfil the following conditions: - be provided by a qualified approved external auditor which is independent and complies with Directive 2006/43/EC (or for public bodies: by a competent independent public officer) - the verification must be carried out according to the highest professional standards to ensure that the statements of contributions comply with the provisions under the Agreement and the applicable JU Regulation, that the contributions cover activities that are part of the action and that they have not been reimbursed by the grant - contributions must comply with the following conditions: - costs covered by financial contributions cannot be claimed for reimbursement under the JU grant. The beneficiaries must comply with the additional IPR, dissemination and exploitation obligations set out in the call conditions (Article 16 and Annex 5), in particular: - for all JU grants: the granting authority right to object to transfers or licensing also applies to results generated by beneficiaries not having received funding under the grant. In addition to the obligations set out in Article 17, communication and dissemination activities as well as infrastructure, equipment or major results funded under JU actions must moreover display the Joint Undertaking’s special logo: and the following text: “The project is supported by the [insert JU name] and its members [OPTION for actions with national contribution top-ups: (including top-up funding by [name of the national funding authority])].” For EuroHPC and Chips JU grants, the beneficiaries must respect the following conditions when implementing actions with national contribution top-ups from Participating States: 8  Associated with document Ref. Ares(2025)1939456 - 11/03/2025 - the beneficiaries must ensure visibility of the national contributions (see below) - the payment deadlines for prefinancing, interim or final payments are automatically suspended if a national funding authority is late with its payments to the Joint Undertaking for the national contribution top-up - the European Anti-Fraud Office (OLAF), European Public Prosecutor’s Office (EPPO), European Court of Auditors (ECA), the National Court of Auditors and other national authorities can exercise their control rights on the project implementation and costs declared, including for the national contribution top-up. Specific rules for blending operations When implementing blending operations, the beneficiaries acknowledge and accept that: - the grant depends on the approved financing from the Implementing Partner and/or public or private investors for the project - they must inform the granting authority both about the approval for financing and the financial close — within 15 days - the payment deadline for the first prefinancing is automatically suspended until the granting authority is informed about the approval for financing - both actions will be managed and monitored in parallel and in close coordination with the Implementing Partner, in particular: - all information, data and documents (including the due diligence by the Implementing Partner and the signed agreement) may be exchanged and may be relied on for the management of the other action (if needed) - issues in one action may impact the other (e.g. suspension or termination in one action may lead to suspension also of the other action; termination of the grant will normally suspend and exit from further financing and vice versa, etc.) - the granting authority may disclose confidential information also to the Implementing Partner. 9  Digitally sealed by the European Commission Date: 2025.03.11 17:50:30 CET This electronic receipt is a digitally signed version of the document submitted by your organisation. Both the content of the document and a set of metadata have been digitally sealed. This digital signature mechanism, using a public-private key pair mechanism, uniquely binds this eReceipt to the modules of the Funding & Tenders Portal of the European Commission, to the transaction for which it was generated and ensures its full integrity. Therefore a complete digitally signed trail of the transaction is available both for your organisation and for the issuer of the eReceipt. Any attempt to modify the content will lead to a break of the integrity of the electronic signature, which can be verified at any time by clicking on the eReceipt validation symbol. More info about eReceipts can be found in the FAQ page of the Funding & Tenders Portal. (https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/support/faq) Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111