European Partnership on Rare Diseases (ERDERA) (Phase 2)

General conditions 1. Admissibility Conditions, proposal page limit and layout Admissibility conditions are  described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 2. Eligible Countries Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide. 3. Other Eligibility Conditions The proposal must be submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2023-DISEASE-07-01: “European Partnership on Rare Diseases”. This eligibility condition is without prejudice to the possibility to include additional partners. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. Because the US contribution will be considered for the calculation of the EU contribution to the partnership, the concerned consortium of research funders from eligible EU Members States and Associated Countries must expressly agree to this participation. The Joint Research Centre (JRC) may participate as member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner. The JRC will not participate in the preparation and submission of the proposal - see General Annex B. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. 4. Financial and operational capacity and exclusion Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 5a. Evaluation and award: Award criteria, scoring and thresholds The evaluation will take into account the existing context and the scope of the initial evaluation as relevant, and related obligations enshrined in the grant agreement. If the proposal is successful, the next stage of the procedure will be grant agreement amendment preparations. If the outcome of amendment preparations is an award decision, the coordinator of the consortium funded under topic HORIZON-HLTH-2023-DISEASE-07-01: “European Partnership on Rare Diseases” will be invited to submit an amendment to the grant agreement, on behalf of the beneficiaries. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. 5c. Evaluation and award: Indicative timeline for evaluation and grant agreement Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 6. Legal and financial set-up of the grants This action is intended to be implemented in the form of an amendment of the grant agreement concluded pursuant to Article 24(2) of the Horizon Europe Regulation. For the additional activities covered by this action: The funding rate is 50% of the eligible costs. This is justified by the pooling of proposers' in-kind contributions and in-house activities and by the nature of activities to be performed: in addition of joint calls, highly integrative activities (EU clinical trial preparedness, training, patients’ empowerment activities etc.) contributing to enhance the rare disease research and innovation ecosystem in the EU and Associated Countries, and beyond. Beneficiaries may provide financial support to third parties (FSTP). The support to third parties can only be provided in the form of grants. As a co-funded European Partnership, providing financial support to third parties is a core activity of this action in order to achieve its objectives. Consequently, the EUR 60 000 threshold laid down in Article 207 of Financial Regulation (EU, Euratom) 2024/2509 does not apply. The maximum amount of FSTP that may be awarded to any single third party for the duration of the partnership is set at EUR 10.00 million. This ceiling is justified by the fact that FSTP is a primary activity of this action, by its expected duration of 7-10 years (exceeding a standard project lifespan), and by the extensive experience gained under predecessor partnerships. This ceiling is also justified by the fact that research on rare diseases, in particular clinical research, is complex and costly to put in place due to the scarcity, for each disease, of patients, of knowledge, of clinicians and of researchers, and by the request, if possible, to group diseases for research purposes, in order to tackle several diseases out of the estimated 6-8.000 rare diseases. However, if the objectives of the action would otherwise be impossible or overly difficult (and duly justified in the proposal) the maximum amount may be higher. The starting date of the grant awarded under this topic may be as of the submission date of the application. Applicants must justify the need for a retroactive starting date in their application. Costs incurred from the starting date of the action may be considered eligible (and will be reflected in the entry into force date of the amendment to the grant agreement). The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and