Global collaboration action for the development of vaccines for reducing the disease burden of Tuberculosis in sub-Saharan Africa

described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.

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.

The conditions are described in General Annex B except for the specific conditions for the Global Health EDCTP3 JU funding as regards entities eligible for funding and consortium composition, the specific rule for countries where the coordinator may be established and the obligation to designate a scientific project leader as below.

Specific conditions replacing the relevant sections in General Annex B to the Horizon Europe Work Programmes.

A. Entities eligible for funding

This section applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA).

To become a beneficiary, legal entities must be eligible for funding. To be eligible for funding, applicants must be established in one of the following countries:

• The Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
• The Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR);
• Countries associated to Horizon Europe^[1]: Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo^[2], Moldova, Montenegro, New Zealand (associated to Pillar II 'Global Challenges and European Industrial Competitiveness' as from the Work Programmes 2023 onwards, including for the institutionalised European partnerships), North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine, United Kingdom;
• Until association agreements start producing legal effects either through provisional application or their entry into force, transitional arrangements apply. The transitional arrangements apply, at the time of the adoption of this Work Programme, with regard to the following countries and legal entities established in these countries, with which association negotiations are being processed or where association is imminent):Morocco, South Korea, Switzerland
• The following countries which are constituent states of the EDCTP Association ^[3]: Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Eswatini, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.

Entities established in low- and middle-income countries that are not members of the EDCTP Association and listed in the Horizon Europe List of Participating Countries on the Funding & Tenders Portal ^[4] are not eligible for funding unless the specific country in which the entity is established, is associated to Horizon Europe or if the participation of the entity is considered essential for implementing the action by the granting authority.

B. Consortium composition

Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the Global Health EDCTP3 JU, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes as beneficiaries:

• At least three legal entities independent from each other and each established in a different country, where legal entities are eligible to receive funding;
• At least one independent legal entity established in a Member State, or in an associated country to Horizon Europe that is a member of the EDCTP Association; and
• At least one independent legal entity established in a sub-Saharan African country that is a member of the EDCTP Association.

This condition applies to both Research and Innovation Actions (RIA) and Coordination and SupportActions (CSA).

For the two CSA topics, i.e. topic HORIZON-JU-GH-EDCTP3-2025-02-FELLOW-01-two-stage and topic HORIZON-JU-GH-EDCTP3-2025-03-NETWORKS-01-two-stage - according to which the EDCTP Association is obligatorily part of the consortium as coordinator, the EDCTP Association must not be counted as one of the three independent legal entities necessary to ensure the eligibility of the consortium composition.

Specific cases:

Affiliated entities — Affiliated entities are eligible for funding if they are established in one of the countries listed above, or in a country identified in the specific call/topic conditions.

Associated partners — Entities not eligible for funding and therefore not able to participate as beneficiaries or affiliated entities (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.

International organisations – International European research organisations are eligible to receive funding. Other international organisations are not eligible to receive funding unless their participation is considered essential for implementing the action by the granting authority. International organisations with headquarters in a Member State or associated country are eligible to receive funding when provided for in the specific call conditions.

Specific rules regarding legal entities that may be the coordinator of an indirect action

In accordance with Article 110(2) of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe^[5], where entities established in a third country without an agreement to protect the financial interests of the Union participate with funding in an indirect action, the coordinator of the indirectaction must be established in a Member State or associated country, or South Africa.

Scientific project leader

If the coordinator is not established in a country in SSA (please see previous paragraph), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described below is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity. The scientific project leader oversees the project scientific governance and leadership. For this purpose, proposals must include a work package where the details of scientific project leadership are laid down. The scientific project leader should indicatively perform the following tasks:

• During the call for proposals and selection process, coordinate meetings on and drafting of the full project proposal;
• Work with the coordinator and other beneficiaries on the drafting and negotiation of the consortium agreement and other legal agreements among the beneficiaries;
• Act as the key contact point for the Global Health EDCTP3 JU regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, without prejudice to the tasks entrusted directly to the coordinator as per the Model Grant Agreement;
• Support and collaborate with the coordinator on its monitoring activities and the adoption of appropriate internal measures, to ensure that beneficiaries are fulfilling their obligations regarding budget, timeline, deliverables, and scientific quality;
• Review the action’s deliverables and reports before their submission by the coordinator;
• Lead the work packages(s) related to the tasks of scientific project leadership.

Annex 1 to the grant agreement and the consortium agreement should address the relationship of the scientific project leader with the coordinator regarding their respective tasks, for example sharing of the information received from or sent to the Global Health EDCTP3 JU on all issues of interest for the proper scientific management of the action.

^[1] The list is correct at the time of adoption of this work programme. Please see the Horizon Europe List of Participating Countries on the Funding & Tenders Portal for up-to-date information on the current list and on the position for Associated Countries: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf

^[2] This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

^[3] The list is correct at the time of adoption of this work programme. For an update, please check the EDCTP Association website www.edctp.org

^[4] Horizon Europe List of Participating Countries on the Funding & Tenders Portal https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf

^[5] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014. OJ L 427, 30.11.2021, p. 17–119; Regulation - 2021/2085 - EN - EUR-Lex (europa.eu).

described in Annex B of the Work Programme General Annexes.

described in Annex C of the Work Programme General Annexes.

are described in Annex D of the Work Programme General Annexes.

Specific conditions related to Scores and weighting

Replacing the scores and weighting section in General Annex D to the Horizon Europe Work Programmes as regards second stage of two-stage evaluations, for both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA)

Evaluation scores will be awarded for the criteria, and not for the different aspects listed in the table. For full applications, each criterion will be scored out of 5. The threshold for individual criteria 1 (Excellence) and 2 (Impact) will be 4 and for criterion 3 (Quality and Efficiency of the implementation) will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12.

Proposals that pass the individual threshold and the overall threshold will be considered for funding, within the limits of the available call budget. Other proposals will be rejected.

Nota bene, for the first stage of the two-stage evaluation of both RIAs and CSAs, the scores and weightingas indicated in Annex D of the General Annexes of the Horizon Europe work programme 2023/2025 apply.

In addition to the aspects of award criteria included in General Annex D, the following aspects are taken into consideration during the evaluation of second-stage proposals:

• For the ‘impact’ criterion: Production of meaningful and significant effects enhancing the impact of the relevant research activities via the inclusion of effective in-kind and/or financial contribution of contributing partners.
• For the ‘quality and efficiency of the implementation’ criterion: Leveraging of financial and/or in-kind contributions from contributing partners that are equal or greater than the requested JU contribution, in order to ensure the necessary resources and effort for the action.

described in Annex F of the Work Programme General Annexes.

Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085 establishing52, grants awarded under this topic will have to include in their Plan for the exploitation and dissemination of results including communication activities to be submitted during the project as a deliverable also the following:

Access plan

Participants must include in their Plan for the exploitation and dissemination of results an appropriate and proportionate access plan that demonstrates their strategies to ensure that the products and services that they develop based or partly based on the results of clinical studies undertaken by their project are affordable, available and accessible to the public (market and end-users) at fair and reasonable conditions. This covers registration targets, plans to meet demand, flexible approaches to IP, engagement with regulators and manufacturers where relevant and other strategies that reflect ability to pay and ensures that economic barriers to access are low. In addition, participants should add, if relevant, as part of the plan, an outline on how to achieve the optimal use of an intervention including, for example, how to avoid irrational use, overuse or abuse (e.g. antimicrobials).

In addition to any updates during the project, a final version of the Plan for the exploitation and dissemination of results including the above access plan, must also be submitted with the final report of the project.

Also in line with Article 114 of the Council Regulation 2021/2085, participants will be subject to the following additional exploitation obligations:

• Participants must – up to four years after the end of the action (see Data Sheet, Point 1) – use their best efforts to ensure that resulting health technologies and services will be broadly available and accessible, as soon as possible and at fair and reasonable conditions. In this respect, if, despite a participants’ best efforts, the results are not exploited within one year after the end of the action, participants must (unless otherwise agreed in writing with the granting authority) use the Horizon Results Platform to find interested parties to exploit the results.
• In case the participants cannot fulfil the preceding obligation, the participants must (if requested by the granting authority) grant non- exclusive licences - under fair and reasonable conditions - to their results to legal entities that commit to rapidly and broadly exploiting the resulting health technologies and services and ensure that they are broadly available and accessible, as soon as possible and at fair and reasonable conditions.
• In case of transfer of the ownership or licensing of results, participants must pass on such additional exploitation obligations to the legal entities exploiting the results.
• For up to four years after the action (see Data Sheet, Point 1), the funding body must be informed every year about the status of the development of the product and any other exploitation of the results through an annual report that is due on each anniversary of the end of the grant agreement.

described in Annex G of the Work Programme General Annexes.