Advancing promising results from Pillar II collaborative research through the innovation journey

The EU and Associated Countries benefit from accelerated commercialisation, adoption and deployment of Horizon Europe results, thereby reinforcing societal benefits, sustainable competitiveness, resilience and strategic autonomy of the Union. Scope: Projects funded under Horizon Europe’s Pillar II generate a wealth of high potential innovative results. Even though such results are many times successfully translated into used solutions, there is a need to increase the efficiency of the R&I investments and foster more uptake of promising results into innovative solutions. If more results [2] were converted into innovative products, processes, services, practices, business models or other novel solutions, they would strongly contribute to European societal benefit, sustainable competitiveness, prosperity, clean transformation, wellbeing or strategic autonomy. This topic aims at supporting actions that bring solutions generated by Pillar II closer to production and adoption by testing and validating them in real world settings, taking into consideration societal needs, cultural diversity and responsible innovation. Consortia do not necessarily have to include beneficiaries from the previous grant(s) but must own or have access to the knowledge assets, including intellectual property, where relevant, as stipulated in the specific conditions of this topic. Applicants should justify the proposed composition of the consortium and how it brings the necessary expertise and results ownership. Proposals may also build on complementary background results from closely related EU actions or national/regional projects contributing to the same innovation pathway, provided that these complementary results strengthen the market-readiness and deployment potential of the main result of the Horizon Europe project. Applicants should evidence that the proposed activities start beyond the laboratory or research environment and should focus on prototyping, testing, demonstrating, piloting, large-scale product validation and market replication under real-world conditions. Proposals should focus on innovation activities that cover the later stages of development, including the use of research and technology infrastructures [3] where relevant, should cover more than one of the following activities: Validation and Testing activities: This could include refining or piloting of prototypes through iterative testing, ensuring they meet the required regulatory or other standards before moving forward; testing to gain approval from potential users, or trial in real-world settings, including to understand user preferences and/or optimise outcomes; stress testing for technical feasibility to ensure the robustness of solutions at scale. Commercialisation aspects: This could include activities around regulatory compliance standardisation or certification, development of business or pricing strategies and planning for market entry. Scaling and Operations: This could include activities around large scale validation such as interoperability and/or standardising processes for quality assurance and control; preparations for supply chains and operational readiness; planning for ramping up manufacturing or delivery. Stakeholder, User and Market Readiness: This could include activities that involve engaging users/customers through co-creation and iterative feedback mechanisms to refine products and strategies, and to ensure that the proposed solutions are aligned with industrial and/or societal needs, concerns and expectations. Deployment and Investment Bridging : This could include partnering activities to expands market reach and securing the required investment commitment for the next phase by EU or national deployment programmes or investment funds. Proposals should clearly outline which wider impact can be expected if the project succeeds, along with convincing Key Performance Indicators or a similar framework to measure and follow up the project impact. Impacts do not have to be only monetary but can also consist of other kinds of societal benefits and impacts on wellbeing, clean transformation, resilience or strategic autonomy etc. To assess the value for investment, proposals should specify, with metrics where relevant, all the following: Describe the expected scale and significance [4] of the identified wider impacts. Include a business plan or exploitation strategy (including risks and mitigation) that will be further developed during the project. Proposals should identify the beneficiary(ies) (e.g. industry, company, public authority, etc.) responsible for the scaling-up of the solutions. The exploitation strategy should envisage a first deployment in the EU and/or Associated Countries. End users should be represented as a beneficiary within the consortium (and identified in the proposal) to test the feasibility of the solution and to ensure that the innovations developed meet the specific needs and requirements of the demand. To support the expected outcomes of the topic, additional end users beyond the project consortium can be subcontracted for further testing and validation activities. The maximum project duration should not exceed 3 years. If the activities to be carried out under the proposal are relevant and align with STEP [5] eligibility, (i.e. digital and deep tech, clean and resource efficient tech and biotech) proposals should demonstrate how they contribute to either: i) bringing innovative, cutting-edge technologies with strong economic potential to the internal market, or ii) reducing or preventing the Union’s strategic dependencies. Where relevant, applicants envisaging to include clinical studies [6] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. Technology Readiness Level - Technology readiness level expected from completed projects The starting TRL for proposals based on results generated within a project funded under Cluster 3, 4, 5 or 6 should be TRL 6. For proposals based on results generated within a project funded under Cluster 1 or 2, the proposed activities must start beyond the laboratory or research environment and focus on prototyping, testing, demonstrating, piloting, large-scale product validation and market replication under real-world conditions. In case of proposals that are based on results generated within more than one projects, the Cluster of the primary project -as stated by the applicants in their proposal- will be the Cluster to be considered. [1] Within this topic end users can be both public and private entities. [2] The term 'results' means any tangible or intangible effect of a given action, such as data, knowhow or information, whatever its form or nature and whether or not it can be protected, as well as any rights attached to it, including intellectual property rights (patents, copyright, trademarks, etc.). [3] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu [4] Scale refers to the breadth or magnitude of an innovation's reach (e.g., the number of users, industries, or markets affected); significance refers to its importance or transformative effect (e.g., whether it represents an incremental improvement or a fundamental shift in how a problem is solved or a need is met). [5] https://strategic-technologies.europa.eu/about_en [6] A clinical study covers clinical studies/trials/investigations/cohorts and is defined as any systematic prospective or retrospective collection and analysis of health data obtained from individual patients or healthy persons in order to address scientific questions related to the understanding, prevention, diagnosis, monitoring or treatment of a disease, mental illness, or physical condition. It includes but it is not limited to clinical studies as defined by Regulation 536/2014 (on medicinal products), clinical investigation and clinical evaluation as defined by Regulation 2017/745 (on medical devices), performance study and performance evaluation as defined by Regulation 2017/746 (on in-vitro diagnostic medical devices). From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS - https://euclinicaltrials.eu ). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. Applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings. Applicants are also encouraged to follow the World Health Organization (WHO) guidance for best practices for clinical trials ( https://www.who.int/publications/i/item/9789240097711 ).

Eligibility and submission conditions

"> 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 following additional eligibility criteria apply: consortia may include a maximum of 6 independent eligible entities as participants. The proposals must be based on results generated within a prior multi-beneficiary project funded directly under the Clusters of Pillar II (Clusters 1 to 6), through a Research and Innovation Action (RIA), an Innovation Action (IA) or a Pre-commercial Procurement Action (PCP). Applicants may submit a proposal based on results generated within more than one such projects (from the same or different Clusters of Pillar II), however only one of these projects will be considered as primary. Applicants must explicitly state in their proposal the project concerned (or the primary project concerned in case the proposal is based on results generated within more than one projects), by providing the relevant grant number and acronym as indicated in the Funding & Tenders Portal. The project(s) must have been completed before the submission deadline[[The ‘end date’ of the grant must be prior to the submission deadline.]]. Ongoing projects[[Projects that have an ‘end date’ after the submission deadline.]] are not considered eligible. Only projects where the granting authority for the completed project is the Commission or Executive Agency[[This means for example that projects such as the ones funded under a co-funded European Partnership or a joint undertaking are not considered eligible.]] are eligible[[Results generated within projects funded via financial support to third parties are not eligible.]]. Proposals must provide evidence[[In case of proposals that are based on results generated within more than one projects, evidence of ownership or access to the knowledge assets, including intellectual property where relevant, must be provided for all these projects.]] that the consortium owns or has access to the knowledge assets, including intellectual property, where relevant. More specifically, proposals must include at least one of the following: Confirmation that at least one of the applicants is the owner or holder of the relevant knowledge assets, including if applicable Intellectual Property Rights (IPR), and possesses the necessary rights to commercialise/use the results, or Commitment letter from the owner(s) of the relevant result(s) confirming the owner(s)’ willingness to negotiate fair, reasonable, and non-discriminatory access to the results, including IPR where relevant, for the purpose of future exploitation. In line with the “restriction on control in innovation actions in critical technology areas” delineated in General Annex B of the General Annexes, entities established in an eligible country but which are directly or indirectly controlled by China or by a legal entity established in China are not eligible to participate in the action. Some activities, resulting from this topic, may involve using classified background and/or producing of security sensitive results (EUCI and SEN). Please refer to the related provisions in section B Security — EU classified and sensitive information of the General Annexes. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). 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 To allow a faster access to funds for small collaborative consortia, grants under this topic will be funded under a Fast Track to Research and Innovation Procedure (FTRI). Indicative timetable for evaluation and grant agreement signature will be: Information on the outcome of the evaluation: Maximum 4 months from the final date for submission; and Indicative date for the signing of grant agreements: Maximum 6 months from the final date for submission. To ensure a balanced project portfolio covering all Clusters of Pillar II (Clusters 1 to 6), grants will be awarded (within available budget) to proposals not only in order of ranking but at least also to those proposals that are the 2 highest ranked within different Clusters targeted[[A proposal is considered to target a Cluster of Pillar II (Cluster 1 to 6), when it is based on results generated within a prior multi-beneficiary project funded directly under that Cluster. In case of proposals that are based on results generated within more than one projects, the Cluster of the primary project -as stated by the applicants in their proposal- will be considered as being the Cluster targeted.]], provided that the proposals attain all thresholds. Eligible proposals submitted under this topic and exceeding all the evaluation thresholds will be awarded a STEP Seal ​​​​​​[ [https://strategic-technologies.europa.eu/about/step-seal_en ]]. 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 Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [This [decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf ]]. 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 model grant agreement (MGA): Application and evaluation form templates Please use the application form that you will find in the Submission System. You can find examples of standard application forms in the Reference Documents page . Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreements (MGA) Lump Sum MGA Call-specific instructions Information on clinical studies (HE) Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" Ownership control declaration Information on security issues/Security section (HE) Information on security practitioners (HE) Additional documents: HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 14. Horizontal Activities HE Main Work Programme 2026-2027 – 15. General Annexes HE Framework Programme and Rules for Participation Regulation 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual [This [decision Standard evaluation form (HE RIA, IA) Lump Sum MGA Information on clinical studies (HE) Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" Ownership control declaration Information on security issues/Security section (HE) Information on security practitioners (HE) HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 14. Horizontal Activities Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions