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Grant Analysis

Purpose & Target

This grant, 'STEP – Biotechnologies – EU Strategic Independence (Path B)', aims to support investment projects by businesses in the biotechnology sector. The core objective is to reduce or combat the European Union's strategic dependence on third countries in critical technologies. It specifically targets the manufacturing of critical technologies, elements of their value chains, or critical medicinal products and their components. This is a SECTOR-SPECIFIC grant within the broader 'European Funds for Modern Economy' program. Target Recipients

Type: Micro, Small, Medium-sized Enterprises (MŚP) and Large Enterprises.
Size: All sizes of enterprises are eligible, provided they meet specific operational history and revenue requirements.

Geographic Scope

Project Location: Projects must be physically implemented within Poland.
Territorial Scope: While implementation is in Poland, the project's impact and contribution to reducing EU strategic dependence can extend across Poland and internationally, specifically benefiting the EU internal market.

Key Filtering Criteria

Industry Focus: Strictly biotechnology.
Project Type: Must be investment projects focused on manufacturing and reducing EU strategic dependence, not solely R&D.
Operational History: Applicants must have been operating for at least 36 months and have 3 closed financial years.
Revenue: Operational revenue averaging at least 20% of the project's qualified costs over the last 3 years.

Grant Frequency and Program Context

This specific call is part of the 'FENG.05.01 Fund for Critical Technology Support' under the 'FENG.05 Support for projects implementing the objectives of the STEP initiative' priority. It's a competitive call with defined application windows. The program's context is to bolster the EU's industrial and technological independence in strategic areas, as defined by the EU's STEP initiative.

Financial Structure

This grant provides financial support in the form of a non-repayable grant. The financial structure dictates how funds can be used, the required co-financing, and reporting obligations. Budget Range and Limitations

Total Call Budget: The total amount allocated for this call is 150,000,000 PLN (one hundred fifty million Polish Zloty).
Maximum Grant Amount per Project: A single project can receive up to 150,000,000 PLN.
Minimum Eligible Project Costs: Projects must have eligible costs of at least 10,000,000 PLN.

Funding Rate and Co-financing

Maximum Funding Rate: The grant can cover up to 75% of the eligible project costs.
Minimum Own Contribution (Co-financing): Applicants are required to provide a minimum of 25% of the eligible costs as their own contribution. This contribution must be in monetary form and cannot originate from public funds (e.g., state or local government subsidies).

Eligible Costs Costs must be incurred after the application submission date (with some exceptions for de minimis aid costs). Eligible costs generally fall under various public aid categories. These include: - Regional Investment Aid (Art. 14, Regulation 651/2014): - Acquisition of land: Up to 10% of total qualified costs (up to 15% for abandoned/post-industrial areas). - Acquisition of built real estate: Up to 10% of total qualified costs (up to 15% for abandoned/post-industrial areas). - Acquisition of new tangible fixed assets: Such as machinery and equipment. For SMEs, used assets might be eligible, but for large enterprises, assets must be new. - Construction works and building materials. - Acquisition of intangible assets: Patents, licenses, know-how, and other intellectual property rights. For large enterprises, these are eligible up to 50% of the total qualified investment costs, while for SMEs, up to 100%. - Advisory Services for SMEs (Art. 18): External advisory services (not continuous or related to ongoing operations, e.g., legal, accounting, tax, advertising). Up to 50% intensity. - Innovation Support for SMEs (Art. 28): Costs related to data banks, cloud services, market research, lab services, HPC, quality testing/certification. Up to 50% intensity. - Training Aid (Art. 31): Costs for external training services (e.g., lecturer fees, travel, accommodation, materials, administration). Excludes mandatory national training or training for management competencies. Intensities vary based on enterprise size (e.g., 50% basic, +10% for medium, +20% for micro/small). - Environmental Protection Aid (Arts. 36, 38, 38a, 41, 47): Costs for investments improving environmental protection, energy efficiency (in buildings and otherwise), promoting renewable energy/hydrogen/high-efficiency cogeneration, and supporting resource efficiency/circular economy. Intensities vary. - De minimis Aid (Regulation 2023/2831): Can cover advisory services, software subscriptions, and innovation support, up to a maximum of 300,000 EUR over three years for a single undertaking. Ineligible Costs

VAT: Generally, Value Added Tax (VAT) is an ineligible cost. It can only be qualified if the applicant has no legal right to deduct input VAT or claim a refund under national law.
Fossil Fuels: Investments in the production, processing, transport, distribution, storage, or combustion of fossil fuels (including natural gas) are explicitly excluded.
Military Use: Solutions exclusively for military applications are ineligible.
Energy Generation as Primary Purpose: If energy generation is the primary purpose of the project, it's generally ineligible, unless it's strictly for own consumption (max 20% can be sold) and qualifies under specific energy sector aid rules (e.g., renewable energy).

Payment Schedule and Mechanisms

Advance Payments: The first payment can be an advance payment, specified in the payment schedule, up to 10 million PLN or at least 5% of the grant value, whichever is lower. This is disbursed to a dedicated bank account upon approval of the payment request.
Payment Requests: Beneficiaries must submit payment requests via the CST2021 system at least once every 6 months.

Financial Reporting and Audit Requirements

Applicants are required to submit financial reports and maintain accurate records. The project's financial feasibility and profitability (NPV, IRR) will be assessed based on provided financial statements (last three years) and a specific financial model (Attachment 5 to the Regulations).
Auditors may be involved in verifying financial compliance, though specific audit requirements for beneficiaries are not detailed in the provided text beyond general financial reporting. If indicators are not met, the grant amount may be reduced proportionally or funds may be subject to return.

Eligibility Requirements

The grant outlines strict non-negotiable criteria for applicants and projects. Failure to meet any of these will result in disqualification in the initial assessment stage. Organizational Eligibility (Stage I Mandatory Criteria)

Eligible Organization Types:
Micro, Small, and Medium-sized Enterprises (MŚP): Defined by EU Commission Regulation (UE) No 651/2014, Annex I. This refers to enterprises employing fewer than 250 persons and having an annual turnover not exceeding 50 million EUR, or an annual balance sheet total not exceeding 43 million EUR.
Large Enterprises (other than MŚP): Also defined by EU Commission Regulation (UE) No 651/2014, Annex I. These are enterprises that do not meet the criteria for MŚP.
Geographic Location for Operations: The applicant must conduct business activities within Poland, confirmed by registration in the National Court Register (KRS) or Central Registration and Information on Economic Activity (CEIDG) (e.g., registered office or at least one branch in Poland).
Operational History: The applicant must have been active for a minimum of 36 months and demonstrate 3 closed financial years (e.g., 2022, 2023, 2024 for a 2025 application). If the applicant is a special purpose vehicle (SPV), this requirement applies to the parent company.
Financial Capacity (Revenue): The applicant's average operational revenue over the last three closed financial years must be at least 20% of the total qualified costs of the project.

Project-Specific Eligibility (Stage I Mandatory Criteria)

Geographic Location for Project Implementation: The project's physical implementation must take place within Poland.
Sector Focus: The project must explicitly fall within the biotechnology sector, specifically as defined in Article 2(1)(a)(iii) of EU Regulation 2024/795 (STEP Regulation).
Technology Focus: The project must pertain to:
Critical Technology: As defined by the STEP Regulation and further specified in the grant documents, meaning technologies that are innovative/cutting-edge/breakthrough with significant economic potential OR contribute to reducing/combating strategic EU dependence.
Critical Technology Value Chain: Elements of the critical technology value chain (e.g., final products, key components, machinery, critical raw materials, related services).
Critical Medicinal Products: Products listed in the EU's critical medicines list and their components (active substances) produced via chemical processes, or reagents for testing/introducing such products.
Nature of Project Activities (Manufacturing): The project must explicitly involve the manufacturing of critical technologies or elements thereof. This includes:
Creating new production lines.
Establishing 'first-of-its-kind' plants.
Expanding or repurposing existing manufacturing facilities.
Scaling up processes to meet demand.
Implementing quality control mechanisms.
Exclusion: The project cannot involve the installation or implementation of final products.
Excluded Activities/Disqualifying Factors: The project must not involve activities explicitly excluded by EU regulations (e.g., Art. 1 of EU Regulations 651/2014 or 2023/2831, Art. 7 of EU Regulation 2021/1058), or Polish regulations (§ 6(11) of the Ministry of Funds and Regional Policy Regulation). This includes:
Production, processing, transport, distribution, storage, or combustion of fossil fuels.
Solutions intended exclusively for military use.
The assessment of exclusions will consider the project description and the PKD (Polish Classification of Activities) code provided by the applicant.

Application Process

Applying for this grant involves a structured online process, strict adherence to deadlines, and specific documentation requirements. It is crucial to monitor communication from the granting authority. Application Deadlines and Submission Windows

Call Announcement Date: June 30, 2025
Application Start Date: July 22, 2025, 00:00 (midnight)
Application End Date: September 9, 2025, 16:00 (4:00 PM Polish time)
Flexibility: The application period can be shortened (minimum 10 days, not earlier than 40 days from announcement, with 7 days notice) or extended by the Intermediate Body (PARP).

Application Procedure and Steps

Review Documentation: Familiarize yourself with the grant regulations, eligibility criteria, and all associated attachments (e.g., expenditure guide, project selection criteria, financial model instructions).
Prepare Necessary Documents: Gather all required attachments for your application. This includes financial statements for the last three closed financial years, documentation supporting your operational history, and details related to the planned investment.
Complete Online Application: Fill out the application form exclusively through the Local Information System (LSI) at https://lsi.parp.gov.pl.
Language: The application must be submitted in Polish. Documents in other languages require a certified translation.
Accuracy: Fill out the application form precisely according to the 'Instruction for filling out the application for co-financing'. Ensure all information allows for a full assessment against all selection criteria.
Submission Confirmation: After submission, you will receive a confirmation with an assigned number and date from the LSI system. No changes can be made after this, except when explicitly requested by PARP for corrections.
Monitor LSI: Regularly check your application status and communications in the LSI system.
Communication: In case of LSI technical issues, report them immediately through the system's contact form within the application period.

Required Documentation and Materials

Application Form: Completed online via LSI (template provided as Attachment 7).
Financial Model: A completed financial model (Attachment 5, updated version v121 from July 24, 2025) including instructions, reflecting the entire activity of the applicant.
Expenditure Eligibility Guide (Attachment 2): For reference on what costs are eligible.
Project Selection Criteria (Attachment 3): Crucial for understanding how your project will be evaluated.
List of Critical Areas and Technologies for Biotechnology (Attachment 1): To ensure project alignment.
Proof of Funds: Documents confirming the acquisition of external funds for co-financing (if applicable) must be attached to the application.
Power of Attorney: If representatives are not legally authorized to represent the applicant based on public registers, a power of attorney must be uploaded to LSI at least one day before any KOP panel meeting.

Project Implementation Timeline and Reporting Obligations

Project Duration: The grant duration is not explicitly stated, but the process from application deadline to contract signing can be up to 100 days initially, potentially longer for complex cases.
Reporting: Beneficiaries must submit payment requests via the CST2021 system at least once every 6 months.
Indicator Achievement: Failure to achieve product indicators may lead to a proportional reduction in funding. Failure to achieve outcome indicators may lead to a proportional return of funding.
Information & Promotion: Beneficiaries are obligated to display EU and Polish symbols on all project-related communications, documents, and materials. This includes a durable information board (for projects over 500,000 EUR) or a poster/electronic display, and a short project description on the beneficiary's website and social media (including specific hashtags like #FunduszeUE or #FunduszeEuropejskie).

Post-Award Requirements

Contract Signing: After project selection, the applicant needs to appoint a project manager and submit a request to PARP. Required documents for the contract (e.g., non-conviction certificate, no public debt, no social security arrears) must be submitted within 7 days of PARP's request. The contract is typically signed electronically. If financial statements or investment permits are missing by the contract signing date, the contract may still be signed, but disbursements will be withheld until these are provided, and the project proceeds at the applicant's own risk.

Evaluation Criteria

The evaluation process is conducted in two stages, with projects needing to pass all mandatory criteria in Stage I to proceed to Stage II. Stage II involves a point-based assessment, with a minimum score required to be considered for funding. Stage I Evaluation (Pass/Fail - 1 point for each met criterion) Projects must achieve 1 point in ALL of the following criteria to pass Stage I: - Applicant Eligibility: Assesses whether the business meets the requirements regarding operation in Poland, minimum 36 months of activity with 3 closed financial years, and average operational revenue equal to at least 20% of qualified project costs. - Project Location: Confirms that the project will be implemented in Poland. - Biotechnology Sector Alignment: Verifies if the project falls within the specified biotechnology sector as per EU Regulation 2024/795. - Critical Technology Manufacturing Focus: Checks if the project is genuinely about manufacturing critical technologies or related components/products, and not, for example, R&D or final product installation. - Exclusion Compliance: Ensures the project does not involve any activities explicitly excluded from support (e.g., fossil fuels, military applications). Stage II Evaluation (Point-Based - Maximum 31 points) Projects are scored on the following criteria, and generally need at least 1 point in each obligatory criterion (1-11) to be considered for funding. The total minimum score for Stage II is 11 points. Obligatory Criteria:

1. Critical Technology Potential (0, 1, 3, 5, or 10 points):
Focus: Assesses how well the project addresses and reduces the EU's strategic dependence on third countries for critical technologies or medicinal products. This includes demonstrating the existence of such dependence (e.g., import concentration, limited EU production) and how the project contributes to EU leadership, critical infrastructure, increased production capacity, supply security, and cross-border cooperation.
Economic Potential: Evaluates the realism and soundness of market analyses, customer identification, market size estimation, competitive advantage, and risk mitigation strategies.
Indicators: Checks if planned results are reflected in project indicators.
Minimum Points Required: 1 point.
2. Applicant Potential for Project Implementation (0, 1, 2, or 3 points):
Preparedness: Assesses if the applicant has necessary permits, licenses, and intellectual property rights, or a clear plan to acquire them.
Resources: Evaluates the sufficiency of technical and human resources, including the experience and involvement of the management team.
Timeline: Checks if the project schedule is realistic, logical, and conducive to achieving planned results.
Bonus Points (up to 2 additional points): Awarded for having a valid building permit (if required, or if not required) and for demonstrating prior successful market implementation of another project in the biotechnology sector.
Minimum Points Required: 1 point (for meeting basic conditions 1-3).
3. Project Expenditures & Public Aid Compliance (0 or 1 point):
Cost Validity: Ensures that proposed costs are necessary, rational, justified, and correctly categorized according to the 'Expenditure Eligibility Guide'.
Funding Limits: Verifies adherence to the minimum eligible cost of 10 million PLN and the maximum funding amount of 150 million PLN.
Co-financing: Confirms a minimum 25% own contribution (from non-public sources) for regional investment aid.
Public Aid Rules: Checks compliance with various state aid regulations (e.g., regional investment aid, de minimis, environmental aid).
Minimum Points Required: 1 point.
4. Financial Feasibility (0 or 1 point): Evaluates the applicant's ability to secure adequate funding for the entire project, including own contribution and any external financing, based on financial statements and the financial model.
Minimum Points Required: 1 point.
5. Project Profitability (0 or 1 point): Assesses the financial viability of the project based on financial forecasts, including Net Present Value (NPV) and Internal Rate of Return (IRR).
Minimum Points Required: 1 point.
6. Project Indicators (0 or 1 point): Checks if product and outcome indicators are appropriate, measurable, verifiable, and realistic, with clear baseline and target values.
Minimum Points Required: 1 point.
7. Incentive Effect (0 or 1 point): Confirms that project implementation has not started before the application submission date (with specific exceptions for certain de minimis costs).
Minimum Points Required: 1 point.
8. Sustainable Development Principle (0 or 1 point): Assesses alignment with EU sustainable development goals, 'do no significant harm' principle, and specific environmental standards (e.g., adherence to '6R' principles like reduce, reuse, recycle, or other positive environmental impacts), supported by quantifiable environmental indicators.
Minimum Points Required: 1 point.
9. Equal Opportunities and Non-discrimination (0 or 1 point): Evaluates compliance with horizontal principles of equal opportunities and non-discrimination, including accessibility for people with disabilities and gender equality.
Minimum Points Required: 1 point.
10. Charter of Fundamental Rights Compliance (0 or 1 point): Checks alignment of the project's scope and implementation with relevant articles of the EU Charter of Fundamental Rights.
Minimum Points Required: 1 point.
11. Convention on the Rights of Persons with Disabilities Compliance (0 or 1 point): Assesses the project's adherence to relevant articles of the Convention on the Rights of Persons with Disabilities.
Minimum Points Required: 1 point.

Optional Criteria:

12. Project Impact Scope (0, 3, 6, or 9 points): Awards points if the critical technology contributes to the applicant's global market growth, significant scaling, market assimilation, and positive broader social, economic, environmental, or climate impacts at the EU level. This criterion is not obligatory and does not have a minimum point requirement.

Tie-Breaking Criteria If multiple projects receive the same score in Stage II and available funding is insufficient for all, the following criteria will be used to prioritize: 1. National Key Cluster Membership: Priority given to applicants who have been members of a National Key Cluster for at least 6 months prior to application submission. 2. Woman-Managed/Co-managed Enterprise: Priority given if the applicant has been managed or co-managed by a woman for at least 6 months prior to application. This is defined as at least one woman being a partner authorized to represent the company, or at least one woman being a partner/shareholder and a member of the management board.

Compliance & Special Requirements

This grant program is embedded within a comprehensive regulatory framework, requiring strict adherence to national and European Union laws, ethical standards, and specific project-related conditions. Regulatory Compliance Requirements

EU Regulations: Compliance with various EU regulations, including but not limited to:
Regulation (UE) 2024/795 (STEP initiative)
Regulation (UE) 651/2014 (General Block Exemption Regulation for State Aid)
Regulation (UE) 2023/2831 (De minimis aid)
Regulation (UE) 2021/1060 (Common Provisions Regulation for EU Funds)
Regulation (UE) 2021/1058 (European Regional Development Fund and Cohesion Fund)
Guidelines related to the STEP Regulation (C/2024/3209)
National Regulations (Poland): Compliance with Polish laws, including:
The Act on the principles of task implementation financed from European funds (2021-2027 financial perspective).
The Act on Public Finance.
The Act on Public Aid procedures.
The Act on Electronic Deliveries.
Ministry of Funds and Regional Policy regulations on financial aid from PARP within the 'European Funds for Modern Economy' program.
Excluded Activities: Projects cannot involve activities related to the production, processing, transport, distribution, storage, or combustion of fossil fuels. Projects must not pertain to solutions for exclusively military use.

Data Protection and Privacy Regulations

Communication between PARP and the applicant typically occurs electronically via the LSI system and designated email addresses. Formal notifications (e.g., evaluation results) are sent via electronic delivery services (PURDE, PUH, or ePUAP until end of 2025). Applicants must ensure their contact information is up-to-date and monitor communications.

Environmental Compliance Requirements

Sustainable Development: Projects must comply with the principle of sustainable development, including contributions to UN Sustainable Development Goals (SDGs), alignment with the Paris Agreement, and the 'do no significant harm' principle. This involves demonstrating positive environmental impact (e.g., adherence to at least two '6R' principles: refuse, reduce, reuse, recover, recycle, rethink, or other specific environmental improvements) and providing measurable environmental indicators.
Resource Efficiency and Circular Economy: Support is available for investments aimed at improving resource management and transitioning to a circular economy (e.g., reducing resource consumption, using secondary raw materials, preventing/reducing waste, recycling).

Ethical Standards and Requirements

Charter of Fundamental Rights: Projects must adhere to the EU Charter of Fundamental Rights, specifically articles related to human dignity, rights to liberty and security, equality, solidarity, and justice.
Convention on the Rights of Persons with Disabilities: Projects must comply with the UN Convention on the Rights of Persons with Disabilities, promoting full and equal enjoyment of all human rights and fundamental freedoms by persons with disabilities.
Equal Opportunities and Non-discrimination: Projects must demonstrate adherence to horizontal principles of equal opportunities and non-discrimination, including ensuring accessibility for persons with disabilities and promoting gender equality.

Intellectual Property Policies

If project implementation relies on intellectual property (IP) rights, the applicant must confirm they possess or have secured necessary rights (e.g., transferred copyrights, licenses, patents) and provide supporting documentation. For SPVs, this can be demonstrated by the parent company.

Risk Management Expectations

Applicants are expected to identify key risks associated with project implementation and outline mitigating actions. This is part of the 'Critical Technology Potential' evaluation criterion.

Strategic Alignment Opportunities

The grant explicitly targets projects that contribute to the EU's strategic independence, leadership, increased production capacity, and supply chain security in the biotechnology sector. Strong alignment with these overarching EU objectives, and detailed analysis of market potential and competitive advantage, will significantly strengthen an application.

Cross-cutting Considerations

Gender and Inclusion: The evaluation specifically includes criteria for 'Equal Opportunities and Non-discrimination' and 'Convention on the Rights of Persons with Disabilities', emphasizing accessibility and gender equality throughout the project.
Woman-managed enterprises: Are explicitly included as a tie-breaking criterion, offering a competitive advantage if other factors are equal.

Research Component Requirements

This grant, managed by PARP, explicitly supports the manufacturing (wytwarzanie) aspect of critical technologies. Research and development (B+R) in critical technologies is supported by a different entity (National Centre for Research and Development - NCBR). Therefore, significant R&D components are generally not the focus of this grant.

Grant Details