1. SCOPE AND EFFECTIVENESS OF THESE GENERAL TERMS AND CONDITIONS

1.1 These general terms and conditions of contract (the “General Terms and Conditions”) govern the provision of services by Evidilya S.r.l., with registered office at Via Brisa 3, 20123 Milan, Italy (VAT No. 06957380964), which for the purposes of these General Terms and Conditions shall be referred to as the “Provider”, to the entity identified in the quotation/purchase order (the “Client”). These General Terms and Conditions form an integral part of the quotation/purchase order and shall prevail over any terms and conditions of the Client, unless expressly waived in writing. These General Terms apply to administrative, commercial and legal aspects of the services to be provided

1.2 In the event of any conflict between the provisions of the quotation/purchase order and these General Terms and Conditions, the latter shall prevail, unless the quotation/purchase order expressly refers to the clause being waived. Any amendments or additions to the Contract shall only be effective if signed by both Parties.

2. DEFINITIONS

In addition to the terms defined elsewhere, the following definitions apply for the purposes of these General Terms and Conditions:

• Contract: the agreement between Provider and Client consisting of these General Terms and Conditions, the quotation/purchase order and any annexes (Statement of Work or “SOW” or Clinical Trial Agreement or “CTA”)  governing scientific, medical, regulatory and GxP obligations
• Services: the activities described in the quotation/purchase order/SOW/CTA(e.g Strategic Consultancy, Scientific Publication support and CRO-related activities for RWE or Clinical Studies implementation as of Project Management, Regulatory and Start up activities, Medical Writing, Biometric, Monitoring, Digital and Electronic Data Capture Services, Supplies Management, Safety and Medical monitoring, De-centralized services) that the Provider undertakes to perform.
• Fees: the amount payable by the Client for the Services, including deposits, instalments, Pass‑Through Costs (costs incurred from third parties) and expense reimbursements.
• Direct Costs: the Provider’s direct costs relating to the Services, calculated on the basis of the hourly/daily rates of the personnel involved and any internal costs directly attributable to the activities described in the SOW.
• Provider Materials: all data, methodologies, software, algorithms, models, documentation, know‑how, reports, tools, templates, libraries, workflows, technical components and other works pre‑existing or developed by the Provider in the performance of the Services, which remain the exclusive property of the Provider. Provider Materials also include – by way of example and without limitation – “open” or editable files (including, among others, .psd, .ai, .indd, .fig, .xd formats), source files, source code, development repositories, software modules, scripts, design elements, technical structures of websites, digital platforms and applications developed or used by the Provider. Such items are not transferred to the Client nor delivered in editable format, unless otherwise agreed in writing and subject to payment of the related consideration.
• Deliverables: the tangible results of the Services (reports, presentations, websites, communication materials) intended for the Client, as further described in the quotation/purchase order.
• Change Request: a document amending a SOW which describes changes to the scope of the Services, costs (Direct Costs and Pass‑Through Costs) or timing. Each Change Request must be agreed in writing and approved by both Parties.
• Pass‑Through Costs: costs incurred or to be incurred by the Provider on behalf of the Client, including – by way of example and without limitation – travel, meals and accommodation, third‑party services (including Investigators grants, Ethical committee fees, study supplies providers, laboratory services, IT services, licence fees, taxes, duties and legal fees). Pass‑Through Costs are recharged to the Client at cost, without mark‑up, except for any management service fee specified in the relevant Order or SOW/CTA if any.

3. SCOPE OF APPLICATION AND ENTIRE AGREEMENT

3.1 The Contract constitutes the entire agreement between the Parties and supersedes all prior communications or agreements, written or oral, relating to the same subject matter. Acceptance of the quotation/purchase order or commencement of the provision of the Services implies full acceptance of these General Terms and Conditions.

3.2 Nothing in the Contract shall be construed as creating an employment relationship, partnership, de facto company, joint venture or agency between Provider and Client. The Provider acts with full organizational autonomy and manages its own personnel independently.

4. SUBJECT MATTER OF THE CONTRACT AND PERFORMANCE OF THE SERVICES

4.1 Performance of the Services. The Provider undertakes to perform the Services described in the quotation/purchase order with professional skill and due care, in accordance with best practices and applicable law. The Provider may use internal or external personnel and shall remain responsible for the proper performance of the Services.

4.2 Client’s cooperation. The Client shall provide all information, materials, access and authorisations required for the performance of the Services within the deadlines indicated in the quotation/purchase order or, failing that, within fifteen (15) days from the date of signature of the Contract. Any delay in providing such materials shall suspend the delivery deadlines; delays exceeding sixty (60) days entitle the Provider to terminate the Contract and charge the Client for the costs incurred as well as a penalty equal to ten per cent (10%) of the outstanding amount.

4.3 Change Request. Any modification, extension or reduction of the scope of the Services compared to what is described in a SOW/CTA shall be governed by a Change Request. This document shall specify changes to content, timing and costs (Direct Costs and Pass‑Through Costs) and must be signed by both Parties before the start of the amended activity. Change Requests entailing an increase in costs of more than ten per cent (10%) of the initial Fees shall require a new quotation; changes exceeding thirty per cent (30%) may justify renegotiation or termination of the relevant SOW. The Provider may reject change requests that are unrealistic or non‑compliant with applicable law. Any change to scope, timeline or budget shall be governed by a Change Request. For regulated studies, Variation rules under the CTA shall supersede this section.”

4.4 Technical and regulatory updates. The Provider may introduce non‑material changes to the Services to comply with regulatory requirements or technological updates, while maintaining equivalent or improved functionality. Changes affecting costs or functionalities shall be notified with at least thirty (30) days’ prior notice and shall become effective only with the Client’s consent. If the Client does not accept such changes, it may terminate the affected service by paying the Fees accrued up to the effective date of termination.

5. INTELLECTUAL PROPERTY, LICENCES AND RESTRICTIONS

5.1 Provider’s rights. All Provider Materials, as defined in Article 2, including – by way of example and without limitation – data, methodologies, software, algorithms, models, documentation, know‑how, reports, tools, templates, workflows, libraries, technical components, “open” files and source files (including, among others, .psd, .ai, .indd, .fig, .xd formats), source code, development repositories, software modules, scripts, design elements and technical architectures of websites or digital platforms, are and shall remain the exclusive property of the Provider or its licensors.

The Client does not acquire any ownership rights in the Provider Materials, nor any right to their delivery in editable format or in source code form, unless such transfer has been expressly agreed in writing between the Parties and is subject to a specific consideration.

In the absence of such written agreement, the Client may not use, reproduce, modify, distribute, assign, sublicense or otherwise make the Provider Materials available to third parties, nor may it attempt to decode, decompile, disassemble or reverse engineer the Deliverables to access or derive the Provider Materials incorporated therein.

5.2 Client’s rights in the Deliverables. Provided that the Client has paid the Fees in full, ownership of the physical/tangible Deliverables shall pass to the Client, with the sole exception of the Provider Materials incorporated therein. The Provider grants the Client a limited, non‑exclusive, non‑transferable and non‑sublicensable licence to use, for internal purposes only, the Provider Materials incorporated in the Deliverables, exclusively for the purposes set out in the Contract. The Client may not, directly or indirectly, decode, decompile, disassemble or analyse the Deliverables to identify processes, algorithms or data underlying the Provider Materials, nor may it reproduce or reverse engineer such methodologies. Notwithstanding any provision of these General Terms, for Clinical Trials and regulated RWE studies, ownership, access, and use of Study Data, Results, Clinical Trial Databases, and Final Reports shall be governed by the SOW or CTA. Evidilya’s Provider Materials remain its exclusive property; however, no restriction on Provider Materials shall limit Sponsor’s rights to Study Data and Results as defined under the CTA

5.3 Restrictions. Unless otherwise agreed, the Client may not grant third parties’ access to the Deliverables or Provider Materials without the Provider’s prior written consent and the execution of a confidentiality agreement with such third party. The Client shall maintain and not remove any copyright notices, trademarks or other proprietary rights affixed to the Deliverables or Provider Materials.

6. FEES, PASS‑THROUGH COSTS AND PAYMENT TERMS

6.1 Payment structure. Unless otherwise specified in the SOW:

• the Client shall pay a deposit of at least forty per cent (40%) of the Fees upon signing the SOW/CTA, as earnest money if not otherwise specified in related SOW/CTA
• the balance shall be paid according to the milestone schedule indicated in the SOW/CTA or, failing that, within ten (10) days from the issuance of the final invoice;
• all invoices shall be paid within thirty (30) days from the invoice date.

6.2 Pass‑Through Costs and expenses. In addition to the Fees, the Client shall reimburse the Provider for Pass‑Through Costs, as defined in Article 2, within the limits and under the conditions set out in Article 7. Such costs shall be documented and invoiced without profit margin, except for any management service fees expressly indicated in the relevant Order or SOW/CTA.

6.3 Late payments. Any undisputed amount paid after the due date indicated on the invoice shall accrue default interest from the day following the due date, at a rate of one per cent (1%) per month (or, if lower, the maximum rate permitted by law). The Client shall also reimburse all legal and administrative costs incurred by the Provider in recovering the debt.

If an undisputed amount remains unpaid for more than fifteen (15) days after its due date, the Provider shall be entitled to suspend performance of the Services upon written notice with a ten (10) business‑day prior notice period. Such suspension shall not entail any liability of the Provider for delays or resulting damages.

6.4 Disputed invoices. If the Client disputes in good faith any amount, it shall notify the Provider in writing within ten (10) days of receipt of the invoice, stating the reasons for the dispute. The Parties shall confer in good faith to resolve the dispute; the Client shall in any event pay the undisputed portion within the agreed payment terms. The disputed amount shall be paid immediately after resolution of the dispute. The Client may not withhold amounts due by way of set‑off against its own claims.

7. PASS‑THROUGH COSTS

7.1 Scope of Pass‑Through Costs. Pass‑Through Costs, as defined in Article 2, specifically include – by way of example and without limitation – travel, meals and accommodation, services provided by third parties as specified in in relative SOW. .

7.2 Recharge and documentation. Pass‑Through Costs are recharged to the Client without mark‑up, subject to any management fees (service fees) specifically indicated in the relevant Order or SOW/CTA. Such costs shall be charged to the Client on the basis of available documentation, which may consist of third‑party invoices, confirmed orders, or other equivalent evidence suitable to demonstrate their actual origin.

7.3 Pass‑Through Costs to be incurred. The Client acknowledges that certain activities – in particular Ethical/Regulatory Authorities fees, study material and supplies, – require incurring costs before the actual invoicing by the third‑party supplier.

Therefore, all Pass‑Through Costs to be incurred for activities already approved by the Client shall be deemed validly chargeable, even if not yet accompanied by the third‑party supplier’s invoice, provided that they are documented by order confirmations, or equivalent documents.

7.4 Operational limits and variations. The Provider may incur or commit Pass‑Through Costs only within the limits of the budgets approved by the Client or validated plans. The Client acknowledges that Pass-Through Costs  may vary due to market dynamics, digital auctions, inventory availability or tariff updates by suppliers. Such variations, if occurring within the overall approved budget, shall not constitute a breach by the Provider.

7.5 Exclusions. Professional services rendered directly by the Provider are excluded from Pass‑Through Costs and shall be invoiced separately in accordance with the applicable Fees.

8. CLIENT’S OBLIGATIONS

8.1 In addition to Article 4, the Client undertakes to:

• ensure the lawfulness and accuracy of the data, materials and information provided to the Provider, and hold the Provider harmless from any third‑party claims in this respect;
• ensure that access by the Provider’s personnel to the Client’s premises and IT systems takes place safely and in accordance with the Client’s internal procedures;
• appoint an internal contact person to facilitate communications and promptly approve the decisions requested;
• not assign the Contract or the rights arising therefrom to third parties without the Provider’s prior written consent.

9. TERM, RENEWAL, TERMINATION AND RESCISSION

9.1 Term and renewal. Each SOW specifies the duration of the Services. Unless otherwise provided, SOWs shall have a term of minimum one (1) year from the date of signature and shall be automatically renewed for successive one‑year periods, unless either Party gives notice of non‑renewal by registered letter with return receipt or certified email (PEC) at least four (4) months before the expiry of the current period. The termination or withdrawal from a SOW shall not affect any other SOW in force.

9.2 Termination without cause. Either Party may terminate a SOW/CTA without cause by giving the other Party sixty (60) days’ prior written notice. In the event of termination by the Client, the Client shall pay the Provider: (i) the Direct Costs accrued for milestones or work units partially completed; (ii) the Pass‑Through Costs,  irrevocable commitments and uncancellable expenses undertaken with third parties; (iii) the remuneration for the time spent by the Provider’s personnel on project closure activities, charged at the rates in force; and (iv) a compensation fee equal to 100% of remaining milestones according to the SOW/CTA.

9.3 Termination for breach. The non‑breaching Party may terminate the Contract or a SOW with immediate effect if the other Party breaches material obligations (e.g. payment, confidentiality, intellectual property) and fails to remedy such breach within thirty (30) days of receipt of a written notice to cure. Termination shall be immediate in the event of licence violations, unauthorised use of Provider Materials, insolvency, liquidation, cessation of business or serious regulatory violations. In such cases, all of the Client’s rights in the Provider Materials and Deliverables shall cease immediately.

9.4 Termination for regulatory or scientific reasons. The Provider may terminate the Contract with immediate effect if events arise that make performance of the Services unlawful or contrary to mandatory regulations, or put at risk the safety of the recipients of the Services or the integrity of the data. The Client shall be entitled to a pro‑rata refund of any amounts paid in advance for Services not yet provided.

9.5 If Evidilya identifies or reasonably foresees delays affecting timelines or resource allocation, it shall notify the Client promptly. The Parties shall agree in good faith on appropriate adjustments to timelines and fees. For Clinical Trials or RWE Studies, the Delay Management procedure and consequences defined in the CTA shall supersede this section.

9.6 Effects of termination. Upon termination, the Provider shall, upon the Client’s request and at the Client’s expense, provide the assistance necessary to transfer the Deliverables and data to the Client or to a new supplier. The Parties shall agree in writing on the “wind‑down” activities and related costs. All accrued payments and non‑cancellable expenses incurred up to the effective date of termination shall remain due.

10. LIMITATIONS OF LIABILITY

10.1 Except in cases of wilful misconduct or gross negligence, the Provider shall in no event be liable for indirect, incidental or consequential damages, loss of profits, loss of revenue, loss of data or goodwill, or for third‑party claims, even if it has been advised of the possibility of such damages. The Provider’s total aggregate liability, on any legal ground whatsoever, shall not exceed the total amount paid by the Client to the Provider in the twelve (12) months preceding the event giving rise to the claim.

10.2 For Clinical Trials or regulated RWE studies, indemnification obligations are governed exclusively by the CTA. Any limitation of liability under these General Terms and Conditions does not apply where incompatible with CTA obligations

10.3 Nothing in these General Terms and Conditions shall exclude or limit either Party’s liability for death or personal injury caused by wilful misconduct or gross negligence, fraud or any other liability that cannot be limited or excluded under applicable law.

11. CONFIDENTIALITY AND DATA PROTECTION

11.1 Confidentiality. Each Party undertakes not to disclose to third parties the confidential information received from the other Party and to use it solely for the performance of the Contract, adopting protection measures at least equivalent to those adopted for its own confidential information. “Confidential information” means technical, commercial and financial data, project documents, methodologies, strategies, prices and any information that, by its nature or by indication, must be treated as confidential. This excludes information that is already in the public domain, has been independently developed without reference to confidential information or has been lawfully obtained from third parties without confidentiality obligations.

11.2 Privacy obligations. The Parties declare that they comply with Regulation (EU) 2016/679 (GDPR) and Italian Legislative Decree no. 196/2003 and that they use personal data solely for contractual purposes. Any appointment as external data processor shall be governed by a specific addendum.

11.3 Publication of references. Unless the Client expressly objects, the Provider may include the Client’s name and logo in its client list and use the Deliverables as case studies for promotional purposes, while respecting confidentiality obligations and refraining from disclosing sensitive data.

12. AUDITS, INSPECTIONS AND DOCUMENT RETENTION

12.1 The Client may, upon at least thirty (30) days’ prior written notice and no more than once per year, carry out audits at the Provider’s premises during business hours to verify compliance of the Services. Audit costs shall be borne by the Client. Inspections by regulatory authorities shall be handled by the Provider; costs incurred by the Provider in responding to inspections related to the Services may be charged to the Client where they arise from the specific nature of the project.

12.2 The Provider shall retain operational documents relating to the Services for at least one (1) year after completion of the SOW and shall make them available to the Client in connection with any inspections or regulatory requests.

13. INSURANCE AND FORCE MAJEURE

13.1 The Provider maintains civil liability insurance coverage for third‑party liability and for its employees. A copy of the policy may be provided at the Client’s request. Any requests for additional coverage shall be at the Client’s expense.

13.2 Neither Party shall be liable for failure to perform due to force majeure events, such as natural disasters, armed conflicts, acts of authorities, cyber‑attacks, pandemics or other circumstances beyond the reasonable control of the affected Party, provided that such Party promptly notifies the other Party. If the force majeure event continues for more than sixty (60) days, either Party may terminate the affected SOW without additional liability.

14. NON‑SOLICITATION AND COMPETITION

14.1 The Client undertakes not to hire or engage directly or indirectly any of the Provider’s personnel involved in the performance of the Services for the entire duration of the Contract and for twelve (12) months after its termination. In the event of breach, the Client shall pay the Provider a penalty equal to twelve (12) months of the employee’s remuneration/fee, without prejudice to compensation for any further damages.

14.2 The Client further undertakes, for a period of two (2) years from termination of the Contract, not to contact or contract with the Provider’s suppliers involved in the Services, and not to disclose or use confidential information relating to the Provider’s know‑how, prices and strategies.

15. GOVERNING LAW AND JURISDICTION

15.1 The Contract shall be governed by and construed in accordance with Italian law. Any dispute relating to the validity, interpretation or performance of the Contract shall be submitted to the exclusive jurisdiction of the Courts of Milan, Italy.

16. FINAL PROVISIONS

16.1 Independence of the Parties. The Parties operate in full autonomy; none of the provisions of the Contract shall constitute a mandate or power of attorney, nor imply representation, joint venture or association.

16.2 Entire agreement. The Contract constitutes the sole understanding between the Parties with respect to its subject matter and supersedes all prior agreements, written or oral. Any other terms and conditions shall not apply unless accepted in writing by both Parties.

16.3 Severability. If any provision is found to be invalid or unenforceable, this shall not affect the validity of the remaining provisions, which shall remain in full force and effect. The Parties shall replace any invalid clause with a new clause that reflects as closely as possible their original intent.

16.4 Waiver. Failure to exercise a right shall not constitute a waiver or acquiescence, nor prevent its subsequent exercise.

16.5 Notices. Unless otherwise provided, all communications relating to the Contract shall be made in writing by certified email (PEC) or registered letter with return receipt to the addresses indicated in the quotation/purchase order.

16.6 Formation of the Contract. Exchange of signed copies by email shall be equivalent to delivery of originals.

16.7 Updates to the General Terms and Conditions. The Provider may amend these General Terms and Conditions to comply with legislative or regulatory changes or technological developments, by notifying the Client at least thirty (30) days in advance. The amendments shall be deemed accepted unless the Client notifies its objection in writing within the same period; in such case, if the Parties do not reach an agreement, either Party may terminate the Contract in accordance with the provisions on termination without cause set out in Article 9.2. A copy of the current version of the terms is available on the website www.sprim.it.

17. USE OF ARTIFICIAL INTELLIGENCE (AI) TECHNOLOGIES

17.1 General principles. In providing the Services, the Provider may use tools and systems based on Artificial Intelligence or machine learning technologies for analysis, content generation, automation and optimisation activities. Such tools shall be used to support human work and shall not replace the supervision and final decision‑making of the Provider’s qualified personnel.

17.2 Quality of results and human supervision. The Client acknowledges that AI‑generated outputs may contain errors, inaccuracies or bias and that quality may depend on the input data and algorithms used. The Provider shall take reasonable measures to verify and, where necessary, correct AI‑generated outputs.

17.3 Data protection. The Provider shall use the Client’s data in compliance with applicable personal data protection laws. Unless strictly necessary for performance of the Services, the Client’s personal data shall not be used to train AI models or for purposes other than those set out in the Contract. Where possible, data shall be processed in anonymised or aggregated form. The Provider may use AI models supplied by third parties, ensuring that they provide adequate security and confidentiality safeguards.

17.4 Intellectual property rights on AI outputs. Unless otherwise agreed, AI‑generated outputs that constitute Deliverables shall be treated in accordance with Article 5: they shall remain the property of the Provider until full payment of the Fees and shall be licensed to the Client for the purposes set out therein. The Client acknowledges that the algorithms, models, prompts and workflows used to generate such outputs are Provider Materials and remain the exclusive property of the Provider or its licensors.

18. USE OF THE “EVIDILYA” LOGO

18.1 Authorisation. Use of the “Evidilya” name or logo by the Client requires the Provider’s prior written authorisation. The authorisation shall specify the channels in which the logo will be published (website, brochures, presentations, social media), the purposes of use, the term and the graphic guidelines to be followed.

18.2 Prohibition of modifications. The logo may not be altered in any way (colour, shape, proportions, font) or combined with other distinctive signs without the Provider’s written consent.

18.3 Informational use. Use of the logo for purely informational purposes (e.g. to mention the collaboration) is permitted provided that such use is limited to objective communication needs, does not create confusion or an apparent commercial affiliation and complies with professional fairness rules.

18.4 Control and revocation. The Provider reserves the right to revoke the authorisation in the event of improper use of the logo or breach of these conditions. In such case, the Client shall immediately cease using the logo and remove it from all materials.

19. SPECIFIC CLAUSES PURSUANT TO ARTICLES 1341 AND 1342 OF THE ITALIAN CIVIL CODE

Pursuant to and for the purposes of Articles 1341 and 1342 of the Italian Civil Code, the Client declares that it has read, understood and expressly approves the following provisions of these General Terms and Conditions of Contract:

– Article 4.2 (Client’s cooperation and consequences of delay); Article 4.3 (Change Request); Article 4.4 (Technical and regulatory updates); Article 5 (Intellectual property, licences and restrictions); Article 6 (Fees, Pass‑Through Costs and payment terms – default interest, suspension of Services, retention of credentials); Article 7 (Pass‑Through Costs and); Article 8 (Client’s obligations and prohibition on assignment of the Contract); Article 9 (Term, renewal, termination without cause, termination for breach and effects of termination); Article 10 (Limitations of liability); Article 11 (Confidentiality and data protection); Article 12 (Audits, inspections and document retention); Article 13 (Insurance and force majeure); Article 14 (Non‑solicitation and competition); Article 15 (Governing law and exclusive jurisdiction of the Courts of Milan); Articles 16.2, 16.3, 16.6 and 16.7 (Entire agreement, severability, formation of the Contract, updates to the General Terms and Conditions); Article 17 (Use of Artificial Intelligence technologies – AI); Article 18 (Use of the Evidilya logo).