General Terms and Conditions of Service

Version: Evidilya - Version 2.1 (website edition) · Effective date: September 2026

These General Terms and Conditions (“GTC”) are made of four parts. Part A applies to all Services. Part B applies in addition where the Services relate to a clinical trial, clinical investigation, non-interventional or real-world evidence study (“Clinical Research Services”). Part C applies in addition to consumer, healthcare professional, patient and scientific surveys, panels and other market research and insight services (“Survey Services”). Part D applies in addition to consulting, scientific, medical writing, publication and other non-clinical services (“Consulting Services”). In the event of conflict, Parts B, C and D prevail over Part A for the Services to which they apply.

PART A – GENERAL TERMS

Article 1 – CONTRACT AND ACCEPTANCE

1.1 These GTC govern the provision of services by Evidilya S.r.l., having its registered office and headquarters at Via Brisa 3, 20123 Milan, Italy, VAT No. 06957380964 (“Evidilya”), to the business customer identified in the quotation or statement of work (“Client”). Evidilya provides Services only to companies, institutions and professionals acting in the course of their business; consumer protection rules do not apply.

1.2 The agreement between the Parties (the “Contract”) consists of: (a) any Clinical Trial Agreement or other agreement signed by both Parties (“CTA”); (b) the quotation or statement of work issued by Evidilya and accepted by the Client, with its annexes (“SOW”); (c) any data processing agreement (“DPA”); (d) these GTC; and (e) any Change Request. In the event of conflict, the CTA prevails over the SOW, the SOW prevails over these GTC only where it expressly refers to the provision of the GTC it departs from, and the DPA prevails on data protection matters.

1.3 Any terms and conditions contained in or referred to in the Client’s purchase order, vendor portal or other document are excluded and do not apply, even if Evidilya does not expressly object to them. A purchase order is accepted only as an administrative document.

1.4 The Contract is formed when the SOW is signed by both Parties, when the Client accepts the SOW in writing (including by email or electronic signature), when the Client issues a purchase order referring to it, or when the Client asks Evidilya to start the Services, whichever occurs first. The version of these GTC in force on the date of the SOW applies to it.

Article 2 – DEFINITIONS

“Affiliate”: any entity that directly or indirectly controls, is controlled by or is under common control with a Party, where control means the ownership of more than fifty per cent (50%) of the voting rights or the power to direct the management and policies of the entity.

“Applicable Law”: the laws, regulations and guidelines applicable to the Services and, for Clinical Research Services, the applicable good clinical practice guidelines (“GCP”).

“Background IP”: all intellectual property, know-how, materials and tools owned, licensed or developed by Evidilya before or independently of the Contract, or developed in the course of the Services and of general application, including methodologies, procedures, templates, software and platforms (including the ECS® Platform and related applications), source code, databases, algorithms, models, prompts, workflows and any improvements to them.

“Change Request”: a written amendment to a SOW signed by both Parties.

“Client Materials”: all data, documents, materials, products and information provided by or on behalf of the Client.

“Deliverables”: the work products identified as deliverables in the SOW and created specifically for the Client. Deliverables do not include Background IP.

“ECS® Platform”: Evidilya’s proprietary electronic clinical system and related applications.

“Fees”: the professional fees for the Services set out in the SOW, excluding Pass-Through Costs and taxes.

“Pass-Through Costs”: costs incurred or committed by Evidilya with third parties on behalf of the Client for the Services, recharged at cost without mark-up, plus any management fee stated in the SOW.

“Services”: the services described in the SOW.

“Sponsor”: the person responsible under Applicable Law for the initiation, management and financing of a Study; where the Client is or acts for the Sponsor, references to the Sponsor include the Client.

“Study”: any clinical trial, clinical investigation, non-interventional or real-world evidence study, registry or research project to which the Services relate.

“Study Data”: the data, results and records generated in a Study.

Article 3 – SERVICES

3.1 Evidilya performs the Services with reasonable skill and care, in accordance with the SOW and Applicable Law. Evidilya’s obligations are obligations of means: Evidilya does not guarantee any scientific, clinical, regulatory, publication or commercial result, enrolment rate or timeline.

3.2 Evidilya may perform the Services through its Affiliates, personnel and qualified subcontractors, and remains responsible for their performance. Investigators, sites, ethics committees, laboratories and vendors selected by the Client are not subcontractors of Evidilya.

3.3 Timelines are estimates based on the assumptions stated in the SOW and depend on the Client and on third parties. Any change to scope, assumptions, timelines or budget, including changes required by protocol amendments, by Applicable Law or by an authority or ethics committee, is documented in a Change Request. Evidilya is not obliged to perform out-of-scope work before a Change Request is signed, except for activities urgently required for the safety of Study participants, the integrity of data or compliance with Applicable Law, which Evidilya may perform and charge at its rates with prompt notice to the Client.

3.4 Evidilya may modify its procedures and the ECS® Platform to comply with Applicable Law, security requirements or technological updates, provided that equivalent functionality is maintained.

Article 4 – CLIENT OBLIGATIONS

4.1 The Client shall provide the Client Materials, information, decisions, approvals and access required for the Services within the timelines in the SOW or, failing that, within ten (10) business days of Evidilya’s request, and shall appoint a contact person authorised to take decisions.

4.2 The Client warrants that the Client Materials are accurate, complete and lawfully obtained, and that their use for the Services does not infringe any third-party right or Applicable Law, and shall hold Evidilya harmless from any related claim.

4.3 Any delay attributable to the Client extends Evidilya’s timelines accordingly; resources kept available during the delay may be charged at Evidilya’s rates.

4.4 If a delay attributable to the Client exceeds sixty (60) days, Evidilya may terminate the affected SOW on fifteen (15) days’ written notice and is entitled to the amounts under Article 10.2(a) to (c) together with a liquidated amount equal to thirty per cent (30%) of the Fees for the Services not yet performed, without prejudice to any further damage.

Article 5 – FEES AND PAYMENT

5.1 Fees are set out in the SOW, are expressed in Euro unless otherwise stated, and are exclusive of VAT and any other tax, duty or withholding. If the Client is required to withhold any tax, it shall pay such additional amount as ensures that Evidilya receives the full amount invoiced. Bank charges are borne by the Client. Estimates for services charged on a time-and-materials basis are not caps.

5.2 Unless otherwise stated in the SOW, the Client pays an advance of forty per cent (40%) of the Fees on signature of the SOW, which is an advance payment on the Fees, is not a deposit or earnest money and is not refundable except under Article 10.4; the balance is invoiced upon the milestones in the SOW or, failing milestones, monthly in arrears. Invoices are payable within thirty (30) days from the invoice date.

5.3 Pass-Through Costs are invoiced separately in accordance with Article 6.

5.4 Amounts not paid when due bear interest, automatically and without notice, at one per cent (1%) per month or, if lower, the maximum rate permitted by Applicable Law, together with the costs of recovery. If any undisputed amount remains unpaid fifteen (15) days after its due date, Evidilya may suspend the Services and the Client’s access to the ECS® Platform on ten (10) business days’ written notice; timelines are extended accordingly and Evidilya is not liable for the consequences of the suspension.

5.5 The Client shall notify any dispute on an invoice in writing, stating the reasons, within ten (10) business days of receipt, failing which the invoice is deemed accepted; the undisputed portion is payable within the ordinary terms. The Client may not withhold, reduce or set off any amount due to Evidilya.

5.6 For SOWs exceeding twelve (12) months, Evidilya may adjust its rates annually in line with the consumer price index of the country of its registered office, on thirty (30) days’ notice. Where the Services benefit an Affiliate of the Client or a third-party Sponsor, the Client remains jointly and severally liable for payment.

Article 6 – PASS-THROUGH COSTS

6.1 Pass-Through Costs include, by way of example, investigator grants and site payments, fees of ethics committees and authorities, laboratory, logistics, courier, translation and licence costs, participant reimbursements, insurance premiums for the Study, and travel, meals and accommodation of Evidilya’s personnel. Professional services performed by Evidilya are not Pass-Through Costs.

6.2 Pass-Through Costs are recharged on the basis of third-party invoices, order confirmations or equivalent evidence, and may be invoiced upon commitment before receipt of the third party’s invoice.

6.3 Evidilya is not obliged to advance Pass-Through Costs from its own funds. Unless otherwise stated in the SOW, the Client provides in advance a fund for Pass-Through Costs in the amount stated in the SOW or estimated by Evidilya for the following quarter, and replenishes it on request; Evidilya reconciles the fund within sixty (60) days of the end of the SOW and returns any unused amount.

6.4 Pass-Through Costs may vary with the number of sites and participants, third-party tariffs, market conditions and exchange rates; variations within the approved budget are not a breach. Evidilya seeks the Client’s approval for expenditure exceeding a budget line by more than ten per cent (10%), except for expenditure urgently required for participant safety or data integrity. Costs in foreign currency are converted at the exchange rate on the date of payment.

Article 7 – INTELLECTUAL PROPERTY

7.1 Background IP is and remains the exclusive property of Evidilya and its licensors. The Client acquires no right in the Background IP and no right to receive it in source, editable or open-file format, unless expressly agreed in writing against a specific consideration.

7.2 Subject to full payment of the related Fees and Pass-Through Costs, the Deliverables become the property of the Client. Until full payment Evidilya retains all rights in the Deliverables and the Client may use them only for the purposes of the SOW. To the extent Background IP is incorporated in a Deliverable, Evidilya grants the Client a non-exclusive, perpetual, royalty-free licence to use it as part of the Deliverable for any lawful purpose, including regulatory submissions and publications; the Client shall not extract, sublicense or make available the Background IP separately from the Deliverable.

7.3 Access to the ECS® Platform and to any software made available by Evidilya is licensed, not sold, on a non-exclusive and non-transferable basis for the purposes and duration of the Services. The Client shall not copy, modify, decompile, disassemble or reverse engineer them, except to the extent permitted by mandatory law, nor give access to them to competitors of Evidilya. Data hosted on the ECS® Platform belong to the Client and are exported to the Client in standard formats at the end of the Services.

7.4 Evidilya may freely use the general knowledge, skills, experience and techniques acquired in performing the Services, and anonymised and aggregated information that does not identify the Client. Client Materials remain the property of the Client, which licenses them to Evidilya for the Services. The Client shall not remove any proprietary notice from the Deliverables.

Article 8 – CONFIDENTIALITY

8.1 Each Party shall keep confidential the information of the other Party that is marked as confidential or that a reasonable person would consider confidential, including the terms of the Contract, use it only for the Contract, and disclose it only to its Affiliates, personnel, subcontractors, advisers and insurers who need to know it and are bound by confidentiality.

8.2 These obligations do not apply to information that is or becomes public without breach, was already known to or is independently developed by the receiving Party, or is lawfully received from a third party, and do not prevent disclosures required by Applicable Law, by a court, by an authority or ethics committee, or necessary for the conduct of a Study.

8.3 These obligations last for the term of the Contract and five (5) years thereafter, and without limit for trade secrets and personal data. Upon written request the receiving Party returns or destroys the confidential information, except for copies it is required or entitled to retain under Applicable Law or its retention procedures.

Article 9 – DATA PROTECTION

9.1 Each Party complies with the data protection laws applicable to it, including Regulation (EU) 2016/679 where applicable. Where Evidilya processes personal data on behalf of the Client, the Parties enter into a DPA before the processing starts; the roles of the Parties in respect of Study participants’ data are defined in the CTA and the DPA.

9.2 The Client is responsible for the lawfulness of the personal data it provides or instructs Evidilya to process, including any consent, notice or impact assessment required. Evidilya applies appropriate technical and organisational security measures and notifies the Client without undue delay of any personal data breach affecting the Client’s data. Personal data are transferred outside the European Economic Area only with appropriate safeguards.

Article 10 – TERM AND TERMINATION

10.1 Each SOW runs until completion of the Services or the end date stated in it. Recurring services with a fixed term (such as platform licences, safety services, hosting or archiving) renew automatically for successive periods of twelve (12) months unless either Party gives three (3) months’ written notice of non-renewal.

10.2 The Client may terminate a SOW for convenience on sixty (60) days’ written notice (or the notice stated in the CTA), paying Evidilya: (a) the Fees for the Services performed up to the effective date, including the portion of any milestone in progress valued at Evidilya’s rates; (b) the Pass-Through Costs incurred or committed and any non-cancellable obligations; (c) the close-out and transition activities at Evidilya’s rates; and (d) an early termination fee equal to twenty per cent (20%) of the Fees for the Services not yet performed.

10.3 Evidilya may terminate a SOW for convenience on sixty (60) days’ written notice, in which case the Client pays only the amounts under Article 10.2(a) to (c). Either Party may terminate the Contract or a SOW with immediate effect if the other Party materially breaches it and does not remedy the breach within thirty (30) days of written notice (fifteen (15) days for payment obligations), or becomes insolvent, enters liquidation or ceases business.

10.4 Either Party may suspend or terminate the affected SOW with immediate effect if the Study is suspended or terminated by an authority, an ethics committee or the Sponsor, if the continuation of the Services becomes unlawful, or if events occur that put at risk the safety of participants or the integrity of data. In such case the Client pays the amounts under Article 10.2(a) to (c) and Evidilya refunds the portion of any advance corresponding to Services not performed.

10.5 Upon termination all accrued amounts become due; Evidilya delivers the Deliverables paid for and, at the Client’s expense, provides the transition assistance agreed in writing. If the Contract is terminated for the Client’s breach, the licences under Articles 7.2 and 7.3 for unpaid Deliverables and Services cease and access to the ECS® Platform may be discontinued, without prejudice to Article B3. Articles 5, 7, 8, 9, 10.5, 11, 13, 14 and 17 survive termination.

Article 11 – LIABILITY

11.1 Except as expressly stated in the Contract, all warranties and conditions implied by law are excluded to the maximum extent permitted. Evidilya is not liable for any indirect or consequential loss, loss of profit, revenue, business, data or goodwill, or for the cost of substitute services.

11.2 Evidilya’s total aggregate liability arising out of or in connection with each SOW, on any legal ground, does not exceed the Fees (excluding Pass-Through Costs) paid by the Client under that SOW in the twelve (12) months preceding the event giving rise to the claim.

11.3 Nothing in the Contract excludes or limits a Party’s liability for death or personal injury, fraud, wilful misconduct or gross negligence, or any other liability that cannot be excluded or limited under Applicable Law.

11.4 The Client shall indemnify and hold harmless Evidilya, its Affiliates and personnel from any third-party claim arising out of the Client Materials, the design of the Study, the investigational product, device or intervention, any product supplied by or on behalf of the Client for use, testing or consumption by participants or respondents, the use of the Deliverables by the Client, or the Client’s breach of Applicable Law or of its obligations as Sponsor, except to the extent caused by Evidilya’s gross negligence or wilful misconduct.

11.5 Any claim under the Contract must be notified in writing within six (6) months from the date on which the claiming Party became, or should have become, aware of the facts giving rise to it, failing which it is forfeited.

Article 12 – INSURANCE AND FORCE MAJEURE

12.1 Evidilya maintains professional and general liability insurance customary for its business. Insurance or indemnification of Study participants required by Applicable Law, product liability insurance and the insurance of respondents who use, test or consume products supplied by or on behalf of the Client are the responsibility of the Client or Sponsor and are not covered by Evidilya’s insurance; premiums for Study-specific insurance procured by Evidilya are Pass-Through Costs.

12.2 Neither Party is liable for any failure or delay, other than in payment, caused by events beyond its reasonable control, including natural disasters, epidemics and related public measures, war, terrorism, strikes, acts of authorities, failures of utilities or networks, and cyber-attacks that could not reasonably have been prevented, provided that it notifies the other Party promptly. If the event lasts more than sixty (60) days either Party may terminate the affected SOW; the amounts under Article 10.2(a) to (c) remain due.

Article 13 – NON-SOLICITATION

13.1 During the term of each SOW and for twelve (12) months thereafter, the Client shall not, directly or indirectly, solicit, hire or engage any personnel of Evidilya involved in the Services, other than through a general public recruitment advertisement. In the event of breach the Client shall pay Evidilya, as liquidated damages, an amount equal to twelve (12) months of the gross remuneration of the person concerned, without prejudice to any further damage.

13.2 For twelve (12) months after the end of a SOW, the Client shall not engage, for services substantially similar to the Services and in order to circumvent Evidilya, any subcontractor first introduced to the Client by Evidilya. Investigators, sites, ethics committees, laboratories and suppliers already known to the Client are excluded.

Article 14 – COMPLIANCE

14.1 Each Party complies with the anti-bribery, anti-corruption, economic sanctions and export control laws applicable to it. Payments to investigators, sites and healthcare professionals are made at fair market value for services actually rendered and are never conditional on the referral of patients or on the prescription, purchase or recommendation of any product. The Client is responsible for its own transfer-of-value reporting.

14.2 Evidilya represents that, to its knowledge, it has not been debarred or excluded from clinical research by any competent authority. A breach of this Article 14 entitles the other Party to terminate the Contract with immediate effect.

Article 15 – ARTIFICIAL INTELLIGENCE

15.1 Evidilya may use tools based on artificial intelligence to support analysis, drafting, quality control and automation, under the supervision of its qualified personnel, which remains responsible for the Deliverables. The Client may require in the SOW that such tools are not used for specific activities, subject to any impact on Fees and timelines.

15.2 Evidilya does not use the Client’s confidential information, Study Data or personal data to train artificial intelligence models made available to third parties, and uses third-party tools only under commitments of confidentiality and no training on customer data. Outputs incorporated in a Deliverable are Deliverables; the tools, models, prompts and workflows are Background IP.

Article 16 – PUBLICITY

16.1 Neither Party uses the name or logo of the other in public communications without prior written consent, except as required by Applicable Law or by clinical trial registration and transparency obligations. Evidilya may refer to the Client by name, without disclosing confidential information, in confidential credentials and proposals to prospective clients unless the Client objects in writing. Any authorised use of the Evidilya name and logo complies with Evidilya’s guidelines and may be revoked in case of improper use.

Article 17 – GENERAL PROVISIONS

17.1 The Parties are independent contractors; nothing in the Contract creates an employment relationship, partnership, joint venture or agency.

17.2 The Client may not assign the Contract or any right under it without Evidilya’s prior written consent. Evidilya may assign the Contract to an Affiliate or to a successor of its business on written notice, and may assign its receivables.

17.3 The Contract is the entire agreement between the Parties on its subject matter and supersedes all prior communications. If any provision is invalid or unenforceable, the remaining provisions remain in force and the invalid provision is replaced by a valid one reflecting the Parties’ intent as closely as possible. Failure to exercise a right is not a waiver.

17.4 Formal notices are given in writing by courier, registered mail or email with acknowledgement of receipt to the addresses in the SOW or, for Evidilya, at www.evidilya.com. Operational communications may be exchanged by email.

17.5 Evidilya may update these GTC by publishing a new version with its effective date at www.evidilya.com/terms-and-conditions. The new version applies to SOWs issued after its effective date; changes required by Applicable Law also apply to SOWs in progress on thirty (30) days’ notice.

17.6 These GTC are drawn up in English, which prevails over any translation. The Contract may be signed electronically and in counterparts; signed copies exchanged by email or through an e-signature platform are equivalent to originals.

17.7 Except as expressly provided, the Contract confers no right on any person other than the Parties. Headings are for convenience only; “including” means “including without limitation”.

17.8 Governing law. The Contract is governed by the laws of the country in which Evidilya has its registered office, excluding its conflict-of-law rules and the United Nations Convention on Contracts for the International Sale of Goods.

17.9 Disputes. The Parties shall first attempt to resolve any dispute arising out of or in connection with the Contract through good-faith discussions between senior representatives for thirty (30) days. Any dispute not so resolved shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one arbitrator appointed in accordance with those Rules. The seat of arbitration is the city in which Evidilya has its registered office; the language of the arbitration is English. Evidilya may nevertheless bring proceedings before any competent court for the recovery of undisputed amounts and for interim or injunctive relief to protect its intellectual property or confidential information.

17.10 Specific approval. Where the governing law requires the specific written approval of certain clauses of general terms and conditions, the Client, by signing the SOW or the clause reproduced in it, specifically approves Articles 1.3, 4.4, 5.4, 5.5, 7.3, 10.1, 10.3, 10.4, 10.5, 11, 12.2, 13, 17.2, 17.5, 17.9, B4, C3 and C11 of these GTC.

PART B – ADDITIONAL TERMS FOR CLINICAL RESEARCH SERVICES

This Part B applies where the Services relate to a Study. The Study is governed by the CTA, the protocol, Applicable Law and GCP; in the event of conflict the CTA prevails over these GTC.

B1 Delegated tasks

B1 Evidilya performs only the Sponsor tasks expressly delegated to it in the SOW or CTA. The Sponsor retains ultimate responsibility for the Study and for all obligations not expressly delegated, including the protocol and its approval, the conformity, quality, safety, supply, labelling and logistics of the investigational product or device, the authorisations and registrations required from the Sponsor, the insurance or indemnification of participants, the pharmacovigilance and safety obligations not delegated, the transparency and results-posting obligations, and the lawfulness of the processing of participants’ data, the informed consent and any impact assessment.

B2 Subcontractors

B2 Subcontractors entrusted with GCP-critical activities are identified in the SOW or CTA or notified to the Client. Investigators, sites, ethics committees, central laboratories and vendors selected by the Client are engaged on behalf of the Sponsor and their costs are Pass-Through Costs.

B3 Study Data and records

B3 The ownership of, access to and use of Study Data, databases and study reports are governed by the CTA. Evidilya makes available to the Sponsor the Study Data and essential documents in its possession that the Sponsor needs to comply with its regulatory and safety obligations, without prejudice to Evidilya’s right to payment. The long-term retention of the trial master file and essential documents required by Applicable Law is an obligation of the Sponsor; Evidilya transfers or archives the documents in its possession at the end of the Services at the fees stated in the SOW or in its rate card, and destroys Study records only on the Sponsor’s written instruction.

B4 Audits and inspections

B4 Unless otherwise agreed in the CTA, the Client may audit Evidilya’s facilities, systems and records relating to the Services once per calendar year, on thirty (30) business days’ written notice, during business hours, under confidentiality and at the Client’s cost, and may conduct an additional audit on reasonable notice where it has documented grounds to suspect a material non-compliance. Each Party informs the other promptly of any inspection by an authority relating to the Services; Evidilya’s support to Study-specific audits and inspections beyond two (2) person-days per year is chargeable at its rates.

B5 Site payments

B5 Investigator grants and site payments are Pass-Through Costs paid out of the fund under Article 6.3; Evidilya is not obliged to pay any site or investigator before receiving the corresponding funds from the Client.

B6 Safety continuity

B6 During any suspension, termination or transition, the activities strictly necessary to protect the safety of participants and to comply with mandatory safety reporting continue until effectively transferred, and are chargeable at Evidilya’s rates.

B7 Termination of a Study

B7 Where the Sponsor or an authority terminates or suspends a Study for any reason, Article 10.4 applies; where the Client terminates the Services while the Study continues, Article 10.2 applies.

B8 Liability

B8 The indemnification and insurance obligations relating to participant injury are governed exclusively by the CTA. Article 11 applies to all other matters.

PART C – ADDITIONAL TERMS FOR SURVEY SERVICES

This Part C applies to consumer surveys, surveys of healthcare professionals, patients, caregivers and other professionals, scientific and opinion surveys, panels, communities, advisory boards, interviews, observatories and other market research and insight services (“Survey Services”). Where a survey requires the opinion of an ethics committee or otherwise qualifies as a Study under Applicable Law, Part B applies instead. Survey Services may be performed on the basis of the SOW alone, without any further agreement: the SOW describes the objectives, target population, sample, methodology, questionnaire, incentives, timelines and Deliverables and, together with these GTC, constitutes the entire agreement for the Survey Services.

C1 Design and questionnaire

C1 Evidilya designs the methodology, the screener and the questionnaire on the basis of the Client’s brief. The Client approves the final questionnaire, screener and any stimulus material in writing before fieldwork starts, and is responsible for the accuracy and lawfulness of the questions, claims, product information and materials it provides or approves, and for ensuring that the survey is not used as disguised promotion or sales. Changes after approval are Change Requests.

C2 Sample and fieldwork

C2 Sample size, incidence, response rates and fieldwork timelines are estimates. Evidilya uses reasonable efforts to reach the target sample; where the target cannot be reached within the agreed timelines, Evidilya may propose an extension of fieldwork, a change of target or a pro-rata adjustment of the Fees, and delivers the sample achieved. Evidilya does not warrant the statistical representativeness of the sample beyond what is expressly stated in the SOW.

C3 Respondents and panels

C3 Respondents are recruited through Evidilya’s proprietary panels and communities, through partner panels or through lists provided by the Client. Evidilya’s panels, communities, recruitment databases, screening and quality tools are Background IP. The identity and contact details of respondents recruited by Evidilya are not disclosed to the Client, and the Client shall not attempt to identify, contact or re-contact them, unless the respondents have expressly consented and the SOW so provides. Where the Client provides lists, it warrants that they may lawfully be used for the survey.

C4 Incentives

C4 Incentives, honoraria and prizes for respondents are Pass-Through Costs, are set at fair market value in proportion to the time and expertise required, are never conditional on the prescription, purchase or recommendation of any product, and are structured in compliance with Applicable Law and the applicable research and industry codes. The Client is responsible for its own transfer-of-value reporting; Evidilya provides the information in its possession where required.

C5 Research standards

C5 Evidilya conducts Survey Services in accordance with generally recognised international codes for market, opinion and social research and, for healthcare market research, the applicable healthcare research codes. Participation of respondents is voluntary and informed; respondents remain anonymous towards the Client and results are reported in aggregated form, unless otherwise stated in the SOW.

C6 Adverse events and product complaints

C6 Where the Client is a marketing authorisation holder or manufacturer and requires the forwarding of adverse events or product complaints spontaneously mentioned by respondents, the Client provides Evidilya with its reporting procedure and contact details before fieldwork starts; Evidilya forwards such mentions in accordance with that procedure and may charge the related time at its rates. Evidilya has no pharmacovigilance or vigilance obligation beyond such forwarding.

C7 Data protection

C7 Evidilya acts as controller of its own panels and of the data it collects for recruitment and quality purposes, and as processor of the lists provided by the Client and of any identifiable data delivered to the Client under the SOW; the Parties enter into a DPA where required. Responses are collected and delivered in pseudonymised or aggregated form. Special categories of data, including health data, are collected only with the explicit consent of the respondents and delivered to the Client only in aggregated or anonymised form, unless the SOW provides otherwise.

C8 Results

C8 Subject to payment, the Client owns the Deliverables and the results relating to its brief and may use and publish them for any lawful purpose, describing the methodology accurately and without attributing to Evidilya conclusions it has not expressed. Raw datasets are delivered only where the SOW so provides, in pseudonymised form. Evidilya may retain and use survey data in anonymised and aggregated form for benchmarks, observatories, methodological development and publications that do not identify the Client, its products or the respondents. Any public reference to Evidilya as the research provider is subject to Article 16.

C9 Syndicated and multi-client studies

C9 Where the SOW identifies the Services as syndicated, observatory or multi-client, the results and reports are Background IP of Evidilya, the Client receives a non-exclusive, non-transferable licence to use them for its internal purposes and for the external uses stated in the SOW, and Article 7.2 does not apply.

C10 Records

C10 Articles B3 and B4 do not apply to Survey Services. Evidilya retains fieldwork records and raw data for the period stated in its retention procedures and may destroy them thereafter, unless the SOW provides for a longer retention at the Client’s cost.

C11 Products supplied for testing

C11 Where the Survey Services involve the use, testing, tasting or consumption by respondents of a product supplied by or on behalf of the Client (including home-use tests, sensory tests and product tests), the Client is and remains solely responsible for the product, and warrants that: (a) the product complies with Applicable Law and may lawfully be supplied to the intended respondents for the intended use; (b) it is safe, of suitable quality and within its shelf life, and is delivered with the labelling, instructions, warnings, allergen and safety information required for its use; (c) the Client holds and maintains product liability insurance, and any insurance required by Applicable Law, covering the use of the product by respondents; and (d) the Client provides the information to be given to respondents about the product and its use. Evidilya’s role is limited to distributing the product to respondents in accordance with the Client’s instructions and collecting their feedback; Evidilya does not verify the conformity, safety or quality of the product and assumes no liability for it. Evidilya may refuse or suspend the distribution of a product that appears unsafe, non-compliant or insufficiently documented, without liability. Adverse reactions reported by respondents are forwarded in accordance with Article C6. Logistics, storage and destruction of the product are Pass-Through Costs. Where the use of the product constitutes a Study under Applicable Law, Part B applies.

PART D – ADDITIONAL TERMS FOR CONSULTING SERVICES

This Part D applies to strategic, scientific and regulatory consultancy, medical writing, scientific publication support, market access, training, digital and other services that do not involve the conduct of a Study or of Survey Services.

D1 Nature of the Deliverables

D1 Deliverables consist of analyses, opinions, recommendations, drafts and materials based on the Client Materials, on publicly available information and on Evidilya’s professional judgement at the time of delivery. The Client is solely responsible for the decisions it takes on the basis of the Deliverables, for their use and for any submission, publication or communication made with them.

D2 Scientific and regulatory content

D2 Evidilya does not warrant that any regulatory authority, ethics committee, journal, congress or third party will accept, approve or publish a Deliverable, and may decline to draft or endorse content that it considers scientifically unsupported, misleading or contrary to Applicable Law or to the applicable publication and promotional codes.

D3 Publications

D3 The Client is responsible for authorship decisions, for compliance with the authorship, disclosure and publication policies of journals and congresses, and for obtaining any consent required from authors, institutions and sponsors. Evidilya’s medical writing support is acknowledged in accordance with good publication practice, without this implying authorship.

D4 Reviews and acceptance

D4 The Client reviews each Deliverable and communicates any comments within ten (10) business days of delivery, failing which the Deliverable is deemed accepted. Unless otherwise stated in the SOW, the Fees include two (2) rounds of revisions; further revisions and changes of scope are charged at Evidilya’s rates.

D5 Audits and records

D5 Articles B3, B4 and Part C do not apply to Consulting Services. Evidilya retains its working files for the period required by its retention procedures and is not obliged to retain Client Materials after delivery.