General Terms & Conditions

These General Terms and Conditions ("T&Cs") govern the business relationship between Trilenda SRL, a limited liability company (SRL) incorporated under Belgian law, with registered office at Rue Clément Ader 10, 6041 Charleroi, Belgium, registered with the BCE/KBO under number BE1028.924.134, operating under the Sanaitio brand for AI medical device consulting ("the Service Provider"), and the client identified in the applicable Work Order ("the Company"), in respect of the provision of services ("Services") subject to individual Work Orders ("WO").

Service Provider and Company are hereinafter referred to individually as "Party" and collectively as "the Parties". The basis for all service contracts is the English version of these T&Cs. Versions in other languages are for information purposes only.

1. Services

1.1 Engagement. Company may engage Service Provider to perform the Services specified in a written WO executed by both Parties. Upon execution, each WO shall incorporate these T&Cs.

1.2 Work Orders. These T&Cs shall govern each WO, except as the Parties may otherwise expressly agree in such WO.

1.3 Change Orders. Any changes to scope, timing, or pricing of a WO shall be reflected in a new or amended WO executed by both Parties.

1.4 No Legal Advice. The Services do not include legal advice. The Company should seek independent legal counsel for legal matters.

1.5 Affiliates and Partners. Service Provider may engage its affiliates and qualified partners to deliver Services. Service Provider remains responsible for their performance and compliance with these T&Cs.

1.6 Commencement Prior to Execution. Where Service Provider commences Services before a WO is finalised at the Company's written request (email sufficing), Company shall pay for such Services in accordance with these T&Cs. Both Parties shall exercise reasonable efforts to finalise the WO promptly.

2. Compensation

2.1 Rate of Compensation. Company shall pay Service Provider as specified in the applicable WO. All prices are stated exclusive of VAT (hors TVA). The Parties agree that the compensation reflects fair market value and was negotiated in good faith at arm's length.

2.2 Invoices and Payment Terms. Service Provider shall submit monthly invoices (unless otherwise stated in the WO). All undisputed amounts are due within thirty (30) days of invoice date, via wire transfer to the bank account designated by Service Provider.

If any undisputed amount is not paid by the due date, Service Provider shall be entitled to charge interest at the rate applied by the European Central Bank plus two percentage points (2%) per annum, calculated from the first day after the due date until full payment.

In addition, Service Provider reserves the right to: (a) suspend Services until all outstanding amounts are paid in full; and (b) charge reasonable administrative and collection costs, including legal fees, incurred in recovering overdue payments.

If Company disputes any portion of an invoice, Company shall pay all undisputed amounts and notify Service Provider in writing within five (5) business days, specifying the nature of the dispute. Service Provider shall respond within thirty (30) days. Resolution of disputes exceeding this timeframe shall follow Section 15.2.

2.3 Indexation. Service Provider may adjust rates for engagements exceeding twelve (12) months, after each twelve-month period, if the applicable inflation index exceeds two percent (2%). Any adjustment shall be made in accordance with principles of equity and good faith.

2.4 Expenses. Where provided in a WO, Service Provider may invoice Company for reasonable and necessary out-of-pocket expenses actually incurred, reimbursed at actual cost without mark-up.

3. Representations and Warranties

3.1 Mutual. Each Party represents and warrants that: (a) it is duly organised, validly existing, and authorised to enter into these T&Cs; and (b) in performing its obligations, it will comply with all applicable laws, including anti-bribery, anti-corruption, healthcare, privacy, and regulatory laws.

3.2 Company. Company warrants that: (i) decisions or directions given to Service Provider conform with applicable laws; and (ii) information provided to Service Provider is true, accurate, and complete to Company's knowledge.

3.3 Service Provider. Service Provider warrants that Services shall be performed by qualified personnel in a competent and professional manner, consistent with applicable laws and the applicable WO.

3.4 Limitation. Except as provided in this Section 3, no other express or implied warranties are made.

4. Anti-Bribery and Regulatory Compliance

4.1 Each Party shall comply with all applicable anti-bribery and anti-corruption laws, including the Belgian Criminal Code provisions on corruption and influence peddling, and, where applicable, the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010.

4.2 Neither Party shall make, offer, or authorise any payment, gift, or thing of value to any public official, government employee, or any other person for the purpose of influencing any act or decision to obtain or retain business.

4.3 Each Party shall promptly notify the other of any investigation or inspection by regulatory authorities directed at the Services.

5. Confidentiality and Privacy

5.1 Definition. "Confidential Information" means all information disclosed by a Party to the other in connection with these T&Cs and any WO, whether written, oral, or electronic, including copies and derivatives. Confidential Information excludes information that: (i) is publicly known through no fault of the Receiving Party; (ii) was known to the Receiving Party prior to disclosure; or (iii) was independently developed without use of the Disclosing Party's information.

5.2 Protection. The Receiving Party shall: (a) hold Confidential Information in confidence and use it solely to fulfil obligations under a WO; (b) not disclose it to third parties without prior written consent; (c) limit disclosure to officers, employees, and authorised agents ("Representatives") on a need-to-know basis; and (d) implement appropriate safeguards.

Each Party shall promptly notify the other of any breach of this Section. Disclosure required by law is permitted, provided prompt notice is given and reasonable efforts are made to secure confidential treatment.

5.3 Indemnity for Breach. The Receiving Party shall indemnify the Disclosing Party against direct damages arising from unauthorised use or disclosure of Confidential Information.

5.4 Duration. Confidentiality obligations shall survive termination for a period of five (5) years, except for trade secrets which shall be protected for as long as they remain trade secrets.

5.5 Data Protection. The Parties shall process personal data in compliance with Regulation (EU) 2016/679 (GDPR) and the Belgian Law of 30 July 2018 on the protection of natural persons with regard to the processing of personal data. Where Services involve processing of personal data on behalf of the Company, a Data Processing Agreement (DPA) in accordance with Article 28 GDPR shall be executed as an annex to the applicable WO.

5.6 Return/Destruction. Upon written request, Confidential Information shall be returned or destroyed. One archival copy may be retained for compliance purposes.

6. Proprietary Rights

6.1 General. Each Party retains all intellectual property owned prior to the commencement of a WO or independently developed.

6.2 Deliverables. All deliverables identified in a WO and fully paid for shall be owned by Company. In accordance with Belgian copyright law (Code de droit économique, Book XI), Service Provider hereby assigns to the Company all intellectual property rights in the Deliverables, including rights of reproduction, adaptation, and communication to the public, for all modes of exploitation, in all formats and media, worldwide, for the full duration of the applicable rights.

6.3 Non-Exclusive Developments. Proprietary methodologies, analytical tools, and know-how developed or used by Service Provider that do not exclusively relate to Company ("Non-Exclusive Developments") shall remain the property of Service Provider. Company receives a limited, non-exclusive, non-transferable licence to use Non-Exclusive Developments solely as embedded in the Deliverables and solely for internal use related to the applicable project.

6.4 Use of Names. Neither Party may use the name of the other in advertising or publicity without prior written consent.

7. AI and Data Science Provisions

7.1 Model Ownership. Unless otherwise specified in the applicable WO: (a) AI models, algorithms, and statistical methodologies developed exclusively for the Company and fully paid for shall be owned by the Company; (b) general-purpose tools, pre-existing models, and methodologies shall remain the property of Service Provider.

7.2 Training Data. Service Provider shall not use Company's proprietary data to train models for other clients without prior written consent. Any use of Company data is limited to the specific project scope defined in the applicable WO.

7.3 Validation and Documentation. Service Provider shall deliver adequate documentation for all models and analyses, including methodology descriptions, validation reports, and reproducibility information as specified in the WO.

7.4 EU AI Act Compliance. Where Services involve the development or deployment of AI systems as defined under Regulation (EU) 2024/1689 (EU AI Act), the following applies:

• (a) Service Provider shall identify and document the risk classification of any AI system developed under a WO (minimal, limited, high, or unacceptable risk) and inform the Company accordingly.
• (b) For AI systems classified as limited risk, Service Provider shall ensure compliance with applicable transparency obligations, including informing end-users that they are interacting with an AI system where required.
• (c) For AI systems classified as high risk, the Parties shall agree on the allocation of responsibilities under the EU AI Act in the applicable WO, including requirements for risk management, data governance, technical documentation, record-keeping, and human oversight.
• (d) Service Provider shall not develop AI systems that fall within the category of unacceptable risk as defined by the EU AI Act.
• (e) The Parties shall cooperate in good faith to comply with any additional obligations arising under the EU AI Act as its implementing measures come into effect.

7.5 No Clinical Decision-Making. Unless expressly stated in a WO and subject to applicable regulatory requirements, the Services and deliverables provided by Service Provider are not intended to be used as the sole basis for clinical decision-making or as a medical device. Company is solely responsible for any decision to use the deliverables for such purposes.

8. Records and Audits

During the term of a WO and for two (2) years thereafter, Service Provider shall maintain records sufficient to verify amounts paid and compliance with these T&Cs. Upon at least thirty (30) days' prior written notice and during normal business hours, Company may audit relevant records no more than once per twelve (12) month period, at its own expense. Audits shall not disrupt Service Provider's business and shall be subject to confidentiality.

9. Termination

9.1 Either Party may terminate a WO immediately for serious breach (after notice and a reasonable cure period of at least ten (10) days), or without cause upon ninety (90) days' written notice, unless otherwise specified in the WO.

9.2 Upon termination, Company shall pay Service Provider for all Services performed and costs incurred up to the effective date of termination.

9.3 Provisions whose meaning requires survival shall survive expiration or termination, including Sections 5, 6, 7, 8, 10, and 11.

10. Indemnification

Each Party agrees to indemnify and hold harmless the other against third-party claims arising out of gross negligence, willful misconduct, or breach of these T&Cs, subject to proportional responsibility. Indemnification obligations shall survive for five (5) years after termination.

11. Limitation of Liability and Insurance

11.1 No Consequential Damages. Neither Party shall be liable for punitive, consequential, incidental, indirect, or special damages, including lost profits.

11.2 Liability Cap. Service Provider's aggregate liability under a WO is tiered as follows: (a) for general claims: the greater of the net fees invoiced under the WO during the twelve (12) months preceding the claim or one hundred thousand euros (€100,000); (b) for claims arising from breach of confidentiality or data protection obligations: the greater of two (2) times the net fees invoiced under the WO or the amount available under Service Provider's combined professional liability and cyber insurance; (c) for claims arising from fraud, willful misconduct, or death/personal injury caused by negligence: uncapped. In no event shall Service Provider's liability under (a) or (b) exceed the amount actually available under its applicable insurance policies. Service Provider's insurance policies cover consultants and subcontractors acting within the scope of a WO.

11.3 Insurance. Service Provider shall maintain, at its own expense, during the term of a WO: (a) commercial general liability insurance; (b) professional liability (errors & omissions) insurance; and (c) cyber liability insurance. Service Provider's insurance policies extend coverage to consultants and subcontractors acting within the scope of a WO. Certificates of insurance shall be provided upon request.

12. Independent Contractor

Service Provider acts as an independent contractor. Nothing herein creates an employer/employee, principal/agent, or joint venture relationship. Service Provider is solely responsible for compensation, taxes, and benefits of its employees.

13. Force Majeure

If either Party is delayed or prevented from performance by events beyond reasonable control (excluding payment obligations), including acts of government, pandemics, war, strikes, fire, flood, or failure of telecommunications systems, performance shall be excused for the duration of such event. Prompt notice shall be given.

14. Non-Solicitation of Service Provider Employees

During the term of a WO and for twelve (12) months thereafter, Company shall not enter into an employment, consultancy, or other service relationship with an employee of Service Provider involved in the Services without paying a fee equal to fifteen percent (15%) of the employee's total annual remuneration. Company shall notify Service Provider and pay the fee within fourteen (14) calendar days.

15. Miscellaneous

15.1 Notices. All notices shall be in writing, served by email with return receipt requested.

15.2 Dispute Resolution. The Parties shall negotiate in good faith for thirty (30) days. Thereafter, the courts of Brussels, Belgium (Tribunal de l'Entreprise francophone de Bruxelles) shall have exclusive jurisdiction.

15.3 Non-Assignment. Neither Party may assign a WO without prior written consent, except in connection with the sale of substantially all of its business.

15.4 Subcontracting. Service Provider may engage subcontractors for administrative or technical support functions without prior consent. For substantive service delivery, prior written disclosure to Company is required. Service Provider remains legally responsible for subcontractor compliance.

15.5 Governing Law. These T&Cs and all WOs shall be governed by and construed in accordance with the laws of Belgium.

15.6 Amendments. These T&Cs may only be modified in writing signed by both Parties with regard to a specific WO.

15.7 Severability. If any provision is held unenforceable, the remaining provisions shall continue in full force and effect.

15.8 Waiver. No waiver of any provision shall be effective unless expressly made in writing.

Trilenda SRL (operating as Sanaitio)
Rue Clément Ader 10, 6041 Charleroi, Belgium
BCE/KBO: BE1028.924.134