GENERAL TERMS AND CONDITIONS OF SALE

Article 1. Definitions

Business Day: means any day, excluding Saturdays, Sundays or public holidays in Belgium.

Charges: means the price payable by the Customer for the supply of the Services in accordance with Article 5.

Conditions: means these general terms and conditions, including its schedules (if any), set out in this document as possibly amended in accordance with Article 12.7.

Contract: means these conditions, the Order and all other documents agreed in writing between the parties.

Controller: shall have the meaning as provided for under the GDPR.

Customer: means the natural or legal person acting for professional purposes who purchases the Services from the Supplier

Customer Data: means all (personal) data, works, materials, information and content provided by the Customer to the Supplier in connection with the Services, including the items provided pursuant to Article 4.1(c). Customer Data may entail Special Category Data.

Customer Default: has the meaning set out in Article 4.2.

Data Protection Legislation: means all applicable data protection and privacy legislation and regulation in force from time to time, including the General Data Protection Regulation (Regulation (EU) 2016/679, known as GDPR) and any applicable national implementing and supplementing law.

Data Subject: means an identified or identifiable natural person, typically the patient, whose Personal Data could be included in the Customer Data and processed under the Contract.

Deliverables: means any output of the Services and any documents or materials produced by the Supplier for the Customer in the context of the Contract, including but not limited to implant designs, and comprehensive measurement reports.

Force Majeure Event: means any circumstance not in a party's reasonable control, including, but not limited to, (a) acts of God, flood, drought, earthquake or other natural disaster; (b) epidemic or pandemic; (c) terrorist attack, civil war, civil commotion or riots, war, threat of or preparation for war, armed conflict, imposition of sanctions, embargo, or breaking off of diplomatic relations; (d) nuclear, chemical or biological contamination or sonic boom; (e) any law or any action taken by a government or public authority, including imposing an export or import restriction, quota or prohibition; (f) collapse of buildings, fire, explosion or accident; (g) any labour or trade dispute, strikes, industrial action or lockouts; (h) non-performance by suppliers or subcontractors; (i) interruption or failure of utility service (including interruption or failure of the internet or other public telecommunications network); (j) hacker attack; (k) denial of service attack; and (l) virus or other malicious software attack.

Intellectual Property Rights: means (non-exhaustive list) patents, utility models, rights to inventions, copyright and neighbouring and related rights, trademarks and service marks, business names and domain names, rights in trade dress, goodwill and the right to sue for passing off or unfair competition, rights in designs, rights in computer software, database rights, rights to use, and protect the confidentiality of, confidential information (including inter alia know-how, ideas, concepts, methodologies, processes and trade secrets), and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.

Order: means the confirmation of the Request in writing on Supplier’s letterhead and with a specific identifier, including the specific details and pricing of the Services requested by the Customer.

Personal Data: shall have the meaning as provided for under the GDPR and can include under the Contract, contact details, gender date of birth and Special Category Data.

Processor: shall have the meaning as provided for under the GDPR.

Request: means an invitation of the Customer to receive an Order for the Services provided by the Supplier.

Services: means the services delivered by the Supplier, such as design services, detailed measurements of hip morphology, 3D and range of motion analysis, potentially including patient-specific implant designs and/or guide designs based on Customer Data analysis for both human and veterinary applications, and including the Deliverables.

Special Category Data: means Personal Data revealing health or medical information, such as anatomical measurements, diagnostic information, medical scans, or other Personal Data falling under Article 9 of the GDPR, which the Customer acting as Controller provides to the Supplier acting as Processor for the performance of the Services.

Supplier: means Replasia, a private limited company (“besloten vennootschap”/ “société de responsabilité limitée”) incorporated under the laws of Belgium, with office at 3001 Leuven, Interleuvenlaan 62, bus 26 and registered with the Crossroads Bank for Enterprises under number VAT BE 0786.802.632 (RLE Leuven), bank account number BE07 7340 5998 0866, www.replasia.com, info@replasia.com.

Article 2. Contract Conclusion

2.1 The submission of a Request by the Customer via the Supplier’s website, portal or email constitutes an invitation to the Supplier to issue an Order, the latter to include a proposal for the provision of Services in accordance with these Conditions as well as pricing.

2.2 The Order, including the pricing and these Conditions, shall be deemed to be accepted if the Customer does not object the Order of the Supplier within three (3) Business Days after receipt thereof, in writing by sending an email to info@replasia.com. In lack of such objection within the given time period, the Contract is deemed to be concluded.

2.3 An Order can be revoked or altered by Supplier at its sole discretion, prior to Contract conclusion.

2.4 For the avoidance of doubt, any documentation provided by the Supplier to the Customer prior to conclusion of the Contract, regardless of its format, is strictly non-binding. Any samples, drawings, descriptive matter or advertising issued by the Supplier, and any descriptions or illustrations on the Supplier's website or contained in the Supplier’s brochures, are issued or published for the sole purpose of giving an approximate idea of the Services. They shall not form part of the Contract or have any contractual force.

2.5 These Conditions are available in English and apply to the Contract to the exclusion of any other terms that the Customer seeks to impose or incorporate (even if these terms state otherwise), or which are implied by law, trade custom, practice or course of dealing.

Article 3. Services

3.1 The Supplier shall use its best efforts to supply the Services to the Customer in accordance with the Contract, with reasonable care and skill, and to meet any performance dates specified in the Order. Any such dates shall be estimates only and time shall not be of the essence for the performance of the Services.

3.2 The Supplier reserves the right to amend the Services if necessary to comply with any applicable law or regulatory requirement, or if the amendment does not materially affect the nature or quality of the Services. The Supplier shall use its best efforts to notify the Customer prior to such changes.

3.3 The Services, and in particular the Deliverables, do not contain any advice, (clinical) judgment, recommendations, suggestions or interpretations of data, solely an objective analysis of the Customer Data. The Customer bears full responsibility for the use or implementation of the Services and/or for any decisions it makes following the receipt of the Services. The Customer acknowledges and agrees that the Services are provided “as is”. Supplier makes no representations or warranties concerning any matter under this Contract, fitness for a particular purpose, merchantability, non-infringement and/or that the Services will be provided uninterrupted or error-free. Supplier expressly disclaims any warranty of non-infringement, accuracy or completeness, or compliance with criteria or parameters provided by the Customer. To the fullest extent permitted by law, the Supplier shall not be liable for any damage, resulting from the Customer’s interpretation or use of the Services.

3.4 Where Services involve processing of Personal Data, the Supplier acting as Processor shall perform such processing strictly in accordance with the documented instructions of the Customer, acting as Controller and in accordance with these Conditions. Parties acknowledge that the performance of the Contract constitutes such a written instruction.

Article 4. Customer’s Obligations

4.1 The Customer shall (a) ensure that the terms of the Request are complete and accurate; (b) co-operate with the Supplier in all matters relating to the Services; (c) provide the Supplier with such information, (technical) support and materials reasonably required by the Supplier, including written prescription for custom made medical devices, and ensure that such information and support is complete and accurate; (d) obtain and maintain all necessary licences, permissions and consents which may be required for the enjoyment of the Services before the date on which the Services are to start; (e) comply with any additional obligations as set out in the Contract or otherwise communicated by the Supplier to the Customer; (f) comply with all applicable legal requirements

4.2 If the Supplier's performance of the Services is prevented or delayed by any act or omission by the Customer or failure by the Customer to perform any relevant obligation (a “Customer Default”) (a) without limiting or affecting any other right or remedy available to it, the Supplier shall have the right to suspend performance of the Services until the Customer remedies the Customer Default; (b) the Supplier shall not be liable for any costs or losses sustained or incurred by the Customer arising directly or indirectly from the Supplier's failure or delay to perform the Services; and (c) the Customer shall reimburse the Supplier on written demand for any costs or losses sustained or incurred by the Supplier arising directly or indirectly from the Customer Default.

Article 5. Charges and Payment

5.1 The Charges, and, if applicable, the VAT, shall be communicated to the Customer by Supplier in the Order or otherwise prior to Contract conclusion.

5.2 The Charges exclude, if applicable, (a) any expenses reasonably incurred by the Supplier, including travel expenses, hotel costs and any associated expenses; (b) the cost of the services provided by third parties; and (c) the cost of any materials used to provide the Services. Such costs shall be invoiced by the Supplier to the Customer in addition to the Charges.

5.3 The Customer shall pay the invoice submitted by the Supplier within thirty (30) calendar days of the invoice date and in euro, in full and in cleared funds to a bank account nominated in writing by the Supplier. Time for payment shall be of the essence of the Contract.

5.4 The amount of any undisputed (part of an) invoice which has not been paid within thirty (30) calendar days from the invoice due date shall without notification by Supplier, automatically be subject to a late payment interest equal to the legal interest rate of the Act of 2 August 2002 on late payment interests in commercial transactions, which interest shall be compounded daily as of the due date until receipt of full payment by Supplier. In addition, the outstanding amount shall be additionally increased by lump sum damages of 50 EUR, as a result of the (extra)judicial enforcement of the Customer’s payment obligation. If the Customer disputes the invoice due, the Customer shall immediately, and in any case no later than fourteen (14) calendar days of the invoice date, notify the Supplier in writing, including any evidence as may be reasonably necessary to verify the disputed invoice. In case of late objection, the invoice shall be deemed to have been accepted by the Customer. Any undisputed amount shall be paid by the Customer in accordance with Article 5.3.

5.5 All amounts due under the Contract shall be paid in full without any set-off, counterclaim, deduction or withholding (other than any deduction or withholding of tax as required by law).

Article 6. Intellectual Property Rights

6.1 All Intellectual Property Rights in, arising out of or in connection with the Services (other than the Intellectual Property Rights in the Customer Data), including the Intellectual Property Rights vested in the Deliverables, as the case may be, shall be owned by the Supplier. Except as expressly set out in these Conditions, nothing in these Conditions shall be deemed as an implied or express assignment of, or grant of a license for, any of the Supplier's Intellectual Property Rights to the Customer.

6.2 Subject to the Contract and timely payment of the Charges, the Supplier grants the Customer, who accepts, a non-exclusive, non-assignable, worldwide, license to any Intellectual Property Rights vested in the Deliverables as the case may be for use for internal business purposes for the duration of said Intellectual Property Rights.

6.3 The Customer grants the Supplier a fully paid-up, non-exclusive, royalty-free, sub-licensable, transferable licence to freely use, copy and modify any (as the case may be, Intellectual Property Rights vested in the) Customer Data for the duration of the Intellectual Property Rights protection (if any) and the purpose of providing the Services to the Customer, Supplier shall also be entitled to use the Customer Data, in anonymous form, for analytic and R&D purposes.

Article 7. GDPR

7.1 Each Party shall comply with all requirements of the Data Protection Legislation.

7.2 The Customer represents and warrants that it has the legal right to disclose any Personal Data, including Special Category Data made available to the Supplier under or in connection with the Contract. In this regard, the Customer specifically guarantees that it has an appropriate legal basis to allow the Supplier to process such Personal Data and it has informed the Data Subject.

7.3 To the extent reasonably possible, all Personal Data of Data Subjects, provided by the Customer to the Supplier, will be pseudonymised by the Customer, before transferring such data to the Supplier.

7.4 In cases where the Supplier acts as the data controller in relation to the Customer’s Personal Data, provisions of the Privacy Statement shall apply.

7.5. For the processing of the Personal Data, included in the Customer Data, the Supplier shall act as Processor on the Customer’s instructions, acting as Controller, and the Supplier shall:

(a) ensure persons authorised to process the Personal Data are bound by confidentiality;

(b) implement appropriate technical and organisational measures to ensure security;

(d) reasonably assist the Customer in ensuring compliance with Articles 32–36 GDPR (security, breach notification, DPIA, consultation with authorities);

(e) make available to the Customer all information necessary to demonstrate compliance and allow for audits;

(f) without undue delay inform the Customer of any personal data breach involving Data Subject Personal Data.

7.6. The Customer explicitly agrees that the Supplier can use sub-processors for the performance of the Contract. The Supplier shall inform the Customer of any intended changes concerning the addition or replacement of sub-processors, thereby giving the Customer the opportunity to object to such changes. The Customer must object to such appointment in writing and on reasonable and evidenced grounds. Subject to Article 9, the Supplier shall remain fully liable to the Customer for any failure by a sub-processor to fulfil its obligations.

Article 8. Customer Data

8.1 The Customer acknowledges that for a proper functioning of the Services, Customer Data must be delivered to the Supplier. All Customer Data shall remain property of the Customer.

8.2 The Customer shall solely be liable and responsible for the lawfulness, accuracy, completeness, pertinence and correctness of the Customer Data. The Customer guarantees that it holds all rights and title to disclose the Customer Data within this context and warrants that the receipt and use of the Customer Data in the performance of the Contract by the Supplier shall not infringe any third party (Intellectual Property) rights

8.3 The Customer shall immediately inform the Supplier in writing of any modifications in the Customer Data in order to enable the Supplier to make the necessary changes.

8.4 The Supplier shall not be liable for damages or liability resulting from incorrect, inaccurate or incomplete Customer Data. The Customer shall indemnify the Supplier in full against all liabilities, costs, expenses, damages and losses (including any direct, indirect or consequential losses, loss of profit, loss of reputation and all interest, penalties and legal costs (calculated on a full indemnity basis) and all other reasonable professional costs and expenses) suffered or incurred by the Supplier arising out of or in connection with any claim brought against the Supplier, its agents, subcontractors or consultants for actual or alleged infringement of a third party's (Intellectual Property) rights arising out of, or in connection with, the receipt or use in the performance of this Contract of the Customer Data.

Article 9. Limitation of Liability

9.1 References to liability in this Article 9 include every kind of liability arising under or in connection with the Contract, including liability in contract, tort (including negligence), misrepresentation, restitution or otherwise.

9.2 Nothing in the Contract excludes or limits any liability which cannot legally be excluded or limited, including liability for (a) death or personal injury caused by fault; (b) fraud or fraudulent misrepresentation; or (c) deliberate default.

9.3 To the maximum extent permitted under applicable law, the Supplier's total liability to the Customer arising under or in connection with this Contract shall not exceed the Charges paid by the Customer to the Supplier under the Contract.

9.4 To the maximum extent permitted under applicable law, indirect damages are wholly excluded, including, but not limited to (a) loss of profits; (b) loss of sales or business; (c) loss of agreements or contracts; (d) loss of anticipated savings; (e) loss of use or corruption of software, data or information; (f) loss of or damage to goodwill; (g) damage to property.

9.5 To the maximum extent permitted under applicable law, the Customer agrees, and accepts, not to hold the employees, directors, subcontractors, agents, advisers, representatives, service providers and consultants of the Supplier personally liable for or in connection with the Contract. Any (liability) claim for or in connection with the Contract (including any extra-contractual liability claim) shall be brought by the Customer solely against the Supplier.

9.6 Unless the Customer notifies the Supplier that it intends to make a claim in respect of an event within three (3) months after the Customer became, or ought reasonably to have become, aware of the event having occurred, the Supplier shall have no liability for that event. The notice must be in writing and must identify the event and the grounds for the claim in reasonable detail.

9.7 This Article 9 shall survive termination of the Contract.

Article 10. Termination

#10.1 Without affecting any other right or remedy available to it, either party may terminate the Contract with immediate effect, without court intervention and without notice or payment of any compensation, by giving written notice to the other party if (a) the other party commits a material breach of any term of the Contract and (if such a breach is remediable) fails to remedy that breach within fourteen (14) calendar days of being notified in writing to do so; (b) the other party takes any step or action in connection with its entering administration (insolvency), provisional liquidation or any composition or arrangement with its creditors (other than in relation to a solvent restructuring), obtaining a moratorium, being wound up (whether voluntarily or by order of the court, unless for the purpose of a solvent restructuring), having a receiver appointed to any of its assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction; (c) the other party suspends, threatens to suspend, ceases or threatens to cease to carry on all or a substantial part of its business; or (d) the other party's financial position deteriorates so far as to reasonably justify the opinion that its ability to give effect to the terms of the Contract is in jeopardy.

10.2 Without affecting any other right or remedy available to it, the Supplier may dissolute (“ontbinding” / “resolution”) or terminate the Contract with immediate effect, without court intervention and without notice or payment of any compensation, by giving written notice to the Customer if the Customer fails to pay any amount due under the Contract on the due date, provided that the Supplier shall continue to safeguard and return or delete all Personal Data in accordance with Article 11.4.

10.3 Without affecting any other right or remedy available, the Supplier may suspend the supply of Services under the Contract or any other contract between the Customer and the Supplier (without court intervention) if the Customer becomes subject to any of the events listed in Article 10.1(a) to Article 10.1(c), or if the Supplier reasonably believes that the Customer is about to become subject to any of them.

10.4 Without affecting any other right or remedy available, either Party may terminate the Contract with immediate effect where continued performance would result in a breach of Data Protection Legislation, including situations where processing of Data Subject Personal Data can no longer be lawfully justified.

Article 11. Consequences of Termination

11.1 On termination or expiry of the Contract the Customer shall immediately pay to the Supplier all of the Supplier's outstanding invoices and interest and, in respect of Services supplied but for which no invoice has been submitted, the Supplier shall submit an invoice, which shall be payable by the Customer immediately on receipt.

11.2 Termination or expiry of the Contract shall not affect any rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination or expiry, including the right to claim damages in respect of any breach of the Contract which existed at or before the date of termination or expiry.

11.3 Any provision of the Contract that expressly or by implication is intended to come into or continue in force on or after termination of the Contract shall remain in full force and effect.

11.4 Upon termination or expiry of the Contract, the Supplier shall, at the choice of the Customer, return or securely delete all Customer Data containing Personal Data of Data Subjects, unless Union or Member State law requires storage. Evidence of deletion or return shall be made available to the Customer upon request.

11.5 The Supplier shall continue to safeguard Data Subject rights under the GDPR after termination to the extent that any Personal Data is lawfully retained, including ensuring integrity, confidentiality, and restricted access.

Article 12. Miscellaneous

12.1 Force Majeure. The Supplier shall not be in breach of the Contract or otherwise liable for any failure or delay in the performance of its obligations under the Contract if such failure or delay results from a Force Majeure Event. The time for performance of such obligations shall be extended accordingly. If the period of failure or delay continues for ninety (90) calendar days, either party may terminate the Contract by giving thirty (30) calendar days' written notice to the other party.

12.2 Status. The relationship of the Supplier to the Customer will be that of an independent contractor and nothing in this Contract shall render the Supplier an employee, worker, agent or partner of the Customer. The Contract constitutes a contract for the supply of services and not a contract of employment.

12.3 Assignment and other encumbrances. The Supplier may at any time assign, transfer, mortgage, charge, subcontract, delegate, or in any other way encumber all or any of its rights or obligations under the Contract. The Customer may not assign, transfer, mortgage, charge, subcontract, delegate, or in any other way encumber any or all of its rights or obligations under the Contract without Supplier’s prior written consent.

12.4 Confidentiality. Each party undertakes that it shall not at any time during the Contract and for a period of two (2) years after termination of the Contract, disclose to any person any confidential information concerning the business, assets, affairs, customers, clients or suppliers of the other party, including the Deliverables and any Personal Data of Data Subjects processed under this Contract, except as expressly permitted by these Conditions. Each party may disclose the other party's confidential information (a) to its employees, officers, representatives, contractors, clients, subcontractors or advisers who need to know such information for the purposes of exercising its rights or carrying out its obligations under the Contract (provided that that party ensures that the recipients to whom it discloses the other party's confidential information is bound by confidentiality undertakings not less strict than those included in these Conditions); (b) as may be required by law, a court of competent jurisdiction or any governmental or regulatory authority; and/or (c) to enforce or defend its rights towards the other party or a third party as the case may be. Neither party shall not use the other party's confidential information for any purpose other than to exercise its rights and carry out its obligations under or in connection with the Contract.

12.5 Entire agreement. The Contract constitutes the entire agreement between the parties and supersedes and extinguishes all previous agreements, promises, assurances, warranties, representations and understandings between them, whether written or oral, relating to its subject matter. Each party acknowledges that in entering into the Contract it does not rely on any statement, representation, assurance or warranty (whether made innocently or negligently) that is not set out in the Contract. Each party agrees that it shall have no claim for innocent or negligent misrepresentation or negligent misstatement based on any statement in the Contract.

12.6 Hierarchy. The Contract can consist of the following items in descending order or priority: (a) the Order; (b) these Conditions; (c) the Request; (d) all other Services specifications, exhibits and all other documents agreed between Supplier and Customer in writing.

For the avoidance of doubt, documents, catalogues, advertising, price lists not expressly mentioned and agreed upon by both parties in writing shall not form part of the Contract.

12.7 Amendments. Should this be required by the circumstances (e.g. in case of far-reaching adjustments to the Services or underlying software used for the provision thereof, required to comply with new legislation or pursuant to technical evolutions or in case of a price increase of third party material used in the context of the Services), the Supplier may amend these Conditions. Such amendment shall be binding on the Customer upon written notice to the Customer unless the Customer disputes the amendment in writing within fourteen (14) calendar days of the Supplier’s notice.

12.8 Waiver. A waiver of any right or remedy is only effective if given in writing and shall not be deemed a waiver of any subsequent right or remedy. A delay or failure to exercise, or the single or partial exercise of, any right or remedy shall not waive that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy.

12.9 Severance. If any provision or part-provision of the Contract is or becomes invalid, illegal or unenforceable, it shall be deemed deleted, this shall not affect the validity and enforceability of the rest of the Contract. If any provision or part-provision of the Contract is deemed deleted the parties shall negotiate in good faith to agree a replacement provision that, to the greatest extent possible, achieves the intended commercial result of the original provision.

12.10 Notices. Any formal notice given to a party under or in connection with the Contract shall be in writing and shall be delivered by email to the other party’s email address with read receipt notification.

12.11 Non-solicitation. The Customer shall not, directly or indirectly, on its own behalf or on behalf of, or in conjunction with, any other firm, company or person, during the term of the Contract, and for a period of two (2) years thereafter, solicit or entice away (or attempt to solicit or entice away), any company or person who is or was employed or engaged by the Supplier during the term of the Contract as principal, agent, employee, independent contractor or any other form of employment or engagement. If the Customer breaches the above non-solicitation obligation, the Customer shall pay liquidated damages to the Supplier equal to sixty thousand (60.000) EUR for each breach and, in addition, thousand (1.000) EUR for each calendar day that the breach continues, without the need for the Supplier to serve a prior written notice or to obtain a court order. The foregoing is without prejudice to the Supplier’s right (notwithstanding article 5.88 Civil Code) to recover the damages in excess of those amounts.

12.12 Governing law. The Contract, and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with the Contract, its subject matter, formation, interpretation or termination, shall be governed by and construed in accordance with the laws of Belgium.

12.13 Jurisdiction. Each party irrevocably agrees that the courts of Leuven shall have exclusive jurisdiction to settle any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with the Contract, its subject matter or formation.