General Terms and Conditions of Sale

Simovision – General Terms and Conditions of Sale (B2B – Medical Devices, EU)

1. Identity of the Seller

The “Seller” is Simovision BV:

Registered office	Vriendschapsstraat 30 3090 Overijse Belgium
Company number	0875.942.068 (RPR/RPM Brussels)
VAT number	BE 0875.942.068
Email	order@simovision.eu
Phone	+32 (0)2 769 70 00

2. Scope and Applicability

2.1 These Terms and Conditions (“Terms”) apply to all offers, quotations, orders and agreements relating to the sale of Products between the Seller and any Sub-Distributor Customer or End-User Customer.

2.2 The Seller operates exclusively in a business-to-business (B2B) context. The Seller sells exclusively to professional customers acting in the course of their trade, business or profession. By placing an order, the Customer represents and warrants that it is a professional and that it will use the Products in a professional capacity. The Seller reserves the right to verify the professional status of any Customer and to refuse access to the Webshop or to cancel any order where professional status cannot be satisfactorily established.

2.3 Any person purchasing without a VAT number acknowledges and agrees that:

it is not acting as a consumer within the meaning of applicable consumer protection laws; and
consumer rights, including withdrawal rights, shall not apply.

2.4 These Terms prevail over any terms and conditions of the Customer unless explicitly agreed otherwise in writing.

2.5 Certain provisions of these Terms apply specifically to Sub-Distributor Customers, as expressly indicated. Where not specifically indicated, all provisions apply equally to both Sub-Distributor Customers and End-User Customers.

3. Definitions

“Customer”: any natural or legal person purchasing Products for professional use as Sub-Distributor Customer or End-User Customer.
“Sub-Distributor Customers”: entities that have received the prior express written authorisation of the Seller to purchase Products for onward commercial distribution.
“End-User Customers”: healthcare institutions, hospitals, clinics, ophthalmological practices and other professionals purchasing Products for direct professional use in the delivery of healthcare services and not for onward commercial distribution.
“Products”: goods supplied by the Seller, including medical devices.
“Agreement”: any contract between the Seller and the Customer.
“MDR”: Regulation (EU) 2017/745 on medical devices.
“Economic Operator”, “UDI”, “Intended Purpose”, “Instructions for Use”, “EUDAMED”, “Field Safety Corrective Action” (“FSCA”) and “Field Safety Notice” shall each have the meaning ascribed to it in the MDR.
“RMA”: Return Merchandise Authorization.
“GDP guidelines”: the guidelines on Good Distribution Practice of medical devices, as published and amended from time to time by the European Commission, competent national authorities, or relevant regulatory bodies.
“Webshop”: the Seller’s online platform through which Customers may browse, order and purchase Products.

4. Offers and Formation of Agreement

4.1 All offers made by the Seller are non-binding and subject to availability, unless explicitly stated otherwise.

4.2 Product descriptions, specifications and images are provided for indicative purposes only and shall not constitute a binding representation or warranty.

4.3 An Agreement is formed only upon written confirmation of an order by the Seller.

4.4 The Seller reserves the right to refuse or cancel any order without liability, including in cases of:

pricing or typographical errors;
stock unavailability;
suspected fraud or misuse;
applicable trade sanctions, export control regulations, or other legal restrictions prohibiting the sale or delivery of the Products to the Customer or to the relevant territory;
Force Majeure;
any other circumstance giving rise to reasonable grounds for the Seller to believe that performance of the order would be unlawful, contrary to public order, or prejudicial to the Seller’s legitimate interests.

5. Access to the Webshop

5.1 Access to the Webshop is restricted to registered professional users. Account registration requires the Customer to provide accurate business information including legal name, registered address, VAT number (where applicable), and relevant regulatory authorisations (where applicable). By creating an account on the Webshop or placing an order, the Customer acknowledges and confirms that it has read, understood and accepted these Terms.

5.2 The Customer is responsible for maintaining the confidentiality of its login credentials and for all activities conducted through its account. The Seller must be notified immediately of any suspected unauthorised use.

5.3 The Seller reserves the right to suspend or terminate access to the Webshop at any time, in particular in the event of: (i) suspected fraud or misuse; (ii) failure to comply with these Terms; (iii) concerns regarding the Customer’s professional status or regulatory authorisation.

5.4 The ordering process on the Webshop constitutes an electronic ordering process. With respect to orders placed via the Webshop, the parties expressly agree to derogate from the provisions of Articles XII.6, § 1, 8°, XII.7, § 1, XII.8 and XII.9 of the Belgian Code of Economic Law. The Customer shall follow the online ordering process and fill in all the required fields. The Customer shall be given the opportunity to review, correct, and confirm its order before it is submitted. Submission of the order constitutes a binding offer. The Seller shall acknowledge receipt of the order electronically, which acknowledgment shall not in itself constitute acceptance or confirmation of the order.

5.5 An Agreement is formed only upon the Seller’s written (including electronic) confirmation of the order. The Seller is not bound by a submitted order that it has not expressly confirmed.

6. Prices and Taxes

6.1 All prices are expressed exclusive of VAT, duties, and other taxes unless stated otherwise.

6.2 VAT treatment shall be determined in accordance with applicable EU and national legislation, including intra-Community supply rules.

6.3 The Customer is responsible for providing a valid VAT identification number where applicable.

6.4 The Seller reserves the right to adjust prices prior to order confirmation. In the event of such adjustment, the Seller shall notify the Customer accordingly, and the Customer shall be entitled to cancel its order without cost or liability within three (3) calendar days of receipt of such notification. In the absence of cancellation within the aforementioned period, the Customer shall be deemed to have accepted the adjusted price.

6.5 Once an order has been confirmed by the Seller, the price shall not be subject to unilateral modification by the Seller, except in the event of a manifest error or for valid reason (such as a change in applicable taxes, duties or levies).

6.6 For deliveries outside Belgium, any import duties, customs charges, local taxes or levies applicable in the country of destination shall be borne exclusively by the Customer. The Seller shall not be responsible for determining or collecting such charges.

7. Payment Terms

7.1 Payment shall be made:

in advance by the Customer on a proforma basis; or
by means of approved online payment methods at the time of checkout on the Webshop.

7.2 The Seller may suspend or cancel performance in case of non-payment.

7.3 In the event that deferred payment is exceptionally granted:

Payment terms shall not exceed thirty (30) calendar days from the invoice date unless otherwise expressly agreed in writing;
late payment interest shall accrue automatically in accordance with the applicable law on combating late payment in B2B transactions;
a fixed compensation of two hundred and fifty euros (EUR 250) for recovery costs shall be due by the Customer, without prejudice to the Seller’s right to claim compensation for any additional recovery costs actually incurred and duly substantiated.

7.4 Payments are processed through secure third-party providers. The Seller does not store payment credentials.

7.5 The Seller reserves the right to set off any amounts owed by the Customer against any amounts owed by the Seller to the Customer.

7.6 In the event of insolvency, bankruptcy, judicial reorganisation, attachment, or any analogous proceedings affecting the Customer, all outstanding invoices shall become immediately due and payable.

8. Delivery and Transfer of Risk

8.1 Unless otherwise agreed in writing, delivery shall be made DAP (Delivered at Place) to the delivery address indicated by the Customer, in accordance with Incoterms® 2020. Risk of loss or damage to the Products shall transfer to the Customer at the point of delivery to the Customer or its designated representative at the agreed place of delivery.

8.2 Delivery times are indicative only and shall not constitute a binding obligation.

8.3 The Seller shall not be liable for delays, losses or damages caused by carriers or third parties.

8.4 Certain Products, including without limitation intraocular liquids, gases, and viscoelastics, may require specific temperature-controlled or otherwise conditioned transport. The Customer shall ensure that appropriate receiving conditions are in place at the delivery address, in accordance with the applicable transport and storage conditions specified in the Instructions for Use and GDP guidelines.

8.5 The Seller shall not be liable for delays attributable to the Customer’s failure to provide accurate delivery information or to ensure adequate receipt conditions.

9. Inspection and Acceptance

9.1 The Customer shall inspect the Products immediately upon delivery.

9.2 Where Products are delivered in a damaged condition, the Customer shall: (i) note all visible damage on the carrier’s delivery document at the time of delivery; (ii) notify the carrier in writing within two (2) calendar days of delivery in accordance with applicable carrier terms; and (iii) notify the Seller in writing within five (5) calendar days of delivery.

9.3 Failure to comply with these obligations in time may prejudice the Customer’s ability to recover damages from the carrier or the Seller. In the absence of such notification, the Products shall be deemed accepted.

9.4 Hidden defects must be reported within fifteen (15) calendar days of their discovery, and in any event within the applicable warranty period. Failure to notify within this period shall constitute acceptance of the Products in respect of those defects.

9.5 Where a non-conformity has been duly established in accordance with this Article, the Seller shall, at its sole discretion, either (i) replace the non-conforming Products with conforming Products within a reasonable timeframe, or (ii) issue a full refund of the invoiced price of the non-conforming Products. The Seller’s choice of remedy shall be final. The remedies set out in this clause shall constitute the Customer’s sole and exclusive remedies in respect of non-conforming Products.

9.6 The Customer shall not use, process, or redistribute Products that have been found to be non-conforming pending resolution by the Seller. In the case of Products that are medical devices, the Customer shall immediately quarantine such Products and follow Seller’s instructions.

10. Returns and RMA Procedure

10.1 No statutory right of withdrawal applies.

10.2 Returns shall only be accepted subject to prior written approval by the Seller and issuance of an RMA. To initiate a return, the Customer shall follow the RMA procedure as described on the Seller’s website and comply with any applicable instructions provided therein. No return shall be processed without a valid RMA number issued by the Seller.

10.3 Conditions for return:

Request submitted by the Customer within 14 days after delivery;
Products unused, undamaged, and in unopened original packaging;
Compliance by the Customer with RMA instructions.

10.4 Return costs shall be borne by the Customer.

10.5 The Seller reserves the right to:

refuse returns if the conditions for return are not met;
apply a restocking fee of up to 15%.

10.6 Unauthorized returns for which no RMA-number is provided may be rejected and returned at the Customer’s expense.

10.7 Notwithstanding the foregoing, the following Products shall not be eligible for return in any circumstances, unless the return is required for the purposes of a recall or FSCA initiated by the Seller: (a) sterile Products or Products with a broken or compromised seal; (b) Products that have been opened, partially used, or in contact with a patient; (c) Products past their expiry date or shelf life; (d) Products that, due to their nature (including intraocular liquids, gases, and viscoelastics), cannot be resold or redistributed without compromising patient safety or regulatory compliance.

11. Retention of Title

11.1 Title to the Products shall remain with the Seller until full payment has been received.

11.2 Until transfer of title, the Customer shall:

not pledge or encumber the Products;
store them in a manner that preserves identification and traceability.

11.3 The Customer shall notify the Seller immediately in writing upon becoming aware of any attachment, seizure, insolvency proceedings, judicial reorganisation, or other event that may affect the Seller’s ownership rights over the Products.

11.4 Sub-Distributor Customers are authorised to resell Products in the ordinary course of their distribution activities prior to full payment of the purchase price. In such event, the Seller shall automatically acquire, by way of assignment or subrogation, all rights and claims of the Sub-Distributor Customer against its own purchasers arising from such onward sale, including the right to payment of the sale proceeds, up to the amount owed by the Sub-Distributor Customer to the Seller. The Sub-Distributor Customer shall, upon the Seller’s first request, execute all documents and take all measures necessary to evidence, perfect or enforce such assignment or subrogation, including notifying its purchasers thereof.

12. Warranty

12.1 The Seller warrants that the Products conform to the Agreement and applicable legal requirements at the time of delivery.

13. Limitation of Liability

13.1 To the maximum extent permitted by law: (a) the Seller shall not be liable for any indirect, incidental or consequential damages, including loss of profit, revenue, or business; (b) the Seller’s total aggregate liability shall be limited to the invoiced value of the Products giving rise to the claim.

13.2 The Seller shall not be liable for damages resulting from:

misuse or improper application of the Products by the Customer or a third-party;
use by unqualified or untrained personnel or use outside the Intended Purpose of the Products;
failure to follow Instructions for Use and storage use.

13.3 Nothing in these Terms shall exclude liability for death or personal injury caused by the Seller’s negligence or by a defective product, fraud, wilful misconduct, or to the extent that any applicable mandatory legal provisions prohibit such exclusion.

14. Compliance with MDR

14.1 Certain Products may qualify as medical devices under the MDR.

14.2 The Seller acts as an economic operator and ensures that Products placed on the market comply with applicable regulatory requirements.

14.3 The Customer undertakes to:

use the Products strictly in accordance with their Intended Purpose and Instructions for Use;
ensure that only appropriately qualified personnel use the Products where required;
comply with all applicable laws and regulations in the country of use.

14.4 Unless otherwise permitted by these Terms or applicable law, the Customer shall not:

alter, relabel, or repackage the Products;
compromise CE marking or regulatory information.

14.5 The Customer, where acting as a Sub-Distributor Customer, shall comply with all obligations applicable to distributors under the MDR. The Customer acknowledges that any alteration, relabelling, or repackaging of a Product that goes beyond what is permitted under the MDR shall result in the Customer being treated as the manufacturer of that Product under the MDR, with all corresponding regulatory obligations and liabilities.

14.6 The Customer shall preserve and transmit UDI information in accordance with the MDR and shall not remove, obscure, or alter any UDI carrier (label, barcode, or RFID element) affixed to any Product.

14.7 The Customer purchasing post-operative protective eyewear, fluostrips, adapters for slit lamps and microscopes, intraocular liquids, gases, viscoelastics, or any other Products that qualify as medical devices under the MDR acknowledges that these products are regulated medical devices and undertakes to use, store, and distribute them exclusively in accordance with their classification under the MDR and applicable national law.

15. Traceability and Recall

15.1 The Customer shall maintain complete and accurate records of all Products received, including at minimum: product name, reference number, UDI (where applicable), lot or batch number, quantity, delivery date, and the identity of the supplier. For Sub-Distributor Customers, records shall also include the identity of all downstream customers to whom Products have been supplied, enabling full downstream traceability.

15.2 Such records shall be retained for a minimum period of ten (10) years from the date of the last transaction involving the Product concerned, or fifteen (15) years for implantable devices, in accordance with the MDR. Records shall be made available to the Seller and/or any competent authority upon request.

15.3 In the event of a recall, Field Safety Corrective Action or Field Safety Notice: (a) the Customer shall immediately quarantine all affected Products and cease their distribution or use; (b) the Customer shall follow Seller’s instructions and those of the relevant competent authority without delay; (c) Sub-Distributor Customers shall immediately notify all downstream customers to whom the affected Products have been supplied, in accordance with the Seller’s instructions; (d) the Customer shall provide the Seller with a full account of affected Products, including quantities and the identity of any downstream recipients, within forty-eight (48) hours of the recall notification.

16. Vigilance and Incident Reporting

16.1 The Customer shall notify the Seller immediately and without delay, and in any event within twenty-four (24) hours, upon becoming aware of: (a) any incident that led, is suspected to have led to or may have led to the death of a patient, user, or other person; (b) any serious deterioration in the state of health of a patient, user, or other person; (c) any malfunction, deterioration in characteristics, or performance of a Product; or (d) any inadequacy in the Instructions for Use that may have contributed to an adverse event.

16.2 The Customer shall cooperate fully in:

investigations relating to the incident;
the fulfilment of regulatory reporting obligations to the Federal Agency for Medicines and Health Products (FAMHP) or any other competent local health authority; and
any corrective actions.

16.3 Sub-Distributor Customers shall maintain their own vigilance system and shall comply with the incident reporting obligations applicable in each country of distribution, and shall immediately relay any relevant information to the Seller.

17. Storage, Handling and Transport

17.1 The Customer shall store, handle and transport the Products in accordance with: (a) the manufacturer’s instructions and storage conditions specified in the Instructions for Use and on the product label; (b) applicable GDP guidelines for medical devices; (c) any specific requirements communicated by the Seller at the time of delivery. The Seller shall have the right, upon reasonable prior notice, to audit or inspect the Customer’s premises and records to verify compliance with this clause.

17.2 Without limiting the foregoing, for Products requiring temperature-controlled storage (including intraocular liquids, gases, and viscoelastics), the Customer shall: (a) maintain the cold chain from the moment of receipt; (b) use appropriate storage facilities with validated temperature monitoring; (c) document storage conditions and make such records available to the Seller upon request. Products that have been exposed to conditions outside the specified storage parameters shall not be used, distributed, or sold, and must be quarantined and reported to the Seller immediately.

17.3 The Seller shall not be liable for any deterioration of Products or harm to patients resulting from improper storage or handling by the Customer after delivery.

18. Resale and Regulatory Responsibility

18.1 This Article applies exclusively to Sub-Distributor Customers and shall only apply for so long as no separate distribution agreement has been concluded between the Seller and the Sub-Distributor Customer concerned. Upon entry into force of such distribution agreement, the provisions of that agreement shall prevail over this Article to the extent of any overlap. If the Customer resells or distributes the Products, it shall act as an independent Economic Operator.

18.2 The Sub-Distributor Customer shall at all times maintain the authorisations, registrations, and licences required to distribute medical devices in each relevant country, and shall provide evidence thereof to the Seller upon request.

18.3 The Sub-Distributor Customer assumes full responsibility for compliance with:

All obligations applicable to distributors under the MDR;
national regulatory requirements;
distribution and documentation obligations.

18.4 Where the Sub-Distributor Customer is required to provide a translation of the Instructions for Use into the language of the target country, such translation shall be accurate and shall faithfully reflect the original Instructions for Use. The Sub-Distributor shall notify the Seller before making any translation available and shall provide the Seller with a copy. Any cost associated with translation shall be borne by the Sub-Distributor unless otherwise agreed.

18.5 The Sub-Distributor Customer shall not rebrand, relabel, or repackage any Product in a manner that goes beyond what is expressly permitted under the MDR without the Seller’s prior written consent. Any such activity beyond what is permitted shall cause the Sub-Distributor Customer to assume full manufacturer liability under the MDR.

18.6 The Sub-Distributor Customer shall maintain a quality management system appropriate to the nature and scale of its distribution activities, and shall make this available for inspection by the Seller upon reasonable notice.

18.7 The Sub-Distributor Customer shall provide the Seller with periodic sales reports in a format to be agreed between the parties, to enable the Seller to fulfil its market surveillance and EUDAMED reporting obligations.

18.8 The Sub-Distributor Customer shall maintain, at its own expense, adequate professional liability and product liability insurance as long as it resells the Products. Evidence of such coverage shall be provided to the Seller upon first request. Failure to maintain adequate insurance shall constitute a material breach of these Terms.

19. Force Majeure

19.1 Neither party shall be liable for any failure or delay in performing its obligations to the extent that such failure or delay is caused by an event of Force Majeure.

19.2 “Force Majeure” means any event beyond the reasonable control of the affected party, unforeseeable at the time the Agreement was concluded, and which cannot be overcome by reasonable means, including but not limited to: acts of God, natural disasters, pandemics or epidemics, acts of government or public authority, embargoes, war or civil unrest, cyberattacks, supply chain disruptions not reasonably foreseeable, transport failures, or IT or network failures at infrastructure level.

19.3 The party affected by a Force Majeure event shall notify the other party in writing as soon as reasonably practicable, setting out the nature and anticipated duration of the event.

19.4 If a Force Majeure event continues for more than thirty (30) consecutive days, either party may terminate the Agreement by written notice without liability, save for payment of amounts already due for Products delivered.

20. Intellectual Property

20.1 All intellectual property rights (including patents, trademarks, design rights, copyrights, trade secrets, and know-how) in or relating to the Products and the Webshop remain vested in the Seller or its licensors. No licence is granted to the Customer other than the limited right to use the Products in accordance with their Intended Purpose and these Terms.

20.2 The Sub-Distributor may use the Seller’s trademarks and product literature solely for the purpose of marketing and distributing the Products, provided that such use complies with the Seller’s brand guidelines as communicated from time to time, and does not imply any partnership, agency, or joint venture between the parties.

21. Data Protection and Confidentiality

21.1 The Seller processes personal data in accordance with applicable data protection laws, including the GDPR, and its privacy policy.

21.2 Each party shall keep confidential all non-public information disclosed by the other party in connection with the Agreement, including pricing, product development information, customer lists, and business strategies. Each party shall: (i) use Confidential Information solely for the purposes of the Agreement; (ii) not disclose Confidential Information to third parties without the other party’s prior written consent, except to employees and professional advisors who need to know the information and are bound by equivalent confidentiality obligations. Confidentiality obligations shall not apply to information that: (i) is or becomes publicly available other than through a breach of this Article; (ii) was already known to the receiving party; (iii) is independently developed by the receiving party; or (iv) must be disclosed by applicable law or regulatory authority.

21.3 This confidentiality obligation shall survive termination of the Agreement for a period of five (5) years.

22. Compliance with laws

22.1 The Customer shall comply with all applicable anti-corruption and anti-bribery laws, including the Belgian Criminal Code provisions on corruption and the applicable EFPIA / MedTech Europe Code of Ethical Business Practice where relevant. The Customer warrants that it shall not, in connection with the Agreement, offer, promise, pay, or give (directly or indirectly) any financial or other advantage to any public official, healthcare professional, or any other person for the purpose of obtaining or retaining business, or as an inducement or reward for the improper performance of a function.

22.2 The Products are subject to export control regulations. The Customer undertakes to comply with all applicable export and import control laws and regulations, including EU dual-use regulations and applicable sanctions regimes. The Customer shall not export, re-export, or transfer the Products to any country, entity, or individual that is the subject of applicable trade sanctions or embargoes without obtaining all required governmental authorisations.

23. Termination

23.1 Either party may terminate the Agreement (or any specific order) with immediate effect by written notice if the other party: (a) commits a material breach of these Terms and (where the breach is remediable) fails to remedy it within fifteen (15) calendar days of written notice; (b) becomes insolvent, enters judicial reorganisation, is placed under administration, or makes an assignment for the benefit of creditors; (c) ceases or threatens to cease to carry on business.

23.2 The Seller may terminate or suspend the Customer’s access to the Webshop immediately upon notice in the event of: (a) breach of any MDR compliance obligation under these Terms; (b) regulatory action by a competent authority affecting the Customer’s ability to distribute medical devices; (c) suspected fraudulent activity.

23.3 Termination shall not affect accrued rights and obligations. Upon termination, the Customer shall immediately cease using the Products for distribution and shall cooperate with any recall or field safety measures in progress.

24. Governing Law and Jurisdiction

24.1 These Terms and all Agreements shall be exclusively governed by and construed in accordance with Belgian law, excluding its conflict of law provisions and the UN Convention on Contracts for the International Sale of Goods (CISG) and the United Nations Convention and Protocol on the Limitation Period in the International Sale of Goods.

24.2 All disputes shall fall under the exclusive jurisdiction of the competent courts of Leuven, Belgium, without prejudice to the Seller’s right to bring proceedings before any other court of competent jurisdiction for the purpose of obtaining interim or conservatory measures.

25. Miscellaneous

25.1 If any provision of these Terms is held to be invalid, illegal, or unenforceable, it shall be modified to the minimum extent necessary to make it valid, legal, and enforceable, or severed if such modification is not possible, without affecting the validity or enforceability of the remaining provisions.

25.2 The Seller reserves the right to amend these Terms at any time by publishing the revised version on the Webshop.

25.3 These Terms, together with any written order confirmation issued by the Seller, constitute the entire agreement between the parties with respect to the subject matter hereof and supersede all prior representations, negotiations, and understandings.

25.4 The Customer may not assign, transfer, or novate any of its rights or obligations under these Terms without the Seller’s prior written consent. The Seller may assign these Terms and any Agreement to any affiliate or successor entity without the Customer’s consent, provided that the Customer is notified in writing.