General terms and conditions of sale and delivery Belux

1. Definitions and applicability

1.1 In these general terms and conditions of sale and delivery, the following terms shall have the following meanings:

Terms and Conditions: these general terms and conditions of sale and delivery of Seller.

Seller: Buyer’s counterparty under the agreement, being the Belgian company MegaGen Belux B.V., registered with the Crossroads Bank for Enterprises under number 0793.466.136.

MDR: Regulation (EU) 2017/745 on medical devices.

Buyer: the healthcare provider, clinic, hospital, dental practice, implantology practice or other party acting in the course of a profession or business and negotiating with Seller, requesting a quotation, placing an order or entering into an agreement.

Product: all dental implants, components, instruments, equipment, regeneration products, consumables, materials, parts, accessories, documentation and related medical devices offered, sold, delivered or made available by Seller and, where agreed, related services.

1.2 These Terms and Conditions apply to all quotations, offers, confirmations, agreements, deliveries and other legal relationships between Seller and Buyer. These Terms and Conditions also apply to follow-up orders, supplementary arrangements and related non-contractual claims. These Terms and Conditions also apply for the benefit of group companies, directors, shareholders, employees, auxiliary persons and third parties engaged by Seller, each of whom may invoke and rely on these Terms and Conditions directly.

1.3 Buyer acknowledges that the Products, where applicable, are medical devices or accessories for medical devices within the meaning of the MDR. Seller may be a distributor or importer in respect of each Product.

1.4 General terms and conditions of Buyer shall not apply, even if Buyer has referred to them in a request, order, portal, confirmation, correspondence, invoice or other document.

1.5 Should any clause be invalid or void, the remaining clauses shall remain in force. The parties shall replace the relevant clause with a valid clause that reflects the purpose of the original clause as closely as possible.

2. Offer and acceptance

2.1 If no period of validity is stated in Seller’s quotations and offers, they shall remain valid for 14 days. Seller may withdraw an offer for as long as Buyer has not accepted it and Seller has not confirmed it in writing.

2.2 An agreement is concluded once Seller confirms the order in writing. If Buyer’s acceptance deviates from Seller’s offer, this shall be deemed to constitute a new offer by Buyer. Seller shall only be bound by such deviation if it accepts it in writing.

3. Price

3.1 If no price has been agreed, the prices set out in Seller’s most recent price list at the time of confirmation shall apply. Prices are stated in euros, exclusive of VAT and additional costs.

3.2 Seller may adjust the price after written confirmation, if external costs that directly affect the delivery of the Products demonstrably increase. This shall in any event include price increases imposed by manufacturers or suppliers and new or amended legal obligations.

3.3 If the price adjustment exceeds 15% of the original price, Buyer may terminate the agreement in writing in respect of the part not yet performed within 8 days after Seller’s notification. This right does not apply to costs passed on directly by Seller, such as taxes, levies, import duties, customs costs, exchange rates, transport costs or other costs imposed by public authorities or third parties.

3.4 If Buyer terminates pursuant to clause 3.3, Buyer shall pay for Products already delivered, work performed, costs incurred, Products specially ordered or custom-made, and reasonable transport, storage and administration costs. Seller may deliver parts already available and invoice them separately if such part has independent value.

3.5 If a price is reasonably based on a mistake, input error or another clear error in a quotation, price list, catalogue, portal, website or confirmation, Seller may correct the price and the order shall be cancelled. The correction shall constitute a new offer by Seller.

4. Performance of the agreement

4.1 Buyer shall provide Seller in a timely manner with all information, data, documentation, instructions and cooperation required for the quotation, preparation, performance and delivery of the Products. Seller may rely on the accuracy and completeness thereof. If Buyer fails to provide information or cooperation in a timely manner, fully or accurately, Seller may suspend performance and any additional costs and loss shall be borne by Buyer.

4.2 Lists, specifications, dimensions, images, drawings, models, samples and other product information of Seller are indicative, unless Seller confirms in writing that they are exact. Minor deviations and changes required due to laws and regulations, manufacturer’s instructions, measures imposed by competent authorities or third-party rights shall not constitute a breach, provided they do not materially reduce the usability, safety or performance of the Product.

4.3 If a custom-made product or patient-specific Product corresponds to the data provided by Buyer or the design approved by Buyer, there shall be no breach by Seller if the Product does not fit, proves unsuitable for the chosen clinical application or does not meet expectations that are not apparent from such data or design.

4.4 Custom-made and patient-specific Products may not be cancelled or returned once production has started.

4.5 Buyer shall store, transport, internally distribute, install, connect, maintain, calibrate, apply and use the Products only in accordance with the instructions, labelling, instructions for use, laws and regulations and applicable professional standards, insofar as those acts are relevant to the Product concerned. Buyer shall retain traceability information regarding receipt, internal distribution, use and application and shall provide this to Seller upon request, insofar as legally permitted and necessary for statutory obligations, complaints, product safety, post-market surveillance, recalls, field safety corrective actions, requests from competent authorities or Seller’s importer obligations.

4.6 Buyer shall notify Seller in writing without undue delay of complaints, suspected defects, incidents, near incidents, safety notices and other relevant signals, insofar as legally permitted and necessary. Buyer shall cooperate with recalls, withdrawals, field safety corrective actions, product investigations and other measures relating to product safety or statutory obligations. If Buyer knows or reasonably suspects that a Product is non-compliant, presents a safety risk, has been blocked, quarantined or is subject to a recall, withdrawal or field safety corrective action, Buyer may not use, internally distribute, apply, return or otherwise make that Product available.

4.7 Buyer may not modify, repackage, relabel, resterilise, combine, process, copy or use the Products, packaging, labelling, instructions for use, safety information, documentation and other materials outside their intended purpose, unless Seller permits this in writing and it is legally permitted. Buyer may also not perform any acts that adversely affect conformity, safety, traceability, intended purpose, importer details, UDIs (unique device identifiers) or Intellectual Property notices.

4.8 Buyer indemnifies Seller against all loss, costs, third-party claims and measures imposed by supervisory authorities arising from Buyer’s non-compliance with this clause, insofar as they were not caused by a breach by Seller.

5. Delivery

5.1 Unless otherwise agreed in writing, Seller shall deliver the Products to the delivery address stated in the confirmation. Delivery shall take place in accordance with DAP (Delivered at Place) Incoterms® 2020.

5.2 Buyer shall take receipt of the Products as soon as they are delivered in accordance with clause 5.1. If Buyer fails to do so, refuses delivery or if necessary information or cooperation is missing, Seller may store the Products for Buyer’s account and risk, offer them again, return them or take other appropriate measures. Any additional costs shall be borne by Buyer.

5.3 Delivery times are indicative, unless it is agreed in writing that time is of the essence. Delivery times commence once all commercial and technical details have been agreed, Seller has received all required information, agreed payment has been received and all other conditions for performance and delivery have been met.

5.4 In the event of delay, Buyer shall, in writing, grant Seller a reasonable period for delivery. For Products produced, purchased, transported or cleared through customs wholly or partly outside the European Union, a period of at least 6 weeks shall apply. In other cases, a period of at least 3 weeks shall apply.

5.5 Seller may deliver in instalments and invoice each instalment separately, unless such instalment has no independent value. Buyer shall accept each instalment and pay for it in accordance with these Terms and Conditions.

6. Payment

6.1 Buyer shall pay Seller’s invoices within 30 days after the invoice date.

6.2 Payments shall first be applied against interest and costs, then against due invoices for which the retention of title has already lapsed, and then against the oldest outstanding invoices, even if Buyer states otherwise when making payment.

6.3 In the event of late payment, Buyer shall owe statutory commercial interest under Dutch law on the outstanding amount.

6.4 If Buyer fails to pay on time, Buyer shall reimburse Seller’s extrajudicial collection costs. These costs shall amount to 15% of the amount due, subject to a minimum of EUR 500. Buyer shall also reimburse any judicial costs reasonably incurred by Seller in obtaining payment.

6.5 Seller may set off claims against Buyer or a group company of Buyer against amounts owed by Seller to Buyer or a group company of Buyer. Buyer may not suspend payment or set off, unless Seller has acknowledged the counterclaim in writing or it has been irrevocably established by a final and binding court judgment.

6.6 Buyer shall dispute an invoice in writing, stating reasons, within 8 working days after receipt. Failing this, the invoice shall be deemed accepted, unless Buyer could not reasonably have discovered the inaccuracy earlier.

7. Immediate payment, suspension and termination

7.1 All claims of Seller against Buyer shall become immediately due and payable if: (a) Buyer is in default; (b) Seller has reasonable grounds to doubt timely or full performance; (c) Buyer fails to comply with obligations towards a bank, financier or significant creditor; (d) suspension of payments, bankruptcy, a WHOA procedure, debt restructuring or a comparable procedure is applied for, offered or pronounced in relation to Buyer; (e) a substantial part of Buyer’s assets or Seller’s Products are seized or become subject to attachment; (f) Buyer ceases, transfers or dissolves its business; or (g) a comparable situation occurs at an affiliated company of Buyer contracting with Seller.

7.2 In the situations referred to in clause 7.1, Seller may, without court intervention and without any further notice of default: suspend current agreements, refuse deliveries, require advance payment or security, cancel outstanding orders or terminate agreements in whole or in part, and repossess Products subject to retention of title in accordance with clause 10.3. Seller shall retain its right to compensation for loss, costs, interest and collection costs.

7.3 Seller may require advance payment or additional security if it has reasonable grounds to doubt timely or full performance by Buyer. If Buyer fails to provide such payment or security within a reasonable period, Seller may suspend performance or dissolve or terminate the agreement in whole or in part, without being liable to pay compensation.

7.4 Suspension or termination by Seller shall not affect Buyer’s obligation to pay for Products already delivered, work performed, costs incurred, Products specially ordered or custom-made, reasonable costs for cancellation, storage, transport and administration and other amounts due.

8. Termination and consequences

8.1 If Seller is in breach of the agreement, Buyer may only terminate the agreement in whole or in part after Seller has been granted written notice of default and a reasonable period to cure the breach. Termination is not allowed if the breach is reasonably too minor to justify termination.

8.2 Buyer may not terminate the agreement in respect of Products already delivered if that part has independent value and is not affected by the breach.

8.3 If Seller terminates the agreement due to irreparable breach by Buyer, it shall be presumed that Seller cannot realise value from the Product and that the value of the Product to Seller is zero, subject to evidence to the contrary by Buyer. If Buyer provides such evidence to the contrary, Seller’s loss shall be presumed to amount to 20% of the invoice value.

9. Commercial defects, product complaints and MDR notifications

9.1 Buyer shall inspect the Products upon delivery or without undue delay thereafter. Buyer shall in any event verify whether the correct Products and quantities have been delivered, whether the packaging and labelling are visibly undamaged and whether there are any visible deviations, damage or other shortcomings.

9.2 Visible commercial defects, such as incorrect quantities, mistaken Products, transport damage or visible deviations in packaging or delivery, shall be notified by Buyer to Seller in writing within 8 days after delivery. Buyer shall clearly describe the complaint and provide relevant evidence. In the event of transport damage, Buyer shall also record the damage on the transport documents.

9.3 Non-visible commercial defects shall be notified by Buyer in writing within 8 days after Buyer has discovered or reasonably should have discovered the defect, but no later than 12 months after delivery. If Buyer fails to notify in time, its rights in respect of that commercial defect shall lapse, insofar as legally permitted.

9.4 Product complaints, suspected product defects, incidents, near incidents, safety notices and signals concerning performance or conformity are not ordinary commercial claims. Buyer shall notify such signals to Seller in writing without undue delay, irrespective of the periods in clauses 9.2 and 9.3. This also applies to information that may be relevant to product safety, post-market surveillance, incident follow-up, recalls, withdrawals or other field safety corrective actions.

9.5 A notification as referred to in clause 9.4 shall include, insofar as known: the Product, batch, lot, serial number or UDI (unique device identifier), delivery date, date of discovery, description of the complaint or incident, relevant patient or user information insofar as legally permitted and necessary, photographs, correspondence, documentation and the measures already taken by Buyer.

9.6 Buyer shall carefully retain Products, packaging, labels, instructions for use, documentation and evidence relating to a claim, product complaint or MDR notification and shall reasonably cooperate with any investigation.

9.7 Reporting or handling a product complaint, incident report or other MDR notification shall not constitute acknowledgement of any defect, breach, non-conformity or liability by Seller. Seller shall assess the notification on the basis of its contractual and applicable statutory obligations.

9.8 If a commercial defect complaint is justified, Seller may choose supplementary delivery, replacement, or restoration of the purchase price or a proportionate part thereof. After implementation of such measure, Buyer shall have no further claims in respect of that commercial claim.

10. Retention of title

10.1 Products delivered and to be delivered shall remain the property of Seller until Buyer has paid the full purchased price relating to those Products.

10.2 Buyer shall keep Products subject to retention of title carefully, recognisably and, where reasonably possible, separate from third-party goods. Buyer shall handle these Products in accordance with the instructions, labelling, instructions for use and storage and transport requirements. Buyer shall not pledge or encumber these Products, nor grant any security right over them to third parties.

10.3 If a situation as referred to in clause 7.1 occurs, Seller may repossess or have repossessed Products subject to retention of title. Buyer shall provide full cooperation, grant access to the premises where the Products are located, identify the Products and provide the administration and traceability information required to identify the Products.

10.4 Buyer shall inform Seller in writing without undue delay if third parties claim rights to Products subject to retention of title, if those Products are seized or become subject to attachment, if the Products are lost or damaged, or if Buyer applies for or becomes subject to suspension of payments, bankruptcy or a comparable situation.

10.5 The risk of loss, damage, depreciation and unsuitability of Products subject to retention of title shall be borne by Buyer from the moment the risk has passed in accordance with clause 5. Buyer shall insure these Products at its own expense against customary risks for as long as the retention of title applies.

10.6 If the retention of title provides insufficient security, Buyer shall provide additional reasonable security at Seller’s first request.

10.7 Consignment stock shall apply only if the parties agree so in writing. Products on consignment shall remain the property of Seller until they are used, applied, consumed, internally released for patient care, supplied to a patient by Buyer or invoiced at another agreed time. Buyer shall keep consignment stock separate, recognisable and traceable, store it in accordance with the instructions of Seller and the manufacturer and bear the risk of loss, damage, disappearance, depreciation and unsuitability from receipt. Buyer shall report use, application, consumption and stock movements in accordance with the arrangements and shall give Seller reasonable access to stock and administration for counting, inspection and traceability. Buyer shall not move, return, use or make consignment stock available to third parties in breach of the agreement or Seller’s instructions. Seller may repossess consignment stock if Buyer fails to comply with its obligations or if this is reasonably necessary for payment, traceability, product safety, statutory obligations or quality assurance.

11. Warranties, exchanges and returns

11.1 Seller provides warranties only insofar as they have been agreed in writing and arise from the warranty terms of Seller or the manufacturer. Product information, catalogues, price lists, brochures, images, specifications, instructions for use and other documentation shall not constitute a warranty.

11.2 Products may be exchanged or returned only with Seller’s prior written consent and subject to the conditions set by Seller. Seller may refuse a request for exchange or return, including if the Product was specially ordered, custom-made, patient-specific, used, installed or connected, damaged, incomplete, not traceable, if the packaging has been opened or damaged, a seal has been broken, storage or transport conditions have not demonstrably been complied with, the expiry date has passed or it cannot reasonably be established that the Product can be safely and compliantly redelivered.

11.3 Returns shall be for Buyer’s account and risk, unless Seller confirms otherwise in writing. Seller may charge return costs, administration costs, reassessment costs or depreciation, or set them off against any credit note.

12. Liability

12.1 Seller’s total liability per event, whereby a series of related events shall be deemed one event, shall be limited to compensation for direct damages up to the invoice amount of the Products to which the liability relates, subject to a maximum of EUR 10,000 per event. In addition, Seller’s liability shall in all cases be limited to the amount actually paid out in the relevant case under Seller’s liability insurance. If, for whatever reason, no payment is made under the liability insurance, Seller’s liability shall remain limited to the maximum amount stated in this clause.

12.2 Direct damages shall consist only of reasonable costs incurred to establish the cause and extent of the loss, reasonable costs incurred to prevent or limit loss, and reasonable costs of repair, replacement or crediting of the relevant Product. These costs shall be eligible for compensation only insofar as Seller is liable for them under these Terms and Conditions.

12.3 Seller shall not be liable for indirect or consequential loss or damages. This includes, among other things, business interruption loss, stagnation loss, loss of turnover or profit, lost savings, reputational damage, loss due to business interruption or delay, third-party claims against Buyer and loss arising from contractual obligations entered into by Buyer with third parties.

12.4 The exclusions and limitations in this clause shall not apply to the extent prohibited by mandatory provisions of law, including in cases of wilful misconduct or gross negligence and mandatory provisions of product liability law.

12.5 Seller shall not be liable for loss or damages arising wholly or partly from incorrect, careless, unskilled or non-compliant use, storage, transport, installation, connection, maintenance, calibration, processing, application, internal distribution, onward delivery, modification, repackaging, relabelling, combination, sterilisation, copying or other use of Products, documentation or related materials by Buyer or persons for whom Buyer is responsible, contrary to instructions, labelling, instructions for use, professional standards, laws and regulations or the agreement.

12.6 Buyer indemnifies Seller against claims by third parties, including patients, users, healthcare professionals, competent authorities, IP right holders and other economic operators, insofar as those claims relate to acts or omissions by Buyer in breach of the agreement, these Terms and Conditions, instructions, labelling, instructions for use, laws and regulations and professional standards. This indemnity also includes reasonable loss, costs, fines, measures, recall costs, investigation and analysis costs, legal costs and defence costs incurred by Seller in connection with the claim.

12.7 Any claim by Buyer against Seller shall lapse one year after Buyer became aware or could reasonably have become aware of the loss and the person liable for it, unless mandatory law prescribes a longer period.

12.8 The exclusions and limitations of liability in this clause shall also apply to group companies, directors, employees, auxiliary persons and third parties engaged by Seller.

13. Force majeure

13.1 If a party is unable to perform its obligations, or to perform them on time or in full, due to force majeure, it may suspend those obligations for as long as the force majeure continues. Force majeure shall in any event include: disruptions at manufacturers or suppliers, international transport, customs, import or export restrictions, measures imposed by authorities, recalls, market withdrawals, quarantine measures, war, strike, fire, natural disasters, pandemics and cyber incidents. The parties shall inform each other as soon as possible of the nature, consequences and expected duration of the force majeure, insofar as known.

13.2 If the force majeure lasts longer than 90 days, or it is reasonably expected that this will be the case, either party may terminate the agreement in writing in respect of the part not yet performed. Neither party shall owe compensation or costs as a result of that termination. If Seller has already made partial delivery or can still make partial delivery, Seller may invoice that part separately. Buyer shall pay that invoice as if it were a separate agreement, unless the delivered or deliverable part has no independent value.

14. Intellectual property

14.1 All intellectual property rights and comparable rights in the Products, designs, models, drawings, specifications, documentation, instructions for use, packaging, labelling, images, know-how, trade names, trade marks and other materials shall remain vested in Seller, the manufacturer or the licensors. The agreement shall not transfer any intellectual property rights to Buyer.

14.2 Buyer may use documentation, instructions for use, product information, images, trade names and trade marks of Seller or the manufacturer only for use within its own healthcare organisation and for communication with practitioners, users and patients, insofar as legally permitted and necessary.

15. Data protection and personal data

15.1 The parties shall process personal data in accordance with applicable privacy legislation. If Buyer provides personal data to Seller, Buyer shall ensure that such provision is legally permitted. Buyer shall provide personal data only insofar as necessary and, where possible, pseudonymised.

15.2 If additional arrangements are required for a specific processing activity, the parties shall reasonably cooperate in entering into a data processing agreement.

16. Governing law and competent court

16.1 All legal relationships between Seller and Buyer shall be governed exclusively by Dutch law. The Vienna Sales Convention (CISG) shall not apply.

16.2 Disputes between Seller and Buyer shall be submitted exclusively to the competent Dutch court of the District Court of Zeeland-West-Brabant, Breda location.

17. Language

17.1 These Terms and Conditions have been drafted in the Dutch language and translated into the English language. In the event of any discrepancy in interpretation, content or scope between the Dutch version and the English translation, the Dutch-language version shall prevail.