General Terms and Conditions of Sale Bien-Air Dental SA
1. Validity
Unless otherwise agreed in writing, these Terms & Conditions of Sale (TCS) apply to all transactions between Bien-Air Dental SA and the purchaser. By sending an order, the purchaser accepts these Terms & Conditions of Sale. Any condition set by the purchaser that would deviate from these Terms & Conditions will only apply if accepted expressly and in writing by Bien-Air Dental SA. The Terms & Conditions of Sale, Warranty and Delivery are available from Bien-Air Dental SA subsidiaries.
2. Offers and orders
Our written offers are valid for a period of 3 months from their issue date unless the offer itself contains another validity period. After receiving the order, Bien-Air Dental SA sends the purchaser an order confirmation. The order confirmation does not need to be signed and may also be sent by e-mail. The contract is considered agreed when Bien-Air Dental SA confirms the order. The purchaser must check that each order confirmation matches the order and report any discrepancy in writing within 3 working days. Otherwise, the contents of the order confirmation are binding.
3. Prices
The prices of our products are net ex-Works, excluding taxes. All ancillary costs for packaging, shipping, drawing up certificates or authentic deeds and other similar costs are charged to the purchaser. A supplementary fee of 20 CHF may be charged if the amount of the invoice is less than 100 CHF.
The prices of our services are net, excluding taxes, unless otherwise stated in the official documentation or website of Bien-Air Dental SA.
Bien-Air Dental SA reserves the right to amend prices without notice.
4. Risks (for dealers only)
The purchaser is responsible for the goods ex-Works (EXW), unless other clauses are included in the contract (Incoterms 2020). Unless otherwise specified, the contract is fulfilled at the factory of Bien-Air Dental SA.
5. Regulatory authorisation (for dealers only)
Obtaining regulatory authorisation for products in the relevant country is also the purchaser’s responsibility. Based on Bien-Air Dental SA's decision and documentation, the purchaser undertakes to submit, obtain and maintain in force all licenses, approvals and registration certificates on behalf of Bien-Air Dental SA for purposes of importing the products in accordance with the country’s legislation. Evidence of approval must be retained by the purchaser for each item. All supporting documents for approvals (certificates, databases) must be sent to Bien-Air Dental SA as soon as they are obtained from the local authorities.
All communications relating to Bien-Air Dental SA products must be sent to Bien-Air Dental SA, which will manage all correspondence.
6. Delivery time
The delivery times stated in the order confirmation will be met whenever possible as long as the purchaser provides, within the deadlines required by Bien-Air Dental SA, all the documents required for shipment. The delivery time will be less than 3 weeks, provided that all delivery conditions are fulfilled. Any claim for loss and damage is dismissed in the event of late delivery except in the event of mismanagement by Bien-Air Dental SA. Under exceptional circumstances (e.g. machine breakdown, delayed delivery of raw materials or energy, strike, natural disasters, war, pandemic, force majeure or accident), the delivery time is extended until the unexpected event is easily resolved. If the interruption lasts more than 3 months, Bien-Air Dental SA and the purchaser have the right to terminate the contract without compensation.
7. Retention of title
The goods delivered remain the property of Bien-Air Dental SA until the related invoice is paid in full. The purchaser is required to participate in measures necessary to protect Bien-Air Dental SA's property rights. At the time the contract is agreed upon, the purchaser gives authority to Bien-Air Dental SA, particularly to register the retention of title in the register of title retention pacts.
8. Receipt and checking of goods
The purchaser has the obligation to check the goods received within 10 days of receipt. If the goods are not checked within this deadline, the purchaser is deemed to have accepted the goods, subject to hidden defects. Written notification of the defect must be received by Bien-Air Dental SA within the aforementioned deadline and must include the name of the purchaser, the purchase date, the product’s reference and the serial number.
In the event of a complaint, Bien-Air Dental SA or its authorised representative repairs or replaces the product free of charge after considering the merits of the complaint. Any other complaint whatever the nature, particularly those for loss or damage, is inadmissible except in the event of fraud or mismanagement.
9. Storage of products (for dealers only)
The purchaser undertakes to use state-of-the-art warehousing and distribution practices for Medical Devices, including during shipment, to ensure that:
10. Traceability (for dealers only)
The purchaser must keep complete, accurate, and up-to-date documentation of all product sales and associated transactions for sixteen (16) years from the issue date to ensure the traceability of each product in the supply chain at all times. The document directory must contain at least:
11. Payment Terms
Payment dates apply as agreed in writing in the offer or order confirmation. In the event of late payment, default interest will be charged at the Swiss Bank's current account credit rate. If the payment deadline agreed between the parties is not met, the purchaser is automatically put on notice to pay.
If a sales or service contract is paid late or unpaid, Bien-Air Dental SA reserves the right to terminate the contract, in whole or in part, with immediate effect. Bien-Air Dental SA is also entitled to suspend or cancel completion of any other order placed by the purchaser. Unless otherwise stipulated in the offer or order confirmation, the place of payment is the domicile of Bien-Air Dental SA in Biel, Switzerland. Deductions for discounts, expenses, taxes, duties, fees, customs and the like are prohibited.
12. Order cancellation
Any cancellation or amendment of an order (before delivery) must be approved by Bien-Air Dental SA.
13. Return of goods
Bien-Air Dental SA only accepts goods returned in good condition and in their original packaging accompanied by the invoice. Returns are not accepted without prior notice.
14. Liability
Bien-Air Dental SA can only be held liable under the terms of the provisions of these Terms & Conditions of Sale as well as the terms of legal provisions regarding product liability and as a "manufacturer" pursuant to Council Directive 93/42/EEC (MDD) or Regulation (EU) 745/2017 (MDR) relating to medical devices and "manufacturer" pursuant to Machinery Directive 2006/42/EC.
The purchaser is solely responsible for choosing products and services appropriate to its needs. The purchaser, as a business, must confirm the conditions of use of the products, in particular the use specified by Bien-Air Dental SA, the contraindications or warnings and, where applicable, the expiry dates.
For the remainder and except in the event of fraud or mismanagement, Bien-Air Dental SA declines all liability. In particular, it cannot be held liable for damage, injuries and their consequences, especially resulting from:
Under no circumstances is the purchaser authorised to modify any product in any way whatsoever. The purchaser is prohibited from selling any products to customers that are out of their original packaging as supplied by Bien-Air Dental SA. Any breach of this clause will invalidate the warranty and the regulatory responsibility of Bien-Air Dental SA for the modified product.
15. Location and time repair
Repairs are carried out in an official Bien-Air centre (list available in the "Where to repair" section of the Bien-Air website) and within less than 3 weeks, provided that all repair conditions are fulfilled. Any claim for damage is dismissed in the event of non-compliance with the repair period except in the event of major mismanagement by Bien-Air Dental SA.
In the event of exceptional circumstances (e.g. delayed delivery of components, raw materials or energy, strikes, natural disasters, war, pandemics, force majeure or accident), the repair period will be extended until the unforeseen event can be easily resolved.
16. Warranty
Only proven defects in material or workmanship of the delivered goods are deemed to be defects. The warranty periods take effect from the invoice date.
The warranty periods can be found in the instructions for use of the products.
In any circumstance, the warranty becomes null and void if the product is worked on inappropriately or modified by third parties not authorised by Bien-Air Dental SA. Where the existence of a defect is disputed, it is the purchaser’s responsibility to establish that the defect exists. Warranty claims will only be considered upon presentation, with the product, of a copy of the sales/repair invoice or the delivery note clearly showing the purchase date, reference and serial number of the product.
In addition to the standard Bien-Air Dental SA warranty, Bien-Air comprehensive Casco warranty programmes (hereinafter, "CASCO") cover wear parts as well as any material damage caused to the products, such as when an instrument accidentally falls on the floor. Bien-Air Dental SA reserves the right not to apply this warranty in the event of abuse.
The comprehensive Casco warranty programmes and the standard Bien-Air Dental SA warranty do not cover damage caused by excessive or inappropriate use, by failure to obey user manuals or assembly and maintenance instructions, by unusual chemical, electrical or electrolytic influences, by incorrect connections, whether to air, water or electricity, or any other inappropriate use outside the intended use for dentistry. The comprehensive warranty programmes take effect as soon as the programme is purchased. The purchaser may register for the CASCO programme no later than 10 days after purchasing the product. The receipt for the product covered by CASCO must be retained as proof of purchase and will be required to claim against the warranty. CASCO warranty programmes can only be offered for families of turbines and contra-angles/hand parts. Bien-Air micromotors are excluded from this programme.
17. Post-market surveillance
Reporting of incidents: the purchaser must immediately notify Bien-Air Dental SA of any incident liable to harm or to have already harmed a patient, a user or a third party. As a manufacturer of medical devices, Bien-Air Dental SA is required, as a last resort, to notify the competent authorities about product safety issues.
In the case of complaints concerning alleged malfunctions or defects in products, the purchaser or their representative/agent is prohibited from expressing any statements as to the causes without the prior agreement of Bien-Air Dental SA and in the absence of a formal examination of the alleged product malfunctions or defects by Bien-Air Dental SA. In all circumstances, the purchaser or its representative/agent is prohibited from issuing statements where the content differs from or adds to the conclusions of Bien-Air Dental SA.
18. Corrective actions for field safety
Bien-Air Dental SA has the exclusive right and alone is obliged to issue and coordinate any corrective actions for field safety or any other corrective action on the products. Upon receipt of a notification of corrective action from Bien-Air Dental SA, the purchaser undertakes to uphold and follow the instructions of Bien-Air Dental SA to comply with the current regulations. These instructions may include but are not limited to, freezing the existing stock of affected products, communicating to customers, and arranging for the affected products to be collected and disposed of or shipped back to Bien-Air Dental SA.
If notification of an incident to the competent authorities and/or corrective action for field safety (including, but not limited to, product recalls, changes to instructions for the use of the product, software updates, etc.) is/are required by law in the relevant country, the purchaser undertakes to support Bien-Air Dental SA in all necessary actions relating to local compliance and its justification. Legal repercussions may arise if the purchaser fails to comply with the obligations for post-market surveillance in the relevant country.
19. Partial nullity
If one of the provisions of these Terms & Conditions should prove to be invalid, the other provisions remain valid. The parties are obliged to replace the invalid provision with a valid provision that matches the economic terms of the original provision.
20. Applicable law – Jurisdiction
This version of the Terms & Conditions of Sale (TCS) cancels and replace any previous version.
Swiss national law (Code of Obligations) applies in addition to the general terms & conditions and special agreements between the purchaser and Bien-Air Dental SA. For any dispute, disagreement or claim arising from the contractual relationship between Bien-Air Dental SA and the purchaser or relating thereto, the courts of Biel, Switzerland, have exclusive jurisdiction.
Biel, March 2024
SU 721-270 Rev. 0006 – 05.03.24 [DG]