General Terms and Conditions

Terms and Condition

GENERAL TERMS AND CONDITIONS OF SALE BIEN-AIR DENTAL SA

1. Validity
Unless otherwise agreed in writing, these present terms and conditions of sale apply to all transactions between Bien-Air Dental SA and Buyer. By sending an order, Buyer accepts the present general terms and conditions of sale. Any condition created by Buyer which derogates from these general terms and conditions shall not apply without express written consent from Bien-Air Dental SA. Terms and conditions of sale, guarantee and local delivery are available from Bien-Air Dental SA branches.

2. Offers and orders
Our written offers are valid for 3 months counting from the date of issue, unless the offer itself specifies another time period. Upon reception of the order, Bien-Air Dental SA shall send the customer an order confirmation. The order confirmation does not need to be signed and can also be sent by e-mail.

3. Price
Our prices are net prices, ex works, excluding tax. All related costs of packaging, dispatch, preparation of certificates or authentic documents and other similar costs shall be invoiced to the customer. The minimum invoice amount is CHF 500.-. Bien-Air Dental SA reserves the right to change prices without notice

4. Risk
Buyer is responsible for the goods after they leave the factory (EXW) unless the contract states otherwise (Incoterms 2010).

5. Regulatory clearance
Regulatory clearance of the Products in the Territory is also Buyer responsibility. Based on Bien-Air Dental decision and documentation, the Buyer shall submit, obtain and keep in force on behalf of Bien-Air Dental any licences, approvals and registrations records required in purpose to import and the Products in accordance with the laws of the territory. The evidence of approval shall be maintained by Buyer at article level. Full evidence of approvals (certificates, databases) shall be transferred to Bien-Air Dental upon obtainment form local authorities. Each and every communication with local bodies with regards to Bien-Air Dental products shall be transferred to Bien-Air Dental who will manage entire correspondence.

6. Delivery period
Delivery periods are complied with as far as possible as long as Buyer provides all the documents required for dispatch within the deadlines specified by Bien-Air Dental SA. Cases of force majeure and act of God shall release Bien-Air Dental SA from all obligations. Claims for compensation in the event of late delivery are excluded except for serious negligence on the part of Bien-Air Dental SA.

7. Retention of title
Delivered goods remain the property of Bien-Air Dental SA until the invoice amount for them has been paid in full.

8. Reception and examination of goods
Buyer has an obligation to verify the goods received within 8 days following reception. If they have not been verified within said period, the customer shall be deemed to have accepted the goods, subject to any hidden defects. Defects must be notified to Bien-Air Dental SA in writing within the aforementioned period together with customer name, date of purchase, reference and product serial number.

9 Products storage
Buyer shall apply state-of-the-art warehousing and distribution practices for medical devices, including during transportation, to ensure that

  • saleable products are stored in their original packaging, in appropriately safe and secure areas where contamination from or of other products is avoided, and according to any particular instructions from Bien-Air Dental SA;
  • Products are not exposed to risks of extreme atmospheric conditions, pests or organic material contamination, throughout the distribution network under Buyer ‘s control;
  • any returned products, particularly those that may have been used on patients thus requiring disinfection prior to further use, are reliably segregated from saleable Products;
  • specific warehousing instructions are observed for dangerous goods and/or perishable products.

10 Traceability
Buyer shall maintain, for sixteen (16) years since the date of issuance, complete, accurate, and up-to-date records of all product sales and related transactions to secure traceability of each product in the supply chain at any time. The log file shall contain, as a minimum:

  • the customer’s name, address, and phone/fax numbers;
  • the Product’s designation, serial number (SN), and quantity supplied.
All traceability documentation shall be made available to Bien-Air Dental and/or to competent authorities, upon request.

11 Payment terms and conditions
As agreed in writing in the offer or order confirmation. In the event of delayed payment, late payment interest will be invoiced according to the current account interest rate at Swiss banks. If a payment term agreed between the parties is not complied with, the customer shall automatically be under notice to pay.

12 Payment by credit card
Direct payment with VISA, Eurocard, Mastercard and American Express credit cards is accepted. Merchant fees shall be invoiced as well.

13 Order cancellation
Any cancellation (before delivery) of an order must be approved by Bien-Air Dental SA.

14 Liability
Bien-Air Dental SA can only be held liable under the provisions in these present terms and conditions of sale and under the legal provisions on product liability and as "manufacturer" within the meaning of Directive 93/42/EEC concerning medical devices and "manufacturer" within the meaning of Directive 2006/42/EC on machinery. The customer is solely responsible for choosing the products and services that meet its needs. The customer, as a professional, must verify the conditions of use for the products, especially the use contemplated by Bien-Air Dental SA, contraindications or warnings and any expiry dates. Otherwise, and subject to fraud or gross negligence, Bien-Air Dental SA disclaims all liability. In particular, the company cannot be held liable for damage, injury and resulting claims due to:

  • excessive wear and tear,
  • improper use,
  • non-observance of operating instructions, assembly and maintenance instructions,
  • unusual chemical, electrical or electrolytic effects,
  • incorrect connections for air, water or electricity.

Under no circumstances shall Buyer modify any product in any manner. Buyer shall not sell any products to customers other than in their original packaging, as supplied by Bien-Air Dental. Failure to comply with this article would cancel the warranty and the regulatory responsibility of Bien-Air Dental over the tampered product.

15 Guarantee
Only proven faults in the material or manufacture of the delivered goods shall be considered faults. Guarantees shall be valid, counting from the invoice date, for the following periods:

  • 12 months for pipes, connections, embeddable electronics and other devices not listed below.
  • 18 months for electric micro-motors in the MC2, MC3 and BASCH series.
  • 36 months for the MX2 LED, MX-i, MX-i LED, MCX, MCX LED series of electric micro-motors.
  • 24 months for Prolab Basic electric micro-motors.
  • 24 months for Bora and Prestige turbines.
  • 24 months for CA 1:1, CA 1:5, CA 20:1, CAP 15:1, PMP 10:1 and PM 1:1.
  • 24 months for electric consoles (Chiropro, iChiropro, Optima int and iOptima).
  • Parts made from synthetic material and parts subject to wear (especially o-rings, ball bearings, bulbs, LED, etc.) are not covered by the guarantee.

The guarantee shall become ineffective in the event of any unsuitable intervention or modification to the product by third parties not authorised by Bien-Air Dental SA. If there is any dispute over the existence or otherwise of a fault, the customer will have to prove there is a fault. Claims under guarantee shall not be considered unless the product is presented with a copy of the invoice or delivery note which must clearly show the date of purchase, the reference and serial number for the product.

16 Post marketing surveillance
Incidents reporting: Buyer shall immediately report any incidents that might cause or have already caused any harm to a patient, user or third party to Bien-Air Dental SA. As medical device manufacturer, Bien-Air Dental SA holds the ultimate responsibility to notify competent authorities about product-related safety issues. In the event of complaints of alleged product malfunction or defect, Buyer or its representatives or agents shall not make any statement as to the cause, without prior consent from Bien-Air Dental and having received Bien-Air Dental’s formal analysis of the alleged malfunction or defect. Under no circumstances shall Buyer or its representatives or agents issue statements different from or in addition to Bien-Air Dental’s conclusions.

17 Field safety corrective action
It is Bien-Air Dental’s exclusive right and obligation to issue and coordinate any necessary field safety corrective actions or similar remedial actions on the products. Upon notification of remedial action from Bien-Air Dental, Buyer will support and follow Bien-Air Dental’s instructions to comply with the applicable regulations, which may include but not be limited to freezing the existing stock of affected products, notifying customers, organizing the collection of affected products and their disposal or shipment to Bien-Air Dental. If the notification of an incident to competent authorities and/or field safety corrective action (including but not limited to: Product recalls, changes related to the product’s instructions for use, software upgrades…) in the territory is required by local law, the Buyer shall support Bien-Air Dental for all necessary actions related to local conformity and evidence of compliance. The Buyer failure to comply with Post-Marketing Surveillance obligations in the territory are subject of legal consequences.

18 Severability
If one of the provisions in these general terms and conditions is found to be null and void, the remaining provisions shall remain valid. The parties shall replace the null and void provision with a valid provision that corresponds to the economic content of the original provision.

19 Governing law - jurisdiction
Swiss domestic law (Code of obligations) shall apply in addition to the general terms and conditions and particular agreements between the customer and Bien-Air Dental SA. Jurisdiction 2504 Bienne, Switzerland.

Bienne, August 2016
SU 721-270 Rev. 0001 – 02.08.16 [AC]