(English) General conditions of sales

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1. Overview

This document contains the General Conditions of Sale (hereinafter, General Conditions) governing purchase and sale relationships between Dental X S.p.A. (Seller) and its Customers (Buyers), for all types of products (hereinafter, Products, goods or devices). The general conditions of sale form an integral and substantial part of every offer and order confirmation. The Buyer undertakes to respect the terms and conditions indicated for each order submitted to Dental X unless otherwise agreed in writing. By accepting these general conditions, the Buyer waives any other general conditions, whether considered individually or as a whole. The Seller reserves the right at its own discretion to modify the general conditions at any time, giving explicit written communication of this to its Customers. The sale is subject to acceptance of these General Conditions by the Buyer, who shall return them to the Seller countersigned for acceptance. The application of these Conditions by the Seller shall be referred to in all order confirmations sent by the latter to its customers. In the event of failure to return the Conditions duly signed, the Seller is entitled to consider the order as cancelled. However, successful completion of the contract shall be considered as implicit acceptance of these Conditions, provided that the Buyer has not expressly objected to their content in writing prior to the completion of the order. The Seller does not recognise verbal agreements or commitments with its staff or representatives: any exceptions to these conditions must therefore be produced in writing.

2. Order procedure

All orders must be submitted in writing (including via fax or e-mail) and completed in all parts necessary for the proper identification of the requested Products. The Seller reserves the right to not accept orders via telephone or verbally. The Buyer may request cancellation or modification of the order only before its completion, through specific written notification. Orders received are understood to be accepted and will be therefore be binding only if confirmed in writing, including via fax or e-mail. The minimum order is set at EUR 200.00, plus VAT.

3. Retention of title

Dental X spa retains the right of ownership of the Products supplied until full payment of the invoice, in accordance with article 1523 et seq. of the Italian Civil Code, also retaining the exercise of privilege in accordance with the law. Delivery Unless otherwise agreed between the parties, the Products will be delivered ex works from the Seller’s warehouse. The Seller, in accordance with art. 1510 paragraph 2 of the Italian Civil Code, is released from delivery obligations once the assigned carrier has custody of the goods. From that moment, therefore, the respective risk of loss or damage of the goods lies with the Buyer. The terms of delivery are 60 days from the day of acceptance of the order by the Seller. The delivery terms are indicative and not binding for the Seller, which is not obliged to pay indemnity of any kind for direct or indirect damage due to delivery delays, interruptions or partial or complete cancellation of the supply. In any event, delays attributable to the Seller may give rise to possible compensation only up to a maximum amount equal to the value of the supply. The Buyer shall take possession of the goods even in the case of partial deliveries or delivery after the agreed date. The Buyer shall bear all costs arising from failure to collect the goods.

4. Prices and terms of Payment

The price of the sold Products is that shown in the price list attached to these general contract conditions, of which it forms an integral and substantial part. This price list cancels and supersedes all previous price lists. Dental X reserves the right to change its prices at any time with no obligation of prior notice, by means including publication of the updated list on its website. The prices shown in the price list are net of VAT. Unless otherwise agreed, which must be in writing, the prices include the cost of packaging. Failure to pay even one single invoice authorizes Dental X to suspend shipments and to consider any other pending orders as cancelled Any claims regarding an individual delivery do not justify refusal to pay other invoices not connected with the dispute.

5. Warranties

Dental X, in its capacity as manufacturer of the Product, certifies its proper construction, the use of top quality materials, the implementation of all necessary testing and its conformity to current standards. The Product is covered by a warranty period of 24 months (or 2,000 cycles in the case of autoclaves) from the date of sale. The warranty is limited to replacement or repair of individual components or parts found to have manufacturing defects, excluding costs for labour, transfer of technical personnel, freight, packing, etc. The warranty confers the right to repair or replacement of the defective part. The right to replacement of the entire appliance is, however, excluded. Dental X is not obliged to provide replacement equipment for use during the repair period. The warranty does not cover faults or damage originating from poor maintenance, incorrect power supplies, negligence, inexperience or causes not attributable to the manufacturer. However, parts subject to wear or damaged through lack of routine maintenance due to negligence by the user, are excluded from the warranty. The manufacturer is excluded from liability for direct or indirect damages of any kind to persons or property caused by misuse, improper use or any use that is not in accordance with the instructions provided in the user manual. For warranty service, the Buyer may refer only to Dental X or the service centres indicated by it. The warranty will be automatically void if the equipment is repaired, modified or tampered with by the Buyer or by unauthorized third parties. The warranty is also void if:

a) the equipment has damages due to dropping, exposure to flames or other causes not attributable to manufacturing defects;
b) installation has not been performed correctly;
c) an improper connection has been made to the electrical mains (incorrect supply voltage);
d) the serial number has been removed, defaced or altered. In the event of any dispute regarding warranty application, quality or the conditions of the delivered equipment, the Buyer may not suspend or delay payment of the price or the payment of purchase instalments. To benefit from the warranty, the returned product must be accompanied by the warranty certificate and a copy of a document valid for tax purposes showing the serial number of the device. The warranty is valid for any person who purchases the product during the warranty period, provided they are in possession of the certificate. For any other circumstances not envisaged in this article, Italian law shall apply and, in particular, the provisions of the Italian Civil Code regarding sales and purchases.

6. After-sales product tracking and monitoring procedure

The parties acknowledge that under Directive 93/42/EEC, as implemented by Legislative Decree 46/’97 concerning regulation of the production and circulation of medical devices, the seller, as manufacturer, is required to implement an adequate traceability procedure for the medical devices to facilitate any necessary corrective actions or withdrawal from the market. In particular, the buyer agrees to use the following procedure:

a) each product is identified with a “medical device number”, which is indicated by the manufacturer not only on the product but also in the documents of sale (invoice and shipping documents);
b) the Buyer is obliged to indicate the medical device number in all documents (invoice, shipping documents, etc.) that confirm the sale of the product to the end customer. If the Buyer does not sell to the end customer but to another person in the distribution chain, the Buyer undertakes to require that person to observe the procedure described above or another traceability procedure in order to enable the seller to comply with the legal requirements.
To facilitate the market monitoring and after-sales surveillance of the products covered by this agreement, which must be performed by the manufacturer pursuant to art. 10 of Directive 93/42/EEC and Annex II, point 3.1, seventh indent, the Buyer undertakes to communicate the following to Dental X:

a) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which could cause or could have caused the death of a patient or user or a serious deterioration in their state of health;
b) the technical or medical reasons related to the characteristics or performance of a device for the reasons specified
in point a), which have led to the systematic recall of devices of the same type by the manufacturer.

7. Information agreement

The Buyer agrees to promptly notify Dental X of every issue related to the performance or safety of the devices, including customer complaints and any actions taken to resolve them. Furthermore, the Buyer agrees to promptly notify Dental X of every request from the Ministry of Health or other competent authority with regard to the devices sold.

8. Privacy

With regard to the provisions for personal data protection, the Parties mutually acknowledge communication of the information referred to in Legislative Decree 196/2003. Each Party shall provide the other with consent to process its data directly or indirectly, through third parties, in accordance with the provisions of Legislative Decree 196/2003 for purposes necessary for the management of the contract.

9. Applicable law and jurisdiction

The competent court for all disputes arising from the interpretation, implementation and application of these Conditions, unless included in those for which the Law expressly recognizes the inviolability of local jurisdiction, is the Court of Vicenza. The applicable law for this contractual relationship is exclusively that of the Italian Republic.

10. Invalidity of terms

In the event that any of the General Conditions or a portion thereof is held invalid or unenforceable, this invalidity shall not invalidate the remaining part of the provision or the other provisions, which shall remain in full effect.
This price list replaces the one previously in force.