ART.1 DEFINITIONS: “PARTIES”:
The present General Terms and Conditions of Purchase, hereinafter the “GTC”, apply to any agreement binding the SOCIETE DEDIENNE SANTE (hereinafter “DS”), Mas des Cavaliers, 217 rue C. Nungesser – F. 34130 MAUGUIO, and a third party supplier or service provider (hereinafter “the SUPPLIER”). DS and SUPPLIER are referred to individually as “the PARTY” and collectively as “the PARTIES”. PRODUCTS” shall mean any type of goods, materials, tools, finished products, semi-finished products, raw materials or services (hereinafter referred to as “PRODUCT”) that DS acquires from a SUPPLIER.
These GTCs define the legal framework of the relationship between DS and SUPPLIER for the procurement of PRODUCTS by DS from SUPPLIER, in addition to the terms and conditions specified in the Purchase Order issued by DS and any special terms and conditions of the Product Specifications, hereinafter the “PSC”. Unless the PARTIES agree otherwise in writing at a later date, any purchase agreement between DS and a SUPPLIER shall consist of these GTCs, the relevant purchase order, which must be signed by an authorised official and stamped by DS, and, if applicable, the PCC.
ART.3 APPLICATION AND ENFORCEABILITY OF GCS:
Unless otherwise agreed by the PARTIES, any acceptance and/or confirmation of an order, in any form, by SUPPLIER shall imply full acceptance of these GCP and of any associated PCC. In the absence of formal confirmation or acceptance, orders placed by DS shall be deemed to have been accepted by SUPPLIER in accordance with the GTC and the PCC, no later than ten days after their receipt by SUPPLIER.
ART.4 SUPPLIER’S OBLIGATIONS:
The SUPPLIER declares that he is fully aware of DS’s business, particularly in its capacity as a manufacturer of implantable medical devices, and of the legal and regulatory constraints that this imposes. It is in this context that SUPPLIER declares that it is a professional in the manufacture and/or marketing of the PRODUCTS covered by this contract and in particular that it has the technical resources and qualified personnel to perform its obligations as specified herein. SUPPLIER therefore undertakes to deliver to DS within the agreed timeframe and for the agreed price, the PRODUCTS covered hereby, in accordance with legal, regulatory and contractual requirements. In this respect, and unless otherwise agreed by the PARTIES, SUPPLIER shall have an obligation of result. The SUPPLIER may only call upon a subcontractor to perform all or part of its obligations under the present contract, subject to the express prior written agreement of DS, in particular through the CCP. In this case, the SUPPLIER shall be liable to DS for the performance of the services by its subcontractor. Throughout the performance of the present contract, DS or any third party appointed by DS shall be entitled to carry out any audit it deems necessary at the SUPPLIER’s premises and at those of any subcontractor, subject to prior notification.
ART.5 TRANSPORT AND DELIVERY:
The PRODUCTS, which are the subject hereof, shall be transported at the sole expense, risk and peril of the SUPPLIER. The PRODUCTS shall be delivered by the SUPPLIER to the address and within the time limits indicated by DS. Likewise, in the case of a service contract, SUPPLIER shall perform the services within the time indicated by DS. DS shall not accept early delivery or delivery outside the days and hours of operation of the sites indicated as the delivery address. The PRODUCTS must be accompanied at the time of delivery by a packing slip bearing the order number and indicating the description of the PRODUCTS being transported, the mode of transport and the date of shipment. Any delay in the delivery of PRODUCTS or in the performance of services shall automatically give rise to the application by DS against SUPPLIER of late payment penalties equal to 3% per week of delay calculated on the amount, exclusive of tax, of the undelivered PRODUCTS or of the non-performed services, without prejudice to any other additional action for damages and interest.
The final acceptance corresponds to the acceptance of the PRODUCTS by DS as signaled by DS’ signature of the delivery note without reservation and starts the period for the payment of the corresponding invoice by DS. Upon delivery of the PRODUCTS, DS reserves the right to make any precise and reasoned reservation regarding the conformity of the PRODUCTS delivered. In the event of a reservation duly notified to SUPPLIER by DS by any written means, SUPPLIER shall replace or refund the non-conforming PRODUCTS delivered, at DS’ discretion.
ART.7 WARRANTIES AND PRODUCT LIABILITY:
In addition to strict compliance with the terms of the order, with the technical specifications of the PCC, with the health and safety laws and regulations in force, and with common law as regards defects, non-conformity and latent defects, SUPPLIER guarantees the proper functioning of the PRODUCTS for 12 consecutive months following final acceptance of the PRODUCTS, unless SUPPLIER issues a more favourable warranty period. SUPPLIER declares that he is covered by adequate third-party liability insurance, particularly in view of DS’s line of business, covering damage and any removal costs that may arise from hidden defects or non-conformity of the PRODUCTS with a first-rate insurer, the minimum amount of coverage for which may be specified in the PCC. No waiver of recourse by DS or its insurers shall be valid without a formal agreement in writing, dated and signed by a corporate officer of DS. SUPPLIER shall indemnify DS against any action by a third party for infringement. It shall bear all the costs, compensation and damages that may result from such an action.
ART.8 PRICES AND TERMS OF PAYMENT:
The prices indicated on the order forms are expressed in Euros and are exclusive of tax. They are firm, final and non-revisable. Unless otherwise specified, prices include packaging and wrapping of the PRODUCTS necessary for their preservation during transport and storage. Unless otherwise agreed by the PARTIES, full payment of the price shall be due only after final acceptance of the PRODUCTS by DS or after the date of performance of the services. SUPPLIER shall send invoices directly to DS at the address indicated in Article 1 hereof. Invoices shall include, in addition to the legally required information: the order number, the references of the PRODUCTS delivered, the quantities, and the number and date of the corresponding delivery notes. All invoices issued hereunder shall be paid within 60 days of the invoice date unless otherwise agreed in writing by the PARTIES.
ART.9 TRANSFER OF RISK, TRANSFER OF OWNERSHIP:
Unless otherwise agreed by the PARTIES, and in particular unless a specific incoterm is specified, the transfer of risk in the PRODUCTS shall occur upon delivery and the transfer of ownership shall occur upon invoicing.
ART.10 INTELLECTUAL PROPERTY:
DS, and all distinctive signs and designations on the PRODUCTS, are registered trademarks, the use of which is not granted to SUPPLIER by this contract. These GCP do not imply any transfer of patent licenses or any other industrial property rights whatsoever, or of marketing and/or distribution rights from DS to SUPPLIER in respect of the PRODUCTS entrusted and/or ordered. Studies, plans, drawings or documents handed over or sent by DS to SUPPLIER shall remain the property of DS; they may not be disclosed to third parties. Any resale to third parties of PRODUCTS, whether conforming or not, is strictly forbidden without the prior written consent of DS. In the event that the agreement between DS and SUPPLIER relates to the production of specific equipment, tools or software, all the work carried out by SUPPLIER in the execution of the PRODUCTS shall be the exclusive property of DS. To this end, SUPPLIER waives any claim to intellectual property rights and retention rights. Should DS be required to finance, either directly or through the sale price of the PRODUCTS, tooling, moulds or any other element contributing to the manufacture of the PRODUCT, SUPPLIER undertakes to identify these elements specifically as the property of DS. Unless otherwise specified in writing, SUPPLIER undertakes to use these items (tools, moulds, etc.) exclusively in the context of the present contract and shall refrain, both directly and indirectly, from executing or using these items on behalf of third parties.
The SUPPLIER with whom PRODUCTS or tools are left on deposit, in the case of toll processing or the application of any subcontracting operation, undertakes to assume the responsibility of the depositary free of charge for the PRODUCTS, and in this respect the SUPPLIER shall take out an insurance policy in his own name and at his own expense against any damage that may affect said PRODUCTS. Any PRODUCT or tooling left on deposit with the SUPPLIER may be taken back at any time by DS, subject to 8 days’ notice. Such withdrawal shall not entitle the SUPPLIER to any compensation. The PRODUCTS or tools must be returned in perfect condition. Should this not be the case, the SUPPLIER shall arrange for the necessary repairs to be carried out as soon as possible at his own expense.
ART.12 FORCE MAJEURE:
Neither of the PARTIES hereto shall be held liable by the other PARTY in the event of non-performance of any of its obligations provided that it proves that such non-performance is due to an impediment beyond its control; that it could not reasonably have been required to foresee such impediment or its effects on its ability to perform the agreement at the time it was entered into; and that it could not reasonably have avoided or overcome such impediment or at least its effects.
Each of the PARTIES hereto undertakes to treat all information received from the other PARTY in connection with the performance of this Agreement as confidential and shall not disclose such information to any unauthorized third party. Each PARTY agrees to take all necessary steps to ensure that its personnel comply with these confidentiality obligations.
In view of the specific regulatory constraints applicable to medical devices in particular, without prejudice to the provisions of the Public Health Code, SUPPLIER undertakes to: (1) ensure full traceability of PRODUCTS used directly or indirectly in the manufacture of all or part of a medical device, (2) report without delay any incident or malfunction likely to affect the safety and/or health of patients or personnel, (3) comply with any instructions given to it by DS or any public body in connection with the PRODUCTS or their use. Acceptance of the order shall constitute acceptance without reservation of these three undertakings.
SUPPLIER undertakes to keep DS duly informed of any modification or change concerning the PRODUCTS covered by this agreement, in particular in the event of discontinuation of manufacture or marketing of any of the PRODUCTS, within a minimum period of 12 months prior to the modification or change for PRODUCTS that are directly incorporated into all or part of a medical device, and 6 months in other cases. SUPPLIER shall systematically inform DS when a certification is obtained, renewed or suspended, and shall provide a copy of any valid certificate each year and/or at DS’ first request. For all PRODUCTS directly or indirectly involved in the manufacture of all or part of a medical device, SUPPLIER undertakes to keep the quality records relating to the manufacture of each batch of PRODUCTS delivered to DS, in such a way that they are accessible, legible and protected for a period of 30 years. In order to guarantee this long-term commitment, at the end of each period ten, SUPPLIER undertakes to provide DS, on first request, with all records for the last expired period.
For all PRODUCTS contributing directly or indirectly to the manufacture of all or part of a medical device, SUPPLIER undertakes to: -use only substances, preparations and articles that comply with REACH EC: 1907/2006 regulations; -inform DS about the pre-registration and registration of substances, preparations and articles; -provide DS with data sheets and safety data sheets for substances, preparations and articles, as well as their raw materials; -inform DS about the presence of Substances of Very High Concern (SVHC) in the substances, preparations and articles supplied and keep DS informed within 45 days of each publication of a new list (art. 57 of the EC regulation: 1907/2006).
The SUPPLIER certifies that he regularly employs his employees in accordance with the provisions of the Labour Code, and that he only employs persons who are duly authorised to carry out a professional activity and to comply with all the provisions relating to environmental protection. Furthermore, SUPPLIER undertakes to comply with all its tax and social security obligations and to provide DS with all the documents referred to in Article D 8222-5 of the Labour Code.
The provisions of this Article are complementary to all written obligations and in particular to those contained in the CCP; in the event of contrary or incompatible provisions, the obligations of the CCP shall prevail.
ART.15 APPLICABLE LAW AND JURISDICTION:
Acceptance of an order from DS implies the CUSTOMER’s final, full and unreserved acceptance of these GTC and of any corresponding PCC. The GTC of DS in force are those appearing on the CCP issued by DS and/or those appearing on the order issued by DS and/or, if applicable, those sent directly to the SUPPLIER by DS. In the event of any contradiction between the provisions of this printed edition of the GTC and the provisions of another edition, the provisions of the most recent edition shall prevail. These GTC shall prevail over any terms and conditions that may appear in SUPPLIER’s documents and shall apply to all purchases by DS in France and abroad. Any condition to the contrary imposed by SUPPLIER shall, in the absence of express acceptance, be unenforceable against DS, irrespective of the time at which it may have been brought to its attention. Any additions, deletions, modifications or deletions to these GTC that are not approved by DS shall be null and void. No special conditions or General Terms and Conditions of Sale of SUPPLIER shall, unless expressly accepted in writing by DS, prevail over these GTC. The fact that DS does not at any time avail itself of any provision of these GTC shall not be construed as a waiver of its right to avail itself of any provision of these GTC at a later date. In the event of special agreements between DS and SUPPLIER, such agreements may derogate from certain provisions of these GTC, the other provisions of which shall remain applicable insofar as they do not conflict with them. These GTC shall be governed by French law. All disputes arising in connection with these GTC shall be referred to the Commercial Court of Montpellier.