GENERAL TERMS AND CONDITIONS OF SALE

1. DEFINITIONS

GTC: Refers to the present General Terms and Conditions of Sale (GTC).
CUSTOMER: Refers to any professional buyer ordering PRODUCTS.
SD : Designates the company SYMATESE DEVICE. Company having its registered office Z.I Du Broteau – 69540 IRIGNY, France, seller of the PRODUCTS.
FORCE MAJEURE : Refers to any external, unforeseeable or irresistible event within the meaning of Article 1148 of the Civil Code.
The following are conventionally assimilated to cases of force majeure: strikes by all or part of the staff of SD or its usual carriers, fire, flood, war, production stoppages due to accidental breakdowns , the impossibility of being supplied with raw materials, epidemics and pandemics, thaw barriers, roadblocks, strikes or breaks in electricity supply, or breaks in supply for a cause not attributable to SD as well as any other cause of disruption of supply attributable to its suppliers.
PRODUCTS: Refers to the PRODUCTS of medical devices, medical accessories and services marketed by SD and listed in SD's price list in effect on the date the CLIENT places the order.
HEALTH CARE FACILITIES: refers to any health care facility (e.g. Hospitals, Clinics, Medical Offices, Doctors,...)

2. GENERAL

These General Terms and Conditions of Sale apply to all offers (including offers by way of pro-forma invoices) and whatever their form (paper or dematerialized format), orders, sales and deliveries of SA, hereinafter referred to as "SA".

These General Terms and Conditions of Sale shall prevail over all clauses and general (purchase) conditions of the CUSTOMER, except in the case of a written agreement to the contrary accepted by SA. SD's General Terms and Conditions of Sale shall be deemed to have been accepted by the CUSTOMER in the absence of an explicit written protest.

SD reserves the right to adapt these General Terms and Conditions of Sale at its best convenience. These changes will always be communicated in writing in the form of a letter, fax or e-mail or updated on its website.

No sale of SD is exclusive and does not grant distribution or agency rights, unless otherwise expressly agreed.

Specific written agreements between the parties or special conditions (e.g. distribution agreement, license agreement...) prevail over the terms of the corresponding articles in this document

3. SUBJECT

These GCS apply to all sales made by SD to CUSTOMERS. They prevail over all clauses that may appear on the CLIENT's documents, and in particular its general terms of purchase, and are applicable to the sale of PRODUCTS in all countries where the CLIENT markets them.
In accordance with the regulations in force, SD reserves the right to derogate from certain clauses of these GCS according to the negotiations carried out with the CUSTOMER, the derogations will then be the subject of a specific written agreement concluded between SD and the CUSTOMER or of special conditions.

4. ORDERS

4.1 ACCEPTANCE

Sales are only perfect after SD has received the written order form from the CUSTOMER in the form of a letter, fax or email and after SD has expressly accepted the CUSTOMER's order in writing within three (3) working days of receiving the order (email or fax), by sending an order acknowledgement.
Unless the CUSTOMER makes a comment within 2 (working) days following the sending of the order acknowledgement, the ORDER will be considered as confirmed by the CUSTOMER.
This order acknowledgement will indicate, among other things, the availability of the requested PRODUCTS and, to the extent possible, the estimated delivery time for each of the PRODUCTS. An order may also be implicitly accepted by the delivery of the order.

4.2 CANCELLATION OR MODIFICATION FOR HEALTHCARE ESTABLISHMENTS

Any request for cancellation, modification of the order placed by the customer can only be taken into account after express agreement of SA. The request must be made in the form of a letter, fax or e-mail and must reach SD no later than 8 (eight) working days after receipt by SD of the initial order.
In the event of SD's agreement to modify or cancel the order, and in the event that the products have already been delivered to the customer or are in the process of being transported, this modification or cancellation will be conditional upon the return of the products in perfect condition in their original packaging, within 8 (eight) working days from their receipt by the CUSTOMER.

4.3 CANCELLATION FOR COMPANIES

Any cancellation of an order requested by the CUSTOMER can only be taken into consideration if it is received by SD in the form of a letter, fax or e-mail, at the latest within 2 (two) working days following the sending of the order acknowledgement. The companies are understood to be the companies delivering the medical devices to the healthcare institutions as defined above.

4.4 MODIFICATION FOR COMPANIES

Any change in the order requested by the CUSTOMER will be accepted by SD only at the sole discretion of SA, and only if notified in the form of a letter, fax or e-mail.
In any case, changes can only be accepted if they are notified to SD at the latest within 2 days (working days) following the sending of the order acknowledgement. After the CUSTOMER has sent a new specific order form, SD may accept the modification of the order with a possible adjustment of the price. In the event of acceptance by SA, an acknowledgement of receipt of the modified order will be sent to the CUSTOMER.

5. DELIVERY

5.1 DELIVERY TIME

The PRODUCTS are delivered to the address indicated by the CLIENT on the order form accepted by SA.
Delivery shall be made in accordance with INCOTERM E.X.W. ("Ex Works") in Bornel and shall be deemed to have taken place upon signature of the delivery note by the CUSTOMER or upon the goods being made available at the agreed upon place of delivery in the form of a letter, fax or e-mail with the CUSTOMER as described in the order acknowledgement.
The CLIENT accepts that the delivery dates of the PRODUCTS are given only as an indication, SD committing itself to implement the reasonable means at SD's disposal to respect these dates.
SD shall not be held responsible for late deliveries, delays or suspension of deliveries attributable to the CLIENT.
In the absence of other arrangements with the CUSTOMER, SD shall be entitled to make deliveries in whole or in part without the CUSTOMER's prior agreement.
For clarity: SD will not intentionally delay deliveries, but it is possible, in the event of product availability problems, that SD may have to allocate available goods on an equitable basis to different Buyers.

5.2 CLAIMS

The CUSTOMER is responsible for checking the apparent condition of the PRODUCTS upon delivery. If no reservations are expressly made in writing within 5 (five) working days from the date of delivery, the PRODUCTS shall be deemed to conform in quantity and quality to the order. Any notification must contain the fullest possible description of the defect, so as to enable SD to react appropriately. The defects and the presumed cause must be mentioned, in addition to the catalog number, the description of the good, the serial or batch number and the expiration date. CUSTOMER shall give SD the opportunity to investigate (or have investigated) a claim.
Any apparent defects must be notified to SD by the CUSTOMER in the form of a letter, fax or e-mail, within 8 (eight) working days of delivery. Any hidden defects must be notified immediately to SD by the CUSTOMER in the form of a letter, fax or e-mail, and in any case, no later than 8 (eight) working days following their discovery.
In the absence of such notification within the aforementioned time limits, the goods shall be irrevocably deemed to have been accepted as is by the CLIENT and SD shall be deemed to have honored its obligations. If the CUSTOMER notifies a claim in time, this does not suspend his obligation to pay. In this case, the CUSTOMER also remains obliged to collect and pay for the goods ordered.
In no event shall SD be liable for any costs or damages, including direct, indirect, special, incidental or consequential damages, incurred or suffered by CUSTOMER as a result of or in connection with a delay in delivery
SYM will replace as soon as possible and at its own expense, the delivered PRODUCTS whose lack of conformity has been duly proven by the CLIENT and approved by SA.

5.3 FORCE MAJEURE

SD shall in no case be held liable in the event of delay or suspension of delivery attributable to a case of Force Majeure. More generally, neither party shall be held liable for any breach of an agreement governed by the General Terms and Conditions of Sale, insofar as this is caused by circumstances of Force Majeure.
In such circumstances, SD shall inform the CLIENT in writing (fax or e-mail confirmed by registered letter with acknowledgement of receipt), as soon as possible, said notification suspending by operation of law and without compensation, as of the date of occurrence of the event, the delivery of the Order.
Insofar as SD has already partially fulfilled or will be able to fully fulfill its obligations under the agreement (e.g. partial delivery) at the time of the occurrence of the force majeure, and a separate value is assigned to the part already performed or to be performed, SD may invoice the part already performed or to be performed separately. The CUSTOMER shall be obliged to honour this invoice as if it were a separate agreement.

6. RETURN OF PRODUCTS

No Product will be taken back, for any reason whatsoever, after a period of 30 (thirty) calendar days following delivery.
Sterile and non-sterile Products in their original and undamaged packaging may exceptionally be taken back or replaced according to the procedure prevailing at the time, and only after acceptance and written approval by SA. In this case, the return of the PRODUCTS shall be organized by SD at the customer's expense and shall comply with the return procedures (products, lots, quantities, packaging and transport procedures) communicated by the latter to the CUSTOMER, the condition of the Products being inspected upon their arrival. A credit note will then be established in favor of the CUSTOMER, with a minimum deduction of 15 (fifteen) % on the value of the Net Invoice Prices, not applicable to Health Establishments. In the event of non-compliance with the terms of return, SD shall be released by right from any obligation to reimburse, replace or compensate the CUSTOMER. In case of breach of the distribution contract, the clauses of the contract shall prevail.

7. TRANSFER OF OWNERSHIP – TRANSFER OF RISKS

- The CLIENT undertakes to store the PRODUCTS in conditions suitable for their proper preservation and in compliance with the storage and preservation instructions communicated by the NV.
- The risks shall be borne by the CLIENT from the time of receipt and acceptance of the PRODUCTS by the CLIENT.
- In the event that a third party initiates a seizure/enforcement procedure against the CLIENT, the CLIENT shall notify the third party of the existence of a retention of title clause in favor of SD and shall promptly notify SD of the existence of such a procedure so that the latter may repossess the PRODUCTS.
- Goods delivered by SD covered by the retention of title clause may not be resold or used as payment.
- The CUSTOMER shall not be entitled to pledge or otherwise encumber the goods covered by the retention of title clause.
- CUSTOMER shall always do everything reasonably expected of it to safeguard SA's property rights.
- The CLIENT undertakes to insure and keep insured the goods covered by the retention of title clause against fire, explosion and water damage as well as against theft and the policy of this insurance must be available to SD on first request. In the event of any insurance compensation, SD shall be entitled to these amounts. Insofar as necessary, the CLIENT undertakes in advance to assist SD in everything that is or seems necessary or desirable in this respect.
- In the event that SD wishes to exercise its ownership rights as described in this section, CUSTOMER irrevocably and unconditionally authorizes SD or SD's designees in advance to access and retrieve any and all premises where property owned by SD is located.

8. COMPLIANCE WITH COMMERCIAL LAW

Products delivered under this Agreement may not be exported, re-exported, sold or transferred. Any use, sale or distribution, whether direct or indirect, must comply with applicable legal provisions.
SD and CUSTOMER agree to comply with all applicable legal requirements, including, but not limited to, export control laws with respect to the cross-border sale, resale, shipment and transfer of goods. SD's obligation to deliver goods to CUSTOMER is contingent upon obtaining any required licenses or permits.
If a license or authorization from a government or other authority is required for the acquisition of the Products, CUSTOMER shall obtain the license and authorization at its own expense unless otherwise provided in the contract and, if requested by SD, provide proof thereof to SA. Failure to obtain a license or authorization shall not entitle CUSTOMER to withhold or defer payment of the price of the Goods. Any costs or charges incurred by SD as a result of such failure shall be borne by CUSTOMER or reimbursed to SD by CUSTOMER if SYM is required to advance such costs.

9. PRICE AND PAYMENT

9.1 PRICE

The price of the PRODUCTS appearing on the general tariff of SD is given as an indication and are expressed in EUROS (currency EUR)
An invoice will be issued for each delivery based on the prices in effect at the time the PRODUCTS are shipped to the CLIENT by SA.
All prices are net and exclude VAT and any other levies decided by an authority. Prices become final upon receipt of the order or upon receipt of a written agreement from the CUSTOMER.
Additional costs incurred by urgent shipping requests, in particular express charges, will be billed to the CUSTOMER. An "express request" is defined as a request for delivery in less than 2 days.
Prices are exclusive of tax, plus VAT at the legal rate, if applicable, and ex works.
Prices are EXW, delivery costs are at the CUSTOMER's expense, unless otherwise agreed

9.2 TERMS OF PAYMENT

Invoices issued by SD shall be payable for their net amount, without discount, on the due date mentioned on the invoice or, failing that, within thirty (30) calendar days of the date of issue of the invoice.
In the event of non-payment, total or partial, of the amounts due on the due date, the CLIENT shall pay SD a late payment penalty equal to the refinancing rate of the European Central Bank (ECB) increased by 10 percentage points, and a fixed compensation of forty (40) euros. They shall be due in the event of failure to pay on the day following the payment date shown on the invoice. The penalties will be applied to the amount due, including VAT, without any prior notice of default being required.
In addition, in the event of non-compliance with the terms of payment listed above, SD reserves the right to suspend or cancel the delivery of orders in progress on the part of the CLIENT.
Any costs incurred by SD in collecting amounts owed by the CUSTOMER will be charged to the CUSTOMER.
Any bank charges related to the payments will be charged to the CUSTOMER. The method of payment of bank charges in the case of a transfer will be "OUR" (to be paid in full by the CLIENT who initiated the payment). The same applies to any foreign exchange fees incurred by the CLIENT.

9.3 RETENTION OF OWNERSHIP CLAUSE

SD reserves until full payment of the price by the CLIENT a right of ownership on the PRODUCTS sold, allowing it to repossess the said PRODUCTS. Any deposit paid by the CUSTOMER will remain acquired by SD as a lump sum compensation without prejudice to any other actions that it may be entitled to take against the CUSTOMER as a result.

10. WARRANTY AND LIABILITY

10.1 WARRANTY AND LIABILITY

SD guarantees that the PRODUCTS delivered comply with the regulations in force and with the specifications stipulated in the PRODUCTS' instructions. This warranty covers the non-conformity of the PRODUCTS with the order and any latent defect resulting from a defect in material, design or manufacture affecting the PRODUCTS delivered and rendering them unfit for use. SD's possible obligation to pay compensation in accordance with this article is always limited to the purchase price of the non-conforming PRODUCT(s) or the defective part of the good.
Regarding the non-conformity of the PRODUCTS to the order, any claim must be notified to SD within 2 (two) working days after the delivery date at the following email address: sacomplaints@symatese.com
Any warranty is excluded in case of misuse, negligence, lack of maintenance or storage, modification of the PRODUCT by the CUSTOMER as well as in case of normal wear and tear of the PRODUCT or FORCE MAJEURE.
Furthermore, SD's liability is expressly excluded in the event of re-sterilization of a PRODUCT, use of a sterile PRODUCT whose packaging is damaged, or use of a PRODUCT after SD's expiration date.

10.2 TRACEABILITY

The CUSTOMER is required to set up a traceability system with a register allowing SD to locate the PRODUCTS, this obligation of traceability will last for at least fifteen (15) years after the last device supplied by SA has been put on the market

10.3 INCIDENTS AND CUSTOMER COMPLAINTS

The CLIENT must immediately inform SD upon becoming aware of any complaint or report from healthcare professionals, patients, users or third parties, of suspected injuries to a patient (including incidents and risk of incidents) or death related to the use of the Products, in writing. The risk of incident or incident is defined as an incident involving a medical device that is likely to lead to a deterioration in the state of health of a patient, user or third party. Incidents or risks of incidents are reported to SA, and communicated to the main email address: sacomplaint@symatese.com. The CUSTOMER shall cooperate to ensure in a timely and effective manner that incidents/risks of incidents and customer complaints are properly investigated.

11. INTELLECTUAL PROPERTY

Unless otherwise agreed in writing, all Products will be sold or resold in the packages or packaging in which they were delivered by SA and, under no circumstances, any brand other than the brand present on the goods at the time of the delivery may not be affixed by the CLIENT in relation to the goods, or the mark present on the goods at the time of delivery modified by the CLIENT. The agreement does not grant any right or license to the CLIENT under any patent, trademark, copyright, registered model or any other intellectual property right, with the exception of the right to use the goods or resell them. SD reserves all the rights and prerogatives that are its under copyright law and other intellectual property laws or regulations. SD has the right to use the information it has collected within the framework of the execution of an agreement also for other purposes, provided that, in doing so, no strictly confidential information of the CLIENT is brought to knowledge of third parties.

12. PROTECTION OF CUSTOMER DATA

The CUSTOMER authorizes SD to use personal information about the CUSTOMER in a confidential manner and solely for the purpose of managing the CUSTOMER's account, including credit reference checks, verification and updating of data, invoicing, credit limit checks, return of PRODUCTS, credit notes, delivery notes and direct mail relating to SA's PRODUCTS, services and commercial terms. This information will be treated as confidential by SD and will only be disclosed to third parties if required by law or if such third parties process the information on behalf of SD in accordance with applicable data protection principles. Personal data protection laws and practices may differ, and such laws may not provide the same level of protection outside the European Economic Area. By executing the transaction, CUSTOMER agrees, on its own behalf and on behalf of its employees - CUSTOMER will duly inform them - in exceptional cases where such agreement is necessary, to the use, disclosure or transfer of personal data.
The CUSTOMER may access his personal information and request its rectification at any time by sending a written request to SA.

13. INTUITU PERSONAE

Orders for PRODUCTS by the CUSTOMER are intuitu personae and their benefit cannot be transferred to a third party without the express and prior authorization of SA.

14. TERMINATION

SD may terminate with immediate effect any agreement governed by the General Terms and Conditions of Sale, without any obligation on its part to pay any compensation or indemnity, if:
- the CLIENT remains in default of payment at the due date(s), SD not being obliged to respect a notice, or if
- CUSTOMER has committed a material breach of any provision of the Terms and Conditions and has not remedied such breach within fifteen (15) calendar days of notification of such breach, or if CUSTOMER is, or is likely to become, bankrupt or insolvent, or if any of the following proceedings are commenced against or by CUSTOMER: bankruptcy proceedings, proceedings under the Business Continuity Act, insolvency legislation, or proceedings for reorganization, receivership, liquidation, dissolution or transfer of ownership.

15. MODIFICATIONS

In the case of existing agreements relating to orders already placed, the General Terms and Conditions of Sale may only be changed or modified by means of a written agreement (e.g. Distribution Agreement), duly signed by SD and the CLIENT. However, SD reserves the right to amend this version of the General Terms and Conditions at any time for agreements concerning new orders. Amended versions shall come into force as soon as they are circulated.

16. APPLICABLE LAW – ATTRIBUTION OF JURISDICTION CLAUSE

By express agreement between the parties, the present GTC and the purchase and sale operations resulting from them are governed by French law.
All the litigations to which the present CGV could give place concerning so much their validity, their interpretation, their execution, their cancellation, their consequences and their continuations will be subjected to the Commercial court of BEAUVAIS (France).