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GENERAL TERMS AND CONDITIONS OF SALE

1. SCOPE

These general terms and conditions of sale (the “Terms and Conditions”) shall apply to the sale of vaccines and sera (the “Products”) by Sanofi Pasteur to the buyer (the “Buyer”). Any terms and conditions set forth on Buyer’s purchase order form or general conditions of sale are hereby explicitly rejected and disregarded by Sanofi Pasteur and shall in no way be binding on Sanofi Pasteur.

2. ORDERS

2.1 Any orders placed by the Buyer shall become binding on the parties upon acceptance of such order by Sanofi Pasteur (the “Firm Order”). The cancellation of any Firm Order, either totally or partially, shall require the express consent of Sanofi Pasteur. The same shall apply for any modification of a Firm Order.

2.2 Notwithstanding the aforesaid, the Buyer acknowledges the particular difficulties of manufacturing biological products, therefore Sanofi Pasteur shall not be liable for any failure to supply any Products pursuant to any Firm Order in the event and to the extent of either of the following (i) any failure in the process of Sanofi Pasteur to manufacture the Products in compliance with the specifications of the product license(s) of the country in which the Product is to be supplied (ii) any inability of Sanofi Pasteur to produce or supply any Products for any reason beyond the control of Sanofi Pasteur.

3. PRICE AND TERMS OF PAYMENT

3.1 The prices for the Products shall be the prices that have been agreed upon by the Parties in writing, exclusive of any applicable taxes. Unless otherwise agreed in writing by Sanofi Pasteur and the Buyer (hereafter referred to as collectively as the “Parties”), no discounts or rebates shall be granted to the Buyer in any form.

3.2 Unless otherwise agreed in writing by the Parties, all orders of Products shall be payable within a period of thirty (30) days as from the issue date of the invoice.

3.3 Should the Buyer fail to pay any amount of money owed to Sanofi Pasteur under these Terms and Conditions in accordance with any terms of payment, the Parties agree to the following:

  • Sanofi Pasteur shall be entitled to withhold or otherwise cancel any future delivery of any Products, even if Sanofi Pasteur has confirmed such delivery to the Buyer, and;
  • Sanofi Pasteur shall have the right to apply an interest rate based on Euribor or otherwise Libor (as the case may be) + 3 % per annum, calculated prorata temporis between the contractual maturity date and the date of settlement on Sanofi Pasteur’s bank account (value date at Sanofi Pasteur credit), and;
  • Sanofi Pasteur shall invoice the Buyer a lump sum of forty Euros (40 €) (or equivalent depending on the currency applicable to the sale of the Product) for debt collection.

4. DELIVERY

Unless otherwise agreed, the Products shall be delivered in accordance with the Ex-Works INCOTERM (INCOTERMS latest release) at the place of delivery designated by Sanofi Pasteur.

Delivery dates communicated by Sanofi Pasteur are approximate. Sanofi Pasteur shall not be held liable for any delivery of Products which is made before or after the communicated date.

Title to Products sold pursuant hereto shall pass onto the Buyer upon payment of the price of the Products by the Buyer. Risks of loss or damages in the Products shall be transferred to the Buyer according to the applicable INCOTERM.

5. SHIPMENT ACCEPTANCE PROCEDURE

Immediately upon delivery of the Product, the Buyer shall, through, visual examination: (i) carefully inspect each shipment of Product with respect to quantities, damages and defects, and, more generally, to the correspondence of the delivered Product with the Firm Order, the invoice and the packing list accompanying such shipment and; (ii) make sure that the cold chain was maintained during the shipment by recording the temperature of the Product and providing immediately such information to Sanofi Pasteur.

In the event of a major problem (damaged containers, leakage, improper tubing, alteration in the cold chain etc.) during transportation and prior to the delivery of the Product to the Buyer, the Buyer shall notify immediately upon receipt of the Product the carrier with such damages, defects, cold chain break or discrepancies and have them specifically noted on the consignment pages of the carrier and have such papers signed by the carrier’s driver. In such latter case, the Buyer shall within three (3) calendar days transmit by facsimile a copy of the signed consignment pages to Sanofi Pasteur.

Any failure of the Buyer to duly and timely notify Sanofi Pasteur of any defect or damage in any delivery of Product within the delay provided above shall be construed as an irrevocable acceptance of the said delivery of Product. In such a case, the delivery of Product shall be deemed to be of good condition and to conform to the packing list, and the corresponding Firm Order.

If it is agreed between the Parties after the conduct of further investigation, that if the Product is not in good condition, or does not conform to the packing list or the Firm Order, Sanofi Pasteur shall replace the damaged or non-conforming Product.

6. PHARMACEUTICAL REQUIREMENTS

6.1 Delivery conditions: the Buyer shall respect the good delivery practices and have to take measures to avoid abnormal temperatures, humidity and light and to ensure the absence of microorganisms, parasites and worms.

6.2 Storage conditions: the Buyer shall respect all the storage conditions as regards moisture, temperature and light which are notified by Sanofi Pasteur and written on the packaging of the Product or provided for in the product license for the Product. The integrity of the initial labeling and packaging must be preserved. The Buyer shall take any and all measures to monitor and control the conditions under which the Products are handled and stored. Furthermore, the Buyer, upon Sanofi Pasteur’s request shall provide Sanofi Pasteur with any and all evidence as well as any and all relevant information regarding the conditions under which the Products are handled and stored.

The Buyer shall inform Sanofi Pasteur of any incident or damage to the Products occurred during the stocking or the shipment that can possibly affect their quality and shall immediately refrain from selling the identified damaged Products. In any event, the Buyer shall warrant that the Products will be stored and shipped in compliance with the license storage conditions that mean between +2°C/+8°C.

6.3 Cold chain break: the Buyer will use adapted containers to deliver the Products according to the official storage conditions as provided in the product license(s) for the Product. In the event of a cold chain break at any time after delivery of the Sanofi Pasteur Products to the Buyer, the Buyer shall immediately notify Sanofi Pasteur to take the right measures in that case. The Buyer will be in charge of maintaining and monitoring the storage conditions of the Products. For the purpose of this section, a cold chain break occurs when the Product is stored at a temperature, which is below, or above the official storage temperature and which might change the characteristics of the Product.

6.4 Physical complaints: Each physical complaint will be notified to Sanofi Pasteur by the Buyer with the defective sample, name of the product, lot number, quantity, description of the defect. For the purpose of this section, physical complaint shall mean any written electronic or oral communication that alleges deficiencies related to the appearance, labeling, identity, quality, safety, stability and efficacy of the product.

6.5 General Standard Operating Procedure: the Buyer undertakes to comply with the frame of references given in the product license for the Product, and to write up and place at the disposal of Sanofi Pasteur, as far as the latter may be concerned any procedures and methods with description of the operating procedure and the equipment used.

6.6 Destruction Standard Operating Procedure: Without prejudice to the foregoing, the Buyer shall not return any Products to Sanofi Pasteur, nor it shall destroy any such Products, for any reason whatsoever, without the prior written consent of Sanofi Pasteur which shall not be unreasonably withheld. If any Product has to be destroyed, the destruction will be performed according to an adapted and validated method.

7. LIABILITY - WARRANTY

7.1 Warranty by Sanofi Pasteur: Except as expressly provided herein, Sanofi Pasteur makes no warranty of any kind, express or implied, of merchantability or fitness for any particular purpose of the Products. Subject to compliance by the Buyer with the articles provided for herein, Sanofi Pasteur warrants that any Products at the time risk in such Products passes onto the Buyer is of good and merchantable quality and meets the specifications of the products license(s) of the country in which the Product is to be procured. In no event shall Sanofi Pasteur be liable for any indirect or consequential loss incurred by the Buyer or any other person howsoever caused.

7.2 Sanofi Pasteur shall not be responsible for any damages or losses resulting from the purchase, handling, storage, transportation, use or sale of the Products by the Buyer after the transfer of risk in Products to the Buyer.

7.3 If the Buyer claims that a Product did not, at the time of transfer of risks in such Products to the Buyer, meet agreed specifications or was not of good and merchantable quality Sanofi Pasteur shall conduct or have conducted an assay of its retained samples from the concerned shipment or batch. If Sanofi Pasteur agrees with the Buyer's claim, Sanofi Pasteur at its option shall either replace such shipment of Products at no cost to the Buyer or reimburse the price paid by the Buyer for the Product. If the parties are unable to resolve their differences with respect to whether the Products meet the agreed specifications, then either Party may refer the matter to the court having jurisdiction in accordance with article 12 hereof.

7.4 Warranty by the Buyer: Sanofi Pasteur shall not be responsible for any damages or losses resulting from the purchase, handling, storage, transportation, use or sale of Products by the Buyer after the transfer of risk in Products to the Buyer.

7.5 Indemnification by the Buyer: the Buyer shall indemnify Sanofi Pasteur, its servants, agents and contractors in respect of all damages incurred by Sanofi Pasteur by reason of or arising out of any actions, suits, claims, demands, costs, charges and expenses (including but not limited to reasonable attorneys' fees) for losses to the extent that such losses shall have been occasioned by any damage to the Products caused by improper care or handling of the Products by the Buyer, its servants or agents after transfer of risk in the Products to the Buyer, or by a negligence of the Buyer, its servants and agents.

7.6 Indemnification by Sanofi Pasteur: Sanofi Pasteur shall, subject the provisions contained in section 6.8 as herein provided, indemnify the Buyer for all moneys expensed in respect of all damages incurred by the Buyer by reason of or arising out of any actions, suits, claims, demands, costs, charges and expenses (including reasonable attorneys' fees) for death or personal injury (a "Loss") to the extent that such Loss :

  • shall have resulted from any failure of the Products at the time of transfer of risks in the Products to the Buyer to meet the specifications of the products license(s) of the country in which the Product is to be sold and/or to be of good and merchantable quality; or
  • shall have been occasioned by any defect in the manufacture, processing, packaging or labeling of the Products or, more generally, by the negligence of Sanofi Pasteur, its servants or agents;
    and provided however, that this indemnity shall not apply where and to the extent that any failure to meet such specifications shall have been caused by a breach by the Buyer of its obligations under these Terms and Conditions.

7.7 Indemnification process: in the event of any claim being made against a party (the "Indemnified Party") for which the other party (the "Indemnifying Party") has agreed to indemnify the Indemnified Party under these Terms and Conditions, the Indemnifying Party shall be promptly notified thereof and may at its own expense conduct all negotiations for the settlement of the same and any litigation that may arise therefrom. The Indemnified Party shall not at any time make any admission or take any steps which might be prejudicial to the settlement or successful defense by Indemnifying Party of any claim or demand until the Indemnifying Party has been notified of the claim and has stated its intention not to negotiate or defend the claim. The parties shall cooperate in good faith where necessary in the defense of claims involving any Products.

7.8 No consequential damages: In no event will Sanofi Pasteur be liable for any special, incidental or consequential damages of any kind suffered by the Buyer as a result of any breach of these Terms and Conditions by Sanofi Pasteur except as regards to any liability resulting from the willful misconduct, reckless or fraud (faute lourde or dol) of Sanofi Pasteur.

8. PHARMACOVIGILANCE

The Buyer undertakes to inform immediately Sanofi Pasteur of all undesirable events and all other problems with respect to pharmacovigilance that may be linked to the use of the Products sold hereunder. Such information shall be provided at the following email address: infoavd@sanofi.com

9. RECALL

9.1 Recall due to manufacturing: If at any time or from time to time any regulatory agency having jurisdiction in the country in which the Product is supplied, requires the Buyer to recall the Products due to a defect in the manufacture, processing, packaging or labeling of the Products or any other matter whatsoever occurring prior to the transfer of risks in the Products to the Buyer, the Buyer shall immediately notify Sanofi Pasteur and review with Sanofi Pasteur the proposed manner in which the recall is to be carried out. The recall shall be carried out by the Buyer wholly at the cost of Sanofi Pasteur in as expeditious manner as possible and in such a way as to comply with good public health practices and to attempt to cause the least disruption of sales of the Products in the country and to preserve the goodwill and reputation of the Products and reputation of the Buyer and Sanofi Pasteur.

9.2 Reimbursement: With respect to any recall resulting from a defect in the manufacture of the Products by Sanofi Pasteur or a defect in the packaging or labeling by Sanofi Pasteur of the Products, Sanofi Pasteur shall credit to the Buyer an amount equal to the purchase price paid by the Buyer to Sanofi Pasteur for shipments of Products so recalled. On the contrary, with respect to any recall resulting from handling, stocking or transportation faults by the Buyer, the Buyer shall not be exempt to its obligation to pay Sanofi Pasteur for the defective Products.

9.3 Recall due to the handling: If at any time or from time to time any regulatory agency having jurisdiction in the Territory requires the Buyer to recall any Products in respect of which risk have passed to the Buyer, due to a defect in the Products resulting from the handling, storage or transportation or any other matter whatsoever occurring after delivery of such Products to the Buyer, the Buyer shall immediately notify Sanofi Pasteur of such event and of the proposed manner in which such recall is to be carried out. The recall shall be carried out by the Buyer, wholly at the cost of the Buyer, in as expeditious a manner as possible and in such a way as to comply with good public health practices and to attempt to cause the least disruption of sales of the Products in the country and to preserve the goodwill and reputation of the Products and the goodwill and reputation of the Buyer and Sanofi Pasteur.

10. BUSINESS ETHICS

The Buyer shall conduct its business in compliance with the OECD Convention dated December 17th, 1997 on combating bribery of foreign officials in international business.

11. FORCE MAJEURE

No party hereto shall be responsible or liable to the other Party hereto for any failure to perform any of its agreements, covenants or obligations under these Terms and Conditions if such failure results from events or circumstances reasonably beyond the control of such Party, including, without limitation, war (whether or not declared) or other national emergency, riot, fire, explosion, flood of other Act of God, strike, lock-out or other major labor difficulty, epidemic, pandemic, any injunction, decree, order, law or regulation of any public authority, or inability to obtain electricity, fuel or raw material (collectively, "Events of Force Majeure").

The affected party shall exert all reasonable efforts to eliminate, cure or overcome any such Event of Force Majeure and to resume performance hereunder with all possible speed; provided, however, that nothing contained herein shall require any party to settle on terms unsatisfactory to such party. Notwithstanding the foregoing, to the extent that an Event of Force Majeure continues for a period in excess of three (3) months, the Parties agree to negotiate in good faith either (i) to resolve the Event of Force Majeure, if possible, (ii) to extend their mutual agreement the time period to resolve, eliminate or overcome such Event of Force Majeure or (iii) cancel any Firm Order under these Terms and Conditions.

12. CONFIDENTIAL INFORMATION

All information which is disclosed by Sanofi Pasteur to the Buyer shall be maintained in confidence and shall not be disclosed to any third-party or used for any purposes other than set out herein, without the prior consent of Sanofi Pasteur and for a period of five years as from the disclosure of such information by Sanofi Pasteur, except to the extent that such information: (i) is known to the Buyer prior to its disclosure by Sanofi Pasteur or (ii) is obtained by the Buyer from a source other than Sanofi Pasteur and which source was legally entitled to disclose the information or has become public otherwise than through the fault of the Buyer; or (iii) is required to be disclosed by the Buyer by law or for the purpose of complying with governmental regulations.

13. TERMINATION

Without prejudice to any other rights Sanofi Pasteur may have, Sanofi Pasteur may terminate the supplies of Products with immediate effect by giving notice to the Buyer, if the Buyer:

  1. is in breach of any provisions contained in these Terms and Conditions;
  2. has failed to pay any amounts to Sanofi Pasteur in accordance with its payment terms, or
  3. is to be declared bankrupt or is to enter into liquidation or otherwise is to be found insolvent.

14. APPLICABLE LAW AND DISPUTES

These Terms and conditions shall be governed and construed in accordance with the laws of the Republic of France exclusive of its conflicts of law principles. Any and all disputes that cannot reach an amicable settlement, arising from or in connection with this Agreement, shall be settled by the competent courts of Lyon (France) Tribunal de Commerce.