1. The Parties and the Products
1.1 In these General Terms and Conditions, the term “the Seller” shall be taken to signify Breas Medical AB or any of it’s subsidiaries. The term “The Buyer” shall be taken to signify any private, public or state owned company with whom agreement on sale of the Seller’s product has been reached or to whom a tender has been submitted.
1.2 The term “the Product” shall be taken to signify the product agreed for sale. The Product includes all manuals and other written instructions about the Product. The term “Product Related Services” shall be taken to signify services rendered or advice given by the Seller or his representatives in relation to the sale of the Product.
2. Applicability
2.1 These General Terms and Conditions shall be applicable to all deliveries of the Product to the Buyer and to any and all Product Related Services unless they have been altered explicitly by the parties in writing. 3. Conclusion of individual sale contracts
3.1 A legally binding agreement in respect of individual deliveries of Products or Product Related Services shall be deemed to have been concluded when the Seller has confirmed the Buyer’s order in writing.
3.2 If the Buyer, in connection with the order, has dictated conditions which are contrary to those set out in the Seller’s confirmation of order or these General Terms and Conditions, failure on the part of the Seller to object to such conditions does not imply that they have been approved by the Seller, but the delivery shall be considered to be done according to the confirmation of order and these General Terms and Conditions.
4. Prices and Payment
4.1 The price of the Product or Product Related Services shall be according to the current price list of the Seller at the time of the formation of the sale contract unless otherwise has been agreed upon in writing.
4.2 Payment shall be made at latest thirty (30) days after the date of the invoice unless otherwise has been agreed upon in writing.
4.3 At payment after due date the Seller has the right to interest on overdue payment at currently 2% per month. 5. Reservation of Title
5.1 Delivered Products shall remain the property of the Seller until paid for in full to the extent that such retention of property is permitted by the applicable law. If the Seller due to default of payment revoke the purchase, the Seller shall have the right to reclaim the Product. Until the title of the Product has been transferred to the Buyer it is incumbent on him to take good care of the Product. 6. The Quality 6.1 The Product shall in all aspects comply with the specifications given in the official product information that the Seller supplies for the Product unless otherwise has been agreed upon in writing. 7. Deliveries 7.1 Trade terms shall be interpreted in accordance with the INCOTERMS in force at the formation of the sale contract. If no trade term is specifically agreed the delivery shall be considered to be Ex Works the Seller’s premises Gothenburg.
7.2 If the price disclosed in the sales contract entails that the Seller shall wholly or partly be responsible for freighting costs, the Seller shall be entitled to choose the mode of transportation.
7.3 If the Seller finds that he will not be able to deliver the Products at the agreed time for delivery or if delay on his part seems likely, he shall forthwith notify the Buyer thereof in writing, stating the reason for the delay and if possible the time when delivery can be expected. 7.4 If delay in delivery is caused by transport delays beyond the Seller’s control, or because of any circumstance encompassed by Article 13, or by an act or omission on the part of the Buyer, the delivery time shall be extended by a period, given all of the circumstances in the case that may be deemed reasonable. This applies regardless of whether the reason for the delay occurs before or after the expiry of the agreed delivery time.
7.5 The Seller’s liability in the event of delay is limited to verified material direct losses (all kind of indirect and consequential losses and damages excluded) and shall not, in any event, exceed 7,5 % of the invoiced value of the delayed delivery. 8. The Buyer’s obligation to take delivery
8.1 Should the Buyer fail to take delivery of the Product at the appointed time, he is nevertheless obliged to make each payment as if delivery of the Product in question had been taken. If the Buyer, regardless of grounds, fails to take delivery of the Product at the appointed time, the Seller shall be entitled, by written notification to the Buyer, to cancel the Agreement in respect of such outstanding part of the Product that, due to the Buyer’s failure has not been received, and receive compensation from the Buyer for any and all damage incurred due to the Buyer’s failure to fulfil his obligations. 9. Inspection and complaints 9.1 The Buyer shall as soon as possible after receipt examine that the Product complies with the order confirmation and with what is stated in the agreement.
9.2 Complaint regarding lack of conformity of delivered Products that the Buyer has noticed or should have noticed at such an upon receipt inspection, shall be lodged at the latest 20 days from the date at which the Products were delivered. Complaint regarding such a fault as could not have been discovered at an upon receipt inspection shall be made directly after the fault is noticed or should have been noticed by the Buyer, however, at the latest within 25 months after delivery. Failing to do so causes the Buyer to lose the rights that belong to him due to lack of conformity of the Products. 10. Purchaser’s handling of the Product 10.1 The Buyer undertakes to transport, handle, store and repair the Product with proper care and always in accordance with professional standards and the instructions of the Seller. The Buyer undertakes not change the Products, remove or change any trademarks, names or any other markings concerning the Products or alter the Product’s packaging or repack the Products in non-approved non-Breas packaging.
10.2 The Buyer undertakes to comply with all the instructions and information about the Product given by the Seller when marketing and selling the Product, educating his personnel and instructing and educating his customers about the handling and use of the Product.
10.3 The Buyer undertakes to, when marketing and selling the Product, not to give any information about the Product or make any warranties or representations as to the Product, its nature or use that is contrary to or goes further or beyond the instructions, information, warranties or representations given by Seller. The same applies when the Seller is educating his customers about the use of the Product. The Buyer undertakes to indemnify and hold the Seller harmless from any and all damages in the event the Seller suffers damage as a result of breach of these undertakings. 10.4 According to the requirements of Annex II of The Medical Device Directive (MDD 93/42/EEC) the Buyer shall maintain adequate records concerning product traceability. The Buyer’s traceability records shall be complete and accurate and trace the Seller’s Products to final point of use by product code, lot number and/or serial number. The Buyer agrees to comply with the rules of these directives and accepts them as legally binding conditions for all deliveries of Products.
11. Warranty (Liability for defects), Product Recall
11.1 Breas Medical warrants, pursuant to Articles 11.2-11.4 below, that the sold Product during a period of twenty four (24) months from date of original shipment from Breas to Buyer or to Buyer’s order, but in no event for a period of more than twenty seven (27) months from the date of original shipment from Breas to a Breas Authorized Dealer, that the Product will be free from defects in material, construction and design and that the Product as well as Product Related Services in all aspects will comply with the Seller’s specifications. In case of non-conformity, the Seller undertakes to repair or replace any defective Product and to render necessary Product Related Services at no charge excluding the return freight cost to the Seller.
Services and expendable parts, such as; spare parts, accessories, Single Patient Use Products; are covered by the same warranty for a period of three (3) months from the date of original delivery to Buyer or to Buyer’s order, but in no event for a period of more than four (4) months from the date of original shipment from Breas to a Breas Authorized Dealer.
11.2 The Seller’s warranty according to Article 11.1 above is conditioned by that the Product has been transported and handled with proper care and stored and used in accordance with the Seller’s instruction for Products, that the Product has been subject to regular maintenance and service, that replacement and repair has been performed according to Seller’s instructions and that the Product is returned in the Seller’s packaging in case return to Seller is necessary.
11.3 The Seller’s warranty does not apply to any Products that have been specifically manufactured or modified at the request of the Purchaser or altered by the Purchaser or third party, nor does it apply to defects caused by abnormal use of the Product or circumstances that have arisen after the risk for the Product has been transferred to the Buyer.
11.4 Except for the warranty described in Article 11.1 above the Seller makes no warranty with respect to the Product or Product Related Services, neither express nor implied, written or oral. In addition, the Seller disclaims all liability for lost earnings, income or profits and all other direct or indirect, incidental or consequential damages resulting or arising from a defect in the Products or wrongly performed Product Related Services.
11.5 The Buyer shall cooperate with the Seller in effecting a recall (field corrections of systematic defects, removals, or upgrades) of the Product at the direction of Breas.
The Seller is responsible for recalls and shall determine when the defect is systematic and when a recall shall be performed. In the event that a recall is deemed to be necessary the Seller shall provide all written instructions to the Buyer as to the correct management of the affected Products.
11.6 Defects, removals or upgrades that have been specifically defined as recalls by the Seller shall be remedied by the Buyer at his business location according to the instructions given by the Seller. If necessary and at the choice of the Seller the Product or parts of the Product may instead be transported from the Buyer to the Seller for remedy. In case of remedy at Buyers location, the Seller shall without any costs for the Buyer deliver necessary new components, software etc. that replaces the item. The Seller shall further at cost price compensate the Buyer for the necessary repair or replacement work performed by him at his location. If the Seller instructs the Buyer to return the Products to the Seller, the Seller shall be liable for the costs for repair performed by the Seller as well as the cost of transportation of the Products from the Buyer to the Seller and back to the Buyer.
The Buyer shall, if required, comply with the country’s regulations regarding such actions and assist the Seller in notifying the appropriate regulatory authorities.
11.7 The Seller’s liability in the event of a Product Recall is limited to the above explicitly stated costs and the Seller has no liability for any costs or damage incurred by the Buyer or his customers that go beyond the costs specified above. 12. Product liability
12.1 Should the Product or the Product Related Services cause bodily injury or damage to property belonging to the Buyer or to third parties (product liability), the Seller’s liability is limited to such damages, such losses, and such amounts as are covered by the Seller’s liability insurance. Above and beyond that which may be payable under such insurance, the Seller assumes no liability whatsoever for any damage or loss caused by defective Products. 13. Force majeure
13.1 If one of the parties is prevented from fulfilling his obligations due to circumstances outside his control, such as labour dispute, stroke of lightning, fire, storm, flood, earthquake, war, terrorist actions, mobilisation or extensive call-ups, requisition, confiscation, currency restrictions, directions from the authorities, insurgencies and riots, restrictions concerning motive force, general scarcities in transportation, goods and energy, measures taken by state or government authorities or errors or delayed deliveries from contractors or subcontractors, this shall constitute reason for exemption, which entails the right to postpone meeting the obligations for as long as the hindrance exists, and relief from fines and other penalties of law. The party shall as soon as possible inform the opposite party if such circumstances arise. If the hindrance endures at least 3 months, the party has the right to terminate the sale agreement in writing without liability to pay compensation. 14. Applicable law and disputes 14.1 All disputes regarding the interpretation or application of these General Terms and Conditions as well as individual sale contracts or contracts regarding Products or Product Related Services shall be subject to Swedish Law.
14.2 Any dispute, controversy or claim arising out of or in connection with this contract, or the breach, termination or invalidity thereof, shall be finally settled by arbitration administered by the Arbitration Institute of the Stockholm Chamber of Commerce (the SCC Institute). The Rules for Expedited Arbitrations of the Arbitration Institute of the Stockholm Chamber of Commerce shall apply, unless the SCC Institute, taking into account the complexity of the case, the amount in dispute and other circumstances, determines, in its discretion, that the Rules of the Arbitration Institute of the Stockholm Chamber of Commerce shall apply. In the latter case, the SCC Institute shall also decide whether the arbitral tribunal shall be composed of one or three arbitrators. The English language shall be used throughout the arbitral proceedings. The place of arbitration shall be Gothenburg, Sweden.
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