General Terms and Conditions of Sale BIOTRONIK AG
These General Terms and Conditions of Sale (“GTCS”) shall apply to all contractual relations between Biotronik AG (hereinafter: “BIOTRONIK”) and customers, inasmuch as they are not consumers within the meaning of Art. 8 UWG and Art. 32 ZPO („Customer“) and shall be part of all contracts BIOTRONIK enters into with Customer with regard to the deliveries and services it offers. All deliveries, services and offers of BIOTRONIK shall be exclusively rendered on the basis of these GTCS which shall apply to any and all further contractual relations between BIOTRONIK and Customer irrespective of whether or not agreed upon expressly. BIOTRONIK objects to the application of standard terms and conditions of Customer even if those are communicated in an order confirmation or in any other way. Even if BIOTRONIK refers to a letter of Customer that includes or refers to standard terms and conditions of Customer, this shall not constitute consent with those standard terms and conditions. Deviating, opposing or additional standard terms and conditions of the Customer shall only and insofar become an integral part of the contract, if BIOTRONIK expressly consents to their application in writing.
2. Conclusion of Contract
All offers of BIOTRONIK are subject to confirmation and non-binding, unless expressly identified as binding or stating a specific acceptance period. This shall also apply if BIOTRONIK provided Customer with catalogues, technical documentation, any other form of product information or documentation (also in electronic form). The placement of an order represents Customer´s binding purchase offer. BIOTRONIK has the right to accept the purchase offer within 14 days after receipt of the order. This acceptance may either be communicated in writing or by delivering the goods to Customer.The contractual relations between BIOTRONIK and Customer are exclusively governed by the written sales contract, including these GTCS which represents the entire agreement between the Parties regarding the subject matter. Verbal covenants of BIOTRONIK prior to the conclusion of the contract and verbal agreements between the Parties shall be replaced by the written contract unless the written contract expressly provides that these remain in force. Any amendments or alterations to the contract concluded between the Parties, including these GTCS, must be agreed in writing to be effective. With the exception of managing directors and procurists, BIOTRONIK employees are not entitled to conclude deviant verbal agreements. The content of such agreements is dependent on a written contract or written confirmation by BIOTRONIK. The written form requirement within the meaning of this section 2 is satisfied by using telefax; however, any other form of telecommunication, especially email, is not sufficient. BIOTRONIK reserves title and retains copyright to all of its offers and quotations as well as all drawings, presentations, catalogues, brochures, designs and other documentation made available to Customer. Customer is not allowed without the express consent of BIOTRONIK to make the aforesaid documents available to a third party, to disclose, to use on its own or through a third party or to reproduce. Upon BIOTRONIK´s request Customer shall return all such documents and destroy copies thereof if these documents are not
3. Delivery and Shipment
BIOTRONIK delivery dates shall be binding only if they have been agreed upon explicitly as binding between the Parties. If shipment is agreed, delivery dates and delivery periods refer to the date of commissioning to the forwarding carrier, freight agent or any third party designated to carry out the shipment. Any confirmation of a delivery date or delivery period shall be subject to BIOTRONIK, for its part, receiving the deliveries and services of its respective suppliers in good time and good order. BIOTRONIK is permitted to partial deliveries, if such partial deliveries are usable for the Customer with regard to the contractually agreed purpose, the supply of the remaining goods ordered is secured and Customer does not accrue any material additional expenditure.The risk of accidental destruction or accidental impairment of the goods shall pass to Customer at the latest upon handing over the goods to the forwarding carrier or freight agent or any third party designated to carry out the shipment. In the event delivery of the goods is delayed due to reasons caused by the Costumer, the risk shall pass at the notification of BIOTRONIK’s readiness for dispatch to the Costumer. Customer shall bear warehousing and storage costs after passing of risk. The preceding shall not apply if something else has been agreed upon by an individual contractual agreement. If not contractually agreed upon otherwise all deliveries of the goods shall be insured by Customer up to the arrival at Customer´s premises against transport risk or risk of loss. If the insurance is concluded by or at cost of BIOTRONIK Customer must report damages and loss to BIOTRONIK (with appropriate documentation of the forwarding carrier) without undue delay upon receipt of the delivery in order to secure possible claims against the transport insurance carrier. The damaged or impaired goods have to be put at the disposal of BIOTRONIK. BIOTRONIK is not liable for failure to perform or delay in performance of its obligations if such failure to perform or delay in performance is a result of Acts of God BIOTRONIK is not responsible for (e.g. downtime of production, disruption of material and energy supply, shipment delays, labor dispute, strike, lockout, shortages of labor force, energy or raw materials, difficulties in obtaining approvals and concessions, faulty or late supply by BIOTRONIK). As long as Acts of God persist BIOTRONIK is free of its obligations. If Acts of God are temporary, the delivery dates and delivery periods are prolonged by the time period of the impediment plus an adequate lead time.If the acceptance of delivery is not reasonable for Customer due to the aforementioned delays, Customer has the right to rescind the contract by immediate written notice to BIOTRONIK. In the event of a delay in performance BIOTRONIK´s liability for damages shall be limited in accordance with section 7 of these GTCS.
4. Prices and Terms of Payment
The prices are effective for the scope of deliveries and contract performance as stated in the order confirmation and are net prices, plus value added tax and other taxes and duties applicable at the time of delivery or service, but including packaging costs. Unless prices are separately agreed in the sales contract, the prices listed in BIOTRONIK´s price list at the time of the order placement shall apply. Payments have to be made in advance unless agreed otherwise. Payments shall regularly be made by bank transfer. Payment shall be deemed made if and when the amount to be paid is irrevocably credited in full to BIOTRONIK´s bank account. In case of Customer’s default in payment, default interest at the statutory rate shall accrue starting at the payment date. The right to assert higher interest or damages incurred as a result of the default shall remain unaffected. Only payments made to BIOTRONIK directly have the effect of discharging the payment obligation. In case of more than one outstanding debt, payments are made successively on default interest, costs incurred and then on the outstanding debt. Payments shall be allocated to the oldest outstanding debt. Customer shall only be entitled to offset against claims which are undisputed by BIOTRONIK or which have been legally established.
5. Retention of Title
BIOTRONIK shall remain the sole owner of the delivered goods until all receivables, current and future of BIOTRONIK against the Customer have been fully paid. BIOTRONIK reserves the right to enter a retention of title at the expense of Customer in the appropriate register at the Customers domicile. By signing the contractual agreement Customer agrees in the sense of Art. 4 (4) EigVV that BIOTRONIK can enter a retention of title in the appropriate register without Customer´s further assistance. Until the sales price has been fully paid BIOTRONIK shall be entitled to label or have labeled the delivered goods indicating sufficiently clear BIOTRONIK´s ownership. Customer shall not be entitled to sell, pledge, assign by way of security or in any other way to commit any delivered goods subject to BIOTRONIK’s retention of title. The Customer shall take all steps to prevent the claim of ownership of BIOTRONIK becoming affected. In case Customer sells the delivered goods contrary to the preceding paragraph, Customer hereby and by signing the contractual agreement incorporating these GTCS assigns in advance to BIOTRONIK the receivables arising from the resale of goods against third parties. BIOTRONIK hereby accepts such assignment. If and insofar a third party has access to goods subject to BIOTRONIK’s retention of title, Customer shall be required to inform the claimant about the reservation of ownership of BIOTRONIK and immediately notify BIOTRONIK. Customer shall bear any costs incurred in the defense against such access of third parties to the goods under ownership of BIOTRONIK. If Customer infringes any of the aforementioned provisions, especially does not pay the purchase price, BIOTRONIK has the right to rescind the contract in accordance with statutory provisions and to demand the return of the goods subject to retention of title and on the basis of rescis.
Regardless of the guarantee conditions of BIOTRONIK, warranty shall only be assumed according to the statutory provisions unless otherwise agreed upon herein. The warranty obligations are primarily based on the agreed composition and quality of the goods. The product description identified as such and handed over to the Customer prior to its order or integrated within the contract in the same way as these GTCS shall be considered such agreement on the composition and quality of the goods. The warranty period shall be two years from delivery or insofar as an acceptance inspection is required from such acceptance inspection. The delivered goods shall be inspected immediately upon delivery to the Customer or to a third party designated by the Customer. The goods are deemed accepted unless BIOTRONIK receives a complaint relating to apparent defects or other defects that would be recognized in an immediate, thorough inspection in writing and within three working days after delivery of the goods, or otherwise within three working days after discovery of the defect or from the time in which the defect could be recognized by the Customer in normal usage without closer inspection. In case of defects BIOTRONIK shall be obliged (upon its own choice to be exercised within reasonable time) either to rectify the defects or provide supplemental performance. If supplemental performance is unsuccessful or fails within an appropriate deadline stipulated in writing by the Customer or such deadline is unnecessary according to statutory provisions, Customer is entitled to rescind the contract or to reduce the purchase price. No right of rescission exists in case of insignificant defects. Customer must allow BIOTRONIK the requisite time and opportunity to perform any repairs or replacements. In the event of the substitute delivery the Customer must return the defective product according to statutory regulations. The expenses necessary for the purpose of inspection and supplementary performance, in particular transport, work and material costs shall be on the account of BIOTRONIK insofar as the product is actually defective. The warranty under this section 6 shall be inapplicable if the Customer makes defect detection by BIOTRONIK impossible or difficult, for example in the case of implantable devices, by not providing after implantation the surgical report of the implantation (if permissible under applicable law) and / or after explantation of the device the explanted device as well as not providing a written explanatory statement for the explantation. The same applies if the product has been manipulated by Customer or a third party.
BIOTRONIK´s liability for damages for whatever reason, especially due to impossibility, default, defective or incorrect supply, breach of contract, breach of obligations with contract negotiations and tort, insofar as such liability is dependent on fault by BIOTRONIK, shall be restricted in accordance with this section 7. BIOTRONIK shall not be liable for simple or medium negligence unless such claims are based on a breach of material contractual duties. Material contractual duties are the obligations for prompt supply, free of defects and duties of consultation, protection and care, which will make the use of the delivered goods in accordance with the contract possible for the Customer or which serve the purpose of protecting the life and limb of personnel of the Customer or third parties or Customer’s property against considerable damage. To the extent BIOTRONIK is accordingly in principle liable for damages, such liability shall be limited to damages which are reasonably foreseeable by BIOTRONIK at the execution date of the contract or which, taking into consideration the circumstances that BIOTRONIK knew or reasonably should have known, BIOTRONIK would have foreseen had BIOTRONIK exercised reasonable care. Furthermore, indirect damage and consequential damage resulting from defects in the delivered goods are only subject to compensation in so far as such damage is typically to be expected when using the goods supplied as stipulated. Insofar as BIOTRONIK provides technical information or acts as an adviser and this information or advice is not part of the contractually agreed scope of duties owed by it, this is done free of charge and under the exclusion of any liability. The limitations of this section 7 do not apply to BIOTRONIK´s liability on account of intent or gross negligence, Art. 100 para. 1 of the Swiss Code of Obligations being reserved, for guaranteed characteristics, on account of injury to life, limb or health or according to the Swiss Product Liability Act. The aforementioned limitations of liability also apply to the liability of the organs and legal representatives of BIOTRONIK. For employees and auxiliaries of BIOTRONIK, liability is also excluded in the event of intent or gross negligence.
8. Traceability of Implants
BIOTRONIK as manufacturer of implantable medical devices (i.e. cardiac pacemakers, defibrillators, hereinafter “Implants”) has to ensure the traceability of such Implants (Swiss Ordinance on Medical Devices (MepV), sec. 5, art. 15 et seq.). Observing the pertinent data protection law provisions, the Customer shall guarantee the traceability of the delivered products by keeping a data overview that contains information on: Product type and Serial number, Date of delivery, Date of a possible subsequent delivery including name and address of the recipient (i.e. physician / clinic), Name of patient implanted with the device, Date of implantation, Date of explantation. The Customer shall ensure that in an emergency the relevant data can be conveyed to BIOTRONIK within five days. The applicable data protection law provisions have to be observed. Emergencies are for example recalls, product liability cases and possible violations of applicable laws. In order to ensure the traceability in case of resale by Customer to medical institutions (i.e. physicians, clinics) or business owners (hereinafter “Subsequent Delivery”) and in order to prevent a loss of data in the course of Subsequent Deliveries (i.e. after insolvency), Customer agrees to give to BIOTRONIK the date plus name and address of the subsequent purchasers at first request within five working days, irrespective of a case of emergency. Customer is responsible that any of its subsequent purchasers and all sub-distributors observe the aforesaid obligations to (i.) Keep a data overview containing the above mentioned content (ii.) Hand over the above described data overview to BIOTRONIK in case of emergency (iii.) Hand over, irrespective of a case of emergency, to BIOTRONIK at first request within five working days the date of a Subsequent Delivery and name and address of the subsequent purchaser and to further oblige subsequent purchasers to observe these obligations In the event of product complaint, Customer shall inform BIOTRONIK in writing or in text form (letter, fax, e-mail) without delay of the cause of the complaint, on no account later than three working days after it becoming known. In case of an explantation, the Customer will send the explanted device to BIOTRONIK without delay, on no account later than ten working days. Customer shall ensure that any subsequent purchaser of its own observes these obligations and that the applicable provisions of the Swiss Ordinance on Medical Devices (MepV) in its respectively current version are observed.
The Customer undertakes to adhere to all applicable export/import provisions, as well as any associated embargo provisions, trade embargos and sanctions. The Customer undertakes particularly, in the absence of a relevant official authorization or order, to export technical data and software (including products that arise from such data or software) neither directly nor indirectly to a proscribed destination or a country of concern as may arise from the pertinent provisions cited above, and not to export or re -export (including passing on to nationals of one of these countries, irrespective of their location). Customer guarantees to implement adequate organizational measures to ensure adherence to EU regulations and insofar as applicable the according U.S. regulations. In case of a Subsequent Delivery according to section 8 Customer shall be responsible for ensuring that the second purchaser and any further purchasers adhere to the obligations set out in this section 9 and that such second purchasers imposes these obligations on their respective customers.
The Parties undertake to treat as confidential – even beyond the term of this contract – all information gained from the respective other Party before or on performance of the contract, irrespective of whether marked as confidential or not, and irrespective of the form of its conveyance (concrete or electronic), and to make it available only to such staff and consultants who need access to the relevant information for the purpose of fulfilling their duties and have submitted to an appropriate obligation of confidentiality. The aforesaid obligation of confidentiality shall not apply to such information already known to the public on conclusion of this agreement or subsequently becomes rightfully known or is relinquished to third parties after consent of the conveying party or must be disclosed due to binding official or court order.
11. Place of Performance and Place of Jurisdiction
The place of performance for all obligations arising from contractual relations subject to the inclusion of these GTCS is the registered office of BIOTRONIK. The place of jurisdiction for all disputes regarding a contractual relationship subject to the inclusion of these GTCS – also in the summary procedure based on documents - is the registered office of BIOTRONIK. Contractual relationships between BIOTRONIK and Customer are exclusively governed by the laws of Switzerland to the exclusion of its conflict of laws and the United Nations Convention on the InternationalSale of Goods.
Bülach, September 2013 Biotronik AG