General Terms and Conditions of Business (GTC)

1. General Information

1.1 The following General Terms and Conditions of Business in the version valid at the time of the order shall apply exclusively to all business transactions with the Purchaser or Customer. We do not recognise any conflicting conditions or deviations from our General Terms and Conditions of Business, even in the case of unconditional provision of services or acceptance of payment, unless we expressly agree to their validity in writing. This also applies to general terms and conditions outside the general terms and conditions of purchase of the Purchaser, in particular, but not only, to quality assurance agreements, contracts for the provision of materials, consignment stock contracts and non-disclosure agreements. The possible legal invalidity or effective amendment of individual provisions shall not affect the validity of the remaining provisions of our General Terms and Conditions of Business.

1.2 The following terms and conditions of business are an integral part of all contracts, our deliveries, other services, and orders placed with us vis-à-vis companies, legal entities under public law and special funds under public law.

2. Offer, order, and conclusion of contract

2.1 Our offers are subject to change and non-binding.

2.2 All orders require our written confirmation to be legally effective. All possible additions and amendments to the order also require our written confirmation to be valid.

2.3 We are not obliged to accept an order.

2.4 Each order is concluded with the content specified by our written order confirmation in conjunction with our General Terms and Conditions of Business.

2.5 All drawings, descriptions and illustrations attached to the order by the Customer require our express written confirmation to be legally binding.

2.6 The data provided by the Customer within the scope of his order are not subject to any control by us. The responsibility for the correctness of the data provided lies exclusively with the Customer.

2.7 Services and prices apply in accordance with our written order confirmation and are agreed individually.

3. Delivery date and delivery periods

3.1 Delivery dates and delivery periods, which can be agreed upon as binding or non-binding, must be stated in writing. If delivery dates or delivery periods are to be binding, they must be expressly designated as such and require our express separate written consent. All information about delivery dates and delivery periods are to be understood in commercial business transactions as non-binding and approximate information and are subject to the reservation of timely delivery of goods to us. If DOPPKON itself is not correctly and timely supplied by its subcontractors, although DOPPKON has placed congruent orders with reliable subcontractors, DOPPKON shall be released from its obligation to perform and may withdraw from the affected partial contract. DOPPKON shall immediately inform the Purchaser about the non- availability of the service and shall search for alternative sources of supply in partnership with the Purchaser. Liability for damages caused by delay is excluded in the aforementioned cases of delivery bottlenecks for which DOPPKON is not responsible. The above provision shall not apply to disruptions in delivery by subcontractors if and to the extent that DOPPKON is responsible for such disruptions.

3.2 If the Purchaser fails to provide necessary documents, permits or other obligations in a timely manner, the delivery date or delivery period shall be extended by a reasonable period of time, but not more than the period of delayed receipt.

3.3 In cases of force majeure or in the event of operational disruptions occurring at DOPPKON GmbH & Co. KG or our suppliers, in particular shortages of raw materials and energy, labour disputes, changes in the official approval and legal situation or other circumstances for which we are not responsible, we shall be entitled to extend the aforementioned dates and deadlines by the duration of the disruptions in performance caused by these circumstances plus a reasonable start-up period.

3.4 If the Customer is in default of acceptance or if he culpably violates other obligations to cooperate, we are entitled to demand compensation for the damage incurred by us in this respect, including any additional expenses. We reserve the right to assert further claims.

4. Prices

4.1 Price changes to the prices stated in the contract/order confirmation are permissible if there are more than 3 months between the conclusion of the contract and the agreed delivery date. This also applies analogously to a change in the statutory value added tax. If the Customer is a legal entity under public law, a special fund under public law or an entrepreneur who, at the time the contract is concluded, is acting in the exercise of his self-employed or commercial activity, we may add any sales price increases of our suppliers and changed sales and operating costs to the agreed sales price, provided this is reasonable for the Customer.

4.2 The prices set out in the contract/order confirmation shall apply exclusively to the scope of the order known at the time the contract is concluded. Visual changes that do not include any functional improvements, correction requests and subsequent changes and services, as well as additional expenses due to defective and incomplete templates and specifications, will be invoiced separately to the Customer. Costs arising from components or suppliers which are prescribed by the Customer, but which do not correspond to required functions or quality are not included in our price and must be paid separately.

4.3 Unless otherwise agreed, prices are ex our office excluding packaging, postage, freight, and statutory value added tax.

4.4 All prices for concepts, developments, projects, designs and prototypes are individually calculated sizes and cannot be derived for possible repeat orders or tasks equivalent in scope.

5. Transfer of risk

The risk of loss and deterioration of the delivery passes to the Customer as soon as the consignment has left our premises. This also applies if the shipment is made with our own means of transport. At the request and expense of the Customer, we will insure the consignment against transport damage, breakage, fire damage and loss. If the dispatch of the goods or services is delayed at the request of the Customer, the risk shall pass to the Customer from the time of readiness for delivery.

6. Liability

6.1 Claims for damages and reimbursement of expenses of any kind can only be asserted against us, our legal representatives, and vicarious agents, in the event of intent, gross negligence or culpable breach of essential primary obligations of the contract.

6.2 Orders based on drawings, sketches or other information provided to us shall be executed at the risk of the Customer. If, as a result of the execution of such orders, we infringe third-party industrial property rights, the Customer shall indemnify us against any claims of such holders of rights. Any further damages shall be borne by the Customer.
6.2.1 Our liability for any infringement of industrial property rights in connection with the application of the delivery items or services or with the connection or use of the delivery items or services with other products is excluded.
6.2.2 In the event of defects of title, we shall be entitled at our discretion: – to procure the necessary licences with regard to the infringed property rights – or to remedy the defects of the delivery item or service by making available a delivery item or service which has been modified to an extent reasonable for the Customer.

6.3 DOPPKON recommends to the Purchaser to take out comprehensive legal insurance coverage, taking into account a business and product liability insurance, an environmental liability and environmental damage insurance and a recall insurance. These insurances shall contain the following provisions: Contrary to section 7.3 GTCLI, the insurer will not raise any objections if the policyholder waives recourse claims against third parties before the occurrence of the insured event.

6.4 Insofar as liability is excluded or limited in accordance with the above, the Purchaser shall also be obliged to indemnify us against third-party claims. Furthermore, the Purchaser must indemnify us against claims of third parties for damages caused by a misuse, independent reworking of the products or re-labelling of our products by the Purchaser or if a medical malpractice cannot be demonstrably excluded as the cause.

7. Payment

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7.1 Unless otherwise agreed, payments shall be made within 14 days of receipt of the invoice by bank transfer to the named accounts. Bills of exchange and cheques are not accepted.

7.2 With non-payment the Customer is in default of payment. A separate reminder is not required. In the event of a delay in payment, interest on arrears will be charged from the due date at a rate of 7% points above the base rate p.a. applicable at the time. We reserve the right to assert higher damages caused by default.

7.3 In the event of default of payment, we are entitled, without the need to set a deadline, to withdraw from unfulfilled delivery obligations and to reclaim services already delivered. If, after conclusion of the contract, there is a significant deterioration in the financial circumstances of the Customer or if the Customer’s payment behaviour deteriorates increasingly, delivery will only be made against prepayment in deviation from the above terms of payment.

7.4 In the case of larger orders or longer periods of performance, we can also demand advance payment or payments on account.

7.5 Offsetting or withholding of payments due to other counterclaims of the contractual partner that are not recognised by us or have not been legally established are excluded.

8. Revocation, order modification and cancellation

8.1 If the Customer orders and buys the subject of the contract from us in the exercise of his commercial or independent professional activity, he is an entrepreneur in the sense of § 14 BGB (German Civil Code). The Customer has no right of revocation.

8.2 Orders confirmed in writing cannot be cancelled or services already delivered cannot be taken back or exchanged. Exceptions require a written agreement with us. In such cases, we generally charge 30% of the purchase price as a compensation payment. Custom-made products and Customer-specific designs are excluded from this possible exception.

8.3 Contractual partners who cancel orders confirmed by us up to 4 weeks before the start of production or the start of order execution or who request a postponement of the date, we can charge an expense allowance of 15% of the order value concerned if these requests are complied with. Order changes or cancellations within the last 4 weeks before the start of production or order execution are generally excluded.

9. Extended reservation of title

The services and in particular concepts and constructions are delivered under extended reservation of title. They remain the property of DOPPKON GmbH & CO. KG until full payment of all claims, including future claims arising from the business relationship with the Customer.

10. Warranty

10.1 Claims due to incomplete or faulty delivery or service shall only exist if these complaints are notified in writing immediately, but no later than 10 days after receipt of the service. Otherwise, the defects shall be deemed to have been accepted. In commercial business transactions, the assertion of claims due to hidden defects is additionally dependent on complaints about the properties of the service being reported to us in writing without delay, at the latest, however, within 10 days after knowledge of these hidden defects.

10.2 The warranty shall only cover defects that were demonstrably present at the time of the transfer of risk. No liability is accepted for defects that are due to overuse, natural wear and tear or improper handling by the Purchaser.

10.3 The return of rejected services from the Purchaser requires our prior consent and must be effected immediately at the Purchaser’s risk and expense. The Purchaser must return the order items complained about – in the case of surgical instruments – cleaned and sterilised or autoclaved.

10.4 Any expenses incurred for the remedy of warranty claims, as well as shipping costs, will be borne by us if the justification of the warranty claim is established.

10.5 In the case of warranty claims, the right of the Purchaser is limited to rectification of defects or replacement delivery of defect-free performance to the exclusion of further warranty claims. In the event of defective rectification or replacement delivery, the Purchaser may demand a reduction of the purchase price or, at his discretion, cancellation of the contract. Further claims are excluded.

10.6 In the case of third party products, even if they have been installed in our products or used in any other way, we are entitled to limit our liability initially to the assignment of the warranty claims to which we are entitled against the supplier of the third party products, unless satisfaction under the assigned right fails or the assigned claim cannot be enforced for other reasons. In this case, the Customer shall again be entitled to the rights from the preceding paragraph 5.

10.7 Unless otherwise agreed, the warranty period for material defects is 12 months. The warranty period begins with the transfer of risk to our Customer. The same applies to goods or parts that are delivered to the Customer under warranty (subsequent performance).

10.8 Reworking in the form of repairs is excluded for surgical instruments previously used in the operating theatre despite cleaning and sterilisation.

11. Technical documentation and concepts

We reserve the property rights and copyrights to documents, such as calculations, drawings, technical plans, computations, technical documentation etc., which were handed over to the Customer during a business relationship. They may not be disclosed or passed on to third parties by the Customer without our express written consent, with the exception of authorities and notified bodies. In the event of infringements, we reserve the right to claim damages.

12. Surgical instruments

12.1 DOPPKON manufactures surgical instruments and sells these without CE or other marking to the contractual partner and is therefore not a distributor nor the original manufacturer.

12.2 DOPPKON reserves the right to improve and change surgical instruments developed in-house as part of a continuous product optimisation. DOPPKON is also entitled to change or stop the production of individual products. The contractual partner shall be informed of this. Orders confirmed by DOPPKON shall remain unaffected.

12.3 The contractual partner shall guarantee the traceability of the products by keeping the products delivered by DOPPKON in the incoming goods department by means of lot numbers, taking into account the delivery notes, and by directing them back to its warehouse in a traceable manner. DOPPKON does not carry out any additional lot number labelling, as the user may not be able to differentiate the contractual partner’s product-related lot number from other lot numbers in the event of an incident and thus correctly identify it.

12.4 The contractual partner shall carry out marking and labelling of the products in accordance with all requirements of traceability for medical products which can be dispensed into the CE area.

12.5 The contractual partner may at any time upon request present its declaration of conformity for the products purchased from DOPPKON.

12.6 If the contractual partner becomes aware of a reportable incident (i.e., a serious undesirable event) during the use of DOPPKON products, it shall be obliged to notify DOPPKON immediately in writing. Likewise, the contractual partner shall inform DOPPKON without delay of any product defects and risks which come to its attention when using surgical instruments.

12.7 The contractual partner shall not be permitted to make changes to the product or to repair it itself or to carry out repair attempts.

13. Data, secrecy

13.1 Personal and company-related data obtained in the course of the business relationship will be processed in accordance with the provisions of the Federal Data Protection Act.

13.2 The Purchaser undertakes to treat all aspects of the business relationship worthy of protection as confidential. In particular, he shall treat all commercial and technical details which are not public knowledge, and which become known to him through the business relationship as business secrets. Nicht unter die Geheimhaltungspflicht fallen Informationen oder Aspekte der Geschäftsbeziehung, die zum Zeitpunkt der Bekanntgabe bereits öffentlich bekannt waren sowie solche Informationen oder Aspekte der Geschäftsbeziehung, die dem Vertragspartner bereits nachweislich vor der Bekanntgabe durch uns bekannt waren. The Purchaser shall ensure that his employees are also obliged to maintain secrecy. An obligation to secrecy shall also apply after the end of the business relationship.

14. Final provisions

14.1 Unless expressly provided otherwise, the parties are not entitled to assign, pledge or have collected by third parties any rights or claims arising from this contract without the prior written consent of the other party.

14.2 Both parties shall only be entitled to set-off and to assert a right of retention if the counterclaim used for this purpose is either undisputed or has been legally established.

14.3 Transmission by fax or e-mail shall also suffice to comply with the written form requirement within the meaning of this contract.

15. Place of performance, place of jurisdiction, written form

15.1 The place of performance for payment and delivery is Spaichingen.

15.2 DOPPKON’s registered office in Spaichingen is agreed as the exclusive place of jurisdiction for all disputes arising out of or in connection with these GTC and all business transactions between the Purchaser and DOPPKON. DOPPKON shall also be entitled to bring an action at the Purchaser’s place of business.

15.3 German law shall apply exclusively to all contractual relationships. The provisions of the UN Sales Convention shall not apply.

15.4 Amendments, supplements and subsidiary agreements for the contractual relationship must be made in writing. This shall also apply to the amendment or cancellation of this written form clause. The legal invalidity of individual provisions shall not affect the legal validity of all other provisions.