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E. HAHNENKRATT GmbH General Terms and Conditions
Rev.: 2021-02 

1. Scope

1.1. E. HAHNENKRATT GmbH, Benzstr. 19, 75203 Königsbach-Stein (hereinafter “HAHNENKRATT”) enters into contracts with, and performs a contract for, other businesses, corporate bodies under public law or special funds under public law (hereinafter called “Customer”) exclusively under these General Terms and Conditions, valid at the time the order is placed.

1.2. MDR (EU) 2017/745: Companies that conclude purchase contracts with us and are located in the EU must comply with the obligations and requirements of MDR (EU) 2017/745 from 26 May 2021; amongst others with regard to post-market surveillance (e.g. MDR Art. 14 + 25).

1.3. Unless prior written consent has been obtained from HAHNENKRATT, any conflicting or supplementary terms and conditions of the Customer shall not become part of the contract, even if HAHNENKRATT should perform a contract or render a service without expressly rejecting such terms and conditions. These General Terms and Conditions shall also apply to any future contract, even if not referred to specifically by HAHNENKRATT in every single case.

1.4. Any contractual guarantees and commitments, especially if beyond these General Terms and Conditions, shall need to be expressly confirmed in writing by HAHNENKRATT to be valid.

2. Offers, Prices

2.1 Unless specified as a firm offer, any offer made by HAHNENKRATT shall be subject to confirmation and is not binding. The order confirmation by HAHNENKRATT is relevant for the purchase order and unless the Customer disagrees immediately in the event of any objection, the contract shall be governed by the order confirmation.

2.2. Governing prices are those quoted in the order confirmation or, insofar as no order confirmation is given, the prices of the valid price list at the given time. All prices quoted are net prices plus VAT at the given valid rate, except in the case of VAT-exempt sales. Prices are quoted ex works and exclusive of any packaging, freight, postage, insurance, customs duties and any other expenses.

3. Deliveries

3.1. Shipment and transportation of the goods shall be at the Customer´s cost and risk. HAHNENKRATT shall have the right to choose the means of transport or, alternatively, the Customer may in advance agree with HAHNENKRATT on the transport or make its own arrangements. Any damage in transit is to be notified to the carrier and to HAHNENKRATT immediately, as soon as the damage is detectable.

3.2. Delivery dates are quoted ex works. The quoted delivery date is no fix date, unless HAHNENKRATT confirms this in writing. Any event of delayed delivery independent of negligence of HAHNENKRATT shall entitle HAHNENKRATT to extend the time for delivery by a reasonable period or to withdraw in part or in full from its delivery commitment.

4. Payment

4.1. Payments shall be made in compliance with the terms of payment and credit specified on the invoice. In the event of any payment not made when due, HAHNENKRATT shall be entitled to charge interest on arrears at the rate laid down in Section 288 BGB (German Civil Code). Any payment by cheque shall not be deemed a payment made until irrevocably credited to the account of HAHNENRKATT.

4.2. The Customer may not set any payment off against any claim, unless such claim is undisputed or based on final court decision. The Customer shall have no right to defer payment or set up any defense of lack of performance of the contract beyond the given contractual relationship.

5. Retention of Title

Ownership of the goods supplied shall remain vested in HAHNENKRATT until the purchase price has been paid in full. The Customer is to notify HAHNENKRATT forthwith in the event of any seizure by a third party, especially in the event of any garnishment and confiscation. Such third party is to be made aware of the title retention forthwith.

6. Warranty and Liability

6.1. The Customer shall assume responsibility for any infringement of third party proprietary rights by any products made to drawings, samples or other specifications provided by the Customer.

6.2. In accordance with its obligation to report any defect under Section 377 HGB (German Commercial Code) the Customer is to inspect the goods immediately upon receipt and notify HAHNENKRATT in writing of any detectable defect without delay. Any hidden defects shall be reported to HAHNENKRATT immediately upon their detection otherwise these shall be deemed accepted.

6.3. In the case of any defect quality HAHNENKRATT may at its discretion provide a new replacement free of any defect, or it may rectify the defect detected, before the Customer may assert any other right under Sections 434ff BGB. HAHNENKRATT shall in such case take receipt of any used goods returned in sterilised condition only, because of the infection risk involved. Should the Customer intend that the inconclusive expiration of a period of grace or a final deadline set by the Customer, results in the cancellation of the contract or a reduction of the remuneration, this consequence shall be expressly threatened by the Customer in writing when setting the grace period or deadline. The deadline shall be set so that it allows HAHNENKRATT at least two attempts at rectification.

6.4. The warranty period is 12 months from the date of delivery, provided it is not a case under item 6.6., in which case the statutory limitation shall be applicable.

6.5. HAHNENKRATT shall be liable in full for any damage caused intentionally or by gross negligence, for any fraudulently concealed defect, for any injury to life and limb or health, under the Product Liability Act and within the framework of any guaranty assumed by HAHNENKRATT.

6.6. In the event that it should fail to comply with any obligation which is essential for achieving the contractual purpose, HAHNENKRATT shall be liable in any case of slight negligence to the extent that the damage has been predictable and typical given the nature of the transaction concerned, liability for each event of loss being limited to €10,000 maximum.

6.7. HAHNENKRATT shall not accept any liability whatsoever beyond the foregoing.

6.8. The above limitation of liability shall also apply to any personal liability of any employees, agents, representatives and executive bodies of HAHNENKRATT.

7. Traceability by batch number

7.1 HAHNENKRATT maintains a certified quality management system according to EN ISO 13485. To ensure the traceability for a recall of medical devices according to RL 93/42/EWG and MDR (EU) 2017:745, the Customer has to comply with the requirements of MDR (EU) 2017:745 and – amongst others – to manage and maintain the batch numbers (LOT) to ensure the traceability in the supply chain to the user.

Download available in all EU-languages:
7.2 Batch traceability – The following must be observed for our root posts:

EN ISO 13485 (2021-12) Special requirements for implantable medicinal products

The records required for traceability must comprise records of components, materials and conditions of the working environment used if these might lead to the fact that the medicinal product does not meet its specified safety and performance requirements.

The organisation must request that providers of distribution services or distribution partners maintain records regarding the delivery of medicinal products, which enable traceability and that these records are kept available for inspection.

The records maintained must list details of the name and address of the intended recipient of the packaging for shipping, see 4.2.5:

EN ISO 13485 (2021-12)

4.2.5 Control of records

Records must be maintained to provide proof of conformity to requirements and of the effective functioning of the quality management system.
The organisation must establish a documented procedure to define the control measures required for the identification, storage, protection, integrity, retrievability, archiving period and availability of records.

In compliance with applicable regulatory requirements, the organisation must determine and implement methods for the protection of confidential health information contained in the records.
Records must remain legible and easy to identify and retrieve. Any amendments made to records must remain identifiable.

The organisation must keep the records at least for the lifetime of the medicinal product defined by the organisation, or as determined by the applicable regulatory requirements, but at least for 2 years from the date of release of the medicinal product by the organisation.

8. Conclusion

8.1. The governing law shall be the law of the Federal Republic of Germany, while the UN Sales Convention and the conflict of laws provisions shall be excluded.

8.2. The place of the registered office of HAHNENKRATT shall be the place of delivery and the exclusive legal venue. However, HAHNENKRATT may at its discretion choose for any court action the general jurisdiction of the Customer.

8.3. These General Terms and Conditions shall remain in effect and binding even if individual items should prove to be legally invalid. 

8.4. This document only contains a translation of the German version of the General terms and conditions of HAHNENKRATT, whereas the German version shall prevail, also in terms of interpreting the wording as used.The German version is available on or will be sent to the Customer on request.

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