of the ASSKEA GmbH – as of 12 December 2022

These general terms and conditions (AGB) apply to all quotations and order acceptances as well as to all deliveries by ASSKEA. They shall also apply to all future business relationships between ASSKEA and the purchaser without the need for any further reference. Other conditions than these do not apply, in particular the purchasing conditions of the purchaser, even if they are not expressly separately rejected; ASSKEA hereby expressly rejects such conditions.

Upon acceptance of the order confirmation by ASSKEA, the purchaser shall waive the application of his terms and conditions, even if these claim exclusivity. Verbal agreements or assurances shall be invalid without our written confirmation.

To the extent that these sales conditions do not include any deviating provisions, the general conditions for the supply of electrical and electronic products and services shall apply.

Quotation and order confirmation
Our quotations are non-binding unless otherwise stated in our order confirmation. Verbal or written orders are deemed to be accepted with the issue of the written order confirmation or with the delivery of the ordered goods within a reasonable time frame. Every order must include accurate information about all the details of our products. We shall not assume liability for faults and damages, which occur due to inaccurate or incomplete ordering details.

We shall also reserve property and copyright rights to cost estimates, drawings and other documentation. The purchaser may not make these available to third-parties. Samples, patterns, verbal instructions, recommendations and other documents and information about the products, such as photocopies, drawings, dimensions and weights etc. are only valid as a benchmark and are not binding, unless an expressly written assurance or guarantee was issued.

Prices and payment terms
Unless otherwise stated in the order confirmation, our prices are to be understood as ex works, excluding packaging and value added tax. Packaging will be charged separately on the invoice and VAT will be shown separately at the statutory amount on the day of the invoice.

Unless otherwise stated in the order confirmation, our invoices shall be due for payment net cash within 30 days from the invoice date. We shall be entitled to charge interest on late payments at the amount of 2 percentage points above the respective base interest rate. If the customer is in payment default, we shall be entitled to demand default interest of 8 percentage points above the respective base interest rate.

Delivery time
Time periods and deadlines are in principle non-binding, unless they have been expressly confirmed by us as binding in the order confirmation.

In case of force majeure, operational disturbances, shortage of workers, energy or raw materials, strikes or other types of incidents for which we are not responsible, the delivery date shall be postponed by the duration of the disruption and its effects. If the delivery period is exceeded by more than two months, the purchaser may withdraw from the contract with the exclusion of all other claims. However, to do this, the purchaser must have previously set a reasonable grace period for us to deliver.

The purchaser is in no case entitled to make backup purchases or to assert any other claims for damages or other claims due to non-fulfilment or delay in delivery against us, unless gross negligence or intent applies to us. Partial deliveries and partial service provision are permitted on our part.

Delivery and briefing
With the delivery of technical medical products by ASSKEA or a specialist medical supplier, the end customer must receive a briefing by an authorized company or an authorized person.

Our customers maintain a registration system so that, if required, they can trace our products to the individual user. They shall commit to immediately notify any reportable incidents and risks in relation to our products by e-mail to .

Unless otherwise agreed, the purchaser shall be responsible for the observance of statutory and official regulations relating to importing, transportation, storage and usage of the goods.

Retention of title
All deliveries shall be made subject to retention of title. The delivered goods shall remain our property until the full payment of all claims – including balance claims in a current account agreement – from the business relationship, regardless of the legal cause, including all ancillary claims (if paid by cheque or bill of exchange up to their redemption). The purchaser may neither pledge nor assign as security the goods subject to retention of title. The purchaser must inform us in writing immediately of any third-party accesses to the goods delivered subject to retention of title. If the purchaser falls into payment default with us, we shall be entitled to take back the goods subject to retention of title and to access the premises for this purpose.

The purchaser shall be entitled to sell the goods in the ordinary course of business. For our security he shall today assign to us all receivables against the acquirer from the resale. The purchaser shall be authorized and shall commit to collect the receivable as long as we do not revoke this authorization. The direct debit authorization of the purchaser shall expire without any express statement by us, if the purchaser discontinues his payments. We shall not use our collection rights, if the purchaser complies with his payment obligations.

If the purchaser rents or leases the goods subject to retention of title in the ordinary course of business or if he permits usage of the goods subject to retention of title in any other way to third-parties against payment, temporarily or permanently, the aforementioned rule regarding a usage fee shall apply accordingly.

The purchaser shall be entitled, within the framework of normal business operations, to combine the goods subject to retention of title with third-party goods; in this case we shall acquire co-ownership of the new item resulting from such combination in proportion to the value of the combined or newly manufactured item according to § 947 IBGB (Book 1 of the German Civil Code). If the purchaser sells the combined or newly manufactured goods, in which we have co-ownership, the purchaser shall assign his purchase price claim in relation to his customers in proportion to the value of our co-ownership to us as collateral and shall hereby authorize us to collect the receivable in our own name.

If the value of the collateral exceeds any receivables still outstanding by more than 20%, on the request of the purchaser we shall release the excess amount of the collateral.

Transfer of risk – packaging
Unless otherwise agreed in our order confirmation, delivery is agreed as ex works. The risk of damage or loss of the goods shall therefore be transferred to the customer as soon as the goods have left our plant or if the customer is in default of acceptance. This shall also apply in cases where we confirm carriage paid delivery.

No transportation or other packaging, in accordance with the Packaging Ordinance, shall be taken back. Our customer shall undertake to dispose of the packaging at his own expense.

Our deliveries will be insured by us at the cost of the customer, unless explicitly agreed otherwise. There is no insurance, if the customers collect the goods themselves.

Complaint claims due to transportation damage will only be processed, if prior to acceptance of the delivery, the customer has the damage, short weights and losses confirmed by the transportation company and informs us immediately.

Defect liability
The customer shall undertake to examine the product immediately after delivery and notify us at once in writing of any defects or supply errors. If the customer complies with this duty to examine and complain, we shall be liable for defects in accordance with the statutory provisions.

The statute of limitations for defect claims for used devices is 1 year.

The pre-requisite for our defect liability is that our customer can provide proof of purchase (via an invoice or delivery note) and that the unchanged serial number can still be seen on our product.

The following shall also apply to our defect liability:

– In any supplementary performance, our provision shall, at our discretion, either be a free repair – either at the customer site or in the factory – or the exchange of the product. We are also entitled to have the supplementary performance provided by a company authorized for this purpose.
– In the event of a return, the customer must return the product to us or to another address notified by us in the original packaging or in another packaging unit offering equivalent protection.

– Our defect liability shall cease to apply, if changes in whatever form have been made to our product, unless the change was carried out by us or by a company authorized by us or we agreed in advance in writing to the change. Equally there shall be no defect liability claims, if repairs have been carried out on our product by third parties or if parts have been exchanged. This shall apply irrespectively of whether these measures individually or taken together, were the cause of a defect.

– Our liability shall cease to apply to defects due to:
– operational or usual wear and tear;
– defective installation or defective or inadequate maintenance;
– improper use or handling errors (contrary to the supplied instruction for use);
– improper or negligent handling and upkeep, in particular dirt, calcification, ingress of fluids, improper cleaning, disinfection or sterilisation;
– use of accessories and/or spare parts, which are not explicitly authorized by us;
– defective assembly or commissioning by customers or third parties;
– customer negligence when handling the product;
– inadmissible operating conditions, in particular due to moisture, temperature, power connections or power supply, vibrations, inadequate ventilation;
– accidents, force majeure or other causes for which we are not responsible, in particular lightning strikes, water, fire, public disorder.

We shall not assume liability for defect-related damages, which do not occur on our products themselves, with the exception of intent or gross negligence including intent and gross negligence of our representatives and vicarious agents. If no intentional contractual infringement is being blamed on us, our compensation liability shall be restricted to foreseeable damages that typically occur. The same shall apply, if we culpably infringe an essential contractual obligation.

The above limitations of liability shall not apply, if a defect was fraudulently concealed by us, if we have provided a guarantee for the quality of the item or if a defect has led to an injury to life, limb or health.

The mandatory regulations of the Product Liability Act remain unaffected.

Distributor obligations under MDR 2017/745
Within the scope of these General Terms and Conditions (GTC), we take the position of a manufacturer for the medical devices according to Article 2 No. 30 of Regulation (EU) 2017/745 and the contractual partner as orderer takes the position of a distributor according to Article 2 No. 34 of the Regulation (EU) 2017/745.

The customer undertakes to comply with the distributor obligations addressed to him as a distributor in accordance with Article 14 of Regulation (EU) 2017/745.

The customer and we work together to ensure the traceability of the goods.

In accordance with Article 25 (2) of Regulation (EU) 2017/745, the customer undertakes to ensure that he can provide the competent authority with information at any time for a period of ten years after he has delivered the last goods from whom he received the goods or to whom he gave the goods. In this respect, the customer undertakes to set up and document a suitable procedure for this provision of information.

The customer undertakes to properly dispose of the documentation suitable for the provision of information after the ten years mentioned have expired.

The customer undertakes to document all experiences and knowledge about the goods, including observed trends, and all complaints or reports received about suspected events in connection with the goods and to keep this documentation for a period of ten years. In this respect, the customer undertakes to set up and document a suitable procedure for receiving such experiences, findings, complaints or reports about the goods and for their documentation and to keep this documentation up to date.

The customer undertakes to pass on to us without delay all experience and knowledge about the goods, including trends to be observed, and all complaints or reports received about suspected events in connection with the goods.

In the case of suspected serious incidents according to Article 2 No. 64 of Regulation (EU) 2017/745, the forwarding must take place by e-mail to .

The customer undertakes to obtain written approval of these advertising materials from us before using specially created advertising materials and in the event of subsequent changes. The customer undertakes to comply with the obligations of this section even if he has ceased operations before the end of the ten years mentioned or if insolvency proceedings are opened against him.

Place of performance and court of jurisdiction
The place of performance and court of jurisdiction for deliveries and payments and for all disputes arising directly or indirectly from the contractual relationship shall be Gebesee.

Material law of the Federal Republic of Germany shall apply exclusively; the regulations of the United Nations Convention on Contracts for the International Sale of Goods (CISG) shall not apply.

If individual parts of these conditions are or become legally invalid, then the validity of the remaining parts of the general terms and conditions shall not be affected.