Terms and Conditions

1 General
These terms and conditions shall form the basis for all commercial transactions between adeor medical AG (ADEOR) and its customers. General conditions of purchase published by the customer, as well as any other conditions shall only be binding, if specifically accepted in writing by ADEOR.

2 Pricing & Orders
The prices quoted by ADEOR are without obligation and subject to change. ADEOR reserves the right to implement reasonable technical changes at any time. Submission of the order by the customer, either by signing and returning a quotation from ADEOR or by submitting a separate order, shall represent a legally binding offer of contract. The contract shall only be considered to be concluded, once ADEOR has issued an order confirmation or, alternatively, has shipped the ordered goods or fulfilled the ordered services. Only the content of the order confirmation issued by ADEOR shall be binding for ADEOR.

3 Payment terms & title retention
Payment terms for all international orders are payment prior to dispatch unless a variation is stated on the ADEOR order confirmation or agreed between ADEOR and the customer in writing. Payment for invoices must be made in full by the due date. Installments will only be accepted if ADEOR has agreed to them in writing. Transaction costs, including bank fees, are the responsibility of the customer. ADEOR reserves the right to charge late penalty fees and interest for overdue payments within the scope of the German law. ADEOR only accepts offsetting of claims by the customer if these claims have been accepted by ADEOR in writing or are legally valid. The ownership of any goods delivered by ADEOR only passes to the customer once payment has been made in full.

4 Delivery & Returns
ADEOR will endeavor to deliver any goods by the date specified in the order confirmation, however no guarantee is provided in regards to delivery dates or times. Delivery times are non-binding as goods are manufactured specifically for the customer. If a delay is inevitable, ADEOR shall inform the customer about the delay, stating a new delivery date. ADEOR is not liable for slight and medium negligence. ADEOR is responsible for arranging the shipment of goods ordered by the customer, unless the customer requests to arrange shipping directly. The risk passes from ADEOR to the customer with the receipt of the goods. Any complaints by the customer in relation to any goods delivered by ADEOR must be made by the customer in writing within 5 days of the receipt of the goods. ADEOR reserves the right of part-deliveries.

5 Warranty
ADEOR provides a manufacturer warranty of 2 years for any material or manufacturing defects. Excluded from the warranty are all used goods, goods for a demonstration purpose as well as consumables. In the case of any valid warranty claims, ADEOR reserves the right to either repair the goods or to provide the customer with a replacement. These terms represent the full scope of the warranty provided by ADEOR. ADEOR is not liable for damages sustained to property other than the ADEOR goods themselves. ADEOR is also not liable for loss of profit or any other financial loss of the customer. The liability for consequential damages is limited to foreseeable damages.

6 Jurisdiction
Place of Jurisdiction is Munich, Germany and all commercial transactions between ADEOR and the customer shall be governed by German law with the exclusion of the UN Convention on Contracts for the International Sale of Goods.

7 General obligations of distributors under regulation (EU) 2017/745 on medical devices (MDR)
ADEOR takes the role of a manufacturer according to Regulation (EU) 2017/745 or Directive 93/42/EEC for medical devices. The obligations of distributors described below apply whenever the customer assumes the role of a distributor under Regulation (EU) 2017/745. The distributor commits to comply with the obligations of distributors according to Art. 14 Regulation (EU) 2017/745. When making a device available on the market, the distributor shall act with due care in relation to the requirements applicable (article 14, paragraph 1). Where the distributor considers or has reason to believe that a device is not in conformity with the requirements of  regulation (EU) 2017/745 (article 14, paragraph 2), the distributor shall not make the device available on the market until it has been brought into conformity and shall inform ADEOR without delay (article 14, paragraph 2). The distributor shall co-operate with ADEOR and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken (article 14, paragraph 4). The customer/distributor shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the following conditions set by ADEOR (article 14, paragraph 3):
- Temperature: -20 °C bis +55 °C
- Humidity: < 80 % RH
Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to ADEOR. Distributors shall keep a register of complaints, of non-conforming devices as well as of recalls and withdrawals and keep ADEOR informed of such monitoring and provide them with any information upon ADEOR’s request (article 14, paragraph 5). The distributor shall, upon request by a competent authority, provide the authority with all the information and documentation that is at the customer’s disposal and is necessary to demonstrate the conformity of a device (article 14, paragraph 6). The distributor shall cooperate with ADEOR to achieve an appropriate level of traceability of devices for 10 years and, in the case of implantable medical devices, 15 years after the last device was placed on the market (article 25). These obligations continue to apply even after the distributor has ceased operations or insolvency proceedings have been initiated against the customer. In case the devices in question are classified as Class III implantable devices, the following obligation applies. The customer/distributor shall record and store, preferably electronically, the UDI of the devices that it has supplied or obtained (article 27, paragraph 8 and 9).

8 Other
If any part or clause of this agreement is or becomes illegal, invalid or unenforceable, the validity or enforceability of the remainder of these general sales conditions shall not be affected.

February 2022