Terms and Conditions of Sale or Service

adeor medical AG (Germany, Headquarters)

February 2022

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.

 

Terms and Conditions of Sale or Service

adeor medical USA INC. (USA, Subsidiary)

July 2024

1 General
These terms and conditions shall form the basis for all commercial transactions between adeor medical USA INC. (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 of the products are those prices specified on the quotation from ADEOR or, if no quotation was given, the front of the invoice from ADEOR. 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. Pricing for undelivered Products may be increased in the event of an increase in ADEOR’s cost, changes in market conditions, or any other causes beyond ADEOR’s reasonable control. Price quotations shall automatically expire in ninety (90) days from the date issued, or as otherwise stated in the quotation from ADEOR.

3 Taxes
Prices are subject to applicable taxes. Unless otherwise agreed to in writing by ADEOR, all prices quoted are exclusive of transportation and insurance costs, duties, and all taxes, including federal, state, and local sales, excise, and value added, goods and services taxes, and any other taxes. ADEOR is not liable for any tax in connection with the sale, as well as the collection or withholding thereof, including penalties and interest thereon. When applicable, transportation and taxes shall appear as separate items on ADEOR’s invoice.

4 Payment terms & title retention
Payment terms for all orders are Net 30, 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, in accordance with the laws of the United States. 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. Payment may be made by check, money order, ACH or wire transfer (all fees are borne by the customer). Where adeor has extended credit to any past due invoice, ADEOR may impose interest at the rate of one and a half percent [1.5%] per month or the maximum legal contract interest rate, whichever is less. If the customer fails to make a payment when it is due, ADEOR reserves the right to change or withdraw credit and thereby suspend or cancel performance under any or all purchase orders or agreements between the parties. In the event of default by Customer, ADEOR shall be entitled to costs, fees, and expenses, including but not limited to recovery of attorney fees, court costs and fees, and collection costs.

5 Delivery and Title
All deliveries will be made "EX WORKS“ (EXW), place of shipment. Title and risk of loss pass to the customer upon delivery of the product to the carrier. 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 many 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. 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 to make partial deliveries.

6 General obligations of Distributors of Medical Devices 
The obligations of distributors described below apply whenever the customer assumes the role of a distributor. When making a device available on the market, the distributor shall act with due care. Where the distributor considers or has reason to believe that a device is not in conformity with the manufacturer’s specifications, the distributor shall not make the device available on the market until it has been brought into conformity and shall inform ADEOR without delay. 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. 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: Temperature: -20 °C bis +55 °C, and 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. 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. 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. 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.

7 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. Save as expressly provided in these terms and conditions, all implied warranties, terms and conditions (whether statutory or otherwise) are excluded to the fullest extent permitted by law. In particular, ADEOR makes no warranty respecting the merchantability of the products or their suitability or fitness for any particular purpose, non-infringement of third party rights and warranties against latent defects.

8 Limitation of Liabilities
Customer shall not be entitled to, and ADEOR shall not be liable for, loss of profits or revenue, promotional or manufacturing expenses, overhead, business interruption cost, loss of data, removal or reinstallation costs, injury to reputation or loss of customers, punitive damages, ipr infringement, loss of contracts or orders or any indirect, special, incidental or consequential damages of any nature. Customers recovery from ADEOR for any claim shall not exceed the purchase price paid for the affected products irrespective of the nature of the claim whether in contract, tort, warranty, or otherwise. Customer will indemnify, defend and hold ADEOR harmless from any claims based on ADEOR’s compliance with customer’s designs, specifications, or instructions, modification of any products by anyone other than adeor, or use in combination with other products.

9 Use of Products
Unless otherwise noted, products sold by ADEOR are designed to be used for the intended use in the FDA approved labeling. Any intended use not in the FDA approved labeling is at customer’s sole risk. ADEOR is not liable, in whole or in part, for any claim or damage arising from such unintended use. Customer. Customer will indemnify, defend and hold ADEOR harmless from and against any and all claims, damages, losses, costs, expenses and liabilities arising out of or in connection with such use or sale.

10 Force Majeure
ADEOR is not liable for failure to fulfill its obligations for any accepted order or for delays in delivery due to causes beyond ADEOR’s reasonable control including, but not limited to, acts of God, natural or artificial disaster, riot, war, strike, delay by carrier, shortage of product, acts or omissions of other parties, acts or omissions of civil or military authority, government priorities, changes in law, material shortages, fire, strikes, floods, epidemics, quarantine restrictions, acts of terrorism, delays in transportation or inability to obtain labor, materials or products through its regular sources, which shall be considered as an event of force majeure excusing ADEOR from performance and barring remedies for non-performance. In an event of force majeure condition, ADEOR’s time for performance shall be extended for a period equal to the time lost as a consequence of the force majeure condition without subjecting ADEOR to any liability or penalty. ADEOR may, at its option, cancel the remaining performance, without any liability or penalty, by giving notice of such cancellation to the customer.

11 Returns
Only products originally shipped from ADEOR or from an authorized supplier (drop-ship) will be considered for return to ADEOR. A Return Material Authorization (RMA) must be requested within 90 days of ship date. Customer requesting return of products to ADEOR, must certify that the products were purchased from ADEOR and there has been no substitution of the product from another supplier, distributor or other source of the product. Any return must be in the original unopened packaging, unused, and re-sellable, except if approved for failure analysis/warranty evaluation by ADEOR.

12 Exchanges
Any item for exchange must be in new condition, in the original unopened packaging, unused, and re-sellable. Exchanges must be requested within 30 days of ship date. Defective item(s) may be exchanged/returned for the same item. Items purchased from ADEOR that have been used or altered and any items that have been sold as non-returnable will not be accepted for exchange.

13 Refunds
Upon receipt and inspection of returned item(s), ADEOR will advise of the refund status. In the case of factory warranty or failure analysis, ADEOR will issue any applicable credit pending confirmation of warranty or failure analysis. ADEOR initiates credits via the original method of payment within 5 business days of approval. Refunds via credit card can take up to 10 business days to post to the account.

14 How to Return Product to ADEOR
Any return requires a Return Material Authorization (RMA) number. Any RMA is issued for a valid reason only. To obtain an RMA, contact ADEOR within 30 days of ship date of item(s) by calling (219) 361-1020, or by email to usa@adeor.com. Once the RMA number is received, item must be returned within 14 days. ADEOR will provide the Customer with specific instructions on where to mail / return item(s) with the RMA number. The Customer must sign and include the signed RMA in the return package stating the reason for the return and the original receipt.

15 Jurisdiction
Place of Jurisdiction is Lake County, Indiana, and all commercial transactions between ADEOR and the customer shall be governed by the laws of the State of Indiana. Customer may not assign these terms and conditions without the prior written consent of ADEOR. ADEOR or its affiliates may perform the obligations under these terms and conditions. These terms and conditions are binding on successor and assigns, products, including software or other intellectual property, are subject to any applicable rights of third parties, such as patents, copyrights and/or user licenses.

16 Confidentiality
Pricing set forth in ADEOR’s quotation and invoice is the confidential and proprietary information of ADEOR and shall not be disclosed by Customer to any third party, including, without limitation, posted on any on-line discounting websites or forums or disclosed to ADEOR competitors. Customer must remove any "Protected Health Information" ("PHI") as defined in the Health Insurance Portability and Accountability Act of 1996 from any items to be sent to ADEOR. Although ADEOR will make reasonably commercial efforts to secure any PHI encountered, ADEOR is not responsible for the security thereof. All medical information and/or data concerning specific patients (including, but not limited to, the identity of the patients), derived from or obtained during the course of the business, shall be treated by ADEOR and the customer as confidential so as to comply with all applicable state and federal laws and regulations regarding confidentiality of patient records, and shall not be released, disclosed, or published to any party other than as required or permitted under applicable laws.

17 Safe Medical Device Act
If customer files with the Federal Food and Drug Administration an FDA Form 3500A or a similar form or medical device report under the Federal Safe Medical Device Act, with respect to ADEOR products or any part of ADEOR products, then customer shall simultaneously furnish to ADEOR a copy of the form or report. If ADEOR recalls products or a part of a product, then customer shall cooperate fully with ADEOR in implementing the recall, including, without limitation, by returning the Products to ADEOR to the extent that ADEOR requests.

18 Proper Reporting of Discounts and Pricing
These terms and conditions comply with the Medicare/Medicaid "Anti-Kickback “statute" (42 U.S.C. 1320a-7b) and regulations promulgated thereunder, and do not in any manner violate either statute or regulation. Notwithstanding any unanticipated effect of any of the provisions herein, neither ADEOR or customer will conduct itself in a manner so as to constitute a violation of the Anti-Kickback Statute or the Advanced Code of Ethics. Under no circumstances shall these terms and conditions be intended in any manner to compensate for or require referrals or business of any kind between ADEOR and the customer. No compensation shall be paid by ADEOR or the customer to the other in connection with these terms and conditions except payment (including discounts, credits and rebates) for product purchases. Customer shall comply with all applicable laws and regulations relating to the accounting and application of discounts related to these terms and conditions, including but not limited to all Federal and State laws and regulations regarding reimbursement and proper reporting of discounting and pricing, such as the requirements of the discount "safe harbor" located at 42 C.F.R. 1001.952(h) (the "Discount “Safe Harbor"). Customer shall properly report and appropriately reflect all prices paid under these terms and conditions net of all discounts as required by law or contract, including on all applicable Medicare, Medicaid and state agency cost reports. Customer shall retain a copy of these terms and conditions and all other communications regarding these terms and conditions, together with the invoices for purchases or lease and shall permit agents of the U.S. Department of Health and Human Services or any state agency access to such records upon request.

19 Insurance
ADEOR will maintain adequate general liability insurance, including coverage for products and completed operations, and workers compensation and employers liability insurance against any claim or claims which might arise out of products purchased by customer from ADEOR. ADEOR has the right to self-fund to comply with this requirement. When requested by customer, ADEOR will furnish an insurance certificate signed by an authorized agent evidencing the above-referenced insurance coverage, excluding those elements which may be self-funded. Customer shall maintain adequate insurance to cover liability arising out of these terms and conditions, including liability arising out of customer’s indemnity obligations set forth hereinabove. Upon request by ADEOR, customer will provide a certificate of insurance evidencing such coverage.

20 No Third-Party Beneficiaries
The rights and remedies conferred under these terms and conditions apply only to ADEOR and the customer, and shall not be construed to inure to the benefit of or provide any right of action to any other person, including without limitation any patient or third-party payor.

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

22 Entire Agreement
These terms and conditions, and a quotation, if supplied, contain the entire terms and conditions between the parties relating to the subject matter hereof and supersedes all oral statements and prior writings with respect thereto. These terms and conditions may not be amended or modified by ADEOR.