REGULATORY TERMS AND CONDITIONS OF SALE
THE FOLLOWING TERMS AND CONDITIONS OF SALE ARE HEREBY INCORPORATED BY THIS REFERENCE INTO ANY INVOICE ISSUED BY SELLER TO BUYER AND SHALL GOVERN THE RIGHTS AND OBLIGATIONS OF THE PARTIES WITH RESPECT TO ALL SALES OF PRODUCTS BY SELLER TO BUYER. BUYER, BY ACCEPTING DELIVERY OF THE PRODUCTS DESCRIBED IN INVOICE (THE "PRODUCTS") PRESENTED BY SELLER, ACCEPTS AND AGREES TO ABIDE BY THE TERMS AND CONDITIONS CONTAINED HEREIN. THESE TERMS AND CONDITIONS TAKE PRECEDENCE OVER BUYER'S ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS, TO WHICH NOTICE OF OBJECTION IS HEREBY GIVEN. ACCEPTANCE BY BUYER IS LIMITED TO THESE TERMS AND CONDITIONS. NEITHER SELLER'S COMMENCEMENT OF PERFORMANCE NOR DELIVERY SHALL BE DEEMED OR CONSTITUTED AS ACCEPTANCE OF BUYER'S ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS, INCLUDING ANY TERMS AND CONDITIONS CONTAINED IN BUYER'S PURCHASE ORDER.
Complaints: Purchaser shall provide timely responses to questions posed by customer/patient concerning the Products and shall forward to Company any complaint(s) as soon as possible but at least within five (5) business days from its receipt thereof that relate in any way to the Products including, without limitation, Product failure incidents upon first use, frequent or persistent Product reliability issues or Product performance dissatisfaction expressed by a customer/patient.
Purchaser shall report any serious injury, safety incident, malfunction that is likely to cause serious injury or reportable field action immediately.
Corrective Actions: Purchaser agrees to participate in and cooperate with the Seller for any recalls of the Product at the Sellers expense.
Records: Purchaser shall establish and maintain a system for recording and maintaining the following information with respect to each Product sold by the Seller, if applicable depending on Product: Product serial/lot number, Product model/part number, date of purchase, and name and address of the Purchaser.
The information recorded with respect to any Product shall be maintained for the greater of (i) the life of the Product as established by the Company; or (ii) in the event the Company does not publish a Product life, for 10 years; or (iii) as otherwise required by local law.
Purchaser shall deliver a copy of all such information to Seller at no charge. Purchaser agrees to return all records listed in this Section if Seller dissolves.
Products and technical data supplied by Seller are subject to export laws and regulations.
Purchaser certifies that he/she will comply with all applicable laws, regulations, restrictions and economic sanctions regarding exports, re-exports and transfers, (especially the prohibition against doing business with certain foreign countries, entities and individuals), including rules established by the U.S. Bureau of Industry and Security (BIS), the Directorate of Defense Trade Controls (DTC), the Office of Foreign Asset Controls (OFAC), the Bureau of Customs and Border Protection, and the Departments of Defense and Homeland Security, and any governmental authority in the Territory, including obtaining any required U.S. or other country licenses, authorizations, or approvals.
Purchaser certifies that he/she will not directly or indirectly ship or sell Products to customers in Syria, Cuba, N. Korea, Iran, Sudan, Crimea or otherwise listed on the current United States Department of Commerce Denied Persons List.