Common use of RECORDS AND TRACEABILITY Clause in Contracts

RECORDS AND TRACEABILITY. Manufacturer hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain complete and accurate records of the FDA Tracking Information for all Products, and all components thereof, that are manufactured and sold under this Agreement, to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws. Purchaser hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain the FDA Tracking Information regarding the sale of all Products manufactured for it by Manufacturer hereunder to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws in the Territory. The Parties agree to provide each other with reasonable access to and copies of such records and information in the event of any Recall or other similar event involving the Products described in Section 9.2 or as necessary for any compliance with Applicable Laws. In furtherance and not in limitation of the foregoing, upon reasonable prior written notice from Manufacturer, Purchaser shall provide to Manufacturer the FDA Tracking Information at the end of each calendar month (or earlier if required by relevant Applicable Law) if, and for so long as, the provision of such FDA Tracking Information has become mandatory under Applicable Law.

RECORDS AND TRACEABILITY. Manufacturer hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain complete and accurate records of the FDA Tracking Information for all Products, and all components thereof, that are manufactured and sold under this Agreement, to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws. Purchaser hereby covenants and agrees that for a minimum period of fifteen (15) years after the sale and purchase of any Product hereunder, it shall maintain the FDA Tracking Information regarding the sale of all Products manufactured for it by Manufacturer hereunder to the extent necessary to meet or exceed all applicable FDA requirements and other Applicable Laws in the TerritoryTerritory and, in the event of a dissolution or liquidation of Purchaser, Purchaser shall transfer such FDA Tracking Information to Manufacturer. The Parties agree to provide each other with reasonable access to and copies of such records and information in the event of any Recall or other similar event involving the Products described in Section 9.2 or as necessary for any compliance with Applicable Laws. In furtherance and not in limitation of the foregoing, upon reasonable prior written notice from Manufacturer, Purchaser shall provide to Manufacturer the FDA Tracking Information at the end of each calendar month (or earlier if required by relevant Applicable Law) if, and for so long as, the provision of such FDA Tracking Information has become mandatory under Applicable Law.