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 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.
RECORDS AND TRACEABILITY. 1.19 If the validity of the agreement with MOTUS GI Medical Technologies Ltd expires, the supplier agrees to transfer to MOTUS GI Medical Technologies Ltd all records related to the company orders at least the last seven years. The agreement scope is listed bellow: Material / service description: Manufacturing of finished disposable Oversleevcs, Work station Connectors, including all packaging, labeling and shipping. Finished good lot packages to be provided & approved to MOTUS GI prior to release I shipping. This supplier Quality agreement has been signed by: for MOTUS GI Medical Technologies Ltd for Polyzen (supplier) By: Mado Otzri By: Jxxx Xxxxxxx Job Description: QA Director Job Description: Director of Quality Date: 4-Jul-2017 Date: 3-Jul-2017 Signature: /s/ Mado Otzri Signature: /s/ Jxxx Xxxxxxx This document is property of MOTUS Gl Medical Technologies LTD, its contents are CONFIDENTIAL and shall not be disclosed, disseminated, copied or used, without a written permission. Exhibit C Price and Suppliers Polyzen Sleeve Assembly Component: Sleeve Assembly Supplier: Polyzen Motus Part Number Volume / Capacity Price ASM100016 * sleeve assemblies per week $ * / sleeve Pricing as of October 2016 Other Polyzen Components Component: Leaf Seals Supplier: Polyzen Motus Part Number Description Quantity Per Device Volume / Capacity Price Leaf Seals – * * Leaf Seals – * * Polyzen Sourced Components Pricing Methodology for Sourced Components: Polyzen will provide open-book pricing on all sourced components, provided that Polyzen charge a mxxx-up all sourced components by * % to account for purchasing, incoming inspection / quality, and supplier management costs. ● Component: Injection Molded Parts Supplier: Medacys Address: C6, Mingzhuo Industrial Park, Guangming New District, Shenzhen, Guangdong, China 518107 Note: Pricing is based on validations being complete. Thus, any additional inspections will be charged as a separate line item. Price Breaks Motus Part Number Rev Part Description Quantity Per Device MOQ = 1,000 2,000 5,000 ASM100003 A * 2 $ * $ * $ * ASM100043 N/A * 1 $ * $ * $ * AXX000000 A * 1 $ * $ * $ * 10,000 50,000 100,000 ASM100003 A * 2 $ * $ * $ * ASM100043 N/A * 1 $ * $ * $ * AXX000000 A * 1 $ * $ * $ * Price Breaks Motus Part Number Rev Part Description Quantity Per Device MOQ = 1,000 2,000 5,000 MFR000388 A * 1 $ * $ * $ * MFR000212 A * 1 $ * $ * $ * MFR000213 N/A * 1 $ * $ * $ * MFR000334 A * 2 $ * $ * $ * 10,000 50,000 100,000 MFR000388 A * 1...
RECORDS AND TRACEABILITY. Each of the Parties hereby covenants and agrees that during the Term of the Distribution Rights, including any extensions thereof, and for a minimum period of seven (7) years thereafter, it shall maintain complete and accurate traceability records for all Licensed Products that are manufactured and sold under this Agreement, including pertinent data, research reports, test results, and know-how data, as required under all applicable FDA regulations and other U.S. or other applicable laws or regulations then in effect. Each of the Parties hereby covenants, during the term of this Agreement and for a minimum period of three (3) years thereafter or such longer period as any regulatory authority may require, to maintain adequate business and sales records regarding the distribution of all Licensed Products that are manufactured and sold under this Agreement, including pertinent data, research reports, test results, and know-how data to meet or exceed all applicable FDA and other U.S. or other applicable laws or regulations then in effect. MRG and MiniMed shall give each other access to these records in the event of an FDA recall or other remedial actions with respect to any product subject to this Agreement, or for other purposes of the Parties in complying with applicable regulatory requirements.
RECORDS AND TRACEABILITY. The Dealer shall for 10 years after the last Product has been made available by Dealer on the market (or longer if required under Applicable Law) keep full and accurate books of accounts and records relating to Products that each customer has bought in order to facilitate the tracking of Products (including model number and serial number or UDI). The records shall clearly show all enquiries, transactions and proceedings, modifications, incidents or suspected incidents or actions relating to the Products, warranty claims, non-conforming devices, modifications and repairs, and in particular include information on the affected Product, the nature and scope of the claimed defect.
RECORDS AND TRACEABILITY. Each of the Parties hereby covenants and agrees that during the Exclusive Marketing Agreement Term and any renewals thereof, and for a minimum period of seven years thereafter, it shall each maintain complete and accurate traceability records for all Long-Term Glucose Sensors and other Licensed Products that are manufactured and sold under this Exclusive Marketing Agreement, including pertinent data, research reports, test results, and know-how data, as required under all applicable FDA regulations and other U.S. or other applicable laws or regulations then in effect. Each of the Parties hereby covenants during the term of this Exclusive Marketing Agreement and any renewals thereof and for a minimum period of three (3) years thereafter or such longer period as may be required by law, to maintain adequate business and sales records regarding the distribution of all Long-Term Glucose Sensors and other Licensed Products, including pertinent data, research reports, test results, and know-how data to meet or exceed all applicable FDA and other U.S. or other applicable laws or regulations then in effect. MRG and MiniMed each shall give each other access to these records in the event of an FDA recall of any product subject to this Exclusive Marketing Agreement, or for other purposes of the Parties in complying with applicable Regulatory requirements.
RECORDS AND TRACEABILITY. The supplier must prepare and maintain adequate quality systems records, including inspection instructions, inspection and test results and engineering specification test methods. These records must be available for review by Winchester Interconnect representatives, Winchester Interconnect customer’s representatives, and any applicable regulatory organizations. All quality records are to be legible, reproductive, identifiable and traceable to the purchase order. Quality records to be stored and maintained in such a way that they are readily retrievable in facility that provides a suitable environment to minimize deterioration or damage and to prevent loss. This applies to our suppliers and any lower-tier suppliers. Retention period for Quality Records are 3 years unless otherwise specified. Winchester Interconnect, its customers, Government, or Regulatory Agency representative shall have access to review quality records as they pertain to this order. At the end of the required retention period, records should be disposed of*, so as not to be available for use. *Disposition as appropriate, including shredding, bulk removal, electronically deleted etc.)
