RECORDS AND TRACEABILITY Sample Clauses

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.
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RECORDS AND TRACEABILITY. 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. 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. 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 Polyzen Sleeve Assembly Component: Sleeve Assembly Supplier: Polyzen ASM100016 * sleeve assemblies per week $ * / sleeve Pricing as of October 2016 Other Polyzen Components Component: Leaf Seals Supplier: Polyzen 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: ________ Note: Pricing is based on validations being complete. Thus, any additional inspections will be charged as a separate line item. ASM100003 A * 2 $ * $ * $ * ASM100043 N/A * 1 $ * $ * $ * AXX000000 A * 1 $ * $ * $ * ASM100003 A * 2 $ * $ * $ * ASM100043 N/A * 1 $ * $ * $ * AXX000000 A * 1 $ * $ * $ * MFR000388 A * 1 $ * $ * $ * MFR000212 A * 1 $ * $ * $ * MFR000213 N/A * 1 $ * $ * $ * MFR000334 A * 2 $ * $ * $ * MFR000388 A * 1 $ * $ * $ * MFR000212 A * 1 $ * $ * $ * MFR000213 N/A * 1 $ * $ * $ * MFR000334 A * 2 $ * $ * $ * ● Component: Tubing Supplier: Nxxxxx Address: _______ MFR000214 * $ * 2 AXX000000 * $ * 1 TUB000052-01 * $ * 1 TUB000052-02 * $ * 1 TUB000052-03 * $ * 1 TUB000051-07 * $ * 1 TUB000051-04 * $ * 1 TUB000051-05 * $ * 1 TUB000051-06 * $ * 1 Supplier: Vesta Address: _______ TBD * TBD Other Sourced Components Borla STP000195 * $ * 2 Xxxxx XXX000000 * $ * 1 Xxxxx XXX000000 * $ * 1 Xxxx XXX000000 * $ * 1 Full Medical Device Assembly Supplier: Polyzen Pricing will be determined and agreed to by the parties once full assembly transfer process has been determined, setup and confirmed. Initial estimates can be provided based on current time-st...
Sample 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.
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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.)
Sample 1
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.
Sample 1
RECORDS AND TRACEABILITY. Supplier 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 Supplier 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 Supplier. 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 Supplier, Purchaser shall provide to Supplier 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.
Sample 1
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.
Sample 1
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Related to RECORDS AND TRACEABILITY

  • Records and Record Keeping Therapist may take notes during session, and will also produce other notes and records regarding Patient’s treatment. These notes constitute Therapist’s clinical and business records, which by law, Therapist is required to maintain. Such records are the sole property of Therapist. Therapist will not alter his/her normal record keeping process at the request of any patient. Should Patient request a copy of Therapist’s records, such a request must be made in writing. Therapist reserves the right, under California law, to provide Patient with a treatment summary in lieu of actual records. Therapist also reserves the right to refuse to produce a copy of the record under certain circumstances, but may, as requested, provide a copy of the record to another treating health care provider. Therapist will maintain Patient’s records for ten years following termination of therapy. However, after ten years, Patient’s records will be destroyed in a manner that preserves Patient’s confidentiality.

  • Access to Records and Properties (a) From the date hereof until the Closing Date or earlier termination of this Agreement, Seller will, and will cause the Companies and their Subsidiaries to: (i) provide Purchaser and its officers, counsel and other representatives with reasonable access during normal business hours to the operations of the Companies and their Subsidiaries, their principal personnel and representatives, and such books and records pertaining to the Companies and their Subsidiaries as Purchaser may reasonably request, provided that (A) Purchaser agrees that such access will give due regard to minimizing interference with the operations, activities and employees of the Companies and their Subsidiaries, (B) such access and disclosure would not violate the terms of any agreement to which the Companies or any of their Subsidiaries is bound or any applicable Law and (C) all arrangements for access shall be made solely through Seller; and (ii) furnish to Purchaser or its representatives such additional financial and operating data and other information relating to the Companies and their Subsidiaries as may be reasonably requested, to the extent that such access and disclosure would not (A) violate the terms of any agreement to which the Companies or any of their Subsidiaries is bound or any applicable Law, or (B) cause significant competitive harm to the Companies or any of their Subsidiaries or their Affiliates if the transactions contemplated by this Agreement are not consummated. (b) From the date hereof until the Closing Date, Purchaser agrees that all information so received from Seller, the Companies and their Subsidiaries shall be deemed received pursuant to the Confidentiality Agreement and that each shall, and shall cause its Affiliates and each of its and their representatives to, comply with the provisions of the Confidentiality Agreement with respect to such information, and the provisions of the Confidentiality Agreement are hereby incorporated herein by reference with the same effect as if fully set forth in this Agreement.

  • Records and Documentation The Sub-Recipient agrees to make available to AAAPP staff and/or any party designated by the AAAPP any and all contract related records and documentation. The Sub-Recipient shall ensure the collection and maintenance of all program related information and documentation on any such system designated by the AAAPP. Maintenance includes valid exports and backups of all data and systems according to AAAPP standards.

  • Maintaining Records; Access to Properties and Inspections Maintain financial records in accordance with GAAP and, upon reasonable notice, permit any representatives designated by the Administrative Agent or any Lender to visit and inspect the financial records and the properties of the Borrower or any Significant Subsidiary during normal business hours and to discuss the affairs, finances and condition of the Borrower or any Significant Subsidiary with the officers thereof and independent accountants therefor.

  • Access to Records and Documents It shall permit the Administrative Agent (or, if Independent Accountants are not engaged by the Collateral Manager or the Borrower, Protiviti, Inc. or another nationally recognized audit firm selected by the Administrative Agent with prior notice to the Borrower and subject to delivery of standard confidentiality agreements) to, upon reasonable advance notice and during normal business hours, but, so long as no Event of Default has occurred and is continuing, no more than one (1) time per calendar year, visit and inspect and make copies thereof at reasonable intervals (i) its books, records and accounts relating to its business, financial condition, operations, assets and its performance under the Facility Documents and the Related Documents and to discuss the foregoing with its and such Person’s officers, partners, employees and accountants, and (ii) all of its Related Documents, in each case as often as the Administrative Agent may reasonably request; provided that so long as no Event of Default has occurred and is continuing, the Borrower shall be responsible for all costs and expenses for only one such visit per fiscal year by the Administrative Agent or its respective designees; provided, further, that an officer or employee of the Collateral Manager shall have the opportunity to be present at any discussion between the Administrative Agent, any Lender or any other Person designated by the Administrative Agent, on the one hand, and the Collateral Manager’s accountants, on the other hand. The Administrative Agent shall provide two (2) Business Days’ prior notice to the Lenders of any such visit and any Lender shall be permitted to accompany the Administrative Agent in such visit. Any such visit and inspection shall be made simultaneously with any visit and inspection pursuant to Section 5.01(e).

  • Access to Records and Personnel Indivior shall ensure the IRO has access to all records and personnel necessary to complete the reviews listed in this Section III.E., and that all records furnished to the IRO are accurate and complete.

  • Access to Records; Copies The Assuming Bank agrees to permit the Receiver and the Corporation access to all Records of which the Assuming Bank has custody, and to use, inspect, make extracts from or request copies of any such Records in the manner and to the extent requested, and to duplicate, in the discretion of the Receiver or the Corporation, any Record in the form of microfilm or microfiche pertaining to Deposit account relationships; provided, that in the event that the Failed Bank maintained one or more duplicate copies of such microfilm or microfiche Records, the Assuming Bank hereby assigns, transfers, and conveys to the Corporation one such duplicate copy of each such Record without cost to the Corporation, and agrees to deliver to the Corporation all Records assigned and transferred to the Corporation under this Article VI as soon as practicable on or after the date of this Agreement. The party requesting a copy of any Record shall bear the cost (based on standard accepted industry charges to the extent applicable, as determined by the Receiver) for providing such duplicate Records. A copy of each Record requested shall be provided as soon as practicable by the party having custody thereof.

  • RECORDS; ACCESS The Advisor shall maintain appropriate records of all its activities hereunder and make such records available for inspection by the Directors and by counsel, auditors and authorized agents of the Company, at any time or from time to time during normal business hours. The Advisor shall at all reasonable times have access to the books and records of the Company.

  • Access to Records after Closing (a) For a period of ------------------------------- six years after the Closing Date, Parent and its representatives shall have reasonable access to all of the books and records of the Companies to the extent that such access may reasonably be required by Parent in connection with matters relating to or affected by the operations of the Companies prior to the Closing Date. Such access shall be afforded by Buyer upon receipt of reasonable advance notice and during normal business hours. Parent shall be solely responsible for any costs or expenses incurred by it pursuant to this Section 13.6(a). If Buyer --------------- or the Companies shall desire to dispose of any of such books and records prior to the expiration of such six-year period, Buyer shall, prior to such disposition, give Parent a reasonable opportunity, at Parent's expense, to segregate and remove such books and records as Parent may select. (b) For a period of six years after the Closing Date, Buyer and its representatives shall have reasonable access to all of the books and records relating to the Companies which Parent or any of its Affiliates may retain after the Closing Date. Such access shall be afforded by Parent and its Affiliates upon receipt of reasonable advance notice and during normal business hours. Buyer shall be solely responsible for any costs and expenses incurred by it pursuant to this Section 13.6(b). If Parent or any of its Affiliates shall --------------- desire to dispose of any of such books and records prior to the expiration of such six-year period, Parent shall, prior to such disposition, give Buyer a reasonable opportunity, at Buyer's expense, to segregate and remove such books and records as Buyer may select.

  • Access to Records; Contractor Financial Records Contractor agrees that District and its authorized representatives are entitled to review all Contractor books, documents, papers, plans, and records, electronic or otherwise (“Records”), directly pertinent to this Contract for the purpose of making audit, examination, excerpts, and transcripts.

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