Manufacturing Records Sample Clauses
The Manufacturing Records clause requires the manufacturer to maintain detailed and accurate records of the production process, including materials used, quality control measures, and batch information. These records typically must be kept for a specified period and made available for inspection by the buyer or regulatory authorities upon request. The core function of this clause is to ensure traceability, accountability, and compliance with regulatory standards, thereby facilitating quality assurance and addressing any issues that may arise with the manufactured products.
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Manufacturing Records. SBS shall maintain, or cause to be maintained, (i) all records necessary to comply with GMP and all other Applicable Law relating to the Manufacture of the Product, (ii) all Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the Manufacturing of the Product, and (iii) such other records as Voyager may reasonably require in order to ensure compliance by SBS with the terms of this Agreement. All such material shall be retained for such period as may be required by GMP and all other Applicable Law or for such longer period as Voyager may reasonably require; provided, however, that all records relating to the Manufacturing, stability and quality control of each batch of the Product shall be retained at least until the first anniversary of the end of the approved shelf life for all Product from such batch.
Manufacturing Records. Patheon shall maintain, or cause to be maintained, (a) all records necessary to comply with GMP and all other Applicable Law relating to the Manufacture of Product, (b) all Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks, and all raw data relating to the Manufacturing of the Product, and (c) such other records as Flexion may reasonably require in order to ensure compliance by Patheon with the terms of this Agreement. The template, form and style of all records referred to herein are the exclusive property of Patheon; Flexion Proprietary Information and all Product-specific related information contained in these records shall be deemed Proprietary Information of Flexion and be retained for such period as may be required by GMP and all other Applicable Law or for such longer period as Flexion may reasonably require.
Manufacturing Records. Biocon shall keep complete, accurate and authentic accounts, notes, data and records pertaining to the Manufacture, processing, testing, storage, and distribution of Clinical Material and of the work performed under this Agreement, including, without limitation, all quality control documentation and the Master Batch Records, for the longer of (i) a period of […***…] after delivery of such Clinical Material to Equillium or (ii) the period of time required by Applicable Law. Biocon shall make available to Equillium copies of such records and shall permit Equillium to inspect the originals of such records as maintained by Biocon, on reasonable notice. After the time period set forth in this Section 4.4(a), Biocon shall notify Equillium prior to the destruction of any records retained under this Section 4.4(a) and, at Equillium’s request and expense, shall transfer such records to Equillium.
Manufacturing Records. Upon the reasonable request of the other Party, the Supplier of an Alliance Product will provide the other Party with copies of, or access to, manufacturing information, including batch records, process flows, analytical performance data, quality assurance documents agreed to by the Parties pursuant to Sections 5.7 and 5.8 and other documentation, requested by the other Party regarding manufacture and quality control of an Alliance Product. The requesting Party will treat all such information disclosed as Confidential Information of the Supplier subject to the provisions of Article XIV.
Manufacturing Records. TANABE shall keep full and complete records of every production lot in accordance with generally accepted industry practices including, but not limited to, the lot production records for each lot supplied (hereinafter referred to as "Records").
Manufacturing Records. Helsinn will maintain complete and accurate records relating to the API and the manufacture, bulk packaging, labeling and testing thereof for the period required by applicable Regulatory Standards, and Helsinn shall provide copies thereof to Indevus upon Indevus’s request. The records shall be subject to audit and inspection under this Article X.
Manufacturing Records. HPA shall maintain, or cause to be maintained, (a) all records necessary to comply with all Applicable Law relating to the Manufacture of the Licensed Products by HPA, (b) all Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the Manufacturing of Licensed Products hereunder, and (c) such other records as Emergent may reasonably require to ensure compliance by HPA with the terms hereof. All such material shall be maintained for such period as may be required by Applicable Law or for such longer period as Emergent may reasonably require; provided, however, that all records relating to the Manufacturing, stability and quality control of each batch of Licensed Product shall be retained until at least the first (1st) anniversary of the end of the approved shelf life for all Licensed Product from such batch.
Manufacturing Records. Patheon shall maintain, or cause to be maintained, (a) all records necessary to comply with GMP and all other Applicable Law relating to the Manufacture of Product, (b) all Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks, and all raw data relating to the Manufacturing of the Product, and (c) such other records as Pacira may reasonably require in order to ensure compliance by Patheon with the terms of this Agreement. The template, form and style of all records referred to herein are the exclusive property of Patheon; Pacira Proprietary Information and all Product-specific related information contained in these records shall be deemed Proprietary Information of Pacira and be retained for such period as may be required by GMP and all other Applicable Law or for such longer period as Pacira may reasonably require.
Manufacturing Records. The original Manufacturing Records shall be held in secure storage by PATHEON, provided that, except as otherwise expressly provided herein, all information contained in the Manufacturing Records shall be Relypsa Confidential Information and shall not be used or disclosed by PATHEON other than for the purposes of permitting PATHEON to exercise its rights or fulfill its obligations under this Agreement and, where necessary, for disclosure to the relevant Regulatory Authorities in order to comply with regulatory requirements relating to the Services. At any time during and after the Term, and from time to time, promptly upon its request, RELYPSA shall be entitled to review and receive copies of Manufacturing Records. Upon expiration or termination of this Agreement, PATHEON will deliver all such records (or copies of any retained records) and information to RELYPSA, but it may retain original records to the extent required by Laws in accordance with and subject to the obligations of confidentiality and non-use set forth in this Agreement.
Manufacturing Records. Each Party shall promptly provide the other Party, upon its reasonable request for the purpose of this Agreement, copies of the Manufacturing records (including specifications, protocols, batch records, master batch records and other CMC information) maintained by the first Party, its Affiliates or Third Party contractors pertaining to Compounds and Products for such other Party’s use in connection with the Manufacture of the Compounds and/or Products under this Agreement (and in the case of MyoKardia, pursuant to its rights under Section 12.3). Each Party hereby grants the other Party the right to reference (and have referenced by its Affiliate, Sublicensee or contract manufacturer) the drug master files, if any, maintained by the first Party, its Affiliates or Third Party contractors pertaining to Compounds and Products for such other Party’s use in connection with the Manufacture of the applicable Compounds and/or Products under this Agreement (and in the case of MyoKardia, pursuant to its rights under Section 12.3).