Manufacturing Records definition

Manufacturing Records means all documents relating to the Manufacture of a Batch, including manufacturing instructions, deviations, test results, out of specification results, investigations, bills of materials and certificates of analysis.

Manufacturing Records. Manufacturing Records" means manufacturing, facility/systems and environmental monitoring and cleaning, packaging and quality control and quality assurance records generated by Medeva in the course of the Manufacture, including, without limitation, the Manufacturing Instructions, production, packaging, quality control, and quality assurance records.

Manufacturing Records means all Specifications, formulations, processes and controls, including all supporting and historical data, product samples, technology transfer, laboratory data, development documentation equipment and other historical validation data and all related regulatory and compliance documents and information and such further information and documentation as HD shall reasonably request to enable it to manufacture and supply Products in accordance with the terms and conditions set forth herein.

Examples of Manufacturing Records in a sentence

• PAR shall make the Manufacturing Records available to HD, promptly after execution hereof and prior to the Commencement Date.

• In connection with such review by or on behalf of Kiniksa, Regeneron will use reasonable efforts to ensure that Regeneron personnel with relevant experience, including with respect to CMC and other Manufacturing activities related to the Product, are reasonably available to Kiniksa to answer questions and discuss such Product Manufacturing Records and the U.S. BLA, including any changes or amendments thereto since its original filing with the FDA.

• HD shall maintain true and complete books and records (including, without limitation, all Manufacturing Records) of all data relating to the manufacture, supply and sale of Products.

• At any time during the Term and for a period of [***] thereafter, PATHEON shall, upon request by RELYPSA, provide Manufacturing Records, support and assistance, including technical assistance, as is reasonably necessary for the effective transfer of the Services to RELYPSA or to another manufacturer(s) nominated by RELYPSA.

• In consideration of the amounts paid hereunder, PATHEON shall deliver to RELYPSA in accordance with the terms hereof all relevant information including Manufacturing Records that is obtained by PATHEON in the course of performing the Services and supplying the Bulk and Finished Product, and that is reasonably requested by RELYPSA.

More Definitions of Manufacturing Records

Manufacturing Records means manufacturing, facility/systems and environmental monitoring and cleaning, packaging and quality control and quality assurance records generated by Oravax in the course of the Manufacture of the Products;

Manufacturing Records means, for a shipment of Product, the following documents: the batch records, certificate of analysis, certificate of conformity, and the BSE/TSE certificate; "Manufacturing Scale Up" means the purchase, installation and validation of equipment and the undertaking of such other capital improvements required to enable Patheon to manufacture Product in batches greater than [***];

Manufacturing Records has the meaning ascribed thereto in Section 6.6 of this Agreement.

Manufacturing Records means all filings, records, and other documents (whether in hardcopy or electronic form) Controlled by ALZA (directly or through its Affiliates) pertaining to the manufacture of Dapoxetine or any Agreement Product, including the portions of any such documents bearing Know-How relating to the manufacture of Dapoxetine or any Agreement Product, the CMC portion of all ALZA Regulatory Submissions and ALZA Marketing Authorizations for Dapoxetine or any Agreement Product, all DMFs for Dapoxetine or any Agreement Product, together with all amendments and supplements, in support thereof, records used to obtain and maintain ALZA Marketing Authorizations or ALZA Regulatory Submissions, and records needed to support clinical development of Dapoxetine or any Agreement Product.

Manufacturing Records means all filings, records, and other documents (whether in hardcopy or electronic form) Controlled by ALZA (directly or through its Affiliates) pertaining to the manufacture of Dapoxetine or any Existing Product, including the portions of any such documents bearing Know-How relating to the manufacture of Dapoxetine or any Existing Product, the chemistry, manufacturing and controls portion of all Regulatory Submissions and Existing Product Registrations for Dapoxetine or any Existing Product, all drug master files for Dapoxetine or any Existing Product, together with all amendments and supplements, in support thereof, records used to obtain and maintain Existing Product Registrations or Regulatory Submissions, and records needed to support clinical development of Dapoxetine or any Existing Product.

Manufacturing Records. (manufacturing build records, device master records in the form and version as of the Effective Date, device history records and lot history records), and (ii) “Development Records” (design history files) of the Acquired Technology.

Manufacturing Records has the meaning set forth in Section 6.12.