Manufacturing data. Details of all fabrication processes, non-destructive examinations, production tests and batch tests Shall be provided; The tolerances for all production processes such as heat treatment, end forming, resin mix ratio, filament winding tension and speed, curing times and temperatures, and auto-frettage procedures shall be specified; Surface finish, thread details, acceptance criteria for ultrasonic scanning (or equivalent), and maximum lot sizes for batch tests shall also be specified. 5.5. (not allocated)
Manufacturing data. Upon request, Lonza shall provide Trubion with the process and manufacturing documentation for each Batch, in Lonza's standard format or in such other format as may be agreed by the Parties, including without limitation copies of applicable Batch Records and other related documentation, data and analytical records, including without limitation deviations, discrepancies, out-of-specifications, failures, investigations, batch-specific environmental monitoring data, and any particular documentation or data listed in Schedule 2 hereto, and all other documentation reasonably requested by Trubion related to such Batch, including without limitation process data. In addition, Lonza shall collect data on the yield from each Batch, as well as the date of manufacture of each such Batch, and make reports of the same available to Trubion upon request in Lonza's standard format or in such other format as may be agreed by the Parties. Lonza shall retain such manufacturing data in accordance with applicable Legal Requirements.
Manufacturing data. CBSB shall collect and retain such data as required by the terms of the Quality Agreement, or as otherwise agreed in writing by CBSB and Tercica.
Manufacturing data. During the facilities audit, TRW, NTI or Affiliate and Seller shall agree on the key manufacturing or testing parameters that directly determine product quality and reliability. As part of a good Statistical Process Control (SPC) process, Seller agrees to monitor, maintain and take whatever corrective action required to keep these key parameters within the control limits. Seller shall agree to notify TRW, NTI or Affiliate within two working days of any out of control situation and the steps being taken to correct it. Seller shall have in place a system to ensure products manufactured during an out of control period are not shipped to TRW, NTI or Affiliate until test results have been analyzed and permission has been obtained from TRW, NTI or Affiliate to ship the product. Reports are required at agreed intervals comprising of copies of SPC data illustrating the key parameter, it's limits and the actual results for the month.
Manufacturing data. In order to enable Anesta to make Finished Goods for use as permitted under Clause 3, ImmuPharma shall itself, and shall use all Commercially Reasonable Efforts to cause its relevant suppliers and contract manufacturer(s) to, cooperate and assist in the transfer to Anesta of the relevant Manufacturing Data and techniques generated by ImmuPharma, such suppliers and contractors, to the extent that ImmuPharma has in its possession and/or has the right to cause its relevant suppliers and contract manufacturer(s) to transfer such Manufacturing Data and techniques at ImmuPharma’s cost and expense.
Manufacturing data a) Assembler shall provide National the manufacturing data deemed necessary as agreed to between Assembler and National. It shall include the amount at die and package level of Assembler's diebank, WIP, and stagnant inventories. Assembler shall be able to provide National on a weekly basis, a summary of shipping activity and die receipts. Assembler shall also provide National weekly reports regarding assembly and test yields, as well as cycletimes for both assembly only and assembled/tested products at the package level. Assembler shall provide National with any other information National reasonably requests. The format for stated data shall be as mutually determined between Assembler and National.
b) Wherever possible, Assembler agrees to allow National to establish a computer-link with the Assembler's computer system to enable quick access to data related to National's Devices only.
Manufacturing data. 5.1 Manufacturing Data—In this Agreement, "Manufacturing Data" means manufacturing information specifically used by Supplier for manufacturing the Products, including, but not limited to, placement files, material specifications, xxxxxxx, xxxx of materials ("BOM"), test documentation, material vendor information, software used for programming and tuning the work product, firmware (including source code), manufacturing tooling designs unique and specific to Xxxxxxx, and prior manufacturing data.
Manufacturing data. Appropriate data regarding chemistry, manufacturing, controls, stability, and the like, necessary or useful in supporting development of Licensed Product will be obtained by Schering during all manufacturing activities conducted by Schering. These data will be made available in a timely manner to BioMedicines as required to support development, registration and/or commercialisation of Licensed Product in accordance with the Development Plan and the CMC Plan but will remain at all times the exclusive property of Schering, subject, however, to the rights granted to BioMedicines hereunder.
Manufacturing data. Genentech shall collect data on the yield from each ------------------ Batch, as well as the date of manufacture of each such Batch and make reports of the same available to Immunex in the form of a monthly manufacturing status report in Genentech's standard format or in such other format as may be agreed by the Parties. Genentech shall retain such manufacturing data in accordance with the requirements of applicable laws, rules and regulations.
Manufacturing data. Lonza shall collect data on the yield from each Batch, as well as the date of manufacture of each such Batch and make reports of the same available to Genentech in the form of a monthly manufacturing status report in Lonza’s standard format or in such other format as may be agreed by the Parties. Lonza shall retain such manufacturing data in accordance with the requirements of applicable laws, rules and regulations.
