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.
Appears in 3 contracts
Sources: Manufacturing Services Agreement (Trubion Pharmaceuticals, Inc), Manufacturing Services Agreement (Trubion Pharmaceuticals, Inc), Manufacturing Services Agreement (Trubion Pharmaceuticals, Inc)