Batch Records. GMN shall prepare and maintain Batch Records with respect to each production lot of Product, including information relating to the manufacturing, quality control testing and analysis in accordance with applicable Laws. Such Batch Records and all other records relating to production hereunder shall be retained by GMN in accordance with the Technical Agreement. In addition, GMN shall make available such Batch Records, as well as updates to the validation package for Product, to PDL during any audit or site visit in accordance with Section 6.2.
Appears in 3 contracts
Sources: Clinical Drug Substance Supply Agreement (Facet Biotech Corp), Asset Purchase Agreement (PDL Biopharma, Inc.), Clinical Drug Substance Supply Agreement (Facet Biotech Corp)