Batch Records. Upon request by Licensee, GPC Biotech shall make available for review copies of the individual and master batch records received from Subcontractors and used for any step in the Manufacture of Licensed Product delivered hereunder. Licensee may use the information in such batch records as provided in the License Agreement, including in regulatory submissions in order to gain or maintain regulatory approvals.
Appears in 2 contracts
Sources: Supply Agreement (Pharmion Corp), Supply Agreement (GPC Biotech Ag)