Common use of Product Records Clause in Contracts

Product Records. Impax shall maintain all records necessary to comply with the Laws and in accordance with the Health Regulations. In addition, Impax shall prepare and adhere to batch process documentation consistent with the Impax Know-How, and in accordance with its normal procedures, including without limitation quality control records and all raw data relating to each batch processed. Specifically, but without limitation, Impax shall maintain complete and accurate records reasonably necessary to support cGMPs and other applicable regulatory requirements in the Territory, including without limitation quality control records. All such records shall be available for inspection, and audit by Schering (at its expense) and its representatives and agents, including Schering's auditors upon reasonable request during normal business hours. All such records shall be maintained for the longest period as may be required by the Laws; provided, however, that all records relating to the Manufacture, testing, stability oversight and quality control of each batch of the Product shall be retained at least until the third anniversary of the end of the approved shelf life for all Product from such batch. Impax shall provide Schering on a periodic basis, and at least annually, such information concerning Product, production batches, yields and quality status as is specified in the Health Registrations (commonly referred to as Annual Product Reviews) and as may be reasonably requested by Schering from time to time. Prior to destruction of any record, Impax shall give notice to Schering, which shall have the right to request and retain such record.

Product Records. Impax shall maintain all records necessary to comply with the Laws and in accordance with the Health Regulations. In addition, Impax shall prepare and adhere to batch process documentation consistent with the Impax Know-How, and in accordance with its normal procedures, including without limitation quality control records and all raw data relating to each batch processed. Specifically, but without limitation, Impax shall maintain complete and accurate records reasonably necessary to support cGMPs and other applicable regulatory requirements in the Territory, including without limitation quality control records. All such records shall be available for inspection, and audit by Schering (at its expense) and its representatives and agents, including Schering's ’s auditors upon reasonable request during normal business hours. All such records shall be maintained for the longest period as may be required by the Laws; provided, however, that all records relating to the Manufacture, testing, stability oversight and quality control of each batch of the Product shall be retained at least until the third anniversary of the end of the approved shelf life for all Product from such batch. Impax shall provide Schering on a periodic basis, and at least annually, such information concerning Product, production batches, yields and quality status as is specified in the Health Registrations (commonly referred to as Annual Product Reviews) and as may be reasonably requested by Schering from time to time. Prior to destruction of any record, Impax shall give notice to Schering, which shall have the right to request and retain such record.