Common use of cGMP Compliance and QA Audits Clause in Contracts

cGMP Compliance and QA Audits. Within ten days of Aviron's written request, PCI shall supply Aviron with copies of PCI's manufacturing records, including its batch records, for the purposes of assuring product quality and compliance with the Specifications. Any found discrepancies, other than discrepancies resulting from directions received from Aviron or its representatives, will be reported to PCI and PCI will within 30 days correct said discrepancies to Aviron's reasonable satisfaction. Failure to do so will give Aviron the right to terminate the Agreement pursuant to Section 10.5. Aviron's failure to exercise its right to audit PCI's Facility will not represent a waiver of any future exercise of this right or of any other rights under this Agreement, nor does it represent acceptance of any conditions past or present that might exist or result from such conditions at the Facility. Aviron acknowledges that all copies of PCI's manufacturing records shall be subject to the confidentiality provisions of Article 12.

cGMP Compliance and QA Audits. Within ten days of Aviron's written request, PCI shall supply Aviron with copies of PCI's manufacturing records, including its batch records, for the purposes of assuring product quality and compliance with the Specifications. Any found discrepancies, other than discrepancies resulting from directions received from Aviron or its representatives, will be reported to PCI and PCI will within 30 days [ * ] correct said discrepancies to Aviron's reasonable satisfaction. Failure to do so will give Aviron the right to terminate the Agreement pursuant to Section 10.5[ * ]. Aviron's failure to exercise its right to audit PCI's Facility will not represent a waiver of any future exercise of this right or of any other rights under this Agreement, nor does it represent acceptance of any conditions past or present that might exist or result from such conditions at the Facility. Aviron acknowledges that all copies of PCI's manufacturing records shall be subject to the confidentiality provisions of Article 12.