Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Drug Substance shall be allocated between PROTEON and LONZA as set forth in the Quality Agreement.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between Helix and CPL as set forth in the Quality Assurance Agreement and in those CPL standard operating procedures which have been agreed upon in writing by Helix and CPL from time to time.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between Helix and BioVectra as set forth in the Quality Assurance Agreement and in those BioVectra standard operating procedures which have been agreed upon in writing by Helix and BioVectra from time to time.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Drug Substance shall be allocated between Tercica and CBSB as set forth in the Quality Agreement and in CBSB standard operating procedures agreed upon in writing by Tercica and CBSB.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Drug Substance shall be allocated between Client and LONZA as set forth in the Quality Agreement and in LONZA standard operating procedures.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between Client and Paragon as set forth in the Quality Agreement.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between FibroGen and STA as set forth in the Quality Agreement and Quality Control Procedures.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between Genentech and Wyeth as set forth in the Quality Agreement. To the extent reasonably practicable and consistent with industry practice and cGMP, Wyeth shall incorporate its obligations under the Quality Agreement into standard operating procedures that comply with the Quality Agreement. In general, (a) Wyeth shall be responsible for performing certain in-process testing and acceptance testing on the Product as set forth in the Technology Transfer Project Plan and the Quality Agreement, and (b) Genentech shall be responsible for acceptance of all test results and authorizing final Release of all Product to the market as set forth in the Quality Agreement.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Bulk Drug Product shall be allocated between AstraZeneca and FibroGen as set forth in the Quality Assurance Agreement.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Bulk Product and Finished Product (as applicable) shall be allocated between Astellas and FibroGen as set forth in the Quality Agreement. For the avoidance of doubt, FibroGen shall be solely responsible for the costs and expenses of quality assurance and quality control of the Bulk Product during the Manufacturing Processes and prior to Transfer.
