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 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 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 Product shall be allocated between Client and Paragon as set forth in the Quality Agreement, Exhibit B.
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 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 Drug shall be allocated between Genentech and Lonza as set forth in the Quality Agreement and in standard operating procedures agreed upon in writing by Genentech and Lonza from time to time. In general, (a) Lonza shall be responsible for performing certain in-process testing and selected acceptance testing on the Bulk Drug as set forth in the Tech Transfer Agreement and the Quality Agreement, and (b) Genentech shall be responsible for all final acceptance testing and authorizing final release of all Bulk Drug to the market.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated between FibroGen and Catalent as set forth in the Quality Agreement.
