Common use of Quality documentation Clause in Contracts

Quality documentation. Novartis shall supply the Novartis Study Drugs to Olema or its designee in accordance with the terms of: (i) a separate supply agreement (“Supply Agreement”) governing forecasting, ordering, procedures for acceptance and rejection, and other customary provisions for the supply of the Novartis Study Drugs for the Combined Therapy Clinical Trials, and (ii) a separate quality agreement (“Quality Agreement”) outlining the additional roles and responsibilities relative to the quality of the Novartis Study Drugs in support of the Combined Therapy Clinical Trials (the Supply Agreement and Quality Agreement collectively referred to herein as “Quality Documentation”). The Parties shall finalize and execute the Quality Documentation before the date on which the first shipment of the Novartis Study Drugs is supplied for use in the Combined Therapy Clinical Trials. The Quality Documentation shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the Novartis Study Drugs for the Combined Therapy Clinical Trials. In addition, the Quality Documentation shall detail the documentation required for each shipment of Novartis Study Drugs supplied to Olema or its designee for use in the Combined Therapy Clinical Trials.