Batch Failure. In the event any Batch is terminated or unable to be released by Provider to Senti hereunder (each, a “Failed Batch”), Provider will conduct an appropriate investigation to determine the cause of such failure (which investigation shall include an impact assessment on products that Provider or Senti reasonably believes may be an Impacted Product at the relevant time), provide Senti with the opportunity to participate in such investigation (to the extent Provider’s obligations with respect thereto are provided in the Quality Agreement, in accordance with the Quality Agreement), disclose to Senti the results of such investigation, and notify Senti in writing of Provider’s good faith conclusions regarding the cause of the nonconformity. If Provider determines that the cause of the nonconformity is Provider’s or its subcontractor’s negligence or willful misconduct or failure to follow the Manufacturing Process as documented in the Master Batch Record, standard operating procedures, or GMP requirements, or equipment failure not caused by Senti or by an event of Force Majeure (any such cause of the nonconformity, a “Provider Processing Default”) or if an independent investigation or analysis conducted pursuant to Section 10.7 (Disputes as to Failed Batches or Product Conformity) determines that the cause of the nonconformity is a Provider Processing Default, then, in each case, Senti will have the remedies set forth in Section 10.6 (Remedies).
Appears in 2 contracts
Sources: Development and Manufacturing Services Agreement (Senti Biosciences, Inc.), Framework Agreement (Senti Biosciences, Inc.)