Common use of Product-Specific Changes Clause in Contracts

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of a Product, then CLIENT and ▇▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes in accordance with the Quality Agreement, and CLIENT shall bear [CONFIDENTIAL TREATMENT REQUESTED] of the reasonable costs thereof; provided, however, that (a) ▇▇▇▇▇▇ shall assure that all such changes to the Product-specific ▇▇▇▇▇▇ SOPs are consistent with the Product Master Plan unless the parties otherwise expressly agree in writing, and (b) any changes to the Product Master Plan shall be made only in accordance with Section 2.2.

Product-Specific Changes. If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply primarily to the Production and supply of a Product, then CLIENT and ▇▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes in accordance with the Quality Agreement, and CLIENT shall bear [CONFIDENTIAL TREATMENT REQUESTED] of the reasonable costs thereof; provided, however, that (a) ▇▇▇▇▇▇ shall assure that all such changes to the Product-specific ▇▇▇▇▇▇ SOPs are consistent with the Product Master Plan unless the parties otherwise expressly agree in writing, and (b) any changes to the Product Master Plan shall be made only in accordance with Section 2.2.. 9.8