Common use of Voluntary Changes Clause in Contracts

Voluntary Changes. ▇▇▇▇▇▇▇▇▇ shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis, components or source of the components, without requesting such change in writing and obtaining the prior written consent of WYETH. If WYETH requests in writing a change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or the Methods of Analysis with respect to the Product that is not a result of a requirement of FDA or any other Regulatory Authority, ▇▇▇▇▇▇▇▇▇ shall use all reasonable efforts to make or accept such change. The requesting Party shall provide the other Party with a detailed written report of all proposed changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis, components or source of components, as applicable. In the event that any changes proposed by WYETH result in an increase in the cost of production of Product by ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ shall notify WYETH of any adjustment to its charges and WYETH shall determine, in its sole discretion, whether to accept such increase or to withdraw the proposed change. In the event that any changes proposed by WYETH result in a decrease in the cost of production of Product by ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ shall adjust its charges to WYETH accordingly and WYETH shall pay the decreased price. All changes proposed by ▇▇▇▇▇▇▇▇▇ shall be paid for by ▇▇▇▇▇▇▇▇▇.

Appears in 2 contracts

Sources: Supply Agreement (Amphastar Pharmaceuticals, Inc.), Supply Agreement (Amphastar Pharmaceuticals, Inc.)