Common use of Specifications Amendments Clause in Contracts

Specifications Amendments. The Specifications shall be amended or supplemented to comply with cGMPs and to comply with any applicable Regulatory Authority directive and may also be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time. In the event GalaGen intends to amend the Specifications, Wyeth-Ayerst shall receive prompt advance notice of any such amendments. No such amendment shall be filed with any applicable Regulatory Authority or otherwise become effective without the prior written mutual approval of Wyeth-Ayerst and GalaGen. In the event that, after the Parties have initially agreed upon the Specifications, Wyeth-Ayerst requests that the Specifications be amended, GalaGen shall receive prompt advance notice of any such amendment for the purpose of determining what, if any, impact the proposed amendment would have on the Manufacture of Ingredient for Wyeth-Ayerst hereunder and Wyeth-Ayerst shall reimburse GalaGen for the actual costs incurred by GalaGen (provided that such costs are approved in writing by Wyeth-Ayerst prior to being incurred by GalaGen) because such amendment requires changes to be made in the processes, equipment, testing procedures, or components used to Manufacture the Ingredient for Wyeth-Ayerst hereunder. Such costs may include, without limitation, validation of new processes, equipment and facilities, development of testing methods and start-up

Specifications Amendments. The Specifications shall be amended or supplemented to comply with cGMPs GMPs and to comply with any applicable Regulatory Authority Agency directive and may also be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time. In the event GalaGen CIMA intends to amend the Specifications, Wyeth-Ayerst WCH shall receive prompt advance notice of any such amendments. No such amendment shall be filed with any applicable Regulatory Authority Agency or otherwise become effective without the prior written mutual approval of Wyeth-Ayerst WCH and GalaGenCIMA. In the event that, that after the Parties parties have initially agreed upon the Specifications, Wyeth-Ayerst WCH requests that the Specifications be amended, GalaGen CIMA shall receive prompt advance notice of any such amendment for the purpose of determining what, if any, impact the proposed amendment would have on the Manufacture manufacture of Ingredient Product for Wyeth-Ayerst WCH hereunder and Wyeth-Ayerst WCH shall reimburse GalaGen CIMA for the actual costs incurred by GalaGen CIMA (provided that such costs are approved in writing by Wyeth-Ayerst WCH prior to being incurred by GalaGenCIMA) because such amendment requires changes to be made in the processes, equipment, testing procedures, or components used to Manufacture the Ingredient manufacture Product for Wyeth-Ayerst WCH hereunder. Such Upon WCH's request, CIMA shall use Commercially Reasonable Efforts to eliminate animal derived materials from the Product and WCH shall reimburse CIMA for the actual costs incurred by CIMA (provided that such are approved in writing by WCH prior to being incurred by CIMA) in connection therewith. In each case, such costs may include, without limitation, validation of new processes, equipment and facilities, development of testing methods and start-upup costs. To the extent that any costs incurred by CIMA in implementing an amendment of the Specifications under this Section have been reimbursed by WCH such costs shall not be included in CIMA's Direct Manufacturing Cost.