CHANGE IN MANUFACTURING PROCESS PROPOSED BY GILEAD Sample Clauses

CHANGE IN MANUFACTURING PROCESS PROPOSED BY GILEAD. Following manufacture of the Lots of each Product data regarding which will be included in the DMF filed with the FDA and used to determine such Product's shelf life in accordance with the NDA in the United States, Gilead shall not make any change in the materials, equipment, process or procedures used to manufacture such Product for supply to OSI hereunder that (i) is not explicitly permitted pursuant to the applicable Specifications, and (ii) would constitute a material change under cGMP without OSI's prior written consent, such consent not to be unreasonably withheld. If OSI agrees to allow any such change requiring OSI's approval to be implemented, then the Parties shall revise the relevant Specifications accordingly, if necessary. Gilead shall not change the manufacturing process for any Product in a manner that would require a filing with a Regulatory Authority without OSI's prior written consent, other than pursuant to a Work Plan and Budget in accordance with Article 4.
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Related to CHANGE IN MANUFACTURING PROCESS PROPOSED BY GILEAD

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