Changes by AMGEN Clause Samples
Changes by AMGEN. 12.1.1 AMGEN shall notify COMPANY of AMGEN’s intention to implement any Material Change. The notification of such Material Change and the details of such Material Change shall be provided to COMPANY by AMGEN according to EXHIBIT C.
12.1.1.1 COMPANY’s QA will respond to such notification for a Material Change within two (2) business days of receipt.
Changes by AMGEN. If Amgen determines to make a material change to the manufacturing of Drug Product to be supplied to Purchaser hereunder (e.g., material change to Specifications or manufacturing process), it shall provide Purchaser prompt written notice of such determination (a “Change Notice”). Such notice shall provide the relevant details of such change (“Manufacturing Change”) (but Amgen shall have no obligation to include any confidential Amgen manufacturing information) and the proposed date for such change. The Parties shall meet and determine if such change would require notice to or approval by a Governmental Authority in the Territory.