definiens: means the following information that is Controlled by [COMPANY] or its Affiliates as ofthe Effective Date or, to the extent applicable, that is Controlled by [COMPANY] or its Affiliates and results from Amgen’sperformance of the transfer of the Manufacturing Processes pursuant to Section 3.2(b ) and Exhibit H : ( 1 ) theRegulatory Documents ; ( 2 ) protocols, data and reports of clinical studies listed in Exhibit I ; ( 3 ) the ManufacturingInformation ; ( 4 ) results of all investigator - sponsored clinical trials, including the Ongoing Clinical Trials listed in ExhibitE ; ( 5 ) all research and preclinical data for Leptin and formulations of Leptin that are available, and ( 6 ) any suchinformation which [COMPANY] expressly designates in writing it intends to include as Licensed Know - How under thisAgreement