definiens: means, with respect to any Program, a plan that describes the plan for conductingDevelopment with respect to each Drug Candidate, including by specifying clinical and nonclinical studies and activities tobe conducted and anticipated Development activities for each Drug Candidate ( including the following anticipated activitiesor events : a description of the indication targeted, timelines, phasing of Development, study treatments, major inclusion andexclusion criteria, primary endpoints, study size, timelines for data preparation and filing of regulatory submissions, toxicology and a plan for selecting appropriate species for toxicology studies, ADME, and pharmacology studies andmanufacturing process development ) . The Initial Development Plan will include drug design and Development activities thatare in keeping with the Parties ’ current drug design and Development practices and that are reasonably calculated to result inthe Development of the Drug Candidates that may be progressed through to Commercialization . The Initial Development Planas of the Effective Date is set forth on Exhibit 1.68, which may be amended from time to time in accordance with Section 3.2.5