definiens: or means, with respect to a Product, ( a ) all non - clinical and clinical drugdevelopment activities that are undertaken after the Effective Date up to and including the date of obtaining of MarketingAuthorization of such Product to obtain including ( i ) the conduct of Clinical Trials, toxicology and pharmacology testing, test method development and stability testing, process development ( including the Manufacture of validation andengineering batches ), formulation development, delivery system development, quality assurance and quality controldevelopment, analytical method development, human clinical studies and regulatory affairs activities and statistical analysisand report writing ; ( ii ) the preparation of Clinical Trial design and operations ; ( iii ) preparing and filing Drug ApprovalApplications, and ( b ) all activities related to Manufacturing Development and ( c ) any and all other activities that may benecessary or useful to obtain Regulatory Approval, Pricing Approval, or Reimbursement Approval . When used as a verb, means to engage in Development and has a corresponding meaning