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 ( as defined below in Section1.84 ) ( including the Manufacture of validation and engineering batches ), formulation development, delivery systemdevelopment, quality assurance and quality control development, analytical method development, human clinical studiesand regulatory affairs activities and statistical analysis and report writing ; ( ii ) the preparation of Clinical Trial design andoperations ; ( iii ) preparing and filing Drug Approval Applications, and ( b ) all activities related to ManufacturingDevelopment and ( c ) any and all other activities that may be necessary or useful to obtain Regulatory Approval . When usedas a verb, means to engage in Development and has a corresponding meaning