definiens: or means, with respect to a Licensed Product, ( a ) all non - clinical and clinical drug development activities that are undertaken after the Effective Date up to and including the date of obtaining Regulatory Approval of such Licensed Product including ( i ) the conduct of Clinical Trials, toxicology and pharmacology testing, test method development and stability testing, process development ( ) ( including the Manufacture of validation and engineering batches ), formulation development, delivery system development, 3 quality assurance and quality control development, analytical method development, human clinical studies and regulatory affairs activities and statistical analysis and report writing ; ( ii ) the preparation of Clinical Trial design and operations ; and ( iii ) preparing and filing Drug Approval Applications, ( b ) all activities related to the optimization of a commercial - grade Manufacturing process for the Manufacture of Licensed Product including, test method development and stability testing, formulation, validation, productivity, trouble shooting and next generation formulation, process development, Manufacturing scale - up, development - stage Manufacturing, and quality assurance / quality control development and ( c ) any and all other activities that may be necessary or useful to obtain Regulatory Approval . When used as a verb, means to engage in Development and has a corresponding meaning