definiens: or shall mean ( a ) activities directly and specificallyrelating to research, pre - clinical and clinical drug development of a Licensed Product in the Field, including, without limitation, test method development and stability testing, assay development, toxicology, pharmacology, formulation, quality assurance / quality control development, technology transfer, statistical analysis, process development and scale - up, pharmacokineticstudies, data collection and management, clinical studies ( including research to design clinicalstudies ), regulatory affairs, project management, drug safety surveillance activities related toclinical studies, the preparation, submission and maintenance of Registration Filings andApprovals ( including post - marketing clinical trials imposed by applicable Law or as required by aRegulatory Authority ( other than Non - Approval Trials ) ) and activities necessary or useful toobtain a Pricing Approval, reimbursement and/or listing on health care providers ’ and payers’formularies, and ( b ) any other development activities with respect to a Licensed Product in theField, including, without limitation, activities to support new product formulations, deliverytechnologies and/or new indications in the Field either before or after the First Commercial Sale