definiens: or shall mean ( a ) activities directly and specifically relating to research, pre - clinical andclinical drug development of a Licensed Product in the Field, including, without limitation, test method development andstability testing, assay development, toxicology, pharmacology, formulation, quality assurance / quality control development, technology transfer, statistical analysis, process development and scale - up, pharmacokinetic studies, data collection andmanagement, clinical studies ( including research to design clinical studies ), regulatory affairs, project management, drugsafety surveillance activities related to clinical studies, the preparation, submission and maintenance of Registration Filingsand Approvals ( including post - marketing clinical trials imposed by applicable Law or as required by a Regulatory Authority)and activities necessary to obtain 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 the Field, including, withoutlimitation, activities to support new product formulations, delivery technologies and/or new indications in the Field eitherbefore or after the First Commercial Sale