definiens: means all activities related to research, pre - clinical and other non - clinical testing, testmethod development and stability testing, toxicology, formulation, process development, manufacturing scale - up, qualification and validation, quality assurance / quality control, Clinical Studies, including Manufacturing in supportthereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwiserequested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a RegulatoryApproval . When used as a verb, means to engage in Development . Development shall exclude Phase 4Studies . For the avoidance of doubt, Development shall include any submissions, and activities required in supportthereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing orreimbursement approval for an approved Licensed Product