definiens: means all activities related to research, pre -clinical and other non -clinical testing, test method developmen t and stability testing, toxicology, formulation, process development, Manufacturing scale -up, qualification and validation, quality assurance / quality control, Clinical Trials, including Manufacturing in support thereof, statistical analysis and report wri ting, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in s upport of obtaining or maintaining a Regulatory Approval . When used as a verb, means to engage in Development, and means to have engaged in Development . For purposes of clarity, Development will include any submissions and activities required in support thereof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved Compound, Product or Diagnostic Product