definiens: shall mean all research, non -clinical, and clinical testing and drug development activities conducted in respect of the License d Vaccines and Licensed Products, including those necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining Regulatory Approvals and to successfully Develop, Manufac ture and Commercialize the Licensed Vaccines and Licensed Products for use in the Field . shall include chemistry, Manufacturing and control ( CMC ), test method development and stability testing, formulation development, delivery system develop ment, non -clinical testing, mechanism studies, toxicology, pharmacokinetics, clinical studies, process development, manufacturing scale -up, qualification and validation, quality assurance / quality control, regulatory affairs activities, statistical analysis and report writing, submission of documents, market research, pharmacoeconomic studies, and epidemiological / real world data studies . Development shall mean both ( a ) Non -clinical and Clinical Development ; and ( b ) CMC Development . and have a correlative meaning