definiens: means all internal and external research, development, and regulatory activitiesregarding the Licensed Compound or the Licensed Products . This includes ( a ) research, non - clinical testing, toxicology, route of synthesis, non - clinical activities, formulation, and clinicalstudies of a Licensed Compound or any Licensed Product, and ( b ) preparation, submission, review, and development of data or information for the purpose of submission to a RegulatoryAuthority to obtain authorization to conduct clinical trials and to obtain or maintain RegulatoryApproval of a Licensed Product . Development will include development and regulatory activitiesfor additional forms, formulations, or indications for a Licensed Product after Regulatory Approvalof such Licensed Product, including clinical trials initiated following receipt of Regulatory Approvalor any clinical trial to be conducted after a Regulatory Approval that was mandated by theapplicable Regulatory Authority as a condition of such Regulatory Approval with respect to anapproved indication ( such as post - marketing studies and observational studies, if required by anyRegulatory Authority in any country in the Territory to maintain Regulatory Approval for aLicensed Product in such country ) . and will be construedaccordingly