definiens: or means all internal and external research, development, and regulatory activities related to pharmaceutical or biologic produ cts, including ( a ) research, non -clinical testing, toxicology, testing and studies, non -clinical and preclinical activities, and Clinical Trials, and ( b ) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Regulatory Approva l in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, but excluding activities directed to Manufacturing, Medical Affairs, or Commercialization . Development will include development and regulatory activi ties for additional forms, formulations, or indications for a pharmaceutical or biologic product after receipt of Regulatory Approval of such product ( including label expansion ), including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved formulation or indication ( such as post -marketing stu dies, observational studies, implementation and management of registries and analysis thereof, in each case, if required by any Regulatory Authority in any region in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic product in such region ) . and will be construed accordingly