definiens: and means all internal and external research, discove ry, development, and regulatory activities related to pharmaceutical or biologic pr oducts, including ( a ) research, non - clinical testin g, toxicology, testing and studies, non - clinical and preclinical a ctivities, 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 obt ain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Re gulatory Approval in the applicable country or region for su ch pharmaceutical or biologic product regarding the foregoing, but expressly excluding activities directed to Manu facturing, performance of Medical Affairs, or Commercialization . Development will include develop ment and regulatory activities for additional forms, formulations, or indications for a pharmaceutical o r biologic product after receipt of Regulatory Appr oval of such product ( including label expansion ), including Clin ical Trials initiated following receipt of Regulato ry Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the ap plicable Regulatory Authority as a condition of such Regulat ory Approval with respect to an approved formulatio n or indication ( such as observational studies, implemen tation and management of registries and analysis th ereof, in each case, if required by any Regulatory Authority in any region in the Territory to support or mainta in Regulatory Approval for a pharmaceutical or biologic product i n such region ) . and will be construed accordingly