definiens: means all internal and external research, development, and regulatory activitiesrelated to products, including ( a ) research, non - clinical testing, toxicology, testing and studies, non - clinical andpreclinical activities, and Clinical Trials, and ( b ) preparation, submission, review, and development of data orinformation for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trialsand to obtain, support, or maintain Regulatory Approval of a product, but excluding activities directed to Manufacturingor Commercialization . Development will include development and regulatory activities for additional forms, formulations, or indications for a product after receipt of Regulatory Approval of such product ( including labelexpansion ), including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to beconducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as acondition of such Regulatory Approval with respect to an approved formulation or indication ( such as post - marketingstudies and observational studies, if required by any Regulatory Authority in any region in the Territory to support ormaintain Regulatory Approval for a product in such region )