definiens: means all internal and external research, develop ment, and regulatory activities related to pharmaceutical or biologic products, including ( a ) research, non - clinical testing, toxicology, test ing and studies, non - clinical and preclinical activitie s, and clinical trials and ( b ) preparation, submiss ion, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct Clinic al Trials and to obtain, support or maintain Regulatory Approval of a pharmaceutical or biologic product, but excluding activities that are directe d to Manufacturing, Medical Affairs, or Commercializa tion . Development will include development and regulatory activities for additional forms, formula tions or indications for a pharmaceutical or biolog ic product after receipt of Regulatory Approval of suc h product ( including label expansion ), including Clinical Trials initiated following receipt of Regu latory Approval or any Clinical Trial to be conduct ed after receipt of Regulatory Approval that was manda ted by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved formulation or indication ( such as post - marketing studies and observational studies, i f required by any Regulatory Authority in any regio n in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic product i n such region ) . and will be construed accordingly