definiens: , or means all internal and external research, develop ment, and regulatory activities related to pharmaceutical, bi ologic, or vaccine products, including ( a ) research, non - clinical testing, toxicology, testing and studies, non - clini cal and preclinical activities, and clinical trials, ( b)and preparation, submission, review, and development of data or information for the purpose of submission to a regulatory authority to obtain authorization to con duct clinical trials and to obtain, support, or mai ntain Regulatory Approval of a pharmaceutical, biologic, or vaccine product, but excluding activities direct ed to Manufacturing, Medical Affairs, or Commercializatio n. Development will include development and regulat ory activities for additional forms, formulations, or i ndications for a pharmaceutical, biologic, or vacci ne product after receipt of Regulatory Approval of such produc t ( including label expansion ), including clinical t rials initiated following receipt of Regulatory Approval or any cli nical trial to be conducted after receipt of Regula tory Approval that was mandated by the applicable regula tory authority as a condition of such Regulatory Ap proval with respect to an approved formulation or indicati on ( such as post - marketing studies, observational s tudies, pediatric studies, implementation and management of registries and analysis thereof, in each case, if required by any regulatory authority in any region worldwide to support or maintain Regulatory Approval for a pharmaceutical, biologic, or vaccine product in suc h region ) . and will be construed accordingly