definiens: or means all internal and external research, develop ment, and regulatory activities related to pharmaceutical or biologic pr oducts, including ( i ) research, non - clinical testin g, toxicology, testing and studies, non - clinical and preclinical a ctivities, and Clinical Trials and ( ii ) 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 Approva l of a pharmaceutical or biologic Product, but excluding a ctivities that are directed to Manufacturing, Medic al Affairs, or Commercialization . Development will include deve lopment and regulatory activities for additional fo rms, formulations, or Indications for a pharmaceutical o r biologic Product after receipt of Regulatory Appr oval of such Product ( including label expansion ), including Clinical Trials initiated following receipt of Reg ulatory Approval or any Clinical Trial to be conducted afte r receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of s uch Regulatory Approval with respect to an approved formulation or Indication ( such as post - marketing s tudies and observational studies, if required by an y Regulatory Authority in any region in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic Product in such region )