definiens: or means all internal and external research, development, and regulatory activities related topharmaceutical products, including ( a ) research, toxicology, non - clinical, and preclinical testing and activities, ClinicalTrials, drug substance and drug product process development, product and process characterization, product and processqualiﬁcation and validation, qualiﬁcation and validation and stability testing of product from development, qualiﬁcation, orvalidation batches, quality assurance and quality control of development, qualiﬁcation, or validation batches, clinicalstudies, statistical analysis, and report writing 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 Trials or toobtain, support, or maintain Regulatory Approval of a pharmaceutical product, and interacting with Regulatory Authoritiesfollowing receipt of Regulatory Approval in the applicable country or region for such pharmaceutical product regarding theforegoing, including all other activities necessary or reasonably useful or otherwise requested or required by a RegulatoryAuthority as a condition or in support of obtaining or maintaining a Regulatory Approval, but expressly excluding activitiesdirected to Manufacturing, Medical Aﬀairs, or Commercialization . Development will include any Clinical Trials to beconducted after receipt of Regulatory Approval ( such as post - marketing studies and observational studies ) anddevelopment and regulatory activities for additional forms, formulations, or Indications for a pharmaceutical product afterreceipt of Regulatory Approval of such product ( including label expansion )