definiens: or means non - clinical and clinical research and drug development activities, includingtoxicology, pharmacology and other discovery eﬀorts, test method development and stability testing, assay development, cell line development, process development and improvement, process validation, process scale - up, formulationdevelopment, delivery system development, quality assurance and quality control development, statistical analysis, ClinicalStudies ( including pre -- approval studies and Post - Approval Required Studies, but excluding Post - Approval Optional Studiesand Investigator Sponsored Clinical Studies ), regulatory aﬀairs, and Regulatory Approval and Clinical Study regulatoryactivities ( excluding regulatory activities directed to obtaining pricing and reimbursement approvals ) and all other activities, including any post - marketing commitments, necessary or reasonably useful or otherwise requested or required by aRegulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval and, to the extent notincluded in the foregoing, any other activities set out in the Global Development Plan