definiens: or means non - clinical and clinical drug or diagnosti c development activities, including drug metabolism and pharmacokinetics, tra nslational research, toxicology, pharmacology, test methoddevelopment and stability testing, process and pack aging development and improvement, process validati on, processscale - up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, conduct of Clinical Studies ( but excluding any Phase IIIb or Phase IV / Post - Appro val ClinicalStudy that is not required to obtain or maintain Re gulatory Approval ), regulatory affairs ( including p reparation forRegulatory Approval Application submission and othe r submission - related activities ), and Regulatory Ap proval andClinical Study regulatory activities ( excluding reg ulatory activities directed to obtaining Pricing an d ReimbursementApprovals ) . Development includes use and importatio n of the relevant compound or product to conduct su chDevelopment activities ( with related importation an d transportation costs only counted once as Develop ment Costsand not double counted elsewhere ) . Development shal l not include Research, Commercialization or Medica l AffairsActivities