definiens: or means all actIVitIes related to ( a ) non - clinical and clinical researcb and drug development ( including preclinical testing and clinical trials ) related to obtaining, maintaining and/or expanding Marketing Approval ( excluding pricing and reimbursement approvals ), ( b ) Post Marketing Commitments:(c ) manufacturing activities for the purposes of producing clinical suppl ( or materials used in preclinical testing or research ), as well as test method development and stability testing and process development and validation for a Product prior to the lirst Marketing Approval of such Product ( including manufacturing batches for validation and registration purposes ), formulation development, delivery system development quality assurance and quality control development for clinical supplies . and ( d ) statistical analysis, regulatory afiairs, and activities directed towards obtaining Marketing Approval ( excluding regulatory activities directed to obtaining pricing and reimbursement approvals ) and clinical study regulatory activities ( excluding regulatory activities directed to pricing and reimbursement approvals ) ; in each case, with respect to the Products in the Field for the TerrilOry . For clarity, and shall not include Manu1acturing or Commercialization