definiens: or means all activities related to ( a ) non - clinical and clinical research and drugdevelopment ( including preclinical testing and clinical trials ) related to obtaining, maintaining and/or expanding MarketingApproval ( excluding pricing and reimbursement approvals ), ( b ) Post - Marketing Commitments ; ( c ) manufacturing activities forthe purposes of producing clinical supplies ( or materials used in preclinical testing or research ), as well as test methoddevelopment and stability testing and process development and validation for a Product prior to the first Marketing Approvalof 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 ) statisticalanalysis, regulatory affairs, and activities directed towards obtaining Marketing Approval ( excluding regulatory activitiesdirected to obtaining pricing and reimbursement approvals ) and clinical study regulatory activities ( excluding regulatoryactivities directed to pricing and reimbursement approvals ) ; in each case, with * * * * * * - Material has been omitted and filed separately with the Commission