definiens: means : ( a ) any compound which : [ ( i ) contains or comprises an [COMPANY] Scaffold or an [COMPANY] Scaffold together with anyone or more chemical groups covalently bound to such scaffold ; and ( ii ) Modulates FXR ] ; and ( b ) [ any salt, metabolite, prod rug, constitutional or geometric isomer, reglOisomer, stereoisomer ( including any enantiomer or diastereoisomer ), salt form, hydrate, solvate, polymorph or other physical form ] of any such compound ; 1.16 or means non - clinical and clinical research and development activities, including toxicology, pharmacology and other discovery efforts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies ( including pre - and post - approval studies ), regulatory affairs, pharmacovigilance and Regulatory Approval and clinical study regulatory activities ( including regulatory activities directed to obtaining pricing and reimbursement approvals )