definiens: . Development means those activities conducted pursuant to a Joint Development Plan, includingnon - clinical ( including, without limitation, pre - clinical ) and clinical drug development activities and related research for aLicensed Product, including, among other things : ( a ) pharmacology studies, ( b ) absorption, distribution, metabolism, elimination ( ADME ) studies, ( c ) toxicology studies, ( d ) statistical analysis and report writing, ( e ) drug Manufacture, formulation and packaging for non - clinical and clinical work, ( f ) compliance related monitoring and activities for theforegoing ( including, but not limited to, biometry, data management, drug safety, integrated analysis, and health andeconomic research ), ( g ) clinical trials for the purpose of obtaining or maintaining Regulatory Approval ( excluding post - marketing studies ), ( h ) safety related studies and risk management programs for the foregoing, ( i ) regulatory affairs related toall of the foregoing, and ( j ) any other activities agreed to by the Parties . Development shall not include Research . When usedas a verb, means to engage in Development