definiens: means the costs incurred by a Party or for its account, during the term and pursuant to thisAgreement, that are specifically identifiable ( or reasonably allocable ) to the Development of a Co - Developed Product in theCo - Development Territory and that are directed to achieving or maintaining Regulatory Approval of such Co - DevelopedProduct in the Co - Development Territory . The Development Costs shall include amounts that a Party pays to Third Partiesinvolved in the Development of a Co - Developed Product ( [ * ] ), and all internal costs incurred by a Party in connection with theDevelopment of such Co - Developed Product . Development Costs include the following : ( a ) preclinical costs such astoxicology and formulation development, test method development, delivery system development, stability testing andstatistical analysis ; ( b ) Clinical Costs ; ( c ) expenses related to adverse event reporting ; ( d ) Manufacturing Costs for a Co - Developed Product for use in preclinical and clinical activities including the manufacture, purchase or packaging ofcomparators or placebo for use in clinical trials ( with the manufacturing costs for comparators or placebo to be determined inthe same manner as Manufacturing Costs are determined for any Product, and with the manufacturing costs for activepharmaceutical ingredients used in combination with a Product to be included at the cost of the Party providing such activepharmaceutical ingredient, without additional mark - up ), as well as the direct costs and expenses of disposal of drugs and othersupplies used in such Clinical Trials and any associated release testing and QA / QC development costs ; ( e ) [ * ] incurred inconnection with [ * ], to the extent provided therein ; and ( f ) development of the Manufacturing process for a Co - DevelopedProduct ( including with respect to any excipients or any active pharmaceutical ingredient included in such Co - DevelopedProducts ) and related scale - up, manufacturing process validation, manufacturing process improvements, and qualification andvalidation of Third Party contract manufacturers ; ( g ) regulatory expenses relating to Development activities for the purpose ofobtaining Regulatory Approval for an indication for a Co - Developed Product ; ( h ) costs of real property rented specifically forDevelopment activities ( to the extent actually used ) ; and ( i ) other out - of pocket development expenses including, withoutlimitation institutional and advisory review boards, investigator meetings, quality of life studies, epidemiology and outcomesresearch