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 ), as well as the direct costs and expenses of disposalof drugs and other supplies used in such Clinical Trials and any associated release testing and QA / QC development costs;(e ) [ * ] incurred in connection with [ * ], to the extent provided therein ; and ( f ) development of the Manufacturing process for aCo - Developed Product ( including with respect to any excipients or any active pharmaceutical ingredient included in such Co - Developed Products ) and related scale - up, manufacturing process validation, manufacturing process improvements, andqualification and validation of Third Party contract manufacturers ; ( g ) regulatory expenses relating to Development activitiesfor the purpose of obtaining Regulatory Approval for an indication for a Co - Developed Product ; ( h ) costs of real propertyrented specifically for Development activities ( to the extent actually used ) ; and ( i ) other out - of pocket development expensesincluding, without limitation institutional and advisory review boards, investigator meetings, quality of life studies, epidemiology and outcomes research