definiens: means the costs incurred by a party or for its account, during the term in accordancewith an Annual Development Plan, including Allocable Overhead ( but no other costs attributable to general corporateactivities ), that are specifically identifiable ( or reasonably allocable ) to the Development of a Licensed Product in the JointDevelopment Territory and that are directed to achieving or maintaining Regulatory Approval of such Licensed Product in theJoint Development Territory . The Joint Development Costs shall include amounts that a party pays to Third Parties involvedin the Development of a Licensed Product ( excluding any Third Party Commercial use Fees ), and all internal costs incurred bya party in connection with the Development of such Licensed Product . Joint Development Costs Exhibit A - 9 - [ * ] Confidential Treatment Request edinclude the following : ( a ) preclinical costs such as toxicology and formulation development, test method development, delivery system development, stability testing and statistical analysis ; ( b ) Clinical Costs ; ( c ) expenses related to adverse eventreporting ; ( d ) Manufacturing Costs for a Licensed Product for use in preclinical and clinical activities including theManufacture, purchase or packaging of comparators or placebo for use in clinical trials ( with the Manufacturing Costs forcomparators or placebo to be determined in the same manner as Manufacturing Costs are determined for any LicensedProduct ), as well as the direct costs and expenses of disposal of drugs and other supplies used in such clinical trials and anyassociated release testing and QA / QC development costs ; ( e ) development of the Manufacturing process for a LicensedProduct ( including with respect to any excipients or any active pharmaceutical ingredient included in such Licensed Products)and related scale - up, Manufacturing process validation, Manufacturing process improvements, and qualification andvalidation of Third Party contract manufacturers ; ( f ) regulatory expenses relating to Development activities for the purpose ofobtaining Regulatory Approval for an indication for a Licensed Product in the Joint Development Territory ; ( g ) costs of realproperty rented specifically for Development activities ( to the extent actually used ) ; and ( h ) other out - of - pocket developmentexpenses including, without limitation institutional and advisory review boards, investigator meetings, quality of life studies, epidemiology and outcomes research