definiens: shall mean the costs recorded as an expense in accordance with GAAP, by or on behalf of aParty or any of its Affiliates on or after the Original Execution Date pursuant to this Agreement in performing the tasks that arespecifically identified in, or reasonably allocable to, the Development Budget and the Americas / Europe Development Planspecifically with respect to Europe or the United States . Subject to the foregoing, Development Costs shall include such costsincurred in connection with only the following activities, but excluding in each case any costs incurred solely with respect toobtaining Regulatory Approvals in jurisdictions other than Europe or the United States : ( a ) non - clinical activities such as toxicology and formulation development, test method development, excluding thedevelopment and testing of a hENT1 Biomarker Assay ; ( b ) Clinical Studies and Post Approval Studies for a Licensed Product, including ( a ) the preparation for and conductof clinical trials, including quality assurance and quality control ; ( b ) data collection and analysis and report writing;(c ) clinical laboratory work ; and ( d ) regulatory activities in connection with such studies, including adverse event recordationand reporting ; ( c ) the direct costs for time recorded by a Party ’s personnel in performing Development activities, which shall becharged at the FTE Rate;- 6 - ( d ) the preparation of a regulatory dossier reasonably necessary to obtain Initial Regulatory Approval for a LicensedProduct in the United States and Europe ; ( e ) Manufacturing Costs for ( i ) a Licensed Product for use in Clinical Studies, Post Approval Studies or otherDevelopment activities for such Licensed Product, ( ii ) the manufacture, purchase or packaging of comparators or placebo foruse in Clinical Studies or Post Approval Studies for a Licensed Product ( with the manufacturing costs for comparators orplacebo to be determined in the same manner as Manufacturing Costs are determined for any Licensed Product ) and ( iii ) costsand expenses of disposal of drugs and other supplies used in such Clinical Studies, Post Approval Studies or otherDevelopment activities ; ( f ) Clinical trial insurance and Losses incurred in connection with Third Party Claims described in Section 13.3 to theextent such Losses are to be included in Development Costs pursuant to Section 13.3 ; and ( g ) Costs for the development of the Manufacturing Process for a Licensed Product, scale - up, stability testing, qualityassurance, quality control development, Manufacturing Process validation, including validation batches ( other than those thatare commercially saleable upon Regulatory Approval ), manufacturing improvements and qualification and validation of ThirdParty contract manufacturers