definiens: means, to the extent incU!fed for Clinical Trials conducted for the Initial Indication in accordance with the Clinical Plan : ( i ) expenses related to trial planning, mat ~ rials, · clinical site recruiting, training and participation, monitoring of clinical sites, data analysis and data quality assurance, preparing documents for initial fillings for Regulatory Authority submission ( including, but not limited to, all fees paid to cliirlcal investigators, consultants and CROs ) ; ( ii ) expenses related to planning, managing, carrying out, analyzing and preparing reports of pre - clinical studies necessary to submit as part of initial regulatory marketing applications ; ( iii ) travel expenses related to planning meetings, clinical development or regulatory submissions ; and ( iv ) a .reasonable allocation of overhead associated with the conduct of such activities ( not to exceed It 62 % lof [COMPANY] ' 8 direct labor * * * costs ) and of general and administratiye expenses in support of Clinical Trials ( not to exceed l!!ffiof the sum of ( i ), ( ii ) and ( iii » . shall not 4lclude any costs * * * incurred to conduct the · Phase V testing referred to in Exhibit A