definiens: shall mean, with respect to each Phase I Plan, andsubject to the cap in Section 5.1.3, those ( i ) costs and expenses directly incurred ( includingpersonnel costs and Allocable Overhead associated with employees and contractors of aParty ) with the performance of any Phase I Studies for Collaboration Compounds or Productsfor such Collaboration Target, ( ii ) costs associated with research or development of CompanionDiagnostics, and ( iii ) fees charged by Third Party service providers and other Out - of - PocketCosts reasonably incurred in connection with the performance of any Phase I Study withrespect to Collaboration Compounds or Products for such Collaboration Target, in each case, inaccordance with the applicable Phase I Plan and that are recorded as an expense inaccordance with IFRS or GAAP as applicable consistently applied . Phase I Development Costsshall include ( A ) the cost of studies on the toxicological, pharmacokinetic, metabolic, pharmacodynamic or clinical aspects of such Product conducted by individual investigators orconsultants in accordance with the applicable Phase I Plan and ( B ) expenses for datamanagement, statistical designs and studies, document preparation, and other expensesassociated with the clinical testing program for the applicable Phase I Plan