definiens: shall mean as to each Collaboration Target in the Field in theTerritory, those ( i ) costs and expenses directly incurred ( including personnel costs andAllocable Overhead associated with employees and contractors of a Party ) with theperformance of any clinical development activities ( other than Phase I Studies ) for CollaborationCompounds, Products or Licensed Products for such Collaboration Target, ( ii ) fees charged byThird Party service providers and other Out of Pocket Costs reasonably incurred in connectionwith the performance of any Clinical Study ( other than Phase I Studies ) with respect toCollaboration Compounds, Products, Licensed Products, or Companion Diagnostics for suchCollaboration Target, and ( iii ) all costs associated with research or development of CompanionDiagnostics, in each case, that are recorded as an expense in accordance with IFRS or GAAPas applicable and consistently applied . In addition, Development Costs shall include ( A ) the costof additional studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of suchProduct or Licensed Product conducted by individual investigators or consultants and ( B)expenses for data management, statistical designs and studies, document preparation, andother expenses associated with the clinical testing program for additional studies . For clarity, Development Costs for each Product or Licensed Product shall include ( a ) manufacturing andsupply costs and expenses associated with such Product or Licensed Product, and ( b ) costsrelated to preparing the initial regulatory dossier for such Product or Licensed Product