definiens: means the FTE Costs ( charged in accordance with Section 5.2.1(d)(ii ) ( FTE Records and Calculation ) ) incurred and the out -of - pocket costs recorded as an expense in accordance with GAAP, by or on behalf of a Party or any of its Affiliates, after the Effective Date and during the Term, that are incurred in accordance with the Joint Development Plan and Budget and specifically identifiable and directly attributable to the following Development activities with respect to a Product in the Territory, as applicable : ( a)pre -clinical and non -clinical activities such as toxicology an d formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis ; ( b)Clinical Trials for a Compound, Product or Diagnostic Product, including : ( i ) the preparation for and Conduct of Clinical Trials ; ( ii ) data collection and analysis and report writing ; ( iii ) clinical laboratory work ; ( iv ) regulatory activities in direct connection with such studies, including adverse event recording and reporting ; and ( v ) advisory meetings in conn ection with a Compound, Product or Diagnostic Product ; ( c)the preparation of a regulatory dossier to the extent necessary to obtain any Regulatory Approval for a Product in the Territory and filing fees in connection with the filing of applications for Reg ulatory Approvals ; ( d)(i ) Manufacturing of Compound, Product or Diagnostic Product for use in Clinical Trials or other Development activities for such Compound, Product or Diagnostic Product ; ( ii ) the Manufacture, purchase or packaging of comparators or p lacebo ( to the extent required by Clinical Trial design ) for use in Clinical Trials for a Compound, Product or Diagnostic Product ( with the manufacturing costs for comparators or placebo ( to the extent required by Clinical Trial design ) to be determined in the same manner as Manufacturing Costs are determined for such Compound, Product or Diagnostic Product ) ; and ( iii ) costs and expenses of disposal of drugs and other supplies used in such Clinical Trials or other Development activities ; -9- ( e)Third Pa rty Payment, including the appropriate allocable portion of upfront payments ; ( f)Diagnostic Third Party Payments ; ( g)maintaining the Global Safety Database ( and, if applicable, the parallel safety database ) pursuant to Section 9.2 ( Global Safety Database ) ; and ( h)costs for the establishment of the Manufacturing process for a Compound, Product or Diagnostic Product, scale -up, Manufacturing process validation, including validation batches, Manufacturing improvements and qualification and validation of Third Party contract manufacturers, but not including the purchase or construction of capital equipment, capital assets or real estate for the purposes of building manufacturing facilities and capabilities