definiens: means those FTE Costs ( charged in accordance with Section 6.10.3 ) ( i ) incurredand the direct out - of - pocket costs recorded as an expense in accordance with Accounting Standards by or on behalfof a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement, and(ii ) specifically identifiable or reasonably allocable to Phase 4 Studies, wherever Conducted, of a Co - PromotionProduct in support of Commercialization of such Co - Promotion Product in the Co - Promotion Territory . Subject to theforegoing, Phase 4 Costs shall include ( i ) costs in connection with the preparation for, or Conduct of, Phase 4Studies, data collection and analysis and report writing, and clinical laboratory work, ( ii ) related Regulatory Expenses, and ( iii ) related Manufacturing Costs, provided that such Phase 4 Costs shall not be counted more than once as anAllowable Expense