definiens: means those FTE Costs ( charged in accordance with Section 6.7 ) ( i ) incurred and thedirect out - of - pocket costs recorded as an expense in accordance with Accounting Standards by or on behalf of aParty 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