definiens: means those FTE Costs ( charged in accordance with Section 6.10.3)(i ) incurred and the direct out - of - pocket costs ( including filing, user, maintenance and other fees paid to RegulatoryAuthorities ) recorded as an expense in accordance with Accounting Standards by or on behalf of [COMPANY] or any of itsAffiliates after the Effective Date, during the Term of and pursuant to this Agreement, and ( ii ) specifically identifiableor reasonably allocable to the preparation of regulatory submissions for, and the obtaining and maintenance ofRegulatory Approval of, any Co - Promotion Product in the Co - Promotion Territory, including compliance withRegulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting andregulatory affairs activities, in each case in the Co - Promotion Territory, provided that such FTE Costs shall not becounted more than once as an Allowable Expense