definiens: means the costs and expenses incurred by Asahi or its Affiliates attributable to, or reasonablyallocable to, the preparation, obtaining or maintaining of Regulatory Materials and Regulatory Approvals for the Product(other than Pricing Approval and Manufacturing - related Regulatory Approvals ), including any filing fees and such costs andexpenses incurred by [COMPANY] or its Affiliates to the extent requested by Asahi or required by this Agreement . shall include ( i ) Out - of - Pocket Costs and ( ii ) internal costs ( e.g., staff or administrative ) that are specificallyattributable to the preparation of Regulatory Materials, and obtaining or maintenance of Regulatory Approvals, for theProduct in the Field in the Territory . For clarity, Regulatory Costs shall exclude Development Costs and any costs andexpenses incurred by [COMPANY] or its Affiliate to supply Regulatory Data that are already in the possession of [COMPANY] or itsAffiliates other than as a result of [COMPANY] ’s obligations hereunder