Regulatory Expenses means, with respect to a Product, all Out-of-Pocket Costs incurred by or on behalf of a Party in connection with the preparation and filing of regulatory submissions for a Product and obtaining of Regulatory Approvals and any applicable governmental price and reimbursement approvals.
Regulatory Expenses means costs incurred to prepare Product regulatory submissions to maintain Regulatory Approval in the U.S. and to comply with post-Regulatory Approvals requirements of the FDA, including FDA user and other fees, reporting and regulatory affairs activities, and recalls and withdrawals for Products (other than costs for Products that are deductible from Net Sales or that are included as Development Costs).
Regulatory Expenses means [***].
Examples of Regulatory Expenses in a sentence
The Final Rule Will Require Plaintiffs to Undertake Significant Administrative and Regulatory Expenses.
The Corps budget accounts are: Investigations; Construction General; Operations and Maintenance; Mississippi Rivers & Tributaries; Formerly Utilized Sites Remedial Action Program (FUSRAP); Flood Control and Coastal Emergencies; Regulatory; Expenses; and Assistant Secretary of the Army.
Appropriations: For the purposes of the District/FOA Commander’s Recommendation, the MSC Commander’s Recommendation and the Chief of Engineer’s Recommendation, there are eight appropriation accounts in the CW Program: Investigations (I), Construction (C), Operation & Maintenance (O&M), Mississippi River and Tributaries (MR&T), Regulatory, Expenses, Formerly Utilized Sites Remedial Action Program (FUSRAP) and Flood Control and Coastal Emergencies (FCCE).
Appropriations: There are nine appropriation accounts in the Civil Works program: Investigations (I), Construction (C), Operation & Maintenance (O&M) Mississippi River and Tributaries (MR&T), Regulatory, Expenses, FUSRAP, Flood Control and Coastal Emergencies (FCCE), and OASA(CW).
We confirmed that the budget setting process takes into account relevant factors including income and expenditure expectations, level of service and the efficiency agenda.
More Definitions of Regulatory Expenses
Regulatory Expenses means, with respect to a Licensed Compound or Licensed Product, all FTE costs (at the FTE Rate) and Out-of-Pocket Costs incurred by or on behalf of a Party in connection with the preparation and filing of regulatory submissions for Licensed Product that are submitted in connection with the obtaining of, maintaining, enhancing or expanding Regulatory Approvals.
Regulatory Expenses 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 Regulatory Authorities) recorded as an expense in accordance with Accounting Standards by or on behalf of Xxxxxx 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 the preparation of regulatory submissions for, and the obtaining and maintenance of Regulatory Approval of, any Co-Promotion Product in the Co-Promotion Territory, including compliance with Regulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting and regulatory affairs activities, in each case in the Co-Promotion Territory, provided that such FTE Costs shall not be counted more than once as an Allowable Expense.
Regulatory Expenses means, with respect to a Development Candidate or related Drug Product, all out-of-pocket costs and fully allocated costs incurred by or on behalf of a party in connection with the preparation and filing of Registration Filings and the maintenance of Regulatory Approvals.
Regulatory Expenses meanss all costs incurred to comply with and to maintain all Regulatory Approvals and all regulatory agencies, including FDA user and other fees, reporting, and other regulatory affairs activities, including post-marketing safety surveillance and reporting.
Regulatory Expenses means, with respect to the applicable Calendar Quarter, the costs and expenses incurred by a Party or any of its Affiliates after the Execution Date in connection with filing, revising, obtaining or maintaining Regulatory Filings with respect to Product in the Field in the Territory in such Calendar Quarter in accordance with the Development Budget, excluding the Cost of Goods for Product used in conducting or performing such activities, calculated on a fully burdened basis (i.e., Regulatory Expenses shall include Allocable Overhead specifically attributable thereto). Regulatory Expenses shall include payments and accruals recorded in such Party’s accounting system according to its standard accounting practices and IFRS.
Regulatory Expenses means all costs incurred, with respect to Shared Products and Companion Diagnostics in any relevant country to obtain or comply with all Regulatory Approvals and requirements of all regulatory agencies, including FDA user and other fees, reporting, and other regulatory affairs activities recorded as an expense in accordance with GAAP, by or on behalf of a Party or any of its Affiliates during the Term and pursuant to this Agreement, that are specifically identifiable or reasonably allocable to the preparation of Regulatory Filings for, and the obtaining and maintenance of reimbursement for, and Regulatory Approval of, Shared Products for U.S. Administration, including without limitation compliance with requirements of such Regulatory Authorities, adverse event recordation and reporting, regulatory affairs activities, and all Product Recall Expenses.
Regulatory Expenses means those FTE Costs and direct out-of-pocket costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) recorded as an expense by or on behalf of a Party or any of its Affiliates or its (Sub)licensees during the Term of and pursuant to this Agreement, that are specifically identifiable or reasonably and directly allocable to the preparation of regulatory submissions for, and the obtaining and maintenance of Regulatory Approvals for, any Product, including compliance with Regulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting and regulatory affairs activities; provided that, with respect to a [***] Product, Regulatory Expenses shall only apply to those activities described in this Section 1.168 that pertain to the United States.