Regulatory Expenses definition

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.

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Regulatory Expenses means [***].

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.

Examples of Regulatory Expenses in a sentence

• If, in a Calendar Year, Regulatory Costs incurred by M Local Affiliates are unusually high, the EMEA Operating Board may modify the Regulatory Expenses Cap to take into account such unusual circumstances.

• The costs of any such recall or withdrawal relating to: (i) the Development of a Product for an indication prior to the approval of the Drug Approval Application (or compendia listing, as the case may be) for such indication; or (ii) the Commercialization of a Product shall each be included in Regulatory Expenses.

• In the event Impax chooses option (a), above, the Parties shall share equally all future Regulatory Expenses and Intellectual Rights Legal Expenses, attributable to such Product(s) in such countries in the Territory, and Impax shall receive the Impax Margin for the applicable Product(s).

• Within sixty (60) days following launch of the applicable terminated Tier 2 Product(s) by Impax or Impax’s Affiliate, nominee, assignee, licensee or other similar entity, Impax shall reimburse Teva an amount equal to all Regulatory Expenses and Intellectual Rights Legal Expenses paid by Teva under this Agreement with respect to the applicable Tier 2 Product(s).

• ALLERGAN shall reimburse MAP for fifty percent (50%) of Allowable Regulatory Expenses incurred by MAP.

More Definitions of Regulatory Expenses

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 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 Costs and Expenses incurred by a Party or any of its Affiliates in conducting regulatory activities in accordance with the applicable Development Plan with respect to Product in the Field for the United States.

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 has the meaning set forth in Exhibit C.

Regulatory Expenses. Regulatory Expenses means, with respect to the Licensed Compound or the Licensed Product, all FTE costs and Out-of-Pocket Costs incurred by or on behalf of a Party in connection with the preparation and filing of regulatory submissions for the Licensed Compound or the Licensed Product and obtaining of Regulatory Approvals.

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.