Regulatory Expenses definition

Regulatory Expenses means, with respect to the Licensed Products, all 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 Products and obtaining of Regulatory Approvals and any applicable governmental price and reimbursement approvals.

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 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).

Examples of Regulatory Expenses in a sentence

• Licensee shall provide Licensor with an invoice for such amount, along with documentation evidencing the actual payment made by Licensee with respect to the Regulatory Expenses.

• Upon mutual agreement of Licensor and Licensee, Licensor shall have the option, at any time during the Initial Term, to reimburse Licensee for all Regulatory Expenses up to, but not exceeding, the Reimbursement Cap, with all Regulatory Expenses in excess of the Reimbursement Cap and any additional fees and expenses incurred thereafter for maintaining the Regulatory Approvals to be borne by Licensee.

• 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).

• 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.

• 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.

More Definitions of Regulatory Expenses

Regulatory Expenses means [***].

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 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.

Regulatory Expenses has the meaning set forth in Exhibit C.

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, including without limitation compliance with requirements of such Regulatory Authorities, adverse event recordation and reporting, regulatory affairs activities, and all Product Recall Expenses.