Drug Application definition

Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

Drug Application means (a) New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) as those terms are defined in section 505 of the FDCA, or (b) a Biologics License Application (BLA) (including a biosimilar application), as that term is defined in section 351 of the PHSA, for any Product, as appropriate, in each case of Parent or any Subsidiary.

Drug Application means an NDA, MAA, or equivalent application, submitted to a Regulatory Authority in a particular jurisdiction, for marketing approval of a pharmaceutical or drug product.

Examples of Drug Application in a sentence

• To the extent required by applicable laws and regulations of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

• The records for all studies performed under an IND will be maintained, at a minimum, for two years after the approval of a New Drug Application (NDA).

• In such a case, the appropriate submission would be an Abbreviated New Drug Application (ANDA) that cites the duplicate product as the reference listed drug.

• The mixing together of two or more products does not constitute a "new" drug as regulated by the Food and Drug Administration (FDA) under the New Drug Application (NDA) process.

• To the extent required by applicable Laws of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable Laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

More Definitions of Drug Application

Drug Application means a pending or approved new drug application, an abbreviated new drug application or a biologic license application, including a section 351(k) application, or an investigational new drug exemption, for any Teligent Product, as appropriate, as those terms are defined in the Food Drug Cosmetic Act and any and all Intellectual Property relating thereto, solely as applied to the Product covered thereunder.

Drug Application means a New Drug Application or an Abbreviated New Drug Application, as those terms are defined in the FDCA and the FDA regulations promulgated thereunder, for any Included Product, as appropriate, in each case of the Company or any Subsidiary.

Drug Application means any New Drug Application (NDA) filed with the FDA, any Abbreviated New Drug Application (ANDA) filed with the FDA, any Supplemental New Drug Application (sNDA) filed with the FDA, any product license or any equivalent drug application or similar pharmaceutical product approval administered by any foreign Governmental Authority, or extension or renewal of any of the foregoing.

Drug Application means any New Drug Application filed with the United States Food & Drug Administration (“FDA”), any Abbreviated New Drug Application filed with the FDA, any Supplemental New Drug Application filed with the FDA, any product license or any equivalent drug application or similar pharmaceutical product approval administered by any foreign Governmental Body, or extension or renewal of any of the foregoing.

Drug Application means a New Drug Application (including a supplemental New Drug Application), a Biologics License Application, an Abbreviated New Drug Application, or a product license application, as those terms are defined in the Food, Drugs and Cosmetics Act (21 U.S.C. ch. 9 § 301 et seq.), for any Product, as appropriate, in each case of the Borrower or any Subsidiary, and equivalents thereof, including Conditional Marketing Authorizations, for submission to Governmental Authorities outside of the United States.

Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FD&C Act, and as may be similarly defined or expressed under the FDA Canada, the CDSA, or as related to or in connection with any drug application under, but not limited to, the FDA Canada, Health Canada, the Therapeutic Products Directorate of Health Canada or the CDSA EBITDA means, for any Person and its Subsidiaries for any period, Consolidated Net Income for such period plus, to the extent deducted in determining such Consolidated Net Income for such period (and without duplication), (i) Interest Expense, (ii) income tax expense (including tax accruals), (iii) depreciation and amortization, (iv) in the case of the Loan Parties, management fees, transaction fees and out-of-pocket expenses paid to its Affiliates to the extent permitted under Section 7.3, (v) nonrecurring cash fees, costs and expenses incurred in connection with the Acquisitions of product licenses and product lines from a third party, and milestone and royalty payments to any third party, in relation to any Material Contract or any other Acquisition made prior to the date of this Agreement, (vi) non-cash expenses relating to equity-based compensation or purchase accounting and (vii) other non-recurring and/or non-cash expenses or charges approved by the Agent. CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDA Law and Regulation. EBITDA means, for any Person and its Subsidiaries for any period, Consolidated Net Income for such period plus, to the extent deducted in determining such Consolidated Net Income for such period (and without duplication), (i) Interest Expense, (ii) income tax expense (including tax accruals), (iii) depreciation and amortization, (iv) nonrecurring cash fees, costs and expenses incurred in connection with the Acquisitions of product licenses and product lines from a third party, and milestone and royalty payments to any third party, in relation to any Material Contract or any other Acquisition made prior to the date of this Agreement, (v) non-cash expenses relating to equity-based compensation or purchase accounting, and (vi) other non-recurring and/or non-cash expenses or charges approved by the Agent.