ANDA Filing definition

ANDA Filing means with respect to Generic Tussionex, the abbreviated new drug application requesting permission to place a drug on the market in accordance with section 505(j) of the FDCA (21 U.S.C. 355(j)) and 21 C.F.R. 314, Part 314 Subpart C, and all supplements filed pursuant to the requirements of the FDA, including all documents, data and other information concerning the applicable drug which are necessary for FDA approval to market the drug in the United States.
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ANDA Filing means that a Third Party files an ANDA with the FDA with regard to a Product in the [†] period after the expiration of the last to expire of U.S. Patents Nos. [†] and [†] (including any patent term extension thereof).
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ANDA Filing has the meaning set forth in Section 7.6.
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Examples of ANDA Filing in a sentence

  • Inc., Civil Action No. 05-CV-1089 (JCL), pending in the United States District Court for the District of New Jersey; and (c) any action filed under Title 35, United States Code, 35 U.S.C. §§ 271 and 281 against any Modafinil Paragraph IV ANDA Filing Entity.

  • As such, only the Regulatory Consultant shall have access to the unredacted ANDA Filing and batch records containing CPI’s RC Confidential Information.

  • The Parties acknowledge that Neos owns the ANDA Filing, including, without limitation, the CMC Section thereof.

  • CPI shall source all bulk materials, active ingredients, excipients and other manufacturing and test materials needed in order to manufacture and release Products in accordance with this Agreement and the ANDA Filing.

  • PFIZER shall have the only right, but no obligation, to initiate patent infringement litigation based on any ANDA Filing concerning any Athersys Exclusive Patent Rights in connection with the Field, at its own expense.

  • In the event of an ANDA Filing, then: (i) the time period for giving notice set forth in Section 7.4(a) shall be [*], and (ii) the time period for bringing an Action set forth in Sections 7.4(b) shall [*], or such shorter time period as may be required in order to avoid a loss of rights under Applicable Laws.

  • Subject to the special circumstances of Section 7.6 (ANDA Filing), if Company does not take steps to xxxxx such infringement or does not intend to prosecute or defend an Action within [*] after receiving notice or otherwise becoming aware of such infringement or claim, Company shall promptly inform MRKDG and MRKDG then shall have the right, but not the obligation, to attempt to resolve such infringement or claim, including by filing an Action and to compromise or settle any such infringement or claim.

  • The Parties have further agreed, pursuant to Section 9.2 of the Agreement, that CPI will file a DMF for DRC and NEOS will file a Supplemental Application with respect to the ANDA Filing.

  • Each Party agrees that its activities under this QAA will be conducted in accordance with applicable Laws and such Party’s SOPs. The Parties acknowledge and agree that certain of CPI’s confidential and proprietary information regarding the manufacture of DRC is contained within the CMC Section of the ANDA Filing (“CPI RC Confidential Information”) to which NEOS shall not have access.

  • For purposes of clarity, nothing in this Agreement or in the Provigil Settlement Agreement shall obligate Cephalon to seek injunctive or other relief to stop any Other Modafinil Paragraph IV ANDA Filing Entity from offering to sell or selling Subject Modafinil Products in the United States.


More Definitions of ANDA Filing

ANDA Filing means that a Third Party files an ANDA with the FDA with regard to a Product in the [†] period after the expiration of the last to expire of U.S. Patents Nos. [†] and [†] (including any patent term extension thereof). [†] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
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Related to ANDA Filing

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications, and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences, or discussions with any Regulatory Authority).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • HSR Filing means filings with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the subject matter of this Agreement, together with all required documentary attachments thereto.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Regulatory Filings means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

  • MAA means a marketing authorization application filed with the EMA after completion of Clinical Studies to obtain Approval for a Product under the centralized European filing procedure or, if the centralized EMA filing procedure is not used, filed using the applicable procedures in any European Union country or other country in Europe.

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Company Filings means all documents publicly filed by or on behalf of the Company on SEDAR since January 1, 2014.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • ANDA means Abbreviated New Drug Application.

  • Regulatory Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, listings, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies necessary for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product in any country or jurisdiction, including any Investigational Application.

  • Filings the filing or recording of (i) the Financing Statements as set forth in Schedule 3, (ii) this Agreement or a notice thereof with respect to Intellectual Property as set forth in Schedule 3, and (iii) any filings after the Closing Date in any other jurisdiction as may be necessary under any Requirement of Law.

  • Regulatory Authorities means the Commissions and the Exchange;

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Other Filings has the meaning set forth in Section 6.8(a).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.