Actavis ANDA definition

Actavis ANDA means ANDA No. 206210 (together with any amendments, supplements, replacements or other changes thereto) seeking approval to engage in the Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.
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Actavis ANDA means ANDA No. 204982, including all amendments, supplements and Replacements thereto as may be required by the FDA in order to obtain FDA approval thereof.
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Actavis ANDA means ANDA No. 207338 as of the Effective Date and any later filed amendments, supplements or replacements thereto seeking approval of a generic product that is AB-Rated to Abstral, excluding additions or substitutions of ingredients which constitute a major amendment to ANDA No. 207338, or if post approval, the addition or substitution requires FDA approval pursuant 21 CFR 314.70(b).
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Examples of Actavis ANDA in a sentence

  • Actavis admits, solely with respect to the Actavis ANDA, the Actavis Product and the Pending Litigation, that the Litigated Patents, and all the claims contained therein, are valid and enforceable.

  • Supernus has prosecuted, and Actavis has defended, an action for patent infringement in the United States District Court for the District of New Jersey (the “Court”) regarding the Actavis ANDA and the Actavis Product, which action is captioned Supernus Pharmaceuticals, Inc.

  • Actavis will agree not to itself, or assist or enable a third party, to: (i) challenge the validity or enforceability of the Patents-in-Suit with respect to the Actavis ANDA or a generic Trokendi XR® Product; or (ii) make, use, sell, offer for sale, and/or import, or otherwise contract with any third party regarding making, using, sale, offer for sale, and/or importation of a generic Trokendi XR® product.

  • Notwithstanding the foregoing, nothing in this Agreement precludes Actavis from (y) maintaining and/or (e.g., in the case of a recertification pursuant to 21 C.F.R.§ 314.96(d)) filing Paragraph IV certifications with respect the Actavis ANDA against the Licensed Patents, or (z) challenging the validity, enforceability and/or infringement of the Licensed Patents in connection with another ANDA or ANDA product owned or sold by Actavis that is not seeking Regulatory Approval of a Generic Equivalent Product.

  • In response, Dr. Fleischer opines on “regulatory issues involved with the review and approval of Amneal’s ANDA 203136 [and] Actavis ANDA 91422.” (Decl.

  • For the avoidance of doubt, nothing in this Section 3.1 (or any other provision of the Settlement Documents) shall in any way preclude or prohibit (i) any act reasonably related to obtaining FDA approval of the Actavis ANDA, (ii) any act protected by 35 U.S.C. § 271(e)(1), (iii) the manufacturing of batches of Actavis ANDA Products necessary for FDA approval (e.g., ** for the purposes of **), or (iv) ** or ** from ** or ** or ** at any time or ** the ** to any ** for ** into a **.

  • Actavis represents and warrants that it has not granted or assigned to any third party, directly or indirectly, any right or license under or to the Actavis ANDA or the Actavis Topiramate XR Products, and covenants that it shall not do any of the foregoing.

  • Solely with respect to the Actavis ANDA, Actavis Topiramate XR Products, and the Pending Litigation, Actavis hereby admits, but for the license granted herein, that U.S. Patent Nos.

  • For any of the Licensed Patents listed in the Orange Book for Trokendi XR, the Covenant Not to Xxx will hereby be treated as a non-exclusive license, so that Actavis or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) and 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect to the Actavis ANDA.

  • For the avoidance of doubt, nothing in sub-sections d or f preclude Actavis from filing or maintaining its PIV certifications against the Licensed Patents with respect to the Actavis ANDA, challenging the Licensed Patents with respect to another product other than Trokendi XR®.


More Definitions of Actavis ANDA

Actavis ANDA means Actavis’ ANDA No. 205063 and any amendments, supplements or replacements thereto, so long as there is no change to the active ingredient, dosage form, Reference Listed Drug or AB rating or the label (except to meet statutory or express FDA requirements) of the Actavis Generic Product as defined herein as of the Execution Date of this License Agreement.
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Actavis ANDA means Actavis’s ANDA No. 209253 as supplemented and amended as of the Execution Date of this License Agreement and including any Permitted Modification after the Execution Date of this License Agreement.
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Related to Actavis ANDA

  • Subco means 0961994 B.C. Ltd., a company existing under the laws of the Province of British Columbia;

  • Acquisition Subsidiary shall have the meaning ascribed to it in the preamble hereto.

  • Representative of the news media means any person actively gathering news for an entity that is organized and operated to publish or broadcast news to the general public.

  • Related Financial Product means any financial product which references directly or indirectly the Preference Shares.

  • Holding Company Transaction means the occurrence of (a) any transaction (including, without limitation, any acquisition, merger or consolidation) the result of which is that a “person” or “group” within the meaning of Section 13(d) of the Securities Exchange Act of 1934, as amended, (i) becomes the direct or indirect ultimate “beneficial owner,” as defined in Rule 13d-3 under that Act, of common equity of the Issuer representing more than 50% of the voting power of the outstanding Common Stock or (ii) is otherwise required to consolidate the Issuer for purposes of generally accepted accounting principles in the United States, or (b) any consolidation or merger of the Issuer or similar transaction or any sale, lease or other transfer in one transaction or a series of related transactions of all or substantially all of the consolidated assets of the Issuer and its subsidiaries, taken as a whole, to any Person other than one of the Issuer’s subsidiaries; provided that, in the case of either clause (a) or (b), the Issuer or the Acquiror is or becomes a Bank Holding Company or Savings and Loan Holding Company.

  • CCC means Customer Care Centre

  • mixed financial holding company means a mixed financial holding company as defined in point (21) of Article 4(1) of Regulation (EU) No 575/2013;

  • WCB means the Workers Compensation Board.

  • haemophilia means an inheritable disease, usually affecting only male but transmitted by women to their male children, characterised by loss or impairment of the normal clotting ability of blood so that a minor would may result in fatal bleeding;

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • CTS means the market rules that allow transactions to be scheduled based on a bidder’s willingness to purchase energy from a source in either the NYISO or PJM Control Area and sell it at a sink in the other Control Area if the forecasted price at the sink minus the forecasted price at the corresponding source is greater than or equal to the dollar value specified in the bid.

  • Bidco means a business and industrial development company licensed under this act. The term includes a business development enterprise.

  • Eligible next Michigan business means that term as defined in section 3 of the Michigan economic growth authority act, 1995 PA 24, MCL 207.803.

  • ANDA means Abbreviated New Drug Application.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • CMBI means Chase Manhattan Bank International, an indirect wholly-owned subsidiary of Bank, located in Moscow, Russia, and any nominee companies appointed by it.

  • Successor Holdings has the meaning assigned to such term in Section 6.03(a)(v).

  • Apex means a point on an alluvial fan or similar landform below which the flow path of the major stream that formed the fan becomes unpredictable and alluvial fan flooding can occur.

  • Spectrum means frequencies of electromagnetic spectrum used to provide fixed or mobile communications services as licensed or authorized by the FCC.

  • Acquiring Company means a person who obtains Control of the Company;

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • parent financial holding company in a Member State means a financial holding company which is not itself a subsidiary of an institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in the same Member State;

  • OPWC means the Ohio Public Works Commission created pursuant to Revised Code Section 164.02.

  • cannabis resin means the separated resin, whether crude or purified, obtained from any plant of the genus Cannabis;

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.

  • Natural parent means a minor's biological or adoptive parent, and includes the minor's noncustodial parent.