Generic Entry Date definition

Generic Entry Date means the date in a Brand/Generic Settlement Agreement, whether certain or contingent, on or after which a Generic Filer is authorized by the NDA Holder to begin manufacturing, using, importing, or Marketing the Generic Subject Drug Product.
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Generic Entry Date is defined in Article 4 below.
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Generic Entry Date means the earlier of (i) April 1, 2021, if Par is not entitled to the 180-day first-filer exclusivity period described in 21 U.S.C. § 355(j)(5)(B)(iv); (ii) October 1, 2020, if Par is entitled to the 180-day first-filer exclusivity period described in 21 U.S.C. § 355(j)(5)(B)(iv); (iii) 12:01 a.m. Eastern Time on the day after a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken, holding the then-asserted and adjudicated claims of the Licensed Patents at issue in the case in which such decision is entered to be invalid, unenforceable, or not infringed by a Generic Equivalent (an “Adverse Decision”); or (iv) the earlier of: (a) thirty (30) days after the date that a Third Party commences sales of a Generic Equivalent without permission, license, acquiescence or authorization by BioMarin or its Affiliates (“At Risk Launch”), provided that BioMarin has not obtained by that time a decision or order by any court granting an application for a preliminary or permanent injunction, temporary restraining order, or [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. other injunctive or equitable relief with respect to the unlicensed product that is the subject of the Third Party At-Risk Launch; (b) denial of the aforementioned application for a preliminary or permanent injunction, temporary restraining order, or other injunctive or equitable relief; or (c) ten (10) days after an At Risk Launch if BioMarin or its Affiliates fail to seek the aforementioned preliminary or permanent injunction, temporary restraining order, or other injunctive or equitable relief during that ten (10) day period. If (i) BioMarin obtains a court order from any court requiring the cessation of sales of the unlicensed product that is the subject of the Third Party At-Risk Launch, or (ii) the Third Party ceases sales of the unlicensed product that is the subject of the Third Party At-Risk Launch, by agreement or otherwise, Par will cease any further shipping and sales of the Par ANDA Products until the occurrence of the Generic Entry Date (as determined without reference to such Third Party At-Risk Launch) or such date that is mutually agreed upon, and no other obligation or attendant liability shall otherwise accrue.
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Examples of Generic Entry Date in a sentence

  • Section 505(b)(2) or 505(j) of the Act referencing NDA No. 022434 (hereinafter, a “Generic Equivalent”) by a date certain (hereinafter, a “Licensed Generic Entry Date”), Eagle shall provide written notice of such authorization or license to Sandoz, including the Licensed Generic Entry Date and the material terms of such authorization or license, within [*], but in no event later than [*] before the date upon which the Generic Equivalent may be sold in the Territory.

  • Effective as of the applicable Generic Entry Date (as defined below) and subject to the terms and conditions of this Agreement, Licensors hereby grant Actavis a fully paid up, royalty-free, irrevocable (except as provided in Paragraph 11) license under the Licensed Patents in the Territory, to make, have made, import, have imported, store, use, distribute, have distributed, sell and offer for sale Actavis Generic Tablets in the Territory (all of the foregoing, the “License”).

  • The license granted in the preceding sentence shall be exclusive as to Third Party Generic Tablets for a period of one hundred and eighty (180) days after the Generic Entry Date, and shall thereafter be non-exclusive.

  • The License commences as to a specific Actavis Generic Tablet on the Generic Entry Date that is applicable to that Actavis Generic Tablet and continues until the last to expire of each of the Licensed Patents (including any extensions thereof) and/or regulatory exclusivities associated therewith, so long as the Agreement remains in effect.

  • Licensors represent and covenant to Actavis that the terms of the Agreement being offered to Actavis are and will be equivalent to or better than the terms being offered by Licensors or its Affiliates to any Third Party with respect to any license(s) or other permissions(s) to Generic Tablets (“Third Party Agreement”) with respect to Paragraphs 1, 2, 3 and 9 (License, Pre-Marketing Activities, Generic Entry Date and Notice of Authorized Generic).

  • Under the License Agreement, we granted Par a non-exclusive license (that is only royalty-bearing in some circumstances) to manufacture and commercialize Par’s generic version of DUEXIS in the U.S. after the Generic Entry Date and to take steps necessary to develop inventory of, and obtain regulatory approval for, but not commercialize, Par’s generic version of DUEXIS prior to the Generic Entry Date.

  • Licensors and their Affiliates hereby waive, with respect to the Actavis ANDA and Actavis Generic Tablets only, any and all regulatory exclusivities for Xxxxx® that may prevent approval or marketing of the Actavis Generic Tablets in the Territory under the Actavis ANDA as of the Generic Entry Date.

  • Further, notwithstanding the Generic Entry Date and the restrictions contained herein, Actavis and its Affiliates shall be permitted to manufacture, have manufactured, import, store or otherwise take such steps necessary to develop inventory of the Actavis Generic Tablets in advance of the Generic Entry Date for the purpose of preparing for the launch of the Actavis Generic Tablets on or after the Generic Entry Date.

  • The Generic Entry Date is January 1, 2023; however, Par may be able to enter the market earlier in certain circumstances.


More Definitions of Generic Entry Date

Generic Entry Date means the date of first regulatory or marketing approval in the Net Sales Territory of a generic equivalent to any Product, including, but not limited to, a product covered by an Abbreviated New Drug Application (ANDA) which references the initial New Drug Application (NDA) filed by LICENSEE or a sublicensee for such Product.
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Generic Entry Date means the first date that a third party who is not an Affiliate or sublicensee of Takeda or BioNumerik is legally distributing a generic version of the Product in the Territory, or just in the United States, and is not being sued by either BioNumerik or Takeda regarding the Product.
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Generic Entry Date means the date of the first bona fide, arm’s length commercial sale of an Equivalent Product in the Territory by a Non-Party. ..
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Generic Entry Date means the earliest to occur of the following dates, as applicable to each specific strength of Actavis Generic Tablets:
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Generic Entry Date means the earliest to occur of the following:
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Related to Generic Entry Date

  • Entry Date means the Effective Date of the Plan and each January 1 and July 1 of each Plan Year after the Effective Date.

  • Plan Entry Date means the Effective Date and: (Choose (d), (e) or (f))

  • Final Order Entry Date means the date on which the Final Order is entered by the Bankruptcy Court.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

  • Commercial Launch means on a country-by-country basis, the first sale of a Product to a Third Party following Regulatory Approval of the Product in such country.

  • Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Domestic end product as used in this clause, means, (1) an unmanufactured end product mined or produced in the United States, or (2) an end product manufactured in the United States, if the cost of its components mined, produced, or manufactured in the United States, exceeds 50 percent of the cost of all its components. Components of foreign origin of the same class or kind as the products referred to in paragraphs (b)(2) or (3) of this clause shall be treated as domestic. Scrap generated, collected, and prepared for processing in the United States is considered domestic.

  • Current placement episode means the period of time that

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Eligible Product means, instead of the definition in FAR 25.003—

  • Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.

  • Commencement Date or Handover Date means the date on which the Licensed Space of first lot of stations as per Annexure 1 is handed over by DMRC to the Selected Bidder, in accordance with the terms of this agreement.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Offering Commencement Date means the first day of each Offering Period.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products