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.
View Source
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.
View Source
Generic Entry Date is defined in Article 4 below.
View Source

Examples of Generic Entry Date in a sentence

  • As soon as practicable after delivery of such notice, with respect to the Authorized Generic Product, or after the Atacand Generic Entry Date, with respect to any Atacand Other Authorized or Owned Generic Product, as the case may be, Sellers shall use reasonable efforts to convey to Buyer the Excluded Assets provided for in clause (j) of the definition thereof, which shall thereafter be deemed Purchased Assets.

  • The Parties herein acknowledge that Par’s ability to launch the Par ANDA Products may be limited by (a) the FDA’s failure to finally approve the Par ANDA Products; (b) a period of exclusivity associated with a Third Party’s “first-filer” status; (c) Par’s inability to manufacture, package, and otherwise prepare a sufficient amount of the Par ANDA Products by the Generic Entry Date; or (d) other situations not currently within the Parties’ contemplation.

  • Buyer shall not, and shall cause its Affiliates not to, and shall use commercially reasonable efforts to cause its licensees, sublicensees and distributors not to, directly or indirectly, Exploit (i) until the AG Abandonment Date, the Authorized Generic Product and (ii) until the Atacand Generic Entry Date, any Atacand Other Authorized or Owned Generic Product, in each case, in the Territory or outside the Territory.

  • 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.

  • 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).

  • 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.

  • 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.

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

  • 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”).


More Definitions of Generic Entry Date

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.
View Source
Generic Entry Date has the meaning set forth in Section 8.5.2 (Reduction for Generic Competition).
View Source
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.
View Source
Generic Entry Date means the earliest to occur of the following:
View Source
Generic Entry Date means the earliest to occur of the following dates, as applicable to each specific strength of Actavis Generic Tablets:
View Source
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. ..
View Source

Related to Generic Entry Date

  • Entry Date means the date as of which an eligible

  • 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 any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.