Generic Launch Date definition

Generic Launch Date means, with respect to any Impax Generic Version, [***].
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Generic Launch Date means, on a country-by-country basis in the Territory, the date of the first sale by a third party, for end use or consumption by a patient, of a Generic Product in the subject country as reported by IQVIA data (or IQVIA-equivalent data if IQVIA data are not available).
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Generic Launch Date means, on a country-by-country basis, the date of the first sale by a third party, for end use or consumption by a patient, of a GENERIC PRODUCT in the subject country.
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Examples of Generic Launch Date in a sentence

  • Beginning with the calendar quarter after the Authorized Generic Launch Date (which shall also include the period from the Authorized Generic Launch Date to the beginning of such calendar quarter) and for each calendar quarter thereafter, a quarterly statement shall be prepared by Core showing the calculation of the Distribution Fee.

  • Subject to the terms and conditions set forth in this Agreement, and beginning on the Authorized Generic Launch Date, King hereby grants to Core a non-exclusive, personal, non-transferable and, except as set forth in Section 11.6, non-assignable license under the King Authorized Generic Patent Rights to Commercialize the Authorized Generic Product in the Territory during the Term.

  • Allergan shall notify NexMed as early as reasonably possible of any expected launch by a Third Party of a Generic Product, which date Allergan shall determine in good faith (the “Estimated Third Party Generic Launch Date”); provided, that Allergan shall not be responsible or liable for any inaccuracies or errors in its determination of such Estimated Third Party Generic Launch Date.

  • King and Core agree that the Authorized Generic Product may only be marketed, distributed or sold by Core beginning on the Authorized Generic Launch Date and continuing through the Term of this Agreement.

  • Allergan shall have final decision-making authority to determine whether and when to launch the Authorized Generic Version of each Product in the Territory; provided, that the AG Launch Date shall occur no sooner than [***] ([***]) weeks in advance of any Estimated Third Party Generic Launch Date.

  • Notwithstanding any reduction of royalties under Section 4.2(b)(i) for a given Licensed Product in a given country due to Generic Competition, if, in any Generic Competition [***], Net Sales of such Licensed Product in such country exceed [***] of the Net Sales of such Licensed Product in the [***] completed just prior to the Generic Launch Date, Teva shall resume payment of royalties consistent with Teva’s payment of royalties prior to the Generic Competition Event.

  • Allergan shall be permitted to book orders for the Authorized Generic Version of a Product at least [***] ([***]) months in advance of the Estimated Third Party Generic Launch Date.


More Definitions of Generic Launch Date

Generic Launch Date has the meaning set out in Clause 10.6.1.
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Generic Launch Date means, with respect to any Generic Product of a particular Licensed Product, on a country-by-country basis, the date of the first sale by a Third Party, for end use or consumption by a patient, of the applicable Generic Product in the subject country.
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Generic Launch Date means the earlier of (A) the date 15 Business Days following the date on which a third party has sold commercial scale quantities of Generic Product in the United States pursuant to a license or authorization from Client or its Affiliates if Client or its Affiliates have not within such 15 Business Day-period commenced the sale of an Authorized Generic Product and (B) the Injunction Failure Date.
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Generic Launch Date will mean, on a country-by-country basis, (a) with respect to sales in the United States, the Primary EU Markets, Japan and China, the date the aggregate sales of the Generic Product by a Third Party to other Third Parties (that are not its Affiliates or sublicensees) for ultimate end use or consumption by a patient in the subject country have exceeded [*], and (b) with respect to sales in any other country, the date of the first sale by a Third Party to other Third Parties (that are not its Affiliates or sublicensees) of a Generic Product for ultimate end use or consumption by a patient in the subject country. [*] 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 Generic Launch Date

  • Launch Date has the meaning specified therefor in Section 2.02(b) of this Agreement.

  • 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.

  • 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:

  • 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.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • 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.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents the approval or marketing of any Biosimilar Product of such Licensed Product in such country.

  • Hemp product means the same as that term is defined in § 3.2-4112.

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

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • 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.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • 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:

  • Licensed Service means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Marketing Period means the first period of 21 consecutive business days throughout and on the last day of which (a) Parent, Merger Sub and their financing sources shall have received completed Offering Documents including Required Information (including the Required Information with respect to the Company’s fiscal year ended January 25, 2010) for all of the Available Financing, and such Required Information contained in all of the Offering Documents is Compliant, (b) all conditions set forth in Section 6.1 and Section 6.2 (other than those that by their nature will not be satisfied until the Effective Time) have been satisfied and nothing has occurred and no condition exists that would cause any of the conditions set forth in Section 6.1 or Section 6.2 not to be satisfied assuming the Effective Time were to be scheduled for any time during such consecutive 21 business day period, and (c) the Company shall have provided all cooperation which it is obligated to provide under the terms of Section 5.5. Notwithstanding the foregoing, the “Marketing Period” shall not commence and shall be deemed not to have commenced if, on or prior to the completion of such consecutive 21 business day period, (x) the Company shall have announced any intention to restate any financial statements or financial information included in the Required Information or that any such restatement is under consideration or may be a possibility, in which case the Marketing Period will be deemed not to commence unless and until such restatement has been completed and the applicable Required Information has been amended or the Company has announced that it has concluded that no restatement shall be required, (y) the Company shall have failed to file any report with the applicable Securities Authorities when due, in which case the Marketing Period will be deemed not to commence unless and until all such reports have been filed, or (z) the Required Information would not be Compliant throughout and on the last day of such 21 business day period, in which case a new 21 business day period shall commence upon Parent, Merger Sub and their financing sources receiving updated Required Information that would be Compliant, and the requirements in clauses (a) and (b) above would be satisfied throughout and on the last day of such new 21 business day period. In no event may a “Marketing Period” commence any later than July 27, 2010, unless at Parent’s election a Marketing Period commenced after such date terminates no later than August 24, 2010.

  • 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.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

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