Generic Launch Date definition

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.
Sample 1Sample 2
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).
Sample 1Sample 2
Generic Launch Date means, with respect to any Impax Generic Version, [***].
Sample 1Sample 2

Examples of Generic Launch Date in a sentence

  • 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.

  • Upon signature of all parties to this Agreement, the CESU Network National Office shall administer support funding to the Hawaiʻi–Pacific Islands CESU Host University in furtherance of the Agreement, to be authorized and executed by a modification to the Agreement.

  • 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.

  • 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.

  • 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.

  • 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 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.

  • 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.


More Definitions of Generic Launch Date

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.
Sample 1
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.
Sample 1
Generic Launch Date has the meaning set out in Clause 10.6.1.
Sample 1
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.
Sample 1

Related to Generic Launch Date

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

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

  • 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, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Commercial Sale means the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.

  • 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 confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Drug Approval Application holder.

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

  • 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 the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Licensed Service means a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.

  • 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.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Marketing Period means fifteen (15) consecutive Business Days after the date on which both the Required Marigold Vote and Required Montage Vote have been received (a) commencing on the date Montage shall have received the Required Financial Information, all of which is Compliant, provided, that, if Marigold shall in good faith reasonably believe it has provided the Required Financial Information, it may deliver to Montage a written notice to that effect (stating when it believes it has completed such delivery), in which case Marigold shall be deemed to have complied with its obligation to provide the Required Financial Information on the date of delivery of such notice, unless Montage in good faith reasonably believes Marigold has not completed the delivery of the Required Financial Information and within three (3) Business Days after the delivery of such notice by Marigold, delivers a written notice to Marigold to that effect (stating with specificity which Required Financial Information Marigold has not delivered), and (b) throughout which nothing has occurred and no condition exists that would cause any of the conditions set forth in Section 7.1 and Section 7.2 to fail to be satisfied, assuming the Closing were to be scheduled for any time during such fifteen (15) Business Day period; provided, however, that (i) the Marketing Period shall end on any earlier date on which the Transaction Financing is consummated and Montage shall have obtained all of the proceeds contemplated thereby, (ii) the Marketing Period shall not be deemed to have commenced if, prior to the completion of such fifteen (15) Business Day period, (A) Deloitte & Touche LLP shall have withdrawn its audit opinion with respect to any year end audited financial statements set forth in the Required Financial Information, in which case the Marketing Period shall be deemed not to commence unless and until a new unqualified audit opinion is issued with respect to such year end audited financial statements by Deloitte & Touche LLP or another independent registered accounting firm reasonably acceptable to Montage, (B) Marigold shall have publicly announced, or the Marigold Board shall have determined, that a restatement of any material financial information included in the Required Financial Information is required, in which case the Marketing Period shall be deemed not to commence unless and until such restatement has been completed and the applicable Required Financial Information has been amended to reflect such restatement or Marigold has determined that no restatement shall be required or (C) the Required Financial Information is not Compliant (it being understood, for the avoidance of doubt, that if at any time during the Marketing Period the Required Financial Information provided on the first day of the Marketing Period ceases to be Compliant, then the Marketing Period shall be deemed not to have commenced) and (iii) (x) November 25, 2016 shall not be deemed to be a Business Day for purposes of calculating such fifteen (15) consecutive Business Days period and (y) such period (1) shall commence no earlier than January 4, 2016, (2) shall either have been completed prior to August 19, 2016 or shall not commence until September 7, 2016 and (3) shall either have been completed prior to December 21, 2016 or shall not commence until January 2, 2017.

  • 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 an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

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

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, 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 a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.