Generic Licensed Product definition

Generic Licensed Product means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis, any pharmaceutical product sold by a Third Party in such country, other than as a Sublicensee under this Agreement that: (a) contains the same active ingredient or active ingredients as the applicable Licensed Product in the same dosage form (e.g., oral, injectable, or intranasal) as the applicable Licensed Product and (b) is categorized by the applicable Regulatory Authority in such country to be therapeutically equivalent to, or interchangeable with, such Licensed Product, such that the pharmaceutical product may be substituted for the Licensed Product at the point of dispensing without any intervention by the prescribing physician in such country.
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Generic Licensed Product means a pharmaceutical product that contains the same active ingredient as a Licensed Product and is bioequivalent to such Licensed Product; provided, that, any product sold by DS or any Affiliate or licensee of DS shall not be a Generic Licensed Product for purposes of this Agreement.
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Generic Licensed Product with respect to a Licensed Product, any pharmaceutical or biological product that is distributed by a Third Party under a Regulatory Approval approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or
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Examples of Generic Licensed Product in a sentence

  • To be clear, ENDO is responsible for 100% of any cost or expenses, and net losses, resulting from the sales of Generic Licensed Product, without any contribution hereunder by NOVARTIS or any of its Affiliates, even if the NOVARTIS Profit Share would otherwise be calculated as an amount less than zero dollars.

  • If there is no Valid Claim, then Roche may reduce the royalties otherwise due for Licensed Product in a given country by *** percent (***%) if, in the country, sales of units of Generic Licensed Product in aggregate total at least *** percent (***%) of the aggregate sales of units of (i) Licensed Product sold by the Roche Group and (ii) Generic Licensed Products.

  • Except for the rights granted in the prior sentence, ENDO shall not use any of the NOVARTIS Parties’ trademarks, trade names or trade dress or any trademarks, trade names or trade dress which are confusingly similar to any of NOVARTIS Parties’ trademarks, trade names or trade dress, in connection with the Commercialization of Generic Licensed Product.

  • Without limiting the foregoing, in no event is ENDO or its Affiliates granted any rights or licenses to or with respect to any generic pharmaceutical product (other than the Generic Licensed Product), any OTC Product or any other diclofenac topical gel.

  • Subject to Section 2.5, ENDO and its Affiliates shall be permitted to use the Product Trade Dress in connection with the Commercialization of the Generic Licensed Product.

  • Notwithstanding any provision in this Agreement to the contrary, in no event shall SANDOZ be obligated to supply ENDO any Generic Licensed Product until the Quality Agreement has been amended or revised to include Generic Licensed Product.

  • In lieu of any royalties on the Generic Licensed Product (but with no effect on any royalties payable on the Branded Licensed Product), ENDO shall pay the NOVARTIS Parties (as designated by SANDOZ) Profits relating to Net Sales of the Generic Licensed Product for the remainder of the Term as follows: ENDO shall receive *** and the NOVARTIS Parties (as designated by SANDOZ) shall receive *** of all Profits resulting from sales of the Generic Licensed Product.

  • Except as expressly set forth herein and subject to the rights reserved to ENDO and its Affiliates in Section 2.5, ENDO shall have no rights in or to the Product Trademark or the goodwill pertaining thereto or in any Product Trade Dress, trademark, tradename or goodwill in respect of the Generic Licensed Product.

  • ENDO shall be solely responsible to Commercialize the Branded Licensed Product under the Product Trademark, itself (or through its Affiliates) and, subject to Section 2.2, to Commercialize the Generic Licensed Product, in each case in the Field in the Territory during the Term of this Agreement.

  • ENDO is responsible for costs and expenses of manufacture of such initial quantities of Generic Licensed Product.


More Definitions of Generic Licensed Product

Generic Licensed Product means, with respect to a particular Licensed Product in a country, a pharmaceutical product that: (a) contains the same Compound as such Licensed Product; and (b) is approved for use in such country pursuant to 21 U.S.C. 355(b)(2), an ANDA, a separate NDA, Compendia Listing, or equivalent drug approval application.
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Generic Licensed Product means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis, any pharmaceutical product sold by a Third Party in such country, other than as a Sublicensee under this Agreement that:
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Generic Licensed Product means, on a Licensed Product-by-Licensed Product (including Combination Product-by-Combination Product) and country-by-country basis in the Territory, any pharmaceutical product sold by a Third Party in such country that: (a) contains the [***] the applicable Licensed Product in the same [***] (e.g., oral, injectable, or intranasal) as the applicable Licensed Product, and (b) is categorized by the applicable Regulatory Authority in such country to be [***] to, [***], such Licensed Product, such that the pharmaceutical product may be substituted for such Licensed Product at the point of dispensing without any intervention by the prescribing physician in such country.
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Generic Licensed Product means the authorized generic of the Branded Licensed Product, under the Licensed Product NDA and for sale as an Rx Product in the Field in the Territory.
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Generic Licensed Product means a product that contains Compound which is offered for sale in a country by a Third Party.
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Generic Licensed Product means, with respect to Xxxxx-SC, any pharmaceutical product sold by a Third Party, other than as a sublicensee to this Agreement, that is approved by the Regulatory Authority in Japan as a substitutable generic for Xxxxx-SC and contains the active ingredients in Xxxxx-SC.
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Related to Generic Licensed Product

  • 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.

  • 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 Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

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

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Licensed Field means [***].

  • Licensed Compound means [***].

  • 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.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Licensed Services means all functions performed by the Licensed System.

  • 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.

  • Licensed Territory means worldwide.

  • 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.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • 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.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether