Impax Product definition

Impax Product means all formulations and dosages of VADOVA® (carbidopa/levadopa), subject to approval by the FDA.
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Impax Product means the Generic Equivalent that is the subject of the Impax ANDA.
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Impax Product means any product that (i) is the subject of the Impax ANDA as of the Effective Date, or (ii) is the subject of the Impax ANDA and which is substantially equivalent to those products that are the subject of the Impax ANDA as of the Effective Date, including any future dosage strengths of the product that is the subject of the Impax ANDA as of the Effective Date. For clarity, a product will be considered “substantially equivalent” to those products that are the subject of the Impax ANDA as of the Effective Date if regulatory approval of such product by the FDA would not require the performance of any additional bioequivalence studies (other than bioequivalence studies required by the FDA for new dosage strengths of or new reference listed drug descriptions for the product that is the subject of the Impax ANDA as of the Effective Date or any other changes that do not substantially change the formulation of the products subject to the Impax ANDA), and if its formulation is substantially the same formulation as the products that are the subject of the Impax ANDA as of the Effective Date.
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Examples of Impax Product in a sentence

  • Impax may elect to include the Impax Product (but not any other product) as the primary or secondary product in any Call it performs as part of the Services, subject to the Call Plan set forth on Schedule 3 and the terms and conditions of this Agreement.

  • Except for the warranties, obligations and undertakings of each of the Parties set forth in this Agreement, no warranty, condition, term, undertaking or representation (express or implied, statutory or otherwise) is given by one Party to the other in respect of the Trademark, the Shire Product or the Impax Product; such warranties, conditions, terms, undertakings and representations are to the extent permitted by law expressly excluded.

  • Except for any Intellectual Property Rights that relate exclusively to the Impax Product, all right, title and interest in any Intellectual Property Rights created, generated or arising in connection with the provision of the Services shall vest in Shire.

  • Impax desires to convert the exclusive license granted under the Agreement with respect to the D-24 Product in the United States, its territories and possessions, to a semi-exclusive license allowing Impax to authorize one other Impax Entity to offer to sell, sell, import, package, and/or distribute Impax Product and WCH is willing to agree to such amendment on the terms and subject to the conditions set forth herein.

  • For all other Impax Product sales, any payments received by Endo from Impax with respect to such sales shall be deemed to be “Applicable Sublicense Consideration” and Penwest shall be entitled to payment thereon pursuant to the Agreement.

  • Endo and/or Penwest shall provide reasonable cooperation to Impax in connection with such waiver, including by (i) submitting a mutually agreeable notice to FDA of the existence of such waiver and (ii) not opposing the approval of Impax Product effective as of the Commencement Date based on any applicable regulatory exclusivity in force at the time.

  • The Impax Product did not, as did Wellbutrin XL and other generics, employ a membrane release mechanism.

  • Impax manufactures Budeprion XL 300mg and Buproprion Hydrochloride XL (150mg) (collectively, the Impax Product), and has a significant contact or aggregation of contacts to the claims at issue herein.

  • For clarity, notwithstanding any other provision of this Agreement, an Impax Product Launch shall not release Shire from its obligation to [***] to Impax under Section 5.

  • Defendants completely ignore the fact that the Complaint lists numerous fraudulent omissions regarding the differences between Wellbutrin XL and the Impax Product, which Plaintiffs allege they relied upon in purchasing the Impax Product.


More Definitions of Impax Product

Impax Product means all formulations and dosages of VADOVA® (carbidopa/levadopa), subject to approval by the FDA. “IMS” means the International Marketing Services Prescription Reporting Service, or such other prescription reporting service to which Impax and Shire may mutually agree to in writing. “Incentive Compensation Plan” means a plan for providing incentive compensation to the Sales Force members for sales of the Shire Product, such plan to contain terms and conditions as are customary for sales representatives in the pharmaceutical industry. “Intellectual Property Rights” means patents, trade marks, service marks, logos, get-up, trade names, internet domain names, rights in designs, copyright (including rights in computer software) and moral rights, database rights, semi-conductor topography rights, utility models, rights in know-how and other intellectual property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world. “IRS” means the Internal Revenue Service of the United States of America and any successor thereto. “Law” means any laws, rules, and regulations, including any statutes, rules, regulations, guidelines, or other requirements that may be in effect from time to time and apply to the development, manufacture, registration, or marketing of the Shire Product in the Territory. “NDA” means a New Drug Application and all supplements filed with the FDA, including all documents, data and other information concerning the Shire Product which are necessary for, or included in, a product approval to market the Shire Product in the United States of America, as more fully defined in the Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, as in effect from time to time. “New Hires” has the meaning given to it in Section 4.3. “Oversight Committee” has the meaning given to it in Section 6.1. “Party” means either Impax or Shire (as applicable) and “Parties” means both Impax and Shire. “PDMA” means the Prescription Drug Marketing Xxx 0000.
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Related to Impax 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.

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

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

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

  • 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.

  • Licensed Compound means [***].

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

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

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

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

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • 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.

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

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

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

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • 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 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.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):