Generic Competitive Product definition

Generic Competitive Product any product that contains *** and *** in combination for which *** has been demonstrated to the satisfaction of the relevant Regulatory Authorities and which can be substituted for Product by ***, which product has a *** in the country in question for use in any of the *** in question.
Generic Competitive Product means a pharmaceutical product sold by a Third Party in a particular country in the GSK Territory, which pharmaceutical product (a) contains the same APIs (e.g. omeprazole and sodium bicarbonate with respect to the capsule and powder formulations of Licensed Product) as the applicable Licensed Product being sold in such country by GSK under this Agreement (the “Comparable Licensed Product”), (b) does not infringe any of the Santarus Patents, (c) is bioequivalent with respect to pharmacokinetic properties to the Comparable Licensed Product, (d) is substantially the same dosage form, strength (for each API) and route of administration, as the Comparable Licensed Product and (e) is approved for marketing and sale by the applicable Regulatory Authority in such country.
Generic Competitive Product means any product, other than a Licensed Product, that contains CBD Botanical Drug Substance and THC Botanical Drug Substance in combination (i) for which bioequivalence with a Licensed Product has been demonstrated to the satisfaction of the FDA and (ii) which has an indication for a Licensed Product approved by the FDA and (iii) which can be substituted for a Licensed Product for such indication by the dispenser and (iv) following the market introduction of which there occurs as a reduction of greater than *** percent (***%) in Net Sales in the Territory of a Licensed Product with respect to a calendar quarter as compared to the Net Sales for such Licensed Product in the same calendar quarter in the preceding year.

Examples of Generic Competitive Product in a sentence

  • With respect to Licensed Products supplied to Otsuka pursuant to the Manufacturing and Supply Agreement, Otsuka shall pay to GW Pharma, for all quantities of Licensed Product on a Licensed Product-by-Licensed Product basis prior to the emergence of a Branded Competitive Product or a Generic Competitive Product in the Territory, an amount equal to the greater of (a) *** percent (***%) of *** or (b) *** (in each case, the “Supply Compensation”).


More Definitions of Generic Competitive Product

Generic Competitive Product means any product, other than a Licensed Product, that contains *** (i) for which bioequivalence with a Licensed Product has been demonstrated to the satisfaction of the FDA and (ii) which has an indication for a Licensed Product approved by the FDA and (iii) which can be substituted for a Licensed Product for such indication by the dispenser and (iv) following the market introduction of which there occurs as a reduction of greater than *** percent (***%) in ***.
Generic Competitive Product means any product that contains or uses one or a combination of one or more active ingredients or substances consisting of Hydralazine HydroChloride, Isosorbide Dinitrate, and/or other salts, bases and isometric forms of each, regardless of any dosage formulation.

Related to Generic Competitive Product

  • Competitive Product means a product or service, made or provided by a Competitor, which is the same as or is directly competitive with one with respect to which the Employee acquired confidential information relating to the Company, or its business, products or services by reason of the Employee's work with the Company.

  • Competitive Products shall include any product or service that directly or indirectly competes with, is substantially similar to, or serves as a reasonable substitute for, any product or service in research, development or design, or manufactured, produced, sold or distributed by the Company;

  • Generic Competition has the meaning set forth in Section 7.4.3.

  • Competing Product means [***].

  • 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.

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • 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.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Competitive Process means a formal sealed, electronic, or web-based bid procedure used for all nonclaims related purchases for goods and services over fifty thousand dollars. For purchases between five thousand dollars and fifty thousand dollars, competitive process means quotations obtained from at least three vendors by telephone or written quotations, or both, and supported by evidence of competition. Purchases up to five thousand dollars are exempt from competitive bids providing procurement is based on obtaining maximum quality at minimum cost.

  • 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.

  • 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.

  • Competitive Products or Services means, as of any time, those products or services of the type that any of the Bank Entities is providing, or is actively preparing to provide, to its customers.

  • 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.

  • 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.

  • Competing Product or Service means any product or service that is sold in competition with, or is being developed and that will compete with, a product or service developed, manufactured, or sold by Fiserv. For purposes of this Section 5, Competing Products or Services as to you are limited to products and/or services with respect to which you participated in the development, planning, testing, sale, marketing or evaluation on behalf of Fiserv during any part of your employment with Fiserv, or after the termination of your employment, during any part of the 24 months preceding the termination of your employment with Fiserv, or for which you supervised one or more Fiserv employees, units, divisions or departments in doing so.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Competitive Infringement has the meaning set forth in Section 7.5.1.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

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

  • Net Sales means [***].

  • Designated country end product means a WTO GPA country end product, a Free Trade Agreement country end product, a least developed country end product, or a Caribbean Basin country end product.

  • 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:

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