Generic Product definition
Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.
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.
Generic Product means a product on the market commercialized by a Third Party (excluding Sublicensees) that (a) is approved, under any then-existing laws and regulations in the applicable country pertaining to approval of “generic” biologic products, as a “generic” version of a Licensed Product labeled for substantially similar indications as such Licensed Product; or (b) otherwise is recognized as a biosimilar or interchangeable biological product to the Licensed Product by the applicable Regulatory Authority.
Examples of Generic Product in a sentence
Subject to Section 7.4(c)(iv), on a country-by-country and Licensed Product-by-Licensed Product basis in the Territory, if in any [***] during the Royalty Term for such Licensed Product in such country, a Generic Product of such Licensed Product [***], then the royalty rates set forth in Section 7.4(a) shall be reduced by [***] for all [***] thereafter for the remainder of the Royalty Term for such Licensed Product (or if sooner, until the consummation of a Partnering Transaction).
Notwithstanding the foregoing, (i) for Net Sales based on sales of a Product in a country in the Territory, any payments owed with respect to such Product pursuant to this Section 3.4 will be reduced by [***] for [***], if at any time a Generic Product [***].
More Definitions of Generic Product
Generic Product means [***].
Generic Product means a drug product that (i) contains the same active ingredient as the Product where the Product is the reference-listed drug, and (ii) is approved by a Governmental Authority pursuant to an Abbreviated New Drug Application, an application under 21 U.S.C. §355(b)(2), or similar application.
Generic Product means, with respect to a particular Licensed Product in a country, a pharmaceutical product that: (a) contains the same active compound or ingredients 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/BLA, compendia listing, or equivalent drug approval application.
Generic Product shall have the meaning set out in Section 6.3(c)(ii).
Generic Product means, with respect to a Product, any intranasal product in an intranasal device that (i) is sold by a Third Party that is not a licensee or a Commercial Sublicensee of Adapt or its Affiliates, under an Abbreviated New Drug Application (ANDA), or any of such Third Party’s direct or indirect licensees or sublicensees; (ii) contains naloxone as the primary active ingredient; and (iii) is approved in reliance, in whole or in part, on the prior approval of such Product. A Product licensed or produced by Adapt or its Affiliates or Commercial Sublicensees (i.e., an authorized generic product) will not constitute a Generic Product.
Generic Product means in any particular country any Third Party product that contains Compound and either (i) for which equivalence with Product has been demonstrated to the satisfaction of the Regulatory Authority in that country or which can be substituted for Product by a dispenser or (ii) which is approved 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 Product as determined by the applicable Regulatory Authority.
Generic Product means any pharmaceutical product sold by a Third Party, not authorized by GSK, an Affiliate or sublicense or GSK, and is approved in reliance on the prior approval of a Licensed Product as determined by the applicable Regulatory Authority, on the basis of it being comparable to and substitutable for such Licensed Product, as stated in a regulatory filing with such Regulatory Authority.