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
EXICURE shall pay ten percent (10%) of its global Net Sales of GPC- 100 or any combined and co-development Products using GPC-100 and its derivatives to GPCR as below, until occurrence of (i) expiration of all patents listed in Exhibit A.2, or (ii) the first approval of a Generic Product by Regulatory Authority, whichever is later on a country- by-country basis (“Royalty Term”).
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 Product in a country, a pharmaceutical product that (a) contains the same active ingredient(s) as such Product, and (b) is approved for use in such country pursuant to an expedited regulatory approval process governing approval of generic biologics based on the then-current standards for regulatory approval in such country and where such regulatory approval was based in significant part upon clinical data generated by the Parties pursuant to an Approved Plan.
Generic Product means, with respect to any Licensed Product and any country in the Territory, any pharmaceutical product, which [***].
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 shall have the meaning set out in Section 6.3(c)(ii).
Generic Product means, with respect to a Product in a country, a [***] product (a) [***] is sold in such country by a Third Party and (b) has achieved Regulatory Approval from a Regulatory Authority in such country jurisdiction in reliance on data supporting a prior approval of such Product by such Regulatory Authority.