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 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.
Generic Product shall have the meaning set out in Section 6.3(c)(ii).
Examples of Generic Product in a sentence
The Generic Product Structure (GPS) is then proposed as the platform for tailoring products to individual customer needs.
More Definitions of Generic Product
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 ***.
Generic Product means any pharmaceutical product that (a) is sold by a Third Party other than pursuant to any rights granted by Centry; and (b) contains the same active pharmaceutical ingredient (or one which is substantially the same, such as a hydrate or salt of the active pharmaceutical ingredient) as the Licensed Product; and (c) was granted pursuant to an application for a marketing authorisation that relies on data held by a regulatory authority in relation to a Licensed Product.
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 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.
Generic Product means any pharmaceutical product sold by a Third Party, not authorized by GSK, an Affiliate or sublicensee, and is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority, on the basis of it being comparable to and substitutable for such Product.
Generic Product means, with respect to a particular Product and a particular country, any pharmaceutical product (other than such Product) that contains the same active ingredient(s) as such Product, has substantially the same formulation, mode of administration and duration of release as such Product, and is approved for the same indications as such Product in such country.