Generic Product definition

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 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 shall have the meaning set out in Section 6.3(c)(ii).

Examples of Generic Product in a sentence

• At a minimum, the Product list shall include the following: Product Category, Product Description, Brand Name or Generic Product, UPC, GTIN (if available), Manufacturer Name, Manufacturer Number, SKU/Item Number, Unit of Measure, X.X. Xxxxxxxx Price or MSRP, MSRP % discount and final sell price to the Customer.

• If the Product is a Generic Product, then the Contractor is considered the Product manufacturer and their established, reasonable price shall be listed.

• At a minimum, Respondents should include the following fields in the Product list: Product Category, Product Description, Brand Name or Generic Product, UPC, GTIN (if available), Manufacturer Name, Manufacturer Number, SKU/Item Number, Unit of Measure, X.X. Xxxxxxxx Quarter 3 2016 Price or MSRP, MSRP % discount and final sell price to the Customer.

• If the Product is a Generic Product, then the Respondent is considered the Product manufacturer and their established, reasonable price shall be listed.

• A Generic Product is comparable to a Manufacturer or Brand Name Product’s intended use, size, quality, and performance characteristics that does not provide a market branding.

More Definitions of Generic Product

Generic Product for a given country means a pharmaceutical product that (i) is sold by a Person that is not a Related Party under a Regulatory Approval granted by a Government Authority to a Third Party, (ii) contains the same active ingredient(s) as are contained in a Product, and (iii) is approved by the Government Authority pursuant to an abbreviated approval process that relies in part on such Government Authority’s previous grant of marketing authorization to a Product.

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 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 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 [***].

Generic Product means ***.