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
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.
Such reduction shall be first applied with respect to such country starting with sales in the Calendar Quarter following the entry of such Generic Product.
If the Product is a Generic Product, then the Respondent is considered the Product manufacturer and their established, reasonable price shall be listed.
If a Non-Patented Product is sold in a country where a Generic Product is also sold at such time, then a royalty of [*] of the Net Sales of the Non-Patented Product in such country shall be paid by Licensee to GenuPro.
If the Product is a Generic Product, then the Contractor is considered the Product manufacturer and their established, reasonable price shall be listed.
More Definitions of Generic 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.
Generic Product means, with respect to a Product and a particular country, any pharmaceutical product (a) that is sold in such country by a Third Party that is not a Sublicensee or Distributor selling such product under authorization from AstraZeneca or its Affiliates, (b) that contains the same Collaboration Compound as the relevant Product and that is in the same dosage form as such Product and for the same route of administration as such Product and is approved by the Regulatory Authority for such country for an indication for which such Product obtained Regulatory Approval in such country and (c) that is approved in reliance on the prior approval of such Product as determined by the applicable Regulatory Authority.
Generic Product means, (a) any pharmaceutical product which has received Regulatory Approval [***] of the Product; and/or (b) any other pharmaceutical product, approved under an Abbreviated New Drug Application, or ANDA, in the United States, under Section 505(b)(2) of the Food Drug and Cosmetic Act, or similar regulatory pathways outside of the U.S., in any case, with the Product as the reference 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 shall have the meaning set out in Section 6.3(c)(ii).
Generic Product means, with respect to a Licensed Product, a generic product in a formulation similar to and substitutable for such Licensed Product.
Generic Product means, with respect to a Product in the Field in a particular country in the Licensed Territory, another pharmaceutical product that is: (a) a Product; (b) approved for use in such country by the relevant Regulatory Authority; and (c) commercialized by a Third Party who has not obtained the right or access to such product (through sublicense, subcontract or chain of distribution) from SIIL or its Affiliates or sublicensees.