Generic Competing Product means, with respect to any given jurisdiction, any product containing the Active Ingredient, including, for purposes of clarity, any AP-rated version of the GSK Product, that has received Regulatory Approval from the FDA and is being sold by a Third Party for not less than thirty (30) consecutive days, where in such jurisdiction (a) no Regulatory Approval is required for the introduction of such product into commerce in such jurisdiction for use in humans or the delivery of such product for such introduction into commerce in such jurisdiction for use in humans or (b) such product has received Regulatory Approval through an abbreviated process (including, with respect to the United States, Abbreviated New Drug Applications under Section 505(j) of the Act (21 USC 355(j)) or New Drug Applications under Section 505(b)(2) of the Act (21 USC 355(b)(2)) or outside the United States, any counterparts thereof); provided, however, that any pharmaceutical product containing the Active Ingredient (other than a Product that is an AP-rated version of the GSK Product) and marketed or otherwise Exploited by Baxter or its Affiliates shall not be a Generic Competing Product; provided, further, for purposes of clarity, any pharmaceutical product marketed or otherwise Exploited by Baxter or its Affiliates that is an AP-rated version of the GSK Product shall be a Generic Competing Product hereunder.
Generic Competing Product has the meaning specified in Section 4.1(c)(ii) hereof.
Generic Competing Product means, with respect to any Competing Product (other than an Over-The-Counter Competing Product) sold by a Third Party in the Territory, any pharmaceutical product that is Therapeutically Equivalent to the applicable Competing Product. For the purposes of this definition, a drug product will be deemed “Therapeutically Equivalent” to the applicable Competing Product (the “Reference Listed Drug”) if each of the following criteria are met regarding that drug product: (1) same active ingredient; (2) same dosage form; (3) same route of administration; (4) same strength; and, in the United States only: (5) assigned by the FDA the same therapeutic equivalence code, starting with the letter “A” and further demonstrates that the Generic Competing Product is bioequivalent; and (6) designates such Competing Product to be the Reference Listed Drug.
Examples of Generic Competing Product in a sentence
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More Definitions of Generic Competing Product
Generic Competing Product has the meaning set forth in Section 2.6.
Generic Competing Product means, with respect to a given Product in a given jurisdiction in the Licensed Territory, any pharmaceutical product that: (a) is marketed for sale in such jurisdiction by a Third Party (not otherwise licensed or authorized by Norgine); (b) contains TZP-101 as an active pharmaceutical ingredient in an equivalent formulation and mode of administration; and (c) such product, as and to the extent required, is approved through an abbreviated process (including, with respect to the European Union approvals issued pursuant to Article 10(1) of Directive 2001/83/EC where the Third Party has provided EMEA with scientific data to substantiate a claim of biosimilarity to the Product in question, or, outside the European Union, any counterparts thereof).
Generic Competing Product has the meaning set forth in Section 8.4.1.