definiens: 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 theFDA and is being sold by a Third Party for not less than thirty ( 30 ) consecutive days, where in such jurisdiction ( a ) noRegulatory Approval is required for the introduction of such product into commerce in such jurisdiction for use in humans orthe delivery of such product for such introduction into commerce in such jurisdiction for use in humans or ( b ) such producthas received Regulatory Approval through an abbreviated process ( including, with respect to the United States, AbbreviatedNew Drug Applications under Section 505(j ) of the Act ( 21 USC 355(j ) ) or New Drug Applications under Section 505(b)(2 ) ofthe Act ( 21 USC 355(b)(2 ) ) or outside the United States, any counterparts thereof ) ; provided, however, that anypharmaceutical 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