definiens: means, with respect to a Licensed Product in a particular regulatory jurisdiction, any pharmaceuticalproduct that ( i ) contains the same qualitative and quantitative composition of active pharmaceutical ingredients, or salts or estersthereof, as such Licensed Product in the same pharmaceutical form as such Licensed Product ; ( ii ) has obtained regulatory approval insuch jurisdiction ( for an indication for which such Licensed Product obtained Regulatory Approval from the applicable RegulatoryAuthority in such jurisdiction ) on an expedited or abbreviated basis in a manner that relied on or incorporated data submitted byGSK, its Affiliates or sublicensees and, in the case of a product containing a salt or ester of an active pharmaceutical ingredientcontained in the Licensed Product, such approval was obtained without reliance on or submission of additional safety or efficacydata ; ( iii ) is bioequivalent to the Licensed Product as determined by the applicable Regulatory Authority in such jurisdiction ; and(iv ) is sold in such jurisdiction by a Third Party that is not a sublicensee of [COMPANY] or its Affiliates and did not purchase such product ina chain of distribution that included any of [COMPANY] or its Affiliates or sublicensees, excluding all pharmaceutical products marketed asof the Effective Date containing levodopa and carbidopa . Without limiting the foregoing, or being limited thereby, with respect to aLicensed Product in the EU Generic Product shall include any pharmaceutical product that has been authorized with respect to suchLicensed Product under the provisions of Articles 10.1, 10.2, 10.3 or 10a of EU Pharma Directive 2001/83