The term “Generic Product” shall mean a product that is not produced, licensed or owned by the Roche Group that # contains a pharmaceutically active ingredient that is the same as the Compound in the Product which is approved through in reliance, in whole or in part, on the prior Regulatory Approval (or on safety or efficacy data submitted in support of the prior Regulatory Approval) of such Product, pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)), or for countries outside the US, any international equivalent laws, and # has the same or substantially the same labelling as the applicable Product for at least one indication of such Product.

“Generic Product”. Generic Product means, with respect to a given Product, any pharmaceutical preparation that contains a Compound as its active pharmaceutical ingredient and # is approved by a Regulatory Authority for sale in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Product as determined by the applicable Regulatory Authority or is approved for sale in reliance, in whole or in part, on the existing drug standard already approved by the applicable Regulatory Authority, or # is otherwise substitutable for such Product under applicable Laws by a pharmacist without the intervention of the prescribing physician.

“Generic Product”. Generic Product means, with respect to a given Product, any pharmaceutical preparation that contains a Compound as its active pharmaceutical ingredient and # is approved for sale in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Product as determined by the applicable Regulatory Authority or is approved for sale in reliance, in whole or in part, on the existing drug standard already approved by the applicable Regulatory Authority, or # is otherwise substitutable for such Product under applicable Laws by a pharmacist without the intervention of the prescribing physician.

“Generic Product” means, with respect to a Product in a particular regulatory jurisdiction, on a Product-by-Product and country-by-country basis, any pharmaceutical product (other than the Product itself) that # is approved by the Regulatory Authority in such country for at least one indication for which such Product obtained Regulatory Approval from the applicable Regulatory Authority in such jurisdiction # through an abbreviated new drug application as defined in 21 U.S.C. 355(j) (or equivalent outside the United States) or # as an A-rated therapeutically equivalent product (or the foreign equivalent thereof), including pursuant to an application under 21 U.S.C. 355(b)(2) (or the foreign equivalent thereof); and # is sold in such jurisdiction by a Third Party that is not a Sublicensee and did not purchase such product in a chain of distribution that included any of Bausch Health or its Affiliates or Sublicensees).