definiens: shall mean infringement or potential infringement of one or more [COMPANY] Patents or one or more Tibotec Patents, as the case may be, by the actions of a Third Party in connection with the Combination Product ( an ) where such infringement or potential infringement relates to the manufacture, importation, sale or offering for sale of such Combination Product in the Territory, ( ii ) shall mean infringement or potential infringement of one or more Tibotec Patents by the actions of a Third Party in connection with a product, which is not an Infringing Combination Product, that would be covered by Section 10.4 if Tibotec or its Affiliates had sold such product ( an ), where such infringement or potential infringement relates to the manufacture, importation, sale or offering for sale of such product in the Territory, and ( iii ) shall include responses to paragraph ( iv ) certification under the Drug Price Competition and Patent Term Restoration Act ( also known as the Hatch - Waxman Act ) ( a ) or a Notice of Allegation, which Paragraph ( iv ) Certification or Notice of Allegation relates to any such [COMPANY] Patent or Tibotec Patent and results from an attempt to market ( A ) in the case of an Infringing Combination Product, a Generic Combination Product or ( B ) in the case of an Other Infringing Product, a generic version ( determined in a manner analogous to, ijledefulltiOiiOt Generic CombinatiOn Product ) ) thereof . For the avoidance of doubt, the Parties acknowledge and agree that infringement of a [COMPANY] Patent or a Tibotec Patent, as the case may be, other than by an Infringing Combination Product, or with respect to the Tibotec Patents, an Other Infringing Product, is outside the scope of this Agreement and shall not create any rights or impose any obligations on the Parties hereunder, including any right or obligation to take actions to respond to such infringement