definiens: shall mean ( A ) infringement or potential infringement of one ( 1 ) or more [COMPANY] Patents and/or one(1 ) or more [COMPANY] Patents, as the case may be, by the actions of a Third Party in connection with a product ( an ) containing, among its active pharmaceutical ingredients, all of TDF, FTC and EFVand / or ( B ) with respect to Canada, [ * ] with respect to the Combination Product and ( ii ) shallinclude, without limitation, responses to paragraph ( iv ) certification under the Drug Price Competition and PatentRestoration Act ( also known as the Hatch - Waxman Act ) ( a ) and actions under section 6of the Patented Medicines ( Notice of Compliance ) Regulations ( Canada ) resulting from an attempt to market a GenericVersion Combination Product . For the avoidance of doubt, the Parties acknowledge and agree that infringement of aGilead Patent or a [COMPANY] Patent, as the case may be, other than by an Infringing Combination Product, is outside thescope of this Agreement and shall not create any rights or impose any obligations on the Parties hereunder, includingany right or obligation to take actions to respond to such infringement