definiens: means, with respect to a Product in a particular country, the period prior to the termination of the Patent Rights in that country 5 for any reason ( including but not limited to any patent restoration period granted by a Governmental Authority to compensate for patent term lost during the clinical trial or regulatory approval process ), and with respect to that country, any period in which Guilford or [COMPANY] has exclusivity rights ( other than Patent Rights ) under Applicable Law that limit the ability of all other Persons in the country to manufacture, obtain regulatory approval, use, sell, offer for sale or import the Product, including data exclusivity and/or exclusivity based on approval of a new chemical entity or new use of a previously approved drug ( including but not limited to that afforded under the Hatch Waxman Act ), pediatric exclusivity, orphan drug exclusivity, or the 180 - day Abbreviated New Drug Application Exclusivity