definiens: means, in the country of sal e in the [COMPANY] Territory, that at least one of the claims of an issued and unexpired patent included within the Licensed Intellectual Property, which would be infringed by the sale of such Royalty Product in that country, i s in effect and has not been revoked or held unenforceable or i nvalid by a final decision of a court or other gove rnmental agency of competent jurisdiction having authority o ver said patent and that final decision is not appe aled or unappealable ( all claims are considered valid until so adjudicated and during prosecution of a patent application containing such claims ) and is sufficient to preven t a Generic Product from being sold in such country . means market exclusivity granted by a Governmental Authority designed to prevent the entr y of Generic Product(s ) onto the market in the Field of Use, including new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity an d 180 - day generic product exclusivity