definiens: shall mean, on an indication by indication basis, i n the case of any Product, in any country in the Licensed Territory, the period o f time commencing on the First Commercial Sale in s uch country and ending upon the earlier of : ( a ) either ( i ) the expiration in such country of th e last - to - expire valid claim of an issued patent within the [COMPANY] Patents covering the composition or use of the Compound or Product ( but excluding va lid claims of an issued patent within the [COMPANY] Patents that cover only [COMPANY] Improvements, which are subject t o the terms of Section 2.6(a ), except as noted below ) or ( ii ) t he expiration of the applicable time period during which the FDA, or applicable governmental or regulatory authority having jurisdiction over the Product in any particu lar country or region in the Licensed Territory, prohibits refe rence, without the consent of Ocera ( or its Sublice nsee ) as the owner of an NDA for the Product, to the clinical an d other data that is contained in such NDA, and tha t is not published or publicly available outside of such NDA in such country, if later than the date in item ( i ) ; or ( b ) when there is Generic Competition in such count ry