definiens: means with respect to a given Product in a given country in the Territory, a product that ( a ) contains the same active pharmaceutical in gredient as such Product and is approved in relianc e, in whole or in part, on a prior Regulatory Approval of such Product, ( b ) is sold or marketed for sale in such country by a Third Party that has not obtained the rights to market or sell such product as a Sublicensee, Subcontractor or Third Party Distribut or of [COMPANY] or any of its Affiliates, Sublicensee s or Subcontractors with respect to such Product and ( c ) is considered by the applicable Regulatory Authority in such country to be therapeutically equ ivalent to, or interchangeable with, such Product, such that, in the U.S., the product may be substitu ted for the Product at the point of dispensing with out any intervention by the prescribing physician in su ch country