definiens: means, with respect to a particular therapeutic [COMPANY] ZF Product in a particular country, a producton the market in such country commercialized by any Third Party that is not a Sublicensee of [COMPANY] or its Affiliates and thatdid not purchase such product in a chain of distribution that included any of [COMPANY] or its Affiliates or Sublicensees, that : ( i ) isapproved, under any then - existing laws and regulations in the applicable country pertaining to approval of [ * * * ] ; ( ii ) isotherwise recognized as a [ * * * ] interchangeable product [ * * * ] ; ( iii ) is a [ * * * ] approved in such country for, or prescribed by [ * * * ], an indication that is [ * * * ] ( iv ) in the case where the [ * * * ] is in effect solely on the basis of [ * * * ] is any [ * * * ] for anindication that is the [ * * * ]