definiens: means the period between the Effective Date and the date on which [COMPANY] is able and ready to makeand sell the System independently, under its own label and a [COMPANY] 510(k ) ( as defined below ), but in any case ending thelater of ( a ) thirty six ( 36 ) months after the Effective Date ( the ) ; and ( b ) at the discretion of [COMPANY], any one(1 ) year extensions in addition to said Initial Term ; provided, however, that ENCORE may terminate the Supply Period ( i ) atany time after ENCORE ceases to manufacture the System based on bona fide product safety, efficacy, or regulatory concerns(described in written detail to [COMPANY] ), in ENCORE ’s sole and absolute discretion ; and ( ii ) with six ( 6 ) months written noticefollowing ENCORE ’s decision to cease manufacturing the System for any other reason