definiens: means ( a ) with respect to the Device for commercial sale in the US, theapplicable quality agreement(s ) between the Parties, amended and restated as of the date hereof and ( b ) with respect to theDevice for commercial sale OUS ( other than Japan ), the Device for commercial sale in Japan, Finished EQW Product forcommercial sale OUS ( other than Japan ) and Finished EQW Product for commercial sale in Japan, the quality agreements asagreed to within ninety ( 90 ) days of the Effective Date or, with respect to the quality agreement for Finished EQW Product forsale in Japan, within a reasonable period of time in advance of any anticipated launch of the Finished EQW Product in Japan(such quality agreements to be consistent with the quality agreements existing between the Parties under clause ( a ), except fordifferences that are reasonably necessary or appropriate given the particular geographic market and the terms set forth herein),and in each case as revised and amended from time to time, which describe certain quality expectations and responsibilitiesrelating to the Manufacture, release testing and supply of the Devices and Finished EQW Products to [COMPANY], and whichinclude appropriate qualified person terms, as applicable