definiens: means ( a ) with respect to the Device for commercial sale in the US, the manufacturing responsibilitiesdocument executed by the Parties prior to the Effective Date and ( b ) with respect to the supply of the Device for commercialsale OUS ( other than Japan ), the Device for commercial sale in Japan, Finished EQW Product for commercial sale OUS ( otherthan Japan ) and Finished EQW Product for commercial sale in Japan, the applicable manufacturing responsibilities documentsexecuted by the Parties within [ … * * * … ] or, with respect to the manufacturing responsibilities document for Finished EQWProduct for sale in Japan, within [ … * * * … ] ( such manufacturing responsibilities documents to be consistent with themanufacturing responsibilities document existing between the Parties under clause ( a ), except for differences that arereasonably necessary or appropriate given the particular geographic market and the terms set forth herein ), in each case whichsets forth written instructions regarding the Manufacture and other technical matters including, without limitation, testingprocedures and supply of Product under this Agreement, and in each case as amended by the Parties from time to time