definiens: shall have the following meaning, with respect to the following products, events, and nations : ( a)with respect to FDA Requisite Regulatory Approval for the Gen 1 Product : ( i)if either : ( A)DexCom submits, on or before [ * * * * * ], a Standard 510k Application for the Gen 1 Product, and such application is subsequently approved ; or ( B)DexCom submits a Standard 510k Application as described in clause ( A ), but suchapplication is not approved, and [COMPANY] submits, on or before [ * * * * * ], a follow - up DeNovo 510k Application for the Gen 1 Product, and ( ii)the FDA Requisite Regulatory Approval of the Standard 510k Application occurs on or after [ * * * * * ], or the FDA Requisite Regulatory Approval of the De Novo 510k Application occurs on orafter [ * * * * * ], then ( iii)subject to clause ( f ) below in this Section 7.6.2, the Delay Adjustment Period with respect to theGen 1 Product in the United States shall mean the number of months set out in TABLE 1 ofExhibit J