definiens: means any ISR, Accessory, or component of the System manufactured in accordance with theForecast or otherwise constituting On - hand Inventory that reaches its Product Expiration Date prior to sale during theSubject Year . Notwithstanding the foregoing, no Annual Inventory Fee shall be payable to Medtronic to the extent:(a ) the Expired ISRs in the Subject Year are less than 5 % of number of ISRs included in the Forecast for thepreceding 18 months measured as of the end of such Subject Year ; ( b ) the Expired ISRs are a result of Medtronic’sbreach or Medtronic ’s termination of this Agreement ; or ( c ) the Expired ISRs result from Medtronic being prohibitedfrom selling the ISR due to regulatory or legal prohibitions, such as a consent decree except, in the case of ( c ), if theExpired ISRs are part of the Limited 1.0 Supply of up to 400 Systems