definiens: for purposes of this Section 1O(b ) shall be defined as : ( i ) Failure of Licensee to make royalty payments as provided in Section 4 hereof ; ( ii ) Failure to begin feasibility clinical studies of the Technology ( such as would be permitted under the exemption of the United States Food and Drug Administration ( » within one ( I ) year of the date hereof if stimulators developed and purchased from an independent producer are used or two ( 2 ) years from the date hereof if a stimulator developed by Licensee is used ; ( iii ) Failwe to begin formal clinical studies of the Technolog y ( such as would be permitted under the Investigational Device Exemption of the FDA ) within three ( 3 ) years from the date hereof ; ( iv ) Failure to file a Pre - Market Approval Application with the FDA within six ( 6 ) years from the date hereof