definiens: shall mean anyone of the following : ( A ) Distributor 's aggregate sales of Product from April 1, 1998 through June 30, 1998, excluding Samples and Demonstration Units, comprise fewer than, i.000 lli~. -(B ) Company is notified in writing by July 31, 1998, that either ( 1 ) the Orthopaedic Device Advisory Panel ( if convened by the FDA to review the IDE for the Product ) has determined that new and/or additional clinical trial data will be required before the Advisory Panel will convene to review, consider, and/or recommend the Product for PMA approval ; or ( 2 ) the FDA elects to proceed toward approval without an Advisory Panel and the FDA requires that new and/or additional clinical data be generated before approval will be granted ( for purposes of this clause, the term expressly excludes follow - up requirements for cases included in the original IDE study )