definiens: ) . Stage IV diligence shall mean the filing of an application for regulatory approval for marketing of a diagnostic product in the U.S., E.U. or Japan within thirty - six Q§ ) months after Stage m completion . [COMPANY] shall have the right to extend for a reasonable period, any of the diligence deadlines set forth above, if unexpected non - technical-, or technical - related, events or difficulties occur during diagnostic product development, provided, that such reasonable period for extending any given diligence deadline for non - technical - related events or difficulties shall not be longer than fifty percent ~% ) of the original time period for such diligence stage ( e.g., the reasonable period for extending Stage II diligence shall not exceed four and one - half ( 4.5 ) months ) . For extensions due to technical - related events or difficulties, [COMPANY] shall provide [COMPANY] with a Written report every month after the diligence deadline that states what technical - related events or difficulties are causing the need for an extension of the diligence period and summarizes what [COMPANY] has done and plans to do to solve such technical - related events or difficulties