definiens: ), or other similar application or filing . MD,::ODMA\PCOOCS\SQU\32848J\4 1.4 shall mean, collectively and individually, [COMPANY] 's ( 0 disposable, bipolar arthroscopic wand, ( ii ) connecting cable and, ( iii ) radio frequency power controller ; in each case as defined in [COMPANY] 's 510 K filed with the U.S. Food and Drug Administration prior to the Effective Date and supplements thereto, to the extent such products are specifically intended for use within the Field and with respect to modifications or improvements thereto, to the extent that [COMPANY] has the right to include the same hereunder . It is understood that Products, and/or any component thereof, may be changed, substituted or added to by [COMPANY] to the extent such changes do not require modifications or changes to a Market Approval Application for a Product approved by the Ministry of Health & Welfare in Japan to market and distribute such Product in Japan, upon ninety ( 90 ) days prior written notice to Kobayashi . If a change to a Product requires modifications or changes to a Market Approval Application for such Product approved by the Ministry of Health & Welfare in Japan . the parties shall consult in good faith to determine a reasonable transition period with respect to implementation of such Product change in Japan . The parties contemplate the addition of other products to the Agreement on terms substantially similar to those herein, which addition shall only be made upon the mutual agreement of the parties