definiens: means a product, other than Product, which is being developed for, or carries alabeled indication approved by the applicable regulatory authority, that is [ * ] approved by the same regulatory authority;provided that, with respect to a Change of Control or Business Combination occurring subsequent to [ * ], in the case of aproduct that would otherwise be a Comparable Product solely by virtue of carrying a labeled indication for 20 * CONFIDENTIAL TREATMENT REQUESTED . CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION [ * ], any such product shall not be deemed to be a Comparable Product unless either ( A ) sales of such product for [ * ] during thefour ( 4 ) calendar quarters immediately prior to such Change of Control or Business Combination ( or for the period of time inwhich such product has carried such labeled indication, if less than four ( 4 ) calendar quarters ) exceed [ * ] of the total sales ofsuch product during the four ( 4 ) calendar quarters immediately prior to such Change of Control or Business Combination ( orfor the period of time in which such product has carried such labeled indication, if less than four ( 4 ) calendar quarters ), or(B ) sales of such product for [ * ] during the four ( 4 ) calendar quarters immediately prior to such Change of Control or BusinessCombination exceed [ * ] . For clarity, if such product carries any other labeled indication ( instead of or in addition to [ * ] ) thatis substantially the same as a labeled indication for Product as of the Amendment Effective Date, such product shall bedeemed a Comparable Product both before and after [ * ], regardless of the level of such product ’s sales for [ * ] . For furtherclarity, a product that carries a labeled indication for [ * ], but does not carry a labeled indication [ * ], is not a ComparableProduct