definiens: means a breach of a material provision of this Agreement or any of the Related Agreements that ( i ) results in a material adverse effect on the business, operations or financial condition of the Companies taken as a whole, or the value of the Companies taken as a whole, and ( ii ) materially frustrates the ability of either S - P or M, as the non - breaching party, as the case may be, to realize the reasonably anticipated benefits from the Companies ( ) . A Material Breach shall also be deemed to occur upon any breach of Section 9.9 of this Agreement, provided that if an alleged breach is by a Person that has been detennined to be an Affiliate ofM or S - P, as the case may be, such breach will not be deemed a Material Breach if M or S - p. as the case may be, demonstrates by a preponderance of the evidence each of the following ( i ) that -30 · 345445 it did not cause, assist or encourage such Affiliate to take the action underlying the alleged breach, ( ii ) that it did not have the power to prevent such Affiliate from taking such action and ( iii ) that it used commercially reasonable efforts to prevent such Affiliate from taking such action . Notwithstanding the prior sentence, such breach may, however, nevertheless be determined to be a Material Breach pursuant to the provisions of the next sentence . The determination of whether a Material Breach has occurred and liability for such breaches shall be made in a judicial proceeding pursuant to Section 9.14 [ Judicial Proceeding ] ; or ( d ) Change of Control . By S - P, in the event of a Change of Control of M, or by M, in the event of a Change .of Control of S - P, as the case may be ; or [ 0 ) Product Discontinuation . By S - P in the event that M stops the development and/or terminates the marketing of a Cholesterol Product pursuant to c1ause ( x)(2 ) ' Jf Section 7.1(b)A ( whether or not such event follows a suspension of a Cholesterol Product pursuant to clause ( y ) of Section 7.1 ( b ) A ) . By M in the event that ( i ) S - P stops the development and/or terminates the marketing of a Cholesterol Product pursuant to Section 7.1(b)B ; or ( ii ) M has stopped the development and/or has terminated the marketing of a Cholesterol Product pursuant to clause ( x)(2 ) above due to a good faith belief that there is a Significant Safety Issue and has paid the costs referenced in clause ( y ) above ; or ( f ) Carcinogenicity Study . By S - P or M in the event that ( i ) a minimum of a 2 - year c ~ rcinogenicity study ( ) is necessary to obtain FDA approval with respect to the ZIE Combination Product or the MIE Combination Product and ( ii ) M or S - P ( as the case may be ) provides to the other written notice within 20 business days after receiving notice that a Carcinogenicity Study is necessary to obtain FDA approval that it will not participate in such study ; provided that, ifno such notice is received within such 20 business days, both M and S - P shall be deemed to have agreed to participate in such study )