definiens: means, with respect to either Indication:(a ) Dermavant or an independent data monitoring safety board has made a reasonable and good faith determination that the Productpresents a risk of death, a life - threatening condition, or such serious safety or health risks to patients such that, based on then - available data, Dermavant can not ethically and in good faith continue to administer the Product to patients ; provided that such a determination shall bedeemed to be a Technical Failure of both Indications ( for clarity, even if such determination is made after a termination due to a reason otherthan for a Technical Failure with respect to one Indication);(b ) Any material adverse development, occurrence or event with respect to the Development of the Product, as a result of which aQualified Party may reasonably make a good faith determination to cease continued Development of the Product ; provided that such adetermination shall be deemed to be a Technical Failure with respect to both Indications ( for clarity, even if such determination is made after atermination due to a reason other than for a Technical Failure with respect to one Indication ) ; or(c ) Dermavant has received either a final, unconditional, non - approval letter pursuant to 21 C.F.R. § 314.120 or a complete responseletter pursuant to 21 C.F.R. § 314.110 from the FDA ( or an equivalent letter from any other Regulatory Authority ) regarding the Product andthe contents of such letter : ( i ) render Dermavant ’s receipt of Marketing Approval in the U.S. on or before September 30, 2023, not reasonablylikely, or ( ii ) would require Dermavant to conduct one or more additional Phase III Trials prior to resubmitting an application for MarketingApproval and such additional Phase III Trial(s ) would reasonably be anticipated to cost more than [ * * * ] ; provided that such a determinationshall be deemed to be a Technical Failure of both Indications ( for clarity, even if such determination is made after a termination due to areason other than for a Technical Failure with respect to one Indication )