definiens: means, with respect to a Product containing Vofatamab : ( i ) Purchaser ( or any Licensee of Purchaser ) or an independent data monitoring safety board has made a reasonable and good faith determination that such Product for use in such indication(s ) presents a risk of death, a life -threatening condition, or such s erious safety or health risks to patients such that, based on then -available data, Purchaser ( directly or indirectly ) can not ethically and in good faith continue to administer the Product to patients ; or ( ii ) any material adverse development, occurrence o r event, including data results, with respect to the development of such Product, as a result of which Purchaser may reasonably make a good faith determination to cease continued development of the Product ) ; or ( iii ) Purchaser ( or any Licensee of Purchase r ) has received either a final, unconditional, non -approval letter pursuant to 21 C.F.R. § 314.120 or a complete response letter pursuant to 21 C.F.R