definiens: means, with respect to the Product in each of ( a ) wet age - related macular degeneration ( AMD ), ( b ) diabetic macular edema ( DME ), and ( c ) re tinal vein occlusion ( including branch retinal vein occlusion ( BRVO ) and central retinal vein occlusion ( CRVO ) ) that ( i ) either ( A ) Sellers or ( B ) at Buye r ’s option and request, an independent third - party reasonably agreed upon between the Parties to review the Clini cal Trials data and results, have made a reasonable and good f aith determination that the Product presents a risk of death, a life - threatening condition, or such serious safety or health risks to patients such that, based on the n - available data, Sellers can not ethically and in good faith co ntinue to administer the Product to patients ; or ( i i ) any material adverse development, occurrence or event with respe ct to the clinical development of the Product, as a result of which Sellers, in consultation with Buyer, may reas onably make a good faith determination to cease con tinued development of the Product ( for example, if one or more Products ( A ) fails as a result of the manufact uring thereof due to failure to achieve a purified yield required to commercialize the Product, or because a manufacturing process can not be established accordi ng to GMP manufacturing guidelines to produce suffi cient material for Commercialization ; or ( B ) is otherwise not reasonably suited for the continuation of Clin ical Trials ( in the case of preclinical or clinical stage trial s, toxicities that would trigger the stoppage of fu rther development, e.g., as may be reported as adverse events, serious adv erse events, or clinical laboratory abnormalities ) ), or ( C ) fails to meet its primary e ndpoint of any Clinical Trial