definiens: shall mean : ( a ) an Emergency Use Authorization issued by th e U.S. Department of Health and HumanServices or the FDA pursuant to Section 564 of the U.S. Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360b bb-3, orany successor authorization thereto in the U.S. ; ( b ) a condi tional marketing authorisation granted by the EMA pursuan t toRegulation ( EC ) No . 507/2006 in the context of a publi c health emergency, or any successor authorization thereto i n the EU, or an equivalent conditional marketing authorization th ereto granted by the applicable Regulatory Authority of a MajorEuropean Country pursuant to equivalent laws in such Major European Country in the context of a public health emer gency, or any successor authorization thereto in a Major European Country ; ( c ) a Special Approval for Emergency granted byJapan ’s Ministry of Health, Labour and Welfare under ar ticle 14 - 3 of Japan ’s Pharmaceuticals and Medical Devices Act, o rany successor approval thereto in Japan ; or ( d ) an equivalen t conditional approval granted by the applicable Regula toryAuthority of any other country or regulatory jurisdiction i n the context of a public health emergency