definiens: means, with respect to any Licensed Product, ( a ) ahuman clinical trial, the principal purpose of which is to demonstrate clinically and statisticallythe eﬃcacy and safety of a Licensed Product for one or more Indications in order to obtainMarketing Approval of such Licensed Product for such Indication(s ), as further deﬁned in 21C.F.R. § 312.21 ; ( b ) a human clinical trial of a product on a suﬃcient number of subjects that, prior to commencement of the trial, satisﬁes both of the following ( both ( i ) and ( ii ) ): ( i ) such trialis designed to establish that a Licensed Product has an acceptable safety and eﬃcacy proﬁlefor its intended use, and to determine warnings, precautions, and adverse reactions that areassociated with such Licensed Product in the dosage range to be prescribed, which trial isintended to support Marketing Approval of such Licensed Product ; and ( ii ) such trial is designedto be a registration trial suﬃcient to support the ﬁling of Marketing Approval Application for suchLicensed Product in the applicable jurisdiction, as evidenced by ( A ) an agreement with orstatement from the FDA or the EMA on a or equivalent, ( B)other guidance or minutes issued by the FDA or EMA, for such registration trial, or ( C ) theequivalent agreement with the applicable Regulatory Authority in such jurisdiction ; or ( c ) ahuman clinical trial that [COMPANY] determines ( in communications with the FDA or the equivalentRegulatory Authority in the applicable jurisdiction ) is intended to support the ﬁling of aMarketing Approval Application for any Licensed Product in the US or the EU, and such trialwill be deemed a Pivotal / Registrational Trial from the date of such determination