definiens: means, in reference to a clinical trial of a Lice nsed Product, a Phase 2 Clinical Trial involving a sufficient number of sub jects that, prior to commencement of the trial or a t any other defined point in the trial, satisfies both of the f ollowing ( ( a ) and ( b ) ): ( a ) such trial is designed to ( i ) establish that the ap plicable Licensed Product is safe and efficacious for its intended use, and ( ii ) define a nd determine warnings, precautions, and adverse reactions that are associated with the Lice nsed Product in the dosage range to be prescribed, which trial is intended to support Mark eting Approval of such Licensed Product or a similar clinical study prescribed by the FDA, wit h respect to the U.S., or other Regulatory Authority with respect to any other country in the Territory ; and ( b ) such trial is or becomes a registration trial suffi cient for filing a Drug Approval Application for such Licensed Product, as evidenced by ( i ) an agreement with or statement from the FDA, with respect to the U.S., or other Re gulatory Authority with respect to any other country in the Territory on a Special Protocol Asse ssment or equivalent, or ( ii ) other guidance or minutes issued by the FDA or such other Regulato ry Authority for such registration trial