definiens: means a Clinical Trial of a Licensed Product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ( ( a ) and ( b ) ): ( a ) such Clinical Trial is designed to establish th at such Licensed Product has an acceptable safety and efficacy profile for its inte nded use, and to determine warnings, 9 * * * Confidential Treatment Requested precautions, and adverse reactions that are associa ted with such Licensed Product in the dosage range to be prescribed, which such clinical trial is intended t o support Regulatory Approval of such Licensed Prod uct, or a similar clinical study prescribed by the United Sta tes or EMA ; and ( b ) such Clinical Trial may be a Phase 2 Clinical T rial or Phase 3 Clinical Trial and satisfies the requirements of any of the expedited development and review pathways available at the FD A or its foreign equivalent