Phase II

Phase II. Means that portion of the clinical development program which provides for continued trials of a product on patients to establish dose ranging and first indication of efficacy of a product for the desired claims and indications, as more closely defined by the rules and regulations of the FDA and corresponding rules and regulations of other countries.

Phase II. Represents aspects of this Agreement that require 12 weeks lead time for implementation (e.g. New Car Page). 2

Phase II. Shall mean that portion of the FDA or equivalent foreign submission on which approval of a New Drug Application ("NDA") will be based which provide for the adequate initial trials of Licensed [***] Product on a limited number of patients and/or healthy volunteers for the purposes of determining dose and evaluating safety and efficacy in the proposed therapeutic indication as more fully defined in 21 C.F.R. Section 312.21 (b).

Phase II. Means that part of the Building denoted as such on Attached Exhibit A. The Premises are contained within Phase II.

Phase II. The same meaning as set forth in the Act and/or the corresponding EU Directives for clinical trials. For purposes of this Agreement, all references to Phase II shall mean the completion of Phase II requirements for [* * *].

Phase II. Which is to extend for four (4) years following the termination of Phase I, if AMVEST elects to proceed and if AMVEST qualifies for entry into Phase II

Phase II. The Phase II development plan of the Company, consisting of two hotels (one on the Company's campus and one in downtown Canton), an indoor waterpark, the Constellation Center for Excellence, the Center for Performance, the Play Action Plaza, and the Hall of Fame Retail Promenade

Phase II. With respect to a clinical trial conducted pursuant to an IND, any controlled human clinical trial conducted in the United States as required under and pursuant to 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical study.