Phase III

Phase III. Means that portion of the clinical development program which provides for the continued trials of a product on sufficient numbers of patients to establish the safety and 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. page 5 of 35

Phase III. Represents aspects of this Agreement that require 24 weeks of lead time for implementation (e.g. Liner Ads)

Phase III. Shall mean that portion of the FDA or equivalent foreign submission on which approval of an NDA will be based which provides for the well-controlled clinical trials of Licensed [***] Product on sufficient numbers of patients and/or healthy volunteers to generate safety, efficacy and pharmacoeconomic data to support regulatory approval in the proposed therapeutic indication as more fully defined as 21 C.F.R. Section 312.21(c) including any study referred to or denominated as a Phase II/III study... in the United States or the equivalent elsewhere. View More

Phase III. Means that portion of the Building denoted as such on Exhibit A which may, but need not, be constructed by Lessor.

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

Phase III. 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(c), or, with respect to a jurisdiction other than the United States, a similar clinical study.