Safety Convention means the International Convention for the Safety of Life at Sea, 1974 (a copy of the English text of the articles of which, and of part of the annex to which, is set forth in Schedule 4), as affected by any amendment, other than an amendment objected to by Australia, made under Article VIII of that Convention and, after the date on which the Protocol of 1978 relating to the Safety Convention enters into force for Australia, as also affected by that Protocol;
Safety zone means the area officially set apart within a roadway for the exclusive use of
Study means the investigation to be conducted in accordance with the Protocol.
Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.
Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.