Loose-fitting facepiece means a respiratory inlet covering that is designed to form a partial seal with the face.
Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.
Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.
motor cycle means any two-wheeled vehicle, with or without side-car, which is equipped with a propelling engine. Contracting Parties may also treat as motor cycles in their domestic legislation three-wheeled vehicles whose unladen mass does not exceed 400 kg. The term "motor cycle" does not include mopeds, although Contracting Parties may treat mopeds as motor cycles for the purpose of the Convention.
Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.