Phase 3 Study means a clinical study of an investigational product in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]
Development Site means any parcel or lot on which exists or which is intended for building development other than the following:
Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.
Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.
Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.
Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
The Works/Project means the works to be executed or done under this contract.
Interconnection Studies means the Interconnection Feasibility Study, the System Impact Study, and the Facilities Study described in Tariff, Part IV and Tariff, Part VI. Interface Pricing Point:
Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).
Project Site(s) means the place(s) specified in the SCC for the supply and installation of the System.
Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.
Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Development Area means that area to which a development plan is applicable.
Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:
project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;
Project site, where applicable, means the place indicated in bidding documents.
Host Site means the site at which the Site Host Load is consumed, including real property, facilities and equipment owned or operated by the Site Host or its Related Entities located at such site.
Work Site means the site where the Work is being performed.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Commissioning Period means, with respect to each Subproject, the period commencing upon the first delivery of Feed Gas to the Subproject in accordance with Sections 4.8 and 11.1 of the Agreement continuing through achievement of RFSU, commissioning, Start Up, Performance Testing and achievement of Substantial Completion for such Subproject.
Interconnection Study means any of the studies defined in the CAISO Tariff or, if applicable, any distribution provider’s tariff that reflect the methodology and costs to interconnect the Project to the Participating Transmission Owner’s electric grid.
Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.
Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.
Commissioning test means tests applied to the Generating Facility, after completion of the construction of the Generating Facility, in order to verify that the Generating Facility may be released for Operation.
Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.