Programme shall have the meaning set forth in Clause 10.1 (iii);
Multiregional Modeling Working Group or “MMWG” shall mean the NERC working group that is charged with multi-regional modeling.
Development Program means the implementation of the development plan.
Video programmer means a person or entity that provides video programming to end-user
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating phar- macy, that provides centralized prescription filling on behalf of the originating pharmacy pursuant to these rules.
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
the Programme means the programme leading to the Degree of Master of Laws – LL.M – in International Maritime Law;
Development Plan has the meaning set forth in Section 3.2.
Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.
Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.
Timeline means the list of critical dates and actions included in the Introductory Materials.
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
Utilization review means the prospective (prior to), concurrent (during) or retrospective (after) review of any service to determine whether such service was properly authorized, constitutes a medically necessary service for purposes of benefit payment, and is a covered healthcare service under this plan. WE, US, and OUR means Blue Cross & Blue Shield of Rhode Island. WE, US, or OUR will have the same meaning whether italicized or not. YOU and YOUR means the subscriber or member enrolled for coverage under this agreement. YOU and YOUR will have the same meaning whether italicized or not.
Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.
Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.
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 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.
Video programming means programming provided by, or generally considered comparable to programming provided by, a television broadcast station.
Approved program or "approved state" means a state or interstate program that has been approved or authorized by EPA under 40 CFR Part 123 (2000).
Firm Transmission Feasibility Study means a study conducted by the Transmission Provider in accordance with Tariff, Part II, section 19.3 and Tariff, Part III, section 32.3.
Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).
Commercialization Plan has the meaning set forth in Section 6.2.
Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.
Research Program has the meaning set forth in Section 3.1.
Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;