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.
Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.
Licensed Level means a) when referenced in the context of a Named User, the quantity of Metric for which each individual Named User category and type is licensed -and- b) when referenced in the context of a Package, the quantity of Metric for which each individual Package is licensed; and
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 [***]
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.
Licensed Nurse means an Oregon licensed practical or registered nurse.
Network plan means a policy of group health insurance offered by an insurer under which the financing and delivery of medical care, including items and services paid for as medical care, are provided, in whole or in part, through a defined set of providers under contract with the insurer. The term does not include an arrangement for the financing of premiums.
Field trip means any experience a child has away from the premises of the center, while under the care of center staff, whether a child walks or is transported.
Commercialization Plan has the meaning set forth in Section 6.2.
Adult exploitation means the illegal use of an incapacitated adult or his resources for another's
Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.
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.
Development Period means the period from the date of this Agreement until the Appointed Date;
Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.
Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.
Research Budget has the meaning set forth in Section 3.2.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
Sound level meter means an instrument which includes a microphone, amplifier, RMS detector, integrator or time averager, output meter, and weighting networks used to measure sound pressure levels.
Development Plans has the meaning set forth in Section 3.2.
Development Plan has the meaning set forth in Section 3.2.
Access Channel means any Channel, or portion thereof, designated for Access purposes or otherwise made available to facilitate or transmit Access programming or services.
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Research Plan shall have the meaning set forth in Section 2.1.