Phase 2 PoC Trial Support Activities definition

Phase 2 PoC Trial Support Activities means the [***] and the [***] identified under the “Phase 2 PoC Trial Support Activities” section of the TTR Development Plan.
Sample 1

Examples of Phase 2 PoC Trial Support Activities in a sentence

  • Subject to the terms of this Section 3.c.i and the terms of the Agreement (as amended by this Amendment), GSK will manufacture and supply finished product and corresponding placebo (new supply) for the Phase 2 PoC Trial and/or the Phase 2 PoC Trial Support Activities.

  • To facilitate GSK in manufacturing the finished product for the Phase 2 PoC Trial, the Phase 2 PoC Trial Support Activities, and Commercialization, the Parties will collaborate to facilitate a technology transfer to a finished product manufacturing site identified by GSK in support thereof.

  • The prices for GSK to supply finished product (or placebo) other than for the Phase 2 PoC Trial and Phase 2 PoC Trial Support Activities will be [***].

  • The GSK-Isis Finished Product Supply Agreement for Clinical Studies will include the manufacturing technology transfer provisions set forth in Section 3ciii below, and will also contain, but not be limited to, the terms only for supply of finished product (or placebo) for the Phase 2 PoC Trial and Phase 2 PoC Trial Support Activities.

  • Subject to this Section 3.a of this Amendment, Isis will be responsible for manufacturing (or having manufactured) a sufficient quantity of API and finished product to complete the Xxxxx 0 XxX Xxxxx and the Phase 2 PoC Trial Support Activities.

Related to Phase 2 PoC Trial Support Activities

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Development Program means the implementation of the development plan.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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).

  • 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.

  • Development Phase means the period before a vehicle type is type approved.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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.

  • 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).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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).

  • Development Plan has the meaning set forth in Section 3.2.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).