Project Candidate definition

Project Candidate has the meaning assigned thereto in Section 1.1.
Sample 1Sample 2
Project Candidate means any substance or compound that is based on or directed to a Viable Target or Accepted Target or which results from the Reverse Genomics Research Program and which is selected by the BG preclinical research steering committee for development as a drug project or for which BG or Third Parties on BG’s behalf commence drug project development activities.
Sample 1
Project Candidate means any substance or compound that is based on or directed to a Viable Y3H Target or Accepted Y3H Target or which results from the Reverse Genomics Research Program and which is selected by the ALTANA preclinical research steering committee for development as a drug project or for which ALTANA or Third Parties on ALTANA’s behalf commence drug project development activities.
Sample 1

Examples of Project Candidate in a sentence

  • A second Council Member must concur with the request to move the project idea onto the Capital Project Candidate List.

  • The Principal Researchers shall keep regular contact as needed for the Project including the sharing of up to date timelines of each Party’s work for the Project and the development of the Project Candidate Vaccine.

  • Within the 3rd stage of the Project, SVT and VBI will conduct in parallel assessments of the potency and stability of the Project Candidate Vaccine (the “Final Analysis”).

  • During the term of this Agreement, the Project Candidate Vaccine will only be used for the performance of the Project according to Schedule A by SVT and VBI under suitable biosafety and containment conditions in accordance with good Laboratory practices and adequate biosafety protections.

  • Content on the Platforms is provided for your general information purposes only.

  • However the Parties already agree and acknowledge that should SVT not exercise its Option, save for the Project Candidate Vaccine, each Party will be entitled to practice and sublicense joint know-how and Joint Inventions without restriction or consent of the other or an obligation to account to the other Party.

  • Notwithstanding anything to the contrary contained herein, including, without limitation, disclosure of the results obtained in the manufacture of the Project Candidate Vaccine using the VBI LPV™ Technology pursuant to Section 10.1, SVT shall not have a license to or rights in any of VBI LPV™ Technology, except as expressly set forth herein, in the License Agreement entered into upon exercise of SVT’s Option or in any Extended License agreement in accordance with Section 8.

  • Arnheim and Venezuela HD Project: Candidate DNA replication initiation regions at human trinucleotide repeat disease loci.

  • Table 4: List of Candidate Projects Selected for Review Candidate Project Candidate Project This component of the research involved review of documents and interviews with representatives of the proponent.

  • The core subproject was selected not only to be viable on its own but also to be effective demonstrators of the proposed interventions that can be replicated in the pipeline subprojects.Figure 1: Irrigated Agriculture Inclusive Development Project Candidate Irrigation System Locations 8.

Related to Project Candidate

  • 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.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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).

  • 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.

  • 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 Compounds means any EZH2 Compound(s) that is:

  • 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.

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • Research Program has the meaning set forth in Section 2.1.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Development Program means the implementation of the development plan.

  • 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 II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

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