Candidate Drug Target Profile definition

Candidate Drug Target Profile means the target profile for a Candidate Drug as further defined under the Joint Research Plan, the criteria for which are attached hereto as Exhibit A.
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Candidate Drug Target Profile means (i) those criteria set forth in Exhibit 1.12, and/or (ii) such other criteria as are approved by the JRC and agreed in writing by the Parties. No criteria shall be deemed part of the Candidate Drug Target Profile under (ii) unless such criteria are formally approved by the JRC and agreed in writing by the Parties, regardless of whether such criteria are used informally or discussed by the Parties in the course of the Research Program.
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Candidate Drug Target Profile or “CDTP” shall mean, with respect to each Collaboration Antigen, the criteria and information requirements approved by the Research Management Committee pursuant to Section 2.2.2(b) and incorporated into the applicable Research Program Work Plan for evaluating whether or not to designate an Antibody that binds to and is directed against such Collaboration Antigen as a Candidate Drug.
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Examples of Candidate Drug Target Profile in a sentence

  • In addition, during the term set forth in this Section 12.4.3(b)(i), Array shall develop for use outside the Field only those Compounds (y) that Array has demonstrated do not meet the Candidate Drug Target Profile, and (z) that were determined to meet the Candidate Drug Target Profile in the course of the Research Program prior to the Change of Control, but that were rejected pursuant to Section 2.5.2(a)(ii) above.

  • Based upon the results of the Research Program, either Party may from time to time request that the JRC recommend a particular Compound meeting the Candidate Drug Target Profile to AZ for selection as a Candidate Drug (a “Recommendation Request”).

  • Such Candidate Drug Target Profile may be amended or subsequent Candidate Drug Target Profiles may be agreed and attached from time to time as appropriate to meet the relevant Compound requirements of AZ.

  • In the event the JRC determines, in its discretion, that a particular Compound does not strictly meet the Candidate Drug Target Profile, but should be considered as a potential Candidate Drug, then the JRC may recommend such Compound to AZ for selection as a Candidate Drug.

  • The Parties have established a Candidate Drug Target Profile, set forth in Exhibit 1.12, to indicate the suitability of Compounds as Candidate Drugs.

  • Promptly after receipt of a Recommendation Request, the JRC shall confirm whether such Compound meets the Candidate Drug Target Profile and, following such confirmation, shall recommend such Compound for selection by AZ as a Candidate Drug.

  • In addition, during the term set forth in this Section 11.6.3(b)(ii), Array shall develop for use outside the Field only those Compounds (y) that Array has demonstrated do not meet the Candidate Drug Target Profile, and (z) that were determined to meet the Candidate Drug Target Profile in the course of the Research Program prior to the termination, but that were rejected as Candidate Drugs pursuant to Section 2.5.2(a)(ii) above.

  • In order to be designated a Candidate Drug, a Research Antibody must meet or exceed the applicable Candidate Drug Target Profile, unless AZ, in its sole discretion, decides otherwise.

  • Any dispute between the Purchaser and the Company as to whether a Research Antibody has met or exceeded the applicable Candidate Drug Target Profile shall be resolved in accordance with the provisions of Section 3.6 of the Collaboration Agreement.

  • However, a Research Antibody that meets or exceeds the applicable Candidate Drug Target Profile may, nonetheless, not be designated as a Candidate Drug.

Related to Candidate Drug Target Profile

  • 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.

  • 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.

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • 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)).

  • 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).

  • 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.

  • 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 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 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • KPI Target means the acceptable performance level for a KPI as set out in relation to each KPI;

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

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

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.