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 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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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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Examples of Candidate Drug Target Profile in a sentence

  • 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.

  • 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.

  • 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.

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

  • 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 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.

  • 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.

  • 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.

  • 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 any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • 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 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.

  • Licensed Compound means [***].

  • 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.

  • 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 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 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.

  • 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 each KPI;

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • 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 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.