Optimized Lead Compound definition

Optimized Lead Compound means (i) with respect to the MERCK Funded Research Projects or MERCK Internal Research Projects, any [***] Compound that the JPT nominates and the JSC accepts as meeting the OLSC for such Program Target; provided, that, no [***] shall, after becoming a [***], be nominated or designated as an Optimized Lead Compound, and (ii) with respect to the ARCHEMIX Internal Research Projects any Compound Candidate that MERCK designates as an Optimized Lead Compound in accordance with Section 3.9.1 or Section 3.9.2.
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Optimized Lead Compound means any Active Compound or ----------------------- Derivative Compound that is optimized to meet the in vitro criteria for activity -- ----- against a Target established in the applicable Annual Research Plan.
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Optimized Lead Compound means a Lead Compound that has undergone Lead Compound Optimization.
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Examples of Optimized Lead Compound in a sentence

  • Nothing contained in this Agreement shall be construed as a warranty on the part of either Party that (a) the Research Program will yield any Lead Compound, Optimized Lead Compound or Development Candidate or otherwise be successful, (b) any Development Program will yield a Product or otherwise be successful or (c) the outcome of the Research Program or any Development Program will be commercially exploitable in any respect.

  • In the event that a Third Party alleges that the conduct of the Research Program or the Development or Commercialization of an Optimized Lead Compound, Development Candidate or Product infringes the Patent Rights of a Third Party, the Party becoming aware of such allegation shall promptly notify the other Party hereof, in writing, reasonably detailing the claim.

  • If the JPT elects to nominate any such Lead Compound as an Optimized Lead Compound, the JPT shall promptly furnish all available information to the JSC.

  • The JSC shall consider such nomination within [***] days, and if the JSC approves the nomination of the Lead Compound, such Lead Compound shall be deemed to be an Optimized Lead Compound for purposes of this Agreement.

  • If the JPT elects to nominate any such Optimized Lead Compound as a Development Candidate, the JPT shall promptly furnish all available information to the JSC.

  • ARCHEMIX agrees that, except as required by Applicable Laws, it shall not publish or present, or permit to be published or presented, any data arising out of the Development Program relating to an Optimized Lead Compound or Product without the prior review and express written approval of TAKEDA which may be withheld at TAKEDA’s sole discretion.

  • Within [***] days after either Party reasonably concludes based upon available project reports that an Optimized Lead Compound meets the applicable DCSC, the JPT shall review the data and information and determine whether to nominate the Optimized Lead Compound for designation as a Development Candidate.

  • If the JPT elects to nominate any such Program Aptamer as an Optimized Lead Compound, the JPT shall promptly furnish all available information to the JSC.

  • Within [***] days after its receipt of each report from ARCHEMIX pursuant to Section 3.4.2 identifying a Program Aptamer as meeting the applicable OLSC (or which either Party reasonably believes should be an Optimized Lead Compound), the JPT shall review the data and information and determine whether to nominate the Program Aptamer to the JSC for designation as an Optimized Lead Compound.

  • Thereafter, subject to Section 4.10.5(a), for each Contract Year during the Term, an Annual Development Plan for each Optimized Lead Compound shall be prepared by MERCK and provided to the JSC for its review and MERCK shall consult with the JSC with respect to all significant Development decisions to be made with respect to such Annual Development Plan.


More Definitions of Optimized Lead Compound

Optimized Lead Compound means a Lead Compound or a ----------------------- BIOCRYST Compound Derivative which, through a process of optimization, demonstrates a specified level of activity in the Field (i) as set forth in the Research Plan or (ii) as otherwise agreed by the parties.
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Optimized Lead Compound or “Optimized Lead” means any Program Aptamer that the JSC accepts as meeting the OLSC for such Program Target and any Aptamer Derived therefrom. The Parties agree that any Program Aptamer for which [***] shall be deemed to have been accepted as an Optimized Lead Compound by the JSC. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
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Optimized Lead Compound means any [***] Compound that the JPT nominates and the JSC accepts as meeting the OLSC for such Program Target; provided, that, no [***] shall, after becoming a [***], be nominated or designated as an Optimized Lead Compound.
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Related to Optimized Lead Compound

  • 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.

  • 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)).

  • Licensed Compound means [***].

  • 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 Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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.

  • 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.

  • 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.

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

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • 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 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 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 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.

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

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • 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.

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

  • 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.