Optimized Lead Compound definition

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 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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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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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.

  • 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.

  • 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.

  • 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.

  • The RC shall have --------------------------------------- responsibility for determining if an Optimized Lead Compound meets the criteria specified in the Research Plan for a Development Candidate.

  • Whereas implementation of existing legislation and judicial follow-up of atrocities and cases of discrimination is insufficient in many states and regions; whereas according to official figures, two women are raped every 60 minutes in India and a young woman is found beaten to death, burnt or driven to suicide, every six hours.

  • If the RC determines that an Optimized Lead Compound is a Development Candidate, it shall promptly give written notice of its decision to each of the parties (a "Development Candidate Notice").

  • McGarr et al., 2002; Guglielmi et al., 2015; Foulger et al., 2018).

  • Any structures in the Meteor Creek floodplain associated with road construction and watercourse crossings should be incorporated in the flood model to assess the impact on flood behaviour and the potential for increased erosion in this area, which is also likely to be impacted by the Meteor Creek Levee.


More Definitions of Optimized Lead Compound

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 a Lead Compound that has undergone Lead Compound Optimization.
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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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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 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.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • 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 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.

  • 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 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 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.

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

  • 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 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 a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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 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 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 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).

  • 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.

  • 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.