Preclinical Compound definition

Preclinical Compound means any *** (i) evaluated, optimized, developed, selected, obtained and/or pursued by or on behalf of ONO, its Affiliates or Licensees for development and/or Commercialization by ONO, its Affiliates or Licensees and (ii) for which ONO or its Affiliates or Licensees initiated (or had initiated on its behalf) fourteen *** Confidential material redacted and filed separately with the Commission.
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Preclinical Compound means an ICAgen Preclinical Compound or a YAMANOUCHI Preclinical Compound.
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Preclinical Compound means any Licensed Compound selected by Wyeth-Ayerst or an Affiliate of Wyeth-Ayerst to enter into Preclinical Development.
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Examples of Preclinical Compound in a sentence

  • Following expiration of the Research Term and on the anniversary of the Expiration Date, ONO shall provide Receptos with annual update summarizing ONO’ s, and its Affiliates’, Licensees’, and Research Partners’ ongoing, active research, development and commercialization activities of any Lead Compound, Preclinical Compound and Product for Collaboration Target (“Annual Update”).

  • Furthermore, if a Development Milestone Event is achieved for a given Preclinical Compound before a prior Development Milestone Event (“prior” and “subsequent” referring to a lower number in the table above, e.g., Development Milestone Event 2 being “prior” to Development Milestone Event 3), then all such prior Development Milestone Events shall be deemed achieved upon achievement of the subsequent Development Milestone Event.

  • The Development Milestone Payments shall be payable only once by ONO with respect to Collaboration Target upon the first achievement of the applicable Development Milestone Event whenever it occurs, regardless of subsequent or repeated achievement of such milestone event by any Preclinical Compound or Product.

  • The following milestone amounts (the “Development Milestone Payments”) shall be paid upon the achievement by ONO, its Affiliates, or Licensees of the milestone events relating to Preclinical Compound (the “Development Milestone Events”) as set forth in the table below, provided that the amount of the Development Milestone Payment shall be determined with reference to whether Condition I or Condition II is satisfied as set forth in the table below.

  • Development Milestone Event Milestone Amount if Condition I is satisfied Milestone Amount if only Condition II is satisfied 1 Selection by ONO, its Affiliates or Licensees of a Preclinical Compound (provided, however, that if this Development Milestone Event is achieved prior to designation of the Lead Compound, then the Research Milestone Payment for Research Milestone Event No. 8 shall be paid at the time of the payment of Development Milestone Payment relating to this Development Milestone Event No. 1.

  • ICAgen may, at any time during the Clinical Compound Selection Period, elect to develop and commercialize in the Secondary Field in the Rest of the World each Secondary Field Preclinical Compound.

  • If pursuant to Section 2.12(a) or (b) either Party elects to develop and commercialize a Preclinical Compound and thereafter at any time ceases, in all Major Countries in the applicable Territory, to use commercially reasonable efforts (as specified in Section 4.1) to develop and commercialize a Clinical Compound and a Product based thereon, it shall promptly so notify the other Party (a “YAMANOUCHI Abandonment Notice” or an “ICAgen Abandonment Notice”, as the case may be).

  • The Party selecting a Back-up Compound shall not have the obligation to develop or commercialize the Back-up Compound for so long as it is developing and commercializing the elected Preclinical Compound in the applicable Field, for the applicable indication or indications and in the applicable Territory.

  • In addition, with respect to each Preclinical Compound which either Party has elected to develop and commercialize under Section 2.12 (a) or (b), such Party shall have a [**] right to replace one of the Back-up Compounds selected by such Party for such Preclinical Compound with a different Back-up Compound.

  • Touch More Modes once.The display shows SELECT PROGRAM 1 - 6.2. Touch the number key 4 or touch More Modes four times.MELT CHOCOLATE and the microwave symbol Î are displayed.


More Definitions of Preclinical Compound

Preclinical Compound means any Licensed Compound selected by Sankyo or an Affiliate of Sankyo to enter into Preclinical Development.
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Preclinical Compound means any Licensed Compound that is not RDEA119 or RDEA436.
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Preclinical Compound means a Licensed Compound that is selected by the RSC for pre-clinical development.
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Related to Preclinical Compound

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

  • 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 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 [***].

  • 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.

  • 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.

  • 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 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 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.

  • 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.

  • 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.

  • 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 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 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.

  • 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.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • 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.

  • 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 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 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.

  • 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.

  • 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.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.