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 any Licensed Compound selected by Sankyo or an Affiliate of Sankyo to enter into Preclinical Development.
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Preclinical Compound means an ICAgen Preclinical Compound or a YAMANOUCHI Preclinical Compound.
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Examples of Preclinical Compound in a sentence

  • 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.

  • 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.

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  • 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.

  • 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 results show that the emissions are still significant and emissions modelling is required.

  • It was found the hypothesized model fit the data well, and social support fully mediated in the association between grief and well-being.

  • YAMANOUCHI may elect, at any time during the period beginning on the Effective Date and, unless extended by mutual agreement of the Parties on a compound-by-compound basis, ending on [**] (the “Clinical Compound Selection Period”), to develop and commercialize each Primary Field Preclinical Compound as a Clinical Compound in the Entire World in the Primary Field and in Asia in the Secondary Field.

  • 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.

  • 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.


More Definitions of Preclinical Compound

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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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.

  • Licensed Compound means [***].

  • 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.

  • 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.

  • 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 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).

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

  • 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 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.

  • 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 human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • 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 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 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.

  • 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 Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.