Pre-Clinical Compound definition

Pre-Clinical Compound shall have the meaning set forth in Section 5.7.5.
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Pre-Clinical Compound means a Targeted AIM controlled or owned by Licensor or any of its Affiliates which has not at the time of license grant or sale to a Third Party been the subject of any Phase I Clinical Study. In the event that in order to comply with non-competition laws of any jurisdiction, Licensor, upon the advice of counsel, determines that it is required to grant to such Third Party such rights in the Licensed Indications, it shall do so only provided it also obtains from such Third Party a negative covenant that such Third Party shall not directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any other Third Party to do so) (i) commercialize any pharmaceutical product containing such Pre-Clinical Compound as an active pharmaceutical ingredient in any country in the Licensee Territory for any Licensed Indication during the Term, (ii) develop any such pharmaceutical product anywhere in the world for the purpose of obtaining or maintaining any regulatory approval for such pharmaceutical product in any country in the Licensee Territory for any Licensed Indication during the Term, or (iii) manufacture or have manufactured any such pharmaceutical product anywhere in the world in support of such commercialization or such development in the Licensed Indications. Nothing in this Section 5.7.5 shall be construed as restricting Licensor’s right to (a) engage Third Party service providers or other vendors to perform research or development activities on behalf of Licensor, such as toxicology studies, chemistry, screening, manufacturing, process development, testing and assays, with respect to any Pre-Clinical Compound; (b) license, sell, or otherwise grant to any Third Party rights in and to any Pre-Clinical Compound for use outside the Licensed Indications, anywhere in the Territory, and (c) license or otherwise grant to any Third Party rights to any Collaboration Compound as to which Licensee has not exercised its Collaboration Candidate Option (subject at all times to the restrictions set forth in Section 5.7.2), or any Targeted AIM described in Section 5.7.4, subject at all times to the terms of Section 5.7.4.
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Pre-Clinical Compound means a Program Compound (a) that has achieved Pre-Clinical Status in the Research Program, as determined in accordance with Section 3.1, or (b) that has been designated by Amgen as a Pre-Clinical Compound [**].
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Examples of Pre-Clinical Compound in a sentence

  • Part a) Consider a putative stationary equilibrium with no consultation.

  • The Parties will cooperate to the extent practicable and at Tularik’s expense (subject to the provisions of this Section 3.4.2) to transition to Tularik a Pre-Clinical Compound, an Amgen Development Compound or an Amgen Development Product [**] that becomes a Tularik Development Compound, TD Product or Tularik Target Product, as the case may be, under Section 3.3, Section 3.1.4(b) or Article 11 or otherwise under this Agreement.

  • If Amgen provided written notification to the Joint Research Committee of its interest in Developing a Pre-Clinical Compound within the Pre-Clinical Notification Period, then such Pre-Clinical Compound shall thereafter be Developed by Amgen as an Amgen Development Compound subject to the terms of this Agreement.

  • Amgen shall promptly notify Tularik of the occurrence of each milestone for each Lead Compound, Pre-Clinical Compound, Amgen Development Compound or Amgen Development Product.


More Definitions of Pre-Clinical Compound

Pre-Clinical Compound means a Targeted AIM controlled or owned by Licensor or any of its Affiliates which has not at the time of license grant or sale to a Third Party been the subject of any Phase I Clinical Study. In the event that in order to comply with non-competition laws of any jurisdiction, Licensor, upon the advice of counsel, determines that it is required to grant to such Third Party such rights in the Licensed Indications, it shall do so only provided it also obtains from such Third Party a negative covenant that such Third Party shall not directly or indirectly (including by licensing, authorizing, appointing, or otherwise enabling any other Third Party to do so) (i) commercialize any pharmaceutical product containing such Pre-Clinical Compound as an active pharmaceutical ingredient in any country in the Licensee Territory for any Licensed Indication during the Term, Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
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Related to Pre-Clinical Compound

  • 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 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 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 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 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 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 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 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 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 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 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. [***]

  • 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 Compound means [***].

  • 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)).

  • 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:

  • 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.

  • 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.

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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 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.

  • 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.

  • 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.

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