Phase I Trials definition

Phase I Trials means the human clinical trials conducted on normal volunteers or patients designed to evaluate the safety, tolerability and/or pharmacokinetic profile of the relevant Collaboration Product, and in accordance with the relevant Development Program.
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Phase I Trials. “Phase II Trials” and “Phase III Trials” mean, respectively, human clinical trials designated by the U.S. Food and Drug Administration (FDA) as Phase I, Phase II (or Phase I/II), or Phase III trials.
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Phase I Trials being defined as clinical trials based on an IND (or equivalent) filing involving at least 25 patients], provided BNP commits to fund and carry out the development work (toxicology, GMP manufacturing, etc.) reasonably necessary to progress the product or technology in question through Phase I Trials in accordance with a development plan which is acceptable to Nair (which acceptance shall not be unreasonably withheld). To the extent possible, the development work shall be carried out by Nair under contract with BNP and the costs for such development work shall not be part of, or offset against, BNP's obligations for Research Funding under the Research Agreement. In addition, as part of the development cost funding commitment, BNP shall pay all of Nair's documented and reasonable patent filing and prosecution costs for any patent application covering the new product or technology in question, as such costs are incurred by Nair. In the event BNP elects not to continue funding of the development work or patent costs on a particular product or technology subject to the exclusive option granted pursuant to this Section 10 of the Agreement, BNP's exclusive option for an exclusive license to such particular product or technology shall expire and Nair shall have the right to exploit those commercial rights owned by Nair to the specific product or technology, itself, or through one or more commercial partners. BNP, however, shall retain an exclusive option on all other products and technology subject to the exclusive option.
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Examples of Phase I Trials in a sentence

  • OncoMed shall, as soon as reasonably practical [***] Scenario #1, commence activities under Scenario #l as set forth in Exhibit 2, attached hereto and incorporated herein by reference, using its Commercially Reasonable Efforts to conduct such Phase I Trials (Parts 1 and 2) as set forth therein through to Completion of such Phase I Trials in accordance with Paragraph 11.

  • If the JSC cannot agree whether additional preclinical studies or Phase I Trials should be conducted, [***].

  • If the JSC determines to conduct such additional preclinical studies or Phase I Trials, the BSP Option Period for such Class will be extended until the date that is [***] after such additional preclinical activities have been completed or such additional Phase I Trials have been Completed, whichever is later.

  • ImmunoGen is obliged to supply BI Pharma with certain quantities of Drug Product in order for BI Pharma to conduct Phase I Trials and non-pivotal Phase IIa Trials.

  • GSK shall have the right to exercise, in GSK’s sole discretion, in accordance with Section 4.1.3(a) of the Agreement and notwithstanding anything to the contrary in Section 4.1 of the Agreement, the GSK Program Option for the Anti-Notch 1 Program within [***] after the Completion of Part 2 of the Phase I Trials for the Anti-Notch 1 Program under Scenario #1 and receipt by GSK of [***] (the “Early Option Exercise Period”).

  • If the JSC determines that additional preclinical studies or Phase I Trials should be performed, OncoMed (reasonably considering any guidance and comments from BSP with respect to such additional preclinical studies or Phase I Trials), or at OncoMed’s discretion BSP, shall conduct such additional preclinical studies or Phase I Trials, at BSP’s expense, pursuant to an updated Biologic Development Plan for such activities, which shall include a timeline for completion of such activities.

  • Following completion of the Phase I Trials, a Medical Advisory Board (the "MAB") having no fewer than three qualified members shall be appointed by the Company's Board of Directors.

  • LICENSEE shall conduct such clinical trials (including without limitation, Phase I Trials, Phase II Trials, and/or Phase III Trials) as LICENSEE deems are desirable or necessary for Commercialization of the Licensed Products.

  • Until completion of the Phase I Trials, any agreement (other than this Agreement and all agreements and instruments contemplated herein) entered into by the Company relating to mCRP, including any license or sublicense with respect thereto, with any person or entity that is related in any way to Immtech or Franklin or any other shareholder or any director of the Company shall require approval by a Special Director Vote (as such term is defined in the Company's Certificate of Incorporation).

  • The Phase I Trials will commence in 1999, and it is anticipated that the Phase I Trials will be completed before the end of 1999.

Related to Phase I Trials

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • 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 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 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 II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).

  • 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 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.

  • 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 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 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 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).

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

  • 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.

  • 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 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 III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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 II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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 1 Trial means a human clinical trial of a Product in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a), or its foreign equivalent.

  • 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.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • 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 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).