Proof of Concept Studies definition

Proof of Concept Studies means the mutually agreed pre-clinical trials under an Approved Research Plan occurring in animals with the goal of supporting the submission of an Invention Disclosure to Ambrx as set forth in Section 4.5.
Sample 1Sample 2Sample 3
Proof of Concept Studies has the meaning set forth in Annex A hereto.
Sample 1
Proof of Concept Studies means studies in humans regarding Product in [CONFIDENTIAL TREATMENT REQUESTED]. The clinical outcome of such studies should - subject to the sole discretion of XXX - not raise safety concerns such as imbalance in global or particular serious adverse events in the Product treated group. ***CONFIDENTIAL TREATMENT REQUESTED***
Sample 1

Examples of Proof of Concept Studies in a sentence

  • The event attracts the best Informatics and Computer Science research with commercial potential from Scottish Universities and creates an environment for industry partners and academics to come together and identify opportunities for: Collaborative Innovation; Studentships & Placements; Technology Licensing & Consultancy; Feasibility & Proof of Concept Studies.

  • It further stated that it was unknown whether the Proof of Concept Studies took into consideration that the accuracy levels have to be maintained when the project is implemented on a high scale of enrolment of 1.2 billion people (See Petitioner’s Vol.

  • Use of the OMX microscope was supported by the Euro-BioImaging PCS and through the MRC Next Generation Optical Microscopy Award (Ref: MR/K015869/1) and part of this work was performed in the frame of the Proof of Concept Studies (PCS) for the ESFRI research infrastructure project Euro- BioImaging at the PCS facility OMX (WTB Dundee).

  • Exhibit D: Clinical Proof of Concept Studies [Exhibit D has been omitted pursuant to Item 601(a)(5) of Regulation S-K.

  • The two-sample t-test and median-test both reject the null that CEO total pay in private firms is the same as that in public firms at the 1% level.On average, total pay in public firms is approximately twice that in private firms.

  • VERTEX, in developing the Research Plan and the Early Development Plan, will take into account the general criteria and guidelines (without being bound in each detail) attached as Schedule 2.4.3 hereto, to ensure a timely continuation of further clinical development of the Drug Candidate after completion of Proof of Concept Studies in accordance with the normal sequence of clinical development activity.

  • Use of inappropriate cleaning techniques or cleaning agents may also damage your appliances and/or void the warranty.

  • The "Referral Matter" shall consist solely of disagreements concerning whether Proof of Concept Studies as specified by the JRC have been completed.

  • During the term of the Research Program and the Extended Development Period, NOVARTIS shall create, reserve and maintain an internal loan facility of [**********], from which it shall advance funds to VERTEX, and from which VERTEX may draw funds from time to time, for purposes of supporting Proof of Concept Studies for Development Candidates hereunder.

  • The VISITS Feasibility and Proof of Concept Studies stream (VISFPC) provides funding for early feasibility and proof of concept studies directed at advancing solutions to demand driven challenges.


More Definitions of Proof of Concept Studies

Proof of Concept Studies means clinical studies conducted in up to 50 patients with multiple dose exposure, or in healthy volunteers if, with the approval of NOVARTIS (which shall not be unreasonably withheld), the objectives of the proof of concept can be achieved in volunteers. The clinical studies will demonstrate the following results (or such other results as may be agreed by NOVARTIS and VERTEX): [******************************************************************* ******************************************************************** ******************************************************************** ******************************************************************** ******************************************************************** ****************************************************************] In addition to human clinical studies, Proof of Concept Studies shall include completion of the following activities. These activities may be modified from time to time by the JRC with respect to a particular Drug Candidate, with the consent of NOVARTIS (which shall not be unreasonably withheld): [******************************************************************* ******************************************************************************** ******************************************************************************** ******************************************************************************** ******************************************************************************** ******************************************************************************** ******************************************************************************** ******************************************************************************** *********************************************************]
Sample 1

Related to Proof of Concept Studies

  • Proof of Concept has the meaning set forth in Section 2.3.

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

  • Concept Plan means the plan for the Project.

  • 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 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).

  • 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)).

  • 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.

  • 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 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.

  • 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 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.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • 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 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 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • 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 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 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).

  • 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.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • 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.

  • 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.

  • 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.