Proof of Concept Criteria definition

Proof of Concept Criteria or “POC Criteria” means the clinical and the non-clinical criteria established by the JSC, pursuant to Section 2.5 (b), which is designed to determine whether a Lead Vector demonstrates Proof of Concept, that is, (i) the endpoints and parameters for the Proof of Concept Study designed to indicate a degree of efficacy, for example determined by the level of gene expression, required to signal differentiation in a particular indication in patients with the disease under study with the appropriate safety profile for such indication, and (ii) the associated non-clinical Proof of Concept Criteria, that is, the non-clinical safety assessment, metabolism, pharmacokinetics and chemical manufacture and control criteria to be defined by the JSC on a Collaboration Program-by-Collaboration Program basis.
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Proof of Concept Criteria means the clinical and/or non-clinical criteria established [ * ], pursuant to Section 2.6.5 and in accordance with the guidelines attached hereto as Exhibit D, to determine whether a Phase I Ready Compound demonstrates [ * ]. This shall include [ * ] and any other reasonable parameters. The Proof of Concept Criteria shall include, without limitation, [ * ]. The criteria may be different for each Dynavax Program.
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Proof of Concept Criteria or "PoC Criteria" means criteria established [********] for a particular Candidate Compound that will be used by GSK after completion of the [********] to determine if the Candidate Compound demonstrates a [********] in treating the applicable disorder. The PoC Criteria may include some or all of the following criteria: (a) the [********] and relevant [********] and [********] for the PoC Trial in such a manner that, following the PoC Trial, a determination can reasonably be made as to whether such [********] have been met; (b) a [********] that is reasonably representative of the [********] for a single indication; (c) appropriate and validated (if available) [********]; (d) PoC Trial dose(s) administered in a dosage form in a PoC Trial which is/are (i) appropriate for a Phase II Trial and as to which there is no [********] which would prevent the Candidate Compound from being Developed into a commercializable dosage formulation and (ii) that may show initial evidence of [********] with a reasonable [********] in view of relevant clinical and regulatory considerations; (e) a drug substance which is in a salt or other chemical form as to which there is no known impediment which would prevent the Candidate Compound from being Developed into a commercializable dosage formulation; and (f) other criteria [********] with regard to ancillary preclinical and clinical trials or the manufacturing, formulation and toxicology work included in the PoC Trial Package as further detailed in Section 3.6 and, by way of example, [********]. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT; [*] DENOTES OMISSIONS.
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Examples of Proof of Concept Criteria in a sentence

  • Following a discussion with Prosensa on 24 Sept, success criteria for this study are now considered related * * * * * 121 Exhibit C Proof of Concept Criteria I.

  • Unless otherwise agreed by the Parties, if requested by GSK, the JSC will schedule an ad hoc meeting not more than [ * ] Calendar Days after receipt of any such PoC Study Report to review such PoC Study Report and confirm whether or not such Phase I Ready Compound satisfies the Proof of Concept Criteria.

  • Prior to the initiation of the first applicable [ * ] for a Program, [ * ] shall establish the provisional clinical trial design, including planned [ * ], for the Proof of Concept Study, and shall [ * ], collectively, as the Proof of Concept Criteria, prior to initiation of the PoC Study.

  • Any modification, amendment or waiver of this Lease or any provision hereof must be in writing and executed by the party against whom enforcement of such modification, amendment or waiver is sought.

  • Prior to the initiation of the first applicable Clinical Trial for a Collaboration Program, the Parties shall through the JSC agree upon the provisional Proof of Concept Criteria for each Collaboration Program, and prior to entering into the relevant Study, the Parties shall agree on the final criteria, subject to GSK’s right to have the final say on the matter under Section 3.2(d).

  • Boerckel, 526 U.S. 838, 842 (1999); see 28 U.S.C. § 2254(b)(1)(A) (“An application for a writ of habeas corpus .

  • All such Proof of Concept Criteria shall be established reasonably in accordance with the guidelines and examples attached hereto as Exhibit D.

  • If the JSC [ * ] decides that the Phase I Ready Compound did not satisfy the Proof of Concept Criteria, then, except as provided in Section 5.3, Dynavax will [ * ] with respect to such Dynavax Program, and GSK may, [ * ].

  • In the event that the Compound fails to satisfy the Proof of Concept Criteria after completion of the Proof of Concept Study, [ * ] which completed the PoC Study, in such case the [ * ] and all other [ * ] for such GSK Development Program shall all be [ * ] from the [ * ] otherwise applicable, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

  • Ed. 2d 18 (1976) (“This Court consistently has held that some form of hearing is required before an individual is finally deprived of a property interest.”).


More Definitions of Proof of Concept Criteria

Proof of Concept Criteria means the criteria that will be determined by the JDC and used to determine if a Collaboration Compound demonstrates a [***] in treating a specific Indication in a Proof of Concept Clinical Trial. Proof of Concept Criteria may also include certain non-clinical studies and assessments as the JDC may determine are appropriate. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
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Related to Proof of Concept Criteria

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

  • ASAM criteria means the most current edition of the American Society of Addiction Medicine's published criteria for admission to treatment, continued services, and discharge.

  • Evaluation Criteria means the criteria set out under the clause 27 (Evaluation Process) of this Part C, which includes the Qualifying Criteria, Functional Criteria and Price and Preferential Points Assessment.

  • Selection Criteria means and includes all of the requirements, considerations,

  • Design Criteria means the design criteria set out in the Ministry’s publication “Design Criteria for Sanitary Sewers, Storm Sewers and Forcemains for Alterations Authorized under Environmental Compliance Approval”, (as amended from time to time).

  • Fitch Criteria means the Collateral Amount shall equal the sum of (i) the product of A multiplied by the xxxx-to-market value of the outstanding Transactions determined by Party A in good faith from time to time, and (ii) the product of B multiplied by the current aggregate notional amount of the outstanding Transactions, where:

  • Functional Criteria means the criteria set out in clause 27 of this Part C.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • proof of B-BBEE status level of contributor means:B-BBEE Status level certificate issued by an authorized body or person;A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice;Any other requirement prescribed in terms of the B-BBEE Act;

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • Dose profile means the dose as a function of position along a line.

  • Business Criteria means any one or any combination of Income before Taxes, Net Income, Return on Equity, Return on Assets, Pre-tax Margin, Free Cash Flow, Valuation or EPS.

  • Proof of Interest means a proof of Interest Filed against any of the Debtors in the Chapter 11 Cases.

  • Proof of age The Company may require evidence of Age of any Annuitant or Owner.

  • Biologically-based mental illness means schizophrenia, schizoaffective disorder, major depressive disorder, bipolar disorder, paranoia and other psychotic disorders, obsessive-compulsive disorder, and panic disorder, as these terms are defined in the most recent edition of the diagnostic and statistical manual of mental disorders published by the American Psychiatric Association.

  • Investment Criteria The criteria specified in Section 12.2(a).

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Design Criteria Professional means a firm who holds a current certificate of registration under Chapter 481 of the Florida Statutes, to practice architecture or landscape architecture, or a firm who holds a current certificate as a registered engineer under Chapter 471 of the Florida Statutes, to practice engineering, and who is employed by or under contract to the District to provide professional architect services, landscape architect services, or engineering services in connection with the preparation of the Design Criteria Package.

  • Goal means the intended or projected result of a comprehensive corrections plan or community corrections program to reduce prison commitment rates, to reduce the length of stay in a jail, or to improve the utilization of a jail.

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.

  • DNA profile means a letter or number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

  • Goals means the annual level of participation by SBEs in City Contracts as established in this chapter, the SBE Regulations, or as necessary to comply with applicable federal and state nondiscrimination laws and regulations. Goals for individual Contracts may be adjusted as provided for in this chapter and shall not be construed as a minimum for any particular Contract or for any particular geographical area.

  • 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.

  • hit means the existence of a match or matches established by the Central System by comparison between biometric […] data recorded in the computerised central database and those transmitted by a Member State with regard to a person, without prejudice to the requirement that Member States shall immediately check the results of the comparison pursuant to Article 26(4);

  • Contract Specific Goals means the subcontracting goals for MBE and WBE participation established for a particular contract.

  • Board-Established Criteria means criteria that the Board of a Regulated Fund may establish from time to time to describe the characteristics of Potential Co-Investment Transactions regarding which the Adviser to the Regulated Fund should be notified under Condition 1. The Board-Established Criteria will be consistent with the Regulated Fund’s Objectives and Strategies (defined below). If no Board-Established Criteria are in effect, then the Regulated Fund’s Adviser will be notified of all Potential Co-Investment Transactions that fall within the Regulated Fund’s then-current Objectives and Strategies. Board-Established Criteria will be objective and testable, meaning that they will be based on observable information, such as industry/sector of the issuer, minimum EBITDA of the issuer, asset class of the investment opportunity or required commitment size, and not on characteristics that involve a discretionary assessment. The Adviser to the Regulated Fund may from time to time recommend criteria for the Board’s consideration, but Board-Established Criteria will only become effective if approved by a majority of the Independent Directors (defined below). The Independent Directors of a Regulated Fund may at any time rescind, suspend or qualify their approval of any Board-Established Criteria, though Applicants anticipate that, under normal circumstances, the Board would not modify these criteria more often than quarterly.