Phase I Ready Criteria definition

Phase I Ready Criteria means the clinical and/or non-clinical criteria (a) set forth in Exhibit C and as modified by the JSC [ * ] for the [ * ] TLR 7/9 Program and (b) established and as modified by the JSC pursuant to Section 2.6.2 for the other Dynavax Programs (including the [ * ]), for advancement of a Pre-Candidate Selection Compound from a Dynavax Program into clinical Development. In general, Phase I Ready Criteria for a particular Compound will be reasonable and appropriate for [ * ] and generally may include: [ * ].
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Phase I Ready Criteria means the clinical and/or non-clinical criteria (a) set forth in Exhibit C and as modified by the JSC [ * ] for the [ *
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Examples of Phase I Ready Criteria in a sentence

  • Within [ * ] after the identification of a Dynavax Program under Section 2.5, the JSC shall establish Phase I Ready Criteria for such Dynavax Program, which shall be substantially similar to the example of Phase I Ready Criteria set forth in Exhibit C.

  • The JSC shall establish the Phase I Ready Criteria for the [ * ] within [ * ] TLR 7/9 Program.

  • Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting not more than [ * ] after receipt by GSK’s JSC representatives of any such complete Phase I Ready Report to review such Phase I Ready Report and to confirm whether or not such Compound meets [ * ] of the Phase I Ready Criteria.

  • As of the Effective Date, the Parties have agreed upon the Phase I Ready Criteria for the [ * ] TLR 7/9 Program, which criteria may be modified by mutual agreement of the JSC [ * ].

  • Dynavax shall consider all such comments in good faith before preparing an updated Development Plan, however each such Development Plan will be designed with the objective of enabling a determination upon completion of the Development Plan as to whether all of the criteria (either Pre-Candidate Selection Criteria, Phase I Ready Criteria, [ * ] Criteria or PoC Criteria) have been met.

Related to Phase I Ready Criteria

  • 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.

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

  • Criteria means one of the eight (8) state defined categories to be scored.

  • 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.

  • 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.

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

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Design Criteria means design and construction code requirements relating to the mode of design and construction of a boiler or pressure vessel.

  • Over-Riding Nomination Criteria means the criteria set out in clause 4.2.

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

  • 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.

  • 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.

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

  • Phase I assessment as described in, and meeting the criteria of, (i) Chapter 5 of the FNMA Multifamily Guide or any successor provisions covering the same subject matter in the case of a Specially Serviced Mortgage Loan as to which the related Mortgaged Property is multifamily property or (ii) the American Society for Testing and Materials in the case of Specially Serviced Mortgage Loan as to which the related Mortgaged Property is not multifamily property.

  • Phase I Report means, with respect to any Facility, a report that (i) conforms to the ASTM Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process, E 1527, (ii) was conducted no more than six months prior to the date such report is required to be delivered hereunder, by one or more environmental consulting firms reasonably satisfactory to Administrative Agent, (iii) includes an assessment of asbestos-containing materials at such Facility, (iv) is accompanied by (a) an estimate of the reasonable worst-case cost of investigating and remediating any Hazardous Materials Activity identified in the Phase I Report as giving rise to an actual or potential material violation of any Environmental Law or as presenting a material risk of giving rise to a material Environmental Claim, and (b) a current compliance audit setting forth an assessment of Holdings’, its Subsidiaries’ and such Facility’s current and past compliance with Environmental Laws and an estimate of the cost of rectifying any non-compliance with current Environmental Laws identified therein and the cost of compliance with reasonably anticipated future Environmental Laws identified therein.

  • Acceptance Criteria means the Specifications, goals, performance measures, testing results and/or other criteria designated by the Agency and against which the Deliverables may be evaluated for purposes of Acceptance or Non-acceptance thereof.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • Operational Acceptance Tests means the tests specified in the Technical Requirements and Agreed Project Plan to be carried out to ascertain whether the System, or a specified Sub system, is able to attain the functional and performance requirements specified in the Technical Requirements and Agreed Project Plan, in accordance with the provisions of GCC Clause 27.2 (Operational Acceptance Test).

  • Interconnection Feasibility Study means either a Generation Interconnection Feasibility Study or Transmission Interconnection Feasibility Study.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Quantitative fit test or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

  • Peer support specialist means an individual who has experienced a severe and persistent mental illness and who has successfully completed standardized training to provide peer support services through the medical assistance program or the Iowa Behavioral Health Care Plan.

  • Applicable Servicing Criteria With respect to the Servicer, the Special Servicer or any Servicing Function Participant, the Servicing Criteria applicable to it, as set forth on Exhibit L attached hereto. For clarification purposes, multiple parties can have responsibility for the same Applicable Servicing Criteria and with respect to a Servicing Function Participant engaged by the Servicer or the Special Servicer, the term “Applicable Servicing Criteria” may refer to a portion of the Applicable Servicing Criteria applicable to the Servicer or the Special Servicer, as the case may be.

  • 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:

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Performance Monitoring System has the meaning given to it in paragraph 1.1.2 in Part B of Schedule 6 (Service Levels, Service Credits and Performance Monitoring);