Achievement of Proof of Concept definition

Achievement of Proof of Concept means, with respect to any Candidate Drug, the first to occur after the Effective Date of (a) achievement of the [********] (as set forth in the applicable Product Development Plan or clinical trial protocol) in a [********] Clinical Trial of such Candidate Drug in any Primary Indication or Schizophrenia (as the case may be) (but excluding, in the case of Ispronicline, the Ongoing Ispronicline Trial) at a dose range that is shown to be safe and tolerable in the patient group of interest and that is acceptable from each of a scientific, statistical, medical, regulatory and commercial perspective or (b) the [********] Clinical Trial of such Candidate Drug. For purposes of clarity, whether achievement of a [********] in a [********] Clinical Trial at a dose range that is shown to be safe and tolerable in the patient group of interest and that is acceptable from each of a scientific, statistical, medical, regulatory and commercial perspective has occurred shall be determined as soon as practicable after reliable information from such trial is available following database lock and shall not require the availability of the final report for such trial. “Achieve Proof of Concept” shall be interpreted accordingly.
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Achievement of Proof of Concept means the point at which the initial human efficacy trial is successfully completed and a compound approved for further development by GW, such decision usually being agreed to at a meeting of the GW Therapeutic Management Team, or its functional equivalent.
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Achievement of Proof of Concept means, with respect to a particular POC Program, a determination by the JSC or an Expert Panel (as applicable) that a POC Program Product that is the subject of such POC Program has demonstrated Proof of Concept in the applicable POC Study.
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Examples of Achievement of Proof of Concept in a sentence

  • Subject to Sections 2.2.4, 2.2.5, 2.3.3, 2.7.1, 3.2, 3.3, and 4.4.2(b) and (c), [**] shall have final decision-making authority with respect to any matter relating to any Development Program after Achievement of Proof of Concept for a Licensed Compound or Licensed Product in such Development Program, and, for purposes of clarity, all global activities related to such Licensed Compound shall be included in the applicable Development Program.

  • Following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, EPIZYME shall continue to have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field in the EPIZYME Territory.

  • Upon Achievement of Proof of Concept in accordance with this Section 3.3.1, [**]; (ii) [**]; (iii) CELGENE shall have final-decision making authority with respect to disputes arising in the JDC with respect to the applicable Development Program as provided in Section 4.4.2(a)(ii); and (iv) subject to Section 6.6, EPIZYME shall assign and transfer to CELGENE all INDs in the CELGENE Territory that relate to Licensed Compounds and Licensed Products Directed to the applicable Selected Target.

  • Subject to Sections 2.2.4, 2.2.5, 2.3.3, 2.7.1, 3.2, 3.3, and 4.4.2(b) and (c), [**] shall have final decision-making authority with respect to any matter relating to activities under the Research Plan and any Development Program prior to Achievement of Proof of Concept for a Compound (including Licensed Compound) or Licensed Product in such Development Program.

  • If a branch is not located within the border of the District, please detail in your submission how you would facilitate deposits of checks and cash including but not limited to remote check scanners and courier services.

  • Notwithstanding anything to the contrary in this Agreement, on a Licensed Compound-by-Licensed Compound basis, (i) prior to Achievement of Proof of Concept, EPIZYME shall have final decision-making authority with respect to all Manufacturing matters in such CMC Subcommittee and (ii) after Achievement of Proof of Concept, [**] shall have final decision-making authority with respect to all such matters; provided that, nothing in this Section 4.4.3(a) shall [**].

  • Prior to Achievement of Proof of Concept of a Licensed Compound or Licensed Product, EPIZYME shall have the sole right to prepare, file and maintain all regulatory filings and Regulatory Approvals necessary for the research, Development or Manufacture of such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field worldwide.

  • After Achievement of Proof of Concept by a Compound (including Licensed Compound) or Licensed Product in a Development Program, [**] shall have the right to designate the chairperson of the JDC for such Development Program, [**].

  • Following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, CELGENE shall have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field in the CELGENE Territory.

  • CELGENE shall not have the right to approve the proposed labeling or any other regulatory filings or submissions for the Licensed Products and related Diagnostic Products worldwide (prior to Achievement of Proof of Concept) or in the EPIZYME Territory (after Achievement of Proof of Concept).

Related to Achievement of Proof of Concept

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

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Performance Measure means one or more of the following selected by the Committee to measure Company, Affiliate, and/or business unit performance for a Performance Period, whether in absolute or relative terms (including, without limitation, terms relative to a peer group or index): basic, diluted, or adjusted earnings per share; sales or revenue; earnings before interest, taxes, and other adjustments (in total or on a per share basis); basic or adjusted net income; returns on equity, assets, capital, revenue or similar measure; economic value added; working capital; total shareholder return; and product development, product market share, research, licensing, litigation, human resources, information services, mergers, acquisitions, sales of assets of Affiliates or business units. Each such measure shall be, to the extent applicable, determined in accordance with generally accepted accounting principles as consistently applied by the Company (or such other standard applied by the Committee) and, if so determined by the Committee, and in the case of a Performance Compensation Award, to the extent permitted under Code Section 162(m), adjusted to omit the effects of extraordinary items, gain or loss on the disposal of a business segment, unusual or infrequently occurring events and transactions and cumulative effects of changes in accounting principles. Performance Measures may vary from Performance Period to Performance Period and from Participant to Participant, and may be established on a stand-alone basis, in tandem or in the alternative.

  • 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;

  • 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.

  • 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.

  • Performance Indicators means the indicators for Project monitoring and evaluation set forth in the Operational Manual.

  • Performance Factors means any of the factors selected by the Committee and specified in an Award Agreement, from among the following objective measures, either individually, alternatively or in any combination, applied to the Company as a whole or any business unit or Subsidiary, either individually, alternatively, or in any combination, on a GAAP or non-GAAP basis, and measured, to the extent applicable on an absolute basis or relative to a pre-established target, to determine whether the performance goals established by the Committee with respect to applicable Awards have been satisfied:

  • ASAM criteria means admission, continued service, transfer, and discharge criteria for the treatment of substance use disorders as published by the American Society of Addiction Medicine (ASAM).

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

  • Performance Goals means, for a Performance Period, the one or more goals established by the Board for the Performance Period based upon the Performance Criteria. Performance Goals may be based on a Company-wide basis, with respect to one or more business units, divisions, Affiliates, or business segments, and in either absolute terms or relative to the performance of one or more comparable companies or the performance of one or more relevant indices. Unless specified otherwise by the Board (i) in the Award Agreement at the time the Award is granted or (ii) in such other document setting forth the Performance Goals at the time the Performance Goals are established, the Board will appropriately make adjustments in the method of calculating the attainment of Performance Goals for a Performance Period as follows: (1) to exclude restructuring and/or other nonrecurring charges; (2) to exclude exchange rate effects; (3) to exclude the effects of changes to generally accepted accounting principles; (4) to exclude the effects of any statutory adjustments to corporate tax rates; (5) to exclude the effects of any “extraordinary items” as determined under generally accepted accounting principles; (6) to exclude the dilutive effects of acquisitions or joint ventures; (7) to assume that any business divested by the Company achieved performance objectives at targeted levels during the balance of a Performance Period following such divestiture; (8) to exclude the effect of any change in the outstanding shares of common stock of the Company by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization, merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change, or any distributions to common stockholders other than regular cash dividends; (9) to exclude the effects of stock based compensation and the award of bonuses under the Company’s bonus plans; (10) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to be expensed under generally accepted accounting principles; (11) to exclude the goodwill and intangible asset impairment charges that are required to be recorded under generally accepted accounting principles; (12) to exclude the effect of any other unusual, non-recurring gain or loss or other extraordinary item; and (13) to exclude the effects of the timing of acceptance for review and/or approval of submissions to the U.S. Food and Drug Administration or any other regulatory body. In addition, the Board retains the discretion to reduce or eliminate the compensation or economic benefit due upon attainment of Performance Goals and to define the manner of calculating the Performance Criteria it selects to use for such Performance Period. Partial achievement of the specified criteria may result in the payment or vesting corresponding to the degree of achievement as specified in the Stock Award Agreement or the written terms of a Performance Cash Award.

  • Performance Targets means the specific objective goal or goals (which may be cumulative and/or alternative) that are timely set in writing by the Committee for each Executive for the Performance Period in respect of any one or more of the Business Criteria.

  • Performance Criteria means the criteria (and adjustments) that the Committee selects for an Award for purposes of establishing the Performance Goal or Performance Goals for a Performance Period, determined as follows:

  • Milestone Events has the meaning set forth in Section 7.2.

  • Performance Measures means measures as described in Article 12 on which the performance goals are based and which are approved by the Company’s shareholders pursuant to this Plan in order to qualify Awards as Performance-Based Compensation.

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

  • Targets means pre-agreed values to be achieved at the end of the period in relation to the result indicators included under a specific objective;

  • 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.

  • Performance Indicator means a measure of HSP performance for which a Performance Target is set; technical specifications of specific Performance Indicators can be found in the MSAA Indicator Technical Specifications document;

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

  • 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.

  • Performance Goal means a performance goal established by the Committee pursuant to Section 10.3.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • 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.