Phase 3 Success Criteria definition

Phase 3 Success Criteria means following topline data read out from the ShORe Trial or the COAST Trial, that the results of the ShORe Trial and the COAST Trial meet the primary endpoints set forth in the ShORe Protocol and the COAST Protocol and constitute clinically meaningful results sufficient to support the decision to submit an application for Regulatory Approval for the Product for the Indication.
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Phase 3 Success Criteria means that the results of the Phase 3 Trial meet at least one of the two primary endpoints set forth in the Phase 3 Trial Protocol.
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Phase 3 Success Criteria means, with respect to the Product, meeting the composite primary endpoint of the first event, whichever occurs first, comprising of cardiovascular death, heart failure event, LVAD implementation/cardiac transplantation, or stroke, with a hazard ratio (HR) of less than 0.85 and cardiovascular death endpoint HR of less than 1.0 in a Phase 3 Clinical Trial.
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Examples of Phase 3 Success Criteria in a sentence

  • Without limiting the foregoing, CymaBay shall submit for filing an NDA for the Product for the Indication in the U.S. within [***] of the date of achievement of the Phase 3 Success Criteria for the Product.

  • Upon achievement of the Phase 3 Success Criteria, CymaBay will use Commercially Reasonable Efforts to obtain Regulatory Approval for the Product in the U.S. and, until achievement of Regulatory Approval in the U.S., in at least one (1) additional non-U.S. Major Market Country.

  • Upon achievement of the Phase 3 Success Criteria, Opthea will (a) file a BLA for the Product in the Indication in the U.S. within [***] thereafter and (b) otherwise use Commercially Reasonable Efforts to obtain Regulatory Approval for the Product in the Indication in the U.S. and, until achievement of Regulatory Approval in the U.S., in the European Union (or, if EMA’s centralized review procedure is not used, at least one (1) additional non-U.S. Major Market Country).

  • Each Party hereby agrees and understands that the other Party makes no representation, guarantee or warranty, express or implied, regarding the outcome of the Clinical Trials (including achievement of the Phase 3 Success Criteria), any Research Results generated after the Effective Date, the ability to obtain Regulatory Approval or the patentability, legal protectability or usefulness of any Intellectual Property arising from the Clinical Trials.

  • In the event that Opthea fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for the Product or fails to file a BLA for the Product for the Indication in the U.S. within [***] following achievement of the Phase 3 Success Criteria for the Product, and this failure is not cured as set forth in Section ‎13.4.2, the Required Investors may terminate this Agreement pursuant to Section ‎13.4.2.

  • As of the Effective Date, the Company is planning to conduct all Clinical Trials, including Phase 3 Clinical Trials, necessary to (a) meet the Phase 3 Success Criteria and (b) receive FDA Approval, in each case of clauses (a) and (b), for the Product as the Product exists as of the Effective Date.

  • In the event that CymaBay fails to use Commercially Reasonable Efforts to soobtain Regulatory Approval for the Product, including a failure to submit for filing an NDA for the Product for the Indication in the U.S. within [***] of the date of achievement of the Phase 3 Success Criteria for the Product for any reason other than a Regulatory Reason, and this failure is not cured as set forth in Section 13.3.1, Abingworth may terminate this Agreement pursuant to Section 13.3.1.

  • In the event that CymaBay fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for the Product, including a failure to submit for filing an NDA for the Product for the Indication in the U.S. within [***] of the date of achievement of the Phase 3 Success Criteria for the Product for any reason other than a Regulatory Reason, and this failure is not cured as set forth in Section 13.3.1, Abingworth may terminate this Agreement pursuant to Section 13.3.1.

  • In the event that Opthea fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for the Product or fails to file a BLA for the Product for the Indication in the U.S. within [***] following achievement of the Phase 3 Success Criteria for the Product, and this failure is not cured as set forth in Section 13.4.2, Investor may terminate this Agreement pursuant to Section 13.4.2.

  • In the event that Alnylam fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for a Product, including the obligation to file an NDA for a Product within [***] of the date of achievement of the Phase 3 Success Criteria for such Product, and this failure is not cured as set forth in Section 13.3.1, Blackstone may terminate this Agreement pursuant to Section 13.3.1.


More Definitions of Phase 3 Success Criteria

Phase 3 Success Criteria means, (a) [***] or (b) [***]; provided that, in each case of (a) and (b), as applicable, [***].
Sample 1

Related to Phase 3 Success Criteria

  • 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).

  • 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.

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

  • 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.

  • Fitch Criteria means the Collateral Amount shall equal the sum of (i) the product of A multiplied by the mark-to-market value of the outstanding Transactions dxxxxmined 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:

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

  • 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.

  • 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.

  • 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).

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

  • Corrective Measure means a measure as defined in Article 3, point 16, of Regulation (EU) 2019/1020;

  • 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”.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • Specific goals means specific goals as contemplated in section 2(1)(d) of the PPPFA which may include contracting with persons, or group of persons, historically disadvantaged by unfair discrimination on the basis of race, gender and disability including the implementation of programmes of the Reconstruction and Development Programme as published in Government Gazette No. 16085 dated 23 November 1994.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Preventive measures means any reasonable measures taken by any person after an incident has occurred to prevent or minimize pollution damage.

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

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • 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.

  • Semi-annual (2/Year) sampling frequency means the sampling shall be done during the months of June and December, unless specifically identified otherwise.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.