Performance Milestone 1 definition

Performance Milestone 1 means Borrower has achieved a statistically significant result on the primary endpoint as defined within the statistical analysis plan for each respective study, or the totality of the results for any study warrant advancement into a subsequent clinical efficacy study as reasonably determined by Borrower and Lender with respect to at least two (2) of the following studies: (i) RESCUE-ALS or HEALEY-ALS; (ii) REPAIR-PD; or (iii) REPAIR- MS.
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Performance Milestone 1 means the satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred and be continuing as of any date of determination; and either (b) (i) the Parent has announced publicly that the Phase 3 PEDFIC1 clinical trial of odevixibat in patients with PFIC has achieved the FDA-supported, protocol-specified primary efficacy endpoint of a statistically significant change in pruritus between baseline and week twenty-four (24), which along with an acceptable safety profile and supporting secondary endpoint data, support the filing of an New Drug Application with the FDA as the immediate next step in clinical development; or (ii) in Lender’s sole discretion, the Parent has announced publicly that the Phase 3 PEDFIC1 clinical trial of odevixibat in patients with PFIC has not achieved a statistically significant improvement on the FDA-supported protocol-specific primary efficacy endpoint, but the totality of efficacy and safety data demonstrates an approvable risk-benefit profile for odevixibat in patients with PFIC in a manner that supports the filing of an New Drug Application with the FDA as the immediate next step in clinical development (based upon FDA communications and the totality of the data package, as would be reviewed by Agent).
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Performance Milestone 1 means satisfaction of each of the following events: (a) no Event of Default shall have occurred and be continuing and (b) Borrower or any other Loan Party shall have received the approval from the FDA of the NDA for lefamulin for the treatment of community-acquired bacterial pneumonia, with a label generally consistent with the target label included in Borrower’s NDA filing.
Sample 1

Examples of Performance Milestone 1 in a sentence

  • Performance Milestone means each of the deliverables and milestones identified as a "Performance Milestone" in Appendix 2 (Performance Milestones and Submittals Schedule).Performance Milestone 1 means the milestone and deliverable identified as " Performance Milestone 1" in Appendix 2 (Performance Milestones and Submittals Schedule).

  • Further, no stamps or vouchers are accepted as the examination fees.

  • Performance Milestones (Section 5.1 “Performance Milestones”): Company will meet the following Performance Milestones: Performance Milestone A2.1 Performance Milestone 1 Company shall have completed XXXXXX by Month Day Year A2.2 Performance Milestone 2 Company shall have completed XXXXXX by Month Day Year A 2.3 Performance Milestone 3 Company shall have completed XXXXXX by Month Day Year A2.4 Performance Milestone 4 Company shall have completed XXXXXX by Month Day Year A3.

  • Subject to the terms and conditions of this Agreement, beginning on Borrower’s achievement of Performance Milestone 1 and continuing through March 31, 2021, Borrower may request and the Lenders shall severally (and not jointly) make an additional Term Loan Advance in a principal amount of Ten Million Dollars ($10,000,000) (the “Tranche 2 Advance”).

  • Performance Milestone 1 Signing of this Schedule and a commitment to collaborate on the VDS program 1 January 2023 57% State allocation of the funding for VET data Infrastructure.

  • If termination occurs before successful completion of Performance Milestone 1 ( Pre- Application Meeting and Approval of GA Plan and CE Plan), the Developer will not be entitled to a Termination Payment.

  • Subject to the terms and conditions of this Agreement, beginning on the date Borrower achieves Performance Milestone 1 and continuing through September 30, 2019, Borrower may request and Lender shall make an additional Term Loan Advance in a principal amount of $10,000,000 (the “Tranche 2 Advance”).

  • The volume-weighted average share price (VWAP) for the last 20 business days of the Company’s shares trading on the ASX equals or exceeds A$0.40/share (Share Performance Milestone 1).

  • Progress and Performance: Milestone 1: Cable subscribers will be able to continue viewing their local broadcast stations after the DTV transition (COMPLETED 2007) Approximately 70% of MVPD subscribers receive their programming through cable.

  • Share Performance Milestone 1 has its meaning given to it by paragraph (1(a)(vi) of Schedule 1 of this Notice.


More Definitions of Performance Milestone 1

Performance Milestone 1 means satisfaction of each of the following events: (a) after May 31, 2017, receipt by Borrower of at least Thirty Million Dollars ($30,000,000) of Net Financing Proceeds (inclusive of amounts raised in satisfaction of Section 4.1(f)) and (b) achievement of either the Phase 0 Xxxxxxx Xxxxxxxxx or the ReSTORE-HF Milestone, in each case, subject to verification by Agent in its reasonable discretion (including supporting documentation reasonably requested by Agent).
Sample 1
Performance Milestone 1 means delivery by Borrower to Bank, on or prior to March 31, 2022, of evidence satisfactory to Bank in its sole but reasonable discretion, that Borrower has filed an IND or CTA for its IL- 17 program.
Sample 1
Performance Milestone 1 means Borrower has delivered evidence to Bank, on or prior to December 31, 2022, satisfactory to Bank in Bank’s sole but reasonable discretion, that Borrower has achieved, on or prior to [***], (a) [***], and (b) [***].”
Sample 1
Performance Milestone 1 means satisfaction of each of the following events prior to December 15, 2022: (a) Borrower shall have announced that the GATHER2 Phase 3 trial of Zimura in patients with geographic atrophy (NCT04435366) has achieved its protocol-specified primary endpoint, (b) an acceptable safety profile has been demonstrated with respect to Zimura, such that along with the results of the GATHER1 (NCT02686658) study Borrower shall, in its reasonable business judgment, have a sufficient clinical data package to support the filing of a New Drug Application with the FDA as the next immediate step in development (subject to Lenders’ reasonable verification), and (c) no Default or Event of Default shall have occurred. “Performance Milestone 1 Date” means the date on which Borrower achieves Performance Milestone 1. “Performance Milestone 2” means satisfaction of each of the following events prior to September 30, 2023: (a) Performance Milestone 1 Date has occurred, (b) Borrower has filed a New Drug Application with the FDA for Zimura for the treatment of geographic atrophy and the FDA has accepted such New Drug Application for review, in each case under this clause (b), subject to Lenders’ reasonable verification and (c) no Default or Event of Default shall have occurred. “Performance Milestone 2 Date” means the date on which Borrower achieves Performance Milestone 2. “Performance Milestone 3” means the satisfaction of each of the following events prior to September 30, 2024: (a) Performance Milestone 2 Date has occurred, (b) the FDA has approved the New Drug Application for Zimura for the treatment of geographic atrophy with a label generally consistent with that sought in Borrower’s filing of such New Drug Application and which continues to support the planned commercialization strategy and outlook, in each case under this clause (b), subject to Lenders’ reasonable verification and (c) no Default or Event of Default shall have occurred.
Sample 1

Related to Performance Milestone 1

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

  • Performance Target means the level of performance expected of the HSP in respect of a Performance Indicator or a Service Volume; “person or entity” includes any individual and any corporation, partnership, firm, joint venture or other single or collective form of organization under which business may be conducted;

  • 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 Objective means a standard established by the Committee to determine in whole or in part whether a Performance Award shall be earned.

  • Performance Measurement Period has the meaning set forth in Section 3.1(e)(ii).

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Performance Metrics means criteria established by the Administrator relating to any of the following, as it may apply to an individual, one or more business units, divisions, or Affiliates, or on a company-wide basis, and in absolute terms, relative to a base period, or relative to the performance of one or more comparable companies, peer groups, or an index covering multiple companies:

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

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

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Performance Objectives means the performance objective or objectives established by the Committee pursuant to the Plan. Any Performance Objectives may relate to the performance of the Company or one or more of its Subsidiaries, divisions, departments, units, functions, partnerships, joint ventures or minority investments, product lines or products, or the performance of the individual Participant, and may include, without limitation, the Performance Objectives set forth in Section 13(b). The Performance Objectives may be made relative to the performance of a group of comparable companies, or published or special index that the Committee, in its sole discretion, deems appropriate, or the Company may select Performance Objectives as compared to various stock market indices. Performance Objectives may be stated as a combination of the listed factors.

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

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Qualifying Performance Criteria means any one or more of the following performance criteria, either individually, alternatively or in any combination, applied to either the Company as a whole or to a business unit, Parent, Subsidiary or business segment, either individually, alternatively or in any combination, and measured either annually or cumulatively over a period of years, on an absolute basis or relative to a pre-established target, to previous years’ results or to a designated comparison group, and on a pre-tax or after-tax basis, in each case as specified by the Committee in the Award: (i) cash flow (including operating cash flow or free cash flow); (ii) earnings (including gross margin, earnings before interest and taxes, earnings before taxes, and net earnings); (iii) earnings per share; (iv) growth in earnings or earnings per share; (v) stock price; (vi) return on equity or average stockholders’ equity; (vii) total stockholder return; (viii) return on capital; (ix) return on assets or net assets; (x) return on investment; (xi) revenue; (xii) income or net income; (xiii) operating income or net operating income; (xiv) operating profit or net operating profit; (xv) operating margin; (xvi) return on operating revenue; (xvii) market share; (xviii) contract awards or backlog; (xix) overhead or other expense reduction; (xx) growth in stockholder value relative to the moving average of the S&P 500 Index or a peer group index; (xxi) credit rating; (xxii) strategic plan development and implementation (including individual performance objectives that relate to achievement of the Company’s or any business unit’s strategic plan); (xxiii) improvement in workforce diversity; (xxiv) expenses; (xxv) economic value added; (xxvi) product quality; (xxvii) number of customers; (xxviii) objective customer indicators; (xxix) customer satisfaction; (xxx) new product invention or innovation; (xxxi) profit after taxes; (xxxii) pre-tax profit; (xxxiii) working capital; (xxxiv) sales; (xxxv) advancement of the Company’s product pipeline; (xxxvi) consummation of strategic transactions; (xxxvii) reduction in cash utilization; and (xxxviii) addition of technologies and products. The Committee may appropriately adjust any evaluation of performance under a Qualifying Performance Criteria to exclude any of the following events that occurs during a performance period: (A) asset write-downs; (B) litigation or claim judgments or settlements; (C) the effect of changes in tax law, accounting principles or other such laws or provisions affecting reported results; (D) accruals for reorganization and restructuring programs; and (E) any gains or losses classified as extraordinary or as discontinued operations in the Company’s financial statements.

  • Performance Level means a reference to one of Performance Level I, Performance Level II, Performance Level III, Performance Level IV or Performance Level V.

  • 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.

  • Performance Period means the one or more periods of time, which may be of varying and overlapping durations, as the Committee may select, over which the attainment of one or more Performance Goals will be measured for the purpose of determining a Participant’s right to, and the payment of, a Performance-Based Award.

  • Performance Year means the calendar year prior to the year in which an Annual Award is made by the Committee.

  • 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: