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).

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 ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ or the ReSTORE-HF Milestone, in each case, subject to verification by Agent in its reasonable discretion (including supporting documentation reasonably requested by Agent).

Examples of Performance Milestone 1 in a sentence

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.
Performance Milestone 1 States agree and sign up to the updated Schedule.
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”).
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”).
Each of the undersigned hereby agrees that Performance Milestone 1 was satisfied as of August 19, 2019.
Subject to the terms and conditions of this Agreement, beginning on the Performance Milestone 1 Date and continuing through December 15, 2022, Borrower may request and the Lenders shall severally (and not jointly) make additional Term Loan Advances in an aggregate principal amount of Fifty Million Dollars ($50,000,000), in minimum increments of $5,000,000 (the “Tranche 2 Advance”).
A2.1 Performance Milestone 1 Company will raise at least $250k in research funding and initiate a research program for Licensed Product in the lab of Principal Investigator with University by one year from the Effective Date.
Subject to the terms and conditions of this Agreement, beginning on the date Borrower achieves Performance Milestone 1 and continuing through September 30, 2017, Borrower may request and Lender shall make an additional Term Loan Advance in a principal amount of $2,500,000 (the “Tranche 2 Advance”).
Disbursement shall be made on a reimbursement basis of eligible costs under LEDA: Tranche Amount of State Contribution Available for Disbursement/Tranche Disbursement Performance Milestone 1 $50,000 Obtain Certificate of Occupancy upon completion of construction of the facility and submit proof of payment for allowable expenditures.
At all times prior to achievement of the earliest to occur of Performance Milestone 1 and Performance Milestone 2, Borrower shall maintain Unrestricted Cash in an amount greater than or equal to Six Million Dollars ($6,000,000) plus the amount of Borrower’s accounts payable under GAAP not paid after the 90th day following the invoice date for such accounts payable.

More Definitions of Performance Milestone 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.

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.

Performance Milestone 1 means satisfaction of each of the following events prior to December 15, 2022:

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) [***].”