Performance Milestone I definition

Performance Milestone I means the achievement of both of the following: (i) the Borrower has publicly announced no later than [***] that the Phase 3 portion of the IMerge clinical trial of imetelstat in patients with lower risk myelodysplastic syndromes (“MDS”) has completed full enrollment of One Hundred Seventy (170) patients, and (ii) Borrower has publicly announced that the planned Phase 3 Refractory MF clinical trial of imetelstat in patients with intermediate-2 or high-risk myelofibrosis (“MF”) has been initiated with the first patient dosed, in each case, subject to reasonable verification by the Agent (including supporting documentation reasonably requested by the Agent).

Performance Milestone I means satisfaction of each of the following events:

Performance Milestone I means Borrower has provided Agent and the Lenders with evidence, on or prior to June 30, 2022, satisfactory to Agent and each Lender in their reasonable discretion, that the FDA has approved Borrower’s new drug application for ibrexafungerp for the treatment of patients with vulvovaginal candidiasis with a label claim generally consistent with that sought in Borrower’s new drug application filing.

Examples of Performance Milestone I in a sentence

• Subject to the terms and conditions of this Agreement, beginning on the later of (i) January 1, 2021 and (ii) the achievement of Performance Milestone I, and continuing through September 30, 2021 (as such date may be extended in Agent’s sole discretion), 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”).

• If the Tranche 2 Term Loan Advance is drawn before Borrower achieves Performance Milestone I, the principal balance of the Tranche 2 Term Loan Advance shall bear interest thereon from such Advance Date at the Tranche 1 Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed.

• There- fore, the accuracy for zygosity determination was at the level of 99.99%.Fig.

• Subject to the terms and conditions of this Agreement, beginning on January 1, 2019 and continuing through March 31, 2019, and subject to Borrower’s satisfactory progress towards the achievement of Performance Milestone I in Lender’s sole discretion, Borrower may request and Lender will make a Term Loan Advance of $2,000,000 (the “Tranche 2 Term Loan Advance”).

• Notwithstanding the above, upon Borrower’s achievement of Performance Milestone I, Agent shall promptly release its lien on Intellectual Property, provided, however, that from and after such release, the Collateral shall include all Accounts and General Intangibles that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in, the Intellectual Property (the “Rights to Payment”).

More Definitions of Performance Milestone I

Performance Milestone I means receipt by Agent prior to March 15, 2021, of evidence reasonably satisfactory to Agent that (a) Borrower has received All Source Proceeds after August 21, 2019 and prior to March 15, 2021 in an amount greater than or equal to Seventy-Five Million Dollars ($75,000,000) and (b) the FDA has not prohibited the Borrower from proceeding with a Phase 1 clinical trial under an IND for a product candidate that is wholly-owned by the Borrower, and the Borrower has provided evidence sufficient to Lender that preparing to launch its planned Phase 1 clinical trial, in each case subject to verification by Agent (including supporting documentation reasonably requested by Agent).

Performance Milestone I means Borrower shall have [**].

Performance Milestone I means (a) no Event of Default shall have occurred and be continuing and (b) Borrower shall h

Performance Milestone I means (a) no Event of Default shall have occurred and be continuing and (b) Borrower shall have achieved the protocol-specified primary endpoints in at least two of the following three clinical trials evaluating the safety of a Product: [***], such that the data supports from each of these two trials, in the judgment of the Borrower’s board of directors, the initiation of Phase 2b or Phase 3 trials in such program as the next step in clinical development, and in each case, Agent shall have received supporting documentation thereof, which shall be subject to Agent’s reasonable verification.

Performance Milestone I means satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred and be continuing; and (b) Borrower has announced efficacy data (including overall response rate as assessed by an independent review committee) from the full Stage 1 cohort of patients with MZL through six-months follow-up in the Phase 2b UNITY-NHL trial of umbralisib (clinical trial protocol UTX-TGR-205 and ClinicalTrials.gov identifier NCT02793583) that supports the submission of a New Drug Application to the FDA under an FDA “accelerated approval” pathway, as such pathway is set forth in 21 C.F.R. § 314 Subpart H, and with umbralisib demonstrating an acceptable safety/tolerability profile such that Borrower’s executive officers have approved proceeding towards the filing of a New Drug Application, in each case subject to reasonable verification by Agent (including supporting documentation reasonably requested by Agent).

Performance Milestone I means no later than June 30, 2020, Borrower shall have announced that Borrower’s Phase 3 ECOSPOR III trial has achieved the protocol-specified primary efficacy endpoint of statistically significant improvement in recurrence of C. difficile infection up to 8 weeks after treatment, which supports the filing of a Biologics License Application with the FDA seeking regulatory approval of a Product for the treatment of C. difficile infection as the next clinical step.

Performance Milestone I means satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred and be continuing; and (b) the FDA has approved: (i) a supplemental New Drug Application with respect to umbralisib; and (ii) a Biologics License Application for ublituxumab, such that the combination of ublituximab and umbralisib may be commercialized in the United States for the treatment of chronic lymphocytic leukemia with an approved label that is acceptable to Agent in its discretion (where such label supports a product profile and on-label patient population which, in Agent’s discretion, support a differentiated and competitive oncology product launch).