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”).

• Subject to the terms and conditions of this Agreement, beginning on the date Borrower achieves Performance Milestone I and continuing through June 30, 2021, Borrower may request and Lenders severally (and not jointly) will make Term Loan Advances in an aggregate amount up to $7,500,000, in minimum increments of $2,500,000, or if the undrawn amount of the Tranche 2 Term Loan is less than $2,500,000, such lesser amount (each, a “Tranche 2 Term Loan 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.

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• 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”).

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 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).

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 (a) no Default or Event of Default shall have occurred and be continuing and (b) Borrower has (i) demonstrated pre-clinical proof-of-concept for all allogeneic iNK cell therapy; (ii) received at least Sixty-Five Million Dollars ($65,000,000) in All Source Proceeds; provided that Agent may, in its sole discretion, reduce such amount of minimum All Source Proceeds consistent with adjustments to Borrower’s projections and the anticipated timing of various events/initiatives, as reviewed and approved by Agent; and (iii) demonstrated pre-clinical proof-of- concept for an allogeneic iT cell therapy product, in each case of the foregoing clauses (i) through (iii), subject to verification by Agent in its reasonable discretion (including supporting documentation reasonably requested by Agent).

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.