Term B Milestone Event means the delivery by Borrower to Bank of evidence reasonably acceptable to Bank in Bank’s reasonable business judgment, on or before June 30, 2015, that the U.S. Food and Drug Administration has granted interim analysis of Borrower’s “C-Pulse Heart Assist System” product for the treatment of heart failure.
Term B Milestone Event means that (a) no Event of Default shall have occurred, and (b) Agent shall have confirmed, in its sole and absolute discretion, each of the following: (i) that Borrower has obtained marketing approval from the Food and Drug Administration for QST with a label claim generally consistent with the desired label claim included in Borrower’s NDA filing, subject to verification by Agent in its reasonable discretion, and (ii) that Borrower has achieved aggregate revenue from the commercial sale of QST, determined in accordance with GAAP, of greater than or equal to Five Million Dollars ($5,000,000.00) prior to September 30, 2018.
Term B Milestone Event means confirmation by Agent and Lender in their sole discretion, that after the Closing Date, but on or prior to March 31, 2017, Borrower has completed a clinical study for TACTT2 that meets its co-primary endpoints with statistical significance and which will be the basis for a NDA submission by the Borrower to the FDA in 2017.
Examples of Term B Milestone Event in a sentence
The Company may draw the Term B Loan during the period commencing on the date of the occurrence of the Term B Milestone Event and ending on the earliest of (i) December 31, 2020, (ii) the thirtieth (30th) day following the occurrence of the Term B Milestone Event, and (iii) the occurrence of an event of default by the Company.The Company’s obligations under the Loan and Security Agreement are secured by all assets of the Company, other than its intellectual property.
The Company may draw the Term B Loan during the period commencing on the date of the occurrence of the Term B Milestone Event and ending on the earliest of (i) September 30, 2021 (ii) the sixtieth (60th) day following the occurrence of the Term B Milestone Event, and (iii) the occurrence of an event of default.
More Definitions of Term B Milestone Event
Term B Milestone Event means Borrower has delivered to Bank, on or prior to July 31, 2026, evidence satisfactory to Bank in its sole and absolute discretion, that Xxxxxxxx has obtained the resources necessary to execute a proposed first-line pivotal Phase 3 clinical trial of palazestrant in combination with ribociclib [ * ].
Term B Milestone Event is the achievement by Borrower of the closing of a new collaboration agreement that includes an upfront payment of at least $50,000,000 to Borrower, as determined by Collateral Agent in its sole and absolute discretion.
Term B Milestone Event means confirmation by Agent in Agent’s reasonable discretion, that on or prior to December 31, 2016, all of the following milestones have been achieved: (a) the Interest Only Period Extension Event No. 1, (b) the Interest Only Period Extension Event No. 2, and (c) Borrower has filed, and the U.S. Food and Drug Administration has accepted, Borrower’s investigational new drug application with respect to any product of Borrower other than Borrower’s “AST-005” product.
Term B Milestone Event is the receipt by Collateral Agent on or after the Effective Date of evidence in form and substance acceptable to Collateral Agent and Lenders, in their sole discretion, that Borrower has received NDA approval from the FDA of INP104.
Term B Milestone Event is set forth on Schedule I hereto.
Term B Milestone Event occurs if and when (if ever), at any time prior to March 31, 2025, Bank confirms in writing that: (a) Borrower has requested and Bank has made all available Term A Loan Advances, (b) Bank has received all necessary internal and credit approvals to make the Term B Loan Advances in an amount not to exceed the Term B Availability Amount, (c) no Event of Default exists at the time the initial Term B Loan Advance is requested or would exist as a result of the initial Term B Loan Advance, and (d) Bank has provided written approval in its sole discretion that the initial Term B Loan Advance shall occur.
Term B Milestone Event means that: (a) no Event of Default shall have occurred and is continuing, and (b) Agent shall have confirmed in writing to Borrower after the Closing Date but on or prior to the end of the Term B Draw Period, that any one of the following events shall have occurred: (i) (x) the FDA has accepted Borrower’s new drug application for marketing approval with respect to Borrower’s “Iclaprim” product for the treatment of patients with acute bacterial skin and skin structure infection (“ABSSSI”), and (y) Borrower has enrolled its first (1st) patient in its Phase 3 clinical study of Borrower’s “Iclaprim” product for the treatment of hospital-acquired bacterial pneumonia (“HABP”), (ii) Borrower has obtained market approval from the FDA with respect to Borrower’s “Iclaprim” product for the treatment of patients with ABSSSI, or (iii) Agent and Lender have determined, in their sole and absolute discretion, to make the Term B Loan Advance.