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) 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.
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.
More Definitions of Term B Milestone Event
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.
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 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 means confirmation by Agent and Lender in their sole discretion, that after the Closing Date, but on or prior to December 15, 2016, Borrower has entered into an arms-length strategic corporate development transaction with a non-affiliated Person that is in a similar line of business and/or industry as Borrower pursuant to which (i) Borrower licenses its Intellectual Property to such non-affiliated Person and (ii) whose financial character is validating in Agent’s and Lender’s sole discretion.
Term B Milestone Event means confirmation by Bank, in Bank’s reasonable discretion, on or prior to August 31, 2016, that Borrower has (a) successfully completed the first (1st) cohort study (the “First Cohort Study”) of the Borrower’s dry age-related macular degeneration Phase 2 clinical trial (the “AMD Trial”), including, without limitation, (i) data which meets the primary or secondary endpoints of the First Cohort Study, including, without limitation, data which is void of substantial evidence of graft failure with respect to, or rejection of, the transplanted cells which are the subject of the First Cohort Study, and (ii) evidence that the First Cohort Study has produced sufficient favorable safety data which supports the advancement of the AMD Trial into a second (2nd) cohort study ((a)(i)-(ii), collectively, the “AMD Requirement”), and (b) on or prior to December 31, 2015 (i) entered into an agreement with one or more licensed broker-dealers providing for “at the market” purchases of the Borrower’s securities from time to time by such broker-dealers or their customers (an “ATM Facility”), (ii) has an effective registration statement on Form S-3 for the offering by the Borrower, on a delayed or continuous basis pursuant to Rule 415 promulgated under the Securities Act of 1933, as amended, of its securities in connection with the ATM Facility, and (iii) obtained all consents and approvals of its stockholders, regulatory authorities (including, without limitation, NASDAQ) and other third parties necessary for the Borrower to offer and sell its securities pursuant to the ATM Facility.
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.