NDA Milestone definition

NDA Milestone means the receipt from the U.S. Food and Drug Administration of a New Drug Application approval for either AEVI-006 or AEVI-007 achieved or occurring prior to the sixty (60)-month anniversary of the date of this Agreement.

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NDA Milestone means the achievement of both of the following: (i) Performance Milestone II; and (ii) the Borrower has [***].

NDA Milestone means satisfaction of each of the following events: (a) no Event of Default shall have occurred and be continuing and (b) on or before December 31, 2019, Borrower has submitted an NDA and the FDA has accepted such NDA for review, in each case, subject to verification by Agent (including supporting documentation requested by Agent).

Examples of NDA Milestone in a sentence

• In no event will any CVR Payment Amount become payable (x) in respect the Study Milestone achieved or occurring on or after the twenty-four (24)-month anniversary of this Agreement, or (b) in respect of the NDA Milestone achieved or occurring on or after the sixty (60)-month anniversary.

• Subject to the terms and conditions of this Agreement and conditioned on Borrower’s achievement of the NDA Milestone in accordance with the definition thereof, on or before December 31, 2019, Borrower may request one additional Term Loan Advance in a principal amount of Thirty-Five Million Dollars ($35,000,000) (“Tranche 3”).

• Promptly (and in any event within five (5) Business Days) following the receipt by Assignee of any report, notice, correspondence or confidential information related to either the NDA Milestone or Commercial Sale Milestone provided by Zevra under the Zevra Agreement, Assignee shall furnish a true, correct and complete copy of the same to Assignor.

• Assignee shall promptly (and in any event within five (5) Business Days) notify Assignor of communication from Zevra to Assignee indicating the NDA Milestone has been achieved.

• Pfizer Payments to BIND 33 8.1. Initial License Fee 33 8.2. Option Fee 34 8.3. Development Milestone Payments 34 8.4. Supplemental NDA Milestone Payments 35 8.5. Regulatory Approval Milestone Payments 36 8.6. First Commercial Sale Milestone Payments 36 8.7. Sales Milestones 37 8.8. Royalties 38 8.9. Third Party Licenses 39 8.10.

• Subject to the terms and conditions of this Agreement and conditioned on Borrower’s achievement of the NDA Milestone in accordance with the definition thereof, on or before December 31, 2019, Borrower may request one additional Term Loan Advance in a principal amount of Fifteen Million Dollars ($15,000,000) (“Tranche 3”).

• For the avoidance of doubt, Buyer (or its successors or assigns, as applicable) shall use Commercially Reasonable Efforts to Exploit (excluding Development activities included within the definition of ‘Exploit’ herein) the Product for APL in the United States, before and after and irrespective of any prepayment of the NDA Milestone Payment.

• If a separate registration statement for the Phase IIb Milestone Shares and the NDA Milestone Shares is required and the Company is not then eligible to use Form S-3, it will file the registration statement on Form S-1 or other available form and shall be required to make such filing no later than thirty (30) days after the issuance thereof.

• In the event of termination of this Agreement by the Acquiror pursuant to Section 12.1(e), the Seller shall pay to the Acquiror an amount equal to the Initial Purchase Price Amount, the NDA Milestone Payment, the Amendment Fee, and an additional amount equal to all Reimbursable Expenses paid by the Acquiror to the Seller hereunder.

• In the event of termination of --------------- this Agreement by the Acquiror pursuant to Section 12.1(d) or Section 12.1(e), --------------- --------------- the Seller shall pay to the Acquiror an amount equal to the Initial Purchase Price Amount and the NDA Milestone Payment, to the extent such payments were previously made by the Acquiror, and shall pay an additional amount to the Acquiror equal to all Reimbursable Expenses paid by the Acquiror to the Seller hereunder.

More Definitions of NDA Milestone

NDA Milestone is defined in ‎‎‎Section 2.3(a).

NDA Milestone is as defined in Section 5.7.

NDA Milestone has the meaning set forth in the definition of “NDA Subsequent Payment Date” in Section 1.1.

NDA Milestone shall be deemed to be achieved upon submission by Parent, its Affiliate, any direct or indirect sublicensee, successor or assignee of Parent or its Affiliate, or any Affiliate of any such sublicensee, successor or assignee, of an NDA with respect to a Product.

NDA Milestone means FDA has accepted Borrower’s NDA for TRC101 (a/k/a veverimer) for filing, subject to verification by Agent (including supporting documentation requested by Agent, to the extent such documentation is available to Borrower). “Net TRC101 Product Revenue” means Borrower’s product revenue from TRC101 (including licensing, royalty and other payments, including from collaboration arrangements, derived from or related to TRC101) that is invoiced and/or recognized as net revenue (as determined in accordance with GAAP as applied by Borrower), calculated in a manner consistent with how such amount is (or is to be) reported in Borrower’s audited Financial Statements. “Non-Disclosure Agreement” means that certain Mutual Confidential Disclosure Agreement by and between Borrower and Hercules Capital, Inc. effective August 1, 2022. “Note(s)” means a Term Note. “OFAC” is the U.S. Department of Treasury Office of Foreign Assets Control. “OFAC Lists” are, collectively, the Specially Designated Nationals and Blocked Persons List maintained by OFAC pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001) and/or any other list of terrorists or other restricted Persons maintained pursuant to any of the rules and regulations of OFAC or pursuant to any other applicable Executive Orders. “Patent License” means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest. “Patents” means all letters patent of, or rights corresponding thereto, in the United States of America or in any other country, all registrations and recordings thereof, and all applications for letters patent of, or rights corresponding thereto, in the United States of America or any other country. “Permits” means all certifications, registrations, licenses, permits, franchises, approvals, clearances, exemptions, authorizations or consents of any governmental entity, necessary for or used in the conduct or operation Borrower’s or any Subsidiary’s business. “Permitted Acquisition” shall mean any Acquisition (including by way of merger), which is conducted in accordance with the following requirements: (a) such Acquisition is of a business or Person engaged in a line of business related to that of the Borrower or its Subsidiaries; (b) if such Acquisition is structured as a stock Acquisition, then the Person so acquired shall either (i) become...