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 [***].
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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).
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Examples of NDA Milestone in a sentence

  • 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”).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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(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.

  • 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.


More Definitions of NDA Milestone

NDA Milestone is defined in ‎‎‎Section 2.3(a).
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NDA Milestone is as defined in Section 5.7.
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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.
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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...
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NDA Milestone has the meaning set forth in the definition of “NDA Subsequent Payment Date” in Section 1.1.
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Related to NDA Milestone

  • Development Milestone is defined in Section 5.3.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Milestone Events has the meaning set forth in Section 7.2.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Milestone Notice has the meaning set forth in Section 2.4(a).

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • Milestone Payments means payments made in connection with any Permitted Acquisition or other acquisition (including any license or the acquisition of any license) of any rights in respect of any drug or other pharmaceutical product (and any related property or assets) to sellers (or licensors) of the assets or Equity Interests acquired (or licensed) therein based on the achievement of specified revenue, profit or other performance targets (financial or otherwise).

  • Initial Indication means the use of a Product for the treatment of opioid addiction.