Submission Milestone definition

Submission Milestone means submission by or on behalf of a Selling Entity of a new drug application to the FDA with respect to a Product for the treatment of ▇▇▇▇.
View Source
Submission Milestone 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’s acceptance for the filing of the NDA submitted by Borrower for Avacopan for the treatment of AAV.
View Source
Submission Milestone means: the submission of the BLA to the FDA. The Submission Milestone is passed when the file has been delivered to, and accepted by, the FDA. The Submission Milestone ensures that all documentation determined by NN to be sufficient to satisfy the applicable requirements for Regulatory Approval is completed and collected and that the BLA is received by the FDA.
View Source

Examples of Submission Milestone in a sentence

  • If a Submission Milestone Payment is paid to Reata after the Unpaid Regulatory Milestone Payment for [***] has been added to the Sales Milestone Payments, then the amount of such Submission Milestone Payment shall be deducted, in reverse order of the sales milestone events set forth in the Sales Milestone Payment table, with the amount deducted from a Sales Milestone Payment not to exceed the amount of the Unpaid Regulatory Milestone Payment for [***] previously added to such Sales Milestone Payment.

  • Subject to the terms and conditions of this Agreement and Borrower’s satisfaction of the Submission Milestone, beginning on the New Loan Effective Date, and continuing through December 15, 2020, Borrower may request, and if requested, Lender shall make New Loan Tranche B Advances in an aggregate principal amount up to $20,000,000 in minimum increments of $1,000,000.

  • Contractor agrees that the SCIP Submission Milestone payment is conditioned upon Contractor’s submittal into Company’s SMS of such number of complete SCIPs per Ring as provided in accordance with Section 3.3.1.

  • Total Number of SCIP Submission Milestones reached by Contractor A metric targeting the timeliness of Contractor performance relative to providing to Company complete SCIPs. For purposes of this metric, completion of the SCIP Submission Milestone is defined as Contractor’s submittal to Company of the completed SCIPs as set forth in Section 3.3.1 of Exhibit C to the Agreement.

  • During the Option Period, if Ophthotech elects to continue the development of tivozanib for non-oncologic diseases of the eye, AVEO is entitled to receive $2 million upon acceptance of the first Investigational New Drug application for the purpose of conducting a human clinical study of tivozanib in ocular diseases (the “IND Submission Milestone Payment”).

  • Upon exercise of the Option, Ophthotech is required to pay AVEO a fee of $2 million in addition to the IND Submission Milestone Payment if such payment has not then been previously paid.