Approval Milestone means on or before December 15, 2020, Borrower shall have obtained final approval for the NDA for TRC101 from the FDA, subject to verification by Agent (including supporting documentation requested by Agent).

Approval Milestone has the meaning set forth in Section 7.3.3.

Approval Milestone means receipt by the Company or one of its Affiliates of the first FDA Approval of AUGMENT Bone Graft based on the AUGMENT PMA.

Examples of Approval Milestone in a sentence

During the teams meeting, the participant informed that there is not documented current operating model.
The Sellers acknowledge and agree that any shares of Purchaser common stock received by the Sellers as the Contingent Equity Payment or FDA Approval Milestone Payment shall be subject to a lockup period through the second anniversary of the Closing Date, which shall be set forth in the subscription agreements for such shares to be entered into by the Sellers at the time of any such issuance.
Histogenics shall pay Intrexon a milestone payment of one million United States dollars ($1,000,000) within thirty (30) days of each instance of the achievement of the Amended Approval Milestone Event, said payment being made, at Histogenics’ option subject to Section 5.3(b) and 5.3(c), either in cash or in shares of Histogenics’ common stock.
The Rights Agent shall hold the Aggregate Regulatory Approval Milestone Payment in a non-interest bearing account until such payment is made in accordance with the foregoing sentence.
Interest on the amounts borrowed under the Term Loan Agreement accrues at an annual fixed rate of (a) prior to the Approval Milestone, 12.50%, 4.0% of which may be deferred during the interest-only period by adding such amount to the aggregate principal loan amount and (b) following the Approval Milestone, 11.50%, 3.5% of which may be deferred during the interest-only period by adding such amount to the aggregate principal loan amount.

More Definitions of Approval Milestone

Approval Milestone means 510(k) clearance for the marketing of T2Bacteria™ by the United States Food and Drug Administration on or prior to April 30, 2018.

Approval Milestone means receipt by the Company or one of its Affiliates, on or before March 31, 2014, of the FDA Approval of alemtuzumab for treatment of multiple sclerosis.

Approval Milestone. Percentage shall have the meaning assigned to it in Section 8.8(c).

Approval Milestone means Borrower shall have obtained approval of the NDA for Ziftomenib from the FDA, with an approved label that is generally consistent with the label sought in Borrower’s NDA, subject to reasonable verification by Agent (including any supporting documentation requested by Agent).

Approval 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 15, 2020, Borrower shall have obtained final approval for the NDA for TRC101 from the FDA, subject to verification by Agent (including supporting documentation requested by Agent).

Approval Milestone means the satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred and be continuing and (b) Parent shall have stated in Parent’s public filings with the Securities and Exchange Commission (as confirmed by Agent in its reasonable discretion) that the FDA has approved the commercialization in the United States of RP1 for either indications related to: (i) the treatment of patients with CSCC or (ii) the treatment of patients with Melanoma who failed anti-PD1 therapy, in each case with a label claim that is generally consistent in all material respects with that sought in Borrower’s BLA filing.

Approval Milestone has the meaning set forth in Section 5.4.3.