Approval Milestone definition

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 has the meaning set forth in Section 6.1.

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 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 means that the FDA has approved the sale and marketing of mavorixafor for the treatment to patients with Warts, Hypogammaglobulinemia, Infections and Myelokathexis (WHIM syndrome) with a label claim that is generally consistent with that sought in Borrower’s New Drug Application filing, subject to Agent’s reasonable verification. “Approval Milestone Date” means the date on which Borrower achieves the Approval Milestone. “Assignee” has the meaning given to it in Section 11.13. “Blocked Person” means any Person: (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list. “Borrower Products” means all products, software, service offerings, technical data or technology currently being designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its incorporation. “Business Day” means any day other than Saturday, Sunday and any other day on which banking institutions in the State of California or the Commonwealth of Massachusetts are closed for business. “Cash” means all cash, cash equivalents and liquid funds.