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

Approval Milestone has the meaning set forth in Section 7.3.3.

Examples of Approval Milestone in a sentence

• Subject to the terms and conditions of this Agreement and conditioned on Borrower’s achievement of the Approval Milestone on or before December 15, 2020 in accordance with the definition thereof, on or before December 31, 2020, Borrower may request one additional Term Loan Advance in a principal amount of Ten Million Dollars ($10,000,000) (“Tranche 4”).

• If Coherus and Licensee are unable to resolve any Licensee comments within such thirty (30)-day period, any delay involved in the filing beyond the initial thirty (30)-day period shall be credited to Coherus, on a day-for-day basis, in determining the order of entrance to market for the EU Regulatory Approval Milestone.

• For the avoidance of doubt, no publication of a Class I recommendation contemplated by the Clinical Recommendation Milestone or approval of a premarket approval application contemplated by the FDA Approval Milestone occurring after the end of the applicable Clinical Recommendation Milestone Period or the FDA Approval Milestone Period, as applicable, shall result in any Milestone Payment becoming due and payable.

• In addition, following the Closing Date, this Agreement may be terminated by the Seller if the FDA Approval Milestone for the Bile Acid Indications is not paid by Buyer in full on or prior to the FDA Approval Milestone Payment Date (after expiration of the 7 day cure period).

• If Buyer fails to deliver to Seller the full FDA Approval Milestone for the Bile Acid Indication on or before the FDA Approval Milestone Payment Date, Buyer shall have an additional seven (7) days in which cure such payment, during which time the late charges contemplated by Section 3.6(g) shall accrue and become payable to Seller.

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 means is defined in Section 6.2.

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 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. 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).