Regulatory Approval Milestone definition

Regulatory Approval Milestone means, and will be deemed to occur upon, Parent’s or its Affiliates’ (or their respective successors or assigns) first receipt of approval by the FDA of a new drug application or other regulatory approval application which approval grants Parent or its Affiliates (or their respective successors or assigns) the right to market and sell the Regulatory Approval Product in the United States.

Regulatory Approval Milestone is defined in Section 5.4.1.

Regulatory Approval Milestone means the occurrence of both of the following (a) Vorasidenib being granted approval for a New Drug Application (NDA) from the FDA for the United States and with an approved label that specifically permits Vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an IDH1 or IDH2 mutation; and (b) if, and only if, the approval for a New Drug Application (NDA) referred to in clause (a) requires the approval of a Vorasidenib Companion Diagnostic Test, then the Vorasidenib Companion Diagnostic Test being granted a Premarket Approval from the FDA for the United States; provided that any accelerated approval by the FDA of Vorasidenib or the Vorasidenib Companion Diagnostic Test shall not be deemed to satisfy clause (a) or (b), as applicable.

Examples of Regulatory Approval Milestone in a sentence

• 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.

• Notwithstanding the foregoing, in no event shall Parent be required to pay the Regulatory Approval Milestone Payment more than once and Parent shall not be required to pay the Regulatory Approval Milestone Payment if the Regulatory Approval Milestone occurs after the expiration of the Regulatory Approval Milestone Period.

• The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate Tax withholding or similar obligations in respect of any payments under this Agreement, including but not limited to the upfront payment or any Development Milestone Payments, Regulatory Approval Milestone Payments, Commercial Milestone Payments, Sales Milestone Payments or royalties paid by GSK to Scynexis under this Agreement.

• The fourth tranche in an aggregate principal amount of $25,000 was available upon satisfaction of certain conditions, including the approval by the FDA of a biologics license application in respect of SER-109 (the "Regulatory Approval Milestone") by no later than December 15, 2023.

• Iterum, in its sole discretion, may defer the Development Milestone Payments for Development Milestone (2) and Development Milestone (3) under Section 5.3 (each event a “Regulatory Approval Milestone” and each payment a “Regulatory Approval Payment”) for up to [ * ] from the occurrence of the Regulatory Approval Milestone.

• GSK shall notify Scynexis within [***] ([***]) following the first achievement of a given Regulatory Approval Milestone Event by GSK or any of its Affiliates or Sublicensees, and the corresponding Regulatory Approval Milestone Payment shall be due within [***] ([***]) after GSK’s receipt of a Valid Invoice in accordance with Section 6.7 for such Regulatory Approval Milestone Payment.

• Regulatory Approval Milestone Event Regulatory Milestone Payment 1.

• The fourth tranche in an aggregate principal amount of $25,000 is available upon satisfaction of certain conditions, including the approval by theFDA of a biologics license application in respect of SER-109 (the "Regulatory Approval Milestone") by no later than December 15, 2023.

More Definitions of Regulatory Approval Milestone

Regulatory Approval Milestone means the Company’s achievement of Regulatory Approval for the Initial Device.

Regulatory Approval Milestone means that (i) the FDA has approved a Biologics License Application for SER-109 for an indication relating to the treatment of recurrent Clostridioides difficile infection with a label or indication that is generally consistent with that sought in Borrower’s Biologics License Application submission and (ii) Borrower has received the $125,000,000 payment related to the “First Regulatory Approval by the FDA for the first Collaboration Product” as set forth in Section 7.2(a) of the Nestle License Agreement (2021).

Regulatory Approval Milestone has the meaning set forth in Section 8.2(b)(i).

Regulatory Approval Milestone means the receipt by the Company of FDA 510(k) Clearance of the Camber Sacroiliac (SI) Fixation System, where such FDA 510(k) Clearance includes an amended indications for use statement that does not include the requirement to use one or more SICONUS SI Joint Fixation System screws) during sacroiliac joint fusion as such requirement is currently set forth in FDA 510(k) Clearance #K203503.

Regulatory Approval Milestone means, and will be deemed to