FDA Milestone definition

FDA Milestone means the Committee’s certification on or prior to the Expiration Date of the approval by the FDA for the commercial sale and marketing of rilonacept in the United States by the Company or any of the Company’s partners for the treatment of recurrent pericarditis, based on the clinical trial data from the RHAPSODY Phase 3 clinical trial.

FDA Milestone shall be deemed to be achieved upon receipt by any member of the Buyer Group of written approval or clearance from the FDA, or a successor entity, allowing for the initiation of the marketing or sales of any version or derivative of the second generation of LipoSonix Product, part number P005700-01 and successor thereto (the “Second Generation LipoSonix Product”), in the United States; provided, that the FDA Milestone shall not be deemed to have been achieved until all conditions and limitations contained in the written approval or clearance from the FDA that preclude immediate marketing and commercialization of the LipoSonix Product have been satisfied or waived.

FDA Milestone means any in-person or telephonic meeting with the FDA regarding, or any written response by the FDA to questions posed by the Company regarding, RP-G28’s path to FDA approval. The parties acknowledge and agree that the FDA Milestone was achieved on February 20, 2012 and thus 35% of 25,000 shares covered by this Option vested as of February 20, 2012 and the balance began vesting in accordance with the foregoing schedule as of March 31, 2012.

Examples of FDA Milestone in a sentence

• The parties hereto agree to issue separate individual press releases, each in a form approved by the other party, to announce the execution of this Agreement and the payment of the FDA Milestone Payment pursuant to Section 4.2(a).

• The Committee shall certify in writing (which may be by approval of the minutes in which the certification was made) whether the FDA Milestone has been achieved as soon as administratively practicable after the earlier of (i) the end of the Performance Period and (ii) the FDA Milestone Date (such date, the “Certification Date”).

• Each of Buyer and Seller hereby acknowledge that the achievement of the FDA Milestone is uncertain and that Buyer and its Affiliates may not achieve the FDA Milestone prior to October 1, 2012 or at all, and it is therefore not assured that Buyer will be required to pay the FDA Milestone Payment at all.

• Subject to the set-off rights of Buyer pursuant to Section 2.7(h) and Article 9 hereof, Buyer shall make a one-xxxx Xxxxxx Contingent Payment equal to the FDA Milestone Payment Amount if and only if the FDA Milestone is achieved on or before October 1, 2012 (the “FDA Milestone Payment”).

• On or prior to the thirtieth (30th) day following the achievement of the FDA Milestone, Buyer shall deliver to Seller the FDA Milestone Payment Amount; provided, however, that Buyer shall not be required to make, and Seller shall not be entitled to receive, the FDA Milestone Payment if the FDA Milestone is achieved after October 1, 2012.

More Definitions of FDA Milestone

FDA Milestone means the first approval by the FDA for the commercial sale and marketing of SGN-CD33A in the United States by the Company, any Subsidiary or any Partner.

FDA Milestone has the meaning set forth in Section 2.6(a)(vii).

FDA Milestone has the meaning set forth in Section 3.9(a)(vi).

FDA Milestone means Borrower’s delivery to Bank of evidence, satisfactory to Bank in its sole discretion, no later than March 31, 2018, that Borrower has obtained FDA certification of its manufacturing facility in Wisconsin.

FDA Milestone means the issuance of the FDA M6-C Approval on or before the Earnout Period End Date.

FDA Milestone means the assignment by the FDA of an AB rating to the Methylphenidate Product (or any Reformulated Methylphenidate Product), as evidenced by the listing of an AB rating for the product in the FDA’s electronic publication “Approved Drug Products with Therapeutic Equivalence Evaluation” (also known as the Orange Book).

FDA Milestone means the receipt by the Company, on or prior to December 31, 2007, of written notice from the FDA granting final written approvals for the marketing and sale of the Gold Shunt in the United States for the glaucoma shunting indication, which approval shall not be subject to limitations that would inhibit marketing or selling to a significant portion of the market for the approved indication.