FDA Milestone definition

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.

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 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.

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).

• This provides information regarding the demand for custom/ self-build plots in Brighton & Hove.

• In addition, in the event it is no longer possible for the Company to achieve the FDA Milestone, all unvested RSUs and any unearned Cash Award will immediately and automatically be cancelled and forfeited for no consideration, unless otherwise determined by the Administrator.

• The remaining US$1 million shall be paid following the FDA Milestone.

• 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”).

More Definitions of FDA Milestone

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 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 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 shall have the meaning set forth on Annex A attached hereto.

FDA Milestone means the approval by the FDA of the sale and marketing of ADCETRIS in the U.S. for a New Indication, which approval is based on clinical trial data from ECHELON-1.

FDA Milestone shall be deemed to be achieved upon Marketing Approval for a Product in the United States or any other country or regulatory jurisdiction.