FDA Milestone definition

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

• 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 Company shall pay the Earned Cash Award to each Participant in a lump sum cash payment, less applicable withholdings, within the next two payroll cycles following achievement of the FDA Milestone, but in any event no later than 45 calendar days following achievement of the FDA Milestone.

• In the event the FDA Milestone is not achieved on or prior to the Expiration Date, all outstanding Cash Awards, outstanding First RSU Awards and any opportunity to receive the Second RSU Award shall automatically be canceled and forfeited on the Expiration Date, unless otherwise determined by the Committee.

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).

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.

FDA Milestone is satisfied upon the Surviving Company receiving regulatory approval prior to the 10th anniversary of the Closing Date from the US Food and Drug Administration for the first Protein Based Product and/or the first Steroid Based Product. Upon satisfaction of the FDA Milestone for the first Protein Based Product, Purchaser will pay $10 million to the Stockholders’ Representative’s designee for further distribution to the Participating Holders if the Protein Based Product is a Product 1 or $15 million if the Protein Based Product is Product 1+. Upon satisfaction of the FDA Milestone for the first Steroid Based Product, Purchaser will pay $5 million to the Stockholders’ Representative’s designee for further distribution to the Participating Holders if the Steroid Based Product is a Product 2 or $7.5 million if the Steroid Based Product is a Product 2+.

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 shall be deemed to be achieved upon receipt by any member of the Buyer Group of a written approval letter from the FDA, or a successor entity, allowing for the initiation of the marketing or sales of any Company Product in the United States for use in permanent female sterilization without any conditions or limitations to such approval other than any conditions or limitations which would not, individually or in the aggregate, materially adversely affect the marketability or commercial viability of such Company Product; provided, however, that the FDA Milestone shall be deemed to be achieved in any event upon the first commercial sale after the Effective Time by a member of the Buyer Group, or its sublicensee or authorized or licensed distributor, of a Company Product in the United States of America outside of a clinical trial.