FDA Approval Date definition

FDA Approval Date means the date on which the United States Food and Drug Administration grants Regulatory Approval of C2B8 for manufacture and sale in the United States.

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FDA Approval Date means the date of receipt of FDA approval allowing for Patheon’s manufacturing, testing, and packaging for the Product from the Phase I Filling Space and Phase II Manufacturing Space.

FDA Approval Date means the date of receipt of FDA approval for Patheon’s manufacturing, testing, and packaging for the Product from Manufacturing Suite A-2.

Examples of FDA Approval Date in a sentence

Should either Flexion or Patheon exercise its right to terminate this Agreement or the Manufacturing and Supply Agreement in its entirety (but not in the event of an expiration of this Agreement as set forth in Section 8.2) prior to the FDA Approval Date, then the Manufacturing and Supply Agreement, this Agreement and the Quality Agreement will concurrently and automatically terminate.
This Agreement shall commence as of the Effective Date and, unless earlier terminated in accordance with the terms hereof, shall expire on the tenth (10th) anniversary of the FDA Approval Date (the “Initial Term”).
If the FDA Approval Date has occurred, Borrower shall thereafter elect (at its option and at any time) and satisfy any one of the following performance covenants: (i) Performance Covenant A, tested at all times during the period such covenant is elected by Borrower, (ii) Performance Covenant B, tested at all times during the period such covenant is elected by Borrower, or (iii) Performance Covenant C, tested at the end of the applicable month during the period such covenant is elected by Borrower.
If the FDA Approval Date has not occurred, inclusive of any Qualified Cash amounts maintained in accordance with Sections 7.20(c) and 7.20(d) from and after June 1, 2022, Borrower shall at all times maintain Qualified Cash in an amount equal to the greater of (i) not less than fifty percent (50%) of the sum of the outstanding principal amount of the Term Loan Advances, or (ii) not less than $30,000,000.
For the avoidance of doubt, if the Expiration Date occurs prior to the FDA Approval Date, this Warrant shall not be exercisable.

More Definitions of FDA Approval Date

FDA Approval Date means the date of receipt by Client of Regulatory Approval in the United States for Products Manufactured at the Manufacturing Suite.

FDA Approval Date means the date upon which any party receives FDA Approval.

FDA Approval Date means the date on which the FDA has granted approval for Anktiva in combination with BCG (Bacillus ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease with a label that is substantially similar to the label included in the Biologics License Application 761336 submitted for approval to the FDA on or around October 20, 2023 in response to the complete response letter delivered by the FDA to the Company on May 9, 2023.

FDA Approval Date means the date on which the U.S. Food and Drug Administration approves the use of KRN 5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics.

FDA Approval Date means the date on which the first Initial Product receives Regulatory Approval from the FDA for labeled indications reasonably consistent with the labels included in the applicable NDA submitted to the FDA prior to the Effective Date and with no BLACK BOX warnings.

FDA Approval Date means the date on which the Company shall have delivered evidence satisfactory to the Purchaser Agent that the FDA has approved maralixibat as a treatment for Alagille Syndrome with a label consistent with the label included in the New Drug Application for maralixibat submitted to the FDA on November 11, 2020 and with no BLACK BOX warnings and with orphan exclusivity, as determined by the Purchaser Agent in its good faith business judgment.

FDA Approval Date has the meaning set forth in Section 2.03(a).