FDA Notification definition

FDA Notification means notification from the Food and Drug Administration stating that the Issuer’s Menaflex product can remain marketable in the United States.
View Source

Examples of FDA Notification in a sentence

  • Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) and the filing of a premerger notification and report form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Seller to enter into, and to perform its obligations under, this Agreement.

  • Except for the submission to the FDA of the FDA Notification Package referenced in Section 3.2(c) and the filing of a premerger notification and report form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Buyer to enter into, and to perform its obligations under, this Agreement.

  • Within thirty (30) days following the Closing, ▇▇▇▇▇▇ agrees, as a courtesy to Buyer and without prejudice to Section 5.06 hereof, that it shall submit the FDA Notification Package to the Subject BLA and, reasonably promptly thereafter, Seller shall provide Buyer with a copy of such submission.

  • Except for the FDA Notification Package and, if applicable, the filing of a Premerger Notification and Report Form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Merck to enter into, and to perform its obligations under, this Agreement.

  • Seller shall submit the FDA Notification Package to the Subject BLA through the FDA’s Electronic Submission Gateway within 14 days following the Closing and within two (2) days thereafter provide Buyer with a copy of Seller’s submission (the “Seller Notice of Transfer Submission”).

  • Except for the FDA Notification Package and the filing of a Premerger Notification and Report Form under the HSR Act, no filing, authorization, consent, approval, permit, order, registration or declaration, governmental or otherwise, is necessary to enable or authorize Buyer to enter into, and to perform its obligations under, this Agreement.

  • By: _____________________________ Name: ___________________________ Title: ____________________________ Exhibit C-1 Form of Joint FDA Notification Cover Letter _____________, 2020 Marion F.

  • If Purchaser fails to pay such amount specified under this Section within forty-five (45) days of Purchaser’s receipt of FDA Notification, Purchaser shall and hereby does assign all right, title and interest in, to and under the Purchased Assets back to Seller.

  • Seller shall submit the FDA Notification Package to the Subject BLA promptly following Buyer’s notification to Seller of its submission, and Seller’s receipt from Buyer, of a copy of the Buyer Notice of Transfer Submission, but in no event later than 30 days following the Closing (provided that Buyer timely complies with its obligations under this Section 3.04).

  • A copy of the joint FDA notification cover letter and the Lumos transfer acknowledgement letter for inclusion in the FDA Notification Package, which FDA cover letter and Lumos transfer acknowledgement letter shall be in the form of Exhibit C-1 and Exhibit C-2, respectively, or such other form as the FDA may require as of the Closing Date.

Related to FDA Notification

  • DDA Notification has the meaning provided therefor in Section 6.13(a)(i).

  • 1940 Act Notification means a notification of registration of the Fund as an investment company under the 1940 Act on Form N-8A, as the 1940 Act Notification may be amended from time to time.

  • Additional Disclosure Notification The form of notification to be included with any Additional Form 10-D Disclosure, Additional Form 10-K Disclosure or Form 8-K Disclosure Information which is attached to this Agreement as Exhibit W.

  • Written Notification means an electronic document (including faxes, emails, internal mail on the client terminal etc.) or an announcement on the Company's website.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken