FDA Notification Clause Samples
The FDA Notification clause requires parties to promptly inform each other about any communications, inquiries, or actions from the U.S. Food and Drug Administration (FDA) that relate to the subject matter of the agreement. In practice, this means that if the FDA contacts one party regarding product safety, regulatory compliance, or inspection results, that party must notify the other party within a specified timeframe and may need to share relevant documentation. This clause ensures transparency and timely information sharing, allowing both parties to coordinate responses and maintain regulatory compliance, thereby minimizing the risk of non-compliance or enforcement actions.
FDA Notification. Immediately following the closing, Eye Tech, with the assistance of OII, shall deliver to the FDA the submission of a PMA supplement setting forth the licensing of OII to manufacture and distribute intraocular lenses under the Licensee's private label. Eye Tech and OII shall each, as promptly as practicable, cooperate with each other, prepare, execute, and file with FDA such documents and take all such other actions as shall be required to obtain from FDA the approval requested in the PMA supplement in the most expeditious manner as practicable. All documents set forth on Exhibit B, not previously supplied to OII by Eye Tech, shall be promptly made available in order to enable OII to complete the FDA filing. All costs of completing such procedure and obtaining such approval shall be paid by OII.
FDA Notification. The Company shall execute and deliver any instruments of transfer and assignment and take such other action following Closing as FDA may request to effectively transfer and assign the 510(k)s to Purchaser or any entity that Purchaser has designated. Section 5.12 CE ▇▇▇▇ Notification. Within twenty-four (24) hours of the Closing, all applicable Sellers shall file the documentation set forth in Section 2.7(k) and the Sellers and the Company shall execute and deliver further instruments of transfer and assignment and take such other action following Closing as any applicable Governmental Entity may request to effectively transfer and assign the rights to the CE ▇▇▇▇ permitting use of the (a) Sonablate® 500 systems and (b) Sonatherm 600 product line in the European Union to Purchaser or any entity that Purchaser has designated. Section 5.13
FDA Notification. The Company shall execute and deliver any instruments of transfer and assignment and take such other action following Closing as FDA may request to effectively transfer and assign the 510(k)s to Purchaser or any entity that Purchaser has designated.
FDA Notification. To the extent required by applicable Law, on or prior to Closing, the Company will have notified the FDA of a change in Company ownership relating to and affecting the pending 510(k) submission for the PharmGuard Toolbox (K042432) and provide written evidence of such notification to and confirmation from the FDA.
FDA Notification. The Seller shall provide the necessary regulatory documents to the FDA, in the form generally required by the FDA, informing the FDA of the transfer of ownership in connection with the transactions contemplated by this Agreement, including, but not limited to, a letter signed by an authorized representative of Seller with substantially the following information:
(a) Name of Buyer or its designee as transferee;
(b) Address of Buyer or its designee transferee;
(c) Name of responsible official or representative of Buyer or its designee as transferee;
(d) Effective date of transfer pursuant to this Agreement;
(e) Signature of the authorized representative of Seller effecting the transfer; and
(f) Typewritten name and title of the authorized representative of Seller effecting the transfer.
FDA Notification. Buyer and Sellers shall file the Buyer FDA Letter and the Seller FDA Letters, respectively, with the FDA within five (5) Business Days after the Closing Date. Notwithstanding anything contrary herein, Buyer shall be solely responsible for the payment of any filing or similar fees payable to the FDA with respect to the transfer of the Acquired Assets to Buyer.