FDA Notification Sample Clauses

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.
Sample 1Sample 2
AutoNDA by SimpleDocs
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 Xxxx 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 Xxxx 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
Sample 1
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.
Sample 1
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.
Sample 1
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:
Sample 1
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.
Sample 1

Related to FDA Notification

  • HSR Notification As soon as practicable after the execution of this ---------------- Agreement, but in any event no later than 30 days after such execution, Seller and Buyer will each complete and file, or cause to be completed and filed, any notification and report required to be filed under the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the "HSR Act"); and each such filing will request early termination of the waiting period imposed by the HSR Act. The parties will use their reasonable best efforts to respond as promptly as reasonably practicable to any inquiries received from the Federal Trade Commission (the "FTC") and the Antitrust Division of the Department of Justice (the "Antitrust Division") for additional information or documentation and to respond as promptly as reasonably practicable to all inquiries and requests received from any other Governmental Authority in connection with antitrust matters. The parties will use their respective reasonable best efforts to overcome any objections which may be raised by the FTC, the Antitrust Division or any other Governmental Authority having jurisdiction over antitrust matters. Notwithstanding the foregoing, Buyer will not be required to make any significant change in the operations or activities of the business (or any material assets employed therein) of Buyer or any of its Affiliates, if Buyer determines in good faith that such change would be materially adverse to the operations or activities of the business (or any material assets employed therein) of Buyer or any of its Affiliates having significant assets, net worth, or revenue. Notwithstanding anything to the contrary in this Agreement, if Buyer or Seller, in its sole opinion, considers a request from a governmental agency for additional data and information in connection with the HSR Act to be unduly burdensome, such party may terminate this Agreement by giving written notice to the other. Within 10 days after receipt of a statement therefor, Seller will reimburse Buyer for one-half of the filing fees payable by Buyer in connection with Buyer's filing under the HSR Act.

  • Tax Notification The Plan is a plan to which Subdivision 83A-C of the Income Tax Assessment Xxx 0000 (Cth) applies (subject to conditions in the Act).

  • Cooperation, Notification Each party shall, and shall cause its subsidiaries to, (i) confer on a regular and frequent basis with one or more representatives of the other party to discuss, subject to applicable law, material operational matters and the general status of its ongoing operations; (ii) promptly notify the other party of any significant changes in its business, properties, assets, condition (financial or other), results of operations or prospects; (iii) advise the other party of any change or event which has had or, insofar as reasonably can be foreseen, is reasonably likely to result in, in the case of the Company, a Company Material Adverse Effect or, in the case of Parent, a Parent Material Adverse Effect; and (iv) promptly provide the other party with copies of all filings made by such party or any of its subsidiaries with any state or federal court, administrative agency, commission or other Governmental Authority in connection with this Agreement and the transactions contemplated hereby.

  • Antitrust Notification If the Holder determines, in its sole judgment upon the advice of counsel, that the issuance of any Warrant Shares pursuant to the terms hereof would be subject to the provisions of the Hxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the “HSR Act”), the Company shall file as soon as practicable after the date on which the Company receives notice from the Holder of the applicability of the HSR Act and a request to so file with the United States Federal Trade Commission and the United States Department of Justice the notification and report form required to be filed by it pursuant to the HSR Act in connection with such issuance.

  • Customer Notification By executing this Agreement, the Advisor acknowledges that as required by the Advisers Act the Sub-Advisor has supplied to the Advisor and the Trust copies of the Sub-Advisor’s Form ADV with all exhibits and attachments (including the Sub-Advisor’s statement of financial condition) and will promptly supply to the Advisor copies of all amendments or restatements of such document. Otherwise, the Advisor’s rights under federal law allow termination of this contract without penalty within five business days after entering into this contract. U.S. law also requires the Sub-Advisor to obtain, verify, and record information that identifies each person or entity that opens an account. The Sub-Advisor will ask for the Trust’s legal name, principal place of business address, and Taxpayer Identification or other identification number, and may ask for other identifying information.

  • Required Notifications Each Grantor shall promptly notify the Administrative Agent, in writing, of: (i) any Lien (other than Permitted Liens) on any of the Collateral which would adversely affect the ability of the Administrative Agent to exercise any of its remedies hereunder and (ii) the occurrence of any other event which could reasonably be expected to have a material impairment on the aggregate value of the Collateral or on the security interests created hereby.

  • HSR Act Notification To the extent required by the HSR Act, the Company shall, to the extent it has not already done so, (a) use all commercially reasonable efforts to file or cause to be filed, as promptly as practicable after the execution and delivery of this Agreement, with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice, all reports and other documents required to be filed by it under the HSR Act concerning the transactions contemplated hereby and (b) use all commercially reasonable efforts to promptly comply with or cause to be complied with any requests by the United States Federal Trade Commission or the Antitrust Division of the United States Department of Justice for additional information concerning such transactions, in each case so that the waiting period applicable to this Agreement and the transactions contemplated hereby under the HSR Act shall expire as soon as practicable after the execution and delivery of this Agreement. The Company agrees to request, and to cooperate with the Purchasers in requesting, early termination of any applicable waiting period under the HSR Act.

  • Prior Notification Unless specifically prohibited by applicable law or court order, each of the Banks and the Agent shall, prior to disclosure thereof, notify the Borrower of any request for disclosure of any such non-public information by any governmental agency or representative thereof (other than any such request in connection with an examination of the financial condition of such Bank by such governmental agency) or pursuant to legal process.

  • Certain Notifications At all times from the date hereof to the Closing Date, each party shall promptly notify the others in writing of the occurrence of any event that will or may result in the failure to satisfy any of the conditions specified in Article 8 hereof.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!