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.
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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.
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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.
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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:
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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.
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Related to FDA Notification

  • Reporting Notification Reports, Evaluations, and Reviews required under this §8 shall be in accordance with the procedures of and in such form as prescribed by the State and in accordance with §19, if applicable.

  • 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.

  • Employee Notification A copy of any disciplinary action or material related to employee performance which is placed in the personnel file shall be provided to the employee (the employee so noting receipt, or the supervisor noting employee refusal to acknowledge receipt) or sent by certified mail (return receipt requested) to the employee's last address appearing on the Employer's records.

  • Recall Notification Notice of recall shall be sent to the bargaining unit member by certified mail. The City shall be deemed to have fulfilled its obligation by mailing the recall notice by certified mail, return receipt requested, to the last address provided by the bargaining unit member.

  • 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.

  • Privacy Notification (1) The authority to request the above personal information from a seller of goods or services or a lessor of real or personal property, and the authority to maintain such information, is found in Section 5 of the State Tax Law. Disclosure of this information by the seller or lessor to the State is mandatory. The principal purpose for which the information is collected is to enable the State to identify individuals, businesses and others who have been delinquent in filing tax returns or may have understated their tax liabilities and to generally identify persons affected by the taxes administered by the Commissioner of Taxation and Finance. The information will be used for tax administration purposes and for any other purpose authorized by law. (2) The personal information is requested by the purchasing unit of the agency contracting to purchase the goods or services or lease the real or personal property covered by this contract or lease. The information is maintained in the Statewide Financial System by the Vendor Management Unit within the Bureau of State Expenditures, Office of the State Comptroller, 000 Xxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000.

  • Union Notification The Union shall be notified of all appointments, hirings, layoffs, transfers, recalls and terminations of employment.

  • Advance Notification The Company shall notify the Shop Committee and the Union not less than six (6) months in advance of intent to institute material changes in working methods of facilities which would involve the discharge or laying off of employees.

  • Layoff Notification The Appointing Authority shall send a layoff notice to the employee in the position to be eliminated. The layoff notice shall be provided to the employee in person whenever practicable and shall otherwise be sent by priority mail. At the Appointing Authority’s discretion, an employee under notice of permanent layoff may be granted up to one hundred and sixty (160) hours of paid leave, ending at the date of layoff. Hours of leave may be granted at any time throughout the layoff notice period and shall not be subject to the Application and Reinstatement provisions of Article 10. Upon request, an Appointing Authority shall provide an employee on notice of layoff assistance in searching for State employment. Provisional, temporary and emergency employees shall be terminated before any layoff of probationary or permanent employees in the same class, employment condition and geographic location/principal place of employment. Provisional employees shall be separated in inverse order of the date of their provisional appointment.

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