Notification to FDA Sample Clauses

Notification to FDA. Immediately following the Closing, the Buyer and the Seller shall work together to make all filings with and give all notices to all Governmental Entities, including the FDA, required in connection with the transfer of the Regulatory Applications and Product Approvals. The parties agree to use their commercially reasonable efforts to take any other actions required by the FDA or any other Governmental Entity to effect such transfer.
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Notification to FDA. Within ten (10) calendar days after the execution of this Side Letter Agreement, the Parties shall execute and deliver to the FDA any and all documents necessary in order to identify RedHill as applicant for the NDA of the Product.
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Notification to FDA. Within twenty one (21) calendar days after the Effective Date, IntelGenx shall execute and deliver to the FDA and Edgemont any and all documents necessary in order to effectuate the transfer of the ownership of NDA to Edgemont, including without limitation the change in ownership submission required under 21 C.F.R. Section 314.72.
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Notification to FDA. Upon execution of this Agreement, the Manufacturer/Athlon Agreement and the Athlon/AAI Agreement, Manufacturer will submit to the FDA a change in ownership letter pursuant to 21 C.F.R. 314.72 with respect to the transfer of the ANDA to AAI in the form set forth in Exhibit B attached hereto, and the Parties agree to cooperate in good faith and to take such actions as are reasonably necessary to reflect such change of ownership of the ANDA to AAI. In addition, Manufacturer will deliver to AAI within ten (10) business days after the Effective Date the Drug Application and all supporting documentation. AAI shall use commercially reasonable efforts to obtain approval of the ANDA for the Product from the FDA and shall not take any action with respect to the ANDA which would impair the ability of or the potential for the Parties to perform their respective obligations hereunder. In addition, once approved by the FDA, AAI shall not withdraw the ANDA unless required to do so by the FDA.
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Notification to FDA. No later than [***] following the date the Seller provides all required Regulatory Approvals and Regulatory Documentation pursuant to Section 2.1(e), (i) the Seller shall execute and deliver to both the FDA contact described therein and the Seller a letter from the Seller to the FDA notifying the FDA of the transfer to the Buyer of the rights to the applicable Regulatory Approvals issued by the FDA, in the form of letter attached hereto as Exhibit E (the “Seller FDA Letter”) and (ii) the Buyer shall execute and deliver to both the FDA contact described therein and the Seller a letter from the Buyer to the FDA of Buyer assuming responsibility for the applicable Regulatory Approvals issued by the FDA, in the form attached hereto as Exhibit F (the “Buyer FDA Letter”). Further, each of the Buyer and the Seller shall work together to make all other filings with and give all other notices to all Governmental Entities, including the FDA, required in connection with the transfer of the Product and the Regulatory Approvals promptly following the Closing.
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Related to Notification to FDA

  • Notification to Union The Hospital will provide the union with a list, monthly of all hirings, lay-offs, recalls and terminations within the bargaining unit where such information is available or becomes readily available through the Hospital's payroll system."

  • Notification to Employer The Union shall notify the Employer of the names of the Employees, including the department wherein the Employee is employed, who are members of the Board of Directors, the Union Executive and Council Committees.

  • Notification to Employees ‌ The Employer will inform new, transferred, promoted, or demoted employees in writing prior to appointment into positions included in the bargaining unit(s) of the Union’s exclusive representation status. Upon appointment to a bargaining unit position, the Employer will furnish the employees with membership materials provided by the Union. The Employer will inform employees in writing if they are subsequently appointed to a position that is not in a bargaining unit.

  • Notification to Holders Upon termination of the Master Servicer or appointment of a successor to the Master Servicer, in each case as provided herein, the Trustee shall promptly mail notice thereof by first class mail to the Securities Administrator and the Certificateholders at their respective addresses appearing on the Certificate Register. The Trustee shall also, within 45 days after the occurrence of any Event of Default known to the Trustee, give written notice thereof to the Securities Administrator and the Certificateholders, unless such Event of Default shall have been cured or waived prior to the issuance of such notice and within such 45-day period.

  • Notification to the Union The Employer will notify the JHSC and union in writing of all incidents related to violence within 4 days. For critical injuries the Employer will notify the JHSC and the union immediately and in writing within 48 hours. Such notices will contain all of the information as prescribed in section 5 of the health care regulation.

  • Authorization to File Borrower hereby authorizes Bank to file UCC financing statements without notice to Borrower, with all appropriate jurisdictions, as Bank deems appropriate, in order to further perfect or protect Bank’s interest in the Collateral, including a notice that any disposition of the Collateral, by either the Borrower or any other Person, shall be deemed to violate the rights of the Bank under the Code.

  • Notification to Lenders Upon the issuance of any Letter of Credit the applicable Issuing Lender shall promptly notify Administrative Agent and each other Lender of such issuance, which notice shall be accompanied by a copy of such Letter of Credit. Promptly after receipt of such notice (or, if Administrative Agent is the Issuing Lender, together with such notice), Administrative Agent shall notify each Lender of the amount of such Lender's respective participation in such Letter of Credit, determined in accordance with subsection 3.1C.

  • Notification to Unsuccessful Job Applicants The parties agree that any unsuccessful candidate for an ONA job posting will be notified, in writing, within one (1) week of the decision being made and prior to the posting of the name of the successful candidate. The parties further agree that the above notification will be copied to the ONA Bargaining Unit President.

  • Authorization to Sell You are to offer and sell shares only at the regular public price currently determined by the respective Funds in the manner described in their offering Prospectuses. This Agreement on your part runs to us and to the respective Funds and is for the benefit of and enforceable by each. The offering Prospectuses and this Agreement set forth the terms applicable to members of the Selling Group and all other representations or documents are subordinate. You understand that Class 529 shares of the Funds are available only as underlying investments through the Program.

  • Annual Notification of Rights If the LEA has a policy of disclosing Education Records and/or Student Data under FERPA (34 CFR § 99.31(a)(1)), LEA shall include a specification of criteria for determining who constitutes a school official and what constitutes a legitimate educational interest in its annual notification of rights.

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