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. 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. 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. 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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Notification to FDA. Promptly after the Closing, Purchaser shall make all filings with, and give all notices to, all Governmental Authorities, including the FDA, required in connection with the transfer of the Transferred Intellectual Property and Seller Permits, and Seller shall provide such assistance in connection therewith as Purchaser may reasonably request. The Parties agree to use their commercially reasonable efforts to take any other actions required by the FDA or any other Governmental Authority to effect such transfer. Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
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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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Related to Notification to FDA

  • Notification to Other Parties I hereby grant consent to notification by the Company to any other parties besides the Company with whom I maintain a consulting or employment relationship, including parties with whom such relationship commences after the effective date of this Agreement, about my rights and obligations under this Agreement.

  • 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.

  • 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 New Employer In the event that I leave the employ of the Company, I hereby grant consent to notification by the Company to my new employer about my rights and obligations under this Agreement.

  • 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.

  • Notification to Noteholders Upon any termination of, or appointment of a successor to, the Servicer pursuant to this Article VII, the Indenture Trustee (or the Relevant Trustee if no Notes are Outstanding) will give prompt written notice thereof to the Owner Trustee, the Issuer, the Administrator, the Asset Representations Reviewer and to the Noteholders and the Certificateholders at their respective addresses of record.

  • 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).

  • Notification to Securityholders Upon any termination of, or appointment of a successor to, the Servicer pursuant to this Article VIII, the Administrator shall give prompt written notice thereof to the Certificateholders and each Rating Agency, and the Indenture Trustee shall give prompt written notice thereof to the Noteholders.

  • AUTHORIZATION TO SUPPLEMENT If any Grantor shall obtain rights to any new trademarks, the provisions of this Trademark Security Agreement shall automatically apply thereto. Grantors shall give prompt notice in writing to Agent with respect to any such new trademarks or renewal or extension of any trademark registration. Without limiting Grantors’ obligations under this Section, Grantors hereby authorize Agent unilaterally to modify this Trademark Security Agreement by amending Schedule I to include any such new trademark rights of each Grantor. Notwithstanding the foregoing, no failure to so modify this Trademark Security Agreement or amend Schedule I shall in any way affect, invalidate or detract from Agent’s continuing security interest in all Collateral, whether or not listed on Schedule I.

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