Notification to FDA Clause Samples
The 'Notification to FDA' clause requires a party to promptly inform the U.S. Food and Drug Administration (FDA) about certain events or developments related to the subject matter of the agreement, such as adverse events, product recalls, or significant regulatory changes. Typically, this clause outlines the types of incidents that trigger notification, the timeframe for reporting, and the method of communication to the FDA. Its core function is to ensure regulatory compliance and timely communication with authorities, thereby minimizing legal risks and protecting public health.
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.
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.
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.
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.
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.