Seller FDA Letter definition

Seller FDA Letter means the letter from Seller to the FDA, duly executed by Seller, to be delivered to Purchaser at the Closing, with regard to the Product NDA in the United States, the form of which is attached hereto as Exhibit E.

Seller FDA Letter means the letter from Eyemax to the FDA, in the form attached as Exhibit D, to be filed with the FDA on the Closing Date in accordance with Section 3.1.

Seller FDA Letter means the transfer of ownership letter from Seller to the FDA as required by 21 CFR § 314.72, in a form mutually agreed between Seller and Buyer, to effectuate the transfer of the Regulatory Approvals from Seller to Buyer.

Examples of Seller FDA Letter in a sentence

• Purchaser and Seller shall file the Purchaser FDA Letter and the Seller FDA Letter, respectively, with the FDA on the Closing Date via overnight courier.

• The transfer of ownership of the Acquired Regulatory Approvals shall be effective on the date on which Purchaser provides notice of exercise of the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller shall provide an executed Seller FDA Letter to Purchaser, notifying the FDA that the Acquired Regulatory Approvals have been transferred to Purchaser as of the Option Closing Date.

• On or as promptly as practical after the Closing, Seller shall deliver the Regulatory Documentation to Buyer and Buyer shall confirm receipt thereof, Within seven (7) Business Days Seller shall file the Seller FDA Letter with the FDA and shall provide notice to Buyer of such filing.

• Buyer shall send Buyer FDA Letter to the FDA, and Seller shall send Seller FDA Letter to the FDA, within ten (10) Business Days after Closing.

• Subject to the approval of the applicable Governmental Authorities, as well as the filing of the Seller FDA Letter and the Buyer FDA Letter with the FDA, all Transferred Permits are freely transferrable to Buyer at the Closing, will be transferred to Buyer at the Closing and will be in full force and effect as of the Closing.

More Definitions of Seller FDA Letter

Seller FDA Letter means a letter from the applicable Seller to the FDA, advising the FDA of the transfer of the NDAs and ANDA included in the Acquired Product Registrations to Buyer, which shall be in customary form reasonably acceptable to the Parties.

Seller FDA Letter means the letter substantially in the form of Exhibit G, with any changes thereto as may be mutually agreed by the Sellers and the Buyer Parties prior to the Closing.

Seller FDA Letter means the letters from the Seller to the FDA, duly executed by the Seller, providing notification of the transfer to Purchaser of all rights of the Seller in and to the Acquired Regulatory Approvals.

Seller FDA Letter means the letters from Seller to the FDA, in the form attached hereto asExhibit B, duly executed by Seller, providing notification of the transfer to Purchaser of all rights of Seller in and to the Acquired Regulatory Approvals.

Seller FDA Letter has the meaning set forth in Section 6.04(a).

Seller FDA Letter means the letter from Seller to the FDA, duly executed by Seller, to be delivered to Buyer on the Closing Date, which shall be in customary form reasonably acceptable to both Parties.

Seller FDA Letter means a letter substantially in the form attached as Exhibit E hereto.