Common use of FDA Contacts Clause in Contracts

FDA Contacts. On and after the Closing Date, Horizon shall be responsible for all contacts with the FDA and other regulatory authorities with respect to the Product, and all other responsibilities under the Registrations; provided that either party shall notify the other party immediately, and in no event later than (A) forty-eight (48) hours after receipt of any contact or communication from the FDA or any other Governmental or Regulatory Authority in the Territory and (B) five (5) Business Days after receipt of any contact or communication with any other third party, that in either case, in any way requests or suggests the need for a recall or withdrawal of a lot of Product manufactured by or on behalf of Warn▇▇-▇▇▇▇▇▇▇ ▇▇ otherwise calls into question the quality or safety of such a Product lot. Horizon shall be responsible for investigating any such request or suggestion and for any communications with any Governmental or Regulatory Authority relating thereto; provided that Horizon shall comply with all reasonable requests by Warn▇▇-▇▇▇▇▇▇▇.