Common use of FDA Notification Clause in Contracts

FDA Notification. Immediately following the closing, Eye Tech, with the assistance of OII, shall deliver to the FDA the submission of a PMA supplement setting forth the licensing of OII to manufacture and distribute intraocular lenses under the Licensee's private label. Eye Tech and OII shall each, as promptly as practicable, cooperate with each other, prepare, execute, and file with FDA such documents and take all such other actions as shall be required to obtain from FDA the approval requested in the PMA supplement in the most expeditious manner as practicable. All documents set forth on Exhibit B, not previously supplied to OII by Eye Tech, shall be promptly made available in order to enable OII to complete the FDA filing. All costs of completing such procedure and obtaining such approval shall be paid by OII.