Common use of FDA Letters Clause in Contracts

FDA Letters. Horizon and AstraZeneca shall file the Horizon FDA Intent Letters and the AstraZeneca FDA Intent Letters, respectively, with the FDA within one Business Day after the Closing Date. Horizon and AstraZeneca shall file the Horizon FDA Transfer Letters and the AstraZeneca FDA Transfer Letters, respectively, with the FDA pursuant to the Transition Agreement. Transfer of title to the NDA and the INDs for the Product shall be effective as of the Closing.

Appears in 2 contracts

Sources: Asset Purchase Agreement (Horizon Pharma, Inc.), Asset Purchase Agreement (Horizon Pharma, Inc.)