Common use of Notification of Communications with FDA Clause in Contracts

Notification of Communications with FDA. Within 30 days after the date of any written report, correspondence, or communication between AstraZeneca and the FDA that materially discusses AstraZeneca’s or a Covered Person’s actual or potential unlawful or improper promotion of AstraZeneca’s products (including any improper dissemination of information about off-label indications), AstraZeneca shall provide a copy of the report, correspondence, or communication to the OIG. AstraZeneca shall also provide written notice to the OIG within 30 days after the resolution of any such disclosed off-label matter, and shall provide the OIG with a description of the findings and/or results of the matter, if any.