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