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 J&J and/or a J&J Pharmaceutical Affiliate and the FDA that materially discusses J&J’s, a J&J Pharmaceutical Affiliate’s or a Covered Person’s actual or potential unlawful or improper promotion of Government Reimbursed Products (including any improper dissemination of information about off-label indications), J&J and/or the applicable J&J Pharmaceutical Affiliates shall provide a copy of the report, correspondence, or communication to the OIG. J&J and/or the applicable J&J Pharmaceutical Affiliates 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.