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 Novartis and the FDA that materially discusses Novartis’ or a Covered Person’s actual or potential unlawful or improper promotion of Novartis’ products (including any improper dissemination of information about off-label indications), Novartis shall provide a copy of the report, correspondence, or communication to the OIG. Novartis 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.

Notification of Communications with FDA. Within 30 days after the date of any written report, correspondence, or communication between Novartis and the FDA that materially discusses Novartis’ or a Covered Person’s actual or potential unlawful non-compliance with any FDA requirements relating to the development, approval, marketing, promotion or improper promotion sale of Novartis’ products (including any improper dissemination of information about off-label indications)products, Novartis shall provide a copy of the report, correspondence, or communication to the OIG. Novartis 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. The notification requirements in this Section shall not apply to any correspondence with the FDA regarding manufacturing.