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

Notification of Communications with FDA. ​ Within 30 days after the date of any written report, correspondence, or communication between Merit and the FDA that materially discusses Merit’s or a Covered Person’s actual or potential unlawful or improper promotion of Merit’s products (including any improper dissemination of information about off-label indications), Merit shall provide a copy of the report, correspondence, or communication to OIG. Merit 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. ​.