Notification of Communications with FDA. Within 30 days after the date of any written report, correspondence, or communication between GSK and the FDA that materially discusses GSK’s or a Covered Person’s actual or potential unlawful or improper promotion of GSK’s products (including any improper dissemination of information about off-label indications), GSK shall provide a copy of the report, correspondence, or communication to the OIG. GSK shall also provide written notice to the OIG within 30 days after the resolution of any such disclosed off-label matter, and GlaxoSmithKline LLC Corporate Integrity Agreement 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 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.
Notification of Communications with FDA. Within 30 days after the date of any written report, correspondence, or communication between Forest and the FDA that materially discusses Forest’s or a Covered Person’s: i) actual or potential unlawful or improper promotion of Forest’s products (including any improper dissemination of information about off-label indications); or ii) actual or potential violation of FDA requirements or guidance relating to the status or classification of, and/or distribution of, any Forest product, Forest shall provide a copy of the report, correspondence, or communication to the OIG. Forest shall also provide written notice to the OIG within 30 days after the resolution of any such disclosed 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 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.
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.
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 non-compliance with any FDA requirements relating to the development, approval, marketing, promotion or sale of Novartis’ products, Novartis shall provide a copy of the report, correspondence, or communication to OIG. Novartis shall also provide written notice to OIG within 30 days after the resolution of Novartis Corporate Integrity Agreement any such disclosed matter, and shall provide 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.
Notification of Communications with FDA. Within 30 days after the date of any written or electronic report, correspondence, or communication between RMS and the FDA that materially discusses RMS’s or a Covered Person’s actual or potential unlawful or improper promotion of RMS’s products (including any improper dissemination of information about off-label indications) or that involves adverse events required to be reported to the FDA under 21 C.F.R. Part 803, RMS shall provide a copy of the report, correspondence, or communication to OIG. RMS 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.
Notification of Communications with FDA. Within 30 days after the date of any written report, correspondence, or communication between Arthrex and the FDA that materially discusses Arthrex’s or a Covered Person’s actual or potential unlawful or improper marketing or sale of Arthrex’s products, Arthrex shall provide a copy of the report, correspondence, or communication to OIG. Arthrex shall also provide written notice to OIG within 30 days after the resolution of any such disclosed 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 Biotronik and the FDA that materially discusses Biotronik’s or a Covered Person’s actual or potential unlawful or improper marketing or sale of Biotronik’s products, Biotronik shall provide a copy of the report, correspondence, or communication to OIG. Within 30 days after resolution of the matter, Biotronik shall notify OIG, in writing, of the resolution.
