Notification of Communications with FDA Sample Clauses
The "Notification of Communications with FDA" clause requires a party to promptly inform the other party about any significant communications with the U.S. Food and Drug Administration (FDA) that relate to the subject matter of the agreement. This typically includes notifications about regulatory submissions, inquiries, inspections, or enforcement actions that could impact the development, approval, or commercialization of a product. By mandating timely disclosure, the clause ensures both parties remain informed about regulatory developments, enabling coordinated responses and minimizing the risk of misunderstandings or compliance issues.
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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 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 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 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 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 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 Allergan and the FDA that materially discusses Allergan’s or a Covered Person’s actual or potential unlawful or improper promotion of Allergan’s products (including any improper dissemination of information about off-label indications), Allergan shall provide a copy of the report, correspondence, or communication to the OIG. Allergan 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 BIPI and the FDA that materially discusses BIPI’s or a Covered Person’s actual or potential unlawful or improper promotion of BIPI’s products (including any improper dissemination of information about off-label indications), BIPI shall provide a copy of the report, correspondence, or communication to the OIG. BIPI 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.