Common use of Contact with Governmental Authorities Clause in Contracts

Contact with Governmental Authorities. Subject to the other provisions of this Section 7.2, Licensee shall be solely responsible for responding to all inquiries, notices of violation, warning letters, inspectional observations, and other actions from or by Governmental Authorities in the Territory, in each case to the extent related to the Licensed Product in the Territory. Licensor and Licensee shall immediately forward to each other copies of any material correspondence from any Governmental Authority that it receives in respect of the Licensed Product. Notwithstanding the other provisions of this Section 7.2, Licensee shall not respond to any inquiries or other correspondence from a Governmental Authority with respect to the Licensed Product in the Territory without first providing Licensor with a copy of its proposed response, and incorporating any reasonable comments of Licensor in such response. Licensor shall cooperate with Licensee in responding to any inquiry or other correspondence from a Governmental Authority in a timely manner, including by promptly responding to all inquiries of Licensee relating thereto.

Contact with Governmental Authorities. Subject to the other provisions of this Section 7.26.2, Licensee shall be solely responsible for responding to all inquiries, notices of violation, warning letters, serious adverse events (as such term is defined by applicable ICH guidelines or at 21 C.F.R. §312.32(a)), inspectional observations, and other actions from or by Governmental Authorities in the Territory, in each case to the extent related to the Licensed Product in the Territory. Licensor and Licensee shall immediately forward to each other copies of any material correspondence from any Governmental Authority that it receives in respect of the Licensed Product. Notwithstanding the other provisions of this Section 7.26.2, Licensee shall not respond to any inquiries or other correspondence from a Governmental Authority with respect to the Licensed Product in the Territory without first providing Licensor with a copy of its proposed response, and incorporating any reasonable comments of Licensor in such response. Licensor shall cooperate with Licensee in responding to any inquiry or other correspondence from a Governmental Authority in a timely manner, including by promptly responding to all inquiries of Licensee relating thereto.