Common use of Communications and Inspections Clause in Contracts

Communications and Inspections. Cisco shall be solely responsible for all contacts and communications with the FDA and other Governmental Authorities with respect to all matters relating to the HealthPresence Products, except with respect to the sales activities performed by Integrator. Integrator shall notify Cisco and, if applicable, provide Cisco with copies of any notices or communications of any FDA or other Governmental Authority inspection, investigation or other inquiry or other material governmental notice or communication, relating to the HealthPresence Products promptly after, but in no case later than three (3) business days after, Integrator becomes aware of such inspection, investigation, inquiry, notice, or communication. In the event that an inspection, or any portion of an inspection, relates specifically to the HealthPresence Products, Integrator will permit representatives of Cisco to be present during the portion of the inspection directly related to HealthPresence Products. Integrator shall provide Cisco with copies of any inspectional findings or observations relating to the HealthPresence Products (e.g., from an FDA Form 483 or Warning Letter) within three (3) business days of receipt by Integrator. Integrator shall provide Cisco with a copy of and opportunity to comment on Integrator’s response(s) to any inspectional findings or observations or any other Governmental Authority inquiry, notice or communication prior to Integrator’s submission of such response(s).

Communications and Inspections. Cisco shall be solely responsible for all contacts and communications with the FDA and other any Governmental Authorities with respect to all matters relating to the HealthPresence Products, except with respect to the sales activities performed by Integrator. Integrator shall notify Cisco and, if applicable, provide Cisco with copies of any notices or communications of any FDA or other Governmental Authority inspection, investigation or other inquiry or other material governmental notice or communication, relating to the HealthPresence Products promptly after, but in no case later than three (3) business days after, Integrator becomes aware of such inspection, investigation, inquiry, notice, or communication. In the event that an inspection, or any portion of an inspection, relates specifically to the HealthPresence Products, Integrator will permit representatives of Cisco to be present during the portion of the inspection directly related to HealthPresence Products. Integrator shall provide Cisco with copies of any inspectional findings or observations relating to the HealthPresence Products (e.g., from an FDA Form 483 or Warning Letter) within three (3) business days of receipt by Integrator. Integrator shall provide Cisco with a copy of and opportunity to comment on Integrator’s response(s) to any inspectional findings or observations or any other Governmental Authority inquiry, notice or communication prior to Integrator’s submission of such response(s).