U.S. GOVERNMENT SITE VISITS, AUDITS, INSPECTIONS, AND COMMUNICATIONS. At the U.S. Government’s request, PARATEK and the U.S. Government together will have the right to conduct site visits, audits, and inspections at Service Provider’s facilities relating to PARATEK’s performance of this Agreement, including for the purpose of inventorying, with 24 hours’ advance notice or without notice with respect to timesensitive or critical circumstances. If PARATEK or the U.S. Government identifies any issues during the visit, Service Provider will prepare a report describing the issues and identifying potential solutions. Service Provider will provide the report to PARATEK for review within seven business days of being notified of any issues.

To the extent permitted by law, Service Provider will also provide PARATEK with notice within 24 hours of any arrival of U.S. Government personnel to conduct site visits or audits at Service Provider’s facility that could cover work performed under this Agreement. Service Provider will also provide PARATEK with a plan for addressing any areas of non‑conformance with regulatory requirements identified in such a site visit or audit, as well as a complete copy of any Form 483 provided to Service Provider by the U.S. Food and Drug Administration in connection with such a site visit or audit. Service Provider will permit [[Identifier]]. Government representatives identified by PARATEK to be present at the final debrief associated with such a site visit or audit.