Diligence in Post-Marketing Matters Sample Clauses

Diligence in Post-Marketing Matters. Promptly after receiving MA Approval for a Licensed Product in a country, TILLOTTS must have made substantive progress in establishing networks and systems to ensure regulatory compliance and facilitate regulatory communications (including the timely reporting and investigation of any and all adverse events reported in connection with the administration of a Licensed Product to a patient), to handle inquiries and complaints about the Licensed Product and to support returns, recalls and withdrawals of the Licensed Product in that country. TILLOTTS must make all regulatory reports to, and communicate with, each Regulatory Authority regarding any reportable adverse event and must provide to CPP each and every adverse event report concurrently with providing each such report to any Regulatory Authority. Likewise, CPP must make all regulatory reports to, and communicate with, each Regulatory Authority regarding any reportable adverse events arising from CPP’s sale of the Licensed Formulation for the Primary Indication outside the Licensed Territory, and must provide to TILLOTTS each and every adverse event report concurrently with proving each such report to any Regulatory Authority. CPP shall create and maintain a global safety database, and TILLOTTS shall provide CPP all safety-related data in a timely manner that permits CPP to comply with applicable laws and regulations.