Common use of Regulatory Reports and Requests Clause in Contracts

Regulatory Reports and Requests. From the Effective Date until Regulatory Transfer occurs in a given country, Licensee will send to Licensor by secure email within 24 hours of its receipt, a copy of any correspondence from that country’s Regulatory Authority specifically involving the Product, with the exception that any information not specifically involving the Product may be redacted at Licensee’s discretion. To the extent reasonably possible, Licensee will provide Licensor with a copy of any documentation pertaining to the request and the response to a Regulatory Authority prior to submission of the response for comments. If time constraints make it impossible or unreasonable to provide Licensor with a copy of the response before submission, Licensee will use diligent efforts to notify Licensor of the circumstances and coordinate in good faith with regard to any areas for Licensor’s input. Licensee will not unreasonably reject suggestions by Licensor for changes in the proposed submission. Licensor will use diligent efforts to respond in a reasonable period of time. In addition, Licensee will provide to Licensor a copy of its responses to any Regulatory Authority’s request. After the Regulatory Transfer in any country, Licensee will keep records of all Regulatory Reports and Requests as mandated by Applicable Law, and will provide Licensor with a monthly report summarizing trend analysis and results but only until the date upon which Licensor’s labeled Products are no longer being offered for sale by Licensor or its agents or distributors anywhere in the world.