Existing regulatory filings Clause Samples

Existing regulatory filings. As soon as practicable after the Effective Date, IND #131184 will be transferred to Company, together with existing agreements, promises and conditions pertaining to such IND. In determining the timing for the transfer of IND #131184 to Company, the Parties will consider, in particular, the ongoing [***] described in Section 4.1c) and the single patient expanded access described in Section 4.1d) (including the respective existing rights of cross-reference), as well as the timing of the transfer of the global safety database relating to the Compound as set forth in Section 3.2d)). Until IND #131184 has been transferred to Company, Licensor will maintain such IND, and will continue to make any required updates, on behalf of Company and at Company’s cost and expense. Furthermore, Licensor will make available to Company copies of its interactions with Regulatory Authorities in other jurisdictions in the Territory outside of the U.S. (e.g., inactive clinical trial submission packages), to the extent relating to the Compound. Prior to the Effective Date, Licensor has provided to Company a copy of the most recent version of the Investigator Brochure for the Compound through the virtual data room hosted by Intralinks. Licensor shall provide to Company in writing any required updates and proposed interactions with Regulatory Authorities reasonably in advance for Company’s review and comment, and Licensor shall consider any such comments in good faith; in case of urgent interactions with Regulatory Authorities, Licensor will inform Company and will provide copies thereof as soon as practicable. The activities under this Section 3.2b) will be conducted in connection with the activities to be undertaken pursuant to Section 3.1, at Company’s cost as set forth in Section 3.1.