Adverse Experiences. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. ​ shall provide a copy of any and all such reports and other required safety information to [[Organization A:Organization]] within […​…] after regulatory submission.

Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility for interacting (either itself or with the support of Third Party subcontractors) with Regulatory Authorities in each country, responding to inquiries of such Regulatory Authorities with regard to the Regulatory Documentation for the Lead Compound and filing all updates to Regulatory Documentation, such as periodic or ad-hoc safety update reports, supplements and amendments, as well as routine maintenance of the submissions of the Regulatory Documentation that must be provided with respect to the ​ products, if any, at periodic intervals to such Regulatory Authorities.