Future Data Clause Samples

Future Data. Each Party shall, in a timely manner and compliant with requirements of the FDA, the EMEA, and any other applicable Regulatory Authority, provide the other Party with copies of all preclinical, non-clinical, analytical, manufacturing, and clinical data relating to the Product, generated by or on behalf of such Party in connection with the performance of the U.S. Development Plan and relevant to any regulatory submission; provided, that information regarding adverse events and serious adverse events shall be provided promptly as set forth in Section 4.8. If the receiving Party requests that copies of such data be provided in compliance with requirements of other Regulatory Authorities, the disclosing Party shall reasonably consider such request. Affymax shall have the full right, without any additional consideration, to use any and all such data and reports in connection with the Development of the Product in the Licensed Territory and/or in connection with the Commercialization of the Product in the U.S., and, Takeda shall have the full right, without any additional consideration, to use any and all such data and reports in connection with the Development and/or the Commercialization of the Product in the Licensed Territory, including the incorporation of such data or reports in any regulatory submissions including MAA and/or NDA submissions.