Transfer of Data and Information. Within sixty (60) days of the Effective Date, MTPC shall provide to LICENSEE copies in English of all substantive or material information (in electronic format where available), relating to the following: (1) pre-clinical and clinical data and other Know-How compiled as of the Effective Date with respect to the Compounds, including any and all data which MTPC reasonably considers necessary for LICENSEE to file an IND with the FDA, and (2) all prior correspondence with the FDA or other regulatory equivalent for countries in the LICENSEE Territory other than the United States and in the MTPC Territory related to the Compound. Notwithstanding anything to the contrary contained herein, if FDA or equivalent regulatory agency outside the US makes a specific request for information, MTPC, as soon as practical but in no event later than fifteen (15) days after such request, must provide to LICENSEE such information, to the extent that it is or was in MTPC’s possession or control at any time, and to the extent such information has not already been transferred to LICENSEE.
Appears in 2 contracts
Sources: License Agreement (Minerva Neurosciences, Inc.), License Agreement (Minerva Neurosciences, Inc.)