Common use of INDs and Drug Approval Applications Clause in Contracts

INDs and Drug Approval Applications. [ * ] shall be responsible for the preparation and filing of, and shall own all regulatory submissions relating to, [ * ] filed in any regulatory jurisdiction. [ * ] shall keep the relevant JDC and JCC informed regarding the schedule and process for the preparation of Drug Approval Applications for Co-Funded Products. [ * ] shall provide a draft copy of the initial Drug Approval Application for each Major Market (as defined in Section 9.3), and all supplemental Drug Approval Applications for each Major Market (e.g., for a new indication) for each Co-Funded Product to EXEL for review, to the extent practical, prior to their submission to the appropriate regulatory authority, provided, however, that [ * ] shall be required to promptly review such submission and in any event shall have [ * ] to comment on such documents, [ * ].