Common use of Development Phase Clause in Contracts

Development Phase. The conduct of the Development Phase shall be the primary responsibility of MMD. MMD may subcontract with Third Parties for portions of the Development Phase and for all or a portion of the manufacture of * . The Development Phase shall consist of the preparation and filing of regulatory submissions and the preclinical and clinical development of * until, with respect to each country in the MMD Territory, final marketing approval for * is obtained in such country. MMD and TKT will cooperate to achieve the milestones described in Appendix A using their respective best efforts using commercially reasonable means consistent with those used by them for other projects with a similar commercial potential. If MMD has been unable to achieve any of the milestones described in Appendix A within the time period indicated in Appendix A for reasons other than those described in subsection 5.1.4, then the Chief Executive Officer of each of TKT and MMD or their respective designees shall jointly determine on what terms the time period for achieving such milestones should be extended and what additional terms, if any, in this Agreement shall be modified as a result of such extension. If such a determination cannot be reached within ******************** after the time period for any such milestone has expired, then such determination shall be made by arbitration in accordance with the procedures for arbitration described in Section 13.6, unless the parties mutually agree to terminate this Agreement. MMD shall have primary responsibility for supervision of the scale-up and the further characterization of the master cell bank, the characterization of clinical trial material, and the supervision of the assembly of all characterization data and other information required for regulatory submissions. At MMD's request, TKT will perform, or assist MMD in performing, the work described in the preceding sentence and provide such other assistance to MMD as may be reasonably necessary to enable MMD to achieve the milestones described in Appendix A, and TKT shall be compensated for such assistance in accordance with Section 5.7. MMD will determine, in its sole discretion after consultation with TKT, the appropriate entity to file and hold the PLA and the ELA. MMD will coordinate preclinical and clinical testing of * and work with designated individuals at MMD and TKT in the CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. preparation of regulatory filings for * within the MMD Territory.

Development Phase. The conduct of the Development Phase shall be the primary responsibility of MMD. MMD may subcontract with Third Parties for portions of the Development Phase and for all or a portion of the manufacture of * GA-EPO. The Development Phase shall consist of the preparation and filing of regulatory submissions and the preclinical and clinical development of * GA-EPO until, with respect to each country in the MMD Territory, final marketing approval for * GA-EPO is obtained in such country. MMD and TKT will cooperate to achieve the milestones described in Appendix A using their respective best efforts using commercially reasonable means consistent with those used by them for other projects with a similar commercial potential. If MMD has been unable to achieve any of the milestones described in Appendix A within the time period indicated in Appendix A for reasons other than those described in subsection 5.1.4, then the Chief Executive Officer of each of TKT and MMD or their respective designees shall jointly determine on what terms the time period for achieving such milestones should be extended and what additional terms, if any, in this Agreement shall be modified as a result of such extension. If such a determination cannot be reached within ******************** after the time period for any such milestone has expired, then such determination shall be made by arbitration in accordance with the procedures for arbitration described in Section 13.6, unless the parties mutually agree to terminate this Agreement. MMD shall have primary responsibility for supervision of the scale-up and the further characterization of the master cell bank, the characterization of clinical trial material, and the supervision of the assembly of all characterization data and other information required for regulatory submissions. At MMD's request, TKT will perform, or assist MMD in performing, the work described in the preceding sentence and provide such other assistance to MMD as may be reasonably necessary to enable MMD to achieve the milestones described in Appendix A, and TKT shall be compensated for such assistance in accordance with Section 5.75.9. MMD will determine, in its sole discretion after consultation with TKT, the appropriate entity to file and hold the PLA and the ELA. MMD will coordinate preclinical and clinical testing of * GA-EPO and work with designated individuals at MMD and TKT in the CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. preparation of regulatory filings for * GA-EPO within the MMD Territory.