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.

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.

Development Phase. The conduct In addition to any of its other obligation under this Agreement, during the development phase, the Lessee shall i. In accordance with the Project Schedule commence and complete the Project to the satisfaction of NRDA. ii. To strictly comply with the timelines and stages mentioned in the Development Milestone clause no (2.2) above and elsewhere in this Agreement iii. Entrust responsibility for Project management and construction to professionally competent Person having skill, technical experience or qualification required to fulfil the obligations under this Agreement. iv. Obtain all necessary Approvals from all the statutory authorities, and such other Approvals and Applicable Permits as may be needed during the construction/operation of the Project; v. The Lessee shall Prepare a layout and building plan, including the area statement, block drawings, schedule of construction as per the applicable Local Building Bye laws, Norms of Naya Raipur Development Phase shall be Plan 2031 and other Applicable Laws and submit to the primary responsibility Authority for its approval, whereby meeting all the requirements mentioned herein, apart from all other requirements of MMDthis Agreement; vi. MMD may subcontract Ensure to obtain approval as per clause 2.2 mentioned in this Agreement; vii. To ensure that the Project Site (Encroachment free plot provided by NRDA) remains free from all encroachments and take all necessary measures to remove encroachments, if any; viii. Comply with Third Parties for portions of Applicable Laws at all times and ensure that the Development Phase and for all Contractor 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 termsPerson, if any, engaged by it comply with the Applicable Laws and give priority to safety in its construction and planning activities as may be required by Applicable Laws or otherwise in order to protect life, health, property and environment; ix. Provide to the representative(s) of the NRDA, at any time access to the Project Land to review progress in construction and operation of Project and to ascertain compliance with any of the requirement of this Agreement shall Agreement; x. Promptly carry out at its cost such further works within the specified timelines as may be modified as a result necessary to remove any defects or deficiencies observed by the Steering Group and NRDA’s representative to ensure completion of such extension. If such a determination cannot be reached within ******************** after construction of the time period for any such milestone has expired, then such determination shall be made by arbitration Project in all respects in accordance with the procedures for arbitration described in Section 13.6, unless the parties mutually agree to terminate provisions of this Agreement;. xi. 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 Furnish operational and other information required as and when requested for regulatory submissionsby NRDA, within a reasonable time; xii. At MMD's requestMeet all the costs of operation, TKT will performmaintenance and repairs of the Project or any part thereof; as per the provisions of this Agreement; xiii. Maintain the Project in accordance with the Good Industry Practice with the objective of providing adequate service standards and ensuring that the Project to be transferred to the NRDA/buyers/members upon expiry of the Development Period are in good condition, or assist MMD in performingnormal wear and tear excepted; xiv. Pay taxes and duties as per Applicable Laws; xv. Disclosure of the relevant information to the perspective buyers of the housing stock created under this agreement; xvi. The Lessee shall ensure at all times that it has all the requisite Approvals, the work described in the preceding sentence and provide such other assistance to MMD Applicable Permits as may be reasonably necessary to enable MMD to achieve required for the milestones described in Appendix A, and TKT shall be compensated for such assistance in accordance with Section 5Project.