Extended Delay. With respect to the most recently approved Critical Target Dates, if ▇▇▇▇▇▇▇ does not initiate Phase III trials within 12 months of the date specified in the Development Plan or file for Regulatory Approval of the Licensed Product in any Major Country within 18 months of the date specified for such filing in the Development Plan then this shall be considered a dispute and shall be resolved according to the process set forth in Section 3.5(c). In the event that ▇▇▇▇▇▇▇ is held to the Critical Target Dates, and does not agree to meet these dates, then DTI may terminate ▇▇▇▇▇▇▇'▇ rights under this Agreement with respect to Licensed Products in the Major Country in question, in which case such Major Country shall be deleted from the Territory. In such event, ▇▇▇▇▇▇▇ shall promptly transfer to DTI all INDs or their non-U.S. equivalent (as applicable) and other relevant regulatory filings as it may hold with respect to Licensed Products in such country, and any information as ▇▇▇▇▇▇▇ may possess which is useful to gain Regulatory Approval for and to commercialize the Licensed Products in such country. Such transfer shall be without cost to DTI, provided however, that DTI shall pay any governmental filing or transfer fees that may be required. ▇▇▇▇▇▇▇ shall also, to the extent it has the right to do so, sublicense to DTI any third party licenses to which ▇▇▇▇▇▇▇ has rights, to the extent that such rights are necessary or useful to make, use and sell the Licensed Products, and DTI shall thereafter assume the cost of maintaining such licenses. As used in this Section, initiation of Phase III trials shall mean enrollment of the first patient.
Appears in 3 contracts
Sources: Exclusive License Agreement (Aderis Pharmaceuticals Inc), Exclusive License Agreement (Aderis Pharmaceuticals Inc), Exclusive License Agreement (Aderis Pharmaceuticals Inc)