Common use of INDs Clause in Contracts

INDs. Subject to this Section 4.1.1, INFI shall own and be responsible for preparing, filing and maintaining all INDs for the IPI-145 Compound and IPI-145 Product in the Field in the Territory as of the Effective Date and Licensee shall reimburse INFI’s reasonable and documented Internal Personnel Expenses and Out-of-Pocket Expenses related thereto. Promptly after the Effective Date and in any event no later than the end of the Transition Period, INFI and Licensee, as applicable, shall make the necessary filings with the Regulatory Authorities in the Territory necessary to transfer the INDs for the IPI-145 Compound and IPI-145 Product to Licensee, and following the approval of such transfer by the applicable Regulatory Authorities (if applicable) or other effectuated transfer, Licensee shall own all such INDs and be the IND holder for the IPI-145 Compound and IPI-145 Product in the Territory. (a) Until such time as the INDs have been transferred to Licensee, INFI shall act as Licensee’s agent to maintain the INDs and communicate with Regulatory Authorities in the Territory relating to the IPI-145 Compound and IPI-145 Product and Licensee shall reimburse INFI’s reasonable and documented Internal Personnel Expenses and Out-of-Pocket Expenses related thereto. Except with respect to non-substantive administrative correspondence with Regulatory Authorities, (i) INFI shall act on Licensee’s behalf as instructed by Licensee with respect to submissions related to the INDs for the IPI-145 Compound and IPI-145 Product and receiving and submitting correspondence with Regulatory Authorities in the Territory related thereto and (ii) INFI will provide to Licensee copies of all correspondence received from Regulatory Authorities within [**] Business Days of receipt or such earlier date as required by applicable Law or the relevant Regulatory Authority or if necessary given the circumstances of the correspondence, and INFI shall not respond to such correspondences or otherwise interact with the Regulatory Authorities except as instructed by Licensee. (b) With respect to the INDs for the IPI-145 Compound and IPI-145 Product, Licensee will provide INFI with copies of all submissions in advance of filing so that INFI may submit such submissions on behalf of Licensee. INFI will provide to Licensee copies of any material written communications to or from Regulatory Authorities related to the IPI-145 Compound and the IPI-145 Product within [**] Business Days of receipt or delivery of such communication, as the case may be, or such earlier date as required by applicable Law or the relevant Regulatory Authority or if necessary given the circumstances of the correspondence. In addition, except for submissions which are required to meet the “Sponsor” obligations under 21 C.F.R. 312 and analogous regulations in non-U.S. jurisdictions, during such period INFI will be responsible for all communications and other dealings with Regulatory Authorities in the Territory with respect to the IPI-145 Compound and the IPI-145 Product, provided, however, that INFI will only communicate with the Regulatory Authorities as instructed by Licensee. To the extent permitted by applicable Law, INFI will arrange all meetings with Regulatory Authorities such that representatives of Licensee are able to attend and participate. Licensee shall reimburse INFI’s reasonable and documented Internal Personnel Expenses and Out-of-Pocket Expenses related to the activities set forth in this Section 4.1.1.