SFJ Responsibilities. SFJ will have primary responsibility for conducting the Phase 3 Trial in the Designated Asian Countries and sole responsibility for conducting the other Clinical Trials in the Designated Asian Countries (provided that SFJ may elect not to conduct Clinical Trials in Hong Kong). If SFJ elects to conduct any PK Study in Japanese Subjects in the US or Chinese Subjects in the US, PB shall, with SFJ’s assistance and cooperation, file an appropriate amendment to the US IND for the Product with the protocol for such PK Study, and SFJ may conduct such PK Study in the applicable Subjects in the US in accordance with such protocol. In connection with any Japanese or Chinese PK Study during the Development Term, (i) SFJ will have sole responsibility for interactions with Regulatory Authorities in Japan and China, with PB to have Participation Rights, and (ii) PB, as the sponsor of the US IND for the Product, will have primary formal responsibility for interactions with the FDA regarding any PK Study conducted in Japanese Subjects or Chinese Subjects (as applicable) in the US, with SFJ to have Participation Rights, but, as between PB and SFJ (but not vis-à-vis the FDA), SFJ shall, in consultation with PB, determine the strategy for such interactions, and, except to the extent contrary to Applicable Law or in violation of PB’s duties as the sponsor of such US IND, PB’s interactions with the FDA shall at all times be consistent with SFJ’s strategy. Thereafter, if the Phase 3 Trial meets the Phase 3 Trial Success Criteria and the necessary endpoints are met in the other Clinical Trials in the SFJ Territory, SFJ will use Commercially Reasonable Efforts to perform all activities associated with submitting BLAs and seeking Regulatory Approval for the Indication in Japan and China, and PB will use Commercially Reasonable Efforts to perform all activities associated with seeking Approval for the Indication in the Designated European Countries. Upon approval of a BLA for the Product for the Indication by NMPA in China or PMDA in Japan, SFJ, on behalf of itself and its Affiliates, shall, and hereby does, assign to PB all of SFJ’s and its Affiliates’ right, title and interest in and to all INDs, BLAs and Regulatory Approvals (including all amendments and supplements to any of the foregoing) and other filings with, and formal submissions to, NMPA or PMDA, respectively, and other applicable Regulatory Authorities in such country, in each case, with respect to the Product in such co...
SFJ Responsibilities. SFJ will have primary responsibility for conducting the HNC Clinical Trials globally. Subject to the terms hereof, SFJ will use Commercially Reasonable Efforts to conduct, or ensure that the applicable Approved CRO conducts, the HNC Clinical Trials in accordance with SFJ’s standard operating procedures (the “SFJ SOPs”) that will be provided to Nektar [***] following the selection of the Approved CRO for Nektar’s review and comment, as well as CRO SOPs, to the extent applicable, and SFJ will reasonably ACTIVE/105681617.22 consider incorporating such comments. Following the Effective Date, SFJ may amend any SFJ SOPs; provided that with respect to material amendments to SFJ SOPs that pertain to Clinical Trial Activities and/or other obligations that are, or will be, performed by SFJ or any Permitted Third Party utilized by SFJ during the remainder of the Term or any time thereafter as set forth in this Agreement, SFJ will provide the JOC with a copy of each such amendment to permit the JOC Representatives to review and comment on such amendments and SFJ will reasonably consider incorporating such comments.
