Unum has operational responsibility for preparing and filing all Regulatory Materials with respect to a Clinical Trial or other regulatory matter in the Shared Territory, and has primary operational responsibility for interactions with Regulatory Authorities in the Shared Territory, including taking the lead role at all meetings with Regulatory Authorities in the Shared Territory, subject to the right of SGI to participate in such activities and provide input (or consent, as may be required pursuant to the other terms of this Agreement). With respect to regulatory activities conducted in any country in support of Regulatory Approvals in the Shared Territory, the scope of this right of participation includes all regulatory activities, including development of regulatory strategy and advance review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Early Clinical Development Program or Late Clinical Development Program or registration package for a particular Development Candidate or Product, and review of outcomes of such meetings (including the rights set forth in [Section 7.1(c)(ii)]).
SGI has operational responsibility for preparing and filing all Regulatory Materials with respect to a Clinical Trial or other regulatory matter in the Licensed Territory, and has primary operational responsibility for interactions with Regulatory Authorities in the Licensed Territory, including taking the lead role at all meetings with Regulatory Authorities in the Licensed Territory, subject to the right of Unum to participate in such activities and provide input (or consent, as may be required pursuant to the other terms of this Agreement), excluding any Drug Master Files maintained by or on behalf of Unum, which will be and remain Unums sole responsibility. With respect to regulatory activities conducted in any country in support of Regulatory Approvals in the Licensed Territory, the scope of this right of participation includes all regulatory activities, including development of regulatory strategy and advance review of regulatory submissions, attendance at all meetings with Regulatory Authorities that may potentially impact the Early Clinical Development Program or Late Clinical Development Program or registration package for a particular Development Candidate or Product, and review of outcomes of such meetings (including the rights set forth in [Section 7.1(c)(ii)]).
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