Regulatory Strategy and Communication Management. The Parties will, through the JSC, establish a Regulatory Sub-Committee comprised of two members from each of Akcea and Isis with requisite experience in Regulatory strategy and communications. The Parties acknowledge that (i) Isis and Akcea will share responsibilities related to devising and implementing Regulatory strategy under this Agreement, and (ii) Regulatory responsibilities for the Products will transition upon mutual agreement after Akcea has demonstrated that it has sufficient capabilities and capacity for such responsibilities. The Regulatory Sub-committee will be responsible for determining by mutual agreement:
Regulatory Strategy and Communication Management. The Parties will, through the JSC, establish a committee comprised of two members from each of Akcea and Ionis with requisite experience in Regulatory strategy and communications (the “Regulatory Sub-Committee”). The Parties acknowledge that, subject to Section 3.5.6 and Section 3.5.8 (a) Ionis and Akcea will share responsibilities related to devising and implementing regulatory strategy under this Agreement, (b) Akcea will lead all regulatory activities related to Akcea Non-Commercial Activities (other than Pre-Approval Akcea Development Activities), (c) the Party that holds the IND (and the NDA following receipt of Approval for the Product in a country) (the “Regulatory Responsible Party”) for the applicable Product will lead all other regulatory activities for such Product (including with respect to Manufacturing), (d) Ionis will be responsible for filing the NDA, MAA, and other marketing authorization applications with Regulatory Authorities for inotersen until such time as the Parties may agree to transfer such responsibilities to Akcea, and (e) Akcea will be responsible for filing the NDA, MAA, and other marketing authorization applications with Regulatory Authorities for IONIS-TTR-LRx. The Regulatory Sub-Committee will be responsible for determining by mutual agreement:
