Approved Changes

Approved Changes. Any changes (including duration of dosing, additional studies, additional endpoints, additional analysis, etc.) to the TTR Registration-Directed Program Documents (including any Material Amendments) that are requested by GSK or required by a Regulatory Authority and mutually agreed by GSK and Isis.

Approved Changes. Any changes (including duration of dosing, additional studies, additional endpoints, additional analysis, additional drug supply, etc.) to the GSK-5 Development Plan (i) that are requested by a Party or required by a Regulatory Authority, (ii) that are required to be agreed upon by the Parties under this Amendment No. 4, and (iii) that are in fact agreed upon by GSK and Isis in accordance with this Amendment No. 4 or are decided through [***] final decision making authority under Section 5.c.... of this Amendment No. 4 and changes made to the GSK-5 Development Plan that do not result in a Material Amendment shall not be considered "Approved Changes" as that term is used in this Amendment No. View More