Common use of Updating the Strategic Plan Clause in Contracts

Updating the Strategic Plan. The Parties will review, evaluate progress, augment, and/or update the Strategic Plan with any changes as needed (but at least once every year), through the Joint Steering Committee, taking into consideration a number of relevant factors, including emerging data, and any changes in the regulatory, medical environment and the competitive landscape. Akcea has primary responsibility for preparing each proposed updated Strategic Plan. Akcea will submit such proposed updated plan to Isis at least fifteen days prior to the next JSC meeting. Any changes to the Strategic Plan altering a Product’s target patient population, key end points or approximate size of the key Clinical Studies, timelines for approval, budget or timing of Product approvals for each patient population (each, a “Material Change”) must be mutually agreed to by the Parties via the JSC.