Common use of Submissions to Regulatory Authorities Clause in Contracts

Submissions to Regulatory Authorities. The Parties will mutually agree on the content of all important written submissions to Regulatory Authorities for the Products, including, but not limited to, INDs, Investigator Brochures, CTDs and NDAs. The Regulatory Sub-committee will mutually develop and agree to a detailed plan for coordination and preparation of Regulatory filings for market approval for the Products (including establishing responsibilities for provision of all sections of the electronic common technical document (“eCTD”) modules, and plan activity timelines) to accelerate eCTD completion and facilitate rapid completion of Regulatory filings for market approval. Once the Parties mutually agree upon such a plan, each Party will use Commercially Reasonable Efforts to execute its respective tasks and responsibilities under such plan in the time frames set forth in such plan. Akcea will bear all costs related to preparing and filing all regulatory submissions, including reimbursing Isis for any costs, including FTE costs, associated with any activities that Isis performs in support of the preparation of Regulatory Documentation in accordance with the scope of work and budget for such activities approved by the JSC.