Regulatory Filings. Graphite may request WuXi ATU to assist with authoring manufacturing and cGMP related sections of the regulatory filings. If such work is needed it will be included as a part of a Work Order. If the Services relate to any cGMP Manufacturing of Product, then prior to filing with the Regulatory Authority any clinical trial application, including any U.S. Investigational New Drug Application, amendments thereto, or EU Investigational Medicinal Product Dossier or Quality Module of the Common Technical Document (the “CTD”), Graphite will provide to WuXi ATU a copy of any documentation that is equivalent to these applications that relates to the application. This disclosure will permit WuXi ATU to review and verify, at Graphite’s reasonable cost, that the application accurately describes the Services that WuXi ATU has performed and the Manufacturing and testing processes that WuXi ATU will perform under a Work Order.

Regulatory Approvals. Graphite will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Graphite's use of any Product Developed and/or Manufactured under this Agreement, including investigational new drug application, biologics license application, new drug application, and abbreviated new drug application submissions in the United States and any analogous submissions filed with the appropriate authority of a country other than the United States. In accordance with the scope and terms of the applicable Work Order, WuXi ATU will provide Graphite or the Regulatory Authority either directly or through access to WuXi ATU’s applicable drug master file(s) (DMFs) with appropriate supporting chemistry, manufacturing, and control (CMC) data and information relating to the Development and/or Manufacture of Product by WuXi ATU to the extent required for such approvals