Obligations of Janssen. Janssen, either itself or through one of its Affiliates, shall use Diligent Efforts to obtain Regulatory Approval of the Product for the Initial Indication in the Territory and to maintain the validity of such Regulatory Approval throughout the Term, including the submission of any additional information requested by any Regulatory Authority in connection with such Regulatory Approval. Janssen shall have no obligation to file any application for Regulatory Approval for the Product in respect of any indication other than the Initial Indication. 6.1.2 Rights of Janssen. Janssen shall be the holder of any and all Regulatory Approvals for the Product in the Territory and shall retain sole authority over all regulatory matters relating to the Product in the Territory. 6.1.3 Communications with Regulatory Authorities. As between Janssen and Company, Janssen shall have the sole authority and responsibility for communicating with any Regulatory Authority regarding any Regulatory Approval of the Product in the Territory or any application or filing therefor, or regarding any other obligation to any Regulatory Authority in relation to the Product. Except as expressly set forth herein or as required by applicable Law or as approved in advance by Janssen in writing, Company shall not communicate directly with any Regulatory Authority regarding the Product or otherwise take any action concerning any application, registration, authorization or approval under which the Product is manufactured, imported, maintained, marketed, reimbursed or sold in the Territory. 6.2 Pharmacovigilance Procedures. The Parties shall comply, and Company shall cause the Sales Representatives and Other Company Employees to comply, with the provisions set forth on Schedule 6.2, which govern the reporting of adverse events/adverse drug reactions associated with the Product, Product quality complaints associated with adverse events and other information concerning the safety of the Product within the Territory. 6.3 Product Complaints. Janssen