For Licensed Vir Programs. Brii Bio shall be responsible for the Development and Commercialization of Licensed Products of each Licensed Vir Program in the Field in the China Territory in accordance with the China Development Plan, and for performing the Development activities assigned to Brii Bio under the Vir Global Plan to support the global Development and registration of Licensed Products for such Licensed Vir Program. Brii Bio shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for at least one (1) Licensed Product for each Licensed Vir Program. Brii Bio shall use Commercially Reasonable Efforts to conduct the tasks assigned to it in the China Development Plan and each Party shall use Commercially Reasonable Efforts to conduct the tasks assigned to it in the Vir Global Plan and achieve the objectives set forth therein. Each Party shall conduct such tasks in a timely, professional manner and in compliance with the China Development Plan and Vir Global Plan, as applicable, and all Applicable Laws, including GLP, GCP, and cGMP.
For Licensed Vir Programs. Up to once per Calendar Year (except in the case of any “for cause” audit, which may be conducted more frequently upon Vir’s reasonable request) and upon reasonable prior notice by Vir and at Vir’s cost and expense, Brii Bio shall permit Vir or its representatives to conduct an audit of any Clinical Trial sites engaged by Brii Bio or its Affiliates or sublicensees to conduct Brii Bio’s obligations under [***]. No later than [***] following the completion of any such audit, Vir shall provide Brii Bio with a written summary of Vir’s findings, including any deficiencies or other areas of remediation that Vir identifies during such audit. Brii Bio shall use Commercially Reasonable Efforts to remediate any such deficiencies within [***] following Brii Bio’s receipt of such report, at Brii Bio’s cost and expense. In addition, Brii Bio shall provide Vir with copies of all quality oversight or audit reports, including English translations thereof, prepared in connection with any audit that Brii Bio, its Affiliates, or sublicensees conduct of a Clinical Trial site that Brii Bio, its Affiliates, or sublicensees have engaged or are evaluating to potentially engage to fulfill Brii Bio’s obligations under a Vir Global Plan or a China Development Plan no later than [***] after receiving or preparing, as applicable, any such report.
For Licensed Vir Programs. Unless Brii Bio elects to initiate a Manufacturing Technology Transfer pursuant to Section 8.3, the Parties shall [***] for a Vir Program on the principal terms of a commercial supply agreement (the “Vir Commercial Supply Agreement”) and a quality agreement (“Vir Commercial Quality Agreement”) pursuant to which Brii Bio may purchase commercial supply of a Licensed Product for such Licensed Vir Program from Vir at [***] to fulfill Brii Bio’s obligations under this Agreement, which terms shall be [***]. At Brii Bio’s request, the Parties shall negotiate such Vir Commercial Supply Agreement and Vir Commercial Quality Agreement in accordance with such agreed-upon terms and conditions.
