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