Common use of Partner Audits Clause in Contracts

Partner Audits. Partner will provide Kiniksa with copies of all quality oversight or audit reports prepared in connection with any audit that Partner or its Affiliates or Sublicensees conduct of any Sublicensee, Subcontractor, or Clinical Trial site that Partner or its Affiliates or Sublicensees have engaged or are evaluating to potentially engage to fulfill Partner’s obligations under a Global Development Plan or a Territory Development Plan no later than [***] days after receiving or preparing any such report (as applicable), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of any such Third Party IP Agreement. If Kiniksa believes in good faith that it is required to submit any such quality oversight or audit report to any Regulatory Authority outside of the Territory in connection with obtaining, supporting, or ​ maintaining one or more Regulatory Approvals for the Licensed Product or for other communications with Regulatory Authorities for the Licensed Product outside of the Territory, then upon Kiniksa’s request, Partner will provide a copy of any such quality oversight or audit report to Kiniksa and Partner will reimburse Kiniksa for any translation expenses reasonably incurred by Kiniksa to obtain translation thereof by translators selected by Kiniksa.

Appears in 1 contract

Sources: Collaboration and License Agreement (Kiniksa Pharmaceuticals, Ltd.)

Partner Audits. Partner will provide Kiniksa with copies of all quality oversight or audit reports prepared in connection with any audit that Partner or its Affiliates or Sublicensees conduct of any Sublicensee, Subcontractor, or Clinical Trial site that Partner or its Affiliates or Sublicensees have engaged or are evaluating to potentially engage to fulfill Partner’s obligations under a Global Development Plan or a Territory Development Plan no later than [***] days after receiving or preparing any such report (as applicable), and Kiniksa may provide any such reports to any counterparty to any Third Party IP Agreement if required by the terms of any such Third Party IP Agreement. If Kiniksa believes in good faith that it is required to submit any such quality oversight or audit report to any Regulatory Authority outside of the Territory in connection with obtaining, supporting, or maintaining one or more Regulatory Approvals for the Licensed Product or for other communications with Regulatory Authorities for the Licensed Product outside of the Territory, then upon Kiniksa’s request, Partner will provide a copy of any such quality oversight or audit report to Kiniksa and Partner will reimburse Kiniksa for any translation ​ ​ expenses reasonably incurred by Kiniksa to obtain translation thereof by translators selected by Kiniksa.

Appears in 1 contract

Sources: Collaboration and License Agreement (Kiniksa Pharmaceuticals, Ltd.)