Common use of Conduct of Audits Clause in Contracts

Conduct of Audits. Upon [***] prior written notification by Xxxxxxxx but no more frequent than once per Calendar Year (except in the event that Xxxxxxxx has reasonable cause), and based on an audit scope agreed upon by the Parties, Xxxxxxxx or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractors to perform Zai’s obligations under any Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zai’s subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractor requires Zai’s assistance, Zai shall provide Xxxxxxxx or its representatives with such assistance at Zai’s cost, to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing Xxxxxxxx or its representatives to conduct such audit, to the extent reasonable. No later than [***] days after the completion of such audit, Xxxxxxxx shall provide Zai with a written summary of Xxxxxxxx’x findings of any deficiencies or other areas of remediation that Xxxxxxxx identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within thirty (30) days following Xxxxxxxx’x receipt of such report. Without limiting the foregoing, Zai shall have the right to be present at any such audit conducted by Xxxxxxxx pursuant to this Section 5.7 of any Sublicensees, subcontractors, subcontractors or Clinical Trial Sites.

Appears in 2 contracts

Samples: License Agreement (Zai Lab LTD), License Agreement (Cullinan Oncology, LLC)

AutoNDA by SimpleDocs

Conduct of Audits. Upon [***] prior written notification by Xxxxxxxx Karuna but no more frequent than once per Calendar Year [***] (except in the event that Xxxxxxxx Karuna has reasonable cause), and based on an audit scope agreed upon by the Parties, Xxxxxxxx Karuna or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, subcontractorsSublicensees or Subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates Affiliates, Sublicensees or Sublicensees, subcontractors Subcontractors to perform Zai’s obligations under any Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zai’s subcontractors Subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractor in each case, requires Zai’s assistance, Zai shall provide Xxxxxxxx Karuna or its representatives with such assistance at Zai’s cost[***], to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing Xxxxxxxx Karuna or its representatives to conduct such audit, to the extent reasonable. No later than [***] days after the completion of such audit, Xxxxxxxx Karuna shall provide Zai with a written summary of Xxxxxxxx’x Xxxxxx’s findings of any deficiencies or other areas of remediation that Xxxxxxxx Karuna identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within thirty (30) days [***] following Xxxxxxxx’x Xxxxxx’s receipt of such report. Without limiting the foregoing, Zai Xxx shall have the right to be present at any such audit conducted by Xxxxxxxx Karuna pursuant to this Section 5.7 4.8 of any Sublicensees, subcontractorsSubcontractors, subcontractors or Clinical Trial Sitessites.

Appears in 1 contract

Samples: License Agreement (Zai Lab LTD)

Conduct of Audits. Upon [***] prior written notification by Xxxxxxxx but no more frequent than once per Calendar Year (except in the event that Xxxxxxxx has reasonable cause), and based on an audit scope agreed upon by the Parties, Xxxxxxxx Deciphera or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractors to perform Zai’s obligations under any Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zai’s subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractor requires Zai’s assistance, Zai shall provide Xxxxxxxx Deciphera or its representatives with such assistance at Zai’s cost[***], to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing Xxxxxxxx Deciphera or its representatives to conduct such audit, to the extent reasonable. No later than [***] thirty (30) days after the completion of such audit, Xxxxxxxx Deciphera shall provide Zai with a written summary of Xxxxxxxx’x Deciphera’s findings of any deficiencies or other areas of remediation that Xxxxxxxx Deciphera identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within thirty (30) days following Xxxxxxxx’x Deciphera’s receipt of such report. Without limiting the foregoing, Zai shall have the right to be present at any such audit conducted by Xxxxxxxx Deciphera pursuant to this Section 5.7 of any Sublicensees, subcontractors, subcontractors or Clinical Trial Sitessites. For the avoidance of doubt, [***].

Appears in 1 contract

Samples: License Agreement (Deciphera Pharmaceuticals, Inc.)

AutoNDA by SimpleDocs

Conduct of Audits. Upon [***] prior written notification by Xxxxxxxx but no more frequent than once per Calendar Year (except in the event that Xxxxxxxx has reasonable cause), and based on an audit scope agreed upon by the Parties, Xxxxxxxx Deciphera or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractors to perform Zai’s obligations under any Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zai’s subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, subcontractor requires Zai’s assistance, Zai shall provide Xxxxxxxx Deciphera or its representatives with such assistance at Zai’s costassistance, to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing Xxxxxxxx Deciphera or its representatives to conduct such audit, to the extent reasonable. No later than [***] thirty (30) days after the completion of such audit, Xxxxxxxx Deciphera shall provide Zai with a written summary of Xxxxxxxx’x Deciphera’s findings of any deficiencies or other areas of remediation that Xxxxxxxx Deciphera identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within thirty (30) days following Xxxxxxxx’x Deciphera’s receipt of such report. Without limiting the foregoing, Zai shall have the right to be present at any such audit conducted by Xxxxxxxx Deciphera pursuant to this Section 5.7 of any Sublicensees, subcontractors, subcontractors or Clinical Trial Sitessites. For the avoidance of doubt, [***]. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appears in 1 contract

Samples: License Agreement (Zai Lab LTD)

Time is Money Join Law Insider Premium to draft better contracts faster.