Safety and Regulatory Audits. In addition to the audit rights under Section 5.7, upon reasonable notification, TPTX shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. TPTX may conduct such audit no more than […***…] (unless an additional audit is warranted for cause) upon […***…] days’ prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, Zai shall notify TPTX of such inspection (a) no later than […***…] Business Days after Zai receives notice of such inspection or (b) within […***…] Business Day after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide TPTX with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. TPTX shall have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to the Products, Zai shall provide TPTX with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days of Zai receiving the same, and (ii) in the event that such findings, notice, or report […***…] of any material finding, notice, or report of a Governmental Authority related to such inspection (to the extent related to the Product) within […***…] days after receiving the same. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.
Safety and Regulatory Audits. Upon reasonable notification, and no more frequently than [*] (provided that the foregoing frequency limit shall not apply if Paratek has cause), Paratek will be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. Further details including notification, timing, response and scope of such audits will be included in the Safety Agreement.
Safety and Regulatory Audits. Upon reasonable notification, DiaMedica or its representatives shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Ahon, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) relating to the Licensed Products. Ahon shall promptly notify DiaMedica of any inspection of Ahon, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) by any Regulatory Authority relating to the Licensed Products and shall provide DiaMedica with all information pertinent thereto. DiaMedica shall have the right, but not the obligation, to be present at any such inspection. Ahon shall also permit the Regulatory Authorities outside the Territory to conduct inspections of Ahon, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) relating to the Licensed Product, and shall ensure that such Affiliates, sublicensees and subcontractors permit such inspections.
Safety and Regulatory Audits. (a) If a Regulatory Authority desires to conduct an inspection or audit of Licensee, its Affiliates, Sublicensees or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound or the Licensed Products, Licensee shall promptly notify Verastem thereof. Verastem shall have the right, but not the obligation, to be present at any such inspection. Licensee shall permit Regulatory Authorities to conduct inspections or audit of Licensee, its Affiliates, Sublicenses or Subcontractors (including Clinical Trial sites) relating to the Licensed Compound or the Licensed Products, and shall ensure that such Affiliates, Sublicensees and Subcontractors permit such inspections or audit. Licensee will provide Verastem with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [* * *] days following any such inspection or audit, and will provide Verastem with an unredacted copy of any report issued by such Regulatory Authority following such audit.
Safety and Regulatory Audits. Upon reasonable notification, Five Prime or its representatives shall be entitled to conduct an audit of safety and regulatory systems, procedures or practices of Zai, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) relating to Licensed Products. Zai shall promptly notify Five Prime of any inspection of Zai, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) by any Regulatory Authority relating to Licensed Products and shall provide Five Prime with all information pertinent thereto. Five Prime shall have the right, but not the obligation, to be present at any such inspection. Zai shall also permit Regulatory Authorities outside the Territory to conduct inspections of Zai, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) relating to Licensed Products, and shall ensure that such Affiliates, sublicensees and subcontractors permit such inspections. Zai will provide Five Prime with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [***] following any such audit, and will provide Five Prime with an unredacted copy of any report issued by such Regulatory Authority, including a English translation thereof, which translation shall be certified if requested by Five Prime[***]. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Safety and Regulatory Audits. If a Regulatory Authority desires to conduct an inspection or audit of Licensee, its Affiliates, Sublicensees or Subcontractors (including any Clinical Trial sites and any facility in which a Licensed Compound or Licensed Product is Manufactured (including any such CMO sites engaged by Licensee)) relating to the Licensed Compound or the Licensed Products in the Territory, then Licensee [***]. At [***] request, [***]. Each such [***] may be redacted of information that is unrelated to the Licensed Compound and Licensed Products.
Safety and Regulatory Audits. With respect to any inspection of a Party or its Affiliates, licensees or sublicensees (including Clinical Trial sites) by any Governmental Authority relating to any Product, each Party will notify the other Party of such inspection (a) no later than [***] Business Days after such Party receives notice of such inspection or (b) within [***] Business Day after the completion of any such inspection of which such Party did not receive prior notice. To the extent required by Applicable Law, each Party will permit Governmental Authorities outside of its respective territory to conduct inspections of such Party or its Affiliates, licensees or sublicensees (including Clinical Trial sites) relating to the Product, and will ensure that all such Affiliates, licensees or sublicensees permit such inspections. Following any such regulatory inspection related to the Product, such Party will provide the other Party with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Product) within [***] days of such Party receiving the same, and (ii) in the event that such findings, notice, or report is in a language other than English, a written English summary of any material finding, notice, or report of a [***] = Certain Confidential Information Omitted Governmental Authority related to such inspection (to the extent related to the Product) within [***] days after receiving the same.
Safety and Regulatory Audits. (i) During the period in which Edison conducts the Initial Clinical Trial, if a Regulatory Authority desires to conduct an inspection or audit of Apollomics, its Affiliates, sublicensees or subcontractors relating to the Licensed Drug Substance and/or the Licensed Products, Apollomics shall promptly, but at least [ ] in advance, provide Edison with all information pertinent thereto. Apollomics shall permit Regulatory Authorities to conduct inspections or audit of Apollomics, its Affiliates, sublicensees or subcontractors relating to the Licensed Drug Substance and/or the Licensed Products, and shall ensure that such Affiliates, sublicensees and subcontractors permit such inspections or audit. Apollomics will provide Edison with a written summary in English of any findings of a Regulatory Authority following a regulatory audit within [ ] following any such inspection or audit, and will provide Edison with an unredacted copy of any report issued by such Regulatory Authority following such audit.
Safety and Regulatory Audits. Upon reasonable advance (not less than [* * *] written notification), AssemblyBio or its representatives shall be entitled to conduct an audit of the safety and regulatory systems, procedures or practices of BeiGene and its Affiliates relating to the Licensed Products no more often than [* * *] period. Upon AssemblyBio’s reasonable request, BeiGene will conduct such audits of its sublicensees and subcontractors hereunder (subject to the terms and conditions of BeiGene’s agreements with such sublicensees and subcontractors) and provide AssemblyBio with the results of such audits.
Safety and Regulatory Audits
