Common use of Regulatory Authority Inspections Clause in Contracts

Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection or audit of any facility in which any Development or Manufacturing activities are being carried out under this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutus, then (a) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or audit, and (b) Arbutus shall (i) cooperate with such Regulatory Authority during such inspection or audit, (ii) immediately update Gritstone during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iii) promptly provide to Gritstone the inspection or audit observations of such Regulatory Authority relating to such activities or data; provided that Arbutus shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (iv) prepare the response to any such observations, (v) provide a copy of such planned response to Gritstone to the extent it relates to the Product, shall consult with Gritstone concerning the response of Arbutus to each such communication and, if such response affects the Product specifications or any Marketing Authorization Approval (or Gritstone’s obligations to comply with any legal requirements), such response shall be subject to Gritstone’s approval, and (vi) conform its activities under this Agreement to any commitments made in such a response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws, Arbutus shall permit Gritstone the opportunity to be present on-site during (but not directly participate in) any such inspection.

Regulatory Authority Inspections. (a) If a Regulatory Authority desires to conduct an inspection or audit of any facility in which any Development or Manufacturing activities are being carried out under this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutus, then (a) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or audit, and (b) Arbutus shall (i) cooperate with such Regulatory Authority during such inspection or audit, (ii) immediately update Gritstone the Company during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iii) promptly provide to Gritstone the Company the inspection or audit observations of such Regulatory Authority relating to such activities or datadata to the extent that it may reasonably be applicable to a Product; provided that Arbutus shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (iv) prepare the response to any such observations, (v) provide a copy of such planned response to Gritstone the Company to the extent it relates to the Product, shall consult with Gritstone the Company concerning the response of Arbutus to each such communication and, if such response affects the Product specifications or any Marketing Authorization Approval (or Gritstonethe Company’s obligations to comply with any legal requirements), such response shall be subject to Gritstonethe Company’s approval, and (vi) conform its activities under this Agreement to any commitments made in such a response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws, Arbutus shall permit Gritstone the Company the opportunity to be present on-site during (but not directly participate in) any such inspection.

Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection or audit of any facility in which any Development or Manufacturing activities are being carried out under this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutus, then (ai) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or audit, and (bii) Arbutus shall (iA) cooperate with such Regulatory Authority during such inspection or audit, (iiB) shall immediately update Gritstone the Alexion during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iiiC) shall promptly provide to Gritstone Alexion the inspection or audit observations of such Regulatory Authority relating to such activities or data; provided provided, that Arbutus shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (ivD) shall prepare the response to any such observations, (vE) shall provide a copy of such planned response to Gritstone Alexion to the extent it relates to the Product, shall consult with Gritstone Alexion concerning the response of Arbutus to each such communication and, if such response affects the Product product specifications or any Marketing Authorization Regulatory Approval (or GritstoneAlexion’s obligations to comply with any legal requirements), such response shall be subject to GritstoneAlexion’s approval, and (viF) shall conform its activities under this Agreement to any commitments made in such a response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws, Arbutus shall permit Gritstone the opportunity to be present on-site during (but not directly participate in) any such inspection.

Regulatory Authority Inspections. If a Regulatory Authority desires to conduct an inspection or audit of any facility in which any Development or Manufacturing activities are being carried out under this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutus, then (ai) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or audit, and (bii) Arbutus shall (iA) cooperate with such Regulatory Authority during such inspection or audit, (iiB) shall immediately update Gritstone the Alexion during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iiiC) shall promptly provide to Gritstone Alexion the inspection or audit observations of such Regulatory Authority relating to such activities or data; provided provided, that Arbutus shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (ivD) shall prepare the response to any such observations, (vE) shall provide a copy of such planned response to Gritstone Alexion to the extent it relates to the Product, shall consult with Gritstone Alexion concerning the response of Arbutus to each such communication and, if such response affects the Product product specifications or any Marketing Authorization Regulatory Approval (or GritstoneAlexion’s obligations to comply with any legal requirements), such response shall be subject to GritstoneAlexion’s approval, and (viF) shall conform its activities under this Agreement to any commitments made in such a response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws, Arbutus shall permit Gritstone the opportunity to be present on-site during (but not directly participate in) any such inspection.ARTICLEVI INTELLECTUAL PROPERTYARTICLE VI - INTELLECTUAL PROPERTY

Regulatory Authority Inspections. If a Fujifilm shall permit Regulatory Authority desires Authorities reasonable access to conduct an inspection or audit enter those areas of any facility in which any Development or Manufacturing activities are being carried out under Fujifilm’s premises concerned with the Program for the purpose of observing and inspecting the performance of the Program and ensuring compliance with this Agreement by or on behalf of Arbutus or any data generated in the conduct of activities under this Agreement by or on behalf of Arbutusand Applicable Laws, then (a) the Party receiving notice of such inspection or audit shall promptly notify the other Party of such inspection or auditas well as those books, records, agreements, and other documents of Fujifilm related to such Program where such entry is reasonably necessary or mandatory in order for Sponsor to maintain, approve, apply for or amend its regulatory application or approval in respect of the Product or such entry is reasonably necessary or mandatory for either Party to otherwise comply with Applicable Laws. With respect to any inspections that are related to a Program, Fujifilm will: (bp) Arbutus shall (i) cooperate with such Regulatory Authority during such inspection or audit, (ii) immediately update Gritstone during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Productsunannounced inspections, (iii) promptly provide to Gritstone the inspection or audit observations notify Sponsor within [***] of such inspection, and in the case of announced inspections, notify Sponsor within [***] of receipt of such notice from a Regulatory Authority relating Authority; (q) if not prohibited by such Regulatory Authority, permit Sponsor’s representatives to be present on site and participate, as appropriate, in such activities or datainspections and any wrap-up sessions; provided that Arbutus shall have the right and (r) both (x) (in addition to redact any material from such inspection or audit observations that do not relate to the Products, (iv) prepare the response to any such observations, (v) provide providing Sponsor with a copy of such planned documents under Section 3(g)), provide Sponsor a copy of any draft responses or other any correspondence or formal communications from Fujifilm to such Regulatory Authority for review and comment at least [***] in advance of sending in such response to Gritstone to the extent it relates to the Product, shall consult with Gritstone concerning the response of Arbutus to each such communication and, if such response affects the Product specifications or any Marketing Authorization Approval (or Gritstone’s obligations to comply with any legal requirements), such response shall be subject to Gritstone’s approvalapplicable Regulatory Authority, and (viy) conform its activities under this Agreement take, in good faith, Sponsor’s comments into account prior to any commitments made sending in such a response. To the extent reasonably practicable any such inspection is being conducted by a Regulatory Authority (a) as a pre-condition to granting regulatory approval for a Product or (b) arising from a Regulatory Authority’s concerns with a Product and not otherwise prohibited by Applicable Lawsdue to any actions or omissions of Fujifilm Group or Subcontractors, Arbutus Sponsor shall permit Gritstone the opportunity to be present on-site during (but not directly participate in) any pay Fujifilm for such inspection/audit at a mutually agreed upon rate.