Common use of Regulatory Inspection or Audit Clause in Contracts

Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of a Party with regard to a Licensed Product in the Field, each Party agrees to cooperate with the other and the Regulatory Authority during such inspection or audit, including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit to the extent it relates to the Development, Manufacture or Commercialization of a Licensed Product for use in the Field under this Agreement. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will promptly provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; provided that the other Party, to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact the Licensed Products in the Field in the Territory, and the Party that received the observations shall consider in good faith the comments made by such other Party. In the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content of the response. Without limiting the foregoing, each Party (and its Third Party subcontractors) shall notify the other Party within forty-eight (48) hours of receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field under this Agreement; provided that such notification shall be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or inspection.

Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of a Party Lilly or Amylin with regard to a Licensed Product in the Fieldor this Agreement, Lilly and Amylin each Party agrees to cooperate with the other Regulatory Authority and the Regulatory Authority other Party during such inspection or audit, including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit to the extent it relates to the Development, Manufacture or Commercialization of a Licensed Product for use in the Field under this Agreementaudit. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will promptly immediately provide to the other Party), the Party Regulatory Lead in receipt of the observations applicable Regulatory Jurisdiction will prepare the response to any appropriate responses; provided observation that concerned this Agreement. The other Party agrees to fully cooperate with the Regulatory Lead when it prepares such a response, including by providing to the Regulatory Lead, within seventy-two (72) hours after its request, such information and documentation in the Party's possession as may be necessary for the Regulatory Lead to prepare such response. Before submitting the response to the Regulatory Authority, the Regulatory Lead agrees to give the other Party, Party an opportunity to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact the Licensed Products in the Field in the Territory, and the Party that received the observations shall consider in good faith the comments made by such other Partyit. In the event the Parties disagree concerning the form or content of a response, the Party that received the observations Regulatory Lead will decide the appropriate form and content of it. Each Party agrees to conform its respective activities under this Agreement to any commitments made in such a response, except to the responseextent a Party believes in good faith that such commitments violate Applicable Laws. Without limiting the foregoing, each Each Party (and its Third Party Person subcontractors) shall notify the other Party within fortytwenty-eight four (4824) hours of receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities used or proposed to be being used for the Manufacture of Licensed Products for use in Products. Each Party (and its Third Person subcontractors) shall also provide the Field under this Agreement; provided that other Party with copies of any written communications received from Regulatory Authorities with respect to such notification shall be given no later than twentyfacilities within thirty-four six (2436) hours prior of receipt. Such Party shall provide the other Party with an opportunity to review and provide input on any proposed response by such Regulatory Authority audit Party (or inspectionThird Person subcontractor) to such communications.

Regulatory Inspection or Audit. If a Regulatory Authority in the Territory desires to conduct an inspection or audit of a Party with regard to a Licensed Collaboration Product in of a Party’s facility or a facility under contract with a Party, or with regard to a Royalty Product of the FieldOpt-Out Party’s facility or a facility under contact with the Opt-Out Party when the Opt-Out Party continues to supply the Royalty Product to the Non-Opt-Out Party pursuant to Section 7.5(b)( vi), each such Party agrees to shall promptly notify the other Party. In such case, the audited Party shall permit and cooperate with such inspection or audit, and shall cause the other contract facility to permit and the cooperate with such Regulatory Authority during such inspection or audit, including by allowing, . The other Party shall have the right to the extent practicable, have a representative of the other Party to be present during the applicable portions of observe such inspection or audit to and shall, if requested by the extent it relates to audited Party, assist the Developmentaudited Party in preparing for, Manufacture facilitating or Commercialization of a Licensed Product for use in the Field under this Agreementenabling such inspection or audit. Following receipt of the inspection or audit observations of the such Regulatory Authority (a copy of which the receiving audited Party will promptly shall immediately provide to the other Party), the audited Party shall prepare a draft response to any such observations, in receipt of the observations will prepare any appropriate responses; provided that consultation with the other Party, to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact the Licensed Products in the Field in the Territory, and the Party that received holds the observations Regulatory Materials in the applicable country or territory shall consider in good faith prepare and file the comments made by final response with such other Regulatory Authority. If the Regulatory Authority is conducting an inspection or audit with regard to a Party. In ’s contract facility, such Party shall (subject to the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content terms of the response. Without limiting the foregoing, each Party (and its applicable contract with a Third Party subcontractorsmanufacturer) shall notify cause its contract facility to prepare, submit to both Parties for input, and file the other Party within forty-eight (48) hours of receipt of a notification from a Regulatory Authority of the intention of final response incorporating such input with such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field under this Agreement; provided that Authority, and copy both Parties on such notification shall be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or inspectionsubmission.

Regulatory Inspection or Audit. If a Regulatory Authority in the Territory desires to conduct an inspection or audit of a Party with regard to a Licensed Collaboration Product in of a Party’s facility or a facility under contract with a Party, or with regard to a Royalty Product of the FieldOpt-Out Party’s facility or a facility under contact with the Opt-Out Party when the Opt-Out Party continues to supply the Royalty Product to the Non-Opt-Out Party pursuant to Section 7.5(b)( vi), each such Party agrees to shall promptly notify the other Party. In such case, the audited Party shall permit and cooperate with such inspection or audit, and shall cause the other contract facility to permit and the cooperate with such Regulatory Authority during such inspection or audit, including by allowing, . The other Party shall have the right to the extent practicable, have a representative of the other Party to be present during the applicable portions of observe such inspection or audit to and shall, if requested by the extent it relates to audited Party, assist the Developmentaudited Party in preparing for, Manufacture facilitating or Commercialization of a Licensed Product for use in the Field under this Agreementenabling such inspection or audit. Following receipt of the inspection or audit observations of the such Regulatory Authority (a copy of which the receiving audited Party will promptly shall immediately provide to the other Party), the audited Party shall prepare a draft response to any such observations, in receipt of the observations will prepare any appropriate responses; provided that consultation with the other Party, to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact the Licensed Products in the Field in the Territory, and the Party that received holds the observations Regulatory Materials in the applicable country or territory shall consider in good faith prepare and file the comments made by final response with such other Regulatory Authority. If the Regulatory Authority is conducting an inspection or audit with regard to a Party. In ’s contract facility, such Party shall (subject to the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content terms of the response. Without limiting the foregoing, each Party (and its applicable contract with a Third Party subcontractorsmanufacturer) shall notify cause its contract facility to prepare, submit to both Parties for input, and file the other Party within forty-eight (48) hours of receipt of a notification from a final response incorporating such input with such Regulatory Authority Authority, and copy both Parties on such submission. [ * ] = 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 intention Securities Exchange Act of such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field under this Agreement; provided that such notification shall be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or inspection1934, as amended.

Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of a Party with regard to a Licensed any Product intended for use in the FieldKiniksa Field in the Territory (excluding a general facilities inspection or audit), then each Party agrees to reasonably cooperate with the other Party and the such Regulatory Authority during such inspection or audit, including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit to the extent it relates to the Development, Manufacture Commercialization, or Commercialization Manufacturing of a Licensed any Product for use in the Field under this AgreementTerritory. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will promptly provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; provided that the other Party, to the extent practicable, shall will have the right to review and comment on such responses to the extent they cover relate to, or may be reasonably expected to adversely impact the Licensed Products impact, any Product in the Kiniksa Field in the Territory, and the Party that received in receipt of the observations shall will consider in good faith the comments made by the other Party within [***] days of receipt by such other Party, or such shorter period as may be required to satisfy requirements under Applicable Law. In the event the Parties disagree concerning the form or content of a response, then the Party that received the observations will decide the appropriate form and content of the response. Without limiting the foregoing, each Party (and its Third Party subcontractors) shall must, to the extent reasonably possible, notify the other Party within forty-eight (48) hours of no later than [***] after receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field any Product under this Agreement; provided that that, to the extent reasonably possible, such notification shall must be given to the other Party no later than twenty-four (24) hours [***] prior to any such Regulatory Authority audit or inspection. In the event that the Party that is subject to such audit or inspection by a Regulatory Authority is not provided with advance notice thereof, then such Party will inform the other Party of the occurrence thereof within [***]. The Fully-Burdened Cost incurred by or on behalf of Regeneron in good faith in the course of any audit or inspection by a Regulatory Authority shall be considered Other Shared Expenses.

Regulatory Inspection or Audit. (a) If a Regulatory Authority desires to conduct an inspection or audit of a Party TBIL (or any of its Subcontractors, including any contract manufacturer) with regard to a Licensed Product in a country in the FieldTerritory in regard to any activities conducted by or on behalf of TBIL under this Agreement, each including the Development Plan, and/or the Commercialization Plan and/or Transfer Plan, to the extent permitted by TBIL’s Third Party agrees agreements relating to cooperate with the other such activities (unless such restrictions relate to confidentiality terms which can be satisfied by agreement to customary terms of confidentiality running in favor of such Third Party by Takeda), TBIL shall inform Takeda of such proposed inspection or audit in writing promptly, and the Regulatory Authority during not later than [***] Business Days prior to such inspection or audit, including by allowing, to the extent practicable, and shall allow, to the extent permitted under Applicable Law, a representative of the other Party Takeda to be present during the applicable portions of such inspection or audit to the extent it relates related to the Development, Manufacture Development or Commercialization of a Licensed Product for use in the Field under this AgreementAgreement (including related Manufacturing activities). Following receipt of the inspection or audit observations of the such Regulatory Authority with respect thereto (a copy of which the receiving Party TBIL will promptly provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; provided that the other PartyTakeda, to the extent practicablepermitted by TBIL’s Third Party agreements relating to such activities (unless such restrictions relate to confidentiality terms, shall have the right in which case, TBIL will use reasonable efforts to review obtain such Third Party’s consent to disclose such inspection or audit observations to Takeda)), TBIL will also prepare any appropriate responses after reasonably considering and comment on such responses incorporating (to the extent they cover or may be reasonably expected to adversely impact the Licensed Products not in the Field in the Territory, and the Party that received the observations shall consider in good faith the violation with Applicable Laws) Takeda’s reasonable comments made by such other Party. In the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content of the response. Without limiting the foregoing, each Party thereto. (and its Third Party subcontractorsb) shall notify the other Party within forty-eight (48) hours of receipt of a notification from If a Regulatory Authority conducts an inspection or audit of Takeda or any of its Affiliates or Subcontractors, which are contract manufacturers, regarding any activities related to the intention Product conducted by or on behalf of such Regulatory Authority to audit Takeda or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field its Affiliates under this Agreement; provided that , including the Development Plan and/or the Commercialization Plan, then Takeda will provide TBIL, to the extent permitted by Takeda’s Third Party agreements relating to such notification shall be given activities (unless such restrictions relate to confidentiality terms, in which case, Takeda will use reasonable efforts to obtain such Third Party’s consent to disclose such verbal or written summary to TBIL)], as soon as reasonably practicable, but in no event later than twenty-four [***] Business Days, with a verbal and written summary of (24i) hours prior the inspection or audit observations of the Regulatory Authority and (ii) Takeda’s response to any such Regulatory Authority. Upon termination of this Agreement pursuant to Section 15.2 by mutual written agreement, by TBIL pursuant to Section 15.3, Section 15.4, or Section 15.7 for Takeda’s material breach, bankruptcy or Shelving Breach, respectively, or by Takeda pursuant to Section 15.5 or Section 15.6, for convenience or Safety Reasons, respectively, then Takeda will provide TBIL to the extent permitted by Takeda’s Third Party agreements relating to such activities (unless such restrictions relate to confidentiality terms, in which case, Takeda will use reasonable efforts to obtain such Third Party’s consent to disclose such inspection or audit observations to TBIL), as soon as reasonably practicable, but in any event within [***] Business Days, with a copy of (i) the inspection or audit observations of the Regulatory Authority audit or inspectionwith respect thereto and (ii) any written response to such Regulatory Authority.

Regulatory Inspection or Audit. If a Each Party shall cooperate with the other Party and any Regulatory Authority desires to conduct in the Territory during an inspection or audit to the extent relating to (a) any of a Party with regard to a Licensed Product the Existing Trials or (b) any other clinical Development under the LCA in respect of the FieldPraluent Compound or the Praluent Products, in each Party agrees to cooperate with the other and the Regulatory Authority during such inspection or audit, case including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit to the extent it relates to the Development, Manufacture or Commercialization of a Licensed Product for use in the Field under this Agreementaudit. Following receipt of the inspection or audit observations of the such Regulatory Authority (a copy of which the receiving Party will promptly immediately provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; responses that concern the Praluent Products, provided that the other Party, to the extent practicable, Party shall have the right to review and comment on such responses responses, except to the extent they cover or may be reasonably expected such responses contain information for which the Party in receipt of the observation owes an obligation of confidentiality to adversely impact the Licensed Products in the Field in the Territorya Third Party, and the such Party that received the observations shall consider in good faith the comments made by such other Party. In the event that the Parties disagree concerning the form or content of a response, the Party that received the observations will shall decide the appropriate form and content of the response. Regulatory inspections and audits pertaining to either Party’s Manufacturing facilities shall be governed by the Praluent Substance Supply Agreement or the Finished Product Supply Agreement, as applicable. Without limiting the foregoing, each Party (and its Third Party subcontractors) shall shall, for so long as Manufacture under an applicable Praluent Supply Agreement is ongoing, notify the other Party within fortytwenty-eight four (4824) hours of after receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used or proposed to be used for the Manufacture of Licensed Products Praluent Product by or on behalf of such Party for use in the Field such other Party under this such Praluent Supply Agreement; provided that such notification shall be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or inspection.