Common use of Facility Audits Clause in Contracts

Facility Audits. Each Party shall be permitted to conduct an inspection or audit of the other Party's facility or a facility of any Third Party contract manufacturer under contract [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. with such other Party for the manufacture and supply of the Bulk API or Finished Product, as applicable, in or for the Licensed Territory. The audited Party shall allow the auditing Party to make such inspection or audit of any such the audited Party facility, and shall exercise its rights under any agreement between the audited Party and any such Third Party contract manufacturer to enable the auditing Party to make such inspection or audit of such Third Party contract manufacturer's facility, in each case to the extent relevant to the Bulk API or Finished Product supplied in or for the Licensed Territory and during normal business hours. The audited Party shall reasonably cooperate with the auditing Party to facilitate such inspection or audit. Any such inspection or audit by the auditing Party pursuant to this Section 7.5 shall be conducted no more frequently than once every year at a given facility, and shall occur as promptly as possible following written notice by the auditing Party of its desire for such inspection or audit, but in no event later than three (3) months thereafter (unless such audit is triggered by a material safety issue, in which case the maximum notice period shall be one (1) week). Notwithstanding the foregoing, if any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the auditing Party may conduct an inspection or audit of such manufacturing facility more frequently than provided in the prior sentence to the extent necessary to confirm that the relevant matters in such notice or observation are adequately addressed. The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree. Costs associated with auditing shall be solely borne by the auditing Party.

Facility Audits. Each Party shall be permitted to conduct an inspection or audit of the other Party's facility or a facility of any Third Party contract manufacturer under contract [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. with such other Party for the manufacture and supply of the Bulk API or Finished Product, as applicable, in or for the Licensed Territory. The audited Party shall allow the auditing Party to make such inspection or audit of any such the audited Party facility, and shall exercise its rights under any agreement between the audited Party and any such Third Party contract manufacturer to enable the auditing Party to make such inspection or audit of such Third Party contract manufacturer's facility, in each case to the extent relevant to the Bulk API or Finished Product supplied in or for the Licensed Territory and during normal business hours. The audited Party shall reasonably cooperate with the auditing Party to facilitate such inspection or audit. Any such inspection or audit by the auditing Party pursuant to this Section 7.5 shall be conducted no more frequently than once every year at a given facility, and shall occur as promptly as possible following written notice by the auditing Party of its desire for such inspection or audit, but in no event later than three (3) months [*] thereafter (unless such audit is triggered by a material safety issue, in which case the maximum notice period shall be one (1) week[*]). Notwithstanding the foregoing, if any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the auditing Party may conduct an inspection or audit of such manufacturing facility more frequently than provided in the prior sentence to the extent necessary to confirm that the relevant matters in such notice or observation are adequately addressed. The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree. Costs associated with auditing shall be solely borne by the auditing Party.

Facility Audits. Each Party shall be permitted to conduct an inspection or audit of the other Party's ’s facility or a facility of any Third Party contract manufacturer under contract [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. with such other Party for the manufacture and supply of the Bulk API or Finished Product, as applicable, in or for the Licensed Territory. The audited Party shall allow the auditing Party to make such inspection or audit of any such the audited Party facility, and shall exercise its rights under any agreement between the audited Party and any such Third Party contract manufacturer to enable the auditing Party to make such inspection or audit of such Third Party contract manufacturer's ’s facility, in each case to the extent relevant to the Bulk API or Finished Product supplied in or for the Licensed Territory and during normal business hours. The audited Party shall reasonably cooperate with the auditing Party to facilitate such inspection or audit. Any such inspection or audit by the auditing Party pursuant to this Section 7.5 shall be conducted no more frequently than once every year at a given facility, and shall occur as promptly as possible following written notice by the auditing Party of its desire for such inspection or audit, but in no event later than three (3) months thereafter (unless such audit is triggered by a material safety issue, in which case the maximum notice period shall be one (1) week). Notwithstanding the foregoing, if any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the auditing Party may conduct an inspection or audit of such manufacturing facility more frequently than provided in the prior sentence to the extent necessary to confirm that the relevant matters in such notice or observation are adequately addressed. The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree. Costs associated with auditing shall be solely borne by the auditing Party.

Facility Audits. Each The JDC shall propose and submit to the JSC for approval a schedule for periodic audit and inspection of the facilities of any Third Party contract manufacturer on at least an annual basis subject to the terms of any applicable existing contract with a Third Party contract manufacturer. Pursuant to the schedule approved by the JSC, or upon request of the JDC, the Lead Manufacturing Party shall be permitted to conduct an inspection or audit of the other Party's facility or a facility of any Third Party contract manufacturer under contract [*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. with such other Party for the manufacture and supply of the Bulk API or Finished Product, as applicable, in or for the Licensed Territory. The audited Party shall allow the auditing Party to make such inspection or audit of any such the audited Party facility, and shall exercise its rights under any agreement between the audited Party and any such Third Party contract manufacturer to enable the auditing Party to make such inspection or audit facilities of such Third Party contract manufacturer's facility, in each case manufacturers. The Lead Manufacturing Party shall provide not less than [ * ] notice to the extent relevant to the Bulk API or Finished Product supplied in or for the Licensed Territory other Party of any planned inspection and during normal business hours. The audited such other Party shall reasonably cooperate be permitted to participate in any audit, provided that, if the consent of the Third [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the auditing Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Party contract manufacturer is required under the applicable contract to allow such other Party to facilitate participate in such inspection or audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any such inspection or audit requested by the auditing Party JDC (other than pursuant to this Section 7.5 the schedule approved by the JSC) shall be conducted no more frequently than once every year [ * ] at a given facility, and shall occur as promptly as possible following written notice by the auditing Party JDC of its desire for such inspection or audit, but in no event shall such inspection commence later than three (3) months [ * ] thereafter (unless such audit is triggered by a material safety or GMP non-conformance issue, in which case the audit may be conducted as frequently as necessary and the maximum notice period shall be one (1) week[ * ] if permitted under the applicable contract). Notwithstanding the foregoing, if any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the auditing Party may conduct an inspection or audit of such manufacturing facility more frequently than provided in the prior sentence to the extent necessary to confirm that the relevant matters in such notice or observation are adequately addressed. The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree. Costs associated with auditing shall be solely borne by the auditing PartyDevelopment Costs or Commercialization Costs as applicable.