Facility Audits. 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 conduct an inspection or audit of the facilities of such Third Party contract manufacturers. The Lead Manufacturing Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall 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 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 participate in such audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any inspection or audit requested by the JDC (other than pursuant to the schedule approved by the JSC) shall be conducted no more frequently than [ * ] at a given facility, and shall occur as promptly as possible following written notice by the JDC of its desire for such inspection or audit, but in no event shall such inspection commence later than [ * ] 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 [ * ] if permitted under the applicable contract). Costs associated with auditing shall be Development Costs or Commercialization Costs as applicable.
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Sources: Collaboration and License Agreement (Facet Biotech Corp)
Facility Audits. 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 Each Party shall be permitted to conduct an inspection or audit of the facilities other Party's facility or a facility of any Third Party contract manufacturer under contract 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 manufacturersmanufacturer'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 Lead Manufacturing audited Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall 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 reasonably cooperate with the 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 auditing Party to participate in facilitate such inspection or audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any such inspection or audit requested by the JDC (other than auditing Party pursuant to the schedule approved by the JSC) 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 JDC auditing Party of its desire for such inspection or audit, but in no event shall such inspection commence later than [ * [*] 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 [ * ] [*]). Notwithstanding the foregoing, if permitted under any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the applicable contract)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 Development Costs or Commercialization Costs as applicablesolely borne by the auditing Party.
Appears in 1 contract
Facility Audits. 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 Each Party shall be permitted to conduct an inspection or audit of the facilities other Party's facility or a facility of any Third Party contract manufacturer under contract 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 manufacturersmanufacturer'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 Lead Manufacturing audited Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall 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 reasonably cooperate with the 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 auditing Party to participate in facilitate such inspection or audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any such inspection or audit requested by the JDC (other than auditing Party pursuant to the schedule approved by the JSC) 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 JDC auditing Party 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). Notwithstanding the foregoing, if permitted under any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the applicable contract)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 Development Costs or Commercialization Costs as applicablesolely borne by the auditing Party.
Appears in 1 contract
Facility Audits. 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 Each Party shall be permitted to conduct an inspection or audit of the facilities other Party’s facility or a facility of any Third Party contract manufacturer under contract 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 manufacturersmanufacturer’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 Lead Manufacturing audited Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall 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 reasonably cooperate with the 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 auditing Party to participate in facilitate such inspection or audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any such inspection or audit requested by the JDC (other than auditing Party pursuant to the schedule approved by the JSC) 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 JDC auditing Party 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). Notwithstanding the foregoing, if permitted under any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the applicable contract)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 Development Costs or Commercialization Costs as applicablesolely borne by the auditing Party.
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