Manufacturing Site Audits. In addition to its rights under Section 3.6.1(g), each Party shall have the right to conduct an audit of the manufacturing sites where any Collaboration CMC Activities for the Phase 1 Activities and Phase 2 Activities are conducted by the other Party (the “Manufacturing Party”) or its Third Party Subcontractors, and subject to the terms of any agreement between the Manufacturing Party and the applicable Third Party Subcontractors. The Manufacturing Party shall facilitate the accommodation of such request with its Third Party Subcontractors. Following the completion of any such audit, the auditing Party may request the remediation of deficiencies that are not in compliance with GMP and identified during such audit. In the case of any critical observation relating to any Collaboration CMC Activities that the Manufacturing Party or its Third Party Subcontractor cannot or do not remediate in a timely [ * ] = 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 Act of 1934, as amended. manner, the auditing Party shall have the right to require the use of a different manufacturer for such Collaboration CMC Activities.
Manufacturing Site Audits. In addition to its rights under Section 4.4(g), each Party shall have the right at its own expense, upon reasonable written notice to such Party, and during normal business hours, to conduct an audit of the other Party’s (or its Third Party subcontractor’s, to the extent such other Party has the right to grant the other Party access to such sites, provided that, if a Party’s agreement with such subcontractor does not permit the other Party such access, the Party will use good faith efforts to facilitate a direct agreement between the applicable subcontractor and such other Party to permit such access) manufacturing sites where any Manufacturing activities with respect to the Product or Compound API are conducted hereunder by the other Party (the “Manufacturing Party”) (or its Third Party subcontractors). Audits of a Third Party subcontractor site will be conducted accompanied by the Manufacturing Party. Following the completion of any such audit, the auditing Party may request the remediation of deficiencies that are not in compliance with GMP and identified during such audit, and the Manufacturing Party shall use Commercially Reasonable Efforts to remediate such deficiencies.
Manufacturing Site Audits. In addition to its rights under Section 3.5.1(g), each Party shall have the right to conduct an audit of the manufacturing sites where any CMC Development activities are conducted by the other Party (the “Manufacturing Party”) or its Third Party Subcontractors, and subject to the terms of any agreement between the Manufacturing Party and the applicable Third Party Subcontractors. The Manufacturing Party shall facilitate the accommodation of such request with its Third Party Subcontractors. Following the completion of any such audit, the auditing Party may request the remediation of deficiencies that are not in compliance with GMP and identified during such audit. In the case of any critical observation relating to any CMC Development activities that the Manufacturing Party or its Third Party Subcontractor cannot or do not remediate in a timely manner, the auditing Party shall have the right to require the use of a different manufacturer for such CMC Development activities.
Manufacturing Site Audits. Promptly after the Effective Date (and in no event more than thirty (30) days after the Effective Date), Company shall have the right to request a prompt audit of all manufacturing sites where Products and Compound API are manufactured by or for TESARO. TESARO shall facilitate the accommodation of such request; provided, that TESARO personnel shall accompany any Company personnel conducting such audit. Following the completion of such audit, Company may request the remediation of deficiencies that are not in compliance with GMP and identified by Company during such audit. In the case of any Critical Observation that TESARO or its contract manufacturer cannot or will not remediate, Company will have the right to request the use of different manufacturers for the supply of Product or Compound API for the Company’s Clinical Trials.
Manufacturing Site Audits. SUPPLIER will permit Company to conduct quality assurance audits and inspections of SUPPLIER’s and its Affiliates’ records and facilities relating to Manufacture of Clinical Products, during normal business hours, in accordance with the terms of the Quality Agreement. Each Company representative participating in any such audit or inspection shall enter into a confidentiality agreement in a form reasonably acceptable to SUPPLIER and any applicable Affiliate.
Manufacturing Site Audits. (a) Until each of the Lonza Manufacturing Agreement and Patheon Manufacturing Agreement have been assigned to Xxxxxxx in accordance with Section 7.1.1 of this Agreement, argenx shall use Diligent Efforts to enable Xxxxxxx to conduct an audit of the sites where such activities are conducted (subject to the terms of such agreements) and argenx shall facilitate the accommodation of such request with Lonza or Patheon as the case may be. argenx may participate as an observer in any such audit upon reasonable request to Xxxxxxx. Following the completion of any such audit, Xxxxxxx will notify argenx of the results thereof. Xxxxxxx may request the remediation of deficiencies that are identified during such audit as not in compliance with GMP. In the case of any critical observation relating to the Licensed Compounds or Licensed Products that argenx, Lonza or Patheon, as the case may be, cannot or do not remediate in a timely manner, the Parties shall present the audit findings to the JMC and discuss whether to requisition an alternative Subcontractor for such activities.
