Clinical Quality Agreement. Within [*****] days after the Effective Date of this Agreement, but in any event before any supply of Merck Compound hereunder, the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study (the “Clinical Quality Agreement”). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control. The Clinical Quality Agreement shall, among other things: (a) detail classification of any Compound found to have a Non-Conformance; (b) include criteria for Manufacturer’s Release and related certificates and documentation; (c) include criteria and timeframes for acceptance of Merck Compound; (d) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (e) include provisions governing the recall of Compounds.
Clinical Quality Agreement. Within [*] days from the Effective Date of this Agreement, the Parties shall enter into a quality agreement that shall address and govern issues related to the quality of clinical Compounds to be supplied by the Parties for use in the Study (“Clinical Quality Agreement”). The Clinical Quality Agreement shall, among other things: (i) detail classification of any Compound found to have a Non-Conformance; (ii) include criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of Merck Compound; (iv) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (v) include provisions governing the recall of Compounds.
Clinical Quality Agreement. Within [***] after the Effective Date of this Agreement, but in any event before any supply of ArriVent Compound and InnoCare Compound hereunder, the Parties (or their respective Affiliates or CMOs) shall enter into a quality agreement that shall address and govern issues related to the quality of the ArriVent Compound and InnoCare Compound for use in the Clinical Study (the “Clinical Quality Agreement”). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control, except for issues related to quality control and procedures. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Clinical Quality Agreement. [***], the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study (the “Clinical Quality Agreement”). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, [***]. The Clinical Quality Agreement shall, among other things: (a) detail classification of any Compound found to have a Non-Conformance; (b) include criteria for Manufacturer’s Release and related certificates and documentation; (c) include criteria and timeframes for acceptance of Merck Compound; (d) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (e) include provisions governing the recall of Compounds.
Clinical Quality Agreement. Promptly following the Effective Date, the JDC shall form a Quality Working Group and the Parties shall negotiate in good faith and use all reasonable efforts to enter into a clinical quality agreement that documents the standards, expectations, and responsibilities of the Parties with respect to managing clinical quality (including quality assurance (QA), quality control (QC), and quality risk management (QRM)) for the Parties’ Development activities with respect to the Products under this Agreement. Such clinical quality agreement shall contain mutually agreed terms and conditions, including with respect to: (i) compliance with applicable Law; and (ii) the communication between the Parties with respect to the management of clinical trial quality and compliance. Among other things, such agreement shall require each Party to maintain complete, current and accurate records of all work conducted by the Parties under this Agreement with respect to the Products and shall grant the other Party the right to review any such records at reasonable times and upon reasonable prior written notice.
Clinical Quality Agreement. Within forty five (45) days from the Effective Date of this Agreement, but in any event before any supply under this Agreement of the Merck Compound, the Parties (or their respective Affiliates) shall enter into a quality agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study (the “Clinical Quality Agreement”). In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control. The Clinical Quality Agreement shall, among other things:
Clinical Quality Agreement. Within *** days from the Effective Date of this Agreement, the Parties shall, either themselves or through an Affiliate, enter into a quality agreement that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study (“Clinical Quality Agreement”). Merck shall have no obligation to supply Merck Compound under this Agreement until the Clinical Quality Agreement has been executed by the Parties. In the event of any inconsistency between the terms of this Agreement and the Clinical Quality Agreement, the terms of this Agreement shall control, save in relation to matters solely relating to quality where Clinical Quality Agreement shall override and supersede. The Clinical Quality Agreement shall, among other things: (i) detail classification of any Compound found to have a Non-Conformance; (ii) include criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of Merck Compound; (iv) include procedures for the resolution of disputes regarding any Compounds found to have a Non-Conformance; and (v) include provisions governing the recall of Compounds.
Clinical Quality Agreement. The Parties will execute the Clinical Quality Agreement prior to any supply of MSD Cxxxxxxx hereunder, and no later than forty-five (45) days after the Effective Date. The Clinical Quality Agreement shall, among other things: (i) detail classification of any Non-Conforming MSD Compound; (ii) include criteria for Manufacturer’s Release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of MSD Compound; (iv) include procedures for the resolution of disputes regarding any Non-Conforming MSD Compound; (v) detail procedures and rights with respect to audit and inspection rights for Manufacturing sites; and (vi) include provisions governing the recall of Compounds. Quality matters and the Manufacture of the MSD Compound shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this Agreement.
Clinical Quality Agreement. As soon as reasonably practicable following the nHCM Supplemental Agreement Effective Date, and in any event no later than the initiation of any activities related to any quantity of the Licensed Product for the conduct of the China Study (excluding, for clarity, selection of Study Sites), the Parties shall amend the Clinical Quality Agreement to provide for each Party’s rights and responsibilities with respect to quality matters with respect to the Licensed Product supplied for use in the China Study, including (a) Licensee will be responsible for collecting all quality complaints relating to the Licensed Product in the PRC or the China Study as required by applicable Laws, (b) Licensee will report to Company all quality complaints relating to the Licensed Product in the PRC or the China Study, and, subject to Section 3.1, will be responsible for reporting (and if instructed by Company, will report) quality complaints relating to the Licensed Product or the China Study to applicable Regulatory Authorities in the PRC, as well as responding (and if instructed by Company, will respond) to all requests of Regulatory Authorities in the PRC relating to any quality complaints, (c) subject to Section 3.1, Licensee shall immediately forward to Company any such inquiry from a Regulatory Authority in the PRC relating to any quality complaints, and shall send any draft responses to Company to review, comment and approve (in Company’s sole discretion) before responding to the applicable Regulatory Authority in the PRC, and (d) if any recall of Licensed Product in the PRC is required under applicable Laws, including any such recall that Company determines must be conducted or that is ordered by the Regulatory Authority in the PRC with respect to the Licensed Product, Licensee shall, under the instruction of Company and at Licensee’s own cost and expense, conduct such recall in accordance with applicable Laws and requirements by any Regulatory Authority in the PRC. For clarity, as between the Parties, Company shall have the final decision-making authority with respect to all quality issues (including recalls) in connection with the China Study.
Clinical Quality Agreement. Within [***] days from the Effective Date, the Parties shall enter into a quality agreement that shall address and govern issues related to the quality of Product to be supplied by the Parties for use in such Clinical Trials (“Clinical Quality Agreement”). In the event of any inconsistency between the terms of this Agreement and a given Clinical Quality Agreement, the terms of this Agreement shall control. The Clinical Quality Agreement shall, among other things: (i) detail classification of any Product found to have a non-conformance; (ii) include criteria for Manufacturer’s release and related certificates and documentation; (iii) include criteria and timeframes for acceptance of the Product; (iv) include procedures for the resolution of disputes regarding any Product found to have a non-conformance; and (v) include provisions governing the recall of Product.
