Clinical Quality Agreement Clause Samples

Clinical Quality Agreement. The Parties will execute the Clinical Quality Agreement prior to any supply of MSD Compound hereunder, and no later than [***]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. 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: (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 [*] 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. 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. [***], 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. 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. Within [***] days after the Effective Date, but in any event before any supply of MSD 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 MSD for use in the Study (the “Clinical Quality

Clinical Quality Agreement. Within [***] after the Effective Date, but in any event before any supply of MSD 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 MSD 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 [***] of the Effective Date, the Parties will enter into the Clinical Quality Agreement. AstraZeneca and SPINCO shall perform their respective obligations and comply with all provisions of the Clinical Quality Agreement. AstraZeneca shall not be required to commence the Manufacture of Supplied Products hereunder until execution of the Clinical Quality Agreement.