Clinical Quality Agreement definition

Clinical Quality Agreement has the meaning set forth in Section 8.2.

Clinical Quality Agreement means that certain clinical quality assurance agreements being entered into by the Parties in conjunction herewith.

Clinical Quality Agreement means an agreement to be entered into by the Parties pursuant to Section 2.4 (Clinical Quality Agreement) to address and govern the quality and handling of clinical drug to be supplied by the Parties for use in the MSD Compound Study.

Examples of Clinical Quality Agreement in a sentence

• Recalls of the Compounds shall be governed by the terms of the Clinical Quality Agreement.

• The process for investigations of any Non-Conformance shall be handled in accordance with the Clinical Quality Agreement.

• Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound, and for validation, documentation and release of its Compound and such other quality assurance and quality control procedures as are required by the Specifications, cGMPs and the Clinical Quality Agreement.

• Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Clinical Quality Agreement in addition to the relevant quality provisions of this Agreement.

• The Parties’ audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.

More Definitions of Clinical Quality Agreement

Clinical Quality Agreement means a quality agreement entered into between the Parties with respect to the Manufacture of Collaboration Product for Development purposes during the Collaboration Term for the applicable Program, including pursuant to Section 6.2(d), 6.2(e) or Exhibit K.

Clinical Quality Agreement means that certain clinical quality agreement being entered into by the Parties within sixty (60) days of the Effective Date.

Clinical Quality Agreement means that certain Quality Agreement between Company, on the one hand, and Lian Cardiovascular HK and Local Regulatory Agent, on the other hand, effective as of August 13, 2021, as may be amended from time to time.

Clinical Quality Agreement means the written agreement (or agreements) to be agreed to by the holder of the Clinical Regulatory Approval, the applicable Party supplying Clinical Product (i.e., ARIAD prior to a Clinical Product Transfer and MERCK after a Clinical Product Transfer) or supplying Clinical API, setting out the quality assurance standards to be applicable to the Manufacturing process for Clinical Product or Clinical API.

Clinical Quality Agreement means that certain clinical quality agreement being entered into by the Parties within thirty (30) days of the Effective Date. Certain portions of this document have been marked “[C.I.]” to indicate that confidential treatment has been requested for such confidential information. The confidential portions have been omitted and submitted separately with the Securities and Exchange Commission.

Clinical Quality Agreement means that Clinical Quality Agreement executed by and between Company and Merck Sharp & Dohme Corp., an Affiliate of MSD, dated [***], as may be amended by the parties thereto from time to time.

Clinical Quality Agreement has the meaning set forth in Section 4.7 below. [***] 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. Confidential treatment has been requested with respect to this information.