Clinical Quality Agreement definition

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

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.

Clinical Quality Agreement means that certain Clinical Quality Agreement entered into by the Parties pursuant to Section 11.1 hereof.

Examples of Clinical Quality Agreement in a sentence

• Recalls of the Compounds shall be governed by the terms of 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.

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

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

More Definitions of Clinical Quality Agreement

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 clinical quality assurance agreements being entered into by the Parties in conjunction herewith.

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 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 has the meaning set forth in Section 8.2. 1.9. “CMC” means “Chemistry Manufacturing and Controls” as such term of art is used in the pharmaceutical industry. 1.10. “Combination” means the use or method of using the Novocure Device and the MSD Compound in concomitant or sequential administration. Use of this term is not intended to denote or imply that the use of the Novocure Device together with the MSD Compound constitutes a combination product as defined by FDA in 21 C.F.R. 3.2(e). 1.11. “Confidential Information” means any information (including personal data), Know-How or other proprietary information or materials furnished to one Party (“Receiving Party”) by or on behalf of the other Party (“Disclosing Party”) in connection with this Agreement, except to the extent that such information or materials: (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party, as demonstrated by competent evidence; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was

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 is defined in Section 6.6 (Related Agreements).