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 assurance agreements being entered into by the Parties in conjunction herewith.
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 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.
Clinical Quality Agreement is defined in Section 6.6 (Related Agreements).
Clinical Quality Agreement means that certain Clinical Quality Agreement entered into by the Parties under the Original Agreement, as may be amended pursuant to Section 11 hereof. 1.18 “Clinical Study” means any clinical trial for a compound or product in humans that is designed to generate data in support or maintenance of Regulatory Approval including any post-approval clinical trial in humans, but excluding any investigator-sponsored clinical trial. 1.19 “Combination Regimen” means the use or method of using any GSK BCMA Product and the SpringWorks Compound in combination, either alone together as a combination therapy, or as a combination together with additional pharmaceutical agents, whether administration is concomitant or sequential administration. 1.20 “Commercialization” or “Commercialize” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a product, including activities directed to Promoting, distributing, importing, exporting and selling a product and interacting with Regulatory Authorities regarding any of the foregoing. 1.21 “Commercialization Territory” means the Required Territory and any other countries or territories for which the Parties agree via the JCC to seek Regulatory Approval of the Combination Regimen. 1.22 “Commercially Reasonable Efforts” means [***]. 1.23 “Committees” has the meaning set forth in Section 6.5. 1.24 “Compounds” means any, some or all of the GSK BCMA Products and the SpringWorks Compound. A “Compound” means any of the GSK BCMA Products or the SpringWorks Compound, as applicable.
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 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