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 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.

Examples of Clinical Quality Agreement in a sentence

• 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.

• Notification related to MSD Compound shall be in accordance with the Clinical Quality Agreement.

• Collaborator shall conduct the acceptance procedures under the Clinical Quality Agreement within the time frames set forth therein.

• MSD hereby represents and warrants to Collaborator that: (i) MSD has the full right, power and authority to grant all of the licenses granted to Collaborator under this Agreement; (ii) MSD Controls the MSD Compound; and (iii) at the time of Delivery of the MSD Compound, such MSD Compound shall have been Manufactured and supplied in compliance with its Specifications, the Clinical Quality Agreement, and all Applicable Law.

• The Parties will execute the Clinical Quality Agreement prior to any supply of MSD Xxxxxxxx hereunder, and no later than [***] days after the Effective Date.

More Definitions of Clinical Quality Agreement

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 being entered into by the Parties within sixty (60) days of the Effective Date.

Clinical Quality Agreement means an agreement to be entered into by the Parties, or their Affiliates, 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 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 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 is defined in Section 6.6 (Related Agreements).

Clinical Quality Agreement means a quality assurance agreement to be agreed between the Parties pursuant to Clause 11.1, which shall include quality responsibilities with respect to, among other things, release testing, stability testing, access to IMP Dossier and record retention requirements, as such agreement may be amended or replaced by agreement between the Parties in writing from time to time;