Quality Agreement definition

Quality Agreement has the meaning set forth in Section 9.6.

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Quality Agreement has the meaning set forth in Section 4.1.

Quality Agreement means the Quality Agreement entered into by the Parties simultaneously with the execution hereof relating to a Product.

Examples of Quality Agreement in a sentence

• Pfizer or its representatives may (at Pfizer’s sole cost and expense), subject to the confidentiality provisions in Section 9, audit such records of Protalix in accordance with the terms of the Quality Agreement at any time during the Supply Term and for the [***] period following the expiration or termination of (x) the Supply Term or (y) the last Purchase Order in effect, whichever occurs later, during normal business hours and upon reasonable advance written notice to Protalix.

• Protalix shall maintain such records for the period of time set forth in the Quality Agreement.

• Following the release of the Drug Substance subject to the Purchase Order hereunder and the submission to Pfizer of the Manufacturing Certificate of Acceptance and the Certificate of Compliance (as defined in the Quality Agreement) relating to such released Drug Substance, each delivery of Drug Substance under a Purchase Order hereunder shall be accompanied by an invoice.

• Following the release of the Drug Substance subject to an applicable Purchase Order by Protalix and before issuing an invoice for such Drug Substance pursuant to Section 5.7(b), Protalix shall supply to Pfizer the applicable batch number for the Drug Substance, and such other information as the parties may set forth in the Quality Agreement with respect to the Manufacture (a “Manufacturing Certificate of Analysis”) for such Drug Substance.

• Protalix shall not make any changes to its process, raw materials, supply sources, manufacturing locations or facilities (including Drug Substance storage facilities and equipment) used to make Drug Substance for Pfizer under this agreement, including any such changes that may require Pfizer to provide notification to Regulatory Authorities, except to the extent permitted under the Quality Agreement.

More Definitions of Quality Agreement

Quality Agreement shall have the meaning set forth in Article 5.2(c).

Quality Agreement has the meaning set forth in Section 2.2.

Quality Agreement means the quality agreement, attached hereto as Appendix B, setting out the responsibilities of the Parties in relation to quality as required for compliance with cGMP.

Quality Agreement means the agreement (the form of which is set forth in Schedule F) between the parties setting out the quality assurance standards for the Manufacturing Services to be performed by Patheon for Client;

Quality Agreement shall have the meaning set forth in Section 3(c).

Quality Agreement has the meaning set forth in Section 3.3.2 (Quality Agreement).

Quality Agreement means an agreement between the Parties that describes the Parties’ quality control, technical, quality assurance and regulatory responsibilities relating to the Manufacture and release of API Bulk Drug Substance Manufactured under this Agreement.