Quality Agreements. The Parties agree that they will enter into one or more separate Quality Agreements that will cover arrangements for quality control, testing documentation, quality assurance and other related matters no later than thirty (30) days after the Effective Date.
Quality Agreements. Within six (6) months following the execution of this Agreement and in any event prior to commencing Processing of the Product, the parties shall execute a Quality Agreement. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with Good Manufacturing Practices or Good Laboratory Practices, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.
Quality Agreements. Within thirty (30) days following the execution of this Agreement, the parties shall execute a Quality Agreement in substantially the form attached to this Agreement as Exhibit C. The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a conflict between the terms of this Agreement and the Quality Agreement, this Agreement shall control.
Quality Agreements. The Parties will enter into one or more quality agreements to govern the transfer of materials, Collaboration Candidates and Licensed Products contemplated under this Article 8.
Quality Agreements. The quality of supplied material is monitored and the results are projected into the Supplier Evaluation. Following indicators are taken into account:
Quality Agreements. Prior to initiating any Processing or Packaging of the Product, the parties shall execute Quality Agreements for Processing and Packaging (the “Quality Agreements”). In the event of a conflict between any of the provisions of this Agreement and such Quality Agreements with respect to quality-related activities, including compliance with Good Manufacturing Practices, the provisions of the Quality Agreements shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreements with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.
Quality Agreements. Each Party shall comply with the provisions of the Quality Agreements. The Quality Agreements shall be reviewed annually by the quality department of each Party and, upon mutual agreement, revised and updated in writing as necessary. In the event of a conflict between a Quality Agreement and this Agreement, this Agreement shall govern and control.
Quality Agreements. No later than [***] following the Effective Date (or such other timeframe as may be agreed by the Parties), but in any event prior to the commencement of the first human clinical trial for any Product to be conducted by Kiniksa in the Kiniksa Field in the Territory, the Parties shall negotiate and enter into a reasonable and customary quality agreement with respect to the Product to be Manufactured by or on behalf of Regeneron and supplied to Kiniksa under the Development Supply Agreement (the “Development Quality Agreement”). At least [***] prior to the anticipated date of receipt of U.S. Marketing Approval, the Parties shall negotiate and enter into a reasonable and customary quality agreement with respect to the Product to be Manufactured by or on Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd. behalf of Regeneron and supplied to Kiniksa under the Commercial Supply Agreement (the “Commercial Quality Agreement” and together with the Development Quality Agreement, the “Quality Agreements”).
Quality Agreements. BDB undertakes to execute with INFLARX, upon the latter request, appropriate quality assurance agreements including but not limited to aspects of oversight, clarification of responsibilities, handling, storage and manufacturing conditions, clinical trial aspects, reporting of incidences and adverse events/reactions etc., safety data exchange agreements or pharmacovigilance agreements as may be deemed appropriate or useful by INFLARX in order to assure adherence to applicable external or internal quality regulations or guidelines and to Applicable Laws which may be applicable to INFLARX.
Quality Agreements. Each Party shall duly and punctually perform all of its obligations under and pursuant to the Quality Agreements to which it is a party. Arena shall release all Products in accordance with the terms of the Quality Agreements. Within three months after the Effective Date, the Parties shall update the Quality Agreements to specify the requirements for the release of Bulk Product.
