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 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. 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. 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. The quality of supplied material is monitored and the results are projected into the Supplier Evaluation. Following indicators are taken into account:
Quality Agreements. At the same time that the Parties enter into the Clinical Supply Agreement, the Parties shall enter into a quality agreement addressing the quality and safety of the Initial Product for use in Clinical Trials in the Territory and related regulatory issues relating thereto (the “Clinical Quality Agreement”), on terms to be negotiated by the Parties in good faith. At the same time that the Parties enter into the Commercial Supply Agreement, the Parties shall enter into a quality agreement addressing the quality and safety of the Initial Product for Commercialization in the Territory and related regulatory issues relating thereto (the “Commercial Quality Agreement”), on terms to be negotiated by the Parties in good faith. (the Clinical Quality Agreement and the Commercial Quality Agreement hereinafter collectively the “Quality Agreements”.)
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. 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. 18.1 Review Quality Agreements every two (2) years and update as necessary. x x [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. EXHIBIT E FORM OF PATENT ASSIGNMENT PATENT ASSIGNMENT
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.
