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. 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 six (6) months following the execution of this Agreement, the parties shall execute a Quality Agreement in substantially the form attached to this Agreement as EXHIBIT E. 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. 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. The quality of supplied material is monitored and the results are projected into the Supplier Evaluation. Following indicators are taken into account:
1. Supplied material (parts) quality – amount of incidents 2. Complaint management Any additional costs related to nonconformal delivery will be charged to the supplier§s account.
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. Forthwith after executing this Agreement, the parties shall execute a Quality Agreement in substantially the form attached to this Agreement as Exhibit B. The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In case of conflict between the terms of the Quality Agreement and this Agreement, this Agreement shall prevail.
Quality Agreements. 6.4.1 Within [***] following the Effective Date, or such longer period as agreed by the Parties, the Parties will develop a mutually acceptable quality agreement for clinical supply (to be agreed upon and executed by the Parties) setting forth the Parties’ respective obligations in detail regarding the manufacture, packaging, testing, storage, and release of clinical Product to assure such Product is manufactured according to agreed specifications and complies with Applicable Laws (the “Clinical Supply Quality Agreement”).
6.4.2 No fewer than [***] prior to the anticipated first Regulatory Approval in the Territory, or such longer period as agreed by the Parties, the JSC will develop a mutually acceptable quality agreement for commercial supply (to be agreed upon and executed by the Parties) setting forth the Parties’ respective obligations in detail regarding the manufacture, packaging, testing, storage, and release of commercial Product to assure such Product is manufactured according to agreed specifications and complies with Applicable Laws (the “Commercial Supply Quality Agreement”).
