Quality Assurance Agreement. Orion and USL will agree upon a Quality Assurance Agreement for the Product. Such Agreement shall be finalized and executed on the Date of Agreement and not be inconsistent with Orion’s and USL’s current quality assurance programs or require material investments by Orion to implement, except to the extent such investments are required to enable the Parties to comply with applicable laws.
Quality Assurance Agreement. Each Party shall duly and punctually perform all of its obligations under and pursuant to the Quality Assurance Agreement.
Quality Assurance Agreement. The Quality Assurance Agreement specifies certain services, including certain testing, storage, release, cGMP, regulatory and other quality assurance requirements to be performed by CPL as part of the Services, all of which shall be deemed a material part of this Agreement.
Quality Assurance Agreement. The Quality Assurance Agreement specifies certain services, including certain testing, storage, release, cGMP, regulatory and other quality assurance requirements to be performed by BioVectra as part of the Services, all of which shall be deemed a material part of this Agreement.
Quality Assurance Agreement. The Parties shall enter into a mutually agreed-upon companion quality agreement (the “Quality Assurance Agreement”) with respect to each of the Clinical Supply Agreement and the Commercial Supply Agreement, which shall set forth in detail the quality assurance arrangements and procedures of the Product and the GMP responsibilities between the Parties prior to the Manufacture of the Compound to be used for the first commercial lot of the Product.
Quality Assurance Agreement. The responsibilities of the Parties concerning the quality of Product shall be set forth in the Quality Assurance Agreement. In the event the Quality Assurance Agreement contains material provisions that substantially differ from applicable Regulatory Standards, the Regulatory Standards shall control. Indevus shall inform Schering about all material revisions to the applicable Regulatory Standards applicable to Product in the Territory.
Quality Assurance Agreement. Within thirty (30) days after the Effective Date, the Parties shall execute a Quality Assurance Agreement in substantially the form attached to this Agreement as Exhibit V. The Quality Assurance Agreement [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 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 Assurance Agreement in relation to quality issues, the Quality Assurance Agreement shall control; in all other cases, the terms and conditions of this Agreement shall control.
Quality Assurance Agreement. Simultaneously with the execution of this Agreement, or prior to such execution, the Parties shall amend and update the QUALITY ASSURANCE AGREEMENT. Such amended and updated QUALITY ASSURANCE AGREEMENT is hereby incorporated by reference herein and that it shall apply to any DRUG SUBSTANCE and PRODUCT produced under this AGREEMENT. The QUALITY ASSURANCE 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 any of the provisions of this Agreement and the QUALITY ASSURANCE AGREEMENT in matters of business, financial or legal nature, the terms of this Agreement shall control and for matters of quality processes (including with respect to PRODUCT disposition), the terms of the Quality Agreement shall prevail.The QUALITY ASSURANCE AGREEMENT may be amended from time to time by the Parties only in accordance with Section 15.9.
Quality Assurance Agreement. Further responsibilities and obligations of the Parties with respect to the quality of the Product and related responsibilities of the Parties are defined in a separate written quality assurance agreement, signed between the Parties with effective date September 12th, 2014, and any amendment thereto (all together the "Quality Assurance Agreement"). The Quality Assurance Agreement and, after signing, any amendment thereto shall become part of this Agreement. If there is any conflict between the terms of this Agreement and the Quality Assurance Agreement, commercial terms shall prevail of this Agreement, and terms covering regulatory or legal requirements shall prevail of the Quality Assurance Agreement.
Quality Assurance Agreement. The Parties shall enter into a “Quality Assurance Agreement” (“QAA”) no later than seven (7) calendar days before the start of any Work Order for Manufacturing of any Deliverable. The QAA shall set forth the Parties' rights and obligations with regard to quality management, quality assurance, quality control, responsibilities of the Parties, documentation, product release procedure including the language of such documentation, regulatory items such as audits and inspections. Upon execution, the QAA for Patient Lots shall be deemed to be incorporated herein as Exhibit C.
