Common use of Manufacturing Practices; Testing Clause in Contracts

Manufacturing Practices; Testing. 3D Line shall manufacture the 60-Leaf MLCs supplied pursuant to Section 2.5 and the Supply Agreement in accordance with mutually agreed quality standards and the Specifications. 3D Line will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive statistical process control records conforming to (1) reasonable standards provided or approved by ViewRay and reasonably comparable to such process or processes conducted by ViewRay at its factory for its own MRI products; (2) appropriate best industry practices, including the then applicable Quality System Regulations of the U.S. Food and Drug Administration (“FDA”) under 21 C.F.R. Part 820 or comparable regulations of any other any supra-national, regional, national, state, or local regulatory agency or authority that has authority to grant registrations, authorizations, approvals, licenses or clearances (collectively, Regulatory Approvals) necessary for the commercial manufacture, distribution, marketing, promotion, sale, use, importation, or export of the 60-Leaf MLCs by 3D Line (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the 60-Leaf MLCs by 3D Line (“Applicable GMP”); and (3) other reasonable requirements set forth herein.

Manufacturing Practices; Testing. 3D Line shall manufacture the 60-Leaf [***] MLCs supplied pursuant to Section 2.5 and the Supply Agreement in accordance with mutually agreed quality standards and the Specifications. 3D Line will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive statistical process control records conforming to (1) reasonable standards provided or approved by ViewRay and reasonably comparable to such process or processes conducted by ViewRay at its factory for its own MRI products; (2) appropriate best industry practices, including the then applicable Quality System Regulations of the U.S. Food and Drug Administration (“FDA”) under 21 C.F.R. Part 820 or comparable regulations of any other any supra-national, regional, national, state, or local regulatory agency or authority that has authority to grant registrations, authorizations, approvals, licenses or clearances (collectively, Regulatory Approvals) necessary for the commercial manufacture, distribution, marketing, promotion, sale, use, importation, or export of the 60-Leaf [***] MLCs by 3D Line (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the 60-Leaf [***] MLCs by 3D Line (“Applicable GMP”); and (3) other reasonable requirements set forth herein.