Common use of Manufacturing Practices; Testing Clause in Contracts

Manufacturing Practices; Testing. MSC shall manufacture the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. MSC will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive statistical process control records conforming to (1) standards provided or approved by ViewRay and/or required of such process or processes for similar products; (2) appropriate best practices, including the then applicable good manufacturing practices regulations of the U.S. Food and Drug Administration (“FDA”) under 21 C.F.R. Part 820, and the then applicable Nuclear Quality Assurance (“NQA”) regulations of the Nuclear Regulatory Commission (“NRC”) under 10 C.F.R. Part 830 or corresponding “Agreement State” regulations (as defined under the NRC regulations), or comparable regulations of any other supra-national, regional, federal, state, or local regulatory agency or authority that has authority to grant registrations, authorizations, licenses and approvals necessary for the commercial manufacture, distribution, marketing, promotion, sale, use, importation, or exportation of the Products (each, including the FDA, the NRC and the Ohio Department of Health (“ODH”) (as an Agreement State), a “Regulatory Authority”) that apply to the manufacture of the Products and the delivery of the Products to ViewRay (“Applicable Standards”); and (3) other requirements set forth herein.

Manufacturing Practices; Testing. MSC shall manufacture the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. MSC [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive statistical process control records conforming to (1) standards provided or approved by ViewRay and/or required of such process or processes for similar products; (2) appropriate best practices, including the then applicable good manufacturing practices regulations of the U.S. Food and Drug Administration (“FDA”) under 21 C.F.R. Part 820, and the then applicable Nuclear Quality Assurance (“NQA”) regulations of the Nuclear Regulatory Commission (“NRC”) under 10 C.F.R. Part 830 or corresponding “Agreement State” regulations (as defined under the NRC regulations), or comparable regulations of any other supra-national, regional, federal, state, or local regulatory agency or authority that has authority to grant registrations, authorizations, licenses and approvals necessary for the commercial manufacture, distribution, marketing, promotion, sale, use, importation, or exportation of the Products (each, including the FDA, the NRC and the Ohio Department of Health (“ODH”) (as an Agreement State), a “Regulatory Authority”) that apply to the manufacture of the Products and the delivery of the Products to ViewRay (“Applicable Standards”); and (3) other requirements set forth herein.