Manufacturing Practices; Testing. QED shall manufacture the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. QED will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to (1) 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 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, including specifically ISO 13485 certification, ISO 9001 certification and MHLW accreditation (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the Products (“Applicable Standards”); and (2) other requirements set forth herein.
Manufacturing Practices; Testing. Tesla shall manufacture the Products supplied pursuant to Section 3 in accordance with the quality standards set out in Attachment 5 and the Specifications. Tesla will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to (1) standards provided or approved by ViewRay and comparable to such process or processes conducted by ViewRay at its factory for its own similar products; (2) appropriate best practices, including the then applicable good manufacturing practices regulations of the International Organization for Standardization (“ISO”) under ISO 9001 certification, ISO 13485 certification and ISO 14001 certification that apply to the manufacture of the Products (“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 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. 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. Jastec shall manufacture the Products in accordance with the Specifications. Jastec will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to ( 1) 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 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, a “Regulatory Authority”) that apply to the manufacture of the Product (“Applicable Standards”) including specifically ISO 9001 certification and ISO 13485 certification (which may be used in lieu of 21 C.F.R. Part 820); and (3) other requirements set forth herein. It is understood that Jastec does not currently hold ISO 13485 certification, but Jastec shall use Commercially Reasonable Efforts to obtain ISO 13485 certification.
Manufacturing Practices; Testing. PEKO shall Assemble the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. PEKO will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to (1) appropriate best practices, including the then applicable good manufacturing practices regulations of the U.S. Food and [***] 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. Drug Administration (“FDA’) under 21 C.F.R. Part 820 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, including specifically ISO 13485 certification, ISO 9001 certification and MHLW accreditation (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the Products (“Applicable Standards”); and (2) other requirements set forth herein.
Manufacturing Practices; Testing. PEKO shall Assemble the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. PEKO will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to (1) 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 or comparable regulations of any other [***] 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. 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, including specifically ISO 13485 certification, ISO 9001 certification and MHLW accreditation (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the Products (“Applicable Standards”); and (2) other requirements set forth herein.
Manufacturing Practices; Testing. 3D Line shall manufacture the [***] 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 [***] 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. 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 [***] MLCs by 3D Line (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the [***] MLCs by 3D Line (“Applicable GMP”); and (3) other reasonable requirements set forth herein.
Manufacturing Practices; Testing. PEKO shall Assemble the Products supplied pursuant to Section 3 in accordance with mutually agreed quality standards and the Specifications. PEKO will install and maintain effective quality control systems, conduct quality assurance testing and keep comprehensive process control records conforming to (1) 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 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, including specifically ISO 13485 certification, ISO 9001 certification and MHLW accreditation (each, including the FDA, a “Regulatory Authority”) that apply to the manufacture of the Products (“Applicable Standards”); and (2) other requirements set forth herein.
