Common use of Manufacturing Practices; Testing Clause in Contracts

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. 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[***].