Common use of Manufacturing Practices; Testing Clause in Contracts

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.