Common use of Quality Assurance Audits Clause in Contracts

Quality Assurance Audits. (a) DO, at its own expense and at its sole discretion, shall have reasonable access during regular business hours, upon prior written notice of not less than ten (10) business days, to the Product Inspection and Acceptance Location(s) where the Products are being manufactured in order to monitor and audit the manufacturing practices for the Products as necessary to ensure satisfaction of the regulatory compliance provisions of this Agreement including FDA QSR and GMP requirements, and, in accordance with paragraph 10 of Section III, to inspect and accept the Products prior to shipping. During such audit or inspection for acceptance, CCSI agrees that either CCSI or its third-party manufacturer of the Products shall, upon written request from DO, promptly make available to DO, for its review but not for copying, the entire DMR documents, including the master document (as amended from time to time) redacted to exclude proprietary information of CCSI and of its third-party manufacturer not needed for such audit or inspection, as follows: the exclusion of the detailed description of parts specifications for Light Emitting Diodes, * for Light Emitting Diodes, optical filters, light sources, calibration color standards, verification color standards and integrated circuit boards, and the specific description in all software documentation (including the Technical File and Design Control documentation) of the algorithms, mathematical formulas or equations, or any other computations or specific descriptions of software code where the specific descriptions are related to the color measurement, the skin color * the adjustments for skin coloration (including under phototherapy) baseline skin coloration, measurement of proprietary standards, computation of spectral data, computation of * data, conversion formulas for spectral and * data, equations for power source, * equations, site computations, * signals and * parameters. CCSI agrees to provide DO with prior written notice of any change in CCSI's third-party manufacturer of the Products, which notice shall identify the name and location of any such manufacturer. (b) CCSI, at its own expense and at its sole discretion, shall have reasonable access during regular business hours, upon prior written notice of not less than ten (10) business days, to audit DO's distribution practices for the Products as necessary to ensure satisfaction of the regulatory compliance provisions of this Agreement.

Quality Assurance Audits. (a) DO, at its own expense and at its sole discretion, shall have reasonable access during regular business hours, upon prior written notice of not less than ten (10) business days, to the Product Inspection and Acceptance Location(s) where the Products are being manufactured in order to monitor and audit the manufacturing practices for the Products as necessary to ensure satisfaction of the regulatory compliance provisions of this Agreement including FDA QSR and GMP requirements, and, in accordance with paragraph 10 of Section III, to inspect and accept the Products prior to shipping. During such audit or inspection for acceptance, CCSI agrees that either CCSI or its third-party manufacturer of the Products shall, upon written request from DO, promptly make available to DO, for its review but not for copying, the entire DMR documents, including the master document (as amended from time to time) redacted to exclude proprietary information of CCSI and of its third-party manufacturer not needed for such audit or inspection, as follows: the exclusion of the detailed description of parts specifications for Light Emitting Diodes, * [*] for Light Emitting Diodes, optical filters, light sources, calibration color standards, verification color standards and integrated circuit boards, and the specific description in all software documentation (including the Technical File and Design Control documentation) of the algorithms, mathematical formulas or equations, or any other computations or specific descriptions of software code where the specific descriptions are related to the color measurement, the skin color * categories, the adjustments for skin coloration (including under phototherapy) baseline skin coloration, measurement of proprietary standards, computation of spectral data, computation of * [*] data, conversion formulas for spectral and * [*] data, equations for power source, * [*] equations, site computations, * [*] signals and * [*] parameters. CCSI agrees to provide DO with prior written notice of any change in CCSI's third-third- party manufacturer of the Products, which notice shall identify the name and location of any such manufacturer. (b) CCSI, at its own expense and at its sole discretion, shall have reasonable access during regular business hours, upon prior written notice of not less than ten (10) business days, to audit DO's distribution practices for the Products as necessary to ensure satisfaction of the regulatory compliance provisions of this Agreement.