Common use of MANUFACTURING AND QUALITY CONTROL Clause in Contracts

MANUFACTURING AND QUALITY CONTROL. 12.1 RTI shall establish and maintain a quality system for all stages of manufacture of the Implants, including donor eligibility and procurement of tissue, in compliance with Applicable Laws and Applicable Industry Standards, such as 21 CFR 1271, parts 820 and ISO 13485. 12.2 RTI shall establish and maintain an effective product and process validation system relative to all aspects of quality, e.g., design, sterilization and packaging. 12.3 RTI shall manage an effective document change control system relative to all aspects of the design, manufacture, storage, and distribution of the Implants. 12.3.1 Prior to making a Major Change to an Implant, RTI will submit written notice of the Major Change to ▇▇▇▇▇▇’▇ Director of RA/QA, via fax or email. This notice shall include a full description of the Major Change with adequate information to determine its impact on the finished Implant Specifications and regulatory status. 12.3.2 Zimmer will review and respond to RTI within fifteen (15) Business Days of receipt of Major Change notice. If the Major Change is being implemented to improve the safety of the Implant, RTI will implement the change as soon as reasonably possible without prior approval by Zimmer. 12.4 RTI shall ensure that its tissue procurement organization and contract suppliers maintain a quality program/system, in compliance with Applicable Laws and Applicable Industry Standards e.g., 21 CFR 1271, United States Department of Agriculture (“USDA”) , EN 12442, as appropriate for the materials and components e.g., bovine bone, bovine tissue, human bone, human tissue. 12.5 Zimmer shall establish and maintain a quality system in compliance with applicable sections of Applicable Laws, e.g., 21 CFR 1271, 820 and ISO 13485.

MANUFACTURING AND QUALITY CONTROL. 12.1 RTI shall establish and maintain a quality system for all stages of manufacture of the Implants, including donor eligibility and procurement of tissue, in compliance with Applicable Laws and Applicable Industry Standards, such as 21 CFR 1271, parts 820 and ISO 13485. 12.2 RTI shall establish and maintain an effective product and process validation system relative to all aspects of quality, e.g., design, sterilization and packaging. 12.3 RTI shall manage an effective document change control system relative to all aspects of the design, manufacture, storage, and distribution of the Implants. 12.3.1 Prior to making a Major Change to an Implant, RTI will submit written notice of the Major Change to ▇Z▇▇▇▇▇’▇ Director of RA/QA, via fax or email. This notice shall include a full description of the Major Change with adequate information to determine its impact on the finished Implant Specifications and regulatory status. 12.3.2 Zimmer will review and respond to RTI within fifteen (15) Business Days of receipt of Major Change notice. If the Major Change is being implemented to improve the safety of the Implant, RTI will implement the change as soon as reasonably possible without prior approval by Zimmer. 12.4 RTI shall ensure that its tissue procurement organization and contract suppliers maintain a quality program/system, in compliance with Applicable Laws and Applicable Industry Standards e.g., 21 CFR 1271, United States Department of Agriculture (“USDA”) , EN 12442, as appropriate for the materials and components e.g., bovine bone, bovine tissue, human bone, human tissue. 12.5 Zimmer shall establish and maintain a quality system in compliance with applicable sections of Applicable Laws, e.g., 21 CFR 1271, 820 and ISO 13485.