Schedules to Manufacturing and Supply Agreement between Closure Medical and [Counterparty] (May 23, 2001)
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Summary
This document contains a series of schedules and attachments related to a manufacturing and supply agreement between Closure Medical and another party. The schedules outline technical specifications, regulatory roles, launch timelines, quality control procedures, and other operational requirements for the manufacture and supply of a medical device. Key obligations include adherence to product and packaging specifications, compliance with regulatory and quality standards, and fulfillment of insurance and employment policies. The schedules support the main agreement by detailing the parties' responsibilities and requirements for product development and delivery.
EX-10.1 3 dex101.txt SCHEDULES DATED MAY 23, 2001 Exhibit 10.1 SCHEDULES SCHEDULE 1.18 DEVICE SPECIFICATIONS [INFORMATION REDACTED] SCHEDULE 1.35 STABILITY REQUIREMENTS [INFORMATION REDACTED] SCHEDULE 1.43 DEFINITION OF MANUFACTURING COST [INFORMATION REDACTED] SCHEDULE 1.55 PRODUCT SPECIFICATIONS [INFORMATION REDACTED] SCHEDULE 1.61 SECONDARY PACKAGING SPECIFICATIONS [INFORMATION REDACTED] SCHEDULE 2.3 LAUNCH SCHEDULES [INFORMATION REDACTED] SCHEDULE 2.6 REGULATORY ROLES AND RESPONSIBILITIES [INFORMATION REDACTED] SCHEDULE 3.1 [**] [INFORMATION REDACTED] SCHEDULE 4.6.1 CLOSURE MEDICAL'S DESIGN CONTROL PROCEDURE [INFORMATION REDACTED] ATTACHMENT 1: DESIGN CONTROL PROCEDURE SUMMARY CHART [INFORMATION REDACTED] ATTACHMENT 2: NEW PRODUCT DEVELOPMENT (NPD) MODEL [INFORMATION REDACTED] ATTACHMENT 3: QUADRANT ANALYSIS CHART [INFORMATION REDACTED] ATTACHMENT 4: [**] [INFORMATION REDACTED] ATTACHMENT 5: DESIGN VERIFICATION MATRIX [INFORMATION REDACTED] ATTACHMENT 6: DESIGN VALIDATION MATRIX [INFORMATION REDACTED] ATTACHMENT 7: DESIGN AND DEVELOPMENT PLAN [INFORMATION REDACTED] ATTACHMENT 8: TEMPLATE GANTT CHARTS [INFORMATION REDACTED] SCHEDULE 4.7 FORM OF CERTIFICATE OF CONFORMANCE [INFORMATION REDACTED] SCHEDULE 4.9.5 POLICY ON EMPLOYMENT OF YOUNG PERSONS [INFORMATION REDACTED] SCHEDULE 4.9.6 STERILIZATION POLICY [INFORMATION REDACTED] SCHEDULE 5.3.1 [**] [INFORMATION REDACTED] SCHEDULE 10.4 FORM OF PRESS RELEASE [INFORMATION REDACTED] SCHEDULE 12.5 INSURANCE REQUIREMENTS [INFORMATION REDACTED]
