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RIM Bio, Inc. Company Presentation 2013

RIM Bio, Inc. Company Presentation 2013. RIM Bio Mission Statement. Our goal is to be recognized by the Bio-Process Industry as the Low Cost solution for high quality Single-Use Containers. RIM Bio History.

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RIM Bio, Inc. Company Presentation 2013

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  1. RIM Bio, Inc.Company Presentation2013 CONFIDENTIAL 2013 RIM Bio, Inc.

  2. RIM Bio Mission Statement Our goal is to be recognized by the Bio-Process Industry as the Low Cost solution for high quality Single-Use Containers. CONFIDENTIAL 2013 RIM Bio, Inc.

  3. RIM Bio History RIM Bio is a privately held US company and manufacturer of single-use Bio-Process Containers. RIM Bio was formerly known as RIM Medical which was established in 2004 as a contract manufacturer of medical device disposables. The name change to RIM Bio took place in 2009 in order to concentrate exclusively on the Bio-Process industry. Our single-use products are now qualified and used at many of the largest companies in the Pharmaceutical and BioTech industries. CONFIDENTIAL 2013 RIM Bio, Inc.

  4. RIM Bio Locations • RIM Bio USA - Seattle, WA • Administration • Customer Service • Warehouse • RIM Bio China – Changzhou, Jiangsu Province • Production Facility • R & D CONFIDENTIAL 2013 RIM Bio, Inc.

  5. Changzhou Changzhou City (Metro pop. 3.3 million), Jiangsu Province Approximately 100 miles northwest of Shanghai, this city boasts a long-time industrial heritage. It is one of ten key cities for the electronics industry. The related machinery industry in Changzhou ranks first in Jiangsu province, while the plastics industry ranks second in China. The surrounding area is home to 130 colleges and universities. CONFIDENTIAL 2013 RIM Bio, Inc.

  6. RIM Bio Production Facility • The RIM Bio China manufacturing facility in Changzhou, Jiangsu province, is a wholly owned US factory of RIM Bio, Inc. USA. • Our 23,000 sq. ft. facility serves exclusively as our manufacturing center for the production of Single-Use Bio-Process Containers. • We utilize a class 10,000 clean room within this building for all production activity. • RIM Bio is GMP compliant and ISO 9001 certified. CONFIDENTIAL 2013 RIM Bio, Inc.

  7. Changzhou Manufacturing Facility CONFIDENTIAL 2013 RIM Bio, Inc.

  8. Validation Checklist • USP<88> Class VI Yes • USP<87> Cytotoxicity Yes • USP<661> Leachable/extractable Yes • Bioburden Yes • LAL Yes • Long Term Sterility, 24 month Yes • Air Leak Testing Yes • Long Term Shelf Life Test Yes • Long Term Gamma Stability Yes • Seal Strength Yes • Horizontal Impact Yes • Drop Yes CONFIDENTIAL 2013 RIM Bio, Inc.

  9. Quality Control • Certified GMP facility, Q1 2013 In Progress • ISO 9001:2008 Yes • ISO Class 7 Clean Room Yes • FDA Device Master File In Progress • Supply Chain Backup: - Resins Yes • Films Yes • Converters Yes • All products fully traceable • All products 100% Leak Tested • All products 100% Light Board Visually Inspected • All Materials are Animal Derived Component Free (ADCF) CONFIDENTIAL 2013 RIM Bio, Inc.

  10. Quality Assurance • RIM Bio production facility is FDA registered • All drawings and product specifications are reviewed. • All components and raw materials are inspected before use.  • All manufacturing and inspection standards are validated before production begins. • All Bio-Process products and components are assembled in the clean room. • All components have strict lot control and traceability. • RIM Bio performs extensive component and product reliability testing in-house and through certified third party laboratories. • RIM Bio utilizes inspection and test methods to specific industry requirements.  • RIM Bio test methods include but are not limited to: • Class VI Toxicity • Cytotoxicity • Particulate Control • Mechanical Properties • Water Vapor Transmission Rate • Oxygen Transmission Rate • LAL testing CONFIDENTIAL 2013 RIM Bio, Inc.

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  13. Single-Use Products We offer a variety of bio-process containers suitable for cell culture and media storage. All our NxFlex films have undergone extensive durability testing, meet cytotoxicity requirements, and are USP Class VI certified by Toxikon, Boston, MA. Our products include: • 2-D Bags (100 ml – 100L) • 3-D Bags (50L – 1600L) • Bags for Rocking Platforms (10L, 20L, 22L, 50L) • Media & Transfer Bags • Multi-Bag Manifolds • Blood Collection Bags • Tube set assemblies CONFIDENTIAL 2013 RIM Bio, Inc.

  14. 2-D Single Port BagEVA Contact Layer CONFIDENTIAL 2013 RIM Bio, Inc.

  15. 2D Three Ports Bag EVA Contact Layer CONFIDENTIAL 2013 RIM Bio, Inc.

  16. 2-D Three Ports BagPE Contact Layer CONFIDENTIAL 2013 RIM Bio, Inc.

  17. 3-D Bag1600L & Test Chamber CONFIDENTIAL 2013 RIM Bio, Inc.

  18. 3-D 1600L Bag Folded for Packaging CONFIDENTIAL 2013 RIM Bio, Inc.

  19. Bags for Rocking Platforms CONFIDENTIAL 2013 RIM Bio, Inc.

  20. Media Bags CONFIDENTIAL 2013 RIM Bio, Inc.

  21. Multi-Bag Manifolds CONFIDENTIAL 2013 RIM Bio, Inc.

  22. Blood Collection Bags CONFIDENTIAL 2013 RIM Bio, Inc.

  23. Engineering • Engineering capability in US and China • Project Management in US and China • Engineering experience and expertise: • Review product designs for manufacturability. • Process and equipment set-up. • Our engineering team can help in the selection of Films, Components, and Bag Designs for your specific applications. CONFIDENTIAL 2013 RIM Bio, Inc.

  24. Manufacturing • We utilize the following processes: • Heat Impulse Sealing • Constant Temperature Sealing • RF Sealing • On Site Gamma Sterilization • Leak Testing • Mechanical and Integrity Testing • Long Term Cycling for Flex Cracking CONFIDENTIAL 2013 RIM Bio, Inc.

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  34. Cycle TestingPlatforms for Rocker Bags http://vimeo.com/30746318 CONFIDENTIAL 2013 RIM Bio, Inc.

  35. Thank you! Contact RIM Bio • Request information • Request a drawing • Request a sample Please contact: Isabelle Knoke PO Box 33595 Seattle, WA 98133 206-362-3992 office phone 206-691-8811 office fax CONFIDENTIAL 2013 RIM Bio, Inc.

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