1. Technology Transfer T 2 Program TBD AMERICA by Barry Stevens, PhD @ 2011 TBD America. All rights reserved

2. We are: an experienced global technology driven consulting firm specializing in the transfer for a full spectrum of technologies capable, methodical, flexible, and dedicated to our clients success and growth composed of a Team with proven field and operational experience with deep industry knowledge Why TBD for T 2 @ 2011 TBD America. All rights reserved Anna Clark, LEEDKeith Dackson, PhD, PE Grant Harrell, MBA Mark Hoy, MBA Henry Ka China & Asia Konstantinos Klislaris Europe Mark McHugh, BA Brazil & South America Steven Richardson, BA Terry Roberts Barry Stevens, PhD 2

3. Transferred RCA’s revolutionary VideoDisc technology to CBS Record’s manufacturing plant. ….. Started up production 4 months ahead of schedule and under budget Developed and transferred a sophisticated product development plan that affected over 5,000 items ….. Reshaped the entire development process between headquarters and offshore Offices in Japan, Hong Kong, Taiwan and Korea ….. Reduced time-to-market from 4 years to 1.5 years ….. Helped jump annual sales by 10% ….. Reduced in-warranty repairs by 21.6% for a total annual savings of $23 million Developed and transferred into production CD-ROM technology for a Fortune 500 company ….. 1985, six years prior to market introduction Transferred a cutting-edge class III medical device from development to manufacturing p..... Started up production on schedule at the right quality and cost T 2 Accomplishments @ 2011 TBD America. All rights reserved3

4. Best practice knowledge transfer / skills development Subcontracting arrangements Joint ventures Licensing of IP Subcontracting arrangements Equipment lease agreements Service agreements Others T 2 Program Structures @ 2011 TBD America. All rights reserved4

5. to ensure the effective and efficient transfer of a robust and well documented production processes from development to manufacturing T 2 Goals 5@ 2011 TBD America. All rights reserved

6. Technology transfer team – T 3 Transfer document Production scale qualification Training development and manufacturing Transfer project champion Formalized 3 rd party communication Elements for Improved Transfers from Development to Manufacturing 6@ 2011 TBD America. All rights reserved

7. Cross-func­tional team representing all departments, manufacturers, and suppliers involved Team requires appropriate resources and tools to accomplish the task Train team on the technology transfer process Train team members on the use of the process tools (eg, database) to help organize and assemble nu­merical data, assign action items, determine the current level of readiness, and identify areas of weakness or omission Define and follow a reason­able course of action Technology transfer team – T 3 7@ 2011 TBD America. All rights reserved

8. Executive summary of transfer package Product description Product release specifications Process description/characterization Development batch records Process development Validation Stability plan and data Documentation 8@ 2011 TBD America. All rights reserved

9. Successful start-up of a new production facility is the objective of every new facilities project. Production Scale Qualification - Goal 9@ 2011 TBD America. All rights reserved

10. Practice’ runs following mechanical completion and validation The production scale qualification (PSQ) lots are not necessarily intended to be consistency lots, thus increasing the flexibility for making necessary improvements to SOPs and batch records. PSQ lots are performed for every new process introduction, or when there has been a major process change, immediately following the traditional installation qualification (IQ), operational qualification (OQ), and process qualification (PQ) validation procedures. The PSQ lots are done under full ISO production conditions, with fully signed SOPs and batch records, in fully validated (IQ, OQ, PQ) equipment and facilities, with fully released raw materials, and full QC testing with validated testing protocols. Production Scale Qualification - Formalization 10@ 2011 TBD America. All rights reserved

11. Effective training of all involved in the new process, from management to line operators is essential to project success. Generally, training is initiated during validation activities (IQ, OQ, PQ) and completed during PSQ. All training is documented, and involves identified members of all relevant departments. Tools  Procedures, story board, flow charts  Review and check lists  SOP  O.J.T.  Test and Certify Training Development and Manufacturing 11@ 2011 TBD America. All rights reserved

12. Consistent leadership throughout the technology transfer process is an important aspect of success. The product transfer champion is a person in manufacturing or development with overall responsibility to move the project forward and the personal and managerial commitment to carry it through to completion. As leader of the technology transfer team, the project transfer champion is required to take a proactive role by directing the technology transfer team through technical and managerial difficulties, and by presenting the progress and needs of the project to the organization to ensure the availability of required resources. The project transfer champion requires a high level perspective of the process, knowledge of project status, and skill in communicating with the organization. Transfer Project Champion 12@ 2011 TBD America. All rights reserved

13. Early in the process of transfer from development to manufacturing, but after firm facilities plans have been established, it is highly desirable to have an informational meeting with appropriate 3 rd party representatives. Formalized 3 rd Party Communication 13@ 2011 TBD America. All rights reserved

14. This T2 process gives a structure for the measurement of compliance at various stages of transfer, allowing corrective action to be taken before major difficulties arise. In each of the six steps, the technology transfer team can review the situation to- date in a given project, and compare the observed situation to the expected result defined by this process. Summary 14@ 2011 TBD America. All rights reserved

15. Questions 15@ 2011 TBD America. All rights reserved Contact Us, see next page

16. Barry Stevens, PhD President TBD America, Inc. 2007 Thames Drive Arlington, TX 76017 LandLine: +1 817.465.2228 Fax: +1 817.465.2228 (prior notification) Cell: +1 817.366.4537 Skype: barrystevens58 Email: barry@tbdamericainc.com Website: www.tbdamericainc.combarry@tbdamericainc.comwww.tbdamericainc.com Contact Information @ 2011 TBD America. All rights reserved16