Technology Commercialization Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. ( Vice President for Affiliate Members Association of University Technology Managers ( Industrial Technology Research Institute Industrial Technology Research Institute Hsinchu, Taiwan October 22, 2003

What is Technology Transfer? A legal process by which rights to an intellectual asset that is owned by an academic institution, industrial organization or an independent inventor are transferred to another organization in order to facilitate the further development of the asset and its eventual commercialization into a marketed product S iuta Consulting, Inc.

What are Intellectual Assets? Intellectual assets are issued patents, patent applications, trademarks, copyrights, trade secrets and know-how that are owned by an organization and have potential commercial value S iuta Consulting, Inc.

Assessment of Intellectual Assets What is the asset What is the asset How will it be usedHow will it be used What is its potential value to industryWhat is its potential value to industry Is there a potential product Is there a potential product Novel or an improvement of a marketed productNovel or an improvement of a marketed product Is there a market for such a productIs there a market for such a product What are the competitive productsWhat are the competitive products Time and cost to develop the productTime and cost to develop the product S iuta Consulting, Inc.

Technology Commercialization Traditional out-licensing Traditional out-licensing Exclusive LicenseExclusive License Non-Exclusive LicenseNon-Exclusive License Option AgreementOption Agreement Field of Use LicenseField of Use License Worldwide or country-by-country LicenseWorldwide or country-by-country License Create a new company Create a new company S iuta Consulting, Inc.

Technology Out-Licensing Advantages Advantages Facilitate new product commercializationFacilitate new product commercialization Immediate financial reward for both University and faculty inventorsImmediate financial reward for both University and faculty inventors No further development expensesNo further development expenses Disadvantages Disadvantages Lose control of technologyLose control of technology Majority of revenue depends upon successful commercialization of technology into a productMajority of revenue depends upon successful commercialization of technology into a product S iuta Consulting, Inc.

Start-Up Company Formation Advantages Advantages Retain control of technologyRetain control of technology Faculty involvement in developmentFaculty involvement in development Financial reward depends upon the success of the company not commercialization of the technologyFinancial reward depends upon the success of the company not commercialization of the technology Disadvantages Disadvantages High risk – most fail before going publicHigh risk – most fail before going public Difficult to raise financingDifficult to raise financing Potential faculty conflicts of interestPotential faculty conflicts of interest S iuta Consulting, Inc.

Technology Licensing Process Identify potential applications Identify potential applications Prepare non-confidential Executive Summary Prepare non-confidential Executive Summary Identify potential licensees Identify potential licensees Companies that market similar productsCompanies that market similar products Have research in the same areaHave research in the same area Have the capability to develop the productHave the capability to develop the product Are seeking to enhance their product pipelineAre seeking to enhance their product pipeline Identify appropriate company contact Identify appropriate company contact S iuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary Invention Title Invention Title Summary paragraph Summary paragraph Brief description of the inventionBrief description of the invention What is the technology What is the technology What does the technology do What does the technology do Why should a licensee be interested Why should a licensee be interested Identify inventor (optional)Identify inventor (optional) Background Background Scientific rationale for the technologyScientific rationale for the technology S iuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary (continued) Detailed description of the invention Detailed description of the invention Summary of available dataSummary of available data Stage of developmentStage of development Potential advantages over marketed productsPotential advantages over marketed products Patent status Patent status What is specifically claimedWhat is specifically claimed Where and when have patents issuedWhere and when have patents issued Where and when have applications been filedWhere and when have applications been filed S iuta Consulting, Inc.

Initial Presentation of the Data: The Executive Summary (continued) Publications Publications Scientific journalsScientific journals Meeting presentationsMeeting presentations Licensing status Licensing status Type of license being offeredType of license being offered Exclusive, Non-Exclusive, Field of Use Exclusive, Non-Exclusive, Field of Use Territories available Territories available S iuta Consulting, Inc.

Basic License Terms License Execution Fee paid upon signing License Execution Fee paid upon signing Milestone Payments Milestone Payments Investigational New Drug Application (IND) filingInvestigational New Drug Application (IND) filing Initiation of Phase I clinical trialsInitiation of Phase I clinical trials Initiation of Phase II and/or Phase III clinical trialsInitiation of Phase II and/or Phase III clinical trials New Drug Application NDA filingNew Drug Application NDA filing Regulatory approval to market the productRegulatory approval to market the product Annual maintenance fees Annual maintenance fees Royalties on net sales of product Royalties on net sales of product S iuta Consulting, Inc.

Why Start a Company? Facilitate commercialization Facilitate commercialization Promote economic development Promote economic development Create employment opportunities locallyCreate employment opportunities locally Faculty recruitment and retention Faculty recruitment and retention Financial incentives Financial incentives Potential for greater financial returnPotential for greater financial return University receives equity in the companyUniversity receives equity in the company Faculty become employees and/or shareholdersFaculty become employees and/or shareholders S iuta Consulting, Inc.

Start-Up Company Formation Assessment of the intellectual asset Assessment of the intellectual asset Early stage discoveryEarly stage discovery Breakthrough platform technologyBreakthrough platform technology Single or multiple productsSingle or multiple products Stage of developmentStage of development Time and cost to develop the product(s)Time and cost to develop the product(s) Worldwide market potentialWorldwide market potential Extensive worldwide patent coverageExtensive worldwide patent coverage S iuta Consulting, Inc.

Creating the Company Identify appropriate business personnel Identify appropriate business personnel Create a Business Plan Create a Business Plan Transfer the technology from the University to the Company through a License Agreement Transfer the technology from the University to the Company through a License Agreement Raise the necessary capital Raise the necessary capital Identify potential inventor/founder conflicts of interest Identify potential inventor/founder conflicts of interest S iuta Consulting, Inc.