2008 Oracle Corporation Proprietary and Confidential*The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decision. The development, release, and timing of any features or functionality described for Oracles products remains at the sole discretion of Oracle.Safe Harbor Statement

2008 Oracle Corporation Proprietary and Confidential

2008 Oracle Corporation Proprietary and Confidential*What is PLM? PLM enables companies to accelerate product innovation and maximize product profitabilitythrough the management of the information, processes and decisions about their products throughout the product lifecycle and across the global product network

2008 Oracle Corporation Proprietary and Confidential

2008 Oracle Corporation Proprietary and Confidential*PLM Mission: Maximize Profitability at each Phase of the Product Lifecycle

2008 Oracle Corporation Proprietary and Confidential

Project ManagerProjectThe Problem No Single View of the Product and Program Information 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

Life Science Enterprise Product Record = PLMManufacturing Data (DMR-ERP/MES Sync)Bills of MaterialsMfg. InstructionsRevision dataQuality ManagementCustomer Complaints/CAPANCMR/DeviationsAudit ManagementVoice of CustomerProcess Data (DHF/DMR)ECOs/MCOs/DeviationsChange HistoryDocumentationSupplier DataApproved VendorsQuality ManagementPricingAvailabilityDesign DataDesign Spec HistoryVerification/ValidationLab/Clinical ResultsE-Submittals (510K/PMA)

DHF Program DataSchedulesResourcesConstraintsRisk 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

*SuppliersArtwork HousesOutsourced PartnersCustomersRegulatory BodiesTesting FacilitiesMarketingSourcingManagersQualityProduct DevelopersAnalystPackManagerTest DataLogosIdeasSite AMLMESERPCostsLIMSComplaintsFormulasFINCompliance DocumentsHCMConcept BriefsCRMHACCPSample The SolutionA Central Repository with One Version of the Truth 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

2008 Oracle Corporation Proprietary and Confidential*

Agile ProductCollaboration

Engineering, Operations & Supply ChainEnterprise product record visibility, management & collaboration

Agile PLM

2008 Oracle Corporation Proprietary and Confidential

Demonstration ScenarioA live DHF/DMR system used to react quickly to issues with full CAPA management in a single system 2008 Oracle Corporation Proprietary and Confidential*C00570Training

2008 Oracle Corporation Proprietary and Confidential

DemoWhen the demo concludes:Close the demo windowClick the play button below to continue

2008 Oracle Corporation Proprietary and Confidential*1,300+ Enterprise PLM CustomersCiscoAppleGSKPhilipMorrisInternationalTysonFoodsCoca Cola

2008 Oracle Corporation Proprietary and Confidential

Agile Life Sciences CustomersAgile is the enterprise PLM market leader in medical device with 170+ customers 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

Business NeedsResults with AgileNPD&I costs were 25% higher than competitionTime to market was 20% slowerMichael Gallagher (CEO/CJO to VP QA): Keep the feds out of my office!$2.7M labor efficiency improvement15% packaging development cost savingsLow-cost compliance with FDA regulations16 global sites, 48 document & change management systemsChange cycle times of 2 weeks to up to 24 weeksNot compliant with FDA Parts 820 and 11Reduced change cycle time by 52% & administrative cost by 25%Reduced scrap and rework by $2MM per linePassed regulatory audits with minimal costsQuickly incorporate acquisitionsReduce lengthy product change cycle timesAchieve compliance with FDA QSR and Part 11Reduced change cycle time by 90%Achieved compliance with FDA QSR /Part 11Primary tool used in acquisitions to leverage new IPBring innovative robotic surgery technology to market firstMaintain compliance with regulatory requirementsBrought first product to market 7 months ahead of competition ($18M in sales & market share)Achieved compliance with FDA QSR and Part 11 requirementsAgile Medical Device Customer Results 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

Enabling Compliance with 21 CFR Part 11Agile CapabilitiesSecurityAll users must log into the system with an individual UserID and PasswordAbility to access / modify/ change / approve product records are based on roles and privilegesChange executions require double authentication which constitute the electronic signatureAgile employs encryption technology from VerisignAgile allows for configurable password management (e.g. password aging)Audit TrailAll prior revisions of product records are maintained in AgileHistory of all actions, including electronic signoff, can be displayed at the application level and printedSignoff information includes: Username, date/time stamp (local and/or server time), action performed, and commentsValidationAgile provides the Agile Validation Protocol Pak to assist Agile users in validating their implementation of Agile software. This supports the validation of Agile as a system that enables compliance with 21 CFR Part 11. 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

Requirements for Life Sciences PLMSingle, Secure Vault for all Product Record ComponentsElectronic NPI and Change Control WorkflowsInclusion of Trading/Development Partners21 CFR Part 11 ComplianceComplete Audit Records and AccountabilityIntegrated Program ManagementClosed Loop CAPA Management SystemSystem ConfigurabilityHigh User Acceptance LevelsIntegration PlatformQuick System ValidationVendor QSR for Product Development and Support 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

VP, Product ManagementVP, OperationsVP, Product ManagementVP, OperationsVP, ITVP, Quality AssuranceVP, Regulatory AffairsVP, Operations or ManufacturingVP, EngineeringVP, Supply Chain ManagementVP, Sourcing or Supply ChainWho Benefits?The challenge to accelerate more new products to market, while following all necessary FDA compliant practices 2008 Oracle Corporation Proprietary and Confidential*

2008 Oracle Corporation Proprietary and Confidential

2008 Oracle Corporation Proprietary and Confidential*Why Agile PLM

2008 Oracle Corporation Proprietary and Confidential

2008 Oracle Corporation Proprietary and Confidential*Q&AQ U E S T I O N SA N S W E R S

2008 Oracle Corporation Proprietary and Confidential

***Agile customer aggregate definition of PLM*Innovation is primary driver today across industries for PLMShift from cost cutting to profitable growth past 1-2 yearsNew products, new markets, new services top innovation drivers

*So, why is that so hard to achieve? What typically happens inside most organizations pre Enterprise PLM? Even if they have a Best of Breed application approach, this situation still occurs.*One location for all med dev product information*What does enterprise PLM solution look like how can one address all the shortcomings on the earlier slide?*Here is how Agile PLM is packaged for the marketplaceThere are 7 modules addressing the needs across an organization (starting in the upper right corner) from Development & Engineering to Operations and Supply Chain to Procurement to Quality to Compliance to Executives and the Program OfficeMore detailed info/training to follow on each of the modules**Key points:

Strong presence with Blue Chip, marquee customers in 6 industry verticalsEnterprise PLM leader in Electronics & High Tech, Life Sciences; Emerging leader in CPG/Food & BeverageStrongest customer referenceability in enterprise PLM with best track record for customer success*Speed: Fastest time to benefit Experience: 170+ medical device customerBest practice templates in AgileMD solutionGlobal team focused on medical device customer success

*Speed: Fastest time to benefit Experience: 160+ medical device customerBest practice templates in AgileMD solutionGlobal team focused on medical device customer success

***d