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The Oracle Health Sciences Cloud Services – GA and EOL Dates document, which is available atwww.oracle.com/contracts, lists current generally available (GA) and end of life (EOL) Oracle HealthSciences Cloud Service versions.Deliverables and Customer DependenciesOracle Responsibilities – The deliverables for a given project are dependent upon the componentsincluded in that project. Not all projects will produce all of the deliverables and entitlements listedbelow. Some common deliverables and entitlements that apply to projects include: InForm Program Release for UAT – This is the initial release by Oracle of the configured InFormprogram in the UAT instance of Your InForm Cloud Service that You may use to conduct useracceptance testing activities. InForm Program Release for Go-Live – This is the release by Oracle of the configured InFormprogram in the Production instance of Your InForm Cloud Service that Your approved Usersmay access. Database Extracts – These database extracts may be used by You to analyze and report onYour data captured by the configured InForm program. Archives – Archives and reports for Your Trial are available for You and Your Sites to generateand download via the InForm CRF Submit self-service functionality within the InForm CloudService, subject to Your obligations below. There is no limit on the number of archives andreports which may be generated by You and Your Sites through CRF Submit during the Trial upto Your Request for Decommission. Online Training for Named Trials for InForm Users and for User Management Tool (UMT)Users – The list of available online courses is provided in the Oracle Health Sciences OnlineTraining for Oracle Health Sciences InForm Cloud Service Data Sheet User Management Tool (UMT) Non-Production Environment – Except for critical patchupdates, the latest generally available release of UMT will be released in the UMT nonproduction environment prior to release in the UMT production environment. Your UMT Usersare entitled to access the latest generally available release of UMT in the UMT non-productionenvironment to try new features, to update sponsor internal standard operating procedures,and to train sponsor end users to perform common trial administration tasks (including importof Users, Sites, and roles) prior to accessing the latest generally available release of UMT in theUMT production environment. The UMT non-production environment has no connectivity toInForm or Identity and Access Management Service (IAMS). Except for critical patch updates,the latest generally available release of UMT will be deployed in the UMT non-productionenvironment at Oracle’s discretion, approximately three calendar weeks to 60 calendar daysprior to release in the UMT production environment. The release preview timeframe will varydepending on the content of the release and the significance of new features. Clinical Development Analytics (CDA) – If requested by You, Oracle will deploy the OracleHealth Sciences Clinical Development Analytics (CDA) integration package into the InForm Trialdatabase to help support integration of the Trial with compatible versions of CDA that Youhave licensed and deployed outside of the Oracle Cloud Services environment. Lab Normals Management Tool – If requested by You, Oracle will deploy Lab NormalsManagement Tool (LNMT) with Your InForm Trial. LNMT must be configured by You, or OracleOracle Health Sciences InForm Cloud Service – Service DescriptionsPage 7 of 28

may assist with Your configuration of LNMT for an additional fee. InForm Integration – If requested by You, Oracle will deploy Standard File-Based Integrationswith Your InForm Trial. A Standard File-Based Integration integrates InForm Trials with certainexternal systems via a flat file transfer. The integration(s) must be configured by You, or Oraclemay assist with Your configuration(s) of the integration(s) for an additional fee. Report Extractor – If requested by You, Oracle will deploy Report Extractor for You to use withYour InForm Trial(s). Oracle will initially configure Report Extractor to connect to up to 200 ofYour InForm Trials. Initial configuration may include configuration of Report Extractor for upto 20 Cognos Reports or SQL objects, which must be developed by You, or Oracle may assistwith Your development of Cognos Reports or SQL objects for an additional fee. Design of theCognos Reports or SQL objects must conform to Report Extractor requirements andspecifications. After initial configuration of Report Extractor by Oracle, You will be responsiblefor any further configuration changes. Clinical One Integration Hub – If Your Trial includes integrations that require Oracle HealthSciences Clinical One Integration Hub, Your use of Oracle Health Sciences Clinical OneIntegration Hub is included with Your purchase of Oracle Health Sciences InForm CloudService. Any such integration(s) must be configured by You, or Oracle may assist with Yourconfiguration(s) of the integration(s) for an additional fee. Maintenance of the Cloud Services – Oracle will maintain the Cloud Services in accordance withthe Oracle Cloud Hosting and Delivery Policies and Oracle Global Business Unit Cloud ServicesPillar Document, including upgrades. Upgrades are applied per InForm server and all Trials onthe same server are upgraded at the same time.oMaintenance of the Production instance – Upgrades and migrations are scheduled with Youand are performed during the maintenance window.oMaintenance of the UAT instanceo Upon request, Oracle will update the UAT instance with a fresh extract of the Productioninstance each time a change or fix to the InForm program in the Production instancerequires testing. Upgrades and migrations are scheduled with You and are performed during businesshours. For Trials using InForm versions prior to version 6.1.1, maintenance of the UAT instancemay require a maintenance window for Your Production instance.Maintenance of the Training instance If applicable, You may request that the Training instance be updated to reflectsubsequent changes or fixes within the Production instance. Copying Data from theProduction instance to the Training instance is not allowed. Upgrades and migrations are scheduled with You and are performed during businesshours.Production instance backups – The terms of the Oracle Cloud Hosting and Delivery Policies andOracle Global Business Unit Cloud Services Pillar Document apply for the purpose of Productioninstance backups. Backups are not intended for and cannot be used for purposes of archiving aOracle Health Sciences InForm Cloud Service – Service DescriptionsPage 8 of 28

Trial. Oracle will make the following backups of Your Data hosted by Oracle in the Productioninstance.oDaily backups of hosted application system and database files.oOn four-hour intervals, backups are made of the Oracle Database Archive files whereapplicable.oDaily replication of backups to an offsite facility. A decommissioning package (i.e. archival Trial database and associated files related to hostingthe Trial Production instance including integrations, if any) will be provided to You fordownload after decommissioning. Notwithstanding anything to the contrary in the agreementor the Service Specifications, Oracle provides Your Data from the Production instance of theCloud Services as part of the decommissioning package. You will have 60 days to review andaccept the decommissioning package as described under Your Responsibilities below. Archival documentation related to Oracle services will be provided to You for downloadperiodically during the Services Period.Your Responsibilities – Your responsibilities related to the above services are dependent upon thecomponents included in the project, including but not limited to: If You require a Training instance for Your Trial, You are responsible for requesting that Oracledeploy a Training instance. If You build Your own Trials, (i) the initial Trial build related to project initiation and programset-up tasks to prepare the InForm program for user acceptance testing; and (ii) any post golive fixes and changes. In accordance with Your standard operating procedures and/or work instructions, testing theInForm program (e.g., conducting user acceptance testing) as well as creating and testing Yourown test cases. In accordance with Your standard operating procedures and/or work instructions, ensuringpackages and scripts are adequately tested before sending them to Oracle for deployment onYour UAT and Production instances. For any packages or scripts submitted by You, it is Yourresponsibility to examine the implementation logs for potential error messages and takeappropriate action. Note that a ‘successful’ ticket completion means the script completed withor without errors. For integration of Your InForm Trials to Clinical Development Analytics (CDA), You areresponsible for submitting a request for the deployment of the CDA integration package toeach InForm Trial. For CDA deployed on Your premise, You will also need to provide necessarynetwork connectivity to support this integration (e.g. VPN, MPLS, other such networkconnectivity) which may need to be ordered separately. User Management – You are responsible for managing access to Your Trial using the Identityand Access Management Service (IAMS), as well as adding Site and User information into UserManagement Tool (UMT), and/or for the initial creation of the Sites and Users by providing acompleted Oracle template listing the Site and User information to be loaded into UMT. Performing testing and training in the UMT non-production environment in accordance withYour standard operating procedures and/or work instructions as well as creating and testingOracle Health Sciences InForm Cloud Service – Service DescriptionsPage 9 of 28

Your own test cases. Ensuring that all users are trained prior to accessing the system. This includes maintaining alltraining records. All Data management activities for the Trial, including but not limited to dictionary coding,query resolution, Serious Adverse Event (“SAE”) reconciliation, and Trial lock. Managing and overseeing third party vendors (e.g., lab vendors, external partners, Yoursubcontractors, etc.). If Oracle will not supply End User Helpdesk support then You mustensure Your End User Helpdesk vendor is aware they need to administer Oracle users whereappropriate. While InForm may be used to assist in adverse event notification, InForm is not designed to bea comprehensive safety case handling system. Should You decide to use the Cloud Service forcollection and reporting of serious adverse events, You remain responsible for ensuring that allapplicable regulatory obligations are met. Database Extracts – It is Your responsibility to request an export online and to download theexport. Authorized Users may obtain a database extract in one of two ways: oProactively log into InForm and generate an extract as neededoRequest Oracle to schedule the extract generation – You may request up to once per dayfor Your Trial in this mannerArchives for Your TrialoYou and Your Sites are responsible for generating, downloading, and maintaining anyarchive and/or study submission PDFs, as well as any reports (“CRF Submit Self-ServiceFiles”) that You or Your Sites may require for Your Trial through CRF Submit. Archive filesare intended to document the Data as it existed in Your Production instance of theconfigured InForm program. There is no limit on the number of CRF Submit Self-Service Files which may begenerated by You and Your Sites through CRF Submit during the Trial up to YourRequest for Decommission. You may choose to generate CRF Submit Self-Service Files on behalf of Your Sites,however You are responsible for ensuring that Your Sites download their CRF SubmitSelf-Service Files directly using CRF Submit. CRF Submit Self-Service Files will be deleted or otherwise rendered inaccessible byOracle upon the earlier of 120 calendar days after they were generated ordecommissioning of the Cloud Service, and the CRF Submit Self-Service Files will not beavailable for download after such time. CRF Submit, and the CRF Submit Self-ServiceFiles, will not be available after decommission. You are responsible for making Your Sites aware of the services and their obligationshereunder. If at any time there is a failure in the storage drive that stores CRF Submit Self-ServiceFiles and storage cannot be restored after commercially reasonable effort, then You areresponsible for regenerating the files using CRF Submit.Oracle Health Sciences InForm Cloud Service – Service DescriptionsPage 10 of 28

Your Request for Decommission confirms both Your and Your Sites’ acceptance of theCRF Submit Self-Service Files. You are responsible for ensuring that You do not submitYour Request for Decommission until You and Your Sites have requested, downloaded,and reviewed the CRF Submit Self-Service Files that You and Your Sites require. It isrecommended that You request Database Lock and that the final CRF Submit SelfService Files be generated and downloaded by You and Your Sites in a manner thatpermits sufficient time for review prior to the end of the Services Period. You areresponsible for executing any extensions to Your order that You and Your Sites mayrequire due to Your failure to submit Your Request for Decommission by the end of theServices Period.Reviewing and accepting the following deliverables within sixty (60) calendar days of Oracle’snotice that the deliverables are available to you (the “acceptance period”) by signing thedesignated Oracle forms within the acceptance period. If You fail to provide written notice ofnon-acceptance to Oracle within the acceptance period, as provided above, the deliverablesshall be deemed accepted as of the end of the acceptance period and Oracle may permanentlydelete or otherwise render inaccessible the deliverables and Your Trial data in Your instance(s):othe decommissioning packageorelevant archival documentation related to Oracle services Distributing the decommissioning package and archival documentation, as appropriate. Submitting Your Request for Decommission prior to the end of the Services Period. oIf You require additional time beyond Your Services Period, You will be required to executean extension to Your contract.oIf You fail to meet Your obligation to submit the Request for Decommission prior to the endof the Services Period and You have not ordered an extension to the Services Period, YourTrial will be decommissioned upon the end of the Services Period.If You build Your Trials, You are responsible for submitting a request for decommission.Oracle Health Sciences InForm Direct Cloud Service – Base Fee – TrialPart #s:B91561 – Oracle Health Sciences InForm Direct Cloud Service, Base Fee, Phase 1 - TrialB91564 – Oracle Health Sciences InForm Direct Cloud Service, Base Fee, Phase 2 - TrialB91567– Oracle Health Sciences InForm Direct Cloud Service, Base Fee, Phase 3 - TrialB91570 – Oracle Health Sciences InForm Direct Cloud Service, Base Fee, Phase 4 - TrialB91573 – Oracle Health Sciences InForm Direct Cloud Service, Base Fee, Device - TrialB91708 – Oracle Health Sciences InForm Direct Cloud Service – Trial (Retired)Modules and FeaturesUsers of this Cloud Service are authorized to access the following modules: InForm programInForm AdapterInForm CRF SubmitOracle Health Sciences InForm Cloud Service – Service DescriptionsPage 11 of 28

InForm PortalInForm PublisherLab Normals Management Tool (LNMT)User Management Tool (UMT)User Management InterfaceIdentity and Access Management Service (IAMS)Users and Access by UsersYour use of the Cloud Services is limited to personnel related to Your Trial as authorized by You.Normally this consists of two main groupings of personnel: sponsor and Site. The sponsor grouptypically consists of personnel from Your company and may also include other sub-contractedpersonnel (such as Contract Research Organization personnel, monitors, and data managers). TheSite personnel typically consist of the Site coordinators (clinical research coordinators) and studyinvestigators (principal investigators and sub-investigators).Identity and Access Management Service (IAMS): Oracle Health Sciences Identity and AccessManagement Service (IAMS) provides Oracle single sign-on (SSO) functionality for InForm DirectCloud Service for IAMS-enabled versions of InForm. IAMS manages identity and access requests byUsers and roles. IAMS uses coarse-grained authentication to evaluate if Users have been assignedprivileges to open an InForm page that they are trying to access. For IAMS-enabled versions ofInForm, Users may access an InForm page to which they are provided privileges using a single signon account. Once an InForm page is accessed by a User using a single sign-on account, the User willautomatically be signed into such InForm page for future access. IAMS is supported for UAT andProduction instances in newly deployed environments of InForm 6.1 or later. IAMS will not besupported for Training instances. Fine-grained privilege access control features may be accessedthrough the InForm program as described in the InForm program documentation.Usage LimitsThe Cloud Service is subject to usage limits based on: A maximum of one (1) Trial Limited to use for the Phase (as defined above) identified in the order The following usage limits apply:CLOUD SERVICEOracle Health Sciences InForm Direct Cloud Service – Phase 1;Oracle Health Sciences InForm Direct Cloud Service – Phase 2;Oracle Health Sciences InForm Direct Cloud Service – Phase 3;Oracle Health Sciences InForm Direct Cloud Service – Phase 4;Oracle Health Sciences InForm Direct Cloud Service – ITH CLOUDSERVICE25 GBN/AN/A1 Trial pack(Production,UAT, Training *)* A Training instance will be provided if requested by You.Service Level TargetsThe Cloud Service has the following service level targets:Oracle Health Sciences InForm Cloud Service – Service DescriptionsPage 12 of 28

CLOUD SERVICERECOVERY TIMEOBJECTIVE (RTO)RECOVERY POINTOBJECTIVE (RPO)TARGET SYSTEMAVAILABILITYOracle Health Sciences InForm Direct Cloud Service (all)90 days48 Hours99%The Service Level Targets do not apply to the non-production instance(s). The Target SystemAvailability does not apply in the event of a declared disaster. The Recovery Time and Recovery PointObjectives do not apply to customizations or third party software. For the purposes of this CloudService, the Service Level Targets above take precedence over anything to the contrary in the OracleCloud Policies.Oracle Cloud PoliciesThe Services are subject to the Oracle Cloud Hosting and Delivery Policies and Oracle Global BusinessUnit Cloud Services Pillar Document, which may be viewed at www.oracle.com/contracts.The Oracle Health Sciences Cloud Services – GA and EOL Dates document, which is available atwww.oracle.com/contracts, lists current generally available (GA) and end of life (EOL) Oracle HealthSciences Cloud Service versions.Deliverables and Customer DependenciesOracle Responsibilities – The deliverables for a given project are dependent upon the componentsincluded in that project. Not all projects will produce all of the deliverables and entitlements listedbelow. Some common deliverables and entitlements that apply to projects include: InForm Program Release for UAT – This is the initial release by Oracle of the configu

Direct Cloud Service, “Phase” refers to the clinical research phase or type of clinical trial, including *Phase 1, *Phase 2 , *Phase 3, *Phase 4 , or *Device. *Phase 1, *Phase 2 , *Phase 3, and *Phase 4 refer to the clinical research phase of a Trial for an investigational d