Oracle Argus Cloud Service Service Descriptions and Metrics

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1 Oracle Argus Service Descriptions and Metrics January 25, 2018 Table of Contents Metric Definitions... 2 Case... 2 Instance... 2 Glossary... 2 Non-Production Environment... 2 Production Environment... 2 Service Descriptions... 3 Oracle Argus Enterprise Edition Case... 3 Oracle Argus Safety Japan Case... 5 Oracle Argus Standard Edition Case... 5 Oracle Argus Enhanced Disaster Recovery Instance... 7 Oracle Argus Additional Non-Production Environment Instance... 8 Retired Skus... 9 Oracle Argus Enterprise Edition Enhanced Disaster Recovery Case... 9 Oracle Argus Standard Edition Enhanced Disaster Recovery Case Oracle Argus Enterprise Edition Additional Test Environment Instance Oracle Argus Standard Edition Additional Test Environment Instance Oracle Argus Service Descriptions Page 1

2 Metric Definitions Case Case is defined as a standard safety concept identified by a case ID number and which contains data elements related to the safety of a medicinal product. If the total number of Cases created in any Oracle Argus in a 12- month period following the s start date exceed the number purchased, then additional Cases must be purchased. Instance Instance is defined as single deployment of the application. For details of deployment specific to the application please refer to service descriptions/entitlements. Glossary Non-Production Environment Non-Production Environment may be either a Test or Development Environment provided to You as part of the Cloud Services. The Non-Production Environment(s) are specifically sized and designed for development and training purposes and may not be used for production purposes or for performance or stress testing. Any service levels, performance targets and disaster recovery described for the applicable Oracle are not applicable to Non-Production Environments. Production Environment Production Environment is defined as the environment provided to You as part of the Oracle that is designed for daily commercial use and production operations of live data. Unless otherwise specified, a single Production Environment is provided for an Oracle. Oracle Argus Service Descriptions Page 2

3 Service Descriptions Oracle Argus Enterprise Edition Case Part #: B73043 Users of the Oracle Argus Enterprise Edition are authorized to access the following modules: Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Dossier Oracle Argus Insight Oracle Argus Analytics Oracle Argus Mart Oracle B2B Usage Limits: The Oracle Argus Enterprise Edition is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle will provision one Production Environment and two Non-Production Environments (Test and Development) for this. The following usage limits apply: Metric Database Storage (TB) File Storage (GB) Bandwidth ,000 Cases* up to 5 terabytes per database instance The Oracle Argus Enterprise Edition provides 2 node RAC database and web servers for the Oracle Argus Enterprise Edition. These are load balanced to provide a high availability solution in the event of a failure on the primary servers. *If You require more than 250,000 Cases of Oracle Argus Enterprise Edition then You may need to place an additional order for Oracle Argus Enterprise Edition Production Service Level Targets: The Oracle Argus Enterprise Edition has the following service level targets: Oracle Argus Enterprise Edition 30 to 90 days 48 Hours 99.5% The Service Level Targets do not apply to the Non Production Environment(s). The does not apply in the event of a declared disaster. Third Party License Requirements: Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions and exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway. Oracle Argus Interchange module can also be used along with Axway Synchrony environment for electronic submission. The Axway Synchrony product is required as the electronic gateway for Partition Mode, as described below. Oracle Argus Service Descriptions Page 3

4 The permitted exchange protocols are AS1 and AS2 with message encryption and/or HTTPS-enabled transmission. For Oracle to provide the Oracle Argus Enterprise Edition, You are required to obtain the necessary licenses to any of the following third party software You will use: Axway Synchrony 5.12 SP4 (Partition Mode) Documentum DFC client V7.2/6.7 SP2 (64 bit) JDrug MedDRA/MedDRA J Dictionaries Microsoft Office 2013 (32 Bit) WHO Drug Dictionary For any required third party software You will use, You must purchase a license, as well as all consents, permits, and authorizations necessary for Oracle to access and use this software on Your behalf directly from such third parties as part of this offering. You must provide evidence of such licenses prior to Oracle s installation of such, as well as a copy of the licensed software if applicable, and You are responsible for supporting such software (including the purchase of support contracts from the third party vendors as applicable). For Axway Synchrony, You must provide Oracle with Your Axway Support Identifier. You will permit Oracle to use your Axway Support Identifier to file service requests with Axway. You will provide the assistance necessary for Oracle to pursue and escalate any issues and requests with Axway as needed to attempt to resolve issues impacting Your ability to use the Services; however, You are ultimately responsible for support of the Axway software. Use of the Oracle Argus Enterprise Edition offering is subject to certain expectations and requirements regarding the following 3 rd party software: 1. To use Documentum, fax, or remote printing capabilities from within the Argus, You must host within Your network the required OpenText Documentum and/or RightFax server(s) and remote printers necessary for these capabilities. You must work with Oracle to establish the necessary private circuit or VPN solution to facilitate secure fax and printer traffic between the Oracle servers and Your network. 2. To use the Oracle Argus Enterprise Edition including MedDRA, You will work with Oracle to establish the necessary private circuit or VPN solution to facilitate secure web service communications between the Oracle servers and Your network. You will be required to have authentication mechanism in place to secure the web service communication. 3. To use the SMTP capabilities from within the Argus, You must host within Your network the required SMTP Server necessary for these capabilities, and the SMTP service must be accessible to the Oracle servers over a private circuit or VPN line. 4. Any digital certificates provided by You to Oracle for the purpose of system integrations must be issued by a commercial certificate authority. The services listed below require a separate service engagement with Oracle to define, configure/ implement, test and deploy: Any data migration between versions Customer-specific migration services required for transformation of Your data to Oracle data models Oracle Argus Service Descriptions Page 4

5 All services not listed in this services description Oracle Argus Safety Japan Case Part #: B73044 Usage Limits: The Oracle Argus Safety Japan is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle will provision one Production Environment and two Non-Production Environments (Test and Development) for this. The following usage limits apply: Metric Database Storage (TB) File Storage (GB) Bandwidth ,000 Cases* up to 5 terabytes per database instance The Oracle Argus Safety Japan provides 2 node RAC database and web servers. These are load balanced to provide a high availability solution in the event of a failure on the primary servers. *If You require more than 250,000 Cases of Oracle Argus Safety Japan then You may need to place an additional order for Oracle Argus Safety Japan Production Service Level Targets: The has the following service level targets: Oracle Argus Safety Japan 30 to 90 days 48 Hours 99.5% The Service Level Targets do not apply to the Non Production Environment(s). The does not apply in the event of a declared disaster. Oracle Argus Standard Edition Case Part #: B73042 Users of Oracle Argus Standard Edition are authorized to use the following modules: Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Service Descriptions Page 5

6 Oracle Argus Dossier Oracle B2B Usage Limits: The Oracle Argus Standard Edition is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle will provision one Production Environment and two Non-Production Environments (Test and Development) for this. The following usage limits apply: Metric Database Storage (TB) File Storage (GB) Bandwidth ,000 Cases* up to 5 terabytes per database instance The Oracle Argus Standard Edition provides 2 node RAC database and web servers for the Oracle Argus Standard Edition. These are load balanced to provide a high availability solution in the event of a failure on the primary servers. *If You require more than 250,000 Cases of Oracle Argus Standard Edition then You may need to place an additional order for Oracle Argus Standard Edition Production Service Level Targets: The Oracle Argus Standard Edition has the following service level targets: Oracle Argus Standard Edition 30 to 90 days 48 Hours 99.5% The Service Level Targets do not apply to the Non Production Environment(s). The does not apply in the event of a declared disaster. Third Party License Requirements: Oracle Argus Interchange module, used with an electronic gateway, enables electronic submissions and exchanges. The Oracle B2B gateway is supported as an option for the electronic gateway. Oracle Argus Interchange module can also be used along with Axway Synchrony environment for electronic submission. The Axway Synchrony product is required as the electronic gateway for Partition Mode, as described below. The permitted exchange protocols are AS1 and AS2 with message encryption and/or HTTPS-enabled transmission. For Oracle to provide the Oracle Argus Standard Edition, You are required to obtain the necessary licenses to any of the following third party software You will use: Axway Synchrony 5.12 SP4 (Partition Mode) Documentum DFC client V7.2/6.7 SP2 (64 bit) JDrug MedDRA/MedDRA J Dictionaries Microsoft Office 2013 (32 Bit) WHO Drug Dictionary For any required third party software You will use, You must purchase a license, as well as all consents, permits, and authorizations necessary for Oracle to access and use this software on Your behalf directly from Oracle Argus Service Descriptions Page 6

7 such third parties as part of this offering. You must provide evidence of such licenses prior to Oracle s installation of such, as well as a copy of the licensed software if applicable, and You are responsible for supporting such software (including the purchase of support contracts from the third party vendors as applicable). For Axway Synchrony, You must provide Oracle with Your Axway Support Identifier. You will permit Oracle to use your Axway Support Identifier to file service requests with Axway. You will provide the assistance necessary for Oracle to pursue and escalate any issues and requests with Axway as needed to attempt to resolve issues impacting Your ability to use the Services; however, You are ultimately responsible for support of the Axway software. Use of the Oracle Argus Standard Edition offering is subject to certain expectations and requirements regarding the following 3 rd party software: 1. To use Documentum, fax, or remote printing capabilities from within the Argus, You must host within Your network the required OpenText Documentum and/or RightFax server(s) and remote printers necessary for these capabilities. You must work with Oracle to establish the necessary private circuit or VPN solution to facilitate secure fax and printer traffic between the Oracle servers and Your network. 2. To use the Oracle Argus Standard Edition including MedDRA, You will work with Oracle to establish the necessary private circuit or VPN solution to facilitate secure web service communications between the Oracle servers and Your network. You will be required to have authentication mechanism in place to secure the web service communication. 3. To use the SMTP capabilities from within the Argus, You must host within Your network the required SMTP Server necessary for these capabilities, and the SMTP service must be accessible to the Oracle servers over a private circuit or VPN line. 4. Any digital certificates provided by You to Oracle for the purpose of system integrations must be issued by a commercial certificate authority. The services listed below require a separate service engagement with Oracle to define, configure/ implement, test and deploy: Any data migration between versions Customer-specific migration services required for transformation of Your data to Oracle data models All services not listed in this services description Oracle Argus Enhanced Disaster Recovery Instance Part #: B86411 Usage Limits: The Oracle Argus Enhanced Disaster Recovery is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle Argus Service Descriptions Page 7

8 Oracle will provision one (1) Production Environment for the number of Cases defined in your order. Service Level Targets: The has the following service level targets: Oracle Argus Enhanced Disaster Recovery* 24 Hours 1 Hour 99.5% *Excluding periods of bulk load. The services listed below require a separate service engagement with Oracle to define, configure/ implement, test and deploy: Any data migration between versions Customer-specific migration services required for transformation of Your data to Oracle data models All services not listed in this services description Oracle Argus Additional Non-Production Environment Instance Part #: B84626 The Oracle Argus Additional Non-Production Environment provides for an additional Non- Production Environment for use with Your Oracle Argus. Certain programs and optional services may not be able to run in the Additional Non-Production Environment. The maintenance or upgrade schedule for the Additional Non-Production Environment is the same as the schedule for Your Production Environment. Each Additional Non-Production Environment will automatically terminate at the end of the Service Period of the associated Oracle. Performance metrics and service levels applicable to Your Production Environment(s) are not applicable to the Additional Non-Production Environment. Disaster Recovery is not available in the Additional Non-Production Environment. Usage Limits: The Oracle Argus Additional Non-Production Environment is subject to usage limits based on: A maximum number of authorized Instances as defined in your order Oracle will provision one (1) Non-Production Environment for the quantity of Instances as defined in your order. Oracle Argus Service Descriptions Page 8

9 Retired Skus Oracle Argus Enterprise Edition Enhanced Disaster Recovery Case Part #: B73048 Users of Oracle Argus Enterprise Edition Enhanced Disaster Recovery are authorized to access the following modules: Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Dossier Oracle Argus Insight Oracle Argus Analytics Oracle Argus Mart Oracle B2B Usage Limits: The Oracle Argus Enterprise Edition Enhanced Disaster Recovery is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle will provision one (1) Production Environment for the number of Cases defined in your order. Service Level Targets: The has the following service level targets: Oracle Argus Enterprise Edition Enhanced Disaster Recovery* *Excluding periods of bulk load. 24 Hours 1 Hour 99.5% The services listed below require a separate service engagement with Oracle to define, configure/ implement, test and deploy: Any data migration between versions Customer-specific migration services required for transformation of Your data to Oracle data models All services not listed in this services description Oracle Argus Service Descriptions Page 9

10 Oracle Argus Standard Edition Enhanced Disaster Recovery Case Part #: B73047 Users of Oracle Argus Standard Edition Enhanced Disaster Recovery are authorized to use the following modules: Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Dossier Oracle B2B Usage Limits: The Oracle Argus Standard Edition Enhanced Disaster Recovery is subject to usage limits based on: A maximum number of authorized Cases as defined in your order. Oracle will provision one (1) Production Environment for the number of Cases defined in your order. Service Level Targets: The has the following service level targets: Oracle Argus Standard Edition Enhanced Disaster Recovery* 24 Hours 1 Hour 99.5% *Excluding periods of bulk load. The services listed below require a separate service engagement with Oracle to define, configure/ implement, test and deploy: Any data migration between versions Customer-specific migration services required for transformation of Your data to Oracle data models All services not listed in this services description Oracle Argus Enterprise Edition Additional Test Environment Instance Part #: B73046 Oracle Argus Safety Enterprise Edition Additional Test Environment includes the following modules: Oracle Argus Service Descriptions Page 10

11 Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Dossier Oracle Argus Insight Oracle Argus Analytics Oracle Argus Mart Usage Limits: The Oracle Argus Enterprise Edition Additional Test Environment is subject to usage limits based on: A maximum number of Authorized Instances as defined in your order Oracle will provision 1 test environment for the quantity of Instances as defined in your order Oracle Argus Standard Edition Additional Test Environment Instance Part #: B73045 Oracle Argus Safety Standard Edition Additional Test Environment includes the following modules: Oracle Argus Safety Oracle Argus Affiliate Oracle Argus Interchange Oracle Argus Dossier Usage Limits: The Oracle Argus Standard Edition Additional Test Environment is subject to usage limits based on: A maximum number of Authorized Instances as defined in your order Oracle will provision 1 Test environment for the quantity of Instances as defined in your order Oracle Argus Service Descriptions Page 11

Oracle Health Sciences. Trial Management and Monitoring Cloud Service Service Descriptions and Metrics

Oracle Health Sciences. Trial Management and Monitoring Cloud Service Service Descriptions and Metrics Trial Management and Monitoring Cloud Service Service Descriptions and Metrics February 1, 2017 Table of Contents Metric Definitions... 2 Instance... 2 Trial... 2 Glossary... 2 Non-Production Environment...