Software and Infrastructure as a Service

Agreement
SERVICE ORDER #2

Service Order No. 2 - GPS United Implementation

4200179534
PO#___________________________

This Service Order

RXLOGIX Corporation Supplier Software and Infrastructure
as a Service with Limited Professional Services Agreement between the Parties effective
February 1, 2023 ons of the
Agreement. This Service Order is effective as of the last date of signature below. No
chargeable work shall commence or accrue prior to such date.
Capitalized words that appear in this Service Order are defined in the Agreement.

Current Start Date: 01-Feb-2023 Projected End Date: 31-May-2025

I. Description of Services and Milestones

1.
RxLogix and Lilly are working together to replace current Global Patient Safety (GPS)
technology environment (e.g., systems, structure, resources, etc.) that are not adequately

analysis of increasingly complex data. RxLogix is proposing to implement PV Case

Management (PVCM), PV Reports (PVR), PV Signal (PVS), PV Quality (PVQ), PV Central
(PVC), PV Analytics (PVA), PV Datahub (PVD) and PV Gateway, PV Risk Manager (PVRM)
and PV Publisher (PVP). Together these applications are called PV Products.
As part of scoping workshops, Lilly and RxLogix agreed to implement the platform in a phased
manner. Phase 1 will focus on delivering the Minimum Viable Product (MVP) for transitioning
over from current safety system and phase 2 to deliver additional features and capabilities that
need to be defined as per business need. Phase 2 scope will be determined during the future state
assessment and to-be process creation that is expected to be executed in the first quarter of
2023.RxLogix will provide necessary support in the future state assessment and share industry
best practices that will help in to-be process creation.
For Phase 1, below are specific purposes of PV products and their Business Processes,
Requirements, and Configuration
Implement PVCM as Case Intake and Case Management platform. PVCM
provides automation across case intake and case processing functions.
Implement PV Surveillance Suite (PVR, PVQ, PVS, PVA and PVC) as integrated
signaling, reporting, and data analysis platform.
Implement PVD and interface with internal and external data sources for
signaling and reporting.
Configure workflow, product/studies/rules (PSR) and other configurations (e.g.,
Letter Templates, Case Forms, Priority, User Groups, Privacy, etc.) in PVCM as
per Lilly requirements
Configure report templates, reports, and queries in PVR as per Lilly requirements
Configure Signal Detection and Signal Management system for Safety
Observation Detection, Signal Validation, Signal Confirmation, Analysis and
Prioritization, Assessment and Recommendation for Action.
Configure standard signal detection algorithms and search strategies.
Calendaring, action tracking, notification, and schedule management for
Signaling and Aggregate Reports Submissions
Infrastructure
Setup and configure five environments for Sandbox, Development, Test/Training,
Validation, and Production
Development, Test/Training, Validation environments are expected to have
redacted production like case data set
Host the following modules from RxLogix Product Suite in RxLogix Cloud:
o PVD
o PVCM
o PVS
o PVR
o PVA
o PVC
o PVQ
o PV Gateway
Provide scalable and performant system to support volume and user base.
Host external data sources such as FAERS and EVDAS (Vigibase is out of scope)

Data Migration
 Leverage RxLogix Standard Pre-Validated ETL to transfer data from Argus to
RxL PVD.
Build and deploy custom mappings to migrate custom tables and custom
transformation logic applied to standard fields existing in LSS that are not
included in the RxLogix Standard Pre-Validated ETL.
Leverage RxLogix standard utility to migrate data from Lilly Signal Management
System to RxL PVD including alerts from EVDAS.

Integrations and Automation (including AI and ML)

Configure interfaces to integrate with other Lilly applications.
Automation of high-volume Lilly forms.
Automation of unstructured sources and handwritten forms.

Validation activities and documentation

Lilly provides input to User Requirement Specifications.
RxLogix and Lilly jointly provide input to develop Functional Requirement
Specifications.
Create Design Specification (for customization such as data migration) and
Configuration Specification documents.
Perform Configuration Verification using Conference Room Pilots and Day in the
life testing. RxLogix team will conduct a conference room pilot as per the product
incremental plan to simulate day-in-a-life scenarios encompassing work
performed in all the sprints.
Develop Application Installation IQs, Regression OQ and Lilly requirements and
configuration driven OQ Test Scripts, and Traceability Matrix.
Dry run and formal execution of IQ and OQ test scripts
Development and dry run of PQ scripts and execution support
Validation deliverables may be created leveraging RxLogix standard validation
package as required.

Training and Controlled Documents

Provide Standard Training Material and User Guide.
Provide project team training in person and remotely.
Support the development of a training plan and end user training content.
Support the impact assessment and update of controlled documents.

Hypercare
Hypercare support for all systems for a duration of 3 months .
2.
The project approach will follow Lilly Agile delivery model that is based on Scrum. RxLogix
commits to Lilly Agile delivery model and commits to agile Scrum training of appointed key
resources. Lilly may offer training to the appointed key resources. In collaboration with Lilly and
RxLogix both parties will be part of prioritization of the defined Epics and Features and must
ensure
strategy in mind. RxLogix will play an active part in the Scrum events and artifacts (e.g., PI
planning, Sprint/Iteration planning, Review, Demo), and thereby defining work, prioritize and
deliver on the planned work.

2.1
The following chart provides the proposed project high-level timelines for Phase 1 and roadmap
for various stages of implementation.

Key project milestones will be defined during Product Increment (PI) planning that will be
initiated in the last sprint of the preceding PI. The effort and cost may get revised based on the
scope defined for a specific PI. Change request may not be required unless the projected
cumulative milestone payment starts to go beyond the total fee for Phase 1 as described in
section II.
2.2
The table below list key resources, their roles and allocation, on-site/offshore split PI
according to the roadmap. As part of PI planning, Business Analysts and Testing Resources
required for supporting configuration, testing and deployment activities will be identified and
added to respective scrum teams.

# Role Description / Expertise Location

1 Portfolio Manager Provide oversight and risk management India
2 Program Scrum Master Provide overall project leadership and project US
management
3 Product Leads Case Provide business and configuration expertise US
Management in Case Management area
4 Product Lead Signal Provide business and configuration expertise US
Management Workstream in Signaling area
Lead
5 Product Lead - Reporting Provide business and configuration expertise US
Workstream Lead in Reporting
6 Product Release Manager Provide installation and technical TBD
configuration expertise
7 Feature Owner Case Scrum master and workstream lead for Case US
Intake and Processing Intake and Processing
8 Feature Owner Product Scrum master and workstream lead for Case India
Study Reportability and Intake and Processing
E2B
9 Feature Owner Japan Scrum master and workstream lead for Japan Japan
Case Management Case Management
10 Feature Owner - Data Technical lead and owner of all Data India
Migration Lead Migration methodologies
11 Feature Owner Signal Scrum master and workstream lead for Signal India
Management Management
12 Feature Owner Signaling Scrum master and workstream lead for India
Data Migration Signaling Data Migration
13 Feature Owner -Global Scrum master and workstream lead for Global India
Reports and Metrics Reports and Metrics
14 Feature Owner -Japan Scrum master and workstream lead for Japan Japan
Reports and Metrics Reports and Metrics
2.3

2.3.1
Agenda

2.3.2
Agenda
 2.3.3
The governance for Scrum teams, communication plan, cadence frequency will be defined
during PI-0. RxLogix and Lilly team will be trained in the agile way of working before
onboarding for effective governance.

2.4
Phase-1 Implementation will be executed by 6 workstreams that are organized by PV
suite/subject area and expected to work collaboratively for delivering an integrated platform.
The 6 workstreams are:
Case Management
Reports & Compliance
Signal Management
Validation
Technology
Change Management
Project Management

The scope of Phase 1 implementation was defined and agreed upon during scoping and planning
sessions jointly conducted by RxLogix and Lilly. To estimate the effort, the key Scope Items
were identified, and the current scope was defined based on current business process. As growth
is expected over the timeframe of implementation, the high value indicates expected growth and
included in effort for delivering Phase 1 scope. Impact indicator is also assigned to estimate level
of effort and impact on project timelines that must be considered if the actual scope is
significantly higher than the current estimated scope or projection for Go-Live. This indicator
shall help Lilly and RxLogix jointly make informed decisions while prioritizing change in scope
during the project execution as scope beyond the project scope for go live may lead into a change
order.
Features identified as backlog for Phase-1 go live shall be considered for inclusion into scope for
Phase -2 or later after the to-be process is created by end of Q1 2023. Some of these backlog
features may be prioritized for Phase-1 jointly by Lilly and RxLogix based on business
criticality. Prioritization may alter the PI plans and associated deliverables and milestones.

2.4.1
The section below describes activities, deliverables for the Case Management workstream.
Activities and Deliverables across Case Management workstream
RxLogix Activities Lilly Activities
RxLogix PVCM Requirements Specifications Provide input, review, and
(RS) approve Requirements
Draft requirements Specifications and CSD.
Conduct the Requirement Workshop to review Participate in required
the draft RS and gather feedback workshops and training
Review and obtain approval of the RS sessions.
Configuration Specifications Document (CSD)
Conduct Configuration Workshop and review
configuration features
Develop CSD using feedback from the
configuration workshop
Review and obtain approval of the CSD
Configure PVCM for the scope specified in
section 2.4.1.1, 2.4.1.2, 2.4.1.3, 2.4.1.4
Deliverables
Requirements Specification Document (RS) N/A
Configuration Specification Document (CSD)
Configured System in various environments

General Assumptions
Lilly will involve their business, IT, and quality teams in the process to ensure that
requirements are well understood.
Requirements will be finalized and agreed upon by Lilly before the configuration
workshop.
RxLogix will leverage existing best practice design documents for PV SUITE
components
Standard Out-of-the-Box (OOTB) features and configuration would be leveraged as the
baseline and modified as per client requirements.
All deliverables and documents will be developed in English using RxLogix standard
templates. Specific summary documents / presentations can also be made in Japanese to
support Lilly.
 The section below describes sub-workstream activities, deliverables, scoping
assumptions, general assumptions, and Responsibility, Accountability, Consulted,
Informed (RACI) matrix.

Case Management workstream involves 4 sub workstreams focusing on the following key
features:
1. Case Intake and Processing
2. Product, Study and Expedited Reporting Configurations
3. Japan Case Management
4. Argus Data Migration

2.4.1.1
This section describes scope Current for Phase 1 and RACI to clearly define the workshare
between RxLogix and Lilly.
 Multilingual The Affiliate process mapping
Forms initiative will define the business
process for case entry and languages
(expected to be up to 10) to be
prioritized based on volume.

Change of
Scope

2.4.1.1.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Updates to RxLogix Feature RxLogix Lilly and Lilly and RxLogix
requirement and Owner Feature Owner RxLogix Portfolio
config specs Product Owners Management
Requirement and RxLogix Feature RxLogix Lilly and Lilly
Design Workshops Owner Feature Owner RxLogix
Product Owners
 and RxLogix
Senior
Management
Conference room RxLogix Feature Lilly Feature Lilly and Lilly and RxLogix
Pilot Owner Owner RxLogix Portfolio
Product Owners Management
Configuration in RxLogix BQA RxLogix Lilly and Lilly and RxLogix
Dev,Val and Prod Feature Owner RxLogix Portfolio
Product Owners Management
Environment Smoke RxLogix BQA RxLogix Lilly and Lilly and RxLogix
Testing Feature Owner RxLogix Portfolio
Product Management
Owners
Approvals of RS, Lilly Feature RxLogix Lilly and Lilly and RxLogix
OQs, PQs and other Owner Feature Owner RxLogix Portfolio
project deliverables Product Owners Management

2.4.1.1.2

Automated
Literature Automated Intake of Literature using ML is on the Product roadmap
Intake and will be leveraged for Literature Intake

2.4.1.2
This section describes scope Current for Phase 1 and RACI to clearly define the workshare
between RxLogix and Lilly.

Projecte
d for Go
Live

Lilly does not use

functionality in Argus.
 Auto-listedness functionality in
PVCM to be evaluated as part of to-
be process exercise

2.4.1.2.1

Activities Responsibility Accountability Consulted Informed

/Deliverable
Updates to RxLogix Feature RxLogix Lilly and Lilly and
requirement and Owner Feature Owner RxLogix RxLogix
config specs Product Owners Portfolio
Management
Workshops RxLogix Feature RxLogix Lilly and Lilly
Owner Feature Owner RxLogix
and RxLogix
Product Owners
Senior
Management
Conference room RxLogix Feature Lilly Feature Lilly and Lilly and
Pilot Owner Owner RxLogix RxLogix
Product Owners Portfolio
Management
Configuration in RxLogix BQA RxLogix Lilly and Lilly and
Sandbox, Dev, Val, Feature Owner RxLogix RxLogix
Training and Prod Product Owners Portfolio
Management
Environment Smoke RxLogix BQA RxLogix Lilly and Rx Lilly and
Testing Feature Owner Logix Product RxLogix
Owners Portfolio
Management
E2B Pilot Lilly Product RxLogix Lilly and Rx Lilly and
Regulatory Owner/ Business Feature Owner Logix Product RxLogix
Communications SME Owners Portfolio
Management
E2B Gateway RxLogix BQA Lilly BQA RxLogix and Lilly and
Testing Lilly Feature RxLogix
Owners Portfolio
Management
E2B Certificate Lilly Feature RxLogix Lilly and Lilly and
Creation and Owner Feature Owner RxLogix RxLogix
Provisioning Product Portfolio
Manager Management

2.4.1.2.2

Veeva CTMS For Phase 1 the proposal is to use existing notification process
Integration PV Admin excel based load can be used for Product and Study Load
Integration with Veeva CTMS may be productized be built as a standard
functionality

2.4.1.3

Complexity of Forms
Medium: 6-9
o U-GUIDE AE Form (Initial)
o GCC/PCP PDF
o Business Alliance
o PMS CSV/PDF Line Listing for
8 11 Non-Serious Cases
Complex: 2
o U-GUIDE AE Form (Follow-up)
o PMS: Max 5 forms. These five
PMS AE Forms follow
standardized format with slight
variation, currently scoped as 1
complex form
 No current interface with EDC.
1 1 Mosaic J sends E2B R3 with
Attachment to Argus
All AE Reports from Business
1 1 Alliance, Call Center and other
sources is sent to 1 mailbox
Complexity: Simple
Not used for Narrative field in a
5 6 case
Used for sender comment, J2.11,
J2.10
Complexity: Simple
5 6

5 reporting destinations for E2B data

exchange with:
PMDA
5 6
Medpace-XML,
LabCorp-XML
2 Business Alliance Partners
Change of Any significant scope increase will
Scope require estimation and may result in
Change Request

2.4.1.3.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Updates to RxLogix RxLogix Lilly Global and Lilly and RxLogix
requirement and Feature Owner Feature Owner Japan and RxLogix Portfolio
config specs Product Owners Management
Requirement and RxLogix RxLogix Lilly Global and Lilly
Design Feature Owner Feature Owner Japan and RxLogix
and RxLogix Senior
Workshops Product Owners
Management
Conference room RxLogix Lilly Feature Lilly Global and Lilly and RxLogix
Pilot Feature Owner Owner Japan and RxLogix Portfolio
Product Owners Management
Configuration in RxLogix BQA RxLogix Lilly Global and Lilly and RxLogix
Sandbox, Dev, Feature Owner Japan and RxLogix Portfolio
Val, Training and Product Owners Management
Prod
Environment RxLogix BQA RxLogix Lilly Global and Lilly and RxLogix
Smoke Testing Feature Owner Japan and RxLogix Portfolio
Product Owners Management
Approvals of RS, Lilly Feature RxLogix Lilly Global, Japan Lilly and RxLogix
OQs, PQs and Owner Feature Owner and RxLogix Product Portfolio
other project Owners Management
deliverables

2.4.1.3.2

Automation of Letter Out of box features will be evaluated

formatting and If not met, the feature may be included as a standard
transmission functionality
Japan Device Case
Entry and Reporting Lilly Japan will continue with iKIKI during Phase 1 and Phase 2

2.4.1.4
This section describes scope Current for data migration from Argus to PV Data Hub and RACI
to clearly define the workshare between RxLogix and Lilly.

Data Migration In- Scope High

 Data Migration Out of High
Scope

Data Migration Change of High

Scope

2.4.1.4.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Data Extraction from Lilly Feature RxLogix Lilly and Lilly and RxLogix
Source Owner Feature Owner RxLogix Portfolio
Product Owners Management
Data Profiling RxLogix Feature RxLogix Lilly and Lilly and RxLogix
Owner Feature Owner RxLogix Portfolio
Product Owners Management
Source to Target RxLogix Feature RxLogix Lilly and Lilly
Mapping Owner Feature Owner RxLogix
and RxLogix
Product Owners
Senior
Management
Dry Run RxLogix Feature Lilly Feature Lilly and Lilly and RxLogix
Owner Owner RxLogix Portfolio
Product Owners Management
Setup in Sandbox, RxLogix BQA RxLogix Lilly and Lilly and RxLogix
Dev, Val and Prod Feature Owner RxLogix Portfolio
Product Owners Management
Migration Dry Run RxLogix BQA RxLogix Lilly and Rx Lilly and RxLogix
Feature Owner Product Portfolio
Owners Management
Business Testing Lilly Feature RxLogix Lilly and Rx Lilly and RxLogix
Owner Feature Owner Product Owners Portfolio
Management
Approvals of Lilly Feature RxLogix Lilly and Lilly and RxLogix
Specifications, OQs, Owner Feature Owner RxLogix Portfolio
PQs and other Product Owners Management
project deliverables

2.4.1.4.2
Not applicable

2.4.2
The section below describes activities, deliverables for the Reports and Compliance
workstream.
RxLogix Activities Lilly Activities
Scoping and Impact Assessment Provide inputs, review, and approve
Conduct Requirement Confirmation Requirements Specifications and
Workshops and Conference Room Pilots CSD.
Update PVR Requirements Specifications Participate in required workshops
(RS) and training sessions.
Draft requirements Configure reports following
Review and obtain approval of the RS configuration specification strategy
Update PVR Configuration Specifications documented in CSD
Document (CSD)
Update CSD
 Review and obtain approval of the
CSD
Configure PVR
standard configuration, baseline
reports, and configure reports as per
the scope defined in section 2.4.2.1
Creating test scenarios
Deliverables
Requirements Specification Document Approved Requirement
(RS) Specification and Configuration
Configuration Specification Document Specification before formal
(CSD) validation
Configured system and reports in
various environments

General Assumptions
Standard Out-of-the-Box (OOTB) Aggregate Global (PBRER, PADER and DSUR)
and Japan Reports (JPSR, NUPR, JDSUR etc.) would be used as the base and
modified as per client requirements.

2.4.2.1
This section describes scope for Reporting and Compliance workstream and RACI to clearly
define the workshare between RxLogix and Lilly.
Change of Any significant scope increase will
Scope require estimation and may result in
Change Request

2.4.2.1.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Updates to RxLogix Feature RxLogix Lilly and Lilly and RxLogix
requirement and Owner Feature Owner RxLogix Portfolio Management
config specs Product
Owners
Workshops RxLogix Feature RxLogix Lilly and Lilly
Owner Feature Owner RxLogix
and RxLogix Senior
Product
Management
Owners
Conference room RxLogix Feature Lilly Feature Lilly and Lilly and RxLogix
Pilot Owner Owner RxLogix Portfolio Management
Product
Owners
Configuration in RxLogix BQA RxLogix Lilly and Lilly and RxLogix
Sandbox, Dev, Feature Owner RxLogix Portfolio Management
Val, Training and Product
Prod Owners
Environment RxLogix BQA Lilly Feature Lilly and Rx Lilly and RxLogix
Smoke Testing Owner Product Portfolio Management
Owners
Configuration of Lilly Feature RxLogix Lilly and Rx Lilly and RxLogix
new visualization Owner/SME Feature Owner Product Portfolio Management
Owners
Approvals of RS, Lilly Feature RxLogix Lilly and Lilly and RxLogix
OQs, PQs and Owner Feature Owner RxLogix Portfolio Management
other project Product
deliverables Owners

2.4.2.1.2
Additional Additional visualizations that are not provided out of the box will be
Visualizations evaluated for productization by RxLogix.

2.4.2.2
This section describes scope for Reporting and Compliance workstream and RACI to clearly
define the workshare between RxLogix and Lilly.

Complexity: High=2, Medium=13,

Low=2
Case management: (Medium
Complexity)
AE Report Compliance and FU
Tracking Checklist #129
Case Assessment Sheet #122
PMDA reported SAEs #123
OTB Reports (Medium Complexity)
JPSR Form 3
NSUR
Re-Examination Yoshiki, 9, 10
DSUR
Infection reports
Japan Configured Reports (Medium
Aggregate 17 20 Complexity) High
Reports Re-Examination for Audit - Case
List
Re-Examination for Audit -
Literature list internal
Re-Examination for Audit -
Literature list external/overseas
Safety Mailing Listing (Lilly
Internal Report #137)
Monthly report for RSD (Lilly
internal report #132)
Configured Reports (High Complexity)
Safety Mailing Listing (Lilly
Internal Report #75) #75 is like
Seiyokukyo
Safety Mailing Listing (Lilly
Internal Report # 128)
 Configured Reports (Low Complexity)
EPPV Reports
Periodic Safety Reporting Data
Extract from PMS #83

Non-
Regulatory Total 2 (High=2)
Reports to be 2 4 All Marketed AEs
configured in Narrative Report
PVR or PVA
Change of Any significant scope increase will
Scope require estimation and may result
in Change Request

2.4.2.2.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Updates to RxLogix Feature RxLogix Lilly Global, Japan Lilly and
requirement and Owner Feature Owner and RxLogix Product RxLogix
config specs Owners Portfolio
Management
Workshops RxLogix Feature RxLogix Lilly Global, Japan Lilly
Owner Feature Owner and RxLogix Product
and RxLogix
Owners
Senior
Management
Conference room RxLogix Feature Lilly Feature Lilly Global, Japan Lilly and
Pilot Owner Owner and RxLogix Product RxLogix
Owners Portfolio
Management
Configuration in RxLogix BQA RxLogix Lilly Global, Japan Lilly and
Sandbox, Dev, Feature Owner and RxLogix Product RxLogix
Val, Training and Owners Portfolio
Prod Management
Environment RxLogix BQA Lilly Feature Lilly Global, Japan Lilly and
Smoke Testing Owner and RxLogix Product RxLogix
Owners Portfolio
Management
Approvals of RS, Lilly Feature RxLogix Lilly Global, Japan Lilly and
OQs, PQs and Owner Feature Owner and RxLogix Product RxLogix
other project Owners Portfolio
deliverables Management

2.4.2.2.2

Japan Non- To be evaluated if these can be achieved out of the box

Regulatory If not, then business criticality to be determined
Reports Custom interface with PVD and Power BI may be required

JPSR Listedness mark modification for PSR and Re-examination

2.4.3
The section below describes activities, deliverables for the Signal Detection and Management
workstream.
RxLogix Activities Lilly Activities
RxLogix PV Signal Requirements Provide inputs, review, and approve
Specifications (RS) Requirements Specifications and
Draft requirements CSD.
Conduct the Requirement Workshop to review Participate in required workshops
the draft RS and gather feedback and training sessions.
Review and obtain approval of the RS
Configuration Specifications Document (CSD)
Conduct Configuration Workshop and review
configuration features
Develop CSD using feedback from the
configuration workshop
Review and obtain approval of the CSD

configuration and following Regeneron Specific

Configurations:
One Workflow configuration to reflect GVP
module IX and internal processes
Integration with FAERS data
Integration with EVDAS data
Deliverables
 Requirements Specification Document (RS) Approved Requirement Specification
Configuration Specification Document (CSD) and Configuration Specification
Configured System in various environments before formal validation

General Assumptions

2.4.3.1
This section describes scope identified for Signal Detection and Management in Phase 1 and
RACI to clearly define the workshare between RxLogix and Lilly.

Aggregate Alerts at Ingredient/Family level

Alerts for Trend calculation is expected
Post ~200 225 for a period of 6 data points. High
Marketed Leverage DSS score based on
Products comparison with previous
period
Aggregate If blinded access is needed, then
Alerts- these alerts will be configured as
98 120 High
Development PVR report instead of
al Products configuration in PVS

OVID Assess feasibility of ingesting

Literature N/A N/A OVID Literature information in High
Integration XML format to be included in
Phase 1

EVDAS (8 Alerts)
In-scope FAERS (30 Alerts)
N/A N/A High
Integrations Sales Data
Batch Data

Out of scope Vigibase Alerts

Integrations/ N/A N/A Qualitative Alerts High
Features Custom Algorithm
Change of Any significant scope increase
Scope will require estimation and may
result in Change Request

2.4.3.1.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Updates to RxLogix Feature RxLogix Lilly and Lilly and RxLogix
requirement and Owner Feature Owner RxLogix Portfolio Management
config specs Product
Owners
Workshops RxLogix Feature RxLogix Lilly and Lilly
Owner Feature Owner RxLogix
and RxLogix Senior
Product
Management
Owners
Conference room RxLogix Feature Lilly Feature Lilly and Lilly and RxLogix
Pilot Owner Owner RxLogix Portfolio Management
Product
Owners
Configuration in RxLogix BQA RxLogix Lilly and Lilly and RxLogix
Sandbox, Dev, Feature Owner RxLogix Portfolio Management
Val, Training and Product
Prod Owners
Environment RxLogix BQA Lilly Feature Lilly and Rx Lilly and RxLogix
Smoke Testing Owner Product Portfolio Management
Owners
Approvals of RS, Lilly Feature RxLogix Lilly and Lilly and RxLogix
OQs, PQs and Owner Feature Owner RxLogix Portfolio Management
other project Product
deliverables Owners

2.4.3.1.2
AEPC Surveillance
Qualitative Alerts
Product complaint cases to be migrated from Track wise
Mann-Kendall Trend Analysis
BRR Analysis
Visualization for Mann-Kendall and BRR Analysis
Leveraging action items in PVCM case for triggering alerts in PVS

2.4.3.2
This section describes the scope identified for Signaling Data Migration in Phase 1 and RACI to
clearly define the workshare between RxLogix and Lilly.

# of fields to migrate
o 28 standard fields
Signal Data 300 360
o 15 custom fields Medium
Migration signals signals
No attachments or Audit data
need to be migrated.
9 fields to migrate
Alerts Data No attachments or Audit data
Migration 14500 15000 need to be migrated
Medium
from alerts Alerts Source data will be available
Empirica as per RxLogix standard
structure CSV files
9 fields to migrate
No attachments or Audit data
Alert Data need to be migrated
5100 5500 Low
from EVDAS Source data will be available
as per RxLogix standard
structure CSV files

2.4.3.2.1
Activities Responsibility Accountability Consulted Informed
/Deliverable
Data Extraction from Lilly Feature RxLogix Lilly and Lilly and
Source Owner Feature Owner RxLogix RxLogix
Product Portfolio
Owners Management
Data Profiling RxLogix Feature RxLogix Lilly and Lilly and
Owner Feature Owner RxLogix RxLogix
 Product Portfolio
Owners Management
Source to Target RxLogix Feature RxLogix Lilly and Lilly
Mapping Owner Feature Owner RxLogix
and RxLogix
Product
Senior
Owners
Management
Dry Run RxLogix Feature Lilly Feature Lilly and Lilly and
Owner Owner RxLogix RxLogix
Product Portfolio
Owners Management
Setup in Sandbox, RxLogix BQA RxLogix Lilly and Lilly and
Dev, Val and Prod Feature Owner RxLogix RxLogix
Product Portfolio
Owners Management
Migration Dry Run RxLogix BQA RxLogix Lilly and Rx Lilly and
Feature Owner Product RxLogix
Owners Portfolio
Management
Business Testing Lilly Feature RxLogix Lilly and Rx Lilly and
Owner Feature Owner Product RxLogix
Owners Portfolio
Management
Approvals of Lilly Feature RxLogix Lilly and Lilly and
Specifications, OQs, Owner Feature Owner RxLogix RxLogix
PQs and other Product Portfolio
project deliverables Owners Management

2.4.4
The section below describes activities, deliverables for the Technology workstream which
involves Infrastructure, Deployment and Integrations.

2.4.4.1
RxLogix Activities
1. Infrastructure Management:
a. System and network architecture
and design
b. Capacity planning and monitoring
c. Domain registration
2. Network Management:
a. Firewalls
Lilly Activities
1. Lilly to provide RxLogix read only access
to the Argus database at Lilly
2. Ensure Lilly users can access the
environment.
3. Setup connectivity between RxLogix
cloud and Lilly network
 b. Load balancing 4. Enable collaboration of Lilly IT resources
c. Network security as appropriate for connectivity setup
3. Security Management:
a. Virus, malware, and spam protection
b. Vulnerability management
c. SSL Certificates
d. OS security configuration
4. Server Management:
a. System provisioning and
administration
b. Database management and refreshes
c. OS updates and patches
d. Application upgrades
5. Application Management:
a. Configuration and testing
b. Documentation
6. User Management:
a. Provisioning
b. Identity and access
c. Training
d. Support
7. Change Control Management:
a. Dedicated environments (Sandbox,
Development, Test/Training,
Validation, and Production)
b. Application change control
c. Infrastructure change control
8. Storage & Backup Management:
a. Backup and restoration
b. Disaster recovery planning
c. System storage management
9. System Monitoring:
a. Resource health metrics
b. Resource performance metrics
c. Log analysis
10. Finalize IT Architecture design document.
11. Build and configure Five (05) environments
(Sandbox, Development, Test/Training,
Validation, and Production) for PV Suite
Platform managed by RxLogix.
12. Develop Installation Qualification (IQ)
scripts for PV Suite platform and associated
pre-requisite software installs:
 a. Draft and dry run execution of IQ test
scripts at the time of Development
environment setup.
b. Formal execution of IQ test scripts at
the time of Validation and Production
environments setup including pre-
execution and post-execution IQ
approvals.
13. Setup and configure PV Suite platform in
Development, Validation, and Production
environments per the Configuration
Specification.
14. Provide a detailed production Cut-over plan
and associated timelines
15. Provide Q&A and issue resolution for
technology work stream during the course
of the project
Deliverables
1. IT Architecture Design Document N/A
2. Five (05) environments (Sandbox,
Development, Validation,Training and
Production) for PV Suite Platform.
3. Cut-over plan (Deployment Plan) for PV
Suite Platform.

General Assumptions
1.
2.

2.4.4.2

Read only access to PVCM case data, User details

EDB/Data Lake Integration
and Codelist data
Attachment, Follow Up Queries and Action Items
will not be pushed to EDB
No application development will be done for PVCM
to achieve this requirement
Near real time (15 min) replication of data preferably
using AWS Technology
Technical Approach to be evaluated during
Implementation
 Preferable approach will be to pull data from PV
Data hub as EDB expects data in transactional
format
RxLogix will provide technical support for Q&A to
support this activity

Complaint Analyzer Tool

Pending Technical Feasibility
(CATool) & Global Product
Implementation options will be explored during
Complaint System (GPC ESI)
implementation & technical feasibility will be
Track wise
agreed

Medium of Integration is E2B R3

Support up to 5 Tags for non E2B R3 fields using
existing tags for Import. For eg: Race etc.
The integration will be established using standard
mechanism which includes Gateway or drop folder
Veeva EDC System Lilly will be responsible for coordinating with Veeva
for Integration activities
Custom mapping will be done by Veeva to use
unused E2B Tag to map non e2b fields to send E2B
R3 file to PVCM and RxLogix will make changes as
per agreed mapping to ingest the E2B File

Medium of Integration is JSON based

RxLogix will provide standard JSON based import
GCC, PCP, DHISP Interface
which is available out of the box
JSON Based Import
Lilly will be responsible for developing GCC and
PCP output which is supported by PVCM

Veeva CTMS -Study Configuration For Phase 1 the proposal is to use existing
& Regulatory Activity Planning notification process
and Tracking (RAPT ESI)- MDM PV Admin excel based load can be used for Product
Integration and Study Load

RxLogix will leverage OOB API to integrate for

Batch Number Look Up Integration Batch lookup on Case Form
on Case Form, PVS and PVDH Lilly will provide data in the format supported by
RxLogix API to consume it

Language Translation Service
Feasibility assessment to be conducted for use of out
of box API
Using the Out of box API, integrate with Lilly
translation service for language translation of case
data from automated intake form and affiliate web
form.

SSO with Multifactor Authentication

Lilly Authentication Services
Open Internet Solution

WHO Drug Organization (WHO Drug ESI)

TransformPV
MyAccess@Lilly
Not in scope SANG If narrative functionality cannot be
achieved through standard features, then integration
will be evaluated for
implementation in Phase 1

Any inclusion of new downstream or upstream

Change in Scope system will require estimation and may result in
Change Request

2.4.4.2.1

A part of to-be state (future) assessment, it is critical

to determine if U-Guides continues considering JR
Japan Representative (JR ESI) ESI must be maintained.
Therefore, U-Guides may continue till Phase 2.

2.4.5
RxLogix is a strong advocate of a risk-based testing approach with a proper balance between
quality, and time and effort. Risk assessments done during the PI-0 will be used to define the
testing strategy. In general, we plan on testing the changes that are applied through the course of
the Implementation.
The section below describes activities, deliverables for the Validation workstream.
 RxLogix Activities Lilly Activities
Author, review and approve PV Products Provide inputs, review, and approve
Validation Plan Validation Plan, UAT scripts,
PV Products Test Scripts (OQ), including Traceability Matrix, and
data migration testing: Validation Summary Report
Author test scripts Perform formal execution of UAT
Dry run test scripts scripts
Execute the test scripts
RxLogix PV Products UAT Scripts
(PQs):
Author test scripts
Dry run test scripts
Support UAT (e.g., UAT Testing
coordination, Q & A, issue/defect
resolution, and review of RxLogix test
scripts executed by Lilly)
Author, review and update the Traceability
Matrix
Develop the Validation Summary Report
Provide Defect Tracking and Management
throughout the testing phase.
Deliverables
Validation Plan Executed UAT Scripts.
Traceability Matrix
Regression Test Scripts (OQ)
UAT Scripts (Pre-Approved) (PQ)
Validation Summary Report

General Assumptions
1. PV Suite is a validated Commercial off-the-shelf (COTS) software, User Acceptance
Testing will be done instead of full system testing.
2. RxLogix internal validation OQ scripts will be referenced for complete traceability in the
RTM. If required, these scripts can be shared for reference in a controlled environment
during an Audit or over a WebEx only.
3. RxLogix Automated Regression Test Suite will be considered to be adopted for
accelerating testing cycles
4. The User Acceptance Test scripts will be developed by the RxLogix team and executed by
Lilly end users.
5. All validation deliverable and documents will be developed as per RxLogix SDLC
requirements.
6. Performance Testing is out of scope of this SOW
7. All deliverables and documents will be developed in English using RxLogix standard
 2.4.5.1
Activities/Deliverable Responsibility Accountability Consulted Informed

Validation Documents RxLogix Lilly Test Lead Lilly and Lilly and RxLogix
Validation RxLogix Portfolio
(For ex: Test Plan,
Lead Workstream Management
Validation summary
leads
report)
Identification of Test RxLogix Lilly Test Lead Lilly and Lilly and RxLogix
Scenarios Validation and RxLogix Portfolio
Business Lead Workstream Management
leads
OQ and PQ Authoring RxLogix BQA Lilly Test Lead Lilly and Lilly and RxLogix
and Updates RxLogix Portfolio
Workstream Management
leads
OQ Dry Run, RxLogix Lilly Test Lead Lilly and Lilly and RxLogix
Execution & Validation RxLogix Portfolio
Documentation Lead Workstream Management
leads

PQ Dry Run, Lilly Test Lead RxLogix Lilly and Lilly and RxLogix
Execution & Validation RxLogix Portfolio
Documentation Lead Workstream Management
leads
Troubleshooting, bug Lilly Test Lead RxLogix Lilly and Lilly and RxLogix
fix related upgrade Validation RxLogix Portfolio
script and related Lead Team Management
updates to OQ, PQ
QA Lilly Test Lead Lilly Test Lead RxLogix Lilly and RxLogix
Validation Portfolio
Lead Management

2.4.6
The following are the activities and deliverables for this Workstream:

RxLogix Activities Lilly Activities

Provide standard product training material Develop a training and
Conduct project team training communication Plan
 Support the development of Business
SOPs and Work Instructions
Support the development of Training Plan
Conduct train-the-trainer session(s)
Conduct refresher training during hyper
care
Deliverables
RxLogix standard Training materials in
English
Training delivery will be in English and
Japanese depending on location of
Trainers and End Users
Develop Lilly Business Standard
Operating Procedures (SOPs) and
Work Instructions (WI)
Schedule and provide logistics for all
training activities
Participate in the training session.
Relevant Lilly personnel to
participate in the training session.
Develop end-user training material
Conduct the end user training
sessions
Manage user training records
Update controlled documents
Lilly Business SOPs and Work
instructions
Training Plan
Training Materials for Instructors
Training Materials for End Users

2.4.6.1

Audience Training Approach Training Material Estimated Timing of

Duration & Training
Sessions
Core Product walk Slide deck with high 4 hours, 1 Beginning of
Project through level feature list and session for Project
Team On-site or WebEx the application each product
based
Train-the- Product functionality Training 4 hours, 1 Prior to Go-
trainer Instructor-led presentation on-site (US) Live.
session for
each product
Assumptions
1. RxLogix will offer a standard Training Material along with the application

2.4.7
RxLogix project management team members have significant experience with global projects.
They are adept at working with teams across the globe and adapting their communication style to
account for cultural differences. For a complex project to be successful, strong project
management and governance will be critical. We believe in several foundational elements that
are critical to project management success:
Open, clear, and timely communications about issues, risks, and mitigation
strategies
Proper coordination of timelines and dependencies across programs
All stakeholders working as one, aligned towards achieving Lilly
To this end, we focus on sound methods, a practical set of supporting tools and a strong Quality
Assurance Process

Activities and Deliverables

RxLogix Activities Lilly Activities
1. Prepare Project Plan 1. Provide inputs, review, and approve
2. Manage RxLogix resources all the listed deliverables.
3. Coordinate with Lilly Project Manager/ 2. Manage Lilly resources and activities.
Lead
4. Manage project scope, timeline, and
financials
5. Maintain Project RAID Log (Risks,
Assumptions, Issues and Dependencies)
6. Create and manage the project SharePoint
collaboration site
7. Develop and distribute weekly project
status reports
8. Create Steering Committee presentations
Deliverables
1. Project Roadmap and Project Plan 1. Project SharePoint site
2. RAID Log
3. Project Status Reports
4. Steering Committee Presentation

2.4.7.1
methodology provides the processes to ensure the project
progresses per the plan. The following is a brief description of the project management processes
our Project Manager will use during the project.
Project Planning
Communications Management
Schedule Management
Scope Management
Issues Management
Risk Management
Quality Management
 2.4.7.2
In addition to its methodologies, RxLogix uses a variety of project management tools to attain
time-bound and budgetary milestones:

Project objectives, stakeholders, and scoping description

Resources identification and responsibilities assignment
Work plan with budget estimates
Documentation plan with defined responsibilities
Risk mitigation strategies document
Change request document
Issues and Action list
Status reports
Communication plan for within the project team and within the organization

We will be using the following as our primary collaboration tools:

Project Schedule a tool, not an end, to communicate the work ahead and hold the team
accountable to the agreed upon due dates.
Assumption & Decision Log more than documenting key assumptions & decisions,
but the rationale behind the decisions. We also use this as a check to ensure all
stakeholders concur.
Risk & Issue Log
to resolve issues
Effort & Resource Plans understaffing is a chronic factor to delays. We try to make
mize the impact on the business and help
them manage their team commitments.
Communications we focus our meetings on issue identification and resolution rather
than a unidirectional report of status
These tools are leveraged as appropriate to the scope and joint RxLogix-Lilly team
structure for each engagement. The appropriate tools for this project will be determined
during the project initiation phase.
General Assumptions
All project deliverables will be in English.
The validation workstream activities and deliverables are the responsibility of Lilly.
All Deliverables will be provided to the Lilly Program Scrum Master for review and
approval.
All Deliverables submitted to Lilly for approval shall be deemed accepted upon receipt of
signed acceptance of the project deliverable.
If RxLogix has not received written notice from the Lilly Program Scrum Master
identifying specifically any basis for not approving the Services or Deliverables within
ten (10) business days after delivery to the Lilly

business period is mutually extended by the parties which such consent to extend shall
not be unreasonably withheld by RxLogix.
 Person primarily responsible for Person primarily responsible for
furnishing the Services (may be contractual relationship under
changed only with approval of this Services Order (may be
Lilly). changed anytime by Supplier).
Name Raj More Jeff Tucker
Position CEO_________ AVP________
Mailing Address 500 College Rd East, 500 College Rd East,
Suite 410 Princeton, Suite 410 Princeton,
NJ 08540, USA NJ 08540, USA
Telephone 1 609 910 1072 1 609 910 1072
E-mail raj.more@rxlogix.com__________ Jeff.tucker@rxlogix.com

IN WITNESS WHEREOF, Lilly and Supplier have caused duly authorized representatives of the
respective parties to execute this Service Order on the date(s) set forth below.
On behalf of Supplier: On behalf of Lilly:

Signed: Signed: Djenaba Ka (Feb 2, 2023 09:29 EST)

Name: Name: Djenaba Ka

Title: Title: Senior Director IDS (IT) Procurement

Date: Date: 02-Feb-2023

 IV. Annexure I

1.1.1
This section captures the initial prioritization of features performed during the scoping workshops
conducted jointly between Lilly and RxLogix and targeted phase for production roll out. The actual
implementation depends on inclusion of these features in the to-be process and availability of feature as
per product roadmap.
# Feature Assumption Phase 1 Phase 2 Later

1 Multilingual Forms Currently there is an internal Project

for Affiliate for Affiliate consolidation going on at
Lilly based on its outcome the
business process will be finalized
RxLogix will provide 4 Multilingual
web case forms (English, Spanish, Yes
Chinese and Japanese) built out of the
box in the UI.
Rest of the multilingual form will be
configured and deployed as part of
project.
2 Automated Automated Intake of Literature using
Literature Intake ML is on the Product roadmap and Yes
will be leveraged for Literature Intake

3 Follow-up Letter During the Implementation phase if

Template the gaps are identified, then the Yes
required functionality will be
productized
4 Track wise If E2B/PDF/API based integration is
Integration not available, then this will be a Yes
backlog
5 Veeva CTMS For Phase 1 the proposal is to use
Integration existing notification process
PV Admin excel based load can be
Yes
used for Product and Study Load
Integration with Veeva CTMS may be
built as a standard functionality
6 Automation of
Out of box features will be evaluated
Japan Letter
If not met, the feature may be included Yes
formatting and
as a standard functionality
transmission
7 Japan Device Case
Entry and Continue with iKiki during Phase 1
Yes
Reporting To be evaluated later
 8 Global Additional visualizations that are not
Visualization provided out of the box will be
evaluated for productization by
RxLogix.
9 Japan Non- To be evaluated if these can be
Regulatory Reports achieved out of the box
Yes
If not, then business criticality to be
determined
10 Aggregate Alerts- Requires additional data security
Developmental controls to allow unblinded Yes
Products information only to selected group.
11 AEPC Surveillance Product complaint cases to be
migrated from Track wise
Mann-Kendall Trend Analysis
Yes
BRR Analysis
Visualization for Mann-Kendall and
BRR Analysis
12 Qualitative Alerts
Leveraging action items in PVCM
Yes
case for triggering alerts in PVS

13 OVID Literature To be considered if Future State

Integration Assessment concludes that OVID
continues to be source of literature
Yes
instead of PubMed or Embase
Deduplication of the search output
from multiple sources to be assessed
14 A part of to-be state (future)
assessment, it is critical to determine if
Japan U-Guides continues considering JR
Representative (JR ESI must be maintained. Yes
ESI)
Therefore, U-Guides may continue till
Phase 2.

V. Annexure II

The estimated effort, role and associated cost for each PI/milestone are detailed in the attached
document. The scoping exercise executed by Lilly and RxLogix jointly is the basis for this
estimation and allocations may change based on PI planning and resource demand projected for
each milestone.

RxLogix Estimated
Effort, Roles and Pricing for Phase 1