ESBD_394347_1738959625023_Exhibit C.pdf

Grant Policies and Procedures Guide

A resource for CPRIT grant applicants and grant recipients.

June 2024

CPRIT Grant Policies & Procedures Guide

Table of Contents

June 2024 Page 2

Table of Contents

Tables and Figures

Version Control

Acronyms

Chapter 1: Introduction

Chapter 2: Applying for a CPRIT Grant

Chapter 3: Review Process

Chapter 4: Approving Grant Award Recommendations

Chapter 5: Grant Contracts

Chapter 6: Required Grant Reports

Chapter 7: Financial Policies Applicable to CPRIT Grants

Chapter 8: Disbursement of Grant Funds

Chapter 9: Allowable Costs

Chapter 10: Grantee Budget/Expense Categories and Required Documentation

Chapter 11: Grantee Monitoring for Progress and Compliance

Chapter 12: Grantee Audits

Chapter 13: Termination, Extension, and Closeout of Grant Contracts

Glossary

Appendix

Tables and Figures

Tables and Figures

Tables

Table 1: Criterion and Overall Ratings

Table 2: Grant Contract Components

Table 3: Required Reports

Table 4: FSR Due Dates

Table 5: Consequences for Failing to Timely File Required Reports

Table 6: Program Specific Audit Methodology

Table 7: Audit Sampling Considerations

Figures

Figure 1: CPRIT Application Receipt System (CARS) Homepage

Figure 2: CPRIT Grant Management System (CGMS/CARS)

Figure 3: CPRIT Grant Management System (CGMS) “Change Request” tab

Figure 4: CPRIT Grant Management System (CGMS) “Budget & Financial Status Reports” tab 83

Figure 5: CPRIT Grant Management System (CGMS) “Progress Reports” tab

Figure 6: CPRIT Grant Management System (CGMS) “Other Financial Reports” subtab

CPRIT Grantee Policies & Procedures Guide

Version Control

June 2024 Page 4

Date Author Chapter/Section Description of change

11/18/2009 n/a Initial Draft

11/15/2013 Section N: Audit

Requirement

Updated audit methodology for grantees regarding the single and program specific audit requirements

3/16/2016 See description of change

Content and formatting updates throughout.

New Sections:

• Applying for CPRIT Grant

• Request for Application

• Approving Grant Award

Recommendations

• Grant Contracts

• Disbursement of Grant Funds

• Cost Principles

• Grantee Budget/Expense Categories and Required Documentation

2/10/2017 Multiple Changes throughout

3/3/2017 Multiple

Grammatical Changes throughout

Additional Changes:

• Submission Deadline and Late

Submissions

• CPRIT Application Receipt System

(CARS)

• Personnel Level of Effort and Non-Key

Personnel Level of Effort forms

• Allowable Travel Costs

• Incidental Expenses

• Other

• Glossary

June 2024 Page 5

3/9/2017 Update Policy Clarify Update Policy

6/12/2017 CPRIT

Chapters 3, 6, 8, 12, and 13; Table 5

Updates to:

• Sections: 3.7.3, 3.18, 6.4, 8.2.2, 8.3.2, 8.3.3, 12.4, 13.4

• Table 5

Removed reference to a version and replaced with “last updated” and date

9/15/2017 CPRIT

Chapters 6, 8, 10;

Table 3; Appendix

Updates to:

• Sections: 6.6.3, 8.3.5, 10.1

• Table 3

• Appendix

Replaced the term “Revenue Sharing Form” with “Revenue Sharing/Program Income

Report Form” throughout.

December

CPRIT Chapters 6, 7, and 10

Updates to

• Sections: 6.3.1, 6.4.4, 6.4.2, 6.4.4, 7.8.1, 10.2.2. 10.2.2.1, 10.2.2.2, 10.3, 10.4.3, 10.4.3.1, 10.4.3.2, 10.4.3.3, 10.4.3.4, 10.7, 10.7.1, 10.8.1

Section Deleted:

• 10.2.4

March 2018 CPRIT Chapters 6, 9, and 10;

Glossary

Updates to Sections:

• 6.4.3, 9.4.3, 10.2.4, 10.4.1, 10.4.3, 10.4.4, 10.7.1 (non-substantive), 10.8, Glossary

June 2018 CPRIT Chapters 5, 6, and 10;

Tables 3 and 5

Updates to Sections:

• 5.15, 6.5.1, 10.2.2, 10.2.2.1, 10.2.5, 10.3.1, Table 3, Table 5

September

CPRIT

Chapters 5, 6, 9, and

Updates to Sections:

• 5.11, 6.4.1, 10.3.3.2, 10.7.1, Glossary

New Section:

• 9.4.3 CPRIT Conference

June 2024 Page 6

December

CPRIT Chapters 6 and 10

Updates to Sections:

• 6.1, 6.8, 10.3.4

March 2019 CPRIT Chapters 2, 6, 11, and

12; Tables 3 and 5

Updates to Sections:

• 2.15, 6.3.1, 6.5.3, 6.5.4, 11.4.2, 12.3, Table 3, Table 5

June 2019 CPRIT Chapters 5, 6, 9, 10, 13; Table 7

Updates to Sections:

• 5.10, 5.11, 5.15, 6.4.3, 9.4.4, 10.3.3.1, 10.6, 13.3.3.1, Table 7

September

CPRIT

Chapters 1, 5, 7, 8, 12, and 13

Stylistic redesign to the entire Policies and

Procedures Guide.

Substantive updates to the following sections:

• 1.4, 1.5, 2.2, 5.5.8, 5.15, 7.5.2, 8.3.2, 12.4, 12.4.2, 12.4.4.2, 12.4.4.3, 12.4.4.4, 12.4.4.5, 12.4.4.6, 12.4.4.7, 12.4.4.9, 12.4.4.10, 12.4.4.11, 13.3.1, 13.3.3

December

CPRIT

Chapters 8, 10, and

Updates to sections:

• 8.3.1, 10.3, 10.8, 13.3.1

March 2020 CPRIT Chapter 6 Updates to section:

• 6.4.4

June 2020 CPRIT Chapters 6, 8, 13

Updates to sections:

• 6.4.4, 8.2.2

New section:

• 13.6

Renumbered sections:

• Previous section 13.6 is now 13.7

March 2021 CPRIT Chapters 2, 6, 9, and

Updates to sections:

• 2.2, 6.3, 9.5.2, 9.5.4, 10.4.1, and

10.5.3

June 2024 Page 7

June 2021 CPRIT Chapters 2, 3, 10, and

Revisions to sections:

• 3.7.4, 10.6.2, 10.7, and 11.6

New section:

• 2.14.1

September

CPRIT

Chapters 9, 11, and

Revisions to section:

• 13.4

New section:

• 9.5.4

Deleted sections:

• 11.5.2; 11.7

Renumbered sections:

• Previous section 11.8 is now 11.7;

previous section 9.5.4 is now 9.5.5

December

CPRIT Chapters 6 and 9

Revisions to sections:

• 6.5.2, 6.5.4, 9.5.4

New Section:

• 6.4.2

Renumbered sections:

• Previous section 6.4.2 is now 6.4.3

• Previous section 6.4.3 is now 6.4.4

• Previous section 6.4.4 is now 6.4.5

April 2022 CPRIT Chapters 2, 6, and 9 Revisions to sections:

• 2.4, 6.4.5, 9.5.4

June 2022 CPRIT Chapters 5 and 7 Revisions to sections:

• 5.12.5, 7.1

April 2023 CPRIT Chapters 2, 5, 6, 8, and 10

New section:

• 2.17

Revisions to sections:

• Acronyms, 5.5.8, 5.12.2, 6.3.2, 6.4.3, 8.3.3, 10.4.4

June 2023 CPRIT Acronyms, Chapters 8 and 10, Glossary

Revisions to sections:

• Acronyms, 8.3.1, 10.8, Glossary

June 2024 Page 8

December

CPRIT Chapters 5, 8, and 10

Revisions to sections:

• 5.3.1, 8.3.1, 10.4.3.7, 10.6.1, 10.8

March 2024 CPRIT Chapters 9 and 10;

Glossary

Revisions to sections:

• 9.5.2, 10.8, Glossary

June 2024 CPRIT Chapters 5, 6, 8, 9, and 10

Revisions to sections:

• 5.15, 6.6.3, 8.1, 8.2.2, 9.4.6, 10.1, 10.2.5, 10.6.1, 10.7, 10.8, 10.10.2

Acronyms

CPRIT’s Commonly Used Acronyms

AICPA American Institute of Certified Public Accountants

ASO Authorized Signing Official

AUP Agreed-Upon Procedures

CARS CPRIT Application Receipt System

CEO Chief Executive Officer

CGMS CPRIT Grants Management System

CPA Certified Public Accountant

CPDO Chief Product Development Officer

COI Conflict of Interest

CPO Chief Prevention Officer

CPRIT Cancer Prevention and Research Institute of Texas

CR Company Representative

CSO Chief Scientific Officer

FICA Federal Insurance Contributions Act

FICR Federal Indirect Cost Rate

FSR Financial Status Report

GAAP Generally Accepted Accounting Principles

GDIT General Dynamics Information Technology

HUB Historically Underutilized Business

IACUC Institutional Animal Care and Use Committee

IRB Institutional Review Board

NCE No Cost Extension

OC Oversight Committee

OTP Outside the Period

PD Program Director

June 2024 Page 10

CPRIT’s Commonly Used Acronyms

PDRC Product Development Review Council

PI Principal Investigator

PIC Program Integration Committee

PRC Prevention Review Council

RFA Request for Application

SRC Scientific Review Council

TA Technical Assistance

TAC Texas Administrative Code

TxGMS Texas Grant Management Standards

TPIA Texas Public Information Act

UGMS Uniform Grant Management Standards

Chapter 1: Introduction

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1.1 Introduction

1.2 Purpose

1.3 Relationship between Policies and Procedures Guide and Other Applicable Requirements 13

1.4 How to Use/Navigate the Policies and Procedures Guide

1.5 Update Policy

June 2024 Page 12

1.1 Introduction

Texas voters approved an amendment to the Texas Constitution in 2007 that establishes the

Cancer Prevention and Research Institute of Texas (“CPRIT” or the “Institute”) and provides the state with the authority to issue three billion dollars in general obligation bonds. Bond proceeds are to be disbursed as Grant Awards for the express purpose of expediting innovation in Cancer

Research and lowering the incidence of cancer in Texas.

CPRIT is responsible to the Texas Legislature and to Texans to cost-effectively carry out its mission to expedite discoveries and innovations across Texas to reduce the burdens of cancer.

In doing so, CPRIT acts with the highest standards of ethics, accountability, transparency, and excellence. CPRIT is charged by the Texas Legislature to:

• Create and expedite innovation in the area of cancer research, thereby enhancing the potential for a medical or scientific breakthrough in the prevention of cancer and cures for cancer;

• Attract, create, or expand research capabilities of public or private institutions of higher education and other public or private entities that will promote a substantial increase in cancer research and in the creation of high-quality new jobs in this State; and

• Continue to develop and implement the Texas Cancer Plan by promoting the development and coordination of effective and efficient statewide public and private policies, programs, and services related to cancer and by encouraging cooperative, comprehensive, and complementary planning among the public, private, and volunteer sectors involved in Cancer Prevention, detection, treatment, and research.

Tex. Health & Safety Code § 102.002, TAC § 701.1

1.2 Purpose

The Policies and Procedures Guide is made available for individuals and organizations interested in the CPRIT cancer research and prevention funding award program. It provides the framework for the review, award, implementation, and monitoring of CPRIT-funded research and prevention grant awards, as well as information on the rules and requirements that applicants and recipients of CPRIT grant awards must follow.

June 2024 Page 13

1.3 Relationship between Policies and Procedures Guide and

Other Applicable Requirements

The Policies and Procedures Guide is intended to address major issues in the application and award process as well as grant management; however, these guidelines are not all-inclusive. A

Grantee should always consult the administrative rules (Texas Administrative Code Chapters

701-703) and the award contract. When possible, the administrative rule(s) applicable to a policy or procedure is noted in the Policies and Procedures Guide. CPRIT’s statute, Texas

Health & Safety Code Chapter 102, and administrative rules are available on CPRIT’s website.

If a conflict exists between a policy described herein and a state regulation, administrative rule, or contract provision, then the provisions of the applicable state regulation, administrative rule, or contract provision prevail. When specific guidance has not been developed, CPRIT relies upon the Texas Grant Management Standards (TxGMS) , which replaced the Uniform Grant

Managements Standards (UGMS) in December 2021.

1.4 How to Use and Navigate the Policies and Procedures Guide

To search for and locate a specific word or term within the Policies and Procedures Guide, use

“Ctrl + F” on a PC or “Command + F” on a Mac.

There are different types of hyperlinks throughout the Policies and Procedures Guide that allow a reader to quickly navigate to a different part of the Guide or to a website with relevant information:

• A royal blue hyperlink will direct the reader to a website or email address outside of the

Policies and Procedures Guide;

• A green, bold hyperlink will direct the reader to a different section within the Policies and Procedures Guide; and

• A green, underlined hyperlink will direct the reader to the Glossary at the end of the

Policies and Procedures Guide.

CPRIT’s administrative rules, statute, contract provisions, and any other applicable state regulation or rule override the Policies and Procedures Guide.

June 2024 Page 14

Many of the sections within the Guide include hyperlinks to CPRIT’s administrative rules and/or statute. These references are designated with a “” symbol followed by a blue hyperlink to the applicable rule or statutory language.

1.5 Update Policy

CPRIT will review the Policies and Procedures Guide at least annually. The information in this document may be revised to address changes in state or federal statutes, regulations, or policies adopted subsequent to its effective date. Questions regarding the Policies and Procedures Guide may be directed to cpritpolicyguide@cprit.texas.gov.

CPRIT maintains a list of substantive changes made to the Policies and Procedures Guide in the

Version Control section of this document. To receive updates about the Policies and

Procedures Guide, subscribe to the list serve by clicking on the “Sign Up for Our Newsletter” link at the bottom of the CPRIT homepage.

Chapter 2: Applying for a CPRIT Grant

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Chapter 2: Applying for a CPRIT Grant

2.1 Overview

2.2 Request for Applications (RFA)

2.3 Organization as Grant Applicant

2.4 Eligibility

2.5 Collaborations with Out of State Entities

2.6 CPRIT Application Receipt System (CARS)

2.7 Authorized Signing Official

2.8 Submission Deadline and Late Submissions

2.9 Identification of Sources of Funding

2.10 Resubmitted Applications Previously Reviewed by CPRIT

2.11 Institutional Limits on the Number of Applications submitted to an Entity

2.12 Competitive Renewals

2.13 Questions During the Application Process

2.14 Restriction on Communication

2.14.1 Exception Related to Product Development Due Diligence Review

2.15 Product Development Research Application Review Fee

2.16 Confidential Information and the Texas Public Information Act

2.16.1 Information that CPRIT Must Provide Upon Request

2.16.2 Information Considered Confidential

2.16.3 CPRIT will Notify the Applicant if a Request is Made for Information in the Application

2.17 CPRIT’s Internal Policies for Handling Confidential Information

June 2024 Page 16

2.1 Overview

Cancer research and prevention proposals are accepted for review in accordance with the requirements of the applicable Request for Applications (RFA. The RFA describes information specific to the grant award type, including eligibility requirements, funding limits, and special review considerations, if any. All applications must be submitted via CPRIT’s electronic portal.

In order to avoid influencing the review process, CPRIT observes a strict restriction on communication between a Grant Applicant and CPRIT employees and Oversight Committee

Members that play a role in recommending or approving an application for a grant award.

2.2 Request for Applications (RFA)

The initial step in the CPRIT funding cycle is the release of a Request for Applications (RFA).

The RFA includes important information about submitting a Grant Application to CPRIT, including applicable deadlines, eligibility, grant award requirements, evaluation criteria, review timeline, and special considerations related to the grant award. If the grant mechanism requires that a principal investigator, co-principal investigator, or any other key personnel commit to minimum levels of effort, the minimum level of effort will be stated in the RFA.

CPRIT publishes all open RFAs on its public website under “Apply for Funding”. In addition to the RFA, a set of instructions may be provided with technical guidance on completing the on-line application. Modifications to an RFA will be available through the “Apply for Funding” page.

The release of a new RFA is announced by an email notice distributed to the subscribers of

CPRIT’s electronic mailing list. If any substantive modifications to a RFA are made after its initial release, notifications will be made by list serve. Potential applicants may sign up to receive email notices about RFA releases by visiting the “Apply for Funding” page on CPRIT’s website and following the instructions to sign up to receive new funding opportunity announcements.

TAC § 703.3(a)-(b)

Certain issues related to CPRIT’s grant application process are highlighted in this section, but applicants should always consult the RFA.

June 2024 Page 17

2.3 Organization as Grant Applicant

A CPRIT grant is made to an organization, not an individual. The applicant organization is legally accountable for the accuracy of the application, the performance of the grant award, and expenditure of funds.

TAC § 701.3(30)

2.4 Eligibility

General guidelines regarding eligibility are described in this section. Be aware that additional eligibility requirements may vary by Grant Mechanism.

Submission via designated portal - Applications must be submitted via the designated electronic portal in order to be eligible for consideration of a grant award. For more information, see section, CPRIT Application Receipt System (CARS) .

Submitting more than one application - An applicant should consult the RFA to determine if more than one application may be submitted by the same Principal Investigator, Program

Director, or Company Representative for a particular grant mechanism or different grant mechanisms in the same review cycle. An applicant is eligible only for the grant mechanism specified by the RFA under which the application is submitted. This means that CPRIT will not award a grant for a grant application that does not match the grant mechanism in the RFA.

Donations to CPRIT make applicant ineligible for CPRIT award - An applicant that has donated money to CPRIT or to a foundation created to support CPRIT on or after June 14, 2013 is not eligible for a CPRIT grant award. During the application process, the applicant must certify that it has not made a donation to CPRIT or a supporting foundation. For purposes of the certification, in addition to the applicant entity, any Senior Member or Key Personnel listed on the application as well as the entity’s officers or a director (or any person related to one or more of these individuals within the second degree of consanguinity or affinity) is considered the applicant. At this time, CPRIT is unaware of any foundation created to support CPRIT. The agency maintains a list of donations made directly to CPRIT on its website.

Applicants should consult the applicable RFA for explicit guidance on eligibility requirements.

June 2024 Page 18

Grantees must be in Texas doing work in Texas - CPRIT grants may be awarded only to institutions, organizations and companies in Texas.

Applications submitted by out-of-state applicants are not eligible, except for applications in response to certain grant mechanisms that are designed to recruit exceptional researchers or companies working on promising cancer treatments to relocate to Texas. For those grant mechanisms, the applicant (or recruitment candidate) may be outside of the state of Texas when the application is submitted and reviewed. However, the applicant is required to demonstrate that they will relocate to Texas as a condition of receiving a CPRIT grant award.

To meet the Texas location requirement, a Grant Applicant for a Product Development Research

Grant Award must meet at least four of the following seven criteria: The U.S. headquarters is physically located in Texas; The Chief Executive Officer resides in Texas; A majority of the company's personnel, including at least two other C-level employees (or equivalent) reside in

Texas; Manufacturing activities take place in Texas; At least 90% of Grant Award funds are paid to individuals and entities in Texas, including salaries and personnel costs for employees and contractors; At least one clinical trial site in Texas; and collaboration with a medical research organization in Texas, including a public or private institution of higher education.

The Grant Contract will detail which location criteria will be fulfilled by the grantee.

Subsequently, CPRIT will send and the grantee will complete an annual attestation documenting which Texas location criteria the grantee fulfills. As part of the attestation, the grantee will provide CPRIT with documentation demonstrating its compliance with the location criteria.

CPRIT’s CEO and a grantee may agree to alternative or additional criteria, which must be presented to the Oversight Committee at an open meeting. The alternative location criteria will be approved unless a simple majority of Oversight Committee members votes to reject.

TAC § 701.19

Although grantees must be working in Texas, CPRIT permits grantees to use some grant funds to purchase goods and services out of state. For more information see section, Collaborations with Out of State Entities.

Applicants with a history of grants terminated for cause or barred from receiving state or federal grants may affect CPRIT eligibility - Applicants must report whether the entity or individuals expected to conduct the work of the proposed grant award, including collaborators or contractors, are currently debarred, suspended, proposed for debarment, declared ineligible, or otherwise excluded from participation in grant awards by any federal or state department or

June 2024 Page 19 agency. An application submitted by an entity or personnel that are debarred, suspended, and ineligible or otherwise excluded from participation in federal or state grant award is not eligible to receive a CPRIT grant.

Applicants must also report whether the individuals expected to conduct the work of proposed grant award had a grant terminated for cause by a federal or state department or agency within five years prior to the submission date of the grant application. This applies to the Principal

Investigator, Program Director, or Company Representative, as well as other individuals who contribute to the execution of the proposed grant award in a substantive, measurable way, whether or not those individuals are slated to receive salary or compensation under the grant award. Termination for cause is not an automatic bar to consideration for a CPRIT award, but the status may be taken into account by the reviewers evaluating the CPRIT grant application.

TAC § 703.3(d), (g), (h), (j)

2.5 Collaborations with Out of State Entities

CPRIT encourages collaborations, and collaborators are not required to reside in Texas.

However, collaborators and collaborating organizations not located in Texas are not eligible to receive CPRIT funds.

2.6 CPRIT Application Receipt System (CARS)

Use of the electronic system to submit an application is required - All applicants must use CPRIT’s designated application system located at www.cpritgrants.org to electronically submit applications to CPRIT. Below is a screenshot of the log-in page for CARS.

Figure 1: CPRIT Application Receipt System (CARS) Homepage

June 2024 Page 20

Create an account - An applicant must create a user account in CARS before an application may be submitted. Applicants should allow enough time ahead of a submission deadline to create user accounts.

Designate an Authorized Signing Official - As part of the registration process, an applicant is required to designate an individual at the institution or organization with the authority to approve the submission of the grant application. This person is considered the

“Authorized Signing Official (ASO.” Generally, the ASO is not the Principal

Investigator/Program Director/Company Representative; however, there may be instances where one individual fulfills both roles. For more information, please see section, Authorized

Signing Official (ASO).

TAC §§ 701.25, 703.3(g)

2.7 Authorized Signing Official

The ASO, including the alternate ASO, is the designated representative of the applicant organization with the authority to act on the organization’s behalf in matters related to the application for and administration of a CPRIT grant award.

By signing the application, the ASO certifies that the applicant organization:

• Complies with all applicable federal and state laws and regulations and that all eligibility requirements have been satisfied; and

• Will assume the obligations imposed by applicable state and federal laws and other terms and conditions of the grant award, including any assurances, if a CPRIT grant award is made. These responsibilities include accountability both for the appropriate use of grant funds and the performance of the CPRIT-supported program or activities as specified in the approved application.

TAC §§ 701.3(6), 701.25

2.8 Submission Deadline and Late Submissions

CARS blocks applications from being submitted to CPRIT once the deadline stated in the RFA has passed. Deadlines are set by CPRIT to provide potential applicants at least 30 days from the release date of the RFA to complete the application. Applicants should allow sufficient time to familiarize themselves with the application format and instructions to avoid unexpected issues.

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Late submissions only in exceptional cases - CPRIT permits late submissions only in exceptional instances, usually for technology failures. The applicant’s failure to adequately plan is not sufficient grounds to justify approval of a late submission.

Requesting an extension of the submission deadline - If an applicant has an issue that prevents the applicant from submitting the application when it is due, the applicant may request to extend the submission deadline for good cause. Because the consideration of the submitted requests and the re-opening of the portal (if approved) occur shortly after CARS closes (usually within 24 – 72 hours), any request to extend the deadline should be submitted immediately after CARS closes. The request should be made to the CPRIT Helpdesk, which is managed by

CPRIT’s third-party grant administrator. The CPRIT Help Desk is available by phone Monday through Friday 8am to 6pm, CST, and by email at Help@CPRITGrants.org.

Approval/notification to extend the submission deadline - The Chief Program Officer considers any requests to extend the submission deadline and may approve submission of a late filing for good cause. When a request to extend the submission deadline is approved, the applicant is notified and CARS is reopened for a brief period – usually two to three hours – shortly after the due date for the applicant to complete the submission.

Late submissions address technical issues, not substantive issues - Allowances for late submissions are not designed to provide the applicant additional time to complete the substance of the application. Potential applicants that are unable to meet the deadline due to issues such as travel, sabbaticals, conferences, prolonged illness, or other leave should not request additional time to submit an application but should instead consider submitting the application in the next review cycle.

TAC § 703.3(g)

2.9 Identification of Sources of Funding

An applicant must identify by name all sources of funding contributing to the grant award proposed for CPRIT funding. Product Development Research grant applications should include a comprehensive capitalization table that reflects all parties who have an investment, stock or rights in the company. The information will be made available to reviewers for purposes of

The submission deadline for each mechanism is stated in the applicable RFA.

June 2024 Page 22 identifying potential conflicts of interest prior to reviewing or taking action on the grant application.

TAC § 703.3(i)

2.10 Resubmitted Applications Previously Reviewed by CPRIT

CPRIT reserves the right to limit the number of times an application may be resubmitted for grant award consideration. The RFA will state the resubmission guidelines, including specific instructions for resubmissions. Applicants who choose to resubmit should consider the reasons for lack of prior success. All resubmitted applications must conform to the structure and guidelines outlined in the RFA.

What is considered a resubmission? An application is considered a resubmission if the proposed project is substantially the same project as originally submitted in a previous review cycle and the original application underwent Peer Review. A change in the identity of the applicant or the Principal Investigator/Program Director /Company Representative or a change to the title of the project does not constitute a new application. If the applicant has a question about whether CPRIT considers an application to be a resubmission, the applicant should contact CPRIT program staff.

Are previously withdrawn applications considered submissions? An application that was originally submitted to CPRIT in a previous review cycle but was administratively withdrawn from review, either by CPRIT or at the request of the applicant prior to undergoing peer review, is not considered a resubmission.

Resubmissions should be carefully considered A resubmitted application should be carefully reconstructed; a simple revision of the prior application with editorial or technical changes is not sufficient. Addressing previous critiques in the resubmission is advisable;

however, it does not guarantee the success of the resubmission.

Undesignated resubmissions may be withdrawn from further consideration - An application that should have been designated as a resubmission but was not may be withdrawn from consideration. In the event of a disagreement between the applicant and CPRIT regarding

Applications that received overall numerical scores of 5 or greater are likely to need considerable attention.

June 2024 Page 23 whether an application is sufficiently similar to a previously submitted application to be considered a resubmission, CPRIT’s determination is final.

2.11 Institutional Limits on the Number of Applications

submitted to an Entity

CPRIT reserves the right to limit the number of applications submitted by an entity for a particular grant mechanism. Institutional limits are used to ensure timely and high-quality review when a large number of submissions are anticipated.

Institutional limits stated in RFA - Any institutional limits set for a particular grant mechanism will be specifically stated in the RFA.

Applications exceeding limit will not be reviewed - Institutions are encouraged to initiate an internal review process and only authorize submission of the appropriate number of applications that are responsive to the RFA. Applications exceeding the institutional limit will not be reviewed.

2.12 Competitive Renewals

CPRIT reserves the right to authorize competitive renewals for particular grant mechanisms.

The RFA will state whether grantees that have previously received CPRIT grant funding may submit applications for competitive renewal under the RFA.

Demonstrate progress made - The applicant should be able to demonstrate their progress on the initial CPRIT funded grant award.

Timing of renewals - The applicant should time the submission of the renewal application so that the new contract execution date for the grant award comes after the contract expiration date of the initial CPRIT award; any overlap in funding should be avoided.

Consult with CPRIT - Prior to submitting a competitive renewal application, applicants should consult with CPRIT program staff to determine whether it is the appropriate time to apply for renewal consideration. The determination will be based upon the amount of original grant funds left to be expended and anticipated completion of the scope of work, as well as other factors specific to the grant award.

June 2024 Page 24

2.13 Questions During the Application Process

CPRIT’s Helpdesk provides support to applicants regarding user registration and online submission of applications. A grant applicant may contact the Helpdesk via phone during business hours or by email (Help@CPRITGrants.org) at any time. Questions submitted via e-mail will be answered within one business day.

Helpdesk staff are not in a position to answer questions regarding programmatic, scientific and commercialization aspects of applications. Questions regarding the CPRIT Program, including questions regarding substantive elements of the application, should be directed to the appropriate CPRIT Program Manager.

Note: A grantee should not contact the CPRIT Chief Program Officer about substantive questions related to the application. For more information on the prohibition against communicating with a Chief Program Officer when applications are being accepted by CPRIT, see section, Restriction on Communication.

2.14 Restriction on Communication

Communication regarding the substance of a pending application is prohibited between the applicant (including someone on the applicant’s behalf) and the following individuals: an

Oversight Committee Member, a Program Integration Committee member, a Review Panel member, or a Review Council member. PIC members include CPRIT’s Chief Executive Officer

(CEO), Chief Scientific Officer (CSO), Chief Prevention Officer (CPO), and Chief Product

Development Officer (CPDO), as well as the Commissioner for the Department of State Health

Services. CPRIT’s CEO may waive the restriction on a case-by-case basis. Any waiver will be publicly available.

Restriction begins when the CARS system is opened for submission of applications to CPRIT - The prohibition on communication begins on the first day that grant applications for the particular grant mechanism may be submitted and extends until the grant applicant receives notice regarding a final decision on the grant application.

The restriction on communication begins the first day that any applications are accepted for the review cycle, even if the applicant has not yet submitted an application.

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The application may be withdrawn from further consideration for serious violations - Intentional, serious, or frequent violations of this rule may result in the disqualification of the grant applicant from further consideration for a grant award.

TAC § 702.19(a) – (c), (e)

2.14.1 Exception Related to Product Development Due Diligence Review

The Product Development Review Council Chairperson may assign a peer review member to participate in the due diligence interview during business and operations due diligence of product development research grant applications. The assigned peer review member and grant applicant may communicate directly with each other during the course of the due diligence interview without violating the general restriction on communication. This exception applies to all applicants that participate in due diligence review.

TAC § 702.19(b)(3)

2.15 Product Development Research Application Review Fee

CPRIT reserves the right to assess an application review fee for Product Development company applications to offset the additional costs of the Product Development company application review process. The RFA will state the amount of the review fee.

Paying the review fee - Payment of the review fee should be made by check or money order payable to CPRIT; electronic and credit card payments are not acceptable. The application ID and the name of the submitter must be indicated on the payment.

Deadline to pay review fee - Unless a request to submit the fee after the deadline has been approved by CPRIT, CPRIT may administratively withdraw an application if the application review fee is not received by CPRIT within seven business days of the application submission deadline.

TAC § 703.3(k)

Refund of review fee – A grant applicant may request a refund of the grant application fee if the application is withdrawn from the grant review process prior to evaluation by the peer review panel.

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The refund request must be sent via e-mail to the Chief Product Development Officer and

Program Manager for Product Development and include a justification for a refund. The request should be submitted within 14 business days of the application withdrawing from review.

CPRIT’s decision whether to refund a review fee is final.

TAC § 703.3(k)(4)

2.16 Confidential Information and the Texas Public Information Act

CPRIT is a state agency and is subject to the Texas Pubic Information Act (TPIA) (Tex. Govt.

Code § 552.101 et seq.). The TPIA gives the public the right to request access to government information, including information held by a government agency that was created by a third party. Although the TPIA makes most government information available to the public, the TPIA provides exceptions to public access for certain information, including Third-Party Information.

State law designates some information as public information, meaning that the following information will always be disclosed upon a TPIA request (and may be made publicly available even without a request).

2.16.1 Information that CPRIT Must Provide Upon Request

CPRIT must provide the following information upon request:

• The applicant’s name and address;

• The amount of grant funding applied for;

• The type of cancer to be addressed by the grant application;

• A high-level summary of the grant application specifically created to be publicly disclosed; and

• Any other third-party information that the third-party consents to disclose.

For all other information submitted by applicants, CPRIT undertakes reasonable efforts to protect the actual or potential value of information from unauthorized public disclosure. For more information, see section, Confidentiality and Nondisclosure.

2.16.2 Information Considered Confidential

Consistent with CPRIT’s statute (Tex. Health & Safety Code § 102.262) and the TPIA, the following information is confidential:

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• Information that relates to an applicant’s product, device, or process that has the potential for being sold, traded, or licensed for a fee, including the application or use of such product, device, or process;

• All technological or scientific information developed in whole or in part by the applicant that has the potential for being sold, traded, or licensed for a fee;

• All information that relates to the plans, specifications, blueprints, and designs, including related proprietary information, of a scientific research and development facility;

• Written comments made by peer reviewers that reveals, directly or indirectly, information relating to the applicant’s product, device, or process that has the potential for being sold, traded, or licensed for a fee, including the application or use of such product, device, or process; and

• Information included in the business operations and management due diligence and intellectual property reviews that reveals, directly or indirectly, information relating to the applicant’s product, device, or process that has the potential for being sold, traded, or licensed for a fee.

CPRIT considers that a product, device, or process and the technological or scientific information described in the application has the potential for being sold, traded, or licensed for a fee unless the applicant informs CPRIT that no economic potential exists.

The confidential nature of the information submitted by the applicant is not dependent upon whether the information is patentable or capable of being registered under copyright or trademark laws.

2.16.3 CPRIT will Notify the Applicant if a Request is Made for Information in the Application

Consistent with statutory requirements, if CPRIT receives a public information request that may require potential public disclosure of the applicant or grantee’s information, CPRIT will notify the entity so that the applicant or grantee has the opportunity to brief the Attorney General’s

Office regarding the confidential nature of the information. No information that may be considered confidential will be disclosed until the Attorney General issues a decision.

The Office of the Attorney General of Texas makes the final determination of whether third-party information held by CPRIT must be disclosed in response to a TPIA request.

June 2024 Page 28

TAC § 701.29

2.17 CPRIT’s Internal Policies for Handling Confidential

Information

CPRIT takes the security of sensitive and confidential information very seriously. Each CPRIT employee signs a nondisclosure agreement that prohibits employees from disclosing, reproducing, or using documents with sensitive or confidential information that employees may be privy to in the course of their work for any purpose but what is necessary to perform their jobs. Furthermore, CPRIT employees must use their encrypted CPRIT-issued computers to review grant information. In CPRIT’s internal telework agreement, teleworking employees certify that they will not download documents with sensitive or confidential information onto non-agency computers or other devices or print out these documents. They also certify that they will protect the confidentiality of these documents while reviewing them on their computer.

Chapter 3: Review Process

June 2024 Page 29

3.1 Overview

3.2 Finality of Grant Review Process

3.3 Administrative Compliance Review

3.4 Peer Review Participants

3.4.1 Review Panel Chairperson

3.4.2 Expert/Scientist Reviewers

3.4.3 Advocate Reviewers

3.4.4 Non-Participating Observers at Peer Review Meetings

3.4.4.1 CPRIT and Grants Management Staff

3.4.4.2 Third Party Observer/Chief Compliance Officer

3.5 Primary Review and Panel Discussion

3.5.1 Primary Review

3.5.1.1 Panel Discussion

3.6 Scores and Written Critiques

3.7 Special Peer Review Processes

3.7.1 Preliminary Review

3.7.2 Recruitment Review (Academic Research)

3.7.3 In Person Presentations (Product Development Research Company Applications)

3.7.4 Due Diligence Review (Product Development Research Company Applications)

3.7.5 Prevention Programmatic Review (Prevention Applications)

3.8 Oversight Committee Program Priorities

3.9 Review Council Recommendations

3.9.1 Ranking Grant Awards

3.9.2 Recommendation provided to PIC and Oversight Committee

3.9.3 Decision to not recommend an application is final

3.10 Program Integration Committee (PIC) Review

3.10.1 Statutory Priorities

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3.10.2 Minority Recommendation

3.11 Oversight Committee Review

3.12 Deferring a Grant Award Recommendation

3.12.1 Deferral by the Program Integration Committee

3.12.2 Deferral by the Oversight Committee

3.12.3 Action on Deferrals Must be taken by August 31st

3.12.4 Deferred Applications Pending on August 31st

3.13 Confidentiality and Nondisclosure

3.14 Reviewer Conflict of Interest

3.14.1 Financial COI

3.14.2 Professional COI

3.14.3 Personal COI

3.15 Identifying COIs

3.15.1 COIs Identified by the Reviewer

3.15.2 COIs Identified by the Applicant

3.16 Reporting Undisclosed Conflicts of Interest

3.16.1 Notifying CPRIT of Undisclosed COI

3.16.2 Investigation and Final Decision of Alleged COI

3.16.3 Actions Taken if Undisclosed COI is Substantiated

3.16.4 Validity of Grant Decision Not Affected Unless Specifically Stated

3.17 Conflict of Interest Waivers

3.18 Prohibition on Providing Professional Services for Compensation

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3.1 Overview

CPRIT relies upon a multi-stage review process that incorporates peer review conducted by outside experts as well as programmatic review and alignment with CPRIT’s statutory and funding priorities.

The decision to recommend a grant application for funding is based upon the sufficiency, merit, and if applicable, Product Development Prospects for the grant application, as determined by

CPRIT’s peer review and programmatic review processes.

In some cases, the PIC or the Oversight Committee may choose to defer making a final decision on one or more applications recommended for grant awards. Generally, a decision to defer an award recommendation until a future meeting is made because of budgetary concerns. An award decision must be acted upon by the end of the fiscal year (August 31) in which it was recommended by the Review Council. Deferred applications that have not been approved by

August 31 will be considered not recommended for a grant award.

At each step in the review process, the reviewers’ decision to not recommend an application to move forward to the next review stage is final.

TAC §§ 703.5, 703.6, 703.7, 703.8, 703.9

3.2 Finality of Grant Review Process

Grant applicants deserve a fair review unaffected by undisclosed conflicts of interest. CPRIT’s

RFAs specify the review criteria; applicants receive the reviewers’ written critiques, and CPRIT documents steps taken to consistently follow the appropriate review process for every application. Nevertheless, the Grant Review Process is subjective; what may appeal to one group of reviewers one cycle is not guaranteed to be met with the same level of enthusiasm in another cycle.

The number of proposals CPRIT receives each year far exceeds the available funding for prevention and research awards. For many of CPRIT’s grant mechanisms, the success rate for applicants is less than 20 percent.

To minimize the potential for conflicts of interest in the review process, all research and prevention peer reviewers live and work outside of the state.

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As a condition of submitting an application to CPRIT for review, the applicant accepts that the only basis for reconsideration of CPRIT’s final decision regarding the application is an undisclosed Conflict of Interest. For more information, see section, Reporting Undisclosed

Conflicts of Interest.

TAC § 703.9

3.3 Administrative Compliance Review

Applications undergo an administrative compliance review to ensure the accurate and complete submission of all components of a grant application required by the RFA. Applications are checked for compliance against the grant mechanism’s administrative requirements listed in the

RFA.

TAC §§ 703.3(d), (f), (g), (h)(1), (i), (j), (k), 703.6(a)

3.4 Peer Review Participants

Experts, scientists, and Patient Advocates are provisionally appointed to the Peer Review Panel review panel by CPRIT’s Chief Executive Officer and approved by the Oversight Committee.

CPRIT’s statue refers to peer review panels as “Scientific research and Prevention Program” committees. To minimize the potential for conflicts of interest, all reviewers live and work outside of Texas unless a special need justifies using a Texas resident. A current list of members by panel is available on CPRIT’s website.

TAC § 703.5(a)

3.4.1 Review Panel Chairperson

The chairperson oversees the review panel, works closely with the grants administrator staff on pre-meeting activities, presides at the panel meeting, and provides leadership in moderating and guiding panel members in their deliberations. The chairperson plays a key role in ensuring that each proposal receives a fair review based on its merit and on the review criteria and that the meeting proceeds expeditiously. Generally, the chairperson does not vote on individual applications.

TAC § 703.6(c)

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3.4.2 Expert/Scientist Reviewers

Each review panel is comprised of distinguished reviewers. Reviewers are assigned to panels in their area of expertise. The Prevention and Product Development Research programs use the term “expert reviewer,” while the Academic Research program uses the term “scientist reviewer.” These reviewers are leaders in their respective fields and have outstanding qualifications, including publications, patents, funding awards, honors, and significant achievements within their respective disciplines.

TAC § 703.5

3.4.3 Advocate Reviewers

At least one advocate reviewer is appointed to each Peer Review Panel to specifically represent the interests of cancer patients. Advocate reviewers keep the needs of the patient and the community at the forefront of expert/scientist reviewers’ discussions and remind them of the human dimension of the disease. This results in increased awareness of the importance of cancer prevention and research and a stronger relationship among the scientific, public health, and advocate communities.

CPRIT selects trained patient advocates on the basis of their patient advocacy and survivorship experience. Advocate reviewers are full voting members of a committee and assess the significance and impact of a grant award as well as provide an overall evaluation. Their participation, like all participants of CPRIT’s review process, is governed by CPRIT’s conflict of interest policies. For more information, see section, Reviewer Conflicts of Interest. A list of advocate reviewers is available on CPRIT’s website.

TAC § 703.5(l)

3.4.4 Non-Participating Observers at Peer Review Meetings

Only the Chairperson and reviewers participate in the substantive discussion of applications and decision making at the peer review meetings. Although they do not participate in the substantive discussion or decision making, other individuals may attend the peer review meeting to provide assistance and observe the meeting.

3.4.4.1 CPRIT and Grants Management Staff

The Chief Program Officer and Program Manager attend the peer review meetings. Other

CPRIT program staff or Oversight Committee members may also attend peer review meetings to

June 2024 Page 34 observe the review process. CPRIT program staff does not participate in the discussion, deliberation, scoring, or vote on any grant applications. They may answer technical questions that do not address the substance of the application. Grant management personnel working for

CPRIT’s third-party grant administrator may attend the peer review meetings to assist the panel chairperson and reviewers with administrative issues and provide technical assistance before, during, and after the meeting. Currently, General Dynamics Information Technology (GDIT) serves as CPRIT’s third-party grant administrator.

TAC § 703.6(f)

3.4.4.2 Third Party Observer/Chief Compliance Officer

CPRIT implemented the use of an independent third-party observer at peer review meetings in

2012 to document that panel discussions are limited to the merits of the application and adhere to established evaluation criteria. In addition, the third-party observer’s written report issued at the completion of the review stage indicates whether any attendees other than the reviewers and panel chair at the peer review meeting participated in the discussion, scoring, or vote on the grant application. This report becomes part of the grant record and is publicly reported as part of the compliance certification of grant awards. The Chief Compliance Officer may fill the role of the independent observer if necessary.

TAC § 703.6(g)

3.5 Primary Review and Panel Discussion

Generally, CPRIT’s peer review process consists of two parts: a comprehensive review of the application by Primary Reviewers (usually three) assigned to review specific applications, followed by a full panel discussion. Certain exceptions to the general process described in this section are necessary for a particular program or grant mechanism. For more information, see section, Special Peer Review Processes.