CTR056041_Contract_Documents.pdf

1st July 21

Christine Ruth

Digitally signed by Christine Ruth Date: 2021.07.01 12:57:03 -07'00'

GRANT APPLICATION

RFGA NO. BPM000334

Arizona Department Of Health Services

150 North 18th Ave, Suite 260 Phoenix, Arizona 85007

TABLE OF CONTENTS

Topic Page

Cover Page

Table of Contents

Introduction to the Arizona Investigator Grant (AZ IG)

Special Instructions to Applicants

Grant Terms and Conditions

Attachment A - Letter of Intent Submission

Attachment B - Application Packet

Attachment C - Grant Offer and Acceptance

Attachment D - Notices, Correspondence, and Payments Form

Attachment E - Designation of Confidential Trade Secret & Proprietary Information .............. 28 - 29

Attachment F - Participation of Boycott of Israel Form

INTRODUCTION

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Application

The Application process consists of two (2) phases:

Phase One (1) Letter of Intent. Candidates are required to submit Letter of Intent, as described in the Special Instructions for Applicants, Provision Seven (7) Application Requirements, Section 7.2.

4.1.1 NOTE: Submission of Letter of Intent will not guarantee an invitation to submit a full Application.

Applicants will be notified in writing if accepted or denied to proceed with Phase Two (2).

Phase Two (2) Full Application. Upon review of the received Letters of Intent, Invitation Letters to submit a full Application will be sent to the selected candidates. As described in the Special Instructions for Applicants, Provision Seven (7) Application Requirements, Section 7.3.

INTRODUCTION TO THE ARIZONA INVESTIGATOR GRANT (AZ IG)

1. Arizona Biomedical Research Centre (ABRC)

The mission of the Arizona Department of Health Services (ADHS) ABRC is to identify and support innovative biomedical research to improve the health of all Arizonans. ABRC is focused on leveraging existing resources, maximizing partnerships, cultivating communication, and promoting innovation. ABRC manages multiple initiatives which are guided by input from leaders and professionals from Arizona’s universities, nonprofit research institutions, hospitals, medical centers, and patient advocacy groups.

2. Funding Source

Funding source for this Grant is the Health Research Fund (Tobacco Tax).

3. Available Funds

3.1 Up to one million three hundred thousand dollars ($1,300,000.00) are available for both RFGAs: BPM000334 AZ New Investigator Award (NIA) and BPM000338, Arizona Investigator Grant (AZ IG). Maximum award per BPM000334 AZ IG Application up to two hundred fifty thousand ($250,000.00.00) annually and maximum project duration up to three (3) years from the award date.

3.2 The total amount to be awarded under this Grant program is subject to decision by the ABRC. ADHS shall not be obligated to select project proposals to cover the full amount of available funding and reserves the right to cancel the RFGA without awarding any Grant funds.

5. Program Goals

The goal of this funding opportunity is to accelerate promising research toward clinical testing and breakthroughs designed to improve the health of Arizonans. While ABRC’s strong emphasis is on funding basic and translational research projects, ABRC continues to seek innovative projects that leverage Arizona’s resources and strengthen collaboration. The Arizona Investigator Grant (AZ IG) is established to fund senior researchers who conduct on-going basic or translational research with the goals of seeking larger federal grant funding, moving into clinical trials/device studies, or commercializing their research. ABRC supports collaborative research approaches. A strong emphasis will be focused on Applications that are multidisciplinary and collaborative. Collaboration among investigators could include: within an institution, across institutions, or across disciplines. Projects with a future impact on the local economy and/or commercialization potential such as shortening recovery time, decreasing health care costs, increasing productivity, or adding new biomedical patents in Arizona are encouraged.

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6. Multiple Applications

6.1 Collaborative partners should designate one (1) primary recipient and should collectively submit only one (1) Application per project.

6.2 Each principal investigator may submit only one (1) Letter of Intent.

6.3 Each institute may submit more than one (1) Application as long as the previous two (2) conditions are met

(6.1 and 6.2).

7. Grant Application Funding

7.1 Research projects shall present value in translating the research to applications that benefit Arizonans.

Research projects supported include those that are aimed at:

7.1.1 The causes, epidemiology, and diagnosis of human diseases,

7.1.2 Public health and community-based participatory research,

7.1.3 Progressing promising practices to evidence-based decision-making,

7.1.4 The formulation of cures and medically accepted treatments,

7.1.5 Prevention of human diseases, including new drug discovery and development,

7.1.6 Advancing the prevention and treatment of tobacco-related disease and addiction, and/or

7.1.7 Behavioral studies and attitude assessments.

7.2 All costs should be specifically detailed in the Full Application package. Eligible costs are those that are directly related to the implementation of the project:

7.2.1 Indirect costs are allowed however cannot exceed ten percent (10%) of the total direct cost for each budget year, and

7.2.2 Up to a maximum of five thousand dollars ($5,000.00) per grant awarded (not annually) for manuscript preparation fees, including page charges and illustration costs.

7.2.3 Tuition remission and other forms of compensation paid as, or in lieu of, wages to students under research grants are allowable. Compensating Research Assistants (RA) for time spent on research by paying for tuition while the student is an RA is allowable.

8. Grant Funding Unallowable Activities and Costs

8.1 Construction costs for facility improvements.

8.2 Travel expenses for the Grant recipient or employees of the Grantee to attend scientific meetings, or any other travel that is not directly related to the specific research project being funded. Funds shall only be used for travel that is essential to the research project outcomes.

8.3 Supply expenses for office costs that would be considered in the administrative overhead or indirect calculations, such as telephone costs, paper, postage, copying costs, etc.

8.4 Equipment not directly associated with the project or which exceeds twenty percent (20%) of the total project budget.

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8.5 Out-of-State Subgrantees or collaborators that exceed more than fifty percent (50%) of the total project budget.

8.6 Subscriptions to journals, membership dues to organizations or societies, purchase of books, library search fees, and journal article copying not directly related to the project.

8.7 ADHS does not fund research that uses human fetal tissue, cells, or organs that are obtained from a living or dead embryo or fetus during or after an induced abortion. This restriction does not apply to research that uses human fetal tissue, cells, or organs that are obtained from a spontaneous abortion or an ectopic pregnancy (A.R.S. §36.2302.A).

9. Eligibility

9.1 Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) are eligible to apply for this Grant.

9.2 Applicants shall hold an independent research position at a domestic (U.S.) institution.

9.2.1 For the purpose of this RFGA, “independent research position” means a position that automatically confers eligibility, by the Applicant’s institutional policy, for an investigator to apply for NIH R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research.

https://grants.nih.gov/grants/funding/r01.htm

9.3 The Principal Investigator (PI) shall reside in Arizona;

9.4 The lead institution shall originate in Arizona.

9.5 Current Grant Recipient may apply for the AZ IG as long as the Eligibility criteria are met.

10. Grant Administration and Reimbursement of Expenses

10.1 Applicants selected to receive Grant funding shall be required to sign the Grant Offer and Acceptance. All services or work carried out under a Grant awarded as a result of this RFGA shall be completed within the scope, time frame, and funding limitations specified in this Grant; and

10.2 Payments will be made on a reimbursement basis for eligible expenses incurred by the Grantee. Applicants shall provide original receipts or paid invoices to support eligible expenses. A copy of a general ledger or balance sheet is not acceptable. There will be no pre-payment of expenses by ADHS. Requests for reimbursement may be submitted to ADHS no more frequently than quarterly. Grantees shall provide documentation to show that equipment or services have been received and the expenses incurred before reimbursement is approved by ADHS.

SPECIAL INSTRUCTIONS TO APPLICANTS

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1. Pre-Application Conference

1.1 Prospective Applicants are invited to attend a Pre-Application Conference. Attendance is encouraged, but is not required. The date, time and location of this conference are indicated on the Cover page. This Conference will be to clarify the contents of this Request for Grant Application (RFGA) in order to prevent any misunderstanding of ADHS’ position. Any doubt as to the requirements of this RFGA or any apparent omission or discrepancy should be presented to ADHS at this conference. ADHS will then determine the appropriate action necessary, if any, and issue a written amendment to the RFGA. Oral statements or instructions shall not constitute an amendment to this

RFGA.

1.2 Teleconference Participation

1.2.1 Prospective Offerors may participate in the Pre-Offer Conference via teleconference. The date and time of this conference are indicated on the solicitation cover sheet. The prospective offeror must RSVP via email to the Procurement Officer at jeffery.jones@azdhs.gov, with number of participants including their names, titles, phone numbers, and email addresses no later than 9:00 a.m., Monday, December 3, 2018. ADHS is not responsible for any technical difficulties for teleconference participation. Prospective Offerors are using this option at their own risk.

1.2.2 The Participant Dialing Instructions are:

1.2.3 Dial the Access Number: 855-212-0212, and

1.2.4 Enter the Participant Passcode: 519-640-559#.

2. Application Submission

2.1 Applicants responding to this RFGA shall submit their Letters of Intent by opening the google doc form. Link to Letter of Intent: www.tinyurl.com/ABRCletter.

See 7.2 Phase One (1) - Letter of Intent Requirements below.

2.2 Full Applications shall be submitted electronically through the Arizona Procurement Portal (APP) in a new

Round. Only Applicants whose Letter of Intent was accepted and are notified will be allowed to submit a full Application. All submissions shall be received before the due date and time as listed in APP.

See 7.3 Phase Two (2) - Full Application Requirements below.

Letters of Intent and the subsequent Full Applications submitted outside of APP or those that are received after the due date will not be accepted. Applications not adhering to the instructions in Provision Seven (7) Application Requirements shall NOT be reviewed.

2.3 Full Applications shall be submitted electronically through the Arizona Procurement Portal (APP) in a new

Round. All submissions shall be received before the due date and time as listed in APP. Letters of Intent and the subsequent Full Applications submitted outside of the above listed systems or those that are received after the due date will not be accepted. Applications not adhering to the instructions in Provision Seven (7) Application Requirements shall NOT be reviewed.

Applicants working for Colleges and/or Universities should work with their Contracts and Grants office to submit all documentation on their behalf.

2.4 Submission of Letters of Intent or Applications by means other than the APP system will not be accepted. Click

[Save] button upon uploading each attachment. To ensure successful submission of the Proposal, click the Validate and Send my Answer button from any page. APP will send you an email confirming the receipt of your answer.

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2.5 Acknowledgement of Solicitation Amendments. Applicants shall acknowledge RFGA Amendments electronically in APP (https://app.az.gov) and copy forward or revise previous responses no later than the RFGA due date and time. Failure to acknowledge all/any Solicitation Amendment may result in rejection of the Application.

2.6 Prospective Applicants with questions shall post the questions in the Discussion Forum tab prior to the

Solicitation’s due date. Questions posted in the discussion forum will be made available to the public. See Item

5. Application Questions below.

3. Deadline for Submission

3.1 Letters of Intent will be accepted for consideration for this RFGA only if received through Google no later than the date indicated on the Cover page. ADHS reserves the right to modify or extend the due date.

3.2 For Applicants invited to submit a Full Application, the due date will be specified in the Invitation Letter.

4. Grant Agreement Terms and Conditions

The Grant contains Terms and Conditions which are standard provisions for Grants awarded through the State of Arizona. Applicants shall identify in the Application any concerns with Terms and Conditions in the Grant. ADHS may agree to modify the Terms and Conditions of the Grant under limited circumstances, but ADHS will not address concerns that are not identified in the Grant Application.

5. Application Questions

At any point during the RFGA process, APP offers a Discussion Forum for all questions and correspondence between the Applicant and the State. The Discussion Forum tab is where clarifications, Q&A, and negotiations will be completed between the Applicant and the State. Applicants can compose a new message, or search within the message history to reference and/or export older conversations. Refer to Using the Discussion Forum on page Four (4) of the Submitting an Offer Quick Reference Guide (QRG) for Suppliers.

All questions regarding this RFGA shall be submitted within APP no later than five (5) calendar days prior to the RFGA due date. Applicants will be referred to the APP Discussion Forum tab for this RFGA to direct questions to the Procurement Officer. Questions will only be answered via APP. To post a question, the interested party must be registered in APP.

6. Application Status

6.1 Upon submission, all Application documents become the property of the State of Arizona and as such become subject to public disclosure. All information is deemed not to be proprietary or confidential.

6.2 If an Applicant believes that their Application contains information that should be withheld from public disclosure, it must be clearly marked “Confidential/Proprietary” on those pages.

6.3 A statement advising the Procurement Officer of this fact and explaining the reasons for confidentiality shall accompany the Application. The Applicant shall stamp or specifically identify all information believed to be confidential. It is the responsibility of the Applicant to explain the basis of a claim of confidentiality.

6.4 The information identified by the Applicant as confidential shall not be disclosed until the Procurement Officer makes a written determination. The Procurement Officer shall review the statement and information and shall determine in writing whether the information shall be withheld. If the Procurement Officer determines the information is not confidential, the Procurement Officer shall inform the Applicant in writing of such determination.

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7.2 Phase One (1) - Letter of Intent Requirements

7. Application Requirements

7.1 One electronic copy of the Application shall be submitted in the APP e-procurement system as attachments in the acceptable format specified below. Acceptable formats include .doc document, xls spreadsheet and .pdf.

Applicants shall copy APP Attachments to their own computer, save the information entered, and submit the completed information as a new, appropriately renamed Attachment in APP will not save information entered directly on the Attachments.

7.2.1 A Letter of Intent Application for this funding opportunity shall be submitted through Google forms www.tinyurl.com/ABRCletter no later than the date indicated on the Cover page.

7.2.2 Submit the Application by using the [SEND] button on the form. Failure to complete all the required information, as marked by an asterisk (*), will result in an incomplete and disqualified Application.

7.2.3 The Letter of Intent shall not include confidential or proprietary information.

7.2.4 An email account associated with Google is required to submit an LOI. If you do not have one, please create one for this process. On the first page of the LOI form, the email address for your organization – even if it is not associated with Google – may be added to the LOI submission.

7.2.4.1 Since it is a Google form, it is recommended that the Google Chrome web browser be used to enter the data for your LOI submission.

7.2.5 The Letter of Intent consists of the following:

7.2.5.1 Contact Information, provide the following information:

7.2.5.1.1 Descriptive Title of Proposed Research;

7.2.5.1.2 Principal Investigator (s) Name, Address, Telephone Number, and E-Mail

Address;

7.2.5.1.3 Names of other Key Personnel; and

7.2.5.1.4 Participating Institution(s)’ Name, Address, Telephone Number, and E-Mail

Address.

7.2.5.2 Letter of Intent, complete and submit to include the information below. The researcher shall explain the connection between the research and the potential value to Arizona in terms of health impacts and economic impacts. The total number of characters including spaces should be 4,800 or less. Total point available is twenty-five (25) points.

7.2.5.2.1 Health Impacts on Arizonans [5 points]: This section is allowed 700 characters including spaces, and should describe how the project will benefit the health and wellness of Arizonans. This Grant opportunity is funded by Arizona taxes. Applicants should think about why Arizonans should fund the proposed research. This could include diseases or health concerns that are particular to Arizona or significantly or disproportionately impact Arizonans.

There is no automatic preference for particular diseases. Some approaches could include discussions on disease burden, business opportunities, community interests, etc. Inclusion of statistics or other evidence is encouraged.

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7.3 Phase Two (2) - Full Application Requirements

7.2.5.2.2 Project Description [Fifteen (15) points]: This section is allowed 3,400 characters including spaces. This project should adequately describe the proposed project and the population potentially affected (e.g. elderly, cancer patients, stroke patients, etc.) The project description should include the following five (5) topics:

7.2.5.2.2.1 Background: The background should address the current state of the research field and why this research is important to the field. This section should provide the necessary information to understand the research problem and approaches presented.

This may include a description of literature and/or preliminary data or previous work;

7.2.5.2.2.2 Research Problem: The research problem or data gap should be clearly stated and should demonstrate why the research project is essential and bridge the background with the proposed project.

7.2.5.2.2.3 Hypothesis / Engineering Goal: the hypothesis or engineering goal should be clearly stated. If using an engineering goal instead of a hypothesis, ensure that the goal(s) and benchmark(s) for success are clearly stated.

7.2.5.2.2.4 Aims: The aims should address the hypothesis and stated research problem and be achievable given the overall budget and project period; and

7.2.5.2.2.5 Projected outcomes: The letter should address how the results from this study could inform the field and should include a description of what the expected outcomes/outputs will be.

7.2.5.2.3 Project Impact [5 points]: This section is allowed 700 characters including spaces and should explain the project's impact and significance on scientific understanding of the problem and next steps such as next project, patents, collaborations, funding, etc.

7.3.1 Upon written invitation based on an accepted Letter of Intent the Applicant shall submit the Full Application through APP no later than the date indicated on the Invitation Letter.

7.3.2 The Full Application shall be single sided, typed using Arial 10-point font, single spaced, and margins shall be no less than 0.9” top/bottom/right/left. The material shall be in sequence and organized as outlined below and related to the RFGA. Failure to include the requested information may have a negative impact on the evaluation of the Applicant’s Application.

7.3.3 On each page of the Application, insert a Footer that specifies: Name of the Applicant, Name of the Attachment, the Solicitation Number, and Page Number. ADHS will not provide any reimbursement for the cost of developing in response to this RFGA.

7.3.4 The Full Application must be uploaded as one (1) attachment in the “Items (F)” tab in APP. All Attachments must be completed before submission.

7.3.5 The Full Application shall consist of the following:

7.3.5.1 Table of Contents for entire Application with page numbers;

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7.3.5.2 Application Packet Attachment B:

7.3.5.2.1 General Information Page (filled in as applicable and W-9 attached),

7.3.5.2.2 Acknowledgement Statement of Acceptance of Terms and Conditions (concerns, if applicable),

7.3.5.2.3 Review Purposes Page,

7.3.5.2.4 Project Abstract Page,

7.3.5.2.5 Detailed Project Description (shall not exceed eight (8) pages total in length),

7.3.5.2.6 Biographical Sketch(es), (There is no page limit for the Biographical Sketch(es). The National Institute of Health (NIH) format is acceptable. The Biographical Sketch(es) must be submitted as outlined in section 7.3 herein.)

7.3.5.2.7 Budget Information, and

7.3.5.2.8 Certifications and Assurances.

7.3.5.3 Attachment C - Grant Offer and Acceptance form shall be completed and signed by authorized representative;

7.3.5.4 Attachment D - Notices, Correspondence, and Payments to the Grantee shall be completed in its entirety;

7.3.5.5 Attachment E - Designation of Confidential Trade Secret & Proprietary Information shall be completed and signed by authorized representative;

7.3.5.6 Attachment F - Participation of Boycott of Israel form shall be completed and signed by authorized representative; make sure the revise form is used

7.3.5.7 Other Attachments – provide itemized list of attachments and a brief statement of importance as to why the attachments have been included for review; and

7.3.6 Complete the “Items (F)” tab in APP, which includes attaching the completed Full Application Packet B.

The information required to be input is the “Total Requested” budget amount from Attachment B, General Information page, Item Five (5) Total Fund Request for Project Budget Period. This step must be completed in order to successfully submit your Application.

8. Selection Criteria

Each scientifically distinct Project should be submitted as a separate Application request. Costs should be broken down so that partial funding could be considered for any Grant.

9. Evaluation Criteria For Full Application

9.1 Applications will be evaluated based on information provided in the Full Application.

9.2 Grant Full Applications will be evaluated according to the Grant requirements per ARS §41-2702 F. The evaluation criteria are listed in the relative order of importance and are based on the following:

9.2.1 Significance (5 points): Relevance of the proposed research to the health of Arizona residents.

Applications focusing on the ABRC’s Strategic Mission may be given favorable consideration. The ABRC’s Mission Statement is to identify and support innovative biomedical research to improve the health of all Arizonans;

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9.2.2 Scientific Merit and Approach (55 points): Scientific merit, including: study design, methodology, feasibility, evaluative content, and importance of the proposed research;

9.2.3 Innovation and collaboration (20 points): Novelty and originality of the proposed research or research methodology and collaborative approach;

9.2.4 Investigator(s) (10 points): Productivity and ability of the investigators in the project to perform the research, as shown by their knowledge and experience; and

9.2.5 Adequacy of Facilities and Budget (10 points): Adequacy of facilities and staff, including: personnel and equipment capable of supporting the proposed research, expertise and competence of staff in the techniques required for performance and in the field of the proposed research. Appropriateness of the budget request: the proposed budget will be evaluated to assure that it is reasonable relative to the proposed research and that the expenditures are justifiable.

9.3 ADHS may select parts of an Application for funding and may offer to fund less than the eligible Grant amounts and/or a smaller amount than requested in the Application.

9.4 Based on the number and types of Applications received, ADHS may establish a cut-off level for Grant selections that is less than the available funding, and projects may be offered a smaller amount of funding or may be held until a later date.

10. Discussion

10.1 ADHS reserves the option to conduct discussions with Applicants. The purpose of these discussions is to provide clarification and to assure full understanding of and responsiveness to the Application requirements regarding the Grant.

10.2 If discussions are conducted, Applicants will be invited to modify their Applications.

11. Multiple Awards

In order to assure that any ensuing Grants will allow the State to fulfill current and future needs, ADHS reserves the right to award Grants to multiple Applicants.

12. Notification of Award

Applicants will be notified by ADHS of their award by an Award Letter and signed Grant Offer and Acceptance.

13. Application Acceptance Period

To be eligible for Grant award, Application cost estimates must be held open for one-hundred twenty (120) days.

14. Authorized Signature

14.1 For any document that requires the Applicant’s signature, the signature provided must be that of the Owner, Partner, Corporate Officer or employee of a College or University, duly authorized to sign Grant agreements.

Additionally, if requested by ADHS, disclosure of ownership information or role shall be submitted.

14.1.1 Privately Owned: The Owner shall sign the Grant Application;

14.1.2 Partnership: A Partner shall sign the Grant Application;

14.1.3 Corporation: A duly authorized Corporate Officer shall sign the Grant Application; or

14.1.4 College or University: a duly authorized Officer shall sign the Grant Application

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14.1.4.1 Associate Vice President of Sponsored Projects;

14.1.4.2 Contract Officer;

14.1.4.3 Sponsored Projects and Contracting Services Officer; or

14.1.4.4 Grant and Contract Officer.

14.2 If a person other than these specified individuals signs the Grant Application, a Power of Attorney indicating the employee’s authority must accompany the Grant Application. All addenda to the Grant Application shall be signed by the authorized individual who signed the Grant Application except that they may be signed by a duly authorized designee.

15. Suspension or Debarment Status

If the firm, business or person submitting this Application has been debarred, suspended or otherwise lawfully precluded from participating in any public procurement activity, including being disapproved as a Grantee with any Federal, State or local government or if any such preclusion from participation from any public procurement activity is currently pending, the Applicant shall fully explain the circumstances relating to the preclusion or proposed preclusion in the Application. The Applicant shall include a letter with its Application setting forth the name and address of the governmental unit, the effective date of this suspension or debarment, the duration of the suspension or debarment, and the relevant circumstances relating to the suspension or debarment. If suspension or debarment is currently pending, a detailed description of all relevant circumstances including the details enumerated above shall be provided. The Application of an Applicant who is currently debarred, suspended or otherwise lawfully prohibited from any public procurement activity shall be rejected.

16. Definition of Terms used in this RFGA

16.1 “Attachment” means a document that must be filled out and included as part of the Grant Application.

16.2 “Exhibit” means a document included only for informational purposes. It is not intended to be submitted as part of the Grant Application.

16.3 “Key personnel” means staff involved in the planning, administration, operation, or monitoring of this Grant.

16.4 “Medically and Scientifically Accurate” information will be determined to be medically and scientifically inaccurate if that information is unsupported or contradicted by a preponderance of peer-reviewed research by leading medical, psychological, psychiatric, and public health publications, organizations and agencies.

16.5 "Shall or Must" indicates a mandatory requirement. Failure to meet these mandatory requirements may result in the rejection of an Application as non-responsive.

16.6 “Principal Investigator” means the person who directs the research project or program. The principal investigator (the PI) oversees the scientific and technical aspects of the Grant, and has responsibility for the management of the research.

GRANT TERMS AND CONDITIONS

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1. Scope of Services

1.1 Grantee shall provide all service and deliverables as required, described, and detailed herein and shall meet all service and delivery timelines as specified in this Grant; and

1.2 Grantee shall use their professional expertise to perform the Project according to the Scope of Services and

Terms and Conditions of this Grant. Grantee shall assign specific individuals to key positions of responsibility as shown in Grantee’s Application and which are attached hereto as part of this Grant. Once assigned to work under this Grant, personnel shall not be removed or replaced without prior written notification to ADHS.

Grantee shall comply with all applicable local, state and federal laws and regulations, and with all applicable licenses and institutional review board requirements.

2. Grant Period

2.1 This Grant shall be effective July 1, 2019 or upon final signature, whichever is later (“Effective Date”) and shall remain in effect for three (3) years unless terminated, canceled, or extended as otherwise provided herein.

2.2 Term Extension. ADHS reserves the right, at its sole option, to extend this Agreement for an additional period of time representing increments of no more than one (1) year, provided that such an extension of the term is affected prior to the current, Agreement expiration date by means of an extension. If ADHS exercises such rights, all terms, conditions and provisions of the original Grant shall remain the same and apply during the option terms.

3. Compensation and Conditions

3.1 ADHS will pay to Grantee an amount not to exceed the amount of funding awarded per year, on a cost reimbursement basis for eligible expenses incurred by the Grantee in the completion of Project. A Purchase Order will be issued in the amount awarded.

3.2 Availability of funds for the next fiscal year: Funds may not presently be available for performance under this

Grant beyond the current State fiscal year. No legal liability on the part of the State for any payment may arise under this Grant beyond the current State fiscal year until funds are made available for performance of this Grant.

3.3 Use of grant funds: Grantee shall use the grant funds only for the purposes set forth in the Scope of Work. In the event that any of the Grant funds cannot be used by Grantee, the unused funds shall be returned to the Tobacco Tax and Health Care Fund – Health Research Account within thirty (30) days after the end of the Grant period. Any failure to provide timely reports and/or completion of activities may affect future funding.

3.4 Contractor expenditure reports: There will be no pre-payment of expenses by ADHS. Requests for reimbursement may be submitted to ADHS quarterly through submission of a Contractor’s Expenditure Report (CER). CER template will be emailed quarterly to Grantee prior to the submission deadline. Grantee shall be required to attach documentation to show that equipment or services have been received and the expenses incurred before reimbursement is provided by ADHS. For a cost to have been incurred the equipment or service must have been received and the cost must have been paid, unless otherwise approved and authorized by ADHS.

3.5 Quarterly update reports: Reports on the progress of completing the Project activities will be required on a quarterly basis, or as specified or otherwise agreed to by ADHS, even if no expenses are submitted for reimbursement during that time. Reports must follow the template provided and be emailed to Biomedical@azdhs.gov . Reports shall include a brief overview of the project, identification number, date of the report, the status of the project at the end of the reporting period and a forecast of the work remaining to be performed.

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3.6 If using human subjects, documentation of the Institutional Review Board (IRB) review and approval/exemption should be submitted to ADHS after the Grant award and prior to conducting research. Documentation must be emailed to Biomedical@azdhs.gov.

3.7 Grantee shall notify ADHS of any material change in the Project. Any issues that have been identified that may affect the budget, timeline, or viability of the project shall be brought to the attention of ADHS as soon as possible.

3.8 Project activities funded under the Grant must be completed by the date specified on the Purchase Order, and all costs must be incurred by this date. Grantee shall notify ADHS in writing if the Project is expected to require a longer period of time to be completed. ADHS’ obligation to reimburse Grantee’s allowable costs incurred and paid under this Grant shall expire forty-five (45) days after ADHS’ notification of Grant close out. If no reimbursement has been requested or paid as of this date, ADHS’ obligation to pay will terminate.

3.9 Arizona Substitute/IRS W-9 Form: In order to receive payment, Grantee shall have a current Arizona Substitute W-9 Form on file with the State of Arizona, unless not required by law.

3.10 Grantee shall attend an ADHS ABRC Research Conference to present and share Project status and findings.

4. Grant Changes

4.1 Amendments. No alteration or amendment of this Grant shall be valid unless the same is made by an instrument in writing signed by the ADHS Procurement Office and the Grantee and no such alteration or amendment shall be construed to alter or amend any other provision of this Grant unless expressly so stated in such written instrument. Changes to the Grant, including the addition of work or materials, the revision of payment terms, or the substitution of work or materials, directed by a person who is not specifically authorized by the ADHS Procurement Office in writing or made unilaterally by the Grantee are violations of the Grant. Such changes, including unauthorized written Amendments shall be void and without effect, and the Grantee shall not be entitled to any claim under this Grant based on those changes.

4.2 Subgrantees. Grantee shall not enter into any Subgrantee under this Grant for the performance of this Grant without the advance written approval of ADHS. Grantee shall clearly list any proposed Subgrantees and the Subgrantee’s proposed responsibilities. The Subgrantee shall incorporate by reference the terms and conditions of this Grant. Grantee shall provide ADHS with a copy of any Subgrantee entered into between Grantee and any party other than its own institutional members within thirty (30) working days after such Subgrant is signed.

Payment for any services rendered or costs incurred with respect to any Subgrantee shall be the sole responsibility of Grantee.

4.3 Assignment and Delegation. This Grant may not be assigned by any party without the prior written consent of the other parties. If consent to an assignment is obtained, this Grant is binding on the successors and assigns of the parties to this Grant.

5. Notices

All notices, requests, demands, consents, approvals, and other communications which may or are required to be served or given hereunder (for the purposes of this provisions collectively called 'Notices'), shall be in writing and shall be sent to:

5.1 Notices Directed to ADHS:

Ana Shoshtarikj, Chief Procurement Officer Arizona Department of Health Services Office of Procurement 150 North 18th Avenue, Suite 260 Phoenix, Arizona 85007 Phone: 602-542-1011 E-mail: ana.shoshtarikj@azdhs.gov

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With a copy to:

Victor Waddell, Executive Director Arizona Department of Health Services Arizona Biomedical Research Centre 250 North 18th Avenue Phoenix, Arizona 85007 E-Mail: Biomedical@azdhs.gov

5.2 Notices Directed to the Grantee:

Completed Application Packets, Attachment C, D, E and F will be incorporated into the Grant upon award.

6. Indemnification

6.1 To the fullest extent permitted by law, Contractor shall defend, indemnify, and hold harmless the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees (hereinafter referred to as “Indemnitee”) from and against any and all claims, actions, liabilities, damages, losses, or expenses (including court costs, attorneys’ fees, and costs of claim processing, investigation and litigation) (hereinafter referred to as “Claims”) for bodily injury or personal injury (including death), or loss or damage to tangible or intangible property caused, or alleged to be caused, in whole or in part, by the negligent or willful acts or omissions of Contractor or any of its owners, officers, directors, agents, employees or subcontractors. This indemnity includes any claim or amount arising out of, or recovered under, the Workers’ Compensation Law or arising out of the failure of such Contractor to conform to any federal, state, or local law, statute, ordinance, rule, regulation, or court decree. It is the specific intention of the parties that the Indemnitee shall, in all instances, except for Claims arising solely from the negligent or willful acts or omissions of the Indemnitee, be indemnified by Contractor from and against any and all claims. It is agreed that Contractor will be responsible for primary loss investigation, defense, and judgment costs where this indemnification is applicable. In consideration of the award of this contract, the Contractor agrees to waive all rights of subrogation against the State of Arizona, its officers, officials, agents, and employees for losses arising from the work performed by the Contractor for the State of Arizona.

6.2 This indemnity shall not apply if the contractor or sub-contractor(s) is/are an agency, board, commission or university of the State of Arizona.

7. Insurance Requirements

7.1 Contractor and subcontractors shall procure and maintain, until all of their obligations have been discharged, including any warranty periods under this Contract, insurance against claims for injury to persons or damage to property arising from, or in connection with, the performance of the work hereunder by the Contractor, its agents, representatives, employees or subcontractors.

7.2 The Insurance Requirements herein are minimum requirements for this Contract and in no way limit the indemnity covenants contained in this Contract. The State of Arizona in no way warrants that the minimum limits contained herein are sufficient to protect the Contractor from liabilities that arise out of the performance of the work under this Contract by the Contractor, its agents, representatives, employees or subcontractors, and the Contractor is free to purchase additional insurance.

7.3 Minimum Scope and Limits of Insurance: Grantee shall provide coverage with limits to liability not less than those stated below.

Contractor shall provide coverage with limits of liability not less than those stated below.

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7.3.1 Commercial General Liability (CGL) – Occurrence Form

Policy shall include bodily injury, property damage, personal injury and broad form Contractual liability coverage.

General Aggregate $2,000,000 Products – Completed Operations Aggregate $1,000,000 Personal and Advertising Injury $1,000,000 Damage to Rented Premises $50,000 Each Occurrence $1,000,000

7.3.1.1 The policy shall be endorsed, as required by this written agreement, to include the State of

Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees as additional insureds with respect to liability arising out of the activities performed by or on behalf of the Contractor.

7.3.1.2 Policy shall contain a waiver of subrogation endorsement, as required by this written agreement, in favor of the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees for losses arising from work performed by or on behalf of the Contractor.

7.3.2 Workers’ Compensation and Employers' Liability

Workers' Compensation Employers' Liability

Statutory

Each Accident $1,000,000 Disease – Each Employee $1,000,000 Disease – Policy Limit $1,000,000

7.3.2.1 Policy shall contain a waiver of subrogation endorsement, as required by this written agreement, in favor of the State of Arizona, and its departments, agencies, boards, commissions, universities, officers, officials, agents, and employees for losses arising from work performed by or on behalf of the Contractor.

7.3.2.2 This requirement shall not apply to each Contractor or subcontractor that is exempt under

A.R.S. § 23-901, and when such Contractor or subcontractor executes the appropriate waiver form (Sole Proprietor or Independent Contractor).

7.4 Additional Insurance Requirements

The policies shall include, or be endorsed to include, as required by this written agreement, the following provisions:

7.4.1 The Contractor's policies, as applicable, shall stipulate that the insurance afforded the Contractor shall be primary and that any insurance carried by the Department, its agents, officials, employees or the State of Arizona shall be excess and not contributory insurance, as provided by A.R.S. § 41-621 (E).

7.4.2 Insurance provided by the Contractor shall not limit the Contractor’s liability assumed under the indemnification provisions of this Contract.

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7.5 Notice of Cancellation

Applicable to all insurance policies required within the Insurance Requirements of this Contract, Contractor’s insurance shall not be permitted to expire, be suspended, be canceled, or be materially changed for any reason without thirty (30) days prior written notice to the State of Arizona. Within two (2) business days of receipt, Contractor must provide notice to the State of Arizona if they receive notice of a policy that has been or will be suspended, canceled, materially changed for any reason, has expired, or will be expiring. Such notice shall be sent directly to the Department and shall be mailed, emailed, hand delivered or sent by facsimile transmission to (State Representative’s Name, Address & Fax Number).

7.6 Acceptability of Insurers

Contractor’s insurance shall be placed with companies licensed in the State of Arizona or hold approved non-admitted status on the Arizona Department of Insurance List of Qualified Unauthorized Insurers. Insurers shall have an “A.M. Best” rating of not less than A- VII. The State of Arizona in no way warrants that the above-required minimum insurer rating is sufficient to protect the Contractor from potential insurer insolvency.

7.7 Verification of Coverage

Contractor shall furnish the State of Arizona with certificates of insurance (valid ACORD form or equivalent approved by the State of Arizona) as required by this Contract. An authorized representative of the insurer shall sign the certificates.

7.7.1 All certificates and endorsements, as required by this written agreement, are to be received and approved by the State of Arizona before work commences. Each insurance policy required by this Contract must be in effect at, or prior to, commencement of work under this Contract. Failure to maintain the insurance policies as required by this Contract, or to provide evidence of renewal, is a material breach of contract.

7.7.2 All certificates required by this Contract shall be sent directly to the Department. The State of Arizona project/contract number and project description shall be noted on the certificate of insurance. The State of Arizona reserves the right to require complete copies of all insurance policies required by this Contract at any time.

7.8 Subgrantees

Contractor’s certificate(s) shall include all subcontractors as insureds under its policies or Contractor shall be responsible for ensuring and/or verifying that all subcontractors have valid and collectable insurance as evidenced by the certificates of insurance and endorsements for each subcontractor. All coverages for subcontractors shall be subject to the minimum Insurance Requirements identified above. The Department reserves the right to require, at any time throughout the life of this contract, proof from the Contractor that its subcontractors have the required coverage.

7.9 Approval and Modifications

The Contracting Agency, in consultation with State Risk, reserves the right to review or make modifications to the insurance limits, required coverages, or endorsements throughout the life of this contract, as deemed necessary.

Such action will not require a formal Contract amendment but may be made by administrative action.

7.10 Exceptions

In the event the Contractor or subcontractor(s) is/are a public entity, then the Insurance Requirements shall not apply. Such public entity shall provide a certificate of self-insurance. If the Contractor or subcontractor(s) is/are a State of Arizona agency, board, commission, or university, none of the above shall apply.

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7.11 Force Majeure

7.11.1 Except for payment of sums due, neither party shall be liable to the other nor deemed in default under this Grant if and to the extent that such party’s performance of this Grant is prevented by reason of force majeure. The term “force majeure” means an occurrence that is beyond the control of the party affected and occurs without its fault or negligence. Without limiting the foregoing, force majeure includes acts of God; acts of the public enemy; war; riots; strikes; mobilization; labor disputes; civil disorders; fire; flood;

lockouts; injunctions-intervention-acts; or failures or refusals to act by government authority; and other similar occurrences beyond the control of the party declaring force majeure which such party is unable to prevent by exercising reasonable diligence.

7.11.2 Force Majeure shall not include the following occurrences:

7.11.2.1 Late delivery of equipment or materials caused by congestion at a manufacturer’s plant or elsewhere, or an oversold condition of the market;

7.11.2.2 Late performance by a Subgrantee unless the delay arises out of a force majeure occurrence in accordance with this force majeure term and condition; or

7.11.2.3 Inability of either the Grantee or any Subgrantee to acquire or maintain any required insurance, bonds, licenses or permits.

7.11.3 If either party is delayed at any time in the progress of the work by force majeure, the delayed party shall notify the other party in writing of such delay, as soon as is practicable and no later than the following working day, of the commencement thereof and shall specify the causes of such delay in such notice. Such notice shall be delivered or mailed certified-return receipt and shall make a specific reference to this article, thereby invoking its provisions. The delayed party shall cause such delay to cease as soon as practicable and shall notify the other party in writing when it has done so. The time of completion shall be extended by an Amendment for a period of time equal to the time that results or effects of such delay prevent the delayed party from performing in accordance with this Agreement.

7.11.4 Any delay or failure in performance by either party hereto shall not constitute default hereunder or give rise to any claim for damages or loss of anticipated profits if, and to the extent that such delay or failure is caused by force majeure.

8. Sole Document

This Grant means the Grant, the Scope of Work, and any other attachments constitute the entire Grant between the parties with respect to the subject matter hereof. This Grant supersedes any and all prior agreements of the parties with respect to the subject matter hereof and may only be amended by the parties by written amendment.

9. Audit of Records and Reports

Grantee agrees to comply with applicable financial and compliance audits described in A.R.S. § 35-181.03(B) and grant appropriation. Grantee shall provide a report of an annual audit and an external evaluation to ADHS by October 1 and annually thereafter during the term of this Grant. Under A.R.S. 35-214 and 35-215, the Grantee shall retain and shall Contractually require each Subgrantee to retain all data, books, and other records relating to the acquisition and performance of this Agreement for a period of five (5) years after completion of this Grant.