Document:

Exhibit
10.9

 

	Notice of Award

                                                                                 

	 	SMALL
                           BUSINESS TECHNOLOGY TRANSFER PROG

                           Department
                           of Health and Human Services

                           National Institutes of Health
	 	Federal Award Date:   06/24/2020	 
	 	NATIONAL INSTITUTE ON
    AGING	 	 	 

 

	Grant Number:	 5R42AG054322-03
	FAIN:	R42AG054322

 

Principal
Investigator(s):

Joshua
M Hare (contact), MD

Sean
Xiao Leng, MD

Anthony
Andrew Oliva, PHD

 

Project
Title: A Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate Longeveron Mesenchymal Stem Cell (LMSC) Therapy
for Treating The Metabolic Syndrome

 

Ms.
Suzanne Liv, Page J.D.

Chief
Operating Officer

Longeveron
LLC

1951
NW 7th Ave.

Ste.
300

Miami,
FL 331361112

 

Award
e-mailed to: spage@longeveron.com

 

Period
Of Performance:

Budget
Period: 07/01/2020 – 03/31/2021

Project
Period: 09/30/2017 – 03/31/2021

 

Dear
Business Official:

 

The
National Institutes of Health hereby awards a grant in the amount of $435,997 (see “Award Calculation” in Section
I and “Terms and Conditions” in Section III) to LONGEVERON, LLC in support of the above referenced project. This award
is pursuant to the authority of 42 USC 241 15 USC 638 42 CFR 52 and is subject to the requirements of this statute and regulation
and of other referenced, incorporated or attached terms and conditions.

 

Acceptance
of this award including the “Terms and Conditions” is acknowledged by the grantee when funds are drawn down or otherwise
obtained from the grant payment system.

 

Each
publication, press release, or other document about research supported by an NIH award must include an acknowledgment of NIH award
support and a disclaimer such as “Research reported in this publication was supported by the National Institute On Aging
of the National Institutes of Health under Award Number R42AG054322. The content is solely the responsibility of the authors and
does not necessarily represent the official views of the National Institutes of Health.” Prior to issuing a press release
concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination.

 

Award
recipients must promote objectivity in research by establishing standards that provide a reasonable expectation that the
design, conduct and reporting of research funded under NIH awards will be free from bias resulting from an
Investigator’s Financial Conflict of Interest (FCOI), in accordance with the 2011 revised regulation at 42 CFR Part 50
Subpart F. The Institution shall submit all FCOI reports to the NIH through the eRA Commons FCOI Module. The regulation does
not apply to Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) awards. Consult
the NIH website http://grants.nih.gov/grants/policy/coi/ for a link to the regulation and additional important
information.

 

If
you have any questions about this award, please contact the individual(s) referenced in Section IV.

 

Sincerely
yours,

 

E.
C. Melvin

Grants
Management Officer

NATIONAL
INSTITUTE ON AGING

 

Additional
information follows

 

     

     

    

 

 

SECTION
I – AWARD DATA – 5R42AG054322-03

 

	Award
    Calculation (U.S. Dollars)	 	 	 
	Salaries
    and Wages	 	$	100,680	 
	Fringe
    Benefits	 	$	18,121	 
	Personnel
    Costs (Subtotal)	 	$	118,801	 
	Materials
    & Supplies	 	$	36,715	 
	Travel	 	$	8,000	 
	Subawards/Consortium/Contractual
    Costs	 	$	167,800	 
	ADP/Computer
    Services	 	$	2,500	 
	 	 	 	 	 
	Federal
    Direct Costs	 	$	333,816	 
	Federal
    F&A Costs	 	$	102,181	 
	Approved
    Budget	 	$	435,997	 
	Total
    Amount of Federal Funds Obligated (Federal Share)	 	$	435,997	 
	TOTAL
    FEDERAL AWARD AMOUNT	 	$	435,997	 
	 	 	 	 	 
	AMOUNT
    OF THIS ACTION (FEDERAL SHARE)	 	$	435,997	 

 

 

SUMMARY
TOTALS FOR ALL YEARS

 

	YR	 	THIS AWARD	 	CUMULATIVE TOTALS	 
	3	 	$	435,997	 	$	435,997	 

 

	Fiscal Information:	 
	CFDA Name:	Aging Research
	CFDA Number:	93.866
	EIN:	1472174146A1
	Document Number:	RAG054322B
	PMS Account Type:	P (Subaccount)
	Fiscal Year:	2020

 

	IC	 	CAN	 	2020
	AG	 	8470736	 	$435,997

  

NIH
Administrative Data:

PCC:
4CCTSSR / OC: 41025 / Released: MELVINEC 06/19/2020

Award
Processed: 06/24/2020 12:02:26 AM

 

 

 

SECTION
II – PAYMENT/HOTLINE INFORMATION – 5R42AG054322-03

 

For
payment and HHS Office of Inspector General Hotline information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm

  

 

 

SECTION
III – TERMS AND CONDITIONS – 5R42AG054322-03

 

This
award is based on the application submitted to, and as approved by, NIH on the above-titled project and is subject to the terms
and conditions incorporated either directly or by reference in the following:

 

		a.	The
                                         grant program legislation and program regulation cited in this Notice of Award.

		b.	Conditions
                                         on activities and expenditure of funds in other statutory requirements, such as those
                                         included in appropriations acts.

		c.	45
                                         CFR Part 75.

		d.	National
                                         Policy Requirements and all other requirements described in the NIH Grants Policy Statement,
                                         including addenda in effect as of the beginning date of the budget period.

		e.	Federal
                                         Award Performance Goals: As required by the periodic report in the RPPR or in the final
                                         progress report when applicable.

		f.	This
                                         award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.

 

(See
NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.)

 

    Page- 2

     

    

 

Research
and Development (R&D): All awards issued by the National Institutes of Health (NIH) meet the definition of “Research
and Development” at 45 CFR Part§ 75.2. As such, auditees should identify NIH awards as part of the R&D cluster
on the Schedule of Expenditures of Federal Awards (SEFA). The auditor should test NIH awards for compliance as instructed in Part
V, Clusters of Programs. NIH recognizes that some awards may have another classification for purposes of indirect costs. The auditor
is not required to report the disconnect (i.e., the award is classified as R&D for Federal Audit Requirement purposes but
non-research for indirect cost rate purposes), unless the auditee is charging indirect costs at a rate other than the rate(s)
specified in the award document(s).

 

An
unobligated balance may be carried over into the next budget period without Grants Management Officer prior approval.

 

This
grant is subject to Streamlined Noncompeting Award Procedures (SNAP).

 

This
award is subject to the requirements of 2 CFR Part 25 for institutions to receive a Dun & Bradstreet Universal Numbering System
(DUNS) number and maintain an active registration in the System for Award Management (SAM). Should a consortium/subaward be issued
under this award, a DUNS requirement must be included. See http://grants.nih.gov/grants/policy/awardconditions.htm for
the full NIH award term implementing this requirement and other additional information.

 

This
award has been assigned the Federal Award Identification Number (FAIN) R42AG054322. Recipients must document the assigned FAIN
on each consortium/subaward issued under this award.

 

Based
on the project period start date of this project, this award is likely subject to the Transparency Act subaward and executive
compensation reporting requirement of 2 CFR Part 170. There are conditions that may exclude this award; see http://grants.nih.gov/grants/policy/awardconditions.htm
for additional award applicability information.

 

In
accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. For more information, see NOT-OD-08-033
and the Public Access website: http://publicaccess.nih.gov/.

 

This
award provides support for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the “responsible
party” must register “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration System
Information Website. NIH encourages registration of all trials whether required under the law or not. For more information,
see http://grants.nih.gov/ClinicalTrials_fdaaa/

 

This award represents the final year of the competitive segment for this
grant. See the NIH Grants Policy Statement Section 8.6 Closeout for complete closeout requirements at: http://grants.nih.gov/grants/policy/policy.htm#gps.

 

A
final expenditure Federal Financial Report (FFR) (SF 425) must be submitted through the eRA Commons (Commons) within 120 days
of the period of performance end date; see the NIH Grants Policy Statement Section 8.6.1 Financial Reports, http://grants.nih.gov/grants/policy/policy.htm#gps,
for additional information on this submission requirement. The final FFR must indicate the exact balance of unobligated funds
and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the
Payment Management System’s (PMS) quarterly cash transaction data. A final quarterly federal cash transaction report is
not required for awards in PMS B subaccounts (i.e., awards to foreign entities and to Federal agencies). NIH will close the awards
using the last recorded cash drawdown level in PMS for awards that do not require a final FFR on expenditures or quarterly federal
cash transaction reporting. It is important to note that for financial closeout, if a grantee fails to submit a required final
expenditure FFR, NIH will close the grant using the last recorded cash drawdown level. If the grantee submits a final expenditure
FFR but does not reconcile any discrepancies between expenditures reported on the final expenditure FFR and the last cash report
to PMS, NIH will close the award at the lower amount. This could be considered a debt or result in disallowed costs.

 

    Page- 3

     

    

 

A
Final Invention Statement and Certification form (HHS 568), (not applicable to training, construction, conference or cancer education
grants) must be submitted within 120 days of the expiration date. The HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm.
This paragraph does not apply to Training grants, Fellowships, and certain other programs—i.e., activity codes C06, D42,
D43, D71, DP7, G07, G08, G11, K12, K16, K30, P09, P40, P41, P51, R13, R25, R28, R30, R90, RL5, RL9, S10, S14, S15, U13, U14, U41,
U42, U45, UC6, UC7, UR2, X01, X02.

 

Unless
an application for competitive renewal is submitted, a Final Research Performance Progress Report (Final RPPR) must also be submitted
within 120 days of the period of performance end date. If a competitive renewal application is submitted prior to that date, then
an Interim RPPR must be submitted by that date as well. Instructions for preparing an Interim or Final RPPR are at: https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf.
Any other specific requirements set forth in the terms and conditions of the award must also be addressed in the Interim or Final
RPPR. Note that data reported within Section I of the Interim and Final RPPR forms will be made public and should be written
for a lay person audience.

 

NIH
strongly encourages electronic submission of the final invention statement through the Closeout feature in the Commons, but will
accept an email or hard copy submission as indicated below.

 

Email:
The final invention statement may be e-mailed as PDF attachments to: NIHCloseoutCenter@mail.nih.gov.

 

Hard
copy: Paper submissions of the final invention statement may be faxed to the NIH Division of Central Grants Processing, Grants
Closeout Center, at 301-480-2304, or mailed to:

 

National
Institutes of Health

Office
of Extramural Research

Division
of Central Grants Processing

Grants
Closeout Center

6705
Rockledge Drive

Suite
5016, MSC 7986

Bethesda,
MD 20892-7986 (for regular or U.S. Postal Service Express mail)

Bethesda,
MD 20817 (for other courier/express deliveries only)

 

NOTE:
If this is the final year of a competitive segment due to the transfer of the grant to another institution, then a Final RPPR
is not required. However, a final expenditure FFR is required and should be submitted electronically as noted above. If not already
submitted, the Final Invention Statement is required and should be sent directly to the assigned Grants Management Specialist.

 

In
accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000
must report and maintain information in the System for Award Management (SAM) about civil, criminal, and administrative proceedings
in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly
available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information
System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75. This term does not apply
to NIH fellowships.

 

Treatment
of Program Income:

Additional
Costs

 

    Page- 4

     

    

  

 

SECTION
IV – AG Special Terms and Conditions – 5R42AG054322-03

 

Clinical
Trial Indicator: Yes

This
award supports one or more NIH-defined Clinical Trials. See the NIH Grants Policy Statement Section 1.2 for NIH definition of
Clinical Trial.

 

This
award includes funds awarded for consortium activity with the University of Miami. Consortiums are to be established and administered
as described in the NIH Grants Policy Statement (NIH GPS). The referenced section of the NIH Grants Policy Statement, 2017 is
available at: http://grants.nih.gov/grants/policy/nihgps/HTML5/section_15/15_consortium_agreements.htm n keeping with NOT-OD-06-054
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06- 054.html), as this grant has multiple Principal Investigators
(PIs), although the signatures of the PIs are not required on prior approval requests submitted to the agency, the grantee institution
must secure and retain the signatures of all of the PIs within their own internal processes.

 

Intellectual
property rights: Normally, the awardee(s) organization retains the principal worldwide patent rights to any invention developed
with United States Government support. Under Title 37 Code of Federal Regulations Part 401, the Government receives a royalty-free
license for its use, reserves the right to require the patent holder to license others in certain circumstances, and requires
that anyone exclusively licensed to sell the invention in the United States must normally manufacture it substantially in the
United States.

 

Rights
and obligations related to inventions created or reduced to practice as a result of this award are detailed in 35 U.S.C. 205 and
37 CFR Part 401. These inventions must be reported to the Extramural Invention Reporting and Technology Resources Branch, OPERA,
NIH, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20892-7750, (301) 435-1986. For additional information, access the NIH link
on the Interagency Edison web site (www.iedison.gov) which includes an electronic invention reporting system, reference
information and the text to 37 CFR 401.

 

To
the extent authorized by 35 U.S.C., Section 205, the Government will not make public any information disclosing an NIH-supported
invention for a 4-year period to allow the awardee organization a reasonable time to file a patent application, nor will the Government
release any information that is part of that patent application.

 

The
fee provided as part of this Notice of Grant Award is in addition to direct and facilities and administrative costs. The fee is
to be drawn down from the DHHS Payment Management System in increments proportionate to the drawdown of costs.

 

Allowable
costs conducted by for-profit organizations will be determined by applying the cost principles of Contracts with Commercial Organizations
set forth in 48 CFR, Subpart 31.2.

 

The
format for the Final Report is as follows:

 

		1.	State
                                         the beginning and ending dates for the period covered by the STTR Phase Phase II grant.

		2.	List
                                         all key personnel who have worked on the project during that period, their titles, dates
                                         of service, and number of hours devoted to the project.

		3.	Summarize
                                         the specific aims of the Phase I grant.

		4.	Provide
                                         a succinct account of published and unpublished results, indicating progress toward their
                                         achievement. Summarize the importance of the findings. Discuss any changes in the specific
                                         aims since the project was initiated. Include the Inclusion Enrollment Report with the
                                         final enrollment data for clinical research (MS Word or PDF).

		5.	List
                                         titles and complete references to publications, and manuscripts accepted for publication,
                                         if any, that resulted from the project’s effort. Submit five copies of such
                                         items, except patent and invention reports, as an Appendix.

		6.	List
                                         patents, copyrights, trademarks, invention reports and other printed materials, if any,
                                         that resulted from the project or describe patent status, trade secrets or other demonstration
                                         of IP protection.

		7.	Describe
                                         the technology developed from this SBIR/STTR, its intended use and who will use it.

 

    Page- 5

     

    

 

		8.	Describe
                                         the current status of the product (e.g., under development, commercialized, in use, discontinued).

		9.	If
                                         applicable, describe the status of FDA approval for your product, process, or service
                                         (e.g., continuing pre-IND studies, filed an IND, in Phase I (or II or III) clinical trials,
                                         applied for approval, review ongoing, approved, not approved).

		10.	Describe
                                         how your company has benefited from the program and/or the technology developed (e.g.,
                                         firm’s growth, follow-on funding, increased technical expertise, licensing agreements,
                                         spin-off companies, public offering [include stock exchange and symbol]).

		11.	List
                                         of the generic and/or commercial name of product, process, or service, if any, that resulted
                                         from SBIR/STTR funding. If applicable, indicate the number of products sold.

		12.	Provide
                                         the current number of employees (total full time equivalents [FTEs]).

 

STAFF
CONTACTS

 

The
Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation
of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical
aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by
an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may
be made via e-mail.

 

Grants
Management Specialist: John Bladen

Email:
bladenj@nia.nih.gov Phone: 301-496-1472 Fax: 301-402-3672

 

Program
Official: Sergei Romashkan

Email:
romashks@nia.nih.gov Phone: (301) 435-3047 Fax: (301) 402 - 1784

 

SPREADSHEET
SUMMARY

GRANT
NUMBER: 5R42AG054322-03

 

INSTITUTION:
LONGEVERON, LLC

 

	Budget	 	Year
    3	 
	Salaries
    and Wages	 	$	100,680	 
	Fringe
    Benefits	 	$	18,121	 
	Personnel
    Costs (Subtotal)	 	$	118,801	 
	Materials
    & Supplies	 	$	36,715	 
	Travel	 	$	8,000	 
	Subawards/Consortium/Contractual
    Costs	 	$	167,800	 
	ADP/Computer
    Services	 	$	2,500	 
	TOTAL
    FEDERAL DC	 	$	333,816	 
	TOTAL
    FEDERAL F&A	 	$	102,181	 
	TOTAL
    COST	 	$	435,997	 

 

	Facilities
    and Administrative Costs	 	Year
    3	 
	F&A
    Cost Rate 1	 	 	30.61	%
	F&A
    Cost Base 1	 	$	333,816	 
	F&A
    Costs 1	 	$	102,181	 

 

    Page- 6Exhibit 10.10

 

	Notice of Award
	 	Ph 1 Explor./Developmental Coop. Agreement 

                           Department of Health and Human Services

                           National Institutes of Health
	 	Federal Award Date:   09/09/2020	 
	 	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	 	 	 

 

	Grant Number:	1UG3HL148318-01A1
	FAIN:	UG3HL148318

 

Principal Investigator(s):

Joshua M Hare, MD

Sunjay Kaushal (contact), MD

 

Project Title: 1/2 Allogeneic Human
Mesenchymal Stem Cell (MSC) Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial

 

Shelley Tiemann

University of Maryland, Baltimore 

620 West
Lexington Street 4155

Baltimore, MD 212011508

 

Award e-mailed to: nga@ordmail.umaryland.edu

 

Period Of Performance:

Budget Period: 09/15/2020 – 08/31/2021

Project Period: 09/15/2020 – 08/31/2021

 

Dear Business Official:

 

The National Institutes of Health hereby awards
a grant in the amount of $657,935 (see “Award Calculation” in Section I and “Terms and Conditions” in Section
III) to UNIVERSITY OF MARYLAND BALTIMORE in support of the above referenced project. This award is pursuant to the authority of
42 USC 241 42 CFR PART 52 and is subject to the requirements of this statute and regulation and of other referenced, incorporated
or attached terms and conditions.

 

Acceptance of this award including the “Terms
and Conditions” is acknowledged by the grantee when funds are drawn down or otherwise obtained from the grant payment system.

 

Each publication, press release, or other document
about research supported by an NIH award must include an acknowledgment of NIH award support and a disclaimer such as “Research
reported in this publication was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health
under Award Number UG3HL148318. The content is solely the responsibility of the authors and does not necessarily represent the
official views of the National Institutes of Health.” Prior to issuing a press release concerning the outcome of this research,
please notify the NIH awarding IC in advance to allow for coordination.

 

Award recipients must promote
objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting
of research funded under NIH awards will be free from bias resulting from an Investigator’s Financial Conflict of Interest
(FCOI), in accordance with the 2011 revised regulation at 42 CFR Part 50 Subpart F. The Institution shall submit all FCOI reports
to the NIH through the eRA Commons FCOI Module. The regulation does not apply to Phase I Small Business Innovative Research (SBIR)
and Small Business Technology Transfer (STTR) awards. Consult the NIH website http://grants.nih.gov/grants/policy/coi/
for a link to the regulation and additional important information.

 

If you have any questions about this award,
please contact the individual(s) referenced in Section IV.

 

Sincerely yours,

John Diggs

Grants Management Officer

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

 

Additional information follows

 

     

     

    

  

 

SECTION I – AWARD DATA – 1UG3HL148318-01A1

 

	Award Calculation (U.S. Dollars)	 	 	 
	Salaries and Wages	 	$	219,825	 
	Personnel Costs (Subtotal)	 	$	219,825	 
	Subawards/Consortium/Contractual Costs	 	$	438,110	 
	 	 	 	 	 
	Federal Direct Costs	 	$	657,935	 
	Approved Budget	 	$	657,935	 
	Total Amount of Federal Funds Obligated (Federal Share)	 	$	657,935	 
	TOTAL FEDERAL AWARD AMOUNT	 	$	657,935	 
	 	 	 	 	 
	AMOUNT OF THIS ACTION (FEDERAL SHARE)	 	$	657,935	 

 

 

SUMMARY TOTALS FOR ALL YEARS

 

	YR	 	 	THIS AWARD	 	 	CUMULATIVE TOTALS	 
	1	 	$	657,935	 	$	657,935	 

 

	Fiscal Information:	 
	CFDA Name:	Cardiovascular Diseases Research
	CFDA Number:	93.837
	EIN:	1526002036A1
	Document Number:	UHL148318A 
	PMS Account Type:	P (Subaccount)
	Fiscal Year:	2020

 

	IC	 	CAN	 	2020
	HL	 	8475146	 	$657,935

 

NIH Administrative Data:

PCC: HHDCPN / OC: 41026 / Released:
DIGGSJ 09/01/2020

Award Processed: 09/09/2020 12:14:42 AM

 

 

 

SECTION II – PAYMENT/HOTLINE INFORMATION
– 1UG3HL148318-01A1

 

For payment and HHS Office of Inspector General
Hotline information, see the NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm

 

 

 

SECTION III – TERMS AND CONDITIONS –
1UG3HL148318-01A1

 

This award is based on the application submitted
to, and as approved by, NIH on the above-titled project and is subject to the terms and conditions incorporated either directly
or by reference in the following:

 

		a.	The grant program legislation and program regulation cited in this Notice of Award.

		b.	Conditions on activities and expenditure of funds in other statutory requirements, such as those
included in appropriations acts.

		c.	45 CFR Part 75.

		d.	National Policy Requirements and all other requirements described in the NIH Grants Policy Statement,
including addenda in effect as of the beginning date of the budget period.

		e.	Federal Award Performance Goals: As required by the periodic report in the RPPR or in the final
progress report when applicable.

		f.	This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.

 

(See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.)

 

    Page-2 

     

    

 

Research
and Development (R&D): All awards issued by the National Institutes of Health (NIH) meet the definition of
“Research and Development” at 45 CFR Part§ 75.2. As such, auditees should identify NIH awards as part
of the R&D cluster on the Schedule of Expenditures of Federal Awards (SEFA). The auditor should test NIH awards for
compliance as instructed in Part V, Clusters of Programs. NIH recognizes that some awards may have another classification for
purposes of indirect costs. The auditor is not required to report the disconnect (i.e., the award is classified as R&D
for Federal Audit Requirement purposes but non-research for indirect cost rate purposes), unless the auditee is charging
indirect costs at a rate other than the rate(s) specified in the award document(s).

  

Carry over of an unobligated balance into
the next budget period requires Grants Management Officer prior approval.

 

This award is subject to
the requirements of 2 CFR Part 25 for institutions to receive a Dun & Bradstreet Universal Numbering System (DUNS) number
and maintain an active registration in the System for Award Management (SAM). Should a consortium/subaward be issued under this
award, a DUNS requirement must be included. See http://grants.nih.gov/grants/policy/awardconditions.htm for the full NIH
award term implementing this requirement and other additional information.

 

This award has been assigned the Federal Award
Identification Number (FAIN) UG3HL148318. Recipients must document the assigned FAIN on each consortium/subaward issued under this
award.

 

Based on the project
period start date of this project, this award is likely subject to the Transparency Act subaward and executive compensation reporting
requirement of 2 CFR Part 170. There are conditions that may exclude this award; see http://grants.nih.gov/grants/policy/awardconditions.htm for additional award applicability information.

 

In accordance with P.L.
110-161, compliance with the NIH Public Access Policy is now mandatory. For more information, see NOT-OD-08-033 and the Public
Access website: http://publicaccess.nih.gov/.

  

This award provides support
for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the “responsible party”
must register “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration System Information Website.
NIH encourages registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

 

This
award represents the final year of the competitive segment for this grant. See the NIH Grants Policy Statement Section 8.6 Closeout
for complete closeout requirements at: http://grants.nih.gov/grants/policy/policy.htm#gps.

 

A final expenditure Federal Financial
Report (FFR) (SF 425) must be submitted through the eRA Commons (Commons) within 120 days of the period of performance end date;
see the NIH Grants Policy Statement Section 8.6.1 Financial Reports, http://grants.nih.gov/grants/policy/policy.htm#gps,
for additional information on this submission requirement. The final FFR must indicate the exact balance of unobligated funds
and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the
Payment Management System’s (PMS) quarterly cash transaction data. A final quarterly federal cash transaction report is not required
for awards in PMS B subaccounts (i.e., awards to foreign entities and to Federal agencies). NIH will close the awards using the
last recorded cash drawdown level in PMS for awards that do not require a final FFR on expenditures or quarterly federal cash
transaction reporting. It is important to note that for financial closeout, if a grantee fails to submit a required final expenditure
FFR, NIH will close the grant using the last recorded cash drawdown level. If the grantee submits a final expenditure FFR but
does not reconcile any discrepancies between expenditures reported on the final expenditure FFR and the last cash report to PMS,
NIH will close the award at the lower amount. This could be considered a debt or result in disallowed costs.

 

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A Final Invention Statement and Certification
form (HHS 568), (not applicable to training, construction, conference or cancer education grants) must be submitted within 120
days of the expiration date. The HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm. This paragraph
does not apply to Training grants, Fellowships, and certain other programs—i.e., activity codes C06, D42, D43, D71, DP7,
G07, G08, G11, K12, K16, K30, P09, P40, P41, P51, R13, R25, R28, R30, R90, RL5, RL9, S10, S14, S15, U13, U14, U41, U42, U45, UC6,
UC7, UR2, X01, X02.

 

Unless an application for competitive
renewal is submitted, a Final Research Performance Progress Report (Final RPPR) must also be submitted within 120 days of the
period of performance end date. If a competitive renewal application is submitted prior to that date, then an Interim RPPR must
be submitted by that date as well. Instructions for preparing an Interim or Final RPPR are at: https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf.
Any other specific requirements set forth in the terms and conditions of the award must also be addressed in the Interim or Final
RPPR. Note that data reported within Section I of the Interim and Final RPPR forms will be made public and should be written
for a lay person audience.

 

NIH strongly encourages electronic submission
of the final invention statement through the Closeout feature in the Commons, but will accept an email or hard copy submission
as indicated below.

 

Email: The final invention
statement may be e-mailed as PDF attachments to: NIHCloseoutCenter@mail.nih.gov.

 

Hard copy: Paper submissions of the final invention
statement may be faxed to the NIH Division of Central Grants Processing, Grants Closeout Center, at 301-480-2304, or mailed to:

 

National Institutes of Health 

Office of Extramural
Research

Division of Central Grants Processing 

Grants
Closeout Center

6705 Rockledge Drive

Suite 5016, MSC 7986

Bethesda, MD 20892-7986 (for regular or U.S.
Postal Service Express mail)

Bethesda, MD 20817 (for other courier/express deliveries only)

 

NOTE: If this is the final year of a competitive
segment due to the transfer of the grant to another institution, then a Final RPPR is not required. However, a final expenditure
FFR is required and should be submitted electronically as noted above. If not already submitted, the Final Invention Statement
is required and should be sent directly to the assigned Grants Management Specialist.

  

In accordance with the regulatory requirements
provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative
agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information
in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also
make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated
integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting
requirements and procedures are found in Appendix XII to 45 CFR Part 75. This term does not apply to NIH fellowships.

 

Treatment of Program Income:

Additional Costs

 

    Page-4 

     

    

 

 

SECTION
IV – HL Special Terms and Conditions – 1UG3HL148318-01A1

  

Clinical Trial Indicator: Yes

This award supports one or more NIH-defined
Clinical Trials. See the NIH Grants Policy Statement Section 1.2 for NIH definition of Clinical Trial.

 

RESTRICTION
- LACK OF IRB APPROVAL: The present award is being made without a currently valid certification of IRB approval for this
project with the following restriction: Only activities that are clearly severable and independent from activities that
involve human subjects may be conducted pending the NHLBI’s acceptance of the certification of IRB approval.

 

No funds may be drawn down from the payment
system and no obligations may be made against Federal funds for any research involving human subjects prior to the NHLBI’s
notification to the recipient that the identified issues have been resolved and this restriction removed.

 

RFA NOTICE

The Terms and Conditions of this award incorporate
the operating guidelines in PAR 19-329, (Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative
UG3/UH3)), which can be found at: https://grants.nih.gov/grants/guide/pa-files/PAR-19-329.html

 

Phased Transition Application

The -02 Application, due on June 1, 2021 shall
be submitted on a PHS 398 application in PDF format to the Grants Management Specialist listed on this award. Failure to submit
by that date may result in not being considered for the UH3.

 

The application shall include;

 

		·	PHS398 Face Page, PHS398 pages 2,4, and 5 including detailed
budget, justification, and checklist page. Please note that the budget cannot exceed the annual direct costs proposed in the initial
peer reviewed application.

		·	An updated research plan and specific aims should reflect
current plans for the UH3 Phase, and general progress.

		·	Detailed budget pages for a non-Ã‚Â�modular
budget and budget justification.

		·	Updated as Just-In-Time Materials as appropriate: IRB
approvals, Other Support, Human Subjects Certifications, Bio sketches for new proposed key personnel.

		·	Copy of any relevant F&A rate agreements.

 

 In addition, in appendix form, a description of the progress related to the mutually agreed upon negotiated milestones (Recipient concurrence dated August 29, 2020). The appendix should also include proposed milestones for a proposed UH3 Project Period.

  

Failure to adhere to this Phased Transition
Application may result in enforcement actions as described by the NIH GPS, including requiring the submission of a close-out
plan for early phase- out of the award if adequate progress is not achieved

 

Administrative Review

The NHLBI will conduct an Administrative Review (referred
to as a transition meeting per the FOA https://grants.nih.gov/grants/guide/pa-files/PAR-19-329.html. This review will determine
whether satisfactory progress has been made towards the mutually agreed upon milestones. Those awardees that are not successful
will be permitted to extend the existing budget and project periods up to one year without prior NHLBI approval. This decision
will be communicated via a counter-signed letter from the assigned program officer and Office of Grants Management. If considered
for funding, the NHLBI will begin negotiations with the Recipient for formal milestones prior to the issuance of the UH3 award.

  

Milestones

The awardee is expected to adhere to these
mutually agreed upon milestones; subsequent funding will be contingent on meeting these milestones and achieving satisfactory progress.

 

Budget Period 01 (19/15/2020 – 08/31/2021)

 

		·	25%
                                         of sites activated

		·	Complete finalized protocol and informed consent
documents

		·	DSMB review and approval of final protocol, template
consent(s) and/or assent(s), and data and safety monitoring plan

		·	Enrollment of the first participant during the
UG3 phase

		·	IRB approval of final protocol and consent and/or
assent

 

Failure to adhere to these Milestones may
result in enforcement actions as described by the NIH GPS, including requiring the submission of a close-out plan for early phase-out
of the award if adequate progress is not achieved.

 

    Page-5 

     

    

 

eConnect

The NHLBI utilizes a reporting system, eConnect,
for both Clinical Trial Milestones and Participate Enrollment/Milestone Accrual. eConnect utilizes the existing Electronic Research
Administration (eRA) logon system and current institutional accounts so no Authorized Organizational Representative or Principal
Investigator will be required to create new accounts with the NHLBI. The system is designed to facilitate NHLBI monitoring traditionally
accomplished through standard paper submissions for Quarterly/Annual Reporting of Patient Recruitment per the NHLBI Milestones
Policy as well as the reporting of Clinical Trial Milestones negotiated and/or peer reviewed on this award. The NHLBI encourages
the recipient to report when milestones are achieved through eConnect as well as report on a quarterly basis recruitment that has
occurred under this award.

 

Clinical Trial Dissemination Plan

The clinical trial(s) supported by this award
is subject to the plan included in the application dated November 11, 2019 submitted to NIH and the NIH policy on Dissemination
of NIH-Funded Clinical Trial Information. The plan states that the clinical trial(s) funded by this award will be registered in
ClinicalTrials.gov not later than 21 calendar days after enrollment of the first participant and primary summary results reported
in ClinicalTrials.gov, not later than one year after the completion date. The reporting of summary results is required by this
term of award even if the primary completion date occurs after the period of performance.

 

1. This award is subject to additional certification
requirements with each submission of the Annual, Interim, and Final Research Performance Progress Report (RPPR). The recipient
must agree to the following annual certification when submitting each RPPR. By submitting the RPPR, the AOR signifies compliance,
as follows:

 

In submitting this RPPR, the SO (or PD/PI with
delegated authority), certifies to the best of his/her knowledge that, for all clinical trials funded under this NIH award, the
recipient and all investigators conducting NIH-funded clinical trials are in compliance with the recipient’s plan addressing
compliance with the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. Any clinical trial funded in whole or
in part under this award has been registered in ClinicalTrials.gov or will be registered not later than 21 calendar days after
enrollment of the first participant. Summary results have been submitted to ClinicalTrials.gov or will be submitted not later than
one year after the completion date, even if the completion date occurs after the period of performance.

 

NHLBI FUNDING GUIDELINES

This award is being
issued in accordance with the NHLBI FY 2020 Operating Guidelines which can be found at: https://www.nhlbi.nih.gov/current-operating-guidelines

 

MULTIPLE PI - Prior Approvals

In keeping with NOT-OD-06-054 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-
054.html), as this award has multiple Principal Investigators (PIs), although the signatures of all the PIs are not required
on prior approval requests submitted to the agency, the recipient institution must secure and retain the signatures of all of
the PIs for their own internal processes.

 

CONSORTIUM/CONTRACTUAL

This award includes funds awarded for consortium
activity with Cincinnati Children’s Hospital Medical Center, Emory University, Johns Hopkins University, Longeveron, LLC., University
of Utah,Children’s Hospital Los Angeles, and Advocate Health Care Network. The recipient, as the direct and primary recipient of
NIH grant funds, is accountable to NIH for the performance project, the appropriate expenditures of grant funds by all parties,
and all other obligations of the recipient, as specified in the NIH Grants Policy Statement. In general, the requirements that
apply to the recipient, including the intellectual property requirements also apply to consortium participant(s).

 

    Page-6 

     

    

 

STAFF CONTACTS

The Grants
Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of
Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and
technical aspects of this project. These individuals work together in overall project administration. Prior approval requests
(signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist.
Requests may be made via e-mail.

 

Grants Management Specialist: Amy Gipson

Email: amy.gipson@nih.gov
Phone: 301-827-8026

 

Program Official: Kristin Burns

Email: burnskr@mail.nih.gov
Phone: 301-594-6859

  

SPREADSHEET SUMMARY

GRANT NUMBER: 1UG3HL148318-01A1

 

INSTITUTION: UNIVERSITY OF MARYLAND BALTIMORE

  

	Budget	 	Year 1	 
	Salaries and Wages	 	$	219,825	 
	Personnel Costs (Subtotal)	 	$	219,825	 
	Subawards/Consortium/Contractual Costs	 	$	438,110	 
	TOTAL FEDERAL DC	 	$	657,935	 
	TOTAL FEDERAL F&A	 	$	0	 
	TOTAL COST	 	$	657,935	 

 

    Page-7

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