Exhibit 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.)


 






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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


 






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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.


 






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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).


 


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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	 



 




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