Exhibit 10.7


 





 


April
11, 2019


 


Anthony
A. Oliva, PhD 

Longeveron LLC


1951
NW 7th Avenue, Suite 520


Miami,
FL 33136


 


Via
e-mail: aoliva@longeveron.com


 


Re:
The Part the Cloud Challenge on Neuroinflammation Supplement


 


Dear
Dr. Oliva:


 


The
Alzheimer’s Association is pleased to confirm that your application PTC-CS-19-623225, “Clinical Evaluation of Allogeneic
Mesenchymal Stem Cells for Mild Alzheimer” has been approved for funding.


 





	 	The
                                         grant will be funded beginning April 1, 2019.


The
granting period is April 1, 2019 to March
31, 2022.


The
total amount of the grant is $3,000,000.00


	 



  


The
award is $3,000,000.00 and bi-annual payments will be aligned with the milestone activities as outlined and attached in
Appendix A. Payment timing will be dependent on achieving milestones as outlined in Appendix A.


 


The
requirements for this grant are detailed in this document which includes the Award Letter, Conditions of Award, Patent Policy
and Appendix A as one document. The document must be signed, initialed where required by the institution/organization authorized
signature and the study’s principle investigator and uploaded to your online file as a “pdf”.


 


The
Alzheimer’s Association also requires the following electronic files to be uploaded to pcCentral
at: https://ProposalCentral.com/login.asp


 


		●	Signed/initialed
                                         Award Letter, Conditions of Award, Patent Policy and Appendix A documentation as a “pdf”



		●	A
                                         5” x 7” black and white or color photograph of you in your lab



 


All
of the above are required and must be submitted electronically to activate the award. Hard
copies of the required documents will not be accepted.


 


The
Alzheimer’s Association depends upon private support to meet its goals and to fund research grants. Therefore, your help
and support are very important in the efforts to educate the general public and the scientific community about the disease and
the Association. In accepting this research grant award, you agree to credit the Alzheimer’s Association for providing funds
for this research whenever you present the research or publish articles about the project. In addition, your acceptance allows
the Alzheimer’s Association to use your likeness in presenting your findings through press releases, interviews, or other
activities such as hosting lay language abstracts on alz.org, and sharing Alzheimer’s Association funding information to
public databases (i.e. International Alzheimer’s & Dementia Research Portfolio, IADRP).. Please note the attached Conditions
of Award for details of this commitment.





 






     


     


    

 


It
is necessary for both you and a representative from the business office or Office of Sponsored Research from the applicant Institution,
to sign the form below. The signatures verify that the award is accepted by the Institution with the attendant requirements and
that no part of this research project has been funded from another source. Also, complete the included form requesting the information
for the business official that has fiscal responsibility for this award. Please retain a copy
for your files and upload the complete Award Letter, Conditions of Award, and Patent Policy document to the pcCentral site.


 


Thank
you for your support of the Alzheimer’s Association and commitment to research on Alzheimer’s disease. If you have
any questions, please call Mary Grilli, Post Award Specialist, Medical and Scientific Relations department at (312) 335-5727. 


 


Sincerely,


 


/s/ Maria
C. Carrillo


 



Maria
C. Carrillo, PhD.


Chief
Science Officer


Alzheimer’s
Association


Medical
& Scientific Relations


 


 


Sincerely,


 


/s/ Heather
M. Snyder


 






Heather
M. Snyder, PhD.


Senior
Director


Alzheimer’s
Association


Medical
& Scientific Relations


 


 


		cc:	Suzanne
Liv Page, Signing Official, spage@longeveron.com



 





 






This
FY2019 Research Grant is accepted on behalf of Longeveron LLC. The requirements as specified in the Award Letter documentation
are accepted. While it is acceptable for a project to have multiple funding sources, no part of this application has overlapping
funding from another source.


 


The
Alzheimer’s Association depends on volunteers for its exemplary grant review process. Your grant could not have
been funded without the hard work of those volunteers. The Association assumes you will want to repay those volunteers by remaining
an active reviewer in our system by connecting to the Alzheimer’s Association in your community (as applicable) and by responding
to the Association’s requests to engage in additional outreach. It is imperative that you respond when called upon
to contribute to this support of the Alzheimer’s and dementia research community.


 


By
signing this document you are agreeing to all of the above terms and conditions.


 


 





	Institutional
Official 	/s/ Suzanne Page	 	Date	April 11, 2019	 



 


Although
not a party to this entire agreement, I have reviewed the Agreement and understand the provisions in the Agreement regarding the
role of the Grantee for this Project. 


 


 





	Principal
Investigator 	 	 	Date	 	 


 



     


     


    

 





 


PTC-CS-19-623225,
Anthony A. Oliva, PhD 


 


Please
provide us with the following information:


 


	Check Payable to:	 	 
		 	 
	Institution EIN:	 	 
		(Required for payment to be sent to the Institution)	 
	 	 	 
	Send Check(s) to:	 	 
	 	Name	 
	 	 	 
	 	 	 
	 	Title	 
	 	 	 
	 	 	 
	 	Institution	 
	 	 	 
	 	 	 
	 	Address	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	Phone:	 	 
	Fax:	 	 
	E-Mail	 	 
	 	 	 
	 	 	 
	Send Financial Report Request Notice to:	 
	 	 	 
	 	 	 
	 	Name	 
	 	 	 
	 	 	 
	 	Title	 
	 	 	 
	Phone:	 	 
	Fax:	 	 
	Email:	 	 








 


 





	Please
contact Mary Grilli, Post-Award Specialist at (312) 335-5727 of any changes to the above information. Fax: 1-866-801-5501






 





 






     


     


    

 


 


 


Conditions
of Award - PTC-CS- (2/2019)


 






 


C
O N D I T I O N S    O F    A W A R D


 


GRANT
TIMELINE


 


The
Alzheimer’s Association expects that your Project will be completed according to the agreed upon timeline as outline in
Appendix A. Continued funding will be determined by progress and satisfactory assessment by the Alzheimer’s Association.


 


To
this end, you are required to do the following:


 


		a)	Payment
                                         to begin work will not be issued without IRB approval.



 


		b)	Participate
                                         in regularly scheduled assessment meetings and/or teleconferences as requested by the
                                         Alzheimer’s Association. Failure to participate in these assessments and to demonstrate
                                         satisfactory progress may result in withholding of future payments. The first assessment
                                         will be held approximately at the six-month mark of your Award by teleconference to review
                                         initial progress. Assessment meetings will be held at the midpoint and completion of
                                         your Award. The individual grantee is required to attend both assessment meetings via
                                         teleconference, unless otherwise informed by the Alzheimer’s Association.



 


		c)	Complete
                                         progress and expense reports detailing your progress against milestones and your associated
                                         expenditures. These reports will be due before the midpoint assessment meeting and at
                                         the completion of your award. When appropriate, additional reports may be requested before
                                         other assessment meetings and teleconferences. Templates will be provided to you to facilitate
                                         this reporting. These reports will be reviewed by the Alzheimer’s Association against
                                         the Assessment Criteria and you may receive suggestions, critique, and feedback.



 


		d)	Participate
                                         openly in discussions regarding your Project with the Alzheimer’s Association scientific
                                         and research staff, and advisors.



 


Failure
to meet milestones, furnish scheduled deliverables, including any reports, satisfactorily meet all Assessment Criteria or comply
with this Agreement may serve as one or more bases for termination of funding by the Alzheimer’s Association.


 


If
at any time circumstances arise that prohibit completion of the Project on schedule, you are required to notify the Alzheimer’s
Association immediately. The Alzheimer’s Association will consider granting a no-cost extension on a case by case basis.
To apply for a no-cost extension, submit a letter detailing the request. The letter should include reasons for delays or changes,
associated rationale, a timeline for continuing the work, and an expense report detailing remaining funds.





 






    	1 	Initial that you accept the terms stated on this page



     


    

 


 


 


Conditions
of Award - PTC-CS- (2/2019)


 






 


HUMAN
RESEARCH SUBJECTS PROTECTIONS


 


The
institution that receives a grant from the Alzheimer’s Association is accountable and has the primary responsibility for
protecting the rights and welfare of individual human subjects who consent to participate in investigations supported by these
funds. Investigators may consult the Public Health Service Grants Policy Statement, or Section 474(a) of the Public Health Service
Act, implemented by 45 CFR Part 46 or The Office of Protection from Research Risks, National Institutes of Health, Bethesda, Maryland
20892 for additional guidance on the necessary safeguards for human research subjects.


 


Certification
of Institutional Review Board (IRB) review and approval is not required at the time of submission of an application. Documentation
is required at the time of award of the grant and on the anniversary date of the award (in conjunction with scientific and financial
reporting). No more than 10% of overall budget may be back-charged for costs incurred in obtaining IRB approvals.


 


ANIMAL
WELFARE ASSURANCE


 


The
Alzheimer’s Association uses the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions. As stated
in the PHS Grants Policy Statement, it “:requires that applicant organizations establish and maintain appropriate policies
and procedures to ensure the humane care and use of live vertebrate animals involved in research activities.......” It is
the responsibility of institutions applying for a grant to the Alzheimer’s Association to ensure that the policies for the
humane care and use of vertebrate animals are appropriately implemented. Investigators may contact The Office for Protection from
Research Risks (OPRR), National Institutes of Health, Bethesda, Maryland 20892, for further information.


 


Animal
welfare assurances for research using vertebrate animals are not required at the time of submission of an application. Documentation
indicating Institutional Animal Care and Use Committee (IACUC) review and approval is required at the time of award of a grant
and on the anniversary date of the award (in conjunction with scientific and financial reporting).


 


RECOMBINANT
DNA APPROVAL


 


The
Alzheimer’s Association expects documentation from the Institutional Biosafety Committee rDNA Approval annually. It is the
responsibility of institutions applying for a grant to the Alzheimer’s Association to ensure that the policies for the use
of recombinant DNA are appropriately implemented.


 


Recombinant
DNA (rDNA) review and approval is required at the time of award of a grant and on the anniversary date of the award (in conjunction
with scientific and financial reporting).


 


ALLOWABLE
COSTS AND OWNERSHIP OF EQUIPMENT


 


Allowable
costs are specified in the Program Announcement for each research mechanism. It is required that most of the funds awarded be
used for the direct support of the research project in general, allowable costs include, but are not limited to:


 


		●	purchase
                                         and care of laboratory animals,



 


		●	small
                                         pieces of laboratory or clinical research equipment,



 






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Conditions
of Award - PTC-CS- (2/2019)


 






 








		●	Special
                                         use computer hardware and software for neuropsychological or imaging studies,



 


		●	laboratory
                                         or clinical supplies,



 


		●	salary
                                         for the Principal Investigator,



 


		●	salary
                                         for scientific staff (including post-doctoral fellows and graduate students) and technical
                                         staff (including laboratory technicians and modest secretarial support),



 


		●	support
                                         for travel -- a total of $5,000 over a two-three year period not to exceed $2,500 per
                                         year (if you request the full $2,500 for 2 years and are requesting a 3 year award you
                                         will not be able to request travel funds for one of those years). Please note, the AARG/AARG-D
                                         awardees are required to participate at least once during the award period in the Alzheimer’s
                                         Association International Conference (AAIC); travel funds may be allocated to support
                                         registration and travel.



 


		●	open
                                         access publication fees for journal articles related to the funded research project



 


		●	membership
                                         to ISTAART, the professional society of the Alzheimer’s Association



 


Costs
not allowed include:


 


		●	computer
                                         hardware and software for general office/word processing use.



 


		●	tuition
                                         costs for students,



 


		●	construction
                                         costs or renovation costs,



 


		●	rent
                                         costs,



 


		●	currency
                                         conversion costs for International Awards,



 


Title
for any approved equipment purchased by the organization with Alzheimer’s Association grant funds belongs to the grantee
organization


 


**IMPORTANT
NOTE**


 


The
Alzheimer’s Association reserves the right to disallow any expenditure(s) that are deemed unacceptable costs.


 


INDIRECT
COSTS


 


Indirect
costs are capped at 10 percent (rent for laboratory/office space is expected to be covered by indirect costs paid to the organization). 


 


PART
THE CLOUD DISTRIBUTION OF INCOME


 


The
attached Patent Policy the Alzheimer’s Association details distribution of net income derived from new patents and/or inventions.
In addition, the Alzheimer’s Association revenue share for any revenue derived with respect to the award intellectual property,
licensing, including upfront and periodic payments, milestone and royalty payments, but excluding funds received for research
support that is not in lieu of Revenue. This revenue share shall be limited to a maximum of five (5) times the Alzheimer’s
Association Award.





 






    	3 	Initial that you accept the terms stated on this page



     


    

 


 


 


Conditions
of Award - PTC-CS- (2/2019)


 






 



AWARDEE
VOLUNTEER ACTIVITIES


 


The
Alzheimer’s Association depends on volunteers to support the scientific enterprise, including the International Research
Grant Program. The Association assumes you will want to repay those volunteers by remaining an active reviewer in our system by
connecting to the Alzheimer’s Association in your community (as applicable) and by responding to the Association’s
requests to engage in additional outreach.


 


INTERIM/
SCIENTIFIC AND FINANCIAL REPORTS


 


The
Alzheimer’s Association requires bi-annual scientific and financial progress reports for the receipt of
continued funding for multi-year grants. The Interim financial report is due on the anniversary date of the award and must be
signed by the responsible business official of the grantee institution. Both reports must be submitted ELECTRONICALLY.
Paper submissions will NOT be accepted. In some cases a hard copy of the financial report may be requested due to
legibility. The Alzheimer’s Association reserves the right to ask for additional information pertaining to details
included in these reports. Scientific reports should include progress to approved milestones, and are required to initiate
subsequent payments.


 


To
download templates for the required reports, and to submit your annual reports; go to the same location that you used previously
to submit your application:


 


https://ProposalCentral.com/login.asp


 


A
tutorial for the submission of annual reports as well as other capabilities of the online system for grantees is available at
the login page. Scroll down to the tutorial called “Grantee Instructions to access award information” or use the following
link in your web browser to download the tutorial directly:


 


https://docs.proposalcentral.com/Instructions_Award_Info.pdf?version=2017.10.0.619


 


Follow
the instructions in the tutorial to download the REQUIRED scientific progress report and financial report forms to be used for
the submission of your annual reports and to attach the completed documents prior to the deadlines listed in your award. 


 


**IMPORTANT
NOTE**


 


Delinquent
reports may cause funding to be delayed or terminated. Reports must be submitted by the requested due date.





 






    	4 	Initial that you accept the terms stated on this page



     


    

 


 


 


Conditions
of Award - PTC-CS- (2/2019)


 






 



FINAL
SCIENTIFIC AND FINANCIAL REPORTS


 


Investigators
are required to submit final scientific and financial reports on all research grants funded by the Alzheimer’s Association.
All final financial reports must be signed by the responsible business official for the institution. Final scientific and financial
reports must be submitted ELECTRONICALLY within 90 days of the end of the award. Paper submissions will NOT be
accepted. In some cases a hard copy of the financial report may be requested due to legibility. The Alzheimer’s Association
reserves the right to ask for additional information pertaining to details included in these reports.


 


To
download templates for the required reports, and to submit your annual reports; go to the same location that you used previously
to submit your application:


 


https://ProposalCentral.altum.com
/login.asp


 


A
tutorial for the submission of annual reports as well as other capabilities of the online system for grantees is available at
the login page. Scroll down to the tutorial called “Grantee Instructions to access award information” or use the following
link in your web browser to download the tutorial directly:


 


https://docs.proposalcentral.com/Instructions_Award_Info.pdf?version=2017.10.0.619


 


Follow
the instructions in the tutorial to download the REQUIRED scientific progress report and financial report forms to be used for
the submission of your annual reports and to attach the completed documents prior to the deadlines listed in your award. 


 


**IMPORTANT
NOTE**


 


Final
Progress Reports must be submitted by the requested due date. Delinquent reports will prevent future submission of the Letter
of Intent (LOI) for consideration of possible funding.


 


DATA
SHARING


 


The
Alzheimer’s Association is committed to data sharing for Alzheimer’s Association International Research Grant Program
grantees. Data sharing is a necessary means to advance Alzheimer research results into systemic knowledge, usable products, and
research procedures, leading to the overall improvement of human health.


 


The
Alzheimer’s Association requires the timely release and the sharing of final research data and other research resources
generated from Alzheimer’s Association funded research studies be shared and administered in accordance with this policy.
Examples included in the “final research data” are the data, samples, physical conditions and other supporting materials
created or gathered during the course of the work.


 


For
clinical data, the rights and privacy of people who participate in Alzheimer’s Association – sponsored research must
be protected at all times. When applicable, data collected during these studies and shared for broader use should be free of identifiers
and variables related to individual subjects.


 






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Conditions
of Award - PTC-CS- (2/2019)


 






 

The
Alzheimer’s Association provides the Global Alzheimer’s Association Interactive Network (GAAIN) as a resource to
link all data generated as a result of this funding (see below for exemption) to be available for sharing. GAAIN –
located at gaain.org - is cloud-based, grid network infrastructure spanning centralized computational facilities in North
America and Europe. The Alzheimer’s Association recognizes there may be difficulties, limitations or other potential
complications regarding an individual’s or an institution’s ability to comply with the Alzheimer’s
Association’s data sharing policy as a result of institutional policies; local, state and federal laws and regulations,
including the Privacy Rule; or local IRB regulations. The rights and privacy of people who participate in Alzheimer’s
Association – sponsored research must be protected at all times. When data sharing may be limited, applicants should be
prepared to explain such limitations to the Alzheimer’s Association.

 


For
non-clinical (i.e. animal related studies testing/ evaluating potential therapeutics in these models), the Alzheimer’s
Association expects researchers to submit their data within 12 months of the conclusion of their project to the AlzPED
database, hosted by the National Institute on Aging/NIH. To submit data through AlzPED, awardees are expected to establish an
account at https://alzped.nia.nih.gov/node/add/alzped-study and provide documentation of their data being submitted
to the appropriate tool. AlzPED provides transgenic model and cross-transgenic model information across relevant
translational criteria data sets such as therapeutic agents, and targets. AlzPED is designed to feature published and
unpublished reports and to help identify the critical data, design elements and methodology missing from studies in order to
increase transparent reporting, reproducibility and translatability of animal model efficacy testing studies. Following
submission of data to AlzPED, researchers will receive a citable d.o.i (digital object identifier); investigators
are expected to include the AlzPED d.o.i. in their final progress report.


 


In
addition, awardees are encouraged to discuss potential impediments to data sharing with their Association contact at the time
they negotiate grant agreement to accept the Alzheimer’s Association grant award.


 


**IMPORTANT
NOTE**


 


Failure
to comply with the Alzheimer’s Association Data Sharing Policy will result in ineligibility of the investigator for future
funding from the Alzheimer’s Association.


 


Public
Access Policy


 


The
Alzheimer’s Association funds biomedical research related to Alzheimer’s and related dementias. The main output of
this research is new knowledge. To ensure this knowledge can be accessed, read, applied, and built upon in fulfillment of our
goals, the Alzheimer’s Association expects its researchers to publish their findings in peer-reviewed journals.


 


In
addition, it is a condition of funding from the Alzheimer’s Association that all peer-reviewed articles supported in whole
or in part by its grants must be made available in the PubMed Central online archive in accordance with the following conditions:


 


		●	Authors
                                         are to deposit an electronic copy of their final peer-reviewed manuscripts in PubMed
                                         Central immediately upon acceptance for journal publication. (http://www.healthra.org/resources.publicaccess.html)



 


		●	The
                                         manuscript is to be made publicly available in PubMed Central no later than 12 months
                                         after the official date of journal publication. This requirement applies to all Alzheimer’s
                                         Association grants awarded.









 






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Conditions
of Award - PTC-CS- (2/2019)


 






 



PubMed
Central is a database of full-text biomedical journal articles available online without a fee. It is hosted by the National Library
of Medicine in the National Institutes of Health. Once posted in PubMed Central, results of research become more accessible, prominent,
and integrated within the context of other research findings, making it easier for scientists worldwide to pursue Alzheimer’s
and related dementia research. Equally important, families, clinicians, patients, educators, funders, and students reap the benefits
of information arising from funding by accessing publications on PubMed Central at no charge.


 


An
author must acknowledge the Alzheimer’s Association’s support in every article arising from such funding. The acknowledgement
statement must include the applicable Alzheimer’s Association grant number. This will enable the Association to link the
published outputs of research to the support it has provided.


 


All
scientific progress reports must include the PMC ID number (PMCnnnnn) to publications in PubMed Central supported by the Alzheimer’s
Association.


 


**IMPORTANT
NOTE**


 


Failure
to comply with the Alzheimer’s Association Public Access Policy will result in ineligibility of the investigator for future
funding from the Alzheimer’s Association.


 


NOTIFICATION
OF PUBLICATIONS


 


One
electronic copy of manuscripts and meeting abstracts reporting research acknowledging funds from the Alzheimer’s Association
must be submitted ELECTRONICALLY at the time of publication. This copy will become part of the official file of
the grant and will be provided to the Communications Division to assist in the efforts to further inform the public about the
research program of the Association. These submissions must be made electronically using the same system outlined above for report
submissions.


 


The
Association will provide publicity assistance when the Principal Investigator notifies the staff prior to the release of findings
in any scientific journal or major meeting presentations and will work with the Public Relations Officer of the institution to
ensure coordination of efforts. Please contact the Communications Division, Media Relations Department at 312-335-5776 as early
as possible in the process, for instance as soon as the manuscript is accepted for publication or presentation.


 


An
acknowledgment of support provided by the Association must be included in any responses to or interviews with radio, television
or print journalists when an Association funded grant is discussed.


 


ACKNOWLEDGEMENT
OF FUNDING SOURCE


 


An
acknowledgment of support provided by the Alzheimer’s Association must appear in publications of any material whether copyrighted
or not, if the data is based on or developed under Association- supported grants. The following wording should be used: This
work was supported by an Alzheimer’s Association Part the Cloud Challenge on Neuroinflammation Supplement (PTC-CS-19-623225).





 






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Conditions
of Award - PTC-CS- (2/2019)


 






 


In
addition, an acknowledgement of support provided by the Alzheimer’s Association must appear in presentations of any material,
if the data is based on or developed under Association-supported grants.


 


Whenever
the Principal Investigator is informed of sponsorship through the generosity of a donor, the specific grant name should be used.
For example, the Alzheimer’s Association/Samuel A. Blank Research Grant.


 


RIGHT
TO AUDIT


 


In
accordance with generally accepted accounting principles, the grantee institution (“Grantee”) shall maintain reasonably
full and complete records of the cost and completion of services performed under this Grant Award and the Conditions of Award
Agreement (together, “Agreements”). During the term of the funding agreement with the Alzheimer’s Association,
and for a period of two years after their termination or completion, the Alzheimer’s Association reserves the right to inquire
and/or audit the Grantee’s records as they pertain to the performance of the Agreements at Grantee’s office. Upon
fifteen business days written notice from the Alzheimer’s Association, Grantee agrees to make available all records for
inspection or audit at its offices during normal business hours (Monday through Friday, 8 a.m. - 5 p.m. local time).


 


RESTRICTIONS
ON FUTURE FUNDING ELIGIBILITY


 


As
of the posting of this policy, the Alzheimer’s Association will not accept new research grant applications from investigators
who are delinquent in submitting interim/final scientific or interim/final financial reports on current and/or previous grants
or are in conflict with the conditions put forth in this document. 


 


This
policy will be strictly adhered to, no exceptions.


 


REQUESTS
FOR ADMINISTRATIVE ACTIONS


 


Submit
requests for administrative actions electronically through the proposalCENTRAL online system used for Interim and Final report
submissions (described above). When the request has been uploaded, please advise Mary Grilli, Post Award Grant Specialist
that a request has been filed (mgrilli@alz.org).





 


**
IMPORTANT NOTE**


 


ALL
letters and reports must be submitted electronically (see instructions above in reporting requirements). 


 





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Conditions
of Award - PTC-CS- (2/2019)


 




 

Requests
for administrative actions (e.g. re-budgeting, carry-over of unexpended funds, replacement of Principal Investigator,
transfer of institution, overlap, extension of award, administrative supplements) must be submitted electronically via
letter which has been signed by the Principal Investigator of the application or grant and the responsible, bonded
business official of the institution. Any request must be submitted 45 days prior to the desired date of action. Association
staff will review draft letters for content and appropriateness prior to submission of the final signed request. The
preliminary review does not indicate advance approval of the request, rather the preliminary review will ensure that all
necessary information has been included.

 


Review
and approval of requests for administrative actions is the responsibility of the staff of the Alzheimer’s Association.


 


Re-budgeting


 


Requests
for re-budgeting of more than 10% of the total awarded amount (direct + indirect costs) for that year must be submitted
electronically for prior approval to the Alzheimer’s Association. Requests to re-budget must be clearly explained
and justified against the timely achievement of the specific aims of the grant. If possible, re-budgeting requests should be
submitted with the interim/non- competing continuation report. If necessary, re-budgeting requests will be accepted mid-grant
year.


 


Carry
over of Unexpended Funds


 


In
general, permission to carry forward unexpended balances into future funding years is allowed. For example, a $10,000 unexpended
balance at the end of the 02 year, of a three year award, will be carried forward automatically and used to supplement to the
$60,000 continuation funding of the 03 year (which would provide the investigator a total of $70,000 for the 03 year).


 


Replacement
of the Principal Investigator


 


For
most programs (exceptions named below), the request to replace a Principal Investigator must be submitted electronically (see
instructions above in reporting requirements) by the appropriate faculty member (usually the Department Chair or Dean) and
countersigned by the responsible business official of the grantee institution. The letter requesting replacement of the Principal
Investigator must contain a curriculum vita of the proposed replacement Principal Investigator. Approval of a replacement Principal
Investigator is the responsibility of the Association and subject to review by staff; the Association reserves the right to terminate
a grant if replacement Principal Investigator is not approved.


 


For
Strategic Grants (SG) and Zenith, the grantee institution may request the replacement of a Principal Investigator. If the Principal
Investigator of a Zenith or Strategic Grant(SG) award leaves research work for some reason, the Alzheimer’s Association
reserves the right to terminate the grant and the remaining funds minus non-cancellable obligations/ fees returned to the Alzheimer’s
Association.


 


Transfer
of Institution


 


The
Association will review requests to transfer a grant to another organization, if applicable. For a Part the Cloud grant, the Alzheimer’s
Association reserves the right to approve the transfer or to terminate the funded grant.


 


The
request to transfer a grant should be submitted electronically at least 60 days in advance of the planned move to ensure
Association staff have adequate time to review the request and ask for and receive additional information should it be
necessary. You may request a six-month extension to complete work proposed in the grant for time loss during your move to the
new institution.


 






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Conditions
of Award - PTC-CS- (2/2019)


 



 


Overlap
with other Funded Applications


 


Investigators
must inform the Association of any overlap, or concern about possible overlap, with other non-Alzheimer’s Association grants.
Overlap is defined as “two or more grants by the same Principal Investigator which shares at least one specific aim”;
in addition, overlap means that the budget line items for each funding mechanism are also shared It is not necessary to provide
information about applications that share specific aims with an Association grant. The concern about overlap arises only when
an investigator has been notified that he/she will be awarded a grant by another organization and that application, soon to be
awarded, shares specific aim(s) with a grant from the Association and has overlap of proposed resources.


 


Extension
of Award


 


An
extension of the term of a grant without funds (no-cost extension) or with funds remaining at the end of the grant period (extension
with cost) may be approved when requested electronically 45 days prior to the grant expiration. Typically, requests range
from six to twelve months however you are allowed a 6 month extension for each year of the award (e.g. a two year award will be
eligible for 2 no- cost extensions, up to 6 months each whereas a three year award will be eligible for 3 no-cost extensions,
up to 6 months each). The Principal Investigator and responsible business official must countersign the letter requesting the
extension, whether the extension is with funds unexpended at the end of the grant period or at no cost. Although requests may
not be made for the sole purpose of spending remaining funds, you may expend remaining funds during the no-cost extension period.
The duration of the extension and the expected products/accomplishments must be detailed in the letter. An extension of term may
only be requested to complete work proposed in the grant.


 


Absence
from work


 


Awardees
must notify the Alzheimer’s Association of any absence from the funded research project longer than 60 days, planned, unplanned
or due to illness. In certain extreme cases when the Awardee is unable to communicate with the Association due to illness or accident,
the department chairperson and/or authorized personnel from the institution may submit the request on their behalf. The Award
is subject to early termination unless the absence has been requested and authorized in advance by the Alzheimer’s Association


 


A
written request should be submitted to Alzheimer’s Association indicating the dates of the leave, the reasons for the request
and the Principal Investigator’s intention to resume their work on the funding project. The Alzheimer’s Association
will review the request and determine the most appropriate course of action.





 






    	10 	Initial that you accept the terms stated on this page



     


    

 





 


 


Conditions
of Award - PTC-CS- (2/2019)


 




 


Change
of Names and Addresses


 


If
an investigator moves while an application is under review by the Association, it is necessary to submit electronic notification
of the new address and the date of the move by updating the PI profile in proposalCENTRAL. In some instances, great difficulty
has been encountered trying to find an investigator to inform him/her of the award of a grant.


 


If
the business official responsible for the grant or application at the institution is changed, the investigator and new business
official should update information electronically in the proposalCENTRAL profile as soon as possible.


 


Prompt
online notification through proposalCENTRAL, of changes in names, titles, addresses, phone and fax numbers, email addresses will
help to avoid delays in processing any actions or requests.


 


Other
Administrative Actions


 


For
other administrative actions not covered in this document, the investigator should submit an electronic letter detailing the request
and the rationale.


 


**
IMPORTANT NOTE**


 


ALL
letters and reports must be submitted electronically (see instructions above in reporting requirements).


 


REEARCH
INTEGRITY


 


Research
misconduct by a Grantee receiving Alzheimer Association support is contrary to the interests of Alzheimer Association and the
patients and their families it seeks to serve, as well as to the integrity of research, and to the conservation of donor funds.
The Parties hereby agree to follow, and Sponsoring Institution shall cause Grantee and Sponsor to follow, the Sponsoring Institution’s
policies as they relate to Research Misconduct and confirm that they are at least as rigorous as those followed by the NIH (Public
Health Service Policies on Research Misconduct 42 CFR 93). 


 


For
the avoidance of doubt, the NIH defines “Research Misconduct” to mean fabrication, falsification, or plagiarism (further
defined below) in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not
include honest error or differences of opinion.


 


		a)	Fabrication:
                                         Making up data or results and recording or reporting them.



 


		b)	Falsification:
                                         Manipulating research materials, equipment, or processes, or changing or omitting data
                                         or results such that the research is not accurately represented in the research record.



 


		c)	Plagiarism:
                                         The appropriation of another person’s ideas, processes, results or words without
                                         giving appropriate credit.



 




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Conditions
of Award - PTC-CS- (2/2019)


 



 


**IMPORTANT
NOTE**


 


Upon
completion of projects, the Association encourages grantees to consider submitting an article describing results to Alzheimer’s
& Dementia: The Journal of the Alzheimer’s Association or its two companion open access journals: Translational Research
& Clinical Interventions (TRCI) or Diagnosis, Assessment & Disease Monitoring (DADM. Note, payments of open
access publication fees are eligible grant expenses, not limited to these two OA journals. For submission information, visit www.elsevier.com/authors.





 






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PATENT
POLICY OF THE ALZHEIMER’S ASSOCIATION®


 


The
primary purpose of the Alzheimer’s Association (the “Association”) funding scientifically meritorious research
is to advance its mission to eliminate Alzheimer’s disease through the advancement of research; to provide and enhance care
and support for all affected; and to reduce the risk of dementia through the promotion of brain health. The Association recognizes
that patentable Inventions (defined below) having public health, scientific, business or commercial application or value may be
made in the course of research supported by the Association. It is the desire of the Association that such Inventions will be
administered in such a manner that they are brought into public use at the earliest possible time. The Association recognizes
that this may be best accomplished through the filing of applications for registration of patents and/or copyrights in such Inventions
and the commercial licensing of such Inventions to third parties. Discoveries, works of authorship, or Inventions derived from
research performed, supervised or subcontracted for by the grantee institution during the term of the grant will be subject to
the Association’s Patent Policy as set forth below:


 


	1.	“Invention”
                                         is any discovery, data, material, method, process, device, product, program, software,
                                         proprietary know-how or other work of authorship, whether or not patentable or copyrightable,
                                         that is created, conceived or discovered in the course of research supported in whole
                                         or in part by the Association, or that arises from research supported in whole or part
                                         by the Association.



 


	2.	All
                                         notices of disclosure of Invention patents must be reported in a timely manner to the
                                         Medical & Scientific Relations Division of the Association. Upon the Association’s
                                         request, all documentation relating to the filing or assertion of rights shall be provided
                                         to the Association. The Association shall agree to maintain the confidentiality of such
                                         documentation by executing a confidentiality agreement mutually agreed to by the grantee
                                         institution /inventor and the Association. All expenses of the Invention patent process
                                         should be borne by the grantee institution or individual awardee.



 


	3.	Unless
                                         otherwise indicated or requested by the grantee institution, title to any invention shall
                                         reside in the grantee institution.



 


	4.	Distribution
                                         of income derived from an Invention shall be according to the policies of the grantee
                                         institution, except that the Association shall participate in net income derived from
                                         the Invention (unless waived in writing by the Association) to the extent, and at a rate
                                         of remuneration, to be determined by mutual agreement between the grantee institution
                                         and the Association at the time a patent application is filed. If the grantee institution
                                         has no established and applicable patent, intellectual property, or technology transfer
                                         policy and procedure for administering Inventions, the Association shall have the sole
                                         right to determine the disposition of the Invention rights in a manner consistent with
                                         this Patent Policy.



 


	5.	The
                                         grantee institution shall not abandon all patents and patent applications without first
                                         notifying the Medical & Scientific Relations Division of the Association and to the
                                         extent the grantee institution has the legal right to do so giving the Association the
                                         opportunity to take title to the Invention and to continue the patent or patent application
                                         at its own expense.






 






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	6.	The
                                         grantee institution shall agree that if it has not taken effective steps, within a reasonable
                                         time frame for the research project advancement after a U.S. patent issues on an Invention
                                         supported by Association funds and administered by the institution, to bring that invention
                                         to the point of practical application, or has not made such Invention available for licensing,
                                         the Association shall have the right to request grantee institution terminate the license
                                         for lack of diligence, grant title to the Association and to locate and proceed with
                                         another licensee.



 


	7.	If
                                         any Invention is made with the joint support of the Association and any agency or department
                                         of the United States Government, the Association may defer to the patent policy of that
                                         agency or department upon written statement by the appropriate agency of government notifying
                                         the Association of its position with respect to the Invention in question.



 


	8.	If
                                         any Invention is made with the joint support of the Association and some other organization,
                                         not an agency or department of the U.S. Government, that organization, the institution,
                                         the inventor(s), and the Association will confer to arrive at a mutually satisfactory
                                         disposition of the Invention rights.



 


Address
all correspondence regarding this policy to:


 


Mary
Grilli


Post
Award Grant Specialist


Alzheimer’s Association®


Medical
& Scientific Relations – Grant Operations


225 N. Michigan Avenue – 17th Floor


Chicago,
IL 60601-7633





 






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Appendix
A


 


	 	


Longeveron LLC


1951
NW 7th Avenue, Suite 520


Miami,
Florida 33136


305-989-2014 | aoliva@longeveron.com















 



 


Months
1 – 6: $850,000


		1.	Continue
                                         enrollment and treatment of subjects on the trial.



		a.	Target
                                         8 subjects



		2.	Production
                                         of lots of LMSCs for remainder of trial.



		3.	Develop
                                         final protocol for MRI volumetric analyses (new milestone from original application)



		4.	Analyze
                                         inflammatory markers from enrolled subjects.



		5.	Analyzing
                                         AD markers from enrolled subjects.



		6.	Analyze
                                         MRI volumetric changes for subjects.



		7.	Continue
                                         trial management activities (IRB renewal, site monitoring, etc.).



		8.	Perform
                                         interim analyses on safety and efficacy.



		a.	Target
                                         date 5/2019



		9.	Hold
                                         DSMB meeting.



		a.	Target
                                         date 5/2019



 


Months
7 – 12: $800,000 


		1.	Complete
                                         enrollment and treatment of all subjects on the trial (i.e., last subject is enrolled).



		a.	Target
                                         10 subjects (full enrollment = 30 subjects)



		2.	Advance
                                         LMSC production to meet requirements for next trial phase.



		a.	Develop
                                         scale-up procedures and required potency and efficacy assays.



		3.	Analyze
                                         inflammatory markers from enrolled subjects.



		4.	Analyzing
                                         AD markers from enrolled subjects.



		5.	Analyze
                                         MRI volumetric changes for subjects.



		6.	Continue
                                         trial management activities (IRB renewal, site monitoring, etc.).



		7.	Perform
                                         interim analyses on safety and efficacy.



		a.	Target
                                         date 11/2019



		8.	Hold
                                         DSMB meeting.



		a.	Target
                                         date 11/2019



 


Months
13 – 18: $750,000 


		1.	Advance
                                         LMSC production to meet requirements for next trial phase.



		2.	Analyze
                                         inflammatory markers from enrolled subjects.



		3.	Analyzing
                                         AD markers from enrolled subjects.



		4.	Analyze
                                         MRI volumetric changes for subjects.



		5.	Continue
                                         trial management activities (IRB renewal, site monitoring, etc.).



		6.	Perform
                                         interim analyses on safety and efficacy.



		a.	Target
date 5/2020






		7.	Hold
DSMB meeting.








		a.	Target
                                         date 5/2020



 






    A-1


     


    

 





	 	


Longeveron LLC


1951
NW 7th Avenue, Suite 520


Miami,
Florida 33136


305-989-2014 | aoliva@longeveron.com















 



  


Months
19 – 24: $600,000


		1.	All
                                         enrolled subjects complete study (i.e., last subjects completes the 12-month follow-up).



		a.	Last
                                         subject completes study in Q7 grant period.



		9.	Advance
                                         LMSC production to meet requirements for next trial phase.









		a.	Develop
                                         scale-up procedures and required potency and efficacy assays.



		2.	Complete
                                         analyses of inflammatory markers from all subjects at all time-points.



		3.	Complete
                                         analyses of AD markers from all subjects at all time-points.



		4.	Complete
                                         analyses of MRI volumetric changes for subjects.



		5.	Complete
                                         efficacy analyses from all subjects at all time-points.



		6.	Final
                                         data lock, analyses, and unblinding, and trial close-out. Target date: 11/2020



		7.	Final
                                         DSMB meeting



		a.	Target
                                         date 11/2020



		8.	Prepare
                                         publications of final results.



		9.	Apply
                                         for Regenerative Advanced Medicine Therapy (RMAT) designation with FDA



		10.	Prepare
                                         for Phase II trial (Q8 of grant award).



		a.	Have
                                         End-of-Phase (EOP) meeting with FDA.



		b.	Obtain
                                         guidance from Scientific Advisory Board.



		c.	Prepare
                                         protocol for next Study Phase.



 


Graphic
timeline and milestones. Milestones are denoted with an asterisk, and major trial milestones are shown in green.


 


 


 






    A-2


     


    

 





	 	


Longeveron LLC


1951
NW 7th Avenue, Suite 520


Miami,
Florida 33136


305-989-2014 | aoliva@longeveron.com















 



  


Enrollment
projection graph.


 





 




    A-3