Exhibit 10.15


 


		Notice of Award	
	SMALL BUSINESS INNOVATION RESEARCH PROG           Issue Date:       07/31/2013
	Department of Health and Human Services

National Institutes of Health
	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES


 


Grant Number: 5R44DK066654-06 REVISED


 


Principal Investigator(s):


WEIZHONG CAI, PHD


 


Project Title: Pilot Clinical Study in Renal
Transplantation


 


Dr. Goldberg, Itzhak D.


President & Scientific Director


1050 Stewart
Ave.


Garden City, NY 11530


 


Award e-mailed to: igoldberg@angion.com


 


Budget Period: 08/01/2010 – 07/31/2014


Project Period: 05/01/2004 – 07/31/2014


 


Dear Business Official:


 


The National Institutes of Health hereby revises
this award (see “Award Calculation” in Section I and “Terms and Conditions” in Section III) to ANGION BIOMEDICA
CORPORATION 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 Of Diabetes And Digestive And Kidney Diseases of the National
Institutes of Health under Award Number R44DK066654. 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 42 CFR Part 50 Subpart F. Subsequent to the compliance date of the 2011 revised FCOI regulation (i.e., on or before August
24, 2012), Awardees must be in compliance with all aspects of the 2011 revised regulation; until then, Awardees must comply with
the 1995 regulation. 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,


 


CAROLYN KOFA


Grants Management Officer


NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND
KIDNEY DISEASES



 


	1	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 




    	 



    	 



    

  


Additional information follows


 


	2	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 


 




    	 



    	 



    

 








 


	 	SECTION I – AWARD DATA – 5R44DK066654-06 REVISED




 


	Award
    Calculation (U.S. Dollars)	 	 	 
	 	 	 	 
	Federal Direct Costs	 	$	[***]	 
	Federal F&A Costs	 	$	[***]	 
	Approved Budget	 	$	[***]	 
	Fee	 	$	[***]	 
	Federal Share	 	$	[***]	 
	TOTAL FEDERAL AWARD AMOUNT	 	$	822,071	 
	 	 	 	 	 
	AMOUNT OF THIS ACTION (FEDERAL SHARE)	 	$	0	 



 


	SUMMARY
    TOTALS FOR ALL YEARS	 
	YR	 	THIS
    AWARD	 	 	CUMULATIVE
    TOTALS	 
	6	 	$	822,071	 	 	$	822,071	 



 


	Fiscal Information:	 
	CFDA Number:	93.847
	EIN:	1113430072A1
	Document Number:	RDK066654C
	Fiscal Year:	2010


 


	IC	 	CAN	 	2010	 
	DK	 	8469933	 	$	822,071	 



 


NIH Administrative Data:


PCC: KMM KSB / OC: 414E / Released:
KOFAC 07/30/2013


Award Processed: 07/31/2013 12:11:51 AM


 


	 	SECTION II – PAYMENT/HOTLINE INFORMATION – 5R44DK066654-06 REVISED




 


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 – 5R44DK066654-06 REVISED




 


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 74 or 45 CFR Part 92 as applicable.



		d.	The NIH Grants Policy Statement, including addenda in effect
as of the beginning date of the budget period.



		e.	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.)


 


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).


 


In accordance with P.L. 110-161, compliance with
the NIH Public Access Policy is now mandatory.


 


	 	3	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 


  




    	 



    	 



    

 


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/#gps
..


 


A final Federal Financial Report (FFR) (SF 425)
must be submitted through the eRA Commons (Commons) within 90 days of the expiration date; see the NIH Grants Policy Statement
Section 8.6.1 Financial Reports, http://grants.nih.gov/grants/policy/#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) cash transaction
data.


 


A Final Invention Statement and Certification form
(HHS 568), (not applicable to training, construction, conference or cancer education grants) must be submitted within 90 days of
the expiration date. The HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm.


 


Unless an application for competitive renewal is
submitted, a final progress report must also be submitted within 90 days of the expiration date. Instructions for preparing a Final
Progress Report are at: http://grants.nih.gov/grants/funding/finalprogressreport.pdf. Any other specific requirements set forth
in the terms and conditions of the award must also be addressed in the final progress report. Institute/Centers may accept the
progress report contained in competitive renewal (type 2) in lieu of a separate final progress report. Contact the awarding IC
for IC- specific policy regarding acceptance of a progress report contained in a competitive renewal application in lieu of a separate
final progress report.


 


NIH strongly encourages electronic submission
of the final progress report and 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 progress report and final invention
statement may be e-mailed as PDF attachments to the NIH Central Closeout Center at: DeasCentralized@od.nih.gov.


 


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


 


NIH Division of Central Grants Processing, OER


6705
Rockledge Drive


Suite 5016, Room 5109


MSC 7986


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


Bethesda, MD 20817 (for other courier/express mail delivery 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 Progress Report is not required. However, a final
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.


 


Treatment of Program Income:


Additional Costs


 


	 	SECTION IV – DK Special Terms and Conditions – 5R44DK066654-06 REVISED




 


REVISION #2:


Revised award issued to extend the budget and project
period for an additional 12 months duation, ending July 31, 2014, as requested in the
grantee’s letter dated June 24, 2013.


 


	 	4	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 





    	 



    	 



    

 


THE FOLLOWING TERMS FROM THE PREVIOUS NOTICE OF AWARD
ISSUED ON MAY 24, 2012, ALSO APPLY TO THIS AWARD:


 


REVISION #1:


Revised award issued to extend the budget and project
period for an additional 12 months duation, ending July 31, 2013, as requested by the grantee.


 


This revised award also reflects the NIDDK’s receipt
and acceptance of the grantee’s notification, certifying IRB approval on January 27, 2010. Accordingly, the restriction prohibiting
research involving human subjects on the Notice of Award issued on September 12, 2010, is removed.


 


No funds may be drawn down from the payment system
and no obligations may be made against Federal funds for research involving human subjects at any site engaged in such research
for any period not covered by an OHRP-approved Assurance and by an IRB approval consistent with 45 CFR Part 46.


 


THE FOLLOWING TERMS FROM THE PREVIOUS NOTICE OF AWARD
ISSUED ON SEPTEMBER 12, 2010, ALSO APPLY TO THIS AWARD:


 


The issuance of this award has been delayed due to
administrative considerations. According to NIH policy, if preaward costs are necessary, they may be approved by the authorized
Institution Official(s).


 


The grantee is required to follow the data and safety
monitoring plan included in the previous application and may not implement any changes in the plan without the written prior approval
of the NIDDK.


 


This award includes funds awarded for consortium
activity with the University of Pittsburg as stated in letter dated 03/29/2010 in the amount of $[***] total cost. 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 is available at http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600251, pages
224-227.


 


In addition to the PI, the following individuals
are named as key personnel: (Dr. Shapiro)


 


Written prior approval is required if any of the
individual(s) named above withdraws from the project entirely, is absent from the project during any continuous period of 3 months
or more, or reduces time devoted to the project by 25 percent or more from the level that was approved at the time of award.


 


Prior to drawing down funds for this award from the
payment management system, you are required to have in place written policies and procedures for financial and business management
systems. Your systems must comply with the standards included in the attachment to the letter/email “Requirements for Financial
and Business Management Systems Requirements for SBIR/STTR Awardees” which was sent to your organization’s Business Official
on May 20, 2009.


 


The policies and procedures must remain in effect
for the duration of this project.


 


Notice: Under governing regulations, Federal funds
administered by the Department of Health and Human Services shall not be expended for research involving human subjects, and individuals
shall not be enrolled in such research, without prior approval by the Office of Human Research Protections (OHRP) of an assurance
to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating
sites without OHRP- approved assurances, whether domestic or foreign, and compliance must be ensured by the awardee.


 


The fee provided as part of this grant award is in
addition to the allowable direct and indirect costs. An adjustment of the fee will be made in the event the grant is terminated.
The fee should


 


	 	5	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


 




    	 



    	 



    

 


be drawn down from the DHHS Payment Management System
in increments proportional to the draw down of funds for costs. Questions concerning access to the Payment Management System should
be directed to the PMS office (877)614-5533.


 


Allowable costs of activities
conducted by for-profit organizations will be determined by applying the cost principles of the Federal Acquisition Regulation
set forth in 48 CFR, Subpart 31.2. (see http://www.access.gpo.gov/nara/cfr/waisidx_01/48cfr31_01.html)


 


Intellectual property rights: Normally, the awardee
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, 6705 Rockledge Drive, MSC 7980, Bethesda, MD
20892-7980, (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. Prior approval to implement budgetary and programmatic changes, where required by NIH Policy, (See the NIH
Grants Policy Statement for prior approval requirements at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600126)
must be obtained in writing from the Grants Management contact shown on this Notice of Award. A letter signed by the Principal
Investigator and a Business Official of the Grantee Institution should include an explanation and justification for the action(s).
Requests may be made via e-mail provided they are routed through these same officials. If there are questions as to whether an
action requires prior approval, contact the Grants Management Specialist.


 


Grantees must access a website to determine which
progress reports are due. The Office of Policy for Extramural Research Administration, OER, National Institutes of Health
(NIH) hosts the website located at: http://era.nih.gov/userreports/pr_due.cfm. Grantees are responsible for periodically
checking the list, which is updated on/around the 30th of each month. In addition to this website, email reminders are sent
to the Principal Investigator.


 


Effective with non-competing progress reports due
on/after October 1, 2004, NIH is centralizing receipt and initial processing of all NIH non-competing progress reports. The new
centralized mailing address for all NIH Institutes/Centers (IC) is now:


 


Division of Extramural
Activities Support, OER


National
Institutes of Health


6705 Rockledge Drive, Room 2207, MSC 7987


Bethesda, MD 20892-7987 (for regular or US Postal
Service Express mail)


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


Phone Number: (301) 594-6584


 


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


 


	 	6	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.






    	 



    	 



    

 


Management Specialist. Requests may be made via e-mail.


 


Grants Management Specialist: Charlette Kenley


Email: kenleyc@extra.niddk.nih.gov Phone:
(301) 594-8847 Fax: (301) 480-3504


 


Program Official: Marva M. Moxey-mims


Email: moxey-mimsm@extra.niddk.nih.gov Phone:
(301) 451-5037 Fax: (301) 480-3510


 


	 	7	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.


  




    	 



    	 



    

 


SPREADSHEET SUMMARY


GRANT NUMBER: 5R44DK066654-06 REVISED


 


INSTITUTION: ANGION BIOMEDICA CORPORATION


 


	Facilities
    and Administrative Costs	 	Year
    6	 
	F&A Cost Rate 1	 	 	90	%
	F&A Cost Base 1	 	$	[***]	 
	F&A Costs 1	 	$	[***]	 



 


	 	8	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.