Grant Agreement dated May 10, 2021 by and between the Registrant and the National Institute of Aging

EX-10.34 33 tm2113659d7_ex10-34.htm EXHIBIT 10.34


Exhibit 10.34


  Department of Health and Human Services
National Institutes of Health

Notice of Award
FAIN# R01AG058660
Federal Award Date



Recipient Information  
1. Recipient Name  
    2403 SIDNEY ST STE 261  
    PITTSBURGH, PA 15203  
2. Congressional District of Recipient  
3. Payment System Identifier (ID)  
4. Employer Identification Number (EIN)  
5. Data Universal Numbering System (DUNS)  
6. Recipient's Unique Entity Identifier  
7. Project Director or Principal Investigator  
    SUSAN M CATALANO, PHD (Contact)  
8. Authorized Official  
    Dr. Susan Catalano Ph.D  
Federal Agency Information  
9. Awarding Agency Contact Information  
    Jennifer Edwards  



10. Program Official Contact Information  
    Laurie M. Ryan  
    Health Scientist Administrator  


Federal Award Information  
11. Award Number  
12. Unique Federal Award Identification Number (FAIN)  
13. Statutory Authority  
     42 USC 241 42 CFR 52  
14. Federal Award Project Title  
     Randomized Double Blind, Placebo Controlled, Parallel Group, Phase II Study to  
     Evaluate the Safety and Efficacy of CT1812 in Subjects with Mild to Moderate  
     Alzheimer’s Disease  
15. Assistance Listing Number  
16. Assistance Listing Program Title  
     Aging Research  
17. Award Action Type  
     Supplement (REVISED)  
18. Is the Award R&D?  
Summary Federal Award Financial Information  
19. Budget Period Start Date 05/01/2020 - End Date 05/31/2022     
20. Total Amount of Federal Funds Obligated by this Action  $0 
20 a. Direct Cost Amount  $0 
20 b. Indirect Cost Amount  $0 
21. Authorized Carryover  $0 
22. Offset  $0 
23. Total Amount of Federal Funds Obligated this budget period  $13,634,548 
24. Total Approved Cost Sharing or Matching, where applicable  $0 
25. Total Federal and Non-Federal Approved this Budget Period  $13,634,548 
26. Project Period Start Date 09/15/2018 - End Date 05/31/2022
27. Total Amount of the Federal Award including Approved Cost  $30,482,877 
       Sharing or Matching this Project Period     


28. Authorized Treatment of Program Income  
     Additional Costs  
29. Grants Management Officer - Signature  
     Robin Laney  


30. Remarks

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


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Notice of Award



Department of Health and Human Services
National Institutes of Health







Principal Investigator(s):


Award e-mailed to: ***@***


Dear Authorized Official:


The National Institutes of Health hereby revises this award (see “Award Calculation” in Section I and “Terms and Conditions” in Section III) to COGNITION THERAPEUTICS, INC. in support of the above referenced project. This award is pursuant to the authority of 42 USC 241 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 recipient when funds are drawn down or otherwise requested from the grant payment system.


Each publication, press release, or other document about research supported by an NIH award must include an acknowledgment of NIH award support and a disclaimer such as “Research reported in this publication was supported by the National Institute On Aging of the National Institutes of Health under Award Number R01AG058660. 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 for a link to the regulation and additional important information.


If you have any questions about this award, please direct questions to the Federal Agency contacts.


Sincerely yours,


Robin Laney
Grants Management Officer


Additional information follows


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Cumulative Award Calculations for this Budget Period (U.S. Dollars)     
 Salaries and Wages  $153,350 
Personnel Costs (Subtotal)  $153,350 
Consultant Services  $132,000 
Materials & Supplies  $78,991 
Other  $10,009,659 
Federal Direct Costs  $10,374,000 
Federal F&A Costs  $3,260,548 
Approved Budget  $13,634,548 
Total Amount of Federal Funds Authorized (Federal Share)  $13,634,548 


SUMMARY TOTAL FEDERAL AWARD AMOUNT YEAR ( 3 ) (for this Document Number)
3R01AG058660-03S1A1  $13,634,548 
5R01AG058660-03  $5,774,586 
3R01AG058660-03S2  $278,623 
TOTAL  $19,687,757 


SUMMARY TOTALS FOR ALL YEARS (for this Document Number) 
3   $13,634,548   $19,687,757 


Fiscal Information:

Payment System Identifier: 1134365359A1
Document Number: RAG058660A
PMS Account Type: P (Subaccount)
Fiscal Year: 2021


IC  CAN   2021 
AG   8033159   $13,634,548 


NIH Administrative Data:
3CCCTLR / OC: 41023 / Released: Laney, Robin 05/07/2021
Award Processed: 05/10/2021 12:04:55 AM




For payment and HHS Office of Inspector General Hotline information, see the NIH Home Page at


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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.


(See NIH Home Page at for certain references cited above.)


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 grant is excluded from Streamlined Noncompeting Award Procedures (SNAP).


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


This award has been assigned the Federal Award Identification Number (FAIN) R01AG058660. 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 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:


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 Protocol Registration System Information Website. NIH encourages registration of all trials whether required under the law or not. For more information, see fdaaa/.


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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:


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,, 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 Page 4 of 7 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.


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: 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: 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: ***@***.


Hard copy: Paper submissions of the final invention statement may be faxed to the NIH Division of Central Grants Processing, Grants Closeout Center, at ###-###-####, 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)


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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




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


This revised award changes the budget and project period end dates to coincide with the parent grant.


Supersedes Notice of Award issued 04/29/2021. Previous terms and conditions apply:


Funding for this award has been provided by Alzheimer’s Disease Initiative funds.


No research involving human subjects may be conducted at any performance site until OHRP has approved a Federalwide Assurance (FWA) for that site and the grantee has ensured that the research has received appropriate Institutional Review Board (IRB) approval.


This award reflects the acceptance of the single Institutional Review Board (sIRB) plan submitted with the application dated 07/01/2020. Any changes to this plan require the written prior approval of the National Institute on Aging.


None of the funds in this award shall be used to pay the salary of an individual at a rate in excess of the current salary cap. Therefore, this award and/or future years are adjusted accordingly, if applicable. Current salary cap levels can be found at the following URL: summary.htm. is a federal registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. In September 2016, NIH issued a final policy to promote broad and responsible dissemination of information from NIH- funded clinical trials through Under this policy, every clinical trial funded in whole or in part by NIH is expected to be registered on and have summary results information submitted and posted in a timely manner, whether subject to FDAAA 801 or not.


Public Policy Requirements and Objectives: 4/4.1 public policy requirements and objectives.htm?Highlight=clinical


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3R01AG058660-03S1A1 REVISED




Budget  Year 3 
Salaries and Wages  $153,350 
Personnel Costs (Subtotal)  $153,350 
Consultant Services  $132,000 
Materials & Supplies  $78,991 
Other  $10,009,659 
TOTAL FEDERAL DC  $10,374,000 
TOTAL FEDERAL F&A  $3,260,548 
TOTAL COST  $13,634,548 


Facilities and Administrative Costs  Year 3 
F&A Cost Rate 1   31.43%
F&A Cost Base 1  $10,374,000 
F&A Costs 1  $3,260,548 


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