Grant Agreement dated May 6, 2021 by and between the Registrant and the National Institute of Aging

EX-10.33 32 tm2113659d7_ex10-33.htm EXHIBIT 10.33


Exhibit 10.33


Department of Health and Human Services
National Institutes of Health


Notice of Award
FAIN# R01AG071643
Federal Award Date


Recipient Information
1. Recipient Name
2. Congressional District of Recipient 14
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
  Senior Vice President Of Research And Development
  914 ###-###-####
8.  Authorized Official
  Dr. Susan Catalano.
  412 ###-###-####
Federal Agency Information
9. Awarding Agency Contact Information
  Jennifer Edwards
  301 ###-###-####
10.  Program Official Contact Information
  Laurie M. Ryan
  Health Scientist Administrator
  301 ###-###-####  


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
  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies
15. Assistance Listing Number
16. Assistance Listing Program Title
  Aging Research
17. Award Action Type
  New Competing
18. Is the Award R&D?


Summary Federal Award Financial Information

19.  Budget Period Start Date 05/15/2021 - End Date 04/30/2022     
20.  Total Amount of Federal Funds Obligated by this Action  $10,764,669 
20 a. Direct Cost Amount  $8,294,565 
20 b. Indirect Cost Amount  $2,470,104 
21.  Authorized Carryover  $0 
22.  Offset  $0 
23.  Total Amount of Federal Funds Obligated this budget period  $10,764,669 
24.  Total Approved Cost Sharing or Matching, where applicable  $0 
25.  Total Federal and Non-Federal Approved this Budget Period  $10,764,669 
26.  Project Period Start Date 05/15/2021 - End Date 04/30/2024     
27.  Total Amount of the Federal Award including Approved Cost  Sharing or Matching this Project Period  $10,764,669 


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.






SECTION I - AWARD DATA - 1R01AG071643-01


Principal Investigator(s):

James E Galvin, MD

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


Dear Authorized Official:


The National Institutes of Health hereby awards a grant in the amount of $10,764,669 (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 R01AG071643. 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  $195,565 
Personnel Costs (Subtotal)  $195,565 
Consultant Services  $1,220,350 
Travel  $308,600 
Other  $6,109,550 
Subawards/Consortium/Contractual Costs  $460,500 


Federal Direct Costs  $8,294,565 
Federal F&A Costs  $2,470,104 
Approved Budget  $10,764,669 
Total Amount of Federal Funds Authorized (Federal Share)  $10,764,669 


SUMMARY TOTALS FOR ALL YEARS (for this Document Number) 
1   $10,764,669   $10,764,669 
2   $10,254,288   $10,254,288 
3   $8,479,107   $8,479,107 


Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project 


Fiscal Information:  
Payment System Identifier: 1134365359A1
Document Number: RAG071643A
PMS Account Type: P (Subaccount)
Fiscal Year: 2021


IC   CAN   2021   2022   2023 
AG    8033159   $10,764,669   $10,254,288   $8,479,107 


Recommended future year total cost support, subject to the availability of funds and satisfactory progress of the project


NIH Administrative Data:

PCC: 3CCCTLR / OC: 41021 / Released: Laney, Robin 04/27/2021

Award Processed: 05/06/2021 12:12:57 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) R01AG071643. 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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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.


RESTRICTION: 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 National Institute on Aging'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 National Institute on Aging's notification to the grantee that the identified issues have been resolved and this restriction removed.


Failure to respond within the 60-day period and/or to otherwise comply with the above requirements may result in suspension and/or termination of this award, audit/or disallowances, and/or other appropriate action.


See the NIH Grants Policy Statement, Chapter 4.1.15 Human Subjects Protections ( 4/4 public policy requirements obje ctives and other appropriation mandates.htm), for specific requirements related to the protection of human subjects, which are applicable to and a term and condition of this award.


Recruitment of participants cannot be initiated until the NIA program staff, IRB, and the DSMB have approved the protocol and data and safety monitoring plan.


This provisional award is issued subject to the following condition:

Under governing policy, Federal funds administered by the NIH may not be expended for research in a foreign entity (Sweden) pending further administrative review. No funds may be drawn from the payment system for a foreign project pending acceptance of the clearance.




Sharing of clinical trial data and bio-samples is expected at the time of publication of the primary results or within 9 months of database lock, whichever comes first.


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


In keeping with NOT-OD-06-054 ( 054.html), as this grant has multiple Principal Investigators (PIs), although the signatures of the PIs are not required on prior approval requests submitted to the agency, the grantee institution must secure and retain the signatures of all of the PIs within their own internal processes.


This award includes funds awarded for consortium activity with University of Miami, Miller School of Medicine in the amount of $460,500 ($300,000 direct costs + $160,500 facilities and administrative costs). 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: 15/15 consortium_agreements.htm.


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. 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 



AWARD NUMBER: 1R01AG071643-01




Budget  Year 1   Year 2   Year 3 
Salaries and Wages  $195,565   $195,565   $195,565 
Personnel Costs (Subtotal)  $195,565   $195,565   $195,565 
Consultant Services  $1,220,350   $665,000   $180,000 
Travel  $308,600   $17,500   $10,000 
Other  $6,109,550   $6,570,500   $5,715,250 
Subawards/Consortium/Contractual Costs  $460,500   $456,782   $452,948 
TOTAL FEDERAL DC  $8,294,565   $7,905,347   $6,553,763 
TOTAL FEDERAL F&A  $2,470,104   $2,348,941   $1,925,344 
TOTAL COST  $10,764,669   $10,254,288   $8,479,107 


Facilities and Administrative Costs  Year 1   Year 2   Year 3 
F&A Cost Rate 1   31.43%   31.43%   31.43%
F&A Cost Base 1  $7,859,065   $7,473,565   $6,125,815 
F&A Costs 1  $2,470,104   $2,348,941   $1,925,344 


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