National Institutes of Health Grant to Longeveron LLC, dated June 24, 2020
Notice of Award
SMALL BUSINESS TECHNOLOGY TRANSFER PROG
Department of Health and Human Services
|Federal Award Date: 06/24/2020|
|NATIONAL INSTITUTE ON AGING|
Joshua M Hare (contact), MD
Sean Xiao Leng, MD
Anthony Andrew Oliva, PHD
Project Title: A Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate Longeveron Mesenchymal Stem Cell (LMSC) Therapy for Treating The Metabolic Syndrome
Ms. Suzanne Liv, Page J.D.
Chief Operating Officer
1951 NW 7th Ave.
Miami, FL 331361112
Award e-mailed to: ***@***
Period Of Performance:
Budget Period: 07/01/2020 – 03/31/2021
Project Period: 09/30/2017 – 03/31/2021
Dear Business Official:
The National Institutes of Health hereby awards a grant in the amount of $435,997 (see “Award Calculation” in Section I and “Terms and Conditions” in Section III) to LONGEVERON, LLC 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 On Aging of the National Institutes of Health under Award Number R42AG054322. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.” Prior to issuing a press release concerning the outcome of this research, please notify the NIH awarding IC in advance to allow for coordination.
Award recipients must promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under NIH awards will be free from bias resulting from an Investigator’s Financial Conflict of Interest (FCOI), in accordance with the 2011 revised regulation at 42 CFR Part 50 Subpart F. The Institution shall submit all FCOI reports to the NIH through the eRA Commons FCOI Module. The regulation does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) awards. Consult the NIH website http://grants.nih.gov/grants/policy/coi/ for a link to the regulation and additional important information.
If you have any questions about this award, please contact the individual(s) referenced in Section IV.
E. C. Melvin
Grants Management Officer
NATIONAL INSTITUTE ON AGING
Additional information follows
SECTION I – AWARD DATA – 5R42AG054322-03
|Award Calculation (U.S. Dollars)|
|Salaries and Wages||$||100,680|
|Personnel Costs (Subtotal)||$||118,801|
|Materials & Supplies||$||36,715|
|Federal Direct Costs||$||333,816|
|Federal F&A Costs||$||102,181|
|Total Amount of Federal Funds Obligated (Federal Share)||$||435,997|
|TOTAL FEDERAL AWARD AMOUNT||$||435,997|
|AMOUNT OF THIS ACTION (FEDERAL SHARE)||$||435,997|
SUMMARY TOTALS FOR ALL YEARS
|YR||THIS AWARD||CUMULATIVE TOTALS|
|CFDA Name:||Aging Research|
|PMS Account Type:||P (Subaccount)|
NIH Administrative Data:
PCC: 4CCTSSR / OC: 41025 / Released: MELVINEC 06/19/2020
Award Processed: 06/24/2020 12:02:26 AM
SECTION II – PAYMENT/HOTLINE INFORMATION – 5R42AG054322-03
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 – 5R42AG054322-03
This award is based on the application submitted to, and as approved by, NIH on the above-titled project and is subject to the terms and conditions incorporated either directly or by reference in the following:
|a.||The grant program legislation and program regulation cited in this Notice of Award.|
|b.||Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriations acts.|
|c.||45 CFR Part 75.|
|d.||National Policy Requirements and all other requirements described in the NIH Grants Policy Statement, including addenda in effect as of the beginning date of the budget period.|
|e.||Federal Award Performance Goals: As required by the periodic report in the RPPR or in the final progress report when applicable.|
|f.||This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.|
(See NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htm for certain references cited above.)
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).
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).
This award is subject to the requirements of 2 CFR Part 25 for institutions to receive a Dun & Bradstreet Universal Numbering System (DUNS) number and maintain an active registration in the System for Award Management (SAM). Should a consortium/subaward be issued under this award, a DUNS requirement must be included. See http://grants.nih.gov/grants/policy/awardconditions.htm for the full NIH award term implementing this requirement and other additional information.
This award has been assigned the Federal Award Identification Number (FAIN) R42AG054322. Recipients must document the assigned FAIN on each consortium/subaward issued under this award.
Based on the project period start date of this project, this award is likely subject to the Transparency Act subaward and executive compensation reporting requirement of 2 CFR Part 170. There are conditions that may exclude this award; see http://grants.nih.gov/grants/policy/awardconditions.htm for additional award applicability information.
In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now mandatory. For more information, see NOT-OD-08-033 and the Public Access website: http://publicaccess.nih.gov/.
This award provides support for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the “responsible party” must register “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration System Information Website. NIH encourages registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
This award represents the final year of the competitive segment for this grant. See the NIH Grants Policy Statement Section 8.6 Closeout for complete closeout requirements at: http://grants.nih.gov/grants/policy/policy.htm#gps.
A final expenditure Federal Financial Report (FFR) (SF 425) must be submitted through the eRA Commons (Commons) within 120 days of the period of performance end date; see the NIH Grants Policy Statement Section 8.6.1 Financial Reports, http://grants.nih.gov/grants/policy/policy.htm#gps, for additional information on this submission requirement. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System’s (PMS) quarterly cash transaction data. A final quarterly federal cash transaction report is not required for awards in PMS B subaccounts (i.e., awards to foreign entities and to Federal agencies). NIH will close the awards using the last recorded cash drawdown level in PMS for awards that do not require a final FFR on expenditures or quarterly federal cash transaction reporting. It is important to note that for financial closeout, if a grantee fails to submit a required final expenditure FFR, NIH will close the grant using the last recorded cash drawdown level. If the grantee submits a final expenditure FFR but does not reconcile any discrepancies between expenditures reported on the final expenditure FFR and the last cash report to PMS, NIH will close the award at the lower amount. This could be considered a debt or result in disallowed costs.
A Final Invention Statement and Certification form (HHS 568), (not applicable to training, construction, conference or cancer education grants) must be submitted within 120 days of the expiration date. The HHS 568 form may be downloaded at: http://grants.nih.gov/grants/forms.htm. This paragraph does not apply to Training grants, Fellowships, and certain other programs—i.e., activity codes C06, D42, D43, D71, DP7, G07, G08, G11, K12, K16, K30, P09, P40, P41, P51, R13, R25, R28, R30, R90, RL5, RL9, S10, S14, S15, U13, U14, U41, U42, U45, UC6, UC7, UR2, X01, X02.
Unless an application for competitive renewal is submitted, a Final Research Performance Progress Report (Final RPPR) must also be submitted within 120 days of the period of performance end date. If a competitive renewal application is submitted prior to that date, then an Interim RPPR must be submitted by that date as well. Instructions for preparing an Interim or Final RPPR are at: https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf. Any other specific requirements set forth in the terms and conditions of the award must also be addressed in the Interim or Final RPPR. Note that data reported within Section I of the Interim and Final RPPR forms will be made public and should be written for a lay person audience.
NIH strongly encourages electronic submission of the final invention statement through the Closeout feature in the Commons, but will accept an email or hard copy submission as indicated below.
Email: The final invention statement may be e-mailed as PDF attachments to: ***@***.
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)
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:
SECTION IV – AG Special Terms and Conditions – 5R42AG054322-03
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 award includes funds awarded for consortium activity with the University of Miami. 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, 2017 is available at: http://grants.nih.gov/grants/policy/nihgps/HTML5/section_15/15_consortium_agreements.htm n keeping with NOT-OD-06-054 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06- 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.
Intellectual property rights: Normally, the awardee(s) 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, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20892-7750, (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.
The fee provided as part of this Notice of Grant Award is in addition to direct and facilities and administrative costs. The fee is to be drawn down from the DHHS Payment Management System in increments proportionate to the drawdown of costs.
Allowable costs conducted by for-profit organizations will be determined by applying the cost principles of Contracts with Commercial Organizations set forth in 48 CFR, Subpart 31.2.
The format for the Final Report is as follows:
|1.||State the beginning and ending dates for the period covered by the STTR Phase Phase II grant.|
|2.||List all key personnel who have worked on the project during that period, their titles, dates of service, and number of hours devoted to the project.|
|3.||Summarize the specific aims of the Phase I grant.|
|4.||Provide a succinct account of published and unpublished results, indicating progress toward their achievement. Summarize the importance of the findings. Discuss any changes in the specific aims since the project was initiated. Include the Inclusion Enrollment Report with the final enrollment data for clinical research (MS Word or PDF).|
|5.||List titles and complete references to publications, and manuscripts accepted for publication, if any, that resulted from the project’s effort. Submit five copies of such items, except patent and invention reports, as an Appendix.|
|6.||List patents, copyrights, trademarks, invention reports and other printed materials, if any, that resulted from the project or describe patent status, trade secrets or other demonstration of IP protection.|
|7.||Describe the technology developed from this SBIR/STTR, its intended use and who will use it.|
|8.||Describe the current status of the product (e.g., under development, commercialized, in use, discontinued).|
|9.||If applicable, describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND studies, filed an IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved).|
|10.||Describe how your company has benefited from the program and/or the technology developed (e.g., firm’s growth, follow-on funding, increased technical expertise, licensing agreements, spin-off companies, public offering [include stock exchange and symbol]).|
|11.||List of the generic and/or commercial name of product, process, or service, if any, that resulted from SBIR/STTR funding. If applicable, indicate the number of products sold.|
|12.||Provide the current number of employees (total full time equivalents [FTEs]).|
The Grants Management Specialist is responsible for the negotiation, award and administration of this project and for interpretation of Grants Administration policies and provisions. The Program Official is responsible for the scientific, programmatic and technical aspects of this project. These individuals work together in overall project administration. Prior approval requests (signed by an Authorized Organizational Representative) should be submitted in writing to the Grants Management Specialist. Requests may be made via e-mail.
Grants Management Specialist: John Bladen
Email: ***@*** Phone: 301 ###-###-#### Fax: 301 ###-###-####
Program Official: Sergei Romashkan
Email: ***@*** Phone: (301) 435-3047 Fax: (301) 402 - 1784
GRANT NUMBER: 5R42AG054322-03
INSTITUTION: LONGEVERON, LLC
|Salaries and Wages||$||100,680|
|Personnel Costs (Subtotal)||$||118,801|
|Materials & Supplies||$||36,715|
|TOTAL FEDERAL DC||$||333,816|
|TOTAL FEDERAL F&A||$||102,181|
|Facilities and Administrative Costs||Year 3|
|F&A Cost Rate 1||30.61||%|
|F&A Cost Base 1||$||333,816|
|F&A Costs 1||$||102,181|