Exhibit 10.23
 | Notice of Award |  |
| SMALL BUSINESS INNOVATION RESEARCH PROG Issue Date: 06/18/2013 |
| Department of Health and Human Services |
| National Institutes of Health |
| NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES |
Grant Number:1R43DK095625-01A1
Principal Investigator(s):
Bert J. W. M. Oehlen, PHD
Project Title:Aldosterone Synthase Inhibitor for CKD
Dr. Oehlen, Bert , PhD
Senior Research Scientist
51 Charles Lindbergh Boulevard
Uniondale, NY 115533658
Award e-mailed to:igoldberg@angion.com
Budget Period:06/20/2013 – 05/31/2014
Project Period:06/20/2013 – 05/31/2014
Dear Business Official:
The National Institutes of Health hereby awards a grant in the amount of $380,911 (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 R43DK095625. 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 websitehttp://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,
CHARLETTE KENLEY
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 – 1R43DK095625-01A1 |
| Award Calculation (U.S. Dollars) | | | |
| Salaries and Wages | | $ | [***] | |
| Fringe Benefits | | $ | [***] | |
| Consultant Services | | $ | [***] | |
| Supplies | | $ | [***] | |
| Travel Costs | | $ | [***] | |
| Consortium/Contractual Cost | | $ | [***] | |
| | | | | |
| Federal Direct Costs | | $ | [***] | |
| Federal F&A Costs | | $ | [***] | |
| Approved Budget | | $ | [***] | |
| Fee | | $ | [***] | |
| Federal Share | | $ | [***] | |
| TOTAL FEDERAL AWARD AMOUNT | | $ | 380,911 | |
| | | | | |
| AMOUNT OF THIS ACTION (FEDERAL SHARE) | | $ | 380,911 | |
| SUMMARY TOTALS FOR ALL YEARS |
| YR | | THIS AWARD | | | CUMULATIVE TOTALS | |
| 1 | | $ | 380,911 | | | $ | 380,911 | |
| Fiscal Information: | |
| CFDA Number: | 93.847 |
| EIN: | 1113430072A1 |
| Document Number: | RDK095625A |
| Fiscal Year: | 2013 |
| IC | | CAN | | | 2013 | |
| DK | | | 8469933 | | | $ | 380,911 | |
NIH Administrative Data:
PCC: KMM KSB /OC: 414A /Released: KENLEYC 06/17/2013
Award Processed:06/18/2013 12:27:39 AM
| | SECTION II – PAYMENT/HOTLINE INFORMATION – 1R43DK095625-01A1 |
For payment and HHS Office of Inspector General Hotline information, see the NIH Home Page athttp://grants.nih.gov/grants/policy/awardconditions.htm
| | SECTION III – TERMS AND CONDITIONS – 1R43DK095625-01A1 |
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.)
Carry over of an unobligated balance into the next budget period requires Grants Management Officer prior approval.
| | 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. |
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 Central Contractor Registration. Should a consortium/subaward be issued under this award, a DUNS requirement must be included. Seehttp://grants.nih.gov/grants/policy/awardconditions.htmfor the full NIH award term implementing this requirement and other additional information.
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; seehttp://grants.nih.gov/grants/policy/awardconditions.htmfor 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 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.
NIHstrongly encourageselectronic 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)
| | 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. |
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 – 1R43DK095625-01A1 |
Although the budget period start date for this award is 06/20/2013, this award includes funds for 12 months of support. Allowable preaward costs may be charged to this award in accordance with the conditions outlined in the NIH Grants Policy Statement (GPS), (October 2012) and with institutional requirements for prior approval. The NIH GPS can be found at http://grants.nih.gov/grants/policy/nihgps_2012/.
This award is issued in accordance with the NIH 2013 fiscal policies described in the NIH Guide Notice NOT-OD-13-064: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-064.html
None of the funds in this award shall be used to pay the salary of an individual at a rate in excess of the applicable salary cap. Current salary cap levels can be found at the following URL: http://grants1.nih.gov/grants/policy/salcap_summary.htm
A review of other support information provided in the pending application for this project indicates that with the award of this project, $[***]’s effort commitment may exceed 100%. If applicable, the awardee is responsible for both eliminating this overcommitment (and any other overcommitment of effort or budgetary overlap) and for obtaining appropriate prior approval)s) in accordance with NIH and institutional policy requirements.
The grantee institution must submit documents certifying resolution of this overcommitment to the grants management specialist named below in writing within 30 days of the issue date of this notice of grant award.
In addition to the PI, the following individuals are named as key personnel:
Dr. Itzhak D. Goldberg
Dr. Prakash Narayan
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 3, 2013. The policies and procedures must remain in effect for the duration of this project.
This award includes funds awarded for consortium activity with [***] in the amount of $[***]. 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://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch15.htm#_Toc271265264
Notice: Under governing policy, Federal funds administered by the National Institutes of Health (NIH) shall not be expended for research involving live vertebrate animals without prior approval by the Office for Laboratory Animal Welfare (OLAW) of an assurance to comply with the NIH policy on humane care and use of laboratory animals. This restriction applies to all performance sites (e.g., collaborating institutions, subcontractors, subgrantees) without OLAW-approved assurances, whether domestic or foreign.
| | 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. |
The fee provided as part of this Notice of Award is in addition to the allowable direct and facilities and administrative costs. An adjustment of the fee will be made in the event the grant is terminated. The fee should be drawn down from the DHHS Payment Management System (PMS) in increments proportionate to the draw down of costs. Questions concerning access to the PMS should be directed to (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 Division of Extramural Invention and Technology Resources, OPERA, NIH, 6705 Rockledge Drive, MSC 7980, Room 310, 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_2012/nihgps_ch8.htm#_Toc271264922) 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, and 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.
The grantee is required to establish a positive time and effort reporting system.
As mentioned in Section III above, this award represents the final year of the competitive segment for this grant. In addition to the instructions outlined in Section III, please follow the guidelines here for submission of the Final Progress Report.
There is no ‘form page’ for a Final Report. The Final Progress Report may be typed on plain white paper (or you may use the PHS 398 Continuation Page). The recommended length for the narrative portion is 10 pages.
Phase I grantees that (1) do not intend to seek Phase II support or (2) are not prepared to submit a Phase II application within four months following the expiration of the Phase I budget period, must submit a final report of their Phase I effort. Otherwise, the Phase I Final Report is a part of the Phase II application.
The format for the Final Report is as follows (also include items mentioned above in Section III):
1. State the beginning and ending dates for the period covered by the SBIR/STTR Phase I/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 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).
| | 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. |
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, which 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]).
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 Management Specialist. Requests may be made via e-mail.
Grants Management Specialist: Amanda Linehan
Email: linehana@mail.nih.govPhone: 301-594-4749Fax: 301-594-9523
Program Official:Marva M. Moxey-mims
Email: moxey-mimsm@extra.niddk.nih.govPhone: (301) 451-5037Fax: (301) 480-3510
SPREADSHEET SUMMARY
GRANT NUMBER:1R43DK095625-01A1
INSTITUTION:ANGION BIOMEDICA CORPORATION
| Budget | | Year 1 | |
| Salaries and Wages | | $ | [***] | |
| Fringe Benefits | | $ | [***] | |
| Consultant Services | | $ | [***] | |
| Supplies | | $ | [***] | |
| Travel Costs | | $ | [***] | |
| Consortium/Contractual Cost | | $ | [***] | |
| FEE | | $ | [***] | |
| TOTAL FEDERAL DC | | $ | [***] | |
| TOTAL FEDERAL F&A | | $ | [***] | |
| TOTAL COST | | $ | [***] | |
| | 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. |
| Facilities and Administrative Costs | | Year 1 | |
| 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. |
