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Advance development of KeraStat Cream as a medical device
Solicitation number
75A50122C00017
Issued by

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This document is an award notice for a cost reimbursable contract issued by the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Keranetics, LLC was awarded contract number 75A50122C00017 on March 18, 2022 for $4,471,066 to advance the development of KeraStat Cream as a medical device for the treatment of cutaneous radiation injury. The scope of work includes pivotal non-clinical studies for $2,848,309, 510(k) regulatory submission for $643,964, and options for engineering scale-up for $582,087 and equipment installation/quality management system updates for $395,952. Funding is provided for the base period of performance with optional future work contingent on availability of funds and contractor performance.

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AWARD/CONTRACT

2. CONTRACT (Proc. Inst. Ident.) NO. 3. EFFECTIVE DATE

5. ISSUED BY CODE 6. ADMINISTERED BY (If other than Item 5)

UNDER DPAS (15 CFR 700)

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

7. NAME AND ADDRESS OF CONTRACTOR (No., street, country, State and ZIP Code)

1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES

8. DELIVERY

9. DISCOUNT FOR PROMPT PAYMENT

10. SUBMIT INVOICES

(4 copies unless otherwise specified)

TO THE ADDRESS SHOWN IN

ITEM

CODE

CODE CODE

FACILITY CODE

11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 14. ACCOUNTING AND APPROPRIATION DATA

75A50122C00017 See Block 20C OS292139

ASPR-BARDA

ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G Washington DC 20201

ASPR-BARDA02

US DEPT OF HEALTH & HUMAN SERVICES

ASST SEC OF PREPAREDNESS & RESPONSE

ACQ MANAGEMENT, CONTRACTS, & GRANTS

O'NEILL HOUSE OFFICE BUILDING

Washington DC 20515

KERANETICS INC 1601652

Attn: LUKE BURNETT

KERANETICS, INC. 200 E 1ST ST

200 E 1ST ST STE 102

WINSTON SALEM NC 27101-4165

OTHER (See below)FOB ORIGIN X

CODE

OS

Office of the Secretary Office of the Secretary 200 Independence Ave. S.W.

Washington DC 20201

ASPR-BARDA

ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

BIOMEDICAL ADVANCED RESEACH & DEVEL

200 INDEPENDENCE AVE, S.W; ROOM 640

Washington DC 20201

See Schedule) )

1601652

SCD-C

15A. ITEM NO 15F. AMOUNT15E. UNIT PRICE15D.

UNIT

15C.

QUANTITY

15B. SUPPLIES/SERVICES

Continued

15G. TOTAL AMOUNT OF CONTRACT $3,492,273.00

16. TABLE OF CONTENTS

(X) SEC. DESCRIPTION (X) PAGE(S) DESCRIPTION SEC.

A

B

C

D

E

F

G

H

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

SOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECS./WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS M

L

K

J

I

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

CONTRACT CLAUSES

LIST OF ATTACHMENTS

REPRESENTATIONS, CERTIFICATIONS AND

INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

OTHER STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

X

X

X

X

X

X

X

X

X

X

PAGE(S)

17. CONTRACTOR' S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

No further contractual document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.)

documents: (a) the Government's solicitation and your bid, and (b) this award/contract.

sheets. This award consummates the contract which consists of the following in full above, is hereby accepted as to the items listed above and on any continuation including the additions or changes made by you which additions or changes are set forth

Solicitation Number

SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on 18.

20C. DATE SIGNED

(Signature of the Contracting Officer)

20B. UNITED STATES OF AMERICA

20A. NAME OF CONTRACTING OFFICER

19B. NAME OF CONTRACTOR

19A. NAME AND TITLE OF SIGNER (Type or print)

BY

(Signature of person authorized to sign)

19C. DATE SIGNED

BY

STANDARD FORM 26 (Rev. 3/2013)

Prescribed by GSA - FAR (48 CFR) 53.214(a)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is NOT usable

X

JILL M. JOHNSON

CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE

KERANETICS INC 1601652

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 77

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

KERANETICS INC 1601652

75A50122C00017

(A) (B) (C) (D) (E) (F)

Tax ID Number: 83-0626324

DUNS Number: 081252398

This contract is to advance the development of KeraStat? Cream as a medical device type of countermeasure for the treatment of Cutaneous Radiation Injury. The scope of work includes clinical, regulatory, and manufacturing activities.

1 ASPR-22-00746 CLIN 0001 Pivotal Non-Clinical 2,848,309.00

Study

Obligated Amount: $2,848,309.00

Accounting Info:

2022.1992022.25106 Appr. Yr.: 2022 CAN: 1992022 Object Class: 25106

Funded: $2,848,309.00

FOB: Destination

2 ASPR-22-00746 CLIN 0002 510(k) Submission 643,964.00

Obligated Amount: $643,964.00

Accounting Info:

2022.1992022.25106 Appr. Yr.: 2022 CAN: 1992022 Object Class: 25106

Funded: $643,964.00

3 Engineering Scale-up 0.00

Amount: $582,087.00(Option Line Item)

Accounting Info:

2010.00000000.00 Appr. Yr.: 2010

Funded: $0.00

4 Equipment Install and QMS updates 0.00

Amount: $395,952.00(Option Line Item)

Accounting Info:

2010.00000000.00 Appr. Yr.: 2010

Funded: $0.00

AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

File details come from the government source that posted it. Updated .