Temporary I.pdf
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- Solicitation number
- 75A50122C00017
About this file
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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Text version
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 .