13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
Exhibit 10.1
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Request with the Commission.
OMB Approval 2700-0042
1. CONTRACT ID CODE | PAGE OF PAGES | |||||||||||||
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1 | 3 | ||||||||||||
2. AMENDMENT/MODIFICATION NO. | 3. EFFECTIVE DATE | 4. REQUISITION/PURCHASE REQ. NO. | 5. PROJECT NO. (If applicable) | |||||||||||
Nineteen (19) | August 10, 2016 | 4291173: | ||||||||||||
6. ISSUED BY | CODE | 7. ADMINISTERED BY (If other than Item 6)
| CODE | N/A | ||||||||||
National Institutes of Health National Institute of Allergy and Infectious Diseases DEA, Office of Acquisitions Room 3214, MSC 7612 6700-B Rockledge Drive Bethesda, MD 20892-7612
|
MID RCB-A | |||||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No. Street, county, State and ZIP: Code) | (X) | 9A. AMENDMENT OF SOLICITATION NO. | ||||||||||||
.
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BIOCRYST PHARMACEUTICALS, INC. | 9B. DATED (SEE ITEM 11) | |||||||||||||
4505 EMPEROR BLVD SUITE 200 | ||||||||||||||
DURHAM, NC 27703 | 10A. MODIFICATION OF CONTRACT/ORDER NO. | |||||||||||||
X | HHSN272201300017C | |||||||||||||
10B. DATED (SEE ITEM 13) | ||||||||||||||
CODE | FACILITY CODE | September 16, 2013 | ||||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||||||
[_] The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers [_] is extended, [_] is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.
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12. ACCOUNTING AND APPROPRIATION DATA (If required) | ||||||||||||||
SOC 25.55   ###-###-#### $2,672 ###-###-#### $1,454,077 Total $4,126,697 | ||||||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||||||
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. | ||||||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
| ||||||||||||||
X | D. OTHER Specify type of modification and authority) Mutual Agreement of the Parties. | |||||||||||||
E. IMPORTANT: Contractor [_] is not, [X] is required to sign this document and return copies to the issuing office. | ||||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
PURPOSE: Execute Option 10
The completion date of the contract is changed to December 30, 2017. Total cost obligated by this action is changed $4,126,697 Total contract ceiling is $39,476,895
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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) | |||||||||||||
Jon P. Stonehouse CEO | John Outen, Contracting Officer Office of Acquisitions, DEA, NIAID, NIH, DHHS | |||||||||||||
15B. CONTRACTOR/OFFEROR | 15C. DATE SIGNED | 16B. UNITED STATES OF AMERICA | 16C. DATE SIGNED | |||||||||||
/s/ Jon P. Stonehouse (Signature of person authorized to sign) | BY /s/ John Outen (Signature of Contracting Officer) | |||||||||||||
NSN 7540-01-152-8070 PREVIOUS EDITION UNUSABLE | 30-105 Computer Generated | STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53.243 |
SPECIAL PROVISIONS
| Contract No. HHSN272201300017C Modification No.19
| Page 2 of 3 |
Beginning with the effective date of this modification, ARTICLE B.2. ESTIMATED COST –OPTION AND ARTICLE G.3 INVOICE SUBMISSION /CONTRACT FINANCING REQUEST IS REVISED
ARTICLE B.2. ESTIMATED COST – OPTION is revised to incorporate changes for execution of Option 10 with changes in the Option table below:
a. | The estimated cost ceiling of this contract is $39,476,895 with the execution of this option. The obligation for this action is $4,126,697 |
c. | Payments from the base and executed options will be made from the following PRISM/NBS Line Item Numbers as follows: |
PRISM/NBS Line Item No. | Option/Increment Description | PRISM/NBS Line Item Period of Performance | Funded Amount | |
1 (BASE) Award | Base Period: Non-GMP manufacture of drug substance, drug disposition, genetic toxicity and in vitro and small animal efficacy studies |
09/16/2013- 03/31/2015 |
$ *** | |
2 (Option 1) Award | Option 1-Manufacture of drug substance and drug product in compliance with cGMP guidance -GMP |
09/16/2013 -12/30/2017 |
$ *** | |
3 (Option 2) Award | Option 2-DP and Development with DS Stability testing |
09/16/2013 -12/30/2017 |
$ *** | |
4 (Option 3) MOD 1 | Option 3-IM IND-Enablement and Submission |
12/24/2013 -12/23/2016 |
$2,506,042 | |
5 (Option 4) MOD 5 | Option 4- IM Phase 1 Clinical Trials |
08/08/2014-06/30/2017 |
$ *** | |
6 (MOD 6) | Line is Cancelled | Line is cancelled | $0 | |
7 (Option 6) Mod 3 | Option 6-IV DP Development and Non-GMP Activities
|
5/25/2014 - 09/30/16 |
$1,886,304 | |
8 (Option 7) Mod 8 |
Option 7- IV GMP DS for Phase 1 Manufacturing |
9/17/2014 - 12/30/2017 |
$ *** | |
9 (Option 8) Mod 8 |
Option 8 – IV DP Stability for eGMP/ICH Manufacturing |
9/17/2014 - 12/30/2017 |
$ *** | |
10 (Option 9) | Option 9 - IV IND-Enablement and Submission |
12/10/2014 -09/04/2017 |
$2,718,329 |
|
11 (Option 10) Modification 19 |
Phase 1 IV Clinical Trials
|
8/10/2017-12/30/2017 |
$4,126,697 | |
12 (Option 5) MOD 7&8 | Option 5- Characterization of Efficacy in a Therapeutic NHP infection model (Equitable Adjustment) |
8/08/2014 - 12/30/2017 |
$ *** |
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Request with the Commission.
SPECIAL PROVISIONS
| Page 3 of 3 |
13 (Option 5) Mod 7&8 | Option 5- Characterization of Efficacy in a Therapeutic NHP infection model (Cost Overrun) |
8/08/2014 - 12/30/2017 |
$ *** |
|
14 (Option 1) Mod 12 | Option 1-Manufacture of drug substance and drug product in compliance with cGMP guidance –GMP-Added Kg |
09/16/2013 -12/30/2017 |
$ *** | |
15 (Option 2) Mod 12 | Option 2-DP and Development with DS Stability testing-Added testing |
09/16/2013 -12/30/2017 |
$ ***
|
|
16 (Option 5) Mod 7&8 | Option 5- Characterization of Efficacy in a Therapeutic NHP infection model (Cost Overrun) |
8/08/2014 - 12/30/2017 |
$ *** | |
17 (Option 4) Cost Overrun | Option 4- IM Phase 1 Clinical Trial |
08/08/2014- 06/30/2017 |
$1,344,780 |
|
18 (Option 5) Equitable Adjustment | Option 5- Characterization of Efficacy in a Therapeutic NHP infection model. |
9/15/2015 - 12/30/2017 |
$2,184,734 |
|
19 (Option 5) Equitable Adjustment | Option 5- Characterization of Efficacy in a Therapeutic NHP infection model. Additional primate studies |
6/30/2016 - 12/30/2017 |
$5,475,146 |
END OF MODIFICATION 19 OF HHSN272201300017C
Pursuant to 17 CFR 20.24b-2, confidential information has been omitted in places marked “***” and has been filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Request with the Commission.