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.

.

 

 

   

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.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If required) SOC
25.55  16-8019776   $2,672,620 16-8470038 $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

 

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.