EX-10.46 5 d117377dex1046.htm EX-10.46 EX-10.46

Exhibit 10.46

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT   1. CONTRACT ID CODE   PAGE OF PAGES
    1   2
2. AMENDMENT/MODIFICATION NO.     3. EFFECTIVE DATE   4. REQUISITION/PURCHASE REQ. NO.     5 PROJECT NO, (If applicable)    

0001

 

      10/15/2015            
5. ISSUED BY   CODE     ASPR-BARDA   7. ADMINISTERED BY (If other than Item 6)   ASPR-BARDA01

 

ASPR - BARDA

200 Independence Ave., S.W.

Room 640-G

Washington DC 20201

 

   

 

ASPR–BARDA

330 Independence Ave, SW, Rm G644

Washington DC 20201

 

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP code

 

PFENEX, INC 1358378

FENEX BIOPHARMACEUTICALS, INC.

10790 ROSELLE ST

SAN DIEGO CA 921211718

  00  

9A. AMENDMENT OF SOLICITATION NO.

 

     

9B. DATED (SEE ITEM 11)

 

 

       
  x     10A. MODIFICATION OF CONTRACT/ORDER NO.
   

HHSO100201500011C

 

   
    10B. DATED (SEE ITEM 13)

CODE 1358378

 

     

FACILITY CODE

 

   

08/14/2015

 

   
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
The above numbered solicitation is amended as set forth in Item 14. The hour end 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          copies 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 ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE 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 date specified.
12. ACCOUNTING AND APPROPRIATION. DATA (if required)
See Schedule
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK

ONE

  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).
x         
  C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
         
    D.    OTHER (Specify type of modification and authority)
             

 

E. IMPORTANT:    Contractor          is not X is required to sign this document and return 1 copies to the issuing office.

 

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Tax ID Number:    27-1356759

DUNS Number:    013603710

Pfenex - RPA563 and Px563L Advanced Development

A. The purpose of this modification is to transfer material from contract # HHS0100201000045C (see inventory list) to contract #HHS0100201 500011C. The material is needed on contract # - 0011C to complete the advanced research and development of a next generation anthrax vaccine. The total cost of the contract and all terms and conditions remain unchanged.

B. Update the Contracting Officer from Francine Hemphill to Wendell Conyers in sections Article F.2, Article G.1 and Article G.5.

 

Continued …

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)
PATRICK LUCY       WENDELL CONYERS   
15B. CONTRACTOR/OFFEROR    15C. DATE SIGNED    16B. UNITED STATES OF AMERICA    16C. DATE SIGNED

 

/s/ Patrick Lucy

(Signature of person authorized to sign)

  

 

21 Oct 15

  

 

/s/ Wendell Conyers

(Signature of Contracting Officer)

  

 

10-21-2015

 

NSN 7540-01-152-8070    STANDARD FORM 30 (REV. 10-83)
Previous edition unusable    Prescribed by GSA
   FAR (48 CFR) 53.243

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


    CONTINUATION SHEET       REFERENCE NO. OF DOCUMENT BEING CONTINUED    PAGE      OF  
  HHS0100201500011C/0001    2    2

NAME OF OFFEROR OR CONTRACTOR

 

PFENEX, INC 1358378

 

ITEM NO. 

(A) 

 

SUPPLIES/SERVICES

(B)

 

QUANTITY    

(C)    

 

UNIT    

(D)    

 

UNIT PRICE    

(E)    

 

AMOUNT    

(F)    

   

Discount Terms: NET 30P

Period of Performance: 08/14/2015 to 08/09/2020

 

               

 

NSN 7540-01-152-8087    OPTIONAL FORM 335 (4-85)   
   Sponsored by GSA   
   FAR (48 CFR) 53.110   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Inventory — [***]

 

item
number

  

Description

   Concentration     Volume     Container     Lot #     Date
of
Manuf.
    Storage     Amount     Inventory
date
    Storage
location
 
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Pfenex Confidential    Page 3 of 7


[***]

 

Sentry Item

number

  

Description

   Concentration     Volume     Container     Lot #     Date of
Manuf.
    Storage     #
Vials
    Inventory
date
    Storage
location
 
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***
[***]   

[***]

     [***     [***     [***     [***     [***     [***     [***     [***     [***

[***]

[***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Pfenex Confidential    Page 4 of 7


[***]

 

Reagent/Materials Name

  

mrPA lot/DOM

  

Description

   Amount
left
(units)
    Storage
Condition
(ºC)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

[***]

 

Reagent/Materials Name

  

mrPA lot

  

Description

   Amount
left
(units)
    Storage
Condition
(°C)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

 

Reagent/Materials Name

  

Lot

  

Description

   Amount
left
(units)
    Storage
Condition
(°C)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

 

Reagent/Materials Name

  

Source

  

Description

   Amount
left
(units)
    Storage
Condition
(ºC)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

 

Reagent/Materials Name

  

Strain

  

Description

   Amount
left
(units)
    Storage
Condition
(°C)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Pfenex Confidential    Page 5 of 7


[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

Reagent/Materials Name

       

Description

   Amount
left
(units)
    Storage
Condition
(°C)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

 

Reagent/Materials Name

       

Description

   Amount
left
(units)
    Storage
Condition
(°C)
    Date  

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

[***]

   [***]   

[***]

     [***     [***     [***

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Pfenex Confidential    Page 6 of 7


ARTICLE F.2. DELIVERABLES

a. Summary of Contract Deliverables

Unless otherwise specified by the Contracting Officer, the deliverables identified in this SECTION F shall also be delivered electronically to the designated eRoom along with a concurrent email notification sent to the Contracting Officer, Contract Specialist, COR, and Alternate COR stating delivery has been made.

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b). Hard copies of deliverables and reports furnished to the USG under the resultant Contract (including invoices) shall be addressed as follows:

HHS/ASPR/AMCG

ATTN: Wendell Conyers, Contracting Officer 330 Independence Avenue,

SW., Room G640 Washington, DC 20201

Email: Wendell.conyers@hhs.gov

ARTICLE G.1. CONTRACTING OFFICER

The following Contracting Officer (CO) will represent the USG for the purpose of this contract:

Wendell Conyers

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W. Room G644 Washington, D.C. 20201

((202) 205-8262

Wendell.conyers@hhs.gov

ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

Include Program Support Center (PSC) In Receipt of Invoices:

Documents shall be delivered electronically to the Contracting Officer (CO), the Contracting Specialist (CS), the Contracting Officer’s Representative (COR) and PSC. Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

 

Wendell Conyers

Contracting Officer

HHS/ASPR/AMCG

330 Independence Ave., S.W.,

Room G640

Washington, DC 20201

Email: wendell.conyers@hhs.gov

  

Daniel Wolfe Contracting

Officer Representative

HHS/ASPR/BARDA

330 Independence Ave., S.W.,

Room G640 Washington, DC 20201

Email: Daniel.wolfe2@hhs.gov

   PSC_Invoices@hhs.gov

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Pfenex Confidential    Page 7 of 7