EX-4.11.7 4 exhibit4_11-7.htm EXHIBIT 4.11.7

Exhibit 4.11.7

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
 
1. CONTRACT ID CODE
 
PAGE OF PAGES
       
1
5
2. AMENDMENT/MODIFICATION NO.
3. EFFECTIVE DATE
4. REQUISITION/PURCHASE REQ. NO.
5. PROJECT NO. (If applicable)
P00008
 
See Block 16C
OS289937
       
6. ISSUED BY
CODE  
ASPR-BARDA
7. ADMINISTERED BY (If other than Item 6)
CODE
ASPR-BARDA01
           
ASPR-BARDA
ASPR-BARDA
       
200 Independence Ave., S.W.
330 Independence Ave, SW, Rm G644
Room 640-G
Washington DC 20201
Washington DC 20201
         
           
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
(x)
9A. AMENDMENT OF SOLICITATION NO.
                   
MEDIWOUND LTD 1477616
                 
MEDIWOUND LTD
42 HAYARKON
   
9B. DATED (SEE ITEM 11)
42 HAYARKON
                 
YAVNE     00812
   
x
10A. MODIFICATION OF CONTRACT/ORDER NO.
       
HHSO100201500035C
       
                   
       
10B. DATED (SEE ITEM 13)
       
CODE      1477616
 
 
 FACILITY CODE
 
 
09/29/2015
 
       
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 ________ 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)
Net Increase:
$8,944,500.00
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:
FAR 52.243-2 Alt I - Changes - Cost Reimbursement and FAR 43.103(a) - By Mutual Agreements of the Parties
 
D. OTHER (Specify type of modification and authority)
 
E. IMPORTANT: Contractor ☐ is not.  ☒ 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:
C0-0000387
DUNS Number: 532040334
The purpose of this modification is to add funds to CLIN 0001 for increased costs as a result of FDA comments, and modify ARTICLE B.2. BASE PERIOD, ARTICLE C.1. STATEMENT OF WORK, ARTICLE G.1. CONTRACTING OFFICER, ARTICLE G.5. INDIRECT COST RATES, and SECTION J.
 
Funds Obligated Prior to this Modification: $ 98,418,394
Funds Obligated with Mod # 8: $ 8,944,500
Total Funds Obligated to Date: $ 107,362,894

Continued ...
 
Except as provided herein, all terms and conditions of the document referenced in Item 9 A 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)
   
Sharon Malka, CEO
KEVIN RESTREPO
 
15B. CONTRACTOR/OFFEROR
15C. DATE SIGNED+
 16B. UNITED STATES OF AMERICA
16C. DATE SIGNED
             /s/ Sharon Malka                     
02/08/2022
           /s/ KEVIN RESTREPO         

(Signature of person authorized to sign)
 
(Signature of Contracting Officer)
02/09/2022
Previous edition unusable
STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243
 
 

       
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED
PAGE OF
HHSO100201500035C/P00008
2
5
NAME OF OFFEROR OR CONTRACTOR
MEDIWOUND LTD 1477616
ITEM NO.
(A)
SUPPLIES/SERVICES
(B)
QUANTITY
(C)
UNIT
(D)
UNIT PRICE
(E)
AMOUNT
(F)
 
In consideration of the modification agreed to herein as complete equitable adjustments, the Contractor, hereby releases the Government from any and all liability under this contract for further equitable adjustments attributable to such fact or circumstance giving rise to this modification.
       
 

       
 
Period of Performance: 09/29/2015 to 09/27/2024
       
 

       
 
Change Item 1 to read as follows(amount shown is the obligated amount):
       
 

       
1
ASPR-15-08828 -- CLIN 0001          Advanced development studies for NexoBrid
     
8,944,500.00
 

       
 
Accounting Info:
2015.1990002.26201 Appr. Yr.: 2015 CAN: 1990002   Object Class:   26201
Funded: $0.00
       
 

       
 
Accounting Info:
2017.1990007.25106 Appr. Yr.: 2017 CAN: 1990007  Object Class:    25106
Funded: $0.00
       
           
 
Accounting Info:
2019.1990051.25106 Appr. Yr.: 2019 CAN: 1990051 Object Class:    25106
Funded: $0.00
     
           

Accounting Info:
2022.1990178.25103 Appr. Yr.: 2022 CAN: 1990178 Object Class:   25103
Funded: $8,944,500.00
     
 

       
 

       
 

       
 

       
 

       
 

       
 

       
 

       
           
           
NSN 7540-01-152-8067
OPTIONAL FORM 336 (4-86)
 
Sponsored by GSA
 
FAR (48 CFR) 53.110



Contract No. HHSO100201500035C
Modification # 8
Supplemental Pages Block 14
Page 3 / 5

SUMMARY OF CHANGES
 
Beginning with the effective date of this modification, the Government and Contractor mutually agree as follows:
 
1.
ARTICLE B.2. BASE PERIOD, is modified to add funding to CLIN 0001.
2.
ARTICLE C.1. STATEMENT OF WORK, is modified to delete reference to the date of the Statement of Work.
3.
ARTICLE G.1. CONTRACTING OFFICER, is modified to replace Matthew Rose with Jill Johnson.
4.
ARTICLE G.5. INDIRECT COST RATES, is modified to reflect current mutual understanding of indirect rates.
5.
SECTION J, Attachment 1, SOW, is replaced in its entirety.

ARTICLE B.2. BASE PERIOD is modified as follows:

CLIN
Period of Performance
Supplies/ Services
Total Est.
Cost
Fixed Fee (7%)
Total Cost Plus Fixed
Fee
 COST REIMBURSEMENT
0001
(Base)
09/28/2015 –
09/27/2024
Licensure, approval, and clearance
of product through the FDA
$47,911,779
$55,986,743
$3,049,644
$3,919,180
$50,961,423
$59,905,923
 
(Funded)
0004A
(Base)- Activate optional Task in July, 2017
08/01/2017-
07/31/2023
Pediatric Study
$23,989,225
$1,455,400
$25,444,625
 
(Funded)
0006A,B,C
(Base) New Task added in Feb 28,2020
1/1/2020 -
6/31/2024
Emergency Readiness Tasks
$4,271,919
$299,034
$4,570,953
 
(Funded)
0007A,B
(Base) New Task added in Feb 28,2020
TBD
Emergency Deployment Preparation
$903,350
$63,235
$966,585
(Funded)
 FIRM FIXED PRICE
CLIN
Period of Performance
Supplies/ Services
Units (# of Product)
Unit Price ($)
Total ($)
0002
(Base)
 
09/28/2017 –
09/27/2019*(*
see advanced
understanding h.)
Initial Purchase, storage, and
delivery of product
 
10,588
$1,052
(includes
VMI)
$11,138,576
(Funded)
 
0002
(Base)
09/28/2019 –
3/31/2022
Initial Purchase, storage, and
delivery of product
5412
$986
(includes
VMI)
$5,336,232
(Funded)
Total
CLINS
001&002&0
04A&006&0
07
09/28/2015 –
09/27/2024
See Above Descriptions
   
$98,418,395
107,362,894
(Funded)


 

Contract No. HHSO100201500035C
Modification # 8
Continuation Sheet
Block 14
Page 4 / 5
 
ARTICLE C.1. STATEMENT OF WORK  is modified as follows:
 
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated September 28, 2015 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.
 
ARTICLE G.1. CONTRACTING OFFICER is modified as follows:
 
The following Contracting Officer (CO) will represent the Government for the purpose of this contract:
 
Jill Johnson, Contracting Officer
202-690-7137
Jill.Johnson@hhs.gov

a.
The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, specifications or other requirements of this contract.
 
b.
The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
 
c.
No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, shall be considered grounds for deviation from this contract.
 
d.
The Government may unilaterally change its CO designation


 
Contract No. HHSO100201500035C
Modification # 8
Continuation Sheet
Block 14
Page 5 / 5
  
ARTICLE G.5. INDIRECT COST RATES is modified as follows:
 
1.
The following interim provisional indirect rates will be utilized for billing purposes during the period of performance:

Direct Labor Overhead - 80%.
Direct Consultant Labor Overhead – 25%
Final rate proposals must be sent to the Contracting Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7, Allowable Cost and Payment.
 
2.
The interim provisional indirect rates used in this contract have been established after approval by the AMCG/BARDA Auditor.

SECTION J LIST OF ATTACHMENTS is modified as follows:
 
The following documents are attached and incorporated in this contract:
 

1.
Statement of Work, dated January 26, 2022
 

2.
Invoice/Financing Instructions for Cost-Reimbursement Type Contracts
 

3.
Invoice Instructions for Fixed-Priced Type Contracts
 

4.
Sample Invoice Form
 

5.
Research Patient Care Costs
 

6.
Report of Government Owned, Contractor Held Property
 

7.
Form SF-LLL, Disclosure of Lobbying Activities
 

8.
Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01)

END OF MODIFICATION P00008 to HHSO100201500035C