Delaware
|
0-23047
|
13-3864870
|
(State or other jurisdiction of incorporation or organization)
|
(Commission file number)
|
(I.R.S. employer identification no.)
|
31 East 62nd Street
|
10065
|
|
New York, New York
|
(Zip code)
|
|
(Address of principal executive offices)
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Item 1.01. |
Entry into a Material Definitive Agreement.
|
· |
Development activities for the IV formulation of TPOXX (IV TPOXX).
|
· |
Delivery to the Strategic National Stockpile of a limited number of courses (approximately 35,700 courses) of the oral formulation of TPOXX (oral TPOXX) for an approximate value of $11 million; such courses being readily available for delivery or to be manufactured using currently-held active pharmaceutical ingredient.
|
· |
Delivery of bulk drug substance to be used for the manufacture of IV TPOXX and the use of such bulk drug substance to manufacture 20,000 courses of final drug product of IV TPOXX, with such activities having a total value of $8 million for 7-day (14-vial) courses; additionally, the Company will be paid for the storage, if applicable, and delivery of final drug product of IV TPOXX.
|
· |
Series of options to procure up to approximately 1,452,300 courses in total of oral TPOXX (exclusive of the courses to be purchased for base period activities), with such options having a total value of up to approximately $450 million.
|
· |
Series of options to procure up to 192,000 courses in total (exclusive of the courses to be purchased for base period activities) of final drug product of IV TPOXX, with such options having a cumulative total value of up to approximately $77 million for the combination of bulk drug substance and final drug product manufacturing; or alternatively, to procure up to 192,000 equivalent courses in total (exclusive of the equivalent courses to be purchased for base period activities) of bulk drug substance that could be used in the future for the manufacture of final drug product of IV TPOXX, with such alternative having a value of up to approximately $31 million.
|
· |
Series of options for vendor-managed storage of either bulk drug substance that would be used in the manufacture of the IV TPOXX or final drug product of IV TPOXX (total option value of approximately $6 million).
|
· |
Separate options to cumulatively provide up to approximately $44 million of funding for post-marketing activities for oral TPOXX and IV TPOXX.
|
Item 9.01. |
Financial Statements and Exhibits
|
Exhibit
No.
|
Description
|
|
Contract, dated as of September 10, 2018, between SIGA Technologies, Inc. and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment).
|
||
Press Release, dated September 10, 2018.
|
SIGA TECHNOLOGIES, INC.
|
|||
By:
|
/s/ Daniel J. Luckshire | ||
Name:
|
Daniel J. Luckshire
|
||
Title:
|
Chief Financial Officer
|
||
Date: September 10, 2018
|
AWARD/CONTRACT
|
1. this contract is a rated order
under dpas (15 cfr 700)
|
rating
|
page of pages
|
|||
1 | 48 |
2. contract (Proc. Inst. Indent.) no.
HHS0100201800019C
|
3. effective date
See Block 20C
|
4. requisition/purchase/project no.
OS227460
|
5. issued by
|
code |
HHS/OS/ASPR/BARDA
|
6. administered by (If other than Item 5)
|
code |
ASPR-BARDA01
|
US DEPT OF HEALTH & HUMAN SERVICES
ASST SEC OF PREPAREDNESS & RESPONSE
ACQ MANAGEMENT, CONTRACTS, & GRANTS
O’NEILL HOUSE OFFICE BUILDING
Washington DC 20515
|
ASPR-BARDA
330 Independence Ave, SW, Rm G644
Washington DC 20201
|
7. name and address of contractor (No., street, county, State and ZIP Code)
SIGA TECHNOLOGIES, INC. 1385150
SIGA TECHNOLOGIES, INC.
31 East 62nd street
NEW YORK NY 100658446
|
8. delivery
|
|||||
☐ fob origin
|
☒ other (See below)
|
|||||
9. discount for prompt payment
|
||||||
10. submit invoices
(4 copies unless otherwise specified)
to the address shown in
|
item
|
|||||
code 1385150
|
facility code
|
|||||
11. ship to/mark for
|
code
|
HHS |
12. payment will be made up by
|
code
|
PSC
|
|
HHS
|
PSC
|
|||||
200 Independence Avenue, SW | ||||||
Washingyon DC 20201 | ||||||
13. authority for using other than full and open competition
|
14. accounting and appropriation data
|
|||||
☐ 10 U.S.C. 2304 (c) ( )
|
☐ 41U.S.C. 253 (c) ( )
|
2018.199TWNP.26402
|
15a. item no
|
15b. supplies/services
|
15c. quantity
|
15d. unit
|
15e. unit price
|
15f. amount
|
Continued
|
15g. total amount of contract
|
$51,641,805.00
|
16. table of contents
|
|||||||
(x)
|
sec.
|
description
|
page(s)
|
(x)
|
sec.
|
description
|
page(s)
|
part i – the schedule
|
part ii – contract clauses
|
||||||
a
|
solicitation/contract form
|
x
|
i
|
contract clauses
|
43
|
||
x
|
b
|
supplies or services and prices/costs
|
2
|
part iii – list of documents, exhibits and other attach.
|
|||
x
|
c
|
description/specs/work statement
|
11
|
x
|
j
|
list of attachments
|
47
|
x
|
d
|
packaging and marking
|
13
|
part iv – representations and instructions
|
|||
x
|
e
|
inspection and acceptance
|
14
|
x
|
k
|
representations, certifications and other statements of offerors
|
48
|
x
|
f
|
deliveries or performance
|
16
|
||||
x
|
g
|
contract administration data
|
24
|
l
|
instrs., conds. and notices to offerors
|
||
x
|
h
|
special contract requirements
|
29
|
m
|
evaluation factors for award
|
contracting officer will complete item 17 (sealed-bid or negotiated procurement) or 18 (sealed-bid procurement) as applicable
|
|||
17. ☒ contractor’s negotiated agreement (Contractor is required to sign this document and return 1 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.)
|
18. ☒ sealed-bid award (Contractor is not required to sign this document.) Your bid on Solicitation Number 18-100-SOL-00011 , including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government's solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.)
|
||
19a. name and title of signer (Type or print.)
Phillip L. Gomez, III, CEO
|
20a. name of contracting officer
BROOKE T. BERNOLD
|
||
19b. name of contractor
by /s/ Phillip L. Gomez, III
(Signature of person authorized to sign.)
|
19c. date signed
10 Sept 2018
|
20b. united states of america
by /s/ Brooke T. Bernold
(Signature of the Contracting Officer.)
|
20c. date signed
10 Sept 2018
|
ARTICLE B.1. |
BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
|
ARTICLE B.2. |
BASE PERIOD
|
Base Period Cost Reimbursement CLIN
|
|||||
CLIN
|
Period of
Performance
|
Supplies/Services
|
Estimated
Cost
|
Fixed Fee
|
Cost + Fixed Fee
(CPFF)
|
0001 (Base)
|
[redacted]*
|
Late stage development activities towards FDA approval for a parenteral (IV) antiviral
|
[redacted]*
|
[redacted]*
|
32,009,375
|
Base Period Fixed Price CLINs
|
|||||
CLIN
|
Period of
Performance
|
Supplies/Services
|
Treatment
Courses (#
of Product)
|
Unit Price
($)
|
Total ($)
|
0002 (Base)
|
[redacted]*
|
Initial purchase and delivery of a nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS.
|
35,718
|
[redacted]*
|
$11,072,580
|
0003 (Base)
|
[redacted]*
|
Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)
*course = 14 vials
|
20,000
|
[redacted]*
|
$3,200,000
|
0004 (Base)
|
[redacted]*
|
Fill/finish of final drug product (from bulk drug substance procured under CLIN0003).
|
20,000
|
[redacted]*
|
4,800,000
|
0005 (Base)
|
[redacted]*
|
Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003).
*Monthly rate/TC = [redacted]*
|
20,000
|
[redacted]*
|
[redacted]*
|
0006 (Base)
|
[redacted]*
|
Delivery of FDP to the SNS
(from bulk drug substance procured under CLIN0003) |
20,000
|
[redacted]*
|
[redacted]*
|
ARTICLE B.3.
|
OPTION PRICES
|
Optional Cost Reimbursement CLINs
|
|||||
CLIN
|
Period of
Performance
|
Supplies/ Services
|
Total Est.
Cost
|
Fixed Fee
|
Total Cost Plus
Fixed Fee ($)
|
0007 (Option)
|
[redacted]*
|
Phase IV post marketing commitments (nonparenteral (oral) formulation) including [redacted]*
|
[redacted]*
|
[redacted]*
|
$40,812,609
|
0008 (Option)
|
[redacted]*
|
Phase IV post marketing commitments (parenteral (IV) formulation) including [redacted]*
|
[redacted]*
|
[redacted]*
|
$3,586,806
|
Optional Fixed Price CLINs
|
|||||
CLIN
|
Period of
Performance
|
Supplies/Services
|
Treatment
Courses (#
of Product)
|
Unit Price
($)
|
Total ($)
|
0009
(Option)
|
[redacted]*
|
Additional procurement of
nonparenteral (oral)
formulated antiviral as FDP and delivery to the SNS
|
363,070
|
[redacted]*
|
$112,551,700
|
0010
(Option)
|
[redacted]*
|
Additional procurement of
nonparenteral (oral)
formulated antiviral as FDP and delivery to the SNS
|
363,070
|
[redacted]*
|
$112,551,700
|
0011 (Option)
|
[redacted]*
|
Additional procurement of a nonparenteral (oral)
formulated antiviral as FDP and delivery to the SNS
|
363,070
|
[redacted]*
|
$112,551,700
|
0012
(Option)
|
[redacted]*
|
Additional procurement of
nonparenteral (oral)
formulated antiviral as FDP and delivery to the SNS
|
363,072
|
[redacted]*
|
$112,552,320
|
0013
(Option)
|
[redacted]*
|
Surge Capacity – Additional
procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)
*course = 14 vials
|
64,000
|
[redacted]*
|
$10,240,000
|
0014
(Option)
|
[redacted]*
|
Surge Capacity – Storage of
parenteral (IV) formulated antiviral as bulk drug substance
(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0013).
*Monthly rate per TC = [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0015
(Option)
|
[redacted]*
|
Surge Capacity –Fill/finish of
final drug product (from bulk drug substance procured under
CLIN0013)
|
64,000
|
[redacted]*
|
$15,360,000
|
0016
(Option)
|
[redacted]*
|
Surge Capacity – Storage of
final drug product in VMI for 5 years (from bulk drug substance procured under
CLIN0013).
*Monthly rate per TC = [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0017
(Option)
|
[redacted]*
|
Surge Capacity – Delivery of
FDP to the SNS (from bulk drug substance procured under
CLIN0013)
*[redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0018
(Option)
|
[redacted]*
|
Surge Capacity – Additional
procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)
*course = 14 vials
|
64,000
|
[redacted]*
|
$10,240,000
|
0019
(Option)
|
[redacted]*
|
Surge Capacity – Storage of
parenteral (IV) formulated antiviral as bulk drug substance
(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0018).
*Monthly rate per TC = [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0020 (Option)
|
[redacted]*
|
Surge Capacity –Fill/finish of final drug product from bulk drug substance procured under CLIN0018).
|
64,000
|
[redacted]*
|
$15,360,000
|
0021 (Option)
|
[redacted]*
|
Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0018).
*Monthly rate per TC: [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0022
(Option)
|
[redacted]*
|
Surge Capacity – Delivery of
FDP to the SNS (from bulk drug substance procured under
CLIN0018).
[redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0023
(Option)
|
[redacted]*
|
Surge Capacity – Additional
procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)
*course = 14 vials
|
64,000
|
[redacted]*
|
$10,240,000
|
0024
(Option)
|
[redacted]*
|
Surge Capacity – Storage of
parenteral (IV) formulated antiviral as bulk drug substance
(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0023).
*Monthly rate per TC = [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0025
(Option)
|
[redacted]*
|
Surge Capacity –Fill/finish of
final drug product (from bulk drug substance procured under
CLIN0023).
|
64,000
|
[redacted]*
|
$15,360,000
|
0026
(Option)
|
[redacted]*
|
Surge Capacity – Storage of
final drug product in VMI for 5 years (from bulk drug substance procured under
CLIN0023).
*Monthly rate per TC: [redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
0027
(Option)
|
[redacted]*
|
Surge Capacity – Delivery of
FDP to the SNS (from bulk drug substance procured under
CLIN0023).
*[redacted]*
|
64,000
|
[redacted]*
|
[redacted]*
|
ARTICLE B.4. |
PROVISIONS TO APPLICABLE COSTS
|
a) |
Acquisition, by purchase or lease, of any interest in real property;
|
b) |
Rearrangement or alteration of facilities;
|
c) |
Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);
|
d) |
Accountable Government Property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value;
|
e) |
Overtime
|
f) |
General scientific meetings/conferences;
|
g) |
Travel costs including domestic/foreign travel;
|
h) |
Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);
|
i) |
Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;
|
j) |
Patient care costs
|
k) |
Refreshments and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility;
|
l) |
Promotional Items
|
m) |
Printing (as defined in the Government Printing and Binding Regulations).
|
ARTICLE B.5. |
ADVANCE UNDERSTANDINGS
|
a. |
Subcontracts and Consultants
|
b. |
Site Visits, Inspections and General Audits
|
· |
If issues are identified during the audit, Contractor shall submit an issue report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit.
|
· |
COR and CO will review the issues report and provide a response to the Contractor within 10 business days.
|
· |
Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR in writing after review of the issues report.
|
c. |
QA Audits
|
· |
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of bi-weekly communications.
|
· |
Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.
|
d. |
Man-in-Plant
|
e. |
Sharing of contract deliverables within United States Government (USG)
|
f. |
Overtime Compensation
|
g. |
Contract Number Designation
|
h. |
Quality Agreement
|
i. |
CAS Compliance
|
j. |
Risk of Loss
|
ARTICLE C.1. |
STATEMENT OF OBJECTIVES
|
ARTICLE C.2. |
REPORTING REQUIREMENTS
|
ARTICLE C.3. |
MEETINGS/SITE VISITS
|
ARTICLE D.1. |
METHOD OF DELIVERY
|
ARTICLE D.2. |
FOB DESTINATION DELIVERIES
|
ARTICLE E.1. |
INSPECTION AND ACCEPTANCE
|
ARTICLE E.2. |
FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE
|
ARTICLE F.1. |
PERIOD OF PERFORMANCE
|
ARTICLE F.2. |
DELIVERIES
|
ARTICLE F.3. |
CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS
|
ARTICLE F.3.1. |
Submission of Contract Deliverables
|
UPS/FedEx/Courier
|
USPS Mail Packages
|
||
[redacted]*
|
[redacted]*
|
UPS/FedEx/Courier
|
USPS Mail Packages
|
||
[redacted]*
|
[redacted]*
|
ARTICLE F.3.2. |
REPORTING REQUIREMENTS
|
A. |
Annual Progress Report
|
B. |
Draft Final Report and Final Report
|
D. |
FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.
|
a) |
Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to the COR. The Contractor shall forward the final minutes when available.
|
b) |
Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to the COR. The Contractor shall forward the final minutes when available and if applicable.
|
c) |
The Contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to the COR as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.
|
d) |
The Contractor shall provide the COR the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide the COR with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.
|
e) |
The Contractor shall forward Standard Operating Procedures (SOPs) upon request from the COR.
|
f) |
The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.
|
g) |
The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The redactions shall be limited to issues that are unrelated to the subcontractor’s performance on any award made under this RFP. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.
|
E. |
Other Requirements/Deliverables
|
a) |
Integrated Master Project Plan
|
1. |
Technology Packages
|
2. |
Experimental Protocols
|
3. |
Annual/Final Invention Report
|
4. |
Publications
|
5. |
Press Releases
|
6. |
Security Report
|
7. |
Security Plan
|
8. |
Quality Management System Plan
|
9. |
Manufacturing Plan
|
ARTICLE F.3.3.
|
DELIVERABLE SCHEDULE
|
Item
No.
|
Description
|
Addresses
|
Deliverable Schedule
|
||||
1
|
Bi-Weekly Meetings and Meeting Minutes
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Meeting minutes are due no later than five business days following each meeting.
|
||||
2
|
Monthly Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 15th of each month following the end of each reporting period.
|
||||
3
|
Annual Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due on or before the 30th calendar day following the end of each reporting period.
|
||||
4
|
Draft Final Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due 45 Calendar days prior to the expiration date of the contract.
|
||||
5
|
Final Progress Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due no later than 30 calendar days after the expiration date of the contract.
|
||||
6
|
FDA/ Regulatory Agency Correspondence and Meeting Summaries
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR.
|
||||
7
|
Integrated Master Project Plan -Critical Path Milestones - Work Breakdown Structure - Risk Mitigation Plan/Matrix
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Report is due within 90 days of contract award. Updates are due as requested by the COR.
|
||||
8
|
Technology Packages
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Upon request from the COR.
|
||||
9
|
Experimental Protocols
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Upon request from the COR.
|
||||
10
|
Annual/Final Invention Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
An Annual Invention Report is due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract.
|
||||
11
|
Publications
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due within 30 calendar days for manuscripts and 15 calendar days for abstracts.
|
||||
12
|
Press Releases
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports/Notices are due for approval to the CO not less than five (5) business days prior to the issuance of any potential press release.
|
||||
13
|
Security Report
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Reports are due within 24 hours after occurrence of an activity or incident.
|
||||
14
|
Security Plan
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Final plan due within 30 days of contract award.
|
||||
15
|
Manufacturing Plan
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Due within 60 days of contract award.
|
||||
16
|
Delivery Schedule
|
CO: (1) electronic copy
COR: (1) electronic copy
|
Due within 30 days of contract award
|
||||
ARTICLE F.4. |
FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
|
ARTICLE G.1. |
CONTRACTING OFFICER
|
ARTICLE G.2 |
CONTRACTING OFFICER'S REPRESENTATIVE (COR)
|
a. |
Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
|
b. |
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;
|
c. |
Performing technical evaluation as required;
|
d. |
Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract;
|
e. |
Assisting in the resolution of technical problems encountered during performance;
|
f. |
The Government may unilaterally change its COR designation(s).
|
ARTICLE G.3. |
KEY CONTRACTOR’S POINTS OF CONTACT
|
ARTICLE G.4. |
KEY PERSONNEL
|
Name
|
Title
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
ARTICLE G.5. |
INVOICE SUBMISSION
|
(a) |
The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract.
|
(b) |
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3.
|
(c) |
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.
|
(d) |
The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost.
|
(e) |
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed below in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
|
(f) |
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment.
|
(g) |
The Contractor may not invoice for any CLIN prior to delivery and acceptance of services.
|
(h) |
Invoices shall submit invoices electronically to the Contracting Officer (CO), the Contracting Specialist (CS), the Contracting Officer’s Representative (COR), PSC (PSC_Invoices@psc.hhs.gov, and e-Room electronically. Unless otherwise specified by the Contracting Officer, all deliverables, invoices, and reports furnished to the Government under the resultant contract shall be addressed as follows:
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
[redacted]*
|
ARTICLE G.6. |
INDIRECT COST RATES
|
ARTICLE G.7. |
PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DECEMBER 2013)
|
(a) |
Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
|
(b) |
The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
|
(c) |
Include the substance of this clause; include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.
|
ARTICLE G.8. |
REIMBURSEMENT OF COST
|
ARTICLE G.9. |
CONTRACT COMMUNICATIONS/CORRESPONDENCE
|
ARTICLE G.10.
|
POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
|
(a) |
Purpose: In accordance with FAR Subpart 42.15, the Contractor’s performance will be periodically evaluated by the government in order to provide current information for current and future source selection purposes. These evaluations will therefore be marked “Source Selection Information.”
|
(b) |
Performance Evaluation Period: The Contractor’s performance will be evaluated at least annually.
|
(c) |
Evaluators: The performance evaluation will be completed jointly by the Contracting Officer’s Representative and the Contracting Officer.
|
(d) |
Performance Evaluation Factors: The Contractor's performance will be evaluated in accordance with FAR Subpart 42.15 and Attachment #5, Contract Performance Evaluation Report. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared Annually as to coincide with the Anniversary date of the contract.
|
(e) |
Contractor Review: A copy of the evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.
|
(f) |
Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, Contractor's response, and review comments, if any, will be retained as part of the evaluation.
|
(g) |
Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than Government personnel and the Contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the Contractor being evaluated, as well as impede the efficiency of Government operations.
|
(h) |
Source Selection Information: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.
|
(i) |
Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of contract performance for the purpose of providing source selection information for future contract awards.
|
(j) |
Electronic Access to Contractor Performance Evaluations: Contractors may access evaluations through a secure website for review and comment at the following: http://cpars.gov
|
ARTICLE G.11.
|
GOVERNMENT PROPERTY
|
(a) |
In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:
|
(b) |
Notwithstanding the provisions outlined in the HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated in this contract in paragraph 1 above, the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.
|
ARTICLE H.1. |
PROTECTION OF HUMAN SUBJECTS
|
(a) |
Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
|
(b) |
The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in accordance with the protocol(s) approved by either the IRB or IEC. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.
|
(c) |
Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).
|
(d) |
If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved Human Subject Assurances.
|
ARTICLE H.2. |
CLINICAL RESEARCH
|
ARTICLE H.2.1.
|
Safety and Monitoring Issues
|
1. |
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
2. |
All changes in informed consent documents, identified by version number, date, or both and dates it is valid.
|
3. |
Termination or temporary suspension of patient accrual.
|
4. |
Termination or temporary suspension of the protocol.
|
5. |
Any change in IRB approval.
|
6. |
Any other problems or issues that could affect the participants in the studies.
|
ARTICLE H.2.2.
|
Data and Safety Monitoring Requirements
|
1. |
Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.
|
2. |
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.
|
3. |
Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) for Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB.
|
H.2.3. |
BARDA Protocol Review Process Before Patient Enrollment Begins
|
1. |
IRB or IEC approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria;
|
2. |
Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name;
|
3. |
IRB or IEC approved informed consent document, identified by version number, date, or both and date it is valid;
|
4. |
Plans for the management of side effects;
|
5. |
Procedures for assessing and reporting adverse events;
|
6. |
Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory;
|
7. |
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.
|
ARTICLE H.2.4.
|
Required Time-Sensitive Notification
|
1. |
Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative within 24 hours of FDA notification.
|
2. |
Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification.
|
3. |
IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification.
|
4. |
Expedited safety reports – shall be sent to the COR concurrently with the report to FDA.
|
5. |
Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR annually.
|
ARTICLE H.3. |
HUMAN MATERIALS
|
ARTICLE H.4. |
NEEDLE EXCHANGE
|
ARTICLE H.5. |
ACKNOWLEDGEMENT OF FEDERAL FUNDING
|
ARTICLE H.6. |
RESTRICTIONS ON ABORTIONS
|
ARTICLE H.7. |
GUN CONTROL
|
ARTICLE H.8. |
CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
|
ARTICLE H.9. |
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
|
ARTICLE H.10. |
CARE OF LIVE VERTEBRATE ANIMALS
|
ARTICLE H.11.
|
ANIMAL WELFARE
|
ARTICLE H.12.
|
PAPERWORK REDUCTION ACT
|
(a) |
This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer's Representative shall be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.
|
(b) |
The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.
|
ARTICLE H.13.
|
RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS
|
ARTICLE H.14.
|
CERTIFICATION OF FILING AND PAYMENT OF TAXES
|
ARTICLE H.15.
|
SUBCONTRACTING PROVISIONS
|
(a) |
Small Business Subcontracting Plan
|
1. |
The Small Business Subcontracting Plan, dated [redacted]* is attached hereto and made a part of this contract.
|
2. |
The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."
|
(b) |
Subcontracting Reports
|
1. |
Individual Subcontract Reports (ISR)
|
· |
[redacted]*
|
· |
[redacted]*
|
· |
[redacted]*
|
2.
|
Summary Subcontract Report (SSR)
|
· |
[redacted]*
|
ARTICLE H.16.
|
ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE
|
a. |
Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.
|
b. |
Accordingly, any Contractor responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.
|
c. |
The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.
|
ARTICLE H.17.
|
CONFIDENTIALITY OF INFORMATION
|
a. |
Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
|
b. |
The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.
|
c. |
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
|
d. |
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
|
e. |
Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
|
f. |
Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.
|
g. |
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
|
ARTICLE H.18.
|
INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS
|
a. |
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:
|
1. |
With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
|
2. |
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest; or
|
3. |
Intellectual property rights and interests, upon receipt of income related to such rights and interest.
|
4. |
Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and
|
5. |
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
|
b. |
Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.
|
c. |
Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research.
|
d. |
Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's spouse and dependent children) no later than the date of submission of the Institution's proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.
|
e. |
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator's significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research.
|
f. |
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).
|
g. |
Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).
|
h. |
Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.
|
i. |
Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
|
j. |
Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors titled "Certification of Institutional Policy on Financial Conflicts of Interest".
|
ARTICLE H.19.
|
PUBLICATION AND PUBLICITY
|
ARTICLE H.20.
|
REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE
|
ARTICLE H.21.
|
PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
|
ARTICLE H.22.
|
ACCESS TO DOCUMENTATION/DATA
|
ARTICLE H.23.
|
IDENTIFICATION AND DISPOSITION OF DATA
|
ARTICLE H.24.
|
DISSEMINATION OF INFORMATION
|
ARTICLE H.25.
|
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
|
ARTICLE H.26.
|
PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM ASPR FUNDED RESEARCH
|
ARTICLE H.27.
|
Public Health Service Act
|
ARTICLE H.28.
|
CONFLICT OF INTEREST
|
ARTICLE H.29.
|
IN-PROCESS REVIEW
|
ARTICLE H.30.
|
PRIVACY ACT APPLICABILITY
|
1) |
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html
|
2) |
The Project Officer/COR is hereby designated as the official who is responsible for monitoring Contractor compliance with the Privacy Act.
|
3) |
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm
|
ARTICLE H.31.
|
BARDA AUDITS
|
· |
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.
|
· |
COR and CO will review the report and provide a response to the Contractor within 10 business days.
|
· |
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
ARTICLE H.32.
|
SECURITY REPORTING REQUIREMENT
|
Reg
|
Clause
|
Date
|
Clause Title
|
||
FAR
|
52.202-1
|
Nov 2013
|
Definitions
|
||
FAR
|
52.203-3
|
Apr 1984
|
Gratuities
|
||
FAR
|
52.203-5
|
May 2014
|
Covenant Against Contingent Fees
|
||
FAR
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the Government
|
||
FAR
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
||
FAR
|
52.203-8
|
May 2014
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
|
||
FAR
|
52.203-10
|
May 2014
|
Price or Fee Adjustment for Illegal or Improper Activity
|
||
FAR
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions
|
||
FAR
|
52.203-13
|
Oct 2015
|
Contractor Code of Business Ethics and Conduct
|
||
FAR
|
52.203-14
|
Oct 2015
|
Display of Hotline Poster(s)
|
||
FAR
|
52.203-17
|
Apr 2014
|
Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights
|
||
FAR
|
52.203-18
|
Jan 2017
|
Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation.
|
||
FAR
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
|
||
FAR
|
52.204-7
|
Oct 2016
|
System for Award Management
|
||
FAR
|
52.204-10
|
Oct 2016
|
Reporting Executive Compensation and First-Tier Subcontract Awards
|
||
FAR
|
52.204-13
|
Oct 2016
|
System for Award Management Maintenance
|
||
FAR
|
52.209-6
|
Oct 2015
|
Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
|
||
FAR
|
52.209-9
|
Jul 2013
|
Updates of Publicly Available Information Regarding Responsibility Matters
|
||
FAR
|
52.209-10
|
Nov 2015
|
Prohibition on Contracting with Inverted Domestic Corporations
|
||
FAR
|
52.210-1
|
Apr 2011
|
Market Research
|
||
FAR
|
52.211-11
|
Sept 2000
|
Liquidated Damages—Supplies, Services, or Research and Development (Sept 2000)
|
||
FAR
|
52.215-2
|
Oct 2010
|
Audit and Records – Negotiation
|
||
FAR
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
||
FAR
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Cost or Pricing Data
|
||
FAR
|
52.215-11
|
Aug 2011
|
Price Reduction for Defective Certified Cost or Pricing Data—Modifications.
|
||
FAR
|
52.215-12
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data
|
||
FAR
|
52.215-13
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data—Modifications
|
||
FAR
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions
|
||
FAR
|
52.215-18
|
Jul 2005
|
Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions
|
||
FAR
|
52.215-19
|
Oct 1997
|
Notification of Ownership Changes
|
Reg
|
Clause
|
Date
|
Clause Title
|
||
FAR
|
52.215-21
|
Oct 2010
|
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications
|
||
FAR
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
||
FAR
|
52.216-7
|
Jun 2013
|
Allowable Cost and Payment
|
||
FAR
|
52.216-8
|
Jun 2011
|
Fixed Fee
|
||
FAR
|
52.219-8
|
Nov 2016
|
Utilization of Small Business Concerns
|
||
FAR
|
52.219-9
|
Jan 2017
|
Small Business Subcontracting Plan
|
||
FAR
|
52.219-16
|
Jan 1999
|
Liquidated Damages - Subcontracting Plan
|
||
FAR
|
52.219-28
|
July 2013
|
Post-Award Small Business Program Representation
|
||
FAR
|
52.222-1
|
Feb 1997
|
Notice to the Government of Labor Disputes
|
||
FAR
|
52.222-2
|
July 1990
|
Payment for Overtime Premiums
|
||
FAR
|
52.222-3
|
Jun2003
|
Convict Labor
|
||
FAR
|
52.222-21
|
Apr 2015
|
Prohibition of Segregated Facilities
|
||
FAR
|
52.222-26
|
Sept 2016
|
Equal Opportunity
|
||
FAR
|
52.222-29
|
Apr 2015
|
Notification of Visa Denial.
|
||
FAR
|
52.222-35
|
Oct 2015
|
Equal Opportunity for Veterans
|
||
FAR
|
52.222-36
|
Jul 2014
|
Equal Opportunity for Workers with Disabilities
|
||
FAR
|
52.222-37
|
Feb 2016
|
Employment Reports on Veterans
|
||
FAR
|
52.222-38
|
Feb 2016
|
Compliance with Veterans’ Employment Reporting Requirements
|
||
FAR
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act
|
||
FAR
|
52.222-43
|
May 2014
|
Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts)
|
||
FAR
|
52.222-50
|
Mar 2015
|
Combating Trafficking in Persons
|
||
FAR
|
52.222-54
|
Oct 2015
|
Employment Eligibility Verification
|
||
FAR
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
||
FAR
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policy to Ban Text Messaging While Driving
|
||
FAR
|
52.224-1
|
April 1984
|
Privacy Act Notification
|
||
FAR
|
52.224-2
|
April 1984
|
Privacy Act
|
||
FAR
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
||
FAR
|
52.225-25
|
Oct 2015
|
Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications
|
||
FAR
|
52.226-1
|
Jun 2000
|
Utilization of Indian Organizations and Indian-Owned Economic Enterprises.
|
||
FAR
|
52.227-1
|
Dec 2007
|
Authorization and Consent, Alternate 1 (APR 1984)
|
||
FAR
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
||
FAR
|
52.227-3
|
Apr 1984
|
Patent Indemnity
|
||
FAR
|
52.227-11
|
May 2014
|
Patent Rights – Ownership by the Contractor
|
||
FAR
|
52.227-14
|
May 2014
|
Rights in Data - General
|
||
FAR
|
52.227-14
|
Dec 2007
|
Rights in Data - General, Alternate 2
|
||
FAR
|
52.227-16
|
June 1987
|
Additional Data Requirements
|
||
FAR
|
52.228-7
|
Mar 1996
|
Insurance – Liability to Third Persons
|
||
FAR
|
52.229-3
|
Feb 2013
|
Federal, State and Local Taxes
|
||
FAR
|
52.230-2
|
Oct 2015
|
Cost Accounting Standards
|
||
FAR
|
52.230-6
|
June 2010
|
Administration of Cost Accounting Standards
|
||
FAR
|
52.232-1
|
Apr 1984
|
Payments
|
||
FAR
|
52.232-2
|
Apr 1984
|
Payments under Fixed-Price Research and Development Contracts
|
||
FAR
|
52.232-8
|
Feb 2002
|
Discounts for Prompt Payment
|
Reg
|
Clause
|
Date
|
Clause Title
|
||
FAR
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
||
FAR
|
52.232-11
|
Apr 1984
|
Extras
|
||
FAR
|
52.232-17
|
May 2014
|
Interest
|
||
FAR
|
52.232-18
|
Apr 1984
|
Availability of Funds
|
||
FAR
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
||
FAR
|
52.232-22
|
Apr 1984
|
Limitation of Funds
|
||
FAR
|
52.232-23
|
May 2014
|
Assignment of Claims
|
||
FAR
|
52.232-25
|
Jan 2017
|
Prompt Payment
|
||
FAR
|
52.232-33
|
Jul 2013
|
Payment by Electronic Funds Transfer--System for Award Management
|
||
FAR
|
52.232-40
|
Dec 2013
|
Providing Accelerated Payments to Small Business Subcontractors
|
||
FAR
|
52.233-1
|
May 2014
|
Disputes
|
||
FAR
|
52.233-3
|
Aug 1996
|
Protest After Award
|
||
FAR
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
||
FAR
|
52.242-1
|
Apr 1984
|
Notice of Intent to Disallow Costs
|
||
FAR
|
52.242-3
|
May 2014
|
Penalties for Unallowable Costs
|
||
FAR
|
52.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
||
FAR
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
||
FAR
|
52.243-1
|
Aug 1987
|
Changes - Fixed-Price Alternate V (Apr 1984).
|
||
FAR
|
52.243-2
|
Aug 1987
|
Changes—Cost-Reimbursement Alternate V (Apr 1984).
|
||
FAR
|
52.243-6
|
Apr 1984
|
Change Order Accounting.
|
||
FAR
|
52.243-7
|
Jan 2017
|
Notification of Changes
|
||
FAR
|
52.244-2
|
Oct 2010
|
Subcontracts, Alternate 1 (Jun 2007)
|
||
FAR
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting
|
||
FAR
|
52.244-6
|
Nov 2017
|
Subcontracts for Commercial Items
|
||
FAR
|
52.245-1
|
Jan 2017
|
Government Property
|
||
FAR
|
52.245-9
|
Apr 2012
|
Use and Charges
|
||
FAR
|
52.246-23
|
Feb 1997
|
Limitation of Liability.
|
||
FAR
|
52.246-25
|
Feb 1997
|
Limitation of Liability—Services
|
||
FAR
|
52.248-1
|
Oct 2010
|
Value Engineering
|
||
FAR
|
52.249-2
|
Apr 2012
|
Termination for the Convenience of the Government (Fixed-Price)
|
||
FAR
|
52.249-6
|
May 2004
|
Termination (Cost-Reimbursement)
|
||
FAR
|
52.249-8
|
Apr 1984
|
Default (Fixed-Price Supply and Service)
|
||
FAR
|
52.249-9
|
Apr 1984
|
Default (Fixed-Price Research and Development)
|
||
FAR
|
52.249-14
|
Apr 1984
|
Excusable Delays
|
||
FAR
|
52.253-1
|
Jan 1991
|
Computer Generated Forms
|
ARTICLE I.2. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR Chapter 3) CLAUSES
|
HHSAR
|
352.203-70
|
Dec 2015
|
Anti-Lobbying
|
||
HHSAR
|
352.211.2
|
Dec 2015
|
Conference Sponsorship Requests and Conference Materials Disclaimer
|
||
HHSAR
|
352.215-70
|
Dec 2015
|
Late Proposals and Revisions
|
||
HHSAR
|
352.216-70
|
Dec 2015
|
Additional Cost Principles
|
||
HHSAR
|
352.222-70
|
Dec 2015
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
HHSAR
|
352.223-70
|
Dec 2015
|
Safety and Health
|
||
HHSAR
|
352.224-70
|
Dec 2015
|
Privacy Act
|
||
HHSAR
|
352.224-71
|
Dec 2015
|
Confidential Information
|
||
HHSAR
|
352.227-70
|
Dec 2015
|
Publications and Publicity
|
||
HHSAR
|
352.233-71
|
Dec 2015
|
Litigation and Claims
|
||
HHSAR
|
352.270-5a
|
Dec 2015
|
Notice of Contractors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals
|
||
HHSAR
|
352.270-6
|
Dec 2015
|
Restriction on use of Human Subjects
|
ARTICLE I.3. |
ADDITIONAL CONTRACT CLAUSES
|
ARTICLE I.3.1.
|
Additional HHS Acquisition Regulation (HHSAR) Clauses – In Full Text
|
(a) |
The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated
|
(b) |
For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary” have the same meaning and are collectively referred to as “direct salary” in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs).
|
(c) |
The salary rate limitation also applies to individuals under subcontracts.
|
(d) |
If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.
|
(e) |
See the salaries and wages pay tables on the U.S. Office of Personnel Management website for federal Executive Schedule salary levels.
|
ARTICLE I.3.2.
|
Additional Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses – In Full Text
|
(a) |
The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.
|
(b) |
If the Government exercises this option, the extended contract shall be considered to include this option clause.
|
(c) |
The total duration of this contract, including the exercise of any options under this clause, shall not exceed ten years
|
1. |
Statement of Objectives, dated [redacted]*, 5 pages
|
2. |
Statement of Work, dated [redacted]*, 2 pages
|
3. |
Invoice Instructions for Cost-Reimbursement Type Contracts
|
4. |
Invoice Instructions for Fixed-Priced Type Contracts
|
5. |
Sample Invoice Form
|
6. |
Form SF-LLL, Disclosure of Lobbying Activities, 2 pages
|
7. |
Protection of Human Subjects, 2 pages
|
8. |
Small Business Subcontracting Plan, dated [redacted]*
|
1. |
The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
|
2. |
Animal Welfare Assurance Numbers (Prime and Subcontractors).
|
3. |
Human Subjects Assurance Identification Numbers (Prime and Subcontractors).
|
C.1. |
STATEMENT OF OBJECTIVES
|
C.2. |
REPORTING REQUIREMENTS
|
C.3. |
MEETINGS/SITE VISITS
|
Appendix D
|
Overall Page 93 of 167
|
(a) |
Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract performance period.
|
(b) |
Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.
|
(c) |
Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).
|
(a) |
Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(b) |
Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).
|
(c) |
Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.
|
(d) |
Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.
|
(e) |
Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).
|
(f) |
Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.
|
(g) |
Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.
|
(h) |
Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.
|
(i) |
Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three- way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(j) |
Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(k) |
Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(l) |
Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
|
(m) |
Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(n) |
Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(o) |
Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.
|
(1) |
Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.
|
(2) |
Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.
|
(3) |
Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without pre-authorization from the CO.
|
(4) |
Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.
|
(5) |
Premium Pay: List remuneration in excess of the basic hourly rate.
|
(6) |
Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
|
(7) |
Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
|
(8) |
Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.).
|
(9) |
Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.
|
(p) |
Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable.
|
(q) |
Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
|
(r) |
Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.
|
(s) |
Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.
|
(t) |
Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
|
(u) |
Grand Totals
|
(v) |
Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:
|
Company Name
|
|||
Designated Billing Office Name and Address:
|
Invoice/Finance Number:
|
||
DHHS/OS/ASPR/AMCG
|
Date Invoice Prepared:
|
||
Attn: Contracting Officer
|
|||
200 C St., S.W.
|
Contract No.
|
||
Washington, D.C. 20201
|
Effective Date:
|
||
Contractor’s Address and Contact Information:
|
Total Estimated Cost of Order:
|
||
Office of Acquisitions:
|
|||
Contracting Officer (insert name here)
|
|||
Office of Acquisitions Management, Contracts, and Grants (AMCG)
|
|||
POC: Name of accountant or COO or signatory authority for invoice
|
|||
Title:
|
|||
Phone:
|
Central Point of Distribution:
|
||
E-Mail:
|
|||
TIN:
|
|||
DUNS #:
|
|||
This invoice represents reimbursable costs for the period from
|
Amount Billed
|
||||||
Expenditure Category
|
Current
|
Cumulative
|
Contract Value
|
|||
Direct Costs:
|
||||||
Direct Labor
|
||||||
Fringe Benefits
|
0.00% | |||||
Total Labor Costs:
|
||||||
Overhead 0.00%
|
||||||
Travel
|
||||||
Subcontracts
|
||||||
Consultant Fees
|
||||||
Materials and Supplies
|
||||||
Other
|
||||||
Total Direct Costs
|
||||||
G&A Rate
|
0.00% | |||||
Subtotal:
|
||||||
Fixed Fee
|
0.0% | |||||
Total Amount Claimed
|
||||||
Adjustments
|
||||||
Grand Total
|
$ -
|
I certify that all payments requested are for appropriate purposes and in accordance with the contract.
|
||
Name/signature of signatory authority for invoicing
|
Appendix M
|
Overall Page 550 of 551
|
Appendix L
|
Overall Page 547 of 551
|
Appendix I
|
Overall Page 432 of 551
|
· |
Development activities for the IV formulation of TPOXX (IV TPOXX).
|
· |
Delivery to the Strategic National Stockpile (SNS) of a limited number of courses (approximately 35,700 courses) of the oral formulation of TPOXX (oral TPOXX) for an approximate value of $11 million; such courses being readily-available for delivery or will be manufactured using currently-held active pharmaceutical ingredient.
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Delivery of bulk drug substance to be used for the manufacture of IV TPOXX and the use of such bulk drug substance to manufacture 20,000 courses of final drug product of IV TPOXX, with such activities having a total value of $8 million for 7-day (14-vial) courses; additionally, SIGA will be paid for the storage, if applicable, and delivery of final drug product of IV TPOXX.
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Series of options to procure up to approximately 1,452,300 courses in total of oral TPOXX (exclusive of the courses to be purchased for base period activities), with such options having a total value of up to approximately $450 million.
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Series of options to procure up to 192,000 courses in total (exclusive of the courses to be purchased for base period activities) of final drug product of IV TPOXX, with such options having a cumulative total value of up to approximately $77 million for the combination of bulk drug substance and final drug product manufacturing; or alternatively, to procure up to 192,000 equivalent courses in total (exclusive of the equivalent courses to be purchased for base period activities) of bulk drug substance that could be used in the future for the manufacture of final drug product of IV TPOXX, with such alternative having a value of up to approximately $31 million.
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Series of options for vendor-managed storage of either bulk drug substance that would be used in the manufacture of the IV TPOXX or final drug product of IV TPOXX (total option value of approximately $6 million).
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Separate options to cumulatively provide up to approximately $44 million of funding for post-marketing activities for oral TPOXX and IV TPOXX.
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