Exhibit 10.1

 

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Double asterisks denote omissions.  

OMB Approval 2700-0042

 

  1. CONTRACT ID CODE PAGE OF PAGES AMENDMENT OF SOLICITATION/MODIFICATION OF
CONTRACT   1 12 2.  AMENDMENT/MODIFICATION NO. 3.  EFFECTIVE DATE
4.  REQUISITION/PURCHASE REQ. NO. 5.  PROJECT NO. (If applicable)    Eleven (11)
See Block 16C. 3503015 N/A 6.  ISSUED BY CODE   

7. ADMINISTERED BY (If other than Item 6)

 

CODE N/A

Office of Acquisitions, DEA 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

6700-B Rockledge Drive 

Room 3214, MSC 7612 

Bethesda, MD 20892-7612 

TIB, BSP, AIDS

 

8.  NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) (4)
9A.  AMENDMENT OF SOLICITATION NO.

Argos Therapeutics, Inc. VIN # 1109171 

4233 Technology Drive 

Durham, NC 27704

      9B.  DATED (SEE ITEM 11)     X 10A.  MODIFICATION OF CONTRACT/ORDER NO.  
HHSN266200600019C   10B.  DATED (SEE ITEM 13) CODE FACILITY CODE   September 30,
2006 11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

[_] The above numbered solicitation is amended as set forth in Item 14. The hour
and date specified for receipt of Offers [_] is extended, [_] is not extended. 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods: 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and data specified.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If required)

SOC 25.55

 

CAN# 4-8470035

 

 

Amount: $505,050

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, 

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. 

(4) 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. X
FAR 52.243-2, Changes – Cost Reimbursement, Alternate V   B. THE ABOVE NUMBERED
CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as
changes in paying office, appropriation date, etc.) SET  

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       2      copies to the issuing office.

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

 

PURPOSE:  To:  1) issue and fund a change order, in the total amount of
$505,050; 2) extend the term of the contract from September 30, 2015 to July 31,
2016; 3) revise Articles B.2., B.4., B.5, C.1, C.2., F.1., F.3., G.1., G.3.,
G.7., H.25., I.1., I.3., and I.4.; 3) incorporate Articles B.3, H.28., H.29.,
and H.30.; and 4) revise Section J – List of Attachments, as reflected on pages
1-12.

 

[exh101.jpg]

Total Funds Currently Obligated Total Estimated Cost Cost Fee Total Cost Fee
Total Prior to this Mod$37,925,232.91$ 1,395,099$ 39,320,331.91$37,925,232.91$
1,395,099$ 39,320,331.91 This Mod #10$ 505,050.00$ 0$ 505,050.00$ 505,050.00$ 0$
505,050.00 Revised Total$38,430,282.91$ 1,395,099$ 39,825,381.91$38,430,282.91$
1,395,099$ 39,825,381.91TOTAL FUNDED AMOUNT: $39,825,381.91 (CHANGED) TOTAL
CONTRACT AMOUNT: $39,825,381.91 (CHANGED)CONTRACT FUNDED THROUGH: July 31, 2016
(CHANGED) CONTRACT EXPIRATION DATE: July 31, 2016 (CHANGED)

 

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) Jeffrey Abbey, President and CEO

John R. Manouelian, Contracting Officer

Office of Acquisitions, DEA, NIAID, NIH, DHHS

15B.  CONTRACTOR/OFFEROR 15C.  DATE SIGNED

16B. UNITED STATES OF AMERICA

16C.  DATE SIGNED

/s/ Jeffrey Abbey________________

(Signature of person authorized to sign)

 

9-17-14

BY /s/ John R. Manouelian                      

(Signature of Contracting Officer)

 

9-18-2014                                      

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105

Computer Generated

STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

 

 

 

BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE
CONTRACTOR MUTUALLY AGREE AS FOLLOWS:

 

The Government is requesting that the Contractor incorporate an additional study
under Option 1 of the contract, in which Argos Therapeutics, Inc. will add up to
10 HIV-infected pediatric patients (who are perinatally infected and that
initiated ART therapy at or within 3 months of birth) under the current phase
IIB clinical study of the experimental autologous therapeutic vaccine approach.
These patients are classified as “acute” and characterized by: (1) healthy CD4+
T cell counts; (2) continuous plasma viral load suppression below the limit of
detection with standard clinical assays; (3) undetectable integrated HIV DNA in
circulating CD4+ T cells; and (4) the absence of anti-HIV immunity. The goal of
the project is to immunize HIV-infected pediatric patients with repeated dosing
of AGS-004, an autologous viral RNA-loaded dendritic cell-based immunotherapy to
achieve long-term remission after cessation of ART drug therapy. AGS-004 is the
test article currently being studied under the contract. The rationale is that
perinatally HIV-infected youth with controlled HIV replication on cART from
early infancy are ideal candidates to assess therapeutic strategies due to: (1)
limited HIV reservoirs; (2) limited viral diversity; (3) preserved immune
function; (4) little to no residual virus producing cells; and (5) absent
HIV-specific immunity. Additionaly, success could mitigate the effects of
medication fatigue and toxicities associated with long-term ART in this patient
population.

 

The Change Order is being issued pursuant to this modification and under the
authority of FAR Part 52.243-2, Changes – Cost Reimbursement, Alternate V. As
stated above, the additional work is within the existing scope of the contract.
Further, the addition of these subjects will not exceed the total number of
subjects originally proposed in the Statement of Work. However, the cost of the
additional work is at a level that would make it difficult to cover within the
existing negotiated amount of Option 1 (Option 1 is currently fully funded at
$[**]). Pursuant to FAR Part 52.243-2, the Government and the Contractor have
negotiated an equitable adjustment associated with the increased costs resulting
from the change order, and this modification will also fully fund the equitable
adjustment. No further equitable adjustment will be considered, following
execution of this modification.

 

ARTICLE B.2. ESTIMATED COST - OPTION, paragraphs a., c. and d. are hereby
revised to reflect the funding of the change order under Option 1 and the
revised period of performance under Option 1, which shall read as follows:

 

a.The estimated cost of this contract is increased by $505,050, from
$37,925,232.91 to $38,430,282.91.

 

c.The total estimated amount of the contract, represented by the sum of the
estimated cost plus the fixed fee, is increased by $505,050, from $39,320,331.91
to $39,825,381.91.

 

d.If the Government exercises its options pursuant to the OPTION PROVISION
Article in SECTION H of this contract, the Government’s total estimated contract
amount, represented by the sum of the estimated cost plus fixed fee, will be
increased as follows:

 

  Period of Performance Estimated Cost Fixed Fee Estimated CPFF Base

09/30/2006-

06/30/2010

[**] [**] [**] Option 1 – Autologous Vaccine and Clinical Trial
07/01/2010-07/31/2016  [**] [**] [**] Total Base Plus Option 1   $38,430,282.91
$1,395,099 $39,825,381.91

 

2

 

ARTICLE B.3. ESTIMATED COST – COST SHARING, is hereby incorporated and shall
read as follows:

 

ARTICLE B.3. ESTIMATED COST – COST SHARING

 

This is a cost-sharing contract. The total estimated cost of performing the work
under this contract is $39,825,381.91 For further provisions regarding the
specific cost-sharing arrangement, see the ADVANCE UNDERSTANDINGS Article in
SECTION B of the Contract.

 

ARTICLE B.3., PROVISIONS APPLICABLE TO DIRECT COSTS, is hereby renumbered as
ARTICLE B.4.

 

ARTICLE B.4., PROVISIONS APPLICABLE TO DIRECT COSTS, paragraph b., is revised to
reflect the revised period of performance under Option 1, which shall read as
follows:

 

b. Travel Costs

 

1. Domestic Travel

 

Total expenditures for domestic travel (transportation, lodging, subsistence,
and incidental expenses) incurred in direct performance of this contract shall
not exceed the total amount $[**], during the Base Period (9/30/2006 –
6/30/2010) without the prior written approval of the Contracting Officer.

 

If the Government exercises its Options pursuant to the OPTION PROVISION Article
in SECTION H of this contract, the Government’s total estimated amount for
domestic travel shall not exceed the amounts indicated below:

 

  Period of Performance Total Cost Not to Exceed Option 1 07/01/2010-07/31/2016
[**] Total Base Plus Option 1   [**]

 

ARTICLE B.4., ADVANCE UNDERSTANDINGS, is hereby renumbered as ARTICLE B.5.

 

ARTICLE B.5. ADVANCE UNDERSTANDINGS, is hereby revised to: 1) revise paragraph
c., to reflect the revised period of performance under Option 1; and 2)
incorporate paragraph i., which shall read as follows:

 

c. Consultants

 

(1) Consultant fees to be paid to the members of the External Advisory Board are
authorized as indicated below:

 

Option Period of Performance

Total Cost,

Excluding Travel,

Not to Exceed

Base 09/30/2006-06/30/2010 [**] Option 1 07/01/2010-07/31/2016 [**] Total Base
Plus Option   [**]

 

3

 

(2) Consultant fees to be paid to [**] are authorized as indicated below:

 

Option Period of Performance

Total Cost,

Excluding Travel,

Not to Exceed

Base 09/30/2006-06/30/2010 [**] Option 1 07/01/2010-07/31/2016 [**] Total Base
Plus Option   [**]

 

(3) Consultant fees to be paid to [**] Medical Services are authorized as
indicated below:

 

Option Period of Performance

Total Cost,

Excluding Travel,

Not to Exceed

Base 09/30/2006-06/30/2010 [**] Option 1 07/01/2010-07/31/2016 [**] Total Base
Period plus Option   [**]

 

i. Cost Sharing

 

1.This is a cost-sharing contract. Monies shall be provided for the total cost
of performance from the National Institutes of Health, National Institute of
Allergy and Infectious Diseases (NIAID) and Argos Therapeutics, Inc..

 

2.The Government shall provide monies in amounts not to exceed those listed
under Government’s Share, during the Base and Option 1, in the table below. The
contractor’s share is estimated at the amount(s) listed under Contractor’s
Share, during the Base and Option 1, in the table below. The table below
provides a breakout of cost sharing under the contract, during the Base and
Option 1, as follows:

 

Option Period of Performance Total Cost, Government’s Share Contractor’s Share
Base 09/30/2006-06/30/2010 [**] [**] [**] Option 1 07/01/2010-07/31/2016 [**]
[**] [**] Total Base Period plus Option   $40,334,480.91 $39,825,381.91
$509,099.00

 

3.The Contractor shall maintain records of all contract costs (including costs
claimed by the Contractor as being its share) and such records shall be subject
to the Audit and Records-Negotiation and Final Decisions on Audit Findings
clauses of the General Clauses.

 

4.Costs contributed by the Contractor shall not be charged to the Government
under any other contract, grant, or cooperative agreement (including allocation
to other grants, contracts, or cooperative agreements as part of an independent
research and development program). The Contractor shall report the
organization’s share of the costs expended by category, on the Invoice/Financing
Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement
Type Contracts, NIH (RC)-4, as referred in the Invoice Submission/Contract
Financial Request and Contract Financial Report Article in SECTION G of this
contract.

 

4

 

ARTICLE C.1. STATEMENT OF WORK, is hereby revised and shall read as follows:

 

a. 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 15, 2014, set forth in Section J, List of
Attachments, attached hereto and made a part of this contract.

 

ARTICLE C.2. REPORTING REQUIREMENTS, paragraph a., item 11., is hereby revised
to reflect the new mailing address for the Contracting Officer’s
Representative’s (COR). In addition, paragraph b. Other Reports/Deliverables is
being incorporated and includes paragraph 1. Reporting of Financial Conflict of
Interest (FCOI). The above revisions and incorporations shall read as follows:

 

a. Technical Reports

 

11. Addressees:

 

DAIDS COR: Targeted Interventions Branch, Bsic Sciences Program, Division of
AIDS 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health, DHHS 

5601 Fishers Lane, Room 9G56 – MSC 9830 

Bethesda, Maryland 20892-9830

 

b. Other Reports/Deliverables

 

1.Reporting of Financial Conflict of Interest (FCOI)

 

All reports and documentation required by 45 CFR Part 94, Responsible
Prospective Contractors including, but not limited to, the New FCOI Report,
Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be
submitted to the Contracting Officer in Electronic format. Thereafter, reports
shall be due in accordance with the regulatory compliance requirements in 45 CFR
Part 94.

 

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-

 

idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.
See Part 94.5, Management and reporting of financial conflicts of interest for
complete information on reporting requirements.

 

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING
INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this
contract.)

 

ARTICLE F.1. DELIVERIES, paragraph b., is hereby revised to reflect the COR’s
new address, which shall read as follows:

 

b. The above items shall be addressed and delivered to:

 

Addressee Deliverable Item Quantity

Contracting Officer’s Representative 

Targeted Interventions Branch, Bsic Sciences Program, Division of AIDS 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health, DHHS 

5601 Fishers Lane, Room 9G56 – MSC 9830 

Bethesda, Maryland 20892-9830Email:conleyto@niaid.nih.gov 

Information Security Plan 

Goals and Milestones Achievement Report 

Deliverables for Project 1 through 5 

Clinical Trials Protocol(s) 

Annual Technical Report 

Annual Site Visit Review and Report 

Final Technical Report 

-- 

1 Copy* 

1 Copy* 

1 Copy* 

1 Copy* 

1 Copy* 

1 Copy* 

1 Copy* 

 

5

 

* Plus one copy on 3.5 inch, high density computer diskette or other digital
medium approved by the COR.

 

ARTICLE F.3. OPTION PERIODS, is hereby revised to reflect the revised period of
performance under Option 1, and shall read as follows:

 

If the Government exercises its options pursuant to the OPTIONS PROVISION
Article in SECTION H of this contract, the completion date of the contract will
be extended as follows:

 

Option Period of Performance Base 09/30/2006-06/30/2010 Option 1
07/01/2010-07/31/2016

 

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR), is hereby revised to
update the mailing address and telephone number, which shall read as follows:

 

Anthony J. Conley, Ph.D. 

Targeted Interventions Branch, Bsic Sciences Program, Division of AIDS 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health, DHHS 

5601 Fishers Lane, Room 9G56 – MSC 9830 

Bethesda, Maryland 20892-9830 

Telephone: (240) 627-3208 

Email: conleyto@niaid.nih.gov

 

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT, is hereby revised to read as follows:

 

a.Invoice Submission/Contract Financing Request and Contract Financial
Reporting, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts are attached and
made part of this contract. The Contractor shall follow the attached
instructions and submission procedures specified below to meet the requirements
of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

 

1.Payment requests shall be submitted to the offices identified below.  Do not
submit supporting documentation (e.g., receipts, time sheets, vendor invoices,
etc.) with your payment request unless specified elsewhere in the contract or
requested by the Contracting Officer.

 

                                        a.    The original invoice shall be
submitted to the following designated billing office:

 

National Institutes of Health
Office of Financial Management
Commercial Accounts
2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500

 

6

 

                                        b.    One copy of the invoice shall be
submitted to the following approving official:

 

Contracting Officer
Office of Acquisitions, Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH, DHHS
6700B Rockledge Drive, Room 3214 MSC 7612
Bethesda, Maryland 20892-7612
If using overnight delivery, use 20817

 

E-mail: NIAIDOAInvoices@niaid.nih.gov

 

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 above 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. [Note: The original payment request must still be
submitted in hard copy and mailed to the designated billing office to meet the
requirements of a “proper invoice.”]

 

2.In addition to the requirements specified in FAR 32.905 for a proper invoice,
the Contractor shall include the following information on the face page of all
payment requests:

 

a.Name of the Office of Acquisitions. The Office of Acquisitions for this
contract is National Institute of Allergy and Infectious Diseases (NIAID).

 

b.Federal Taxpayer Identification Number (TIN).  If the Contractor does not have
a valid TIN, it shall identify the Vendor Identification Number (VIN) on the
payment request.  The VIN is the number that appears after the Contractor’s name
on the face page of the contract.  [Note:  A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include
the VIN number.]   If the Contractor has neither a TIN, DUNS, or VIN, contact
the Contracting Officer.

 

c.DUNS or DUNS+4 Number.  The DUNS number must identify the Contractor’s name
and address exactly as stated in the contract and as registered in the Central
Contractor Registration (CCR) database.  If the Contractor does not have a valid
DUNS number, it shall identify the Vendor Identification Number (VIN) on the
payment request.  The VIN is the number that appears after the Contractor’s name
on the face page of the contract.  [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include
the VIN number.]   If the Contractor has neither a TIN, DUNS, or VIN, contact
the Contracting Officer. 

 

d.Invoice Matching Option.  This contract requires a two-way match. 

 

e.Unique Invoice Number.  Each payment request must be identified by a unique
invoice number, which can only be used one time regardless of the number of
contracts or orders held by an organization.

 

f.The Contract title must be identified on the face page of the invoice. The
Contract Title is: “HIV Vaccine Design and Development Teams (HVDDT)”.

 

g.Payments shall be made from the following PRISM/NBS Line Item Numbers. The
table below sets forth the specific line item numbers to be designated on
invoices.

 

7

 

Line Item No. Option Description Line Item Period of Performance Funded Amount
8. Option 1 July 1, 2010 – July 31, 2016 $5,415,284 9. Option 1 July 1, 2010 –
July 31, 2016 $505,050

NOTE: When additional funding is provided by exercise of an Option, new line
item numbers, including the line item descriptions, line item periods of
performance, and funded amounts will be added to the above table in a subsequent
modification.

 

b.Inquiries regarding payment of invoices shall be directed to the designated
billing office,
(301) 496-6452.

 

c.The Contractor shall include the following certification on every invoice for
reimbursable costs incurred with The Contractor shall include the following
certification on every invoice for reimbursable costs incurred with Fiscal Year
funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of
this contract. For billing purposes, certified invoices are required for the
billing period during which the applicable Fiscal Year funds were initially
charged through the final billing period utilizing the applicable Fiscal Year
funds:

 

“I hereby certify that the salaries charged in this invoice are in compliance
with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above
referenced contract.”

 

ARTICLE G.7. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,
52.232-40 (December 2013), is hereby incorporated under the contract and shall
read as follows:

 

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 H.25. OPTION PROVISION, is hereby revised to read as follows:

 

Unless the Government exercises its option pursuant to the Option Clauses set
forth in SECTION I., the contract will consist only of the Base Period of the
Statement of Work as defined in Sections C and F of the contract. Pursuant to
FAR 52.217-7, Option for Increased Quantity – Separately Priced Line Item, set
forth in SECTION I. of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform additional options set forth in
the Statement of Work and also defined in Sections C and F of the contract. If
the Government exercises this option, notice must be given at least 60 days
prior to the expiration date of this contract, and the estimated cost plus fixed
fee of the contract will be increased as set forth in the ESTIMATED COST OPTION
Article in SECTION B of this contract.

 

ARTICLE H.28. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS, is hereby
incorporated under the contract and shall read as follows:

 

The Contractor shall not use contract funds to maintain or establish a computer
network unless such network blocks the viewing, downloading, and exchanging of
pornography.

 

8

 

ARTICLE H.29. GUN CONTROL, is hereby incorporated under the contract and shall
read as follows:

 

The Contractor shall not use contract funds in whole or in part, to advocate or
promote gun control.

 

ARTICLE H.30. CERTIFICATION OF FILING AND PAYMENT OF TAXES, is hereby
incorporated under the contract and shall read as follows:

 

The Contractor must be in compliance with Section 518 of the Consolidated
Appropriations Act of FY 2014.

 

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT, is hereby revised to update the general clauses as follows:

 

This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically as follows: FAR Clauses

 

at: http://www.acquisition.gov/far/. HHSAR Clauses 

at: http://www.hhs.gov/policies/hhsar/subpart352.html .

 

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

FAR
CLAUSE NO. DATE TITLE 52.202-1 Nov 2013 Definitions (Over the Simplified
Acquisition Threshold) 52.203-3 Apr 1984 Gratuities (Over the Simplified
Acquisition Threshold) 52.203-5 May 2014 Covenant Against Contingent Fees (Over
the Simplified Acquisition Threshold) 52.203-6 Sep 2006 Restrictions on
Subcontractor Sales to the Government (Over the Simplified Acquisition
Threshold) 52.203-7 May 2014 Anti-Kickback Procedures (Over the Simplified
Acquisition Threshold) 52.203-8 May 2014 Cancellation, Rescission, and Recovery
of Funds for Illegal or Improper Activity (Over the Simplified Acquisition
Threshold) 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper
Activity (Over the Simplified Acquisition Threshold) 52.203-12 Oct 2010
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)
52.203-17 Apr 2014 Contractor Employee Whistleblower Rights and Requirements to
Inform Employees of Whistleblower Rights (Over the Simplified Acquisition
Threshold) 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer
Fiber Content Paper(Over the Simplified Acquisition Threshold) 52.204-10
Jul 2013 Reporting Executive Compensation and First-Tier Subcontract Awards
($25,000 or more) 52.204-13 Jul 2013 System for Award Management Maintenance
52.209-6 Aug 2013 Protecting the Government’s Interest When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
52.215-2 Oct 2010 Audit and Records - Negotiation [Note: Applies to ALL
contracts funded in whole or in part with Recovery Act funds, regardless of
dollar value, AND contracts over the Simplified Acquisition Threshold funded
exclusively with non-Recovery Act funds.]

9

 

FAR
CLAUSE NO. DATE TITLE

52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format 52.215-10
Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data (Over
$700,000) 52.215-12 Oct 2010 Subcontractor Cost or Pricing Data (Over $700,000)
52.215-14 Oct 2010 Integrity of Unit Prices (Over the Simplified Acquisition
Threshold) 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over
$700,000) 52.215-18 Jul 2005 Reversion or Adjustment of Plans for
Post-Retirement Benefits (PRB) other than Pensions 52.215-19 Oct 1997
Notification of Ownership Changes 52.215-21 Oct 2010 Requirements for Certified
Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -
Modifications 52.215-23 Oct 2009 Limitations on Pass-Through Charges (Over the
Simplified Acquisition Threshold) 52.216-7 Jun 2013 Allowable Cost and Payment
52.216-8 Jun 2011 Fixed Fee 52.219-8 May 2014 Utilization of Small Business
Concerns (Over the Simplified Acquisition Threshold) 52.219-9 Jul 2013 Small
Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5
million for Construction) 52.222-2 Jul 1990 Payment for Overtime Premium (Over
the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a)
of this clause is $0 unless otherwise specified in the contract.) 52.222-3
Jun 2003 Convict Labor 52.222-21 Feb 1999 Prohibition of Segregated Facilities
52.222-26 Mar 2007 Equal Opportunity 52.222-35 Jul 2014 Equal Opportunity for
Veterans ($100,000 or more) 52.222-36 Jul 2014 Equal Opportunity for Workers
with Disabilities 52.222-37 Jul 2014 Employment Reports on Veterans ($100,000 or
more) 52.222-40 Dec 2010 Notification of Employee Rights Under the National
Labor Relations Act (Over the Simplified Acquisition Threshold) 52.222-50
Feb 2009 Combating Trafficking in Persons 52.222-54 Aug 2013 Employment
Eligibility Verification (Over the Simplified Acquisition Threshold) 52.223-6
May 2001 Drug-Free Workplace 52.223-18 Aug 2011 Encouraging Contractor Policies
to Ban Text Messaging While Driving 52.225-1 May 2014 Buy American - Supplies
52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases 52.227-1 Dec 2007
Authorization and Consent, Alternate I (Apr 1984) 52.227-2 Dec 2007 Notice and
Assistance Regarding Patent and Copyright Infringement 52.227-11 May 2014 Patent
Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2),
paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i)
through (iv). The frequency of reporting in (i) is annual. 52.227-14 May 2014
Rights in Data - General 52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 May 2014 Interest (Over the Simplified Acquisition Threshold)
52.232-20 Apr 1984 Limitation of Cost 52.232-23 May 2014 Assignment of Claims

10

 

FAR
CLAUSE NO. DATE TITLE

52.232-25 Jul 2013 Prompt Payment, Alternate I (Feb 2002) 52.232-33 Jul 2013
Payment by Electronic Funds Transfer--System for Award Management 52.232-39
Jun 2013 Unenforceability of Unauthorized Obligations 52.233-1 May 2014 Disputes
52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985) 52.233-4 Oct 2004
Applicable Law for Breach of Contract Claim 52.242-1 Apr 1984 Notice of Intent
to Disallow Costs 52.242-3 May 2001 Penalties for Unallowable Costs (Over
$700,000) 52.242-4 Jan 1997 Certification of Final Indirect Costs 52.242-13
Jul 1995 Bankruptcy (Over the Simplified Acquisition Threshold) 52.243-2
Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984) 52.244-2 Oct 2010
Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June
2007) 52.244-5 Dec 1996 Competition in Subcontracting (Over the Simplified
Acquisition Threshold) 52.244-6 Jul 2014 Subcontracts for Commercial Items
52.245-1 Apr 2012 Government Property 52.245-9 Apr 2012 Use and Charges
52.246-23 Feb 1997 Limitation of Liability (Over the Simplified Acquisition
Threshold) 52.249-6 May 2004 Termination (Cost-Reimbursement) 52.249-14 Apr 1984
Excusable Delays 52.253-1 Jan 1991 Computer Generated Forms

 

b.DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR
CHAPTER 3) CLAUSES:

 

HHSAR

 

CLAUSE NO.

 

DATE TITLE 352.202-1 Jan 2006 Definitions - with Alternate paragraph (h) (Jan
2006) 352.203-70 Mar 2012 Anti-Lobbying 352.216-70 Jan 2006 Additional Cost
Principles 352.222-70 Jan 2010 Contractor Cooperation in Equal Employment
Opportunity Investigations 352.227-70 Jan 2006 Publications and Publicity
352.228-7 Dec 1991 Insurance - Liability to Third Persons 352.233-71 Jan 2006
Litigation and Claims 352.242-70 Jan 2006 Key Personnel 352.242-73 Jan 2006
Withholding of Contract Payments 352.242-74 Apr 1984 Final Decisions on Audit
Findings

 

ARTICLE I.3. Additional Contract Clauses, is hereby revised to incorporate item
(12) and shall read as follows:

 

Paragraph b, DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES, subparagraph 4, is hereby incorporated under the
contract to include HHSAR Clause 352.231-70, Salary Rate Limitation (August
2012) and shall read as follows:

 

12. FAR Clause 52.216-12, Cost-Sharing Contract – No Fee (April 1984). Alternate
I (April 1984) is not applicable to this contract.

 

11

 

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT, is hereby
revised to delete FAR Clause 52.219-28, Post-Award Small Business Program
Representation (this clause is now incorporated under Article I.3. Additional
Contract Clauses). In addition, this article is revised to incorporate FAR
Clause 52.209-9, Updates of Policy Available Information Regarding
Responsibility Matter (July 2013), and shall read as follows:

 

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

1.FAR Clause 52.209-9, Updates of Publicly Available Information Regarding
Responsibility Matters (July 2013)

 

As prescribed in 32.706-1(b), insert the following clause:

 

a.The Contractor shall update the information in the Federal Awardee Performance
and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the
life of the contract, by posting the required information in the System for
Award Management (SAM) database at http://www.acquisition.gov .

 

b.As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub.
L. 111-212), all information posted in FAPIIS on or after April 15, 2011, except
past performance reviews, will be publicly available. FAPIIS consists of two
segments--

 

1.The non-public segment, into which Government officials and the Contractor
post information, which can only be viewed by—

 

i.Government personnel and authorized users performing business on behalf of the
Government; or

 

ii.The Contractor, when viewing data on itself; and

 

2.The publicly-available segment, to which all data in the non-public segment of
FAPIIS is automatically transferred after a waiting period of 14 calendar days,
except for—

 

i.Past performance reviews required by subpart 42.15;

 

ii.Information that was entered prior to April 15, 2011; or

 

iii.Information that is withdrawn during the 14-calendar-day waiting period by
the Government official who posted it in accordance with paragraph (c)(1) of
this clause.

 

c.The Contractor will receive notification when the Government posts new
information to the Contractor’s record.

 

1.If the Contractor asserts in writing within 7 calendar days, to the Government
official who posted the information, that some of the information posted to the
non-public segment of FAPIIS is covered by a disclosure exemption under the
Freedom of Information Act, the Government official who posted the information
must within 7 calendar days remove the posting from FAPIIS and resolve the issue
in accordance with agency Freedom of Information procedures, prior to reposting
the releasable information. The contractor must cite 52.209-9 and request
removal within 7 calendar days of the posting to FAPIIS.

 

12

 

2.The Contractor will also have an opportunity to post comments regarding
information that has been posted by the Government. The comments will be
retained as long as the associated information is retained, i.e., for a total
period of 6 years. Contractor comments will remain a part of the record unless
the Contractor revises them.

 

3.As required by section 3010 of Pub. L. 111-212, all information posted in
FAPIIS on or after April 15, 2011, except past performance reviews, will be
publicly available.

 

d.Public requests for system information posted prior to April 15, 2011, will be
handled under Freedom of Information Act procedures, including, where
appropriate, procedures promulgated under E.O. 12600.

 

(End of clause)

 

PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J – LIST OF
ATTACHMENTS, is revised to replace Attachment 1 and 2 with the most current
version, which shall read as follows:

 

1.Statement of Work, September 2014, 17 pages.

 

2.Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (7/2013), 6 pages.

 

All other terms and conditions of the contract remain unchanged.

 

END OF MODIFICATION NO. 11 - CONTRACT NO. HHSN266200600019C

 

13

 

Final Statement of Work

 

related to

 

RFP-NIH-NIAID-DAIDS-BAA-06-19

 

HIV Vaccine Design and Development Teams (HVDDT)

 

PRINCIPAL INVESTIGATOR: [**]

 

Submitted to:

 

Eileen Webster-Cissel 

Chief, AIDS Research Contracts Branch 

Office of Acquisitions/DEA/NIAID 

6700-B Rockledge Dr., Rm 3108, MSC 7612 

Bethesda, MD 20892-7612

 

Submitted by:

 

Argos Therapeutics, Inc. 

4233 technology drive 

Durham, NC 27704

 

1

 

Statement Of Work

 

Independently, and not as an agent of the Government, the Contractor shall
furnish all necessary services, qualified professional, technical, and
administrative personnel, material, equipment and facilities, not otherwise
provided by the Government under the terms of this contract, as needed to
perform the tasks set forth below.

 

The goal of this Research Program is to design, develop, and clinically test an
autologous HIV immunotherapy capable of eliciting therapeutic immune responses
and which is comprised of autologous monocyte-derived dendritic cells modified
to express selected autologous HIV proteins representing a multiplicity of
patient-specific quasispecies. The Research Program described in this proposal
is divided into 5 Projects, an Administrative Core and a pre-clinical RNA Core.
A schematic of the overall Research Program is depicted in Figure 1 below:

 

[**]

 

Figure 1. Schematic of the overall Research program. See text for details

 

Argos therapeutics has developed an autologous HIV immunotherapy. This product,
designated AGS-004, consists of [**].

 

.

 

Project 1:

 

Summary.

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of two pages were omitted. [**].

 

Project 1 deliverables:

 

[**].

 

Project 2:

 

Summary.

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of three pages were omitted. [**].

 

Project 2 deliverables:

 

[**]

 

Project 3:

 

Summary. Activities described in Project 3 will [**]

 

2

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of one page was omitted. [**].

 

Project 3 deliverables:

 

[**]

 

Project 4:

 

Summary. In order to [**]

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of one page was omitted. [**].

 

Project 4 deliverables:

 

[**]

 

Project 5:

 

Summary. Since the overall goal of this Contract is to identify improvements to
Argos’ RNA/DC HIV ‘base product’ (designated AGS-004),

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of one page was omitted. [**].

 

Project 5 deliverables.

 

[**]

 

3

 

·Timelines

 

[**]

 

Milestones

 

[**]

 

Contract Administration and Organizational Structure

 

The organizational structure for this Program centers upon the Administrative
Core. This Core provides a formal structure for oversight and planning of the
research and other activities, and provides for coordination among the research
projects and between research, research translation, and clinical activities.
Lines of accountability are clearly defined. This structure monitors scientific
progress, quality control and operational issues, and budgetary oversight. This
structure also provides a mechanism for sharing of information or resources with
investigators at other institutions. An organizational diagram appears below. In
this diagram, the direct reporting lines from Project and Core and Project
Directors to the PI denote scientific exchange, while the Administrative Core
itself provides a structure for assimilation of this information and
dissemination of findings among investigators.

 

[core.jpg]

 

The Administrative Core is designed to cover 3 functional areas:

 

1.Program administration - The Principle Investigator will administer over all
technical aspects of the Contract and assume responsibility for all reporting
requirements.

 

2.Fiscal administration - Oversight of all fiscal matters including invoice
tracking, financial reporting to NIAD, and periodic financial audits of
subcontractors.

 

4

 

3.General administration - Management of all documents associated with the
Contract, maintain current contact information, and coordinate NIAID site
visits, Executive Committee meetings, and External Advisory Board meetings.

 

Executive Committee. The Executive Committee will teleconference [**] with each
active performance site to coordinate activities, monitor progress, and to
discuss how to overcome problems that have been or may be encountered. Minutes
from these teleconferences will be distributed to all performance sites for the
purpose of sharing data and progress updates, soliciting feedback and
facilitating communication between the researchers.

 

External Advisory Board. Members of the External Advisory Board will be jointly
agreed upon by the Contractor and NIAID after award of the Contract. Members
should be experts in the relevant field(s) of research and not associated in any
way with the contracted work plan. The Contractor suggests that the Board should
consist of [**] members and has budgeted accordingly for estimated annual travel
and per diem consulting fees.

 

Reporting. The Principle Investigator assumes responsibility for all technical
and fiscal reporting requirements. The Administrative Core along with the
Executive Committee provides support for these activities.

 

Specifically, the Contractor shall furnish, from the office of the Principle
Investigator:

 

·An Information Security plan within [**] weeks of the Contract award

 

·Goals and Milestones Achievement Reports at NIAID’s request

 

·An annual Technical Report within [**] weeks of each annual anniversary

 

·An annual Site Visit Review Report within [**] weeks of each meeting

 

·A Final Technical Report no later than the completion date of the Contract

 

End of Statement of Work for Base Work

 

5

 

Option 1:

 

Statement of Work for Option 1 - see the following Attachments:

 

·Statement of Work − Attachment A (issued via a change order associated with
Contract Modification #6).

 

·Statement of Work − Attachment B (issued via a change order associated with
Contract Modification #11).

 

6

 

Attachment A

 

Change Order Associated with Modification #6

 

Modification of

 

Contract No. HHSN266200600019C

 

In Reference to:

RFP-NIH-NIAID-DAIDS-BAA-06-19

HIV Vaccine Design and Development Teams (HVDDT)

 

PRINCIPAL INVESTIGATOR: [**]

 

Submitted to:

 

Michelle Scala
Contracting Officer
Office of Acquisitions, DHHS/NIH/NIAID/DEA
ROOM 3106
6700-B Rockledge Drive,
Bethesda, MD 20892-7612

 

Submitted by:

 

Argos Therapeutics, Inc.
4233 Technology Drive
Durham, NC 27704

 

1

 

Statement of Work

 

This modification, herein referred to as Amendment 2 to study AGS-004-003, is
designed to test the clinical and immunologic effects of AGS-004 in subjects
that [**].

 

AGS-004-003 study Amendment 1, dated 05 May 2010 is being conducted to confirm
results from a previous uncontrolled open label study in subjects with a similar
study design. In the previous study, it was observed that [**]. AGS-004-003
Amendment 2 is focused on the [**].

 

Based on data from the previous study, it is possible that AGS-004 could
potentially [**]. The Specific Aims and Deliverables for this study amendment
are briefly described below:

 

Specific Aims of Amendment 2 to AGS-004-003:

 

·Specific aim 1: [**]

 

·Specific aim 2: [**].

 

Deliverables related to Amendment 2 to AGS-004-003:

 

[**]

 

2

 

Attachment B

Change Order Associated with Modification #11

 

Modification of

Contract No. HHSN266200600019C

In Reference to:

RFP-NIH-NIAID-DAIDS-BAA-06-19

HIV Vaccine Design and Development Teams (HVDDT)

PRINCIPAL INVESTIGATOR: [**]

Submitted to:

John Manouelian
Contracting Officer
Office of Acquisitions, DHHS/NIH/NIAID/DEA
ROOM 3151
6700-B Rockledge Drive,
Bethesda, MD 20892-7612

 

Submitted by:

 

Argos Therapeutics, Inc.
4233 Technology Drive
Durham, NC 27704

 

1

 

Statement of Work

 

Independently, and not as an agent of the Government, the Contractor is
furnishing all necessary services, qualified professional, technical, and
administrative personnel, material, equipment and facilities, not otherwise
provided by the Government under the terms of this contract, as needed to
perform the tasks set forth below.

 

This statement of work is an addendum to an existing Contract (No.
HHSN266200600019C) awarded through a previously issued RFP
(RFP-NIH-NIAID-DAIDS-BAA-06-19) entitled “HIV VACCINE DESIGN AND DEVELOPMENT
TEAMS (HVDDT). This Contract Modification (#11) comprises a total budget
increment of $505,050 to jointly fund with Argos (Argos will fund $509,099)
additional work and deliverables related to the conduct of a newly conceived
clinical study involving up to 10 HIV-infected pediatric patients. It is the
understanding of the Contractor that separate and additional funding will be
forthcoming to fund the clinical sites that will be involved in this work.

 

This project resulted from discussions with [**]. After numerous discussions
with Drs. [**], an in-person meeting was convened in Boston on March 3rd, 2014
to discuss the project in detail. A transcript of this meeting is attached as
Appendix 1.

 

Project Overview

 

Up to 10 HIV-infected pediatric patients who are adolescents perinatally
infected and that initiated ART therapy at or within 3 months of birth. These
patients are classified as ‘acute’ and characterized by (1) healthy CD4+ T cell
counts, (2) continuous plasma viral load suppression below the limit of
detection with standard clinical assays, (3) undetectable integrated HIV DNA in
circulating CD4+ T cells and (4) the absence of anti-HIV immunity. The goal of
the project is to immunize the patients with repeated dosing of AGS-004, an
autologous viral RNA-loaded dendritic cell-based immunotherapy to achieve
long-term remission after cessation of ART drug therapy. AGS-004 is the test
article being studied under the original Contract including Modifications #1-10.

 

Rationale

 

Perinatally HIV-infected youth with controlled HIV replication on cART from
early infancy are ideal candidates to assess therapeutic HIV vaccine strategies
due to:

 

·Limited HIV reservoirs

 

·Limited viral diversity

 

·Preserved immune function

 

·Little to no residual virus producing cells

 

·Absent HIV-specific immunity

 

Additionally, success could mitigate the effects of medication fatigue and
toxicities associated with long-term ART in this patient population.

 

2

 

Protocol Synopsis

NOTE: This protocol is tentative and subject to change based on additional input
from the Protocol Chairs, DAIDS (CSRC Reviewers), IMPAACT Network leadership,
Argos, Ethics Committee reviewers and Review Boards of participating
institutions.

 

Study Title: [**]

 

Sponsor: Argos Therapeutics, Inc. 4233 Technology Drive Durham, NC 27704-2173

 

Name of Investigational Product: AGS-004

 

Study Phase: 2B

 

Protocol Chairs: [**]

 

Study Centers: Study sites in North America, including [**]

 

Study Period: Up to [**] weeks in the treatment period; up to [**] weeks safety
follow-up.

 

Hypothesis: [**].

 

Primary Objective: The primary objective is to evaluate the [**].

 

Secondary Objective: The secondary objectives include [**].

 

Study Design: [**]

 

Methodology: This will be an [**].

 

Study Schema:[**]

 

 

Study Population: Up to 10 subjects will receive open-label AGS-004.

 

3

 

Diagnosis and Main Criteria for Inclusion

 

Subjects must meet the following criteria to be eligible for participation in
the study:

 

Inclusion Criteria:

 

[**].

 

Exclusion Criteria:

 

[**].

 

Test Product, Dose, and Mode of Administration:

 

AGS-004 consists of [**]

 

AGS-004 is provided in a [**].

 

Administration consists of [**].

 

Reference Therapy, Dose, and Mode of Administration:

 

All study participants are [**].

 

Duration of Treatment:

 

Recruitment Period: [**] 

Pre-Treatment Period: [**] 

Treatment Period: [**] 

Long-Term Safety Follow-Up: [**]

 

4

 

Criteria for Evaluation:

 

Primary Endpoints:

 

[**].

 

Secondary Endpoints:

 

[**]

 

Immunogenicity and Mechanism of Action:

 

[**].

 

Statistical Methods:

 

This study is [**].

 

Deliverables

·[**].

 

5

 

Appendix 1

 

Minutes: Pediatric HIV protocol discussions at CROI

Boston, March 3 2014

 

[argos.jpg]

 

Authors:
[**]

 

6

 

Attendees

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of one page was omitted. [**]

 

 

 

 

7

 

 

Introduction and background

Notes:

 

· First and last name initials are used to assign dialogue to individuals

 

· [**]

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of eight pages were omitted. [**]

 

Meeting adjourned.

 

8

 

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH
COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4

 

Format: Submit payment requests on the Contractor’s self-generated form in the
manner and format prescribed herein and as illustrated in the Sample
Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and
Services Other Than Personal, may be used in lieu of the Contractor’s
self-generated form provided it contains all of the information shown on the
Sample Invoice/Financing Request. DO NOT include a cover letter with the payment
request.

 

Number of Copies: Submit payment requests in the quantity specified in the
Invoice Submission Instructions in Section G of the Contract Schedule.

 

Frequency: Payment requests shall not be submitted more frequently than once
every two weeks in accordance with the Allowable Cost and Payment Clause
incorporated into this contract. Small business concerns may submit
invoices/financing requests more frequently than every two weeks.

 

Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.

 

Billing of Costs Incurred: : If billed costs include (1) costs of a prior
billing period, but not previously billed, or (2) costs incurred during the
contract period and claimed after the contract period has expired, the
Contractor shall cite the amount(s) and month(s) in which the costs were
incurred.

 

Contractor’s Fiscal Year: Prepare payment requests in such a manner that the
Government can identify costs claimed with the Contractor’s fiscal year.

 

Currency: All NIH contracts are expressed in United States dollars. When the
Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other
currency at amounts coincident with actual costs incurred. Currency fluctuations
may not be a basis of gain or loss to the Contractor. Notwithstanding the above,
the total of all invoices paid under this contract shall not exceed the United
States dollars authorized.

 

Costs Requiring Advance Approval: Costs requiring advance approval by the
Contracting Officer, which are not set forth in the Contract Schedule shall be
identified by the Contracting Officer’s Authorization (COA) Number as a separate
expenditure category on the payment request. In addition, the Contractor shall
show any cost limitation or ceiling set forth in the Contract Schedule, i.e. an
Advance Understanding, as a separate expenditure category on the payment
request.

 

Invoice/Financing Request Identification: Identify each payment as either:

 

(a)Interim Invoice/Contract Financing Request: These are interim payment
requests submitted during the contract performance period.

 

(b)Completion Invoice: Submit the completion invoice 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 all performance provisions have been completed.

 

1

 

(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).

 

Preparation and Itemization of the Invoice/Financing Request:

 

The Contractor shall furnish the information set forth in the instructions
below. The instructions are keyed to the entries on the Sample Invoice/Financing
Request. All information must be legible or the invoice will be considered
improper and returned to the Contractor.

 

(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, TIN, and DUNS or DUNS+4 Number:
Show the Contractor’s name and address exactly as they appear in the contract.
Any invoice identified as improper will be sent to this address. Also include
the name, title, phone number, and email address of the Point of Contact in case
of questions. If the remittance name differs from the legal business name, both
names must appear on the invoice. Provide the Contractor’s Federal Taxpayer
Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4
number. The DUNS number must identify the Contractor’s name and address exactly
as stated in the contract, and as registered in the System for Award Management
(SAM) database.

 

When an approved assignment of claims has been executed, the Contractor shall
provide the same information for the assignee as is required for the Contractor
(i.e., name, address, point of contact, TIN, and DUNS number), with the
remittance information clearly identified as such.

 

(c)Invoice/Financing Request Number: Identify each payment request by a unique
invoice number, which can only be used one time regardless of the number of
contracts or orders held by an organization. For example, if a contractor has
already submitted invoice number 05 on one of its contracts or orders, it cannot
use that same invoice number on any other contract or order. Payment requests
with duplicate invoice numbers will be considered improper and returned to the
contractor.

 

The NIH does not prescribe a particular numbering format but suggests using a
job or account number for each contract and order followed by a sequential
invoice number (example: 8675309-05). Invoice numbers are limited to 30
characters. There are no restrictions on the use of special characters, such as
colons, dashes, forward slashes, or parentheses.

 

If all or part of an invoice is suspended and the contractor chooses to reclaim
those costs on a supplemental invoice, the contractor may use the same unique
invoice number followed by an alpha character, such as “R” for revised (example:
8675309-05R).

 

(d)Date Invoice/Financing Request Prepared: Insert the date the payment request
is prepared.

 

2

 

(e)Contract Number and Order Number (if applicable): Insert the contract number
and order number (as applicable).

 

(f)Contract Title: Insert the contract title exactly as it appears on the cover
page of the contract and/or Section G of the Contract Schedule.

 

(g)Current Contract Period of Performance: Insert the contract start
date/effective date through the current completion date of the contract.

 

(h)Total Estimated Cost of Contract/Order: Insert the total estimated cost of
the contract, exclusive of fee. If billing under an order, insert the total
estimated cost of the order, exclusive of fee. For contracts/orders with options
or incremental funding provisions, enter the amount currently obligated and
available for payment.

 

(i)Total Fixed-Fee: Insert the total fixed-fee (where applicable). For
contracts/orders with options or incremental funding provisions, enter the
amount currently obligated and available for payment (where applicable). Note:
If the contract provides for another type of Fee, i.e. Award or Incentive Fee,
insert the amount available to be earned as identified in the contract and
indicate the type of fee to be billed on the payment request.

 

(j)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.

 

(k)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.

 

(l)Central Point of Distribution: Insert the Central Point of Distribution, as
identified in the Invoice Submission Instructions in Section G of the Contract
Schedule.

 

(m)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.

 

(n)Amount Billed - Current Period: Insert the amount claimed for the current
billing period by major cost element, including any adjustments and 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)Amount Billed - Cumulative: Insert the cumulative amounts claimed by major
cost element, including any adjustments and 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.

 

(p)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.

 

3

 

For Level of Effort contracts only, the Contractor shall provide the following
information on a separate sheet of paper attached to the payment request:

 

-hours or percentage of effort and cost by labor category (as specified in the
Level of Effort Article in Section F of the Contract Schedule) for the current
billing period, and

 

-hours or percentage of effort and cost by labor category from contract
inception through the current billing period. (NOTE: The Contracting Officer may
require the Contractor to provide additional breakdown for direct labor, such as
position title, employee name, and salary or hourly rate.)

 

2)Fringe Benefits: List any fringe benefits applicable to direct labor and
billed as a direct cost. Cite the rate(s) used to calculate fringe benefit
costs, if applicable.

 

3)Accountable Personal Property: Include permanent research equipment and
general purpose equipment having a unit acquisition cost of $1,000 or more, with
a life expectancy of more than two years, and sensitive property regardless of
cost (see the HHS Contractor’s Guide for Contract of Government Property). Show
permanent research equipment separate from general purpose equipment.

 

On a separate sheet of paper attached to the payment request, list each item for
which reimbursement is requested. Precede the item with an asterisk (*) if the
equipment is below the $1,000 approval level. Include reference to the following
(as applicable):

 

-item number for the specific piece of equipment listed in the Property
Schedule, and,

 

-Contracting Officer Authorization (COA) number, if the equipment is not covered
by the Property Schedule.

 

The Contracting Officer may require the Contractor to provide further
itemization of property having specific limitations set forth in the contract.

 

4)Materials and Supplies: Include equipment with unit costs of less than $1,000
or an expected service life of two years or less, and consumable material and
supplies regardless of amount.

 

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 the United States and its territories and possessions. However, for an
organization located outside 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.

 

4

 

9)Other: List all other direct costs in total unless exceeding $1,000 in amount.
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.

 

(q)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.

 

(r)Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate,
and amount billed for each indirect cost category.

 

(s)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. Note:
If the contract provides for another type of Fee, i.e. Award or Incentive Fee,
provide the same documentation for the amount claimed.

 

(t)Total Amounts Claimed: Insert the total amounts claimed for the current and
cumulative periods.

 

(u)Adjustments: Include amounts conceded by the Contractor, outstanding
suspensions, and/or disapprovals subject to appeal.

 

(v)Grand Totals

 

(w)Certification: The Contractor shall include the following certification at
the bottom of each payment request:

 

“Pursuant to authority vested in me, I certify that this voucher is correct and
proper for payment.”

 

Note: The contract may require additional certifications (See Invoice Submission
Instructions in Section G of the Contract Schedule)

 

The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim payment requests.

 

FINANCIAL REPORTING INSTRUCTIONS:

 

These instructions correspond to the Columns on the Sample Invoice/Financing
Request.

 

Column A - Expenditure Category: Enter the expenditure categories required by
the contract.

 

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated: Enter the
percentage of effort or number of hours agreed to for each employee or labor
category listed in Column A.

 

Column C - Cumulative Percentage of Effort/Hrs. - Actual: Enter the percentage
of effort or number of hours worked by each employee or labor category listed in
Column A.

 

Column D - Amount Billed - Current: Enter amounts billed during the current
period.

 

Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.

 

Column F - Cost at Completion: Enter data only when the Contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.

 

5

 

Column G - Contract Amount: Enter the costs agreed to for all expenditure
categories listed in Column A.

 

Column H - Variance (Over or Under): Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost Clause in
the contract.

 

Modifications: List all new modification(s) (not previously reported) in the
amount negotiated for an item in the appropriate cost category.

 

Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance and
will be explained along with those identified under H above.

 

 

6

 

 

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

(a) Designated Billing Office Name and Address: 

National Institutes of Health 

Office of Financial Management 

Commercial Accounts 

2115 East Jefferson Street, Room 4B432, MSC 8500 

Bethesda, MD 20892-8500

 

(b) Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4
Number: 

ABC CORPORATION 

100 Main Street 

Anywhere, U.S.A. Zip+4 

Name, Title, Phone Number, and E-mail Address of Contractor’s Point of Contact.
DUNS or DUNS+4: ________________ 

TIN: ____________________ 

(c) Invoice/Financing Request No.:____________

(d) Date Invoice/Financing Request Prepared:
_________________________________ 

(e) Contract No. and Order No. (if applicable):
________________________________ 

(f) Contract Title:
________________________________ 

(g) Current Contract Period of Performance:
________________________________ 

(h) Total Estimated Cost of Contract/Order:
________________________________ 

(i) Total Fixed Fee (if applicable): _____________

(j) Two-Way Match: ______________________
Three-Wav Match: _____________________

(k) Office of Acquisitions: __________________

(l) Central Point of Distribution: ______________ 

(m) This invoice/financing request represents reimbursable costs for the period
from _____ to ______.     Cumulative % of Efforts/Hrs Amount Billed      

Expenditure Catetory*

A

Neg.

B

Actual

C

(n) Current

D

(o) Cum

E

Cost at Comp

F

Contract Value

G

Variance

H

(p) Direct Costs:               (1) Direct Labor               (2) Fringe
Benefits __%               (3) Accountable Property               (4) Materials
& Supplies               (5) Premium Pay               (6) Consultant Fees      
        (7) Travel               (8) Subcontracts               (9) Other      
        Total Direct Costs               (q) Cost of Money __%               (r)
Indirect Costs __%               (s) Fixed Fee __%               (t) Total
Amount Claimed               (u) Adjustments               (v) Grand Totals    
          “Pursuant to authority vested in me, I certify that this voucher is
correct and proper for payment.”

____________________

(Name of Official)

 

___________________

(Title)

* Attach details as specified in the contract or requested by the Contracting
Officer

 

 

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