Document:

Contract No. HHSN266200600019C

 Exhibit 10.23 

 

			
	Argos Therapeutics, Inc.	 	Contract No. HHSN266200600019C

 Confidential Materials omitted and filed separately with the Securities and 

Exchange Commission. Asterisks denote omissions. 
 PART I - THE SCHEDULE 
 SECTION A - SOLICITATION/CONTRACT FORM 

 

													
	 	 	 1.     THIS CONTRACT IS A RATED
ORDER
	 	RATING	 	PAGE OF PAGES
	AWARD/CONTRACT	 	   UNDER DPAS (15 CFR 350)
	 	u	 	N/A	 	1	 	39
	 2.     CONTRACT
(Proc. Inst. blank) NO.
	 	 3.     EFFECTIVE DATE
	 	
4.     REQUISITION/PURCHASE REQUEST/PROJECT BO.

	  HHSN266200600019C
	 	09/30/2006	 	 	 		 		 		 	 
	 5.     ISSUED BY
CODE
	 	 	 	6. ADMINISTERED BY (If other than Item 6)         CODE	 	N/A	 	 
	  
  National Institutes of Health
  National Institutes of Allergy and
Infectious Diseases
  DEA, Contract Management Program

 6700-B Rockledge Dr., Room 3214, MSC 7612
  Bethesda, Maryland 20892-7612
	 		 		 	                  
  OMB Approval No. 2700-0042
	 	ADB NUMBER N01-AI-60019	 		 		 	 
	 	 RFP NIH-NIAID-06-19
  

 
  
	 		 		 		 	 

							
	
7.     NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and Zip Code)
	  	8. DELIVERY	  	 
	 	  		  	 ̈ FOB ORIGIN	  	  x OTHER (see below)
	 Argos Therapeutics, Inc.

4233 Technology Drive
 Durham, North Carolina 27704
	  		  	FOB Destination
	  	
9.     DISCOUNT FOR PROMPT PAYMENT

	  	N/A	  	 
	 		 	 
	 	  		  	10. SUBMIT INVOICES	  	ITEM
	 	  		  	OMB Approval 2700-0042
	CODE	  	FACILITY CODE	  	ADDRESS SHOWN IN	  	ARTICLE G.3

															
	 11.   SHIP TO MARK
FOR
	 	CODE	 	N/A	 	 12.   PAYMENT WILL BE MADE BY
	 	CODE	 	N/A	 	 
	 		 				 
	  SECTION D and SECTION F
	 		 	See ARTICLE G.3.	 		 		 		 	 
	 13.   AUTHORITY
FOR USING OTHER FULL AND OPEN COMPETITION
	 	
14.   ACCOUNTING AND APPROPRIATION DATA

	   ̈ 10 U.S.C. 2304(c)
(     )
	 	 ̈ 41 U.S.C. 253(c) (   )	 	EIN 1-56-211007-A1        SOCC
25.55        CAN     6-8467038     $[**]
	  15A. ITEM NO.
	 	        15B. SUPPLIES/SERVICES	 	15C. QUANTITY	 	15D. UNIT	 	15E. UNIT PRICE	 	15F. AMOUNT
	 Title: HIV Vaccine Design
and Development Teams (HVDDT)
 Period: September 30, 2006 through September 29, 2011

Principal Investigator: Charles Nicolette, Ph.D.
	 	 	 	 	 	FY 2006	 	 	 	[**]
	 	 	 	 	 	FY 2007	 	 	 	[**]
	 	 	 	 	 	FY 2008	 	 	 	[**]
	 	 	 	 	 	FY 2009	 	 	 	[**]
	 	 	 	 	 	FY 2010	 	 	 	[**]
	          
                                         
                                         
                                15G. TOTAL AMOUNT OF
CONTRACT                    u	 	 	 	$ 21,325,093

															
	16. TABLE OF
CONTENTS
	(ü)	 	SEC.	 	DESCRIPTION	 	PAGE(S)	 	(ü)	 	SEC.	 	DESCRIPTION	 	PAGE(S)
	PART I – THE SCHEDULE	 	PART II – CONTRACT CLAUSES
	x	 	A	 	SOLICITATION/CONTRACT FORM	 	1	 	x	 	I	 	CONTRACT CLAUSES	 	30
	x	 	B	 	SUPPLIES OR SERVICES AND PRICE/COST	 	4	 	    PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER
ATTACH.
	x	 	C	 	DESCRIPTION/SPECS/WORK STATEMENT	 	9	 	x	 	J	 	LIST OF ATTACHMENTS	 	38
	x	 	D	 	PACKAGING AND MARKING	 	14	 	PART IV – REPRESENTATIONS AND INSTRUCTIONS
	x	 	E	 	INSPECTION AND ACCEPTANCE	 	14	 	x	 	K	 	REPRESENTATIONS, CERTIFICATIONS	 	38
	x	 	F	 	DELIVERIES OR PERFORMANCE	 	14	 		 		 	AND OTHER STATEMENTS OF OFFERORS	 	 
	x	 	G	 	CONTRACT ADMINISTRATION DATA	 	16	 	 ̈	 	L	 	INSTRS., CONDS., AND NOTICES TO OFFERORS	 	 
	x	 	H	 	SPECIAL CONTRACT REQUIREMENTS	 	19	 	 ̈	 	M	 	EVALUATION FACTORS FOR AWARD	 	 

							
	CONTRACTING
OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
	17.     x
CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return 2 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.      ̈
AWARD (Contractor is not required to sign this document) Your offer on solicitation Number
                                         
                           , including the additions or changes made by you which additions or changes are set
forth 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 offer, and (b) this
award/contract. No further contractual document is necessary.
	19A.     NAME AND TITLE OF SIGNER (Type or
print)	  	20A.     NAME OF CONTRACTING OFFICER
	Jeff Abbey, Vice President Business Devel.	  	Eileen Webster-Cissel
	 	  		  	Contracting Officer, Office of Acquisitions, NIAID
	19B.    NAME OF CONTRACTOR	  	 19C. DATE
 SIGNED
	  	20B.    UNITED STATES OF AMERICA	  	20C. DATE SIGNED
	 	 	 	 
	            /s/ Jeff
Abbey                                       
                 	  	9/28/06	  	BY     /s/ Eileen Webster Cissel                	  	9/28/06
	            (Signature of
person authorized to sign)	  	 	  	                    (Signature of
Contracting Officer)	  	 

					
	NSN 7540-01-152-8069	 	26-107	 	STANDARD FORM 26 (REV 485)
	PREVIOUS EDITION UNUSUABLE	 	Computer Generated	 	Prescribed by GSA
		 		 	FAR (48 CFR) 53.214(a)

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 DETAILED TABLE OF CONTRACT CONTENTS 

 

							
	 PART I - THE SCHEDULE
	  	 	1	  
	 SECTION A - SOLICITATION/CONTRACT FORM
	  	 	1	  
	 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
	  	 	4	  
	 ARTICLE B.1
	  	BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	  	 	4	  
	 ARTICLE B.2
	  	ESTIMATED COST AND FIXED FEE	  	 	4	  
	 ARTICLE B.3
	  	PROVISIONS APPLICABLE TO DIRECT COSTS	  	 	5	  
	 ARTICLE B.4
	  	ADVANCE UNDERSTANDINGS	  	 	6	  
	 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
	  	 	9	  
	 ARTICLE C.1
	  	STATEMENT OF WORK	  	 	9	  
	 ARTICLE C.2
	  	REPORTING REQUIREMENTS	  	 	9	  
	 ARTICLE C.3
	  	INVENTION REPORTING REQUIREMENT	  	 	13	  
	 SECTION D - PACKAGING, MARKING AND SHIPPING
	  	 	14	  
	 SECTION E - INSPECTION AND ACCEPTANCE
	  	 	14	  
	 SECTION F - DELIVERIES OR PERFORMANCE
	  	 	14	  
	 ARTICLE F.1
	  	DELIVERIES	  	 	14	  
	 ARTICLE F.2
	  	CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)	  	 	15	  
	 SECTION G - CONTRACT ADMINISTRATION DATA
	  	 	16	  
	 ARTICLE G.1
	  	PROJECT OFFICER	  	 	16	  
	 ARTICLE G.2
	  	KEY PERSONNEL	  	 	16	  
	 ARTICLE G.3
	  	INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT	  	 	17	  
	 ARTICLE G.4
	  	INDIRECT COST RATES	  	 	18	  
	 ARTICLE G.5
	  	GOVERNMENT PROPERTY	  	 	18	  
	 ARTICLE G.6
	  	POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	  	 	19	  
	 SECTION H - SPECIAL CONTRACT REQUIREMENTS
	  	 	19	  
	 ARTICLE H.1.
	  	HUMAN SUBJECTS	  	 	19	  
	 ARTICLE H.2.
	  	REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS	  	 	20	  
	 ARTICLE H.3.
	  	DATA AND SAFETY MONITORING IN CLINICAL TRIALS	  	 	20	  
	 ARTICLE H.4.
	  	HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)	  	 	21	  
	 ARTICLE H.5.
	  	RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene Transfer Research)	  	 	21	  
	 ARTICLE H.6.
	  	CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH	  	 	22	  
	 ARTICLE H.7.
	  	NEEDLE EXCHANGE	  	 	22	  
	 ARTICLE H.8.
	  	PRIVACY ACT	  	 	23	  
	 ARTICLE H.9.
	  	OMB CLEARANCE	  	 	23	  
	 ARTICLE H.10.
	  	SALARY RATE LIMITATION LEGISLATION PROVISIONS	  	 	23	  
	 ARTICLE H.11.
	  	INFORMATION SECURITY	  	 	24	  
	 ARTICLE H.12.
	  	ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS	  	 	27	  
	 ARTICLE H.13.
	  	ENERGY STAR REQUIREMENTS	  	 	27	  

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

							
	 ARTICLE H.14.
	  	CONFIDENTIALITY OF INFORMATION	  	 	27	  
	 ARTICLE H.15.
	  	PUBLICATION AND PUBLICITY	  	 	28	  
	 ARTICLE H.16.
	  	PRESS RELEASES	  	 	28	  
	 ARTICLE H.17.
	  	REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	  	 	28	  
	 ARTICLE H.18.
	  	ANTI -LOBBYING	  	 	28	  
	 ARTICLE H.19.
	  	SHARING RESEARCH DATA	  	 	29	  
	 ARTICLE H.20.
	  	HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L	  	 	29	  
	 ARTICLE H.21.
	  	NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH	  	 	29	  
		
	 PART II - CONTRACT CLAUSES
	  	 	30	  
	 SECTION I - CONTRACT CLAUSES
	  	 	30	  
	 ARTICLE I.1.
	  	GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)	  	 	30	  
	 ARTICLE I.2.
	  	AUTHORIZED SUBSTITUTIONS OF CLAUSES	  	 	33	  
	 ARTICLE I.3.
	  	ADDITIONAL CONTRACT CLAUSES	  	 	33	  
	 ARTICLE I.4.
	  	ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT	  	 	34	  
		
	 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
	  	 	37	  
	 SECTION J - LIST OF ATTACHMENTS
	  	 	37	  
		
	 PART IV - REPRESENTATION AND CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS
	  	 	38	  
	 SECTION K - REPRESENTATIONS AND CERTIFICATIONS
	  	 	38	  

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS 

ARTICLE B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES 
 The goal of this contract is to design, develop and clinically test an autologous HIV vaccine capable of eliciting therapeutic immune responses which is comprised of autologous monocyte-derived dendritic
cells modified to express selected autologous HIV proteins representing a multiplicity of patient specific quasispecies. 
 ARTICLE B.2
ESTIMATED COST AND FIXED FEE 
  

	a.	The estimated cost of this contract is $19,929,994. 

  

	b.	The fixed fee for this contract is $1,395,099. The fixed feel shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE
referenced in the General Clause Listing in Part II, ARTICLE I.l, of this contract. The Contractor shall complete all work in accordance with the Statement of Work and the contract milestones set forth below. The distribution of the fixed fee shall
be paid in installments based on the Project Officer’s written certification regarding the completion of these milestones as follows: 

  

					
	  	 	MILESTONES	  	FIXED FEE
	1.	 	[**]	  	[**]
	2.	 	[**]	  	[**]
	3.	 	[**]	  	[**]
	4.	 	[**]	  	[**]
	5.	 	[**]	  	[**]
	6.	 	[**]	  	[**]
	7.	 	[**]	  	[**]
	8.	 	[**]	  	[**]
	9.	 	[**]	  	[**]
	10.	 	[**]	  	[**]
	11.	 	[**]	  	[**]
	12.	 	[**]	  	[**]
	13.	 	[**]	  	[**]
	14.	 	[**]	  	[**]
	15.	 	[**]	  	[**]
	16.	 	[**]	  	[**]
	17.	 	[**]	  	[**]
	  18.  	 	[**]	  	[**]

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

					
	  	  	MILESTONES	  	FIXED FEE
	19.	  	[**]	  	[**]
	  20.  	  	[**]	  	[**]

  

	c.	The Government’s obligation, represented by the sum of the estimated cost plus the fixed fee, is $21,325,093. 

 

	d.	Total funds currently available for payment and allotted to this contract are $[**], of which $[**] represents the estimated costs, and of which $[**] represents the
fixed fee. For further provisions on funding see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE 1.2., Authorized Substitutions of Clauses. 

  

	e.	It is estimated that the amount currently allotted will cover performance of the contract through September 29, 2007. 

 

	f.	The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor. Future increments to be allotted to this contract are
estimated as follows: 

  

							
	Period	  	Estimated Cost	  	Fixed Fee	  	Total CPFF
	 09/30/07-09/29/08
	  	[**]	  	[**]	  	[**]
	 091/30/08-09/29/09
	  	[**]	  	[**]	  	[**]
	 09/30/09-09/29/10
	  	[**]	  	[**]	  	[**]
	
09/30/10-09/29/11
	  	[**]	  	[**]	  	[**]

 ARTICLE B.3 PROVISIONS APPLICABLE TO DIRECT COSTS 

 

	a.	Items Unallowable Unless Otherwise Provided 

 Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or
activities shall be unallowable as direct costs: 
  

	 	(1)	Acquisition, by purchase or lease, of any interest in real property; 

  

	 	(2)	Special rearrangement or alteration of facilities; 

  

	 	(3)	Purchase or 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.); 

  

	 	(4)	Travel to attend general scientific meetings; 

  

	 	(5)	Consultant costs; 

  

	 	(6)	Subcontracts; 

  

	 	(7)	Patient care costs; 

  

	 	(8)	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 and listed in the Contractor’s Guide for Control of Government Property), regardless of acquisition value. 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	b.	Light Refreshment 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 project officer, with a copy to the contracting officer, at
least six (6) weeks in advance of the event. 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 refreshment and/or meal costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held somewhere
other than a government facility, provide an explanation of why the event is not being held at a government facility. Refer to NIH Manual Chapter 1160-1, Entertainment, for more information on NIH’s policy on the use of appropriated funds for
light refreshments and meals. 
  

	c.	Travel Costs 

  

	 	(1)	Domestic Travel 

  

	 	(a)	Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed
$138,650 without the prior written approval of the Contracting Officer. 

  

	 	(b)	The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46. 

ARTICLE B.4 ADVANCE UNDERSTANDINGS 

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further
authorization from the Contracting Officer. 
  

	a.	Fringe Benefits, Overhead, and G&A 

  

	  	The proposed rates of [**]% of direct salaries and wages for fringe benefits, [**]% of direct salaries and wages plus fringe benefits for Overhead and [**]% of total
direct costs excluding equipment and subcontract costs in excess of $25,000 per subcontract for G&A, are used for funding and billing purposes until such time that an indirect rate agreement is executed between Argos Therapeutics, Inc. and DFAS,
OAMP, NIH. Argos Therapeutics, Inc. will no longer be reimbursed indirect costs under the contract if it does not submit an adequate indirect cost proposal within the first 90 days of contract performance to DFAS, OAMP, NIH. Argos Therapeutics, Inc.
should immediately contact DFAS at 301-496-2444 to start the negotiation process. 

  

	b.	To negotiate a cost reimbursement type subcontract with [**] for an amount not to exceed $[**]. Award of the subcontract shall not proceed without the prior written
approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this contract. (After written approval of the subcontract by the Contracting Officer, a
copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	c.	To negotiate a cost reimbursement type subcontract with [**] for an amount not to exceed $[**] during the period September 30, 2006 through September 29,
2011. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this
contract. (After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	d.	To negotiate a cost reimbursement type subcontract with [**] for an amount not to exceed $[**] during the period September 30, 2006 through September 29,
2011. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this
contract. (After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	e.	To negotiate a cost reimbursement type subcontract with [**], for an amount not to exceed $[**] during the period September 30, 2006 through September 29,
2011. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this
contract. (After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	f.	To negotiate a cost reimbursement type subcontract with the [**] for an amount not to exceed $[**] during the period September 30, 2006 through September 29,
2011. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this
contract. (After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	g.	To negotiate a cost reimbursement type subcontract with [**] for an amount not to exceed $[**] during the period September 30, 2006 through September 29,
2011. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this
contract. (After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	h.	To negotiate a cost reimbursement type subcontract with [**] for an amount not to exceed $[**] during the period September 30,2006 through September 29, 2011.
Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this contract.
(After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.) 

 

	i.	Consultants 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	(1)	Consultant fees to be paid to the members of the External Advisory Board at a rate of $[**]/hour for [**] hours per year shall not exceed $[**] during the period
September 30, 2006 through September 29, 2011. 

  

	 	(2)	Consultant fees to be paid to [**] not exceed $[**] during the period September 30, 2006 through September 29, 2011. 

 

	j.	Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget 

 

	 	(1)	The contractor agrees to provide a detailed breakdown on invoices of the following cost categories: 

 

	 	(a)	Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed. 

 

	 	(b)	Fringe Benefits - Cite rate and amount 

  

	 	(c)	Overhead - Cite rate and amount 

  

	 	(d)	Materials & Supplies 

  

	 	(e)	Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting
travel, and foreign travel. 

  

	 	(f)	Consultants - Identify individuals and amounts. 

  

	 	(g)	Other Direct Costs - Include detailed breakdown when total amount is over $1,000. 

 

	 	(h)	Subcontracts - Identify by name and attach subcontractor invoice(s). 

  

	 	(i)	Equipment - Cite authorization and amount. 

  

	 	(j)	G&A - Cite rate and amount. 

  

	 	(k)	Total Cost 

 Monthly invoices
must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. 
  

	 	(2)	The contractor agrees to immediately notify the contracting officer in writing if there is an anticipated over run (any amount) or unexpended balance (greater than [**]
percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract. 

 

	k.	Confidential Treatment of Sensitive Information 

 The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. 

Disclosure of the information/data, in, whole or in part, by the Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. 

 

	l.	Audit of Production Facility 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 The Contractor will be audited at the Project Officer’s discretion for GMP, GLP,
and QC/A capabilities. If efficiencies are noted, they shall be corrected (or addressed) within [**] months after issuance of the audit report. 
  

	m.	Contract Number Designation 

 On all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows: 

Contract No. HHSN266200600019C 
 ADB Contract No. N01-AI-60019 
 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 ARTICLE C.1 STATEMENT OF WORK 
  

	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 5, 2006, set forth in SECTION J, List of Attachments, attached hereto and made a part of this contract. 

ARTICLE C.2 REPORTING REQUIREMENTS 
 All
reports required herein shall be submitted in electronic format. In addition, one (l) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified. 

 

	a.	Technical Reports 

 In
addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES ARTICLE in SECTION F of this contract: 

 

	 	1.	Within [**] weeks after contract award, the Contractor shall submit a contract-specific information security plan for review and approval by NIAID.

  

	 	2.	Goals and Milestones Achievement Reports. Management milestones, and their expected accomplishment dates, will be re-established yearly by discussion between the
DAIDS Project Officer and the PI of each HIV Vaccine Team to facilitate monitoring contract progress; these milestones will not be written into the Contract document. The Contractor shall submit Goals and Milestones Achievement Reports for these
milestones during the contract period as specified by consultation with the DAIDS Project Officer. For for-profit Contractors, since the payment of contract fee portions will be tied to the accomplishment of predetermined goals and milestones
specified in the Contract, the Contractor shall submit similar Goals and Milestones Achievement Reports for fee-attached milestones prior to invoicing for fee payments. The original hard copy of each milestone achievement report shall be submitted
to the NIAID Contracting Officer, and two (2) copies (one hard copy and a copy in a digital medium) to the DAIDS Project Officer. Each report must consist of: 

  
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	 	(a)	A cover page identifying the Contract, Contractor, addressee, date of submission, and milestone. 

 

	 	(b)	Two clearly marked sections: 

  

	 	•	 	 SECTION A - An introduction describing the goal or milestone in detail 

 

	 	•	 	 SECTION B - A complete description of the results. The description shall include pertinent data and/or figures in sufficient detail to explain any
significant results from analysis and scientific evaluation of data accumulated to date under the goal or milestone. When appropriate, this report should detail specific requests and approvals for the conduct of human trials.

  

	 	3.	Clinical Trial Protocols and Data for Contractors who elect to perform clinical studies independently rather than through an NIAID/DAIDS-supported clinical trials
network Clinical Trial Protocol(s). NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in NIAID-supported clinical trials. Therefore, as described in the NIAID Clinical Terms of
Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractors performing any clinical studies independently (i.e., not within a DAIDS-supported clinical trial network) with HIV Vaccine Team contract funds shall develop a protocol for
each clinical trial. Those HIV Vaccine Teams developing a therapeutic vaccine shall submit all protocols for review and approval by the NIAID Clinical Science Review Committee (CSRC). Protocols must include: (1) a description of the product;
(2) the results of preclinical (IND-enabling) toxicology studies; (3) a description of the trial design including definition of objectives, approaches, and procedures for implementation; (4) the plan for participant recruitment,
retention and follow-up; (5) the plan for data collection, quality control and management; (6) the data and safety monitoring plan; (7) the proposed approach to the analysis and interpretation of study data; (8) plans for
publication of results; and (9) a sample Informed Consent. Final approval of the protocol must take place prior to FDA IND submission and participant enrollment. [For trials to be conducted through DAIDS-sponsored Clinical Trial Networks, the
protocol must be developed in conjunction with the appropriate network and will be submitted by the network.]. 

  

	 	4.	DAIDS-Enterprise System (DAIDS-ES) Reporting. HIV Vaccine Teams Contractors who elect to perform clinical studies independently rather than through an
NIAID/DAIDS-supported clinical trials network will be required to provide clinical trials data through the DAIDS-ES as the appropriate components of the system become operational. Reporting of adverse events will be done through the DAIDS Expedited
Adverse Event Reporting System. Reporting on protocol development, registration, conduct, accrual, oversight, site monitoring, tracking and clinical trial closeout will be done through the DAIDS Protocol Management System. Details on interfacing
with these information management systems will be provided as the systems become operational. 

  

	 	5.	 Annual Technical Report. By the [**] working day of the twelfth month of each contract year, the Contractor shall submit an Annual Technical
Report as described below. The original hard copy shall be submitted to the NIAID 

  
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Contracting Officer, and two (2) copies (one hard copy and one copy in a digital medium) to the DAIDS Project Officer. The report should be factual and concise and consist of the following:

  

	 	(a)	A cover page identifying the Contract, Contractor, addressee, and date of submission 

 

	 	(b)	Four clearly marked 

  

	 	•	 	 Section A – An introduction covering the purpose and scope of the contract effort 

 

	 	•	 	 Section B – A description of overall progress plus a separate description for each task or other logical segment of work on which effort was
expended during the reporting period. The description shall include pertinent data and/or figures in sufficient detail to explain any significant results from analysis and scientific evaluation of data accumulated to date under the project. Special
emphasis shall be placed on goals or milestones that were reached, or problems that were encountered that prevented reaching a scheduled goal or milestone during the reporting period and how those problems were/will be addressed. In addition,
requests and approvals to conduct human trials, and Inclusion Enrollment Reports, when appropriate, shall be included. 

  

	 	•	 	 Section C – A summary of the proposed goals and milestones for the duration of the Contract, including any proposed revisions based on results
generated to date. For those goals and milestones expected to be completed during the next 12 months, provide a detailed description of the criteria to be used to define their accomplishment. 

 

	 	•	 	 Section D – Human Subject Enrollment Reports for non-NIAID network clinical studies or trials underway. To aid NIAID in fulfilling reporting
requirements, the Contractor must complete the Inclusion Enrollment Report showing cumulative accrual information for each active clinical study or clinical trial protocol. The format for the Inclusion Enrollment Report may be found at
http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf. 

  

	 	6.	Annual Site Visit Review Report. A report of the annual site visit review shall be prepared by the Contractor and submitted to the DAIDS Project Officer (in hard
copy and digital medium) and the NIAID Contracting Officer (original hard copy) within [**] weeks following the date of the site visit. This report shall include the slide presentations made at the review as well as summaries of all discussions
about modifying goals or milestones, and discussions ofapproaches to overcoming problems encountered. 

  

	 	7.	 Final Technical Report. The Contractor shall submit the Final Technical Report, two (2) copies (one hard copy and one copy in a digital
medium) to the DAIDS 

  
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Project Officer, and the original hard copy to the NIAID Contracting Officer by the completion date of the Contract. The report should consist of the following: 

(1) A cover page identifying the Contract, Contractor, addressee, and date of submission 

(2) An introduction covering the purpose and scope of the contract effort including a short summary of salient results achieved during the
performance of the contract 
 (3) A detailed summary of the results of the entire contract work for the complete performance
period including the specifications of the optimized AIDS vaccine product developed during the course of the contract. These specifications shall include: (l) the identity of the vaccine strain or strains in the final product, (2) a
detailed description of the manipulations used in the vaccine design, (3) a detailed description of all processes used to expand, attenuate, inactivate, or purify the final vaccine product, (4) a detailed description of any adjuvants or
other potentiating agents used in the delivery of the final optimized product, (5) a detailed description of the suggested immunization schedule to be used for optimal reactivity in humans, (6) evidence that the vaccine product can be
manufactured under GMP conditions for use in human vaccine trials, (7) a list of all patent filings that have resulted from this Contract, and (8) data from clinical trials using the vaccine. In addition, the Contractor shall indicate
whether INDs were filed in relation to vaccine products developed during the course of the Contract, and provide a description of the IND and the results of the filings. For Contractors with foreign subcontracts, this report shall include details
concerning approvals for manufacturing or testing that have been obtained for or by the foreign subcontractors. 
  

	 	8.	Report Distribution 

  

					
	Type of Report	  	No. of Copies	  	Due Date
	Information Security Plan	  	 Original – NAID CO
 1 hard copy/1 electronic copy – DAIDS PO
	  	Within [**] weeks of contract award.
	Goals and Milestones Achievement Reports	  	 Original – NIAID CO
 1 hard copy/1 electronic copy – DAIDS PO
	  	Specific dates will be negotiated with the DAIDS PO
	Annual Technical Report	  	 Original – NIAID CO
 1 hard copy/1 electronic copy – DAIDS PO
	  	Due on/before the [**] working day after the anniversary date of the Contract. Not due when
the Final Report is due.
	Annual Site Visit Review Report	  	 Original – NIAID CO
 1 hard copy/1 electronic copy – DAIDS PO
	  	Due within [**] weeks following the date of the meeting.
	Final Technical Report	  	 Original – NIAID CO

1 hard copy/1 electronic copy – DAIDS PO
	  	Due on/before the completion date of the
Contract.

  

	 	9.	 If the Contractor is unable to deliver the reports specified hereunder within the established due dates because of unforeseen difficulties,
notwithstanding the 

  
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exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons therefore. A
new delivery date must be established. 

  

	 	10.	Other Deliverables. Specific deliverables outlined in the Statement of Work for Projects 1 through 5, Clinical Trial Protocols, and DAIDS-Enterprise System
(DAIDS-ES) Reporting. 

  

	 	11.	Addressees: 

  

			
	 DAIDS Project Officer:
	  	National Institutes of Health, DHHS National Institute of Allergy and Infectious Diseases Division of AIDS, BSP 6700-B Rockledge Drive, Room 4100, MSC 7626 Bethesda, MD
20892-7626
		
	 NIAID Contracting Officer:
	  	National Institutes of Health, DHHS National Institute of Allergy and Infectious Diseases Office of Acquisitions, Division of Extramural Activities 6700-B Rockledge Drive, Room
3214, MSC 7612 Bethesda, MD 20892-7612

 ARTICLE C.3 INVENTION REPORTING REQUIREMENT 
 All reports and documentation required by FAR CLAUSE 52.227-11 including, but not limited to, the invention disclosure report, the confirmatory license, and the government support certification, shall be
directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040-A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a
copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract. 

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement
(see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address: 
 Contracting Officer 
 National Institutes of Health, DHHS 

National Institute of Allergy and Infectious Diseases 
 Office of Acquisitions, Division of Extramural Activities 
 6700B Rockledge Drive,
Room 3214, MSC 7612 
 Bethesda, Maryland 20892 -7612 
 If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the
address listed above. 

  
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 To assist contractors in complying with invention reporting requirements of the clause, the NIH has
developed “Interagency Edison,” an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive
Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions
and Technology Resources Branch, OPERA, NIH. 
 SECTION D - PACKAGING, MARKING AND SHIPPING 

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. 

SECTION E - INSPECTION AND ACCEPTANCE 
  

	a.	The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. 

 

	b.	For the purpose of this SECTION, the Project Officer indicated in ARTICLE G.1. is the authorized representative of the Contracting Officer. 

 

	c.	Inspection and acceptance will be performed at the location listed in ARTICLE G.1. Acceptance may be presumed unless otherwise indicated in writing by the Contracting
Officer or the duly authorized representative within [**] days of receipt. 

  

	d.	This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer
will make its full text available. 

 FAR Clause 52.246-9, Inspection of Research And Development (Short
Form) (April 1984). 
 SECTION F - DELIVERIES OR PERFORMANCE 
 ARTICLE F.1 DELIVERIES 
 Satisfactory performance of the final contract shall be deemed to
occur upon performance of the work described in Article C.l. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule: 

 

	a.	The items specified below as described in SECTION C, ARTICLE C.2. will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below: 

  

					
	Item  	  	Description	  	Delivery Schedule
	 1.
	  	 Information Security Plan

 
	  	Within [**] weeks of contract award.

  
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	Item  	  	Description	  	Delivery Schedule
	
2.
	  	 Goals and Milestones Achievement Reports

 
	  	Specific dates will be negotiated with the DAIDS PO
	
3.
	  	 Specific Deliverables for Projects 1 through 5, as outlined in the Statement of Work

 
	  	As required by the Project Officer
	
4.
	  	 Clinical Trials Protocol(s)
  
	  	As required by the Project Officer
	
5.
	  	 DAIDS Enterprise Systems Reporting

 
	  	On an ongoing basis as directed by DAIDS, NIAID
	
6.
	  	 Annual Technical Report
  
	  	[**] day of the twelfth month of each contract year
	
7.
	  	 Annual Site Visit Review and Report

 
	  	[**] month of each contract year
	 8.
	  	 Final Technical Report

 
	  	On or before contract expiration

  

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

  

					
	Addressee	  	Deliverable Item	  	Quantity
	 Contracting Officer

OA, NIAID, NIH
 Room 3214, MSC 7612

6700-B Rockledge Drive
 Bethesda, MD
20892-7612
	  	 Information Security Plan
 Goals and Milestones Achievement Report
 Deliverables for Projects 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

	 Project
Officer
 Targeted Interventions Branch

Basic Science Program
 Division of AIDS,
NIAID,
 NIH Room 4100, MSC 7626
 6700-B
Rockledge Drive
 Bethesda, MD 20892-7626
	  	 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 *

  

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

ARTICLE F.2 CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998) 

  
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 This contract incorporates the following clause(s) by reference, with the same force and effect as if it
were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html. 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE: 

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984). 

SECTION G - CONTRACT ADMINISTRATION DATA 

ARTICLE G.1 PROJECT OFFICER 
 The
following Project Officer will represent the Government for the purpose of this contract: 
 Anthony J. Conley, Ph.D. 

Targeted Interventions Branch 
 Basic Science Program Division of AIDS, NIAID, NIH, DHHS 
 Room 4100, MSC 7626

 6700-B Rockledge Drive, Bethesda, MD 20892-7626 
 Phone: (301) 451-2739              Fax: (301) 402-3211 
 Email: conleyto@niaid.nih.gov 
 The Project Officer is responsible for: (l) monitoring
the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer
has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred
during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. 
 The Contracting Officer
hereby delegates the Project Officer as the Contracting Officer’s authorized representative responsible for signing software license agreements issued as a result of this contract. 
 The Government may unilaterally change its Project Officer designation. 
 ARTICLE G.2 KEY
PERSONNEL 
 Pursuant to HHSAR Clause 352.270-5, Key Personnel, incorporated in Section I of this contract, the following individual is
considered to be essential to the work being performed hereunder: 
  

			
	Name	  	Title
	 [**]
	  	Principal 
Investigator

  
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 Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the
Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written
consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer. The contract may be modified from time to time during the
course of the contract to either add or delete personnel, as appropriate 
 ARTICLE G.3 INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND
CONTRACT FINANCIAL REPORT 
  

	a.	Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract.
The instructions and the following directions for the submission of invoices/financing request must be followed to meet the requirements of a “proper” payment request pursuant to FAR 32.9. 

These instructions also provide for the submission of financial and personnel reporting required by HHSAR 342.7002. 

 

	 	(1)	Invoices/financing requests shall be submitted as follows: 

  

	 	(a)	To be considered a “proper” invoice in accordance with FAR 32.9, Prompt Payment, each invoice shall clearly identify the two contract numbers that appear on
the face page of the contract as follows: 

 Contract No.: HHSN266200600019C 

ADB Contract No.: N0I-AI-60019 
  

	 	(b)	An original and two copies to the following designated billing office: 

Contracting Officer 
 National Institutes of Health, DHHS 
 National Institute of
Allergy and Infectious Diseases 
 Office of Acquisitions, Division of Extramural Activities 

6700B Rockledge Drive, Room 3214, MSC 7612 

Bethesda, Maryland 20892 -7612 
  

	 	(2)	Inquiries regarding payment of invoices should be directed to the designated billing office, (301) 496-0612. 

 

	b.	The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION
LEGISLATION PROVISIONS ARTICLE in SECTION H 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: 

  
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 “I hereby certify that the salaries charged in this invoice are in compliance with
P.L 109-149 and the SALARY RATE LIMITATION LEGISLATION PROVISIONS ARTICLE in SECTION H of the above referenced contract.” 
 ARTICLE G.4
INDIRECT COST RATES 
 In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and
Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows. These rates are hereby
incorporated without further action of the Contracting Officer. 
 Director, Division of Financial Advisory Services 

Office of Acquisition Management and Policy 
 National Institutes of Health 
 6100 Building, Room 6B05 

6100 EXECUTIVE BLVD MSC-7540 
 BETHESDA MD 20892-7540 
 ARTICLE G.5 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: 

http://www.knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm. Among other issues, this publication provides a
summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract. A copy of this publication is available upon request to the Contracts Property Administrator.

 Requests for information regarding property under this contract should be directed to the following office: 

Division of Personal Property Services, NIH 
 6011 Building, Suite 637 
 6011 EXECUTIVE BLVD MSC 7670 

BETHESDA MD 20892-7670 
 (301) 496-6466 
  

	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 a. above, the contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for performing annual inventories required under this contract. This form is included as an attachment in
SECTION J of this contract. 

  

	c.	Contractor-Acquired Government Property - Schedule I-A 

  
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	 	 	Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor is hereby authorized to acquire the property listed in the Schedule I-A below
for use in direct performance of the contract. 

 SCHEDULE 1-A 

 

									
	Item No.  	  	Description	  	Quantity	  	Unit Price	  	Total
	
1.
	  	[**]	  	[**]	  	[**]  	  	[**]
	 2.
	  	[**]	  	[**]	  	[**]  	  	[**]

 ARTICLE G.6 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE 

 

	a.	Contractor Performance Evaluations 

 Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work.
In addition to the final evaluation, interim evaluations will be prepared bi-annually to coincide with the anniversary date of the contract. 
 Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted [**] days to review the document and to submit
additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. 

Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be
used to support future award decisions. 
  

	b.	Electronic Access to Contractor Performance Evaluations 

 Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

 http://oamp.od.nih.gov/OD/CPS/cps.asp 
 The registration process requires the contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the
contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required [**]-day time frame.

 SECTION H - SPECIAL CONTRACT REQUIREMENTS 
 ARTICLE H.1. HUMAN SUBJECTS 
 Research involving human subjects shall not be conducted under
this contract until the protocol developed in Phase I has been approved by the NIAID, written notice of such approval has been 

  
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provided by the NIAID, and the Contractor has provided to the Contracting Officer a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of
Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor’s self designated form, provided
that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310). 

When research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain, and keep on file,
a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRE review and approval of the research. 

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS 
 NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the
NIH Policy announcement on required education in the protection of human subject participants, the contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 
 The information below is a summary of the NIH Policy Announcement: 
 The contractor shall maintain
the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the
education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and
all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract. 

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the
contract, the contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement. 

ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS 
 The contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites: 

  
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 http://grants.nih.gov/grants/guide/notice-files/not98-084.html 

http://grants.nih.gov/grants/guide/notice-files/not99-107.html 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html 
 The contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract. 

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan. 

The Data and Safety Monitoring Board and Plan shall be established and approved prior to beginning the conduct of the clinical trial. 

ARTICLE H.4. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE) 
 The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws
and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. 

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under
this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect
human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor. 
 Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No.
0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a
self designated form, provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310).

 ARTICLE H.5. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES 
 (Including Human Gene Transfer Research) 
 All research involving Recombinant DNA Molecules
shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) and the May 28, 2002 Notice, Compliance with the NIH Guidelines for
Research Involving Recombinant DNA Molecules (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html) (and any subsequent revisions to the Guide Notice) which stipulates biosafety and containment measures for recombinant DNA
research and delineates critical, ethical principles and key safety reporting 

  
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requirements for human gene transfer research (See Appendix M of the Guidelines). These guidelines apply to both basic and clinical research studies. 

The Recombinant DNA Advisory Committee (RAC) is charged with the safety of manipulation of genetic material through the use of recombinant DNA
techniques. Prior to beginning any clinical trials involving the transfer of recombinant DNA to humans, the trial must be registered with the RAC. If this contract involves new protocols that contain unique and/or novel issues, the RAC must discuss
them in a public forum and then the Institutional Biosafety Committee (IBC), the Institutional Review Board (IRB), and the project officer and contracting officer must approve the protocol prior to the start of the research. 

Failure to comply with these requirements may result in suspension, limitation, or termination of the contract for any work related to Recombinant DNA
Research or a requirement for contracting officer prior approval of any or all Recombinant DNA projects under this contract. This includes the requirements of the Standing Institutional Biosafety Committee (IBC) (See
http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm). 
 As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious adverse event must
be reported immediately to the IRB, the IBC, the Office for Human Research Protections (if applicable), and the NIH Office for Biotechnology Activities (OBA), followed by the filing of a written report with each office/group and copies to the
project officer and contracting officer. (http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836). 
 ARTICLE H.6.
CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH 
  

	a.	Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited from using appropriated funds to support human embryo research. Contract funds may not be used
for (l) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research
on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the
date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. 

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

  

							
	b.	  	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		  	 P. L. 109-149, Title V-General Provisions

Section 509
	  	2006	  	(10/1/2005-9/30/2006)

 ARTICLE H.7. NEEDLE EXCHANGE 
  

	a.	Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to carry out any program of distributing sterile needles or syringes for the
hypodermic injection of any illegal drug. 

  
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	b.	  	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		  	 P. L. 109-149, Title V-General Provisions Section 505
	  	2006	  	(10/1/2005-9/30/2006)

 ARTICLE H.8. PRIVACY ACT 
 This procurement action requires the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the
Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties. 

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document may be accessed on the Internet at the
following URL: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm . 
 ARTICLE H.9. OMB CLEARANCE 

In accordance with HHSAR 352.270-7, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of
Management and Budget (OMS) Clearance for conducting interviews has been obtained by the Project Officer and the Contracting Officer has issued written approval to proceed. 
 ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS 
  

	a.	Pursuant to the P.L.(s) cited in paragraph b., below, no NIH Fiscal Year funds may be used to pay the direct salary of an individual through this contract at a rate in
excess of the applicable amount shown or the applicable Executive Level for the fiscal year covered. Direct salary is exclusive of fringe benefits, overhead and general and administrative expenses (also referred to as indirect costs or facilities
and administrative (F&A) costs). Direct salary has the same meaning as the term institutional base salary. An individual’s direct salary (or institutional base salary) is the annual compensation that the contractor pays for an
individual’s appointment whether that individual’s time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside
of duties to the contractor. The per year salary rate limitation also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject to unilateral
modifications by the Government if an individual’s salary rate used to establish contract funding exceeds any salary rate limitation subsequently established in future HHS appropriation acts. 

 

							
	b.	  	Public Law No.	  	Fiscal Year	  	 Dollar amount of
 Salary Rate Limitation

		  	 P.L. 109-149, Public Health & Social Services Emergency Fund General Provisions, Section 204
	  	FY 06	  	Executive Level I

  
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	c.	Payment of direct salaries is limited to the Executive Level 1* rate which was in effect on the date(s) the expense was incurred. 

For the period 10/1/05 -12/31/05, the Executive Level I rate is $180,100. Effective January 1, 2006, the Executive Level I rate
increased to $183,500 and will remain at that rate until it is revised. See the web site listed below for the Executive Schedule rates of pay: 
 FOR FY-06 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2006:  
 http://www.opm.gov/oca/06tables/html/ex.asp  
 (Note: This site
shows the FY-06 rates. For previous years, click on “salaries and wages” and then scroll down to the bottom of the page and click on the year to locate the desired Executive Level salary rates.) 

ARTICLE H.11. INFORMATION SECURITY 
 The
Statement of Work (SOW) requires the contractor to (1) develop, (2) have the ability to access, or (3) host and/or maintain a Federal information system(s). Pursuant to Federal and HHS Information Security Program Policies, the
contractor and any subcontractor performing under this contract shall comply with the following requirements: 
  

	 	Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002);
http://csrc.nist.gov/policies/FISMA-final.pdf 

  

	a.	Information Type 

Administrative, Management and Support Information 
  

	b.	Security Category and Levels 

  

									
	 Confidentiality
	  	Level:	  	[   ] Low	  	[X] Moderate	  	[   ] High
	 Integrity
	  	Level:	  	[   ] Low	  	[X] Moderate	  	[   ] High
	 Availability
	  	Level:	  	[X] Low	  	[   ] Moderate	  	[   ] High
	
Overall
	  	Level:	  	[   ] Low	  	[X] Moderate	  	[   ] High

  

	c.	Position Sensitivity Designations 

  

	 	(1)	The following position sensitivity designations and associated clearance and investigation requirements apply under this contract. 

Level 1: Non Sensitive (Requires Suitability Determination with an NACI). Contractor employees assigned to a Level I position are
subject to a National Agency Check and Inquiry Investigation (NACI). 
  

	 	(2)	 The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract who
will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the 

  
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Contracting Officer, within [**] calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within [**] calendar days of
the change. The Contracting Officer shall notify the contractor of the appropriate level of suitability investigations to be performed. An electronic template, “Roster of Employees Requiring Suitability Investigations,” is available for
contractor use at: 
 http://ais.nci.nih.gov/forms/Suitabilitv-roster.xls. 

Upon receipt of the Government’s notification of applicable Suitability Investigations required, the contractor shall complete and
submit the required forms within [**] days of the notification. Additional submission instructions can be found at the “NCI Information Technology Security Policies, Background Investigation Process” website: http://ais.nci.nih.gov.

 Contractor/subcontractor employees who have met investigative requirements within the past [**] years may only require an
updated or upgraded investigation. 
  

	 	(3)	Contractor/subcontractor employees shall comply with the HHS criteria for the assigned position sensitivity designations prior to performing any work under this
contract. The following exceptions apply: 

 Levels 5 and 1: Contractor/subcontractor employees may begin
work under the contract after he contractor has submitted the name, position and responsibility of the employee to the Project Officer, as described in paragraph c.(2) above. 
 Level 6: In special circumstances the Project Officer may request a waiver of the pre-appointment investigation. If the waiver is granted, the Project Officer will provide written authorization for
the contractor/subcontractor employee to work under the contract. 
  

	 	d.	Information Security Training 

 The contractor shall ensure that each contractor/subcontractor employee has completed the NIH Computer Security Awareness Training course at: http://irtsectraining.nih.gov/ prior to performing any
contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract. 
 The contractor shall maintain a listing by name and title of each contractor/subcontractor employee working under this contract that has completed the NIH required training. Any additional security
training completed by contractor/subcontractor staff shall be included on this listing. The listing of completed training shall be included in the first technical progress report. (See Article C.2. Reporting Requirements.) Any revisions to this
listing as a result of staffing changes shall be submitted with next required technical progress report. 
  

	e.	Rules of Behavior 

  
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 The contractor/subcontractor employees shall comply with the NIH Information Technology
General Rules of Behavior at: http://irm.cit.nih.gov/security/nihitrob.html. 
  

	f.	Personnel Security Responsibilities 

 The contractor shall perform and document the actions identified in the “Employee Separation Checklist”, attached and made a part of this contract, when a contractor/subcontractor employee
terminates work under this contract. All documentation shall be made available to the Project Officer and/or Contracting Officer upon request. 
  

	g.	Commitment to Protect Non-Public Departmental Information Systems and Data 

 

	 	(1)	Contractor Agreement 

 The
Contractor and its subcontractors performing under this SOW shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in accordance with provisions of the following laws
and any other pertinent laws and regulations governing the confidentiality of such information: 
  

	 	•	 	 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) 

 

	 	•	 	 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) 

 

	 	•	 	 Public Law 96-511 (Paperwork Reduction Act) 

  

	 	(2)	Contractor-Employee Non-Disclosure Agreements 

 Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete the Commitment to Protect Non-Public Information - Contractor Agreement.
A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer prior to performing any work under the contract. 
  

	h.	NIST SP 800-26 Self-Assessment Questionnaire 

 The contractor shall annually update and re-submit its Self-Assessment Questionnaire required by NIST Draft SP 800-26, Revision 1, Guide for Information Security Program Assessments and System Reporting
Form (http://csrc.nist.gov/publications/drafts/Draft-sp800-26Revl.pdf - See Appendix B for format). 
 Subcontracts: The
contractor’s annual update to its Self-Assessment Questionnaire shall include similar information for any subcontractor that performs under the SOW to (1) develop a Federal information system(s) at the
contractor’s/subcontractor’s facility, or (2) host and/or maintain a Federal information system(s) at the contractor’s/subcontractor’s facility. 
 The annual update shall be submitted to the Project Officer, with a copy to the Contracting Officer on the anniversary date of the contract award. 

  
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	 	i.	Information System Security Plan 

 The contractor’s draft ISSP submitted with its proposal shall be finalized in coordination with the Project Officer no later than [**] calendar days after contract award. 

Following approval of its draft ISSP, the contractor shall update and resubmit its ISSP to the Project Officer every [**] years or when a
major modification has been made to its internal system. The contractor shall use the current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems.
(http://csrc.nist.gov/publications/nistpubs/800-18-Revl/sp800-18-Revl-final.pdf). The details contained in the contractor’s ISSP shall be commensurate with the size and complexity of the requirements of the SOW based on the System
Categorization determined above in subparagraph (b) Security Categories and Levels of this Article. 
 Subcontracts: The
contractor shall include similar information for any subcontractor performing under the SOW with the contractor whenever the submission of an ISSP is required. 
 ARTICLE H.12. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS 
 Pursuant to Section 508
of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by P.L. 105-220 under Title IV (Rehabilitation Act Amendments of 1998) all Electronic and Information Technology (EIT) developed, procured, maintained and/or used under this contract
shall be in compliance with the “Electronic and Information Technology Accessibility Standards set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board” in 36 CFR Part 1194.
The complete text of Section 508 Final Standards can be accessed at http://www.access-board.gov/. The standards applicable to this requirement are identified in the Statement of Work. 

ARTICLE H.13. ENERGY STAR REQUIREMENTS 

Executive Order 13123, “Greening the Government Through Efficient Energy Management” and FAR 23.203 require that when Federal Agencies acquire
energy using products, they select, where life-cycle cost-effective, and available, ENERGY STAR7 or other energy efficient products. 
 Unless
the Contracting Officer determines otherwise, all energy-using products acquired under this contract must be either an ENERGY STAR7 or other energy efficient product designated by the Department of Energy’s Federal Energy Management Program
(FEMP). 
 For more information about ENERGY STAR7 see http://www.energystar.gov/ For more information about FEMP see
http://www.eere.energy.gov/ 
 ARTICLE H.14. CONFIDENTIALITY OF INFORMATION 

The following information is covered by HHSAR Clause 352.224-70, Confidentiality of Information (MARCH 2005): Any information that includes patient
identifiers. 

  
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 ARTICLE H.15. PUBLICATION AND PUBLICITY 
 The contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

 “This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. N0I-AI-60019.” 

ARTICLE H.16. PRESS RELEASES 
  

	a.	Pursuant to Public Law(s) cited in paragraph b., below, the contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid
solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar
amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. 

 

									
	b.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered	  	 
		 	 P.L. 109-149, Title V-General Provisions
	  	2006	  	(10/1/2005-9/30/2006)	  	
		 	 Section 506
	  		  		  	

 ARTICLE H.17. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE 

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to
the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov and the mailing address is: 
 Office of Inspector General 

Department of Health and Human Services 
 TIPS HOTLINE 
 P.O. Box 23489 

Washington, D.C. 20026 

ARTICLE H.18. ANTI-LOBBYING 
  

	a.	Pursuant to Public Law(s) cited in paragraph C., below, contract funds shall only be used for normal and recognized executive-legislative relationships. Contract funds
shall not be used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the
Congress or any State legislature, except in presentation to the Congress or any State legislature itself. 

  
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	b.	Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence
legislation or appropriations pending before the Congress or any State legislature. 

  

									
	c.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered	  	
		 	for a., above: P. L. 109-149, Title V-General Provisions Section 503a	  	FY-06	  	(10/1/2005-9/30/2006)	  	
		 	for b., above: P.L. 109-149, Title V-General Provisions Section 503b.	  	FY-06	  	(10/1/2005-9/30/2006)	  	

 ARTICLE H.19. SHARING RESEARCH DATA 
 The data sharing plan submitted by the contractor is acceptable. The contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

 The NIH endorses the sharing of final research data to expedite the translation of research results into knowledge, products, and procedures
to improve human health. This contract is expected to generate research data that must be shared with the public and other researchers. NIH’s data sharing policy may be found at the following Web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html 
 NIH recognizes that data sharing may be complicated or limited, in
some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and
privacy of people who participate in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead
to deductive disclosure of the identity of individual subjects. 
 ARTICLE H.20. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

 Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or
training seminar that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This
restriction applies to public accommodations both foreign and domestic. Public accommodations that meet the requirements can be accessed at: http://www.usfa.fema.gov/hotel/index.htm 
 ARTICLE H.21. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH 
 The Policy requests that beginning May 2, 2005, NIH-funded investigators submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s
final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication, and includes
all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic

  
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submissions to the NIHINLM/PMC: http://www.pubmedcentral.nih.gov. Additional information is available at http://grants.nih.gov/grants/guide/notice-filesINOT-OD-05-022.html.

 PART II - CONTRACT CLAUSES 
 SECTION I - CONTRACT CLAUSES 
 ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
RESEARCH AND DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998) 
 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 at this
address: http://www.acquisition.gov/comp/far/index.html. 
 a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

  

					
	 FAR
 CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	 52.202-1
	  	Jul 2004	  	Definitions (Over $100,000)
			
	 52.203-3
	  	Apr 1984	  	Gratuities (Over $100,000)
			
	 52.203-5
	  	Apr 1984	  	Covenant Against Contingent Fees (Over $100,000)
			
	 52.203-6
	  	Jul 1995	  	Restrictions on Subcontractor Sales to the Government (Over $100,000)
			
	 52.203-7
	  	Jul 1995	  	Anti-Kickback Procedures (Over $100,000)
			
	 52.203-8
	  	Jan 1997	  	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)
			
	 52.203-10
	  	Jan 1997	  	Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
			
	 52.203-12
	  	Sep 2005	  	Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
			
	 52.204-4
	  	Aug 2000	  	Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
			
	 52.204-7
	  	Jul 2006	  	Central Contractor Registration
			
	 52.209-6
	  	Jan 2005	  	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000)
			
	 52.215-2
	  	Jun 1999	  	Audit and Records - Negotiation (Over $100,000)
			
	 52.215-8
	  	Oct 1997	  	Order of Precedence - Uniform Contract Format
			
	 52.215-10
	  	Oct 1997	  	Price Reduction for Defective Cost or Pricing Data

  
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	 FAR
 CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	 52.215-12
	  	Oct 1997	  	Subcontractor Cost or Pricing Data (Over $500,000)
			
	 52.215-14
	  	Oct 1997	  	Integrity of Unit Prices (Over $100,000)
			
	 52.215-15
	  	Oct 2004	  	Pension Adjustments and Asset Reversions
			
	 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 1997	  	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data – Modifications
			
	 52.216-7
	  	Dec 2002	  	Allowable Cost and Payment
			
	 52.216-8
	  	Mar 1997	  	Fixed Fee
			
	 52.219-8
	  	May 2004	  	Utilization of Small Business Concerns (Over $100,000)
			
	 52.219-9
	  	Jul 2005	  	Small Business Subcontracting Plan (Over $500,000, $1,000,000 for Construction)
			
	 52.219-16
	  	Jan 1999	  	Liquidated Damages - Subcontracting Plan (Over $500,000, $1,000,000 for Construction)
			
	 52.222-2
	  	Jul 1990	  	Payment for Overtime Premium (Over $100,000) (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
	  	Apr 2002	  	Equal Opportunity
			
	 52.222-35
	  	Dec 2001	  	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans
			
	 52.222-36
	  	Jun 1998	  	Affirmative Action for Workers with Disabilities
			
	 52.222-37
	  	Dec 2001	  	Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans
			
	 52.222-50
	  	Apr 2006	  	Combating Trafficking in Persons
			
	 52.223-6
	  	May 2001	  	Drug-Free Workplace
			
	 52.223-14
	  	Aug 2003	  	Toxic Chemical Release Reporting (Over $100,000)
			
	 52.225-1
	  	Jun 2003	  	Buy American Act -Supplies
			
	 52.225-13
	  	Feb 2006	  	Restrictions on Certain Foreign Purchases
			
	 52.227-1
	  	Jul 1995	  	Authorization and Consent, Alternate I (Apr 1984)
			
	 52.227-2
	  	Aug 1996	  	Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)

  
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	 FAR
 CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	 52.227-11
	  	Jun 1997	  	Patent Rights -Retention by the Contractor (Short Form) (Note: In accordance with FAR 27.303(a)(2), paragraph (f) is modified to include the requirements in FAR 27.303(a)(2)(i)
through (iv). The frequency of reporting in (i) is annual.
			
	 52.227-14
	  	Jun 1987	  	Rights in Data - General
			
	 52.232-9
	  	Apr 1984	  	Limitation on Withholding of Payments
			
	 52.232-17
	  	Jun 1996	  	Interest (Over $100,000)
			
	 52.232-20
	  	Apr 1984	  	Limitation of Cost
			
	 52.232-23
	  	Jan 1986	  	Assignment of Claims
			
	 52.232-25
	  	Oct 2003	  	Prompt Payment, Alternate I (Feb 2002)
			
	 52.232-33
	  	Oct 2003	  	Payment by Electronic Funds Transfer--Central Contractor Registration
			
	 52.233-1
	  	Jul 2002	  	Disputes
			
	 52.233-3
	  	Aug 1996	  	Protest After Award, Alternate I (Jun 1985)
			
	 523.233-4
	  	Oct 2004	  	Applicable Law for Breach of Contract Claim
			
	 52.242-1
	  	Apr 1984	  	Notice of Intent to Disallow Costs
			
	 52.242-3
	  	Aug 1996	  	Penalties for Unallowable Costs (Over $500,000)
			
	 52.242-4
	  	Jan 1997	  	Certification of Final Indirect Costs
			
	 52.242-13
	  	Jul 1995	  	Bankruptcy (Over $100,000)
			
	 52.243-2
	  	Aug 1987	  	Changes - Cost Reimbursement, Alternate V (Apr 1984)
			
	 52.244-2
	  	Aug 1998	  	Subcontracts, Alternate I (January 2006)
			
	 52.244-5
	  	Dec 1996	  	Competition in Subcontracting (Over $100,000)
			
	 52.244-6
	  	Feb 2006	  	Subcontracts for Commercial Items
			
	 52.245-5
	  	May 2004	  	Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)
			
	 52.245-9
	  	Aug 2005	  	Use and Charges
			
	 52.246-23
	  	Feb 1997	  	Limitation of Liability (Over $100,000)
			
	 52.249-6
	  	Sep 1996	  	Termination (Cost-Reimbursement)
			
	 52.249-14
	  	Apr 1984	  	Excusable Delays
			
	 52.253-1
	  	Jan 1991	  	Computer Generated Forms

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

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

 

					
	 HHSAR CLAUSE NO
	  	 DATE
	  	 TITLE

			
	 352.202-1
	  	Jan 2001	  	Definitions - with Alternate paragraph (h) (Jan 2001)
			
	 352.216-72
	  	Oct 1990	  	Additional Cost Principles
			
	 352.228-7
	  	Dec 1991	  	Insurance - Liability to Third Persons
			
	 352.232-9
	  	Apr 1984	  	Withholding of Contract Payments
			
	 352.233-70
	  	Apr 1984	  	Litigation and Claims
			
	 352.242-71
	  	Apr 1984	  	Final Decisions on Audit Findings
			
	 352.270-5
	  	Apr 1984	  	Key Personnel
			
	 352.270-6
	  	Jul 1991	  	Publications and Publicity
			
	 352.270-7
	  	Jan 2001	  	Paperwork Reduction Act

 ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES 
 ARTICLE 1.1. of this SECTION is hereby modified as follows: 
 FAR
Clause 52.232-20, Limitation of Cost (April 1984), is deleted in its entirety and FAR Clause 52.232-22, Limitation Of Funds (April 1984) is substituted therefor. [NOTE: When
this contract is fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will become applicable.] 
 ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES 
 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. 
  

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

  

	 	(1)	FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997). 

 

	 	(2)	FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005). 

“(c) Waiver of evaluation preference... 
         [ ] Offeror elects to waive the evaluation preference.” 
  

	 	(3)	FAR Clause 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (October 1999). 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	(4)	FAR Clause 52.223-12, Refrigeration Equipment and Air Conditioners (May 1995) 

 

	 	(5)	FAR Clause 52.224-1, Privacy Act Notification (April 1984). 

  

	 	(6)	FAR Clause 52.224-2, Privacy Act (April 1984). 

  

	 	(7)	FAR Clause 52.227-14, Rights in Data - General (June 1987). 

  

	 	(8)	Alternate V (June 1987), FAR Clause 52.227-14, Rights in Data - General (June 1987). Specific data items that are not subject to paragraph
(j) include: None 

  

	 	(9)	FAR Clause 52.227-16, Additional Data Requirements (June 2987) 

  

	 	(10)	FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001). 

  

	 	(11)	FAR Clause 52.247-63, Preference for U.S. Flag Air Carriers (June 2003). 

 

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

 

	 	(1)	HHSAR Clause 352.223-70, Safety and Health (January 2001). [This clause is provided in full text in SECTION J - Attachments.] 

 

	 	(2)	HHSAR Clause 352.224-70, Confidentiality of Information (April 1984 -including revisions mandated by the 1/3/2005 Federal Register notice which was effective
March 2005). 

  

	 	(3)	HHSAR Clause 352.270-8, Protection of Human Subjects (March 2005). 

 

	c.	NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES: 

 The following clauses are attached and made a part of this contract: 
  

	 	(1)	NIH (RC)-7, Procurement of Certain Equipment (April 1984). 

  

	 	(2)	NIH(RC)-11, Research Patient Care Costs (4/1/84). 

 ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT 
 This contract
incorporates the following clauses in full text. 
 FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES: 

 

	a.	FAR Clause 52.222-39, Notification Of Employee Rights Concerning Payment Of Union Dues Or Fees (December 2004) 

 

	 	(a)	Definition. As used in this clause— - 

  
 34 

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 United States means the 50 States, the District of Columbia, Puerto Rico, the
Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island. 
  

	 	(b)	Except as provided in paragraph (e) of this clause, during the term of this contract, the Contractor shall post a notice, in the form of a poster, informing
employees of their rights concerning union membership and payment of union dues and fees, in conspicuous places in and about all its plants and offices, including all places where notices to employees are customarily posted. The notice shall include
the following information (except that the information pertaining to National Labor Relations Board shall not be included in notices posted in the plants or offices of carriers subject to the Railway Labor Act, as amended (45 U.S.C. 151-188)).

 Notice to Employees 
 Under Federal law, employees cannot be required to join a union or maintain membership in a union in order to retain their jobs. Under certain conditions, the law permits a union and an employer to enter
into a union-security agreement requiring employees to pay uniform periodic dues and initiation fees. However, employees who are not union members can object to the use of their payments for certain purposes and can only be required to pay their
share of union costs relating to collective bargaining, contract administration, and grievance adjustment. 
 If you do not want
to pay that portion of dues or fees used to support activities not related to collective bargaining, contract administration, or grievance adjustment, you are entitled to an appropriate reduction in your payment. If you believe that you have been
required to pay dues or fees used in part to support activities not related to collective bargaining, contract administration, or grievance adjustment, you may be entitled to a refund and to an appropriate reduction in future payments. 

For further information concerning your rights, you may wish to contact the National Labor Relations Board (NLRB) either at one of its
Regional offices or at the following address or toll free number: 
 National Labor Relations Board 

Division of Information 
 1099 14th Street, N.W. 
 Washington, DC 20570 

1-866-667-6572 

1-866-316-6572 (TTY) 
 To locate the nearest NLRB office, see NLRB’s website at http://www.nlrb.gov. 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	(c)	The Contractor shall comply with all provisions of Executive Order 13201 of February 17, 2001, and related implementing regulations at 29 CFR part 470, and orders
of the Secretary of Labor. 

  

	 	(d)	In the event that the Contractor does not comply with any of the requirements set forth in paragraphs (b), (c), or (g), the Secretary may direct that this contract be
cancelled, terminated, or suspended in whole or in part, and declare the Contractor ineligible for further Government contracts in accordance with procedures at 29 CFR part 470, Subpart B—Compliance Evaluations, Complaint Investigations and
Enforcement Procedures. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 470, which implements Executive Order 13201, or as are otherwise provided by law. 

 

	 	(e)	The requirement to post the employee notice in paragraph (b) does not apply to— 

 

	 	(1)	Contractors and subcontractors that employ fewer than 15 persons; 

  

	 	(2)	Contractor establishments or construction work sites where no union has been formally recognized by the Contractor or certified as the exclusive bargaining
representative of the Contractor’s employees; 

  

	 	(3)	Contractor establishments or construction work sites located in a jurisdiction named in the definition of the United States in which the law of that jurisdiction
forbids enforcement of union-security agreements; 

  

	 	(4)	Contractor facilities where upon the written request of the Contractor, the Department of Labor Deputy Assistant Secretary for Labor-Management Programs has waived the
posting requirements with respect to any of the Contractor’s facilities if the Deputy Assistant Secretary finds that the Contractor has demonstrated that— 

 

	 	(i)	The facility is in all respects separate and distinct from activities of the Contractor related to the performance of a contract; and 

 

	 	(ii)	Such a waiver will not interfere with or impede the effectuation of the Executive order; or 

 

	 	(5)	Work outside the United States that does not involve the recruitment or employment of workers within the United States. 

 

	 	(f)	The Department of Labor publishes the official employee notice in two variations; one for contractors covered by the Railway Labor Act and a second for all other
contractors. The Contractor shall— 

  

	 	(1)	 Obtain the required employee notice poster from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of
Labor, 200 Constitution Avenue, NW, Room N-5605, Washington, DC 20210, or from any field office of the Department’s 

  
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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	
Office of Labor-Management Standards or Office of Federal Contract Compliance Programs; 

  

	 	(2)	Download a copy of the poster from the Office of Labor-Management Standards website at http://www.olms.dol.gov; or 

 

	 	(3)	Reproduce and use exact duplicate copies of the Department of Labor’s official poster. 

 

	 	(g)	The Contractor shall include the substance of this clause in every subcontract or purchase order that exceeds the simplified acquisition threshold, entered into in
connection with this contract, unless exempted by the Department of Labor Deputy Assistant Secretary for Labor-Management Programs on account of special circumstances in the national interest under authority of 29 CFR 470.3(c). For indefinite
quantity subcontracts, the Contractor shall include the substance of this clause if the value of orders in any calendar year of the subcontract is expected to exceed the simplified acquisition threshold. Pursuant to 29 CFR part 470, Subpart
B—Compliance Evaluations, Complaint Investigations and Enforcement Procedures, the Secretary of Labor may direct the Contractor to take such action in the enforcement of these regulations, including the imposition of sanctions for noncompliance
with respect to any such subcontractor purchase order. If the Contractor becomes involved in litigation with a subcontractor or vendor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United
States, through the Secretary of Labor, to enter into such litigation to protect the interests of the United States. 

 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS 
 SECTION J - LIST OF
ATTACHMENTS 
 The following documents are attached and incorporated in this contract: 

 

	 	1.	Statement of Work, August 2006, 15 pages. 

  

	 	2.	Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (11/03), 5 pages.

  

	 	3.	Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 2 pages. 

  

	 	4.	Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page. 

  

	 	5.	Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page. 

  

	 	6.	Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page 

  

	 	7.	Disclosure of Lobbying Activities, SF LLL, 3 pages. 

  

	 	8.	Employee Separation Checklist, 1 page. Fillable PDF format located at: http://rcb.cancer.gov/rcb-internet.nci.nih.gov/forms/Emp-sep-checklist.pdf

  

	 	9.	Report of Government Owned, Contractor Held Property, 1 page. 

  
 37 

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 PART IV - REPRESENTATION AND CERTIFICATIONS 

AND OTHER STATEMENTS OF OFFERORS 
 SECTION K - REPRESENTATIONS AND CERTIFICATIONS 
 The following documents are incorporated by
reference in this contract: 
  

	1.	Representations and Certifications dated 8/10/06. In addition, the Contractor agrees to complete an Annual Representations and Certifications located at the Online
Representations and Certifications Application (ORCA) website. [This includes the changes identified in paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained in the contractor’s proposal.

  

	2.	Human Subjects Assurance Identification Number FWA00010561, dated 08/28/2006. 

END of the SCHEDULE 
 (CONTRACT) 

  
 38 

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 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 [**]. 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. [**]. 

Project 1 deliverables: 
  

	 	•	 	 [**]. 

 
 Project 2: 

 Summary. 
 [**]. 
 Project 2 deliverables: 

 

	 	•	 	 [**] 

 
 Project 3: 

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

Project 3 deliverables: 
  

	 	•	 	 [**] 

 
 Project 4: 

  

					
	Statement of Work dated 08/2006	 	1	 	Attachment 1

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 Summary. In order to [**]. 
 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), [**]. 

 Project 5 deliverables. 
 [**] 
 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. 

  

					
	Statement of Work dated 08/2006	 	2	 	Attachment 1

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 

 
 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.

  

	 	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. 

  

					
	Statement of Work dated 08/2006	 	3	 	Attachment 1

					
	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

 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 

  

					
	Statement of Work dated 08/2006	 	4	 	Attachment 1

					
		 		 	Contract No. HHSN266200600019C

  

 INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH
COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4 
 General: The contractor shall submit claims for reimbursement in the manner and format
described herein and as illustrated in the sample invoice/financing request. 
 Format: Standard Form 1034, “Public Voucher for
Purchases and Services Other Than Personal,” and Standard Form 1035, “Public Voucher for Purchases and Services Other Than Personal—Continuation Sheet,” or reproduced copies of such forms marked ORIGINAL should be used to submit
claims for reimbursement. In lieu of SF-1034 and SF-1035, claims may be submitted on the payee’s letter-head or self-designed form provided that it contains the information shown on the sample invoice/financing request. 

Number of Copies: As indicated in the Invoice Submission Clause in the contract. 
 Frequency: Invoices/financing requests submitted in accordance with the Payment Clause shall be submitted monthly unless otherwise authorized by the contracting officer. 

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 amount and month(s) in which such costs were incurred shall be cited. 
 Contractor’s Fiscal Year: Invoices/financing requests shall be prepared in such a manner that costs claimed can be identified with the contractor’s fiscal year. 

Currency: All NIH contracts are expressed in United States dollars. When payments are made in a currency other than United States dollars,
billings on the contract shall be expressed, and payment by the United States 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 may not exceed the United States dollars authorized. 

Costs Requiring Prior Approval: Costs requiring the contracting officer’s approval, which are not set forth in an Advance Understanding in
the contract shall be so identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, any cost set forth in an Advance Understanding shall be shown as a separate line item on the request. 

Invoice/Financing Request Identification: Each invoice/financing request shall be identified as either: 

 

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

 

	(b)	 Completion Invoice - The completion invoice is submitted promptly upon completion of the work; but no later than one year from the contract
completion date, or within 120 

  

					
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days after settlement of the final indirect cost rates covering the year in which this contract is physically complete (whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance provisions have been completed. 

  

	(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 explanatory notes below. These notes are keyed to the entries on the sample invoice/financing request. 
  

	(a)	Designated Billing Office Name and Address - Enter the designated billing office and address, identified in the Invoice Submission Clause of the contract, on all
copies of the invoice/financing request. 

  

	(b)	Invoice/Financing Request Number - Insert the appropriate serial number of the invoice/financing request. 

 

	(c)	Date Invoice/Financing Request Prepared - Insert the date the invoice/financing request is prepared. 

 

	(d)	Contract Number, ADB Number and Date - Insert both the contract number and the ADS number (which appears in the upper left hand corner of the face page of the
contract), and the effective date of the contract. 

  

	(e)	Payee’s Name and Address - Show the contractor’s name (as it appears in the contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved assignment has been made by the contractor, or a different payee has been designated, then insert the name and address of the payee instead of the contractor.

  

	(f)	Total Estimated Cost of Contract - Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount
currently obligated and available for payment. 

  

	(g)	Total Fixed-Fee - Insert the total fixed-fee (where applicable). For incrementally funded contracts, enter the amount currently obligated and available for
payment. 

  

	(h)	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.

  

	(i)	Incurred Cost - Current - Insert the amount billed for the major cost elements, adjustments, and adjusted amounts for the current period.

  

	(j)	Incurred Cost - Cumulative - Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract.

  

					
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	(k)	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. 

  

	 	(l)	Direct Labor - Include salaries and wages paid (or accrued) for direct performance of the contract. For Key Personnel, list each employee on a separate line.
List other employees as one amount unless otherwise required by the contract. 

  

	 	(2)	Fringe Benefits - List any fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be
identified here. 

  

	 	(3)	Accountable Personal Property - Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more and having an
expected service life of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment.
Prepare and attach the NIH Form entitled, Report of Government Owned, Contractor Held Property,” in accordance with the following instructions: 

 List each item for which reimbursement is requested. A reference shall be made to the following (as applicable): 
  

	 	•	 	 The item number for the specific piece of equipment listed in the Property Schedule. 

 

	 	•	 	 The Contracting Officer’s Authorization letter and number, if the equipment is not covered by the Property Schedule. 

 

	 	•	 	 An asterisk (*) shall precede the item if the equipment is below the approval level. 

 

	 	(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’s Advance Understanding or in the COA
letter, as well as the effort (i.e., number of hours, days, etc.) and rate being 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. 

  

					
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	 	(8)	Subcontract Costs - List subcontractor(s) by name and amount billed. 

 

	 	(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. 

  

	(l)	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.

  

	(m)	Indirect Costs - Overhead - Identify the cost base, indirect cost rate, and amount billed for each indirect cost category. 

 

	(n)	Fixed-Fee Earned - Cite the formula or method of computation for the fixed-fee (if any). The fixed-fee must be claimed as provided for by the contract.

  

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

 

	(p)	Adjustments - Include amounts conceded by the contractor, outstanding suspensions, and/or disapprovals subject to appeal. 

 

	(q)	Grand Totals 

 The contracting officer
may require the contractor to submit detailed support for costs claimed on one or more interim invoices/financing requests. 

  

					
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		 		 	Contract No. HHSN266200600019C

  

 FINANCIAL REPORTING INSTRUCTIONS: 
 These instructions are keyed 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 doing contract negotiations 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—Incurred Cost-Current - Enter the costs, which were incurred during the current period. 

Column E—Incurred Cost-Cumulative - Enter the cumulative cost 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.

 Column G—Contract Amount - Enter the costs agreed to during contract negotiations 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 (Funds) Clause of the contract. 

Modifications: Any modification in the amount negotiated for an item since the preceding report should be listed 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.

  

					
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		 		 	Contract No. HHSN266200600019C

  

 SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT 

			
	 (a)    Billing Office Name and Address
	  	 (b)    Invoice/Financing Request
No.
                                         
                                         
      

	  
 NATIONAL INSTITUTES OF HEALTH

National Cancer Institute, OA EPS
 Room 6120, EXECUTIVE BLVD MSC
 Bethesda, MD 20892-

 
 (e)    Payee’s Name
and Address
 ABC CORPORATION
 100 Main Street
 Anywhere, USA zip code

 
 Attn: Name, Title & Phone Number of
Official to
           Whom Payment is
Sent
	  	  

(c)    Date Invoice

Prepared
                                         
                                     

 

(d)    Contract
 No.
                                         
                                         
      
 ADB
 No.
                                         
                                         
      
 Effective

Date
                                         
                                         
    
  

(f)     Total Estimated Cost
          __________________________________________
  

(g)    Total Fixed
 Fee                                 
                                         
                         

																	
	 
	 (h)        This invoice/financing request represents reimbursable costs for
the period from              to
            

															
	 	 	 	 	 	 
	Expenditure Category*
A	  	Cumulative Percentage of
Efforts/Hrs.	  	Incurred Cost	  	Cost at
Completion
F	  	Contact
Amount
G	  	Variance
H
	  	Negotiated
B	  	Actual
C	  	(i) Current
D	  	(j) Cumulative
E	  	  	  
	 (k) Direct Costs:
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (1) Direct Labor
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (2) Fringe Benefits
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (3) Accountable Property
(attach HHS-565)
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (4) Materials & Supplies
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (5) Premium Pay
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (6) Consultant Fees
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (7) Travel
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (8) Subcontracts
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (9) Other
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 Total Direct Costs
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (1) Cost of Money
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (m) Overhead
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 G&A
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (n) Fixed Fee
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (o) Total Amount Claimed
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (p) Adjustments
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (q) Grand Totals
	  	 	  	 	  	 	  	 	  	 	  	 	  	 

 I certify that all payments are for appropriate purposes and in accordance with the contract. 

 

					
		  	____________________________________________	  	______________________________________________
		  	(Name of Official)	  	(Title)

  

	*	Attach details as specified in the contract 

  

  

					
	 NIH(RC)-4
 Rev.
11/2003
	 	6	 	ATTACHMENT 2

					
		 		 	Contract No. HHSN266200600019C

  

 INCLUSION ENROLLMENT REPORT 

This report format should NOT be used for data collection from study participants 

 

											
	 Study Title:
	  	 	  	 	  	 	  	 	  	 
	 Total
Enrollment:
	  	Protocol Number:
	 Contract
Number:
	  	 
	 PART A.   TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

									
	Ethnic Category	  	Sex/Gender
	  	Females	  	Males	  	Unknown or Not
Reported	  	Total
	 Hispanic or Latino
	  	 	  	 	  	 	  	 
	 Not Hispanic or Latino
	  	 	  	 	  	 	  	 
	 Unknown (Individuals not reporting
ethnicity)
	  	 	  	 	  	 	  	 
	 Ethnic Category: Total of all
Subjects*
	  	 	  	 	  	 	  	 
	Racial Categories	  	  	  	  	  	  	  	  
	 American Indian/Alaska
Native
	  	 	  	 	  	 	  	 
	 Asian
	  	 	  	 	  	 	  	 
	 Native Hawaiian or Other Pacific
Islander
	  	 	  	 	  	 	  	 
	 Black or African American
	  	 	  	 	  	 	  	 
	 White
	  	 	  	 	  	 	  	 
	 More than one race
	  	 	  	 	  	 	  	 
	 Unknown or not reported
	  	 	  	 	  	 	  	 
	 Racial Categories: Total of all
Subjects*
	  	 	  	 	  	 	  	 
	 
	 
	 PART B:   HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

	 	 	 	 	 
	Racial Categories	  	Females	  	Males	  	Unknown or Not
Reported	  	Total
	 American Indian or Alaska
Native
	  	 	  	 	  	 	  	 
	 Asian
	  	 	  	 	  	 	  	 
	 Native
Hawaiian or Other Pacific Islander
	  	 	  	 	  	 	  	 

  

					
	 Annual Technical Progress Report Format
 July, 1994
	 	1	 	ATTACHMENT 3

					
		 		 	Contract No. HHSN266200600019C

  

									
	 Black or African American
	  	 	  	 	  	 	  	 
	 White
	  	 	  	 	  	 	  	 
	 More Than One Race
	  	 	  	 	  	 	  	 
	 Unknown or not reported
	  	 	  	 	  	 	  	 
	 Racial
Categories: Total of Hispanics or Latinos**
	  	 	  	 	  	 	  	 
	 *       These totals must agree
 **     These totals must agree
	  	 	  	 	  	 	  	 

  

					
	 Annual Technical Progress Report Format
 July, 1994
	 	2	 	ATTACHMENT 3

					
		 		 	Contract No. HHSN266200600019C

  

 HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001) 

 

	(a)	To help ensure the protection of the life and health of all persons and to help prevent damage to property, the Contractor shall comply with all Federal, State and
local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration and other agencies at the Federal,
State and local levels (Federal, State and local regulatory/enforcement agencies). 

  

	(b)	Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer in conjunction with the project or other appropriate
officer, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will
be made in accordance with the applicable “Changes” Clause set forth in this contract. 

  

	(c)	The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to
toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any
Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to
be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary
corrective action. 

  

	(d)	If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and
prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and
documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. 

 

	(e)	The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations. Compliance with the
provisions of this clause by subcontractors will be the responsibility of the Contractor. 

 (End of clause)

  

					
	 Safety and Health Clause
 HHSR
352.223-70, (1/01)
	 	1	 	ATTACHMENT 4

					
		 		 	Contract No. HHSN266200600019C

  

 PROCUREMENT OF CERTAIN EQUIPMENT 

Notwithstanding any other clause in this contract, the Contractor will not be reimbursed for the purchase, lease, or rental of any item of equipment
listed in the following Federal Supply Groups, regardless of the dollar value, without the prior written approval of the Contracting Officer. 
  

	
	 67 – Photographic Equipment

	 69 – Training Aids and Devices

	 70 – General Purpose ADP Equipment, Software, Supplies and Support (Excluding 7045-ADP Supplies and Support
    Equipment.)

	 71 – Furniture

	 72 – Household and Commercial Furnishings and Appliances

	 74 – Office Machines and Visible Record Equipment

	 77 – Musical Instruments, Phonographs, and Home-type Radios

	 78 – Recreational and Athletic Equipment

 When equipment in these Federal Supply Groups is requested by the Contractor and determined essential by the Contracting
Officer, the Government will endeavor to fulfill the requirement with equipment available from its excess personal property sources, provided the request is made under a contract. Extensions or renewals of approved existing leases or rentals for
equipment in these Federal Supply Groups are excluded from the provisions of this article. 

  

					
	NIH(RC)-7 (4/1/84)	 		 	ATTACHMENT 5

					
		 		 	Contract No. HHSN266200600019C

  

 RESEARCH PATIENT CARE COSTS 

 

	(a)	Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.

  

	(b)	Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare
reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or
amounts shall be established by the Secretary of HHS or his duly authorized representative. 

  

	(c)	Prior to submitting an invoice for patient care costs under this contract, the contractor must make every reasonable effort to obtain third party payment, where third
party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care. 

 

	(d)	The contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.

  

	(e)	Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this
contract. 

  

					
	 NIH (RC)-11

(4/1/84)
	 		 	ATTACHMENT 6

					
		 		 	Contract No. HHSN266200600019C

  

 DISCLOSURE OF LOBBYING ACTIVITIES 

Approved by OMB 

0348-0046 

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352 

(See reverse for public burden disclosure). 
  

					
	1. Type of Federal Action:	  	2. Status of Federal Action	  	3. Report Type:
	 	 	 
	 	  		  	 
	 	 	 
	 a. contract
 b. grant
 c. Cooperative agreement
 d. loan
 e. loan guarantee
 f. loan insurance
	  	 a. bid/offer application
 b.
initial award
 c. post-award
	  	 a. initial filing
 b. material change
 For Material Change Only:

year ____ quarter _____
 date of last report
_____

							
	 4. Name and Address of Reporting
Entity:
 Prime
	  	 5. If Reporting Entity in
No.4 is Subawardee, Enter
 Name and Address of Prime

	 	 	G         Subawardee	  	 
	 	 	Tier             , if known:	  	 
	 	 
	Congressional District, if known:	  	Congressional District, if known:
	 6. Federal
Department/Agency:
	  	 7. Federal Program
Name/Description
  
 CFDA Number, if applicable:
_______________

	 8. Federal Action Number, if
known:
  
 a. Name and Address of Lobbying Entity

    (if individual, last name, first name, MI):
  

Information requested through this form is authorized by title 31 U.S.C. section. This disclosure o( lobbying activities is a material representation of
fact upon reliance was placed by the tier above when this transaction was made or into. This disclosure is required pursuant to 31 U.S.C. 1352. This information available for public inspection. Any person who fails to file the required di shall be
subject to a civil penalty of not less than $10,000 and not mo $100,000 for each failure.
  
  
	  	 9. Award Amount, if
known:
     $
  

Individual Performing Services (including address if different from No. 10a) (last name, first name, MI)

 
 Signature:___________________________________

 
 Print Name:__________________________________

 
 Title:_______________________________________

 
 Telephone No.:_____________ Date:______________

	  

Federal Use Only
	  	  

Authorized for Local Reproduction
 Standard Form
– LL (Rev 7-97)

  

					
	 Disclosure of Lobbying Activities
 SF-LLLL
	 	1	 	ATTACHMENT 7

					
		 		 	Contract No. HHSN266200600019C

  

 INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES 

This disclosure form shall be completed by the reporting entity, whether subawardee of prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing of attempting to influence an
officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action. Use the SF-LLL-A Continuation Sheet for additional information if the
space on the form is inadequate. Complete all items that apply for both the initial filing and material change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information. 

 

	1.	Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

  

	2.	Identify the status of the covered Federal action. 

  

	3.	Identify the appropriate classification of this report. If this is a follow-up report caused by a material change to the information previously reported, enter the year
and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action. 

  

	4.	Enter the full name, address, city, state and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the
reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts,
subgrants and contract awards under grants. 

  

	5.	If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address. city, state and zip code of the prime Federal
recipient. Include Congressional District, if known. 

  

	6.	Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department
of Transportation, United States Coast Guard. 

  

	7.	Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for
grants, cooperative agreements, loans, and loan commitments. 

  

	8.	Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number, Invitation for Bid
(IFB) number, grant announcement number, the contract, grant, or loan award number, the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.” 

  

					
	 Disclosure of Lobbying Activities
 SF-LLLL
	 	2	 	ATTACHMENT 7

					
		 		 	Contract No. HHSN266200600019C

  

	9.	For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime
entity identified in item 4 or 5. 

  

	10.    (a)    	Enter the full name, address, city, state and zip code of the lobbying registrant under the Lobbying Disclosure of 1995 engaged by the reporting entity identified in
item 4 to influence the covered Federal action. 

  

	 	(b)   	Enter the full names of the individual(s) performing services, and include full address if different from 10(a); Enter Last Name, First Name, and Middle Initial (MI).

  

	11.	The certifying official shall sign and date the form, print his/her name, title and telephone number. 

 

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection
of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMS 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response,
including time for reviewing instructions. searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, D.C. 20503. 

  

					
	 Disclosure of Lobbying Activities
 SF-LLLL
	 	3	 	ATTACHMENT 7

					
		 		 	Contract No. HHSN266200600019C

  

 DISCLOSURE OF LOBBYING ACTIVITIES 

CONTINUATION SHEET 
 Approved by OMB 
 0348-0046 

 

Reporting Entity:
                                       Page
         of          
  

Authorized for Local Production 

  

					
	 Disclosure of Lobbying Activities
 SF-LLLL
	 	4	 	ATTACHMENT 7

					
		 		 	Contract No. HHSN266200600019C

  

 Standard Form – LLL-A 

  

					
	 Disclosure of Lobbying Activities
 SF-LLLL
	 	5	 	ATTACHMENT 7

					
		 		 	Contract No. HHSN266200600019C

  

 EMPLOYEE SEPARATION CHECKLIST 

 

			
	Contractor:
                                         
                                       	 	Contract No.:
                                         
       
		
	Departing Staff Member’s Name:
                                         
   	 	Separation Date:
                                         
   

 Check and complete one of the columns below as appropriate: 

 

							
	 I. FRIENDLY
SEPARATION
  
	  	 II. UNFRIENDLY
SEPARATION
  

	Date
(Mandatory)	  	Action	  	Date
(Mandatory)	  	Action
	 	  	Remove all network and system access privileges.	  	 	  	Disable system access as quickly as possible preferably just before the individual is
notified of his or her dismissal.
	 	 	 	 
	 	  	Collect any authentication tokens.	  		  	Terminate access to systems immediately when an employee notifies the Department of a resignation that is on unfriendly
terms.
	 	 	 	 
	 	  	Retrieve any access cards or Departmental identification badges.	  		  	Notify support functions (e.g., help desk) that an employee is no longer authorized access.
	 	 	 	 
	 	  	Recover all keys.	  		  	Restrict the area and function of employees during the period between termination and leaving.
	 	 	 	 
	 	  	Brief employee on continuing confidentiality and privacy responsibilities.	  		  	Immediately notify the Project Officer, appropriate NIH security officials (including the NIH Help Desk at 301496-4357),
and the assigned IT Systems Manager of the time of removal.
	 	 	 	 
	 	  	Review any employee contracts that remain valid after separation.	  		  	Request the Project Officer to have the combinations changed on all locks to which the contractor employee has
access.
	 	 	 	 
	 	  	Return property belonging to the United States Government.	  		  	Collect any authentication tokens.
	 	 	 	 
	 	  	Identify any unique problems, filing schemes, or data backups created by the employee.	  		  	Retrieve any access cards or Departmental identification badges.
	 	 	 	 
	 	  	Instruct employees on proper Aclean up@ procedures for their personal computers (PC) before leaving.	  		  	Recover all keys.
	 	 	 	 
	 	  	Determine the employee’s access termination date, and notify the Project Officer, appropriate NIH security officials (including the NIH Help Desk at 301 ~496-4357), and the
assigned IT Systems Manager within 24 hours of the time of termination.	  		  	Review the employee’s duties and responsibilities under this contract with the Project Officer and assess the level of
risk to the Government.
	 	 	 	 
	 	  	Notify the Project Officer in writing upon completion of these actions.	  		  	Escort individual off premises in cases where the potential for retaliation is high.
	 	 	 	 
	 	  	 	  	 	  	Notify the Project Officer in writing upon completion of these actions.

 CERTIFICATION: By signing below, I certify that the above actions were taken on the dates indicated.

  

					
	  	 		 	  
	Signature and Date	 		 	Typed Name of Individual Authorized to Certify for Contractor
			
		 		 	 
		 		 	Title of Individual Authorized to Certify for Contractor

  

					
	 Contract Handbook – Rev. 8/4/06
 Employee Separation Checklist
	 	1	 	ATTACHMENT 8

					
		 		 	Contract No. HHSN266200600019C

  

 REPORT OF GOVERNMENT OWNED, CONTRACTOR 

HELD PROPERTY 
  

			
	CONTRACTOR:	 	CONTRACT NUMBER
		
	ADDRESS	 	REPORT DATE:
		
		 	FISCAL YEAR:

  

															
	 CLASSIFICATION
	  	BEGINNING OF
PERIOD	  	ADJUSTMENTS	  	END OF PERIOD
	 	  	#
ITEMS	  	VALUE	  	GFP
ADDED	  	CAP
ADDED	  	DELETIONS	  	#
ITEMS	  	VALUE
	 LAND > = $25K
	  		  		  		  		  		  		  	
	 LAND < = $25K
	  		  		  		  		  		  		  	
	 OTHER REAL > = $25K
	  		  		  		  		  		  		  	
	 OTHER REAL < = $25K
	  		  		  		  		  		  		  	
	 PROPERTY UNDER CONST > = $25K
	  		  		  		  		  		  		  	
	 PROPERTY UNDER CONST < = $25K
	  		  		  		  		  		  		  	
	 PLANT EQUIP > = $25K
	  		  		  		  		  		  		  	
	 PLANT EQUIP < = $25K
	  		  		  		  		  		  		  	
	 SPECIAL TOOLING>= $25K
	  		  		  		  		  		  		  	
	 SPECIAL TOOLING<= $25K
	  		  		  		  		  		  		  	
	 SPECIAL TEST EQUIP>$25K
	  		  		  		  		  		  		  	
	 SPECIAL TEST EQUIP<$25K
	  		  		  		  		  		  		  	
	 AGENCY PECULIAR> =$25K
	  		  		  		  		  		  		  	
	 AGENCY PECULIAR< =$25K
	  		  		  		  		  		  		  	
	 MATERIAL> =$25K (CUMULATIVE)
	  		  		  		  		  		  		  	
	 PROPERTY UNDER MFR>=$25K
	  		  		  		  		  		  		  	
	 PROPERTY UNDER MFR>=$25K
	  		  		  		  		  		  		  	
			
	 SIGNED BY:
	  		  	DATE SIGNED:

  

					
	 Contract Handbook – Rev. 8/4/06
 Report of Government Owned,
 Contractor Held Property
	 		 	ATTACHMENT 9

					
	DEPARTMENT OF HEALTH & HUMAN SERVICES	 	Public Health Service

  
  

 

			
	 	 	National Institutes of Health (NIH)
	Phone: 301-496-0612	 	National Institute of Allergy and Infectious Diseases (NIAID)
	Fax: 301-480-5253	 	Office of Acquisitions, DEA
	http://www.niaid.nih.gov/	 	6700B Rockledge Drive, Room 3214
		 	Bethesda, MD 20892-7612

 June 21, 2007 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 

	Subject:	Contract No.: NO1-AI-60019 

	    	Modification No. 1 

 Dear Mr. Abbey:

 The purpose of this modification is to revise the contract article that describes the process for submitting invoices for payment. An e-mail
was sent to your organization’s business representative. The NIH has launched a new business system. This system requires a change to the current invoice submission procedures. All contracts are being modified to reflect these new procedures.

 Effective June 4, the Office of Financial Management (OFM), NIH, is the official point of receipt for invoices (details included in the
enclosed modification). All original invoices must be sent to the OFM where they will be received, processed and forwarded to the designated Institute for review and approval. Failure to follow the new instructions may result in the return of your
invoice. Please note that the NIAID is not requiring the receipt of duplicate copies by our contract specialists. 
 I am enclosing an
executed copy of the subject modification for your retention. If you have any questions regarding its administration, please contact the undersigned at (301) 451-3691. 

 

	
	Sincerely,
	
	/s/ Cassandra Ellis
	Cassandra Ellis
	Contract Specialist

 Enclosure: a/s 

 OMB Approval 2700-0042 

																							
	AMENDMENT 
OF SOLICITATION/MODIFICATION OF CONTRACT	  	 1.   CONTRACT ID
CODE
	  	PAGE      OF PAGES
	  	 	  	 	  	 	  	1	  	2
	 	 	 	 
	 2.   AMENDMENT/MODIFICATION NO.
  

      One (1)
	  	
3.   EFFECTIVE DATE

 

      06/04/2007
	  	
4.   REQUISITION/PURCHASE REQ. NO
	  	 5.   PROJECT NO. (If applicable)

	 	 	 	 	 	 
	 6.   ISSUED BY
	  	CODE    	  	 	  	 7.   ADMINISTERED BY (IF OTHER THAN ITEM 6)
	  	 CODE
	  	 
			 	 	 
	
      Office of Acquisitions, DEA, NIAID

      National Institutes of Health, DHHS

      Room 3214, MSC 7612

      6700-B Rockledge Drive

      Bethesda, MD 20892-7612
	  	 	  	 	  	 	  	 
	 8.   NAME AND ADDRESS OF CONTRACTOR (No., Street, County,
State, and Zip Code)
	  	( ̈)	  	 9A.  AMENDMENT OF SOLICITATION NO.

	       Argos Therapeutics, Inc.

      4233 Technology Drive

      Durham, NC 27704
	  	 	  	
	  		  	 9B.   DATED (SEE ITEM
11)
  

	  		  	 10A.MODIFICATION OF CONTRACT/ORDER
NO.
  

        N01-AI-60019

	 	  	 	  	X	  	
10B.DATED (SEE ITEM 11)
  

        September 30, 2006

	CODE	  	FACILITY CODE	  	  
	
	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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an
offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 

									
	 
	 12. ACCOUNTING AND APPROPRIATION DATA
(If Required)
  

    N/A

	
	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14

	
( ̈)
	  	 A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

	 	  	 
	 X
	  	 B.    THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO
REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	 	  	 C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO
PURSUANT TO AUTHORITY OF:

	 	  	 D.    OTHER (Specify type of modification and
authority)

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

	
	 14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
  
 PURPOSE: To modify the invoicing instructions for the contract.
  

TOTAL ESTIMATED COST: $[**] (Unchanged)

TOTAL FUNDS ALLOTTED: $[**] (Unchanged)

 
 FUNDED THROUGH: September 29, 2007
(Unchanged)
 COMPLETION DATE: September 29, 2011 (Unchanged)

	
	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 pint)

 
 Michelle L. Scala
 Contracting Officer, OA, NIAID, NIH, DHHS

	 15B.   CONTRACTOR/OFFEROR
	  	 15C.   DATE SIGNED
	  	 16B.   UNITED STATES OF
AMERICA
  
 BY /s/ Michelle L.
Scala                                        

	  	 16C.   DATE SIGNED

 

        6/25/07

	(Signature of person authorized
to sign)	  	 	  	(Signature of Contracting Officer)	  	 

					
			
	NSN 7540-01-152-8070	  	30-105	  	STANDARD FORM 30 (REV. 10-83)
	PREVIOUS EDITION UNUSABLE	  	Computer Generated	  	 Prescribed by GSA
 FAR (48 CFR)
53.

					
	 Contract No. N01-AI-60019

Modification No. 1
	 	Special Provisions	 	Page 2 of 2

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

	a.	Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 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 as follows: 

 One original 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 
  

	 	(2)	In addition to the requirements specified in FAR Subpart 32.9 for a proper invoice, the Contractor shall include the following information on all payment requests:

  

	 	(a)	Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID. 

 

	 	(b)	Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices. 

 

	 	(c)	Vendor Identification Number: 1109171. 

  

	 	(d)	DUNS number or DUNS+4 that identifies the Contractor’s name and address exactly as stated on the face page of the contract. 

 

	 	(e)	Identification of whether payment is to be made using a two-way or three-way match. This contract requires a two-way match. 

 

	 	b.	Inquiries regarding payment shall be directed to the designated billing office, (301) 496-6088. 

SECTION J – Attachment 2, Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts
NIH(RC)-4 is hereby replaced with the following updated attachment. 

  
 HHS-556 

 INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH COST-REIMBURSEMENT
CONTRACTS, NlH(RC)-4 
 Format: Payment requests shall be submitted 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: Payment requests shall be submitted 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 when authorized by the Contracting Officer. 

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 site the amount(s) and month(s) in which it incurred such costs. 
 Contractor’s Fiscal Year: Payment requests shall be prepared 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 may not exceed the United States dollars authorized. 
 Costs Requiring Prior Approval:
Costs requiring the Contracting Officer’s approval, which are not set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the
Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request. 
 Invoice/Financing
Request Identification: Each payment request shall be identified as either: 
  

	(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). 

  

			
	NIH(RC)-4	  	Attachment 2
	Rev. 05/2007	  	Page 1 of 6

 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. 
  

	(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). For incrementally funded contracts/orders, enter the amount currently obligated and available for
payment. 

  

	(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. 

  

			
	NIH(RC)-4	  	Attachment 2
	Rev. 05/2007	  	Page 2 of 6

	(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. 

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) 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. Do not include in this category fringe benefits that are
included in indirect costs. 

  

	 	(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 Control 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. An asterisk (*) shall precede the item 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 

 

	 	•	 	 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. 

  

			
	 NIH(RC)-4
 Rev.
05/2007
	 	 Attachment 2
 Page 3 of 6

	 	(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. 

 

	 	(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. 

  

	(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.

  

	(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: 

 “I hereby certify that the
salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.” 

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

  

			
	 NIH(RC)-4
 Rev.
05/2007
	 	 Attachment 2
 Page 4 of 6

 FINANCIAL REPORTING INSTRUCTIONS: 
 These instructions are keyed 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.

 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 (Funds) Clause of the contract. 
 Modifications: Any modification in the amount negotiated for an item since the preceding report should be listed 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. 

  

			
	 NIH(RC)-4
 Rev.
05/2007
	 	 Attachment 2
 Page 5 of 6

 SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT 

 

			
	 (a)    Designated Billing Office Name and Address:
	  	 (c)    Invoice/Financing Request No.:

		 
	 National Institutes of Health Office of Financial Management Commercial Accounts
	  	 (d)    Date Invoice Prepared:

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

	 2115 East Jefferson Street, Room 4B432, MSC 8500

Bethesda, MD 20892-8500
	  	 (f)     Effective Date:

	 (b)    Contractor’s Name, Address, Point of Contact, VIN, and
DUNS or DUNS+4 Number:
	  	 (g)    Total Estimated Cost of Contract/Order:

		 
	 ABC CORPORATION
	  	 (h)    Total Fixed-Fee (if applicable):

	 100 Main Street
 Anywhere, USA Zip Code
	  	  

(i)     Two-Way
Match:   ̈    Three-Way Mate   ̈

		 
		  	 (j)     Office of Acquisitions:

		 
	 Name, Title, Phone Number, and E-mail Address of 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.
	  	 (k)    Central Point of Distribution:

		 
	 VIN:

DUNS or DUNS+4:
  
	  	 

	(I)	This invoice/financing request represents reimbursable costs for the period from             
to 

															
	  	  	Cumulative Percentage of
Effort/Hrs.	  	Amount Billed	  	Cost at
Completion
F	  	Contract
Amount
G	  	Variance
H
	 Expenditure Category*

            A
	  	Negotiated
B	  	Actual
C	  	(m)
Current
D	  	
(n)

Cumulative

E
	  	  	  
	 (o)
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
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (p) Cost
of Money
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (q)
Indirect Costs
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (r) Fixed
Fee
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (s) Total
Amount Claimed
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (t)
Adjustments
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
	 (u) Grand
Totals
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
			
	I certify that all payments are for appropriate purposes and in accordance with the contract.	  		  	
			
	
                  
                                         
                                         
                    

            (Name of
Official)                                 (Title)
	  		  	

  

	*	Attach details as specified in the contract 

  

  

			
	 NIH(RC)-4
 Rev.
05/2007
	 	 Attachment 2
 Page 6 of 6

			
	DEPARTMENT OF HEALTH & HUMAN SERVICES	  	Public Health Service

  
  

 

			
		  	National Institutes of Health (NIH)
	 Phone: 301-496-0612
 Fax:
301-480-5253
 http://www.niaid.nih.gov/
	  	 National Institute of Allergy and Infectious Diseases (NIAID)
 Office of Acquisitions, DEA
 6700B Rockledge Drive, Room 3214

Bethesda, MD 20892-7612

 August 20, 2007 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 

			
	Subject:	  	 Contract No.: HHSN266200600019C/ NO1-AI-60019
 Modification No. 2

 Dear Mr. Abbey: 
 I am enclosing an executed copy of the subject modification for your retention. If you have any questions regarding its administration, please contact the undersigned at (301) 451-0612. 

 

	
	Sincerely,
	
	/s/ Michelle L. Scala
	 Michelle L. Scala

Contracting Officer

	
	Enclosure: a/s

 OMB Approval 2700-0042 

 

																							
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	  	 1. CONTRACT ID CODE
	  	PAGE     OF PAGES
	  		  		  		  	1    	  	2
	 2. AMENDMENT/MODIFICATION NO.

 
 Two (2)
	  	 3. EFFECTIVE DATE

 
 See Block 16C
	  	 4. REQUISITION/PURCHASE REQ. NO

 
 48159
	  	5. PROJECT NO. (If applicable)
	6. ISSUED BY	  	CODE    	  	 	  	7. ADMINISTERED BY (IF OTHER THAN ITEM 6)	  	CODE    	  	 
	  
 Office of Acquisitions, DEA,
NIAID
 National Institutes of Health, DHHS
 Room 3214, MSC 7612
 6700-B Rockledge Drive

Bethesda, MD 20892-7612
	  	  
 AIDS
RCB

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

	  
 Argos Therapeutics,
Inc.
 4233 Technology Drive
 Durham, NC 27704
	  	 	  	
	  		  	 9B. DATED (SEE ITEM 11)

 

	  	 	  	 10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSN266200600019C/N01-AI-60019

	  	X	  	 10B. DATED (SEE ITEM
13)
         September 30, 2006

	 CODE
	  	 	  	 	  	FACILITY CODE	  	 	  
	
	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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already
submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 

 

									
	 12.ACCOUNTING AND APPROPRIATION DATA (If
Required)
 EIN: 1-56-211007-AI SOCC: 255.55 CAN: 7-8470035 Amount: $[**]

	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14

	 ( ̈)
	  	 A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

	 	  	
	 	  	 B.    THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO
REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	 	  	 C.    THIS SUPPLEMENTAL
AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
  

	 X
	  	 D.    OTHER (Specify
type of modification and authority)
 FAR 1.602-1; FAR 52.232-22, Limitation of Funds; and Public Law 110-005

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

	
	 14. DESCRIPTIONOF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
  
 PURPOSE: To provide FY 07 incremental funding and update provisions in Section H.

  

																									
	 	  	TOTAL FUNDS ALLOTTED	 	    	TOTAL ESTIMATED COSTS	 
	 	  	Cost	 	  	Fixed Fee	 	  	Total CPFF	 	    	Cost	 	  	Fixed Fee	 	  	Total CPFF	 
	 Prior to this mod
	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  	    	 	[**]	  	  	 	[**]	  	  	 	[**]	  
	 This mod. No. 2
	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  	    	 	-	  	  	 	-	  	  	 	-	  
		  				  				  				    	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total
	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  	    	 	[**]	  	  	 	[**]	  	  	 	[**]	  

  

			
	 TOTAL ESTIMATED COST: $[**] (Unchanged)
	  	FUNDED THROUGH: September 29, 2008 (Changed)
	 TOTAL FUNDS ALLOTTED: $[**] (Changed)
	  	COMPLETION DATE: September 29, 2011 (Unchanged)

  

							
	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. NAMEAND TITLE OF CONTRACTING OFFICER (Type or pint)
Michelle L. Scala
Contracting Officer, OA, NIAID, NIH,
DHHS
	 15B. CONTRACTOR/OFFEROR
	  	 15C.DATE SIGNED
	  	16B.UNITED STATES OF AMERICA  

BY /s/ Michelle L. Scala                 
   
	  	 16C. DATE SIGNED

 
 8/16/07

	  

(Signature of person authorized to sign)
	  	 	  	(Signature of Contracting Officer)	  	 

					
			
	NSN 7540-01-152-8070	  	30-105	  	STANDARD FORM 30 (REV. 10-83)
	PREVIOUS EDITION UNUSABLE	  	Computer Generated	  	Prescribed by GSA
FAR (48 CFR) 53.

					
	 Contract No. N01-AI-60019
 Modification No: 2
	  	SPECIAL PROVISIONS	  	Page 2 of 2

 ARTICLE
B.2. ESTIMATED COST AND FIXED FEE, paragraphs d. and e., are hereby read as follows: 
  

	 	d.	Total funds currently available for payment and allotted to this contract are hereby increased by $[**] from $[**] to $[**]; of which $[**] represents an increase to
the estimated cost from $[**] to $[**]; and of which $[**] represents an increase to the fixed fee from $[**] to $[**]. 

  

	 	e.	It is estimated that the amount currently allotted will cover performance of the contract through September 29, 2008. 

ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH, paragraph b. is hereby modified to add the following: 

 

							
	b.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		 	P.L. 110-005*	  	2007	  	10/01/06 - 09/30/07

  

	*	Public Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the legislative provisions provided in the FY 2006 Appropriations Act (Public Law
109-149) through the end of FY 2007. 

 ARTICLE H.7. NEEDLE EXCHANGE, paragraph b. is hereby modified to add the
following: 
  

							
	b.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		 	P.L. 110-005*	  	2007	  	10/01/06 - 09/30/07

  

	*	Public Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the legislative provisions provided in the FY 2006 Appropriations Act (Public Law
109-149) through the end of FY 2007. 

 ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS, paragraphs
b. and c. are hereby modified to add the following: 
  

							
	b.	 	Public Law No.	  	Fiscal Year	  	Salary Limitation*
		 	P.L. 110-005*	  	2007	  	Executive Level I

  

	*	Public Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the legislative provisions provided in the FY 2006 Appropriations Act (Public Law
109-149) through the end of FY 2007. Therefore, the provision that restricts the amount of direct salary to Executive Level I of the Federal Executive Pay Scale continues through FY 2007. The Executive Level I annual salary rate was $183,500 for the
period January 1 through December 31, 2006. Effective January 1, 2007, the Executive Level 1 salary rate increased to $186,600. 

  

	c.	Payment of direct salaries is limited to the Executive Level I rate which was in effect on the date(s) the expense was incurred. 

 

	NOTE:	All prior Public Laws and related Executive Levels incorporated in the Basic Award and all previous Modifications shall remain in effect for the applicable fiscal
year and related funds. 

 ARTICLE H. 16. PRESS RELEASES, paragraph b., is hereby modified to add the
following: 
  

							
	b.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		 	P.L. 110-005*	  	2007	  	10/01/06 - 09/30/07

  

	*	Public Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the legislative provisions provided in the FY  2006 Appropriations Act (Public
Law 109-149) through the end of FY 2007. 

 ARTICLE H.18. ANTI-LOBBYING. paragraph c., is hereby modified to add
the following: 
  

							
	c.	 	Public Law and Section No.	  	Fiscal Year	  	Period Covered
		 	P.L. 110-005*	  	2007	  	10/1/06 - 9/30/07

  

	*	Public Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the legislative provisions provided in the FY2006 Appropriations Act (Public Law
109-149) through the end of FY 2007. 

  

			
	DEPARTMENT OF HEALTH & HUMAN SERVICES	  	Public Health Service

  

 
  

			
	 	  	National Institutes of Health (NIH)
	 Phone: 301-496-0612
	  	National Institute of Allergy and Infectious Diseases (NIAID)
	 Fax: 301-480-5253
	  	Office of Acquisitions, DEA
	 http://www.niaid.nih.gov/
	  	6700B Rockledge Drive, Room 3214
		  	Bethesda, MD 20892-7612

 September 19, 2008 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 

			
	Subject:	  	 Contract No.: N01-AI-60019

Modification No. 3

 Dear Mr. Abbey: 
 Enclosed is an executed copy of the referenced modification for your retention. Should you have any questions regarding its administration, please contact Jason Bell, Contract Specialist, at
belljas@niaid.nih.gov or write to: 
 Contracting Officer 

Office of Acquisitions, DEA 
 National Institute of Allergy and Infectious Diseases 
 National Institutes of
Health, DHHS 
 6700-B Rockledge Drive 
 Room 3214, MSC 7612 
 Bethesda, Maryland 20892-7612 

 

	
	Sincerely,
	
	  
	Michelle L. Scala

 Michelle L. Scala 
 Contracting Officer 
 Office of Acquisitions 

AIDS Research Contracts Branch 
 National
Institute of Allergy 
 and Infectious Diseases 
 Enclosure 

 OMB Approval 2700-0042         

 

																							
	AMENDMENT OF SOLICITATION/MODIFICATION OF
CONTRACT	  	 1.   CONTRACT ID CODE
	  	PAGE      OF PAGES
	  	 	  	 	  	 	  	1	  	1
	
2.   AMENDMENT/MODIFICATION NO.

 
       Three
(3)
	  	
3.   EFFECTIVE DATE

 

      09/09/2008
	  	
4.   REQUISITION/PURCHASE REQ. NO
	  	 5.   PROJECT NO. (If
applicable)

	 6.   ISSUED BY
	  	CODE  	  	 	  	 7.   ADMINISTERED BY (IF OTHER THAN ITEM 6)
	  	 CODE
	  	 
			 	 	 
	
      Office of Acquisitions, DEA, NIAID

      National Institutes of Health, DHHS

      Room 3214, MSC 7612

      6700-B Rockledge Drive

      Bethesda, MD 20892-7612
	  	 	  	 	  	 	  	 
	 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State,
and Zip Code)
  
 Argos Therapeutics, Inc.

4233 Technology Drive
 Durham, NC 27704
	  	( ̈)  	  	 9A.  AMENDMENT OF SOLICITATION
NO.

	  	 	  	 9B.   DATED (SEE ITEM
11)

		  		  		  		  		  	 	  	
10A.MODIFICATION OF CONTRACT/ORDER NO.

 

        N01-AI-60019

		  		  	X  	  	
10B.DATED (SEE ITEM 13)
  

        September 30, 2006

	CODE	  	FACILITY CODE	  	  
	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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an
offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 

									
	
12. ACCOUNTING AND APPROPRIATION DATA (If Required)

 
     N/A

	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14

	
( ̈)
	  	 A.        THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify
authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

	 	  	 	  	 	  	 	  	 
	 X
	  	 B.         THE ABOVE NUMBERED
CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	 	  	
C.         THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO
AUTHORITY OF:
  

	 	  	
D.         OTHER (Specify type of modification and
authority)
  

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

	
	 14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
  
 PURPOSE: To modify an internal accounting administrative change for the contract.
  

TOTAL ESTIMATED COST: $[**] (Unchanged)

TOTAL FUNDS ALLOTTED: $[**] (Unchanged)

 
 FUNDED THROUGH: September 29, 2008
(Unchanged)
 COMPLETION DATE: September 29, 2011 (Unchanged)

	
	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 pint)

 
 Michelle L. Scala
 Contracting Officer, OA, NIAID, HIH, DHHS

	 15B.   CONTRACTOR/OFFEROR
	  	 15C.   DATE SIGNED
	  	 16B.   UNITED STATES OF AMERICA

 
 BY /s/ Michelle L.
Scala                                        

	  	 16C.   DATE SIGNED

 

        9/19/08

	(Signature of person authorized to sign)	  	 	  	(Signature of Contracting Officer)	  	 

					
			
	NSN 7540-01-152-8070	  	30-105	  	STANDARD FORM 30 (REV. 10-83)
	PREVIOUS EDITION UNUSABLE	  	Computer Generated	  	 Prescribed by GSA
 FAR (48 CFR)
53.

					
	DEPARTMENT OF HEALTH & HUMAN SERVICES	  		  	Public Health Service

  
  

			
		  	National Institutes of Health (NIH)
	 Phone: 301-496-0612
	  	National Institute of Allergy and Infectious Diseases (NIAID)
	 Fax: 301-480-5253
	  	Office of Acquisitions, DEA
	 http://www.niaid.nih.gov/
	  	6700B Rockledge Drive, Room 3214
		  	Bethesda, MD 20892-7612

 September 24, 2008 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 

					
	 Subject:
	  	 Contract No.: N01-AI-60019

Modification No. 4
	  	

 Dear Mr. Abbey: 
 Enclosed is an executed copy of the referenced modification for your retention. Should you have any questions regarding its administration, please contact Jason Bell, Contract Specialist, at
belljas@niaid.nih.gov or write to: 
 Jason Bell 
 Contract Specialist 
 Office of Acquisitions, DEA 

National Institute of Allergy and Infectious Diseases 
 National Institutes of Health, DHHS 
 6700-B Rockledge Drive 

Room 3214, MSC 7612 
 Bethesda, Maryland 20892-7612 
 Sincerely, 

	
	
	/s/ Matthew Gormley
	 Matthew Gormley
 Contracting
Specialist
 Office of Acquisitions

Division of AIDS Research Contracts Branch

National Institute of Allergy and Infectious Diseases

 Enclosure 

 OMB Approval 2700-0042         

 

																							
	AMENDMENT OF
SOLICITATION/MODIFICATION OF CONTRACT	  	 1.   CONTRACT ID CODE

      N/A
	  	PAGE      OF PAGES
	  	  	1	  	4
	 2.   AMENDMENT/MODIFICATION NO.
  

      Four (4)
	  	 3.   EFFECTIVE DATE
  

      See Block 16C
	  	 4.   REQUISITION/PURCHASE REQ. NO
  

      755503
	  	
5.   PROJECT NO. (If applicable)

 

      N/A

	 6.   ISSUED BY
	  	CODE  	  	 	  	 7.   ADMINISTERED BY (IF OTHER THAN ITEM
6)
	  	
        CODE  
	  	
    N/A

	 	 
	       Office of Acquisitions, DEA
       National Institutes of Allergy and Infectious Diseases
       National Institutes of Health, DHHS
       Room 3214, MSC 7612

      6700-B Rockledge Drive

      Bethesda, MD 20892-7612
	  	       AIDS-RCB

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

	 Argos Therapeutics, Inc.

4233 Technology Drive
 Durham, NC 27704
	  	 	  	 
	  	 	  	
9B.   DATED (SEE ITEM 11)

 

	  	 	  	
10A. MODIFICATION OF CONTRACT/ORDER NO.

 

        HHSN266200600019C

	 	  	 	  	X  	  	
10B. DATED (SEE ITEM 13)

 

        September 30, 2006

	CODE	  	FACILITY CODE	  	  
	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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an
offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 

									
	
12. ACCOUNTING AND APPROPRIATION DATA (If Required)

 
     EIN:
1-56-211007-A1        SOC: 25.55        CAN 8-8470035        AMOUNT $[**]

	
	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14

		 
	
( ̈)
	  	 A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

	 	  	 
		 
	 	  	 B.    THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO
REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

		 
	 	  	 C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO
PURSUANT TO AUTHORITY OF:

		 
	X	  	 D.    OTHER (Specify
type of modification and authority)
  
 FAR 52.232-22, Limitation of Funds;
and P.L. 110-161

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

	
	 14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
  
 PURPOSE: To provide incremental funding and update provisions in Sections B and H.

 

													
	 	  	TOTAL FUNDS ALLOTTED	 
	 	  	Cost	 	 	Fixed Fee	 	 	Total CPFF	 
	 Prior to this mod:
	  	 	[	**] 	 	 	[	**] 	 	 	[	**] 
	 This mod. No. 4:
	  	 	[	**] 	 	 	[	**] 	 	 	[	**] 
	 Total
	  	 	[	**] 	 	 	[	**] 	 	 	[	**] 

  

			
	TOTAL ESTIMATED COST: $[**] (Unchanged)	  	FUNDED THROUGH: March 31, 2010 (Changed)
	TOTAL FUNDS ALLOTTED: $[**](Changed)	  	COMPLETION DATE: September 29, 2011 (Unchanged)

									
	
	
	
	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 pint)
  
 Eileen Webster-Cissel

Contracting Officer, OA, NIAID, NIH, DHHS

	 15B.   CONTRACTOR/OFFEROR
	  	 15C.   DATE SIGNED
	  	 16B.   UNITED STATES OF AMERICA

 
 BY /s/ Eileen Webster-Cissel
                                        

	  	 16C.   DATE SIGNED

 

        9/24/08

	(Signature of person authorized to sign)	  	 	  	(Signature of Contracting Officer)	  	 

					
			
	NSN 7540-01-152-8070	  	30-105	  	STANDARD FORM 30 (REV. 10-83)
	PREVIOUS EDITION UNUSABLE	  	Computer Generated	  	 Prescribed by GSA
 FAR (48 CFR)
53.

					
	 Contract No. N01-AI-60019
 Modification No: 4
	  	SPECIAL PROVISIONS	  	Page 2 of 4

  

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE CONTRACT IS HEREBY REVISED AS FOLLOWS:

 ARTICLE B.2. ESTIMATED COST AND FIXED FEE, paragraphs d, e., and f., are hereby modified to read as follows: 

 

	 	d.	Total funds currently available for payment and allotted to this contract are hereby increased from $[**] to $[**]; a net increase of $[**]; of which $[**] represents
an increase to the estimated cost from $[**] to $[**]; and of which $[**] represents an increase to the fixed fee from $[**] to $[**]. 

  

	 	e.	It is estimated that the amount currently allotted will cover performance of the contract through March 31, 2010. 

 

	 	f.	The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor. Future increments to be allotted to this contract are
estimated as follows: 

  

							
	 Period
	  	Estimated
Cost	 	Fixed
Fee	 	Total
CPFF
	 09/30/09-09/29/10
	  	[**]	 	[**]	 	[**]
	 09/30/10-09/29/11
	  	[**]	 	[**]	 	[**]

 ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH is deleted in its entirety and replaced
with: 
 Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds for (1) the creation of a human
embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act,
that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. 

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings. 

ARTICLE H.7. NEEDLE EXCHANGE is deleted in its entirety and replaced with: 
 Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any
illegal drug. 
 ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS is deleted in its entirety and replaced with:

 Pursuant to the current HHS annual appropriations act, the Contractor shall not use NIH Fiscal Year funds to pay the direct
salary of an individual through this contract at a rate in excess of Executive Level I. Direct salary is exclusive of fringe benefits, overhead and general and administrative expenses (also referred to as “indirect costs” or
“facilities and administrative (F&A) costs”). Direct salary has the same meaning as the term “institutional base salary.” An individual’s direct salary (or institutional base salary) is the annual compensation that the
Contractor pays for an individual’s appointment whether that individual’s time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be
permitted to earn outside of duties to the Contractor. The annual saiary rate limitation also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject
to unilateral modifications by the Government if an individual’s salary rate used to establish contract funding exceeds any salary rate limitation subsequently established in future HHS appropriation acts. 

  

					
	 Contract No. N01-AI-60019
 Modification No: 4
	  	SPECIAL PROVISIONS	  	Page 3 of 4

  

	b.	Payment of direct salaries is limited to the Executive Level I rate which was in effect on the date(s) the expense was incurred. See the following Web site for
Executive Schedule rates of pay: http://www.opm,qov/oca/. (For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages / cursor to
bottom of page and select year / Executive Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.) 

 

			
	 NOTE:
	 	All prior Public Laws and related Executive Levels incorporated in the Basic Award and all previous Modifications shall remain in effect for the applicable fiscal year and
related funds.

 ARTICLE H.16. PRESS RELEASES is deleted in its entirety and replaced with: 

Pursuant to the current HHS annual appropriations act, the Contractor shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money;
(2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. 

ARTICLE H.18. ANTI-LOBBYING is deleted in its entirety. It is now covered under HHSAR Clause 352.270-10, incorporated in ARTICLE 1.1.

 THE FOLLOWING ARTICLES ARE RENUMBERED AS A RESULT OF THE ABOVE CHANGES: 
 ARTICLE H.19. SHARING RESEARCH DATA, is renumbered to read ARTICLE H18.  
 ARTICLE
H.20. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990, is renumbered to read ARTICLE H.19.  
 ARTICLE H.21. NIH POLICY ON ENHANCING PUBLIC
ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH, is renumbered to read ARTICLE H.20. 
 THE FOLLOWING NEW ARTICLES ARE
HEREBY ADDED TO THIS CONTRACT IN COMPLIANCE WITH THE CONTINUING LEGISLATIVE MANDATES FOR FY2008 (P.L. 110-161). 
 ARTICLE H.21.
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION 
 Pursuant to the current HHS annual appropriations act, the
Contractor shall not use contract funds to disseminate scientific information that is deliberately false or misleading. 
 ARTICLE H.22.
RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS 
 Pursuant to the current HHS annual appropriations act, the Contractor shall
not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows: 

“(3) Definition of unauthorized alien.-As used in this section, the term ‘unauthorized alien’ means, with respect to the employment of an
alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.” 

ARTICLE H.23. RESTRICTION ON ABORTIONS 
 Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds for any abortion. 
 ARTICLE H.24. REGISTRATION OF CLINICAL TRIALS IN THE GOVERNMENT DATABASE (ClinicalTrials.gov) 
 Pursuant to Public Law 110-85, Food and Drug Administration Amendments Act of 2007, Title Vlll-Clinical Trial Databases, the Contractor shall register the clinical trial(s) performed under this contract
in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov ) by the later of December 27, 2007, or 21 days after the first patient is enrolled. 

  

					
	 Contract No. N01-AI-60019
 Modification No: 4
	  	SPECIAL PROVISIONS	  	Page 4 of 4

  

 Additional information is available at: http://prsinfo.ciinicaltrials.gov . 

THE FOLLOWING SECTON I ARTICLE IS UPDATED IN COMPLIANCE WITH PUBLIC LAW (P.L.) 110-161: 
 ARTICLE I.1. GENERAL CONTRACT CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT, subparagraph b., is revised to add the following clause: 

HHSAR Clause No. 352.270-10, Jan 2006, Anti-Lobbying 
 END OF MODIFICATION #4 CONTRACT NO. HHSN266200600019C 

  

			
	DEPARTMENT OF HEALTH & HUMAN SERVICES	  	Public Health Service

  
  

 

			
	 National Institutes of Health (NIH)
	  	
	 Phone: 301-496-0612
	  	National Institute of Allergy and Infectious Diseases (NIAID)
	 Fax: 301-480-4675
	  	Office of Acquisitions, DEA
	http://www.niaid.nih.gov/	  	6700B Rockledge Drive, Room 3214
		  	Bethesda, MD 20892-7612

 July 17, 2009 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 

	Subject:	    Contract No. N01-AI-60019 

 Modification No. 5 
 Dear Mr. Abbey: 

Enclosed is an executed copy of the referenced modification for your retention. Should you have any questions regarding its administration, please contact
Jason Bell, Contracting Officer Representative, at belljas@niaid.nih.gov or write to: 
 Sincerely, 

	
	
	  
	Jason Bell

 Contracting Officer Representative 
 Office of Acquisitions, DEA 
 National Institute of Allergy and Infectious Diseases 

National Institutes of Health, DHHS 
 6700-B
Rockledge Drive 
 Room 3214, MSC 7612 

Bethesda, Maryland 20892-7612 
 Enclosure

 OMB Control
No. 2700-0042                                      
   

																							
	AMENDMENT OF
SOLICITATION/MODIFICATION OF CONTRACT	  	
1.   CONTRACT ID CODE

N/A
	  	PAGE    OF PAGES
	  	  	1	  	3
	
2.   AMENDMENT/MODIFICATION NO.

 
       Five
(5)
	  	
3.   EFFECTIVE DATE

 
       See
Block 16C
	  	
4.   REQUISITION/PURCHASE REQ. NO
	  	
5.   PROJECT NO. (If applicable)
 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

      Room 3214, MSC 7612

      6700-B Rockledge Drive

      Bethesda, MD 20892-7612
	  	AIDS-RCB
	 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, county, State, and ZIP
Code)
	  	(X)  	  	 9A.  AMENDMENT OF SOLICITATION NO.

	 Argos Therapeutics, Inc.

4233 Technology Drive
 Durham, NC 27704
	  	 	  	
	  		  	 9B.   DATED (SEE ITEM
11)
  

	  	X  	  	
10A.MODIFICATION OF CONTRACT/ORDER NO.

 

        HHSN266200600019C

	  	 	  	
10B. DATED (SEE ITEM 13)

 

        September 30, 2006

	CODE	  	FACILITY CODE	  	  
	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)

 
     N/A

	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14

	 (X)
	  	 A.        THIS CHANGE
ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

	 	  
	 	  	 B.         THE ABOVE NUMBERED
CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	 	  	 C.         THIS SUPPLEMENTAL
AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

	 X
	  	
D.         OTHER Specify type of modification and
authority)
 Public Law (P.L.) 111-8 and P.L. 110-85

 

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

	 14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
  
 PURPOSE: To update provisions in Sections H and I.4
  

TOTAL ESTIMATED COST: $[**] (Unchanged)

TOTAL FUNDS ALLOTTED: $[**] (Unchanged)

 
 FUNDED THROUGH: March 29, 2010
(Unchanged)
 COMPLETION DATE: September 29, 2011 (Unchanged)

	
	Except at 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)
  
 Michelle L. Scala

Contracting Officer, OA, DEA, NIAID, NIH, DHHS

													
	15B. CONTRACTOR/OFFEROR	 	 	  	15C. DATE SIGNED	  	16B. UNITED STATES OF AMERICA	  	16C. DATE SIGNED
				 		 	
		 		 		  	 	  	BY	  	/s/ Michelle L. Scala	  	7/17/09
	 	 	(Signature of person authorized to sign)	 	 	  	 	  	 	  	(Signature of Contracting Officer)	  	 
		 		 		  		  		  		  	

  

											
	 NSN 7540-01-152-8070

30 (REV. 10-83)
 PREVIOUS EDITION
UNUSABLE
	  	 30-105
  

Computer Generated
	  	 STANDARD FORM
  

Prescribed by GSA
 FAR (48 CFR)
53.243

  

					
	 Contract No. N01-AI-60019

Modification No: 5
	  	SPECIAL PROVISIONS	  	Page 2 of 3

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE CONTRACT IS HEREBY REVISED AS FOLLOWS: 

ARTICLE H.25. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH is added as follows:

 NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the
author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication,
and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic
submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov. 
 Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html 
 THE FOLLOWING ARTICLE IS ADDED IN COMPLIANCE WITH PUBLIC LAW
(P.L.) 110-85: 
 ARTICLE 1.4. ADDITIONAL FAR CONTRACT CLAUSE INCLUDED IN FULL TEXT, is modified to
add 
 This contract incorporates the following clause in full text. 
 FAR Clause 52.219-28, Post-Award Small Business Program Representation (April 2009). (a) Definitions. As used in this clause— 

Long-term contract means a contract of more than five years in duration, including options. However, the term does not include
contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority. 

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the
field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is “not dominant in its field
of operation” when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration
shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales
territory, and nature of business activity. 
 (b) If the Contractor represented that it was a small business concern prior to
award of this contract, the Contractor shall represent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following: 

 (1) Within 30 days after execution of a novation agreement or within 30 days after
modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract. 
 (2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred
prior to inclusion of this clause in the contract. 
 (3) For long-term contracts— 

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and 

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter. 

 

					
	 Contract No. N01-AI-60019

Modification No: 5
	  	SPECIAL PROVISIONS	  	Page 3 of 3

 (c) The Contractor shall represent its size status in accordance with the size standard in effect at the
time of this representation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at
http://www.sba.gov/services/contractingopportunities/sizestandardstopics/ . 
 (d) The small business size standard for a
Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees. 
 (e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in
the Online Representations and Certifications Application and its data in the Central Contractor Registration, as necessary, to ensure that they reflect the Contractor’s current status. The Contractor shall notify the contracting office in
writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update. 
 (f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs
(e) or (g) of this clause. 
 (g) If the Contractor does not have representations and certifications in ORCA, or does
not have a representation in ORCA for the NAICS code applicable to this contract, the Contractor is required to complete the following representation and submit it to the contracting office, along with the contract number and the date on which the
representation was completed: 
 The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code
assigned to contract number. 
 [Contractor to sign and date and insert authorized signer’s name and title].

 (End of clause) 
 END OF MODIFICATION #5 CONTRACT NO. HHSN266200600019C 

			
	DEPARTMENT OF HEALTH & HUMAN SERVICES	  	Public Health Service

  
  

 

			
	 Phone: 301-496-0612
 Fax:
301-480-4675
 http://www.niaid.nih.gov/
	 	 National Institutes of Health (NIH)
 National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions, DEA
 6700B
Rockledge Drive, Room 3214
 Bethesda, MD 20892-7612

 October 5, 2010 
 Jeffrey Abbey 
 Argos Therapeutics, Inc. 
 4233 Technology Drive 
 Durham, NC 27704 

 
  

			
	 Subject:
	  	 Contract No.: N01-AI-60019

Modification No. 6

 Dear Mr. Abbey: 
 Enclosed is an executed copy of the referenced modification for your retention. Should you have any questions regarding its administration, please contact the undersigned at patelkianiaid.nih.gov
or write to: 
 Office of Acquisitions, DEA 
 National Institute of Allergy and Infectious Diseases 
 National Institutes of
Health, DHHS 
 6700-B Rockledge Drive 
 Room 3214, MSC 7612 
 Bethesda, Maryland 20892-7612 

 

	
	Sincerely,
	
	  
	 Kishan Patel
 Contract
Specialist
 Office of Acquisitions

Division of AIDS Research Contracts Branch

National Institute of Allergy
 and Infectious
Diseases

 Enclosure: a/s 

																													
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	  	1. CONTRACT ID CODE	 	PAGE         OF PAGES
	  	  	  	  	  	  	 	1	 	13
	 2. AMENDMENT/MODIFICATION NO.
Six
(6)
	  	 3. EFFECTIVE DATE
July 1,
2010
	  	 4.
REQUISITION/PURCHASE REQ. N0.
1796906
	  	
5. PROJECT NO. (If applicable)
N/A

	
6. ISSUED BY                     
                    CODE
	  	 	  	7. ADMINISTERED BY (If other than Item 6)         CODE	  	N/A
	  
 National Institutes of Health
 National Institute of Allergy and Infectious
Diseases
 DEA, Office of Acquisitions
 Room 3214, MSC 7612
 6700-B Rockledge Drive

Bethesda, MD 20892-7612
	  	  
 AIDS-RCB

	 8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP
Code)
	  	( ̈)  	  	9A. AMENDMENT OF SOLICITATION NO.
	  
 Argos Therapeutics, Inc.
 4233 Technology Drive

Durham, NC 27704
	  	VIN # 1109171	  	 	  	  
 9B. DATED (SEE ITEM 11)

	  		  		  		  	X  	  	 10A. MODIFICATION OF CONTRACT/ORDER NO.

 
 HHSN266200600019C

 

	  	 	  	 	  	 	  	 	  	 10B. DATED (SEE ITEM
13)
  
 September 30, 2006

	 CODE
	  	FACILITY CODE	  	 	  
	  
 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
TIN: 56211007 DUNS: [**] CAN: 10-8470035 AMOUNT: $[**] (Reg. #1796906) $[**] (Reg. #1817895)

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

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

 

																													
	
( ̈)
	  	 A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

		  		  		  		  		  		  		  		  		  		  		  		  		  		  	
	 	  	
B.    THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc.) SET
  

	  
 X
	  	  

C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 
 FAR 1.602-1; FAR 17.202; FAR 43.102

 

	 	  	 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 modify the contract to incorporate: 1) Identify one separate non-severable Option within the existing Statement of Work; 2) to exercise Option 1; 3)
change the Completion Date; and 4) update contract provisions.

  

																									
	 	  	Total Funds Currently Obligated	 	  	Total Estimated Cost	 
	 	  	Cost	 	  	Fee	 	  	Total	 	  	Cost	 	  	Fee	 	  	Total	 
	 Prior to this Mod
	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  	  	$	26,482,126	  	  	$	1,395,099	  	  	$	27,877,225	  
	 This Mod #
	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  	  	 	0	  	  	 	0	  	  	 	0	  
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Revised Total
	  	$	26,482,126	  	  	$	1,395,099	  	  	$	27,877,225	  	  	$	26,482,126	  	  	$	1,395,099	  	  	$	27,877,225	  

																													
								
	COMPLETION DATE: May 31, 2013	  		  		  		  		  		  		  	
	  
 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)

 
 Jeff Abbey, President and CEO
	 	 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 
 Michelle L Scala

 
 Contracting Officer, OA, DEA, NIAID, NIH

											
	 15B. CONTRACTOR/OFFEROR
  

/s/ Jeff
Abbey                        
 (Signature of person authorized to sign)
	  	 15C. DATE SIGNED
  

9-27-10
	  	 16B. UNITED STATES OF AMERICA
  

By:/s/ Michelle L. Scala                

(Signature of Contracting Officer)
  
	  	 16C. DATE SIGNED
  

9/28/10

											
			
	 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

					
	 Contract No.
HHSN266200600019C 
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 1 of 13

  

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY
AGRESS AS FOLLOWS: 
 ARTICLE B.2. ESTIMATED COST, is hereby deleted in its entirety and replaced with the following:

 ARTICLE B.2. ESTIMATED COST - OPTION 
  

	a.	The estimated cost of this contract is $26,482,126. 

  

	b.	The fixed fee for this contract is $1,395,099. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT, and FIXED FEE,
referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. The Contractor shall complete all work in accordance with the Statement of Work and the contract milestones set forth below. The distribution of the fixed fee shall
be paid in installments based on the Project Officer’s written certification regarding the completion of these milestones as follows: 

  

							
	  	  	MILESTONES FOR THE BASE	  	FIXED FEE	 
	 	 	 
	1.	  	[**]	  	 	[**]	  
	 	 	 
	2.	  	[**]	  	 	[**]	  
	 	 	 
	3.	  	[**]	  	 	[**]	  
	 	 	 
	4.	  	[**]	  	 	[**]	  
	 	 	 
	5.	  	[**]	  	 	[**]	  
	 	 	 
	6.	  	[**]	  	 	[**]	  
	 	 	 
	7.	  	[**]	  	 	[**]	  
	 	 	 
	8.	  	[**]	  	 	[**]	  
	 	 	 
	9.	  	[**]	  	 	[**]	  
	 	 	 
	10.	  	[**]	  	 	[**]	  
	 	 	 
	 	  	[**]	  	 	 	 
	 	 	 
	11.	  	[**]	  	 	[**]	  
	 	 	 
	12.	  	[**]	  	 	[**]	  
	 	 	 
	13.	  	[**]	  	 	[**]	  

  

					
	 Contract No.

HHSN266200600019C

 Modification No:
06
	 	SPECIAL PROVISIONS	 	Page 2 of 13

  

							
	  	  	MILESTONES FOR THE BASE	  	FIXED FEE	 
	 	 	 
	14.	  	[**]	  	 	[**]	  
	 	 	 
	15.	  	[**]	  	 	[**]	  
	 	 	 
	16.	  	[**]	  	 	[**]	  
	 	 	 
	17.	  	[**]	  	 	[**]	  
	 	 	 
	18.	  	[**]	  	 	[**]	  
	 	 	 
	19.	  	[**]	  	 	[**]	  
	 	 	 
	20.	  	[**]	  	 	[**]	  

  

	c.	The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee is $27,877,225. 

 

	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
	  	09/30/2006-05/31/2013	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  
	 Option 1 - Autologous Vaccine and Clinical Trial
	  	07/01/2010-05/31/2013	  	 	[**]	  	  	 	[**]	  	  	 	[**]	  
	 Total Base Period plus Option
	  	 	  	$	26,482,126	  	  	$	1,395,099	  	  	$	27,877,225	  

 ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS, paragraph c, Travel Costs, subparagraph 1, Domestic
Travel, is hereby revised to incorporate Option periods as follows: 
  

	 	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 of $[**], 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: 

  

					
	 Contract No.
HHSN266200600019C

 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 3 of 13

  

					
	  	  	Period of Performance	  	Total Cost
Not to Exceed
	 Base
	  	09/30/2006-05/31/2013	  	[**]
	 Option 1
	  	07/01/2010-05/31/2013	  	[**]
	 Total Base
plus Options
	  	 	  	[**]

 ARTICLE B.4. ADVANCE UNDERSTANDINGS, is hereby revised to read as follows: 

Paragraph b, c, d, e, f, g and h, is hereby deleted in its entirety and incorporated to read as follows: 

 

	b.	Subcontract Modification 

  

	 	1.	The Contractor is authorized to negotiate a modification to their subcontracts with the following: 

[**] 
 The
subcontracts shall reflect the Estimated Base and Option Periods and related Estimated Cost/Price identified in the below table. Award of the subcontract modification shall not proceed without the prior written consent of the Contracting Officer
upon review of the supporting documentation required by FAR 52.244-2, Subcontracts. After receiving written consent of the subcontract modification by the Contracting Officer, a copy of the signed, executed subcontract modification shall be provided
to the Contracting Officer. 
  

	2.	The subcontract shall include pre-negotiated Options for periods of performance not to exceed beyond the prime contractor’s period of performance, as follows:

  

							
	Subcontractors	  	Base Period	  	Option 1	  	Total Cost 
Not to
Exceed
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]
	 [**]
	  	[**]	  	[**]	  	[**]

  

	3.	The Contractor shall submit a draft of the subcontract modification within [**] days following the effective date of this modification. The subcontract modification
shall include a breakdown (by Base Year and Options) of cost and effort (hours) similar to that shown in this contract under Articles B.2 and F.3. 

  

					
	 Contract No.
HHSN266200600019C
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 4 of 13

  

	4.	Within [**] calendar days after receiving written consent from the Contracting Officer to enter into the subcontract modification, a copy of the signed, executed
subcontract modification shall be provided to the Contracting Officer. 

 The Contractor is required to negotiate modifications
with all existing Subcontractors to coordinate with the Base and Option Periods identified in Article B.2. per this Modification, and submit these subcontract modifications to the Contracting Officer for consent. Award of these subcontract
modifications shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR 52.244-2, Subcontracts. After receiving written consent to the modifications of these
subcontracts by the Contracting Officer, a copy of each signed, executed subcontract modification shall be provided to the Contracting Officer. 

Paragraph i, Consultants is hereby renumbered and modified to 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
	  	09/30/2006-05/31/2013	  	 	[**]	  
	 Option 1
	  	07/01/2010-05/31/2013	  	 	[**]	  
	 Total Base Plus Option
	  		  	 	[**]	  

  

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

  

							
	 Option
	  	Period of Performance	  	Total Cost,
Excluding Travel,
Not to Exceed	 
	 Base
	  	09/30/2006-05/31/2013	  	 	[**]	  
	 Option 1
	  	07/01/2010-05/31/2013	  	 	[**]	  
	 Total Base Plus Option
	  		  	 	[**]	  

 Paragraph j. is renumbered to d., Paragraph k. is renumbered to e., Paragraph l. is renumbered to f., Paragraph m. is
renumbered to g., and paragraph h. is incorporated and shall read as follows: 
  

	h.	Subcontract Modifications 

The Contractor is required to negotiate modifications with all existing Subcontractors to coordinate with the Base and Option Periods
identified in Article B.2. per this Modification, and submit these subcontract modifications to the Contracting Officer for consent. Award of these subcontract modifications shall not proceed without the prior written consent of the Contracting
Officer upon review of the supporting documentation required by FAR 52.244-2, Subcontracts. After receiving written consent to the modifications of these subcontracts by the Contracting Officer, a copy of each signed, executed subcontract
modification shall be provided to the Contracting Officer. 

  

					
	 Contract No.
HHSN266200600019C
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 5 of 13

  

 ARTICLE C.1. STATEMENT OF WORK, Attachment 1, Statement of Work, dated August, 2006, is
hereby modified to delineate the work to be performed during the Base and Option Period. 
 ARTICLE F.1. DELIVERIES. Paragraph a,
is hereby revised to identify deliverables for the Base and Option Periods as follows: 
  

	a.	For Base, the items specified below as described in SECTION C, ARTICLE C.2. REPORTING REQUIREMENTS will be required to be delivered F.O.B Destination as set forth in
FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

  

							
	Items	  	Description	  	Quantity	  	Delivery Schedule
	1.	  	Information Security Plan	  	1 - Original - CO
1 - Copy -COTR	  	Within [**] weeks of contract award
	2.	  	Goals and Milestones Achievement Reports	  	1 - Copy - COTR	  	Specific dates will be negotiated with the DAIDS
COTR
	3.	  	Specific Deliverable for Projects 1, 2, 3 and 5 as outlined in the Statement of
Work	  	1 - Copy - COTR	  	As Required by the COTR
	4.	  	DAIDS Enterprise Systems Reporting	  	 	  	On an ongoing basis as directed by DAIDS,
NIAID
	5.	  	Annual Technical Report	  	1 - Original - CO
1 - Copy - COTR	  	[**] day of the twelfth month of each contract
year
	6.	  	Annual Site Visit Review and Report	  	1 - Original - CO
1 - Copy - COTR	  	[**] month of each contract year.

  

	b.	For Option 1, the items specified below as described in SECTION C, ARTICLE C.2. REPORTING REQUIREMENTS will be required to be delivered F.O.B. Destination as set forth
in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below and any specification stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

  

							
	Items	  	Description	  	Quantity	  	Delivery Schedule
	1.	  	Goals and Milestones Achievement Reports	  	1 - Copy - COTR	  	Specific dates will be negotiated with the DAIDS
COTR
	2.	  	Specific Deliverable for Projects 4 and 5 as outlined in the Statement of
Work	  	1 - Copy - COTR	  	As Required by the COTR
	3.	  	Clinical Trial Protocol(s)	  	1 - Copy - COTR	  	As Required by the COTR
	4.	  	DAIDS Enterprise Systems Reporting	  	 	  	On an ongoing basts as directed by DAIDS,
NIAID
	5.	  	Annual Technical Report	  	1 - Original - CO
1 - Copy - COTR	  	[**] day of the twelfth month of each contract
year
	6.	  	Annual Site Visit Review and Report	  	1 - Original - CO
1 - Copy - COTR	  	[**] month of each contract
year.

  

					
	 Contract No.
HHSN266200600019C
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 6 of 13

  

							
	7.	  	Final Technical Report	  	1 - Original - CO
1 - Copy - COTR	  	On or before contract expiration

 ARTICLE F.3. OPTION PERIODS, is hereby incorporated into this contract and shall read as follows:

 ARTICLE F.3. OPTION PERIODS  
 If the Government exercises its options pursuant to the OPTION PROVISION Article in Section H of this contract, the completion date of the contract will be extended as follows: 

 

					
	Option	  	Period	 
	 Base Period
	  	 	09/30/2006-05/31/2013	  
	 Option 1
	  	 	07/01/2010-05/31/2013	  

 ARTICLE G.1. PROJECT OFFICER, is hereby deleted in its entirety and replaced with the following:

 ARTICLE G.1. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)  

The following Contracting Officer’s Technical Representative (COTR) will represent the Government for the purpose of this contract: 

Anthony J. Conley, Ph.D. 
 Targeted Interventions Branch 
 Basic Science Program Division of AIDS, NIAID, NIH,
DHHS 
 Room 4100, MSC 7626 
 6700B Rockledge Drive 
 Bethesda, Maryland 20892-7626 

Email: conleytoaniaid.nih.gov 
 The COTR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in
requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract;
and (5) assisting in the resolution of technical problems encountered during performance. 
 The Contracting Officer is the only person
with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance;
(3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. 

The Government may unilaterally change its COTR designation. 

  

					
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 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 7 of 13

  

 ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT,
is hereby modified to incorporate the following paragraph: 
  

	c.	The Contractor’s invoices shall include a summary page of the expenditures for the current billing period, showing a breakdown by each expenditure category. In
addition, the Contractor shall provide a separate attachment for each individual funding period (base and any option periods) utilizing the same cost breakdown by cost category. Monthly invoices shall include the cumulative total expenses to date,
adjusted (as applicable) to show any amounts suspended by the Government. 

 SECTION H SPECIAL CONTRACT
REQUIREMENTS, is hereby revised to update special contract provisions as follows: 
 ARTICLE H.5. RESEARCH INVOLVING RECOMBINANT
DNA MOLECULES (Including Human Gene Transfer Research, is hereby modified to update the link and to reference the most recent policy on this issue, and shall read as follows: 
 All research involving Recombinant DNA Molecules shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules
(http://oba.od.nih.gov/rdna/nih_guidelines_oba.html) and the September 24, 2007 Notice, “Reminder of NIH Policy for Enhancing the Science, Safety, and Ethics of Recombinant DNA Research”
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-096.html) (and any subsequent revisions to the Guide Notice) which stipulates biosafety and containment measures for recombinant DNA research and delineates critical, ethical principles and
key safety reporting requirements for human gene transfer research (See Appendix M of the Guidelines). These guidelines apply to both basic and clinical research studies. 
 The Recombinant DNA Advisory Committee (RAC) is charged with the safety of manipulation of genetic material through the use of recombinant DNA techniques. Prior to beginning any clinical trials involving
the transfer of recombinant DNA to humans, the trial must be registered with the RAC. If this contract involves new protocols that contain unique and/or novel issues, the RAC must discuss them in a public forum and then the Institutional Biosafety
Committee (IBC), the Institutional Review Board (IRB), and the Contracting Officer’s Technical Representative (COTR) and Contracting Officer must approve the protocol prior to the start of the research. 

Failure to comply with these requirements may result in suspension, limitation, or termination of the contract for any work related to Recombinant DNA
Research or a requirement for Contracting Officer prior approval of any or all Recombinant DNA projects under this contract. This includes the requirements of the Standing Institutional Biosafety Committee (IBC) (See
http://oba.od.nih.gov/rdnaibc/ibc.html). 
 As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious adverse event must be
reported immediately to the IRB, the IBC, the Office for Human Research Protections (if applicable), and the NIH Office for Biotechnology Activities (OBA), followed by the filing of a written report with each office/group and copies to the COTR and
Contracting Officer. (http://oba.od.nih.gov/oba/rac/quidelines_02/APPENDIX_M.htm). 
 ARTICLE H.7. NEEDLE EXCHANGE, is
hereby deleted in its entirety and replaced with the following: 

  

					
	 Contract No.
HHSN266200600019C
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 8 of 13

  

 ARTICLE H.7. NEEDLE DISTRIBUTION  
 The Contractor shall not use contract funds to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by authorities to
be inappropriate for such distribution. 
 ARTICLE H.8. PRIVACY ACT, is hereby deleted in its entirety and replaced with the
following: 
 ARTICLE H.8. PRIVACY ACT. HHSAR 352.224-70 (January 2006)  
 This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in
accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term “system of records” means a group of any records under the control of any agency from which information is retrieved by the
name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C.
552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health
and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract
work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance. (End
of clause) 
 45 CFR Part 5b contains additional information which includes, the rules of conduct and other Privacy Act requirements and can be
found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html 
 The Privacy Act System of Records applicable to this project
is Number. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm 

ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS, is hereby deleted in its entirety and replaced with the following: 

ARTICLE H.10. SALARY RATE LIMITATION, HHSAR 352.231-70 (January 2010) 

 

	 	a.	Pursuant to the current and applicable prior HHS appropriations acts, 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 I in effect on the date an expense is incurred. 

  

	 	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 [F&A] costs). 

  

					
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 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 9 of 13

  

 Note: The salary rate limitation does not restrict the salary that an organization may
pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds. 
  

	 	c.	The salary rate limitation also applies to individuals under subcontracts. 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 in effect when the expense is incurred regardless of the rate initially used to
establish contract or order funding. 

  

	 	d.	See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and
prior periods. 

 (End of clause) 
 See the following Web site for Executive Schedule rates of pay: http://www.opm.gov/oca/. (For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the
Executive Schedule. For prior year rates, click on Salaries and Wages / select Another Year at the top of the page / Executive Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless
otherwise noted.) 
 ARTICLE H.15. PUBLICATION AND PUBLICITY, is hereby modified to read as follows: 

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract,
the Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows: 

“This project has been funded in whole or in part with Federal funds from the National Institutes of Allergy and Infectious Diseases,
National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN266200600019C.” 
 ARTICLE H.16. PRESS
RELEASES, is hereby modified to read as follows: 
 The Contractor shall clearly state, when issuing statements, press releases,
requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal
money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. 

ARTICLE H.20. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH, is hereby modified to read
as follows: 

  

					
	 Contract No.
HHSN266200600019C
 Modification No: 06
	 	SPECIAL PROVISIONS	 	Page 10 of 13

  

 NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed
Central (PMC) an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final
version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and
NIH. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov. 
 Additional information is
available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html 
 ARTICLE H.25. NIH POLICY ON ENHANCING PUBLIC
ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH, is deleted in its entirety since it is already stated in the contract as ARTICLE H.20. 
 ARTICLE H.25. OPTION PROVISIONS, is hereby incorporated into this contract as follows: 
 Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., 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 Clause 52.217-7 - Option for Increased Quantity - Separately Priced Line Item set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform
an additional option 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 within [**] days prior to the completion date of this contract, and the
estimated cost of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract. 
 ARTICLE I.2.
AUTHORIZED SUBSTITUTION OF CLAUSES, is hereby modified to delete the following clause: 
 FAR Clause 52.232-20, Limitation of
Cost (April 1984), is deleted in its entirety and FAR Clause 52.232-22, Limitation of Funds (April 1984) is substituted therefore. [NOTE: When this contract is fully funded, FAR Clause 52.232-22, Limitation of Funds will no
longer apply and FAR Clause 52.232-20, Limitation of Cost will become applicable.] 
 ARTICLE I.3. ADDITIONAL CONTRACT
CLAUSES, is hereby modified to incorporate the following clauses: 
  

	(12)	FAR Clause 52.217-7, Option for Increased Quantity - Separately Priced Line Item (March 1989) 

“...The Contracting Officer may exercise the option by written notice to the Contractor within [**] days,” 

END OF MODIFICATION 6 CONTRACT NO. HHSN266200600019CRelease and Settlement Agreement - John Bonfiglio

 Exhibit 10.24 
 RELEASE AND SETTLEMENT AGREEMENT 
 This Release and Settlement Agreement
(“Agreement”) is entered into effective as of February 23, 2010 (the “Effective Date”) by and between Argos Therapeutics, Inc., a Delaware corporation (the “Company”), and John Bonfiglio
(“Employee”). 
 WHEREAS, Employee’s employment with the Company was involuntarily terminated on the
Effective Date and Employee and the Company now desire to fully and finally settle and resolve all matters arising, directly or indirectly, out of Employee’s employment or the conclusion thereof according to the terms of this Agreement; and

 WHEREAS, this Agreement provides Employee with valuable consideration to which Employee is not otherwise entitled, and as a
partial inducement to the Company to grant such consideration, Employee and the Company have agreed to enter into this Agreement. 
 NOW, THEREFORE, in consideration of the premises and the mutual promises contained herein and the payment of the monies hereinafter recited, the receipt and adequacy of which are hereby acknowledged, the
parties hereby agree as follows: 
 1. Employee’s employment with the Company was involuntarily terminated as of the
Effective Date. Employee hereby waives all rights to reemployment or reinstatement from and after that date and Employee agrees that Employee will not reapply for employment with the Company. 

2. (A) In accordance with the employment offer letter between Employee and the Company dated December 14, 2006, as amended on
February 22, 2008, and in accordance with the agreement reached between Employee and the Company following the Effective Date, in consideration of 
 (a) the payment by the Company to Employee of $257,500.00, (less all applicable deductions) (the “Termination Payment”) (which shall be paid as set forth below); 

(b) the Company’s agreement to pay the insurance premium to continue Employee’s health insurance through the Company-sponsored
plan at the same average level and on the same terms and conditions which applied immediately prior to the date of the Employee’s termination through December 31, 2010 provided that Employee (i) first executes and does not
revoke this Agreement and (ii) properly elects and maintains continued coverage under such plan and provided further that such benefits continue to be offered under the Company-sponsored plans (if such benefits are discontinued by the Company,
Employee shall either (i) utilize the new benefit plan sponsored by the Company, or (ii) if no new benefit plan is sponsored by the Company or if Employee is not eligible for the new plan, then the Company shall pay Employee, on the first
business day of each month, an amount equal to the amount the Company had previously been paying for such benefits during the term of this Agreement through December 31, 2010); 

(c) the payment by the Company to the Employee of $5,463.90 (less all applicable deductions) (the “Benefits Payment”)
(which shall be paid as set forth below) which amount 

 
represents the aggregate cost of the premiums for a ten month period for the Company-sponsored insurance benefits (other than health insurance) that Employee participated in immediately prior to
the Effective Date including life insurance, accidental death & dismemberment insurance, long-term disability insurance, short-term disability insurance, supplemental disability insurance, and long-term care insurance; 

(d) the Company’s transfer of ownership to the Employee of the cellular phone and computer the Company provided to Employee for his
use during his employment (the “Equipment”) (which transfer shall be considered complete upon the Company’s execution of this Agreement provided that (i) Employee has first provided the Equipment to the Company so the
Company may remove any Company property (as determined by the Company) from the Equipment, (ii) Employee agrees to pay all future charges associated with post-Effective Date use of the cellular phone, (iii) and Employee promptly causes the
cellular phone bills to be registered in Employee’s name); 
 (e) the Company’s release of Employee on the terms and
conditions stated in Section 2(B) below; 
 (f) the amendment of Employee’s stock options as set forth in
Section 5 below; and 
 (g) other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, 
 Employee for Employee, Employee’s executors, heirs, administrators, assigns, and anyone claiming by, through, or under
them, hereby irrevocably (except as specifically set forth below) and unconditionally releases and forever discharges the Company and each of its past, present, and future officers, directors, employees, stockholders, representatives, subsidiaries
and affiliates (the “Releasees”) from any and all claims, demands, lawsuits, debts, defenses, actions or causes of action, obligations, damages, sums of money, loss of services, compensation, pain and suffering, attorneys’
fees, cost and expenses of suit, and liabilities whatsoever (“Employee Claims”), which Employee had, now has or may have, whether the same be at law, in equity, or mixed, whether known or unknown, suspected or unsuspected, now
existing or which may arise hereafter, arising out of or related to, any matter, cause, or event which has happened, developed, or occurred before the execution of this Agreement, including without limitation, any and all suits in tort or contract,
and any Employee Claims or suits relating to the breach of an oral or written contract, misrepresentation, defamation, and interference with prospective economic advantage, interference with contract, intentional and negligent infliction of
emotional distress, negligence, promissory estoppel, invasion of privacy, libel, slander, breach of the covenant of good faith and fair dealing, any claims relating to or arising out of Employee’s right to purchase any shares of stock of the
Company, including without limitation any claims for misrepresentation, fraud or securities fraud under any state or federal law, and Employee Claims arising out of, based on, or connected with Employee’s employment by the Company and the
termination of that employment including any causes of action or Employee Claims for unlawful employment discrimination arising under or based on Title VII of the Civil Rights Act of 1964, as amended; the Employee Retirement Income Security Act of
1974, as amended; the Rehabilitation Act of 1973, as amended; the Americans with Disabilities Act, as amended; the Occupational Safety and Health Act of 1970, as amended; the 

  
 2 

 
National Labor Relations Act of 1935, as amended; the Family and Medical Leave Act of 1993, as amended; the Age Discrimination in Employment Act, as amended; the Older Workers Benefit Protection
Act, as amended; Section 1981 of the Civil Rights Act of 1866; the Equal Pay Act of 1963; Section 1985 of the Civil Rights Act of 1871; and any other local, state or federal equal employment opportunity law, public policy, order, or
regulation affecting or relating to the claims or rights of employees, which Employee ever had, now has, or claims to have against the Company (including all officers, directors, partners, employees, stockholders, representatives, subsidiaries and
affiliates thereof and all officers, directors, partners, employees, stockholders, representatives and affiliates of any affiliate or subsidiary thereof), except as otherwise prohibited by law or such rights, benefits, and claims of Employee which
expressly accrue under and pursuant to this Agreement; provided that Employee and Company further agree that (i) Employee Claims pursuant to the Age Discrimination in Employment Act, as amended, which arise after the date of the execution of
this Agreement shall not be released and (ii) Employee expressly retains the right to file a charge or complaint or participate in an investigation or procedure with the Equal Employment Opportunity Commission or equivalent deferral agency, but
waives any and all right to receipt of damages resulting from any charge or complaint brought by Employee, the Equal Employment Opportunity Commission, equivalent deferral agency or anyone else. Employee further represents that Employee has no cause
to believe any violation of any local, state or federal law has occurred with regard to Employee’s employment or separation from employment. Employee further admits that as of the date Employee receives Employee’s final pay check
(including all wages and any accrued but unused vacation), Employee will have been paid by the Company for all time Employee worked for the Company. Employee further agrees not to institute any complaint, or lawsuit to challenge the validity of this
Agreement or the circumstances surrounding its execution. It is expressly agreed and understood that the release contained herein is a GENERAL RELEASE. Employee agrees that the amount specified above as the consideration for the release granted in
this Section 2 is valid consideration to which Employee is not otherwise entitled. 
 The Company will pay the Termination
Payment in approximately equal installments over a ten month period in accordance with the current generally applicable payroll schedule of the Company, commencing on the first pay date after the eighth day after the date Employee delivers an
executed copy of this Agreement to the Company and does not revoke it as set forth below. The Company will pay the Benefits Payment in a lump sum on the first pay date after the eighth day after the date Employee delivers an executed copy of this
Agreement to the Company and does not revoke it as set forth below. Notwithstanding anything to the contrary, the Termination Payment shall be fully paid before the end of the second calendar year following the year in which Employee’s
employment terminated. 
 (B) Subject to and effective upon the Company’s and Employee’s execution of this Agreement
and except as set forth in this Section 2(B) below, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Company, for itself and anyone claiming by,
through or under it or them, hereby irrevocably and unconditionally releases and forever discharges Employee, his executors, heirs, administrators, agents and assigns, from any and all claims, demands, lawsuits, debts, defenses, actions or causes of
action, obligations, damages, sums of money, loss of services, attorneys’ fees, costs and expenses of suit and liabilities whatsoever which the Company had, now has or may have, whether with the same be at law, in equity, or mixed, whether
known or unknown, suspected or 

  
 3 

 
unsuspected, now existing or which may arise hereafter, arising out of or related to any matter, cause or event which has happened, developed or occurred before the execution of this Agreement,
including, without limitation, relating to Employee’s employment with the Company and termination of employment therefrom, including without limitation, any and all suits in tort or contract, which the Company ever had, now has or claims to
have against the Employee, except such rights, benefits and claims (i) which expressly accrue or have accrued under and pursuant to this Agreement, the Confidentiality Agreement (as defined in Section 10 below) or the
Investment Documents (as defined in Section 15 below); or (ii) which arise in connection with theft, disclosure or improper use of intellectual property, trade secrets, confidential information or proprietary information obtained during
the course of Employee’s employment; or (iii) which arise in connection with fraud, embezzlement, theft, or violation of any criminal law. It is expressly agreed and stated that the release contained herein is a GENERAL RELEASE.

 3. The Company hereby advises Employee to consult with an attorney prior to executing this Agreement. Employee is also
advised that Employee has at least forty-five (45) days to consider the meaning and effect of this Agreement. If Employee elects to sign this Agreement and return it to the Company before forty-five (45) days have elapsed from the date
Employee has received this Agreement, Employee acknowledges that any such election is a knowing and voluntary waiver of the right to take forty-five (45) days to consider this Agreement and that Employee has made this decision after receiving
advice from legal counsel or after rejecting the Company’s recommendation that Employee obtain the advice of counsel. Employee further understands that Employee may revoke the releases granted by Employee in Section 2 of this Agreement
relating to the Age Discrimination in Employment Act and the Older Workers Benefit Protection Act, (the “Preserved Claims”), for a period of seven (7) days following the date Employee executes this Agreement (the
“Revocation Period”). This Agreement shall become effective and enforceable with respect to the Preserved Claims once the Revocation Period has expired without exercise by Employee of Employee’s rights described in this
Section 3. If Employee shall exercise the revocation rights contemplated in this Section, Employee shall retain, and not release, Employee’s respective rights with respect to the Preserved Claims. Any revocation within the Revocation
Period must be submitted in writing to the Company and shall state, “I, John Bonfiglio, hereby revoke my acceptance of the release by me of the Preserved Claims as described in our Agreement which I signed and dated on
                 , 2010.” Any such revocation shall be delivered personally to the Company or sent to the Company by fax at
(919) 287-6345 to the attention of the Human Resources Director, and received within seven (7) days of execution of this Agreement. If Employee elects to accept this Agreement, Employee must execute and return it to the Company on or
before the date that is forty-five (45) calendar days from the day that Employee receives this Agreement. Employee acknowledges that the waivers and releases contained herein are made knowingly, consciously, and with full appreciation that
Employee will be forever foreclosed from pursuing any of the rights so waived and released. 
 A list of the ages and job titles
of the persons in the decisional unit who were and were not selected for termination and other applicable information is attached as an Exhibit to this Agreement. By signing below, Employee acknowledges that Employee received a copy of this
information. 

  
 4 

 4. (A) Employee hereby represents and warrants to the Company that Employee is the sole and
exclusive owner of the claims or causes of action being released by this Agreement, that Employee has not conveyed or assigned any interest in such claims or causes of action to any person or entity, and that such claims and causes of action have
been fully and effectively released for all purposes. Employee further represents and warrants that Employee has no claims, lawsuits or actions pending in Employee’s own name or on behalf of any other person or entity against any of the
Releasees and does not intend to bring any claims on behalf of Employee or any other person against any of the Releasees. Employee further represents and warrants that Employee will not participate or provide assistance to any person or entity who
files a claim or intends to file a claim against the Company, unless ordered to do so by a court of competent jurisdiction or otherwise allowed by law. 
 (B) The Company hereby represents and warrants to Employee that the Company is the sole and exclusive owner of the claims or causes of action being released by this Agreement, that the Company has not
conveyed or assigned any interest in such claims or causes of action to any person or entity, and that such claims and causes of action have been fully and effectively released for all purposes. The Company further represents and warrants that the
Company has no claims, lawsuits or actions pending in its own name or on behalf of any other person or entity against the Employee and does not intend to bring any claims on behalf of itself or any other person against Employee. The Company further
represents and warrants that the Company will not participate or provide assistance to any person or entity who files a claim or intends to file a claim against Employee, unless ordered to do so by a court of competent jurisdiction, otherwise
allowed by law or the subject matter at issue pertains or relates to a matter not released pursuant to Section 2(B) above. 

5. The Company and Employee acknowledge and agree that the Company has issued to the Employee options to purchase an aggregate of Eight
Million, Eight Hundred Forty-Nine Thousand, Nine Hundred Twenty-Seven (8,849,927) shares of the common stock of the Company, Seven Million, Nine Hundred Twenty-Eight Thousand, Fifty-Nine (7,928,059) of which are fully vested as of the
Effective Date (the “Options”). Employee acknowledges and agrees that the terms and conditions of the Options shall be as set forth in the agreements which are as follows: Incentive Stock Option Agreement Dated July 2, 2008;
and Incentive Stock Option Agreement Dated December 11, 2008 (collectively the “Stock Option Agreements”). In accordance with Section 2(A)(f) above, the Stock Option Agreements are hereby amended to extend Employee’s
post-termination exercise period stated in Section 3(c) of each respective Stock Option Agreement from 3 months from the Effective Date until December 31, 2010, subject to any limitations imposed under the Stock Option Agreements. Except
as amended hereby, the Stock Option Agreements shall remain in full force and effect. Employee understands that the above amendment shall disqualify the Options from being treated as incentive stock options for tax purposes. 

6. Employee acknowledges that Employee has read this Agreement and fully understands its meaning and intent, and has executed this
Agreement knowingly and voluntarily, as a free and voluntary act, without duress, coercion, or undue influence exerted by or on behalf of any person or entity. 

  
 5 

 7. Neither the Company nor Employee shall be regarded as a prevailing party for any purpose,
including, but not limited to, determining responsibility for or entitlement to attorneys’ fees or costs under any statute or otherwise. The Company and Employee expressly waive, as to each other, any and all claims for attorneys’ fees or
costs. 
 8. This Agreement will not be used or construed by any person or entity as an admission of liability or finding or
admission that any party’s rights were in any way violated by any other party and this Agreement may not be offered or received in evidence in any action or proceeding as an admission or concession of liability or wrongdoing on the part of any
party. 
 9. Each of the Company and Employee will keep the terms of this Agreement strictly confidential and shall not disclose
any information concerning the terms of this Agreement or provide a copy of the same to anyone except the party’s spouse (if applicable), legal or tax advisor, unless otherwise required by a court of competent jurisdiction. The Company shall be
permitted to disclose information concerning this Agreement and provide a copy to persons under an obligation of confidentiality for business purposes it determines to be legitimate. If required by law to produce a copy or to make such disclosure,
Employee will give the Company reasonable advance notice prior to such production or disclosure. 
 10. A. Except as required by
law, Employee will not do or say anything that a reasonable person would expect at the time would have the effect of diminishing or constraining the goodwill and good reputation of the Company or the Releasees or the Company’s business,
products or services. This obligation will include, but shall not be limited to refraining from making negative statements about the Releasees or the Company’s methods of doing business, the effectiveness of its business policies, or the
quality of any of its services or personnel. This is a continuing obligation that shall survive this Agreement. 
 B. Except as
required by law, the Company will not do or say anything that a reasonable person would expect at the time would have the effect of diminishing or constraining the good reputation of the Employee. This obligation will include, but shall not be
limited to refraining from making negative statements about the Employee. This is a continuing obligation that shall survive this Agreement. 
 11. Employee hereby acknowledges and agrees that Employee will continue to be bound by the terms of the Confidentiality, Inventions, Non-Solicitation and Non-Competition Agreement between Employee and the
Company dated December 19, 2006 (the “Confidentiality Agreement”), which terms are in full force and effect and will survive Employee’s termination of employment with the Company. 

12. Employee agrees upon request to cooperate with and provide reasonable assistance to the Company and the Releasees and their legal
counsel in connection with any litigation (including without limitation arbitration or administrative hearings) or investigations affecting the Company or the Releasees, in which Employee’s assistance or cooperation is needed as determined by
the Company or its legal counsel. Employee further agrees that, in the event Employee is subpoenaed by any person or entity (including without limitation any government agency) to give testimony which in any way relates to Employee’s employment
by the Company or with respect to 

  
 6 

 
any relationship with the Releasees, Employee will give prompt notice of such request to the Company and will make no disclosure until the Company has had a reasonable opportunity to contest the
right of the requesting person or entity to such disclosure. 
 13. Except for the Equipment specified in Section 2(A)(d)
above, Employee will return all property of the Company to the Company wherever located on or before February 26, 2010, unless extended at the Company’s discretion, including, without limitation, all reports, files, memoranda, records,
computer hardware and software, laptop computer and accessories, credit cards, telephone calling cards, card-key passes, identification badges, door, file, vehicle and other keys, computer access codes, disks and instructional manuals, calculators,
cellular telephones, and other physical or personal property which have been provided for Employee’s use in connection with Employee’s employment with the Company. Notwithstanding anything to the contrary, the Company’s obligation to
provide Employee with the consideration specified in this Agreement shall be contingent upon Employee returning all Company property on or before the above date. 
 14. This Agreement shall be binding upon and inure to the benefit of each of the Company and Employee and their respective predecessors, successors, assigns, heirs, executors, and administrators. Employee
shall not assign this Agreement or delegate Employee’s obligations hereunder without the prior written consent of the Company. 
 15. The Company and Employee acknowledge that this Agreement is intended to be a binding contract between them and shall not be modified except by writing signed by each of the Company and Employee.
Employee acknowledges that Employee has not relied on any representation or statement by any of the Releasees or by any of the Releasees’ agents, representatives or attorneys regarding the subject matter, basis or effect of this Agreement. The
Company and Employee acknowledge that this Agreement, the Stock Option Agreements and the Confidentiality Agreement contain and comprise the entire agreement and understanding of the parties with respect to the subject matter hereof and supersede
any and all prior oral and written agreements and understandings, and that there are no agreements or understandings other than those contained herein and therein, except for any issued and outstanding stock option agreements between the Company and
Employee. For clarity, nothing in this Agreement is intended to affect the investment documents to which Employee is a party including without limitation (a) that certain Series C Preferred Stock Purchase Agreement dated March 31, 2008, as
amended by the First Amendment and Agreement to Join as a Party to Series C Preferred Stock Purchase Agreement dated April 22, 2008, (b) that certain Third Amended and Restated Stockholders’ Agreement dated March 31, 2008, as
amended by the First Amendment and Agreement to Join as a Party to Third Amended and Restated Stockholders’ Agreement dated April 22, 2008 and (c) that certain Second Amended and Restated Registration Rights Agreement dated
March 31, 2008, as amended by the First Amendment and Agreement to Join as a Party to Second Amended and Restated Registration Rights Agreement dated April 22, 2008 (collectively, the “Investment Documents”). The
Investment Documents shall continue in full force and effect. 
 16. Each of the parties acknowledges and recognizes that a
violation of this Agreement and its covenants will cause irreparable damage to the other party and that the other party will have no adequate remedy at law for such violation. Accordingly, each of the parties agrees that the other party will be
entitled, as a matter of right, to an injunction from any court of competent jurisdiction 

  
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restraining any further violation of the Agreement or covenant. This right to injunctive relief will be cumulative and in addition to whatever remedies the parties may otherwise have at law.

 17. The parties agree that the Company’s past, present, and future officers, directors, agents, stockholders, debt
holders, employees, and representatives are each beneficiaries of this Agreement, and may rely on it directly for enforcement of the release set forth in Section 2 and the other benefits contained herein. 

18. If one or more of the provisions, or portions thereof, of this Agreement are determined to be illegal or unenforceable, such
provision, or portion thereof, shall be modified to the extent necessary to be valid or enforceable. Such modification shall not affect the enforceability of any remaining provisions. To the extent that it is determined that the provisions, or
portions thereof, cannot be modified, the Agreement will be read as though the same were deleted, the remainder of this Agreement will not be affected by that determination and each remaining provision, or portion thereof, will continue to be valid
and effective and will be enforceable to the fullest extent permitted by law. 
 19. This Agreement is made and entered into in
the State of North Carolina and shall be governed by and construed in accordance with the laws of the State of North Carolina, except with regard to the conflict of laws rules of such State. 

20. All payments to Employee hereunder shall be treated as separate to the fullest extent permitted by law. Employee’s rights to
payments hereunder are not subject to anticipation, alienation, sale, transfer, pledge, encumbrance, attachment or garnishment and, where applicable, may only be transferred by will or the laws of descent and distribution. Deferral or acceleration
of any payment hereunder is strictly prohibited unless specifically permitted by Internal Revenue Code Section 409A and the regulations thereunder. 
 PLEASE READ CAREFULLY. THIS AGREEMENT INCLUDES A RELEASE OF ALL KNOWN AND UNKNOWN CLAIMS. 
 [Signature page follows] 

  
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 IN WITNESS WHEREOF, the parties hereto, intending to be legally bound hereby, have executed
this RELEASE AND SETTLEMENT AGREEMENT as of the date below, to be effective as of the Effective Date. 
  

			
	EMPLOYEE:
		
	Signature:	 	/s/    John Bonfiglio     4/5/10
		 	John Bonfiglio

  

					
	ARGOS THERAPEUTICS, INC.
		
	By:	 	/s/    Jeff Abbey
	Printed Name:	 	  Jeff Abbey
	Its:	 	President & CEO 4/18/10            

  
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