Document:

EX-10.14

 Exhibit 10.14 

INDEMNIFICATION AGREEMENT 

[Note: Bracketed provisions to be included for directors appointed by investment funds] 

This Agreement is made as of the      day of             
20    , by and between Argos Therapeutics, Inc., a Delaware corporation (the “Corporation), and                      (the
“Indemnitee”), a director or officer of the Corporation. 
 WHEREAS, it is essential to the Corporation to retain and attract as
directors and officers the most capable persons available, and 
 WHEREAS, the substantial increase in corporate litigation subjects
directors and officers to expensive litigation risks at the same time that the availability of directors’ and officers’ liability insurance has been severely limited, and 

WHEREAS, it is now and has always been the express policy of the Corporation to indemnify its directors and officers, and 

WHEREAS, the Indemnitee does not regard the protection available under the Corporation’s Restated Certificate of Incorporation and
insurance as adequate in the present circumstances, and may not be willing to serve or continue to serve as a director or officer without adequate protection, and 

[WHEREAS, the Indemnitee is a representative of or affiliated with
                     (together with any affiliated venture capital funds and the general partners, managing members or other control persons and/or
any affiliated management companies, the “VC Funds,” and each, individually, a “VC Fund”), and has certain rights to indemnification and/or insurance provided by the VC Funds, which Indemnitee and the VC Fund intend to be
secondary to the primary obligation of the Corporation to indemnify Indemnitee as provided herein, with the Corporation’s acknowledgement and agreement to the foregoing being a material condition to Indemnitee’s willingness to serve on the
Board of Directors of the Corporation; and] 
 WHEREAS, the Corporation desires the Indemnitee to serve, or continue to serve, as a director
or officer of the Corporation. 
 NOW THEREFORE, the Corporation and the Indemnitee do hereby agree as follows: 

1. Agreement to Serve. The Indemnitee agrees to serve or continue to serve as a director and/or officer of the Corporation for so long
as the Indemnitee is duly elected or appointed or until such time as the Indemnitee tenders a resignation in writing or becomes otherwise incapable of serving due to his or her disability or death. 

2. Definitions. As used in this Agreement: 

(a) The term “Proceeding” shall include any threatened, pending or completed action, suit, arbitration, alternative dispute
resolution proceeding, administrative hearing or other proceeding, whether brought by or in the right of the Corporation or otherwise and whether of a civil, criminal, administrative or investigative nature, and any appeal therefrom. 

  
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 (b) The term “Corporate Status” shall mean the status of a person who is or was, or has
agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, fiduciary, partner, trustee, member, employee or agent of, or in a similar capacity
with, another corporation, partnership, joint venture, trust, limited liability company or other enterprise. 
 (c) The term
“Expenses” shall include, without limitation, attorneys’ fees, retainers, court costs, transcript costs, fees and expenses of experts, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage,
delivery service fees and other disbursements or expenses of the types customarily incurred in connection with investigations, judicial or administrative proceedings or appeals, but shall not include the amount of judgments, fines or penalties
against Indemnitee or amounts paid in settlement in connection with such matters. 
 (d) References to “other enterprise” shall
include employee benefit plans; references to “fines” shall include any excise tax assessed with respect to any employee benefit plan; references to “serving at the request of the Corporation” shall include any service as a
director, officer, employee or agent of the Corporation which imposes duties on, or involves services by, such director, officer, employee, or agent with respect to an employee benefit plan, its participants, or beneficiaries; and a person who acted
in good faith and in a manner such person reasonably believed to be in the interests of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the
Corporation” as referred to in this Agreement. 
 3. Indemnity of Indemnitee. Subject to Sections 6, 7 and 9, the Corporation
shall indemnify the Indemnitee in connection with any Proceeding as to which the Indemnitee is, was or is threatened to be made a party (or is otherwise involved) by reason of the Indemnitee’s Corporate Status, to the fullest extent permitted
by law (as such may be amended from time to time). In furtherance of the foregoing and without limiting the generality thereof: 
 (a)
Indemnification in Third-Party Proceedings. The Corporation shall indemnify the Indemnitee in accordance with the provisions of this Section 3(a) if the Indemnitee was or is a party to or threatened to be made a party to or otherwise
involved in any Proceeding (other than a Proceeding by or in the right of the Corporation to procure a judgment in its favor or a Proceeding referred to in Section 6 below) by reason of the Indemnitee’s Corporate Status or by reason of any
action alleged to have been taken or omitted in connection therewith, against all Expenses, judgments, fines, penalties and amounts paid in settlement actually and reasonably incurred by or on behalf of the Indemnitee in connection with such
Proceeding, if the Indemnitee acted in good faith and in a manner which the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation and, with respect to any criminal Proceeding, had no reasonable cause to
believe that his or her conduct was unlawful. 
 (b) Indemnification in Proceedings by or in the Right of the Corporation. The
Corporation shall indemnify the Indemnitee in accordance with the provisions of this Section 3(b) 

  
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if the Indemnitee was or is a party to or threatened to be made a party to or otherwise involved in any Proceeding by or in the right of the Corporation to procure a judgment in its favor by
reason of the Indemnitee’s Corporate Status or by reason of any action alleged to have been taken or omitted in connection therewith, against all Expenses and, to the extent permitted by law, amounts paid in settlement actually and reasonably
incurred by or on behalf of the Indemnitee in connection with such Proceeding, if the Indemnitee acted in good faith and in a manner which the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except
that, if applicable law so provides, no indemnification shall be made under this Section 3(b) in respect of any claim, issue, or matter as to which the Indemnitee shall have been adjudged to be liable to the Corporation, unless, and only to the
extent, that the Court of Chancery of Delaware or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of such liability but in view of all the circumstances of the case, the Indemnitee
is fairly and reasonably entitled to indemnity for such Expenses as the Court of Chancery or such other court shall deem proper. 
 4.
Indemnification of Expenses of Successful Party. Notwithstanding any other provision of this Agreement, to the extent that the Indemnitee has been successful, on the merits or otherwise, in defense of any Proceeding or in defense of any
claim, issue or matter therein (other than a Proceeding referred to in Section 6), the Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by or on behalf of the Indemnitee in connection therewith. Without
limiting the foregoing, if any Proceeding or any claim, issue or matter therein is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to the Indemnitee, (ii) an
adjudication that the Indemnitee was liable to the Corporation, (iii) a plea of guilty or nolo contendere by the Indemnitee, (iv) an adjudication that the Indemnitee did not act in good faith and in a manner the Indemnitee
reasonably believed to be in or not opposed to the best interests of the Corporation, and (v) with respect to any criminal proceeding, an adjudication that the Indemnitee had reasonable cause to believe his or her conduct was unlawful, the
Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto. 
 5. Indemnification for
Expenses of a Witness. To the extent that the Indemnitee is, by reason of the Indemnitee’s Corporate Status, a witness in any Proceeding to which the Indemnitee is not a party, the Indemnitee shall be indemnified against all Expenses
actually and reasonably incurred by or on behalf of the Indemnitee in connection therewith. 
 6. Exceptions to Right of
Indemnification. Notwithstanding anything to the contrary in this Agreement, except as set forth in Section 10, the Corporation shall not indemnify the Indemnitee in connection with a Proceeding (or part thereof) initiated by the Indemnitee
unless the initiation thereof was approved by the Board of Directors of the Corporation. Notwithstanding anything to the contrary in this Agreement, the Corporation shall not indemnify the Indemnitee to the extent the Indemnitee is reimbursed from
the proceeds of insurance, and in the event the Corporation makes any indemnification payments to the Indemnitee and the Indemnitee is subsequently reimbursed from the proceeds of insurance, the Indemnitee shall promptly refund such indemnification
payments to the Corporation to the extent of such insurance reimbursement [provided, that the foregoing shall not affect the rights of Indemnitee or the Fund Indemnitors set forth in Section 14(c) below. Except as provided in Section 14(c)
below,] the Corporation’s obligation to indemnify or advance Expenses hereunder to Indemnitee 

  
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who is or was serving at the request of the Corporation as a director, officer, employee or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other
enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise. 

7. Notification and Defense of Claim. As a condition precedent to the Indemnitee’s right to be indemnified, the Indemnitee must
notify the Corporation in writing as soon as practicable of any Proceeding for which indemnity will or could be sought. With respect to any Proceeding of which the Corporation is so notified, the Corporation will be entitled to participate therein
at its own expense and/or to assume the defense thereof at its own expense, with legal counsel reasonably acceptable to the Indemnitee. After notice from the Corporation to the Indemnitee of its election so to assume such defense, the Corporation
shall not be liable to the Indemnitee for any legal or other expenses subsequently incurred by the Indemnitee in connection with such Proceeding, other than as provided below in this Section 7. The Indemnitee shall have the right to employ his
or her own counsel in connection with such Proceeding, but the fees and expenses of such counsel incurred after notice from the Corporation of its assumption of the defense thereof shall be at the expense of the Indemnitee unless (i) the
employment of counsel by the Indemnitee has been authorized by the Corporation, (ii) counsel to the Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on any significant issue between the Corporation
and the Indemnitee in the conduct of the defense of such Proceeding or (iii) the Corporation shall not in fact have employed counsel to assume the defense of such Proceeding, in each of which cases the fees and expenses of counsel for the
Indemnitee shall be at the expense of the Corporation, except as otherwise expressly provided by this Agreement, and provided that Indemnitee’s counsel shall cooperate reasonably with the Corporation’s counsel to minimize the cost of
defending claims against the Corporation and the Indemnitee. The Corporation shall not be entitled, without the consent of the Indemnitee, to assume the defense of any claim brought by or in the right of the Corporation or as to which counsel for
the Indemnitee shall have reasonably made the conclusion provided for in clause (ii) above. The Corporation shall not be required to indemnify the Indemnitee under this Agreement for any amounts paid in settlement of any Proceeding effected
without its written consent. The Corporation shall not settle any Proceeding in any manner that would impose any penalty or limitation on the Indemnitee without the Indemnitee’s written consent. Neither the Corporation nor the Indemnitee will
unreasonably withhold or delay their consent to any proposed settlement. 
 8. Advancement of Expenses. Subject to the provisions of
Section 9, in the event that the Corporation does not assume the defense pursuant to Section 7 of any Proceeding of which the Corporation receives notice under this Agreement, any Expenses actually and reasonably incurred by or on behalf
of the Indemnitee in defending such Proceeding shall be paid by the Corporation in advance of the final disposition of such Proceeding; provided, however, that the payment of such Expenses incurred by or on behalf of the Indemnitee in
advance of the final disposition of such Proceeding shall be made only upon receipt of an undertaking by or on behalf of the Indemnitee to repay all amounts so advanced in the event that it shall ultimately be determined by final judicial decision
from which there is no further right to appeal that the Indemnitee is not entitled to be indemnified by the Corporation as authorized in this Agreement. Such undertaking shall be accepted without reference to the financial ability of the Indemnitee
to make repayment. Any advances and undertakings to repay pursuant to this Section 8 shall be unsecured and interest-free. 

  
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 9. Procedures. 

(a) In order to obtain indemnification or advancement of Expenses pursuant to this Agreement, the Indemnitee shall submit to the Corporation a
written request, including in such request such documentation and information as is reasonably available to the Indemnitee and is reasonably necessary to determine whether and to what extent the Indemnitee is entitled to indemnification or
advancement of Expenses. Any such indemnification or advancement of Expenses shall be made promptly, and in any event within sixty (60) days after receipt by the Corporation of the written request of the Indemnitee, unless the Corporation
determines within such sixty (60) -day period that the Indemnitee did not meet the applicable standard of conduct. Such determination, and any determination that advanced Expenses must be repaid to the Corporation, shall be made in each
instance (a) by a majority vote of the directors of the Corporation consisting of persons who are not at that time parties to the Proceeding (“disinterested directors”), whether or not a quorum, (b) by a committee of
disinterested directors designated by a majority vote of disinterested directors, whether or not a quorum, (c) if there are no disinterested directors, or if the disinterested directors so direct, by independent legal counsel (who may, to the
extent permitted by applicable law, be regular legal counsel to the Corporation) in a written opinion, or (d) by the stockholders of the Corporation. 

(b) The termination of any Proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent, shall
not, of itself, create a presumption that the Indemnitee did not act in good faith and in a manner that the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal
Proceeding, had reasonable cause to believe that his or her conduct was unlawful. 
 (c) The Indemnitee shall cooperate with the person,
persons or entity making such determination with respect to the Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not
privileged or otherwise protected from disclosure and which is reasonably available to the Indemnitee and reasonably necessary to such determination. Any Expenses actually and reasonably incurred by the Indemnitee in so cooperating shall be borne by
the Corporation (irrespective of the determination as to the Indemnitee’s entitlement to indemnification) and the Corporation hereby indemnifies the Indemnitee therefrom. 

10. Remedies. The right to indemnification or advancement of Expenses as provided by this Agreement shall be enforceable by the
Indemnitee in any court of competent jurisdiction if the Corporation denies such request, in whole or in part, or if no disposition thereof is made within the applicable period referred to in Section 9. Unless otherwise required by law, the
burden of proving that indemnification or advancement of Expenses is not appropriate shall be on the Corporation. Neither the failure of the Corporation to have made a determination prior to the commencement of such action that indemnification is
proper in the circumstances because the Indemnitee has met the applicable standard of conduct, nor an actual determination by the Corporation that the Indemnitee has not met such applicable standard of conduct, shall be a

  
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defense to the action or create a presumption that the Indemnitee has not met the applicable standard of conduct. The Indemnitee’s Expenses actually and reasonably incurred in connection
with successfully establishing the Indemnitee’s right to indemnification, in whole or in part, in any such Proceeding shall also be indemnified by the Corporation. 

11. Partial Indemnification. If the Indemnitee is entitled under any provision of this Agreement to indemnification by the Corporation
for some or a portion of the Expenses, judgments, fines, penalties or amounts paid in settlement actually and reasonably incurred by or on behalf of the Indemnitee in connection with any Proceeding but not, however, for the total amount thereof, the
Corporation shall nevertheless indemnify the Indemnitee for the portion of such Expenses, judgments, fines, penalties or amounts paid in settlement to which the Indemnitee is entitled. 

12. Subrogation. [Except as provided in Section 14(c) below,] in the event of any payment under this Agreement, the Corporation
shall be subrogated to the extent of such payment to all of the rights of recovery of the Indemnitee [(other than against the Fund Indemnitors)], who shall execute all papers required and take all action necessary to secure such rights, including
execution of such documents as are necessary to enable the Corporation to bring suit to enforce such rights. 
 13. Term of
Agreement. This Agreement shall continue until and terminate upon the later of (a) six years after the date that the Indemnitee shall have ceased to serve as a director or officer of the Corporation or, at the request of the Corporation, as
a director, officer, partner, trustee, member, employee or agent of another corporation, partnership, joint venture, trust, limited liability company or other enterprise or (b) the final termination of all Proceedings pending on the date set
forth in clause (a) in respect of which the Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by the Indemnitee pursuant to Section 10 of this Agreement relating thereto.

 14. Indemnification Hereunder Not Exclusive. 

(a) The indemnification and advancement of Expenses provided by this Agreement shall not be deemed exclusive of any other rights to which the
Indemnitee may be entitled under the Restated Certification of Incorporation, the Amended and Restated By-Laws, any other agreement, any vote of stockholders or disinterested directors, the General Corporation Law of Delaware, any other law (common
or statutory), or otherwise, both as to action in the Indemnitee’s official capacity and as to action in another capacity while holding office for the Corporation. 

(b) Nothing contained in this Agreement shall be deemed to prohibit the Corporation from purchasing and maintaining insurance, at its expense,
to protect itself or the Indemnitee against any expense, liability or loss incurred by it or the Indemnitee in any such capacity, or arising out of the Indemnitee’s status as such, whether or not the Indemnitee would be indemnified against such
expense, liability or loss under this Agreement; provided that, [except as provided in paragraph (c) below,] the Corporation shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the
extent that the Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise. 

  
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 (c) [The Corporation hereby acknowledges that Indemnitee has certain rights to indemnification,
advancement of expenses and/or insurance provided by certain VC Funds and certain of their affiliates (collectively, the “Fund Indemnitors”). The Corporation hereby agrees (i) that it is the indemnitor of first resort (i.e., its
obligations to Indemnitee are primary and any obligation of the Fund Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by Indemnitee are secondary), (ii) that it shall be required to
advance the full amount of expenses incurred by Indemnitee and shall be liable for the full amount of all Expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this
Agreement and the Certificate of Incorporation or Bylaws of the Corporation (or any other agreement between the Corporation and Indemnitee), without regard to any rights Indemnitee may have against the Fund Indemnitors, and (iii) that it
irrevocably waives, relinquishes and releases the Fund Indemnitors from any and all claims against the Fund Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof. The Corporation further agrees that no
advancement or payment by the Fund Indemnitors on behalf of Indemnitee with respect to any claim for which Indemnitee has sought indemnification from the Corporation shall affect the foregoing and the Fund Indemnitors shall have a right of
contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Indemnitee against the Corporation. The Corporation and Indemnitee agree that the Fund Indemnitors are express third party
beneficiaries of the terms of this Section 14(c).] 
 15. No Special Rights. Nothing herein shall confer upon the Indemnitee any
right to continue to serve as an officer or director of the Corporation for any period of time or at any particular rate of compensation. 

16. Savings Clause. If this Agreement or any portion thereof shall be invalidated on any ground by any court of competent jurisdiction,
then the Corporation shall nevertheless indemnify the Indemnitee as to Expenses, judgments, fines, penalties and amounts paid in settlement with respect to any Proceeding to the full extent permitted by any applicable portion of this Agreement that
shall not have been invalidated and to the fullest extent permitted by applicable law. 
 17. Counterparts. This Agreement may be
executed in any number of counterparts, each of which shall constitute the original. 
 18. Successors and Assigns. This Agreement
shall be binding upon the Corporation and its successors and assigns and shall inure to the benefit of the estate, heirs, executors, administrators and personal representatives of the Indemnitee. 

19. Headings. The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute
part of this Agreement or to affect the construction thereof. 

  
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 20. Modification and Waiver. This Agreement may be amended from time to time to reflect
changes in Delaware law or for other reasons. No supplement, modification or amendment of this Agreement shall be binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed
or shall constitute a waiver of any other provision hereof nor shall any such waiver constitute a continuing waiver. 
 21. Notices.
All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been given (i) when delivered by hand or (ii) if mailed by certified or registered mail with postage prepaid, on the third
day after the date on which it is so mailed: 
  

	 	(a)	if to the Indemnitee, to: 

 [    ] 

 

	 	(b)	if to the Corporation, to: 

 Argos Therapeutics, Inc. 

4233 Technology Drive 
 Durham,
North Carolina 27704 
 Attn: Chief Executive Officer 

Phone: (919) 287-6300 
 or to such other
address as may have been furnished to the Indemnitee by the Corporation or to the Corporation by the Indemnitee, as the case may be. 
 22.
Applicable Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware. The Indemnitee may elect to have the right to indemnification or reimbursement or advancement of Expenses
interpreted on the basis of the applicable law in effect at the time of the occurrence of the event or events giving rise to the applicable Proceeding, to the extent permitted by law, or on the basis of the applicable law in effect at the time such
indemnification or reimbursement or advancement of Expenses is sought. Such election shall be made, by a notice in writing to the Corporation, at the time indemnification or reimbursement or advancement of Expenses is sought; provided,
however, that if no such notice is given, and if the General Corporation Law of Delaware is amended, or other Delaware law is enacted, to permit further indemnification of the directors and officers, then the Indemnitee shall be indemnified
to the fullest extent permitted under the General Corporation Law, as so amended, or by such other Delaware law, as so enacted. 
 23.
Enforcement. The Corporation expressly confirms and agrees that it has entered into this Agreement in order to induce the Indemnitee to continue to serve as a director and/or officer of the Corporation, and acknowledges that the Indemnitee is
relying upon this Agreement in continuing in such capacity. 

  
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 24. Entire Agreement. This Agreement sets forth the entire agreement of the parties hereto
in respect of the subject matter contained herein and supercedes all prior agreements, whether oral or written, by any officer, employee or representative of any party hereto in respect of the subject matter contained herein; and any prior agreement
of the parties hereto in respect of the subject matter contained herein is hereby terminated and cancelled. For avoidance of doubt, the parties confirm that the foregoing does not apply to or limit the Indemnitee’s rights under Delaware law or
the Corporation’s Restated Certificate of Incorporation or Amended and Restated By-Laws. 
 25. Consent to Suit. In the case of
any dispute under or in connection with this Agreement, the Indemnitee may only bring suit against the Corporation in the Court of Chancery of the State of Delaware. The Indemnitee hereby consents to the exclusive jurisdiction and venue of the
courts of the State of Delaware, and the Indemnitee hereby waives any claim the Indemnitee may have at any time as to forum non conveniens with respect to such venue. The Corporation shall have the right to institute any legal action arising out of
or relating to this Agreement in any court of competent jurisdiction. Any judgment entered against either of the parties in any proceeding hereunder may be entered and enforced by any court of competent jurisdiction. 

  
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 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year
first above written. 
  

			
	ARGOS THERAPEUTICS, INC.
		
	By:	 	  

		
	Name:	 	  

		
	Title:	 	  

	
	INDEMNITEE:
	
	  

  
 10EX-10.15

 Exhibit 10.15 

 

			
	Argos Therapeutics, Inc.	 	Contract No. HHSN266200600019C

 Confidential Materials omitted and filed separately with the Securities and 

Exchange Commission. Double 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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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	(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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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	
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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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	 	
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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	Argos Therapeutics, Inc.	 		 	Contract No. HHSN266200600019C

  

	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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	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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	 	(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— - 

  
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 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. 

  
 35 

					
	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 

  

  

					
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		 		 	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. 

(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. 

  

					
	 Contract No.
HHSN266200600019C
 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). 

  

					
	 Contract No.
HHSN266200600019C
 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. HHSN266200600019C 

  

																									
	  

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
  
	  	1. CONTRACT ID CODE        	 	Page of Pages
	  	N/A.	 	1	  	2

																									
	 2. AMENDMENT/MODIFICATION
NO.        
     Seven (7)    
	 	
3. EFFECTIVE DATE                    

     See Block 16C    
	 	 4. REQUISITION/PURCHASE

REQ. NO.

        2166401
	  		 	
5. PROJECT NO. (If applicable)            

        N/A.    

	 	 	  	 	 	 
	 6.  ISSUED BY
	 	CODE 	  	N/A.	 	7. ADMINISTERED BY (If other than Item 6)	  	CODE 	  	 
	   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)
  

    Argos Therapeutics, Inc.
                                         
           VIN #1109171

    4233 Technology Drive

    Durham, NC 27704
	 	(X) 	  	 9A.  AMENDMENT OF SOLICITATION NO.

	 	 	  		  		 		  		  	
	 	 ̈	  	 9B.   DATED (SEE ITEM 11)

	 	 	  		  		 		  		  	
	 	 	  	
10A.  MODIFICATION OF CONTRACT/ORDER NO.

	 	x 	  	           HHSN266200600019C    

	 	  	 10B.   DATED (SEE ITEM 13)

	 CODE	  	FACILITY CODE 	  	 	 	 	  	            September
30, 2006    

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	  ̈ The above numbered solicitation
is amended as set forth in Item 14. The hour and date specified for receipt of
Offers            
         ̈ is extended.          ̈ is not extended.
  
 Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

 
 (a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By
acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE
DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your 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)
	                     
                   SOC: 25.55
                            CAN: 11-8470035
                                         
   Amount: $1,985,104
	 13. THIS ITEM ONLY APPLIES TO MODIFICATION 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).
	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 Article B.2. of the contract to include funding for a direct rate
adjustment and correct an error in fee line.

  

																									
	 	  	 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	  	  	$	26,482,126	  	  	$	 1,395,099	  	  	$	27,877,225	  
	 This Mod #
	  	$	 1,985,104	  	  	$	 0	  	  	$	 1,985,104	  	  	$	 1,985,104	  	  	$	 0	  	  	$	 1,985,104	  
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Revised Total
	  	$	28,467,230	  	  	$	 1,395,099	  	  	$	 29,862,329	  	  	$	28,467,230	  	  	$	 1,395,099	  	  	$	 29,862,329	  

   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)	 		  	16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
	 Jeffrey Abbey,

President & CEO
	 	 	  	 Michelle L. Scala

Contracting Officer, OA, DEA, NIAID, NIH

	15B. CONTRACTOR/OFFEROR	 	15C. DATE SIGNED        	 		  	16B. UNITED STATES OF AMERICA	  	16C. DATE SIGNED
	
By            /s/ Jeffrey Abbey     
                               
                   (Signature of person authorized to sign)
	 	6/29/11    
	 	
    By                     
                                         
                

                (Signature of Contracting Officer)
	  	 
	 NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE
	 	 30-105
 Computer Generated
	  	 STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA
 FAR (48 CFR) 53.24

					
	Contract No.
HHSN266200600019C
Modification No.: 7	 	SPECIAL PROVISIONS	 	PAGE 2 OF 2

  

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY
AGREES AS FOLLOWS: 
 ARTICLE B.2. ESTIMATED COST – OPTION, paragraph a., c. and d. are hereby modified as follows: 

ARTICLE B.2. ESTIMATED COST – OPTION 
  

	a.	The estimated cost of this contract is increased by $1,985,104, from $26,482,126 to $28,467,230. 

 

	c.	The total estimated amount of the contract, represented by the sum of the estimated cost, plus the fixed fee is increased by $1,985,104 from $27,877,225
to $29,862,329. 

  

	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
	  				  	$	28,467,230	  	  	$	1,395,099	  	  	$	29,862.329	  
		  				  	  
	  
	 	  	  
	  
	 	  	  
	  
	 

 END OF MODIFICATION 7 CONTRACT NO. HHSN266200600019C 

  

																									
	  

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
  
	  	1. CONTRACT ID CODE        	  	PAGE     OF     PAGES
	  	 	  	1	  	        3

																									
	 2. AMENDMENT/MODIFICATION
NO.        
     Eight (8)    
	 	
3. EFFECTIVE DATE                    

     09/30/2011    
	 	 4. REQUISITION/PURCHASE

REQ. NO.

        2285024
	  		 	
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, 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)
  

    Argos Therapeutics, Inc.
                                         
           VIN# 1109171

    4233 Technology Drive

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

	 	 	  		  		 		  		  	
	 	 	  	 9B.   DATED (SEE ITEM 11)

	 	 	  		  		 		  		  	
	 	x 	  	 10A.  MODIFICATION OF CONTRACT/ORDER NO.

	 	 	  	           HHSN266200600019C    

	 	 	  	 10B.   DATED (SEE ITEM 13)

	 CODE	  	FACILITY CODE 	  	 	 	 	  	            September
30, 2006    

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	  ̈ The above numbered solicitation
is amended as set forth in Item 14. The hour and date specified for receipt of Offers                     ̈ is extended,          ̈ is not extended.
  

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

	12. ACCOUNTING AND APPROPRIATION DATA (If required)
	                    
            
        SOC: 25.55
                            CAN: 11-8470035
                                         
   Amount: $4,042,726
	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,
 IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN
ITEM 14.

																											
	(C)   	 	  
 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.
 FAR 52,243-2 Changes – Cost
Reimbursement, Alternate V
  

	 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)
	 	Public Law (P.L.) 111-8 and P.L. 110-85
	 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 provide
supplemental funds to cover the cost of a change order.

  

																									
	 	  	 Total Funds Currently Obligated
	 	  	 Total Estimated Cost
	 
	 	  	 Cost
	 	  	 Fee
	 	  	 Total
	 	  	 Cost
	 	  	 Fee
	 	  	 Total
	 
	 Prior to this Mod
	  	$	28,467,230	  	  	$	1,395,099	  	  	$	29,862,329	  	  	$	28,467,230	  	  	$	 1,395,099	  	  	$	29,862,329	  
	 This Mod #
	  	$	 4,042,726	  	  	$	 0	  	  	$	 4,042,726	  	  	$	 4,042,726	  	  	$	 0	  	  	$	 4,042,726	  
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Revised Total
	  	$	32,509,956	  	  	$	 1,395,099	  	  	$	 33,905,055	  	  	$	32,509,956	  	  	$	 1,395,099	  	  	$	 33,905,055	  

   COMPLETION DATE: May 31, 2013 

 

									
	 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)
	 Jeff Abbey

President & CEO
	 	 	  	 Michelle L. Scala

Contracting Officer, OA, DEA, NIAID, NIH,

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

                  (Signature of person authorized to
sign)
	 	9/26/11    
	 	
    BY              /s/ Michelle L. Scala 
                     

                (Signature of Contracting Officer)
	  	    
9/26/11
	 NSN 7540-01 152-8070

PREVIOUS EDITION UNUSABLE
	 	 30-105
 Computer Generated
	  	 STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA
 FAR (48 CFR) 53.243

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY AGREE
AS FOLLOWS: 
 The Government is requesting that the Contractor perform increased activities which are within scope. The costs of these
activities are at a level that would make them difficult to cover under the costs provided for Option 1 of the contract. The activities are included below: 
 Argos Therapeutics, Inc. will add 12 additional subjects to the current phase IIB clinical study of the experimental autologous therapeutic DC based vaccine approach. This additional work is within the
scope of the contract and the addition of these subjects will not exceed the total number of subjects originally proposed in the statement of work. 
 In accordance with FAR 52.243-2, Changes-Cost Reimbursement, Alternate V, the above change is hereby made and in effect immediately. While there is no change in the
scope of work, the tasks described above will increase contract activity beyond what was originally anticipated. Pursuant to FAR 52,243-2, the Government and Contractor have negotiated increased costs for the
changes noted above. This modification provides supplemental funds to cover costs of this change order. Therefore, no further editable adjustment will be accepted. 
 ARTICLE B.2. ESTIMATED COST - OPTION, paragraph a., c., and d. are hereby modified as follows: 
  

	a.	The estimated cost of this contract is increased by $4,042,726, from $28,467,230 to $32,509,956. 

 

	c.	The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee is increased by $4,042,726, from $29,862,329
to $33,905,055. 

  

	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
	  		  	$	32,509,956	  	  	$	1,395,099	  	  	$	33,905,055	  
		  		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 

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

Paragraph b, Subcontract Modifications, subparagraph 2, is revised to reflect the increased “Not to Exceed” amounts for the subcontracts with
[**], as follows: 
  

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

 Paragraph c, Consultants, is hereby modified to add paragraph (3), and shall read as follows: 

 

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

 

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

 END OF MODIFICATION 8 CONTRACT NO. HHSN266200600019C 

																									
	  

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
	  	1. CONTRACT ID CODE        	  	PAGE OF PAGES
	  	 	  	1	  	7

																									
	 2. AMENDMENT/MODIFICATION
NO.        
         Nine (9)    
	 	
3. EFFECTIVE DATE                    

     Block 16C    
	 	 4. REQUISITION/PURCHASE

REQ. NO.

        2937465
	  		 	
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)
  
 Argos Therapeutics, Inc.
                                         
           VIN # 1109171
 4233 Technology Drive

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

	 	 	  		  		 		  		  	
	 	 	  	 9B.   DATED (SEE ITEM
11)

	 	 	  		  		 		  		  	
	 	X 	  	 10A.  MODIFICATION OF CONTRACT/ORDER NO.

	 	 	  	           HHSN266200600019C    

	 	 	  	 10B.   DATED (SEE ITEM
13)

	 CODE	  	FACILITY CODE 	  	 	 	 	  	            September
30, 2006    

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	 ̈ The above numbered
solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers	  	 ̈ is extended,    	  	 ̈ is not extended.
	 Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods;
  
 (a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter
or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to
the opening hour and data specified.

	12. ACCOUNTING AND APPROPRIATION DATA (if required)
	SOC 25.55
                            CAN: 3-8470035
                                         
   AMOUNT $5,415,284
	
           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 52.232-20 Limitation of Cost, and P.L. 110-161
	 	 	D.	 	OTHER (Specify type of modification and authority)
	 	 
	E.
IMPORTANT:
Contractor             ̈ is not,        x is required to sign this document and return
    2     copies to the issuing office.
	 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject
matter where feasible.)

PURPOSE: To 1) extend the term
of the contract from May 31, 2013 to September 30, 2015; 2) to fund a cost overrun under Option 1, in the total amount of $5,415,284; and 3) revise Article B.2. Estimate Cost – Option, to reflect the additional funding; 4) revise
Articles B.3, B.4, F.3, G.1, G.2 and I.3; and 5) revise Sections H and J, as reflected on pages 1-7.

  

																									
	 	  	Total Funds Currently Obligated	 	  	Total Estimated Cost	 
	 	  	Cost	 	  	Fee	 	  	Total	 	  	Cost	 	  	Fee	 	  	Total	 
	 Prior to this Mod
	  	$	32,509,956	  	  	$	1,395,099	  	  	$	33,905,055	  	  	$	32,509,956	  	  	$	 1,395,099	  	  	$	33,095,055	  
	 This Mod #
	  	$	5,415,284	  	  	$	 0	  	  	$	5,415,284	  	  	$	5,415,284	  	  	$	 0	  	  	$	 5,415,284	  
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Revised Total
	  	$	37,925,240	  	  	$	1,395,099	  	  	$	37,925,240	  	  	$	37,925,240	  	  	$	1,395,099	  	  	$	39,320,339	  

  

							
	TOTAL FUNDED AMOUNT: $39,320,339 (CHANGED)	  	TOTAL CONTRACT AMOUNT: $39,320,339 (CHANGED)
	CONTRACT FUNDED THROUGH: September 30, 2015 (CHANGED)	  	CONTRACT EXPIRATION DATE: September 30, 2015 (CHANGED)

  

							
	Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed,
remains unchanged and in full force and effect.
	15A. NAME AND TITLE OF SIGNER (Type or print)	  	16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
	Jeff Abbey, President and CEO	  	 John R. Manouelian, Contracting Officer

Office of Acquisitions, DEA, NIAID, NIH, DHHS

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

 (Signature of person authorized to sign)
     
	 	  
 4-15-13    

	  	  

By: /s/ John R. Manouelian                      

 (Signature of Contracting Officer)

    
	  	  
 4-16-2013

					
	 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: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 2 of 8

  

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY
AGREE AS FOLLOWS: 
 ARTICLE B.2. ESTIMATED COST - OPTION, is hereby revised to reflect additional funding required for a cost
overrun under Option 1. Paragraphs a., c. and d. are hereby revised to read as follows: 
  

	a.	The estimated cost of this contract is increased by $5,415,284, from $32,509,956 to $37,925,240. 

 

	c.	The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee, is increased by $5,415,284, from $33,905,055
to $39,320,339, 

  

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

  

															
	 	  	 Period of
Performance
	  	Estimated Cost	 	 	Fixed Fee	 	 	Estimated CPFF	 
	 Base
	  	09/30/2006-06/30/2010	  	 	[**	] 	 	 	[**	] 	 	 	[**	] 
	 Option 1 - Autologous Vaccine and Clinical Trial
	  	07/01/2010-09/30/2015	  	 	[**	] 	 	 	[**	] 	 	 	[**	] 
		  		  	  
	  
	 	 	  
	  
	 	 	  
	  
	 
	 Total Base Period Plus Option 1
	  		  	$	37,925,240	  	 	$	1,395,099	  	 	$	39,320,339	  
		  		  	  
	  
	 	 	  
	  
	 	 	  
	  
	 

 ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS, is revised to: 1) incorporate items 1. Conferences and
Meeting, 2. Food for Meals, Light Refreshments, and Beverages and 3. Promotional Items under paragraph a. Items Unallowable Unless Otherwise Provided; 2) delete paragraph b. Light Refreshments and Meal Expenditures in its entirety; and 3) reflect
the revised period of performance under paragraph c. Travel Costs (now called paragraph b. Travel Costs, as a result of the deletion of paragraph b. Light Refreshments and Meal Expenditures). Following the aforementioned revisions, Article B.3
Provisions Applicable to Direct Costs shall read as follows: 
  

	 	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.	Conferences and Meetings 

  

	 	2.	Food for Meals, Light Refreshments, and Beverages 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 3 of 8

  

	 	3.	Promotional Items [includes, but is not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are
sometimes provided to visitors, employees, grantees, or conference attendees.] 

  

	 	4.	Acquisition, by purchase or lease, of any interest in real property; 

  

	 	5.	Special rearrangement or alteration of facilities; 

  

	 	6.	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.); 

  

	 	7.	Travel to attend general scientific meetings; 

  

	 	8.	Consultant costs; 

  

	 	9.	Subcontracts; 

  

	 	10.	Patient care costs; 

  

	 	11.	Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more) and “sensitive items” (defined as
items of personal property - supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value. 

  

	 	b.	Travel Costs 

  

	 	1.	Domestic Travel 

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

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

							
	 	  	 Period of Performance
	  	Total Cost Not to Exceed	 
	 Base
	  	09/30/2006-06/30/2010	  	 	[**	] 
	 Option 1
	  	07/01/2010-09/30/2015	  	 	[**	] 
		  		  	  
	  
	 
	 Total Base Period Plus Option 1
	  		  	 	[**	] 
		  		  	  
	  
	 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 4 of 8

  

 ARTICLE B.4. ADVANCE UNDERSTANDINGS, paragraphs b.2. and c. are hereby revised and shall
read as follows: 
  

	b.	Subcontract Modification 

  

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

  

	c.	Consultants 

  

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

 

							
	 Option
	  	 Period of Performance
	  	Total Cost,
Excluding Travel, Not
to
Exceed	 
	 Base
	  	09/30/2006-06/30/2010	  	 	[**	] 
	 Option 1
	  	07/01/2010-09/30/2015	  	 	[**	] 
		  		  	  
	  
	 
	 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
	  	09/30/2006-06/30/2010	  	 	[**	] 
	 Option 1
	  	07/01/2010-09/30/2015	  	 	[**	] 
		  		  	  
	  
	 
	 Total Base Plus Option
	  		  	 	[**	] 
		  		  	  
	  
	 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 5 of 8

  

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

 

							
	 Option
	  	 Period of Performance
	  	Total Cost,
Excluding Travel, Not
to
Exceed	 
	 Base
	  	09/30/2006-06/30/2010	  	 	[**	] 
	 Option 1
	  	07/01/2010-09/30/2015	  	 	[**	] 
		  		  	  
	  
	 
	 Total Base Period Plus Option
	  		  	 	[**	] 
		  		  	  
	  
	 

 ARTICLE F.3. OPTION PERIODS, is hereby revised and shall read as follows: 

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

			
	 Option
	  	 Period of Performance

	 Base
	  	09/30/2006-06/30/2010
	 Option 1
	  	07/01/2010-09/30/2015

 ARTICLE G.1. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR), is hereby deleted in its entirety
and replaced with the following: 
 ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR) 

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

Anthony J, Conley, Ph.D. 
 Targeted Inercentions Branch 
 Basic Science Program Division of AIDS, NIAID, NIH,
DHHS 
 Room 5207, MSC 7626 
 6700B Rockledge Drive 
 Bethesda, Maryland 20892-7626 

Email: conleyto(5)niaid.nih.gov 
 The COR 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. 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 6 of 8

  

 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 COR designation. 
 ARTICLE G.2. KEY PERSONNEL,
HHSAR 352.270-5 (January 2006). is hereby deleted in its entirety and replaced with the following, which cites the current HHSAR Clause reference for the Key Personnel article. 
 ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006) 
 The key personnel
specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for
example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key
personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may
modify the contract to add or delete key personnel at the request of the Contractor or Government. (End of Clause) 
 The following individual
is considered to be essential to the work being performed hereunder: 
  

			
	 Name
	  	 Title

	[**]	  	Principle Investigator

 ARTICLE H.7. NEEDLE DISTRIBUTION, is hereby deleted in its entirety and replaced with the following:

 ARTICLE H.7. NEEDLE DISTRIBUTION 
 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 hereby deleted in its entirety. The Salary Rate Limitation Legislation
Provisions are now incorporated under Article I.3. Additional Contract Clauses. 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 7 of 8

  

 ARTICLE H.21. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION, is
hereby deleted in its entirety and replaced with the following: 
 ARTICLE H.21. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING
SCIENTIFIC INFORMATION 
 The Contractor shall not use contract funds to disseminate information that is deliberately false or
misleading. 
 ARTICLE H.22. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS, is hereby deleted In its entirety.

 ARTICLE H.26. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD, is hereby incorporated into the contract and shall read as
follows: 
 The Contractor shall not use contract funds to conduct meetings or conferences without prior written Contracting Officer approval.

 In addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited. 

ARTICLE H.27. USE OF FUNDS FOR PROMOTIONAL ITEMS, is hereby incorporated into the contract and shall read as follows: 

The Contractor shall not use contract funds to purchase promotional items. Promotional items include, but are not limited to: clothing and commemorative
items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees. This includes items or tokens given to individuals as these are considered personal
gifts for which contract funds may not be expended. 
 ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, paragraph b., is hereby revised
to incorporate subparagraph 12: 
  

	4.	HHSAR Clause 352.231-70, Salary Rate Limitation (March 2012). 

 Note: P.L. 112-74 sets forth the Salary Rate Limitation at the Executive Level II Rate, effective December 23, 2011. 
 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.) 

					
	 Contract: HHSN266200600019C
 Modification No: 09
	 	SPECIAL PROVISIONS	 	Page 8 of 8

  

 SECTION J - LIST OF ATTACHMENTS, Attachment 2. Invoice/Financing Request Instructions and
Contract Financial Report for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 is revised to reflect the most current invoice instructions and shall read as follows: 
  

	 	2.	Invoice/Financing Request Instructions and Contract Financial Report for NIH Cost-Reimbursement Type Contracts NIH(RC)-4, (08/2012), 6 pages. 

All other terms and conditions of the contract remain unchanged. 

END OF MODIFICATION NO. 9 - CONTRACT NO. HHSN266200600019C 

 INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING 

INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4 
 Format: Submit payment requests on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form
1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover
letter with the payment request. 
 Number of Copies: Submit payment requests in the quantity specified in the Invoice Submission
Instructions in Section G of the Contract Schedule. 
 Frequency: Payment requests shall not be submitted more frequently than once every
two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Office.

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

 Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or
(2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall cite the amount(s) and month(s) in which the costs were incurred. 
 Contractor’s Fiscal Year: Prepare payment requests in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year. 

Currency: All NIH contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars,
billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above,
the total of all invoices paid under this contract shall not exceed the United States dollars authorized. 
 Costs Requiring Prior
Approval: Identify and reference the Contracting Officer’s Authorization (COA) Number for costs requiring the Contracting Officer’s approval, which are not set forth in an Advance Understanding in the contract. In addition, the
Contractor shall show any cost set forth in an Advance Understanding as a separate entry under the appropriate expenditure category on the payment request. 
 Invoice/Financing Request Identification: Identify each payment as either: 
  

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

  
 1 

	(b)	Completion Invoice: Submit the completion invoice promptly upon completion of the work, but no later than one year from the contract completion date, or within
120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract
and all performance provisions have been completed. 

  

	(c)	Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all
suspensions and audit exceptions). 

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

  

	(a)	Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section
G of the Contract Schedule. 

  

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

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

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

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

  
 2 

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

 

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

 

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

 

	(f)	Contract Title: Insert the contract title exactly as it appears on the cover page of the contract. 

 

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

  

	(h)	Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order. 

 

	(i)	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 contracts/orders with options or incremental funding provisions, enter the amount currently obligated and available for payment. 

 

	(j)	Total Fixed-Fee: Insert the total fixed-fee (where applicable). For contracts/orders with options or incremental funding provisions, enter the amount currently
obligated and available for payment (where applicable). 

  

	(k)	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. 

  

	(l)	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. 

  

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

  

	(n)	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.

  

	(o)	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. 

 

	(p)	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. 

  
 3 

	(q)	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 Schedule) for the
current billing period, and 

  

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

  

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

  

	 	3)	Accountable Personal Property: Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life
expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for 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. Precede the item with an asterisk (*) if the equipment is below the $1,000 approval level. Include reference to the following (as applicable): 
  

	 	•	 	 item number for the specific piece of equipment listed in the Property Schedule, and Contracting Officer Authorization (COA) number, if the equipment
is not covered by the Property Schedule. 

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

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

  

	 	5)	Premium Pay: List remuneration in excess of the basic hourly rate. 

  
 4 

	 	6)	Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number
of hours, days, etc.) and rate billed. 

  

	 	7)	Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an
organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel. 

 

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

 

	 	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. 

  

	(r)	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.

  

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

 

	(t)	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.

  

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

 

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

 

	(w)	Grand Totals 

 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 certify that all payments requested are for appropriate purposes and in accordance with the contract and the salaries billed are
in compliance with the Salary Rate Limitation Provisions in Section I of the contract,” 
 The Contracting Officer may require the
Contractor to submit detailed support for costs claimed on one or more interim payment requests. 
 FINANCIAL REPORTING INSTRUCTIONS:

 These instructions are keyed to the Columns on the sample invoice/financing request. 

  
 5 

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

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

  
 6 

 SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT 

 

					
	(a)	 	Designated Billing Office Name and Address:
		
		 	National Institutes of Health
		 	Office of Financial Management
		 	Commercial Accounts
		 	2115 East Jefferson Street, Room 4B432, MSC 8500
		 	Bethesda, MD 20892-8500
		
	(b)	 	Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number:
		
		 	ABC CORPORATION
		 	100 Main Street
		 	Anywhere, USA Zip+4
		
		 	Name, Title, Phone Number, and E-mail Address of Contractor’s Point of Contact.

							
				
		 	DUNS or DUNS+4:	 	  
	 	

							
		 	TIN:	 	  
	 	

							
				
	(c)	 	Invoice/Financing Request No.:	 	  
	 	

					
			
	(d)	 	Date Invoice/Financing Request Prepared:	 	  

		 	  

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

					
		 	  

					
		
	(f)	 	Contract Title:
		 	  

		 	  

					
		
	(g)	 	Current Contract Period of Performance:
		 	  

					
			
	(h)	 	Effective Date:	 	  

					
		
	(i)	 	Total Estimated Cost of Contract/Order:
		 	  

			
	(j)	 	Total Fixed Fee (if applicable):	 	  

							
				
	(k)	 	Two-Way Match:	 	  
	 	

							
		 	Three-Way Match:	 	  
	 	

							
			
	(l)	 	Office of Acquisitions:	 	
		 	  
	 	:
		 	  
	 	
		 	  
	 	
				
	(m)	 	Central Point of Distribution:	 	  
	 	

 
 

  

	(n)	This invoice/financing request represents reimbursable costs for the 5period from
                     to                     

  

															
	 	  	Cumulative Percentage of
Effort/Hrs.	  	Amount Billed	  	 	  	 	  	 
	 Expenditure Category* A
	  	Negotiated
B	  	Actual
C	  	(o) Current
D	  	(p) Cumulative
E	  	Cost at
Completion
F	  	Contract
Value
G	  	Variance
H
	 (q) 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
	  		  		  		  		  		  		  	
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  

	 (r) Cost of Money     %
	  		  		  		  		  		  		  	
	 (s) Indirect Costs     %
	  		  		  		  		  		  		  	
	 (t) Fixed Fee     %
	  		  		  		  		  		  		  	
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  

	 (u) Total Amount Claimed
	  		  		  		  		  		  		  	
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  

	 (v) Adjustments
	  		  		  		  		  		  		  	
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  

	 (w) Grand Totals
	  		  		  		  		  		  		  	
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  

 “I certify that all payments requested are for appropriate purposes and in accordance with the
contract and the salaries billed are in compliance with the Salary Rate Limitation Provisions in Section I of the contract.” 
  

									
		 	  
	 		 	  
	 	
		 	(Name of)	 		 	(Title)	 	

  

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

 OMB Approval 2700-0042 

 

																									
	  

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

 
	  	1. CONTRACT ID CODE         
	  	PAGE     OF     PAGES
	  	 	  	1        	  	        4

																									
	
2. AMENDMENT/MODIFICATION NO.        

    Ten (10)   
 
	 	
3. EFFECTIVE DATE                    

     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
	   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)
  

    Argos Therapeutics, Inc.
                                         
   VIN # 1109171
     4233 Technology Drive

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

	 	 	 		  		 		  		  	
	 	 	 	 9B.   DATED (SEE ITEM 11)

	 	 	 		  		 		  		  	
	 	X 	 	10A. MODIFICATION OF CONTRACT/ORDER NO.
	 	 	 	           HHSN266200600019C     

	 	 	 	 10B.   DATED (SEE ITEM 11)

	 CODE	  	FACILITY
CODE 	  	 	 	 	 	            September 30, 2006    

	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	  ̈ The above numbered solicitation
is amended as set forth in item  14. The hour and date specified for receipt of Offers  ̈ is extended  ̈ is not
extended.
  
 Offers must acknowledge receipt of this amendment prior to the
hour and date specified in the solicitation or as amended, by one of the following methods:
  
 (a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter
or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND 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)
	                    
            
        SOC 25.55
                            CAN# 8-8470035
                                         
   AMOUNT: ($7.09)
	 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

 

	 	 	D.	 	OTHER (Specify type of modification and authority)
	 	    
	 E. IMPORTANT: Contractor            
 ̈ is not,        x is required to sign this document and return
    2     copies to the issuing office.
  

	 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject
matter where feasible.)
 PURPOSE:
To: 1) revise Article B.2. Estimated Cost- Option, to reflect the de-obligation of expiring-FY2008 funds in the total amount of $7.09; 2) revise Article G.1, Contracting Officer’s Representative (COR); 3) revise Article G.6, Post Award
Evaluation of Contractor Performance; 4) revise Article H.26, Use of Funds for Conferences, Meetings, and Food; and 5) revise Article 1.1, General Clauses for a Cost-Reimbursement Research and Development Contract, as reflected on pages
1-4.

  

																									
	  	  	Total Funds Currently Obligated	 	 	Total Estimated Cost	 
	  	  	Cost	 	 	Fee	 	  	Total	 	 	Cost	 	 	Fee	 	  	Total	 
	 Prior to this Mod
	  	$	37,925,240.00	  	 	$	1,395,099	  	  	$	39,320,339.00	  	 	$	37,925,240.00	  	 	$	1,395,099	  	  	$	39,320,339.00	  
	 This Mod #10
	  	$	(7.09	) 	 	$	0	  	  	$	(7.09	) 	 	$	(7.09	) 	 	$	0	  	  	$	(7.09	) 
		  	  
	  
	 	 	  
	  
	 	  	  
	  
	 	 	  
	  
	 	 	  
	  
	 	  	  
	  
	 
	 Revised Total
	  	$	37,925,232.91	  	 	$	1,395,099	  	  	$	39,320,331.91	  	 	$	37,925,232.91	  	 	$	1,395,099	  	  	$	39,320,331.91	  

 
									
	TOTAL FUNDED AMOUNT: $39,320,331.91 (CHANGED)	  	TOTAL CONTRACT AMOUNT: $39,320,331.91 (CHANGED)
	CONTRACT FUNDED THROUGH: September 30, 2015 (UNCHANGED)	  	CONTRACT EXPIRATION DATE: September 30, 2015 (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 print)
	  
 Jeffrey Abbey, President and CEO
	  	 John R. Manouelian, Contracting Officer

Office of Acquisitions, DEA, NIAID, NIH, DHHS

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

              (Signature of person authorized to 
sign)
	 	    
8-20-13	  	 BY /s/
John R. Manouelian                  
     

        (Signature of Contracting Officer)
	  	    
8.21.2013
	 NSN 7540-01-152-8070
 PREVIOUS
EDITION UNUSABLE
	 	 30-105
 Computer Generated
	  	 STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA
 FAR (48 CFR) 53.243

 BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY AGREE
AS FOLLOWS: 
 ARTICLE B.2. ESTIMATED COST - OPTION, paragraphs a., c. and d. are hereby revised to reflect the de-obligation
of unexpended, expiring FY2008 funds from the Base Period of the contract and shall read as follows: 
  

	a.	The estimated cost of this contract is decreased by $7.09, from $37,925,240 to $37,925,232.91. 

 

	c.	The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee, is decreased by $7.09, from $39,320,339 to
$39,320,331.91. 

  

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

  

																	
	 	  	Period of
Performance	 	  	Estimated Cost	 	 	Fixed Fee	 	 	Estimated CPFF	 
	 Base
	  	 
 	09/30/2006-
06/30/2010	 
  	  	 	[**	] 	 	 	[**	] 	 	 	[**	] 
	 Option 1 – Autologous Vaccine and Clinical Trial
	  	 
 	07/01/2010-
09/30/2015	 
  	  	 	[**	] 	 	 	[**	] 	 	 	[**	] 
		  				  	  
	  
	 	 	  
	  
	 	 	  
	  
	 
	 Total Base PeriodPlus Option 1
	  				  	$	37,925,232.91	  	 	$	1,395,099	  	 	$	39,320,331.91	  
		  				  	  
	  
	 	 	  
	  
	 	 	  
	  
	 

 ARTICLE G.l. CONTRACTING OFFICER’S REPRESENTATIVE (COR) is hereby deleted in its entirety and replaced
with the following: 
 ARTICLE G.l. CONTRACTING OFFICER’S REPRESENTATIVE (COR) 

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

Anthony J. Conley, Ph.D. 
 Targeted Inercentions Branch 
 Basic Science Program Division of AIDS, NIAID, NIH,
DHHS 
 Room 5207, MSC 7626 
 6700B Rockledge Drive 
 Bethesda, Maryland 20892-7626 

Email: conleyto@niaid.nih.gov 
 The COR 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; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by
reference in Section K of the contract. 
 The Government may unilaterally change its COR designation. 

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTING PERFORMANCE is hereby deleted in its entirety and replaced with the following:

 ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTING PERFORMANCE 

 

	a.	Contractor Performance Evaluations 

 Interim and Final evaluations of Contractor performance will be prepared on this contract In accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion
of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on September 30th. 
 Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty 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 

 EvaluationsContractors may access evaluations through a secure Web site for review and comment at the following address: 
 http://www.cpars.gov 
 ARTICLE H.26. USE OF FUNDS FOR CONFERENCES, MEETINGS AND
FOOD is revised to read as follows: 
 The Contractor shall not use contract funds (direct or indirect) to conduct meetings or
conferences in performance of this contract without prior written Contracting Officer approval. 
 In addition, the use of contract funds to
purchase food for meals, light refreshments, or beverages is expressly prohibited. 

 ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT,
paragraph a., is hereby revised to incorporate the current FAR clause number reference for Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more) and shall read as follows: 

 

					
	 FAR CLAUSE NO.
	  	 DATE
	  	 TITLE

	52.204-10	  	August 2012	  	Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)

 All other terms and conditions of the contract remain unchanged. 

END OF MODIFICATION NO. 10 - CONTRACT NO. HHSN266200600019C

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