Document:

Defense Advance Research Projects Agency Contract Award, dated December 6, 2002

 Exhibit 10.34 
  
 2003537 
 EFFECTIVE
DATE: 9-DEC-02 
 ORIGINAL CONTRACT AWARD 
  

													
	AWARD/CONTRACT	  	 1.     THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 350)
	  	RATING	  	PAGE Of PAGES
	  	  	  	        1	  	        7
				
	2. CONTRACT (proc. Inst. Ident.) NO. DAAD19-03-C-0002	  	 3.     EFFECTIVE DATE
	  	06 Dec 2002	  	4. REQUISITION/PURCHASE REQUEST/PROJECT NO. P-444498-LS-02248-1
						
	 5. ISSUED BY
 U.S. ARMY ROBERT MORRIS
ACQUISITION
 P.O. BOX 12211
 RESEARCH TRIANGLE PARK NC
27709-2211
	 	 CODE
	  	DAAD19	  	 6. ADMINISTERED BY (If other than Item 5)
  

See Item 5
	  	CODE	  	 
		
	7. NAME AND ADDRESS OF CONTRACTOR (No:, street, city, country, state and zip code)	  	 8. DELIVERY
  ̈  FOB ORIGIN    x  OTHER (See below)

			
	 COLEY PHARMACEUTICALS
 93 WORCESTER
ST
 WELLESLEY MA 02481-3609
	  	 	  	9. DISCOUNT FOR PROMPT PAYMENT N/A
					
	 	  	 	  	 	  	 10. SUBMIT INVOICES (4 copies unless otherwise specified)
 TO THE ADDRESS
 SHOWN IN:
	  	 ITEM
  
 Section G

	CODE 38G55	 	 	  	FACILITY CODE	  	 	  	 	  	 	  	 
						
	11. SHIP TO/MARK FOR	 	CODE	  	DAAD19	  	12. PAYMENT WILL BE MADE BY	  	CODE	  	HQ0303
	 U. S. ARMY RESEARCH OFFICE
 RECEIVING
 P. O. BOX 12211
 RESEARCH TRIANGLE PARK NC
27709-2211
	  	 	  	 DEFENSE FINANCE AND ACCOUNTING SERVICE
 ROCK
ISLAND OPERATING LOCATION
 ATTN: DFAS-RI-FPV
 BUILDING
68
 ROCK ISLAND IL 61299-8000
	  	 	  	 
				
	 13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:
 [        ] 10 U.S.C. 2304(c) (        ) [        ]
41.U.S.C.253(c)(        )
	  	14. ACCOUNTING AND APPROPRIATION DATA See Schedule	  	 	  	 
						
	15A. ITEM NO.	  	15B. SUPPLIES/ SERVICES	  	15C. QUANTITY	  	15D. UNIT	  	15E. UNIT PRICE	  	15F. AMOUNT
						
	 	  	SEE SCHEDULE	  	 	  	 	  	 	  	 
				
	 	  	 	  	15G. TOTAL AMOUNT OF CONTRACT	  	$6,000,001.00

															
	
	16. TABLE OF CONTENTS
								
	x	  	SEC	  	DESCRIPTION	  	PAGE(S)	  	x	  	SEC	  	DESCRIPTION	  	PAGE(S)
	PART I—THE SCHEDULE	  	PART II—CONTRACT CLAUSES
	x	  	A	  	SOLICITATION/ CONTRACT FORM	  	1-1	  	x	  	I	  	CONTRACT CLAUSES	  	5-7
	x	  	B	  	SUPPLIES OR SERVICES AND PRICES/ COSTS	  	2	  	PART III—LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
	x	  	C	  	DESCRIPTION/ SPECS/WORK STATEMENT	  	2	  	 	  	J	  	LIST OF ATTACHMENTS	  	 
	x	  	D	  	PACKAGING AND MARKING	  	2	  	PART IV—REPRESENTATIONS AND INSTRUCTIONS
	x	  	E	  	INSPECTION AND ACCEPTANCE	  	2-3	  	 	  	K	  	REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS	  	 
	x	  	F	  	DELIVERIES OR PERFORMANCE	  	3	  	 	  	 	  	 	  	 
	x	  	G	  	CONTRACT ADMINISTRATION DATA	  	3-4	  	 	  	L	  	INSTRS, CONDS, AND NOTICES TO OFFERORS	  	 
	x	  	H	  	SPECIAL CONTRACT REQUIREMENTS	  	4-5	  	 	  	M	  	EVALUATION FACTORS FOR AWARD	  	 

											
	CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR IS AS APPLICABLE	  	 
	 17. x  CONTRACTOR’S NEGOTIATED AGREEMENT Contractor is required to sign this
document and return 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.)
	  	 I8.  ̈  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 in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the
contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.

		
	 19A. NAME AND TITLE OF SIGNER (Type or print)
 Charles E. Yon, Vice President, General Counsel
	  	 20A. NAME AND TITLE OF CONTRACTING OFFICER
 PATSY. S ASHE/ GRANTS/CONTRACTING OFFICER

				
	19B. NAME OF CONTRACTOR	  	19C. DATE SIGNED	  	20B. UNITED STATES OF AMERICA	  	20C. DATE SIGNED
						
	BY	 	 /s/ Charles E. Yon

	  	12-3-02	  	BY	  	 /s/ Patsy S. Ashe

	  	03-Dec-2002
	(Signature of person authorized to sign)	  	 	  	(Signature of Contracting Officer)	  	 

  
 Portions of this
Exhibit were omitted and have been filed separately with the Secretary of the Commission 
 pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 2
 of 7 
  

 SECTION B Supplies or Services and Prices 
  

							
	ITEM NO 0001	  	SUPPLIES/SERVICES
		
	 	  	PROPOSAL NO. 44498-I.S
	 	  	COST - The research to be accomplished is identified in the recipient’s proposal, “Enhancement of Anthrax AVA Vaccine with CpG ODN’s” dated 5 August:2002 which
is incorporated by reference. The estimated costs of the research are set forth in the cost proposal dated September 5, 2002 and identified on the contract line item 0001.	  	 
				
	 	  	 	  	ESTIMATED COST	  	$6,000,001.00
				
	ITEM NO 000101	  	SUPPLIES/SERVICES	  	 	  	 
				
	 	  	COST	  	 	  	 
				
	 	  	 	  	ESTIMATED COST	  	 
				
	 	  	ACRN AA Funded Amount	  	 	  	$6,000,001.00

  

	B.1	The type of contract is Cost Reimbursable 

  

	B.2	The estimated Total Cost of performance of this contract is as follows: 

  
 Estimated Cost: $6,000,001 
  
 The final price of this contract shall be the total of all costs determined reimbursable in accordance with the general provision of the contract entitled’
“Allowable Cost and Payment” but not exceeding the estimated cost plus the fixed fee, if any, both of which are specified above. 
  
 SECTION C Descriptions and Specifications 
  
 C. 1 The research to be performed under this contract will be in accordance with details in the contractor’s proposal and modifications thereto, if any, described
below. (A copy of the proposal including revisions, are on file at the Army Research Office.) 
  
 Proposal Title: “Enhancement of the Anthrax AVA Vaccine with CpG ODN’s” 
 Proposal No: 44498-LS

 Proposal Date: 5 August 2002, for a 4-Month Effort. 
 Cost
Proposal: dated, 2 August 2002, Revised: 5 September 2002, & 26 November 2002. 
 Principal investigator: Dr. Arthur Kreig 
  
 The Principal Investigator shall be closely involved and continuously responsible for the
conduct of the work. The contractor must obtain the contracting officer’s approval to change the principal investigator or acquire the approval of the contracting officer to change plans to devote substantially less effort to the work than
anticipated. 
  
 SECTION D Packaging and Marking 
  
 D.l Reports delivered under this contract shall be afforded the degree of packaging
(preservation and packing) required to prevent damages due to the hazards of shipment and handling. 

  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 3
 of 7 
  

 
SECTION E Inspection and Acceptance 
  
 E.1 The contractor will submit all scientific reports to the office specified in ARO Form l8 located at www.aro.army.mil/forms/forms2.htm/frm18 for inspection and
acceptance. This contract takes precedence for email address identified in ARO Form 18. 
  
 SECTION F Deliveries or Performance 
  
 F.1 Research called for by this
contract shall be performed during the period of 06 December 2002 – 05 March 2003. This contract contains no options. 
  
 F.2 ARO Reports called for by this contract shall be submitted electronically in PDF format when possible. You may download the electronic Form SF298 and SF298
continuation sheet from the ARO’s home page at www.aro.army.mil/forms/forms2.html/frm18. The forms were created in MS Word and MS Word 97. Refer to ARO Form 18 for specific reporting requirements for each type of report. If you are not
able to submit reports electronically you should submit as indicated in ARO Form 18. The use of color in reports is discouraged for both electronic documents and hard copy documents. 
  
 F.3 DARPA requires Financial and progress reporting at the end of every quarter; in the format to be provided Reports shall contain a brief
summary of that period’s progress, plans for the upcoming period, major accomplishments or problems, and shows the planned-versus-actual expenditures; other reports including the final will follow normal ARO requirements. The DARPA technical
POC for this effort is Dr. John Carney, (703) 696-4641; the DARPA Business POC for this effort as Claire Ricaurte, (703) 696-4641. The special report is to be submitted to DARPA by E-mail address: jearney@darpa.mil, or physical address; Defense
Advanced Research Project DSO, ATTN: Dr. John Carney, 3701 N. Fairfax Drive, Arlington, VA 22203-1714. 
  
 **** A Final Patent Report (DD Form 582) is required to be submitted within sixty (60) days after completion of the contract.**** 
  
 SECTION G Contract Administration Data 
  
 G.1 Delegation of Administrative Functions; 
  
 All contract administration functions are retained by the Army Research Office (ARO). 
 All vouchers, both interim and final, shall be submitted for approval to the following office: 
  
 Defence Contract Audit Agency 
 Boston Branch Office 
 101 Merrimac Street, Suite 820A 
 Boston, Massachusetts 
 Phone Number (617) 450-0450 
 FAX (617) 450-0475 
 E-mail Address dcaa-fao2171@dcaa.mil 
  
 G.2
Payment Information and Inquiries: The Contractor should contact the DFAS Office indicated in Block 12 of the SF 26 for information or inquiries regarding payments on this contract. Telephonic inquires may be made on 1-888-332-7742 or electronic
inquiries on http://www.dfas.mil/money/vendor/index.htm in the event DFAS cannot answer the Contractor’s inquiry, the Contracting Officer may be contacted for assistance. 
  
 G.3 Invoicing. The government shall make payments to the Contractor when requested as work progresses, but not more often that once every 2
weeks, in the amounts determined to be allowable by DCAA in accordance with SubPart 31.2 of the Federal Acquisition Regulation in effect on the date of this contract and terms of the contract. 
  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 4
 of 7 
  

 G.4 ACCOUNTING AND APPROPRIATION DATA 
  

			
	AA.	  	972040013012RPAROD2310N9270PU255Y2XTA012AR44498LSTA012XTA01S18129
	AMOUNT:	  	$6,000,001.00

  
 G.5 Payment Instructions for Multiple
Accounting Classification Citations: Payments are to be made from the earliest available fiscal year funding source across accounting classification citations assigned to the line item. 
  
 G.6 Pre-Contract Costs: Pre-Contract costs are limited to $5,410,080. Costs incurred before the effective date of the contract directly
pursuant to the negotiation and in anticipation of the contract award were necessary to comply with the proposed contract delivery schedule. These costs are allowable to the extent that they would have been allowable if incurred after the date of
the contract 
  
 G.7 The Contracting Officer’s Representative for this
contract is as follows: 
  
 Dr. Micheline Strand

 US Army Research Office 
 P.O. Box 12211 
 Research Triangle Park, NC 27709-2211 
 Phone; (9l9) 549-4343 
 FAX: (919) 549-4310 
 Email:strandmk@afo.arl.army.mil 
  
 G.8 Ceiling Provisional Indirect Rates: (1) The Government will not be obligated to pay any additional amount should the final indirect cost
rates exceed the negotiated ceiling rates and (2) In the event the Final indirect cost rates are less than the negotiated ceiling rates, the negotiated rates will be reduced to conform with the lower rates. Ceilings in the indirect cost rates are
hereby established to prevent the acceptance of an unreasonable amount of indirect costs to the contract. 
  
 The ceiling rate for the duration of performance of the contract is as follows: 
  

					
	 Line Item

	  	 Over head Rate

	  	 General Administrative Rate

	 0001
	  	.23	  	.13

  
 Indirect costs are to include all
fringe benefits, over head, facilities, general and administrative bardens. 
  
 SECTION H Special Contract Requirements 
  
 H.1 Acknowledgment of
Sponsorship 
  
 The contractor agrees that in the release of information relating
to this contract, such release shall include a statement to the effect that the project or effort depicted was or is sponsored by DARPA and the U.S. Army Research Office, and that the content of the information does not necessarily reflect the
position or the policy of the Government, and no official endorsement should be inferred. 
  
 For the purpose of this provision, “information” includes news releases, articles, manuscripts, brochures, advertisements, still and motion pictures, speeches, trade association proceedings, symposia, etc
The contractor further agrees to include this provision if any subcontract awarded as a result of this contract. 
  
 H.2 Publications 
  
 Publication of results of the research project in appropriate professional journals is encouraged as an important method of recording and reporting scientific information. One copy of each paper planned for
publication will be 

  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 5
 of 7 
  

 
submitted to the Contracting Officer’s Representative simultaneously with its submission for publication. Following publication, copies of published
papers shall be submitted to the Contracting Officer’s representative, or to the other addresses in quantities publication. Following publication, copies of published papers shall be submitted to the Contracting Officer’s Representative,
or to the other addressees in quantities as may be directed by the Contracting Officer. 
  
 H.3 The contractor is to note acknowledgements in publications or other media that support is from DARPA as well as technical/contract support from ARO. 
  
 H.4 Research Responsibility 
  
 The contractor shall bear responsibility for the conduct of the research specified in the contractor’s proposal identified in the contract. The contractor will
exercise judgment in obtaining the stated research objectives within the limits of the terms and conditions of the contract: provided, however, that the contractor will obtain the contracting officer’s approval to change the Statement of Work.
Consistent with the foregoing the contractor shall conduct the work as set forth in his proposal and accepted by the contract award. 
  
 The principal investigator identified in the proposal shall be continuously responsible for the conduct of the research project, and shall be closely involved with the
research efforts. 
  
 The contractor shall advise the contracting officer if the
principal investigator(s) identified in the contract plan to devote less effort to the work than set forth in the proposal. The contractor shall obtain the contracting officer’s approval prior to changing the principal investigator’s
identified in the proposal. 
  
 H.5 Restriction on Printing 
  
 The Government authorizes the reproduction of reports, data or other written material, if
required, provided the material produced does not exceed 5,000 production units of any page, and items consisting of multiple pages do not exceed 25,000 production units in the aggregate. The contractor shall obtain the express prior written
authorization of the contracting officer to reproduce material in excess of the quantities cited above. 
  
 H.7 Human Use 
  
 The contractor proposes to use
human subjects in the performance of this research. In accordance with 32 CFR 219.103 each contractor shall have a Federally approved, written assurance of compliance for the research proposed prior to the signing this contract. 
  
 H.6 Animal Use 
  
 The contractor proposes to use animal subjects in the performance of this research. In accordance with (7 USC 2131et seq.) and regulations
pertaining to it, the contractor has provided a copy of their Institutional Approval for Protocols Using Animal Subjects (IACUC). The contractor is expected to ensure that the guidelines described in the DFARS Clause 252.235-7002. Animal Welfare
(Dec 1991) are complied with. 
  
 PART II – GENERAL PROVISIONS

  
 SECTION I – General Provisions 
  
 FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1)
CLAUSES 
  
 FAR 52.252-1 Clauses
Incorporated by Reference (FEB 1998) 
  
 This contract incorporates one or more
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/these
address(es): http://web2.deskbook.osd.mil/default.asp? or http://farsire.hill.af.mil/YFFARa.htm 
  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 6
 of 7 
  

 CAUSES INCORPORATED BY REFERENCE: 
  

					
	 52.203-3
	 	Gratuities	  	APR 1984
	 52.203-5
	 	Covenant Against Contingent Fees	  	APR 1984
	 52.203-6
	 	Restrictions On Subcontractor Sales To The Government	  	JUL 1995
	 52.203-7
	 	Anti-Kickback Procedures	  	JUL 1995
	 52.203-8
	 	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity	  	JAN 1997
	 52.203-10
	 	Price Or Fee Adjustment For Illegal Or Improper Activity	  	JAN 1997
	 52.203-12
	 	Limitation On Payments To Influence Certain Federal Transactions	  	JUN 1997
	 52.204-4
	 	Printing/Copying Double-Sided on Recycled Paper	  	JUN 1996
	 52.209-6
	 	Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment	  	JUL 1995
	 52.215-8
	 	Order of Precedence—Uniform Contract Format	  	OCT 1997
	 52.215-14
	 	Integrity of Unit Prices	  	OCT 1997
	 52.215-10
	 	Price Reduction for Defective Cost or Pricing Data	  	OCT 1997
	 52.215-11
	 	Price Reduction for Defective Cost or Pricing Data–Modifications	  	OCT 1997
	 52.215-12
	 	Subcontractor Cost or Pricing Data (OCT 1997)	  	OCT 1997
	 52.215-13
	 	13 Subcontractor Cost or Pricing Data Modifications	  	OCT 1997
	 52.215-14
	 	Integrity of Unit Prices	  	OCT 1997
			
	 52.215-18
	 	Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other than Pensions	  	OCT 1997
	 52.215-19
	 	Notification of Ownership Changes	  	OCT 1997
	 52.215-21
	 	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data—Modifications	  	OCT 1997
	 52.216-7
	 	Allowable Cost And Payment	  	MAR 2000
	 52.217-8
	 	Option to Extend Services	  	NOV 1999
	 52.217-9
	 	Option to Extend the Term of the Contract	  	NOV 1999
	 52.219-8
	 	Utilization of Small Business Concerns	  	OCT 1999
	 52.222-2
	 	Payment for Overtime Premiums	  	JUL 1990
	 52.222-3
	 	Convict Labor	  	AUG 1996
	 52.222-21
	 	Prohibition Of Segregated Facilities	  	FEB 1999
	 52.222-22
	 	Previous Contracts and Compliance Reports	  	FEB 1999
	 52.222-26
	 	Equal Opportunity	  	FEB 1999
	 52.222-35
	 	Affirmative Action For Disabled Veterans And Veterans of the Vietnam Era	  	APR 1998
	 52.222-36
	 	Affirmative Action For Workers With Disabilities	  	JUN 1998
	 52.222-37
	 	Employment Reports on Disabled Veterans And Veterans Of The Vietnam Era	  	JAN 1999
	 52.223-6
	 	Drug Free Workplace	  	JAN 1997
	 52.223
	 	II Ozone-Depleting Substances	  	MAY 2001
	 52.225-13
	 	Restrictions on Certain Foreign Purchases	  	JUL 2000
	 52.225-16
	 	Sanctioned European Union Country Services	  	FEB 2000
	 52.227-1 Alt I
	 	Authorization And Consent (Jul 1995) - Alternate I	  	JUL 1995
	 52.227-2
	 	Notice And Assistance Regarding Patent And Copyright Infringement	  	AUG 1996
	 52.227-11
	 	Patent Rights-Retention by the Contractor (Short Form)	  	JUN 1997
	 52.228-7
	 	Insurance—Liability To Third Persons	  	MAR 1996
	 52.232-9
	 	Limitation on Withholding of Payments	  	APR 1984
	 52.232-17
	 	Interest	  	JUN 1996
	 52.232-20
	 	Limitation Of Cost	  	APR 1984
	 52.232-22
	 	Limitation of Funds	  	APR 1984
	 52.232-23
	 	Assignment Of Claims	  	JAN 1986
	 52.232-25
	 	Prompt Payment	  	JUN 1997
	 52.232-33
	 	Payment of Electronic Funds Transfer–Central Contractor Registration	  	MAY 1999
	 52.233-1
	 	Disputes	  	DEC 1998

  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
  
  Page
 7
 of 7 
  

					
	52.233-3	 	Protest After Award (AUG 1996) - Alternate I	  	JUN 1985
	52.223-3	 	Hazardous Material Identification And Material Safety Data	  	JAN 1997
	52.242-1	 	Notice of Intent to Disallow Costs	  	APR 1984
	52.242-3	 	Penalties for Unallowable Costs	  	OCT 1995
	52.242-4	 	Certification of Final Indirect Costs	  	JAN 1997
	52.242-13	 	Bankruptcy	  	JUL 1995
	52.243-2 Alt V	 	Changes—Cost-Reimbursement (Aug 1987) - Alternate V	  	APR 1984
	52.244-2 Alt I	 	Subcontracts (Aug 1998) - Alternate I	  	AUG 1998
	52.244-5	 	Competition In Subcontracting	  	DEC 1996
	52.244-6	 	Subcontracts For Commercial Items	  	MAY 2001
	52.245-5	 	Government Property (Cost-Reimbursement Time-And-Materials, Or Labor Hour Contracts)	  	JAN 1986
	52.245-18	 	Special Test Equipment	  	FEB 1993
	52.246-9	 	Inspection Of Research And Development (Short Form)	  	APR 1984
	52.247-1	 	Commercial Bill Of Lading Notations	  	APR 1984
	52.249-6	 	Termination (Cost Reimbursement)	  	SEP 1996
	52.251-1	 	Government Supply Sources	  	APR 1984
	52.253-1	 	Computer Generated Forms	  	JAN 1991
	252.201-7000	 	Contracting Officer’s Representative	  	DEC 1991
	252.203-7001	 	Prohibition On Persons Convicted of Fraud or Other Defense-Contract-Related Felonies	  	MAR 1999
	252.204-7002	 	Payment For Subline Items Not Separately Priced	  	DEC 1991
	252.204-7003	 	Control Of Government Personnel Work Product	  	APR 1992
	252.209-7000	 	Acquisition From Subcontractors Subject To On-Site Inspection Under The Intermediate Range Nuclear Forces (INF) Treaty	  	NOV 1995
	252.209-7004	 	Subcontracting With Firms That Are Owned or Controlled By The Government of a Terrorist Country	  	MAR 1998
	252.215-7000	 	Pricing Adjustments	  	DEC 1991
	252.215-7002	 	Cost Estimating System Requirements	  	OCT 1998
	252.219-7003	 	Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan (DoD Contracts)	  	APR 1996
	252.223-7006	 	Prohibition on Storage and disposal of Toxic and Hazardous Materials	  	APR 1993
	252.225-7012	 	Preference for Certain Domestic Commodities	  	MAY 1999
	252.225-7031	 	Secondary Arab Boycott of Israel	  	JUN 1992
	252.227-7013 Alt I	 	Rights in Technical Data—Noncommercial Items	  	NOV 1995
	252.227-7014	 	Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation (JUN 1995) - Alternate I	  	JUN 1995
	252.227-7016	 	Rights in Bid or Proposal Information	  	JUN 1995
	252.227-7030	 	Technical Data—Withholding Of Payment	  	MAR 2000
	252.227-7034	 	Patents—Subcontracts	  	APR 1984
	252.227-7036	 	Declaration of Technical Data Conformity	  	JAN 1997
	252.227-7037	 	Validation of Restrictive Markings on Technical Data	  	SEP 1999
	252.227-7039	 	Patents—Reporting Of Subject Inventions	  	APR 1990
	252.231-7000	 	Supplemental Cost Principles	  	DEC 1991
	252.235-7010	 	Acknowledgment of Support and Disclaimer	  	MAY 1995
	252.235-7011	 	Final Scientific or Technical Report	  	SEP 1999
	252.235-7002	 	Animal Welfare	  	DEC 1991
	252.242-7004	 	Material Management And Accounting System	  	SEP 1996
	252.243-7002	 	Requests for Equitable Adjustment	  	MAR 1998
	252.245-7001	 	Reports Of Government Property	  	MAY 1994
	252.247-7022	 	Representation of Extent of Transportation by Sea	  	AUG 1992
	252.247-7024	 	Notification of Transportation of Supplies by Sea	  	MAR 2000
	242.249-7002	 	Notification of Anticipated Contract Termination or Reduction	  	DEC 1996
	252.251-7000	 	Ordering From Government Supply Sources	  	MAY 2005
	Taxpayer Identification Number: 06-1506689	  	 

  

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

  

																	
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	  	 1. CONTRACT ID CODE
 S
	  	PAGE OF
PAGES
	  	  	1	  	3
				
	 2. AMENDMENT/MODIFICATION NO.
 P00003
	  	 3. EFFECTIVE DATE
 05-Jun-2003
	  	 4. REQUISITION/PURCHASE REQ. NO.
 P-444498-LS-02248-1
	  	5. PROJECT NO.(If applicable)
					
	6. ISSUED BY CODE	  	DAAD19	  	 7. ADMINISTERED BY (If other than item 6)
	  	CODE	  	DAAD19
					
	U.S. ARMY ROBERT MORRIS ACQUISITION CTR P.O. BOX 12211 RESEARCH TRIANGLE PARK NC 27709-2211	  	 	  	U.S. ARMY ROBERT MORRIS ACQUISITION P.O. BOX 12211 RESEARCH TRIANGLE PARK NC 27709-2211	  	 	  	 

  

																			
	 8.     NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and
Zip Code)
 COLEY PHARMACEUTICALS GROUP INC
 93 WORCESTER ST
 WELLESLEY MA 02481-3609
	  	 	  	9A. AMENDMENT OF SOLICITATION NO.
	 	  	 	  	 	  	9B. DATED (SEE ITEM 11)
	 	  	 	  	x	  	 10A. MOD. OF CONTRACT/ORDER NO.
 DAAD19-03-C-0002

	 CODE 3BG55
	  	FACILITY CODE	  	x	  	 10B. DATED (SEE ITEM 13)
 03-Dec-2002

																			
	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 Offer
  ̈  is extended,  ̈  is not extended.

		
	 	  	Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing Items 8
and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF
YOUR ACKNOWLEDGMENT TO BE 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)
       See Schedule

	 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.
 FAR 52.243-2 Alt V

		
	 	  	 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  ̈  is not, x  is required to sign this document and return 1 copies to the issuing office.
	
	 14.    DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible.)
   The purpose of this modification is to increase funding to the
contract, add additional work, and extend the period of performance 9 months.
   This modification is also authorization the purchase the following
equipment:
   A. Amersham FineLine 75 Column including a Source 15Q anion-exchanger packing: Estimated at $10,000.
   B. Millipore Ultra filtration Equipment: Estimated at $10,000.
   C. Buchi Mini Spray Dryer B-290 Advanced: Estimated at $22,000.
  
 See Summary of Changes for details.
  
 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)
				
	 	  	 	  	TEL:	  	EMAIL:
				
	15B. CONTRACTOR/OFFEROR	  	15C. DATE SIGNED	  	16B. UNITED STATES OF AMERICA	  	16C. DATE SIGNED
					
	  

	  	 	  	BY	  	  

	  	 
	(Signature of person authorized to sign)	  	 	  	 	  	(Signature of Contracting Officer)	  	 
			
	EXCEPTION TO SF 30 APPROVED BY OIRM 11-84	  	30-105-04	  	STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA FAR (48 CFR) 53.243

  
 Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
 P00003 
 Page 2 of 3 
  

SECTION SF 30 BLOCK 14 CONTINUATION PAGE 
  
 SUMMARY OF CHANGES 
  
 SECTION A - SOLICITATION/CONTRACT FORM 
  
 The total cost of this contract was increased by $6,000,000.00 from $6,000,001.00 to $12,000,001.00. 
  
 SECTION B - SUPPLIES OR SERVICES AND PRICES 
  
 CLIN 0001 
  
 The estimated/max cost has increased by $6,000,000.00 from $6,000,001.00 to $12,000,001.00. 
 The total cost of this line item has increased by $6,000,000.00 from $6,000,001.00 to $12,000,001.00. 
  
 SUBCLIN 000102 is added as follows: 
  

												
	 ITEM NO

	  	 SUPPLIES/SERVICES

	  	QUANTITY

	  	UNIT

	  	UNIT PRICE

	  	AMOUNT

	 000102
	  	 COST
 Add-On Proposal entitled:
“Prevention of Anthrax Infection by CpG Oligodeoxynucleotices” is hereby incorporated and made a part of this contract.

				
	 	  	 	  	ESTIMATED COST	  	$	6,000,000.00
			
	 	  	ACRN AB Funded Amount	  	$	5,998,693.00
	 	  	ACRN AC Funded Amount	  	$	1,307.00

  
 SECTION F - DELIVERIES OR PERFORMANCE

  
 The period of performance in Section F.1 of this contract is amended to
reflect an increase of an additional nine months of performance. 
  
 Amend Section
F1, Period of Performance: 
  
 FORM: 6 December 2003 – 5 June 2003

  
 TO: 6 December 2003 – 4 March 2004 
  
 SECTION G - CONTRACT ADMINISTRATION DATA 
  
 Accounting and Appropriation 
  
 Summary for the Payment Office 
  
 As a result of this modification, the total funded amount for this document was increased by $6,000,000.00 from $6,000,001.00 to $12,000,001.00.

  
 SUBCLIN 000102: 
 Funding on SUBCLIN 000102 is initiated as follows: 
  
 ACRN: AB 
  
 Acctng Data:
970304040013010181293RPAROD3310M9270PU255Y3AR44498LSVC013XVC01018129 
  
 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 DAAD19-03-C-0002 
 P00003 
 Page 3 of 3 
  

Increase: $5,998,693.00 
  
 Total: $5,998,693.00 
  
 ACRN: AC 
  
 Acctng Data: 970203040013010181292RPAROD2310P1480PU255Y2AR44498LSTE012XTE01018129 
  
 Increase: $1,307.00 
  
 Total: $1,307.00 
  
 (End of Summary of Changes) 
  
 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the
Securities Act. 

																													
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	  	 1.     CONTRACT ID CODE
	  	PAGE OF PAGES
	 	  	                    S	  	    1	  	  1
				
	 2.     AMENDMENT/MODIFICATION NO.
 P00008
	  	 3.     EFFECTIVE DATE
  
 28-Feb-2005
	  	 4.     REQUISITION/PURCHASE REQ. NO.
  
 P-444498-LS-02248-1
	  	 5.     PROJECT NO. (If applicable)

						
	 6.     ISSUED BY
  
 US ARMY RDECOM ACO CTR - W911NF
 4300 S. MIAMI BLVD
 DURHAM NC
27703-
	  	CODE	  	W911NF	  	 7.     ADMINISTERED BY (If other than item 6)
  
 U.S. ARMY ROBERT MORRIS ACQUISITION
 P.O. BOX 12211
 RESEARCH TRIANGLE PARK NC 27709-2211
	  	CODE	  	DAAD19
			
	 8.     NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)
COLEY PHARMACEUTICALS
GROUP INC
93 WORCESTER ST
WELLESLEY MA 02481-3609
	  	 	  	 9A.  AMENDMENT OF SOLICITATION NO.

			
	 	  	 	  	 9B.   DATED (SEE ITEM 11)

			
	 	  	x	  	 10A.MOD. OF CONTRACT/ORDER NO.
 DAAD19-03-C-0002

			
	 	  	x	  	 10B.DATED (SEE ITEM 13)
 03-Dec-2002

				
	CODE 3BG55	  	FACILITY CODE 3BG55	  	 	  	 
	
	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
					
	  ̈      The above numbered solicitation is amended as set forth in item 14. This hour and date specified for receipt of Offer
	  	 ̈	  	is extended,	  	 ̈	  	is not extended.
	
	 Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following
methods:
(a) By completing Items 8 and 15, and returning ______ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the
solicitation and, amendment numbers. FAILURE OF YOUR 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)

	
	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. FAR 52.243-2ALT V

		
	 	  	 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.)

	
	The purpose of this modification is to extend the performance period of this contract for six months at no additional cost to the government, and to approve a revised scope of work
dated, February 2005 Entitled: “Prevention of Anthrax Infection by CPG Oligodeoxynucleotides”, pages 1 through 15.
		
	 1.     Amend Section F.1, Period of Performance:
	  	FROM: 6 December 2002 – 28 February 2005
	 	  	TO: 6 December 2002 – 28 August 2005.
	
	 2.     The revised scope of work as proposed by Coley Pharmaceuticals has been reviewed and approved by
the Technical Monitor on 16 February 2005 and will become effective upon the date of this modification. See attachment A.

	
	 3.     All else remains the same.

	
	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)
 DIANE C. HODOR / GRANTS/CONTRACTING OFFICER

	 	  	TEL: (919) 549-4301	  	EMAIL: hodord@aro-ernh1.army.mil
				
	 15B.CONTRACTOR/OFFEROR
	  	 15C.DATE SIGNED
	  	 16B.UNITED STATES OF AMERICA
	  	 16C.DATE SIGNED

								
	  

	  	 	  	 BY /s/ Diane C. Hodor

	  	 	  	 	  	 	  	 	  	28-Feb-2005
					
	(Signature of person authorized to sign)	  	 	  	            (Signature of Contracting Officer)	  	 	  	 
			
	EXCEPTION TO SF 30 APPROVED BY OIRM 11-84	  	30-105-04	  	STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA FAR (48 CFR) 53.243

  
 Portions of this
Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 PREVENTION OF ANTHRAX INFECTION BY CPG OLIGODEOXYNUCLEOTIDES 
  
 EXECUTIVE SUMMARY 
  
 The [******************] vaccine against anthrax [*****************] has been demonstrated
to be safe and effective in its approved regimen of [*] injections over [**] months. However, there is great interest in further improving the safety and efficacy of the vaccine by reducing the number of doses that need to be given in order to
achieve protective antibody levels against the anthrax toxin proteins. Human and animal data suggest that combining a Coley TLR9 agonist with [***] would offer the following advantages compared to the current vaccine: i) much faster seroconversion
with induction of protective antibody levels in most subjects within [*] weeks; ii) reduced number of [***] doses required, to no more than [***********************] dose vaccination; iii) generation of higher affinity antibodies targeted against a
broader range of epitopes to give improved protection against mutant strains; and iv) improved duration of protective serum antibodies and memory responses. 
  
 Coley Pharmaceutical Group proposes to make available to DARPA CPG 7909 for lead development as an adjuvant for co-formulation in the anthrax vaccine
[********************] by [***********************]. Coley has CPG 7909 in phase II clinical development in oncology and has demonstrated proof-of-concept of the drug as a vaccine adjuvant in human vaccine studies. The advanced stage of development
of CPG 7909 makes this molecule the best candidate for further rapid development and approval as a vaccine adjuvant. Further, Coley proposes to develop a second TLR9 agonist, differentiated from CPG 7909 in its immuno-pharmacological and metabolic
profile, as a back-up compound. 
  
 The final part of this proposal is to develop
a different TLR9 agonist as a prophylactic that would be given to activate immune resistance to an anticipated BW attack. The human innate immune system encompasses a remarkable array of pathogen defenses that may be able to protect a non-immune
individual from anthrax infection acquired as a consequence of a BW attack. A TLR9 agonist delivered by [*******] [*********] may be able to activate the innate immune system in the [*****] and thus induce broad-spectrum resistance against [******]
pathogens including B. anthracis. Coley has identified three classes of TLR9 agonist, each with distinct structures and immune effects. The innate immune defenses activated by certain A-Class or B-Class TLR9 agonists can protect rodents
against several different viral, bacterial, and parasitic pathogens. The work in this proposal will support determining which of these 3 TLR9 agonist classes will be best for protecting against an [******] anthrax challenge in animal models, and
will initiate development of that product for military use. 
  

					
	 Contact: Iain Sim
	 	1/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 BACKGROUND 
  
 This program proposal is a request for a re-direct of funds previously awarded to Coley Pharmaceutical Group under contract DAAD19-03-C-0002. The overall rationale and
approach remains unchanged and are not repeated in this document. In this current proposal, Coley offers a more advanced drug development candidate, CPG 7909, for use as an adjuvant in combination with [*******] anthrax vaccine. In addition, Coley
proposes to DARPA the development of a representative of a new class of TLR9 agonists, exemplified by [*********], as a back-up molecule to CPG 7909. 
  
 Development Of CPG 7909 
  
 CPG 7909 is a B-Class TLR9 agonist that is a potent activator of B cells as well as of plasmacytoid dendritic cells. Coley has demonstrated the adjuvant activity of CPG
7909 in clinical studies in combination with Engerix B®, a commercially approved hepatitis B vaccine. CPG 7909 substantially enhanced the antibody response to Engerix B in both normal subjects and in immunoincompetent HIV-infected individuals when compared to controls
receiving Engerix B vaccine alone. In addition, it has been shown that the co-administration of CPG 7909 [********] to monkeys enhances the anti-PA antibody response when compared to the controls. Coley has offered to make CPG 7909, now in phase II
clinical development, available to DARPA for the purposes of improving the performance of the anthrax vaccine. CPG 7909 is the most advanced TLR9 agonist currently in development at Coley and offers the opportunity to fast track a development
program of such an agonist in combination with the anthrax vaccine. Coley has made substantial investments in the manufacturing and analysis of CPG 7909, in the characterization of its safety in rodents and non-human primates, and in the
understanding of its pharmacodynamics and anti-cancer activity in human subjects. Coley is preparing to file an IND with the DVRPA, CBER, FDA to support the immediate conduct of a proof-of-concept clinical study of CPG 7909 in combination
[********]. The [*********] will be [***************************] for [***********] and will [**********************************************] under a [********************]. 
  
 Development of a Back-Up Molecule as a Vaccine Adjuvant 
  
 It is Coley’s understanding that DARPA wishes Coley to develop and offer to DARPA and the vaccine-manufacturing partners a second TLR9
agonist that will serve as a back-up to the lead molecule. DARPA has suggested that the back-up molecule be [*********]. Whereas [*********************************************] to CPG 7909 [****] at the [********************] in
[*******************] Coley wishes to propose for DARPA consideration the selection of a new type of immunomodulatory TLR9 agonist with a unique set of properties. 
  
 CPG 7909 contains a phosphorothioate backbone designed to make the molecule resistant to exo- and endonuclease cleavage. When [************]
at [******************** ******************] for a [***************] to [****************] CPG 7909 has been [******************] in the [********************] and to be [************ 

  

					
	 Contact: Iain Sim
	 	2/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 
******] by [****************] to the [********************************]. These [********************] are known to [***************************]. In addition
it has been [****] in [***************] that [**********] of CPG 7909 [***************************] and [*******] and [*******************************] in a [****************] including [*********************] into the [*****] of the [*********].
While this [******] has not been [********] with any [*********** **********] in over [************] who have [******] CPG 7909 [*****], including a [****] of [*******] who have [*************************************] Coley believes that a molecule
designated as a back-up to CPG 7909 should be [****] of the [********] to [********] in the [****] while retaining the desired B cell stimulating activities of CPG 7909. [*******************************] to CPG 7909, contains a phosphorothioate
backbone, [***********] immunomodulatory activity and is [******] to have a [*********************]. On the other hand, Coley has [*******] a [**] [******] to the [****] of TLR9 agonists [**************] of the [****] contains [**] [*************]
and [*****************]. By this means the [******] is [******] to [**********************] to [***************] and to [*********************] in the [****] as compared to [***************************] such as CPG 7909 and [*********]. Moreover, by
[*********] the [***************] between the [**] and the [************], it is [******] that the [********************] from [********** *****] will be [***************] in [****] than the [************] and [****] of [********************]. These
[********************] have been called [********************]. 
  
 [*********] is
a C-Class TLR9 agonist [*****] of this [******] of [********************************]. In general terms the C-Class TLR9 agonists show good stimulation of B cells (efficient antibody secretion or induction of B cell proliferation) with a potency
similar to the B-Class molecules such as CPG 7909. In addition, C-Class oligodeoxynucleotide TLR9 agonists demonstrate very strong Th1-inducing capacities (efficient induction of secretion of type I interferons or stimulation of NK cells) similar to
the TLR9 agonists of the A-Class. This pattern of in vitro immunostimulatory activities places the molecules of the C-Class between the previously defined B- and A-Classes and demonstrates their potential to induce favorable immune responses
in vivo. 
  
 When [********] to [**************************] shows
[**************] in the [****] as compared to the corresponding [***************************] and there is [*****************] after [*****************] in [****] as compared to [*** *******************************************] suggest that
[*********] is [*************] through [***********] at the [**********************] to [***** ********] as would be [******] from the [*******] of the [***************] in the [********************] this [**************] of [*********************]
they appear to be [***********************] than their [**************************]. 
  

					
	 Contact: Iain Sim
	 	3/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 GOALS 
  
 The goals of this proposal are: 
  

	 	1.	To file an IND that will support the conduct of a proof-of-concept clinical study of CPG 7909 administered [********************] to human volunteers. 

  

	 	2.	To conduct [***********************] and non-clinical safety studies of CPG 7909 that will be adequate to support the comprehensive development of the molecule as an adjuvant in a
clinically superior anthrax vaccine formulation. 

  

	 	3.	To identify a second TLR9 agonist that is differentiated from CPG 7909 and to conduct pre-clinical development studies adequate to support its further clinical development, if
needed, as a back-up to CPG 7909. 

  

	 	4.	To manufacture and support evaluation of representative A-, B- and C-Class TLR9 agonists for their ability to stimulate the innate immune system and protect a non-human primate from
a non-lethal virus infection following administration to the [*************], in order to generate data supporting the testing of the most promising candidates for protection of a primate against a lethal [*****] anthrax challenge.

  
 These goals will be achieved through the completion of the
following tasks: 
  

	 	1.	File an IND to support the conduct of a proof-of-concept clinical study of [*** ***] CPG 7909 

  

	 	2.	Develop an efficient [***************************] for CPG 7909 

  

	 	3.	Develop and validate analytical methods for the determination of the identity, potency, purity and stability of CPG 7909 

  

	 	4.	Characterize the toxicological profile of CPG 7909 in rodents and non-human primates [**********] by the [**************] 

  

	 	5.	Develop and qualify methods for the assay of CPG 7909 in biological specimens 

  

	 	6.	Establish the key in vitro and in vivo biological characteristics of additional TLR9 agonists 

  

	 	7.	Manufacture a back-up molecule 

  

	 	8.	Develop and qualify analytical methods for the determination of the identity, potency, purity and stability of the back-up molecule. Determine the stability of the back-up molecule

  

	 	9.	Characterize the toxicological profile of the back-up molecule 

  

	 	10.	Develop and qualify methods for the assay of the back-up molecule in biological specimens 

  

	 	11.	Manufacture and characterize examples of A-, B- and C-Class TLR9 agonists 

  

					
	 Contact: Iain Sim
	 	4/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 Statement of Work 
  
 Task 1. File an IND to Support the Conduct of a Proof-of-Concept Clinical Study of [******] CPG 7909 
  
 Coley, [****************] and DARPA have agreed to conduct a
proof-of-concept clinical study of [********] CPG 7909. This study will be conducted under a Coley-sponsored IND. At a Pre-IND teleconference held on July 1, 2003 with the Division of Vaccine and Related Product Applications, CBER, FDA, the Agency
requested Coley to submit a [***********] IND without [***********] to the [****************] in the [****************]. More over, [***********] the [*******] of additional [*********] in the IND that [***] must now [*****]. As a result of the
[******] from [***], the [**********] of the IND [********] is now [******] to be [*****************] than was [**************] and will [*********** ********************************]. 
  
 In addition, the [***] has [*******] that Coley [*****] a [*************** **********] of [*********************]
from a [*********************** ****************] of the [**************] and CPG 7909 and [********* ******] in the IND [********]. This activity was previously judged not to be required and has not been budgeted for. 
  
 While the majority of the cost burden of managing the proof-of-concept
clinical study will be borne by others, Coley has agreed to manage the supply of clinical trial products - CPG 7909 and saline – to the study sites. Coley will manage the supply of materials to the clinical sites using an experienced
sub-contractor. 
  
 The following activities will be conducted:

  

	 	a.	[****************************************] and [***] an IND submission to DVRPA, CBER, FDA. 

  

	 	b.	Conduct a [************************] of [*********] from the [***] [************] of [******] CPG 7909. 

  

	 	c.	Supply CPG 7909 Injection and saline for injection; manage the shipment of these products to clinical study sites. 

  
 Task 2. Develop an efficient [********************] for CPG 7909 
  
 Approximately [***] g of CPG 7909 active pharmaceutical ingredient (API) are
currently available and assigned to the initial development of the proposed combined [********] CPG 7909 vaccine product (see also Task 3 below). Moreover, the current manufacturing process is adequate for the present stage of [*********] and is
[*****] of [***********************] of [*******] g. However, in the opinion of Coley the manufacturing process is not optimized or sufficiently defined and controlled for it to be used for the routine manufacture of CPG 7909 API for use in an
FDA-approved commercial vaccine product. 
  

					
	 Contact: Iain Sim
	 	5/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 Production of GMP CPG 7909 active pharmaceutical ingredient for pivotal studies and for commercial
supplies will be contracted out by Coley to a third party manufacturer. As the sponsor company, Coley remains responsible for ensuring that the contract manufacturer is in GMP compliance and also adheres to the information in Coley’s regulatory
filings. As such, Coley personnel will be integrated into many of the contract manufacturer operations. 
  
 Since CPG 7909 is a pharmacologically active substance it is anticipated that the manufacture of CPG 7909 will be regulated by the FDA in a manner similar
to the manufacture of API for drug products. The following activities must be completed to support the development of a commercially viable, validatable manufacturing process: 
  

	 	a.	Refine the current manufacturing process, both synthetic chemistry and purification, for the efficient production of API on a scale and of a quality adequate to meet the needs of
the future market place 

  

	 	b.	Define, develop and set specifications for in-process controls for the manufacture of API to afford better control of the manufacturing process 

  

	 	c.	Define, develop and set specifications for starting materials used in the manufacturing process 

  

	 	d.	Prepare and maintain an up-to-date Drug Master File for cross-reference 

  

	 	e.	Conduct GMP-compliance audits 

  
 Task 3. Develop and validate analytical methods for the determination of the identity, potency, purity and stability of CPG 7909 
  
 Approximately [***] of CPG 7909 [*******************] in 2002 at a [*****
***********] as part of the collaboration between Coley and DARPA. This [******] did not meet the [************] when [*********] and was [*************] by [**************************]. It is expected that this [*****] can be
[*********************************************] of the [************] CPG 7909 [*****]. However, additional [*****] of the [*****] is [******] to [****] that it [*****] to [*********************] current, state of the art [*******************]; a
[***********] must be [*******] to the IND to [********] for [***]. 
  
 Coley has made significant advances in the development and application of analytical methods suitable for the determination of the identity, potency, purity and stability of CPG 7909. The optimization of the analytical methods is in
progress. The development and conduct of such test methods requires the use of reference materials that characterize the performance of the pure compound, as well as the known manufacturing impurities, within the assay. Coley will use its expertise
in the synthetic and analytical chemistry of oligodeoxynucleotides to 

  

					
	 Contact: Iain Sim
	 	6/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 
prepare in part in its own laboratories and in part have prepared by a contract manufacturer samples of such reference materials. Fully optimized methods
must be qualified, validated and the technology transferred from the development laboratory to the qualified contract facility that will have responsibility for the quality control release testing of the API. The methods will also be transferred to
[******************] for their use in the development of the combined [*****] CPG 7909 product. While the analytical methods available at present are judged to be adequate for the development of CPG 7909, it is recognized that as new information is
gained the development of additional analytical techniques may be required to address the detection of new impurities arising from the final manufacturing process. 
  
 Coley has used internal expertise as well as contracts with competent contract laboratories to development sensitive,
reproducible analytical methods. Coley will continue to provide expert advice on the chemistry and detection of CPG 7909 and will closely monitor the work of the contract laboratories to assure the objectives are achieved. The following activities
must be completed before commercialization: 
  

	 	a.	Optimize, qualify, validate and transfer GMP analytical methods 

  

	 	b.	Prepare reference standards and impurity markers 

  

	 	c.	Monitor the of production lots of CPG 7909 for new impurities and development of new analytical methods as the need arises 

  

	 	d.	Perform comparability analysis of production lots 

  

	 	e.	Perform release testing of lots of active pharmaceutical ingredient 

  

	 	f.	Determine the stability of the active pharmaceutical ingredient under a variety of storage conditions 

  

	 	g.	Perform physical/chemical characterization of individual lots of active pharmaceutical ingredient 

  

	 	h.	Develop analytical methods for the qualification of starting materials 

  

	 	i.	Develop analytical methods adapted for application to in-process controls 

  
 Task 4. Characterize the toxicological profile of CPG 7909 in rodents and non-human primates [**********] by the [***************] 
  
 Coley has extensive data on the safety of CPG 7909 in rodents and non-human
primates when [********] by the [*********] and [***************]. [************] has expressed its desire to explore the [**************] for [***********] of a [**************] CPG 7909 vaccine product. Therefore it is important to understand
first the safety of CPG 7909 alone when [*********] by this [***]. Coley will place and manage contracts with competent, approved contract research organizations for the performance toxicological studies designed to characterize the non-clinical
safety of CPG 7909 [**********] by the [*************], and to demonstrate a margin of safety between the proposed adjuvant dose and the doses which caused toxicity in previous CPG 7909 studies. All studies will be conducted according to the
principles of Good Laboratory 

  

					
	 Contact: Iain Sim
	 	7/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 
Practice and will be supported by toxicokinetic analyses. Coley will provide expert toxicological advice on the design and conduct of the studies, the
interpretation of the results and the preparation of the final study reports. Coley will also engage a consultants experienced in oligodeoxynucleotide toxicology and in the regulatory aspects of vaccine adjuvant development. The following studies
are planned: 
  

	 	a.	[***]-month sub-acute [***] toxicology in the rodent 

  

	 	b.	[***]-month sub-acute [***] toxicology in the non-human primate 

  
 Task 5. Develop and qualify methods for the assay of CPG 7909 in biological specimens 
  
 Sensitive, reproducible assays are required in order to be able to detect and quantitate the presence of CPG 7909 in
biological specimens. Such specimens may include blood and urine as well as tissue samples. Such assays are required to demonstrate the kinetics of absorption and elimination of CPG 7909 when administered to rodents and non-human primates in
toxicological studies (toxicokinetics) either alone or when formulated with anthrax vaccine antigens in prototype formulations. Such assays may also be used if needed to characterize more thoroughly the absorption, tissue distribution and
elimination of CPG 7909 in animals (ADME studies) and in human subjects. 
  
 Coley has recently made significant efforts to develop and apply a sensitive, reproducible assay for the detection of CPG 7909 in biological specimens. Coley will complete the development and validation of this assay
and provide expert advice during the transfer of the assay to [************]. 
  
 Task 6. Establish the key in vitro and in vivo biological characteristics of additional TLR9 agonists 
  

As discussed, Coley believes that a molecule that is a candidate for designation as a back-up to CPG 7909 should satisfy two principal criteria: (i)
exhibit vaccine adjuvant potency that is at least equivalent to that of CPOG 7909; and (ii) demonstrate pharmocokinetic properties, including metabolic profile, that [****] the [***] of [**********] of the [*************] and of [**************
**********] in the [****] and [*********]. While [********] appears to meet these requirements based on initial experiments, direct comparisons of the adjuvant and pharmacokinetic properties of CPG 7909 and [*********] should be performed. Coley has
other [********] oligodeoxynucleotides TLR9 agonists that may also be candidates for selection as a back-up molecule. To identify a candidate back-up molecule Coley will conduct experiments to: 
  

	 	a.	Define immune cell activation in human cell screens in vitro 

  

	 	b.	Define adjuvant activity in vivo 

  

	 	c.	Define tissue distribution and metabolism in vivo 

  

					
	 Contact: Iain Sim
	 	8/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 Task 7. Manufacture a back-up molecule 
  
 When a candidate back-up compound has been selected and accepted by DARPA, Coley will initiate the production of GMP quality
active pharmaceutical ingredient for non-clinical GLP development studies and for clinical trials. Coley will work closely with a third party manufacturer experienced in the manufacture of Coley CPG molecules. As the sponsor company, Coley remains
responsible for ensuring that the contract manufacturer is in GMP compliance and also adheres to the information in Coley’s regulatory filings. As such, Coley personnel will be integrated into many of the contract manufacturer operations. These
activities include: 
  

	 	a.	Develop and refine the process for the efficient production of active pharmaceutical ingredient on a scale and of a quality adequate to meet the needs of the development program

  

	 	b.	Forecast, schedule, and conduct all drug substance manufacturing operations to ensure adequate drug supplies for non-clinical development and clinical trials

  

	 	c.	Select and evaluate container/closure configuration for API 

  

	 	d.	Conduct of GMP-compliance audits 

  
 Task 8. Develop and qualify analytical methods for the determination of the identity, potency, purity and stability of the back-up molecule. Determine the stability of
the back-up molecule 
  
 Coley will place and manage a
contract with a competent contract laboratory for the development of sensitive, reproducible methods for the measurement of the identity, purity, potency and stability of the back-up molecule active pharmaceutical ingredient. Coley will provide
expert advice on the chemistry and detection of Oligodeoxynucleotides and will closely monitor the work of the contract laboratory to assure the objectives are achieved. Upon successful completion of the test method development, the methods will be
established and qualified in the same or another contract laboratory for the following applications: 
  

	 	a.	Define and perform release testing of lots of active pharmaceutical ingredient 

  

	 	b.	Determine the stability of the active pharmaceutical ingredient under a variety of storage conditions 

  

	 	c.	Perform physical/chemical characterization of individual lots of active pharmaceutical ingredient 

  
 The development and conduct of such test methods requires the use of reference materials that characterize the performance
of the pure compound, as well as the known manufacturing impurities, within the assay. Coley will use its expertise in 

  

					
	 Contact: Iain Sim
	 	9/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 
the synthetic and analytical chemistry of Oligodeoxynucleotides to prepare in part in its own laboratories and in part have prepared by a contract
manufacturer samples of such reference materials. Coley will also use its expertise in analytical chemistry to search for and to characterize other impurities that may occur from time to time in lots of the active pharmaceutical ingredient prepared
by a third party manufacturer. 
  
 Task 9. Characterize the toxicological
profile of the back-up molecule 
  
 Coley will place and
manage contracts with competent, approved contract research organizations for the performance of a number of studies designed to characterize the non-clinical safety and tolerability of the back-up molecule. All studies will be conducted according
to the principles of Good Laboratory Practice and will be supported by toxicokinetic analyses where appropriate. Coley will provide expert toxicological advice on the design and conduct of the studies, the interpretation of the results and the
preparation of the final study reports. Coley will also engage a consultants experienced in ODN non-clinical toxicology and in adjuvant regulatory development. The following studies are planned: 
  

	 	a.	Safety pharmacology in the non-human primate 

  

	 	b.	[***]-month [*******] toxicology in the rodent 

  

	 	c.	Mutagenic potential 

  
 Task 10. Develop and qualify methods for the assay of the back-up molecule in biological specimens 
  
 Sensitive, reproducible assays are required in order to be able to detect and quantitate the presence of the back-up molecule in biological specimens.
Such specimens may include blood and urine as well as tissue samples. Such assays are required to demonstrate the kinetics of absorption and elimination of the back-up molecule when administered to rodents and non-human primates in toxicological
studies (toxicokinetics) and in humans in clinical studies. Coley may conduct studies in-house, or may place and manage contracts with a competent contract laboratory, for the development of a sensitive, reproducible assay. Coley will provide expert
advice on the chemistry and detection of oligodeoxynucleotides and will closely monitor the work of the contract laboratory to assure the objectives are achieved. Upon successful completion of the development of a detection assay, the assay will be
established and for use in detecting the back-up molecule in biological specimens in studies conducted according to Good Laboratory Practice standards. The assay will also be transferred to [************] to be available for use in support of future
clinical studies. 
  
 Task 11. Manufacture and characterize examples of A-, B-
and C-Class TLR9 agonists 
  
 Coley will manufacture and
characterize, or supply from inventory, quantities of research grade A-, B- and C-Class TLR9 agonists in amounts adequate to support 

  

					
	 Contact: Iain Sim
	 	10/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Protection from Anthrax Infection Using
	 	Program Director: Krieg
	 CpG Oligodeoxynucleotides
	 	Coley Pharmaceutical Group

  

 
evaluation as prophylactic agents in a non-human primate model of a respiratory infection. The outcome of the NHP model studies will be used to select the
optimal TLR9 agonist for further development as a prophylactic agent. Coley will direct its contract manufacturer to manufacture a larger quantity of the TLR9 agonist according to the principles of GMP to support further pre-clinical research
studies and non-clinical GLP development studies. 
  
 TRA 2028419vl 
  

					
	 Contact: Iain Sim
	 	11/11	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 PREVENTION OF ANTHRAX INFECTION BY CPG OLIGODEOXYNUCLEOTIDES 
  

					
	 Name: Krieg, Arthur, M.
	  	 Title: SVP R&D; CSO
	  	             Institution: Coley Pharmaceutical Group, Inc

	
	 Location: 93 Worcester Street, Wellesley, MA 02481

		
	 Phone: 1-781-431-9000
	  	 E-mail: akrieg@coleypharma.com

	
	 Contract Number: DAAD19-03-C-002

		
	 Contract Start Date: December 6, 2002
	  	 Contract End Date: June 4, 2004

	
	 Total Contract Value: $12,000,001

  
 REVISED STATEMENT OF
WORK 
  
 THIS APPLICATION 
  
 Contract History 
  
 Contract DAAD19-03-C-002, Prevention of Anthrax Infection by CpG oligodeoxynucleotides, was
awarded with an effective date of December 6th, 2002 and a value of $6,000,001. The contract was amended with an
additional award of $6,000,000 to run until March 4th, 2004 subsequently amended with a revised scope of work to run
through June 4th, 2004. This current application proposes a further limited amendment to the scope of work and an
extension of the contract period with a new end date of February 28, 2005. There is no proposal to change the total value of the contract. 
  
 Proposed Change In Scope 
  
 Two changes are proposed to the scope of work as summarized in the table below and detailed in the description of Tasks. 
  

					
	 Task
#

	  	 Description

	  	 Amended Scope

	1	  	File an IND to support the conduct of a proof-of-concept clinical study of [*******] CPG 7909	  	This task is extended to include supporting the conduct of the proposed proof-of-concept clinical study. Coley will provide financial resources to one of the two planned clinical investigational
centers – [********************************].
	11	  	Manufacture and characterize examples of A-, B- and C-Class TLR9 agonists	  	Coley will continue to manufacture or supply from inventory quantities of research grade A-, B- and C-class TLR9 agonists for evaluation in animals. However, the identification of a lead
compound from research testing will only occur after the termination of this current contract. Therefore, the manufacture of a larger quantity of GMP-grade material of a lead compound is now deleted.

  

					
	 Contact: Iain Sim
	 	1/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 Changes in the scope of Tasks 1 and 11 are also defined in the appropriate sections below. 
  
 Re-direction of Funds 
  
 The program of research designed to identify the optimal class of TLR9 agonist for use in
prevention of disease resulting from exposure to airborne pathogens is underway. However, Coley judges that the large-scale manufacture of a lead TLR9 agonist will not be initiated within the timeframe of this contract. In addition, Coley finds that
it has used less contract labor than originally anticipated in the preparation of the IND submission for the proposed proof-of-concept clinical study of CpG 7909 [*******]. Coley therefore proposes that the funds originally assigned to the
manufacturing activity referenced above, and associated chemical analytical method development, together with the funds not allocated to contract labor, be re-directed to the support the clinical investigation defined in the amended Task 1. No
increase in funds is requested. 
  
 Extension
of Contract Duration 
  
 The duration of the proof-of-concept clinical study
is estimated to be approximately one year. This is driven by the time required to conduct and complete the proof-of-concept clinical study. Volunteers will be recruited for 8 weeks prior to the initial enrollment in the trial, and will be enrolled
over an 8-week period. Follow-up laboratory and safety data will be collected up to 6 months after the last vaccine. Approximately one to two additional months will be required to finalize all of the data collection and to close out the trial.
Volunteer recruitment is planned to start in March 2004. Therefore, Coley requests that the period of the contract be extended to February 28, 2005. 
  
 EXECUTIVE SUMMARY 
  
 The [******************] vaccine against anthrax [*****************] has been demonstrated to be safe and effective in its approved regimen of [*] injections over [**]
months. However, there is great interest in further improving the safety and efficacy of the vaccine by reducing the number of doses that need to be given in order to achieve protective antibody levels against the anthrax toxin proteins. Human and
animal data suggest that combining a Coley TLR9 agonist with [***] would offer the following 

  

					
	 Contact: Iain Sim
	 	2/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
advantages compared to the current vaccine: i) much faster seroconversion with induction of protective antibody levels in most subjects within [*] weeks; ii)
reduced number of [***] doses required, to no more than [***], and [**************] dose vaccination; iii) generation of higher affinity antibodies targeted against a broader range of epitopes to give improved protection against mutant strains; and
iv) improved duration of protective serum antibodies and memory responses. 
  
 Coley Pharmaceutical Group proposes to make available to DARPA CPG 7909 for lead development as an adjuvant for co-formulation in the anthrax vaccine [*******************************************]. Coley has CPG 7909 in phase II clinical
development in oncology and has demonstrated proof-of-concept of the drug as a vaccine adjuvant in human vaccine studies. The advanced stage of development of CPG 7909 makes this molecule the best candidate for further rapid development and approval
as a vaccine adjuvant. Further, Coley proposes to develop a second TLR9 agonist, differentiated from CPG 7909 in its immuno-pharmacological and metabolic profile, as a back-up compound. 
  
 The final part of this proposal is to develop a different TLR9 agonist as a prophylactic that would be given to activate immune resistance
to an anticipated BW attack. The human innate immune system encompasses a remarkable array of pathogen defenses that may be able to protect a non-immune individual from anthrax infection acquired as a consequence of a BW attack. A TLR9 agonist
delivered by [******************] may be able to activate the innate immune system in the [*****] and thus induce broad-spectrum resistance against [*******] pathogens including B. anthracis. Coley has identified three classes of TLR9
agonist, each with distinct structures and immune effects. The innate immune defenses activated by certain A-Class or B-Class TLR9 agonists can protect rodents against several different viral, bacterial, and parasitic pathogens. The work in this
proposal will support determining which of these 3 TLR9 agonist classes will be best for protecting against an [*******] anthrax challenge in animal models, and will initiate development of that product for military use. 
  
 BACKGROUND 
  
 This program proposal is a request for a re-direct of funds previously awarded to Coley Pharmaceutical Group under contract
DAAD19-03-C-0002. The overall rationale and approach remains unchanged and are not repeated in this document. In this current proposal, Coley offers a more advanced drug development candidate, CPG 7909, for use as an adjuvant in combination with
[*********] anthrax vaccine. In addition, Coley proposes to DARPA the development of a representative of a new class of TLR9 agonists, exemplified by [*******], as a back-up molecule to CPG 7909. 
  
 Development Of CPG 7909 
  
 CPG 7909 is a B-Class TLR9
agonist that is a potent activator of B cells as well as of plasmacytoid dendritic cells. Coley has demonstrated the adjuvant activity of CPG 7909 in clinical studies in combination with Engerix B®, a commercially approved hepatitis B 

  

					
	 Contact: Iain Sim
	 	3/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 .Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
vaccine. CPG 7909 substantially enhanced the antibody response to Engerix B in both normal subjects and in immunoincompetent HIV-infected individuals when
compared to controls receiving Engerix B vaccine alone. In addition, it has been shown that the co-administration of CPG 7909 [******] to monkeys enhances the anti-PA antibody response when compared to the controls. Coley has offered to make CPG
7909, now in phase II clinical development, available to DARPA for the purposes of improving the performance of the anthrax vaccine. CPG 7909 is the most advanced TLR9 agonist currently in development at Coley and offers the opportunity to fast
track a development program of such an agonist in combination with the anthrax vaccine. Coley has made substantial investments in the manufacturing and analysis of CPG 7909, in the characterization of its safety in rodents and non-human primates,
and in the understanding of its pharmacodynamics and anti-cancer activity in human subjects. Coley is preparing to file an IND with the DVRPA, CBER, FDA to support the immediate conduct of a proof-of-concept clinical study of CPG 7909 in
[***************]. [*********] will be [**************************] for [***********] and will [*********************************************] under a [*******************]. 
  
 Development of a Back-Up Molecule as a Vaccine Adjuvant 
  
 It is Coley’s understanding that DARPA wishes Coley to develop and offer to DARPA and the vaccine-manufacturing partners a second TLR9
agonist that will serve as a back-up to the lead molecule. DARPA has suggested that the back-up molecule be CPG 10103. Whereas [*****************************************] to CPG 7909 while [***************************] in [****************], Coley
wishes to propose for DARPA consideration the selection of a new type of immunomodulatory TLR9 agonist with a unique set of properties. 
  
 CPG 7909 contains a phosphorothioate backbone designed to make the molecule resistant to exo- and endonuclease cleavage. When [************************************
******************************************************], CPG 7909 has been [**************] in the [******************] and to be [**********************************] to the [*******************************]. These [*********************] are [****]
to [***************************]. In addition, it has been [***] in [*****************] that [**********] of CPG 7909 [************* *************] and [***************************************] in a [****************], including
[*********************], into the [****] of the [********]. While this [*****] has not been [******] with any [******************** **********] in [*****************] who have [******] CPG 7909 [****], including a [****] of [******] who have
[**********] weekly for [************], Coley believes that a molecule designated as a back-up to CPG 7909 should [******] of the [******] to [*******] in the [****] while retaining the desired B cell stimulating activities of CPG 7909.
[****************************] to CPG 7909, contains a phosphorothioate backbone, [**********] immunomodulatory activity and is [*****] to [***] a [**************]. On the other hand, Coley has [******] a [*********] to the [****] of TLR9
agonists [************************************************* 

  

					
	 Contact: Iain Sim
	 	4/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
**********] and [*****************]. By this means the [****] is [*****] to [************************] to [***************] and to [******************] in
the [****] as compared to [****************************] such as CPG 7909 and [******]. Moreover, by [********] the [***********************] the [**] and the [***********], it is [******] that the [****************] from [*****************] will be
[*************] in [****] than the [***********] and [****] of [*********************]. These [********************] have been called [********************]. 
  
 [*******] is a C-Class TLR9 agonist and is an [*****] of this [******] of [*****************************]. In general terms the C-Class TLR9 agonists show good
stimulation of B cells (efficient antibody secretion or induction of B cell proliferation) with a potency similar to the B-Class molecules such as CPG 7909. In addition, C-Class oligodeoxynucleotide TLR9 agonists demonstrate very strong Thl-inducing
capacities (efficient induction of secretion of type I interferons or stimulation of NK cells) similar to the TLR9 agonists of the A-Class. This pattern of in vitro immunostimulatory activities places the molecules of the C-Class between the
previously defined B- and A-Classes and demonstrates their potential to induce favorable immune responses in vivo. 
  
 When [**********] to [*************************] shows [****************] in the [****] as compared to the corresponding [****************************] and there is
[****************] after [****************] in [****] as compared to [**** *******************************************************] that [*******] is [********************************] at the [********************] to [*************] as would be
[*****] from the [*******] of the [****************] in the [*******************] this [*************] of [********************], they appear to be [********************] than their [*******************************]. 
  
 GOALS 
  
 The goals of this proposal are: 
  

	 	1.	To file an IND that will support the conduct of a proof-of-concept clinical study of CPG 7909 administered [***********************] to human volunteers. 

 

	 	2.	To facilitate the execution of a proof-of-concept clinical study. 

  

	 	3.	To conduct [*********************] and non-clinical safety studies of CPG 7909 that will be adequate to support the comprehensive development of the molecule as an adjuvant in a
clinically superior anthrax vaccine formulation. 

  

	 	4.	To identify a second TLR9 agonist that is differentiated from CPG 7909 and to conduct pre-clinical development studies adequate to support its further clinical development, if
needed, as a back-up to CPG 7909. 

  

					
	 Contact: Iain Sim
	 	5/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

	 	5.	To manufacture and support evaluation of representative A-, B- and C-Class TLR9 agonists for their ability to stimulate the innate immune system and protect experimental animals,
including a non-human primate, from infection following administration of pathogens to the [***************], in order to generate data supporting the testing of the most promising candidates for protection of a primate against a lethal [*****]
anthrax challenge. 

  
 These goals will be achieved through the
completion of the following tasks: 
  

	 	1.	File an IND and support the conduct of a proof-of-concept clinical study of [*******] CPG 7909 

  

	 	2.	Develop an efficient [**********************] for CPG 7909 

  

	 	3.	Develop and validate analytical methods for the determination of the identity, potency, purity and stability of CPG 7909 

  

	 	4.	Characterize the toxicological profile of CPG 7909 in rodents and non-human primates [**********] by the [*****************] 

  

	 	5.	Develop and qualify methods for the assay of CPG 7909 in biological specimens 

  

	 	6.	Establish the key in vitro and in vivo biological characteristics of additional TLR9 agonists 

  

	 	7.	Manufacture a back-up molecule 

  

	 	8.	Develop and qualify analytical methods for the determination of the identity, potency, purity and stability of the back-up molecule. Determine the stability of the back-up molecule

  

	 	9.	Characterize the toxicological profile of the back-up molecule 

  

	 	10.	Develop and qualify methods for the assay of the back-up molecule in biological specimens 

  

	 	11.	Manufacture and characterize examples of A-, B- and C-Class TLR9 agonists 

  
 Statement of Work 
  
 Task 1. File an IND to Support the Conduct of a Proof-of-Concept Clinical Study of [*******] CPG 7909 
  
 Coley, [*****************] and DARPA have agreed to conduct a
proof-of-concept clinical study of [***************] CPG 7909. This study will be conducted under a Coley-sponsored IND. At a Pre-IND teleconference held on July 1, 2003 with the Division of Vaccine and Related Product Applications, CBER, FDA, the
Agency requested Coley to submit a [***********] IND without [**********] to the [*******************] in the [************** ***************]. More over, [***********] the [*******] of additional [********] in the IND that [****] must now [*****].
As a result of the [******] from [***], the [**********] of the IND [********] is now [******] to be [***************] than was [***************] and will [**************** ******************************]. 
  

					
	 Contact: Iain Sim
	 	6/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

  
 In addition, the [***]
has [*******] that Coley [*****] a [*************** *********] of [******************] from a [*********************** ************] of the [****************] and CPG 7909 and [******** ******] in the [************]. This activity was previously
judged not to be required and has not been budgeted for. 
  
 The
cost burden of managing the proof-of-concept clinical study will be borne by Coley and by others. Coley will fund an investigator at the [****************** *****************************] to recruit and treat approximately half of the planned number
of study subjects. As the clinical study sponsor (IND holder) Coley will obtain the customary clinical trail insurance. Coley has agreed to manage the supply of clinical trial products - CPG 7909 and saline - to the study sites. Coley will manage
the supply of materials to the clinical sites using an experienced sub-contractor. 
  
 The following activities will be conducted: 
  

	 	a	[*******************************************] and [***] and IND submission to DVRPA, CBER, FDA. 

  

	 	b	[*****] a [**********************] of [*********] from the [**************] of [*******] CPG 7909. 

  

	 	c.	Supply CPG 7909 Injection and saline for injection; manage the shipment of these products to clinical study sites. 

  

	 	d.	Conduct the proof-of-concept clinical study of CpG 7909 [******] as described in the clinical study protocol and approved by the FDA. 

  
 Task 2. Develop an efficient [*************************] for CPG 7909 
  
 Approximately [***] g of CPG 7909 active pharmaceutical ingredient (API) are
currently available and assigned to the initial development of the proposed combined [*******] CPG 7909 vaccine product (see also Task 3 below). Moreover, the current manufacturing process is adequate for the present stage of [**********] and is
[*****] of [***********************] g. However, in the opinion of Coley the manufacturing process is not optimized or sufficiently defined and controlled for it to be used for the routine manufacture of CPG 7909 API for use in an FDA-approved
commercial vaccine product. 
  
 Production of GMP CPG 7909 active
pharmaceutical ingredient for pivotal studies and for commercial supplies will be contracted out by Coley to a third party manufacturer. As the sponsor company, Coley remains responsible for ensuring that the contract manufacturer is in GMP
compliance and also adheres to the information in Coley’s regulatory filings. As such, Coley personnel will be integrated into many of the contract manufacturer operations. 
  
 Since CPG 7909 is a pharmacologically active substance it is anticipated that the manufacture of CPG 7909 will be regulated
by the FDA in a manner similar to the 

  

					
	 Contact: Iain Sim
	 	7/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
manufacture of API for drug products. The following activities must be completed to support the development of a commercially viable, validatable
manufacturing process: 
  

	 	a.	Refine the current manufacturing process, both synthetic chemistry and purification, for the efficient production of API on a scale and of a quality adequate to meet the needs of
the future market place 

  

	 	b.	Define, develop and set specifications for in-process controls for the manufacture of API to afford better control of the manufacturing process 

  

	 	c.	Define, develop and set specifications for starting materials used in the manufacturing process 

  

	 	d.	Prepare and maintain an up-to-date Drug Master File for cross-reference 

  

	 	e.	Conduct GMP-compliance audits 

  
 Task 3. Develop and validate analytical methods for the determination of the identity, potency, purity and stability of CPG 7909 
  
 Approximately [***] g of CPG 7909 [*****************] in 2002 at a
[*****************] as part of the collaboration between Coley and DARPA. This [********] did not meet the [******************] when [***********] and was [**********] by [***********************]. It is expected that this [****] can be
[*********************************] of the [******* ****] CPG 7909 [*****]. However, additional [****] of the [***************] to [****] that it [********************************] current, state of the art [*********************]; a [***********]
must be submitted to the [***] to [********] for [***]. 
  
 Coley
has made significant advances in the development and application of analytical methods suitable for the determination of the identity, potency, purity and stability of CPG 7909. The optimization of the analytical methods is in progress. The
development and conduct of such test methods requires the use of reference materials that characterize the performance of the pure compound, as well as the known manufacturing impurities, within the assay. Coley will use its expertise in the
synthetic and analytical chemistry of oligodeoxynucleotides to prepare in part in its own laboratories and in part have prepared by a contract manufacturer samples of such reference materials. Fully optimized methods must be qualified, validated and
the technology transferred from the development laboratory to the qualified contract facility that will have responsibility for the quality control release testing of the API. The methods will also be transferred to [******************] for their
use in the development of the [************] CPG 7909 product. While the analytical methods available at present are judged to be adequate for the development of CPG 7909, it is recognized that as new information is gained the development of
additional analytical techniques may be required to address the detection of new impurities arising from the final manufacturing process. 
  

					
	 Contact: Iain Sim
	 	8/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 Coley has used internal expertise as well as contracts with competent contract laboratories to
development sensitive, reproducible analytical methods. Coley will continue to provide expert advice on the chemistry and detection of CPG 7909 and will closely monitor the work of the contract laboratories to assure the objectives are achieved. The
following activities must be completed before commercialization: 
  

	 	a.	Optimize, qualify, validate and transfer GMP analytical methods 

  

	 	b.	Prepare reference standards and impurity markers 

  

	 	c.	Monitor the of production lots of CPG 7909 for new impurities and development of new analytical methods as the need arises 

  

	 	d.	Perform comparability analysis of production lots 

  

	 	e.	Perform release testing of lots of active pharmaceutical ingredient 

  

	 	f.	Determine the stability of the active pharmaceutical ingredient under a variety of storage conditions 

  

	 	g.	Perform physical/chemical characterization of individual lots of active pharmaceutical ingredient 

  

	 	h.	Develop analytical methods for the qualification of starting materials 

  

	 	i.	Develop analytical methods adapted for application to in-process controls 

  
 Task 4. Characterize the toxicological profile of CPG 7909 in rodents and non-human primates [**********] by the [****************] 
  
 Coley has extensive data on the safety of CPG 7909 in
rodents and non-human primates when [********] by the [*******] and [***************]. [****************] has expressed its desire to explore the [***************] for [**********] of a [**************] CPG 7909 vaccine product. Therefore it is
important to understand first the safety of CPG 7909 alone when [********] by this [***]. Coley will place and manage contracts with competent, approved contract research organizations for the performance toxicological studies designed to
characterize the non-clinical safety of CPG 7909 [*********] by the [***************], and to demonstrate a margin of safety between the proposed adjuvant dose and the doses which caused toxicity in previous CPG 7909 studies. All studies will be
conducted according to the principles of Good Laboratory Practice and will be supported by toxicokinetic analyses. Coley will provide expert toxicological advice on the design and conduct of the studies, the interpretation of the results and the
preparation of the final study reports. Coley will also engage a consultants experienced in oligodeoxynucleotide toxicology and in the regulatory aspects of vaccine adjuvant development. The following studies are planned: 
  

	 	a.	[***]-month sub-acute [***] toxicology in the rodent 

  

	 	b.	[***]-month sub-acute [***] toxicology in the non-human primate 

  

					
	 Contact: Iain Sim
	 	9/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 Task 5. Develop and qualify methods for the assay of CPG 7909 in biological specimens 
  
 Sensitive, reproducible assays are required in order to be able to detect
and quantitate the presence of CPG 7909 in biological specimens. Such specimens may include blood and urine as well as tissue samples. Such assays are required to demonstrate the kinetics of absorption and elimination of CPG 7909 when administered
to rodents and non-human primates in toxicological studies (toxicokinetics) either alone or when formulated with anthrax vaccine antigens in prototype formulations. Such assays may also be used if needed to characterize more thoroughly the
absorption, tissue distribution and elimination of CPG 7909 in animals (ADME studies) and in human subjects. 
  
 Coley has recently made significant efforts to develop and apply a sensitive, reproducible assay for the detection of CPG 7909 in biological specimens.
Coley will complete the development and validation of this assay and provide expert advice during the transfer of the assay to [***************]. 
  
 Task 6. Establish the key in vitro and in vivo biological characteristics of additional TLR9 agonists 
  
 As discussed, Coley believes that a molecule that is a candidate for
designation as a back-up to CPG 7909 should satisfy two principal criteria: (i) exhibit vaccine adjuvant potency that is at least equivalent to that of CPOG 7909; and (ii) demonstrate pharmocokinetic properties, including metabolic profile, that
[****] the [***] of [**********] of the [************] and of [*************** *********] in the [****] and [**********]. While [*******] appears to meet these requirements based on initial experiments, direct comparisons of the adjuvant and
pharmacokinetic properties of CPG 7909 and [*******] should be performed. Coley has other [*******] oligodeoxynucleotides TLR9 agonists that may also be candidates for selection as a back-up molecule. To identify a candidate back-up molecule Coley
will conduct experiments to: 
  

	 	a.	Define immune cell activation in human cell screens in vitro 

  

	 	b.	Define adjuvant activity in vivo 

  

	 	c.	Define tissue distribution and metabolism in vivo 

  
 Task 7. Manufacture a back-up molecule 
  
 When a candidate back-up compound has been selected and accepted by DARPA, Coley will initiate the production of GMP quality active pharmaceutical
ingredient for non-clinical GLP development studies and for clinical trials. Coley will work closely with a third party manufacturer experienced in the manufacture of Coley CPG molecules. As the sponsor company, Coley remains responsible for 

  

					
	 Contact: Iain Sim
	 	10/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
ensuring that the contract manufacturer is in GMP compliance and also adheres to the information in Coley’s regulatory filings. As such, Coley personnel
will be integrated into many of the contract manufacturer operations. These activities include: 
  

	 	a.	Develop and refine the process for the efficient production of active pharmaceutical ingredient on a scale and of a quality adequate to meet the needs of the development program

  

	 	b.	Forecast, schedule, and conduct all drug substance manufacturing operations to ensure adequate drug supplies for non-clinical development and clinical trials

  

	 	c.	Select and evaluate container/closure configuration for API 

  

	 	d.	Conduct of GMP-compliance audits 

  
 Task 8. Develop and qualify analytical methods for the determination of the identity, potency, purity and stability of the back-up molecule. Determine the stability of
the back-up molecule 
  
 Coley will place and manage a
contract with a competent contract laboratory for the development of sensitive, reproducible methods for the measurement of the identity, purity, potency and stability of the back-up molecule active pharmaceutical ingredient. Coley will provide
expert advice on the chemistry and detection of oligodeoxynucleotides and will closely monitor the work of the contract laboratory to assure the objectives are achieved. Upon successful completion of the test method development, the methods will be
established and qualified in the same or another contract laboratory for the following applications: 
  

	 	a.	Define and perform release testing of lots of active pharmaceutical ingredient 

  

	 	b.	Determine the stability of the active pharmaceutical ingredient under a variety of storage conditions 

  

	 	c.	Perform physical/chemical characterization of individual lots of active pharmaceutical ingredient 

  
 The development and conduct of such test methods requires the use of reference materials that characterize the performance
of the pure compound, as well as the known manufacturing impurities, within the assay. Coley will use its expertise in the synthetic and analytical chemistry of oligodeoxynucleotides to prepare in part in its own laboratories and in part have
prepared by a contract manufacturer samples of such reference materials. Coley will also use its expertise in analytical chemistry to search for and to characterize other impurities that may occur from time to time in lots of the active
pharmaceutical ingredient prepared by a third party manufacturer. 
  
 Task 9.
Characterize the toxicological profile of the back-up molecule 
  
 Coley will place and manage contracts with competent, approved contract 

  

					
	 Contact: Iain Sim
	 	11/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

			
	 Contract: DAAD19-03-C-002
	 	Program Director: Krieg
	 Revised: February, 2004
	 	Coley Pharmaceutical Group

  

 
research organizations for the performance of a number of studies designed to characterize the non-clinical safety and tolerability of the back-up molecule.
All studies will be conducted according to the principles of Good Laboratory Practice and will be supported by toxicokinetic analyses where appropriate. Coley will provide expert toxicological advice on the design and conduct of the studies, the
interpretation of the results and the preparation of the final study reports. Coley will also engage a consultants experienced in ODN non-clinical toxicology and in adjuvant regulatory development. The following studies are planned: 
  

	 	a.	Safety pharmacology in the non-human primate 

  

	 	b.	[***]-month [*****] toxicology in the rodent 

  

	 	c.	Mutagenic potential 

  
 Task 10. Develop and qualify methods for the assay of the back-up molecule in biological specimens 
  
 Sensitive, reproducible assays are required in order to be able to detect and quantitate the presence of the back-up molecule in biological specimens.
Such specimens may include blood and urine as well as tissue samples. Such assays are required to demonstrate the kinetics of absorption and elimination of the back-up molecule when administered to rodents and non-human primates in toxicological
studies (toxicokinetics) and in humans in clinical studies. Coley may conduct studies in-house, or may place and manage contracts with a competent contract laboratory, for the development of a sensitive, reproducible assay. Coley will provide expert
advice on the chemistry and detection of oligodeoxynucleotides and will closely monitor the work of the contract laboratory to assure the objectives are achieved. Upon successful completion of the development of a detection assay, the assay will be
established and for use in detecting the back-up molecule in biological specimens in studies conducted according to Good Laboratory Practice standards. The assay will also be transferred to [****** **********] to be available for use in support of
future clinical studies. 
  
 Task 11. Manufacture and characterize examples of
A-, B- and C-Class TLR9 agonists 
  
 Coley will manufacture
and characterize, or supply from inventory, quantities of research grade A-, B- and C-Class TLR9 agonists in amounts adequate to support evaluation as prophylactic agents in experimental animal models of disease, including in a non-human primate
model of a respiratory infection. The outcome of the experimental animal model studies will be used to select the optimal TLR9 agonist for further development as a prophylactic agent. 
  

					
	 Contact: Iain Sim
	 	12/12	 	Tel: (781) 431 9000, x1293
	 Coley Pharmaceutical Group
	 	 	 	E-mail: isim@coleypharma.com
	Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.

				
	2005 Revised Budget	  	 	 
		
	 Contract amount
	  	$	12,000,001
	 Billed to date
	  	$	11,003,662
	 	  	
	

	 Balance remaining
	  	$	996,339
	 	  	
	

	 Costs for CPG [****] activities contracted but not yet billed to Coley
	  	$	67,620
	 Direct costs
	  	$	622,413
	 Coley labor
	  	$	40,000
	 Travel
	  	$	3,000
	 Overhead, G&A @36%
	  	$	263,892
	 	  	
	

	 Total
	  	$	996,925
	 	  	
	

  

				
	 Activity

	  	Cost

	 Patient costs, advertising and materials
	  	$	285,831
	 Study site audit
	  	$	14,000
	 Additional clinical trial supplies
	  	$	585
	 Extended trial insurance
	  	$	40,000
		
	 CPG 7909 analytical method validation and API stability
	  	$	148,997
	 Manufacture API for [*****]
	  	$	133,000
	 	  	
	

	 Total Direct costs
	  	$	622,413
	 	  	
	

  
 Portions of this Exhibit were
omitted and have been filed separately with the secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.Contract #HHSN266200400044C/NO1-40044, dated June 30, 2004

 Exhibit 10.36 
  

			
	 ADB NUMBER: NO1A140044
	  	OMB Approval 2700-0042

											
	AWARD/CONTRACT	  	 1      THIS CONTRACT IS A RATED ORDER
 UNDER DPAS (15 CFR
350)                                        
                Ø
	  	RATING	  	PAGE OF PAGES
	 	  	  	N/A	  	1	  	23
	 2.     CONTRACT (Proc.
Inst. Ident.) NO.
	  	 3.     EFFECTIVE DATE
	  	4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
	 HHSN266200400044C/N01-A1-40044
	  	 June 30, 2004
	  	PRCB163                

											
	 5.     ISSUED BY
	 	 CODE
	  	 	  	 6.     ADMINISTERED BY (if other than item 6)
	  	CODE	  	 
	             National Institutes of Health
             Contract Management Program, NIAID, DEA
             Room 3214
             6700-B Rockledge Dr., MSC 7612
             Bethesda, Maryland 20892-7612
	  	         DAIT-PRCB
	  	 

							
	   7.   NAME AND ADDRESS OF CONTRACTOR (No, street, county, state and ZIP
Code)
	  	 8.     DELIVERY
	  	 
	  
 Coley Pharmaceutical Group
 Wellesley Gateway
 93 Worcester Street, Suite 101
 Wellesley, MA 02481
	  	    ̈FOB ORIGIN
	  	 x  OTHER (See below)
 FOB Destination

	  	 9. DISCOUNT FOR PROMPT PAYMENT
     N/A

	 	  	 	  	10. SUBMIT INVOICES	  	ITEM
	 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        
		 
	     Article
F.1.
  
	  	        See Article
G.3.
  

	 13.AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: NA
	  	 14.ACCOUNTING AND APPROPRIATION DATA
     E1N#061506689-A1  SOC 25.55 FY2004 $3,545,113 CAN# 4-8460923

	 ̈ 10 U.S.C. 2304(c)(    )                     ̈ 41 U.S.C. 253(c)(    )	  	 

											
	 15A.  ITEMNO.  
	  	15B. SUPPLIES/SERVICES	  	15C. UNIT PRICE	  	15D. AMOUNT	  	15E. UNIT PRICE	  	15F. AMOUNT
	 Title: Innate Immune Receptors and Adjuvant Discovery
 Period: June 30, 2004 through June 29,2009
 Amount Allotted:
$3,545,113
 Contract Type: Cost-Reimbursement/Completion
	  	FY 04	  	$3,545,113	  	 	  	 
	  	FY 05	  	$2,970,509	  	 	  	 
	  	FY 06	  	$3,704,797	  	 	  	 
	  	FY 07	  	$3,295,677	  	 	  	 
	  	FY 08	  	$3,386,018	  	 	  	 
	 	  	 	  	 15G. TOTAL AMOUNT OF
CONTRACT                            Ø    
	  	$16,902,114
	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	  	17
	x	  	B	  	SUPPLIES OR SERVICES AND PRICE/COST	  	2	  	PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
	x	  	C	  	DESCRIPTION/SPECS./WORK STATEMENT	  	5	  	x	  	J	  	LIST OF ATTACHMENTS	  	22
	x	  	D	  	PACKAGING AND MARKING	  	8	  	 	  	PART IV - REPRESENTATIONS AND INSTRUCTIONS
	x	  	E	  	INSPECTION AND ACCEPTANCE	  	8	  	x	  	K	  	REPRESENTATIONS, CERTIFICATIONS
AND OTHER STATEMENTS OF OFFERORS	  	23
	x	  	F	  	DELIVERIES OR PERFORMANCE	  	8	  	  	  	  
	x	  	G	  	CONTRACT ADMINISTRATION DATA	  	9	  	 ̈	  	L	  	INSTRS., CONDS., AND NOTICES TO OFFERORS	  	 
	x	  	H	  	SPECIAL CONTRACT REQUIREMENTS	  	12	  	 ̈	  	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 in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents:
(a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.
	 19A. NAME AND TITLE OF SIGNER (Type or print)
     Justin A. Renz
     Senior
Director, Global Accounting & Finance, Assistant Treasurer
	  	 20A. NAME OF CONTRACTING OFFICER
 Paquetta N. Myrick-Hancock, Contracting Officer
 PRCB, CMP, DEA, NIAID, NIH, DHHS

									
	 19B. NAME OF CONTRACTOR
	  	 19C. DATE SIGNED
 6/28/04
	  	 20B. UNITED STATES OF AMERICA
	  	 20C. DATE SIGNED
 6/30/04

		 	 		 
	 /s/ Justin A. Renz

	  	 	  	By	  	 /s/ Paquetta N. Myrick-Hancock

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

					
	 NSN 7540-01-152-8068
	 	26-107	 	 STANDARD FORM 26 (REV. 4-85)

	 PREVIOUS EDITION UNUSABLE
	 	Computer Generated	 	 Prescribed by GSA
 FAR (48 CFR) 53.214(a)

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS 
  
 ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES 
  
 The purpose of this contract is establish a pipeline of new adjuvant leads that exploit the
natural capacity of the innate immune system to initiate and sustain appropriate T and B cell responses. 
  
 ARTICLE B.2. ESTIMATED COST 
  

	a.	The estimated cost of this contract is $16,902,114. 

  

	b.	Total funds currently available for payment and allotted to this contract are $3,545,113. For further provisions on funding see the LIMITATION OF FUNDS clause referenced in Part II,
ARTICLE I.2. Authorized Substitution of Clauses. 

  

	c.	It is estimated that the amount currently allotted will cover performance of the contract through June 29, 2005. 

  

	d.	Increments to be allotted to this contract are estimated as follows 

  

							
	 Fiscal Year

	  	Period

	  	Amount

	 
	 FY 04
	  	06/30/04 – 06/29/05	  	$	3,545,113	*
	 FY 05
	  	06/30/05 – 06/29/06	  	$	2,970,509	 
	 FY 06
	  	06/30/06 – 06/29/07	  	$	3,704,797	 
	 FY 07
	  	06/30/07 – 06/29/08	  	$	3,295,677	 
	 FY 08
	  	06/30/08 – 06/29/09	  	$	3,386,018	 
	 	  	 	  	
	
	

	 Total
	  	 	  	$	16,902,114	 
	 	  	 	  	
	
	

	*	Indicates amount is funded. 

  

	e.	The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor. 

  
 ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS 
  

	a.	Items Unallowable Unless Otherwise Provided 

  
 Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, 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)	Foreign travel - See paragraph b.(2); 

  

	 	(6)	Consultant costs; 

  

	 	(7)	Subcontracts, except as provided in B.4; 

  

 Page 2 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	 	(8)	Patient care costs; 

  

	 	(9)	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), 1990, regardless of acquisition value. 

  

	b.	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
$14,594 without the prior written approval of the Contracting Officer. 

  

	 	(b)	The Contractor shall invoice and be reimbursed for all travel costs in accordance with FTR. 

  

	 	(2)	Foreign Travel 

  

	 	(a)	Total expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed $11,466
without the prior written approval of the Contracting Officer. 

  

	 	(b)	Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following: (a) meeting(s) and place(s) to be visited, with costs and dates; (b)
name(s) and title(s) of Contractor personnel to travel and their functions in the contract project; (c) contract purposes to be served by the travel; (d) how travel of contractor personnel will benefit and contribute to accomplishing the contract
project, or will otherwise justify the expenditure of NIH contract funds; (e) how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and (f) what additional functions may be
performed by the travelers to accomplish other purposes of the contract and thus further benefit the project. 

  
 ARTICLE B.4. ADVANCE UNDERSTANDINGS 
  
 The following advance understandings are applicable to this contract: 
  

	1.	Subcontract 

  
 a. Funds are set aside to negotiate a cost reimbursement type subcontract with University of California - Davis for an amount not to exceed
$1,961,957. 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.) 
  
 b. Funds are set aside to negotiate a cost reimbursement type subcontract with University of New Mexico for an amount not to exceed
$808,424. 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.) 
  
 c. Funds are set aside to negotiate a cost reimbursement type subcontract with University of Alabama for an
amount not to exceed $557,783. 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.) 
  

 Page 3 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 d. Funds are set aside to negotiate a cost reimbursement type subcontract with Munich
for an amount not to exceed $801,584. 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.) 
  

	2.	Consultants 

  

					
	 Name

	  	 Cost per year

	  	 Not-to-exceed Contract Total

	 [************]
	  	$100/hr* x 149/hr per year	  	$79,500 (excluding travel)

	*	hourly rate gets 3% escalation per contract year 

  

	3.	Equipment Costs 

  
 Of the total contract value, $811,197 is hereby set aside for the purchase of the equipment identified in Article G.4.c, Contractor-Acquired
Government Property – Schedule I-A. Schedule I-A is provided as Attachment 7 of this contract. A variance of 10% of each estimated cost shown in the Attachment is authorized without further action by the Contracting Officer. Any substitutions
of the listed equipment shall require prior written approval of the Contracting Officer. 
  

	4.	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: 

  

	 	(2)    (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)	Total Direct Labor & Fringe Benefits 

  

	 	(d)	Materials & Supplies - Include detailed breakdown when total amount is over $1,000. 

  

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

  

	 	(f)	Equipment – Cite authorization and amount. Cite COA, if appropriate. 

  

	 	(g)	Other Direct Costs 

  

	 	(h)	Subcontracts – Attach subcontractor invoices, an estimate of the monthly expense of each subcontractor or a note that the subcontractor did not incur any expenses in the
current billing period. 

  

	 	(i)	Overhead (G&A) - Cite rate and amount 

  

	 	(j)	Overhead (G&A on subcontractors) – Cite rate and amount 

  

	 	(k)	Total Costs 

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

	 	(3)	The contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the
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. 

  

	5.	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. 
  

 Page 4 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 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. 
  

	6.	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.
HHSN266200400044C 
 ADB Contract No. N01-AI-40044 
  
 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 
  
 ARTICLE C.1. STATEMENT OF WORK 
  
 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, SECTION J, ATTACHMENT 1, April 30, 2004, attached hereto and made a part of this contract. 
  
 ARTICLE C.2. REPORTING REQUIREMENTS 
  

	1.	Semi-Annual Progress Reports 

  
 Semi-Annual Progress Reports shall summarize the results of the contract work for the six month period covered. The report is due by the 15th of the month following the end of each semiannual performance period. The Contractor shall submit two (2) paper copies AND two
copies on digital magnetic media such as computer files on 3.5 inch, high density computer diskettes or other digital medium approved by the Project Officer, in formats readable using IBM-type personal computer; for example, Microsoft WordTM 2000 version 9.0 for Windows and Microsoft ExcelTM 2000 version 9.0 for Windows. The Project Officer may
approve alternate forms of transmittal of reports (such as via email as attached files). The report shall include the following: 
  

	 	(A)	Face page to include contract number, contract title, performance period covered, Contractor’s name and address, telephone, and telefax numbers, e-mail address, and the
submission date. 

  

	 	(B)	An executive summary, to include: 

  

	 	(1)	An overview of the status of the project, including personnel, adherence to timelines and milestones, and research and development activity; 

  

	 	(2)	A brief overview of the work that was completed for the reporting period and/or justification for failure to complete intended work or performance of work beyond that initially
planned; 

  

	 	(3)	A brief overview of the activities that occurred during the current reporting period and any problems (technical or financial) that occurred during the current reporting period; and

  

	 	(4)	The fulfillment of goals and of the specific aims set forth in the proposal. 

  

	 	(C)	A full description of: 

  

	 	(1)	The work performed during the reporting period; 

  

	 	(2)	The relation between the accomplishments and the goals and objectives of the contract; and 

  

	 	(3)	A full discussion of the results and their relevance; explanations of any differences between planned and actual progress, and, if necessary, what corrective steps are planned or
have been implemented. 

  

 Page 5 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	 	(D)	Copies of manuscripts (published or unpublished) derived from research performed under the contract and copies of all abstracts, manuscripts, preprints and publications that
resulted from work conducted or any protocol or method developed specifically under this contract during the performance period. 

  

	 	(E)	A full disclosure of intent to file patent applications within or outside of the US on materials, reagents, animals models or procedures derived or established by the work supported
under this contract; full disclosure of patent applications filed, as well as copies of patent applications. 

  
 Semiannual Progress Reports are not required for periods in which an Annual or Final Report is due. 
  

	2.	Annual Progress Reports 

  
 Annual Progress Reports shall summarize the results of the entire contract work for the 12 month period covered. The report is due by the 30th of the month following each anniversary date of the contract. The Contractor shall submit two (2) paper copies AND two copies
on digital magnetic media as specified for semi-annual reports. The report shall include the following: 
  

	 	(F)	Face page to include contract number, contract title, performance period covered, Contractor’s name and address, telephone, and telefax numbers, e-mail address, and the
submission date. 

  

	 	(G)	An executive summary, to include the fulfillment of production goals and of the specific aims set forth in the proposal; 

  

	 	(H)	A detailed description of the work performed, the results obtained, and a discussion of the relevance of the results and their relation to work being conducted in the area by other
groups. 

  

	3.	Final Report 

  
 The Final Report shall document and summarize the results of the entire contract period of performance. The report is due on or before the completion date
of the contract. The Contractor shall submit two (2) paper copies AND two copies on digital magnetic media as specified for semi-annual reports. The report shall include the following: 
  

	 	(I)	Face page to include contract number, contract title, performance period covered, Contractor’s name and address, telephone, and telefax numbers, e-mail address, and the
submission date. 

  

	 	(J)	Summary of salient results. The Contractor shall submit a summary, not to exceed 250 words, of salient results achieved during the performance of the contract;

  

	 	(K)	An executive summary, to include the fulfillment of production goals and of the specific aims set forth in the proposal; 

  

	 	(L)	A detailed description of the work performed, the results obtained, and a discussion of the relevance of the results and their relation to work being conducted in the area by other
groups. 

  

	4.	Other Deliverables 

  
 Deliverables required on or before the contract completion date: The Contractor shall return to NIH or deliver to a successor contractor equipment
supplied or procured under this contract. 
  

 Page 6 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	5.	Reports submitted to the Government shall not include any individual identifiers of human subjects, i.e., volunteers or patients whose cells or tissues are used in the funded
studies. 

  

	 	(A)	Summary of Salient Results 

  
 With the final report, the Contractor shall submit a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

  

	 	(B)	Transition Plan 

  
 Four months prior to the contract’s expiration (or as directed by the Contracting Officer), the Contractor shall provide a plan for a orderly
transition of data and samples to a subsequent contractor or to the Government, subject to Project Officer approval, and shall deliver, if requested by the Project Officer and by the completion date of the contract, the following items: accurate and
updated protocols and databases, a computer generated listing of accurate and updated preserved strains, samples, labeled and inventoried paper files, any other government-owned property and any necessary information related thereto. 
  
 If the Contractor becomes unable to deliver the reports specified hereunder
within the period of performance because of unforeseen difficulties, notwithstanding the 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 reason therefore. 
  
 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 the annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer at the address
listed below. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted within 90 days after contract expiration to the following address: 
  
 Contracting Officer 
 Preclinical Research
Contracts Branch 
 Contract Management Program 
 DEA, NIAID, NIH, DHHS 
 6700-B Rockledge Drive, Room 3214, MSC 7612 
 Bethesda, Maryland 20892 - 7612 
  
 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. 
  

 Page 7 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 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 identified in Article G.1 is the authorized representative of the Contracting Officer. 

  

	c.	Inspection and acceptance will be performed at the address listed for the Project Officer in Section G, Article G. 1. Acceptance rnay be presumed unless otherwise indicated in
writing by the Contracting Officer or duly authorized representative within 30 days. 

  

	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 No 52.246-8,
INSPECTION OF RESEARCH AND DEVELOPMENT - COST REIMBURSEMENT (MAY 2001). 
  
 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.1. 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 date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract: 

  
 Report Distribution 
  

							
	 Deliverable

	  	No. of
Copies

	 	 Addressee/Distribution

	  	 Due Dates

	Semi-Annual Progress Report	  	2*	 	 Project Officer,
 DAIT, BIB, NIAID
 6610 Rockledge Drive, #3014
 Bethesda, MD 20892-6603
	  	Within 15 calendar days after the end of the sixth month of the project and at the same 15 day period following the end of each sixth monthly period thereafter.
				
	Semi-Annual Progress Report	  	1	 	 Contracting Officer,
 PRCB, CMP, DEA, NIAID
 6700-B Rockledge Drive,
 Room 3214, MSC 7612 Bethesda, MD
20892-7612
	  	Same as above
				
	Annual Progress Report	  	2*	 	Project Officer, as above.	  	Within 15 calendar days after the end of the twelfth month of the project and the same 15 day period following the end of each twelfth month period thereafter.
				
	Annual Progress Report	  	1	 	Contracting Officer, as above.	  	Same as above
				
	Final	  	2*	 	Project Officer, as above.	  	30 days after completion date.
				
	Final	  	1	 	Contracting Officer, as above.	  	30 days after completion date.

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

  

 Page 8 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	b.	If the Contractor is unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the 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. 

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

  
 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. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/. 

 
 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(s) will represent the Government for the purpose of this
contract: 
  
 David Winter, Ph.D. 
 Program Officer, Basic Immunology Branch 
 Division of Allergy, Immunology and Transplantation 
 National Institute of Allergy and Infectious Diseases 
 6610 Rockledge Drive, Rm 3014 
 Bethesda, MD.
20892-(Fed Ex zip =20817) 
 Phone: 301-451-3127-Fax: 301-480-2381- Email: dwinter@niaid.nih.gov 
  
 The Project Officer 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 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 Project Officer designation. 
  

 Page 9 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 ARTICLE G.2. KEY PERSONNEL 
  
 The personnel specified in this contract are considered to be essential to the work to be performed hereunder. 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 required by this article. The contract may be amended from time to time during the course of the contract to either add or delete personnel, as appropriate. 
  
 The following individuals are considered to be essential to the work being performed hereunder: 
  

			
	 Name

	  	 Title

	 Arthur Krieg, Ph.D.
	  	Principal Investigator

  
 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 (Attachment 2) is 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
HHSN266200400044C (This is the 17-digit number that appears in Block 2 of the SF-26.) ADB Contract N01-AI-40044 (This is the 10-digit number that appears in the upper, left-hand corner of the SF-26.) 
  

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

  
 Contracting Officer 
 Preclinical Research Contracts Branch 
 Contract Management Program 
 DEA, NIAID, NIH, DHHS 
 Room 3214, MSC 7612 
 6700-B Rockledge Drive 
 Bethesda, MD 20892-7612 
  

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

  

 Page 10 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 ARTICLE G.4. 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 DHHS Publication,
Contractor’s Guide for Control of Government Property, 1990, which is incorporated into this contract by reference. 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 20852-7670 
 (301) 496-6466 
  

	b.	Notwithstanding the provisions outlined in the DHHS Publication, Contractor’s Guide for Control of Government Property, 1990 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 

  
 Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor is hereby authorized to acquire the property listed in the
attached Schedule I-A (Attachment 5) for use in direct performance of the contract. 
  
 ARTICLE G.5. 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 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 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 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://ocm.od.nih.gov/cdmp/cps_contractor.htm 
  

 Page 11 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 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 30-day time frame. 
  
 SECTION H - SPECIAL CONTRACT REQUIREMENTS 
  
 ARTICLE H.1. HUMAN SUBJECTS 
  
 It is hereby understood and
agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be
used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer. 
  
 ARTICLE H.2. 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 (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 46.208(a)(2) 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. 108-199, Title V-General Provisions, Section 510	  	2004	  	10/1/03 - 9/30/04

  
 ARTICLE H.3. 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. 

  

							
	b.	  	Public Law and Section No.	  	Fiscal Year	  	Period Covered
				
	 	  	P.L. 108-199, Title V-General Provisions, Section 505	  	2004	  	10/1/03 - 9/30/04

  
 ARTICLE H.4. ANIMAL WELFARE

  
 The Contractor shall obtain prior to the start of any work under this
contract, an approved Animal Welfare Assurance from the Office of Protection from Research Risks (OPRR), Office of the Director, NIH, as required by Section 1-43-30 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
The Contractor shall maintain such assurance for the duration of this contract, and any subcontractors performing work under this contract involving the use of animals shall also obtain and maintain an approved Animal Welfare Assurance. 

 

 Page 12 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service
Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at http://grants1.nih.gov/grants/olaw/references/phspo1.htm 
  
 ARTICLE H.5. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS 
  
 UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS WITHOUT PRIOR
APPROVAL BY THE OFFICE FOR LABORATORY ANIMAL WELFARE (OLAW), OF AN ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES WITHOUT OLAW-APPROVED ASSURANCES, WHETHER
DOMESTIC OR FOREIGN. 
  
 ARTICLE H.6. SALARY RATE LIMITATION LEGISLATION
PROVISIONS 
  

	a.	Pursuant to Public Law(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
applicable amount shown for the fiscal year covered. Direct salary is exclusive of fringe benefits, overhead, and general and administrative expenses (also referred to as “indirect cost” 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 limit 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 exceeds any salary rate ceiling established in future HHS appropriation acts. 

  

							
	b.	  	Public Law No.	  	Fiscal Year	  	 Dollar Amount of
 Salary
Limitation*

				
	 	  	 P.L. 108-199 Title II,
 General Provisions, Section
204
	  	2004	  	Executive Level I

  

	c.	Direct salaries which will be paid with FY-04 funds are limited to the Executive Level 1 rate which was in effect on the date(s) the expense was incurred.

	*	For contract expenditures using FY-04 funds, the Executive Level I rate for the period 10/1/03 - 12/31/03 is $171,900. Effective 1/1/04, for contract expenditures using FY-04
funds, the Executive Level I rate was increased to $174,500. Effective 3/3/04, for contract expenditures wing FY-04 funds, the Executive Level I rate was increased to $175,700 and will remain at that level until such time as it is determined to
raise the Executive Schedule annual rates. See the web site listed below for Executive Schedule rates of pay. 

  
 LINK to EXECUTIVE LEVEL SALARIES: http://www.opm.gov/oca/PAYRATES/index.htm 
 (Click on “Executive Schedule” for the current Fiscal Year’s salary rate or scroll down to the “General Schedule Salary Tables from Previous Years” to locate the Executive Level salary
rates from previous years.) 
  
 ARTICLE H.7. 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 STAR® or other energy efficient products. 
  
 Unless the Contracting Officer determines otherwise, all energy-using products acquired under this contract must be either an ENERGY
STAR® or other energy efficient product designated by the Department of Energy’s Federal Energy Management Program (FEMP). 
  

 Page 13 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 For more information about ENERGY STAR® see http://www.energystar.gov/  
 For more information about FEMP sec http://www.eren.doe.gov/femp/procurement 
  
 ARTICLE H.8. 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 HHSN266200400044C/N01-AI-40044. 
  
 ARTICLE H.9. 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. 108-199, Title V-General Provisions, Section 507	  	2004	  	10/1/03 - 9/30/04

  
 ARTICLE H.10. 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.11. YEAR 2000 COMPLIANCE 
  
 In accordance with FAR 39.106, Information Technology acquired under this contract must be Year 2000 compliant as set forth in the following clause(s): 
  

	1.	Service Involving the Use of Information Technology 

  
 YEAR 2000 COMPLIANCE-SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY 
  
 The Contractor agrees that each item of hardware, software, and firmware used under this contract shall be able to accurately process date data (including, but not
limited to, calculating, comparing and sequencing) from, into and between the twentieth and twenty-first centuries and the Year 1999 and the Year 2000 and leap year calculations. 
  
 ARTICLE H.12. 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 

  

 Page 14 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 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. 
  

	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. 108-199, Title V-
General Provisions, Section 503a
	  	2004	  	10/1/03 - 9/30/04
				
	 	  	 for b., above: P.L. 108-199, Title V-
General Provisions, Section 503b
	  	2004	  	10/1/03 - 9/30/04

  
 ARTICLE H.13. LIMITATION ON USE OF
FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES 
  

	a.	Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to support activities that promote the legalization of any drug or other substance included
in schedule I of the schedules of controlled substances established by section 202 of the Controlled Substances Act (21 U.S.C. 812). This limitation shall not apply when the contractor makes known to the contracting officer that there is significant
medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage. 

  

							
	b.	  	Public Law and Section No.	  	Fiscal Year	  	Period Covered
				
	 	  	P.L. 108-199, Title V-General Provisions, Section 511	  	2004	  	10/1/03 - 9/30/04

  
 ARTICLE H.14. POSSESSION USE AND
TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS 
  
 Work involving select
biological agents or toxins shall not be conducted under this contract until the contractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to work with the applicable agents. 
  
 For prime or subcontract awards to domestic institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must complete registration with the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services (APHIS), U.S.
Department of Agriculture (USDA), as applicable, before using NIH funds for research involving Select Agents. No NIH funds can be used for research involving Select Agents if the final registration certificate is denied. 
  
 For prime or subcontract awards to foreign institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions is in place and will be
administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The contractor must provide information addressing the following key elements appropriate for the
foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. An NIAID-chaired
committee of U.S. federal employees (including representatives of NIH grants/contracts and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will assess the policies and
procedures for comparability to the U.S. requirements described in 42 CFR Part 73. When requested by the contracting officer, the contractor should provide key information delineating any laws, regulations, policies, and procedures applicable to the
foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes concise summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk
assessments, the contractor must provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under
the contract. 
  

 Page 15 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as
information about the registration process, can be obtained on the Select Agent Program Web site at http://www.cdc.gov/od/sap/ 
  
 ARTICLE H.15. 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.16. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES 
  
 The contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and
organizations associated with terrorism. It is the legal responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract. 
  

 Page 16 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 PART II - CONTRACT CLAUSES 
  
 SECTION I - CONTRACT CLAUSES 
  
 ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT CONTRACT WITH EDUCATIONAL INSTITUTIONS - 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.arnet.gov/far/. 
  

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

  

					
	 FAR
CLAUSE NO.

	  	 DATE

	  	 TITLE

	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	  	Jun 2003	  	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	  	Oct 2003	  	Central Contractor Registration
			
	52.209-6	  	Jul 1995	  	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000)
			
	52.215-2	  	Jun l999	  	Audit and Records - Negotiation (Over $100,000)
			
	52.215-8	  	Oct l997	  	Order of Precedence - Uniform Contract Format
			
	52.215-11	  	Oct 1997	  	Price Reduction for Defective Cost or Pricing Data – Modifications
			
	52.215-13	  	Oct 1997	  	Subcontractor Cost or Pricing Data - Modifications
			
	52.215-14	  	Oct 1997	  	Integrity of Unit Prices (Over $100,000)
			
	52.215-15	  	Jan 2004	  	Pension Adjustments and Asset Reversions
			
	52.215-18	  	Oct 1997	  	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
			
	52.216-11	  	Apr 1984	  	Cost Contract - No Fee

  

 Page 17 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

					
	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
			
	52.223-6	  	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	  	Dec 2003	  	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)
			
	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
			
	52.232-20	  	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)
			
	52.242-1	  	Apr 1984	  	Notice of Intent to Disallow Costs
			
	52.242-4	  	Jan 1997	  	Certification of Final Indirect Costs
			
	52.242-13	  	Jul 1995	  	Bankruptcy (Over $100,000)
			
	52.244-2	  	Aug 1998	  	Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required, the identified subcontracts are listed in ARTICLE B, Advance Understandings.
			
	52.244-5	  	Dec 1996	  	Competition in Subcontracting (Over $100,000)
			
	52.245-5	  	May 2004	  	Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract), Alternate I (Jul 1985)
			
	52.246-23	  	Feb 1997	  	Limitation of Liability (Over $100,000)
			
	52.249-6	  	May 2004	  	Termination (Cost-Reimbursement)
			
	52.253-1	  	Jan 1991	  	Computer Generated Forms

  

 Page 18 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	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
			
	352.249-14	  	Apr 1984	  	Excusable Delays
			
	352.270-5	  	Apr 1984	  	Key Personnel
			
	352.270-6	  	Jul 1991	  	Publications and Publicity
			
	352.270-7	  	Jan 2001	  	Paperwork Reduction Act

  
 [End of GENERAL CLAUSES FOR A
NEGOTIATED COST-REIMBURSEMENT CONTRACT WITH EDUCATIONAL INSTITUTIONS - Rev. 05/2004]. 
  
 ARTICLE I:2 AUTHORIZED SUBSTITUTION OF CLAUSES 
  
 ARTICLE I.1.
of this SECTION is hereby modified as follows: 
  
 ALTERNATE II (APRIL 1998) of
FAR Clause 52.215-2, AUDIT AND RECORDS-NEGOTIATION (JUNE 1999) is added. 
  
 FAR
Clause 52.216-8, FIXED FEE (MARCH 1997), is deleted in its entirety and FAR Clause 52.216-11, COST CONTRACT-NO FEE (APRIL 1984) is substituted therefor. 
  
 FAR Clause 52.249-14, EXCUSABLE DELAYS (APRIL 1984) is deleted and HHSAR Clause 352.249-14, EXCUSABLE DELAYS (APRIL 1984) is substituted therefor. 
  
 ALTERNATE I of FAR Clause 52.216-11, COST CONTRACT-NO FEE (APRIL 1984), is added. 

 
 FAR Clause 52.232-20, LIMITATION OF COST, 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.

  
 ALTERNATE II, (SEPTEMBER 1996), of FAR. Clause 52.249-6, TERMINATION
(COST-REIMBURSEMENT) (SEPTEMBER 1996) is added. 
  
 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 

  

 Page 19 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	 	(1)	FAR 52.204-2, Security Requirements (AUGUST 1996). 

  

	 	(2)	FAR 52.216-15, Predetermined Indirect Cost Rates (APRIL 1998). 

  

	 	(3)	FAR 52.217-2, Cancellation Under Multiyear Contracts (JULY 1996). 

  

	 	(4)	FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JANUARY 1999). 

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

	 	(5)	FAR 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (OCTOBER 1999). 

  

	 	(6)	FAR 52.223-5, Pollution Prevention and Right-to-Know Information (AUGUST 2003)[with ALTERNATE I (AUGUST 2003) and/or with ALTERNATE II (AUGUST)]. 

  

	 	(7)	FAR 52.226-1, Utilization of Indian organizations and Indian-owned Economic Enterprises (JUNE 2000). 

  

	 	(8)	FAR 52.227-14, Rights in Data - General (JUNE 1987). 

  

	 	(9)	Alternate IV (JUNE 1987), FAR 52.227-14, Rights in Data - General (JUNE 1987). 

  

	 	(10)	FAR 52.230-5, Cost Accounting Standards - Educational Institution (APRIL 1998). 

  

	 	(11)	FAR 52.230-6, Administration of Cost Accounting Standards (NOVEMBER 1999). 

  

	 	(12)	FAR 52.242-3, Penalties for Unallowable Costs (MAY 2001). 

  

	 	(13)	FAR 52.243-2, Changes—Cost Reimbursement (AUGUST 1987), Alternate V (APRIL 1984). 

  

	 	(14)	FAR 52.245-1, Property Records (APRIL 1984). 

  

	 	(15)	FAR 52.246-23, Limitation of Liability (FEBRUARY 1997) . 

 AND/OR 
  

	 	(16)	FAR 52.246-24, Limitation of Liability - High-Value Items (FEBRUARY 1997). 

  

	 	(17)	FAR 52.248-1, Value Engineering (FEBRUARY 2000). 

  

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

  

	 	(1)	HHSAR 352.223-70, Safety and Health (JANUARY 2001). [This clause is provided in full text in SECTION J – ATTACHMENT 6.] 

  

	 	(2)	HHSAR 352.224-70, Confidentiality of Information (APRIL 1984). 

  

	 	(3)	HHSAR 352.270-5, Key Personnel (APRIL 1984). 

  

	 	(4)	HHSAR 352.270-8, Protection of Human Subjects (JANUARY 2001). 

  
 Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office
responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH) wherever it appears in this clause. 
  

 Page 20 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

	 	(5)	HHSARS 352.270-9, Care of Live Vertebrate Animals (JANUARY 2001). 

  

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

  
 The following clause is attached (Attachment 9) and made a part of this contract: 
  

	 	(1)	NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81-16). 

  

 Page 21 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 PART III 
  
 SECTION J - LIST OF ATTACHMENTS 
  
 The following documents are attached and incorporated in this contract: 
  

	 	1.	Statement of Work, date April 30, 2004, 6 pages. 

  

	 	2.	Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4 (5/97), 5 pages. 

  

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

  

	 	4.	NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81 -16), 1 page. 

  

	 	5.	Government Property – Schedule: I-A, 1 page. 

  

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

  

 Page 22 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Coley Pharmaceutical Group 
 Contract No. HHSN266200400044 
 N01-AI-40044 
  

 PART IV 
  
 SECTION K - REPRESENTATIONS AND CERTIFICATIONS 
  
 The following documents are incorporated by reference in this contract: 
  
 1. Representations and Certifications, dated April 28, 2004. 
  
 END of the SCHEDULE 
 (CONTRACT) 
  

 Page 23 of 23 
  

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act. 

 Statement of Work 
 Innate Immune Receptors and Adjuvant Discovery 
  
 Overview: The work in this proposal addresses [************* **** **] in using [*********************] to investigate [*********************] We will [*********] their [****************]:.
[**********************] and [********************] and perform [*******************************] of [****************************] using, either [*******************************], or [*********] or [******************]. We include in the work under
[********************] of the [**********] to [******] in [*************************]. We also address [****] in our proposal, by [*************************] the [*************************] to [**********], in [*****] of the [**********] and
[********] that are [*********]. 
  
 [***] is addressed by
[**********] in [*****] the [************] are [*****] in [******] for [*************] on the [*****] and [***********], and for [**************] on [*****] and [****************] in [*****] to [*************************] of
[*************************], in order to [*****************************] and to [********] the [***************] to be [*********] in [***] the work in this [***] also will allow us to [*******] between the [*****] and [*************], so that the
[****************] and [****************] will allow us to [*****] from the [*******************] of [*******************] that may be general to [*******] and [******], to the [*****] that this is possible. 
  
 [***] is addressed by [********************] that will [********************]
the [*************************] of [********************] from the [********************]. These [****] will be [****] for the [*************************] of [*************************] under [***]. To [***********] the number of [*************]
that have to be [*****] into the [*****************************], and to [*********] the [*********] of the [********************], we will [*************************] at an [***********]. Finally in [***] we will [****] the [*********] of
[************] both as [*************************] for the [*************************] of [*****************************], and also as [*************************] for the [********************] of [****] to [***************************] with
[********], and for the [***********] of [***] to [****************************] against a [*******], of [********], including [******]. The [********] for these [***********] and the [*************] we will [****] are on the following pages.

  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of Commission pursuant to
the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

											
	 [****]
     [*]
	  	 [*]
	 	 [*]
	 	 [*]
	  	 [*]
	  	 
	 [**************]
	  	 	 	 	 	 	  	 	  	 
	 A.      [************************]
	  	 	 	 	 	 	  	 	  	 
	 a.      [********************]
	  	 [**************** ***]
	 	 	  	 	  	 
	 b.      [*****************]
	  	 __________________ [*]
	 	 	  	 	  	 
	 i.       [*************]
	  	             _____________________ [*]
	  	 	  	 
	 ii.      [***********]
	  	 	 	 	  	 	  	 
	 iii.     [*******************]
	  	 	  	 	  	 
	 1.      [****]
	  	 [*********** **]                                  
   [*********]                            

	 2.      [*******]
	  	 [*********** **]                 [*********]               
                         

	 iv.     [************]
	  	 	 	 	 	 	  	 	  	 
	 1.      [****]
	  	 [*********** **]           [*********]                     
                           

	 2.      [******]
	  	                 [*********** **]        [*********]        
                                    

	 v.      [****************]
	  	 	 	 	 	 	  	 	  	 
	 1.      [****]
	  	 [*********** **                       **********]         
                       

	 2.      [******]
	  	 [*********** **             *********]                   
                     

	 B.     [************************]
	  	 	 	 	 	 	  	 	  	 
	 a.      [*************************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [***********]
	  	_____________ [*]	  	 	  	 
	 ii.      [***********]
	  	 	 	 _____________ [*]
	  	 
	 iii.     [***********]
	  	 	 	 	 	 _____________

	                    [*]
	  	 	 	 	 	 	  	 	  	 
	 C.     [**********************]
	  	 	  	 	  	 
	 a.      [*************************]
	  	 	 	 	  	 	  	 
	 i.       [****]
	  	                                [*]      
          	  	 	  	 
	 ii.      [*******]
	  	                                      
                       [*]	  	 
	 b.      [*****************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [****]
	  	[******* ** ***********]  	  	 	  	 
	 ii.      [*******]
	  	    [*******        * ************] 	 	 	  	 	  	 
	 c.      [*****************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [****]
	  	    [********                             *  
                      ***********]            
	 ii.      [*******]
	  	                     [********                
    *     ***********]                      
	 D.     [*****************************]
	  	 	 	 	 	 	  	 	  	 
	 a.      [********************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [***********]
	  	_____________ [*]	  	 	  	 
	 ii.      [***********]
	  	 	 	 _____________ *]
	  	 
	 iii.     [***********]
	  	 	 	 	 	 _____________

	 [*************]
	  	___________	  	 	  	 
	 E.     [******************]
	  	 	 	 	 	 	  	 	  	 
	 [****************]
	  	 	 	 	 	 	  	 	  	 
	 a.      [*****************]
	  	[*******]	 	            [*]	  	            [*******]            
	 b.      [****************]
	  	__________________  [*]	  	 	  	 
	 c.      [**************]
	  	[*******]__________ [*]	  	            [*******]            
	 d.      [********************]
	  	[*******]__________ [*]	  	            [*******]            
	 F.      [*********************]
	  	[*******]                     [*******]	  	 	  	 
	 C.     [***************]
	  	            _____________        ___________           
 _____________
	 i.       [******]
	  	_____________ [*]	  	 	  	 
	 ii.      [******]
	  	 	 	 _____________ [*]
	  	 
	 iii.     [******]                        [*]
	  	 	 	 	 	 _____________

	 D.     [*******************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [******]
	  	_____________ [*]	  	 	  	 
	 ii.      [******]
	  	 	 	 _____________
	  	 
	 iii.     [******]
	  	 	 	 	 	 _____________

	          [*]
	  	 	 	 	 	 	  	 	  	 
	 G.     [****************************]
	  	 	 	 	 	 	  	 	  	 
	 i.       [*********]
	  	_____________ [*]	  	 	  	 
	 ii.      [*********]
	  	 	 	 _____________
	  	 
	          [*]
	  	 	 	 	 	 _____________

	 iii.    [*********]                  [*]
	  	 	 	 	 	 	  	 	  	 

  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

											
	[**********]	  	 	  	 	  	 	  	 	  	 
	 H.     [********************]
	  	 	  	 	  	 	  	 	  	 
	 [********]
	  	_________[*]	  	_________[*]	  	_________[*]	  	_________	  	_________
	 [*]            [*]
	  	                  [*]	  	_________[*]	  	_________[*]	  	 	  	 
	 [*****]
	  	_________	  	_________	  	_________	  	_________	  	_________
						
	 [*]            [*]
	  	_________[*]	  	_________[*]	  	_________[*]	  	_________	  	_________
	 [*******************]
	  	 	  	 	  	_________	  	_________	  	_________
	 [*]            [*]
	  	 	  	 	  	 	  	 	  	 
	 I.       [*************************]
	  	 	  	 	  	 	  	 	  	 
						
	 [****]
	  	_________[*]	  	                    [*]	  	                    [*]	  	 	  	 
	 [*]            [*]
	  	 	  	 	  	                    [*]	  	 	  	 
	 [*******]
	  	 	  	 	  	 	  	 	  	 
	 [*]            [*]
	  	 	  	 	  	 	  	 	  	 

  
 Milestones:

  
 [***] 
  

	 	A.	[*******************] 

  

	 	a.	[****************************] 

  

	 	i.	Yr. [*************************************************] and [**********] of [*************************************] 

  

	 	b.	[********************************] 

  

	 	i.	Yr [*******************************************] and [************] of [****] and [*] 

  

	 	ii.	Yr [****************************] of [****] and [*] 

  

	 	iii.	[***********************************] 

  

	 	a.	Yr [****************************************************] [*********] and [**********] of [**************************] of [****] 

  

	 	b.	Yr [****************************************************] [*********] and [**********] of [****] and [*], [******************] of [****] and [*] 

  

	 	iv.	[*************] 

  

	 	a.	Yr [**********************************************] of [*********] for [****], [***************************] of [*****] in [***] 

  

	 	b.	Yr [************************] of [**************] for [****] and [*], [******************] of [*****] in [***] 

  

	 	v.	[***************************] 

  

	 	a.	Yr [*********************] of [***************] for [****], [*********************] of [*****] in [***] 

	 	b.	Yr [*********************] of [***************] for [****] [*****], [*********************] of [*****] in [***] 

  

	 	B.	[************************] 

  

	 	a.	[****************************************] 

  

	 	i.	Yr [****************************] of [******************************] in [**************************] for [****************] 

  

	 	ii.	Yr [****************************] of [******************************] in [**************************] for [*************] 

  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

	 	iii.	Yr [********************] of [*********************************] in [************************] for [*****] [***] 

  

	 	C.	[****************************************] 

	 	a.	[******************************] 

	 	i	Yr [**************************] and [***] for [**********] [********] of [ ****] 

  

	 	ii.	Yr [**************************] and [***] for [**********] [********] of [ ****] and [*] 

  

	 	b.	[*****************] 

	 	i.	Yr [**********************************************] for [************************] of [ *****] in [***] 

	 	ii.	Yr [****************************************] for [ ****] [************************] of [ *****] in [***] 

  

	 	c.	[*************] 

  

	 	i.	Yr [****************************************] for [****] [************************] of [ *****] in [***] 

  

	 	ii.	Yr [****************************************] for [****] [************************] of [ *****] in [***] 

  

	 	D.	[*******************] 

  

	 	a.	[********] and [**********************] 

	 	i.	Yr [********************] of [ **********************************] in [**********************] for [*******] [***] of [*******] and [*********************************]

  

	 	ii.	Yr [******************] of [********** ****************] in [********************] for [*********] of [*******] and [********************************] 

  

	 	iii.	Yr [******************] of [********** ****************] in [********************] for [*********] of [*******] and [********************************] 

  
 [***] 
  

	 	A.	[************************************] 

  

	 	a.	Yr [*****************] and [********] of [ ***********] for [***] in [************************] to [*******************] in [*************] and [*********] 

 

	 	b.	Yr [*********************] of [ ***********************] and [**********************] of [***********************] for [********] to [ *****************************] to [ ***] of
[********] *************] and [****************] 

  

	 	c.	Yr [***********************] of [***************************] and [************************] of [*********************] for [********] to [****************************] to [***] of
[********] in [*************] and [********] 

  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

	 	d.	Yr [*********************] of [******************] in [**********************] of [******************] for [*********] to [****************] 

  

	 	B.	[*****************] 

  

	 	a.	[*****************] 

  

	 	i.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	ii.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	iii.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	b.	[*****************] 

  

	 	i.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	ii.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	iii.	Yr [**********] the [*******] of [*********************************] according to the [**********************] 

  

	 	C.	[************************] 

  

	 	i.	Yr. [**********] the [*******] of [******************** ************] that have been [******] in [*************************] according to the [**********************]

  

	 	ii.	Yr. [**********] the [*******] of [********************************] that have been [******] in [*************************] according to the [**********************]

  

	 	iii.	Yr. [**********] the [*******] of [********************************] that have been [******] in [*************************] according to the [**********************]

  
 [***] 
  

	 	A.	[***************************** in ****] 

  

	 	a.	[*************************] 

  

	 	a.	Yr [******] the [*****] [******************] to [********] for [*************************************************] and [*************************] by
[*********************************************************************************] after [**********] in [****] or [*********************] 

  

	 	b.	Yr [******************] for [********] as in [****], and for [***************************************] 

  

	 	c.	Yr [******************] for [********] as in [****] 

  

	 	d.	Yr [******************] for [********] as in [****] 

  

	 	e.	Yr [******************] for [********] as in [****] 

  

	 	b.	[*******] 

  

	 	a.	Yr [*] no [********] 

  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

	 	b.	Yr [******] the [************] (from [************], for [****] and [*********************] 

  

	 	c.	Yr [******] the [**************] as above 

  

	 	d.	Yr [*******] of the [******] as above 

  

	 	e.	Yr [**********] of the [***********] as above 

  

	 	c.	[******] in [**************************] 

  

	 	a.	Yr [*]: no [*******] 

  

	 	b.	Yr [*****] the [************] (from [**************] for [********] of [ *******************] to [**************] at [*********] and [******************] to [********].

  

	 	c.	Yr [******] the [****************] as above at [*********] [************************] to [********]. 

  

	 	d.	Yr [*********] of the [*************] as above at [*************] and [***********************] to [********]. 

  

	 	e.	Yr [*********] the [*************] and [******] of [*********] with [***] of the [*************] as above 

  

	 	B.	[************] as [***************] 

  

	 	a.	[*********************] with [******] 

  

	 	a.	Yr [*****] the [***************************************] for [***********************************] 

  

	 	b.	Yr [****] at [*****************] as above 

  

	 	c.	Yr [****] at [*****************] as above 

  

	 	d.	Yr [****] at [*****************] as above 

  

	 	e.	Yr [****] at [*****************] as above 

  

	 	b.	[*****************] as [********] to [**********************] yr. [**] 

  

	 	a.	Yr [****] at [*******************] for [*******] of [******] [******] and [********] to [***********] in [****] 

  

	 	b.	Yr [****] at [*****************] as above 

  

	 	c.	Yr [****] at [*****************] as above 

  

	 	d.	Yr [****] at [*****************] as above 

  

	 	c.	[**********************] as [********] in [*************] yr [*] 

  

	 	a.	Yr [******************] for [*******] of [*****] and [**************] to [*****************] 

  

	 	b.	Yr [****] at [****************] as above 

  

	 	c.	Yr [****] at [****************] as above 

  
 [END OF STATEMENT OF WORK] 
  

			
	 Statement of Work
 April 30, 2004
	  	Attachment 1        

 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Contract HHSN26620040044C 
  
 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
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 the 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 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 Submissions 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. 

  

			
	 NIH(RC)-4
	 	ATTACHMENT 2
	 Rev. 5/97
	 	 

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 
  

			
	 	  	 

 Contract HHSN266200400044C 
  

	(d)	Contract Number and Date — Insert the contract number 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.

  

	(k)	Direct Costs — Insert the major cost elements. For each element, consider 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 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 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 DHHS Contractor’s Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment. Prepare and
attach Form HHS-565, “Report of Accountable 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. 

  

	 	•	 	Be preceded by an asterisk(*) 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. 

  

			
	 NIH(RC)-4
	 	ATTACHMENT 2
	 Rev. 5/97
	 	 

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 
  

			
	 	  	 

 Contract HHSN266200400044C 
  

	 	(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. 
  

			
	 NIH(RC)-4
	 	ATTACHMENT 2
	 Rev. 5/97
	 	 

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Contract HHSN266200400044C 
  
 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 (not 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. 5/97
	  	ATTACHMENT 2

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Contract HHSN266200400044C 
  
 SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT 
  

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

	 	 
	 NATIONAL INSTITUTES OF HEALTH
	 	 (c)    Date Invoice
Prepared__________________________

	National Institute of Allergy and Infectious Diseases	 	 
	Room 2230, MSC 7612	 	 (d)    Contract
No:_________________________________

	 6700-B Rockledge Drive
	 	 
	 Bethesda, MD 20892-7612
	 	 Effective Date________________________________

	 	 
	 (e)      Payee’s
Name and Address
	 	 
	 ABC CORPORATION
	 	 
	 100 Main Street
	 	(f) Total Estimated Cost___________________________
	 Anywhere, USA zip code
	 	 
	 	 
	  
 Attn:     Name, Title, & Phone Number of Official to Whom Payment is Sent
  
	 	(g) Total Fixed Fee______________________________

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

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

	 	 	Negotiated B	 	Actual C	 	(i) Current D	 	(i) 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
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (l) Cost of Money
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (m) Overhead
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 G&A
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (n) Fixed Fee
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (o) Total Amount Claimed
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (p) Adjustments
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 (q) Grand Totals
	 	 	 	 	 	 	 	 	 	 	 	 	 	 

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

	 	  	 	  	 
	
	  	
	  	 
	 (Name of Official)
	  	 (Title)
	  	 
	 	  	 	  	 
	
 *  Attach details as specified in the contract
	  	 
	 

  
  

			
	 NIH(RC)-4
 Rev. 5/97
	  	ATTACHMENT 2

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 
Contract HHSN266200400044C 
  
 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
 HHSAR 352.223-70,
(1/01)
	  	ATTACHMENT 3

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Contract No. HHSN266200400044C 
  
 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. 
  

			
	 Procurement of Certain Equipment
 NIH(RC)-7
(4/1/84)
	  	ATTACHMENT 4

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

 Contract No. HHSN266200400044C 
  
 Government Property - Schedule I-A 
  

									
	 Description

	  	Quantity

	  	Unit Price

	  	Total

	 Protein Modeling Workstation
	  	1	  	$	34,339.00	  	$	34,339.00
				
	 Biacore S51
	  	1	  	$	524,328.00	  	$	524,328.00
				
	 Luminex 100
	  	1	  	$	66,019.00	  	$	66,019.00
				
	 CTL Assay Irradiator X_RAD
	  	1	  	$	99,968.00	  	$	99,968.00
				
	 Mouse Holding Rack–(2)
	  	2	  	$	21,030.00	  	$	42,060.00
				
	 Spectramax plus 384 plate reader
	  	1	  	$	24,482.00	  	$	24,482.00
				
	 Freezer (with-80 with temp monitor)
	  	1	  	$	9,957.00	  	$	9,957.00
				
	 Analytical Balance
	  	1	  	$	3,074.00	  	$	3,074.00
				
	 Large Capacity Refrigerator- 3 Door
	  	1	  	$	4,013.00	  	$	4,013.00
				
	 Peristaltic Pump
	  	1	  	$	2,957.00	  	$	2,957.00

  

			
	 Government Property Schedule I-A
 June 30,
2004
	  	ATTACHMENT 5

  
 Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 

							
	 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:

  
  

			
	     Government Property Schedule
	 	ATTACHMENT 6        

  
  
 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities Act.

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