Exhibit 10.5


Confidential Treatment Requested

Under 17 C.F.R. §§200.80(b)(4),

200.83 and 240.24b-2


ADB No. N01-AI-40100


OMB
App-al 2700-0042


	
  AWARD/CONTRACT

  	
  1. THIS CONTRACT IS A RATED ORDER

  UNDER DPAS (15 CFR 350)

  	
  RATING

  N/A

  	
   

  
	
  2. CONTRACT
  (Proc. Inst. Ident.) NO.

  	
  3.
  EFFECTIVE DATE

  	
  4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

  
	
  HHSN266200400100C

  	
  September 30, 2004

  	
  PRCB223

  
	
  5. ISSUED BY                                                                CODE
  I

  	
  S.
  ADMINISTERED BY (If other than Item 6)                           CODE

  
	
  National Institutes of Health, DHHS

  	
  PRCB-DMID

  
	
  NIAID, DEA, CMP, PRCB

  Room [***], MSC [***]

  	
  RFP NIH-NIAID-DMID-04-22

  
	
  6700-B Rockledge Drive

  Bethesda, Maryland 20892-7612

  	
   

  
	
  7. NAME AND
  ADDRESS OF CONTRACTOR (No. street, county state and ZIP Code)

  	
  8. DELIVERY

  
	
  ISIS
  Pharmaceuticals

  	
  0 FOB ORIGIN ® OTHER (Seebe/ow)

  
	
  Ibis
  Therapeutics Division

  	
   

  
	
  2292
  Faraday Ave

  	
  9/ DISCOUNT FOR PROMPT PAYMENT

  
	
  Carlsbad,
  California, 92008

  	
  N/A

  
	
   

  	
  10. SUBMIT INVOICES

  	
  ITEM

  
	
  CODE

  	
  FACILITY
  CODE

  	
  ADDRESS SHOWN IN:

  	
  Art. 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: N/A

  	
  14.
  ACCOUNTING AND APPROPRIATION DATA

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

  	
  EIN# 1330336973A1     SOC
  25.55 CAN# 4-8460924 $2,489,423

  
	
  15A. ITEM NO.                         15B. SUPPLIES/SERVICES

  	
  15C. UNIT PRICE

  	
  15D. AMOUNT

  	
  15E. UNIT PRICE

  	
  15F. AMOUNT

  
	
  Title:
  Assessing Safety of Cell Substrates and Vaccine Components, Part

  	
  FY 04

  	
  [***]

  	
   

  	
  [***]

  
	
  E: Develop,
  characterize and validate assays for detection of novel or

  	
  FY 06

  	
  [***]

  	
   

  	
  [***]

  
	
  latent/occult
  adventitious agents in cell substrates

  	
  FY 07

  	
  [***]

  	
   

  	
  [***]

  
	
  Period:
  September 24, 2004 through September 23, 2009

  	
  FY 08

  	
  [***]

  	
   

  	
  [***]

  
	
  Contract
  Type: CPFF-Completion

   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  $5,613,317

  
								



15G. TOTAL

AMOUNT OF

CONTRACT


16. TABLE  OF  CONTENTS


I PAGE(S) (r)  ISEC.I


	
  (V)  ISEC. I

  	
  DESCRIPTION

  PART I - THE SCHEDULE

  	
   

  	
   

  	
   

  	
  DESCRIPTION

  PART II - CONTRACT CLAUSES

  	
  PAGE(S)

  
	
  ý

  	
  A

  	
  SOLICITATION/CONTRACT
  FORM

  	
  1

  	
  X I I (CONTRACT CLAUSES

  	
  26

  
	
  ý

  	
  B

  	
  SUPPLIES OR
  SERVICES AND PRICE/COST

  	
  3

  	
  PART III –
  LIST OF DOCUMENTS, EXHIBITS AND OTHER A ACH.

  
	
  ý

  	
  C

  	
  DESCRIPTION/SPECS./WORK
  STATEMENT

  	
  7

  	
  XI J JUST OF ATTACHMENTS

  	
  31

  
	
  ý

  	
  D

  	
  PACKAGING
  AND MARKING

  	
  12

  	
  PART IV - REPRESENTATIONS AND INSTRUCTIONS

  
	
  ý

  	
  E

  	
  INSPECTION
  AND ACCEPTANCE

  	
  12

  	
  ý

  	
  K

  	
  REPRESENTATIONS,
  CERTIFICATIONS

  AND OTHER
  STATEMENTS OF OFFERORS

  	
  32

  
	
  ý

  	
  F

  	
  DELIVERIES
  OR PERFORMANCE

  	
  12

  
	
  ý

  	
  G

  	
  CONTRACT
  ADMINISTRATION DATA

  	
  14

  	
  o

  	
  L

  	
  INSTRS.,
  CONDS., AND NOTICES TO OFFERORS

  	
   

  
	
  ý

  	
  H

  	
  SPECIAL
  CONTRACT REQUIREMENTS

  	
  17

  	
  o

  	
  M

  	
  EVALUATION
  FACTORS FOR AWARD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

  
	
  17. ý 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.o  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)

  	
   

  	
  20A NAME OF CONTRACTING OFFICER

  	
   

  
	
   

  	
   

  	
  S-F-fa, t.tt_ay 'T C2o KE

  	
   

  	
  Carl A. Newman

  Contracting
  Officer, PRCB, CMP, NIAID, NIH, DHHS

  	
   

  
	
  Gc=cJ

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  

  	
  9C. DATE SIGNED

   

  	
   

  	
  

  

  

  

  B

  Y

  	
  20B. U ED
  STATES OF AMERICA

   

  

  (Signature of Contracting Officer)

  	
  20C. DATE SIGNED

   

  
	
  NSN
  7540-01-152-8069

  PREVIOUS
  EDITION UNUSABLE

  	
  26-107

  Computer Generated

  	
   

  	
   

  	
  STANDARD FORM 26 (REV. 4-85) 

  Prescribed by GSA

  FAR (48 CFR) 53.214(a)

  	
   

  
												



 


1





















 


	
  PART I - THE SCHEDULE

  	
   

  
	
   

  	
   

  
	
  PART I - THE SCHEDULE

  	
   

  
	
  SECTIONA - SOLICITATION/CONTRACT FORM

  	
   

  
	
  SECTION B -
  SUPPLIES OR SERVICES AND PRICES/COSTS

  	
   

  
	
  ARTICLE B. 1. BRIEF DESCRIPTION
  OF SUPPLIES OR SERVICES

  	
   

  
	
  ARTICLE B.2. ESTIMATED COST AND FIXED FEE

  	
   

  
	
  ARTICLE B.3. PROVISIONS
  APPLICABLE TO DIRECT COSTS

  	
   

  
	
  ARTICLE B.4. ADVANCE UNDERSTANDINGS

  	
   

  
	
  SECTION C - WORK STATEMENT

  	
   

  
	
  ARTICLE C.1. STATEMENT OF WORK

  	
   

  
	
  ARTICLE C.2. REPORTING REQUIREMENTS

  	
   

  
	
  ARTICLE C.3. INVENTION REPORTING REQUIREMENT

  	
   

  
	
  SECTION D - PACKAGING, MARKING AND SHIPPING

  	
   

  
	
  SECTION E -
  INSPECTION AND ACCEPTANCE

  	
   

  
	
  SECTION F - DELIVERIES OR PERFORMANCE

  	
   

  
	
  ARTICLE F.1. DELIVERIES

  	
   

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

  	
   

  
	
  SECTION G - CONTRACT ADMINISTRATION DATA

  	
   

  
	
  ARTICLE G.1. PROJECT OFFICER

  	
   

  
	
  ARTICLE G.2. KEY PERSONNEL

  	
   

  
	
  ARTICLE G.3. INVOICE
  SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

  	
   

  
	
  ARTICLE G.4. INDIRECT COST RATES

  	
   

  
	
  ARTICLE G.5. GOVERNMENT PROPERTY

  	
   

  
	
  ARTICLE G.6. POST AWARD
  EVALUATION OF CONTRACTOR PERFORMANCE

  	
   

  
	
   

  	
   

  
	
  SECTION H -
  SPECIAL CONTRACT REQUIREMENTS

  	
   

  
	
  ARTICLE H. 1.
  REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCHAND DEVELOPMENT PROJECTS

  	
   

  
	
  ARTICLE H.2. HUMAN
  SUBJECTS

  	
   

  
	
  ARTICLE H.3. CONTINUED
  BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

  	
   

  
	
  ARTICLE H.4. NEEDLE EXCHANGE

  	
   

  
	
  ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION
  PROVISIONS

  	
   

  
	
  ARTICLE H.6. EPA ENERGY STAR
  REQUIREMENTS

  	
   

  
	
  ARTICLE H.7. PUBLICATION AND PUBLICITY

  	
   

  
	
  ARTICLE H.8. PRESS RELEASES

  	
   

  
	
  ARTICLE H.9. REPORTING
  MATTERS INVOLVING FRAUD, WASTE AND ABUSE

  	
   

  
	
  ARTICLE H.10. YEAR 2000 COMPLIANCE

  	
   

  
	
  ARTICLE H.11. ANTI -LOBBYING

  	
   

  
	
  ARTICLE H.12. SHARING RESEARCH DATA

  	
   

  



 


1





















 


	
  ARTICLE H.13. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391) 

  	
   

  
	
  ARTICLE H.14. PROHIBITION ON CONTRACTOR INVOLVEMENT
  WITH TERRORIST ACTIVITIES

  	
   

  
	
  ARTICLE H.15. NOTIFICATION OF EMPLOYEE RIGHTS CONCERNING
  PAYMENT OF UNION DUES OR FEES

  	
   

  
	
  ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL
  RESEARCH RESOURCES

  	
   

  
	
  PART II - CONTRACT CLAUSES

  	
   

  
	
  SECTION I -
  CONTRACT CLAUSES

  	
   

  
	
  ARTICLE 1.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
  RESEARCH AND DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE
  (FEBRUARY 1998)

  	
   

  
	
  ARTICLE 1.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

  	
   

  
	
  ARTICLE 1.3. ADDITIONAL CONTRACT
  CLAUSES

  	
   

  
	
  ARTICLE 1.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN
  FULL TEXT

  	
   

  
	
   

  	
   

  
	
  PART III

  	
   

  
	
  SECTION J - LIST
  OF ATTACHMENTS

  	
   

  
	
  1. Statement of Work, September
  10, 2004, 3 pages

  	
   

  
	
  2. Invoice/Financing
  Request and Contract Financial Reporting Instructions for NIH Cost Reimbursement
  Type Contracts, NIH(RC)-4, (11/03), 6 pages

  	
   

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

  	
   

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

  	
   

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

  	
   

  
	
  6. Government Property - Schedule I-A,
  dated September 10, 2004, 1 page

  	
   

  
	
  7. Data Sharing Plan, September 29, 2004

  	
   

  
	
  PART IV

  	
   

  
	
  SECTION K - REPRESENTATIONS AND
  CERTIFICATIONS

  	
   

  
	
  1. Representations and
  Certifications, dated September 13, 2004

  	
   

  



 


2





















 


SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS


 


ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES


 


The focus of this contract is to
develop methods to assess current and future safety concerns that arise regarding vaccines and
vaccine manufacturing and/or formulation. The contractor shall develop, characterize and validate
assays for detection of novel or latent/occult adventitious agents.


 


ARTICLE B.2. ESTIMATED COST
AND FIXED FEE


 


a.            The estimated cost of this
contract is [***].


 


b.                                 The fixed fee for this contract is
[***]. The fixed fee shall be paid in installments based on the percentage of
completion of work, as determined by the Contracting Officer, and subject to the withholding provisions of the
clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General
Clause Listing in Part II, ARTICLE 1.1. of this contract. Payment of fixed fee
shall not be made in less than monthly
increments.


 


c.                                     The Government’s obligation,
represented by the sum of the estimated cost plus the fixed fee, is $5,613,317.


 


d.                                 Total funds currently available
for payment and allotted to this contract are [***]. The estimated cost is [***] and
the fixed fee is [***]. For further provisions on funding see the LIMITATION OF
FUNDS clause referenced in Part II, ARTICLE 1.3. Authorized Substitutions of Clauses.


 


e.                                  It is estimated that the amount
currently allotted will cover performance of the contract through January 31, 2007.


 


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


 


Increments to be
allotted to this contract are estimated as follows:


 


	
  g.

  	
  Fiscal Year

  	
   

  	
  Total Cost

  Excluding Fee

  	
   

  	
  Fixed Fee

  	
   

  	
  Amount

  	
   

  
	
   

  	
  FY 04

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
  FY 06

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
  FY 07

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
  FY 08

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
  Total

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  5,613,317

  	
   

  
										



 


3





















 


ARTICLE B.3. PROVISIONS
APPLICABLE TO DIRECT COSTS


 


a.            Items Unallowable Unless Otherwise Provided


 


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


 


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


(2)                             Special rearrangement or alteration of facilities;


(3)                             Purchase or lease of any item of general purpose office
furniture or office equipment regardless of dollar value. (General purpose equipment is defined
as any items of
personal property which are usable for purposes other than research, such as office equipment and
furnishings, pocket calculators, etc.);


(4)                             Travel to attend general scientific meetings;


(5)                             Foreign travel - See paragraph b.2. below;


(6)                             Consultant costs;


(7)                             Subcontracts;


(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


 


          Domestic Travel


 


(1)                 (a)       Total
expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in
direct performance of this contract shall not exceed [***] without the prior
written approval of the Contracting Officer. The Contractor is authorized to
travel to attend programmatic meetings.


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


 


(2)                 Foreign Travel


 


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


 


4





















 


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


 


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


 


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


 


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


 


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


(b)                              Fringe Benefits - Cite
rate and amount


(c)                               Overhead - Cite rate and
amount


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


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


(f)                                 Consultant Fees - Identify individuals and amounts.


(g)                              Subcontracts - Attach subcontractor invoice(s).


(h)                              Equipment - Cite authorization and amount.


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


(j)                                  Total Cost


(k)                               Fixed Fee


(1)                               Total CPFF


 


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


 


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


 


b.            Indirect Costs Rates


 


The Contractor may apply the following provisional indirect
rates for the initial [***] days of the
contract: Fringe Benefit at [***], Overhead at [***] and G&A at [***].
Final rates will
apply once the cognizant Government audit agency completes the audit and


 


5





















 


provides an indirect rate
agreement.


 


c.            Consultants


 


Consultant fee to
be paid to the following individual for the period [***] through [***]:


 


	
  Name

  	
   

  	
  Fiscal Year

  	
   

  	
  Rate Per Hour

  	
   

  	
  Number of

  Hours

  	
   

  	
  Total Cost Excluding

  Travel Not to Exceed

  	
   

  
	
  [***] Ph.D.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***] Ph.D.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***] Ph.D.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***] Ph.D.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  [***] Ph.D.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


d.            Government Property


 


Of the total contract value, [***] is hereby set aside for the
purchase of the equipment identified in
ARTICLE G.5.c., Contractor- Acquired Government Property - Schedule I­A. Schedule I-A is provided as
Attachment 6 to this contract. A variance of [***] of each cost per item 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.


 


e.            Correspondence Procedures


 


To promote
timely and effective administration, correspondence (except for financial
reports, technical progress reports/other deliverables) submitted under this
contract shall be subject to the following procedures:


 


1.               Technical correspondence shall be addressed to the
Project Officer with an information copy of
the basic correspondence to the Contracting Officer. (As used herein, technical
correspondence excludes correspondence
which proposes deviations from or modifications of contract
requirements, terms or conditions.)


 


2.               Other correspondence shall be
addressed to the Contracting Officer, with an information copy of the basic correspondence
to the Project Officer.


 


3.               Subject Line(s). All
correspondence shall contain a subject line commencing with the contract number as illustrated below:


 


6





















 


SUBJECT: Contract No. HHSN266200400100C

ADB
Contract No. NO1-AI-40100


 


Request for Approval of


 


f.              Confidential Treatment Of Sensitive Information


 


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


 


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


 


SECTION C - WORK STATEMENT


 


ARTICLE C.1. STATEMENT OF WORK


 


a.                                       Independently and not as an agent
of the Government, the Contractor shall furnish all the necessary services, qualified
personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, dated September 10,
attached hereto and made a part of this contract.


 


ARTICLE C.2. REPORTING REQUIREMENTS


 


In addition to those reports
required by the other terms of this contract, the Contractor shall prepare and submit the following
reports in the manner stated below and in accordance with Article F. 1. Deliveries of this
contract. The Contractor shall submit electronic and hard copy versions of each
report.


 


All reports shall contain a title page that includes:


 


Contract number
and title

Contract
Project Officer

Type of report (Quarterly, Annual, or
Final)

Period of performance being reported

Contractor’s name and address

Author(s)

Date of Submission


 


7





















 


I.              SEMI-ANNUAL TECHNICAL PROGRESS REPORT


 


By the thirtieth
calendar day of the month following the end of each six month period, the Contractor shall submit three (3) copies of a
semi-annual Technical Progress Report, comprising
two (2) copies [one (1) hard copy and one (1) electronic copy] to the Project Officer and one (1) hard copy to the Contracting
Officer. The semi-Annual Report shall be factual and concise and consist
of the following:


 


a. Section I: An introduction covering the purpose and scope of the contract
effort.


 


b. Section II: Brief overview of all work performed on
development and validation in the previous six months.


 


c. Section III: Description of overall progress, plus a
separate description for each task or segment of work on which effort was expended during
the reporting period.
The description for each task will include:


 


i. Pertinent data and/or graphs in sufficient detail to
explain any significant results
achieved and preliminary conclusions resulting from analysis and scientific
evaluation of data accumulated to date under the project;


ii. Any scientific, technical, or other problems/difficulties
encountered;


iii. Brief description of planned work for the following six
month period;


iv. Any recommendations for the modification, expansion,
curtailment and/or termination of
development/validation of the assay.


 


d. Section IV: An anticipated work plan for the following six
months.


 


e. Section V: A description of all impediments in carrying out
the work tasks, whether affecting
performance or costs, and methods implemented to overcome impediments. If impediments are ongoing, report
should include recommendations for their resolutions.


 


f. Semi-annual Technical Progress Reports are not due for periods in which an annual or final report is due.


 


II. ANNUAL REPORT


 


By the thirtieth calendar day
after the anniversary date of the contract, the Contractor shall submit three
(3) copies of an Annual Technical Progress Report, comprising two (2) copies to
the Project
Officer [one (1) hard copy and one (1) electronic copy] and one (1) hard copy
to the Contracting
Officer. Such reports shall detail, document, and summarize the results of the
entire contract work for the period
covered.


 


a. Section I: An introduction covering the purpose and scope of the contract
effort.


 


8





















 


b. Section II: Brief overview of all work performed since the
last annual report, including progress on meeting objectives identified in the previous annual
report.


 


c. Section III: Description of overall progress, plus a
separate description for each task
or segment of work on which effort was
expended during the report period. The description for each task will include:


 


i. Pertinent data and/or graphs in sufficient detail to
explain any significant results achieved and preliminary conclusions resulting from
analysis and scientific evaluation of data
accumulated to date under the project;


ii. Any scientific, technical, or other
problems/difficulties encountered;


iii. Brief
description of planned work for the following six month period;


iv. Any recommendations for the modification, expansion,
curtailment and/or termination of
development/validation of the assay.


 


d. Section IV:
Objectives for the upcoming 12-month period, and an anticipated work plan that will allow the
objectives to be met.


 


e. Section
V: A description of all impediments in carrying out the work tasks, whether affecting performance or costs, and methods
implemented to overcome impediments. If impediments are ongoing, report should include
recommendations for their resolutions.


 


f. An annual report will not be
required for the period when the final report is due.


 


III.                                        FINAL REPORT


 


At the completion of the contract
period, the Contractor shall submit the Final Technical Report summarizing the results for the
entire contract work for the complete performance period. A draft of the Final Report shall be
submitted 30 calendar days prior to the expiration date of the contract. Project Officer will have 14
calendar days from date of receipt to review and comment on the draft final report. The Final Report
shall be submitted by the expiration date of the contract and shall be submitted in place of the last
Annual Report. The Contractor shall submit three (3) copies of the Final Report, comprising two (2)
copies to the Project Officer [one (1) hard copy and one (1) electronic copy] and one (1) hard copy to the
Contracting Officer.


 


The Final Report shall include:


 


a.                    A detailed description of the
results of all work conducted under this contract. Description should be in
sufficient detail to explain comprehensively the results achieved.


 


b.              Conclusions regarding work
performed and recommendations for continued development of assays.


 


9





















 


c. Recommendations for new assays/approaches that could be investigated to achieve the aims laid out in the
contract.


 


d. Final cost of work performed on each assay.


 


e. A discussion of problems and obstacles encountered while
performing assay development and validation. Discussion should include both technical and programmatic issues, and should
detail methods (both successful and unsuccessful) that were used to overcome
the problems and obstacles, and recommendations
for improvements.


 


IV. OTHER DELIVERABLES


 


1.   Draft
assay development protocols will be delivered to the project officer for review
and approval
at least 30 calendar days prior to planned study initiation. Final assay development protocols will be delivered to the project
officer at least 7 calendar days prior to
planned study initiation.


 


2.   Draft
assay validation plans will be delivered to the project officer for review and
approval at least 45 calendar days prior to planned study initiation.
Validation plans will include the following information/sections: Cover page,
table of contents, purpose, study objective, responsibilities, definitions, summary of
completed studies, study description, sample description, materials and
supplies, equipment information, test methods, Standard Operating Procedures (SOPs), test protocol
(Test functions describing each validation parameter, how it will be tested,
and the acceptance criteria), data handling and analysis, and report requirements. Final assay
validation protocols will be delivered to the project officer at least 7 calendar days prior to planned study
initiation.


 


3.   Draft
and Final study reports for all implemented studies, including assay
development, assay
validation, and assays that were terminated/curtailed prior to completion of
assay development or
assay validation. Draft reports are due 60 calendar days following completion
of validation studies, or termination/curtailment of studies. Report will
include the following sections/information: Cover page, table of contents,
abstract, methods
and materials, results (which will include data analysis and compilation of
data into figures and/or tables as
requested by the NIAID Project Officer), conclusions, and appendices. For assay validation study reports, the
`results’ section of the study report will
be divided into subsections, with each subsection dedicated to one of the
validation parameters (based on the
test protocol). Final study reports are due 30 calendar days after the contractor has received comments from the NIAD
Project Officer.


 


4.   Contractor
shall provide data, reports, and other information related to this Contract as requested by the Project Officer.


 


10





















 


V. TRANSITION PLAN


 


Twelve months prior to the
completion date of this contract, a transition plan shall be submitted by the Contractor to the NIAID
Project Officer for review and approval. The transition plan will be a detailed plan for the
orderly transition of contract-related material to a successor contractor or the government. The transition
plan will include a detailed description of the methods and procedures for the transition,
the timeline for preparation and delivery of various materials, and the mechanism(s) to be used to
provide access to all data generated under this contract.


 


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 [***], MSC [***], Bethesda, Maryland
20892­7980 (Telephone:
301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be
submitted to the Contracting Officer. The final invention statement (see
FAR 27.303(a)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.


 


The annual utilization report
shall be submitted in accordance with ARTICLE F. 1. DELIVERIES of this contract. The final
invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the contract to the following
address:


 


Contracting Officer

PRCB, CMP, DEA, NIAID, NIH, DHHS

Room [***]

6700-B Rockledge Drive, MSC [***]

Bethesda, MD 20892-7612


 


If no invention is disclosed or
no activity has occurred on a previously disclosed invention during the applicable reporting period,
a negative report shall be submitted to the Contracting Officer at the address listed above.


 


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


 


SECTION D - PACKAGING, MARKING AND SHIPPING


 


All deliverables required under this contract shall be
packaged, marked and shipped in


 


11





















 


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 may be presumed unless otherwise indicated
in writing by the Contracting Officer
or the duly authorized representative within 30 days of receipt.


 


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


 


FAR Clause No. 52.246-9, INSPECTION OF
RESEARCH AND DEVELOPMENT (SHORT FORM) (APRIL
1984).


 


SECTION F - DELIVERIES OR PERFORMANCE


 


ARTICLE F.1. DELIVERIES


 


Satisfactory performance of this
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:


 


12





















 


Report
Distribution


 


	
  Deliverable

  	
   

  	
  No. of

  Copies

  	
   

  	
  Addressee/Distribution

  	
   

  	
  Due Dates

  	
   

  	
   

  	
   

  
	
  Semi-Annual
  Progress Reports

  	
   

  	
   

  	
   

  	
  Project Officer ORA,
  DMID, NIAID, NIH, DHHS Room [***], MSC [***] 6610 Rockledge Drive Bethesda, MD 20892-6603 

  	
   

  	
  The 30th  of the end of performance

  	
   

  	
  the month following each semi-annual period.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  1

  	
   

  	
  Contracting Officer PRCB,CMP, DEA, NIAID, NIH, DHHS
  6700-B Rockledge Drive Room [***], MSC
  [***] Bethesda, MD 20892-7612

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Annual Progress
  Reports

  	
   

  	
  2

  	
   

  	
  Project Officer, as above.

  	
   

  	
  The 30th of the month
  following the yearly anniversary date of
  the contract.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  1

  	
   

  	
  Contracting Officer, as above.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Draft Final
  Report

  	
   

  	
  2

  	
   

  	
  Project Officer, as above.

  	
   

  	
  30 days prior to completion date of the contract.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final Report

  	
   

  	
  2

  	
   

  	
  Project Officer, as above.

  	
   

  	
  Completion date of the contract.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  1

  	
   

  	
  Contracting Officer, as above.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Deliverables

  	
   

  	
  3

  	
   

  	
  TBD

  	
   

  	
  TBD

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Invention
  Reporting

  	
   

  	
  1

  	
   

  	
  Contracting Officer, as above.

  	
   

  	
  The 30th of the month following the yearly
  anniversary date of the contract.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Transition
  Report

  	
   

  	
  2

  	
   

  	
  Project Officer, as above.

  	
   

  	
  12 months prior to completion date of the contract.

  	
   

  
	
   

  	
   

  	
  1

  	
   

  	
  Contracting Officer, as above.

  	
   

  	
   

  	
   

  



 


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).


 


13





















 


SECTION G - CONTRACT
ADMINISTRATION DATA


 


ARTICLE G.1. PROJECT OFFICER


 


The following Project Officer
will represent the Government for the purpose of this contract:


 


[***], Ph.D.


Project Officer, Office of Regulatory
Affairs Division of Microbiology and Infectious Diseases NIAID, NIH, DHHS


6610 Rockledge Dr. MSC [***];Rm [***]


Bethesda, MD 20892-6603 (Fed Ex zip =
20817)


Phone: [***]; Fax: [***]


Email: [***]


 


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. 


 


ARTICLE G.2. KEY PERSONNEL


 


Pursuant to the Key Personnel clause incorporated in
this contract, the following individual is considered to be essential to the
work being performed hereunder:


 




	
  Name

  	
   

  	
  Title

  	
   

  
	
  [***], 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 Cost­Reimbursement
Type Contracts NIH(RC)-4 are attached and made part of this contract. The
instructions and the following directions for the submission of
invoices/financing


 


14





















 


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, each invoice shall clearly identify the two contract numbers
that appear on the face page of the
contract as follows:


 


Contract
No. HHSN266200400100C


 


ADB Contract No. NO 1-AI-40100


 


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


 


Contracting Officer


Contract Management Program


National
Institute of Allergies and Infectious Diseases, , NIH 6700-B ROCKLEDGE DRIVE


ROOM [***],
MSC [***]


BETHESDA MD 20892-7612


 


(2)           Inquiries regarding payment of invoices should be
directed to the designated billing office, [***].


 


ARTICLE G.4. INDIRECT COST RATES


 


In accordance with Federal Acquisition Regulation (FAR)
(48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment
incorporated by reference in this contract in Part II, Section I, the cognizant
Contracting Officer representative responsible for negotiating provisional
and/or final indirect cost rates is
identified as follows:


 


Director, Division of Financial
Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6100 Building, Room [***]

6100 EXECUTIVE BLVD MSC-[***]

BETHESDA MD 20892-7540


 


These rates are hereby incorporated without further
action of the Contracting Officer.


 


15





















 


 


ARTICLE G.5. GOVERNMENT PROPERTY


 


a.                                  In addition to the requirements
of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall
comply with the provisions of 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 BLVE MSC [***]


BETHESDA MD 20852-7670


[***]


 


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 for use in direct performance of the contract.


 


ARTICLE G.6. POST AWARD
EVALUATION OF CONTRACTOR PERFORMANCE


 


a.            Contractor Performance Evaluations


 


Interim and final evaluations of contractor performance
will be prepared on this contract in
accordance with FAR 42.15. The final performance evaluation will be prepared at
the time of completion of work. In addition to the final evaluation, interim
evaluations will be prepared every two years.


 


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.


 


16





















 


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:


 


htt
://ocm.od.nihgov/cdmp/cps contractor.htm


 


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. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS


 


The primary purpose of the Public
Health Service (PHS) is to support and advance independent research within the scientific community. PHS has
established effective, time tested and well recognized procedures for stimulating
and supporting this independent research
by selecting from multitudes of
applications those research projects most worthy of support within the constraints of its appropriations. The
reimbursement through the indirect cost mechanism of independent research and development costs not
incidental to product improvement would circumvent this competitive process.


 


To ensure that all research and development projects
receive similar and equal consideration, all organizations
may compete for direct funding of independent research and development projects
they consider worthy of support by submitting those projects to the
appropriate Public Health Service grant
office for review. Since these projects may be submitted for direct funding,
the Contractor agrees that no costs for any independent research and
development project, including all
applicable indirect costs, will be claimed under this contract.


 


ARTICLE H.2. 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


 


17





















 


Contracting Officer.


 


ARTICLE H.3. 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.4. 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.5. 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


 


18





















 


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 I rate which
was in effect on the date(s) the expense was incurred.


 










*For
contract expenditures using FY-04 funds, the Executive Level Irate 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 is $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.opnLzov/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.6. EPA 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).


 


For more information about ENERGY STAR® see http://www.enerpystar.gov/


For more
information about FEMP see http://www.eren.doe.gov/femp/procurement


 


ARTICLE H.7. 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:


 


19





















 


“This project has been funded in whole or in part with Federal
funds from the National Institute
Allergy and Infectious Diseases, National Institutes of Health, Department of
Health and Human Services, under Contract No. HHSN2662004001000.”


 


ARTICLE H.8. 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.9. 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 (1­800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips(a0s.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.10. 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


 


20





















 


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 twenty­first centuries and the Year 1999
and the Year 2000 and leap year calculations.


 


2.             Noncommercial Supply Items Warranty


 


YEAR 2000 WARRANTY—NONCOMMERCIAL
SUPPLY ITEMS


 


The contractor
warrants that each noncommercial item of hardware, software, and firmware delivered or developed
under this contract and listed below 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, when used in accordance with the item documentation provided by the
contractor, provided that all listed or unlisted items (e.g., hardware,
software and firmware) used in combination with such listed item properly exchange date data with it. If the
contract requires that specific listed items must perform as a system in accordance with the
foregoing warranty, then that warranty shall apply to those listed items as a system. The duration of this warranty
and the remedies available to the
Government for breach of this warranty shall be as defined in, and subject to,
the terms and limitations of any general warranty provisions of this contract
provided that notwithstanding any provision
to the contrary in such warranty provision(s), or in the absence of any such warranty
provision(s), the remedies available to the Government under this warranty shall include repair or
replacement of any listed item whose noncompliance
is discovered and made known to the contractor in writing within ninety (90) days after acceptance. Nothing in this
warranty shall be construed to limit any rights or remedies the Government may otherwise have under this contract with
respect to defects other than Year 2000 performance.


 


YEAR 2000
COMPLIANT ITEMS


 


None


 


3.            Commercial Supply Products Warranty


 


YEAR 2000 WARRANTY—COMMERCIAL
SUPPLY ITEMS


 


The contractor warrants that each hardware, software
and firmware product delivered under this
contract and listed below 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, when used in accordance with
the product documentation provided by the contractor, provided that all listed
or unlisted products (e.g., hardware, software,
firmware) used in combination with such listed product properly exchange date data with it. If the contract requires that
specific listed products must perform as a system in accordance with the
foregoing warranty, then that warranty shall apply to those


 


21





















 


listed products as a system. The duration of this warranty and
the remedies available to the Government for breach of this warranty shall be as defined
in, and subject to, the terms and limitations of the contractor’s standard commercial warranty or
warranties contained
in this contract, provided that notwithstanding any provision to the contrary
in such commercial warranty or warranties,
the remedies available to the Government under this warranty shall include
repair or replacement of any listed product whose non­compliance is discovered and made known to the contractor in writing
within ninety (90) days after
acceptance. Nothing in this warranty shall be construed to limit any rights or remedies the Government may otherwise have under
this contract with respect to defects other
than Year 2000 performance.


 


YEAR 2000 COMPLIANT ITEMS 


 


None


 


ARTICLE H.11. ANTI -LOBBYING


 


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


 


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 for 

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30/04

  	
   

  
	
   

  	
  b., above: P.L.
  108-199, Title V- General Provisions, Section 503b

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30/04

  	
   

  



 


ARTICLE H.12. SHARING RESEARCH DATA


 


The contractor’s data sharing
plan, dated September 29, 2004 is hereby incorporated by reference. The contractor agrees to adhere
to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.


 


The NIH endorses the sharing of
final research data to expedite the translation of research results into knowledge, products, and
procedures to improve human health. This contract is expected to generate
research data that must be shared with the public and other researchers. NIH’s
data sharing policy
may be found at the following Web site:


 


22





















 


http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html


 


NIH recognizes that data sharing
may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well
as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published
documentation on the Privacy Rule at http://www.hhs.gov/ocrf). The rights and privacy of people
who participate in NIH-funded research must be protected at all times; thus, data intended for
broader use should be free of identifiers that would permit linkages to individual research participants
and variables that could lead to deductive disclosure of the identity of individual subjects.


 


ARTICLE H.13. 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.14. 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.


 


ARTICLE H.15. NOTIFICATION OF EMPLOYEE RIGHTS CONCERNING PAYMENT OF UNION
DUES OR FEES


 


[Note: This posting
requirement does not apply to: contractors with fewer than 15 employees; contractor
establishments or construction work sites where no union has been formally
recognized by the prime contractor or certified as the exclusive
bargaining representative of the prime contractor’s employees; contractor establishments where
state law forbids enforcement of union­security clauses (“right-to-work” states); or
workperformed outside the United States that does not involve the recruitment or employment of workers within
the United States.]


 


 


(1)              During the term of this contract, the
contractor agrees to post a notice*, of such size and in such form as the Secretary of Labor will prescribe, in conspicuous places in and about its plants and offices, including all places where
notices to employees are customarily posted. The information required to
be included in the notice can be found at http://www.dol.gov/esa/regs/compliance/olmsBeckPosterWithNLRB.pdf
except that the


 


23





















 


last two
sentences must not be included in notices posted in the plants or offices of carriers subject to the Railway
Labor Act, as amended (45 U.S.C. 151-188).


 


(2)                                  The contractor will comply with
all provisions of Executive Order 13201 of February 17, 2001, and related rules, regulations, and orders of the
Secretary of Labor.


 


(3)                                  In the event that the contractor
does not comply with any of the requirements set forth in paragraphs (1) or (2) above, this
contract may be cancelled, terminated, or suspended in whole or in part, and the
contractor may be declared ineligible for further Government contracts in
accordance with procedures authorized in or adopted pursuant to Executive Order 13201 of February 17, 2001.
Such other sanctions or remedies may be imposed as are provided in Executive Order
13201 of February 17, 2001, or by rule, regulation, or order of the Secretary
of Labor, or as are otherwise provided by law.


 


(4)            The contractor will include the
provisions of paragraphs (1) through (4) herein in every subcontract or
purchase order entered into in connection with this contract unless exempted by rules, regulations, or orders of the
Secretary of Labor issued pursuant to section 3 of Executive Order 13201 of
February 17, 2001, so that such provisions will be binding upon each subcontractor or vendor. The contractor will take
such action with respect to any such
subcontract or purchase order as may be directed by the Secretary of Labor as a means of enforcing such provisions,
including the imposition of sanctions for noncompliance: However, if the
contractor becomes involved in litigation with a subcontractor or vendor, or is threatened with such involvement, as a
result of such direction, the
contractor may request the United States to enter into such litigation to protect the interests of the United States. The
full text of Executive Order 13201 is available at
http://www.dol.gov/esa/regs/statutes/olms/eol3201.htm.  The final rule published in the Federal
Register on March 29, 2004 is available at
http://www.dol.gov/esa/regs/fedreg/final/2004006823.htm.


 










*The required employee notice poster may be obtained
from the Division of Interpretations and Standards, Office of Labor-Management
Standards, U.S. Department of Labor, 200
Constitution Avenue, NW., Room [***], Washington, DC 20210, or from any field office of the Department’s 


 


(5)                                  Office of Labor-Management
Standards or Office of Federal Contract
Compliance Programs. A copy of the poster may also be downloaded from the
Office of Labor-Management Standards Web site at http://www.olms.dol.gov.
Additionally, contractors may reproduce and use exact duplicate copies of the Department’s official poster. See
http://www.dol.gov/esa/regs/compliance/olmsBeckPosterWithNLRB.pdf for an
exact duplication of the official notification poster.


 


24





















 


ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES


 


Unique
research resources arising from NIH-funded research are to be shared with the
scientific research community. NIH provides
guidance, entitled, “Sharing Biomedical Research Resources: Principles and
Guidelines for Recipients of NIH Research Grants and Contracts,” (Federal
Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate
terms for disseminating and acquiring these
research resources. This guidance, found at http://ott.od.nih.gov/NewPages/64FR72090.pdf.
is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will
facilitate further biomedical
research, consistent with the requirements of the Bayh-Dole Act and NIH funding
policy.


 


Note: For the
purposes of this Article, the terms, “research tools, “ “research
materials, “ and “research
resources” are used interchangeably and have the same meaning.


 


25





















 


PART II - CONTRACT CLAUSES


 


SECTION I - CONTRACT CLAUSES


 


ARTICLE 1.1. GENERAL CLAUSES FOR A
COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)


 


This contract incorporates the following clauses by reference,
with the same force and effect as if they were given in full text. Upon request,
the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at
this address: http://www.arnet.gov/far/.


 


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


 


	
  FAR
  CLAUSE

  NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.202-1

  	
   

  	
  Jul 2004

  	
   

  	
  Definitions

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  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 1999

  	
   

  	
  Audit and Records - Negotiation
  (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-8

  	
   

  	
  Oct 1997

  	
   

  	
  Order of Precedence - Uniform Contract Format

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-10

  	
   

  	
  Oct 1997

  	
   

  	
  Price Reduction for Defective Cost or Pricing Data

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-12

  	
   

  	
  Oct 1997

  	
   

  	
  Subcontractor Cost or Pricing Data (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-14

  	
   

  	
  Oct 1997

  	
   

  	
  Integrity of Unit Prices (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-15

  	
   

  	
  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

  



 


26





















 


	
  52.215-19

  	
   

  	
  Oct 1997

  	
   

  	
  Notification of
  Ownership Changes

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-21

  	
   

  	
  Oct 1997

  	
   

  	
  Requirements for Cost or Pricing Data or Information
  Other Than Cost or Pricing Data - Modifications 

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.216-7

  	
   

  	
  Dec 2002

  	
   

  	
  Allowable Cost and Payment

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.216-8

  	
   

  	
  Mar 1997

  	
   

  	
  Fixed Fee

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-8

  	
   

  	
  May 2004

  	
   

  	
  Utilization of Small Business Concerns (Over
  $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-9

  	
   

  	
  Jan 2002

  	
   

  	
  Small Business Subcontracting Plan (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-16

  	
   

  	
  Jan 1999

  	
   

  	
  Liquidated Damages - Subcontracting Plan (Over
  $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  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

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-26

  	
   

  	
  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

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation on Withholding of Payments

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-17

  	
   

  	
  Jun 1996

  	
   

  	
  Interest (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-20

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation of Cost

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-23

  	
   

  	
  Jan 1986

  	
   

  	
  Assignment of Claims

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-25

  	
   

  	
  Oct 2003

  	
   

  	
  Prompt Payment, Alternate I (Feb 2002)

  



 


27





















 


	
  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

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-3

  	
   

  	
  May 2001

  	
   

  	
  Penalties for Unallowable Costs (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-4

  	
   

  	
  Jan 1997

  	
   

  	
  Certification of
  Final Indirect Costs

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-13

  	
   

  	
  Jul 1995

  	
   

  	
  Bankruptcy (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.243-2

  	
   

  	
  Aug 1987

  	
   

  	
  Changes - Cost Reimbursement, Alternate V (Apr 1984)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.244-2

  	
   

  	
  Aug 1998

  	
   

  	
  Subcontracts, Alternate 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)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.246-23

  	
   

  	
  Feb 1997

  	
   

  	
  Limitation of Liability (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.249-6

  	
   

  	
  Sep 1996

  	
   

  	
  Termination (Cost-Reimbursement)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.249-14

  	
   

  	
  Apr 1984

  	
   

  	
  Excusable Delays

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.253-1

  	
   

  	
  Jan 1991

  	
   

  	
  Computer Generated Forms

  



 


	
  b.

  	
   

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

  



 


	
  HHSAR 

  CLAUSE

  NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.202-1

  	
   

  	
  Jan 2001

  	
   

  	
  Definitions - with Alternate paragraph (h) (Jan
  2001)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.216-72

  	
   

  	
  Oct 1990

  	
   

  	
  Additional Cost Principles

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.228-7

  	
   

  	
  Dec 1991

  	
   

  	
  Insurance - Liability
  to Third Persons

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Withholding of
  Contract Payments

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.233-70

  	
   

  	
  Apr 1984

  	
   

  	
  Litigation and Claims

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.242-71

  	
   

  	
  Apr 1984

  	
   

  	
  Final Decisions on Audit Findings

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-5

  	
   

  	
  Apr 1984

  	
   

  	
  Key Personnel

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-6

  	
   

  	
  Jul 1991

  	
   

  	
  Publications and Publicity

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-7

  	
   

  	
  Jan 2001

  	
   

  	
  Paperwork Reduction Act

  



 


[ End of GENERAL CLAUSES FOR A
COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - Rev. 07/2004].


 


28





















 


ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES 


 


ARTICLE I.1. of this SECTION is
hereby modified as follows:


 


FAR Clause 52.204-7, CENTRAL CONTRACTOR REGISTRATION
(OCTOBER 2003) is deleted in its entirety.


 


FAR
Clause 52.232-33, PAYMENT BY ELECTRONIC FUNDS TRANSFER—CENTRAL CONTRACTOR REGISTRATION (OCTOBER 2003) is deleted
in its entirety and FAR Clause 52.232-34, PAYMENT BY ELECTRONIC FUNDS
TRANSFER—OTHER THAN CENTRAL CONTRACTOR REGISTRATION (MAY 1999) is substituted
therefore.


 


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
therefore. Note: When this contract is fully funded, FAR Clause 52.232-22,
LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION
OF COST will become applicable.


 


ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES


 


This contract incorporates the following clauses by reference,
with the same force and effect, as if they were given in full text. Upon request, the
contracting officer will make their full text available.


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


 


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


 


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


 


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


 


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 - ATTACHMENTS.]


 


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


 


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


 


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


 


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


 


29





















 


ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT


 


This contract incorporates the
following clauses in full text.


 


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


 


a. FAR Clause
52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (JULY 2004)


 


(a) Definitions. As used in this clause-


 


Commercial item,
has the meaning contained in Federal Acquisition Regulation 52.202-1, Definitions.


 


Subcontract, includes a transfer of
commercial items between divisions, subsidiaries, or affiliates of the
Contractor or subcontractor at any tier.


 


(b) To
the maximum extent practicable, the Contractor shall incorporate, and require
its subcontractors at all tiers to incorporate, commercial items or
nondevelopmental items as components of items to be supplied under this
contract.


 


(c) (1)
The Contractor shall insert the following clauses in subcontracts for
commercial items:


 


(i)
52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C.
637(d)(2) and (3)), in all subcontracts that offer further subcontracting
opportunities. If the subcontract (except subcontracts to small business
concerns) exceeds $500,000 ($1,000,000 for construction of any public
facility), the subcontractor must include 52.219-8 in lower tier subcontracts
that offer subcontracting opportunities.


 


(ii)
52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).


 


(iii)
52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam
Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).


 


(iv) 52.222-36, Affirmative Action for
Workers with Disabilities (JUN 1998) (29 U.S.C. 793).


 


(v)
52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (APR
2003) (46 U.S.C. Appx 1241 and 10 U.S.C. 2631) (flow down required in
accordance with paragraph (d) of FAR clause 52.247-64).


 


(2) While
not required, the Contractor may flow down to subcontracts for commercial items
a minimal number of additional clauses necessary to satisfy its contractual
obligations.


 


(d) The Contractor
shall include the terms of this clause, including this paragraph (d), in
subcontracts awarded under this contract.


 


30





















 


PART III


 


SECTION J - LIST OF
ATTACHMENTS


 


The following documents are attached and incorporated in this
contract:


 


1. Statement of
Work, September 10, 2004, 3 pages.


 


2. Invoice/Financing Request
and Contract Financial Reporting Instructions for NIH Cost­Reimbursement Type
Contracts, NIH(RC)-4, (11/03), 6 pages.


 


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


 


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


 


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


 


6. Government Property  - Schedule I-A,
dated September 10, 2004, 1 page.


 


7. Data Sharing Plan, September
29, 2004


 


31





















 


PART IV


 


SECTION K - REPRESENTATIONS AND CERTIFICATIONS


 


The following
documents are incorporated by reference in this contract:


 


1.                 Representations and Certifications, dated
September 13, 2004


 


32





















 


ATTACHMENT 1


 


STATEMENT OF WORK


 


ASSAYS FOR DETECTION OF NOVEL OR LATENT/OCCULT

ADVENTITIOUSAGENTS IN CELL SUBSTRATES


 


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


 


The Contractor
shall be responsible for 1) developing one or more assays to identify latent
and/or occult
adventitious agents present in cell substrates, and 2) if approved by the
Project Officer, developing
a validation plan and conducting studies to validate the assay(s). Each assay
must be tested using two cell substrates. To the extent possible, efforts
should focus on applying existing technologies, reagents, techniques, and
animal strains to the assay development. Assays that show promise during the first
stage of development will be candidates for the second stage of development, validation.


 


Specifically, the
Contractor shall:


 


I.             Develop, characterize and validate
assays for the detection of novel or latent/occult adventitious agents in cell
substrates. Assays can include in vitro assays, in vivo animal models, and/or assays that contain both an in vitro assay and an in vivo animal model component.


 


1.               During the first stage of
development, characterize assays that can be used to screen for unidentified
latent adventitious agents. Examples of potential assays to be developed
include:


 


a.               Assays to identify cellular genes
that are normally inactivated but become specifically activated in the presence of a wide range
of infectious agents.


b.              Development of degenerative primers
for either microarray or PCR analysis to
screen for previously unidentified viruses that are related to known viruses.


c.                   Use of chemical stimulants to
activate latent viruses in the cell substrate. Stimulation could be coupled with a non-specific detection
system, such as PERT
or TEM to look for activated viruses.


d.              Using whole cell lysate in in vitro assays and in animal models to determine if virus is released from latency or otherwise
activated following cell lysis.


 


33





















 


2.               During the first stage of
development, characterize sensitive methods to screen for TSE agents in cell substrates. Examples of potential
assays to be developed include:


 


a.        Screening for TSE infection and ability to propagate TSE
in cells


exposed to BSE contaminated serum.


b.        Assays to determine if cell substrates
are producing the variant form of


the PrP protein.


 


3.               Upon completion of the first stage
of development, the NIAID Project Officer will determine if the assay will be a candidate for further
development and validation. The decision process will consist of two steps. Immediately
following completion of the assay
development stage, the NIAID Project Officer and Contractor will meet to discuss the data, results, and conclusions
from the development studies. If the Project Officer determines that
sufficient information is available to warrant further development, the
Contractor will be directed to prepare a concept validation plan. The concept validation plan will outline the studies to
be performed to meet each of the
assay validation criteria in accordance with the most current version of the ICH Q2A and Q2B documents. The Project
Officer will then review the
validation plan in consultation with the Contractor, the Advisory Committee
(see section II below), regulatory agencies, and/or other experts as deemed
necessary by the Project Officer, to determine if the assay validation plan is
appropriate, and, if validated, whether the assay will provide meaningful, relevant information for regulatory
agencies and vaccine manufacturers to better characterize novel cell
substrates. The final decision on whether or
not the assay will be a candidate for validation will be based on the Project
Officer’s assessment that 1) the assay can be validated; and 2) if validated, the
assay will provide meaningful, relevant information for regulatory agencies and vaccine manufacturers to better characterize
novel cell substrates. Following selection
of an animal model for validation, the Contractor will plan, prepare and conduct validation of the animal model. This will
include:


 


a.           Develop a detailed validation plan. Validation must be
performed in accordance with the most
current version of the ICH Q2A and Q2B documents.
As indicated in ICH Q2A, validation characteristics should include: Accuracy,
Precision, Specificity, Detection Limit, Quantitation Limit, Linearity, and
Range. The validation plan will include the following information/sections:
Cover page, table of contents, purpose, study objective,
responsibilities, definitions, summary of completed studies, study description,
sample description, materials and supplies, equipment information, test
methods, Standard Operating Procedures (SOPs), test protocol (Test functions
describing each validation parameter, how it will be tested, and the acceptance
criteria), data handling and analysis, and
report requirements.


b.          Conduct validation studies according to validation plan.


c.           Perform data analysis at the conclusion of the validation
studies.


 


 


34





















 


d.          Prepare study report. Report will include the following
sections/information: Cover page, table of contents, abstract, methods and materials, results,
conclusions, and appendices. The `results’ section of the study report will be divided into
subsections, with each subsection dedicated to one of the validation parameters (based on the test protocol).


 


II. PARTICIPATE
IN ADVISORY COMMITTEE ACTIVITIES


 


The NIAID
Project Officer will form an Advisory Committee to provide expert advice on certain issues related to the ongoing work performed
under this contract. The input and advice
provided by the Advisory Committee, in conjunction with input from regulatory agencies and the Contractor, will be used by the
Project Officer to aid in making decisions regarding assay development and assay validation. The Project Officer
will determine the composition and number of members of the Advisory Committee.
Members may be added or removed as necessary to meet the needs of the
Government. Two-day Advisory Committee meetings will be held twice each year of
the contract in the Bethesda, MD area. The Contractor will participate in these meetings to support the Advisory
Committee as requested by the Project
Officer. Participation will include presenting and discussing test results, and
providing expert opinions on methodologies and assay development and
validation. The Contractor will also
provide additional support for Advisory Committee activities, including providing read ahead documents prior to a
committee meeting; scheduling and making all logistical arrangements for Committee meetings; and support the travel
of two (2) non­Federal Committee
members.


 


III. PROVIDE FOR AN ORDERLY TRANSITION TO A SUBSEQUENT
CONTRACTOR OR THE GOVERNMENT ON OR
BEFORE THE COMPLETION DATE OF THIS CONTRACT


 


Twelve months prior to the
completion date of this contract, a transition plan, which will include access to all data, shall
be submitted to the NIAID Project Officer for review and approval, in order to ensure
orderly transition of contract-related material to a successor contractor or the Government. The
transition plan will include a detailed description of the methods and procedures for the
transition, the timeline for preparation and delivery of various materials, and the
mechanism(s) to be used to provide access to all data generated under this contract.


 





















 


ATTACHMENT
2


 


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 SF­1035, 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: (I)
costs of a prior billing period, but not previously billed; or (2) costs
incurred during the contract period and claimed after the contract period has
expired, the amount and month(s) in which such costs were incurred shall be
cited.


 


Contractor’s Fiscal Year: Invoices/financing requests
shall be prepared in such a manner that costs claimed can be identified with
the contractor’s fiscal year.


 


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


 


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


 


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


 





















 


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


 


(b)              Completion Invoice - The completion
invoice is submitted promptly upon completion of the work; but no later than one year from the contract completion date,
or within 120 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
maybe required after the amounts owed have been settled between the Government and the
contractor (e.g., resolution of all suspensions and audit exceptions).


 


Preparation and Itemization of the
Invoice/Financing Request: The contractor shall furnish the information set forth in the
explanatory notes below. These notes are keyed to the entries on the sample invoice/financing
request.


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


 


1





















 


(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 the application of the paragraph entitled “Costs Requiring Prior
Approval” on page 1 of these instructions.


 


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


 


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


 


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


 


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


 


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


 


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


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


 


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


 


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


 


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


 





















 


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


 


(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.


 


1





















 


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/H rs. -Negotiated - Enter the percentage of effort or number of hours agreed to doing contract
negotiations for each employee or labor category listed in Column A.


 


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


 


Column D–Incurred Cost-Current - Enter the costs,
which were incurred during the current period.


 


Column E–Incurred Cost-Cumulative - Enter the
cumulative cost to date.


 


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


 


Column G– Contract Amount - Enter the costs
agreed to during contract negotiations for all expenditure categories listed in
Column A.


 


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


 


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


 


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


 





















SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL
REPORT


 


	
  (a)

  	
  Billing Office
  Name and Address



  NATIONAL INSTITUTES OF HEALTH

  	
   

  	
  (b) Invoice/Financing

  	
   

  	
  Request
  No.

  	
   

  	
   

  
	
   

  	
  National
  Institute of Allergies and

  Infectious Diseases, CMP

  6700B Rockledge
  Drive

  Room [***], MSC [***]

  Bethesda, MD 20892-7612

  	
   

  	
   

  (c) Date

  Invoice

  	
   

  	
  Prepared

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  No.

  	
   

  	
   

  
	
  (e)

  	
  Payee’s Name and Address

  ABC CORPORATION

  100 Main Street

  Anywhere, USA zip code

  	
   

  	
  

  (d) Contract

  ADB No. Effective

  	
   

  	
      Date

  	
   

  	
   

  	
   

  
	
   

  	
  Cost

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  (f) Total
  Estimated

  	
   

  	
  Fee

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Attn:

  	
  Name, Title,
  & Phone Number of Official to

  	
   

  	
  (g) Total Fixed

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Whom Payment is Sent

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (h) 

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

  
	
  Expenditure
  Category*

  A

  	
  Cumulative
  Percentage

  [ILLEGIBLE]

  	
   

  	
   

  	
  Incurred

  Cost

  	
  Cost at

  Completion

  F

  	
  Contract

  Amount

  G

  	
  Variance

  H

  
	
  Negotiated

  B

  	
  Actual

  C

  	
  (i) Current

  D

  	
  (j) Cumulative

  E

  
	
  (k) Direct Costs:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Direct Labor

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (2) Fringe Benefits

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (3) Accountable Property
  (attach HHS-565)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (4) Materials &

  Supplies

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (5)
  Premium Pay

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (6) Consultant Fees

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (7) Travel

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (8) Subcontracts

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (9) Other

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (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

  
																			



6





















 


ATTACHMENT 3


 


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 this 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)


 





















 


OMB Bulletin 81-16


 


ATTACHMENT 4


 


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 7045­ADP Supplies and Support Equipment.)

  
	
  71

  	
  -

  	
  Furniture

  
	
  72

  	
  -

  	
  Household and Commercial Furnishings
  and Appliances

  
	
  74

  	
  -

  	
  Office Machines
  and Visible Record Equipment

  
	
  77

  	
  -

  	
  Recreational
  and Athletic Equipment

  
	
  78

  	
  -

  	
  Musical
  Instruments, Phonographs, and Home-type Radios

  



 


 


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.


 


 





















 


ATTACHMENT
5  GOVERNMENT


 


PROPERTY -
SCHEDULE


 


	
  CONTRACTOR:

  	
  REPORT OF GOVERNMENT

  	
   

  	
  CONTRACT NUMBER

  	
  OWNED,

  PROPERTY

  
	
   

  	
  CONTRACTOR HELD

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  ADDRESS

  	
   

  	
   

  
	
   

  	
   

  	
  REPORT DATE:

  
	
   

  	
   

  	
   

  
	
  CLASSIFICATION

  	
   

  	
  FISCAL YEAR:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  ANF)--$25K

  	
   

  	
   

  
	
  I”\D<S25K

  	
   

  	
   

  



 


	
   

  	
   

  	
  BEGINNING
  OF

  PERIOD

  	
   

  	
   

  	
   

  	
  AD] F IAtI1Oi N

  	
   

  	
   

  	
   

  	
  END OF
  I'FI IOI)

  
	
   

  	
   

  	
  n 1: LTS

  	
   

  	
  VALUL

  	
   

  	
  (jI F ADDED

  	
   

  	
  CAP ADDED

  	
   

  	
  DLLI? 11ONS

  	
   

  	
  011515

  	
   

  	
  V'A['1;17(7)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1)TI II:R RI AL.---S K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OTI IE.R RLAL-A25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERLY UNDER

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  C()NST% =.25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
    ITROPI;R J7 UNDUE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PLANT FQUIP>=$25K PL-%N

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  T'EQUIP<R25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TOOLING'-52511

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL 7 1C)ZING =S2SK

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TGST EQUIP>=525K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL 1 EST EQUIP<525K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  EUUNCY PEC'I:L1AR>-=535K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  IliENCT PECCLTAR-b25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  MATFRIAT _ -$25K 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (CI’A+iJLA1rVE)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPER I')' UNDER N11 K%--

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  $25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERLY UNDER A-IFR--5'25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SIGNED BY:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  DATE SIGNED:

  	
   

  	
   

  	
   

  	
   

  



 





















 


ATTACHMENT 6


 


GOVERNMENT PROPERTY - SCHEDULE


 


CONTRACTOR-ACQUIRED
GOVERNMENT PROPERTY - SCHEDULE I-A


 


	
  Quantity

  	
   

  	
  Equipment

  	
   

  	
  Cost/item*

  	
   

  	
  Total cost

  
	
  1

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  1

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  3

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  1

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
  TOTAL

  	
   

  	
   

  	
   

  	
  [***]

  



 










*+/- [***] variance related to cost allowed for
each line item without prior approval of the Contracting Officer.


 


 





















 


ATTACHMENT 7


 


DATA SHARING PLAN


 


Date: September 29, 2004


 


The contractor (Isis
Pharmaceuticals, Inc.) shall present at appropriate scientific meetings and
submit for publication significant data
arising as a direct result of performing under the contract. The contractor, in discussions with the project
officer, will identify suitable journals for publication, with a bias toward open access journals, and
appropriate technical and commercial conferences for presentations. The contractor may seek patent
protection of any inventions conceived or reduced to practice as a result of its performing under the
contract. The contractor will retain title and exclusive rights to commercialize such information and
inventions and fully intends to make such information and inventions commercially available. In
addition, the contractor intends to make commercially available the intellectual property underlying its
TIGER methodology, as well as primers (including chemical modifications) and protocols not developed as a direct result of
performing under the contract.