Exhibit 10.1
(AWARD CONTRACT FORM) [w26628w2662801.gif]
(*) = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS. OMITTED TEXT IS INDICATED BY AN "*".

1. THIS CONTRACT IS A RATED ORDER            RATING            PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 350) N/A 1 56 —— —— —— —— — 2. CONTRACT (Proc.
Inst. Ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
N01-AO-60027, HHSN272200600027C            September 30, 2006 VRC-06-05 —— —— —
5. ISSUED BY            CODE 6. ADMINISTERED BY (If other than Item 6) CODE
National Institute of Allergy and Infectious Diseases (NIAID) Acquisitions
Management and Operations Branch 10401 Fernwood Road, Room 2NE-28, MSC 4813
Bethesda, MD 20817-4813 — 7. NAME AND ADDRESS OF CONTRACTOR (No. street, county,
state and ZIP Code) 8. DELIVERY FOB ORIGIN OTHER (See below) FOB Destination
GenVec, Inc. 9/ DISCOUNT FOR PROMPT PAYMENT 65 West Watkins
Avenue            N/A Gaithersburg, MD 20878 10. SUBMIT
INVOICES            ITEM. CODE            FACILITY CODE            ADDRESS SHOWN
IN: G.2 —— — 11. SHIP TO/MARK FOR CODE            N/A 12. PAYMENT WILL BE MADE
BY CODE            N/A -— — Article F.2. See Article G.2 —— — 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 1-232705690-A1; OC Code 25.12; CAN
6-8335320, AMT $7,024,304 15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY
15D. UNIT 15E. UNIT PRICE 15F. AMOUNT —— —— —— — FY 06 $7,502,680.00 FY 07
$11,079,615.00 Title: Technology Licensing, Cell Development, and Manufacturing
Technical Support            FY 08 $11,070,353.00 Period: September 30, 2006
through September 29, 2007 FY 09 $11,154,542.00 Contract Type: Fixed Price and
Cost Plus Fixed Fee/IDIQ            FY10 $11,225,101.00 —— — 15G. TOTAL AMOUNT
OF CONTRACT $52,032,291.00.000 —— — 16. TABLE OF CONTENTS — (ü) SEC.
DESCRIPTION            PAGE(S) (ü) SEC. DESCRIPTION            PAGE(S) —— —— ——
—— —— —— —— — PART I — THE SCHEDULE            PART II — CONTRACT CLAUSES —— —
A            SOLICITATION/CONTRACT FORM 1 I            CONTRACT CLAUSES 19-27 ——
—— —— —— —— — B            SUPPLIES OR SERVICES AND PRICE/COST 4-9 PART III —
LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. —— —— —— —
C            DESCRIPTION/SPECS./WORK STATEMENT 9 J             LIST OF
ATTACHMENTS 28 —— —— —— —— —— — D            PACKAGING AND MARKING 10 PART IV —
REPRESENTATIONS AND INSTRUCTIONS —— —— —— — E            INSPECTION AND
ACCEPTANCE 10-11 K            REPRESENTATIONS, CERTIFICATIONS 29 —— —— —
F            DELIVERIES OR PERFORMANCE 11-12 AND OTHER STATEMENTS OF OFFERORS ——
—— —— — G            CONTRACT ADMINISTRATION DATA 12-16 L            INSTRS.,
CONDS., AND NOTICES TO OFFERORS —— —— —— —— — H            SPECIAL CONTRACT
REQUIREMENTS 16-18 M            EVALUATION FACTORS FOR AWARD —— —— —— —— —
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE 17. 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 18. AWARD (Contractor is not required to sign this document.)
Your offer on Solicitation Number ___, including the the parties to this
contract shall be subject to and governed by the following documents: (a) this
award/contract, (b) 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 solicitation, if any, and (c) such
provisions, representations, certifications, and specifications, as are attached
or            sheets. This award consummates the contract which consists of the
following documents: (a) the Government’s solicitation and your offer, and
(b) this incorporated by reference herein. (Attachments are listed herein.)
award/contract. No further contractual document is necessary. —— — 19A. NAME AND
TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER Terrie Nestor
Contracting Officer, AMOB, NIAID 19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B.
UNITED STATES OF AMERICA 20C. DATE SIGNED ___BY ___ (Signature of person
authorized to sign) (Signature of Contracting Officer) —— —

OMB Approval 2700-0042

NSN 7540-01-152-8069 26-107 STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA, FAR (48 CFR)
53.214(a)

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
DETAILED TABLE OF CONTRACT CONTENTS

         
PART I — THE SCHEDULE
       
 
       
SECTION A — SOLICITATION/CONTRACT FORM
       
 
       
SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS
    4  
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
    4  
ARTICLE B.2. PRICES
    4  
ARTICLE B.3. OPTION PRICES
    4  
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
    7  
ARTICLE B.4. ADVANCE UNDERSTANDINGS
    8  
SECTION C — DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
    9  
ARTICLE C.1. STATEMENT OF WORK
    9  
ARTICLE C.2. REPORTING REQUIREMENTS
    9  
SECTION D — PACKAGING, MARKING AND SHIPPING
    10  
ARTICLE D.1. PACKAGING
    10  
ARTICLE D.3. SHIPPING
    10  
SECTION E — INSPECTION AND ACCEPTANCE
    10  
SECTION F — DELIVERIES OR PERFORMANCE
    11  
ARTICLE F.1. PERIOD OF PERFORMANCE
    11  
ARTICLE F. 2. DELIVERIES
    11  
ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE
    12  
SECTION G — CONTRACT ADMINISTRATION DATA
    12  
ARTICLE G.1. PROJECT OFFICER
    12  
ARTICLE G.2. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
    13  
ARTICLE G.3. INDIRECT COST RATES
    15  
ARTICLE G.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
    15  
SECTION H — SPECIAL CONTRACT REQUIREMENTS
    16  
ARTICLE H.1. HUMAN SUBJECTS
    16  
ARTICLE H.2. NEEDLE EXCHANGE
    16  
ARTICLE H.3 . OPTION PROVISION
    16  
ARTICLE H.4 . SALARY RATE LIMITATION LEGISLATION PROVISIONS
    17  
ARTICLE H.5. PUBLICATION AND PUBLICITY
    17  
ARTICLE H.6. PRESS RELEASES
    17  
ARTICLE H.7. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
    18  
ARTICLE H.8. ANTI -LOBBYING
    18  
 
       
PART II — CONTRACT CLAUSES
    19  
SECTION I — CONTRACT CLAUSES
    19  
ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY AND
COST-REIMBURSEMEMT SERVICE CONTRACT
    19  
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
    22  
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
    22  
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
    24  
 
       
PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
    28  
SECTION J — LIST OF ATTACHMENTS
    28  
1. Statement of Work
    28  
2. Sample Contract Task Order Form
    28  
3. Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1
    28  

2

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

         
4. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2,
Invoice/Financing Request
    28  
5. Financial Report of Individual Project/Contract, NIH 2706
    28  
6. Instructions for Completing form NIH 2706, Financial Report of Individual
Project/Contract
    28  
7. Procurement of Certain Equipment, NIH(RC)-7
    28  
8. Disclosure of Lobbying Activities, SF-LLL
    28  
PART IV
    29  
SECTION K — REPRESENTATIONS AND CERTIFICATIONS
    29  
1. Annual Representations and Certifications
    29  

3

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The contractor will provide a five-year research license, as well as an executed
annual license, renewable each year for four (4) years at the Government’s
option, to the Vaccine Pilot Plant (VPP)/Vaccine Research Center (VRC) granting
access to, and use of, the contractor’s proprietary technology, cultivating
packaging cell line, and manufacturing production processes for the development
of adenoviral vectors containing HIV inserts. Contractor will also provide
technical support and trouble-shooting and scale-up assistance during the
performance of engineering runs and manufacturing activities.
ARTICLE B.2. PRICES
     FIXED PRICE

                               Line Item   Description   Unit   Unit Price  
Total Base, Contract Year I                        
 
                          September 30, 2006 through September 29, 2011        
               
 
                          0001  
Licensing and Technology Transfer Of Adenovector Manufacturing Process
  1   $ *     $ *      
 
                          September 30, 2006 through September 29, 2007        
               
 
                          0002  
Licensing of Adenovector & Packaging Cell Line
  1   $ *     $ *  

CLINs 0003-0044 are optional line items and will be exercised independently as
needed. CLINS 0007-0044 may be exercised at any time during the specified period
of performance.
ARTICLE B.3. OPTION PRICES

a.   Unless the Government exercises its option pursuant to the option clause
referenced in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists
only of the Base Period specified in the Statement of Work as defined in
SECTIONS C and F, for the price set forth in the PRICES Article in SECTION B of
this contract.

b.   Pursuant to FAR Clause 52.217-5 set forth in ARTICLE I.3. ADDITIONAL
CONTRACT CLAUSES of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform the Option Period(s) specified
in the Statement of Work as defined in SECTIONS C and F of this contract. If the
Government exercises this/these option(s), notice must be given before the
expiration date of the contract. Specific information regarding the time frame
for this notice is set forth in the OPTION PROVISION Article in SECTION H of
this contract. The fixed price of this contract will be increased as set forth
in paragraph c., below.

c.   Upon the delivery and acceptance of the Option Item(s)/Service(s) described
in SECTION C of the contract and identified in the schedule of charges below,
the Government shall pay the Contractor the unit price(s) set forth below:

4

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
1. Fixed Price

                               Line Item   Description   Unit   Unit Price  
Total Option I, Contract Year II                        
 
                         September 30, 2007 through September 29, 2008          
             
 
                         0003  
Licensing of Adenovector & Packaging Cell Line
  1   $ *     $ *      
 
                    Option II, Contract Year III                        
 
                         September 30, 2008 through September 29, 2009          
             
 
                         0004  
Licensing of Adenovector & Packaging Cell Line
  1   $ *     $ *      
 
                    Option III, Contract Year IV                        
 
                         September 30, 2009 through September 29, 2010          
             
 
                         0005  
Licensing of Adenovector & Packaging Cell Line
  1   $ *     $ *      
 
                    Option IV, Contract Year V                        
 
                         September 30, 2010 through September 29, 2011          
             
 
                         0006  
Licensing of Adenovector & Packaging Cell Line
  1   $ *     $ *  

2. COST REIMBURSEMENT/IDIQ
     The following items will be ordered as needed:

                                                      Cost Plus                
        Fixed Fee      Line Item   Description   Cost   Fee   (Max) Base,
Contract Year I                            
 
                             September 30, 2006 through September 29, 2007      
                     
 
                             0007  
Task 1a-Vector Seed Stock Production
  $ *     $ *     $ *        0008  
Task 1b-Ad41 Vectors Targeted to Mucosa
  $ *     $ *     $ *        0009  
Task 2/Subtask 1-Manufacturing Process Technology Transfer
  $ *     $ *     $ *  

5

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

                                                Cost Plus                      
Fixed Fee      Line Item   Description   Cost   Fee   (Max)      0010  
Task 2/Subtask 2-QC Method Technology Transfer
  $ *     $ *     $ *        0011  
Task 3/Subtask 1-GMP Manufacturing Process Support
  $ *     $ *     $ *        0012  
Task 3/Subtask 3-PD For New Vector
  $ *     $ *     $ *      
 
                    Option I, Contract Year II                        
 
                         September 30, 2007 through September 29, 2008          
             
 
                         0013  
Task 1a-Vector Seed Stock Production
  $ *     $ *     $ *        0014  
Task 1b-Ad41 Vectors Targeted to Mucosa
  $ *     $ *     $ *        0015  
Task 2/Subtask 1-Manufacturing Process Technology Transfer
  $ *     $ *     $ *        0016  
Task 2/Subtask 2-QC Method Technology Transfer
  $ *     $ *     $ *        0017  
Task 3/Subtask 1-GMP Manufacturing Process Support
  $ *     $ *     $ *        0018  
Task 3/Subtask 2-QC Method Support
  $ *     $ *     $ *        0019  
Task 3/Subtask 3 PD For New Vector
  $ *     $ *     $ *        0020  
Task 3/Subtask 4-Support of Scale-Up Activities
  $ *     $ *     $ *      
 
                    Option II, Contract Year III                        
 
                         September 30, 2008 through September 29, 2009          
             
 
                         0021  
Task 1a-Vector Seed Stock Production
  $ *     $ *     $ *        0022  
Task 1b-Ad41 Vectors Targeted to Mucosa
  $ *     $ *     $ *        0023  
Task 2/Subtask 1-Manufacturing Process Technology Transfer
  $ *     $ *     $ *        0024  
Task 2/Subtask 2-QC Method Technology Transfer
  $ *     $ *     $ *        0025  
Task 3/Subtask 1-GMP Manufacturing Process Support
  $ *     $ *     $ *        0026  
Task 3/Subtask 2-QC Method Support
  $ *     $ *     $ *        0027  
Task 3/Subtask 3 PD For New Vector
  $ *     $ *     $ *        0028  
Task 3/Subtask 4-Support of Scale-Up Activities
  $ *     $ *     $ *      
 
                    Option III, Contract Year IV                        
 
                         September 30, 2009 through September 29, 2010          
             
 
                          0029  
Task 1a-Vector Seed Stock Production
  $ *     $ *     $ *  

6

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

                                                      Cost Plus                
        Fixed Fee      Line Item   Description   Cost   Fee   (Max)       0030  
Task 1b-Ad41 Vectors Targeted to Mucosa
  $ *     $ *     $ *         0031  
Task 2/Subtask 1-Manufacturing Process Technology Transfer
  $ *     $ *     $ *         0032  
Task 2/Subtask 2-QC Method Technology Transfer
  $ *     $ *     $ *         0033  
Task 3/Subtask 1-GMP Manufacturing Process Support
  $ *     $ *     $ *         0034  
Task 3/Subtask 2-QC Method Support
  $ *     $ *     $ *         0035  
Task 3/Subtask 3 PD For New Vector
  $ *     $ *     $ *         0036  
Task 3/Subtask 4-Support of Scale-Up Activities
  $ *     $ *     $ *      
 
                        Option IV, Contract Year V                            
 
                             September 30, 2010 through September 29, 2011      
                     
 
                              0037  
Task 1a-Vector Seed Stock Production
  $ *     $ *     $ *         0038  
Task 1b-Ad41 Vectors Targeted to Mucosa
  $ *     $ *     $ *         0039  
Task 2/Subtask 1-Manufacturing Process Technology Transfer
  $ *     $ *     $ *         0040  
Task 2/Subtask 2-QC Method Technology Transfer
  $ *     $ *     $ *         0041  
Task 3/Subtask 1-GMP Manufacturing Process Support
  $ *     $ *     $ *         0042  
Task 3/Subtask 2-QC Method Support
  $ *     $ *     $ *         0043  
Task 3/Subtask 3 PD For New Vector
  $ *     $ *     $ *         0044  
Task 3/Subtask 4-Support of Scale-Up Activities
  $ *     $ *     $ *  

d.   The contractor shall be reimbursed by the Government in an amount not less
than a total of $    *     (minimum) nor more than a total of $52,032,290
(maximum) for successful performance of this contract.

e.   The estimated amount and quantity of items set forth in Sections c.1. and
c.2. above is not a guarantee that the estimated quantities will be required or
ordered.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a.   Items Unallowable Unless Otherwise Provided       Notwithstanding the
clause[s], 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;

7

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  (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 See
subparagraph b. 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.

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.   Indirect Costs

  (1)   Contractor will establish a negotiated rate agreement with a Government
auditing agency. Until such time that the negotiated rate agreement is
established, the Contractor will use the current provisional indirect rates of
*% fringe and bonus and *% combined G&A and overhead are the ceiling for billing
purposes. When the contractor establishes an indirect rate agreement, the
provisional and final rates contained therein will be incorporated into the
contract without further action. Final invoices will not be paid until a
negotiated rate agreement is established.     (2)   The Contractor shall
complete all work in accordance with the Statement of Work, terms and conditions
of this contract.

b.   Any costs for items included in Article B.3 that were included in the
contractor =s final proposal, dated 9/25/06, are hereby approved at the
estimated costs without further notification.   c.   Non-Personal Services and
Inherently Government Functions

8

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  (1)   Pursuant to FAR 37.1, no personal services shall be performed under this
contract. All work requirements shall flow only from the Project Officer to the
Contractor’s Project Manager. No Contractor employee will be directly supervised
by the Government. All individual employee assignments, and daily work
direction, shall be given by the applicable employee supervisor. If the
Contractor believes any Government action or communication has been given that
would create a personal services relationship between the Government and any
Contractor employee, the Contractor shall promptly notify the Contracting
Officer of this communication or action.     (2)   Pursuant to FAR 7.5, the
Contractor shall not perform any inherently Governmental actions under this
contract. No Contractor employee shall hold him or herself out to be a
Government employee, agent, or representative. No Contractor employee shall
state orally or in writing at any time that he or she is acting on behalf of the
Government. In all communications with third parties in connection with this
contract, Contractor employees shall identify themselves as Contractor employees
and specify the name of the company for which they work. In all communications
with other Government contractors in connection with this contract, the
Contractor employee shall state that they have no authority to in any way change
the contract and that if the other contractor believes this communication to be
a direction to change their contract, they should notify the Contracting Officer
for that contract and not carry out the direction until a clarification has been
issued by the Contracting Officer.     (3)   The Contractor shall insure that
all of its employees working on this contract are informed of the substance of
this article. Nothing in this article shall limit the Government=s rights in any
way under the other provisions of the contract, including those related to the
Government=s right to inspect and accept the services to be performed under this
contract. The substance of this article shall be included in all subcontracts at
any tier.

d.   Task order 1 is hereby incorporated into the contract. Funds have been
obligated in the amount of $* for this requirement.

SECTION C — DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK

a.   Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work, dated, 9/13/06 , set forth in SECTION J-List of
Attachments, attached hereto and made a part of this contract.

ARTICLE C.2. REPORTING REQUIREMENTS

9

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
See Statement of Work for reporting requirements
SECTION D — PACKAGING, MARKING AND SHIPPING
ARTICLE D.1. PACKAGING
All non-frozen cell sample material shall be shipped at room temperature in a
cardboard container. Frozen samples are to be shipped on dry ice in a styrofoam
container.
ARTICLE D.3. SHIPPING
All cell samples shall be shipped F.O.B destination. The specific address for
shipment of samples will be specified by the project officer. Please note that
some items may ship directly to the Vaccine Pilot Plant in Frederick, MD.
Kimberlee Wallace (Project Officer)
Vaccine Research Center/Vaccine Pilot Plant
National Institutes of Allergy and Infectious Diseases
40 Convent Drive
Room 5507
Bethesda, MD 20892
All other deliverables required under this contract shall be packaged, marked,
and shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and contractor name. The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.
SECTION E — INSPECTION AND ACCEPTANCE

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

b.   For the purpose of this SECTION, Kimberlee Wallace is the authorized
representative of the Contracting Officer.

c.   Inspection and acceptance will be performed at: the Government’s facility
or the Contractor’s plant during development and testing.

    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 52.246-2, Inspection
Of Supplies—Fixed Price (August 1996).

10

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

    FAR Clause 52.246-5, Inspection Of Services—Cost Reimbursement (April 1984).

SECTION F — DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE

a.   The period of performance of this contract shall be from September 30, 2006
through September 29, 2011 (for CLIN 0001).

b.   If the Government exercises its option(s), pursuant to Article H.3 of the
contract, the period of performance for CLINs 0003 — 0044 will be increased as
follows:

      Option Year Number   Option Period
Option I, Contract Year II
  September 30, 2007 through September 29, 2008
Option II, Contract Year III
  September 30, 2008 through September 29, 2009
Option III, Contract Year IV
  September 30, 2009 through September 29, 2010
Option IV, Contract Year V
  September 30, 2010 through September 29, 2011

ARTICLE F. 2. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in Article C.1. and upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative, of
the following items in accordance with the stated delivery schedule:

a.   The items specified below as described in SECTION C, ARTICLE C.2. will be
required to be delivered F.O.B. Destination as set forth in FAR Clause
52.247-35, F.O.B. Destination, Within Consignees Premises (April 1984), and in
accordance with and by the date(s) specified below[and any specifications stated
in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:

                  Item   Description   Quantity                   Delivery
Schedule
(1)
  Quarterly/Annual Report     2     10th of the following month
(2)
  5-Year Executed License of Adenovector Manufacturing Process     1     Within
60 days of Award
(3)
  Executed license of Packaging Cell Line     1     Within 60 days of Award and
yearly if requested
(4)
  Technology Transfer Report of Adenovector Manufacturing Process     1     As
Requested
(5)
  Packaging Cell Line     1     As Requested
(6)
  Adenoviral Seed Stock     1     As Requested

11

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

b.   The above items shall be addressed and delivered as indicated below, or as
specified by the Project Officer. Note that delivery of some items may directed
to the Vaccine Pilot Plant in Frederick, MD

              Addressee   Deliverable Item No.   Quantity  
Kimberlee Wallace, Project Officer
  1-6     1  
Vaccine Research Center/Vaccine Pilot Plant
           
NIH/National Institutes of Allergy and
           
Infectious Diseases
           
40 Convent Drive
           
Room 5507
           
Bethesda, MD 20892
           
 
           
Terrie Nestor, Contracting Officer
  1-2     1  
NIH/National Institutes of Allergy and
           
Infectious Diseases
           
10401 Fernwood Road, Suite 2NE70
           
Bethesda, MD 20892
           

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE
This contract incorporates the following clause(s) by reference, with the same
force and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available. Also, the full text of a clause may
be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
     52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).
     52.247-35, F.O.B. Destination Within Consignees Premises (April 1984).
SECTION G — CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose
of this contract: Kimberlee Wallace
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)

12

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
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. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT

a.   Invoice/Financing Request Instructions and Contract Financial Reporting for
NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of
this contract. The instructions and the following directions for the submission
of invoices/financing request must be followed to meet the requirements of a
“proper” payment request pursuant to FAR 32.9.       These instructions also
provide for the submission of financial and personnel reporting required by
HHSAR 342.7002.

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

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

Contract No. HHSN272200600027C
ADB Contract No. N01-AO-60027

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

LaDonna Stewart
Contract Specialist
NIH/National Institutes of Allergy and Infectious Diseases
10401 Fernwood Road, Suite 2NE14
Bethesda, MD 20892

  (2)   Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496 – 3878.

b.   Financial reports on the attached Form NIH 2706, Financial Report of
Individual Project/Contract, shall be submitted by the Contractor in accordance
with the Instructions for Completing Form NIH

13

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

    2706, which accompany the form, in an original and two copies, not later
than the 30th working day after the close of the reporting period. The line
entries for subdivisions of work and elements of cost (expenditure categories),
which shall be reported within the total contract, are listed in paragraph e.,
below. Subsequent changes and/or additions in the line entries shall be made in
writing.

  (1)   Unless otherwise stated in that part of the Instructions for Completing
Form NIH 2706, entitled “PREPARATION INSTRUCTIONS,” all columns A through J,
shall be completed for each report submitted.     (2)   The first financial
report shall cover the period consisting of the FIRST FULL THREE CALENDAR MONTHS
following the date of the contract, in addition to any fractional part of the
initial month. Thereafter, reports will be on a quarterly basis.     (3)   The
Contracting Officer may require the Contractor to submit detailed support for
costs contained in one or more interim financial reports. This clause does not
supersede the record retention requirements in FAR Part 4.7.     (4)   The
following is a listing of expenditure categories to be reported:

          Expenditure Category   Percentage of   A   Effort/Hours  
(a) Direct Labor
       
1) Principal Investigator
       
2) Co-Principal Investigator
       
3) Key Personnel
       
(i)
       
(ii)
       
(iii)
       
(b) Other Professional Personnel
       
(c) Personnel — Other
       
(d) Fringe Benefits
       
(e) Accountable Personal Property
       
(f) Materials/Supplies
       
(g) Patient Care Costs
       
(h) Travel
       
(i) Consultant Costs
       
(j) Premium Pay
       
(k) Computer Costs
       
(l) Subcontract Costs
       
(m) Other Direct Costs
       
(n) Indirect Costs
       
(o) G&A Expense
       
(p) Total Cost
       
(q) Fee
       
(r) Total Cost Plus Fixed Fee
       

14

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  (5)   The Government may unilaterally revise the NIH 2706 to reflect the
allotment of additional funds.

c.   For Fixed-Price line items only: The contractor need not submit an itemized
breakdown as described above. Invoice instructions for NIH Fixed-Price Type
Contracts, NIH (RC)-2, are attached for informational purposes. Invoices for
CLINs 0001 through 0006, can be submitted in accordance with these instructions.
However, invoices for fixed-price and cost-reimbursement items may be combined
onto one invoice detailing the appropriate information for each.

ARTICLE G.3. 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 6B05
6100 EXECUTIVE BLVD MSC-7540
BETHESDA MD 20892-7540
Relevant to Article B.4 ADVANCED UNDERSTANDINGS of this contract; the contractor
must establish an Indirect Rate Agreement with a Government agency. At such time
that an Indirect Rate Agreement is established, the negotiated rates will be
incorporated into the contract without further action of the Contracting
Officer.
ARTICLE G.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

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

15

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  of the contract file, and may be used to support future award decisions.

b.   Electronic Access to Contractor Performance Evaluations       Contractors
that have Internet capability may access evaluations through a secure Web site
for review and comment by completing the registration form that can be obtained
at the following address:

          http://oamp.od.nih.gov/OD/CPS/cps.asp

    The registration process requires the contractor to identify an individual
that will serve as a primary contact and who will be authorized access to the
evaluation for review and comment. In addition, the contractor will be required
to identify an alternate contact who will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.

SECTION H — SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. HUMAN SUBJECTS
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract.
ARTICLE H.2. 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. 109-149, Title V-General Provisions Section 505     2006    
(10/1/2005-9/30/2006)

ARTICLE H.3. OPTION PROVISION
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of Year I of the Statement
of Work (as detailed in Sections B.2. and B.3.) and the Five-year Licensing and
Technology Transfer of the Adenovector Manufacturing Process as defined in
Sections C and F of the contract. Pursuant to clause 52.217-9 set forth in
ARTICLE I.3. of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform Contract Year(s) II, III, IV,
and V of the Statement of Work as also defined in Sections C and F of this
contract. If the Government exercises this option, notice must be given at least
60 days prior to the expiration date of this contract, and the estimated price
and/or cost plus fixed fee of the contract will be increased as set forth in
Article B.2. and B.3.

16

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
ARTICLE H.4. SALARY RATE LIMITATION LEGISLATION PROVISIONS

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

                  b.   Public Law No.   Fiscal Year     Dollar Amount of Salary
Limitation
 
               
 
  P.L. 109-149, Public Health & Social Services Emergency Fund General
Provisions, Section 204   FY 06       Executive Level I

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

ARTICLE H.5. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:

    “This project has been funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National Institutes
of Health, Department of Health and Human Services, under Contract No.
N01-AO-60027.”

ARTICLE H.6. 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

17

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

    financed by non-governmental sources.

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

ARTICLE H.7. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General=s Office in writing or on the Inspector General=s Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
ARTICLE H.8. 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. 109-149, Title V-General Provisions Section 503a.  
FY-06   (10/1/2005-9/30/2006)
 
               
 
  for b., above:   P.L. 109-149, Title V-General Provisions Section 503b.  
FY-06   (10/1/2005-9/30/2006)

18

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
PART II — CONTRACT CLAUSES
SECTION I — CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY AND
COST-REIMBURSEMEMT SERVICE CONTRACT — FAR 52.252-2, CLAUSES INCORPORATED BY
REFERENCE (FEBRUARY 1998)
This contract incorporates one or more clauses by reference, with the same force
and effect, as if they were given in full text. Upon request, the Contracting
Officer will make their full text available. Also, the full text of a clause may
be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES

          FAR         CLAUSE NO.   DATE   TITLE 52.202-1   Jul 2004  
Definitions (Over $100,000)
       
 
52.203-3   Apr 1984  
Gratuities (Over $100,000)
       
 
52.203-5   Apr 1984  
Covenant Against Contingent Fees (Over $100,000)
       
 
52.203-6   Jul 1995  
Restrictions on Subcontractor Sales to the Government (Over $100,000)
       
 
52.203-7   Jul 1995  
Anti-Kickback Procedures (Over $100,000)
       
 
52.203-8   Jan 1997  
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over $100,000)
       
 
52.203-10   Jan 1997  
Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
       
 
52.203-12   Sep 2005  
Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
       
 
52.204-4   Aug 2000  
Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
       
 
52.204-7   Oct 2003  
Central Contractor Registration
       
 
52.209-6   Jan 2005  
Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $25,000)
       
 
52.215-2   Jun 1999  
Audit and Records — Negotiation (Over $100,000)
       
 
52.215-8   Oct 1997  
Order of Precedence — Uniform Contract Format
       
 
52.215-10   Oct 1997  
Price Reduction for Defective Cost or Pricing Data
       
 
52.215-12   Oct 1997  
Subcontractor Cost or Pricing Data (Over $500,000)
       
 
52.215-14   Oct 1997  
Integrity of Unit Prices (Over $100,000)
       
 
52.215-15   Oct 2004  
Pension Adjustments and Asset Reversions
       
 
52.215-18   Jul 2005  
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions

19

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

          FAR         CLAUSE NO.   DATE   TITLE 52.215-19   Oct 1997  
Notification of Ownership Changes
       
 
52.215-20   Oct 1997  
Requirements for Cost or Pricing Data or Information Other Than Cost or
Pricing Data
       
 
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 Costs and Payment
       
 
52.216-8   Mar 1997  
Fixed Fee
       
 
52.219-8   May 2004  
Utilization of Small Business Concerns (Over $100,000)
       
 
52.222-2   July 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   June 2003  
Convict Labor
       
 
52.222-19   Jan 2006  
Child Labor Cooperation with Authorities and Remedies
       
 
52.222-21   Feb 1999  
Prohibition of Segregated Facilities
       
 
52.222-26   Apr 2002  
Equal Opportunity
       
 
52.222-35   Dec 2001  
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans
       
 
52.222-36   Jun 1998  
Affirmative Action for Workers with Disabilities
       
 
52.222-37   Dec 2001  
Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans
       
 
52.225-13   Feb 2006  
Restrictions on Certain Foreign Purchases
       
 
52.227-1   Jul 1995  
Authorization and Consent
       
 
52.227-2   Aug 1996  
Notice and Assistance Regarding Patent and Copyright Infringement (Over
$100,000)
       
 
52.227-3   Apr 1984  
Patent Indemnity
       
 
52.227-14   June 1987  
Rights in Data — General
       
 
52.229-3   Apr 2003  
Federal, State, and Local Taxes (Over $100,000)
       
 
52.232-1   Apr 1984  
Payments
       
 
52.232-8   Feb 2002  
Discounts for Prompt Payment
       
 
52.232-9   Apr 1984  
Limitation on Withholding of Payments
       
 
52.232-11   Apr 1984  
Extras
       
 
52.232-17   Jun 1996  
Interest (Over $100,000)
       
 
52.232-20   Apr 1984  
Limitation of Costs

20

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

          FAR         CLAUSE NO.   DATE   TITLE 52.232-23   Jan 1986  
Assignment of Claims
       
 
52.232-25   Oct 2003  
Prompt Payment
       
 
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
       
 
52.233-4   Oct 2004  
Applicable Law for Breach of Contract Claim
       
 
52.242-3   May 2001  
Penalty for Unallowable Costs (Over $500,000)
       
 
52.242-4   Jan 1997  
Certification of Final Indirect Costs
       
 
52.242-13   July 1995  
Bankruptcy (Over $100,000)
       
 
52.243-1   Aug 1987  
Changes — Fixed-Price
       
 
52.243-2   Aug 1987  
Changes Cost Reimbursement w/ Alternate I (Apr 1984)
       
 
52.244-2   Aug 1998  
Subcontracts
       
 
52.244-6   Feb 2006  
Subcontracts for Commercial Items
       
 
52.245-2   May 2004  
Government Property (Fixed-Price Contracts)
       
 
52.245-5   May 2004  
Government Property (Cost Reimbursement, Time and Material, or Labor-Hour
Contract)
       
 
52.245-9   Aug 2005  
Use and Charges
       
 
52.246-25   Feb 1997  
Limitation of Liability- Services (Over $100,000)
       
 
52.249-2   May 2004  
Termination for the Convenience of the Government (Fixed-Price)
       
 
52.249-6   Sept 1996  
Termination (Cost-Reimbursement)
       
 
52.249-8   Apr 1984  
Default (Fixed-Price Supply and Service)(Over $100,000)
       
 
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
       
 
352.228-7   Dec 1997  
Insurance — Liability to Third Persons
       
 
352.232-9   Apr 1984  
Withholding of Contract Payments
       
 
352.242-70   Apr 1984  
Litigation and Claims
       
 
352.242-71   Apr 1984  
Final Decisions and Audit Findings

21

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

          HHSAR         CLAUSE NO.   DATE   TITLE 352.270-4   Jan 2001  
Pricing of Adjustments
       
 
352.270-5   Apr 1984  
Key Personnel
       
 
352.270-6   Jul 1991  
Publications and Publicity
       
 
352.270-7   Jan 2001  
Paperwork Reduction Act

[ End of GENERAL CLAUSES FOR A NEGOTIATED FIXED PRICE SUPPLY CONTRACT — Rev.
04/2006].
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
     ARTICLE I.1. of this SECTION is hereby modified as follows:
     Alternate I (October 1997) of FAR Clause 52.215-14, Integrity of Unit
Prices (October 1997) is added.
     Alternate II (June 1987) of FAR Clause 52.227-14, Rights in Data – General
(June 1987) is added.
               Alternate II (June 1987). As prescribed in 27.409(c), insert the
following paragraph (g)(2) in the clause:
     (g)(2) Notwithstanding paragraph (g)(1) of this clause, the contract may
identify and specify the delivery of limited rights data, or the Contracting
Officer may require by written request the delivery of limited rights data that
has been withheld or would otherwise be withholdable. If delivery of such data
is so required, the Contractor may affix the following “Limited Rights Notice”
to the data and the Government will thereafter treat the data, subject to the
provisions of paragraphs (e) and (f) of this clause, in accordance with such
Notice:
Limited Rights Notice (June 1987)
     (a) These data are submitted with limited rights under Government Contract
No. HHSN272200600027. These data may be reproduced and used by the Government
with the express limitation that they will not, without written permission of
the Contractor, be used for purposes of manufacture nor disclosed outside the
Government; except that the Government may disclose these data outside the
Government for the following purposes, if any; provided that the Government
makes such disclosure subject to prohibition against further use and disclosure:
[Agencies may list additional purposes as set forth in 27.404(d)(1) or if none,
so state.]
     i. Use (Except for Manufacture) by support service contractors; and by
support service and other contractors participating in the Government’s program
of which the specific contract is a part, solely for information and use in
connection with the work performed under the contract.
     (b) This Notice shall be marked on any reproduction of these data, in whole
or in part.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
contracting officer will make their full text available.

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

  (1)   FAR Clause 52.204-9, Personal Identity Verification of Contractor
Personnel, (Jan 2006) is added         FAR Clause 52.216-18, Ordering
(October 1995)

22

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  (a)   Any supplies and services to be furnished under this contract (CLINs
0007-0044) shall be ordered by issuance of delivery orders or task orders by the
individuals or activities designated in the Schedule. Such orders may be issued
from September 30, 2006 through September 29, 2007.     (b)   All delivery
orders or task orders are subject to the terms and conditions of this contract.
In the event of conflict between delivery order or task order and this contract,
the contract shall control.

  (2)   FAR Clause 52.216-22, Indefinite Quantity (October 1995)

  (a)   This is an indefinite-quantity contract for the supplies or services
specified, and effective for the period stated, in the Schedule. The quantities
of supplies and services specified in the schedule are estimates only and are
not purchased by this contract.     (b)   Delivery or performance shall be made
only as authorized by orders issued in accordance with the Ordering clause. The
Contractor shall furnish to the Government, when and if ordered, the supplies or
services specified in the Schedule up to and including the quantity designated
in the Schedule as the “maximum.” The Government shall order at least the
quantity of supplies or services designated in the Schedule as the “minimum.”  
  (c)   Except for any limitations on quantities in the Schedule, there is no
limit on the number of orders that may be issued The Government may issue orders
requiring delivery to multiple destinations or performance at multiple
locations.     (d)   Any order issued during the effective period of this
contract and not completed within that period shall be completed by the
Contractor within the time specified in the order. The contract shall govern the
Contractor’s and Government’s rights and obligations with respect to that order
to the same extent as if the order were completed during the contract’s
effective period; provided, that the Contractor shall not be required to make
any deliveries under this contract after September 29, 2007 .

(End of clause)

  (3)   FAR Clause 52.217-2, Cancellation under Multi-year Contract (July 1996)
    (4)   FAR Clause 52.217-5, Evaluation of Options (July 1990)     (5)   FAR
Clause 52.217-8, Option to Extend Services (November 1999)

“...The Contracting Officer may exercise the option by written notice to the
Contractor within 60 calendar days prior to contract expiration date, including
options, if any.”

  (6)   FAR Clause 52.217-9, Option to Extend the Term of the Contract
(March 2000)

  (a)   The Government may extend the term of this contract by written notice to
the Contractor within 60 calendar days prior to the contract expiration date
including options, if any; provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least 60 days before the
contract expires. The preliminary notice does not commit the Government to an
extension.     (b)   The total duration of this contract, including the exercise
of any options under this clause, shall not exceed 5 years.

  (7)   FAR Clause 52.223-5, Pollution Prevention and Right to Know Information
(Aug 2003)     (8)   FAR Clause 52.232-18, Availability of Funds (April 1984)  
  (9)   FAR Clause 52.237-2, Protection of Government Buildings, Equipment, and
Vegetation (Apr 1984)     (10)   FAR Clause 52.246-23, Limitation of Liability
(Feb 1997)

23

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

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

          THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.

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

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

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

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 52.216-19, Order Limitations (October 1995)

  (a)   Minimum Order. When the Government requires supplies or services covered
by this contract in an amount of less than $50,000, the Government is not
obligated to purchase, nor is the Contractor obligated to furnish, those
supplies or services under the contract.     (b)   Maximum Order. The Contractor
is not obligated to honor--

  (1)   Any order for a single item in excess of $*.     (2)   Any order for a
combination of items in excess of $* ; or     (3)   A series of orders from the
same ordering office within 30 days that together call for quantities exceeding
the limitation in subparagraph (1) or (2) above.

  (c)   If this is a requirements contract (i.e., includes the Requirements
clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the
Government is not required to order a part of any one requirement from the
Contractor if that requirement exceeds the maximum-order limitations in
paragraph (b) above.     (d)   Notwithstanding paragraphs (b) and (c) above, the
Contractor shall honor any order exceeding the maximum order limitations in
paragraph (b), unless that order (or orders) is returned to the ordering office
within    5   days after issuance, with written notice stating the Contractor’s
intent not to ship the item (or items) called for and the reasons. Upon
receiving this notice, the Government may acquire the supplies or services from
another source.

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

24

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

(a)   Definition. As used in this clause--       United States means the 50
States, the District of Columbia, Puerto Rico, the Northern Mariana Islands,
American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.

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

Notice to Employees
Under Federal law, employees cannot be required to join a union or maintain
membership in a union in order to retain their jobs. Under certain conditions,
the law permits a union and an employer to enter into a union-security agreement
requiring employees to pay uniform periodic dues and initiation fees. However,
employees who are not union members can object to the use of their payments for
certain purposes and can only be required to pay their share of union costs
relating to collective bargaining, contract administration, and grievance
adjustment.
If you do not want to pay that portion of dues or fees used to support
activities not related to collective bargaining, contract administration, or
grievance adjustment, you are entitled to an appropriate reduction in your
payment. If you believe that you have been required to pay dues or fees used in
part to support activities not related to collective bargaining, contract
administration, or grievance adjustment, you may be entitled to a refund and to
an appropriate reduction in future payments.
For further information concerning your rights, you may wish to contact the
National Labor Relations Board (NLRB) either at one of its Regional offices or
at the following address or toll free number:
National Labor Relations Board
Division of Information
1099 14th Street, N.W.
Washington, DC 20570
1-866-667-6572
1-866-316-6572 (TTY)
To locate the nearest NLRB office, see NLRB’s website at http://www.nlrb.gov.

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

25

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

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

  (1)   Contractors and subcontractors that employ fewer than 15 persons;    
(2)   Contractor establishments or construction work sites where no union has
been formally recognized by the Contractor or certified as the exclusive
bargaining representative of the Contractor’s employees;     (3)   Contractor
establishments or construction work sites located in a jurisdiction named in the
definition of the United States in which the law of that jurisdiction forbids
enforcement of union-security agreements;     (4)   Contractor facilities where
upon the written request of the Contractor, the Department of Labor Deputy
Assistant Secretary for Labor-Management Programs has waived the posting
requirements with respect to any of the Contractor’s facilities if the Deputy
Assistant Secretary finds that the Contractor has demonstrated that—

  (i)   The facility is in all respects separate and distinct from activities of
the Contractor related to the performance of a contract; and     (ii)   Such a
waiver will not interfere with or impede the effectuation of the Executive
order; or

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

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

  (1)   Obtain the required employee notice poster from the Division of
Interpretations and Standards, Office of Labor-Management Standards, U.S.
Department of Labor, 200 Constitution Avenue, NW, Room N-5605, Washington, DC
20210, or from any field office of the Department’s Office of Labor-Management
Standards or Office of Federal Contract Compliance Programs;     (2)   Download
a copy of the poster from the Office of Labor-Management Standards website at
http://www.olms.dol.gov; or

26

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

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

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

27

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J — LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:

1.   Statement of Work, dated 9/13/06, 6 pages.   2.   Sample Contract Task
Order Form, 3 pages.   3.   Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (5/97), 4 pages.   4.   Invoice Instructions for NIH
Fixed-Price Contracts, NIH(RC)-2, (5/97), 1 page. Invoice/Financing Request   5.
  Financial Report of Individual Project/Contract, NIH 2706, (5/97), 1 page.  
6.   Instructions for Completing form NIH 2706, Financial Report of Individual
Project/Contract, (5/97), 3 pages.   7.   Procurement of Certain Equipment,
NIH(RC)-7, 4/1/84, 1 page.   8.   Disclosure of Lobbying Activities,
SF-LLL,dated 7/97, 3 pages.

28

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
PART IV
SECTION K — REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:

1.   Annual Representations and Certifications completed and located at the
Online Representations and Certifications Application (ORCA) website. [This
includes the changes identified in paragraph (b) of the FAR provision 52.204-8,
Annual Representations and Certifications, contained in the contractor’s
proposal.]

END of the SCHEDULE
(CONTRACT)

29

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
STATEMENT OF WORK
I. Background
The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National
Institutes of Health was established to facilitate research in vaccine
development. The VRC is dedicated to improving global human health through the
rigorous pursuit of effective vaccines for human diseases. The Vaccine
Production Program at the VRC is responsible for the manufacture, pre-clinical
safety testing, and regulatory submission of VRC vaccines for clinical trials.
To date, these materials are obtained through collaborations with companies in
the vaccine/biotechnology industry as well as through contract manufacturing.
Such an approach is costly and prohibits the VRC from rapidly responding to
emerging public health threats.
One of the key components of the VRC mission involves the rapid advancement of
promising vaccine candidates from the laboratory to the clinic. Meeting this
mission necessitates the development of a vaccine production infrastructure that
includes the capacity for cGMP production of materials for Phase I/II clinical
trials. To expeditiously meet the critical program needs of the clinical
department, the VRC developed a Vaccine Pilot Plant (VPP) for the manufacture of
clinical materials for Phase I/II/III trials
II. General
This contract covers the licensing and technology transfer of a manufacturing
process for the production of non-replication competent adenoviral vector-based
vaccines against HIV. A team consisting of representatives from the VRC/NIH and
the Contractor will mutually determine the specific vector constructs to be used
in the clinical trials. The material for the clinical trials will be
manufactured at the VPP located in Frederick, MD. The VPP is a multi-product
facility consisting of four processing suites with processing scales from 15L to
2000L. VPP personnel will conduct the engineering runs, production of clinical
materials and scale-up activities associated with manufacturing while relying
upon the technical expertise of the Contractor to troubleshoot potential
problems. Although the manufacturing will be completed at the VPP, instances may
arise which require some contract work to be performed at the Contractor’s site.
Examples of such instances include, but are not limited to the following: *
The licensing requirements of the contract will be procured on a firm fixed
price basis. The technical consultations and troubleshooting requirements will
be procured on an IDIQ/Cost Reimbursement basis.
III. Fixed Price Requirements

A.   Licensing and technology transfer of the Contractor’s proprietary
Adenovector manufacturing process to the VRC for production of non-replication
competent adenoviral vectors containing HIV gene inserts.       *

          Statement of Work
(09/13/06 )   1   ATTACHMENT 1
Page 1

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
*

B.   Licensing of the Contractor’s packaging cell line to be used for the
propagation of the adenoviral vectors containing HIV gene inserts.

*

          Statement of Work
(09/13/06 )   2   ATTACHMENT 1
Page 2

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
*

C.   Deliverables

  1)   Executed five (5) year licensing agreement covering the manufacturing
process used in the production of clinical grade adenoviral vector vaccines
against HIV     2)   Technology transfer report that includes the components
listed in Item A above and describes the Contractor’s existing manufacturing
process     3)   Executed annual licensing agreement providing the VRC with
access to the Contractor’s proprietary packaging cell line for cultivating
adenoviral vectors containing HIV inserts     4)   Five (5) vials of a research
cell stock or master cell bank of the packaging cell line for use for
propagation at the VPP     5)   Certificate of Analysis (COA) for the specific
lot of packaging cells transferred to the VPP for propagation. The COA should be
reviewed and approved by the Contractor’s Quality department prior to issuance
to the VRC/VPP     6)   A yearly report detailing any changes or modifications
to the Contractor’s manufacturing process. If available, draft batch records or
development reports should also be provided

IV. Cost Reimbursement Tasks
Issuance of Tasks:

          Statement of Work
(09/13/06 )   3   ATTACHMENT 1
Page 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
The following IDIQ tasks involve production of a vector seed stock,
troubleshooting and scaling up of the manufacturing process and will be procured
on a cost-reimbursement basis. NIH may issue the tasks for this contract in
several ways: individually; as a grouping of multiple issuances of a single task
(e.g., issue task #1 three times for three different constructs); or groupings
of multiple tasks (e.g., perform tasks 1-4). If groupings of multiple tasks
orders are issued, written permission from the NIH Project Officer may be
required to proceed from one task to the next. This will be specified in such
tasks.
Task #1a — Provide an Adenoviral Vector Seed Stock Containing the Appropriate
VRC Insert.
*
Task #1b — Provide vector seed stocks for novel recombinant Ad41 containing
vectors targeted to mucosa.
*
Task #2 — Provide Technical Support and Troubleshooting Assistance During the
Performance of Technology Transfer/Engineering Runs
*

          Statement of Work
(09/13/06 )   4   ATTACHMENT 1
Page 4

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
*
Task #3 — Provide Manufacturing and Scale-Up Support for Ad5 or Alternate
Serotype Vectors
*

          Statement of Work       ATTACHMENT 1 (09/13/06)   5   Page 5

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
V. Contract Management and Reporting Requirements
The Contractor shall provide the technical and functional activities necessary
for the management of this SOW and resulting Contract activities. The Contractor
shall employ a management approach, organizational resources, and implement a
quality control plan to achieve cost, schedule, and performance requirements
throughout Contract execution. The Contractor shall meet with the Project
Officer on a regular basis and provide regular Contract status and financial
reports, including status of individual tasks where relevant.
At the request of the Project Officer, the Contractor shall provide
deliverables, including written reports, presentations, and other materials — in
draft form for Government review and comment, and in final form — conforming to
schedule, format, and other requirements as specified by the Project Officer. In
addition to Contract status reports, deliverables may include project plans,
management briefings, financial reports, analyses, evaluations, reviews, and
other reports as required. Specific requirements for status reports follow.
Contractor may invoice monthly or quarterly, following submission of these
reports, based upon the percentage of the work completion.
In addition to the reporting requirements detailed in the above deliverables
section, the following reports are also required under this contract. For all
reports listed below, deliver one (1) copy to the Project Officer and one
(1) copy to the Contracting Officer.
1) Quarterly Progress Report: Quarterly progress reports should contain the
following information:
Summary of the results for each task in progress/completed during the quarter
Identification of any problems incurred during the quarter and whether they have
an impact on delivery/completion. If the problems are anticipated to impact
delivery/completion, new delivery dates should be noted
Percent of funds expended and percent of work completed for each task order on a
quarterly and year to date basis
A. Delivery Schedule

      Deliverable   Deliverable Due Date
Status Reports
  Monthly or as mutually agreed.
Revised Status Reports
  Within five days of request.
Progress Reports
  Quarterly or as mutually agreed
Other Deliverable Products
  As required & specified in Government requests.
Revised Deliverable Products
  Within mutually agreed period.

VI. Place of Performance
Tasks will be performed at NIH offices/laboratories of the Vaccine Pilot Plant
located in Frederick, MD and/or the Contractor’s facilities as required.

          Statement of Work       ATTACHMENT 1 (09/13/06)   6   Page 6

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
CONTRACT TASK ORDER FORM

         
Contractor:                                        
  Task Order Title:    
 
       
Contract No:                                        
       
 
       
Task Order No:                              Modification
No.:                    
  Task Order Originator:    
 
       
Contracted Task Area:                                        
  Date Prepared:    

 
Part I. INITIATOR’S REQUEST

  A.   Period of Performance: From                    to     B.   Task
Description     C.   Task Leader     D.   Deliverables     E.   Task Order
Response Due Date:

          Contract Task Order Form       ATTACHMENT 2     1   Page 1

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
CONTRACT TASK ORDER FORM

         
Contractor:                                        
  Contract No:    
 
       
Task Order No:                              Modification No:                    
  Date Prepared:    

 

PART II.   CONTRACTOR’S RESPONSE TO TASK ORDER. REQUEST
(The Contractor may attach additional sheets to this form to present requested
data.)

  A.   Estimated Cost and Effort

  1.   Labor hours — list Task Order. leader, specific individuals to be
assigned, labor category, and estimated hours for each.     2.   Labor costs —
list by labor category and total.     3.   Employee benefits.     4.   Direct
materials     5.   Travel     6.   Subcontracts     7.   Other direct costs    
8.   Indirect costs     9.   Total estimated costs for this Order

  B.   Detailed description of the approach to be used and of the
deliverable(s). (Be specific.)

 
APPROVAL TO PROCEED: The Contractor shall not exceed the estimated labor hours,
estimated Task Order amount, or change the Task Order leader without the prior
written approval of the Project Officer and the Contracting Officer.
 

             
l.
  For the Contractor:       Date:
 
           
 
      (Signature)    
 
           
 
  Typed name:        
 
           
2.
  For the Government:       Date:
 
           
 
      (Project Officer)    
 
          Date:
 
           
 
      (Contracting Officer)    

          Contract Task Order Form       ATTACHMENT 2     2   Page 2

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
CONTRACT TASK ORDER FORM

         
Contractor:                                        
  Contract No:    
 
       
Task Order No:                              Modification No:                    
  Date Prepared:    

 

PART III.   CONTRACTOR’S REPORT OF TASK ORDER PERFORMANCE

(The Contractor may attach additional sheets to this form to present the
requested data.)

  A.   Actual Cost and Effort

  1.   Labor hours — list specific assigned individuals, labor category, and
actual hours worked.     2.   Labor costs — list labor category, individual, and
total amount.     3.   Employee benefits     4.   Direct Materials     5.  
Travel     6.   Subcontracts     7.   Other direct costs     8.   Indirect costs
    9.   Total costs for this Task Order.

  B.   Report of Deliverables

 

REVIEW AND APPROVAL OF SATISFACTORY PERFORMANCE
The signatures below indicate that the services/products required under Task
Order No.              have been delivered, received and satisfactorily meet the
requirements of this Task Order.

 

             
l.
  For the Contractor:       Date:
 
           
 
      (Signature)    
 
           
 
  Typed name:        
 
           
2.
  For the Government:       Date:
 
           
 
      (Project Officer)    
 
           
 
          Date:
 
           
 
      (Contracting Officer)    

          Contract Task Order Form       ATTACHMENT 2     3   Page 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
INVOICE/FINANCING REQUEST INSTRUCTIONS
FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS, NIH(RC)-1
General: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
Format: Standard Form 1034, “Public Voucher for Purchases and Services Other
Than Personal,” and Standard Form 1035, “Public Voucher for Purchases and
Services Other Than Personal— Continuation Sheet,” or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee’s letter-head or
self-designed form provided that it contains the information shown on the sample
invoice/financing request.
Number of Copies: As indicated in the Invoice Submission Clause in the contract.
Frequency: Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the contracting
officer.
Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
Billing of Costs Incurred: If billed costs include: (l) 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 may be required after the amounts owed have been
settled between the Government and the contractor (e.g., resolution of all
suspensions and audit exceptions).

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

          NIH(RC)-1       ATTACHMENT 3 Rev. 11/2003       Page 1

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

(a)   Designated Billing Office Name and Address — Enter the designated billing
office name 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.   (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)   Amount
Billed for Current Period — Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the period.   (j)   Cumulative
Amount from Inception — 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.

  (l)   Direct Labor — Include salaries and wages paid (or accrued) for direct
performance of 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 COA letter and number, if the equipment is not covered by
the Property Schedule.     •   An asterisk (*) shall precede the item if the
equipment is below the approval level.

      Further itemization of invoices/financing requests shall only be required
for items having specific limitations set forth in the contract.

          NIH(RC)-1       ATTACHMENT 3 Rev. 11/2003       Page 2

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

  (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.

          NIH(RC)-1       ATTACHMENT 3 Rev. 11/2003       Page 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
SAMPLE INVOICE/FINANCING REQUEST

                  (a)   Billing Office Name and Address   (b)  
Invoice/Financing Request No.
 
               
 
  NATIONAL INSTITUTES OF HEALTH                 National Cancer Institute, OA  
(c)   Date Invoice Prepared
 
  EPS, Room___            
 
  6120 EXECUTIVE BLVD MSC                 Bethesda, MD 20892-____________   (d)
  Contract No., ADB No., and Effective Date
(e)
  Payee’s Name and Address                     (f)   Total Estimated Cost of
Contract
 
  ABC CORPORATION            
 
  100 Main Street            
 
  Anywhere, U.S.A. zip code       (g)   Total Fixed Fee

Attention:   Name, Title, and Phone Number
of Official to Whom Payment is Sent

 
(h) This invoice/financing request represents reimbursable costs from Aug. l,
2003 through Aug. 31, 2003
 

                                      (i) Amount Billed     (j) Cumulative
Amount               for Current Period     From Inception   (k)   Direct Costs
                    (l)  
Direct Labor
  $ 3,400     $ 6,800       (2)  
Fringe Benefits
    600       1,200       (3)  
Accountable Personal Property (Attach Form HHS-565)
                       
Permanent Research
    3,000       6,000          
General Purpose
    2,000       2,000       (4)  
Materials and Supplies
    2,000       4,000       (5)  
Premium Pay
    100       150       (6)  
Consultant Fee-Dr. Jones 1 day @ 100 (COA #3)
    100       100       (7)  
Travel (Domestic)
    200       200          
(Foreign)
    200       200       (8)  
Subcontract Costs
    -0-       -0-       (9)  
Other
    -0-       -0-       Total Direct Costs   $ 11,600     $ 20,650          
 
                   
 
                (l)   Cost of Money (Factor) of (Appropriate Base)     2,400    
  3,600   (m)   Indirect Costs — Overhead ______% of Direct Labor or Other Base
(Formula)     4,000       6,000   (n)   Fixed-Fee Earned (Formula)     700      
1,400          
 
            (o)   Total Amount Claimed   $ 18,700     $ 31,650   (p)  
Adjustments                        
Outstanding Suspensions
            (1,700 )        
 
              (q)   Grand Totals   $ 18,700     $ 29,950  

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

     
 
Name of Official)
    (Title)

          NIH(RC)-1       ATTACHMENT 3 Rev. 11/2003       Page 4

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
INVOICE INSTRUCTIONS FOR NIH FIXED-PRICE CONTRACTS, NIH(RC)-2
General The contractor shall submit vouchers or invoices as prescribed herein.
Format Standard Form l034, Public Voucher for Purchases and Services Other Than
Personal, and Standard Form l035, Public Voucher for Purchases and Services
Other than Personal—Continuation Sheet, or the payee’s letterhead or
self-designed form should be used to submit claims for reimbursement.
Number of Copies As indicated in the Invoice Submission Clause in the contract.
Frequency Invoices submitted in accordance with the Payment Clause shall be
submitted upon delivery of goods or services unless otherwise authorized by the
contracting officer.
Preparation and Itemization of the Invoice The invoice shall be prepared in ink
or typewriter as follows:

  (a)   Designated Billing Office and address     (b)   Invoice Number     (c)  
Date of Invoice     (d)   Both the contract number and the ADB number (which
appears in the upper left hand corner of the face page of the contract), and
date     (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)  
Description of goods or services, quantity, unit price, (where appropriate), and
total amount.     (g)   Charges for freight or express shipments other than
F.o.b. destination. (If shipped by freight or express and charges are more than
$25, attach prepaid bill.)     (h)   Equipment If there is a contract clause
authorizing the purchase of any item of equipment, the final invoice must
contain a statement indicating that no item of equipment was purchased or
include a completed NIH Form entitled, “Report of Government Owned, Contractor
Held Property.”

Currency All NIH contracts are expressed in United States dollars. Where
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.

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

 

--------------------------------------------------------------------------------

 

                 
National Institutes of Health
  Project Task:   Contract No.:   Date of Report:    
 
               
FINANCIAL REPORT OF INDIVIDUAL
              0990-0134
PROJECT/CONTRACT, NIH FORM 2706
              0990-0131
 
               
Note: Complete this Form in Accordance with
  Reporting Period:   Contractor Name and Address:        
Accompanying Instructions.
               

                                                                               
              Cumulative   Incurred                         Percentage of  
Incurred Cost   Cost —   Cumulative   Estimated   Estimated Cost at   Negotiated
  Variance (Over     Effort/Hours   at End of Prior   Current   Cost to Date  
Cost to   Completion   Contract   or Under) Expenditure Category   Negotiated  
Actual   Period   Period   (D + E)   Complete   (F + G)   Amount   (I - H)
A
    B       C       D       E       F       G       H       I       J  

          NIH 2706 (5/92) (Formerly HHS-646)       ATTACHMENT 5

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
INSTRUCTIONS FOR COMPLETING FORM NIH 2706
“FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT”
GENERAL INFORMATION
Purpose. Form NIH 2706 is designed to: (1) provide a management tool for use by
be NIH in monitoring the application of financial and personnel resources to the
NIH contracts; (2) provide contractors with financial and personnel management
data which is usable in their management processes; (3) promptly indicate
potential areas of contract underruns or overruns by making possible comparisons
of actual performance and projections with prior estimates on individual
elements of cost and personnel; and (4) obtain contractor’s analyses of cause
and effect of significant variations between actual and prior estimates of
financial and personnel performance.
REPORTING REQUIREMENTS
Scope. The specific cost and personnel elements to be reported shall be
established by mutual agreement prior to award. The Government may require the
contractor to provide detailed documentation to support any element(s) on one or
more financial reports.
Number of Copies and Mailing Address. An original and two (2) copies of the
report(s) shall be sent to the contracting officer at the address shown on the
face page of the contract, no later than 30 working days after the end of the
period reported. However, the contract may provide for one of the copies to be
sent directly to the project officer.
REPORTING STATISTICS
A modification which extends the period of performance of an existing contract
will not require reporting on a separate Form NIH 2706, except where it is
determined by the contracting officer that separate reporting is necessary.
Furthermore, when incrementally funded contracts are involved, each separate
allotment is not considered a separate contract entity (only a funding action).
Therefore, the statistics under incrementally funded contracts should be
reported cumulatively from the inception of the contract through completion.
Definitions and Instructions for Completing Form NIH 2706. For the purpose of
establishing expenditure categories in Column A, the following definitions and
instructions will be utilized. Each contract will specify the categories to be
reported.

(1)   Key Personnel. Include key personnel regardless of annual salary rates.
All such individuals should be listed by names and job titles on a separate line
including those whose salary is not directly charged to the contract but whose
effort is directly associated with the contract. The listing must be kept up to
date.   (2)   Personnel—Other. List as one amount unless otherwise required by
the contract.   (3)   Fringe Benefits. Include allowances and services provided
by the contractor to employees as compensation in addition to regular salaries
and wages. If a fringe benefit rate(s) has been established, identify the base,
rate, and amount billed for each category. If a rate has not been established,
the various fringe benefit costs may be required to be shown separately. Fringe
benefits which are included in the indirect cost rate should not be shown here.
  (4)   Accountable Personal Property. Include nonexpendable personal property
with an acquisition cost of $1,000 or more and with an expected useful life of
two or more years, and sensitive items regardless of cost. Form HHS 565, “Report
of Accountable Property,” must accompany the contractor’s public voucher (SF
1034/SF 1035) or this report if not previously submitted. See “Contractor’s
Guide for Control of Government Property.”

          Form NIH 2706, Instructions       ATTACHMENT 6         Page 1

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C

(5)   Supplies. Include the cost of supplies and material and equipment charged
directly to the contract, but excludes the cost of nonexpendable equipment as
defined in (4) above.   (6)   Inpatient Care. Include costs associated with a
subject while occupying a bed in a patient care setting. It normally includes
both routine and ancillary costs.   (7)   Outpatient Care. Include costs
associated with a subject while not occupying a bed. It normally includes
ancillary costs only.   (8)   Travel. Include all direct costs of travel,
including transportation, subsistence and miscellaneous expenses. Travel for
staff and consultants shall be shown separately. Identify foreign and domestic
travel separately. If required by the contract, the following information shall
be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure,
destination and return, including time and dates; and (iii) Total cost of trip.
  (9)   Consultant Fee. Include fees paid to consultant(s). Identify each
consultant with effort expended, billing rate, and amount billed.   (10)  
Premium Pay. Include the amount of salaries and wages over and above the basic
rate of pay.   (11)   Subcontracts. List each subcontract by name and amount
billed.   (12)   Other Costs. Include any expenditure categories for which the
Government does not require individual line item reporting. It may include some
of the above categories.   (13)   Overhead/Indirect Costs. Identify the cost
base, indirect cost rate, and amount billed for each indirect cost category.  
(14)   General and Administrative Expense. Cite the rate and the base. In the
case of nonprofit organizations, this item will usually be included in the
indirect cost.   (15)   Fee. Cite the fee earned, if any.   (16)   Total Costs
to the Government.

PREPARATION INSTRUCTIONS
These instructions are keyed to the Columns on Form NIH 2706.
Column A—Expenditure Category. Enter the expenditure categories required by the
contract.
Column B—Percentage of Effort/Hours Negotiated. Enter the percentage of effort
or number of hours agreed to during contract negotiations for each labor
category listed in Column A.
Column C—Percentage of Effort/Hours-Actual. Enter the cumulative percentage of
effort or number of hours worked by each employee or group of employees listed
in Column A.
Column D—Cumulative Incurred Cost at End of Prior Period. Enter the cumulative
incurred costs up to the end of the prior reporting period. This column will be
blank at the time of the submission of the initial report.
Column E—Incurred Cost-Current Period. Enter the costs which were incurred
during the current period.
Column F—Cumulative Incurred Cost to Date. Enter the combined total of Columns D
and E.

          Form NIH 2706, Instructions       ATTACHMENT 6         Page 2

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
Column G—Estimated Cost to Complete. Make entries only when the contractor
estimates that a particular expenditure category will vary from the amount
negotiated. Realistic estimates are essential.
Column H—Estimated Costs at Completion. Complete only if an entry is made in
Column G.
Column I—Negotiated Contract Amount. Enter in this column the costs agreed to
during contract negotiations for all expenditure categories listed in Column A.
Column J—Variance (Over or Under). Complete only if an entry is made in Column
H. When entries have been made in Column H, this column should show the
difference between the estimated costs at completion (Column H) and negotiated
costs (Column I). When a line item varies by plus or minus 10 percent, i.e., the
percentage arrived at by dividing Column J by Column I, an explanation of the
variance should be submitted. In the case of an overrun (net negative variance),
this submission shall not be deemed as notice under the Limitation of Cost
(Funds) Clause of the contract.
Modifications. List any modification in the amount negotiated for an item since
the preceding report in the appropriate cost category.
Expenditures Not Negotiated. List any expenditure for an item for which no
amount was negotiated (e.g., at the discretion of the contractor in performance
of its contract) in the appropriate cost category and complete all columns
except for I. Column J will of course show a 100 percent variance and will be
explained along with those identified under J above.

          Form NIH 2706, Instructions       ATTACHMENT 6         Page 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.

  67   — Photographic Equipment     69   — Training Aids and Devices     70   —
General Purpose ADP Equipment, Software, Supplies and Support (Excluding
7045-ADP Supplies and Support Equipment.)     71   — Furniture     72   —
Household and Commercial Furnishings and Appliances     74   — Office Machines
and Visible Record Equipment     77   — Musical Instruments, Phonographs, and
Home-type Radios     78   — Recreational and Athletic Equipment

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

          NIH(RC)-7 (4/1/84)       ATTACHMENT 7 OMB Bulletin 81-16        

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C                    

    DISCLOSURE OF LOBBYING ACTIVITIES   Approved by OMB
0348-0046

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
(See reverse for public burden disclosure.)

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

     
4. Name and Address of Reporting Entity:
   5. If Reporting Entity in No. 4 is Subawardee, Enter Name and Address of
Prime
o Prime        o Subawardee
   
                          Tier                    , if known:
   
 
   
Congressional District, if known:
  Congressional District, if known:
 
   
6. Federal Department/Agency:
   7. Federal Program Name/Description
 
   
 
  CFDA Number, if applicable:                     
 
   
8. Federal Action Number, if known:
   9. Award Amount, if known:
 
   
 
   $
 
   
10. a. Name and Address of Lobbying Entity
 
b. Individual Performing Services (including address if different from No. 10a)
               (if individual, last name, first name, MI):
      (last name, first name, MI)
 
   
11. Information requested through this form is authorized by title 31 U.S.C.
section 1352. This disclosure of lobbying activities is a material
representation of fact upon which reliance was placed by the tier above when
this transaction was made or entered into. This disclosure is required pursuant
to 31 U.S.C. 1352. This information will be available for public inspection. Any
person who fails to file the required disclosure shall be subject to a civil
penalty of not less than $10,000 and not more than $100,000 for each failure.
  Signature:                                                             

Print Name:                                                             

Title:                                                                          

Telephone No.:                                        Date:                    

     
 
  Authorized for Local Reproduction
Federal Use Only
  Standard Form—LLL (Rev 7-97)

      Disclosure of Lobbying Activities
SF-LLL   ATTACHMENT 8
Page 1 of 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES
This disclosure form shall be completed by the reporting entity, whether
subawardee of prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31
U.S.C. section 1352. The filing of a form is required for each payment or
agreement to make payment to any lobbying entity for influencing of attempting
to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress in
connection with a covered Federal action. Use the SF-LLL-A Continuation Sheet
for additional information if the space on the form is inadequate. Complete all
items that apply for both the initial filing and material change report. Refer
to the implementing guidance published by the Office of Management and Budget
for additional information.

1.   Identify the type of covered Federal action for which lobbying activity is
and/or has been secured to influence the outcome of a covered Federal action.  
2.   Identify the status of the covered Federal action.   3.   Identify the
appropriate classification of this report. If this is a follow-up report caused
by a material change to the information previously reported, enter the year and
quarter in which the change occurred. Enter the date of the last previously
submitted report by this reporting entity for this covered Federal action.   4.
  Enter the full name, address, city, state and zip code of the reporting
entity. Include Congressional District, if known. Check the appropriate
classification of the reporting entity that designates if it is, or expects to
be, a prime or subaward recipient. Identify the tier of the subawardee, e.g.,
the first subawardee of the prime is the 1st tier. Subawards include but are not
limited to subcontracts, subgrants and contract awards under grants.   5.   If
the organization filing the report in item 4 checks “Subawardee,” then enter the
full name, address, city, state and zip code of the prime Federal recipient.
Include Congressional District, if known.   6.   Enter the name of the Federal
agency making the award or loan commitment. Include at least one organizational
level below agency name, if known. For example, Department of Transportation,
United States Coast Guard.   7.   Enter the Federal program name or description
for the covered Federal action (item 1). If known, enter the full Catalog of
Federal Domestic Assistance (CFDA) number for grants, cooperative agreements,
loans, and loan commitments.   8.   Enter the most appropriate Federal
identifying number available for the Federal action identified in item 1 (e.g.,
Request for Proposal (RFP) number, Invitation for Bid (IFB) number, grant
announcement number, the contract, grant, or loan award number, the
application/proposal control number assigned by the Federal agency). Include
prefixes, e.g., “RFP-DE-90-001.”   9.   For a covered Federal action where there
has been an award or loan commitment by the Federal agency, enter the Federal
amount of the award/loan commitment for the prime entity identified in item 4 or
5.   10.   (a) Enter the full name, address, city, state and zip code of the
lobbying registrant under the Lobbying Disclosure of 1995 engaged by the
reporting entity identified in item 4 to influence the covered Federal action.

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

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

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

      Disclosure of Lobbying Activities
SF-LLL   ATTACHMENT 8
Page 2 of 3

 

--------------------------------------------------------------------------------

 

Contract No. HHSN272200600027C
DISCLOSURE OF LOBBYING ACTIVITIES
CONTINUATION SHEET
Approved by OMB
0348-0046

Reporting Entity:                                                        Page
                     of                     
Authorized for Local Reproduction
Standard Form—LLL-A

      Disclosure of Lobbying Activities
SF-LLL   ATTACHMENT 8
Page 3 of 3