Exhibit 10.46


 


	
  AWARD/CONTRACT

  	
  1.

  	
  THIS CONTRACT IS A RATED ORDER 

  	
   

  	
  RATING

  	
  PAGE

  	
  OF

  	
  PAGES

  
	
   

  	
   

  	
  UNDER DPAS (15 CFR 350)

  	
   

  	
   

  	
  1

  	
   

  	
  25

  
	
   

  	
   

  	
   

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

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQUEST/PROJECT NO.

  
	
  HSSN266200400034C

  	
  9/30/04

  	
  VRCB149

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5.  ISSUED BY

  	
  CODE

  	
   

  	
  6.  ADMINISTERED BY (If other
  than Item 5)

  	
     CODE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of Health, DHHS

  Contract Management Program, NIAID

  Room 3214

  8700B Rockledge Drive, MSC 7812

  Bethesda, Maryland  20892-7612



  	
   

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

  	
  8.  DELIVERY

  
	
   

  	
  o FOB ORIGIN

  	
  x OTHER (See below)

  FOB
  Destination

  
	
  Avecia
  Limited

  	
   

  9.  DISCOUNT FOR PROMPT PAYMENT

  
	
  P.O.
  Box 42, Hexagon House

  	
  N/A

  
	
  Blackley,
  Manchester, M9 8ZS, UK

  	
   

  
	
   

  	
  10.  SUBMIT INVOICES

  	
  ITEM

  
	
   

  	
  (4 copies unless other-wise

  	
   

  
	
   

  	
  specified) TO THE

  	
  G.3

  
	
  CODE

  	
  FACILITY CODE

  	
  ADDRESS SHOWN IN

  	
   

  
																



 


	
  11.  SHIP TO/MARK FOR

  	
  CODE

  	
   

  	
  12.  PAYMENT WILL BE MADE BY

  	
  CODE

  	
   

  
	
  See
  Article F.1

  	
  See
  Article G.3

  



 


	
  13.  AUTHORITY FOR USING OTHER THAN FULL AND OPEN
  COMPETITION:

  	
  14.  ACCOUNTING AND APPROPRIATION DATA

  
	
  o 10 U.S.C. 2304(c)(  )

  	
  o 41 U.S.C. 253(c)(  )

  	
  E/N
  # 1-900216013-A1     SOC #25.55     ADB # N01-AI-40034

  CAN # 4-8480924      Amount: 
  $21,067,201

  # 4-8461247        Amount: 
  $8,595,999

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15A.  ITEM NO.

  	
  15B.  SUPPLIES/SERVICES

  	
  15C.  QUANTITY

  	
  15D.  UNIT

  	
  15E.  UNIT PRICE

  	
  15F.  AMOUNT

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title-Development,
  Testing and Evaluation of Condition

  Vaccined
  Against Plague

  Period:  September 30, 2004 through
  March 29, 2007

  Amount
  Alotted:  $27,664,200

               
  Type:  Cost Reimbursement Completion

  	
  FY
  2004  $27,664,200

   

   

   

   

  
	
   

  	
      15G. TOTAL AMOUNT OF CONTRACT      $27,664,200

  
	
  16.  TABLE OF CONTENTS

  
							



 


	
  (ü)

  	
   

  	
  SEC.

  	
   

  	
  DESCRIPTION

  	
   

  	
  PAGE(S)

  	
   

  	
  (ü)

  	
   

  	
  SEC.

  	
   

  	
  DESCRIPTION

  	
   

  	
  PAGE(S)

  
	
   

  	
   

  	
   

  	
   

  	
  PART I - THE
  SCHEDULE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PART II - CONTRACT CLAUSES

  	
   

  	
   

  
	
  x

  	
   

  	
  A

  	
   

  	
  SOLICITATION/CONTRACT
  FORM

  	
   

  	
  1

  	
   

  	
  x

  	
   

  	
  I

  	
   

  	
  CONTRACT CLAUSES

  	
   

  	
  19

  
	
  x

  	
   

  	
  B

  	
   

  	
  SUPPLIES
  OR SERVICES AND PRICES/COST

  	
   

  	
  2

  	
   

  	
  PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER
  ATTACH.

  
	
  x

  	
   

  	
  C

  	
   

  	
  DESCRIPTION/SPECS./WORK
  STATEMENT

  	
   

  	
  7

  	
   

  	
  x

  	
   

  	
  J

  	
   

  	
  LIST OF
  ATTACHMENTS

  	
   

  	
  24

  
	
  x

  	
   

  	
  D

  	
   

  	
  PACKAGING
  AND MARKING

  	
   

  	
  8

  	
   

  	
   

  	
   

  	
  PART IV - REPRESENTATIONS AND INSTRUCTIONS

  
	
  x

  	
   

  	
  E

  	
   

  	
  INSPECTION
  AND ACCEPTANCE

  	
   

  	
  8

  	
   

  	
  x

  	
   

  	
  K

  	
   

  	
  REPRESENTATIONS,
  CERTIFICATIONS AND 

  	
   

  	
   

  
	
  x

  	
   

  	
  F

  	
   

  	
  DELIVERIES
  OR PERFORMANCE

  	
   

  	
  9

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  OTHER
  STATEMENTS OF OFFERORS

  	
   

  	
  25

  
	
  x

  	
   

  	
  G

  	
   

  	
  CONTRACT
  ADMINISTRATION DATA

  	
   

  	
  10

  	
   

  	
  o

  	
   

  	
  L

  	
   

  	
  INSTRS.,
  CONDS., AND NOTICES TO OFFERORS

  	
   

  	
   

  
	
  x

  	
   

  	
  H

  	
   

  	
  SPECIAL
  CONTRACT REQUIREMENTS

  	
   

  	
  12

  	
   

  	
  o

  	
   

  	
  M

  	
   

  	
  EVALUATION
  FACTORS FOR AWARD

  	
   

  	
   

  



 


	
  CONTRACTING
  OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

  
	
   

  
	
  17.  x  CONTRACTOR’S NEGOTIATED AGREEMENT
  (Contractor is required to sign this
  document and return 2 copies to issuing office.)  Contractor agrees to furnish and deliver
  all items or perform all the services set forth or otherwise identified above
  and on any continuation sheets for the consideration stated herein.  The rights and obligations of the parties
  to this contract shall be subject to and governed by the following
  documents:  (a) this
  award/contract, (b) the solicitation, if any, and (c) such
  provisions, representations, certifications, and specifications, as are
  attached or incorporated by reference herein. 
  (Attachments are listed herein.)

  	
  18.  o  AWARD (Contractor is not required to sign this document.)  Your offer on Solicitation Number                                           ,
  including the additions or changes made by you which additions or changes are
  set forth in full above, is hereby accepted as to the items listed above and
  on any condition sheets.  This award
  consummates the contract which consists of the following documents:  (a) the Government’s solicitation and
  your offer, and (b) this award/contract. 
  No further contractual document is necessary.

  
	
   

  
	
  19A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  20A.  NAME OF CONTRACTING OFFICER

  
	
  Derrick Nicholson

  Chief Financial Officer

  	
  Janet M. Mattson

  Contracting Officer

  Contract Management Program, NIAID, NIH, DHHS

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  19B.  AVECIA LIMITED

  	
  19C.  DATE SIGNED

  	
  20B.  UNITED STATES OF AMERICA

  	
   

  	
  20C.  DATE SIGNED

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   /s/ 
  Derrick Nicholson

  	
   

  	
  29/09/04

  	
  BY

  	
   /s/ 
  Janet M. Mattson

  	
   

  	
  9/30/04

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  MAN 7540-01-152-0208

  PREVIOUS EDITION
  UNUSABLE

  	
  M-107

  Computer Generated

   

  	
  STANDARD FORM 28
  (REV. d-85)12/2002)

  Prescribed by GSA

  FAR (48 CFR) 53.214(a)

  
									



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


SECTION B
- SUPPLIES OR SERVICES AND PRICES/COSTS


 


ARTICLE
B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES


 


The purpose of this contract
is to begin early advanced product development for pilot lot manufacture, release
and animal testing, and initial human clinical trials of a recombinant plague
vaccine.


 


ARTICLE
B.2. ESTIMATED COST AND FIXED FEE


 


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


 


b.                                      The fixed fee for Part A of this
contract is [***].  The fixed fee shall
be paid in installments based on the negotiated milestones set forth in ARTICLE
B.4.h. and subject to the withholding provisions of the clauses ALLOWABLE COST
AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II,
ARTICLE 1.1. of this contract.  Payment
of fixed fee shall not be made in less than monthly increments.


 


c.                                       The Government’s obligation, represented by
the sum of the estimated cost plus the fixed fee for Part A of this
contract is [***].


 


d.                                      If the Government exercises its option
pursuant to ARTICLE H.10. of this contract, the Government’s total obligation
represented by the sum of the estimated cost plus the fixed fee will be
increased as follows:


 


	
   

  	
   

  	
  Estimated Cost

  	
   

  	
  Fixed Fee

  	
   

  	
  Estimated Cost

  Plus Fixed Fee

  	
   

  
	
  Base Period - Part A

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Option Period - Part B

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total (Base Period and Option)

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


ARTICLE
B.3. PROVISIONS APPLICABLE TO DIRECT COSTS


 


a.                                       Items Unallowable Unless
Otherwise Provided


 


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


 


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


 


(2)                                  Special rearrangement or alteration of facilities;


 


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


 


(4)                                  Travel to attend general scientific meetings;


 


2

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


(5)                                  Consultant costs;


 


(6)                                  Subcontracts;


 


(7)                                  Patient care costs;


 


(8)                                  Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life expectancy of
more than two years) and “sensitive items” (defined and listed in the
Contractor’s Guide for Control of Government Property), 1990, regardless of
acquisition value.


 


b.                                      Travel
Costs


 


(1)                                  Travel


 


(a)                                  Total expenditures for travel (transportation, lodging, subsistence, and
incidental expenses) incurred in direct performance of Part A of this
contract shall not exceed [***] without the prior written approval of the
Contracting Officer.  Total expenditures
for travel incurred in direct performance of Option Part B, if exercised,
shall not exceed [***] without the prior written approval of the Contracting
Officer.


 


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


 


ARTICLE
B.4. ADVANCE UNDERSTANDINGS


 


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


 


a.                                       Subcontract


 


To negotiate a firm fixed
price type subcontract with Baxter Pharmaceutical Solutions LLC for an amount
not to exceed [***].  Award of the
subcontract shall not proceed without the prior written approval of the Contracting
Officer upon review of the supporting documentation as required by the
Subcontracts clause of the General Clauses incorporated in this contract and a
copy of the draft subcontract agreement. 
(After written approval of the subcontract by the Contracting Officer, a
copy of the signed, approved subcontract shall be provided to the Contracting
Officer.)


 


b.                                      Subcontract


 


To negotiate a cost plus
fixed fee type subcontract with the Defence Science and Technology Laboratory
(DSTL) for an amount not to exceed [***]. 
Award of the subcontract shall not proceed without the prior written
approval of the Contracting Officer upon review of the supporting documentation
as required by the Subcontracts clause of the General Clauses incorporated in
this contract and a copy of the draft subcontract agreement.  (After written approval of the subcontract by
the Contracting Officer, a copy of the signed, approved subcontract shall be
provided to the Contracting Officer.)


 


c.                                       Subcontract


 


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


 


3

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


d.                                      Subcontract


 


To negotiate a fixed price
type subcontract with Inveresk Research International Ltd. for an amount not to
exceed [***].  Award of the subcontract
shall not proceed without the prior written approval of the Contracting Officer
upon review of the supporting documentation as required by the Subcontracts
clause of the General Clauses incorporated in this contract and a copy of the
draft subcontract agreement.  (After
written approval of the subcontract by the Contracting Officer, a copy of the
signed, approved subcontract shall be provided to the Contracting Officer.)


 


e.                                       Subcontract


 


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


 


f.                                         Subcontract


 


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


 


g.                                      Subcontract


 


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


 


h.                                      Consultants


 


Consultant fee(s) to be
paid to the following individual(s):


 


	
  Name

  	
   

  	
  Rate Per Day

  	
   

  	
  Number of Days

  	
   

  	
  Including Travel

  	
   

  	
  Total Cost

  Not to Exceed

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TBD

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


i.                                          Contract
Milestones


 


The contractor shall
complete all work in accordance with the Statement of Work and the Contract
Milestones set forth below.  The
distribution of the fixed fee shall be paid in milestone based installments and
payment of this fee is determined by the Project Officer’s written
certification that the milestone has been satisfactorily performed and that the
technical requirements have been met regarding the completion of the following
milestones.  If the contractor meets the
milestones earlier than the dates set forth below, then the fee will be paid at
the earlier date after completion of the milestone.


 


4

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


	
   

  	
   

  	
  MILESTONES
  FOR AVECIA

  	
   

  	
  ESTIMATED
  COST

  	
   

  	
  FIXED
  FEE

  	
   

  	
  TOTAL
  CPFF

  
	
  1

  	
   

  	
  Produce
  a cGMP pilot lot, sufficient for 2000 doses and capable of supporting an IND
  on or before February 21, 2005

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  Release
  2000 doses and file an IND on or before October 13, 2000

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  Assess
  safety and efficacy to aerosol challenge in animal models on or before
  October 13, 2005

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  Produce
  a protocol for Phase I clinical trial on or before December 31, 2004 and
  Phase II clinical trial on or before August 22, 2006

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  Conduct
  Phase I clinical trial on or before December 8, 2005

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6

  	
   

  	
  Feasibility
  to manufacture 3 million doses and put into inventory on or before
  September 30, 2005

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  Interim
  report on Phase I trial on or before June 8, 2006

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

  	
  Final
  report on Phase I trial on or before January 4, 2007

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  



 


j.                                          Scientific
Meetings


 


Travel to general scientific
meetings as follows:


 


Authorization to expend
contract funds for general scientific meeting travel is not provided
herein.  The Contractor shall request
approval to expend contract funds for general scientific meeting travel, in
writing, 4 weeks in advance of the proposed travel.  The Contractor’s written request shall
include the name(s) and title(s) of personnel proposed to travel, the
meeting dates and location, details of proposed costs (airfare, per diem/subsistence,
other), and a description of the benefit to be derived (to this contract) from
the proposed travel.


 


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


 


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


 


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


(b)                                 Fringe Benefits - Cite rate and amount


(c)                                  Overhead - Cite rate and amount


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


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


(f)                                    Consultant Fees - Identify individuals and amounts.


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


(h)                                 Equipment - Cite authorization and amount.


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


(j)                                     Total Cost


(k)                                  Fixed Fee


(l)                                     Total CPFF


 


5

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


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


 


(2)                                  The contractor agrees to immediately notify the contracting officer in
writing if there is an anticipated overrun (any amount) or unexpended balance
(greater than 10 percent) of the amount allotted to the contract, and the
reasons for the variance.  Also refer to
the requirements of the Limitation of Funds and Limitation of Cost Clauses in
the contract.


 


l.                                          Contract
Number Designation


 


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


 


Contract No. HHSN266200400034C

ADB Contract No. N01-AI-40034


 


m.                                    Understanding
regarding FAR 52.223-6


 


FAR Clause 52.223-6 Drug
Free Workplace is included in this contract, however, FAR
23.501(c) provides that the clause does not apply to work that is
“(c) Performed outside of the United States and its outlying areas or any
part of a contract performed outside the United States and its outlying areas.”


 


n.                                      Understanding
regarding FAR 52.222-36


 


FAR 22.1408(a) requires
the Contracting Officer to “Insert the clause at 52.222-36, Affirmative Action
for Workers with Disabilities, in solicitations and contracts that exceed or
are expected to exceed $10,000, except when -


 


“(1) Both performance
of the work and the recruitment of workers will occur outside the United
States, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the
U.S. Virgin Islands, and Wake Island; or


 


“(2) The agency head
has waived, in accordance with 22.1403(a) or 22.1403(b) all the terms
of the clause.”


 


It is the mutual
understanding of the contracting officer and Avecia that a significant portion
of the work, including all self-performed work, under this contract will be
performed outside the United States and other named territories by the workers
recruited from outside the United States and the named territories.  However, it is also mutually understood that
some subcontracted work will be performed in the United States.  Therefore both parties agree that FAR
52.222-36(a), (b), and (c) will not apply to Avecia and that FAR 52.222-36
(d) “Subcontracts” will only apply to subcontracts that will be performed
in the United States or by workers recruited from the United States and the
named territories; i.e., FAR 52.222-36 would apply in its entirety to any
subcontractor that performs work in the United States.  It is also agreed that Avecia will flow-down
language similar to that in this paragraph to its subcontracts not performed in
the United States; i.e., FAR 52.222-36 would apply in its entirety to any
second-tier (or lower) subcontracts performed in the United States.


 


o.                                      Understanding
regarding FAR 52.222-37


 


FAR
22.1310(a)(1)(i) provides that FAR 52.222-35, Equal Opportunity for
Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans, is required to be in contracts over $25,000, except when “Work is
performed outside the United States by employees recruited from outside the
United States.  As FAR 52.222-35(d) contains
an “Applicability” clause that limits its reach to the listing of employment
openings within the United States and named territories, no additional
understanding beyond that applicability clause is necessary.


 


FAR 22.1310(b) provides
that 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of
the Vietnam Era, and Other Eligible Veterans, in solicitations and contracts
containing the clause at


 


6

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


FAR 52.222-35, Equal Opportunity
for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans.  Therefore, if “Work is to be
performed outside the United States by Employees recruited outside the United
States,” FAR 52.222-37 would not be required.


 


It is the mutual
understanding of the contracting officer and Avecia that a significant portion
of the work, including all self-performed work, under this contract will be
performed outside the United States and the other named territories by workers
recruited from outside the United States and the named territories.  However, it is also mutually understood that
some subcontracted work will be performed in the United States.  Therefore, both parties agree that FAR
52.222-37(a) through (e) will not apply to Avecia and that FAR
52.222-37(f) will only apply to subcontracts that will be performed in the
United States or by workers recruited from the United States; i.e., FAR
52.222-37 would apply in its entirety to any subcontractor that performs work
in the United States.  It is also agreed
that Avecia will flow-down language similar to that in this paragraph to its
subcontracts not performed in the United States; i.e., FAR 52.222-37 would
apply in its entirety to any second-tier (or lower) subcontracts performed in the
United States.


 


SECTION C - DESCRIPTION/SPECIFICATIONS/WORK
STATEMENT


 


ARTICLE C.1. STATEMENT OF WORK


 


Independently and not as an
agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not
otherwise provided by the Government as needed to perform the Statement of
Work, SECTION J, ATTACHMENT 1, dated September 30, 2004, attached
hereto and made a part of this contract.


 


ARTICLE C.2. REPORTING
REQUIREMENTS


 


The Contractor shall submit
to the Contracting Officer and to the Project Officer technical progress
reports covering the work accomplished during each reporting period, a detailed
forecast of work planned for the next 30 day reporting period, and an
assessment of how this reconciles with work proposed for the upcoming 90
days.  These reports are subject to the
technical inspection and requests for clarification by the Project
Officer.  Execution of the 30 day work
plan will be contingent upon NIAID review and approval.  These shall be brief and factual and prepared
in accordance with the following format:


 


A.                                    Technical Reports


 


The Contractor shall prepare
and submit the following reports in the manner stated below:


 


(1)                                  Monthly Technical Progress Reports - On the
due date specified in the contract of each month for the previous calendar
month, the Contractor shall submit five (5) copies of a Monthly Technical
Progress Report, comprising four (4) copies to the Project Officer and one
(1) copy to the Contracting Officer. 
Such reports shall include the following specific information:


 


a.                                                                                       A
cover page that lists the contract number and title, the period of
performance being reported, the contractor’s names and address, the author(s),
and the date of submission;


 


b.                                                                                      SECTION I
- An introduction covering the purpose and scope of the contract effort;


 


c.                                                                                       SECTION II
- The report shall detail, document, and summarize the results of work done
during the period covered.  These reports
shall be in sufficient detail to explain comprehensively the results
achieved.  The description shall include
pertinent data and/or graphs in sufficient detail to explain any significant
results achieved and preliminary conclusions resulting from analysis and scientific
evaluation of data accumulated to date under the project.  Also to be included in the report is a
summary of work proposed for the next reporting period.  Specific requirements are set forth in the
Work Statement.  A one-page summary
of each ongoing and completed protocol shall be submitted at this time.  A monthly report will not be required for the
period when the final report is due. 
Preprints and reprints of papers and abstracts shall be submitted with
the Annual Report.


 


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d.                                                                                      SECTION III
- Substantive performance; a description of current technical or substantive
performance and any problems encountered and/or which may exist along with
proposed corrective action.  An
explanation of any difference between planned progress and actual progress, why
the differences have occurred, and if behind planned progress what corrective
steps are planned.  The report should
include an assessment of percent effort compared to percent complete for each
major category.


 


(2)                                  Milestone Reports - A milestone report will
be provided after the completion of each Milestone unless otherwise agreed upon
by the Principal Investigator and the Project Officer.  Milestone reports and monthly reports may be
combined if agreed by the Contracting Officer and the Project Officer.


 


(3)                                  Final Report - By the expiration date of the
contract, the Contractor shall submit four (4) copies of a comprehensive
Final Report, as above, comprising three (3) copies to the Project Officer
and one (1) copy to the Contracting Officer.  This final report shall detail, document and
summarize the results of the entire contract work for the period covered.  This report shall be in sufficient detail to
explain comprehensively the results achieved. 
Specific requirements are set forth in the Work Statement.  Preprints and reprints not submitted
previously shall be submitted.


 


(4)                                  Summary of Salient Results - With
the monthly report nearest the anniversary date of contract award, and with the
final report, the Contractor shall submit a summary (not to exceed 200 words)
of salient results achieved during the performance of the contract.


 


SECTION D - PACKAGING, MARKING AND SHIPPING


 


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


 


SECTION E - INSPECTION AND ACCEPTANCE


 


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


 


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


 


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


 


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


 


FAR Clause No 52.246-8,
INSPECTION OF RESEARCH AND DEVELOPMENT - COST REIMBURSEMENT (MAY 2001).


 


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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


SECTION F - DELIVERIES
OR PERFORMANCE


 


ARTICLE F.1.
PERIOD OF PERFORMANCE


 


a.                                       The
period of performance of this contract shall be from September 30, 2004
through March 29, 2007.


 


b.                                      If
the Government exercises its option(s) pursuant to Article H.10. of
this contract, the period of performance will be increased as listed below:


 


	
   

  	
  Option
  Part B

  	
  Option Period: 30 months

  	
   

  



 


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 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance
with and by the date(s) specified below:


 


	
  Type of report

  	
   

  	
  No. Copies

  	
   

  	
  Addressee

  	
   

  	
  Due Dates

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Monthly Progress

  	
   

  	
  4

  	
   

  	
  Project Officer (PO)

  DMID/NIAID/NIH

  6610 Rockledge Dr.

  MSC 6605, Room 5117

  Bethesda, MD 20892-6605

  	
   

  	
  Fifteenth of each month

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Monthly Progress

  	
   

  	
  1

  	
   

  	
  Contracting Officer (CO)

  CMB/NIAID/NIH

  6700-B Rockledge Dr.

  MSC 7612, Room 3214

  Bethesda, MD 20892-7612

  	
   

  	
  Same as above

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Milestone Reports

  	
   

  	
  4

  	
   

  	
  Submitted after Milestone
  completion (3 to Project Officer and 1 to Contracting Officer)

  	
   

  	
  On the fifteenth day after
  completion of each milestone

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Final

  	
   

  	
  4

  	
   

  	
  Submitted with Final
  Report (3 to Project Officer and 1 to Contracting Officer)

  	
   

  	
  Expiration date of the
  contract

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Summary of Salient Results

  	
   

  	
  4

  	
   

  	
  Same as above

  	
   

  	
  Anniversary and expiration
  date

  



 


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


 


	
  Project
  Officer

  	
  Contracting
  Officer

  
	
  Office of Biodefense Research Affairs

  	
  Contract Management Program

  
	
  Division of Microbiology and Infectious Diseases

  	
  DHHS/NIH/NIAID

  
	
  DHHS/NIH/NIAID

  	
  6700B Rockledge Dr., Rm. 3214, MSC 7612

  
	
  Room 5001, MSC 6604

  	
  Bethesda, MD 20892-7612

  
	
  6610 Rockledge Drive

  	
   

  
	
  Bethesda, MD 20892

  	
   

  



 


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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


ARTICLE F.3.
CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)


 


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


 


FEDERAL
ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:


 


52.242-15, Stop Work Order (AUGUST 1989) with
ALTERNATE I (APRIL 1984).


 


SECTION G - CONTRACT
ADMINISTRATION DATA


 


ARTICLE G.1.
PROJECT OFFICER


 


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


 


Vicki L. Pierson, Ph.D.

Office of Biodefense Research Affairs

Division of Microbiology and Infectious Diseases

DHHS/NIH/NIAID

Room 5001, MSC 6604

6610 Rockledge Drive

Bethesda, MD 20892-6604


 


The Project
Officer is responsible for:  (1) monitoring
the Contractor’s technical progress, including the surveillance and assessment
of performance and recommending to the Contracting Officer changes in
requirements; (2) interpreting the Statement of Work and any other
technical performance requirements; (3) performing technical evaluation as
required; (4) performing technical inspections and acceptances required by
this contract; and (5) assisting in the resolution of technical problems
encountered during performance.


 


The
Contracting Officer is the only person with authority to act as agent of the
Government under this contract.  Only the
Contracting Officer has authority to:  (1) direct
or negotiate any changes in the Statement of Work; (2) modify or extend
the period of performance; (3) change the delivery schedule; (4) authorize
reimbursement to the Contractor any costs incurred during the performance of
this contract; or (5) otherwise change any terms and conditions of this
contract.


 


The Government
may unilaterally change its Project Officer designation.


 


ARTICLE G.2.
KEY PERSONNEL


 


Pursuant to
the Key Personnel clause incorporated in Section 1 of this contract, the
following individual are considered to be essential to the work being performed
hereunder:


 


	
  Name

  	
   

  	
  Title

  
	
   

  	
   

  	
   

  
	
  Mark Carver, Ph.D.

  	
   

  	
  Principal
  Investigator

  



 


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


 


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


 


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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


(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. HHSN266200400034C

ADB Contract No. N0l-AI-40034


 


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


 


Contracting Officer

Contract Management Program

National Institute of Allergy and Infectious Diseases, NIH 

6700-B Rockledge Drive, Room 3214, MSC 7612

BETHESDA MD 20892-7612


 


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


 


b.                                      The
Contractor shall include the following certification on every invoice for
reimbursable costs incurred with Fiscal Year funds subject to the salary rate
limitation provisions as specified in ARTICLE H.12. of this contract.  For billing purposes, certified invoices are
required for the billing period during which the applicable Fiscal Year Funds
were initially charged through the final billing period utilizing the
applicable Fiscal Year Funds:


 


“I hereby certify that the salaries charged
in this invoice are in compliance with P.L. 108-199 and ARTICLE H.12. of the
above referenced contract.”


 


ARTICLE G.4.
INDIRECT COST RATES


 


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


 


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


 


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


 


ARTICLE
G.5.  GOVERNMENT PROPERTY


 


a.                                       In
addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated
in SECTION I of this contract, the Contractor shall comply with the
provisions of DHHS Publication, Contractor’s Guide for
Control of Government Property, 1990, which is incorporated into
this contract by reference.  Among other
issues, this publication provides a summary of the Contractor’s
responsibilities regarding purchasing authorizations and inventory and
reporting requirements under the contract. 
A copy of this publication is available upon request to the Contracts
Property Administrator.


 


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


 


Division of Personal Property Services, NIH

6011 Building, Suite 637

6011 EXECUTIVE BLVD MSC 7670

BETHESDA MD 20852-7670

(301) 496-6466


 


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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


b.                                      Notwithstanding
the provisions outlined in the DHHS Publication, Contractor’s
Guide for Control of Government Property, 1990 which is incorporated
in this contract in paragraph a. above, the contractor shall use the form
entitled, “Report of Government Owned, Contractor Held Property” for performing
annual inventories required under this contract.  This form is included as an attachment in SECTION J
of this contract.


 


ARTICLE G.6.
POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE


 


a.                                       Contractor
Performance Evaluations


 


Interim and
final evaluations of contractor performance will be prepared on this contract
in accordance with FAR 42.15.  The final
performance evaluation will be prepared at the time of completion of work.  In addition to the final evaluation, an
interim evaluation will be prepared mid-point in the contract to coincide with
the anniversary date of the contract.


 


Interim and
final evaluations will be provided to the Contractor as soon as practicable
after completion of the evaluation.  The
Contractor will be permitted thirty days to review the document and to submit
additional information or a rebutting statement. If agreement cannot be reached
between the parties, the matter will be referred to an individual one level
above the Contracting Officer, whose decision will be final.


 


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


 


b.                                      Electronic
Access to Contractor Performance Evaluations


 


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


 


http://ocm.od.nih.gov/cdmp/cps_contractor.htm


 


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


 


SECTION H - SPECIAL
CONTRACT REQUIREMENTS


 


ARTICLE H.1.
REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS


 


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


 


To ensure that
all research and development projects receive similar and equal consideration,
all organizations may compete for direct funding of independent research and
development projects they consider worthy of support by submitting those
projects to the appropriate Public Health Service grant office for review.  Since these projects may 


 


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ADB NO. N01-AI-400034


 


be submitted
for direct funding, the Contractor agrees that no costs for any independent
research and development project, including all applicable indirect costs, will
be claimed under this contract.


 


ARTICLE H.2.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS


 


NIH policy
requires education on the protection of human subject participants for all
investigators receiving NIH contract awards for research involving human
subjects.  For a complete description of
the NIH Policy announcement on required education in the protection of human
subject participants, the contractor should access the NIH Guide for Grants
and Contracts Announcement dated June 5, 2000 at the following
website:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.htm.  The information below is a summary of the NIH
Policy Announcement:


 


The contractor
shall maintain the following information: 
(1) a list of the names and titles of the principal investigator
and any other individuals working under the contract who are responsible for
the design and/or conduct of the research; (2) the title of the education
program(s) in the protection of human subjects that has been completed for
each named personnel and; (3) a one sentence description of the
educational program(s) listed in (2) above.  This requirement extends to investigators and
all individuals responsible for the design and/or conduct of the research who
are working as subcontractors or consultants under the contract.


 


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


 


ARTICLE H.3.
DATA AND SAFETY MONITORING IN CLINICAL TRIALS


 


The contractor
is directed to the full text of the NIH Policy regarding Data and Safety
Monitoring and Reporting of Adverse Events, which may be found at the following
web sites:


 


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

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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html


 


The contractor
must comply with the NIH Policy cited in these NIH Announcements and any other
data and safety monitoring requirements found elsewhere in this contract.


 


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


 


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


 


ARTICLE H.4.
HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)


 


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


 


The Contractor
shall provide written documentation that all human materials obtained as a
result of research involving human subjects conducted under this contract, by
collaborating sites, or by subcontractors identified under this contract, were
obtained with prior approval by the Office for Human Research Protections
(OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect
human research subjects.  This
restriction applies to all collaborating sites without OHRP-approved
Assurances, whether domestic or foreign, and compliance must be ensured by the
Contractor.


 


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


 


ARTICLE H.5.
CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH


 


	
  a.

  	
  Pursuant to
  Public Law(s) cited in paragraph b., below, NIH is prohibited from using
  appropriated funds to support human embryo research.  Contract funds may not be used for (1) the
  creation of a human embryo or embryos for research purposes; or (2) research
  in which a human embryo or embryos are destroyed, discarded, or knowingly
  subjected to risk of injury or death greater than that allowed for research
  on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of
  the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or
  embryos” includes any organism, not protected as a human subject under 45 CFR
  46 as of the date of the enactment of this Act, that is derived by
  fertilization, parthenogenesis, cloning, or any other means from one or more
  human gametes or human diploid cells.

  
	
   

  	
   

  
	
   

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

  
	
   

  	
   

  
	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  108-199, Title V-General Provisions, Section 510

  	
   

  	
  2004

  	
   

  	
  10/l/03 - 9/30/04

  	
   

  
	
   

  	
   

  
	
  ARTICLE
  H.6. NEEDLE EXCHANGE

  
	
   

  	
   

  
	
  a.

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

  
	
   

  	
   

  
	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  108-199. Title V-General Provisions, Section 505

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30/04

  	
   

  
								



 


ARTICLE H.7.
PRIVACY ACT


 


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


 


The Privacy
Act System of Records applicable to this project is Number 09-25-0200.  This document is incorporated into this
contract as Attachment 4.


 


ARTICLE H.8.
ANIMAL WELFARE


 


All research
involving live, vertebrate animals shall be conducted in accordance with the
Public Health Service Policy on Humane Care and Use of Laboratory Animals.  This policy may be accessed at http://grants1.nih.gov/grants/olaw/references/phspol.htm



 


ARTICLE H.9.
RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS


 


UNDER
GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS)
SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS 


 


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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


WITHOUT PRIOR
APPROVAL BY THE OFFICE FOR LABORATORY ANIMAL WELFARE (OLAW), OF AN ASSURANCE TO
COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS.  THIS RESTRICTION APPLIES TO ALL PERFORMANCE
SITES WITHOUT OLAW-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN.


 


ARTICLE H.10.
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 Part A of the Statement of
Work 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 Part B of the Statement of Work as also
defined in Sections C and F of the 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 cost
plus fixed fee of the contract will be increased as set forth in ARTICLE B.2.


 


ARTICLE H.11.
SALARY RATE LIMITATION LEGISLATION PROVISIONS


 


	
  a.

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

  
	
   

  	
   

  
	
  b. 

  	
  Public Law No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Dollar Amount of

  Salary Limitation*

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-199
  Title II,

  General Provisions, Section 204

  	
   

  	
  2004

  	
   

  	
  Executive Level I

  	
   

  
	
   

  	
   

  
	
  c.

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

  



 










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


 


LINK to EXECUTIVE LEVEL
SALARIES:  http://www.opm.gov/oca/PAYRATES/index.htm


(Click on “Executive Schedule” for the current Fiscal Year’s salary
rate or scroll dawn to the “General Schedule Salary Tables from Previous Years”
to locate the Executive Level salary rates from previous years.)


 


ARTICLE H.12.
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 Cancer
Institute, National Institutes of Health, Department of Health and Human
Services, under Contract No. HHSN266200400034C.”


 


15

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


ARTICLE H.13.
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:  (l) the
  percentage of the total costs of the program or project which will be
  financed with Federal money; (2) the dollar amount of Federal funds for
  the project or program; and (3) the percentage and dollar amount of the
  total costs of the project or program that will be financed by nongovernmental
  sources.

  
	
   

  	
   

  
	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  108-199, Title V-General Provisions,

  Section 507

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30/04

  	
   

  



 


ARTICLE H.14.
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.15.
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 Stale legislature, except in presentation to the Congress or
  any State legislature itself.

  
	
   

  	
   

  
	
  b.

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

  
	
   

  	
   

  
	
  c.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

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

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30104

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

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

  	
   

  	
  2004

  	
   

  	
  10/1/03 - 9/30/04

  	
   

  



 


ARTICLE H.16.
OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES


 


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


 


16

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


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


 


ARTICLE H.17.
SHARING RESEARCH DATA


 


The contractor’s
data sharing plan, dated June 4, 2004 is hereby incorporated by
reference.  The contractor agrees to
adhere to its plan and shall request prior approval of the Contracting Officer
for any changes in its plan.


 


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


 


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


 


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


 


ARTICLE H.18.
POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS


 


Work involving
select biological agents or toxins shall not be conducted under this contract
until the contractor and any affected subcontractor(s) are granted a
certificate of registration or are authorized to work with the applicable
agents.


 


For prime or
subcontract awards to domestic institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must complete registration
with the Centers for Disease Control and Prevention (CDC), Department of Health
and Human Services (DHHS) or the Animal and Plant Health Inspection Services
(APHIS), U.S. Department of Agriculture (USDA), as applicable, before using NIH
funds for research involving Select Agents. 
No NIH funds can be used for research involving Select Agents if the
final registration certificate is denied.


 


For prime or
subcontract awards to foreign institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must provide information
satisfactory to the NIH that a process equivalent to that described in 42
CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions
is in place and will be administered on behalf of all Select Agent work
sponsored by these funds before using these funds for any work directly
involving the Select Agents.  The
contractor must provide information addressing the following key elements
appropriate for the foreign institution: 
safety, security, training, procedures for ensuring that only
approved/appropriate individuals have access to the Select Agents, and any
applicable laws, regulations and policies equivalent to 42 CFR 73.  An NIAID-chaired committee of U.S. federal
employees (including representatives of NIH grants/contracts and scientific
program management, CDC, Department of Justice and other federal intelligence
agencies, and Department of State) will assess the policies and procedures for
comparability to the U.S. requirements described in 42 CFR Part 73.  When requested by the contracting officer,
the contractor should provide key information delineating any laws,
regulations, policies, and procedures applicable to the foreign institution for
the safe and secure possession, use, and transfer of Select Agents.  This includes concise summaries of safety,
security, and training plans, and applicable laws, regulations, and
policies.  For the purpose of security
risk assessments, the contractor must provide the names of all individuals at
the foreign institution who will have access to the Select Agents and
procedures for ensuring that only approved and appropriate individuals have
access to Select Agents under the contract.


 


Listings of
HHS select agents and toxins, biologic agents and toxins, and overlap agents or
toxins as well as information about the registration process, can be obtained
on the Select Agent Program Web site at http://www.cdc.gov/od/gap/


 


17

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


ARTICLE H.19.
PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES


 


The contractor
acknowledges that U.S. Executive Orders and Laws, including but not limited to
E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of
resources and support to, individuals and organizations associated with
terrorism.  It is the legal responsibility
of the contractor to ensure compliance with these Executive Orders and
Laws.  This clause must be included in
all subcontracts issued under this contract.


 


18
















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


PART II -
CONTRACT CLAUSES


 


SECTION I - CONTRACT
CLAUSES


 


ARTICLE I.1.
GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT -
FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)


 


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


 


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


 


	
  FAR CLAUSE

  NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.202-l

  	
   

  	
  Jul 2004

  	
   

  	
  Definitions

  
	
  52.203-3

  	
   

  	
  Apr 1984

  	
   

  	
  Gratuities (Over $100,000)

  
	
  52.203-5

  	
   

  	
  Apr 1984

  	
   

  	
  Covenant Against
  Contingent Fees (Over $100,000)

  
	
  52.203-6

  	
   

  	
  Jul 1995

  	
   

  	
  Restrictions on
  Subcontractor Sales to the Government (Over $100,000)

  
	
  52.203-7

  	
   

  	
  Jul 1995

  	
   

  	
  Anti-Kickback Procedures
  (Over $100,000)

  
	
  52.203-8

  	
   

  	
  Jan 1997

  	
   

  	
  Cancellation, Rescission,
  and Recovery of Funds for Illegal or Improper Activity (Over $100,000)

  
	
  52.203-10

  	
   

  	
  Jan 1997

  	
   

  	
  Price or Fee Adjustment
  for Illegal or Improper Activity (Over $100,000)

  
	
  52.203-12

  	
   

  	
  Jun 2003

  	
   

  	
  Limitation on Payments to
  Influence Certain Federal Transactions (Over $100,000)

  
	
  52.204-4

  	
   

  	
  Aug 2000

  	
   

  	
  Printed or Copied
  Double-Sided on Recycled Paper (Over $100,000)

  
	
  52.204-7

  	
   

  	
  Oct 2003

  	
   

  	
  Central Contractor
  Registration

  
	
  52.209-6

  	
   

  	
  Jul 1995

  	
   

  	
  Protecting the
  Government’s Interests When Subcontracting With Contractors Debarred,
  Suspended, or Proposed for Debarment (Over $25,000)

  
	
  52.215-2

  	
   

  	
  Jun 1999

  	
   

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

  
	
  52.215-8

  	
   

  	
  Oct 1997

  	
   

  	
  Order of Precedence -
  Uniform Contract Format

  
	
  52.215-10

  	
   

  	
  Oct 1997

  	
   

  	
  Price Reduction for
  Defective Cost or Pricing Data

  
	
  52.215-12

  	
   

  	
  Oct 1997

  	
   

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

  
	
  52.215-14

  	
   

  	
  Oct 1997

  	
   

  	
  Integrity of Unit Prices
  (Over $100,000)

  
	
  52.215-15

  	
   

  	
  Jan 2004

  	
   

  	
  Pension Adjustments and
  Asset Reversions

  
	
  52.215-18

  	
   

  	
  Oct 1997

  	
   

  	
  Reversion or Adjustment of
  Plans for Post-Retirement Benefits (PRB) other than Pensions

  
	
  52.215-19

  	
   

  	
  Oct 1997

  	
   

  	
  Notification of Ownership
  Changes

  
	
  52.215-21

  	
   

  	
  Oct 1997

  	
   

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

  
	
  52.216-7

  	
   

  	
  Dec 2002

  	
   

  	
  Allowable Cost and Payment

  
	
  52.216-8

  	
   

  	
  Mar 1997

  	
   

  	
  Fixed Fee

  
	
  52.219-8

  	
   

  	
  May 2004

  	
   

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

  
	
  52.219-9

  	
   

  	
  Jan 2002

  	
   

  	
  Small Business
  Subcontracting Plan (Over $500,000)

  
	
  52.219-16

  	
   

  	
  Jan 1999

  	
   

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

  
	
  52.222-2

  	
   

  	
  Jul 1990

  	
   

  	
  Payment for Overtime
  Premium (Over $100,000) (Note: The dollar amount in paragraph (a) of
  this clause is $0 unless otherwise specified in the contract.)

  
	
  52.222-3

  	
   

  	
  Jun 2003

  	
   

  	
  Convict Labor

  
	
  52.222-26

  	
   

  	
  Apr 2002

  	
   

  	
  Equal Opportunity

  
	
  52.222-35

  	
   

  	
  Dec 2001

  	
   

  	
  Equal Opportunity for
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans

  
	
  52.222-36

  	
   

  	
  Jun 1998

  	
   

  	
  Affirmative Action for
  Workers with Disabilities

  



 


19

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


	
  52.222-37

  	
   

  	
  Dec 2001

  	
   

  	
  Employment Reports on
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans

  
	
  52.223-6

  	
   

  	
  May 2001

  	
   

  	
  Drug-Free Workplace

  
	
  52.223-14

  	
   

  	
  Aug 2003

  	
   

  	
  Toxic Chemical Release
  Reporting (Over $100,000)

  
	
  52.225-l

  	
   

  	
  Jun 2003

  	
   

  	
  Buy American Act -
  Supplies

  
	
  52.225-13

  	
   

  	
  Dec 2003

  	
   

  	
  Restrictions on Certain
  Foreign Purchases

  
	
  52.227-l

  	
   

  	
  Jul 1995

  	
   

  	
  Authorization and Consent,
  Alternate I (Apr 1984)

  
	
  52.227-2

  	
   

  	
  Aug 1996

  	
   

  	
  Notice and Assistance
  Regarding Patent and Copyright Infringement (Over $100,000)

  
	
  52.227-11

  	
   

  	
  Jun 1997

  	
   

  	
  Patent Rights - Retention
  by the Contractor (Short Form) (Note: In accordance with FAR 27.303(a)(2),
  paragraph (f) is modified to include the requirements in FAR
  27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is
  annual.

  
	
  52.227-14

  	
   

  	
  Jun 1987

  	
   

  	
  Rights in Data - General

  
	
  52.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation on Withholding
  of Payments

  
	
  52.232-17

  	
   

  	
  Jun 1996

  	
   

  	
  Interest (Over $100,000)

  
	
  52.232-20

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation of Cost

  
	
  52.232-23

  	
   

  	
  Jan 1986

  	
   

  	
  Assignment of Claims

  
	
  52.232-25

  	
   

  	
  Oct 2003

  	
   

  	
  Prompt Payment, Alternate
  I (Feb 2002)

  
	
  52.232-33

  	
   

  	
  Oct 2003

  	
   

  	
  Payment by Electronic
  Funds Transfer—Central Contractor Registration

  
	
  52.233-l

  	
   

  	
  Jul 2002

  	
   

  	
  Disputes

  
	
  52.233-3

  	
   

  	
  Aug 1996

  	
   

  	
  Protest After Award,
  Alternate I (Jun 1985)

  
	
  52.242-1

  	
   

  	
  Apr 1984

  	
   

  	
  Notice of Intent to
  Disallow Costs

  
	
  52.242-3

  	
   

  	
  May 2001

  	
   

  	
  Penalties for Unallowable
  Costs (Over $500,000)

  
	
  52.242-4

  	
   

  	
  Jan 1997

  	
   

  	
  Certification of Final Indirect
  Costs

  
	
  52.242-13

  	
   

  	
  Jul 1995

  	
   

  	
  Bankruptcy (Over $100,000)

  
	
  52.243-2

  	
   

  	
  Aug 1987

  	
   

  	
  Changes - Cost
  Reimbursement, Alternate V (Apr 1984)

  
	
  52.244-2

  	
   

  	
  Aug 1998

  	
   

  	
  Subcontracts, Alternate II
  (Aug 1998) *lf written consent to subcontract is required, the identified
  subcontracts are listed in ARTICLE B, Advance Understandings.

  
	
  52.244-5

  	
   

  	
  Dec 1996

  	
   

  	
  Competition in
  Subcontracting (Over $100,000)

  
	
  52.245-5

  	
   

  	
  May 2004

  	
   

  	
  Government Property
  (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)

  
	
  52.246-23

  	
   

  	
  Feb 1997

  	
   

  	
  Limitation of Liability
  (Over $100,000)

  
	
  52.249-6

  	
   

  	
  Sep 1996

  	
   

  	
  Termination
  (Cost-Reimbursement)

  
	
  52.249-14

  	
   

  	
  Apr 1984

  	
   

  	
  Excusable Delays

  
	
  52.253-1

  	
   

  	
  Jan 1991

  	
   

  	
  Computer Generated Forms

  



 


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


 


	
  HHSAR

  CLAUSE NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.202-1

  	
   

  	
  Jan 2001

  	
   

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

  
	
  352.216-72

  	
   

  	
  Oct 1990

  	
   

  	
  Additional
  Cost Principles

  
	
  352.228-7

  	
   

  	
  Dec 1991

  	
   

  	
  Insurance -
  Liability to Third Persons

  
	
  352.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Withholding
  of Contract Payments

  
	
  352.233-70

  	
   

  	
  Apr 1984

  	
   

  	
  Litigation
  and Claims

  
	
  352.242-71

  	
   

  	
  Apr 1984

  	
   

  	
  Final
  Decisions on Audit Findings

  
	
  352.270-5

  	
   

  	
  Apr 1984

  	
   

  	
  Key
  Personnel

  
	
  352.270-6

  	
   

  	
  Jul 1991

  	
   

  	
  Publications
  and Publicity

  
	
  352.270-7

  	
   

  	
  Jan 2001

  	
   

  	
  Paperwork
  Reduction Act

  



 


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


 


20

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


ARTICLE I.2.
AUTHORIZED SUBSTITUTION OF CLAUSES


 


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


 


None.


 


ARTICLE I.3.
ADDITIONAL CONTRACT CLAUSES


 


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


 


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


 


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


 


(2)                                  FAR
52.217-8, Option to Extend Services (NOVEMBER 1999).


 


“...The
Contracting Officer may exercise the option by written notice to the Contractor
within at least 30 days before the contract expires?’


 


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


 


“(c) Waiver
of evaluation preference....


 


      [  ] Offeror elects to waive the evaluation
preference.”


 


(4)                                  ALTERNATE
I (OCTOBER 1998), FAR Clause 52.219-23, Notice of Price Evaluation Adjustment
for Small Disadvantaged Business Concerns (OCTOBER 1999).


 


(5)                                  FAR
52.224-l, Privacy Act Notification (APRIL 1984).


 


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


 


(7)                                  FAR
52.229-8, Taxes-Foreign Cost-Reimbursement Contracts (MARCH 1990).


 


(8)                                  FAR
52.229-9, Taxes-Cost-Reimbursement Contracts with Foreign Governments (MARCH 1990).


 


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


 


(10)                            FAR
52.247-63, Preference for U.S. Flag Air Carriers (JUNE 2003).


 


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


 


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


 


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


 


Note: 
The Office for Human Research Protections (OHRP), Office of the
Secretary (OS), Department of Health and Human Services (DHHS) is the office
responsible for oversight of the 


 


21

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


Protection of Human subjects and should
replace office for Protection from Research Risks (OPRR), National Institutes
of Health (NIH) wherever it appears in this clause.


 


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


 


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


 


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


 


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


 


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


 


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


 


This contract
incorporates the following clauses in full text.


 


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


 


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


 


(a)                                  Definitions.  As used
in this clause-


 


Commercial item, has the meaning contained in
Federal Acquisition Regulation 52.201-1, Definitions.


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


22

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


PART III


 


SECTION J - LIST OF
ATTACHMENTS


 


The following
documents are attached and incorporated in this contract:


 


1.                                       Statement
of Work, September 30, 2004, 2 pages.


 


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


 


3.                                       Inclusion
Enrollment Report, 5/01 (Modified OAMP: 
10/01), 1 page.


 


4.                                       Privacy
Act System of Records, Number 09-25-0200, as cited in the Federal Register
Notice issued in Volume 62, Number 66, pages 16596-16602, dated April 7,
1997, 9 pages.


 


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


 


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


 


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


 


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


 


23

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


STATEMENT OF
WORK


 


[***]


 


	
  Statement of
  Work

  	
   

  	
  ATTACHMENT 1

  
	
  (9/30/04)

  	
   

  	
  Page 1

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


STATEMENT OF
WORK


 


[***]


 


	
  Statement of
  Work

  	
   

  	
  ATTACHMENT 1

  
	
  (9/30/04)

  	
   

  	
  Page 2

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


INVOICE/FINANCING
REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS FOR NIH

COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4


 


General: 
The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.


 


Format: 
Standard Form 1034, “Public Voucher for Purchases and Services
Other Than Personal,” and Standard Form 1035, “Public Voucher for
Purchases and Services Other Than Personal—Continuation Sheet,” or reproduced
copies of such forms marked ORIGINAL should be used to submit claims for
reimbursement.  In lieu of SF-1034 and
SF-1035, claims may be submitted on the payee’s letter-head or self-designed
form provided that it contains the information shown on the sample
invoice/financing request.


 


Number of Copies:  As indicated in the Invoice Submission Clause
in the contract.


 


Frequency: 
Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the
contracting officer.


 


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


 


Billing of Costs Incurred:  If billed costs include:  (1) costs of a prior billing period, but
not previously billed; or (2) costs incurred during the contract period
and claimed after the contract period has expired, the amount and month(s) in
which such costs were incurred shall be cited.


 


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


 


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


 


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


 


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


 


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


 


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


 


	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


(h)                                 Billing Period — Insert the beginning and ending dates
(month, day, and year) of the period in which costs were incurred and for which
reimbursement is claimed.


 


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


 


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


 


(k)                                  Direct Costs — Insert the major cost elements.  For each element, consider the application of
the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these
instructions.


 


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


 


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


 


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


 


	
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  ATTACHMENT 2

  
	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


(7)                                  Travel — Include domestic and foreign travel.  Foreign travel is travel outside of Canada,
the United States and its territories and possessions.  However, for an organization located outside
Canada, the United States and its territories and possessions, foreign travel
means travel outside that country. Foreign travel must be billed separately
front 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)-4

  	
  ATTACHMENT 2

  
	
  Rev. 11/2003

  	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


FINANCIAL
REPORTING INSTRUCTIONS:


 


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


 


Column
A—Expenditure Category
- Enter the expenditure categories required by the contract.


 


Column
B—Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage of effort or number
of hours agreed to doing contract negotiations for each employee or labor
category listed in Column A.


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


SAMPLE
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT


 


(a)         Billing Office Name and Address


 


NATIONAL INSTITUTES OF HEALTH
NIAID, CMP


6700B Rockledge Dr., Rm.
3214, MSC 7612


Bethesda, MD 20892-7612


 


(b)         Invoice/Financing Request No.


 


(c)          Date Invoice Prepared


 


(d)         Contract No.


 


ADB
No.


 


Effective Date


 


(e)         Payee’s Name and Address


 


ABC CORPORATION


100 Main Street


Anywhere, USA zip code


 


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


 


(f)            Total Estimated Cost


 


(g)         Total Fixed Fee


 


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


 


	
   

  	
   

  	
  Cumulative Percentage of

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Effort/Hrs.

  	
   

  	
  Incurred Cost

  	
   

  	
  Cost at

  	
   

  	
  Contract

  	
   

  	
   

  	
   

  
	
  Expenditure Category*

  	
   

  	
  Negotiated

  	
   

  	
  Actual

  	
   

  	
  (i) Current

  	
   

  	
  (j) Cumulative

  	
   

  	
  Completion

  	
   

  	
  Amount

  	
   

  	
  Variance

  	
   

  
	
  A

  	
   

  	
  B

  	
   

  	
  C

  	
   

  	
  D

  	
   

  	
  E

  	
   

  	
  F

  	
   

  	
  G

  	
   

  	
  H

  	
   

  
	
  (k) Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Direct Labor

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (2) Fringe Benefits

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (3) Accountable Property (attach
  HHS-565)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (4) Materials & Supplies

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (5) Premium Pay

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (6) Consultant Fees

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (7) Travel

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (8) Subcontracts

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (9) Other

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (l) Cost of Money

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (m) Overhead

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  G&A

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (n) Fixed Fee

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (o) Total Amount Claimed

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (p) Adjustments

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (q) Grand Totals

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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


 


	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  (Name of Official)

  	
   

  	
  (Title)

  	
   

  



 






*Attach details as specified
in the contract


 


	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


INCLUSION ENROLLMENT REPORT


 


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


 


	
  Study
  Title:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total
  Enrollment:

  	
   

  	
  Protocol
  Number:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Contract
  Number:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


PART A.
TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by
Ethnicity and Race


 


	
   

  	
   

  	
  Sex/Gender

  
	
   

  	
   

  	
  Female

  	
   

  	
  Males

  	
   

  	
  Unknown
  or Not

  	
   

  	
  Total

  
	
  Ethnic Category

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hispanic or Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Not Hispanic or Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown (Individuals not
  reporting ethnicity)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ethnic Category: Total of
  All Subjects*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial Categories

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  American Indian/Alaskan
  Native

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Native Hawaiian or Other
  Pacific Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Black or African American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  More than one race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown or not reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial Categories: Total of
  All Subjects*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


PART B.
HISPANIC ENROLLMENT REPORT Number of Hispanics or Latinos Enrolled to Date
(Cumulative)


 


	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Unknown
  or Not

  	
   

  	
   

  
	
   

  	
   

  	
  Females

  	
   

  	
  Males

  	
   

  	
  Reported

  	
   

  	
  Total

  
	
  Racial Categories

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  American Indian/Alaskan
  Native

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Native Hawaiian or Other
  Pacific Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Black or African American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  More than one race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown or not reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial
  Categories: Total of Hispanic or Latinos

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 






*These totals must agree



**These totals must agree


 


	
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  (Modified OAMP: October, 2001)

  	
   

  	
   

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


PRIVACY
ACT SYSTEM OF RECORDS


09-25-0200


 


SYSTEM
NAME:


 


Clinical, Basic and
Population-based Research Studies of the National Institutes of Health (NIH),
HHS/NIH/OD.


 


SECURITY
CLASSIFICATION:


 


None.


 


SYSTEM
LOCATION:


 


Records are located at NIH
and Contractor research facilities which collect or provide research data for
this system.  Contractors may include,
but are not limited to:  Research
centers, clinics, hospitals, universities, medical schools, research
institutions/foundations, national associations, commercial organizations,
collaborating State and Federal Government agencies, and coordinating
centers.  A current list of sites,
including the address of any Federal Records Center where records from this
system may be stored, is available by writing to the appropriate Coordinator
listed under Notification Procedure.


 


CATEGORIES
OF INDIVIDUALS COVERED BY THE SYSTEM:


 


Adults and/or children who
arc the subjects of clinical, basic, or population-based research studies of
the NIH.  Individuals with disease.  Individuals who are representative of the
general population or of special groups including, but not limited to:  normal controls, normal volunteers, family
members and relatives; providers of services (e.g., health care and social
work); health care professionals and educators, and demographic sub-groups as
applicable, such as age, sex, ethnicity, race, occupation, geographic location;
and groups exposed to real and/or hypothesized risks (e.g., exposure to
biohazardous microbial agents).


 


CATEGORIES
OF RECORDS IN THE SYSTEM:


 


The system contains data
about individuals as relevant to a particular research study.  Examples include, but are not limited
to:  name, study identification number,
address, relevant telephone numbers, social security number (voluntary), drives
license number, date of birth, weight, height, sex, race; medical,
psychological and dental information, laboratory and diagnostic testing
results; registries; social, economic and demographic data; health services utilization;
insurance and hospital cost data, employers, conditions of the work
environment, exposure to hazardous substances/compounds; information pertaining
to stored biologic specimens (including blood, urine, tissue and genetic
materials), characteristics and activities of health care providers and
educators and trainers (including curricula vitae); and associated
correspondence.


 


AUTHORITY
FOR MAINTENANCE OF THE SYSTEM:


 


“Research and
Investigation,” “Appointment and Authority of the Directors of the National
Research Institutes,” “National Cancer Institute,” “National Eye Institute,”
“National Heart, Lung and Blood Institute,” “National Institute on Aging,”
“National Institute on Alcohol Abuse and Alcoholism,” “National Institute on
Allergy and Infectious Diseases,” “National Institute of Arthritis and
Musculoskeletal and Skin Diseases,” “National Institute of Child Health and
Human Development,” “National Institute on Deafness and Other Communication
Disorders,” “National Institute of Dental and Craniofacial Research,” “National
Institute of Diabetes, and Digestive and Kidney Diseases,” “National Institute
of Drug Abuse,” “National Institute of Environmental Health Sciences,”
“National Institute of Mental Health,” “National Institute of Neurological Disorders
and Stroke, and the “National Human Genome Research Institute” of the Public
Health Service Act.  (42 U.S.C. 241, 242,
248, 281, 282, 284, 285a, 285b,


 


	
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285c, 285d, 285e, 285f,
285g, 285h, 285i, 285j, 2851, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c,
289a, 289c, and 44 U.S.C. 3101.)


 


PURPOSE(S):


 


To document, track, monitor
and evaluate NIH clinical, basic, and population-based research activities.


 


ROUTINE
USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE
PURPOSES OF SUCH USES:


 


(3)                                  A record may be disclosed for a research
purpose, when the Department:  (A) has
determined that the use or disclosure does not violate legal or policy
limitations under which the record was provided, collected, or obtained; e.g.,
disclosure of alcohol or drug abuse patient records will be made only in
accordance with the restrictions of confidentiality statutes and regulations 42
U.S.C. 241, 42 U.S.C. 290dd-2, 42 CFR Part 2, and where applicable, no
disclosures will be made inconsistent with an authorization of confidentiality
under 42 U.S.C. 241 and 42 CFR Part 2a; (B) has determined that the
research purpose (1) cannot be reasonably accomplished unless the record
is provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record might
bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent unauthorized use
or disclosure of the record, (2) remove or destroy the information that
identifies the individual at the earliest time at which removal or destruction
can be accomplished consistent with the purpose of the research project, unless
the recipient has presented adequate justification of a research or health
nature for retaining such information, and (3) make no further use or
disclosure of the record except (a) in emergency circumstances affecting
the health or safety of any individual, (b) for use in another research
project, under these same conditions, and with written authorization of the
Department, (c) for disclosure to a properly identified person for the
purpose of an audit related to the research project, if information that would
enable research subjects to be identified is removed or destroyed at the
earliest opportunity consistent with the purpose of the audit, or (d) when
required by law; and (D) has secured a written statement attesting to the
recipient’s understanding of, and willingness to abide by, these provisions.


 


(4)                                  Disclosure may be made to a Member of
Congress or to a Congressional staff member in response to an inquiry of the
Congressional office made at the written request of the constituent about whom
the record is maintained.


 


(5)                                  The Department of Health and Human Services
(HHS) may disclose information from this system of records to the Department of
Justice when:  (a) The agency or any
component thereof; or (b) any employee of the agency in his or her
official capacity where the Department of Justice has agreed to represent the
employee; or (c) the United States Government, is a party to litigation or
has an interest in such litigation, and by careful review, the agency
determines that the records are both relevant and necessary to the litigation
and the use of such records by the Department of Justice is, therefore, deemed
by the agency to be for a purpose that is compatible with the purpose for which
the agency collected the records.


 


(6)                                  Disclosure may be made to agency contractors,
grantees, experts, consultants, collaborating researchers, or volunteers who
have been engaged by the agency to assist in the performance of a service
related to this system of records and who need to have access to the records in
order to perform the activity. 
Recipients shall be required to comply with the requirements of the
Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).


 


(7)                                  Information from this system may be disclosed
to Federal agencies, State agencies (including the Motor Vehicle Administration
and State vital statistics offices, private agencies, and other third parties
(such as current or prior employers, acquaintances, relatives), when necessary
to obtain information on morbidity and mortality experiences and to locate
individuals for follow-up studies. 
Social security numbers, date of birth and other identifiers may be
disclosed:  (I) to the National
Center for Health Statistics to ascertain vital status through the National
Death Index; (2) to the Health Care Financing Agency to ascertain 


 


	
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morbidities; and (3) to
the Social Security Administration to ascertain disabilities and/or location of
participants.  Social security numbers
may also be given to other Federal agencies, and State and local agencies when
necessary to locating individuals for participation in follow-up studies.


 


(8)           Medical information may be disclosed in identifiable form to tumor
registries for maintenance of health statistics, e.g., for use in research
studies.


 


(9)           PHS may inform the sexual and/or needle-sharing partner(s) of a
subject individual who is infected with the human immunodeficiency virus (HIV)
of their exposure to HIV, under the following circumstances:  (1) The information has been obtained in
the course of clinical activities at PHS facilities carried out by PHS
personnel or contractors; (2) The PHS employee or contractor has made
reasonable efforts to counsel and encourage the subject individual to provide
the information to the individual’s sexual or needle-sharing partner(s); (3) The
PHS employee or contractor determines that the subject individual is unlikely
to provide the information to the sexual or needle-sharing partner(s) or
that the provision of such information cannot reasonably be verified; and (4) The
notification of the partner(s) is made, whenever possible, by the subject individual’s
physician or by a professional counselor and shall follow standard counseling
practices.


PHS may disclose information
to State or local public health departments, to assist in the notification of
the subject individual’s sexual and/or needle-sharing partner(s), or in the
verification that the subject individual has notified such sexual or
needle-sharing partner(s).


 


(10)         Certain diseases and conditions, including infectious diseases, may be
reported to appropriate representatives of Stale or Federal Government as
required by State or Federal law.


 


(11)         Disclosure may be made to authorized organizations which provide health
services to subject individuals or provide third-party reimbursement or fiscal
intermediary functions, for the purpose of planning for or providing such
services, billing or collecting third-party reimbursements.


 


(12)         The Secretary may disclose information to organizations deemed
qualified to carry out quality assessment, medical audits or utilization
reviews.


 


(13)         Disclosure may be made for the purpose of reporting child, elder or
spousal abuse or neglect or any other type of abuse or neglect as required by
State or Federal law.


 


POLICIES
AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF
RECORDS IN THE SYSTEM:


 


STORAGE:


 


Records may be stored on
index cards, file folders, computer tapes and disks (including optical disks),
photography media, microfiche, microfilm, and audio and video tapes.  For certain studies, factual data with study
code numbers are stored on computer tape or disk, while the key to personal
identifiers is stored separately, without factual data, in paper/computer
files.


 


RETRIEVABILITY:


 


During data collection
stages and follow-up, retrieval is by personal identifier (e.g., name, social
security number, medical record or study identification number, etc.).  During the data analysis stage, data are
normally retrieved by the variables of interest (e.g., diagnosis, age,
occupation).


 


	
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SAFEGUARDS:


 


	
  (1)

  	
  Authorized Users: Access
  to identifiers and to link files is strictly limited to the authorized
  personnel whose duties require such access. Procedures for determining
  authorized access to identified data are established as appropriate for each
  location. Personnel, including contractor personnel, who may be so authorized
  include those directly involved in data collection and in the design of
  research studies, e.g., interviewers and interviewer supervisors; project
  managers; and statisticians involved in designing sampling plans. Other
  one-time and special access by other employees is granted on a need-to-know
  basis as specifically authorized by the system manager. Researchers
  authorized to conduct research on biologic specimens will typically access
  the system through the use of encrypted identifiers sufficient to link
  individuals with records in such a manner that does not compromise
  confidentiality of the individual.

  
	
   

  	
   

  
	
  (2)

  	
  Physical Safeguards:
  Records are either stored in locked rooms during off-duty hours, locked file
  cabinets, and/or secured computer facilities. For certain studies, personal
  identifiers and link files are separated and stored in locked files. Computer
  data access is limited through the use of key words known only to authorized
  personnel.

  
	
   

  	
   

  
	
  (3)

  	
  Procedural Safeguards:
  Collection and maintenance of data is consistent with legislation and
  regulations in the protection of human subjects, informed consent,
  confidentiality, and confidentiality specific to drug and alcohol abuse
  patients where these apply. When anonymous data is provided to research
  scientists for analysis, study numbers which can be matched to personal
  identifiers will be eliminated, scrambled, or replaced by the agency or
  contractor with random numbers which cannot be matched. Contractors who
  maintain records in this system are instructed to make no further disclosure
  of the records. Privacy Act requirements are specifically included in contracts
  for survey and research activities related to this system. The OHS project
  directors, contract officers, and project officers oversee compliance with
  these requirements. Personnel having access are trained in Privacy Act
  requirements. Depending upon the sensitivity of the information in the
  record, additional safeguard measures may be employed.

  
	
   

  	
   

  
	
  (4)

  	
  Implementation Guidelines:
  These practices are in compliance with the standards of Chapter 45-13 of the
  HHS General Administration Manual, “Safeguarding Records Contained in Systems
  of Records,” supplementary Chapter PHS hf: 45-13, and the HHS Automated
  Information Systems Security Program Handbook.

  



 


RETENTION
AND DISPOSAL:


 


Records are retained and
disposed of under the authority of the NIH Records Control Schedule contained
in NIH Manual Chapter 1743, Appendix 1B “Keeping and Destroying Records” (HHS
Records Management Manual, Appendix B-361), item 3000-G-3, which allows records
to be kept as long as they are useful in scientific research.  Collaborative Perinatal Project records are
retained in accordance with item 3000-G-4, which does not allow records to be
destroyed.  Refer to the NIH Manual
Chapter for specific conditions on disposal or retention instructions.


 


SYSTEM
MANAGER(S) AND ADDRESS(ES):


 


See Appendix I for a listing
of current System Managers.  This system
is for use by all NIH Institutes and Centers.


 


NOTIFICATION
PROCEDURE:


 


To determine if a record
exists, write to the appropriate IC Privacy Act Coordinator listed below.  In cases where the requester knows
specifically which System Manager to contact, he or she may contact the System
Manager directly (See Appendix I). 
Notification requests should include: 
individual’s name; current address; date of birth; date, place and
nature of participation in specific research study; name of individual or
organization administering the research study (if known); name or description
of the research study (if known); address at the time of participation; and in
specific cases, a notarized statement (some highly sensitive systems require
two witnesses attesting to the 


 


	
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individual’s identity).  A requester must verify his or her identity
by providing either a notarization of the request or by submitting a written
certification that the is who he or she claims to be and understands that the
knowing and willful request for acquisition of a record pertaining to an
individual under false pretenses is a criminal offense under the Act, subject
to a five thousand dollar fine.


 


Individuals will be granted
direct access to their medical records unless the System Manager determines
that such access is likely to have an adverse effect (i.e., could cause harm)
on the individual.  In such cases when
the System Manager has determined that the nature of the record information
requires medical interpretation, the subject of the record shall be requested
to designate, in writing, a responsible representative who will be wilting to
review the record and inform the subject individual of its contents at the
representative’s discretion.  The
representative may be a physician, other health professional, or other responsible
individual.  In this case, the medical/dental
record will be sent to the designated representative.  Individuals will be informed in writing if
the record is sent to the representative. 
This same procedure will apply in cases where a parent or guardian
requests notification of, or access to, a child’s or incompetent person’s
medical record.  The parent or guardian
must also verify (provide adequate documentation) their relationship to the
child or incompetent person as well as his or her own identity to prove their
relationship.


 


If the requester does not
know which Institute or Center Privacy Act Coordinator to contact for
notification purposes, he or she may contact directly the NIH Privacy Act
Officer at the following address:  NIH
Privacy Act Officer, Office of Management Assessment, 6011 Executive Blvd., Room 601L,
Rockville, MD 20852.


 


NIH Privacy
Act Coordinators


 


Associate Director for
Disease Prevention, Office of the Director (OD), Building 1, Room 260, 1
Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
Clinical Center (CC), Building 10, Room 1N208, 10 Center Drive, Bethesda,
MD 20892.


 


Privacy Act Coordinator,
National Center for Complementary and Alternative Medicine (NCCAM), Building
31, Room 2B11, 31 Center Drive, Bethesda, MD 20892-2182.


 


Privacy Act Coordinator, National
Cancer Institute (NCI), Building 31, Room 10A34, 31 Center Drive,
Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Center on Minority Health and Health Disparities (NCMHD), Democracy
Plaza II, Room 800, 6707 Democracy Boulevard, Bethesda, MD 20892-5465.


 


Privacy Act Coordinator,
National Center for Research Resources (NCRR), Rockledge 1, Room 5140,
6705 Rockledge Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Eye Institute (NEI), Building 31, Room 6A32, 31 Center Drive,
Bethesda, MD 20892-2510.


 


Privacy Act Coordinator,
National Human Genome Research Institute (NHGRI), Building 10, 3C710, 10 Center
Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Heart, Lung, and Blood Institute (NHLBI), Building 31, Room 5A33,
31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National institute on Aging (NIA), Gateway Building 31, Room 2C234, 7201
Wisconsin Avenue, Bethesda, MD 20892.


 


	
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Privacy Act Coordinator,
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Willco Building, Room 400,
6000 Executive Boulevard, Bethesda, MD 20892-7003.


 


Privacy Act Coordinator,
National Institute of Allergy and Infectious Diseases (NIAID), 6700-B Rockledge
Drive, Room 2143, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
Natcher Building, Room 5AS49, 45 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Biomedical Imaging and Bioengineering (NIBIB), Building
31, Room 1B37, 31 Center Drive, Bethesda, MD 20892-2077.


 


Privacy Act Coordinator,
National Institute of Child Health and Human Development (NICHD), Building 31, Room 2A11,
31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
Office of Extramural Affairs, National Institute on Drug Abuse (NIDA),
Neuroscience Center, 6001 Executive Boulevard, Room 3158, Bethesda, MD
20892-9547.


 


Privacy Act Coordinator,
National Institute on Deafness and Other Communication Disorders (NIDCD),
Building 31, Room 3C02, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Dental and Craniofacial Research (NIDCR), Natcher
Building, Room 4AS25, 45 Center Drive, Bethesda, MD 20892-6401.


 


Privacy Act Coordinator,
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK),
Building 31, Room 9A47, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Environmental Health Sciences (NIEHS), P.O. Box
12233, Research Triangle Park, NC 27709.


 


Privacy Act Coordinator,
National Institute of General Medical Sciences (NIGMS), Natcher Building, Room 2AN32,
45 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Mental Health (NIMH), Neuroscience Center, 6001 Executive
Boulevard, Room 8102, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Neurological Disorders and Stroke (NINDS), Building 31, Room 8A33,
31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Nursing Research (NINR), Rockledge II, Room 710,
6701 Rockledge Drive, Bethesda, MD 20892.


 


RECORD
ACCESS PROCEDURE:


 


Same as Notification
Procedures.  Requesters should reasonably
specify the record contents being sought. 
An individual may also request an accounting of disclosures of his/her
record, if any.


 


CONTESTING
RECORD PROCEDURE:


 


Contact the appropriate
official at the address specified under Notification Procedure, and reasonably
identify the record, specify the information being contested, and state
corrective action sought, with supporting information to show how the record is
inaccurate, incomplete, untimely, or irrelevant.


 


	
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RECORD
SOURCE CATEGORIES:


 


The system contains
information obtained directly from the subject individual by interview
(face-to-face or telephone), written questionnaire, or by other tests,
recording devices or observations, consistent with legislation and regulation
regarding informed consent and protection of human subjects.  Information is also obtained from other
sources, including but not limited to: 
referring medical physicians, mental health/alcohol/drug abuse or other
health care providers; hospitals; organizations providing biological specimens;
relatives; guardians; schools; and clinical medical research records.


 


SYSTEMS
EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:


 


None.


 


Appendix
I:  System Manager(s) and
Address(es)


 


Associate Director for
Disease Prevention, Office of the Director (OD), Building 1, Room 260, 1
Center Drive, Bethesda, MD 20892.


 


Computer Systems Analyst,
Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI),
Executive Plaza North, Room 344, 6130 Executive Boulevard, Bethesda, MD
20892.


 


American Burkitt’s Lymphoma
Registry, Division of Cancer Etiology, National Cancer Institute (NCI),
Executive Plaza North, Suite 434, 6130 Executive Boulevard, Bethesda, MD
20892.


 


Chief, Genetic Epidemiology
Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute
(NCI). Executive Plaza South, Room 7122, 6120 Executive Boulevard,
Bethesda, MD 20892-7236.


 


Program Director, Research
Resources, Biological Carcinogenesis Branch, Division of Cancer Etiology,
National Cancer Institute (NCI), Executive Plaza North, Room 540, 6130
Executive Boulevard, Bethesda, MD 20892.


 


Chief, Environmental
Epidemiology Branch, Division of Cancer Etiology, National Cancer Institute
(NCI), Executive Plaza North, Room 443, 6130 Executive Boulevard,
Bethesda, MD 20892.


 


Associate Director,
Surveillance Program, Division of Cancer Prevention, National Cancer Institute
(NCI), Executive Plaza North, Room 343K, 6130 Executive Boulevard,
Bethesda, MD 20892.


 


Head, Biostatistics and Data
Management Section, Center for Cancer Research, National Cancer Institute
(NCI), Building 6116, Room 702, 6116 Executive Boulevard, Bethesda, MD
20892.


 


Chief, Clinical Research
Branch, Center for Cancer Research, Frederick Cancer Research and Development
Center, National Cancer Institute (NCI), 501 W. 7th Street, Room 3,
Frederick, MD 21702.


 


Deputy Branch Chief, Navy
Hospital, NCI-Naval Medical Oncology Branch, Center for Cancer Research,
National Cancer Institute (NCI), Building 8, Room 5101, Bethesda, MD
20814.


 


Chief, Pharmaceutical
Management Branch, Cancer Therapy Evaluation Program, Division of Cancer
Treatment and Diagnosis, National Cancer Institute (NCI), Executive Plaza
North, Room 804, 6130 Executive Boulevard, Bethesda, MD 20892.


 


Director, Extramural
Clinical Studies, Frederick Cancer Research and Development Center, National
Cancer Institute (NCI), Fort Detrick, Frederick, MD 21702.


 


	
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Clinical Operations Manager,
National Eye Institute (NEI), Building 10, Room 10S224, 10 Center Drive,
Bethesda, MD 20892.


 


Director, Division of
Biometry and Epidemiology, National Eye Institute (NEI), Building 31, Room 6A52,
31 Center Drive, Bethesda, MD 20892.


 


Associate Director, Office
of Clinical Affairs, National Heart, Lung, and Blood Institute (NHLBI),
Building 10, Room 8C104,10 Center Drive, Bethesda, MD 20892-1754.


 


Senior Scientific Advisor,
Office of the Director, Division of Epidemiology and Clinical Applications,
National Heart, Lung, and Blood Institute (NHLBI), Federal Building, Room 220,
7550 Wisconsin Avenue, Bethesda, MD 20892.


 


Chief, Laboratory of
Epidemiology, Demography and Biometry, National Institute on Aging (NIA),
Gateway Building, Room 3C309, 7201 Wisconsin Avenue, Bethesda, MD 20892.


 


Chief, Research Resources
Branch, Intramural Research Program, National Institute on Aging (NIA), 5600
Nathan Shock Drive, Baltimore, MD 21224.


 


Clinical Director, National
Institute on Aging (NIA), 5600 Nathan Shock Drive, Baltimore, MD 21224.


 


Deputy Director, Division of
Biometry and Epidemiology, National Institute on Alcohol Abuse and Alcoholism
(NIAAA), Willco Building, Room 514, 6000 Executive Boulevard, Bethesda, MD
20892-7003.


 


Deputy Director, Division of
Clinical and Prevention Research, National Institute on Alcohol Abuse and
Alcoholism (NIAAA), Willco) Building, Room 505, 6000 Executive Boulevard,
Bethesda, MD 20892-7003.


 


Chief, Respiratory Viruses
Section, Laboratory of Infectious Diseases, National Institute of Allergy and
Infectious Diseases (NIAID), Building 7, Room 106, 7 Memorial Drive,
Bethesda, MD 20892.


 


Chief, Hepatitis Virus
Section, Laboratory of Infectious Diseases, National Institute of Allergy and
Infectious Diseases (NIAID), Building 7, Room 202, 7 Memorial Drive,
Bethesda, MD) 20892.


 


Chief, Biometry Branch,
Division of Microbiology and Infectious Diseases, National Institute of Allergy
and Infectious Diseases (MAID), 6700-B Rockledge Drive, Room 3120,
Bethesda, MD) 20892.


 


Clinical Director, National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Building
10, Room 9S205, 10 Center Drive, Bethesda, MD 20892.


 


Chief, Contracts Management
Branch, National Institute of Child Health and Human Development (NICHD),
Executive Plaza North, Room 7A07, 6130 Executive Boulevard, Bethesda, MD
20892.


 


Director of Intramural
Research, National Institute on Deafness and Other Communication Disorders
(NIDCD), Building 31, Room 3C02, 31 Center Drive, Bethesda, MD 20892.


 


Chief, Scientific Programs
Branch, National Institute on Deafness and Other Communication Disorders
(NIDCD), Executive Plaza South, Room 400C, 6120 Executive Boulevard,
Bethesda, MD 20892-7180.


 


Clinical Director, National
Institute of Dental and Craniofacial Research (NIDCR), Building 10, Room INl17,
10 Center Drive, Bethesda, MD 20892-1191.


 


Chief, Scientific Review
Branch, National Institute of Dental and Craniofacial Research (NIDCR),
Building 10, Room IN117, 10 Center Drive, Bethesda, MD 20892-1191.


 


	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


Research Psychologist, Gene
Therapy and Therapeutics Branch, National Institute of Dental and Craniofacial
Research (NIDCR), Building 10, Room 1N105, 10 Center Drive, Bethesda, MD
20892-1190.


 


Chief, Clinical
Investigations, National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), Building 10, Room 9N222, 10 Center Drive, Bethesda, MD
20892.


 


Chief, Phoenix Clinical
Research Section, National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), Phoenix Area Indian Hospital, Room 541, 4212 North 16th
Street, Phoenix, AZ 85016.


 


Chief, Diabetes Research
Section, Division of Diabetes, Endocrinology, and Metabolic Diseases, National
Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Natcher
Building, Room 5AN18G, 45 Center Drive, Bethesda, MD 20892-6600.


 


Privacy Act Coordinator,
Office of Extramural Affairs, National Institute on Drug Abuse (NIDA), 6001
Executive Boulevard, Room 3158, Bethesda, MD 20892-9547.


 


Chief, Epidemiology Branch,
National Institute of Environmental Health Sciences (NIEHS), P.O. Box
12233, Research Triangle Park, NC 27709.


 


Director, Intramural
Research Program, National Institute of Mental Health (NIMH), Building 10, Room 4N224,
10 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator,
National Institute of Mental Health (NIMH), Neuroscience Center, Room 8102,
6001 Executive Boulevard, Bethesda, MD) 20982.


 


Privacy Act Coordinator,
National Institute of Neurological Disorders and Stroke (NINDS), Building 31, Room 8A33,
31 Center Drive, Bethesda, MD 20892.


 


Chief, Epilepsy Branch,
National Institute of Neurological Disorders and Stroke (NINDS), Neuroscience
Center, 6001 Executive Boulevard, Suite 2110, Bethesda, MD 20892-9523.


 


Assistant Director, Clinical
Neurosciences Program, Division of Intramural Research, National Institute of
Neurological Disorders and Stroke (NINDS), Building 10, Room 5N234, 10
Center Drive, Bethesda, MD 20892.


 


Acting Chief, Laboratory of
Central Nervous Systems Studies, Intramural Research Program, National
Institute of Neurological Disorders and Stroke (NINDS), Building 36, Room 4A21,
36 Convent Drive, Bethesda, MD 20892-4123.


 


Clinical Director, National
Human Genome Research Institute (NHGRI), Building 10, Room 10C101D, 10
Center Drive, Bethesda, MD 20892.


 


Deputy Director, Division of
Extramural Research, National Institute of Neurological Disorders and Stroke
(NINDS), Neuroscience Center, Room 3307, 6001 Executive Boulevard,
Bethesda, MD 20892.


 


Director, Office of Clinical
and Regulatory Affairs, Division of Extramural Research and Training, Democracy
Plaza II, Room 401, 6707 Democracy Boulevard, Bethesda, MD 20892-5475.


 


Privacy Act Coordinator,
National Institute of Biomedical Imaging and Bioengineering (NIBIB), Building
31, Room 1837, 31 Center Drive, Bethesda, MD 20892-2077.


 


Privacy Act Coordinator,
National Center on Minority Health and Health Disparities (NCMHD), Democracy
Plaza II, Room 800, 6707 Democracy Boulevard, Bethesda, MD 20892-5465.


 


	
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Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


HHSAR
352.223-70 SAFETY AND HEALTH (JANUARY 2001)


 


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


 


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


 


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


 


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


 


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


 


(End
of clause)


 


	
  Safety and
  Health Clause

  	
   

  	
  ATTACHMENT 5

  
	
  HHSAR
  352.223-70 (1/01)

  	
   

  	
   

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


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 Croups 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 6

  
	
  OMB Bulletin
  81-16

  	
   

  	
   

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


RESEARCH
PATIENT CARE COSTS


 


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


 


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


 


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


 


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


 


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


 


	
  NIH (RC)-11

  	
   

  	
  ATTACHMENT 7

  
	
  (4/1/84)

  	
   

  	
   

  



 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY


 


	
  CONTRACTOR:

  	
   

  	
  CONTRACTOR NUMBER

  
	
   

  	
   

  	
   

  
	
  ADDRESS

  	
   

  	
  REPORT DATE:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FISCAL YEAR:

  
	
   

  	
   

  	
   

  



 


	
   

  	
   

  	
  BEGINNING OF

  PERIOD

  	
   

  	
  ADJUSTMENTS

  	
   

  	
  END OF PERIOD

  	
   

  
	
  CLASSIFICATION

  	
   

  	
  #ITEMS

  	
   

  	
  VALUE

  	
   

  	
  GFP ADDED

  	
   

  	
  CAP ADDED

  	
   

  	
  DELETIONS

  	
   

  	
  #ITEMS

  	
   

  	
  VALUE

  	
   

  
	
  LAND>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  LAND<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OTHER REAL>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OTHER REAL<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER CONST>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER CONST<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PLANT EQUIP>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PLANT EQUIP<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TOOLING>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TOOLING<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TEST EQUIP>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TEST EQUIP<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AGENCY PECULIAR>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AGENCY PECULIAR<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  MATERIAL>=$25K (CUMULATIVE)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER MFR>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER MFR<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 




	
  SIGNED BY:

  	
   

  	
  DATE SIGNED:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Report of
  Government Owned, Contractor Held Property

  	
   

  	
  ATTACHMENT 8

  
					






 

















 


Contract No. HHSN2662004000034C


ADB NO. N01-AI-400034


 


PART IV


 


[***]


 


END of the SCHEDULE


(CONTRACT)


 


2