CONTRACT NO. N01-AI-95381
BBI - BIOTECH RESEARCH LABORATORIES, INC.
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.................................. 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES...................... 4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE................................... 4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS.......................... 4
ARTICLE B.4. ADVANCE UNDERSTANDINGS......................................... 6
SECTION C - STATEMENT OF WORK...................................................... 7
ARTICLE C.1. STATEMENT OF WORK.............................................. 7
ARTICLE C.2. REPORTING REQUIREMENTS......................................... 7
SECTION D - PACKAGING, MARKING AND SHIPPING........................................ 9
SECTION E - INSPECTION AND ACCEPTANCE.............................................. 9
SECTION F - DELIVERIES OR PERFORMANCE.............................................. 10
ARTICLE F.1. DELIVERIES..................................................... 10
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE.............................. 10
SECTION G - CONTRACT ADMINISTRATION DATA........................................... 11
ARTICLE G.1. PROJECT OFFICER................................................ 11
ARTICLE G.2. KEY PERSONNEL.................................................. 11
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT........................................... 12
ARTICLE G.4. INDIRECT COST RATES............................................ 13
ARTICLE G.5. GOVERNMENT PROPERTY............................................ 13
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE...................... 14
SECTION H - SPECIAL CONTRACT REQUIREMENTS.......................................... 15
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND
DEVELOPMENT PROJECTS....................................... 15
ARTICLE H.2. HUMAN SUBJECTS................................................. 15
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH.............. 15
ARTICLE H.4. NEEDLE EXCHANGE................................................ 16
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS.................. 16
ARTICLE H.6. EPA ENERGY STAR REQUIREMENTS................................... 16
ARTICLE H.7. PUBLICATION AND PUBLICITY...................................... 16
ARTICLE H.8. PRESS RELEASES................................................. 17
ARTICLE H.9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE............. 17
ARTICLE H.10. YEAR 2000 COMPLIANCE........................................... 17
PART II - CONTRACT CLAUSES............................................................... 19
SECTION I - CONTRACT CLAUSES....................................................... 19
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT ..... 19
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES.............................. 22
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES.................................... 22
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ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT.......... 23
PART III................................................................................. 25
SECTION J - LIST OF ATTACHMENTS.................................................... 25
PART IV.................................................................................. 25
SECTION K - REPRESENTATIONS AND CERTIFICATIONS..................................... 25
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CONTRACT NO1-A1-95381
BBI - BIOTECH RESEARCH LABORATORIES, INC.
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this contract is to provide a specimen repository for domestic
and international HIV epidemiology studies, HIV vaccine trials, and other
clinical and prevention research studies supported by the DAIDS in the NIAID.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this contract is $9,154,511.
b. The fixed fee for this contract is $452,450. The fixed fee shall be paid
in installments based on the percentage of completion of work, as
determined by the Contracting Officer, and subject to the withholding
provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE
referenced in the General Clause Listing in Part II, ARTICLE I.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 fixed fee, is $9,606,961.
d. Total funds currently available for payment and allotted to this contract
are $1,295,817, of which $1,241,460 represents the estimated costs, and
of which $54,357 represents the fixed fee. For further provisions on
funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE
I.2. Authorized Substitutions of Clauses.
e. It is estimated that the amount currently allotted will cover performance
of the contract through August 15, 2000.
f. Increments to be allotted to this contract are estimated as follows:
Total Estimated
FY Period Estimated Cost Fixed Fee Cost Plus Fee
-- ------ -------------- --------- ----------------
1999 8/16/99-8/15/00 $1,241,460 $ 54,357 $1,295,817
2000 8/16/00-8/15/01 $1,027,597 $ 52,767 $1,080,364
2001 8/16/01-8/15/02 $1,242,260 $ 60,496 $1,302,756
2002 8/16/02-8/15/03 $1,280,768 $ 64,427 $1,345,195
2003 8/16/03-8/15/04 $1,340,291 $ 67,626 $1,407,917
2004 8/16/04-8/15/05 $1,399,171 $ 70,776 $1,469,947
2005 8/16/05-8/15/06 $1,622,964 $ 82,001 $1,704,965
---------- -------- ----------
TOTAL $9,154,511 $452,450 $9,606,961
g. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. ITEMS UNALLOWABLE UNLESS OTHERWISE PROVIDED
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
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(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of ANY item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel - See b(2) below ;
(6) Patient care costs;
(7) 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;
(8) Consultants; and
(9) Subcontract(s).
b. TRAVEL COSTS
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation,
lodging, subsistence, and incidental expenses) incurred in
direct performance of this contract shall not exceed $22,470
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 Regulation (FAR)
31.205-46.
(2) Foreign Travel
Requests for foreign travel must be submitted at least six weeks
in advance and shall contain the following: (a) meeting(s) and
place(s) to be visited, with costs and dates; (b) name(s) and
title(s) of Contractor personnel to travel and their functions in
the contract project; (C) contract purposes to be served by the
travel; (d) how travel of contractor personnel will benefit and
contribute to accomplishing the contract project, or will otherwise
justify the expenditure of NIH contract funds; (e) how such
advantages justify the costs for travel and absence from the
project of more than one person if such are suggested; and (f)
what additional functions may be performed by the travelers to
accomplish other purposes of the contract and thus further benefit
the project.
(3) Government Discount Air Travel Rates
(a) To the maximum extent practicable consistent with travel
requirements, the Contractor agrees to use the reduced air
transportation rates and services provided through available
Government discount air fares. These fares are available only
for bona-fide employees' travel that is otherwise reimbursable
as a direct cost pursuant to this contract. The objective is
to achieve the lowest overall cost to the Contractor and,
thus, to the Government. The Contractor shall submit written
requests to the Contracting Officer for authorization to use
these rates. The request shall provide the full name of the
traveler(s), the number of the contract for which the travel
is being performed, the contract objective that is to be
fulfilled, and the dates during which the travel is to occur.
Contracting Officer approval, if given, will be on official
agency letterhead so that
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the letter can be presented to the airline as confirmation
of the authorization.
(b) Nothing in this clause shall authorize transportation or
services which are not otherwise reimbursable under this
contract. Nothing in this clause requires air carriers to make
available to the Contractor any government discount airfares.
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. PRE-CONTRACT COSTS
Within the dollar limitation set forth under SECTION B, ARTICLE B.2., the
Contractor shall be entitled to reimbursement for costs incurred during
the period August 16, 1999 through August 31, 1999, in an amount not to
exceed $50,000, which if incurred after this contract had been entered
into would have been reimbursable under the provisions of this contract.
b. INDIRECT COSTS
Pending the establishment of final indirect cost rates for any period,
billing and reimbursement shall be made on the basis of provisional
billing rates set forth in the Negotiated Indirect Cost Rate Agreement of
April 1, 1998.
c. SUBCONTRACT
To negotiate a cost type subcontract with Information Management Services,
Inc. (IMS) for Computerized biological specimen inventory and tracking for
an amount not to exceed $275,628. Award of the subcontract shall not
proceed without the prior written approval of the Contracting Officer upon
review of the supporting documentation as required by the Subcontracts
clause of the General Clauses incorporated in this contract. (After
written approval of the subcontract by the Contracting Officer, a copy of
the signed, approved subcontract shall be provided to the Contracting
Officer.)
d. USE OF SAMPLES/PRODUCTS RECEIVED UNDER THIS CONTRACT
The contractor agrees that samples/products received from/through the
Government for utilization under this contract shall be used only for
purposes required to fulfill the Statement of Work and for no other
purpose, specifically not for manufacturing or selling in conjunction with
its parent company.
e. CORRESPONDENCE PROCEDURES
To promote timely and effective administration, correspondence (except
for invoices, technical progress reports/other deliverables) submitted
under this contract shall be subject to the following procedures:
(1) Technical correspondence shall be addressed to the Project Officer
with an information copy of the basic correspondence to the
Contracting Officer. (As used herein, technical correspondence
EXCLUDES correspondence which proposes deviations from or
modifications of contract requirements, terms or conditions)
(2) Other correspondence shall be addressed to the Contracting Officer,
with an information copy of the basic correspondence to the Project
Officer.
(3) Subject Line(s). All correspondence shall contain a subject line
commencing with the contract number as illustrated below:
SUBJECT: Contract No. NO1-AI-95381
Request for Approval of
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g. CONFIDENTIAL TREATMENT OF SENSITIVE INFORMATION
The Contractor shall guarantee strict confidentiality of the
information/data that is provided by the Government during the performance
of the contract. The Government has determined that the information/data
that the Contractor will be provided during the performance of the
contract is of a sensitive nature and can not be disclosed in any matter.
Disclosure of the information/data, in whole or in part, by the Contractor
can only be made after the Contractor receives prior written approval from
the Contracting Officer. Whenever the Contractor is uncertain with regard
to the proper handling of information/data under the contract, the
Contractor shall obtain a written determination from the Contracting
Officer.
SECTION C - STATEMENT OF WORK
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government as
needed to perform the Statement of Work SECTION J, ATTACHMENT 1 , dated
August 16, 1999, attached hereto and made a part of this contract.
ARTICLE C.2. REPORTING REQUIREMENTS
a. TECHNICAL REPORTS
In addition to those reports required by the other terms of this contract,
the Contractor shall prepare and submit the following reports in the
manner stated below and in accordance with ARTICLE F.1. DELIVERIES of this
contract:
1) Quarterly Progress Reports
By the fifteenth day of the month following the end of each quarter,
the Contractor shall submit two (2) copies of a quarterly progress
report as described below. The first reporting period shall consist
of the first full three months of performance including any
fractional part of the initial month (August 16, 1999 through
November 30, 1999). One (1) copy shall be submitted to the Project
Officer and one (1) copy to the Contracting Officer. A quarterly
report is not due when an annual report is due. The quarterly report
should be factual, concise, and consist of the following:
a) Title page containing:
(1) Contract number and title
(2) Sequence of report; (e.g., "Year 1, 2nd Quarterly Report")
(3) Period of performance being reported
(4) Contractor's name and address
(5) Date of submission
b) Reports shall include, but are not limited to the following
information:
(1) A brief introduction covering the objective and scope of
the contract effort.
(2) A description of the overall work accomplished during
the quarter plus brief descriptions of shipping activity
both into and out of the Repository, including specimen
disbursement requests.
(3) A description of any technical or performance problems
encountered and corrective actions planned or taken.
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(4) An explanation of any differences between planned and
actual progress.
(5) Selected other information as may be required by the
Project Officer.
2) Annual Progress Report
Thirty (30) days after each anniversary date of the contract, the
Contractor shall submit two (2) copies of an annual report. One (1)
copy shall be submitted to the Project Officer and one (1) copy to
the Contracting Officer. The annual report shall be factual and
concise and summarize progress for the entire contract year,
following the same format as for the Quarterly Progress Reports and
shall take the place of the fourth Quarterly Progress Report each
year. An annual report is not required when the final report is due.
3) Interim Reports
Upon request by the Project Officer, and within five working days of
such a request, the Contractor shall provide an interim report to
cover the period of the current week or latest 1 - 4 weeks, and
describing:
a) the specific work accomplished and in progress
b) a summary of all shipping activity into and out of the
Repository
c) a description of any technical or performance problems
encountered and corrective actions
planned or taken
d) estimated time taken to complete the work described
e) selected other items as required by the Project Officer
4) Final Report
The contractor shall submit two (2) copies of the final report,
which will summarize the results of the entire contract work for the
complete performance period. One (1) copy shall be submitted to the
Project Officer and one (1) copy to the Contracting Officer. This
report will follow the same format as for the Annual Progress Report
and shall take the place of the last Annual Progress Report. It
shall be in sufficient detail to explain comprehensively the results
achieved and shall be submitted no later than the completion date of
the contract.
5) Other Deliverables
a) The Contractor shall prepare a transition plan within 30
calendar days of award date.
b) The Contractor shall prepare a User Manual of SOPs, subject
to Project Officer approval, for all aspects of specimen
handling within 45 calendar days of award date.
c) By February 1, 2000, the Contractor shall prepare (in
coordination with the Project Officer and other DAIDS cohorts)
a Repository Management Plan, subject to Project Officer
approval, which addresses issues of a proposed maximum
capacity that the DAIDS Specimen Repository should maintain;
criteria for determining which specimens are collected,
stored, or discarded for each research study;
availability/accessibility of specimens to the scientific
community; quality control; and specific steps to institute
the plan's targeted goals.
d) The Contractor, subject to Project Officer approval, shall
deliver to the Government or its designee the following items
by the completion date of the Contract:
(1) Stored specimens including those received by the
Contractor from the Project Officer or designated
investigators.
(2) A computer-generated listing of accurate and updated
information on specimen inventory, including activities
of the contractor, computerized data files, original
data, and any necessary information related thereto;
(3) Labeled and inventoried paper files; and
(4) Government-owned equipment and specimen property.
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b. Delivery of Reports
If the Contractor becomes unable to deliver the reports or other
deliverables specified hereunder within the period of performance because
of unforeseen difficulties, notwithstanding the exercise of good faith and
diligent efforts in performance of the work, the Contractor shall give the
Contracting Officer immediate written notice of anticipated delays with
reasons therefore at the address given below.
1) Project Officer
ETB, VPRP, DAIDS, NIAID, NIH
6700-B Rockledge Drive, Room 4232, MSC 7628
Bethesda, Maryland 20892-7628
2) Contracting Officer
CMB, DEA, NIAID, NIH
6700-B Rockledge Drive, Room 2230, MSC 7612
Bethesda, Maryland 20892-7612
SECTION D - PACKAGING, MARKING AND SHIPPING
All Specimens under this contract shall be packaged, marked and shipped in
accordance with Government specifications. Specifically, shipping containers
must be used which comply with U.S. DOT or IATA regulations for infectious
substances, styrofoam boxes, liquid nitrogen shipping containers, labeling
material, shipping forms, and any other IATA requirements.
The contractor shall operate in accordance with the basic references and
other modifications by the Public Health Service which include but are not
limited to:
(1) Title 49 CFR Part 100-199 Transportation
(2) Title 42 CFR Part 71.54 and 72.3 Etiologic Agents, Hosts and
Vectors; Interstate Shipment of Etiologic Agents
(3) Title 39 CFR Part 124 Postal Services
(4) International Air Transport Association (IATA), Dangerous Goods
Regulations 36th Edition 1995, and 1997 changes to the IATA
Dangerous Good Regulations
(5) International Civil Aviation Organization (ICAO) Technical
Instructions for the Safe Transportation of Dangerous Good by Air
1995-1996
(6) United Nations Recommendations on the Transport of Dangerous Good
8th Edition
All other deliverables required under this contract shall be packaged, marked
and shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and 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 ARTICLE the Project Officer is the authorized
representative of the Contracting Officer.
c. Inspection and acceptance will be performed at:
ETB, VPRP, DAIDS, NIAID, NIH
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6700-B Rockledge Drive, Room 4232, MSC 7628
Bethesda, Maryland 20892-7628
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. 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT
(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
a. Satisfactory performance of this contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the items specified in the Delivery Schedule which are
described in SECTION C of this contract.
b. Deliveries required by the contractor shall be made f.o.b. destination as
set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES
(APRIL 1984), and in accordance with and by the dates specified below:
- -----------------------------------------------------------------------------------------------------
TYPE OF REPORT NO OF COPIES ADDRESS DUE DATES
- -------------- ------------ ------------------------------- ----------------------------
Quarterly 1 Project Officer Beginning on December 15,
VPRP, ETB, DAIDS 1999, and quarterly
NIAID, NIH thereafter. A quarterly
6700-B Rockledge Dr. will not be due when
Rm. 4232 submitting an annual or
Bethesda, MD 20892 final report.
- -------------- ------------ ------------------------------- ----------------------------
Quarterly 1 Contracting Officer Same as above
(Original) NIH, NIAID, CMB
6700-B Rockledge Dr.
Rm. 2230, MSC 7612
Bethesda, MD 20892-7612
- -------------- ------------ ------------------------------- ----------------------------
Annual 1 P.O.'s Address above Beginning September 15,
2000, and 30 days following
each anniversary date of
the contract thereafter.
- -------------- ------------ ------------------------------- ----------------------------
Annual 1 C.O.'s Address above Same as above
(Original)
- -------------- ------------ ------------------------------- ----------------------------
Final 1 P.O.'s Address above On/before August 15, 2006
- -------------- ------------ ------------------------------- ----------------------------
Final 1 C.O.'s Address above Same as above
(Original)
- ------------------------------------ ----------------------------------- -----------------------------
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ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the
purpose of this contract:
Elaine Matzen, R.N., Health Specialist
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 Contracting Officer hereby delegates the Project Officer as the
Contracting Officer's authorized representative responsible for signing
software license agreements issued as a result of this contract.
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
The personnel specified in this contract are considered to be essential to
the work to be performed hereunder. Prior to diverting any of the specified
individuals to other programs, the Contractor shall notify the Contracting
Officer reasonably in advance and shall submit justification (including
proposed substitutions) in sufficient detail to permit evaluation of the
impact on the program. No diversion shall be made by the Contractor without
the written consent of the Contracting Officer; provided, that the
Contracting Officer may ratify in writing such diversion and such
ratification shall constitute the consent of the Contracting Officer required
by this article. The contract may be amended from time to time during the
course of the contract to either add or delete personnel, as appropriate.
The following individuals are considered to be essential to the work being
performed hereunder:
NAME TITLE
Mark Cosentino, Ph.D., D.P.M. Principal Investigator
Carla Hanson Co-Project Manager
Kathi Shea Co-Project Manager
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Jiuping (Jay) Ji, Ph.D. Co-Investigator
Hanna Weissberger, Ph.D. Co-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.
b. These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002. Unless otherwise stated in
that part of the Instructions for Completing Form NIH(RC)-4 (see
ATTACHMENT 1), all columns A through H shall be completed for each invoice
submitted.
c. The Contracting Officer may require the Contractor to submit detailed
support for costs contained in one or more interim financial invoices.
This clause does not supersede the record retention requirements of FAR
Part 4.7.
d. The contractor agrees to provide a detailed breakdown on invoices of cost
and personnel reporting and variances from the negotiated budget in the
following cost categories:
1) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount claimed.
2) Fringe Benefits - Cite rate and amount
3) Overhead - Cite rate and amount
4) Materials & Supplies - Include detailed breakdown when total amount
is over $1,000.
5) 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.
6) Consultant Fees - Identify individuals and amounts.
7) Subcontracts - Attach subcontractor invoice(s).
8) Other Direct Costs - Provide breakdown when total amount is over
$1,000.
9) Equipment - Cite authorization and amount.
10) G&A - Cite rate and amount.
11) Total Cost
12) Fixed Fee
13) Total Amount Claimed
14) Adjustments
15) Grand Totals
e. Invoices must include the cumulative total expenses to date, adjusted (as
applicable) to reflect any amounts suspended by the Government.
e. 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 CURRENTLY ALLOTTED TO THE
CONTRACT AND THE REASONS FOR THE VARIANCE. Also, refer to the requirements
of FAR 52.232-20, Limitation of Cost, referenced in the contract.
f. Invoices/financing requests shall be submitted in the form of an ORIGINAL
AND TWO COPIES to the following designated BILLING office:
Contracting Officer
Contract Management Branch, DEA
National Institute of Allergy and Infectious Diseases, NIH
6700-B Rockledge Drive, Room 2230, MSC 7612
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Bethesda, Maryland 20892-7612
g. Inquiries regarding approval of invoices should be directed to the
designated BILLING office, (301) 496-0612.
h. 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.5. 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 the Public Law (P.L.) cited for the applicable
Fiscal Year as stated in ARTICLE H.5. 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
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Director, Division of Financial Advisory Services
Office of Contracts Management
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC-7540
BETHESDA MD 20892-7540
Please see Article B.4. Advance Understandings, paragraph b., Indirect Costs.
These rates are hereby incorporated without further action of the Contracting
Officer. The above information notwithstanding, the notification required to be
submitted to the Contracting Officer pursuant to FAR 52.232-22, "Limitation of
Funds," of this contract shall remain in effect.
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 Contract Property
Administrator.
This contract's Contract Property Administrator is:
Charles Varga
Contracts Property Administrator
Research Contracts Property Administration, NIH
6011Building, Room 641E
6011 EXECUTIVE BLVE MSC 7670
BETHESDA MD 20852-7670
(301) 496-6466
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CONTRACT NO1-A1-95381
BBI - BIOTECH RESEARCH LABORATORIES, INC.
b. CONTRACTOR-ACQUIRED GOVERNMENT PROPERTY - SCHEDULE I-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor is hereby authorized to acquire the property
listed in Schedule I-A below for use in direct performance of the
contract. Title of this property shall vest in the Government
SCHEDULE I-A - (Year 1)
Item No. Quantity Description Est. Cost
-------- -------- ----------- ---------
1-15 15 -70 degrees freezers @ $7,550 each $ 113,250
16-19 4 LN2 freezers (XLC-1830) @ $20,450 each $ 81,800
17 1 Racking System for LN2 $ 4,740
18 1 Additional LN2 Vacuum Piping $ 9,500
19-25 7 Racking System for -70c @ $3,388 each $ 23,716
26-28 3 Bar Coding Scanner @ $1,300 each $ 3,900
29-32 4 Computers @ $887 each $ 3,548
33 1 T1 Line for Computer System $ 1,000
----------
TOTAL $ 241,454
c. CONTRACTOR-ACQUIRED GOVERNMENT PROPERTY - SCHEDULE I-B
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor will be authorized to acquire the property listed
in Schedule I-B for use in direct performance of the contract, following
receipt of the Contracting Officer's written approval, based on
contractor-furnished prices and evidence of competition.
SCHEDULE I-B -- (Years 2-7)
Description Yr.2 Yr.3 Yr.4 Yr.5 Yr.6 Yr.7 Total (Yrs. 2-7)
----------- ---- ---- ---- ---- ---- ---- ----------------
-70(degree)freezer & 8 units 13 units 13 units 13 units 13 units 13 units 73 units
racking system $ 90,129 $147,259 $151,677 $156,228 $160,914 $165,741 $871,948
LN2 freezer & 1 unit 2 units 1 unit 1 unit 1 unit 2 units 8 units
racking system $25,946 $53,447 $27,526 $28,352 $29,202 $60,157 $224,630
Total $116,075 $200,706 $179,203 $184,580 $190,116 $225,898 $1,096,578
d. GOVERNMENT FURNISHED PROPERTY - SCHEDULE II-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract,
the Contractor is hereby authorized to retain custody of the property
listed in Attachment 5, Schedule II-A for use in direct performance of this
contract. Accountability for the items listed in Schedule II-A is hereby
transferred to this contract from predecessor Contract No. NO1-AI-45204 ,
under which these items were provided by the Government. Title to this
property shall remain in the Government.
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CONTRACT NO1-A1-95381
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ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE
Interim and final evaluations of contractor performance will be prepared on
this contract in accordance with FAR 42.15. The final performance evaluation
will be prepared at the time of completion of work. In addition to the final
evaluation, interim evaluations will be prepared annually to coincide with
the anniversary date of the contract.
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. Any disagreement between the parties
regarding an evaluation 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.
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. This support is
provided in the form of contracts and grants totaling approximately 7 billion
dollars annually. PHS has established effective, time tested and well
recognized procedures for stimulating and supporting this independent
RESEARCH by selecting from multitudes of applications those research projects
most worthy of support within the constraints of its appropriations. The
reimbursement through the indirect cost mechanism of independent research and
development costs not incidental to product improvement would circumvent this
competitive process.
To ensure that all research and development projects receive similar and
equal consideration, all organizations may compete for direct funding of
independent research and development projects they consider worthy of support
by submitting those projects to the appropriate Public Health Service grant
office for review. Since these projects may be submitted for direct funding,
the Contractor agrees that no costs for any independent research and
development project, including all applicable indirect costs, will be claimed
under this contract.
ARTICLE H.2. HUMAN SUBJECTS
It is hereby understood and agreed that research involving human subjects
shall not be conducted under this contract, and that no material developed,
modified, or delivered by or to the Government under this contract, or any
subsequent modification of such material, will be used by the Contractor or
made available by the Contractor for use by anyone other than the Government,
for experimental or therapeutic use involving humans without the prior
written approval of the Contracting Officer.
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) cited in paragraph b. , below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos
for research purposes; or (2) research in which a human embryo or embryos
are destroyed, discarded, or knowingly
14
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
105-297, Section 511 1999 10/1/98 - 9/30/99
ARTICLE H.4. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds
shall not be used to carry out any program of distributing sterile needles
or syringes for the hypodermic injection of any illegal drug.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
105-277, Section 505 1999 10/1/98 - 9/30/99
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds for the applicable fiscal year(s) and periods cited in paragraph b.,
below 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
and period covered. Direct salary is exclusive of overhead, fringe benefits
and general and administrative expenses. The per year salary rate limit
also applies to individuals proposed under subcontracts. If this is a
multi-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 DHHS appropriation acts.
DOLLAR AMOUNT OF
b. PUBLIC LAW NO. FISCAL YEAR PERIOD COVERED SALARY LIMITATION
105-277 1999 10/1/98 - 9/30/99 $125,900
ARTICLE H.6. EPA ENERGY STAR REQUIREMENTS
In compliance with Executive Order 12845 (requiring Agencies to purchase
energy efficient computer equipment) all microcomputers, including personal
computers, monitors, and printers that are deliverables under the procurement
or are purchased by the contractor using Government funds in performance of a
contract shall be equipped with or meet the energy efficient low-power
standby feature as defined by the EPA Energy Star program unless the
equipment always meets EPA Energy Star efficiency levels. The microcomputer,
as configured with all components, must be Energy Star compliant.
This low-power feature must already be activated when the computer equipment
is delivered to the agency and be of equivalent functionality of similar
power managed models. If the equipment will be used on a local area network,
the vendor must provide equipment that is fully compatible with the network
environment. In addition, the equipment will run commercial off-the-shelf
software both before and after recovery from its energy conservation mode.
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CONTRACT NO1-A1-95381
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ARTICLE H.7. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, under Contract No. NO1-AI-95381."
ARTICLE H.8. PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage
of the total costs of the program or project which will be financed with
Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of the
project or program that will be financed by nongovernmental sources.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
105-277, Section 507 1999 10/1/98-9/30/99
ARTICLE H.9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud,
waste and abuse in NIH funded programs is encouraged to report such matters
to the HHS Inspector General's Office in writing or on the Inspector
General's Hotline. The toll free number is 1-800-HHS-TIPS (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
Information regarding procedural matters is contained in the NIH Manual
Chapter 1754, which is available on (http://www1.od.nih.gov/oma/oma.htm)
ARTICLE H.10. YEAR 2000 COMPLIANCEARTICLE H.10. YEAR 2000 COMPLIANCE
In accordance with FAR 39.106, Information Technology acquired under this
contract must be Year 2000 compliant as set forth in the following clause(s):
1. SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
YEAR 2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
The Contractor agrees that each item of hardware, software, and firmware
used under this contract shall be able to accurately process date data
(including, but not limited to, calculating, comparing and sequencing)
from, into and between the twentieth and twenty-first centuries and the
Year 1999 and the Year 2000 and leap year calculations.
(End of Clause)
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CONTRACT NO1-A1-95381
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2. NONCOMMERCIAL SUPPLY ITEMS WARRANTY
YEAR 2000 WARRANTY--NONCOMMERCIAL SUPPLY ITEMS
The contractor warrants that each noncommercial item of hardware, software,
and firmware delivered or developed under this contract and listed below
shall be able to accurately process date data (including, but not limited
to, calculating, comparing and sequencing) from, into and between the
twentieth and twenty-first centuries and the Year 1999 and the Year 2000
and leap year calculations, when used in accordance with the item
documentation provided by the contractor, provided that all listed or
unlisted items (e.g., hardware, software and firmware) used in combination
with such listed item properly exchange date data with it. If the contract
requires that specific listed items must perform as a system in accordance
with the foregoing warranty, then that warranty shall apply to those listed
items as a system. The duration of this warranty and the remedies available
to the Government for breach of this warranty shall be as defined in, and
subject to, the terms and limitations of any general warranty provisions of
this contract provided that notwithstanding any provision to the contrary
in such warranty provision(s), or in the absence of any such warranty
provision(s), the remedies available to the Government under this warranty
shall include repair or replacement of any listed item whose noncompliance
is discovered and made known to the contractor in writing within ninety
(90) days after acceptance. Nothing in this warranty shall be construed to
limit any rights or remedies the Government may otherwise have under this
contract with respect to defects other than Year 2000 performance.
YEAR 2000 COMPLIANT ITEMS
Any database or software programs developed under this contract.
----------------------------------------------------------------
----------------------------------------------------------------
----------------------------------------------------------------
(end of clause)
3. COMMERCIAL SUPPLY PRODUCTS WARRANTY
YEAR 2000 WARRANTY--COMMERCIAL SUPPLY ITEMS
The contractor warrants that each hardware, software and firmware product
delivered under this contract and listed below shall be able to accurately
process date data (including, but not limited to, calculating, comparing,
and sequencing) from, into, and between the twentieth and twenty-first
centuries and the Year 1999 and the Year 2000 and leap year calculations,
when used in accordance with the product documentation provided by the
contractor, provided that all listed or unlisted products (e.g., hardware,
software, firmware) used in combination with such listed product properly
exchange date data with it. If the contract requires that specific listed
products must perform as a system in accordance with the foregoing
warranty, then that warranty shall apply to those listed products as a
system. The duration of this warranty and the remedies available to the
Government for breach of this warranty shall be as defined in, and subject
to, the terms and limitations of the contractor's standard commercial
warranty or warranties contained in this contract, provided that
notwithstanding any provision to the contrary in such commercial warranty
or warranties, the remedies available to the Government under this warranty
shall include repair or replacement of any listed product whose
non-compliance is discovered and made known to the contractor in writing
within ninety (90) days after acceptance. Nothing in this warranty shall be
construed to limit any rights or remedies the Government may otherwise have
under this contract with respect to defects other than Year 2000
performance.
YEAR 2000 COMPLIANT ITEMS ANY
Database or software programs developed under this contract.
----------------------------------------------------------------
----------------------------------------------------------------
----------------------------------------------------------------
(end of clause)
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CONTRACT NO1-A1-95381
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PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - FAR
52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text
of a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR CLAUSE
NO. DATE TITLE
- ----------- --------- -----
52.202-1 Oct 1995 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, Recission, 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 1997 Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
52.204-4 Jun 1996 Printing/Copying Double-Sided on Recycled Paper (Over $100,000)
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)
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CONTRACT NO1-A1-95381
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FAR CLAUSE
NO. DATE TITLE
- ----------- --------- -----
52.215-15 Dec 1998 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 Apr 1998 Allowable Cost and Payment
52.216-8 Mar 1997 Fixed Fee
52.219-8 Jun 1999 Utilization of Small Business Concerns (Over $100,000)
52.219-9 Jan 1999 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 Aug 1996 Convict Labor
52.222-26 Feb 1999 Equal Opportunity
52.222-35 Apr 1998 Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Jan 1999 Employment Reports on Disabled Veterans and Veterans of the Vietnam Era
52.223-2 Apr 1984 Clean Air and Water (Over $100,000)
52.223-6 Jan 1997 Drug-Free Workplace
52.223-14 Oct 1996 Toxic Chemical Release Reporting
52.225-11 Aug 1998 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)
52.227-3 Apr 1984 Patent Indemnity
52.227-14 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 Jun 1997 Prompt Payment
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FAR CLAUSE
NO. DATE TITLE
- ----------- --------- -----
52.232-34 May 1999 Payment by Electronic Funds Transfer--Other Than Central Contractor Registration
52.233-1 Dec 1998 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 Oct 1995 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 I (Apr 1984)
52.244-2 Aug 1998 Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required,
the identified subcontracts are listed in ARTICLE B, Advance Understandings.
52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)
52.245-5 Jan 1986 Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)
52.246-25 Feb 1997 Limitation of Liability - Services (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 Apr 1984 Definitions - Alternate I (Apr 1984)
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 Publication and Publicity
352.270-7 Apr 1984 Paperwork Reduction Act
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE
CONTRACT - Rev. 7/1999].
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CONTRACT NO1-A1-95381
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ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
FAR Clause 52.219-9, SMALL BUSINESS SUBCONTRACTING PLAN (JANUARY 1999), and
FAR Clause 52.219-16, LIQUIDATED DAMAGES--SUBCONTRACTING PLAN (JANUARY 1999)
are deleted in their entirety.
FAR Clause 52.225-3, BUY AMERICAN ACT - SUPPLIES (JANUARY 1994) is deleted in
its entirety and FAR Clause 52.225-7 BALANCE OF PAYMENTS PROGRAM (APRIL 1984)
is substituted therefor.
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
FAR Clause 52.243-1, CHANGES, FIXED PRICE, ALTERNATE I (AUGUST 1987) is
hereby deleted in its entirety and FAR Clause 52.243-1, CHANGES, FIXED PRICE,
ALTERNATE II (AUGUST 1987) is substituted therefor.
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 52.219-6, Notice of Total Small Business Set-Aside (JULY 1996).
(3) FAR 52.219-14, Limitation on Subcontracting (DECEMBER 1996).
(4) FAR 52.223-3, Hazardous Material Identification and Material Safety
Data (JANUARY 1997), ALTERNATE I (JULY 1995).
(5) FAR 52.223-11, Ozone-Depleting Substances (JUNE 1996).
(6) FAR 52.223-12, Refrigeration Equipment and Air Conditioners
(MAY 1995).
(7) FAR 52.237-3, Continuity of Services (JANUARY 1991).
(8) FAR 52.245-19, Government Property Furnished "As Is" (APRIL 1984).
(9) FAR 52.247-63, Preference for U.S. Flag Air Carriers (JANUARY 1997).
(10) FAR 52.247-64, Preference for Privately Owned U.S. Flag Commercial
Vessels (JUNE 1997).
(11) FAR 52.251-1, Government Supply Sources (APRIL 1984).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC
HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3)
CLAUSES:
(1) PHS 352.223-70, Safety and Health (Deviation) (AUGUST 1997).
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CONTRACT NO1-A1-95381
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(2) HHSAR 352.224-70, Confidentiality of Information (APRIL 1984).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
(1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB
Bulletin 81-16).
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 52.225-9, TRADE AGREEMENTS ACT (DEVIATION)
(a) This clause implements the Trade Agreements Act of 1979 (19 U.S.C.
2501-2582) by providing a preference for U.S. made end products,
North American Free Trade Agreement (NAFTA) country end products,
designated country end products, and Caribbean Basin country end
products over other products.
"CARIBBEAN BASIN COUNTRY END PRODUCTS," as used in this clause,
means an article that: (1) is wholly the growth, product, or
manufacture of a Caribbean Basin country (as defined in section
25.401 of the Federal Acquisition Regulation (FAR), or (2) in the
case of an article which consists in whole or in part of materials
from another country or instrumentality, has been substantially
transformed into a new and different article of commerce with a
name, character, or use distinct from that of the article or
articles from which it was so transformed. The term refers to a
product, offered for purchase under a supply contract, but for
purposes of calculating the value of the end product includes
services (except transportation services) incidental to its supply;
provided that the value of those incidental services does not exceed
that of the product itself. The term excludes products that are
excluded from duty-free treatment for Caribbean countries under the
Caribbean Basin Economic Recovery Act (19 U.S.C. 2703(b)). These
exclusions presently consist of (I) textiles and apparel articles
that are subject to textile agreements; (ii) footwear, handbags,
luggage, flat goods, work gloves, and leather wearing apparel not
designated as eligible articles for the purpose of the Generalized
System of Preferences under title V of the Trade Act of 1974; (iii)
tuna, prepared or preserved in any manner in airtight containers;
(iv) petroleum; and (v) watches and watch parts (including cases,
bracelets and straps) of whatever type including, but not limited
to, mechanical, quartz digital or quartz analog, if such watches or
watch parts contain any material that is the product of any country
to which the Tariff Schedule of the United States (TSUS) column 2
rates of duty apply.
"DESIGNATED COUNTRY END PRODUCT," as used in this clause, means an
article that (1) is wholly the growth, product, or manufacture of
the designated country (as defined in section 25.401 of the Federal
Acquisition Regulation (FAR), or (2) in the case of an article which
consists in whole or in part of materials from another country or
instrumentality, has been substantially transformed into a new and
different article of commerce with a name, character, or use
distinct from that of the article or articles from which it was so
transformed. The term refers to a product offered for purchase under
a supply contract, but for purposes of calculating the value of the
end product includes services (except transportation services)
incidental to its supply; provided that the value of those
incidental services does not exceed that of the product itself.
"ELIGIBLE PRODUCT," as used in this clause, means a designated,
North American Free Trade Agreement (NAFTA), or Caribbean Basin
country end product.
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"END PRODUCTS," as used in this clause, means those articles,
materials, and supplies to be acquired under this contract for
public use.
"NAFTA COUNTRY END PRODUCT," as used in this clause, means an
article that (1) is wholly the growth, product, or manufacture of a
NAFTA country, or (2) in the case of an article which consists in
whole or in part of materials from another country or
instrumentality, has been substantially transformed in a NAFTA
country into a new and different article of commerce with a name,
character, or use distinct from that of the article or articles from
which it was transformed. The term refers to a product offered for
purchase under a supply contract, but for purposes of calculating
the value of the end product includes services (except
transportation services) incidental to its supply; provided, that
the value of those incidental services does not exceed that of the
product itself.
"U.S. MADE END PRODUCT" as used in this clause, means an article
which (1) is wholly the growth, product or manufacture of the United
States, or (2) in the case of an article which consists in whole or
in part of materials from another country or instrumentality, has
been substantially transformed in the United States into a new and
different article of commerce with a name, character, or use
distinct from that of the article or articles from which it was so
transformed.
"NONDESIGNATED COUNTRY END PRODUCTS," as used in this clause, means
any end product which is not a U.S. made end product or a designated
country end product.
"UNITED STATES," as used in this clause, means the United States,
its possessions, Puerto Rico, and any other place which is subject
to its jurisdiction, but does not include leased bases or trust
territories.
(b) The Contractor agrees to deliver under this contract only U.S. made
end products, designated country end products, Caribbean Basin
country end products, or, if a national interest waiver is granted
under section 302 of the Trade Agreements Act of 1979, nondesignated
country end products. Only if such waiver is granted may a
nondesignated country end product be delivered under this contract.
(c) Offers will be evaluated in accordance with the policies and
procedures of Part 25 of the FAR except that offers of U.S. made end
products shall be evaluated without the restrictions of the Buy
American Act or Balance of Payments Program.
b. FAR CLAUSE 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (OCTOBER 1998)
(a) Definition.
Commercial item, as used in this clause, has the meaning contained
in the clause at 52.202-1, Definitions.
Subcontract, as used in this clause, includes a transfer of
commercial items between divisions, subsidiaries, or affiliates of
the Contractor or subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate,
and require its subcontractors at all tiers to incorporate,
commercial items or nondevelopmental items as components of items to
be supplied under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is
not required to include any FAR provision or clause, other than
those listed below to the extent they are applicable and as may be
required to establish the reasonableness of prices under Part 15, in
a subcontract at any tier for commercial items or commercial
components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Disabled Veterans and
Veterans of the Vietnam Era (38 U.S.C.
23
CONTRACT NO1-A1-95381
BBI - BIOTECH RESEARCH LABORATORIES, INC.
4212(a));
(3) 52.222-36, Affirmative Action for Workers with Disabilities
(29 U.S.C. 793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged
Commercial Vessels (46 U.S.C. 1241) (flow down not required
for subcontracts awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including
this paragraph (d), in subcontracts awarded under this contract.
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1) Statement of Work, (8/16/99).
2) Invoice/Financing Request and Financial Reporting Instructions for
NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97).
3) Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97).
4) Procurement of Certain Equipment, NIH(RC)-7, (4/1/84).
5) Government Property - Schedule II-A, (8/16/99).
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
Representations and Certifications, dated November 6, 1998.
END OF THE SCHEDULE
(CONTRACT)
24
WORK STATEMENT
DIVISION OF AIDS SPECIMEN REPOSITORY
Independently, and not as an agent of the Government, the contractor shall
furnish services, qualified professional and technical personnel, material,
equipment, and facilities not otherwise provided by the Government under the
terms of this contract to perform the work set forth below.
In general, the Contractor shall: (1) secure, receive, catalog, process,
store, and disburse clinical specimens from human immunodeficiency virus
(HIV)-infected patients, cohort participants, recipients of candidate HIV
vaccines and other biomedical interventions in studies sponsored by the
National Institute of Allergy and Infectious Diseases (NIAID), Division of
AIDS (DAIDS); (2) provide a computerized specimen inventory management system
in a format identified and approved by DAIDS; (3) provide adequate
cold-storage facilities for clinical specimens, and provide experienced
professional personnel (formally trained in dangerous goods biosafety) to
support specimen handling and repository management; (4) provide labeling and
shipping procedure training and oversight to study sites; (5) report progress
to the Project Officer and provide specimen availability summaries as
requested by the Project Officer; (6) complete the development and the
execution of a DAIDS Repository Management Plan which may include, but is not
limited to: systematic effort to discard identified specimens with low
research potential, reduce the numbers of duplicate specimens, discard
specimens with missing key clinical data, and/or expand the freezer capacity
of the repository as requested by the Project Officer; and (7) ensure an
orderly and safe transition of the Repository from the incumbent Contractor,
and to a successor contractor, if necessary. Transition to a successor
contractor shall include all Repository data including all source codes.
Specifically, the Contractor shall:
1. Secure, receive, process as necessary, catalog, store and ship clinical
specimens to and from both domestic and international DAIDS study sites,
and distribute clinical specimens to other investigators at the request of
the Project Officer. Currently the specimen repository supports these
DAIDS studies: MACS, WITS, WIHS, HIVNET, AACTG, PACTG, AVEG, DATRI, and
maintains specimens from other completed DAIDS studies such as the Jump
Start Project, the HATS, and the San Francisco Men's Health Study. These
specimens may include, but are not limited to, peripheral blood
mononuclear cells, serum, plasma, tissue specimens, and other bodily
fluids or substances such as cervical-vaginal lavage (CVL), breast milk,
semen, saliva, urine, feces, mucosal, autopsy and biopsy materials, and
specimen spots dried on filter paper.
A. Advise investigators from study sites on procedures required for
maintaining proper specimen temperature and ensuring specimen
identification in the shipment of samples; provide appropriate
packaging material (e.g., shipping containers which comply with U.S.
DOT or IATA regulations for infectious substances, styrofoam boxes,
liquid nitrogen shipping containers, labeling material, shipping
forms, etc.) to maintain appropriate environmental safeguards and
desired refrigeration levels for specific specimens in transit;
provide concise shipping instructions appropriate to the types of
specimens and packaging materials; and cover costs for all shipments
to the Repository. (See section 4 for information on training the
study sites in the above procedures.) All shipments shall be
coordinated by the Contractor to preserve sample integrity and
utility. The contractor shall operate in accordance with the basic
references and other modifications by the Public Health Service
which include but are not limited to:
(1) Title 49 CFR Part 100-199 Transportation
(2) Title 42 CFR Part 71.54 and 72.3 Etiologic Agents, Hosts and
Vectors; Interstate Shipment of Etiologic Agents
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 1 of 3
(3) Title 39 CFR Part 124 Postal Services
(4) International Air Transport Association (IATA), Dangerous
Goods Regulations 36th Edition 1995, and 1997 changes to the
IATA Dangerous Good Regulations
(5) International Civil Aviation Organization (ICAO) Technical
Instructions for the Safe Transportation of Dangerous Good by
Air 1995-1996
(6) United Nations Recommendations on the Transport of Dangerous
Good 8th Edition
B. Arrange for the shipping of specimens to the repository from all
designated Domestic study sites WITHIN 24 HOURS of pickup and by
overnight express shipment. Assist the NIAID in efforts to establish
SOPs/guidelines for shipping of specimens to the repository from
International study sites. This service shall be performed by an
established carrier with a proven record for handling
medical/clinical specimens on dry ice and in liquid nitrogen
shipping container. Obtain appropriate shipping licenses and permits
from local, state, Federal and international authorities for the
safe import, storage and distribution of biohazardous materials.
C. Provide protective garments, equipment, and supplies to conduct work
in Biosafety Level 2 containment facilities under aseptic and/or
sterile conditions as appropriate and in accordance with all
applicable Federal, state, and local laws, codes, ordinances, and
regulations. It is expected that the contractor will operate in
accordance with the following basic references and other related
modifications by the Public Health Service, which include but are
not limited to:
(1) Title 29 CFR 1910.1030 OSHA Bloodborne Pathogen Standard
(2) Health & Safety Guidelines for Grantees and Contractors, NIH
Guide, Vol. 24, No. 33, dated September 22, 1995
(3) Biosafety in the Laboratory: Prudent Practices for Handling
and Disposal of Infectious Materials; National Academy Press,
Wash., D.C.
(4) Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Centers for Disease
Control and Prevention and National Institutes of Health, HHS
Pub. No. (CDC) 93-8395 published by the U.S. Government
Printing Office. (Website:
WWW.NIEHS.NIH.GOV/ODHSB/BIOSAFE/BMBL/BMBL-1.HTM)
(5) Recommendations for Prevention of HIV transmission in Health
Care Settings, Morbidity and Mortality Weekly Report, Vol. 36,
No. 2-S, dated August 21, 1987.
(6) Agent Summary Statement for Human Immunodeficiency Virus and
Report on Laboratory-Acquired Infection with Human
Immunodeficiency virus, Morbidity and Mortality Weekly Report,
Vol. 37, No.S-4, pp. 1-22, dated April 1, 1988.
D. Receive, catalog, process, and store incoming samples according to
Standard Operating Procedures approved by the Project Officer, which
shall include but not be limited to a 15% random inspection of tubes
within each freezer box received, and a detailed quality assurance
plan for ascertaining sample and shipment condition, validation of
key information, criteria for specimen rejection, and guidelines for
handling leaking or broken specimens. All problems and corrective
action for each shipment shall be discussed with the Project Officer
and study site staff and documented within 3 days of shipment
receipt,
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 2 of 3
and noted in the Quarterly Progress Reports. Pertinent information
(such as originating site, specimen number, quantity, shipping date,
and/or other information as required) shall be maintained in the
Specimen Inventory System. (See number 2 in this attachment for
details.) The contractor shall support NIAID's efforts in the
design, certification, and subsequent periodic re-certification
of government-sponsored and owned DOD or commercial shipping
containers for use under this contract.
E. Retrieve specimens from the repository; prepare aliquots, when
necessary; disburse samples to national and/or international
destinations upon specific written authorization from the Project
Officer; provide for the return shipment of unused specimen portions
and empty shipping containers and packing materials. Costs
associated with such shipments are the responsibility of the
Repository Contractor. Pertinent information (such as "shipped to"
code, specimen number, quantity, shipping date, and/or other
information as required) shall be maintained using the Specimen
Inventory system. (See section 2.B for details.) Mention of these
requests and resulting action shall be detailed in the Quarterly
Progress Report.
F. Upon direction of the Project Officer, provide technical support to
DAIDS staff in the practical application and execution in continuing
the development and implementation of a Repository Management Plan
(as noted below) (see Appendix for additional info).
2. Provide and maintain a computer facility and Specimen Inventory Database
Management System to track samples and activities in the Repository. This
system shall be adaptable/programmable to include the capability to print
and scan specimen labels that are bar-coded. (Approximately 4% of all
Repository specimens stored/disbursed currently are bar-coded.)
A. Provide for the security of the Specimen Inventory Database with
confidential access codes. The Project Officer will determine the
level of information to be disseminated and to whom it shall be made
available.
B. Perform complete weekly back-up of database files and programs and
store in a location separate from the computer facility. Perform
daily back-up of database files and programs and store on-site.
C. Provide the Project Officer read/print-only access to the repository
database system via modem as requested.
D. Maintain (and update as necessary) the existing database management
system (ORACLE RDBMS on a Hewlett-Packard 9000/800 G40 with the
HP-UNIX operating system) on government furnished or approved
central automated data processing system to integrate specimen
information from all NIAID study sites and the specimen repository
site.
E. Support and manage the NARDS system and database hardware and
software. Utilize and/or modify the current data entry software
modules for data entry of specimen specifications at the repository.
Specifications include, but are not limited to: type of storage
(i.e., mechanical freezer or liquid nitrogen); freezer, rack, and
box numbers; sample position within the box; subject and site
identification numbers; specimen collection date; type and volume of
specimen; aliquot tracking; shipment or disbursement information;
shipping problems; sample condition on receipt; and other data as
requested by the Project Officer. Study sites shall provide both
hard copy and electronic manifests for each shipment.
F. Maintain communications between the repository, study sites, data
centers, central laboratories and Project Officer regarding
reliability and timeliness of specimen identification, shipment,
storage, and retrieval details.
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 3 of 3
3. Provide facilities and resources to store/handle/package specimens.
A. Provide sufficient floor space or vertical storage stacking system
as needed in a single facility to accommodate up to 90 ADDITIONAL
thirty-six cubic foot storage chest freezers (or their equivalent)
and 45 ADDITIONAL liquid nitrogen freezers (added to those that will
transfer from the incumbent contractor: see Offeror NOTE 10); a
repair and spare-parts storage area measuring at least 200 square
feet; a designated laboratory work area for handling HIV specimens
under Biosafety Level 2 containment conditions (as per regulations
in section 1.C); a receiving area and a packaging area measuring at
least 200 square feet; and an office for system and data management
activities.
B. Maintain and operate controlled freezers for -100 to -200 Celsius
[C], -700 to -900 C, and -1200 to -1950 C (vapor phase, liquid
nitrogen conditions). The Project Officer shall designate the
specimen types stored in each temperature range. Three (3) spare,
readily usable mechanical freezers and two (2) Liquid Nitrogen
freezers which can be charged and ready for use shall be available
for transfer of contents within 2 hours of the malfunction of an
operating freezer.
C. Provide a central alarm system to monitor each freezer. This alarm
system shall automatically contact a Refrigeration Engineer by
telephone, and have an on-site audible alarm to alert personnel in
the repository of a freezer malfunction. After notification, the
engineer shall respond by being present to correct the alarm
situation at the repository within one hour. Weekly tests shall be
performed on the alarm system and the results included in the
Quarterly Progress Report. Permanent printed records of storage
temperatures and alarm condition reports noting events and actions
taken shall be maintained at the facility.
D. Provide adequate electrical power to accommodate all mechanical
freezers, the central alarm system, and the air conditioning system.
There shall be a generator or generators on-site to handle the
complete backup power supply in case of electrical power failure.
All freezers, air conditioners and the central alarm system shall be
electrically hooked-up so that should the power fail, complete power
(capable of continuous operation for up to 48 hours) shall be
immediately available from the generator(s).
E. Perform regular operational quality assurance maintenance for all
cold storage equipment, the central alarm system, the air
conditioning system, and the backup power system according to a
Standard Operating Procedure approved by the Project Officer.
Maintain a log of regular inspections and include inspection
records/problems encountered/action taken results in the Quarterly
Progress Report.
F. Provide security measures that ensure the facility and equipment
against fire and personal intrusion.
4. Provide training, instruction and oversight for all aspects of interaction
between the repository and study sites.
A. Utilize and/or modify the current Standard Operating Procedures
(SOPs) for all aspects of specimen handling as needed by study
sites, including but not limited to, labeling, freezing, storing and
shipping (at the request of the Project Officer).
B. Develop/update and maintain a User Manual that includes the SOPs and
other guidance and reference materials relevant to specimen handling
/shipping and their logging into the inventory database. The
contents and format of the Manual shall be approved by the Project
Officer prior to distribution. Development/update and distribution
to study sites will be designated by the Project Officer to occur
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 4 of 3
within 120 days of the contract award date.
C. At the request of the Project Officer, provide operational
information, participation at study group meetings (and other
related group meetings), and training through telephone conference
calls, on-site instruction, training sessions at study meetings,
consultative interactions and periodic review.
5. Report on progress, anticipated or existing problems, and discuss the work
to be performed with the Project Officer.
6. Follow Reporting Requirements. (Refer to ARTICLE C.2. REPORTING
REQUIREMENTS)
7. Contractor's key personnel shall meet with the Project Officer at periodic
intervals after contract award to review Repository status.
8. Ensure an orderly and safe transition of the Repository from the incumbent
Contractor, at the beginning of the period of performance; and to a
successor Contractor, at the end of the period of performance. Transition
to a successor Contractor shall include all data files and source codes.
A. Provide, at the beginning of the contract term, for an orderly and
safe transition from incumbent Contractor to the successful offeror,
operate in accordance with approved SOPs and the contract Work
Statement, and assist in the transfer of the following items from
the incumbent:
(1) Government-owned equipment and property;
(2) Entire Repository inventory of stored specimens;
(3) National AIDS Repository Database System (NARDS);
(4) Supporting hardware and software documentation including
source codes;
(5) User manuals and training materials;
(6) Labeled and inventoried paper files.
B. No later than sixty (60) days after the beginning of this contract,
The Contractor shall meet with the Project Officer to present
recommendations for developing and/or implementing additional
Standard Operating Procedures and/or a plan for revising current
Standard Operating Procedures.
C. For an orderly and safe transition from this contract to the
Government or its designee at the conclusion of this contract,
deliver the following items by the expiration date of this contract:
(1) Government-owned equipment and property;
(2) National AIDS Repository Database System (NARDS);
(3) Supporting hardware and software documentation including
source codes;
(4) User manuals and training materials;
(5) Labeled and inventoried paper files, and
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 5 of 3
(6) Entire Repository inventory of stored specimens.
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: (l) costs of a prior
billing period, but not previously billed; or (2) costs incurred during the
contract period and claimed after the contract period has expired, the amount
and month(s) in which such costs were incurred shall be cited.
Contractor's Fiscal Year: Invoices/financing requests shall be prepared in
such a manner that costs claimed can be identified with the contractor's
fiscal year.
Currency: All NIH contracts are expressed in United States dollars. When
payments are made in a currency other than United States dollars, billings on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under
this contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the contracting officer's
approval, which are not set forth in an Advance Understanding in the contract
shall be so identified and reference the Contracting Officer's Authorization
(COA) Number. In addition, any cost set forth in an Advance Understanding
shall be shown as a separate line item on the request.
Invoice/Financing Request Identification: Each invoice/financing request
shall be identified as either:
(a) Interim Invoice/Contract Financing Request -- These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice -- The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final
indirect cost rates covering the year in which this contract is
physically complete (whichever date is later). The completion invoice
should be submitted when all costs have been assigned to the contract and
all performance provisions have been completed.
(c) Final Invoice -- A final invoice may be required after the amounts owed
have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).
Statement of Work (N01-AI-95381) ATTACHMENT 1
08/16/99 Page 6 of 3
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 and Date -- Insert the contract number and the effective
date of the contract.
(e) Payee's Name and Address -- Show the contractor's name (as it appears in
the contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved
assignment has been made by the contractor, or a different payee has been
designated, then insert the name and address of the payee instead of the
contractor.
(f) Total Estimated Cost of Contract -- Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts,
enter the amount currently obligated and available for payment.
(g) Total Fixed-Fee -- Insert the total fixed-fee (where applicable). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(h) Billing Period -- Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which
reimbursement is claimed.
(I) Incurred Cost - Current -- Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.
(j) Incurred Cost - Cumulative -- Insert the cumulative amounts billed for the
major cost elements and adjusted amounts claimed during this contract.
(k) Direct Costs -- Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(l) Direct Labor -- Include salaries and wages paid (or accrued) for
direct performance of the contract. For Key Personnel, list each
employee on a separate line. List other employees as one amount
unless otherwise required by the contract.
(2) Fringe Benefits -- List any fringe benefits applicable to direct
labor and billed as a direct cost. Fringe benefits included in
indirect costs should not be identified here.
(3) Accountable Personal Property -- Include permanent research
equipment and general purpose equipment having a unit acquisition
cost of $1,000 or more and having an expected service life of more
than two years, and sensitive property regardless of cost (see the
DHHS CONTRACTOR'S GUIDE FOR CONTROL OF GOVERNMENT PROPERTY). Show
permanent research equipment separate from general purpose
equipment. Prepare and attach Form HHS-565, "Report of Accountable
Property," in accordance with the following instructions:
List each item for which reimbursement is requested. A reference shall
be made to the following (as applicable):
- The item number for the specific piece of equipment listed in the
Property Schedule.
- The Contracting Officer's Authorization letter and number, if the
equipment is not covered by the Property Schedule.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
- Be preceded by an asterisk (*) if the equipment is below the
approval level.
(4) Materials and Supplies -- Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) Premium Pay -- List remuneration in excess of the basic hourly rate.
(6) Consultant Fee -- List fees paid to consultants. Identify consultant
by name or category as set forth in the contract's Advance
Understanding or in the COA letter, as well as the effort (i.e.,
number of hours, days, etc.) and rate being billed.
(7) Travel -- Include domestic and foreign travel. Foreign travel is
travel outside of Canada, the United States and its territories and
possessions. However, for an organization located outside Canada,
the United States and its territories and possessions, foreign
travel means travel outside that country. Foreign travel must be
billed separately from domestic travel.
(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.
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing
request.
Column A--Expenditure Category - Enter the expenditure categories required by
the contract.
Column B--Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the
percentage of effort or number of hours agreed to doing contract negotiations
for each employee or labor category listed in Column A.
Column C--Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage
of effort or number of hours worked by each employee or labor category listed
in Column A.
Column D--Incurred Cost-Current - Enter the costs, which were incurred during
the current period.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
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.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
(a) Billing Office Name and Address (b) Invoice/Financing Request No.__________________________
NATIONAL INSTITUTES OF HEALTH
National Institute of Allergy and Infectious (C) Date Invoice Prepared__________________________________
Diseases, CMB
6700-B Rockledge Drive, Room 2230, MSC 7612
Bethesda, MD 20892-7612 (d) Contract No.___________________________________________
(e) Payee's Name and Address Effective Date_________________________________________
ABC CORPORATION
100 Main Street (f) Total Estimated Cost___________________________________
Anywhere, USA zip code
(g) Total Fixed Fee________________________________________
Attn: Name, Title, & Phone Number of Official to
Whom Payment is Sent
(h) This invoice/financing request represents reimbursable costs for the period from _________ to _________
Expenditure Category* Cumulative Percentage Incurred Cost Cost at Contract Variance
A of Effort/Hrs. Completion Amount H
F G
---------------------- -------------------------------
Negotiated Actual (I) Current (j) Cumulative
B C D E
- ------------------------------ ---------- ------ ----------- --------------- ---------- -------- ---------
(k) Direct Costs:
(1) Direct Labor
(2) Fringe Benefits
(3) Accountable Property
(attach HHS-565)
(4) Materials & Supplies
(5) Premium Pay
(6) Consultant Fees
(7) Travel
(8) Subcontracts
(9) Other
Total Direct Costs
(l) Cost of Money
(m) Overhead
G&A
(n) Fixed Fee
(o) Total Amount Claimed
(p) Adjustments
(q) Grand Totals
I certify that all payments are for appropriate purposes and in accordance with
the contract.
--------------------------- --------------------
(Name of Official) (Title)
* Attach details as specified in the contract
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97
PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(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 (Deviation) ATTACHMENT 3
PHS 352.223-70, (8/97)
PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed
in the following Federal Supply Groups, regardless of the dollar value,
without the prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and
Support (Excluding 7045-ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
When equipment in these Federal Supply Groups is requested by the Contractor
and determined essential by the Contracting Officer, the Government will
endeavor to fulfill the requirement with equipment available from its excess
personal property sources, provided the request is made under a
cost-reimbursement 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 4
OMB Bulletin 81-16
SCHEDULE II-A - GOVERNMENT FURNISHED PROPERTY
ITEM DESCRIPTION MANUFACTURER MODEL NUMBER QUANTITY
- ----------------------------------------------------------------------------------------------------------------------
GENERAL REPOSITORY EQUIPMENT
1 BIOLOGICAL SAFETY CABINET CCI 740 2
2 WATER BATHS ELEMCO 70 2
3 -70(DEGREE)MECHANICAL FREEZER WITH RACKS REVCO ULT2090EN 28
4 -70(DEGREE)MECHANICAL FREEZER WITH RACKS HARRIS HLT19LS85 17
5 LN2 FREEZER WITH RACKS MVE A4500 12
6 LN2 FREEZER WITH RACKS MVE XLC-1840 5
7 LN2 CRYOGENIC SHIPPER MVE TA-60 2
8 -70(DEGREE)MECHANICAL FREEZER WITH RACKS RUSH 3185 8
9 LN2 CRYOGENIC SHIPPER CUSTOM BIOGENICS DS-3 3
10 LN2 CRYOGENIC SHIPPER TAYLOR-WHARTON CP65 4
11 LN2 FREEZER WITH RACKS TAYLOR-WHARTON 33K 7
12 LN2 BULK STORAGE TANK MVE VVXC3000NC1 1
13 VACUUM JACKETED LN2 DISTRIBUTION PIPE MVE NONE 1
14 -70(DEGREE)MECHANICAL FREEZER WITH RACKS HARRIS HLT-36LS86 15
15 PLASTIC SHIPPING CASE FOR LN2 SHIPPER MVE NONE 1
16 LN2 FREEZER WITH RACKS TAYLOR-WHARTON 38KM21 7
17 DOT CERTIFIED DRY ICE SHIPPING CONTAINER U.S. ARMY FSSU-21 15 (APPROX.)
18 DOT CERTIFIED DRY ICE SHIPPING CONTAINER U.S. ARMY FSSU-4 5 (APPROX.)
COMPUTER HARDWARE, SOFTWARE AND DATA COMMUNICATIONS EQUIPMENT
1 9000/800 G40 BUSINESS SERVER WITH HEWLETT- 9000/G40 1
128 MB RAM, 7 GB HARD DISK STORAGE, PACKARD
DAT CARTRIDGE TAPE DRIVE, CD-ROM DRIVE, 16
PORT MUX, HP-IB INTERFACE
Government Furnished Property ATTACHMENT 5
Schedule II-A (8/16/99) Page 2 of 3
- ----------------------------------------------------------------------------------------------------------------------
2 HP-UNIX OPERATING SYSTEM SOFTWARE HEWLETT-PACKARD V10.20 1
3 ORACLE RDBMS SOFTWARE ORACLE V7.3 1
4 CASE DESIGNER 2000 SOFTWARE ORACLE NONE 1
5 CASE DEVELOPER 2000 SOFTWARE ORACLE NONE 1
6 ANSI C COMPILER HEWLETT-PACKARD NONE 1
7 POWERMON SOFTWARE SYSTEMS V1.3 1
ENHANCEMENT
CORPORATION
8 X-TERMINAL HEWLETT-PACKARD A1097C 1
9 ENVIZEX COMPUTER TERMINAL HEWLETT-PACKARD D1196A 4
10 ENTRIA WORKSTATION HEWLETT-PACKARD C3264A 1
11 COMPUTER TERMINAL DEC VT420-CA 2
12 UNINTERRUPTIBLE POWER SUPPLY FOR HP DEC NONE 1
13 GATEWAY 2000 PERSONAL COMPUTER WITH PENTIUM GATEWAY 4DX-33 1
OVERDRIVE CHIP, 32 MB RAM, 200 MB AND 1.6 GB
HDS, DUAL FLOPPY DRIVE, CD-ROM DRIVE, LAN
CARD, INTERNAL FAX-MODEM, AND COLOR MONITOR
14 COMPAQ PRESARIO PERSONAL COMPUTER WITH PENTIUM COMPAQ PRESARIO 1
CHIP, 32 MB RAM, 4.3 GB HD, FLOPPY DRIVES,
CD-ROM, LAN CARD, INTERNAL FAX-MODEM, AND
COLOR MONITOR
15 WINDOWS 95 SOFTWARE MICROSOFT WINDOWS 95 2
- ----------------------------------------------------------------------------------------------------------------------
16 WORDPERFECT SUITE 7 COREL V7.0 2
17 DBMS/COPY SPSS, INC. V5.0 1
18 SMARTERM ESSENTIALS PERSOFT, INC. V7.0 2
19 PLATINUM DB MONITORING SW FOR HP G40 PLAT.TECHNOLOGIES V3.1 1
20 14400 BAUD EXTERNAL MODEM PRACTICAL PM14400FXMT
PERIPHERALS
21 POWER SURGE PROTECTOR TRIPPE ISOBAR 4 1
22 DOT MATRIX PRINTER DEC LA-424 1
23 PRINTER WITH POSTSCRIPT AND 4 MB RAM MODULES HEWLETT-PACKARD LASERJET 4 1
24 EXTERNAL CASSETTE TAPE DRIVE FOR COMPAQ IOMEGA DITTO EASY 3200 1
25 SMART 650VA UNINTERRUPTIBLE POWER SUPPLY FOR PC APC VS650 2
26 BAR CODE SCANNER AMERICAN 5310HP4342 1
MICROSYSTEMS
27 DELTA PLUS LABEL PRINTER ELTRON TLP2642PSA 1
28 LABEL WORKS SOFTWARE AMERICAN V2.0 1
MICROSYSTEMS
29 DESKPRO PERSONAL COMPUTER WITH 1 MB RAM, COMPAQ 286E 1
FLOPPY DRIVES, 40 MB HARD DRIVE, AND
MONOCHROME MONITOR
30 PAPER COPIER MINOLTA EP-2121 1
31 PLAIN PAPER FACSIMILE MACHINE MURATEC F-86 1
32 LASER JET COLOR PRINTER HEWLETT-PACKARD 5M 1
Government Furnished Property ATTACHMENT 5
Schedule II-A (8/16/99) Page 4 of 3