Award Contract for HIV Vaccine Production - VaxGen Inc. and National Institutes of Health
STANDARD FORM 26 (REV. 4-85) NSN 7540-01-152-8069 0MB No. 0990-0115 RFP 99-21
AWARD/CONTRACT
1. THIS CONTRACT IS A RATED ORDER > RATING PAGE OF PAGES
UNDER IPAS (15 CFR 350) > 1 27
2. CONTRACT (Proc. inst. ident.) No.
N01-AI-95373
3. EFFECTIVE DATE
July 9, 1999
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
091
5. ISSUED BY CODE 2668-95373
-----------
National Institutes of Health
Contract Management Branch, NIAID
Room 2230
6700-B Rockledge Dr., MSC 7612
Bethesda, Maryland 20892-7612
6. ADMINISTERED BY (If other than item 5) CODE
------------
7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, country, State and ZIP
Code)
VaxGen Incorporated
1000 Marina Blvd., Suite 200
Brisbane, CA 94005-1841
8. DELIVERY
|_| FOB ORIGIN |X| OTHER (See below)
9. DISCOUNT FOR PROMPT PAYMENT
N/A
10. SUBMIT INVOICES ITEM
(4 copies unless otherwise specified) TO THE > G.5
ADDRESS SHOWN IN
CODE FACILITY CODE
------------ ------------
11. SHIP TO/MARK FOR
See Article F.1.
12. PAYMENT WILL BE MADE BY CODE
------------
See Article G.5.
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
N/A
|_| 10 U.S.C. 2304 (c) (_) |_| 41 U.S.C 253 (c) (_)
14. ACCOUNTING AND APPROPRIATION DATA
EIN# 1-943236309-A1 SOC# 25.55 DOC# 300N1AI9S373A
CAN# 9-8425674
OBLIGATION OF FUNDS IN THE AMOUNT OF $200,000
15A. ITEM NO.
15B. SUPPLIES/SERVICES
15C. QUANTITY
15D. UNIT
15E. UNIT PRICE
15F. AMOUNT
Research & Development Contract FY 99 200,000
Title; HIV VACCINE PRODUCTION
Period: July 9, 1999 through July 8, 2006
Amount allotted: $200,000
Contract Type: IDIQ (FFP, CR, CPFF, TIME & MATERIALS, LABOR HOUR)
15G. TOTAL AMOUNT OF CONTRACT -> $ 200,000
16. TABLE OF CONTENTS
<TABLE>
<CAPTION>
|X| SEC. DESCRIPTION PAGE(S) |X| SEC. DESCRIPTION PAGE(S)
--- ---- ----------- ------- --- --- ----------- -------
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
--------------------- --------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
X A SOLICITATION/CONTRACT FORM 1 |X| I CONTRACT CLAUSES 20
X B SUPPLIES OR SERVICES AND PRICES/COSTS 4 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X C DESCRIPTION/SPECS./WORK STATEMENT 6 |X| J LIST OF ATTACHMENTS 26
X D PACKAGING AND MARKING 9 PART IV - REPRESENTATIONS AND INSTRUCTIONS
X E INSPECTION AND ACCEPTANCE 9 |X| K REPRESENTATIONS, CERTIFICATIONS AND 27
X F DELIVERIES OR PERFORMANCE 9 OTHER STATEMENTS OF OFFEPORS
X G CONTRACT ADMINISTRATION DATA 10 |_| L INSTRS., CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 14 |_| M EVALUATION FACTORS FOR AWARD
</TABLE>
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
-------------------------------------------------------------------------------
17. |X| CONTRACTOR'S NEGOTIATED AGREEMTNT (Contractor is required to sign this
document and return 3 copies to issuing office.) Contractor agrees to
furnish and deliver all items or perform all the services set forth or
otherwise identified above and on any continuation sheets for the
consideration stated herein. The rights and obligations of the parties to
this contract shall be subject to and governed by the following documents:
(a) this award/contract, (b) the solicitation, if any, and (c) such
provisions, representations, modifications, and specifications, as are
attached or incorporated by reference herein. (Attachments are listed
herein.)
18. |_| AWARD (Contractor is not required to sign this document.) Your offer
on Solicitation Number ______________________ including the full additions
or changes made by you which additions or changes are set forth in full
above, is hereby accepted as to the items listed above and on any
continuation sheets. This award consummates the contract which consists of
the following documents: (a) the Government's solicitation and your offer,
and (b) this award/contract. No further contractual document is necessary.
19A. NAME AND TITLE OF SIGNER (Type or print)
Carter A. Lee
19B. NAME OF CONTRACTOR
BY [GRAPHIC OMITTED]
---------------------------------------
(Signature of person authorized to sign)
19C. DATE SIGNED
06/28/99
20A. NAME OF CONTRACTING OFFICER
Lawrence M. Butler, Contracting Officer
Contract Management Branch, NIAID, NIH
20B. UNITED STATES OF AMERICA
/s/ Lawrence M. Butler
----------------------------------
(Signature of Contracting Officer)
20C. DATE SIGNED
06/30/99
<PAGE>
Contract No. NO1-AI-95373
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
<TABLE>
<S> <C>
SECTION A - SOLICITATION/CONTRACT FORM ................................................... 1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS ........................................ 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES ............................. 4
ARTICLE B.2. PRICES ................................................................ 4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS ................................. 4
ARTICLE B.4. ADVANCE UNDERSTANDINGS ................................................ 5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT .................................... 6
ARTICLE C.1. [DESCRIPTION-SPECIFICATION-WORK STATEMENT-STATEMENT OF WORK] .......... 6
ARTICLE C.2. REPORTING REQUIREMENTS ................................................ 6
ARTICLE C.3. INVENTION REPORTING REQUIREMENT ....................................... 8
SECTION D - PACKAGING, MARKING AND SHIPPING .............................................. 9
SECTION E - INSPECTION AND ACCEPTANCE .................................................... 9
SECTION F - DELIVERIES OR PERFORMANCE .................................................... 9
ARTICLE F.1. DELIVERIES ............................................................ 9
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE ..................................... 10
SECTION G - CONTRACT ADMINISTRATION DATA ................................................. 10
ARTICLE G.I. PROJECT OFFICER ....................................................... 10
ARTICLE G.2. KEY PERSONNEL ......................................................... 11
ARTICLE G.3. TASK ORDER PROCEDURES ................................................. 11
ARTICLE G.4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD ........................... 12
ARTICLE G.5. INVOICE SUBMISSION .................................................... 13
ARTICLE G.6. INDIRECT COST RATES ................................................... 13
ARTICLE G.7. GOVERNMENT PROPERTY ................................................... 13
ARTICLE G.8. POST AWARD EVALUATION OF PAST PERFORMANCE ............................. 14
SECTION H - SPECIAL CONTRACT REQUIREMENTS ................................................ 14
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS ........................................................................ 14
ARTICLE H.2. HUMAN SUBJECTS ........................................................ 14
ARTICLE H.3. RESTRICTION FROM USE OF HUMAN SUBJECTS ................................ 14
ARTICLE H.4. HUMAN MATERIALS ....................................................... 15
ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH ..................... 15
ARTICLE H.6. NEEDLE EXCHANGE ....................................................... 15
ARTICLE H.7. INTRODUCTION OF RODENTS AND RODENT PRODUCTS ........................... 15
ARTICLE H.8. ANIMAL WELFARE ASSURANCE .............................................. 16
ARTICLE H.9. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS ....................... 16
ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS ........................ 16
ARTICLE H.11. EPA ENERGY STAR REQUIREMENTS ......................................... 16
ARTICLE H.12. PUBLICATION AND PUBLICITY ............................................ 17
ARTICLE H.13. PRESS RELEASES ....................................................... 17
ARTICLE H.14. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN ......................... 17
ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE ................... 17
ARTICLE H.16. YEAR 2000 COMPLIANCE ................................................. 18
PART II- CONTRACT CLAUSES ...................................................................... 20
SECTION I - CONTRACT CLAUSES ............................................................. 20
ARTICLE I.1 GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT ....................................................................... 21
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES .................................... 24
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES ........................................... 24
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT ................. 25
</TABLE>
2
<PAGE>
Contract No. NO1-AI-95373
<TABLE>
<S> <C>
PART III ....................................................................................... 26
SECTION J - LIST OF ATTACHMENTS .......................................................... 26
1. Statement of Work................................................................ 26
2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts. 26
3. Safety and Health................................................................ 26
4. Procurement of Certain Equipment................................................. 26
PART IV ........................................................................................ 27
SECTION K - REPRESENTATIONS AND CERTIFICATIONS ........................................... 27
1. Representations and Certifications .............................................. 27
</TABLE>
3
<PAGE>
Contract No. NO1-AI-95373
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this contract is to develop candidate vaccines including scale-up
and production of GLP/GMP lots suitable for human use and to perform the
necessary characterization tests required for release of vaccines for clinical
use.
ARTICLE B.2. PRICES
a. The contractor shall be reimbursed by the Government in an amount not less
than a total of $200,000 nor more than a total of $76,624,622 for
successful performance of this contract.
b. If an order for at least the minimum amount is not issued within 12 months
of award, the funds obligated at the time of award shall be used to
satisfy the minimum guarantee.
c. The prices set forth in this ARTICLE B.2. will cover the contract period
from July 9, 1999 through July 8, 2006.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel;
(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) Subcontracts
b. Travel Costs
Domestic Travel
The Contractor shall invoice and be reimbursed for all travel costs in
accordance with Federal Acquisition Regulations (FAR) 31.205-46.
4
<PAGE>
Contract No. NO1-AI-95373
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. GLP/GMP Compliance
The Contractor certifies that all laboratory facilities used in the
production of vaccine products as a result of task orders issued under the
subject contract are GLP/CMP compliant and adhere to the guidelines set
forth for such compliance by the FDA.
b. Indirect Costs
(1) In no event shall any costs for fringe benefits, R&D Overhead, or
General and Administrative expenses billed under the subject
contract be reimbursable until a negotiated agreement is in place
with the Government.
(2) The Contractor shall complete all work in accordance with
the Statement of Work, terms and conditions of this contract.
c. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated
Budget
(1) The contractor agrees to provide a detailed breakdown on invoices of
the following cost categories for each task order:
(a) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount claimed.
(b) Fringe Benefits - Cite rate and amount
(c) Overhead - Cite rate and amount
(d) Materials & Supplies - Include detailed breakdown when total
amount is over $1,000.
(e) Travel - Identify travelers, dates, destination, purpose of
trip, and amount. Cite COA, if appropriate. List separately,
domestic travel, general scientific meeting travel, and
foreign travel.
(f) Equipment (Attach HHS. 565 and cite COA number for each item
if applicable)
(g) Subcontract (List each subcontract as a separate line item)
(h) Other Expenses - Provide breakdown of these items and required
authorizations if applicable.
(i) G&A - Cite rate and amount.
(j) Total Cost
(k) Fixed Fee
(1) Total CPFF
Monthly invoices must include the cumulative total expenses to date,
adjusted (as applicable) to show any amounts suspended by the
Government.
(2) The contractor agrees to immediately notify the contracting officer
in writing if there is an anticipated overrun (any amount) or
unexpended balance (greater than 10 percent) of the amount allotted
to the contract, and the reasons for the variance. Also refer to the
requirements of the Limitation of Funds and Limitation of Cost
Clauses in the contract.
5
<PAGE>
Contract No. NO1-AI-95373
h. Task Order Provisions
(1) It is anticipated that all task orders shall be awarded on a
cost-plus-fixed basis. Clauses and Articles applicable to a
cost-plus-fixed-fee type contract, as appropriate, shall be
incorporated into this contract as each task order is awarded.
(2) The requirements set forth in FAR Clause 52.219-14, Limitation on
Subcontracting (DECEMBER 1996), incorporated by reference in this
contract in Part II, Article I.3., shall be applicable to EACH
individual task order as they are awarded.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. [DESCRITPION-SPECIFICATION-WORK STATEMENT-STATEMENT OF WORK]
Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work, SECTION J, ATTACHMENT 1, dated July 9, 1999, attached
hereto and made apart of this contract.
ARTICLE C.2. REPORTING REQUIREMENTS
In addition to those reports required by the Statement of Work and other terms
of the Contract, the Contractor shall prepare and submit the following reports
in the manner stated below. Reports will be required for Contractors with active
Task Orders throughout the period of the Contract.
a. Milestone Reports (each task order will include guidelines for milestone
reports).
Upon the completion of each milestone as indicated in the Task Order, the
Contractor shall submit three (3) copies of a milestone report as
described below. Two (2) copies should be submitted to the Project Officer
and one (1) copy to the Contracting Officer. The milestone report should
be factual and concise and consist of the following:
1) A title page containing:
(a) Contract number and title
(b) Sequence of report; e.g., "Year 1, 2nd Milestone Report"
(c) Period of performance being reported
(d) Contractor's name and address
(e) Date of submission
2) Reports shall include, but are not limited to the following
information:
(a) A report detailing the actions taken to achieve the milestone.
(b) A report of all products, procedures and outcomes achieved.
(c) Graphs and tables of data obtained.
(d) A detailed budget report with invoices and cost justifications
related to achieving this milestone.
(e) Other information as may be required by the Project Officer.
6
<PAGE>
Contract No. NO1-AI-95373
b. Quarterly Progress Reports
By the fifteenth (15) working day of the month following the end of each
quarter, the Contractor shall submit three (3) copies of a quarterly
progress report as described below. Two (2) copies should be submitted to
the Project Officer and one (1) copy to the Contracting Officer. The
quarterly report should be factual and concise and consist of the
following:
1) A title page containing:
(a) Contract number and title
(b) Sequence of report; e.g., "Year 1, 2nd Quarterly Report"
(c) Period of performance being reported
(d) Contractor's name and address
(e) Date of submission
2) Reports shall include, but are not limited to the following
information:
(a) A brief introduction covering the objective and scope of the
contract effort.
(b) Progress and report of problems and proposed solutions in
development/production of a vaccine for Task Orders
issued under Part A.
(c) Progress and report of problems and solutions for safety and
inmnunogenicity testing for Task Orders issued under Part B.
(d) Progress and report of problems and solutions for FDA
submissions for Task Orders issued under Part C.
(e) Selected other information as may be required by the Project
Officer.
3) A quarterly report is not due when an annual report is due.
c. Annual Reports
On or before the last day of the Contract year, the Contractor shall
submit three (3) copies of an annual report. Two (2) copies shall be
submitted to the Project Officer and one (1) copy shall be submitted to
the Contracting Officer. The annual report shall summarize progress for
the entire contract year, following the same format as for the quarterly
reports, and shall take the place of the fourth quarterly report. In
addition, it should include abstracts, manuscripts in progress or
submitted, and publications resulting from the performance of work under
the contract.
d. Individual Task Order Final Reports
The contractor shall submit three (3) copies of each Task Order final
report, two (2) copies to the Project Officer and one (1) copy to the
Contracting Officer, which will summarize the results of the each
completed Task Order. This report will be in sufficient detail to explain
comprehensively the results achieved and will be submitted no later than
the completion date of the Task Order.
The final report shall contain:
1) Title Page as described above in paragraph a.1).
2) Introduction covering the purpose and scope of the active Task
Order.
3) Description of the overall progress of the active Task Order.
Descriptions shall include pertinent data in tables or graphs as
appropriate to present significant results achieved, conclusions
resulting from analysis, and a scientific evaluation of the data
accrued under the active task.
4) Copies of any abstracts, manuscripts, and publications.
7
<PAGE>
Contract No. NO1-AI-95373
e. Other Deliverables
The Contractor, at the request of the Project Officer, shall deliver to
the Government or its designee by the completion date of the Task Order,
the following items:
PART A:
(a) Test lots of vaccine products, as they are produced.
(b) cGMP quality pilot lots of candidate vaccine products and
adjuvants, as they are produced.
(c) All vaccine candidates and adjuvants in various stages of
production at termination of the contract with detailed
information on them.
(d) A compete listing of accurate and updated information on
design, development and production including activities of the
Contractor, computerized data files, original data and any
necessary information related thereto.
(e) A complete list of accurate and updated information on
activities of subcontracts.
(f) Labeled and inventoried paper files.
(g) Government-owned equipment and property.
PART B:
(a) All data obtained from safety and immunogenicity trials.
(b) All vaccine products, adjuvants, etc., remaining from these
studies.
PART C:
(a) All files pertaining to the contract at the request of the
Project Officer.
(b) Copies of all FDA submissions.
f. If the Contractor becomes unable to deliver the reports or other
deliverables here specified 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 in section F.
ARTICLE C.3. INVENTION REPORTING REQUIREMENT
All reports and documentation required by [FAR Clause 52.227-11/FAR Clause
52.227-11 (Deviation)/FAR Clause 52.227-13] including, but not limited to,
the invention disclosure report, the confirmatory license, and the
government support certification, shall be directed to the Office of
Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6701
Rockledge Drive, Room 3190, Bethesda, Maryland 20892-7750 (Telephone:
301-435-1986). In addition, one copy of the annual utilization report, and
a copy of the final invention statement, shall be submitted do the
Contracting Officer at the address listed below. The final invention
statement (see FAR 27.303(a)(2)(ii)) shall be submitted within 90 days
after contract expiration to the following address:
Contracting Officer
National Institutes of Health
Contract Management Branch, CMB
6700-B Rockledge Drive, Room 2230 MSC 7612
Bethesda, Maryland 20893-7612
8
<PAGE>
Contract No. NO1-AI-95373
To assist contractors in complying with invention reporting requirements of the
clause, the NIH has developed "Interagency Edison," an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov), or by
contacting the Office of Extramural Inventions and Technology Resources Branch,
OPERA, NIH.
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and
shipped in 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 the address listed for the
Project Officer in Section C, Article G.2.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
d. This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause No. 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT
FORM) (APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery
schedule:
a. The items specified below as described in SECTION C, ARTICLE C2, will be
required to be delivered F.O.B. Destination as set forth in FAR 52.247-35,
F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in
accordance with and by the dates specified below and any specifications
stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:
Item Description Quantity Delivery Schedule
(a) Milestone Report 3 To Be Determined
(b) Quarterly Report 3 To Be Determined
(c) Annual Report 3 To Be Determined
(d) Final Report 3 At The Completion Of
Each Task
9
<PAGE>
Contract No. NO1-AI-95373
b. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
Project Officer, (a) 2
PRB, VPRP, NIAID, NIH (b) 2
6700-B Rockledge Drive, Room 4106 MSC 7628 (c) 2
Bethesda, MD 20892-7628 (d) 2
Contracting Officer, (a) 1
CMB, DEA, NL&ID, NIH (b) 1
6700-B Rockledge Drive, Room 2230 MSC 7612 (c) 1
Bethesda, Maryland 20892-7612 (d) 1
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 will represent the Government for the purpose of
this contract:
Chris Butler, Ph.D.
Project Officer,
PRB, VPRP, NIAID, NIH
6700-B Rockledge Drive, Room 4106 MSC 7628
Bethesda, Maryland 20892-7628
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Government may unilaterally change its Project Officer designation.
10
<PAGE>
Contract No. NO1-AI-95373
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work being
performed hereunder:
Name Title
Phiilip W. Berman, Ph.D. Principal Investigator
ARTICLE G.3. TASK ORDER PROCEDURES
In providing services under the contract, the following procedures shall apply
to the award of task orders.
All work required under the contract shall be authorized through the execution
of a bilateral modification to the contract. Each modification will obligate the
necessary funds to complete the task order and will include the work statement
of the task order as an attachment. Task orders may be issued at any time within
the contract period.
When the Government elects to fill a requirement that is estimated to exceed
$2,500, the Contracting Officer shall provide a Task Order Request (TOR) to the
awardees that received contacts for the particular Part for which responses are
being solicited. A TOR shall, at a minimum, include a Statement of Work,
evaluation factors, specific reporting requirements, deliverables and delivery
schedule, the relevant importance of technical and cost factors, and any special
instructions.
Business proposals shall include direct and indirect costs necessary for
performing the proposed task. Task order proposals shall generally be limited to
a total of 20 pages, including attachments.
Within the time allowed for proposal preparation (time allowed for proposal
preparation and submission will vary depending on the task) which will be
designated in the task order request, Contractors shall submit their proposals
in response to a task order request, which shall include, but not necessarily be
limited to the following information:
(i) A statement of the contractor's clear understanding of the task
requirements;
(ii) A statement of technical and managerial resources and expertise the
contractor can provide to satisfy the requirement;
(iii) An approach to perform the work;
(iv) The labor category necessary, and the numbers of hours for each labor
category necessary, and an explanation of the rationale for determining
hours;
(v) Resumes with identification of the actual personnel proposed for the
work;
(vi) A schedule of performance identifying major milestones, deliverables
and deliver date, and task completion; and
(vii) an itemization of all costs, both direct and indirect, (i.e.
personnel, fringe benefits, equipment, travel, supplies, other direct
costs, overhead, etc.) necessary to complete the work.
The Government will evaluate proposals and conduct negotiations as necessary.
Task orders will be awarded to the contractor whose proposal is determined to be
the most advantageous to the Government based on the technical and price factors
specified in the TOR. The Government reserves the right to make an award on the
most favorable initial proposal without discussion.
The Contracting Officer is the only individual authorized to issue a TOR or
award a task order under the contract. Unless specifically authorized by the
Contracting Officer, the contractor shall not commence work on a requirement
until a modification to the contract has been fully executed.
11
<PAGE>
Contract No. NO1-AI-95373
It is anticipated that task orders will be awarded within 30 calendar days from
receipt of task order proposals. Each task order shall, at a minimum, contain
the following information:
o Date of order
o Contract number and task order number sequentially; e.g.,
N0l-A.I-12345 (Task order No. 001, 002, 003, etc).
o Description of services, and estimated cost.
o Performance period.
o Name and address of sponsoring office.
o Name of Contracting Officer's technical representative.
o Place of performance.
o Packaging, packing, and shipping instructions, if any,
o Accounting and appropriation data.
o Pricing Arrangements
Contractors are required to propose hourly rates for each labor
classification in their response to each TOR, with cost-reimbursable
contract line items proposed for other elements of cost (i.e. fringe
benefits, supplies, travel, equipment, other direct costs, indirect
costs, fee, etc.). A 3% annual allowance for salary increases will
be allowed for each of the subsequent years of each task if
applicable. The subsequent negotiation of TORs issued to successful
contractors eligible to submit a proposal under a TOR for which they
qualify will focus on the number of hours proposed for each labor
category and the estimated costs required for all other elements.
o Any other pertinent information.
No protest under FAR Subpart 323.1 is authorized in connection with the issuance
or proposed issuance of a task order under the contract except for a protest on
the grounds that the order increases the scope, period, or maximum value of the
contract. Task orders awarded under the contract are not subject to the
competition requirements of FAR Part 6.
ARTICLE G4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD
To initiate and receive prompt payment, the Contractor shall comply with the
following procedure:
a. A Task Order Number shall be given to you at the time the order is
placed. The Contractor is cautioned not to accept an order unless
one of these numbers is issued. Invoices shall cite the Contract
Number and the Task Order Number for each order for which payment is
being requested.
b. Invoices shall be submitted monthly to the address indicated below
in ARTICLE G.5. iNVOICE SUBMISSION.
12
<PAGE>
Contract No. NO1-AI-95373
ARTICLE G.5. INVOICE SUBMISSION
a. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contacts NIH(RC)-1 are attached and made part of this contract. The
instructions and the following directions for the submission of
invoices/financing requests must be followed to meet the requirements of
a "proper" payment request pursuant to FAR 32.9.
(1) Invoices/financing requests shall be submitted as follows:
An original and two copies to the following designated billing
office:
Contracting Officer
Contract Management Branch
National Institute of Allergy and
Infectious Diseases, NIH
6700-B Rockledge Drive, Room 2230
BETHESDA MD 20892-7612
(2) Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496-0192.
ARTICLE G.6. 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
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.7. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contact, 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:
Contracts Property Administrator
Research Contracts Property Administration, NIH
601 Building, Room 641E
6011 EXECUTIVE BLVD MSC 7670
BETHESDA MD 20852-7670
(301) 496-6466
13
<PAGE>
Contract No. NO1-AI-95373
ARTICLE G.8. POST AWARD EVALUATION OF PAST PERFORMANCE
Interim and final evaluations of contractor performance shall be conducted on
this contract in accordance with OFPP Policy Letter 92-5, issued January 11,
1993 and HHSAR 342.70002(c)(2)(iv). A final performance evaluation shall be
completed at the time of completion of work. In addition to the final
evaluation, interim evaluations will be prepared by the Project Officer and
submitted to the Contracting Officer. The Contracting Officer will concur by
initialing the appropriate block of the NIH Contractor Performance Report, and
will submit the document to the Contractor as soon as practicable. The
Contractor will be permitted thirty days to review the document and to submit
additional informnation or a rebutting statement.
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 comnmnunity. 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. RESTRICTION FROM USE OF HUMAN SUBJECTS
NOTICE: UNDER GOVERNING REGULATIONS, FEDERAL FUNDS ADMINISTERED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES SHALL NOT BE EXPENDED FOR RESEARCH
INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS SHALL NOT BE ENROLLED IN SUCH
RESEARCH, WiTHOUT PRIOR APPROVAL BY THE OFFICE FOR PROTECTION FROM RESEARCH
RISKS (OPRR) OF AN ASSURANCE TO COMPLY WITH THE REQUIREMENTS OF 45 CFR 46 TO
PROTECT HUMAN RESEARCH SUBJECTS. THIS RESTRICTION APPLIES TO ALL COLLABORATING
SITES WITHOUT OPRR-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN, AND
COMPLIANCE MUST BE ENSURED BY THE AWARDEE.
14
<PAGE>
Contract No. NO1-AI-95373
ARTICLE H.4. HUMAN MATERIALS
It is understood that the acquisition and supply of all human specimen material
(including fetal material) used under this contract will be obtained by the
Contractor in full compliance with applicable State and Local laws and the
provisions of the Uniform Anatomical Gift Act in the United States and that no
undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.
ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos
for research purposes; or (2) research in which a human embryo or embryos
are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45
CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42
U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism,
not protected as a human subject under 45 CFR 46 as of the date of the
enactment of this Act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or human
diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
b. Public Law and Section No. Fiscal Year Period Covered
105-277 99 10/01/98 - 09/30/99
ARTICLE H.6. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds
shall not be used to carry out any program of distributing sterile needles
or syringes for the hypodermic injection of any illegal drug.
b. Public Law and Section No. Fiscal Year Period Covered
105-277 99 10/01/98 - 09/30/99
ARTICLE H.7. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
No rodent or rodent product shall be delivered into the NIH, NIAID environment
directly, or through collaborative research or holding facilities under contract
to NIAID except by permit. Direct shipments to NIH from a commercial colony will
be considered exempt. Non-exempt sources must be approved by permit issued
through the National Center for Research Resources (NCRR). The permit must be
obtained by the Contractor prior to the shipment to NIH of the rodents and/or
rodent products. The Contractor must be sure that this permit exists and is
current before transferring rodents or rodent products into the NIH, NIAID
environment. Refusal or negligence to do so will be considered a material breach
of contract and may be treated as any other such material breach. Applications
for permits should be submitted not less than 30 days prior to shipping date to:
NIH Veterinary Resources Branch (VRP), National Center for Research Resources
(NCRR), Scientific Services Branch, Laboratory Sciences Section, Building 28A,
Room 111, 28 LIBRARY DR MSC 5210, BETHESDA MD 20892-5210, (301)496-4463.
15
<PAGE>
Contract No. NO1-AI-95373
ARTICLE H.8. ANIMAL WELFARE ASSURANCE
The Contractor shall obtain, prior to the start of any work under this contract,
an approved Animal Welfare Assurance from the Office of Protection from Research
Risks (OPRR), Office of the Director, NIH, as required by Section I-43-30 of the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. The
Contractor shall maintain such assurance for the duration of this contract, and
any subcontractors performing work under this contract involving the use of
animals shall also obtain and maintain an approved Animal Welfare Assurance.
ARTICLE H.9. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS
UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE
(PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS
WITHOUT PRIOR APPROVAL BY THE OFFICE FOR PROTECTION PROM RESEARCH RISKS (OPRR)
OF AN ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF
LABORATORY ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES WITHOUT
OPRR-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN.
ARTICLE H.1O. 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 99 10/01/98 - 09/30/99 $125,900
ARTICLE H.11. 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.
16
<PAGE>
Contract No. NO1-AI-95373
ARTICLE H.12. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from
the National Institute of Allergy and Infectious Diseases, National
Institutes of Health, under Contract No. N01-AI-95373."
ARTICLE H.13. PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (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 99 10/01/98 - 09/30/99
ARTICLE H.14. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN
In accordance with FAR 16.505(b)(4), the following individual has been
designated as the NIH Ombudsman for task order and delivery order contracts.
James F. O'Donnell, Ph.D, Director, Office of Extramural Programs
OR
Philip S. Chen, Jr., Ph.D., Associate Director for Intramural Affairs
ARTICLE H.15. 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-mai1 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)
17
<PAGE>
Contract No. NO1-AI-95373
ARTICLE 11.16. 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)
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
All hardware and software items used to manipulate data under
this contract
--------------------------------------------------------------
--------------------------------------------------------------
(end of clause)
18
<PAGE>
Contract No. NO1-AI-95373
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
All hardware and software items used to manipulate data under
this contract
--------------------------------------------------------------
--------------------------------------------------------------
(end of clause)
19
<PAGE>
Contract No. NO1-AI-95373
PART II - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
20
<PAGE>
Contract No. NO1-AI-95373
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE
(FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. DATE TITLE
---------- ---- -----
52.202-1 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, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000)
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000)
52.203-12 Jun 1997 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000)
52.204-4 Jun 1996 Printing or 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 Aug 1996 Audit and Records - Negotiation (Over $100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
52.215-15 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
21
<PAGE>
Contract No. NO1-AI-95373
52.216-8 Mar 1997 Fixed Fee
52.219-8 Jan 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
52.222-24 Feb 1999 Preaward On-Site Equal Opportunity Compliance
Evaluation
52.222-26 Feb 1999 Equal Opportunity
52.222-35 Apr 1998 Affirmative Action for Disabled Veterans and Veterans
of the Veitnam 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
52.225-3 Jan 1994 Buy American Act - Supplies
52.225-11 Aug 1998 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr 1984)
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000)
52.227-11 Jun 1997 Patent Rights - Retention by the Contractor (Short
Form) (Note: In accordance with FAR 27.303(a)(2),
paragraph (f) is modified to include the requirements
in FAR 27.303(a)(2)(i) through (iv). The frequency of
reporting in (i) is annual.
52.227-14 Jun 1987 Rights in Data - General
52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 Jun 1996 Interest (Over $100,000)
52.232-20 Apr 1984 Limitation of Cost
52.232-23 Jan 1986 Assignment of Claims
52.232-25 Jun 1997 Prompt Payment
52.232-33 May 1999 Payment by Electronic Funds Transfer--Central
Contractor Registration
52.233-1 Dec 1998 Disputes
22
<PAGE>
Contract No. NO1-AI-95373
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 V (Apr 1984)
52.243-7 Apr 1984 Notification of Changes
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)
52.246-23 Feb 1997 Limitation of Liability (Over $100,000)
52.249-6 Sep 1996 Termination (Cost-Reimbursement)
52.249-14 Apr 1984 Excusable Delays
52.253-1 Jan 1991 Computer Generated Forms
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. DATE TITLE
---------- ---- -----
352.202-1 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 RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 5/1999].
23
<PAGE>
Contract No. NO1-AI-95373
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
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.
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 52.216-15, Predetermined Indirect Cost Rates (APRIL 1998).
(3) FAR 52.216-18, Ordering (OCTOBER 1995). Such orders may be issued
from the effective date of this contract through the expiration date
of this contract.
(4) FAR 52.216-22, Indefinite Quantity (OCTOBER 1995). The Contractor
shall not be required to make any deliveries under this contract
after the expiration date of the contract.
(5) FAR 52.219.4, Notice of Price Evaluation Preference for HUBZone
Small Business Concerns (JANUARY 1999).
"(c) Waiver of evaluation preference.....
|_| Offeror elects to waive the evaluation preference."
(6) FAR 52.219-14, Limitation of Subcontracting (DECEMBER 1996).
(7) FAR 52.219-25, Small Disadvantaged Business Participation Program--
Disadvantaged Status and Reporting (JANUARY 1999).
(8) FAR 52.227-14, Rights in Data - General (JUNE 1987).
(9) Alternate IV (JUNE 1987), FAR 52.227-14, Rights in Data - General
(JUNE 1987).
(10) FAR 52.243.2, Changes--Cost Reimbursement (AUGUST 1987), Alternate V
(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).
(2) HHSAR 352.224-70, Confidentiality of Information (APRIL 1984).
(3) PHS 352.280-1b, Protection of Human Subjects (OCTOBER 1986).
24
<PAGE>
Contract No. NO1-AI-95373
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:
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 offer clause of this contract, the Contractor is
not required to include and FAR provision or clause, other than
those listed below to the extent they are applicable and as may be
required to establish the responableness 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. 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.
25
<PAGE>
Contract No. NO1-AI-95373
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work, July 9, 4 pages.
2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1, (5/97), 4 pages.
3. Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97), 1 page.
4. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
26
<PAGE>
Contract No. NO1-AI-95373
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated May 13, 1999.
END of the SCHEDULE
(CONTRACT)
27
<PAGE>
Contract No. N01-AI-95373
STATEMENT OF WORK
ATTACHMENT A
BACKGROUND
The development of a vaccine to prevent the spread of HIV infection has been
identified by the NIAID as a goal of the highest priority. While advances in
immunology and molecular biology continue to offer an ever expanding array of
approaches to the development of new candidates, the limited capacity to move
promising concepts through the development process presents a substantial
barrier to the full achievement of this potential. Limited industry involvement
in key areas, especially international (non-clade B) vaccines, calls for a
non-traditional, more active and developmentally oriented response by NIH and
NIAID to meet the public health threat of the AIDS epidemic. Resources that
could rapidly and efficiently close development and production gaps would
greatly enhance the capacity to respond to emerging needs identified by NIAID
and its advisory groups. The HIV Vaccine Production Contract will support
applied research that is not adequately being pursued by industry and will
further develop leads derived from investigator-initiated research.
INTRODUCTION
The objective of the Contract is to provide to the NIAID with a full range of
developmental resources to bring an HIV vaccine concept from the laboratory to
initial human testing. It is envisioned that the ability to encourage and to
support the development of multiple approaches will result in a shared knowledge
base from which the best vaccine prototypes will emerge.
STATEMENT OF WORK
WORK STATEMENT for the HIV Vaccine Production Contract.
Independently, and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, materials, equipment,
and facilities, not otherwise provided by the Government under the terms of the
contract, directly or through subcontractors and/or consultants, as needed to
undertake targeted research essential to translating basic research concepts
into prototype vaccine products, under the direction of NIAID staff and as
commended by existing and ad hoc NIAID advisory groups.
Statement of Work ATTACHMENT 1
(07/09/99) 1 Page 1
<PAGE>
Contract No. NO1-AI-95373
Specifically, the Contractor shall:
PART A: VACCINE PRODUCTION
1. Produce, scale-up, characterize and formulate specific vaccine antigens
and reagents as directed by the Project Officer via a Task Order issued by
the NIAID, Produce pilot lots of candidate vaccines under GLP/cGMP
appropriate for Phase I and Phase II human clinical trials, at the
direction of the Project Officer in one or more of the following vaccine
Categories:
(a) Synthetic peptides--Clinical grade purified HIV peptide vaccines.
(b) Recombinant subunits--Clinical grade purified subunit vaccines.
(c) Plasmid DNA vaccines--Clinical grade recombinant plasmid DNA with
sequence(s) of genes relevant to AIDS vaccines.
(d) Vector based vaccines--Clinical grade recombinant vaccines
containing relevant genes (eg. vaccinia, avipox, adenovirus, polio,
BCG, Salmonella, etc.).
(e) Whole killed/Virus-like Particle - Clinical grade nonviable HIV-1
virus vaccine.
(f) Live attenuated virus--Attenuated HIV-1 virus vaccine.
2. Develop and manufacture specific vaccine products.
a) Consult and coordinate with the product inventor throughout the
development process. Complete a material transfer agreement, if
needed.
b) Develop detailed production plan and budgets for manufacture of lots
of candidate vaccine products prior to undertaking GLP/cGMP
production.
c) Assure that facilities and all planned procedures meet FDA standards
and requirements prior to GLP/cGMP production. -
d) Prepare, where applicable, master stocks, cell banks, bacterial or
viral clones, etc.
e) Purchase, where applicable, products and materials necessary for
vaccine production.
Statement of Work ATTACHMENT 1
(07/09/99) 2 Page 2
<PAGE>
Contract No. NO1-AI-95373
f) Optimize expression in systems suitable for vaccine production and
scale-up production to required capacity.
g) Maintain an inventory of test and pilot lots of vaccine candidates
that have been produced. Periodically, as required, examine titer or
potency of vaccine products.
h) Produce reagents necessary for the testing or evaluation of immune
responses to vaccine products.
i) Ship the manufactured, packaged, and labeled dosage forms utilizing
shipping procedures and materials to maximize product stability.
j) Manage and account for intellectual property rights that pre-exist
or may develop through the activities of the Contractor, including
maintenance of security of confidential and/or proprietary data.
3. Provide facilities, equipment and resources:
a) Receive, store and manipulate biohazardous materials (Biosafety
Level 2 and 3 Containment as required) and maintain their viability
in facilities which provide aseptic and/or sterile conditions as
appropriate.
b) Maintain and operate controlled storage of samples at appropriate
temperatures with appropriate monitoring for failure (Room
temperature through -90 (degree) C. liquid nitrogen storage may be
required for some products).
e) Provide facilities and equipment suitable for GLP/cGMP production of
vaccine products.
d) Provide protective garments, equipment and sufficient monitoring to
assure safe handling of potentially hazardous materials, including
radioactive materials, for the safety and protection of workers.
e) Conduct work under the contract in accordance with all applicable
and current Federal, state, and local laws, codes, ordinances and
regulations, as well as all PHS Safety and Health provisions)
4. Perform vaccine lot characterization tests.
At various steps during the manufacture of a vaccine the product must be
characterized. Prior to use of a vaccine in clinical studies the manufactured
vaccine will need to undergo final lot release testing. As described in the
regulations for General Biological Product Standards (21 CFR 610) the following
tests must be performed for each lot of vaccine.
Statement of Work ATTACHMENT 1
(07/09/99) 3 Page 3
<PAGE>
Contract No. NO1-AI-95373
a) Test for Potency. A test for potency (21 CFR 610.10) will evaluate
in an in vitro or in vivo test the specific ability of the vaccine
to effect a given response, such as an immune response in mice,
which should be supportive of the efficacy of the vaccine in humans.
In the case of DNA vaccines potency maybe evidenced by the
production of the pertinent antigen in a transfected cell line.
b) Test for General Safety. The general safety test (21 CFR 610.11)
must be performed in mice and guinea pigs on each lot of vaccine to
detect extraneous toxic contaminants potentially introduced during
manufacture.
c) Test for Sterility. A test for sterility (21 CFR 610.12) must be
performed as described in the regulations.
d) Test for Purity. A test for purity (21 CFR 610.13) must be performed
on each lot to ensure that the product is free from extraneous
material except for that which is unavoidable due to the
manufacturing process. In addition, the test for purity includes an
evaluation of residual moisture and the presence of pyrogenic
substances in the product.
e) Test for Identity. The test for identity (21 CFR 601.14) is
generally a physical or chemical test performed to establish the
identity of the material in the final container.
f) Test for Quantity. A measure of the amount of material present is
imperative for calculating the dilution of the bulk material
required for the final container fill.
g) All other tests as may be required for specific vaccine types.
5. Perform stability testing.
6. Participate in discussions with the FDA during pre-IND and IND meetings.
7. Ensure an orderly transition to a successor Contractor.
Six months before the end of the awarded Contract, the Contractor shall
define and implement an orderly transition of data, specimens and products
to any successor Contractor or to the Government, subject to Project
Officer direction, and shall deliver, if requested by the Project Officer
and by the completion date of the Contract, the following items: original
data, reagents, stored specimens (and any necessary information related
thereto), Government-owned equipment and property.
8. Meet with the Project Officer at periodic intervals, to be scheduled after
contract award.
9. Retain all records, samples, histopathological slides, etc. as indicated
under GLP and cGMP guidelines and be able to make them available.
Statement of Work ATTACHMENT 1
(07/09/99) 4 Page 4
<PAGE>
Contract No. NO1-AI-95373
INVOICE/FINANCING REQUEST INSTRUCTIONS
FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS, NIH(RC)-1
General: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
Format: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal," and Standard Form 1035, "Public Voucher for Purchases and
Services Other Than Personal--Continuation Sheet," or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1O35, claims maybe 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 less otherwise authorized by the contracting
officer.
Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
Billing of Costs Incurred: If billed costs include: (1) costs of a prior
billing period, but not previously billed; or (2) costs incurred during the
contract period and claimed after the contract period has expired, the
amount and month(s) 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 in 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 the request.
Invoice/Financing Request Identification: Each invoice/financing request shall
be identified as either:
(a) Interim Invoice/Contract Financing Request - These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice--The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final indirect
cost rates covering the year in which this contract is physically complete
(whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance
provisions have been completed.
(c) Final Invoice--A final invoice may be required after the amounts owed
have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).
Preparation and Itemization of the Invoice/Financing Request: The contractor
shall furnish the information set forth the explanatory notes below. These notes
are keyed to the entries on the sample invoice/financing request.
NIH(RC)-1 ATTACHMENT 2
Rev. 5/97 Page 1
<PAGE>
Contract No. NO1-AI-95373
(a) Designated Billing Office Name and Address--Enter the designated billing
office name and address, identified in the Invoice Submission Clause of
the contract, on all copies of the invoice/financing request.
(b) Invoice/Financing Request Number--Insert the appropriate serial number
of the invoice/financing request.
(c) Date Invoice/Financing Request Prepared--Insert the date the
invoice/financing request is prepared.
(d) Contract Number 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) Amount Billed for Current Period--Insert the amount billed for the
major cost elements, adjustments, and adjusted amounts for the period.
(j) Cumulative Amount from Inception--Insert the cumulative amounts billed
for the major cost elements and adjusted amounts claimed during this
contract.
(k) Direct Costs--Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(1) Direct Labor--Include salaries and wages paid (or accrued) for
direct performance of the contract.
(2) Fringe Benefits--List any fringe benefits applicable to direct labor
and billed as a direct cost. Fringe benefits included in indirect
costs should not be identified here.
(3) Accountable Personal Property--Include permanent research equipment
and general purpose equipment having a unit acquisition cost of
$1,000 or more and having an expected service life of more than two
years, and sensitive property regardless of cost (see the DHHS
Contractor's Guide for Control of Government Property). Show
permanent research equipment separate from general purpose
equipment. Prepare and attach 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 COA letter and number, if the equipment is not covered by
the Property Schedule.
- Be preceded by an asterisk (*) if the equipment is below the
approval level.
Further itemization of invoices/financing requests shall only be
required for items having specific limitations set forth in the
contract.
NIH(RC)-1 ATTACHMENT 2
Rev. 5/97 Page 2
<PAGE>
Contract No. NO1-AI-95373
(4) Materials and Supplies--Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) Premium Pay--List remuneration in excess of the basic hourly rate.
(6) Consultant Fee--List fees paid to consultants. Identify consultant
by name or category as set forth in the contract's advance
understanding or in the COA letter, as well as the effort (i.e.,
number of hours, days, etc.) and rate being billed.
(7) Travel--Include domestic and foreign travel. Foreign travel is
travel outside of Canada, the United States and its territories and
possessions. However, for an organization located outside Canada,
the United States and its territories and possessions, foreign
travel means travel outside that country. Foreign travel must be
billed separately from domestic travel.
(8) Subcontract Costs--List subcontractor(s) by name and amount billed.
(9) Other--List all other direct costs in total unless exceeding $1,000
in amount. If over $1,000, list cost elements and dollar amounts
separately. If the contract contains restrictions on any cost
element, that cost element must be listed separately.
(l) Cost of Money (COM)--Cite the COM factor and base in effect during the
time the cost was incurred and for which reimbursement is claimed.
(m) Indirect Costs--Overhead--Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(n) Fixed-Fee Earned--Cite the formula or method of computation for the
fixed-fee (if any). The fixed-fee must be claimed as provided for by the
contract.
(o) Total Amounts Claimed--Insert the total amounts claimed for the current
and cumulative periods.
(p) Adjustments--Include amounts conceded by the contractor, outstanding
suspensions, and/or disapprovals subject to appeal.
(q) Grand Totals
The contracting officer may require the contractor to submit detailed support
for costs claimed on one or more interim invoices/financing requests.
NIH(RC)-1 ATTACHMENT 2
Rev. 5/97 Page 3
<PAGE>
Contract No. NO1-AI-95373
SAMPLE INVOICE/FINANCING REQUEST
(a) Billing Office Name and Address (b) Invoice/Financing Request No.
--------------------------------
NATIONAL INSTITUTES OF HEALTH (c) Date Invoice Prepared
NIAID, CMB
Rockledge Drive, room 2230 --------------------------------
6700-B Rockledge Drive, MSC 7612
Bethesda, MD 20892-7612 (d) Contract No. and Effective Date
--------------------------------
(e) Payee's Name and Address
(f) Total Estimated Cost of Contract
ABC CORPORATION
100 Main Street --------------------------------
Anywhere, U.S.A. zip code
(g) Total Fixed Fee
--------------------------------
Attention: Name, Title, and Phone Number
of Official to Whom Payment is
Sent
--------------------------------------------------------------------------------
(h) This invoice/financing request represents reimbursable costs from Aug. 1,
1982 through Aug. 31, 1982
--------------------------------------------------------------------------------
(i) Amount Billed
(j) Cumulative Amount
for Current Period From Inception
------------------ --------------
(k) Direct Costs
(1) Direct Labor $ 3,400 $ 6,800
(2) Fringe Benefits 600 1,200
(3) Accountable Personal Property
(Attach Form HHS-565)
Permanent Research 3,000 6,000
General Purpose 2,000 2,000
(4) Materials and Supplies 2,000 4,000
(5) Premium Pay 100 150
(6) Consultant Fee-Dr. Jones 1 day
@ 100 (COA #3) 100 100
(7) Travel (Domestic) 200 200
(Foreign) 200 200
(8) Subcontract Costs -0- -0-
(9) Other -0- -0-
------- -------
Total Direct Costs $11,600 $20,650
(l) Cost of Money (Factor) of
(Appropriate Base) 2,400 3,600
(m) Indirect Costs--Overhead
___% of Direct Labor or Other Base
(Formula) 4,000 6,000
(n) Fixed-Fee Earned (Formula) 700 1,400
------- -------
(o) Total Amount Claimed $18,700 $31,650
(p) Adjustments
Outstanding Suspensions (1,700)
-------
(q) Grand Totals $18,700 $29,950
"I certify that all payments requested are for appropriate purposes and in
accordance with the contract."
---------------------------- ----------------------------------------
(Name of Official) (Title)
NIH(RC)-1 ATTACHMENT 2
Rev. 5/97 Page 4
<PAGE>
Contract No. NO1-AI-95373
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)
<PAGE>
Contract No. NO1-AI-95373
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