EXHIBIT 10.3
STANDARD FORM 26 (REV. 4-85)
NSN 7540-01-152-8069
OMB No. 0990-0115
RFP 95-32
AWARD/CONTRACT
1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350)
RATING
PAGE 1 OF PAGES 20
2. CONTRACT (Proc. inst. ident.) No. ND1-AI-55273
3. EFFECTIVE DATE September 30, 1995
4. REQUISITION/PURCHASE REQUEST/PROJECT N-933
5. ISSUED BY CODE 2668-55273
National Institutes of Health
Contract Management Branch, NIAID
Solar Building, Room 3007
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
6. ADMINISTERED BY (if other than item 5) CODE
7. NAME AND ADDRESS OF CONTRACTOR (No., street, city, country, State and Zip
Code)
BTRL Contracts and Services, Inc., dba/
Biotech Research Laboratories, Inc.
3 Taft Court
Rockville, Maryland 20850
8. DELIVERY
FOB ORIGIN
OTHER (See below Destination)
9. DISCOUNT FOR PROMPT PAYMENT N/A
10. SUBMIT INVOICES
(4 copies unless otherwise specified) TO THE ADDRESS SHOWN IN ITEM G.3
CODE
FACILITY CODE
11. SHIP TO/MARK FOR
See Article F.1.
12. PAYMENT WILL BE MADE BY
See Article G.3.
CODE
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 CAN#5-8425674 DOC#300N1A155273 TIN#1-
043152484-A1
SOC#25.55
FY 95 $343,987
15A. ITEM NO.
15B. SUPPLIES/SERVICES
15C. QUANTITY
15D. UNIT
15E. UNIT PRICE
15F. AMOUNT
Research & Development Contract
Title: MAO/Detection of Antibodies & Proteins; Isolation of Virus (E)
Period: September 30, 1995 through September 29, 1997
Amount allotted: $343,987 Awarded under MA N01-AI-42602
Contract Type: Cost Reimbursement/Completion
FY 95 343,987
FY 96 778,668
15G. TOTAL AMOUNT OF CONTRACT $1,122,655
16. TABLE OF CONTENTS
( ) SEC. DESCRIPTION PAGE(S) ( ) SEC. DESCRIPTION PAGE(S)
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
X A SOLICITATION/CONTRACT FORM 1 X 1 CONTRACT CLAUSES 13
X B SUPPLIES OR SERVICES AND PRICES/COSTS 4 PART III - LIST OF DOCUMENTS,
EXHIBITS AND OTHER ATTACH.
X C DESCRIPTION/SPECS./WORK STATEMENT 8 X J LIST OF ATTACHMENTS 13
X D PACKAGING AND MARKING 8 PART IV- REPRESENTATIONS AND INSTRUCTIONS
X E INSPECTION AND ACCEPTANCE 9 X K REPRESENTATIONS, CERTIFICATIONS AND OTHER
STATEMENTS OF OFFERORS 13
X F DELIVERIES OR PERFORMANCE 10
X G CONTRACT ADMINISTRATION DATA 11 L INSTRS., CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 12 M EVALUATION FACTORS FOR AWARD
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
17. X CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return 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,
certifications, 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)
Mark Manak, Senior Vice President
20A. NAME OF CONTRACTING OFFICER
Nancy Hershey, Contracting Officer
CMB, NIAID, HIH
19B. NAME OF CONTRACTOR
BY Mark Manak
(Signature of person authorized to sign)
19C. DATE SIGNED
9/21/95
20B. UNITED STATES OF AMERICA
BY Lawrence M. Butler
(Signature of Contracting Officer)
20C. DATE SIGNED
9/22/95
DETAILED TABLE OF MASTER AGREEMENT ORDER (MAO) CONTENTS
-------------------------------------------------------
PART I - THE SCHEDULE
SECTION A - SOLICITATION/MAO FORM............................................. 1
- ---------------------------------
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............................ 5
ARTICLE B.4. ADVANCE UNDERSTANDINGS........................................... 6
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT......................... 8
- -----------------------------------------------------
ARTICLE C.1. STATEMENT OF WORK................................................ 8
ARTICLE C.2. REPORTING REQUIREMENTS........................................... 8
SECTION D - PACKAGING, MARKING AND SHIPPING................................... 8
- -------------------------------------------
SECTION E - INSPECTION AND ACCEPTANCE......................................... 9
- -------------------------------------
SECTION F - DELIVERIES OR PERFORMANCE........................................ 10
- -------------------------------------
ARTICLE F.1. DELIVERIES...................................................... 10
ARTICLE F.2. STOP WORK ORDER................................................. 10
SECTION G - MAO ADMINISTRATION DATA.......................................... 11
- -----------------------------------
ARTICLE G.1. PROJECT OFFICER................................................. 11
ARTICLE G.2. KEY PERSONNEL................................................... 11
ARTICLE G.3. INVOICE SUBMISSION . . . . . . . . . . ..........................11
ARTICLE G.4. GOVERNMENT PROPERTY............................................. 12
ARTICLE G.5. GOVERNMENT SUPPLY SOURCES........................................12
SECTION H - SPECIAL MASTER AGREEMENT ORDER REQUIREMENTS.......................12
- -------------------------------------------------------
ARTICLE H.1. HUMAN SUBJECTS . . . . ......................................... 12
ARTICLE H.2. SALARY RATE LIMITATION LEGISLATION PROVISIONS................... 12
PART II...................................................................... 13
SECTION I - MASTER AGREEMENT ORDER CLAUSES................................... 13
- ------------------------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED COST-PLUS-A-FIXED FEE
MASTER AGREEMENT ORDER ...................................................... 13
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES............................. 13
ARTICLE I.3. ADDITIONAL MAO CLAUSES.......................................... 13
ARTICLE I.4. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT.................... 13
2
PART III..................................................................... 13
SECTION J - LIST OF ATTACHMENTS.............................................. 13
Statement of Work.............................................................13
PART IV...................................................................... 13
SECTION K - REPRESENTATIONS AND CERTIFICATIONS............................... 13
Representations and Certifications........................................... 13
3
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
- -------------------------------------------------
[THIS MAO IS AWARDED UNDER MASTER AGREEMENT NO1-AI-42602 FOR HIV PRECLINICAL
VACCINE DEVELOPMENT].
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this master agreement order (MAO) is for the "Detection of
Antibodies and Proteins; Isolation of Virus; Section A: Immunization with HIV
Vaccines and Challenge with SHIV.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of this MAO is $1,057,412.
b. The fixed fee for this MAO is $65,243. The 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 MAO. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated
cost plus the fixed fee, is $1,122,655.
d. Total funds currently available for payment and allotted to this MAO
are $343,987, of which $323,996 represents the estimated costs, and of
which $19,991 represents the fixed fee. For further provisions on
funding, see the LIMITATION OF FUNDS referenced in Part II, ARTICLE I.2
Authorized Substitutions of Clauses of the MA.
e. It is estimated that the amount currently allotted will cover
performance of the MAO through September 29, 1996.
f. Increments to be allotted to this contract are estimated as follows:
Estimated Fixed Total Estimated
FY Period Cost Fee Cost
-- ------ ---- --- ----
95 9/30/95 - 9/29/96 $ 323,996 $ 19,991 $ 343,987
96 9/30/96 - 9/29/97 $ 733,416 $ 45,252 $ 778,668
Total $1,057,412 $ 65,243 $1,122,655
g. The Contracting Officer may allot additional funds to the MAO without
the concurrence of the MA Holder.
4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
- ---------------------------------------------------
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, [and FIXED FEE]
incorporated into this MAO, 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 (a general
scientific meeting is defined as an assemblage of
scientific/technical personnel held to exchange information
and ideas through a scheduled program of presentations;
includes conferences, congresses, seminars, symposia and
workshops; usually sponsored by a national organization);
(5) Foreign travel - See Paragraph b. below;
(6) Overtime premium;
(7) Consultant fees;
(8) Subcontracts;
(9) Accountable Government property (defined as both real and
personal property with an acquisition cost of $1,000 or more
and a life expectancy of more than two years) and "sensitive
items" (defined and listed in the Contractor's Guide for
Control of Government Property, 1990, regardless of
acquisition value.
b. Travel Costs
(1) 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 MAO's
personnel to travel and their functions in the specific MAO project;
(c) the MAO purposes to be served by the travel; (d) how travel of MAO
personnel will benefit and contribute to accomplishing the specific MAO
project, or will otherwise justify the expenditure of NIH MAO 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 specific MAO and thus further benefit the
project.
5
ARTICLE B.4. ADVANCE UNDERSTANDINGS
- ------------------------------------
a. The estimated level of effort set forth below is for guidance to serve
not as a measure of the MAO Holder's obligation but as a further
description of the required tasks. It will represent the basis of
direct labor agreed to in the MAO negotiations for the period from
September 30, 1995 through September 29, 1997, and will be used by both
the Government and the MAO Holder to monitor progress toward
achievement of the MAO objectives.
Total Estimated Total Estimated Total Estimated
Labor Category Year 1 Hours Year 2 Hours Number of Hours
-------------- ------------ ------------ ---------------
[Language Deleted due to Confidential Treatment Request.]
TOTAL
b. The MAO Holder agrees to abide by the terms of FAR 52.247-63,
Preference for U.S.-Flag Air Carriers. This provision states in part
that, in performing work under this MAO, the MAO Holder shall utilize
U.S. flag air carriers unless service by those carriers is not
available. If U.S. flag air carriers are not available the MAO Holder
shall so certify in writing and include that
certification/justification in the request for advance approval of
foreign travel. (Cost/lower fares are not acceptable reasons for
proposing to utilize foreign air carriers.)
c. The MAO Holder agrees to submit an annual and a final inventory of
Government property as required by the DHHS "Contractor's Guide for
Control of Government Property." Inventories shall be submitted to the
Contract Property Administrator identified in Article G.4. of this
contract, with a copy to the Contracting Officer. Annual inventories
shall be submitted by October 31 each year.
d. The MAO Holder agrees to immediately notify the Contracting Officer in
writing if there is a projected overrun (in any amount) or unexpended
balance (greater than 10%) in the overall budget at the end of any
funding period, and the reasons for the variance (see also the
requirements of the Limitation of Funds clause in the MAO).
e. If the MAO contains any specific limitations/ceilings on particular
costs, these shall always prevail until modified in the MAO.
f. The MAO Holder agrees that samples/products received from/through the
Government for utilization under this MAO shall be used only for
purposes required by this MAO.
g. Publication of Manuscripts or Abstracts
Because there is a likelihood that the MAO Holder will be evaluating
proprietary compounds provided to the Government by a third party, it
is essential to include provisions that will protect the rights of the
third party suppliers as follows:
The MAO Holder agrees that manuscripts/abstracts based on
data/information generated under this MAO will not be
submitted for publication until written Project Officer
clearance has been received. MAO support shall be acknowledged
in all such publications. A "publication" is defined as an
issue of printed material offered for distribution or any
communication or oral presentation of information.
6
The Project Officer will review all manuscripts/documents in a
period of time not to exceed 30 calendar days from receipt,
and will either grant clearance for publication/disclosure,
recommend changes or, as applicable, refer the document to the
Supplier of the compound for their review.
NIAID will use its best efforts to assist and expedite the
review process by the Supplier wherever possible.
h. Correspondence Procedures
To promote timely and effective administration, correspondence (except
for invoices/financial reports, technical progress reports/other
deliverables) submitted under this MAO 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 MAO 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 MAO number as illustrated below:
SUBJECT: MAO No. NO1-AI-55273
Request for Approval of
7
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
- -----------------------------------------------------
ARTICLE C.1. STATEMENT OF WORK
- -------------------------------
a. Independently and not as an agent of the Government, the MAO Holder
shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Work, SECTION J,
ATTACHMENT 1, dated September 30, 1995 attached hereto and incorporated
herein.
b. If there is any inconsistency between the MAO Holder's technical
proposals dated March 7, 1995, June 20, 1995 and August 7, 1995, and
the work described in this Article C.1., Paragraph a., the terms and
conditions of this Article C.1., Paragraph a, shall control.
ARTICLE C.2. REPORTING REQUIREMENTS
- ------------------------------------
a. Technical Reports
In addition to those reports required by the other terms of this MAO,
the MAO Holder shall prepare and submit the following reports in the
manner stated below and in accordance with ARTICLE F.1. DELIVERIES of
this MAO:
(1) Quarterly Progress Report
By the fifteenth calendar day of the month following the end
of each quarter, the MA Holder shall submit (5) copies of a
quarterly technical report. Four (4) copies shall be submitted
to the Project Officer and one (1) copy shall be submitted to
the Contracting Officer. This report shall include a
(description of the activities during the reporting period,
and the activities planned for the ensuing reporting period.
The first reporting period consists of the first full three
months of performance including any fractional part of the
initial month. Thereafter, the reporting period shall consist
of three full calendar months. A quarterly report shall not be
submitted when a final report is due.
(2) Final Report
The MAO Holder shall submit five (5) copies of the final
report documents. Four (4) copies shall be submitted to the
Project Officer and (1) copy shall be submitted to the
Contracting Officer. This report is to include a summation of
the work performed and results obtained for the entire MAO
period of performance. This report shall be in sufficient
detail to describe comprehensively the results achieved. The
Final Report shall be submitted no later than the completion
date of this MAO.
SECTION D - PACKAGING, MARKING AND SHIPPING
- -------------------------------------------
All deliverables required under this MAO shall be packaged, marked and shipped
in accordance with Government specifications. The MAO Holder shall guarantee
that all required materials shall be delivered in immediate usable and
acceptable condition.
8
SECTION E - INSPECTION AND ACCEPTANCE
- -------------------------------------
a. For the purpose of this ARTICLE, the designated Project Officer is the
authorized representative of the Contracting Officer, who shall perform
inspection and acceptance of materials and services to be provided.
b. Inspection and acceptance will be performed at the Project Officer's
address listed in the clause entitled "Deliveries" in Section F.
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30
days of receipt.
c. This MAO incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT - (SHORT
FORM)(APRIL 1984).
9
SECTION F - DELIVERIES OR PERFORMANCE
- -------------------------------------
ARTICLE F.1. DELIVERIES
- ------------------------
Satisfactory performance of this MAO 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:
The items specified below as described in (SECTION C, ARTICLE C.2. shall be
delivered f.o.b. destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the
date(s) specified below [and any specifications stated in SECTION D, PACKAGING,
MARKING AND SHIPPING, of this MAO]:
Item Description QuantityDelivery Schedule
---- ----------- -------------------------
1. Quarterly 5 1/15/96, 97
4/15/96, 97
7/15/96, 97
10/15/96
2. Final 5 By completion date of this MAO
The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
--------- -------------------- --------
Project Officer 1. 4
PRB, DAIDS 2. 4
Solar Bldg., Rm. 2A31
6003 Executive Blvd.
Bethesda, MD. 20892
Contracting Officer 1. 1
CMB, DEA, NIAID, NIH 2. 1
Solar Bldg., Rm. 3C07
6003 Executive Blvd.
Bethesda, MD. 20892
ARTICLE F.2. STOP WORK ORDER
- -----------------------------
This MAO 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.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.212-13, STOP WORK ORDER (AUGUST 1989) with ALTERNATE I (APRIL 1984).
10
SECTION G - MAO ADMINISTRATION DATA
- -----------------------------------
ARTICLE G.1. PROJECT OFFICER
- -----------------------------
Pursuant to the Project Officer Article incorporated in the MA, the following
Project Officer will represent the Government for the purpose of this MAO:
MAO Project Officer: Marta J. Glass, M.S.
The Project Officer is responsible for: (1) monitoring the MAO Holder'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 MAO; 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 MAO. 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 MAO Holder any costs incurred during the performance of
this MAO; or (5) otherwise change any terms and conditions of this MAO.
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
- ---------------------------
Pursuant to the Key Personnel clause incorporated in the MAO, the following
individuals are considered to be essential for the work being performed
hereunder:
NAME TITLE
---- -----
Chang Chih-Tai, Ph.D. Principal Investigator
Hanna Weissberger, Ph.D. Co-Principal Investigator
ARTICLE G.3. INVOICE SUBMISSION
- -------------------------------
The Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1, set forth in your Master Agreement are incoporated herein.
The invoice instructions and directions for the submission of invoice/financing
requests contained in the MA must be followed to meet the requirements of a
"proper" invoice, pursuant to FAR 32.9.
11
ARTICLE G.4. GOVERNMENT PROPERTY
- ---------------------------------
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in this Section I of this MAO, the MAO Holder shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control
of Government Property, (1990), which is incorporated into this MAO by
reference. Among other issues, this publication provides a summary of
the MAO Holder's responsibilities regarding purchasing authorizations
and inventory and reporting requirements under the MAO. A copy of this
publication is available upon request to the Contract Property
Administrator at the following address:
Contracts Property Administrator
Research Contracts Property Administration, NIH
Building 13, Room 2E-65
9000 Rockville Pike
Bethesda, Maryland 20892
(301) 496-6466
ARTICLE G.5. GOVERNMENT SUPPLY SOURCES, is hereby incorporated into this MAO by
reference pursuant to the Master Agreement.
SECTION H - SPECIAL MASTER AGREEMENT ORDER REQUIREMENTS
- -------------------------------------------------------
The following Articles are incorporated into this MAO by reference pursuant to
the Master Agreement. [(Any MAO Articles which are not contained in the MA are
set forth below in full text)]:
a. ARTICLE H.1. HUMAN SUBJECTS
----------------------------
b. ARTICLE H.2. SALARY RATE LIMITATION LEGISLATION PROVISIONS
-----------------------------------------------------------
Paragraph b. of this ARTICLE is revised as follows:
b. Public Law No. Fiscal Year Salary Limitation
-------------- ----------- -----------------
103-333 1995 $125,000
12
PART II
- -------
SECTION I - MASTER AGREEMENT ORDER CLAUSES
- ------------------------------------------
The following Articles are incorporated into this MAO by reference pursuant to
the Master Agreement. [(Any MAO Articles which are not contained in the MA are
set forth below in full text)]:
a. ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED COST PLUS A FIXED FEE
MASTER AGREEMENT ORDER
b. ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES, [Cost-Reimbursement]
c. ARTICLE I.3. ADDITIONAL MASTER AGREEMENT CLAUSES, [Cost-Reimbursement]
d. ARTICLE I.4. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT
PART III
- --------
SECTION J - LIST OF ATTACHMENTS
- -------------------------------
Unless otherwise indicated below, the following documents are attached and
incorporated in this MAO:
1. Statement of Work, September 30, 1995, 7 pages.
2. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 6/18/92, 4 pages. [This attachment is part of the
Master Agreement document and is incorporated into this MAO by
reference].
3. Safety and Health, PHSAR clause 352.223-70, (4/84), 2 pages. [This
attachment is part of the Master Agreement document and is incorporated
into this MAO by reference.
4. Procurement of Certain Equipment, NIH(RC)-7, (4/1/84), 1 page. [This
attachment is part of the Master Agreement document and is incorporated
into this MAO by reference.
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this MAO:
1. Representations and Certifications, dated August 7, 1995.
END of the SCHEDULE
(MASTER AGREEMENT ORDER)
13
STATEMENT OF WORK
-----------------
SECTION A: IMMUNIZATION WITH HIV VACCINES AND CHALLENGE WITH SHIV
- ---------- ------------------------------------------------------
Independently, and not as an agent of the Government, the Master Agreement Order
holder shall provide the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government, as needed
to perform the tasks of the Statement of Work below:
The MAO Holder shall:
1. Perform assays to assess the humoral immune responses of macaques that have
been immunized with HIVenv (or with a combination of HIVenv and SIV non-env)
vaccines. Specifically the MAO Holder shall:
a. Conduct assays (such as ELISA and western blots) to detect
antibodies to the envelope of HIV (and to non-envelope
proteins of SIV that are included in the immunization
protocol) in the sera or other fluids of immunized or
virus-infected monkeys for all vaccine studies assigned.
b. Develop assays to detect antibodies to the above proteins or
antigens if an assay system is not currently available to
detect those antibodies or if existing assays are not of
sufficient sensitivity or specificity to provide the
information required by NIAID.
MAO Statement of Work ATTACHMENT 1
(09/30/95) Page 1
2. Conduct assays to determine whether monkeys become infected after exposure to
SHIV:
a. Determine whether SHIV can be isolated from PBMC, lymph nodes,
or other tissue of monkeys after virus challenge by
co-cultivating the cells or tissue with primary simian and/or
human peripheral blood cells, other primary cells, and/or cell
lines. Evaluate the virus load in the PBMC of infected monkeys
by conducting limitingdilution virus isolations.
Confirm virus transmission to the target cells by
demonstration of the presence of virus or viral protein(s) in
the culture supernatant and/or the presence of viral protein
or nucleic acid in the cultured cells.
b. Conduct assays to detect HIV proteins and/or SIV proteins, or
SHIV nucleic acids (using HIV or SIV primers or probes, as
appropriate) in peripheral blood lymphocytes or other tissues
of animals after challenge with virus.
c. Conduct assays (such as antigen capture assays) to detect
viral antigens or conduct assays to detect viral nucleic acids
in the plasma of animals after challenge with virus.
MAO Statement of Work ATTACHMENT 1
(09/30/95) Page 2
3. Receive, catalog, track, and maintain an inventory of the specimens
that arrive for evaluation:
a) Advise sample suppliers (Category B MAO contractors) of the most
suitable manner for shipment of sera, whole blood, cells or other
specimens for evaluation and arrange for the transfer of these
specimens from primate laboratories to the MAO Holder. All shipments
must be coordinated so that activity/viability of specimens will not be
adversely affected.
b) When necessary, pick up or arrange for pick up of incoming specimen
shipments from a specified airport or other contact site in a timely
manner and assure maintenance of activity and/or viability of the
specimens by providing the appropriate temperature in transit from the
airport or other contact site to the MAO Holder's laboratory.
c) Receive and catalog specimens arriving for evaluation from the
primate laboratories. Maintain documentation on file for all incoming
specimens, including but not limited to:primate subject identification
number, trial site, protocol identification number, specimen collection
date and condition of sample upon arrival.
d) Store cataloged, aliquotted specimens under appropriate conditions
to retain maximum immunological activity.
e) Maintain specimen tracking and inventory system such that specimens
can be traced and located from receipt through processing and assay
analysis.
4. Maintain test result database and transfer data electronically:
a) Compile and maintain a computerized database of all assay and virus
isolation results, using a format compatible with the FOX-PRO data base
that NIAID plans to use to compile records and data from the vaccine
studies. Results are to be recorded with designations of study protocol
number, animal number, specimen collection date, and other information
requested by the Project Officer.
b) Transfer specified data electronically to the AIDS Vaccine
Evaluation Group (AVEG) Statistical and Coordinating Center (SCC) and
to the Project Officer at regular intervals as instructed by the
Project Officer (Format to be agreed upon betwen NIAID and the MAO
Holder).
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c) Ensure protection against the loss of data by the duplication of
data base files and programs for storage; provide for the security and
safety of data on the specimen inventory and the test results database.
5. Provide facilities and resources:
a) Provide facilities and equipment for the work to be conducted,
including a biosafety level 2 or 3 laboratory for conducting work with
live HIV and SHIV as well as samples from infected monkeys.
b) Provide, maintain, and operate facilities for controlled storage of
sera, virus stocks, cell stocks, and other samples and reagents,
including storage at -10 to -20 degrees C, at -70 to - 90 degrees C,
and in liquid nitrogen conditions, with appropriate monitoring of
storage conditions to guarantee continuous proper storage. The
reliability of supply systems, electrical power, and backup support
systems shall be ensured by the MAO Holder.
c) Provide protective garments, equipment and sufficient monitoring to
assure safe handling of potentially hazardous materials, including
radioactive materials. Specifically, the MAO Holder shall comply with
all applicable health and safety regulations while conducting the work
set forth herein.
d) Conduct work under this MAO in accordance with all applicable
Federal, state, and local laws, codes, ordinances and regulations, and
with the following basic references and other related modifications by
the Public Health Service:
(1) Biosafety in Microbiological and Biomedical
Laboratories, U.S. Department of Health and Human
Services, Centers for Disease Control and National
Institutes of Health, HHS Pub. No. (NIH) 93-8395
published by the U.S. Government Printing Office,
third edition, May 1993, stock number 17-040-
00523-7.
(2) Recommendations for Prevention of HIV Transmission in
Health Care Settings, Morbidity and Mortality Weekly
Report, Vol. 36, No. 2-S.
(3) 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.
(4) "Guidelines to Prevent Simian Immunodeficiency Virus
Infection in Laboratory Workers and Animal Handlers,"
Morbidity and Mortality Weekly Report, Vol. 37, No.
45, pp. 693-704.
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6. Designate a project coordinator to manage the day-to-day conduct of the
study, to interact with the Category B MAO laboratory or laboratories providing
non-human primate samples from the vaccine study or studies, and to provide
information on the status of the assay results to the Project Officer.
7. Report data and results to NIAID or to a designated NIAID contractor.
Printouts of data and verbal reports of the status of the study are to be
provided on an ongoing basis during the course of the study at the request of
the Project Officer, in addition to the required periodic (quarterly and final)
written reports describing the progress of the study, and in addition to the
periodic electronic transfer of data described in item (6) above.
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SUMMARY OF VACCINE STUDIES FOR WHICH ASSAYS WILL BE REQUIRED
------------------------------------------------------------
(SECTION A: IMMUNIZATION WITH HIV VACCINES AND CHALLENGE
WITH SHIV)
VACCINE STUDY 4
- ---------------
Title: Testing of Recombinant Poxvirus/HIV Together with Recombinant
Poxvirus/SIV Vaccines in the SHIV Model
Description: Rhesus monkeys will be immunized with recombinant vaccina
expressing HIV-1 env, recombinant vaccina expressing SIV non-envelope genes or
with both; monkeys will be immunized with recombinant fowlpox expressing HIV-1
env, recombinant fowlpox expressing SIV non-envelope genes, or with both.
Immunized monkeys will be boosted with purified HIV-1 env protein and/or with
SIV proteins. Monkeys will be challenged with a SHIV. The experiment is designed
to evaluate the contribution of env versus non-env immune responses in providing
protection from infection and to compare the efficacy of vaccinia-based versus
fowlpox-based vaccines when followed by a protein boost.
Number of monkeys: 48 (8 groups of 6)
Length of study: 18 months
Number of inoculations per animal: 5 immunizations plus 1 virus challenge
Number of bleeds per animal: approximately 40
VACCINE STUDY 13
- ----------------
Title: Immunogenicity of a Soluble Oligomeric Form of the HIV-1 Envelope Protein
Description: Rhesus monkeys will be immunized with a purified oligomeric form of
the HIV-1 envelope protein to determine if monkeys will generate antibodies
(presumably to conformational epitopes of the oligomeric envelope) that are able
to neutralize genetically divergent strains of HIV- 1. Vaccines based on
monomeric forms of the HIV-1 envelope generate predominantly type-specific
antibodies that neutralize a limited range of HIV-1 isolates, but preliminary
studies with the oligomeric form of the envelope indicate that antibodies to it
may be more broadly reactive. Animals will be challenged with SHIV after
immunization to determine the ability of the immune response to the oligomeric
envelope to protect monkeys from infection.
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Number of monkeys: 36 (6 groups of 6)
Length of study: 24 months
Number of inoculations per animal: 5 immunizations plus 1 virus challenge
VACCINE STUDY 16
- ----------------
Title: Evaluation of a Recombinant Semliki Forest Virus/HIV Vaccine
Description: Rhesus monkeys will be immunized with an avirulent recombinant
Semliki Forest virus expressing HIV-1 envelope and SIV gag proteins. The monkeys
will be infected with the virus, which has a broad tissue tropism, by either
intramuscular, intravenous, subcutaneous, or mucosal site administration.
Animals will be challenged with SHIV to determine the efficacy of this vaccine
in protecting from virus infection.
Number of monkeys: 10 (5 groups of 2)
Length of study: 18 months
Number of inoculations per animal: 8 immunizations plus l virus challenge
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