Exhibit 10.24
December 31, 2001
Xx. Xxxxxx X. Xxxxx
GenVec, Inc.
00 Xxxx Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
SUBJECT: LETTER CONTRACT NO. 21XS073A FOR THE PRODUCTION OF ADENOVIRAL
VECTOR-BASED HIV VACCINE CANDIDATES CONSISTENT WITH FDA
REQUIREMENTS SUITABLE FOR SUBSEQUENT PHASE III CLINICAL TRIALS
Dear Mr. Smart:
This Letter Contract No. 21XS073A entered into between SAIC-Xxxxxxxxx, Inc. and
Genvec, Inc., hereinafter referred to as the "Contractor," is to provide for the
initiation of work related to the production of adenoviral vector based HIV
vaccine candidates consistent with FDA requirements suitable for subsequent
Phase III clinical trials in accordance with the enclosed Sections B - J,
incorporated herein. As such, the following clauses and provisions are hereby
incorporated and made part of this letter contract.
1) 52.216-23 EXECUTION AND COMMENCEMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by
signing three copies of the contract and returning them to the
Contracting Officer not later than December 31, 2001. Upon acceptance by
both parties, the Contractor shall proceed with performance of the work,
including purchase of necessary materials.
2) 52.216-24 LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this contract, the Contractor is not authorized
to make expenditures or incur obligations exceeding $*.
(b) The maximum amount for which the Government shall be liable if
this contract is terminated is $*.
(*)=CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS. OMITTED TEXT IS INDICATED BY A "*".
Page 1 of 55
3) CONTRACT DEFINITIZATION
(a) NEGOTIATION OF DEFINITIVE CONTRACT. The parties contemplate
that this letter contract will be superseded on or before
January 28, 2002 by a definitized contract consisting of the
terms and conditions set forth in Sections B through J attached
hereto, except for the "TBD" figures set forth in Articles B.3
(relating to estimated costs of contract performance) and F.2
(relating to the required level of effort), and the definitized
actual dollar amounts to be supplied in Article B.4 (relating to
fee). Based upon GenVec's updated cost proposal and supporting
data submitted on December 28, 2001, the parties agree to
continue to diligently negotiate the estimated costs of contract
performance and the corresponding level of effort. Upon
definitization of the estimated costs of contract performance,
the parties shall convert the agreed-upon fixed base fee
percentages and fixed incentive fee percentages set forth in
Article B.4 of this letter contract to actual dollar amounts and
definitize Article B.4 at those amounts. As part of
definitization, the parties shall also agree on: (i) a
definition of "critical Milestone I activities" as used in
Article B.4; and (ii) authorized travel costs as used in Article
B.5.
(b) SCHEDULE FOR DEFINITIZATION. The parties are currently
negotiating the estimated costs of contract performance and
required level of effort. The target date for definitization of
the contract is January 28, 2002.
(c) TERMINATION OF LETTER CONTRACT. This letter contract shall
terminate upon (i) the execution of a definitized contract; or
(ii) unless sooner extended by mutual agreement of the
parties, at 5:00 p.m. EST on January 28, 2002, whichever
occurs first. In the event of termination under the foregoing
alternative (ii), the termination shall be deemed to be a
termination for convenience pursuant to the termination clause
of this letter contract, FAR 52.249-6, Termination
(Cost-Reimbursement).
4) PAYMENTS OF ALLOWABLE COSTS BEFORE DEFINITIZATION
(a) REIMBURSEMENT RATE. Pending the placing of the definitive
contract referred to in this letter contract, the Government
will promptly reimburse the Contractor for all allowable costs
under this contract at the following rates:
- Direct Costs: * percent of all allowable, and if applicable,
approved costs
- Other Direct Costs: * percent of all allowable, and if
applicable, approved costs
- Indirect Rates as follows:
- Fringe Benefits (FB): *% of Direct Labor Costs (DLC)
- Overhead (OH): *% of the sum of DLC and FB
- G&A: *% of the sum of DLC, FB, and OH
(b) LIMITATION OF REIMBURSEMENT. To determine the amounts payable to
the Contractor under this letter contract, the Contracting
Officer shall determine allowable costs in accordance with the
applicable cost principles in Part 31 of the Federal Acquisition
Page 2 of 55
Regulation (FAR). The total reimbursement made under this
paragraph shall not exceed * percent of the maximum amount of
the Government's liability, as stated in Section 2.B of this
contract.
(c) INVOICING. Payments shall be made promptly to the Contractor
when requested as work progresses, but (except for small
business concerns) not more often than every 2 weeks, in amounts
approved by the Contracting Officer. The Contractor shall submit
to an authorized representative of the Contracting Officer, in
such form an invoice or voucher supported by a statement of the
claimed allowable cost incurred by the Contractor in the
performance of this contract in accordance with Attachment 2
entitled, "INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL
REPORTING INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS,
NIH(RC)-4."
(d) ALLOWABLE COSTS. For the purpose of determining allowable
costs, the term "costs" includes--(1) Those recorded costs that
result, at the time of the request for reimbursement, from
payment by cash, check, or other form of actual payment for
items or services purchased directly for the contract; (2) When
the Contractor is not delinquent in payment of costs of contract
performance in the ordinary course of business, costs incurred,
but not necessarily paid, for- (i) Supplies and services
purchased directly for the contract, provided payments will be
made-- (A) In accordance with the terms and conditions of a
subcontract or invoice; and (B) Ordinarily prior to the
submission of the Contractor's next payment request to the
Government; (ii) Material issued from the Contractor's stores
inventory and placed in the production process for use on the
contract; (iii) Direct labor; (iv) Direct travel; (v) Other
direct in-house costs; and (vi) Properly allocable and allowable
indirect costs as shown on the records maintained by the
Contractor for purposes of obtaining reimbursement under
Government contracts; and (3) The amount of financing payments
that the Contractor has paid by cash, check, or other forms of
payment to subcontractors.
(e) SMALL BUSINESS CONCERNS. A small business concern may receive
more frequent payments than every 2 weeks.
(f) AUDIT. At any time before final payment, the Contracting Officer
may have the Contractor's invoices or vouchers and statements of
costs audited. Any payment may be - (1) Reduced by any amounts
found by the Contracting Officer not to constitute allowable
costs; or (2) Adjusted for overpayments made on preceding
invoices or vouchers.
Page 3 of 55
Upon your acceptance below, this letter constitutes a contract and signifies
mutual agreement.
Sincerely,
SAIC Xxxxxxxxx
Xxxxxx X. Xxxxxxxxx
Manager, Research Contracts
DJD:JBL
--------------------------------------------------------------------------------
Date:
-------------------
Accepted:
------------------------------------------------
By:
------------------------------------------------
(Signature)
Title:
------------------------------------------------
Page 4 of 55
CONTRACT NO.
21XS073A
SPECIAL PROVISIONS
TABLE OF CONTRACT CONTENTS
NOTICE...................................................................................................7
PART I...................................................................................................8
SECTION B - SUPPLIES OR SERVICES AND COST PROVISIONS..................................................8
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES..........................................8
ARTICLE B.2. TYPE OF CONTRACT...................................................................8
ARTICLE B.3. CONTRACT PRICE/COST................................................................8
ARTICLE B.4. FEE................................................................................9
ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS.............................................10
ARTICLE B.6. LIMITATION OF COST................................................................10
ARTICLE B.7. AVAILABILITY OF FUNDS.............................................................11
SECTION C - DESCRIPTION/SPECIFICATION/STATEMENT OF WORK..............................................12
ARTICLE C.1. BACKGROUND........................................................................12
ARTICLE C.2. STATEMENT OF WORK (SOW)...........................................................12
ARTICLE C.3. DELIVERABLES......................................................................22
ARTICLE C.4. ITEMS TO BE FURNISHED TO THE CONTRACTOR...........................................25
SECTION D - PACKAGING AND SHIPMENT...................................................................26
ARTICLE D.1. PACKAGING AND SHIPMENT............................................................26
SECTION E - INSPECTION AND ACCEPTANCE................................................................27
ARTICLE E.1. INSPECTION AND ACCEPTANCE.........................................................27
ARTICLE E.2. cGMP INSPECTION REQUIREMENTS......................................................27
SECTION F - DELIVERIES OR PERFORMANCE................................................................28
ARTICLE F.1. PERIOD OF PERFORMANCE.............................................................28
ARTICLE F.2. LEVEL OF EFFORT...................................................................29
ARTICLE F.3. WORKING FILES.....................................................................29
SECTION G - CONTRACT ADMINISTRATION DATA.............................................................30
ARTICLE G.1. CONTRACT REPRESENTATIVES..........................................................30
ARTICLE G.2. KEY PERSONNEL.....................................................................31
ARTICLE G.3. INVOICE SUBMISSION................................................................31
ARTICLE G.4. INDIRECT COST RATES...............................................................32
ARTICLE G.5. GOVERNMENT PROPERTY...............................................................32
ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE...................................33
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................................................34
ARTICLE H.1. REFERENCES TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES PROJECTS................34
ARTICLE H.2. SAFETY AND BIOSAFETY STANDARDS....................................................34
ARTICLE H.3. HUMAN SUBJECTS....................................................................34
ARTICLE H.4. HUMAN MATERIALS...................................................................34
ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH.................................34
ARTICLE H.6. NEEDLE EXCHANGE...................................................................35
ARTICLE H.7. ANIMAL WELFARE ASSURANCE..........................................................35
ARTICLE H.8. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS...................................35
ARTICLE H.9. PUBLICATIONS AND PUBLICITY........................................................36
ARTICLE H.10.SALARY RATE LIMITATION LEGISLATION PROVISIONS.....................................36
ARTICLE X.00.XXXXX RELEASES....................................................................36
ARTICLE H.12.REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE...............................37
ARTICLE H.13.EPA ENERGY STAR REQUIREMENTS......................................................37
ARTICLE H.14.cGMP COMPLIANCE REQUIREMENTS......................................................37
ARTICLE H.15 BUY AMERICAN ACT - BALANCE OF PAYMENTS PROGRAM CERTIFICATE........................38
ARTICLE H.16.APPLICATION FOR INDEMNIFICATION PURSUANT TO PUBLIC LAW 85-804.....................38
ARTICLE H.17.REQUIREMENT TO PROCURE AND MAINTAIN INSURANCE PURSUANT TO HHSAR 352.228-7,
INSURANCE - LIABILITY TO THIRD PERSONS (DEC 1991)............................................39
ARTICLE H.18.INTELLECTUAL PROPERTY AND DATA RIGHTS.............................................39
ARTICLE H.19.HOLD HARMLESS AND INDEMNITY.......................................................40
ARTICLE H.20.EXCLUSIVE REMEDY FOR DEFAULT......................................................41
PART II.................................................................................................42
SECTION I - CONTRACT CLAUSES.........................................................................42
ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEB 1998)........................42
ARTICLE I.2. ADDITIONAL CLAUSES................................................................43
PART III................................................................................................46
SECTION J LIST OF DOCUMENTS, EXHIBIT AND OTHER ATTACHMENTS..........................................46
ARTICLE J.1. ATTACHMENTS.......................................................................46
TERMS AND CONDITIONS....................................................................................47
NOTICE
Although SAIC Xxxxxxxxx, Inc., the issuer of this Solicitation, is a commercial
organization, it has in the interest of economy, used Government contract
clauses, provisions, and forms throughout this subcontract. Except as otherwise
stated, the following definitions apply throughout this subcontract:
- The terms "Contracting Officer" and "Government" mean "Contractor"
(SAIC Xxxxxxxxx, Inc.) provided; however, the terms "Government"
and "Contracting Officer" shall retain their original meaning in
the herein FAR clauses relating to audit of books and records and
the inspection of research and development and articles related to
intellectual property and data.
- The term "Contractor" means "Subcontractor" (GenVec, Inc.) and the
term "Contract" means "Subcontract".
These above conditions also apply to the usage of these words as they appear
through the SPECIAL PROVISIONS and all other terms and conditions applicable to
this Solicitation.
PART I
SECTION B - SUPPLIES OR SERVICES AND COST PROVISIONS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
Independently, and not as an agent of SAIC Xxxxxxxxx/NCI, the Contractor shall
use its best efforts, within the level of effort specified in this Contract for
the base period and each option period that may be exercised, to furnish
services, qualified personnel, materials, equipment, and facilities (other than
materials, equipment and facilities to be provided by SAIC Xxxxxxxxx/NCI under
the terms of this Contract) as needed to perform the work specified in the
Statement of Work (SOW) set forth in Section C below. In particular, the
Contractor shall use its best efforts to produce adenoviral vectors
(Adenovectors) containing HIV-1 genes supplied by the NIH for the use in HIV
vaccine clinical trials. The Contractor shall also use its best efforts to
provide a packaging cell line appropriate for adenovectors that are designed to
exclude the possibility of producing replication competent adenovirus (RCA). The
Contractor shall also use its best efforts to produce cell banks of the
packaging cell line and viral constructs; manufacture lots to support toxicology
testing; and produce lots for Phase I clinical manufacturing under current Good
Manufacturing Practices (cGMPs). The packaging cell line and the viral vectors
used must be compliant with cGMPs and regulatory guidance and suitable for
proceeding to Phase II-III trials, as well as ultimate product manufacture
licensure. Finally, the Contractor shall also use its best efforts to develop
production methods amenable to large-scale cGMP production and to provide any
other supplies or services specified in the SOW. It is understood by both
parties that the HIV-1 genes supplied have not been fully evaluated for their
suitability for insertion into Adenovectors, and if they can be inserted, that
the resulting adenovectors can be produced in a manner and scale suitable for
clinical testing. The Contractor will provide best efforts to manufacture these
vectors and will notify the Government at such time that it deems the project
can not yield the deliverables identified in Section C and will schedule a
meeting with the Project Officer and Contracting Officer to explain why the
project can not yield the required deliverables.
ARTICLE B.2. TYPE OF CONTRACT
A. The contract shall be a Cost Plus Fixed Fee (CPFF), Level of Effort (XXX)
contract.
ARTICLE B.3. CONTRACT PRICE/COST
A. To be determined in accordance with Paragraph 3., "Contract
Definitization," of Letter Contract 21XS073A.
B. The total cost of this Contract, including the base period and two option
years, is $ [TBD].
C. The total costs applicable to the base period and each option period is as
follows:
Period Period Covered Total Cost
-------------- ----------------- ------------
Base Period 12 months from date of contract award $ [TBD]
----------
Option Year 1 Subsequent 12 months $ [TBD]
----------
Option Year 2 Subsequent 12 months $ [TBD]
----------
ARTICLE B.4. FEE
A. To be determined in accordance with Paragraph 3, "Contract
Definitization," of Letter Contract 21XS073A. The stated percentages
shall be converted upon definitization to absolute dollar amounts based
on the estimated costs for Milestones I, II, and III.
B. FIXED FEE.
(1) For work pertaining to the milestones listed below, the Government
shall pay the Contractor a fixed fee as follows:
Milestone Fee
------------------ ----------------
I $ [*% OF MILESTONE I COSTS]
-----------------------------
II $ [*% OF MILESTONE II COSTS]
------------------------------
III $ [*% OF MILESTONE III COSTS]
-------------------------------
(2) The Contractor earns and may invoice for, and the Government
shall pay, the base fee for each period on a pro rata basis
throughout that period.
C. Incentive Fee.
(1) In addition to the base fee, the Government shall pay the
Contractor an incentive fee for early completion of critical
Milestone I activities, which shall be defined during contract
definitization. The amount of incentive fee shall be
determined based upon the actual date of successful
completion, as follows:
Completion Date Incentive Fee
------------------ ------------------
Contract Award + * $ [*% OF MILESTONE I COSTS]
------------------------------
Contract Award + * $ [*% OF MILESTONE I COSTS]
-----------------------------
Contract Award + * $ [*% OF MILESTONE I COSTS]
-----------------------------
Contract Award + * $ [*% OF MILESTONE I COSTS]
-----------------------------
(2) The Contractor may invoice for, and the Government shall pay,
the appropriate
specified incentive fee consistent with Paragraph C.1. at any time
following successful completion of the critical Milestone I
activities within one of the designated time periods.
(3) The Government is not obligated to *.
ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS
A. Items Unallowable Unless Otherwise Provided
Notwithstanding the clause(s), ALLOWABLE COST AND PAYMENT, 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 whether at domestic or
foreign locations;
(5) Consultant expenses;
(6) Subcontracts.
B. Travel Costs
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct
performance of this Contract shall not exceed $ TBD without prior
written approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed for all travel
costs in accordance with FAR Subpart 31.205-46.
ARTICLE B.6. LIMITATION OF COST
This Contract incorporates the Federal Acquisition Regulation Clause 52.232-20,
"Limitation of Cost (Apr 1984)" by reference, with the same force and effect as
if it were given in full text. The
full text of this clause is available at xxxx://xxx.xxxxx.xxx/xxx. Upon request,
the Contracting Officer will make the full text available.
ARTICLE B.7. AVAILABILITY OF FUNDS
52.232-19 Availability of Funds for the Next Fiscal Year (April 1984)
Funds are not presently available for performance under this contract beyond
twelve months after contract award. The Government's obligation for performance
of this contract beyond that date is contingent upon the availability of
appropriated funds from which payment for contract purposes can be made. No
legal liability on the part of the Government for any payment may arise for
performance under this contract beyond twelve months after contract award until
funds are made available to the Contracting Officer for performance and until
the Contractor receives notice of availability, to be confirmed in writing by
the Contracting Officer.
SECTION C - DESCRIPTION/SPECIFICATION/STATEMENT OF WORK
ARTICLE C.1. BACKGROUND
There are four main pieces of work:
1. PROVISION OF A PACKAGING CELL LINE FOR ADENOVIRAL VECTORS
2. ADENOVIRAL VECTOR CONSTRUCTION
3. cGMP PRODUCTION AND TESTING OF THESE MATERIALS
4. DEVELOPMENT OF SCALABLE MANUFACTURING PROCESSES AND TESTING METHODS
These four main pieces of work are expanded in the Statement of Work (SOW) below
into three detailed Milestones, which together constitute the entire
requirement. The three Milestones, each representing the critical phases, are
listed in the approximate chronological order in which they are to be initiated.
ARTICLE C.2. STATEMENT OF WORK (SOW)
MILESTONE NUMBER 1 - PRODUCTION OF SIX (6) ADENOVIRAL VECTORS FOR PRE-CLINICAL
TOXICOLOGY TESTING AND CLINICAL SEED STOCK ESTABLISHMENT
A. 1. Produce Specific Vaccine Products as Directed by the COTR
Produce, scale-up, characterize and formulate specific vaccine
products as directed by the COTR. Develop and produce SIX LOTS
OF AT LEAST 1 x 10(13) PARTICLES OF ADENOVIRAL VECTORS
CONTAINING SIX SEPARATE HIV-1 GENES IN A SUITABLE PACKAGING
CELL LINE WITH APPROPRIATE PURITY FOR PRE-CLINICAL TOXICOLOGY
TESTING. These lots will be used in the support of production
of material suitable for Phase I clinical testing. SAIC
Xxxxxxxxx will maintain Quality oversight and conduct audits
of all operations associated with this project.
TASK I: Construct adenoviral vectors and verify that sequences
are correct using genes provided by the Vaccine Research
Center (VRC), National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes Health (NIH). This will
include insertion of HIV-1 genes into shuttle plasmids,
conversion of plasmids to adenovectors, expansion of vector
seed stocks, and certification of vectors to ensure sequences
are correct.
TASK II: Produce six (6) lots of Adenovectors using a
qualified packaging cell line consisting of at least 1 x
10/13/ particles per lot. The Contractor will use clinical
seed lots which are acceptable for production of clinical
trial material.
TASK III: Perform preclinical toxicology testing on each
production lot bulk harvest. The tests will include, but are
not limited to the following:
(1) Sterility testing on cell harvest (as per 21
CFR 610.12)
(2) Cultivatable and non-cultivatable mycoplasma
assay (as per FDA PTC, 1993)
(3) IN VITRO assay for adventitious viral
contaminants
(4) Bovine viral assay in cell lysates
(5) Porcine parvovirus detection in cell lysates
(6) RT-PCR assay for Hepatitis C
(7) Replication competent adenoviruses (RCA) using
A549 cells
(8) The following PCR-based assays for the
detection of:
a. Adeno-Associated viruses
b. B-19 parvovirus
c. HIV-1 and 2
d. HTLV-I/II
e. Hepatitis B
f. CMV
g. EBV
The above listed tests may be modified during the
duration of this Contract based on regulatory
developments within the adenoviral vector vaccine
field. Any changes to the above tests must be
approved by the SAIC Xxxxxxxxx COTR.
The following guidelines shall apply to the production of the
lots for toxicology testing:
a) Where applicable, obtain starting materials
from product inventory/supplier. Complete a
material transfer agreement and confidentiality
agreement, if needed.
b) Develop detailed production plan, timeline and
budget for manufacture of lots of candidate
vaccine products.
c) Where applicable, purchase or otherwise
acquire, products and materials necessary
for production of stated vaccine product.
Ensure all raw materials and reagents
conform to the FDA's current requirements on
TSE risk and, where possible, remove all
materials of animal origin from processes.
d) Scale-up production to required capacity.
e) Produce vaccine product in a form suitable
for use in pre-clinical toxicology testing
(including characterization, formulation,
vialing, labeling, packaging and storage).
These products shall be prepared under
appropriate quality conditions and provide no
possibility of replication competent
adenoviral particles due to homologous
recombination.
f) Maintain an inventory of test and pilot lots
of vaccine products that have been produced.
Periodically, as required by the COTR,
examine titer or potency of vaccine
products.
g) Ship the manufactured, packaged, and labeled
dosage forms utilizing shipping procedures
and materials to maximize product stability.
h) 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.
i) Where applicable and as directed by the
COTR, produce reagents necessary for the
testing or evaluation of immune responses to
the vaccine product.
[NOTE #1. THE SIX HIV-1 GENES WILL BE PROVIDED BY THE VACCINE RESEARCH CENTER,
NIH. THE INSERTS ARE GENES FOR HIV PROTEINS. THE MATERIAL DOES NOT CONTAIN
ENOUGH OF THE VIRAL GENOME TO CAUSE INFECTION. THE GOVERNMENT WILL SUPPLY THE
DNA SEQUENCE AND APPROXIMATELY 1 MCG OF THE DNA PLASMID.]
2. Provide Facilities, Equipment and Resources
a) Provide and/or contract facilities and equipment
suitable for pre-clinical production of vaccine
product.
b) Manage the receipt, storage and manipulation of
biohazardous materials and maintain their viability
in facilities that provide aseptic and/or sterile
conditions as appropriate (as per Center for Disease
Control(CDC)/NIH Biosafety in Microbiological and
Biomedical Laboratories, U.S. Department of Health
and Human Services.)
c) Contract and/or maintain and operate controlled
storage of samples at appropriate temperatures with
appropriate monitoring for failure (controlled room
temperature through -90(DEG.)C, liquid nitrogen
storage may be required for some products).
d) Contract and/or 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.
3. Perform Vaccine Lot Characterization Tests
TASK IV: The following tests will be performed on the final
product:
At various steps during the manufacture of a vaccine, the
product must be characterized. Prior to the use of a vaccine
in pre-clinical studies that will support 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.
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 affect 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 viral vaccines constructs,
potency may be evidenced by the production of the
pertinent antigen in a transfected cell line. This
test will be developed and performed in conjunction
with the VRC/NIAID/NIH.
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. In addition, bacteriostasis/fungistasis
testing will also be performed.
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.
e) Test for Identity. The test for identity (21 CFR
610.14) 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. Develop and validate procedures as
needed.
4. Perform Stability Testing
Initiate and maintain appropriate stability tests that are required for
further development of product to clinical trials. Maintain stability
program as directed by the Contracting Officer's Technical
Representative, SAIC Xxxxxxxxx. Stability studies will be continued per
FDA discussion between the contractor, VRC/NIAID/NIH and SAIC
Xxxxxxxxx.
5. Deliverables
a) Six (6) pre-clinical lots composed of separate HIV-1
genes containing a
total of at least 1.0 x 10(13) particles per lot.
Material packaging/labeling for pre-clinical
toxicology testing will be specified by the SAIC
Xxxxxxxxx COTR.
b) Contractor will provide the requisite documentation
of the pre-clinical production, a review of the Batch
Production Records, along with the results of all
bulk and final product release tests, to the SAIC
Xxxxxxxxx COTR.
MILESTONE NUMBER 2 - EXPEDITIOUS PHASE I PRODUCTION OF ADENOVIRAL VECTORS
C. 1. Produce Specific Vaccine Products as Directed by the COTR
Produce, scale-up, characterize and formulate specific vaccine
products as directed by the COTR. Develop and produce SIX (6)
LOTS OF AT LEAST 1 x 10(13) PARTICLES OF CLINICAL GRADE (cGMP)
ADENOVIRAL VECTORS CONTAINING SIX SEPARATE HIV-1 GENES in a
suitable packaging cell line with appropriate purity for
clinical human vaccine trials. SAIC Xxxxxxxxx will maintain
Quality oversight and conduct audits of all operations
associated with this project.
TASK I: Production of six (6) lots of at least 1 x 10(13)
particles of clinical grade (cGMP) adenoviral vectors. The
bulk cell harvests will be tested for use in clinical trials.
These tests will include, but are not limited to the
following:
(1) Sterility testing on cell harvest (as per 21
CFR 610.12)
(2) Cultivatable and non-cultivatable
mycoplasma assay (as per FDA PTC, 1993)
(3) IN VITRO assay for adventitious viral
contaminants
(4) Bovine viral assay in cell lysates
(5) Porcine parvovirus detection in cell lysates
(6) RT-PCR assay for Hepatitis C
(7) Replication competent adenoviruses
RCA) using A549 cells
(8) The following PCR-based assays for the
detection of:
a. Adeno-Associated viruses
b. B-19 parvovirus
c. HIV-1 and 2
d. HTLV-I/II
e. Hepatitis B
f. CMV
g. EBV
The above listed tests may be modified during the
duration of this contract based on regulatory
developments within the adenoviral vector vaccine
field. Any changes to the above tests will be
forwarded to the SAIC Xxxxxxxxx Contracting Officer's
Technical Representative.
The following guidelines shall apply to the production of the
lots for Phase I Clinical Lot testing:
a) Where applicable, obtain starting
materials from product inventory/supplier.
Complete a material transfer agreement and
confidentiality agreement, if needed.
b) Where applicable, purchase or otherwise
acquire, products and materials necessary
for production of stated vaccine product.
Ensure all raw materials and reagents
conform to current requirements by FDA on
TSE risk and, where possible, remove all
materials of animal origin from processes.
c) Scale-up production to required capacity.
d) Produce vaccine product in a form suitable
for use in human clinical studies (including
characterization, formulation, vialing,
labeling, packaging and storage). These
products shall be prepared under cGMP
conditions and provide no possibility of
replication competent adenoviral particles
due to homologous recombination.
e) Maintain an inventory of test and pilot lots
of vaccine products that have been produced.
Periodically, as required by the technical
officer, examine titer or potency of vaccine
products.
f) Ship the manufactured, packaged, and labeled
dosage forms utilizing shipping procedures
and materials to maximize product stability.
g) 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.
h) Where applicable and as directed by the
COTR, produce reagents necessary for the
testing or evaluation of immune responses to
the vaccine product.
2. Provide Facilities, Equipment and Resources
The following shall apply to the production of the cGMP lots
for clinical trials:
a) Provide and/or contract facilities and equipment
suitable for cGMP production of vaccine product.
b) Manage the receipt, storage and manipulation of
biohazardous materials and maintain their viability
in facilities that provide aseptic and/or sterile
conditions as appropriate (as per CDC (Center for
Disease Control)/NIH Biosafety in Microbiological and
Biomedical Laboratories, U.S. Department of Health
and Human Services.)
c) Contract and/or maintain and operate controlled
storage of samples at appropriate temperatures with
appropriate monitoring for failure (controlled room
temperature through -90(DEG.)C, liquid nitrogen
storage may be required for some products).
d) Contract and/or 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.
3. Perform Vaccine Lot Characterization Tests
At various steps during the manufacture of a vaccine, the
product must be characterized. Prior to the 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.
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 affect 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 viral vaccines constructs,
potency may be evidenced by the production of the
pertinent antigen in a transfected cell line. This
test will be developed and performed in conjunction
with the VRC/NIAID/NIH.
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. In additional, bacteriostasis/
fungistasis testing will also be performed.
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.
e) Test for Identity. The test for identity (21 CFR
610.14) 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. Develop and validate procedures as
needed.
4. Perform Stability Testing
Initiate and maintain appropriate stability tests that are
required for further development of product to clinical
trials. Maintain a stability program as directed by the
Contracting Officer's Technical Representative, SAIC
Xxxxxxxxx. Stability studies will be continued per FDA
discussion between contractor, VRC/NIAID/NIH and SAIC
Xxxxxxxxx.
5. Deliverables
a) Six (6) Phase I clinical lots composed of separate
HIV-1 genes containing a total of at least 1.0 x
10(13) particles per lot. Material packaging/labeling
for clinical trial use will be specified by the SAIC
Xxxxxxxxx COTR.
b) Contractor will provide the requisite documentation
of the cGMP clinical production, a review of the
Batch Production Records, along with the results of
all bulk and final product release tests, to the SAIC
Xxxxxxxxx COTR.
MILESTONE NUMBER 3 - DEVELOPMENT OF SCALEABLE MANUFACTURING PROCESSES AND
TEST METHODS FOR TWO (2) HIV-1 ADENOVECTORS
D. 1. Produce Specific Vaccine Products as Directed by the COTR
Develop scaleable production techniques and analytical methods
suitable for Phase I production of adenoviral vectors as
directed by the COTR. Develop scaleable production techniques
and analytical methods that will support production of AT
LEAST 1 x 10(13) PARTICLES OF CLINICAL GRADE (CGMP) ADENOVIRAL
VECTORS CONTAINING TWO SEPARATE HIV-1 GENES IN A SUITABLE
PACKAGING CELL LINE. These developed processes and analytical
techniques must be approvable by regulatory authorities,
including adherence to the highest known standards for
adenovector vaccine products. SAIC Xxxxxxxxx will maintain
Quality oversight and conduct audits of all operations
associated with this project.
TASK I: Development of scaleable production
techniques and analytical methods suitable for Phase
I production of adenovectors containing two (2)
different HIV-1 genes that will support future
production of at least 1 x 10(13) particles of
clinical grade (cGMP) adenoviral vectors. Develop
appropriate virus banks from clinical seed stock
material and provide an appropriate packaging cell
line to support development.
The following guidelines shall apply to the development of a
manufacturing process for the production Ad vectors for
clinical lot testing:
a) Processes will be developed utilizing
industrially scaleable technology. This
technology should include production of
adenoviral vectors in bioreactors using animal
derived component-free media, column
chromatography/ ultrafiltration, or equivalent
purification techniques. Alternative
manufacturing systems may be used pending
approval by COTR.
b) Where applicable, obtain starting materials
from product inventory/supplier. Complete a
material transfer agreement and confidentiality
agreement, if needed.
c) Where applicable, purchase or otherwise
acquire, products and materials necessary
for production of stated vaccine product.
Ensure all raw materials and reagents
conform to current requirements by FDA on
TSE risk, where possible, remove all
materials of animal origin from processes.
d) Develop processes for production in a form
suitable for use in human clinical studies
(including characterization, formulation,
vialing, labeling, packaging and storage).
The products shall provide no possibility of
replication competent adenoviral particles
due to homologous recombination.
e) Maintain an inventory of test and pilot lots
of vaccine products that have been produced.
Periodically, as required by the technical
officer, examine titer or potency of vaccine
products.
f) Ship the manufactured, packaged, and labeled
dosage forms utilizing shipping procedures
and materials to maximize product stability.
g) 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.
h) Where applicable and as directed by the
COTR, produce reagents necessary for the
testing or evaluation of immune responses to
the vaccine product.
2. Perform Vaccine Lot Characterization Tests
At various steps during the manufacture of a vaccine, the
product must be characterized to determine the performance of
the manufacturing process. Appropriate tests should be
conducted to support eventual clinical manufacturing of Ad
vectors.
3. Perform Stability Testing
Initiate and maintain appropriate stability tests that are
required for further development of product to clinical
trials. Maintain a stability program as directed
by the COTR. Stability studies will be continued per FDA
discussion between contractor, VRC/NIAID/NIH and SAIC
Xxxxxxxxx.
[NOTE #2: STABILITY TESTING WILL BE REQUIRED AT VARIOUS POINTS DURING THE
PRODUCTION PROCESS. THERE IS NO SINGLE STABILITY-INDICATING ASSAY OR PARAMETER
FOR ALL BIOLOGICAL PRODUCTS. THEREFORE, MANUFACTURERS SHOULD PROPOSE ON A
CASE-BY-CASE BASIS STABILITY-INDICATING PROFILES FOR THEIR PRODUCTS WHICH
PROVIDE ASSURANCE THAT CHANGES IN IDENTITY, PURITY AND POTENCY OF THE PRODUCT
WILL BE DETECTED.]
ARTICLE C.3. DELIVERABLES
A. Deliverables
1. The Contractor shall provide the following deliverables for
Milestone 1:
a) Six (6) pre-clinical lots composed of separate HIV-1
genes containing a total of at least 1.0 x 10/13/
particles per lot. Material packaging/labeling for
pre-clinical toxicology testing will be specified by
the COTR.
b) The requisite documentation of the pre-clinical
production, a review of the Batch Production Records,
along with the results of all bulk and final product
release tests, to the COTR.
2. The Contractor shall provide the following deliverables for
Milestone 2
a) Six (6) Phase I clinical lots composed of separate
HIV-1 genes containing a total of at least 1.0 x
10(13) particles per lot. Material packaging/labeling
for clinical trial use will be specified by the COTR.
b) The requisite documentation of the cGMP clinical
production, a review of the Batch Production Records,
along with the results of all bulk and final product
release tests, to the COTR.
3. The Contractor shall provide the following deliverables for
Milestone 3
a) A scaleable manufacturing process for two (2) Phase I
clinical lots composed of separate HIV-1 genes
containing a total of at least 1.0 x 1013 particles
per lot. Material packaging/labeling for clinical
trial use will be specified by the COTR.
b) The requisite documentation of the cGMP clinical
production, a review of the Batch Production Records,
along with the results of all bulk and final product
release tests, to the COTR.
B. Other Deliverables
1. Monthly status reports
The Principal Investigator (PI) shall provide written status
reports on a monthly basis to the COTR. The updates may be
transmitted by email, FAX, or by traditional mail. The monthly
updates shall include a summary of results for each milestone,
a detailed risk assessment, and an update on the probability
that the Contractor can complete the tasks and provide the
specified deliverables within the proposed level of effort by
the target completion dates.
2. Documentation related to manufacturing processes
All Standard Operating Procedure's (SOPs) and manufacturing
documents shall be available to the VRC and SAIC Xxxxxxxxx for
review at Contractor's facilities upon request to the
Contractor.
3. Participation in discussions with the FDA during pre-IND and
IND Meetings, a completed CMC section, and all documents
related to IND submission as necessary for the successful
filing of the IND
a) Provide all data, information and records required
for the writing and submission of the Master File,
Investigator's Brochure, and all other documents
related in IND submission to the COTR or to a
designated third party. Provide information
pertaining to the composition manufacture, and
quality control of the vaccine product as appropriate
for particular investigations to be covered by an
IND.
b) Provide for an orderly transition of data, specimens
and products to any successor Contractor or to the
Government, subject to COTR direction, within six (6)
months of the end of the contract. The Contractor
shall deliver, as requested by the COTR and by the
completion date of the Contract, the following items:
original data, reagents, stored specimens (and any
necessary information related thereto), and any
Government-owned equipment and property. The
transition does not include training of the
Government or a successor Contractor.
c) Retain and have available all records, samples, etc.
as indicated under cGMP guidelines.
[NOTE #3: THIS MAY INCLUDE INFORMATION CONTAINED IN MASTER PRODUCTION AND
CONTROL RECORDS, BATCH PRODUCTION AND CONTROL RECORDS, STANDARD OPERATING
PROCEDURES (SOP) AND LABORATORY RECORDS. THIS INFORMATION WILL BE REQUESTED WHEN
REQUIRED BY THE FDA AND SHOULD BE SUBMITTED WITHIN THREE (3) WEEKS FROM THE TIME
THE COTR MAKES THE REQUEST.]
C. Reports
In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following report in the manner stated
below:
1. Final Technical Progress Report
The Contractor shall submit seven (7) copies of the Final
Report to the addresses noted below, which shall summarize the
results of the entire contract work for the complete
performance period. This report will be comprehensive detail
to explain the results achieved and shall be submitted on or
before the last day of the contract period.
The Final Report shall contain:
i. Title page to include the following
information:
1. Contract number and title
2. Period of performance being reported
3. Contractor's name and address
4. Date of submission
ii. Introduction describing the purpose and scope
of the contract effort.
iii. Description of the overall progress during the
entire contract tenure. Descriptions will
include pertinent data to present significant
results achieved and a scientific evaluation of
the data accrued under the contract.
2. Summary of Results
The Contractor shall submit, with the final report, a summary
(not to exceed 200 words) of the results achieved during the
performance of the contract.
Copies of all reports shall be submitted to the following
addresses:
Xx. Xxxx X. Xxxxxx, Contracting Officers Technical
Representative
Vaccine Development Program
SAIC Xxxxxxxxx, Inc.
NCI-Xxxxxxxxx
00 Xxxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Xx. Xxxxxx Xxxxx, NIAID Project Manager
Vaccine Research Center
NIAID/NIH
Building 40, Room 5502
Xxxxxxxx, XX 00000
Mr. Xxxxxx Xxxxxxxxx, Contracting Officer
SAIC Xxxxxxxxx, Inc.
XXX-Xxxxxxxxx, Xxxx 000
X.X. Xxx X
Xxxxxxxxx, XX 00000-0000
D. Meetings
SAIC Xxxxxxxxx and the VRC will require periodic meetings with the Contractor.
In the event that Contractor's facilities are not within close proximity to the
NIH and SAIC Xxxxxxxxx, meetings shall be conducted via
telephone/teleconference. It is anticipated that meetings with the Contractor
shall occur as needed, but not less than monthly to keep SAIC Frederick and the
VRC informed regarding the progress on specific projects/task objectives.
ARTICLE C.4. ITEMS TO BE FURNISHED TO THE CONTRACTOR
All biological materials provided by the SAIC Frederick/NCI shall be used for
this project only and shall not be used subsequently by the Contractor for any
for-profit or not-for-profit venture without explicit written permission of the
SAIC Frederick/NCI. Any unused materials provided shall be returned to the SAIC
Xxxxxxxxx/NCI no later than at the conclusion of the contract.
SECTION D - PACKAGING AND SHIPMENT
ARTICLE D.1. PACKAGING AND SHIPMENT
A. Any deliverables, required under this contract, shall be packaged,
marked, and shipped in accordance with all applicable Federal, State,
and Local specifications, or as specified herein. The contractor shall
guarantee that all required materials be delivered in immediate usable
and acceptable condition.
B. The Contractor shall make arrangements to expeditiously pick up or ship
out biological reagents and cell lines from the airport or other
specified sites, following procedures and policies as designated by the
COTR. The COTR will address final product packaging, labeling, or
biohazard concerns with the Contractor as necessary. It is essential
that personnel be available to receive incoming shipments at any given
time, and to arrange for their immediate and appropriate storage, in
order to avoid the loss of important biological material. It is
expected that there will be approximately 50 incoming and 50 outgoing
shipments in any year.
SECTION E - INSPECTION AND ACCEPTANCE
ARTICLE E.1. INSPECTION AND ACCEPTANCE
A. The Contracting Officer or a duly authorized representative will
perform evaluation of the research services and acceptance of
deliverables provided.
B. 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 of a clause may be
accessed electronically at xxxx://xxx.xxxxx.xxx/xxx/.
FEDERAL ACQUISTION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
FAR Clause No. Clause Title Date
-------------- ------------ ----
52.246-9 Inspection of Research and Development - (Short Form) Apr-1984
ARTICLE E.2. cGMP INSPECTION REQUIREMENTS
The contractor shall have established procedures for regularly assessing a
contract manufacturing facility's compliance with the applicable product and
establishment standards. This may include, but is not limited to, review of all
batch records and manufacturing deviations and defects, and periodic audits.
Contract facilities engaged in the manufacture of a biological product are
responsible for compliance with applicable provisions of the FD&C Act and will
be subject to FDA inspection as provided for in section 351(c) of the PHS Act
and section 704(a) of the FD&C Act. The contractor shall ensure that all owned
and contract facilities are ready for inspection by SAIC and Government staff.
The contractor shall provide written documentation to the SAIC Technical Project
Officer and Sponsor of any FDA citation of a deviation from cGMP to allow
evaluation of its impact on the purity, potency, and safety of the product.
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
A. The initial period of performance of this CPFF, XXX contract shall be
for twelve (12) months from the date of contract award. The Contracting
Officer may extend the period of performance by exercising one or both
of the two priced twelve (12) months option years in accordance with
paragraph B below.
B. Execution of option years will be based upon actual Contractor
performance.
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 1989)
The Government may extend the term of this contract by written notice
to the Contractor within thirty (30) days provided, that the Government
shall give the Contractor a preliminary written notice of its intent to
extend at least sixty (60) days before the contract expires. The
preliminary notice does not commit the Government to an extension.
If the Government exercises this option, the extended contract shall be
considered to include this option provision.
The total duration of this contract, including the exercise of any
options under this clause, shall not exceed 36 months.
C. If SAIC Xxxxxxxxx exercises its option (s) pursuant to Article F.1,
paragraph B, the period of performance will be increased as listed
below:
OPTION YEAR NUMBER PERIOD OF PERFORMANCE
Option 1: Twelve (12) months
Option 2: Twelve (12) months
ARTICLE F.2. LEVEL OF EFFORT
A. In accomplishing the work set forth herein, the Contractor shall
provide ______ hours direct labor effort during the periods set forth
below. The labor effort EXCLUDES vacation, sick leave, and holidays.
These labor HOURS EXCLUDE subcontractor labor HOURS. It is estimated
that the labor hours will be expended approximately as follows:
PERIOD OF PERFORMANCE LABOR CATEGORY DIRECT LABOR HOURS
Base Period
XXX XXX
XXX XXX
Option Year 1
XXX XXX
XXX XXX
Option Year 2
XXX XXX
XXX XXX
B. The Contractor shall have satisfied the requirement herein if furnishes
not less than 90% nor more than 110% of the total direct labor hours
specified herein are furnished.
ARTICLE F.3. WORKING FILES
The Contractor shall maintain accurate working files of all work documentation
including calculations, assumptions, interpretations of technical regulations,
sources of information, and other raw data required in the performance of this
Contract. The Contractor shall provide access to the information contained in
its working files upon request of the SAIC Contracting Officer.
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACT REPRESENTATIVES
A. The following individual is designated as SAIC Frederick's Contracting
Officer and is the only person with the authority to act as an agent of
SAIC Xxxxxxxxx, Inc. 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 for
any costs incurred during the performance of this contract; or (5)
otherwise change any terms and conditions of this contract.
Mr. Xxxxxx Xxxxxxxxx, Contracting Officer
SAIC Xxxxxxxxx
NCI-Frederick
X.X. Xxx X, Xxxxxxxx 000
Xxxxxxxxx, XX 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
E-mail: xxxxxxxxxx@xxxx.xxxxxxx.xxx
B. The following individual is designated as SAIC Frederick's Contracting
Officer's Technical Representative (COTR) and is authorized to provide
technical guidance and 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.
Xx. Xxxx X. Xxxxxx, Contracting Officer's Technical
Representative
Vaccine Development Facility
SAIC Xxxxxxxxx
NCI-Frederick
XX Xxx X, Xxxxxxxx 000
Xxxxxxxxx, XX 00000-0000
Phone: 000-000-0000
Fax: 000-000-0000
E-mail: xxxxxxx@xxxxxxx.xxx
C. The following individual is designated as the Vaccine Research Center
(VRC) Project Manager (PM) and is authorized to provide technical
guidance:
Xx. Xxxxxxx Xxxxx
Vaccine Research Center
NIAID/NIH
Building 40, Room 5502
Xxxxxxxx, XX 00000
Phone: 000.000.0000
Fax: 000.000.0000
Email: xxxxxx@xxxx.xxx.xxx
D. The following individual has been designated as SAIC Frederick's
Contract Specialist for purposes of administering, processing and
handling contractual documentation:
Xx. Xxxx XxXxxxxx
SAIC Xxxxxxxxx
NCI Xxxxxxxxx
X.X. Xxx X, Xxxxxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000--0000
Phone: 000-000-0000
Fax: 000-000-0000
E-mail: xxxxxxxxx@xxxxxxx.xxx
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
TBD
ARTICLE G.3. INVOICE SUBMISSION
A. Invoices shall be prepared and submitted as follows:
An original and one (1) copy to the following designated payment
office:
ATTN: NCI-Xxxxxxxxx
SAIC Frederick Inc.
Accounts Xxxxxxx Xxxxxxxxxx
X.X.Xxx X, Xxxxxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000-0000
B. Inquiries regarding payment of invoices should be directed to the
attention of Xxxxxx X. Xxxxxxxxx, Manager, Contracts, at (301)
846-1087.
C. An invoice is a written request for payment under the contract for
items delivered or services rendered. In order to be proper, an
invoice must include, as applicable, the following:
(1) Invoice date (note: date of Contractor's invoice shall not be
earlier than delivery/service date
(2) Contractor name
(3) Contract number (including delivery order number, if
applicable)
(4) Description of items or services, quantity, contract unit of
measure, contract unit price, and extended total
(5) Payment terms and any trade discounts or allowances
(6) Name and address to which payment is to be sent; and
(7) Name, title, phone number, and mailing address of person to be
notified in eventof a defective invoice
D. SAIC Xxxxxxxxx shall pay the Contractor, upon the submission of proper
invoices or vouchers, the prices stipulated in this contract for
services rendered and accepted, less any deductions provided in this
contract.
E. A proper invoice will be deemed to have been received, when it is
received by the office designated in the contract, or delivery order
issued hereunder, for receipts of invoices and acceptance of the items
delivered or services rendered has occurred.
F. Payment shall be considered made on the date on which a check for such
payment is dated. If the Contractor opts to receive electronic funds
transfer (EFT), payment shall be considered made on the date of the
transfer.
ARTICLE G.4. INDIRECT COST RATES
In accordance with FAR Clause No. 52.216-7, "Allowable Cost and Payment", which
is incorporated into the contract, indirect cost rates reimbursable hereunder
shall be consistent with those established by the cognizant Federal Audit
Agency, if any, for your organization, as may be amended. Final approval will be
determined by the Contracting Officer.
ARTICLE G.5. GOVERNMENT PROPERTY
No non-expendable property or equipment will be acquired or furnished under this
contract, unless prior written authorization is obtained from the Contracting
Officer.
ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
Final evaluation of contractor performance will be prepared on this contract in
accordance with FAR 42.15. The final performance evaluation will be prepared at
the time of completion of work.
Final evaluations will be provided to the Contractor as soon as practicable
after completion of the evaluation. The Contractor will be permitted thirty days
to review the document and to submit additional information or a rebutting
statement.
Any disagreement between the parties regarding an evaluation will be referred to
an individual one level above the Contracting Officer, whose decision will be
final. Copies of the evaluation, contractor responses, and review comments, if
any, will be retained as part of the contract file, and may be used to support
future award decisions.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. REFERENCES TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES PROJECTS
All references to the Secretary, Department of Health, Education and Welfare,
HEW, HEWPR, HEW forms, etc., shall be changed to Secretary, Department of Health
and Human Services, HHS, HHSAR, etc., as appropriate.
ARTICLE H.2. SAFETY AND BIOSAFETY STANDARDS
All work performed under this contract shall be conducted in accordance with the
Publication entitled, "Biosafety in Microbiological and Biomedical Laboratories"
(HHS Publication No. (DCD) 84-8395).
ARTICLE H.3. HUMAN SUBJECTS
Research involving human subjects shall not be conducted under this contract.
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
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.
Public Law and Section No. Fiscal Year Period Covered
P.L. 106-554, Section 510 2001 (10/1/00 - 9/30/01)
ARTICLE H.6. NEEDLE EXCHANGE
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.
Public Law and Section No. Fiscal Year Period Covered
P.L. 106-554, Section 505 2001 (10/1/00 - 9/30/01)
ARTICLE H.7. ANIMAL WELFARE ASSURANCE
The Contractor shall obtain, prior to the start of any work utilizing laboratory
animals under this contract, an approved Animal Welfare Assurance from the
Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW),
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.8. 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 OF LABORATORY ANIMAL WELFARE (OLAW), OF AN
ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY
ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g. COLLABORATING
INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OLAW-APPROVED ASSURANCES,
WHETHER DOMESTIC OR FOREIGN.
ARTICLE H.9. PUBLICATIONS AND PUBLICITY
A. The Contractor agrees that it will not publish, have published or
otherwise disseminate any manuscripts/abstracts describing original
research work conducted under the contract where a Contractor employee
is primary author, without first submitting same, thirty (30) days in
advance, for review by the Project Manager and Contracting Officer. The
Contractor shall inform the Project Manager when the article or other
publication is published, and furnish a copy of it as finally
published.
B. The Contractor shall acknowledge the support of the Department of
Health and Human Services whenever publicizing the work under this
contract in any media. To effectuate the foregoing, the Contractor
shall include in any publication, resulting from work performed under
this contract, an acknowledgment as follows:
"This project has been funded at least in part with Federal
funds from the Department of Health and Human Services under
Contract Number NO1-CO-56000. The contents of this publication
do not necessarily reflect the views or policies of the
Department of Health and Human Services nor does mention of
trade names, commercial products, or organization imply
endorsement by the U.S. Government."
ARTICLE H.10. SALARY RATE LIMITATION LEGISLATION PROVISIONS
Pursuant to Public Law(s) cited below, no NIH Fiscal Year funds may be used to
pay the direct salary of an individual through this contract at a rate in excess
of applicable amount shown for the fiscal year covered. Direct salary is
exclusive of 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 multiple year contract, it may be subject to
unilateral modifications by the Government if an individual's salary rate
exceeds any salary rate ceiling established in future DHHS appropriation acts.
Dollar Amount of
Public Law No. Fiscal Year Salary Limitation
-------------- ----------- -----------------
106-554 FY-01 $161,200
ARTICLE H.11. PRESS RELEASES
Pursuant to the Public Law(s) cited 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.
Public Law and Section No. Fiscal Year Period Covered
P.L. 106-554, Section 507 2001 (10/1/00 - 9/30/01)
ARTICLE H.12. 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 0-000-XXX-XXXX (0-000-000-0000). All telephone calls will be
handled confidentially. The email address is xxxxx@xx.xxxx.xxx and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
X.X. Xxx 00000
Xxxxxxxxxx, XX 00000
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (xxxx://xxx0.xx.xxx.xxx/xxx/xxx.xxx)
ARTICLE H.13. 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.
ARTICLE H.14. cGMP COMPLIANCE REQUIREMENTS
The contractor shall be responsible for assuring compliance with both product
and establishment standards consistent with the phase of clinical development.
The product and establishment standards and cGMPs include, but are not limited
to, the following:
1. Safety and effectiveness (identity, purity, strength, quality, potency,
safety, efficacy, release and in-process specifications)
2. Adverse event, error and accident, and product complaint reporting
systems
3. Development and validation of the production process
4. Reporting changes to the production process as required by 21 CFR
601.12
5. Quality assurance oversight and change control for master and batch
production records
6. Quality control methodology as it relates to the production process
7. Submission of protocols and samples for lot release where applicable
8. Content of the license application
9. Labeling
10. Contracts with the establishment(s) at which manufacturing and testing
is being performed
11. Validation, maintenance and proper functioning of all equipment and
systems, as well as the facility itself
12. Environmental and other required monitoring
13. Reporting changes at applicable facilities to the SAIC-Xxxxxxxxx and
FDA, as required in 21 CFR 601.12
14. Training of personnel
ARTICLE H.15 BUY AMERICAN ACT - BALANCE OF PAYMENTS PROGRAM CERTIFICATE
(a) The offeror certifies that each end product, except those listed in
paragraph (b) of this provision, is a domestic end product as defined
in the clause of this solicitation entitled, "Buy American Act -
Balance of Payments Program - Supplies" and that the offeror has
considered components of unknown origin to have been mined, produced,
or manufactured outside the United States. The offeror shall list as
foreign end products those end products manufactured in the United
States that do not qualify as domestic end products.
(b) Foreign End Products:
LINE ITEM NO.: TBD
COUNTRY OF ORIGIN: TBD
ARTICLE H.16. APPLICATION FOR INDEMNIFICATION PURSUANT TO PUBLIC LAW 00-000
Xxxxxxxx to FAR 50.403, SAIC has submitted a written request to the Government
to modify its
prime contract to include FAR 52.250-1, Indemnification Under Public Law 85-804
(April 1984), to cover certain unusually hazardous risks, including certain
risks relating to HIV vaccines. If the Government approves SAIC's request
(either in whole or as it relates to HIV vaccine-related risks), SAIC shall
promptly request, and use its best efforts to promptly obtain, the Government's
approval to include FAR 52.250-1 in this contract so as to cover the risk to
GenVec of claims or demands by or liability to third parties arising out of or
resulting from any acts or omissions by GenVec in the research and development,
production, supply, distribution, or use of adenovector-based HIV vaccines. SAIC
shall keep GenVec reasonably informed of the status of this request. If the
Government approves this request, SAIC shall promptly modify this contract, for
no additional consideration, to include FAR 52.250-1, so as to cover the
foregoing risk.
ARTICLE H.17. REQUIREMENT TO PROCURE AND MAINTAIN INSURANCE PURSUANT TO HHSAR
352.228-7, INSURANCE - LIABILITY TO THIRD PERSONS (DEC 1991)
As provided for in paragraph (a)(1) of HHSAR 352.228-7, Insurance - Liability to
Third Parties (December 1991), the Contracting Officer hereby requires the
Contractor to procure and maintain insurance covering the risk of claims or
demands by or liability to third parties arising out of or resulting from any
acts or omissions by GenVec in the research and development, production, supply,
distribution, or use of adenovector-based HIV vaccines (the "project-specific
risk"). The Contractor is authorized to procure and maintain such insurance in
amounts, at times, and for terms (including tail coverage) that the Contractor
deems prudent. The Contractor shall promptly notify the Contracting Officer of
the procurement or termination of any such insurance. The Contractor's costs of
procuring and maintaining such insurance shall be allowable costs of this
contract.
ARTICLE H.18. INTELLECTUAL PROPERTY AND DATA RIGHTS
A. Submission of Deviation Request
The level of Contractor ownership of intellectual property has not been
determined. SAIC shall promptly request, and use its best efforts to
obtain, NIH approval to insert in this subcontract an intellectual
property clause substantially in the form to be proposed by GenVec in a
letter to be delivered to SAIC on or about January 2, 2002 (See
Attachment 3) in place of FAR 52.227-11, Patent Rights - Retention by
Contractor (Short Form), and FAR 52.227-14, Rights in Data - General.
SAIC shall keep GenVec reasonably informed of the status of this
exception request and shall notify GenVec within two (2) business days
of receipt of notice of NIH approval or disapproval. In the event of
approval, SAIC shall, without further consideration, modify the
subcontract to include GenVec's proposed intellectual property rights
clause, as described above.
B. Consequences of Actual or Deemed Disapproval
Unless GenVec timely elects to continue the contract in the manner set
forth in paragraph C below, this subcontract will automatically
terminate if: (1) NIH disapproves SAIC's exception request, which will
constitute "actual disapproval"; or (2) NIH fails to approve SAIC's
exception request by January 28, 2002 (or such further date as the
parties may agree), which will constitute "deemed disapproval." Any
such termination will become effective on the earlier of: (1) in the
event of actual disapproval, the fifth business day following GenVec's
receipt of notice from SAIC of such disapproval; or (2) in the event of
deemed disapproval, the fifth business day following the date of deemed
disapproval. In the event of termination under this paragraph B, the
termination shall be deemed to be a termination for convenience
pursuant to the termination clause of this subcontract, FAR 52.249-6,
Termination (Cost-Reimbursement).
C. GenVec's Election to Continue Contract Notwithstanding Actual or Deemed
Disapproval
In the event of actual or deemed disapproval of SAIC's exception
request as described in paragraph B above, GenVec may elect to waive
such disapproval by providing written notice to SAIC of such election
prior to 5:00 p.m. EST on the effective date of the termination, in
which case the contract will not terminate, but rather will continue in
full force and effect.
ARTICLE H.19. HOLD HARMLESS AND INDEMNITY
Except for liability arising out of or resulting from risks defined in this
contract as unusually hazardous or as project-specific risk related to Articles
H.16 and H.17, each party (the Indemnifying Party) agrees to indemnify, defend
and hold harmless the other party (the Indemnified Party) from and against any
and all liability for injury to persons or damage to or loss of property to the
extent caused by the negligent act or omission of the Indemnifying Party, its
lower-tier subcontractors, agents or employees, including any and all expense
and cost, legal or otherwise, incurred by the Indemnified Party in the defense
of any claim, demand or action arising out of the work performed under this
Agreement, provided, however, that the Indemnified Party shall not be liable for
injury to persons or damage to or loss of property caused by the sole negligence
of the Indemnified Party, its subcontractor, agents or employees.
The Indemnified Party shall promptly notify the Indemnifying Party of any claim,
demand or action which his covered by this indemnification provision and shall
authorize representatives of the Indemnifying Party, at its sole costs and
expense, to settle or defend any such claim, demand or action and to represent
the Indemnified Party in, or to take charge of, any litigation in connection
therewith.
ARTICLE H.20. EXCLUSIVE REMEDY FOR DEFAULT
In the event that SAIC terminates this subcontract for default, SAIC's remedies
shall be exclusively as set forth in FAR 52.249-6, Termination
(Cost-Reimbursement), incorporated in Section I of this subcontract. In no event
will GenVec be liable for consequential or incidental damages, excess
reprocurement costs, or for any amounts in excess of the amounts already paid to
GenVec at the time of termination.
PART II
SECTION I - CONTRACT CLAUSES
ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
Except to the extent modified herein, 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
xxxx://xxx.xxxxx.xxx/xxx/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
FAR
CLAUSE NO. TITLE DATE
---------- ----- ----
52.202-1 Definitions May-2001
52.203-3 Gratuities Apr-1984
52.203-5 Covenant Against Contingent Fees Apr-1984
52.203-6 Restrictions on Subcontractor Sales to the Government Jul-1995
52.203-7 Anti-Kickback Procedures Jul-1995
52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity Jan-1997
52.203-10 Price or Fee Adjustment for Illegal or Improper Activity Jan-1997
52.203-12 Limitation on Payments to Influence Certain Federal Transactions Jun-1997
52.204-4 Printed or Copied Double-Sided on Recycled Paper Aug-2000
52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Jul-1995
Suspended, or Proposed for Debarment
52.215-2 Audit and Records - Negotiation Jun-1999
52.215-8 Order of Precedence - Uniform Contract Format Oct-1997
52.216-7 Allowable Cost and Payment Mar-2000
52.216-8 Fixed Fee Mar-1997
52.219-8 Utilization of Small Business Concerns Oct-2000
52.219-9 Small Business Subcontracting Plan Oct-2000
52.219-16 Liquidated Damages - Subcontracting Plan Jan-1999
52.222-2 Payment for Overtime Premium Jul-1990
52.222-3 Convict Labor Aug-1996
52.222-21 Prohibition of Segregated Facilities Feb-1999
52.222-26 Equal Opportunity Feb-1999
52.222-35 Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era Apr-1998
52.222-36 Affirmative Action for Workers with Disabilities Jun-1998
52.222-37 Employment Reports on Disabled Veterans and Veterans of the Vietnam Era Jan-1999
52.223-6 Drug-Free Workplace May-2001
52.223-14 Toxic Chemical Release Reporting Oct-2000
52.225-1 Buy American Act - Balance of Payments Program - Supplies Feb-2000
52.225-13 Restrictions on Certain Foreign Purchases Jul-2000
52.227-1 Authorization and Consent, Alternative I Apr-1984
52.227-11 Patent Rights - Retention by the Contractor (Short Form) Jun-1997
52.227-14 Rights in Data - General Jun-1987
52.232-9 Limitation on Withholding of Payments Apr-1984
52.232-17 Interest Jun-1996
52.232-20 Limitation of Cost Apr-1984
52.232-22 Limitation of Funds Apr-1984
52.232-23 Assignment of Claims Jan-1986
52.232-25 Prompt Payment May-2001
52.232-34 Payment by Electronic Funds Transfer - Other Than Central Contractor Registration May-1999
52.233-3 Protest after Award, Alternate I Jun-1985
52.242-1 Notice of Intent to Disallow Costs Apr-1984
52.242-3 Penalties for Unallowable Costs May-2001
52.242-4 Certification of Final Indirect Costs Jan-1997
52.242-13 Bankruptcy Jul-1995
52.242-15 Stop Work Order, Alternate I Apr-1984
52.243-2 Changes - Cost Reimbursement, Alternate V Apr-1984
52.244-2 Subcontracts Aug 1998
52.244-5 Competition in Subcontracting Dec-1996
52.245-5 Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract) Jan-1986
52.246-23 Limitation of Liability Feb-1997
52.249-6 Termination (Cost Reimbursement) Sep-1996
52.249-14 Excusable Delays Apr-1984
52.253-1 Computer Generated Forms Jan-1991
ARTICLE I.2. ADDITIONAL CLAUSES
52.215-19 NOTIFICATION OF OWNERSHIP CHANGES. (OCT 1997)
(a) The Contractor shall make the following notifications in writing:
(1) When the Contractor becomes aware that a change in its
ownership has occurred, or is certain to occur, that could
result in changes in the valuation of its capitalized assets
in the accounting records, the Contractor shall notify the
Administrative Contracting Officer (ACO) within 30 days.
(2) The Contractor shall also notify the ACO within 30 days
whenever changes to asset valuations or any other cost changes
have occurred or are certain to occur as a result of a change
in ownership.
(b) The Contractor shall--
(1) Maintain current, accurate, and complete inventory records of
assets and their costs;
(2) Provide the ACO or designated representative ready access to
the records upon request;
(3) Ensure that all individual and grouped assets, their
capitalized values, accumulated depreciation or amortization,
and remaining useful lives are identified accurately before
and after each of the Contractor's ownership changes; and
(4) Retain and continue to maintain depreciation and amortization
schedules based on the asset records maintained before each
Contractor ownership change.
(c) The Contractor shall include the substance of this clause in all
subcontracts under this contract that meet the applicability
requirement of FAR 15.408(k).
52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL COMPONENTS
(OCT 1998)
(a) DEFINITIONS.
"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 non-developmental items as components of items to be supplied
under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is
not required to include any FAR provision or clause, other than those
listed below to the extent they are applicable and as may be required
to establish the reasonableness of prices under Part 15, in a
subcontract at any tier for commercial items or commercial components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Disabled Veterans and
Veterans of the Vietnam Era (38 U.S.C. 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.
B. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)
(48 CFR CHAPTER 3) CLAUSES:
Hhsar Clause No. Clause Title Date
---------------- ------------ ----
352.228-7 Insurance - Liability to Third Persons Dec-1991
352.223-70 Safety and Health Jan-2001
352.224-70 Confidentiality of Information Apr-1984
352.232-9 Withholding of Contract Payments Apr-1984
352.233-70 Litigation and Claims Apr-1984
352.270-5 Key Personnel Apr-1984
352.270-6 Publication and Publicity Jul-1991
352.270-7 Paperwork Reduction Act Jan-2001
PART III
SECTION J LIST OF DOCUMENTS, EXHIBIT AND OTHER ATTACHMENTS
ARTICLE J.1. ATTACHMENTS
1. SAIC Xxxxxxxxx - NCI Frederick Cancer Research & Development Center
Terms and Conditions
2. Invoicing Instructions
3. Genvec's Proposed Property Rights Clause
ATTACHMENT 1
[SAIC(R) LOGO] SAIC Xxxxxxxxx
An Employee-Owne Company
A Division of Science Applications
International Corporation
SUPPORTING THE NATIONAL CANCER INSTITUTE
XXXXXXXXX CANCER RESEARCH AND DEVELOPMENT CENTER
TERMS AND CONDITIONS
1. GOVERNMENT RELATIONSHIP
The award of this subcontract is made by SAIC Xxxxxxxxx, Inc. a
Division of Science Applications International Corporation (hereafter
"SAIC Xxxxxxxxx" or "SAIC") under its prime contract with the National
Cancer Institute, Frederick Cancer Research and Development Center. The
provisions and clauses contained herein are influenced by and reflect
the relationship of the parties to the prime contract, which was
awarded and is administered under the provision of the Federal
Acquisition Regulations (FAR). There is no privity of contract between
the Subcontractor and the Government.
2. DEFINITIONS
Buyer - SAIC Xxxxxxxxx or SAIC
Seller or Contractor - The party receiving the award from SAIC
Contracting Officer - The SAIC person with the authority to enter into
and administer contractual Agreements. The term includes authorized
representatives of the Contracting Officer acting within their
delegated authority.
Agreement - The contractual Agreement between SAIC and the Seller or
Subcontractor
Special Definitions - See paragraph 3 for the special definitions that
apply in the use of the solicitation and award clauses of this
Agreement.
3. SOLICITATION AND AWARD CLAUSES - SPECIAL DEFINITIONS
FAR clauses included in this Agreement, including any solicitation
document shall be interpreted as follows:
Unless a purposeful distinction is made clear and the context of the
clause requires
retention of the original definition, the term "Contractor" shall mean
Seller, the term "Contract" shall mean this Agreement, the term
"Subcontractor" shall mean subcontractors of Seller at any tier, and
the terms "Government", "Contracting Officer" and equivalent phrases
shall mean SAIC and SAIC's Contracting Officer, respectively. It is
intended that the referenced clauses shall apply to Seller in such
manner as is necessary to reflect the position of Seller as a
subcontractor to SAIC to insure Seller's obligations to SAIC and to the
United States Government, and to enable SAIC to meet its obligations
under its Prime Contract.
Full text of the referenced clauses may be found in Chapter 1 of the
FAR (Code of Federal Regulations (CFR) Title 48) obtainable from the
Superintendent of Documents, Government Printing Office (GPO),
Xxxxxxxxxx, XX 00000 or online at xxxx://xxx.xxxxx.xxx/xxx/.
Copies of the clauses will be furnished by the Contracting Officer upon
request.
4. DISPUTES
Notwithstanding any provisions in the standard FAR clauses made a part
of this Agreement by reference, there is no formal procedure
established for resolving disputes between SAIC and the Seller. It is
SAIC policy to make every reasonable effort to resolve all contractual
issues fairly by negotiation without litigation. Either party may
litigate any dispute under or relating to this Agreement.
Pending final resolution of any dispute between the parties, the Seller
shall proceed diligently with performance as directed by the
Contracting Officer.
5. AUTHORITY
Only the Contracting Officer has the authority to enter into, change,
or administer this Agreement. Any activity that changes or affects the
obligation of the parties to this Agreement must be in writing.
6. LEGAL CONSTRUCTION AND INTERPRETATIONS
This Agreement shall be governed by and interpreted in accordance with
the principles of Federal Contract Law, and to the extent that Federal
Contract Law is not dispositive, and the state law becomes applicable,
the law of the State of Maryland shall apply.
7. WAIVER OF TERMS AND CONDITIONS
The failure of SAIC in any one or more instances to enforce one or more
of the terms or conditions of this award or to exercise any right or
privilege in this Agreement, or the waiver of any breach of the terms
or conditions of this Agreement shall not be construed
as thereafter waiving any such terms, conditions, rights or privileges,
and the same shall continue and remain in force and effect as if no
such failures to enforce had occurred.
8. MARYLAND SALES AND USE TAX
The State of Maryland has issued Direct Payment Permit #3 to SAIC
Frederick for all vendor purchases for the National Cancer
Institute-Frederick Cancer Research and Development Center (NCI-FCRDC)
effective August 29, 1996. A copy of this certificate is available to
vendors upon request. SAIC Xxxxxxxxx is authorized to make direct
payment of sales and use tax to the State of Maryland and vendors are
not to add sales tax to invoices, nor are they responsible for
collection of such taxes for purchases by SAIC Xxxxxxxxx for the
NCI-FCRDC after the above date.
9. INSURANCE REQUIREMENTS - FOR WORK ON GOVERNMENT INSTALLATION
If this Agreement entails effort on a Government installation,
including any off-site buildings owned or leased by the Government, the
Subcontractor must provide and maintain the minimum amounts of
insurance stated below.
EACH EACH PROPERTY
PERSON OCCURRENCE DAMAGE
1. Xxxxxxx'x Compensation as required by law
2. Employer's Liability $100,000 $500,000
3. Comprehensive General Liability $500,000 $500,000 $100,000
4. Comprehensive Automobile Liability $200,000 $500,000 $ 50,000
The certification and other requirements of FAR Clause 52.228-5
Insurance - Work on a Government Installation apply.
10. PRICING OF ADJUSTMENT
When costs are a factor in the determination of a contract price
adjustment pursuant to the Changes Clause or any other provision of
this Agreement, such cost information shall be furnished to SAIC and
costs shall be determined in accordance with the cost principles and
procedures of Subpart 31.2 of the FAR.
11. RELEASE OF INFORMATION
Seller agrees that prior to the issuance of any publicity or
publication of any advertising which in either case makes reference to
this Agreement, or to SAIC, Seller will obtain the written permission
of SAIC with respect thereto.
12. WARRANTY PERIODS
The period of warranty, if applicable to this Agreement is noted in the
clause itself.
13. ASSIGNMENT
Neither this Agreement nor any interest herein may be assigned, in
whole or in part, without the prior written consent of SAIC except that
the Seller shall have the right to assign this Agreement to any
successor of such party by way of merger or consolidation or the
acquisition of substantially all of the business and assets of the
Seller relating to the subject matter of this Agreement. This right
shall be retained provided that such successor shall expressly assume
all of the obligations and liabilities of the Seller under this
Agreement, and that the Seller shall remain liable and responsible to
SAIC for the performance and observance of all such obligations.
Notwithstanding the foregoing, any amounts due the Seller may be
assigned in accordance with the provisions of the clause 52.232-23,
Assignment of Claims.
In the event the prime contract of SAIC with the Government is
succeeded by a successor contractor selected by the Government, this
Agreement may be assigned to the successor contractor.
ATTACHMENT 2
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS
FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
GENERAL: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
FORMAT: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal," and Standard Form 1035, "Public Voucher for Purchases and
Services Other Than Personal-- Continuation Sheet," or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or
self-designed form provided that it contains the information shown on the sample
invoice/financing request.
NUMBER OF COPIES: As indicated in the Invoice Submission Clause in the
contract.
FREQUENCY: Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the Contracting
Officer.
COST INCURRENCE PERIOD: Costs incurred must be within the contract performance
period or covered by pre-contract cost provisions.
BILLING OF COSTS INCURRED: If billed costs include: (l) costs of a prior billing
period, but not previously billed; or (2) costs incurred during the contract
period and claimed after the contract period has expired, the amount and
month(s) in which such costs were incurred shall be cited.
CONTRACTOR'S FISCAL YEAR: Invoices/financing requests shall be prepared in such
a manner that costs claimed can be identified with the contractor's fiscal year.
CURRENCY: All NIH contracts are expressed in United States dollars. When
payments are made in a currency other than United States dollars, xxxxxxxx on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized.
COSTS REQUIRING PRIOR APPROVAL: Costs requiring the contracting officer's
approval, which are not set forth in an Advance Understanding in the contract
shall be so identified and reference the Contracting Officer's Authorization
(COA) Number. In addition, any cost set forth in an Advance Understanding shall
be shown as a separate line item on the request.
INVOICE/FINANCING REQUEST IDENTIFICATION: Each invoice/financing request shall
be identified as either:
(a) INTERIM INVOICE/CONTRACT FINANCING REQUEST -- These are interim payment
requests submitted during the contract performance period.
(b) COMPLETION INVOICE -- The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final
Page 51
indirect cost rates covering the year in which this contract is physically
complete (whichever date is later). The completion invoice should be
submitted when all costs have been assigned to the contract and all
performance provisions have been completed.
(c) FINAL INVOICE -- A final invoice may be required after the amounts owed
have been settled between the Government and the Contractor (e.g.,
resolution of all suspensions and audit exceptions).
PREPARATION AND ITEMIZATION OF THE INVOICE/FINANCING REQUEST: The Contractor
shall furnish the information set forth in the explanatory notes below. These
notes are keyed to the entries on the sample invoice/financing request.
(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 C 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 current period.
(j) CUMULATIVE AMOUNT FROM INCEPTION -- Insert the cumulative amounts billed
for the major cost elements and adjusted amounts claimed during this
contract.
(k) DIRECT COSTS -- Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(l) DIRECT LABOR -- Include salaries and wages paid (or accrued) for
direct performance of the contract. For Key Personnel, list each
employee on a separate line. List other employees as one amount
unless otherwise required by the contract.
Page 52
(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.
(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.
Page 53
(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.
Page 54
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the Financial Report Of
Individual Project/Contract, NIH Form 2706
COLUMN A--EXPENDITURE CATEGORY - Enter the expenditure categories required by
the contract.
COLUMN B--CUMULATIVE PERCENTAGE OF EFFORT/HRS.-NEGOTIATED - Enter the percentage
of effort or number of hours agreed to doing contract negotiations for each
employee or labor category listed in Column A.
COLUMN C--CUMULATIVE PERCENTAGE OF EFFORT/HRS.-ACTUAL - Enter the percentage of
effort or number of hours worked by each employee or labor category listed in
Column A.
COLUMN D--INCURRED COST-CURRENT - Enter the costs, which were incurred during
the current period.
COLUMN E--INCURRED COST-CUMULATIVE - Enter the cumulative cost to date.
COLUMN F--COST AT COMPLETION - Enter data only when the contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
COLUMN G--CONTRACT AMOUNT - Enter the costs agreed to during contract
negotiations for all expenditure categories listed in Column A.
COLUMN H--VARIANCE (OVER OR UNDER) - Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost (Funds)
Clause of the contract.
MODIFICATIONS: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
EXPENDITURES NOT NEGOTIATED: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance and
will be explained along with those identified under H above.
Page 55
SAMPLE INVOICE/FINANCING REQUEST
(a) Billing Office Name and Address (b) Invoice/Financing Request No. -----------
Xx. Xxxxx Xxxxxx (c) Date Invoice Prepared -----------
Accounts Payable Department
Building 244 (d) Contract No. and Effective Date -----------
NCI at Frederick
SAIC Frederick (f) Total Estimated Cost of Contract -----------
P. X. Xxx X - Xxxx 0xx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000 (g) Total Fixed Fee -----------
(e) Payee's Name and Address
ABC CORPORATION
000 Xxxx Xxxxxx
Xxxxxxxx, X.X.X. Zip Code
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 for (j) Cumulative
Current Period Amount From
Inception
-------------- -----------
(k) Direct Costs
(l) Direct Labor $ 3,400 $ 6,800
(2) Fringe Benefits 600 1,200
(3) Accountable Personal Property
(Attach Form HHS-565)
Permanent Research 3,000 6,000
General Purpose 2,000
2,000
(4) Materials and Supplies 2,000 4,000
(5) Premium Pay 100
150
(6) Consultant Fee-Xx. Xxxxx 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
Page 56
(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)
*Attach details as specified in the contract
Page 57
AMENDMENT OF SOLICITATION/MODIFICATION OF SUBCONTRACT
AMENDMENT/MODIFICATION NO.: 01 EFFECTIVE DATE: January 25, 2002
SUBCONTRACTOR NAME AND ADDRESS: ISSUED BY: Xxxxxx X. Xxxxxxxxx
GenVec, Inc. SAIC-Frederick Inc.
00 Xxxx Xxxxxxx Xxxx Xxxx NCI-Xxxxxxxxx Cancer Research & Development Ctr.
Gaithersburg, MD X.X. Xxx X, Xxxxxxxx 000
Xxxxxxxxx, XX 00000-0000
AMENDMENT OF SOLICITATION MODIFICATION OF SUBCONTRACT NO.:
21XS073A
NO: DATED: NO.: 01 DATED: January 25, 2002
THIS BLOCK APPLIES ONLY TO AMENDMENTS OF SOLICITATIONS
/ / The above numbered solicitation is amended as set forth below. The hour and
date specified for receipt of offers / / is extended, / / is not extended.
Offerors must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation, or as amended, by signing and returning
____copies of this amendment; by acknowledging receipt of this amendment on each
copy of the offer submitted; or by separate letter referencing the solicitation
and amendment numbers.
FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE ISSUING OFFICE PRIOR TO THE
HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.
THIS BLOCK APPLIES ONLY TO MODIFICATION OF SUBCONTRACTS
/ /This Change Order is issued pursuant to the General Provisions entitled
"CHANGES"
/X/ Supplemental Agreement
/X/ Subcontractor / / is not required /X/ is required to sign this document
and return 2 copies to issuing office.
RETURN TWO (2) COPIES TO THE ATTENTION OF Xxxx XxXxxxxx
DESCRIPTION OF AMENDMENT/MODIFICATION BUILDING NO. n/a
THE ABOVE REFERENCED SUBCONTRACT IS HEREBY MODIFIED AS FOLLOWS:
Section B.3. - See page 2
Section B.4. - See page 2
Section B.5. - See page 3
Section F.1. - See pages 3 and 4
Section F.2. - See pages 5 and 6
Section H.18 - See pages 7 and 8
ALL OTHER TERMS AND CONDITIONS OF THIS CONTRACT REMAIN UNCHANGED.
OFFEROR/SUBCONTRACTOR SAIC Xxxxxxxxx
BY BY
NAME AND TITLE OF SIGNER DATE SIGNED CONTRACTING OFFICER DATE SIGNED
Xxxxxx X. Xxxxx Xxxxxx X. Xxxxxxxxx
Senior VP, Corporate Development Manager, Research Contracts
Contract No. 21XS073a
Modification 01
ARTICLE B.3. CONTRACT PRICE/COST
A. The total estimated cost of this contract for the base year, exclusive
of any fee, is $*.
B. In accordance with ARTICLE F.1. PERIOD OF PERFORMANCE, the contract
includes two priced option years as follows:
PERIOD PERIOD COVERED TOTAL ESTIMATED COST
-------------- -------------------------- -------------------------
Option Year 1 12/31/2002 - 12/30/2003 $*
Option Year 2 12/31/2003 - 12/30/2004 $*
ARTICLE B.4. FEE
A. FIXED FEE.
(1) For work pertaining to the milestones listed below, the
Government shall pay the Contractor a fixed fee as follows:
PERIOD OF PERFORMANCE FIXED FEE
--------------------- ---------
Base Period $*
Option Year 1 $*
Option Year 2 $*
(2) The Contractor earns and may invoice for, and the Government
shall pay, the fixed fee for each period on a pro rata basis
throughout that period.
B. Incentive Fee.
(1) In addition to the fixed fee, the Government shall pay the
Contractor an incentive fee for early completion of critical
Milestone I, defined as the successful completion of the six
(6) adenovectors and the delivery of the six (6) adenovectors
to the appropriate organization as specified by the VRC. The
amount of incentive fee shall be determined based upon the
actual date of successful completion as follows:
COMPLETION DATE INCENTIVE FEE
--------------- -------------
Contract Award + * $*
Contract Award + * $*
Contract Award + * $*
Contract Award + * $*
(2) The Contractor may invoice for, and the Government shall pay,
the appropriate specified incentive
Page 2
fee consistent with Paragraph B.1. at any time following
successful completion of the critical Milestone I activities
within one of the designated time periods.
(3) The Government is not obligated to pay incentive fees for
early completion of Milestones II or III.
ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS
A. Items Unallowable Unless Otherwise Provided
Notwithstanding the clause(s), ALLOWABLE COST AND PAYMENT, 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 whether at
domestic or foreign locations;
(5) Consultant expenses;
(6) Subcontracts.
B. Travel Costs
(1) Domestic Travel
(a) Total expenditures for domestic travel
(transportation, lodging, subsistence, and incidental
expenses) incurred in direct performance of this
Contract shall not exceed $ * without prior written
approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed
for all travel costs in accordance with FAR
Subpart 31.205-46
ARTICLE F.1. PERIOD OF PERFORMANCE
A. The initial period of performance of this CPFF, XXX contract shall be
from December 31, 2001 - December 30, 2002. The Contracting Officer may
extend the period of performance by exercising one or both of the two
priced twelve (12) months option years in accordance with paragraph B
below.
B. Execution of option years will be based upon actual Contractor
performance.
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 1989)
Page 3
The Government may extend the term of this contract by written notice
to the Contractor within thirty (30) days provided, that the Government
shall give the Contractor a preliminary written notice of its intent to
extend at least sixty (60) days before the contract expires. The
preliminary notice does not commit the Government to an extension.
If the Government exercises this option, the extended contract shall be
considered to include this option provision.
The total duration of this contract, including the exercise of any
options under this clause, shall not exceed 36 months.
C. If SAIC Frederick exercises its option(s) pursuant to Article F.1,
paragraph B, the period of performance will be increased as listed
below:
OPTION YEAR NUMBER PERIOD OF PERFORMANCE
Option 1: December 31, 2002 - December 30, 2003
Option 2: December 31, 2003 - December 30, 2004
Page 4
ARTICLE F.2. LEVEL OF EFFORT
A. In accomplishing the work set forth herein, the Contractor shall
provide * hours direct labor effort during the periods set forth below.
These labor HOURS EXCLUDE subcontractor labor HOURS. It is estimated
that the labor hours will be expended approximately as follows:
PERIOD OF PERFORMANCE LABOR CATEGORY DIRECT LABOR HOURS
Base Period
* *
TOTAL HOURS - BASE PERIOD *
Page 5
Option Year 1
* *
TOTAL HOURS - OPTION YEAR 1 *
Option Year 2
* *
TOTAL HOURS - OPTION YEAR 2 *
B. The Contractor shall have satisfied the requirement herein if it
furnishes not less than 90% or more than 110% of the total direct
labor hours specified herein.
Page 6
Delete:
ARTICLE H.18. INTELLECTUAL PROPERTY AND DATA RIGHTS.
Replace with:
ARTICLE H.18. SUBMISSION OF REQUEST FOR CONTRACT MODIFICATION RELATING TO
GOVERNMENT REPORTING OF INVENTIONS
A. SUBMISSION OF REQUEST. In consideration of GenVec's election to continue
the subcontract notwithstanding NIH's actual or deemed disapproval of the
deviation request previously submitted by SAIC pursuant to Article H.17 of this
subcontract, SAIC shall promptly request, and use its best efforts to obtain,
NIH approval to insert in this subcontract a clause relating to government
disclosure and reporting of inventions, with such clause to be substantially in
the form set forth in paragraph B below. SAIC shall keep GenVec reasonably
informed of the status of this request and shall notify GenVec within two (2)
business days of receipt of notice of NIH approval or disapproval. In the event
of approval, SAIC shall, without further consideration, issue a bilateral
modification to the subcontract to include the clause relating to government
disclosure and reporting of inventions, as described above.
B. FORM OF REQUESTED MODIFICATION. The form of the modification request
referred to in paragraph A above is as follows:
"ARTICLE H.18. REPORTING OF GOVERNMENT INVENTIONS"
A. DEFINITIONS.
As used in this article, the following terms shall have the indicated
meanings:
(1) "Government" means the Government of the United States, as
represented through the Public Health Service ("PHS") and its
subdivision, the National Institutes of Health ("NIH").
(2) "IP" means intellectual property.
(3) "Inventing Parties" means the Government and GenVec.
(4) "Invention" means any invention or discovery which is or may
be patentable or otherwise protected under Xxxxx 00, Xxxxxx
Xxxxxx Code, Sections 101 or 161, or any novel variety or
plant which is or may be protected under the Plant Variety
Protection Act (7 U.S.C. Section 2321 ET SEQ.).
(5) "Made," when used in relation to any invention, means the
conception or first actual reduction to practice of such
invention.
(6) "PHS" means the Public Health Service, of which NIH is a
subdivision.
(7) "Government Subject Invention" means any Invention of the
Government made in connection with this contract or using any
biological materials supplied by GenVec under this contract.
Page 7
B. IMPLEMENTATION
(1) As prime contractor, SAIC represents and warrants that the
Government has authorized SAIC in writing to include this
clause in this subcontract for the purposes of providing for
Government disclosure and reporting of inventions to GenVec,
as specified below.
(2) The Government, SAIC and GenVec agree that the mutual
obligations of the Inventing Parties created by this clause
constitute a contract between the Government and GenVec with
respect to the matters covered by the clause; PROVIDED,
HOWEVER, that nothing in this paragraph is intended to confer
any jurisdiction under the Contract Disputes Act in connection
with proceedings relating to third-party licenses. (CF. FAR
52.227-11(g)(3).)
C. GOVERNMENT DISCLOSURE AND REPORTING OF INVENTIONS
(1) DISCLOSURE. The Government shall disclose each Government
Subject Invention to GenVec within two (2) months after the
inventor discloses it in writing to NIH personnel responsible
for patent matters. NIH agrees to inform its affected
employees, other than clerical and nontechnical employees, of
their obligation to promptly disclose each Government Subject
Invention in writing to NIH personnel identified as
responsible for patent matters under the SAIC prime contract.
(2) REPORTING ON PATENT APPLICATIONS. Within one month of filing a
patent application on a Government Subject Invention, the
Government shall provide GenVec with copies of the application
and all documents filed with the relevant patent or other IP
office in connection with the prosecution of such
applications. The Government shall also provide GenVec with
the power to inspect and make copies of all documents retained
in the patent or other IP application files by the applicable
patent or other IP office. Where licensing is contemplated by
GenVec, the Inventing Parties agree to consult with each other
with respect to the prosecution of applications for Government
Subject Inventions and joint Subject Inventions. If the
Inventing Parties agree that GenVec shall file and prosecute
IP applications on joint Subject Inventions, then GenVec
agrees to grant PHS an associate power of attorney (or its
equivalent) on such IP applications.
(3) LICENSING. The Government shall give due consideration to any
applications by GenVec for licenses to any Government Subject
Inventions. In negotiating the terms and conditions of any
such licenses, the Government assgrees to take into account
the nature of the invention, the relative contributions of the
Inventing Parties to the invention, the risks incurred by
GenVec and the costs of subsequent research and development
needed to bring the invention to the marketplace.
D. SURVIVAL
The provisions of this Article survive the termination of this
contract."
Page 8
