Exhibit 10.36
[SAIC(R) LOGO]
SCIENCE APPLICATIONS
INTERNATIONAL CORPORATION
AN EMPLOYEE OWNED COMPANY
SUBCONTRACT AGREEMENT
IN SUPPORT OF:
THE SMA PROJECT: A COLLABORATIVE PROGRAM TO ACCELERATE THERAPEUTICS DEVELOPMENT
FOR SPINAL MUSCULAR ATROPHY (SMA)
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS)
[NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE LOGO]
UPDATED AS OF APRIL 23, 2004
AN SAIC-MANAGED PROGRAM TO SUPPORT THE NINDS,
NATIONAL INSTITUTES OF HEALTH (NIH),
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
INDEFINITE DELIVERY/INDEFINITE QUANTITY (ID/IQ)
TIME AND MATERIAL/LABOR HOUR
SUBCONTRACTOR: SUBCONTRACT # 4600006260
COMBINATORX, INC. MODIFICATION # N/A
ADDRESS: 000 XXXXXX XXXXXX SUBPROJECT # TBD BY TASK ORDER
XXXXXX, XX 00000 TYPE: ID/IQ - TIME AND MATERIAL / LABOR HOUR
PHONE: 000-000-0000 FAX: 000-000-0000 MAXIMUM VALUE: $1,917,356.95
MINIMUM VALUE: INITIAL FUNDING OF TASK ORDER
SAIC Federal Procurement Procedures
Pro forma Agreements ID/IQ-Time and Material/Labor Hour/CPFF
TABLE OF CONTENTS
INTRODUCTION..........................................................................1
SCHEDULE A - SPECIFIC TERMS AND CONDITIONS............................................1
1. Indefinite Quantity..............................................................1
1.1 Labor Rates.................................................................2
1.2 Inspection..................................................................2
1.2.1 Inspection - Time and Materials......................................2
1.3 Invoices....................................................................2
1.4 Payment.....................................................................3
1.4.1 Payment Time and Material Tasks......................................3
1.5 Audit.......................................................................3
1.6 Warranty....................................................................3
1.7 Options to Extend the Term of the Subcontract...............................4
1.8 Task Orders.................................................................4
2. Technical and Contractual Representatives........................................5
2.1 Contacts....................................................................5
2.2 Changes.....................................................................5
3. Disclosure.......................................................................5
4. Key Personnel....................................................................5
5. Assignments and Subcontracts.....................................................6
6. Insurance........................................................................6
6.1 Coverage....................................................................7
7. Indemnification..................................................................8
8. Infringement Indemnity...........................................................8
9. Proprietary Information, Tools, Materials, Etc...................................8
10. Disputes.........................................................................9
11. Default..........................................................................9
12. Subcontract Closeout............................................................10
13. General Relationship............................................................11
14. Non-Waiver of Rights............................................................11
15. Applicable State Law and Compliance.............................................11
16. Export Control Compliance for Foreign Persons...................................11
17. Export Laws and Regulations.....................................................12
18. Order of Precedence.............................................................12
19. Entire Agreement................................................................12
ATTACHMENT I - STATEMENT OF WORK...........................ERROR! BOOKMARK NOT DEFINED.
1. Introduction..........................................ERROR! BOOKMARK NOT DEFINED.
1.1 Background.......................................ERROR! BOOKMARK NOT DEFINED.
2. Scope.................................................ERROR! BOOKMARK NOT DEFINED.
SCHEDULE B - PART 1 - FAR CLAUSES....................................................16
1. Definitions.....................................................................16
2. Identification of Contract Numbers..............................................16
3. Disputes........................................................................16
4. Other Government Procurement....................................................17
5. Indemnification - Cost or Pricing Data - Cost Accounting Standards..............17
6. Termination for Convenience.....................................................17
7. Government Property.............................................................18
8. Contract Cost Principles and Procedures.........................................18
9. Far Clauses Applicable to this Order............................................18
SCHEDULE B - PART II - SPECIAL REQUIREMENTS/CONTRACT CLAUSES.........................21
1. Definitions.....................................................................21
2. Human Subjects and Human Specimens..............................................21
3. Continued Ban on Funding of Human Embryo Research...............................22
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4. Recombinant DNA and Human Gene Transfer Research(1).............................22
5. Restriction from Use of Live Vertebrate Animals.................................22
6. Animal Welfare Assurance (AWA)..................................................23
7. Salary Rate Limitation Legislation Provisions...................................23
8. Publication and Publicity.......................................................24
9. Press Releases..................................................................24
10. Reporting Matters Involving Fraud, Waste, and Abuse.............................24
11. Anti-Lobbying...................................................................24
12. Reimbursement of Costs for Independent Research and Development Projects........25
13. Obtaining and Disseminating Biomedical Research Resources.......................25
14. Electronic and Information Technology Standards.................................25
15. Sharing Research Data...........................................................26
16. Intellectual Property Management Plan...........................................26
17. Hotel and Motel Fire Safety Act of 1990 (PL 101-391)............................26
18. Invention Reporting Requirement.................................................27
19. Provisions Applicable to Direct Costs...........................................27
20. PHS Metric Program..............................................................28
21. Access to Research Data.........................................................28
22. Research Misconduct.............................................................29
23. Needle Exchange.................................................................29
24. HHSAR 352.223-70 Safety and Health (Deviation) (August 1997)....................29
25. Additional Contract Clauses.....................................................30
ATTACHMENT II - MEMORANDUM...........................................................32
SCHEDULE B - PART III - REPORTING REQUIREMENTS.......................................34
1. Monthly Progress Reports........................................................34
2. Quarterly Progress Reports......................................................34
3. Other Reports...................................................................35
4. Final Report....................................................................35
5. Packaging, Marking, and Shipping................................................35
6. Deliveries......................................................................36
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INTRODUCTION
This
Subcontract Agreement, effective AUGUST 10, 2005 is made between SCIENCE
APPLICATIONS INTERNATIONAL CORPORATION (hereinafter known as "Buyer"), a
Delaware corporation with principal offices in San Diego, California, and
CombinatoRx, Inc. (hereinafter known as "Seller"), a corporation with offices in
Boston, MA. The effort to be performed by Seller under this Subcontract will be
part of Buyer's Prime Contract #N01-NS-3-2356 that has been issued by NIH/NINDS.
The work, defined in Attachment I (Statement of Work) will be performed on a
Time and Material/Labor Hour basis, in accordance with Schedules A (Specific
Terms and Conditions), B (U.S. Government Terms and Conditions) and any
referenced document in section 16 of this agreement.
SCHEDULE A
SPECIFIC TERMS AND CONDITIONS
1. INDEFINITE QUANTITY
(a) The term of this subcontract shall commence upon the date of issuance of
the initial Delivery Order ("the Effective Date") and shall terminate on
[insert date] unless Buyer exercises its option to extend the period of
performance or otherwise change this subcontract in accordance with
paragraph 1.7.
(b) The hourly rates shall be fixed for the term of this subcontract for Time
and Material Delivery Orders. The Billing Rates shall be adjusted based on
fiscal year end actuals, on an annual basis for all Cost Reimbursable
Tasks.
(c) Delivery or performance shall be made only as authorized by orders issued
in accordance with the clause 1.8 below. The Seller shall furnish to the
Buyer, when ordered, the hours or services specified in Attachment I up to
and including the quantity designated in Attachment I as the "Maximum".
The "Minimum" quantity of hours or services that the Buyer shall order
will be those amounts designated in the initial Delivery Order issued
hereunder. Individual Task Order will establish funding. Unless this
Agreement is amended in writing by mutual agreement of the parties, Seller
is not obligated to incur expenses or make commitments in excess of the
amount stated in each Task Order and Buyer is not obligated to compensate
Seller beyond the amount stated.
(d) There is no limit on the number of orders that may be issued. The Buyer
may issue orders requiring delivery to multiple destinations or
performance at multiple locations.
(e) Any order issued but not completed during the effective period of this
Subcontract shall be completed by the Seller within the time specified in
the order. The Subcontract shall govern the Seller's and Buyer's rights
and obligations with respect to that order to the same extent as if the
order were completed during the Subcontract's effective term; provided,
that the Seller shall not be required to make any deliveries under this
contract on orders issued after [insert date].
(f) Buyer's obligation under this agreement is limited to the "Minimum"
quantity of hours or services specified in Article 1 (c) hereof and
includes only those labor categories identified in Attachment I and that
are required for this contract/program.
(g) Exclusivity of supply is neither implied nor intended and buyer is free to
purchase the same or similar services from sources other than the Seller.
(h) Buyer may substitute new technology services or current services of other
than Seller's that offer price/performance benefits in place of those
services included in Attachment 1.
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1.1 LABOR RATES
SAIC shall pay SELLER up to $1,917,356.95 in compensation for the performance of
the tasks set forth in Attachment 1 of this Agreement. This payment is based on
the expenses outlined in Attachment 2. Funding is limited to that established in
individual task orders.
FTE rates as provided in Attachment 2 shall remain fixed for the period of
performance of this
subcontract agreement for all Time and Material Task Orders
issued hereunder.
1.2 INSPECTION
1.2.1 INSPECTION - TIME AND MATERIALS
All materials furnished and services performed pursuant hereto shall be subject
to inspection and test by Buyer and its agents and by its customers at all times
and places, during the period of performance, and in any event before
acceptance. In the event that material furnished or services supplied are not
performed in accordance with the specifications and instructions of Buyer, Buyer
may require Seller to replace or correct services or materials. The cost of
replacement or correction shall be determined under the Payment clause of this
subcontract, but the "hourly rate" for labor hours incurred in the replacement
or correction shall be reduced to exclude that portion of the rate attributable
to profit. If the Seller fails to proceed with reasonable promptness to perform
required replacement or correction, and if the replacement or correction cannot
be performed within the Not-To-Exceed price, the Buyer may terminate the
subcontract for default.
1.3 INVOICES
Invoices shall be prepared in duplicate and contain the following information;
subcontract number, subproject number, labor categories, hourly rates, labor
hours, extended totals by category, material and other direct costs detail shall
be separated from labor costs.
Invoices will be mailed to:
Science Applications International Corporation
Attention: Xxxxxxxx Xxxxx
0000 Xxxxxxxx Xxxxx, Xxxxx X
Xxxxxxxxx, XX 00000-0000
Invoices shall reference only one (1) purchase order (P.O.) per invoice
although, there may be multiple invoices per P.O. Invoices shall clearly
reference a unique invoice number on each invoice, period of incurred costs, and
the date of the invoice. Invoices shall include the "Amount Previously Billed,"
the "Amount of this Invoice," the "Withhold Amount", and the "Total Amount
Billed to Date" for each labor category. Seller shall submit invoices for the
full amount stating the amount of withhold/retention for each line item billed.
Example: Line Item 1: $ 10,000
- Less withhold: $ 1,000
--------
Total Amount Owed: $ 9,000
Seller's total charges shall be presented in U.S. Dollars for payment in U.S.
Dollars. Any applicable sales tax, use tax, excise tax or duty imposed or levied
by the laws of the nation where the work is being performed, or political
subdivision thereof, shall be separately identified as paid upon every invoice
in order to be eligible for payment.
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Invoices shall be signed and dated by the cognizant Contractual Representative
of the Seller, verifying the costs included are correct.
1.4 PAYMENT
1.4.1 PAYMENT TIME AND MATERIAL TASKS
The Buyer shall pay the Seller upon the submission of invoices approved by the
Buyer as follows:
(a) FTE Rate: The amounts shall be computed by multiplying the appropriate FTE
rates in Section 1.1 by the percentage of effort performed during that
period directly attributable to work performed under the agreement.
Invoices may be submitted once each month to the Buyer. The Seller shall
substantiate invoices by evidence of actual payment, or by individual time
cards, or other substantiation approved by the Buyer. The Buyer shall pay
the invoice within 30 days after approval by Buyer. Overtime rates are not
authorized unless negotiated and approved by Buyer.
(b) Materials and other direct costs. Material and other direct costs, such as
travel, will be reimbursed on an actual-cost basis in accordance with
consistently applied Generally Accepted Accounting Principles. Where
materials are withdrawn from inventories, cost must be determined in
accordance with proper accounting practices consistently followed by
Seller. Seller shall support all material cost claims by submitting
invoices, storeroom requisitions, expense reports, or other substantiation
acceptable to Buyer. Reasonable and allocable materials handling costs may
be included in the charge for material at cost to the extent they are
clearly excluded from hourly rates. The material handling cost shall be 0%
of direct material and other direct costs.
(c) Total cost. It is estimated that the total cost to the Buyer for the
performance of this subcontract shall not exceed the ceiling price. The
Seller agrees to use its best efforts to perform the work within the
ceiling price. If at any time the Seller has reason to believe that the
total price to the Buyer will be substantially greater or less than the
ceiling price, the Seller shall notify the Buyer and provide a revised
estimate for performing the work. The Buyer may withhold 5 percent of the
amount due until contract closeout.
1.5 AUDIT
At any time before final payment the Buyer may request and perform an audit of
the invoices and substantiating material. Each payment previously made shall be
subject to reduction to the extent of amounts that are found by the Buyer not to
have been properly payable in accordance with the payment terms of this
subcontract. Audit will include, but not be limited to, individual daily job
time cards, invoices for material, storeroom requisitions, expense reports, and
other substantiation supporting invoiced amounts.
1.6 WARRANTY
Seller represents and warrants (1) that the rates charged for the goods and/or
services purchased pursuant hereto shall be no higher than Seller's current
rates to any other customer for the same quality and quantity of such goods or
services; (2) that all goods and services delivered pursuant hereto will be new,
unless otherwise specified, and free from defects in material and workmanship;
(3) that all goods and services will conform to applicable specifications,
drawings, and standards of quality and performance, and that all items will be
free from defects in design and suitable for their intended purpose; (4) that
the goods covered by this order are fit and safe for consumer use, if so
intended. All representations and
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warranties of Seller together with its service warranties and guarantees, if
any, shall run to Buyer and Buyer's customers. The foregoing warranties shall
survive any delivery, inspection, acceptance, or payment by Buyer.
1.7 OPTIONS TO EXTEND THE TERM OF THE SUBCONTRACT
This Subcontract is renewable at the hourly rates stated in Attachment I to the
Subcontract, at the option of Buyer, by giving written notice of renewal to the
Subcontractor by the first day of October of each Government fiscal year. The
term of this Subcontract, as renewed, shall be deemed to include this option
provision. However, the term of this subcontract, including the exercise of any
options under this clause, shall not exceed September 29, 2007.
1.8 TASK ORDERS
(a) Only the Buyer's designated Subcontract Representative, as set forth in
paragraph 2.0 hereto, is authorized to place orders hereunder.
(b) All task orders issued hereunder are subject to the terms and conditions
of this Subcontract. The Subcontract shall control in the event of
conflict with any task order. When mailed, a task order shall be "issued"
for purposes of this Subcontract at the time Buyer deposits the order in
the mail, or, if transmitted by other means, when physically delivered to
Seller.
(c) In addition to any other data that may be called for in the subcontract,
the following information shall be specified in each task order, as
applicable:
- Date of order - Period of performance - Buyer furnished
material/value
- Subcontract and order number - Place of performance
- Estimated categories/
- Statement of Work - Acceptance criteria hours
- Not-To-Exceed Ceiling
Price
- Fee (Cost Reimbursable)
(d) The information contained in each task order respecting labor
categories/hours, period of performance, and the Not-To-Exceed Price shall
be the result of either Buyer's estimate or the negotiated agreement
reached by the parties in advance of task order issuance.
(e) Upon receipt of the delivery order, if Seller considers the labor
categories/hours, period of performance, or Not-To-Exceed Price to be
unreasonable, he shall promptly notify Buyer in writing, stating why the
labor categories/hours, period of performance, or Not-To-Exceed Price
considered unreasonable. Notwithstanding this notification, Seller shall,
without delay, provide the services ordered and accomplish the work to the
best of his ability.
(f) Orders may be modified by written agreement between Buyer's Subcontract
Representative and the Seller. Modifications to task orders shall include
the information set forth in paragraph (c) above, as applicable. Buyer's
Subcontract Representative in emergency circumstances may modify orders
orally. Oral modifications shall be confirmed by issuance of a written
modification within seven (7) working days from the time of the oral
communication modifying the order.
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2. TECHNICAL AND CONTRACTUAL REPRESENTATIVES
The following authorized representatives are hereby designated for this
Subcontract:
SELLER: BUYER: SAIC
TECHNICAL: Xxxx Xxxxxxxx TECHNICAL: TBD by Task Order
---------------------- -------------------------
CONTRACTUAL: Xxxxxx Xxxxx CONTRACTUAL: Xxxxxxxx Xxxxx
---------------------- -------------------------
2.1 CONTACTS
Contacts with Buyer, which affect the subcontract prices, schedule, statement of
work, and subcontract terms and conditions shall be made with the authorized
contractual representative. No changes to this Subcontract shall be binding upon
Buyer unless incorporated in a written modification to the Subcontract and
signed by Buyer's contractual representative.
2.2 CHANGES
Buyer may, by written notice to Seller at any time before completion of this
subcontract, make changes within the general scope of this subcontract in any
one of the following: (a) drawings, designs, or specifications; (b) quantity;
(c) place of delivery; (d) method of shipment or routing; and (e) make changes
in the amount of Buyer furnished property. If any such change causes a an
increase or decrease in any labor rate, the ceiling price, or the time required
for the performance of any part of the work under this subcontract, the Buyer
shall make an equitable adjustment in the Not-To-Exceed price, labor rates, or
delivery schedule, and shall modify the subcontract. The Seller must have
notified Buyer in writing of any request for such adjustment within twenty (20)
days from the date of such notice from Buyer or from the date of any act of
Buyer, which Seller considers, constitutes a change. Failure to agree to any
adjustment shall be a dispute under the Disputes clause of this subcontract.
However, Seller shall proceed with the work as changed without interruption and
without awaiting settlement of any such claim under Time and Material Tasks.
3. DISCLOSURE
Seller shall not disclose information concerning work under this Subcontract to
any third party, unless such disclosure is necessary for the performance of the
subcontract effort. No news releases, public announcement, denial or
confirmation of any part of the subject matter of this Subcontract or any phase
of any program hereunder shall be made without prior written consent of Buyer.
The restrictions of this paragraph shall continue in effect upon completion or
the parties may mutually agree upon termination of this Subcontract for such
period of time as in writing. In the absence of a written established period, no
disclosure is authorized. Failure to comply with the provisions of this Clause
may be cause for termination of this subcontract.
Notwithstanding anything to the herein contained, Seller shall be entitled to
disclose the existence of this Agreement, the relationship and the general
provisions of the Agreement on its website, for business communications and in
connection with any regulatory or governmental filing or financing. Such
disclosure shall be provided to SAIC for approval.
4. KEY PERSONNEL
(a) For purposes of this clause, "Key Personnel" is defined as those
individuals who are mutually recognized by Buyer and Seller as essential
to the successful completion and execution of this Subcontract.
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(b) Personnel designated, as "Key Personnel" shall be assigned to the extent
necessary for the timely completion of the task to which assigned. Any
substitution or reassignment involving Seller's "Key Personnel" assigned
to this work shall be made only with persons of equal abilities and
qualifications and is subject to prior approval of Buyer, in writing.
(c) Buyer reserves the right to direct the removal of any individual assigned
to this Subcontract due to inferior performance and/or unethical behavior.
(d) Seller's Key Personnel are: XXXX XXXXXXXX, XLAOWEI JIN
5. ASSIGNMENTS AND SUBCONTRACTS
This Subcontract is not assignable and shall not be assigned by Seller without
the prior written consent of Buyer. Further, Seller agrees to obtain Buyer's
approval before subcontracting this order or any substantial portion thereof;
provided, however, that this limitation shall not apply to the purchase of
standard commercial supplies or raw materials.
6. INSURANCE
Without prejudice to Seller's liability to indemnify Buyer as stated in the
INDEMNIFICATION provision of this Agreement, Seller shall procure, at its
expense, and maintain for the duration of the Agreement, the insurance policies
described below with financially responsible insurance companies, reasonably
acceptable to Buyer, with policy limits not less than those indicated below.
Notwithstanding any provision contained herein, the Seller, and its employees,
agents, representatives, consultants and lower-tier subcontractors and
suppliers, are not insured by Buyer, and are not covered under any policy of
insurance that Buyer has obtained or has in place.
SPECIAL PROVISIONS APPLICABLE TO SELLER'S INSURANCE COVERAGE:
(a) ADDITIONAL INSURED - Seller shall have all policies, except Workers'
Compensation and Employer's Liability, endorsed to name Buyer as an
Additional Insured with respect to the work to be performed by the Seller.
(b) DEDUCTIBLES - Subject to the reasonable review and approval of Buyer, the
Seller may arrange deductibles or self-insured retention's as part of the
required insurance coverage's. However, it is expressly agreed that all
deductibles or self-insured retention's are the sole responsibility of the
Seller.
(c) ADEQUACY OF INSURANCE LIMITS - The insurance coverage limits stated below
are minimum coverage requirements, not limits of liability, and shall not
be construed in any way as Buyer's acceptance of responsibility of the
Seller.
(d) CERTIFICATES OF INSURANCE - Prior to commencement of any work under this
Agreement, the Seller shall furnish Buyer with Certificates of Insurance,
in a format acceptable to Buyer, evidencing the insurance coverage
required in this Agreement and containing the following information:
1. Identify Buyer as an "Additional Insured" with respect to all policies
except Workers' Compensation and employers' liability.
2. State that the underwriters agree to provide Buyer with at least 30
days prior written notice of any cancellation or material change in
the coverage.
(e) Work Within 50' of a Railroad - Exclusion deleted. (If applicable due to
performance of work within 50 feet of a railway)
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6.1 COVERAGE
(a) WORKERS' COMPENSATION - Insurance for statutory obligations imposed by law
including, where applicable, coverage under United States Longshoremen's
and Harbor Workers' Act and Xxxxx Act. (if applicable, Defense Base Act
for those employees working on a U.S. Military installation outside of the
United States).
(b) EMPLOYERS LIABILITY - Insurance with limits of $500,000 for bodily injury
by accident and $500,000 for bodily injury by disease, including, if
applicable, maritime coverage endorsement.
(c) COMMERCIAL GENERAL LIABILITY - including products and completed operations
coverage, full fire legal liability and contractual liability, with a per
occurrence limit of $1,000,000.
(d) BUSINESS AUTO LIABILITY - Coverage for bodily injury and property damage
liability for all owned, hired or non-owned vehicles, with an each
accident limit of $1,000,000.
THE FOLLOWING CLAUSES ARE APPLICABLE TO THIS AGREEMENT IF CHECKED:
/ /(e) PROFESSIONAL LIABILITY - $1,000,000 per occurrence and aggregate
providing coverage for claims arising out of the performance of
professional services, resulting from any error, omission or negligent
act of the Seller.
/ /(f) AIRCRAFT LIABILITY - Covering liability arising out of the use,
operation or maintenance of any aircraft, including passenger
liability, with a per occurrence limit of not less than $10,000,000.
/ /(g) VESSEL LIABILITY - Covering liability arising out of the use,
operation, or charter of a vessel. Protection and Indemnity (including
Xxxxx Act) with limits of liability not less than $5,000,000.
/ /(h) VESSEL HULL & MACHINERY - Covering damage or destruction to the vessel
hull or machinery, Hull and Machinery insurance for the replacement
value of the vessel. Waiver of subrogation in favor of Buyer provided.
/ /(i) SHIP REPAIRERS LEGAL LIABILITY - Covering legal liability arising out
of ship repair or ship maintenance operations, with a per occurrence
limit of liability of not less than $1,000,000.
/ /(j) CONTRACTOR POLLUTION LIABILITY - Covering sudden and non-sudden
release of pollutants resulting in damage to the environment or in
bodily injury arising out of the operations or services of Seller.
Minimum per occurrence limits of liability of $1,000,000.
/ /(k) CONSTRUCTION CONTRACTS - All-Risk Builders risk insurance covering
Seller and Buyer as their interests may appear, on the work, to the
full value thereof, and for loss to Seller's equipment.
/ /(l) AIRCRAFT PRODUCTS LIABILITY - Covering liability arising out of the
manufacture, sale, servicing, repair, distribution, instruction and
operation of aircraft related products or services with a per
occurrence limit of $1,000,000.
/ /(m) NUCLEAR S&T LIABILITY - Covering legal liability due to bodily injury
or property damage caused by the nuclear energy hazard, excluding work
performed at or for a nuclear facility, with a per occurrence limit of
$1,000,000.
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7. INDEMNIFICATION
(a) Seller shall indemnify, defend and hold SAIC and SAIC's customers harmless
from and against any and all damages, losses, liabilities and expenses
(including reasonable attorneys' fees) arising out of or relating to any
claims, causes of action, lawsuits or other proceedings, regardless of
legal theory, that result, in whole or in part, from Seller's (or any of
Seller's subcontractors, suppliers, employees, agents or representatives):
(i) intentional misconduct, negligence, or fraud, (ii) breach of any
representation, warranty or covenant made herein, or (iii) products or
services including, without limitation, any claims that such products or
services infringe any United States patent, copyright, trademark, trade
secret or any other proprietary right of any third party. Notwithstanding
the foregoing, Seller's obligations under this Section shall not apply to
any claims, which are finally determined by a court of competent
jurisdiction to be occasioned by the negligence or willful misconduct of
SAIC.
{b) Buyer shall promptly notify Seller of any claim against Buyer, which is
covered by this indemnification provision and shall authorize
representatives of Seller to settle or defend any such claim or suit and
to represent Buyer in, or to take charge of, any litigation in connection
therewith.
8. INFRINGEMENT INDEMNITY
(a) In lieu of any warranty by Buyer or Seller against infringement, statutory
or otherwise, it is agreed that Seller shall defend, at its expense, any
suit against Buyer or its customers based on a claim that any item
furnished under this order or the normal use or sale thereof infringes any
U.S. Letters patent or copyright, and shall pay costs and damages finally
awarded in any such suit, provided that Seller is notified in writing of
the suit and given authority, information, and assistance at Seller's
expense for the defense of same. If the use or sale of said item is
enjoined as a result of such suit, Seller, at no expense to Buyer, shall
obtain for Buyer and its customers the right to use and sell said item or
shall substitute an equivalent item acceptable to Buyer and extend this
patent indemnity thereto.
(b) Notwithstanding the foregoing paragraph, when this order is performed
under the Authorization and Consent of the U.S. Government to infringe
U.S. Patents, Seller's liability for infringement of such Patents in such
performance shall be limited to the extent of the obligation of Buyer to
indemnify the U.S. Government.
9. PROPRIETARY INFORMATION, TOOLS, MATERIALS, ETC.
(a) Seller agrees it will keep confidential and not use any material, jigs,
dies, fixtures, molds, patterns, taps, gauges, other equipment, designs,
sketches, specifications, drawings, computer programs and software, or
other data or information furnished by Buyer for any purpose whatsoever
other than as herein specified, including but not limited to the
manufacture of large quantities, without prior written consent of Buyer.
All materials, jigs, dies, fixtures, molds, patterns, taps, gauges, other
equipment, designs, sketches, specifications, drawings, computer programs
and software, or other data or information furnished by Buyer, whether
loaned to Seller or fabricated, manufactured, purchased, or otherwise
acquired by Seller for the performance of this Subcontract and
specifically charged to Buyer are the property of Buyer. They are to be
marked for identification as Buyer may designate, and upon completion or
termination of this Subcontract shall be returned to Buyer in good
condition, reasonable wear only excepted, together with all spoiled and
surplus material, unless otherwise directed in writing by Buyer. Seller
agrees
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to replace, at its expense, all such items not so returned. Seller shall
make no charge for any storage, maintenance or retention of such property
of Buyer. Seller shall bear all risk of loss for all of Buyer's property
in Seller's possession.
(b) If Buyer furnishes any material for fabrication hereunder, Seller agrees:
(i) not to substitute any other material in such fabrication without
Buyer's prior written consent, (ii) that title to such material shall not
be affected by incorporation in or attachment to any other property; and
(iii) to state and warrant on its packing sheet and invoice for final
parts: "All materials furnished by Buyer on this order (except that which
becomes normal industrial waste or was replaced at Seller's expense) has
been returned in the form of parts or held as unused material for Buyer's
disposition."
(c) The commercialization of models and other research tools developed under
this program must not be restricted. Investigators should be aware of and
are expected to follow along with, as appropriate, the provisions of the
PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS AND
CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
(64 FR 72090, December 23, 1999) and the NIH GRANTS POLICY STATEMENT
concerning the availability of research results: publications,
intellectual property rights, and sharing biomedical research resources.
10. DISPUTES
Any dispute not disposed of in accordance with the "Disputes Clause" of Schedule
B, if any, shall be determined in the following manner.
(a) Buyer and Seller agree to enter into Negotiation to resolve any dispute.
Both parties agree to negotiate in good faith to reach a mutually
agreeable settlement within a reasonable amount of time.
(b) If negotiations are unsuccessful, Buyer and Seller agree to enter into
binding Arbitration. The American Arbitration Association (AAA) Commercial
Arbitration Rules (most recent edition) are to govern this Arbitration.
The Arbitration shall take place in the County of Fairfax, State of
Virginia. The Arbitrator shall be bound to follow the applicable
subcontract provisions and Virginia law in adjudicating the dispute. It is
agreed by both parties that the Arbitrator's decision is final, and that
no party may take any action, judicial or administrative, to overturn this
decision. The judgment rendered by the Arbitrator may be entered in any
court having jurisdiction thereof.
Pending any decision, appeal or judgment referred to in this provision or
the settlement of any dispute arising under this Subcontract, Seller shall
proceed diligently with the performance of this Subcontract.
11. DEFAULT
(a) The Buyer may, by written notice of default to the Seller, terminate the
whole or any part of this Subcontract in any one of the following
circumstances: (i) if Seller fails to make progress in the work so as to
endanger performance or (ii) if Seller fails to perform any of the other
provisions of this Subcontract in accordance with its terms, and in either
of these two circumstances does not provide a plan to cure such failure
within a period of 10 days (or such longer period as Buyer may authorize
in writing) after receipt of notice from the Buyer specifying such
failure; or (iii) Seller becomes insolvent or the subject of proceedings
under any law relating to bankruptcy or the relief of debtors or admits in
writing its inability to pay its debts as they become due.
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(b) If this Subcontract is so terminated, Seller shall submit a final
termination settlement proposal to the Buyer. The Seller shall submit the
proposal promptly but no later than six (i) months from the effective date
of the termination. If Seller fails to submit the proposal within the time
allowed, the Buyer may determine the amount, if any, due the Seller
because of the termination. For Time and Materials, the amount will be
determined as follows; (i) An amount for direct labor hours determined by
multiplying the number of direct labor hours expended before the effective
date of termination by the hourly rates, less profit, in the Schedule,
less any hourly rate payments already made to the Seller; (ii) An amount
for material expenses incurred before the effective date of termination,
not previously paid to the Seller.
(c) Seller shall transfer title and deliver to Buyer, in the manner and to the
extent requested in writing by Buyer at or after termination such complete
articles, partially completed articles and materials, parts, tools, dies,
patterns, jigs, fixtures, plans, drawings, information and contract rights
as Seller has produced or acquired for the performance of the terminated
part of this Subcontract, and Buyer will pay Seller the contract price for
complete articles delivered to and accepted by Buyer and the fair value of
the other property of Seller so requested and delivered.
(d) Seller shall continue performance of this Subcontract to the extent not
terminated. Buyer shall have no obligations to Seller with respect to the
terminated part of this Subcontract except as herein provided. In case of
Seller's default, Buyer's rights as set forth herein shall be in addition
to Buyer's other rights although not set forth in this Subcontract.
(e) Seller shall not be liable for damages resulting from default due to
causes beyond the Seller's control and without Seller's fault or
negligence, provided, however, that if Seller's default is caused by the
default of a subcontractor or supplier, such default must arise out of
causes beyond the control of both Seller and subcontractor or supplier,
and without the fault or negligence of either of them and, provided
further, the supplies or services to be furnished by the subcontractor or
supplier were not obtainable from other sources.
12. SUBCONTRACT CLOSEOUT
Within sixty-calendar days after the end of the period of performance for the
services to be procured herein, as described in the Attachment I Statement of
Work and the satisfactory completion of which shall be solely determined by
Buyer, Buyer will issue to Seller a Subcontract Closeout Package. The Package
will include, as applicable, Subcontractor Release of Claims; Subcontractor's
Assignment of Refunds, Rebates, Credits, and Other Amounts; Subcontract Patents
Report; and any other documentation or request for information considered
necessary by Buyer to closeout this
Subcontract Agreement.
Seller agrees to submit all information and documentation, including a FINAL
invoice bearing the statement, "THIS FINAL INVOICE WAS PREPARED USING FINAL
AUDITED RATES" as required by the Subcontract Closeout Package within
thirty-calendar days of the date of the Package. The parties further agree if
the information and documentation submitted by Seller is found acceptable by
Buyer, with or without negotiations (the necessity for which shall be solely
determined by Buyer), to be bound by Seller's closeout submission as the final
agreement between the parties with respect thereto.
In the event Seller fails to submit the required closeout information and
documentation in a timely manner, such failure shall constitute Seller's express
agreement that the amounts paid to date by Buyer pursuant to this Agreement, as
determined by Buyer's records, constitute the full, complete and final extent of
Buyer's financial obligation to Seller, that Seller does forever fully and
finally remise, release, and discharge Buyer, its officers, agents and
employees, of and
SAIC Federal Procurement Procedures Page 10
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from any and all liabilities, obligations, claims, and demands whatsoever
arising under or relating to this
Subcontract Agreement, and that Seller
expressly authorizes Buyer to rely on the foregoing representations and release
in connection with Buyer's closeout of or other actions taken with respect to
Buyer's contract with the Government.
13. GENERAL RELATIONSHIP
The Subcontractor is not an employee of SAIC for any purpose whatsoever. Seller
agrees that in all matters relating to this Subcontract it shall be acting as an
independent contractor and shall assume and pay all liabilities and perform all
obligations imposed with respect to the performance of this Subcontract. Seller
shall have no right, power or authority to create any obligation, expressed or
implied, on behalf of Buyer and/or the Government and shall have no authority to
represent Buyer as an agent.
14. NON-WAIVER OF RIGHTS
The failure of Buyer to insist upon strict performance of any of the terms and
conditions in the Subcontract, or to exercise any rights or remedies, shall not
be construed as a waiver of its rights to assert any of the same or to rely on
any such terms or conditions at any time thereafter. The invalidity in whole or
in part of any term or condition of this subcontract shall not affect the
validity of other parts hereof.
15. APPLICABLE STATE LAW AND COMPLIANCE
This Subcontract shall be governed by and construed in accordance with the laws
of the State of California. Seller agrees to comply with the applicable
provisions of any Federal, state or local law or ordinance and all orders, rules
and regulations issued there under.
16. EXPORT CONTROL COMPLIANCE FOR FOREIGN PERSONS
The subject technology of this Subcontract (together including data, services,
and hardware provided hereunder) may be controlled for export purposes under the
International Traffic in Arms Regulations (ITAR) controlled by the U.S.
Department of State or the Export Administration Regulations ("EAR") controlled
by the U.S. Department of Commerce. ITAR controlled technology may not be
exported without prior written authorization and certain EAR technology requires
a prior license depending upon its categorization, destination, end-user and
end-use. Exports of any U.S. technology to Iran, Iraq, Libya, North Korea,
Sudan, Cuba, and other destinations under U.S. sanction or embargo are
forbidden.
Access to certain technology ("Controlled Technology") by Foreign Persons
(working legally in the U.S.), as defined below, may require an export license
if the Controlled Technology would require a license prior to delivery to the
Foreign Person's country of origin. SELLER is bound by U.S. export statutes and
regulations and shall comply with all U.S. export laws. SELLER shall have full
responsibility for obtaining any export licenses or authorization required to
fulfill its obligations under this Subcontract.
SELLER hereby certifies that all SELLER employees who have access to the
Controlled Technology are U.S. citizens, have a valid green card or, have been
granted political asylum or refugee status in accordance with
8 U.S.C. 1324b(a)(3). Any non-citizens who do not meet one of these criteria are
"Foreign Persons" within the meaning of this clause but have been authorized
under export licenses to perform their work hereunder.
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17. EXPORT LAWS AND REGULATIONS
Each Party agrees that it will comply with all applicable U.S. Export Laws and
Regulations and that each will neither undertake, nor cause, nor permit to be
undertaken, any activity which is (1) illegal under any laws, decrees, rules or
regulations in effect in the United States; or (2) would have the effect of
causing the other Party to be in violation of any laws, decrees, rules or
regulations in effect in the United States through the period of this Agreement
and any applicable Addenda, as these laws are modified from time to time.
18. ORDER OF PRECEDENCE
The documents listed below are hereby incorporated by reference. In the event of
an inconsistency or conflict between or among the provisions of this
Subcontract, the inconsistency shall be resolved by giving precedence in the
following order:
1. Attachment I: Statement of Work dated May 15, 2005.
2. Attachment II: Summary of Costs
3. Schedule A: Specific Terms and Conditions Form 0-000-000 (Rev.
5/14/2003).
4. Schedule B: Part I U.S. Government Terms and Conditions Form 0-000-000
(Rev. 7/00).
5. Schedule B: Part II Special Requirements/Contract Clauses
6. Schedule B: Part III Reporting Requirements
7. Intellectual Property Management Plan, Dated June 3, 2005
8. Any Referenced Specifications (current edition).
19. ENTIRE AGREEMENT
The parties hereby agree that this Subcontract, including all documents
incorporated herein by reference, shall constitute the entire agreement and
understanding between the parties hereto and shall supersede and replace any and
all prior or contemporaneous representations, agreements or understandings of
any kind, whether written or oral, relating to the subject matter hereof.
In witness whereof, the duly authorized representatives of Buyer and the Seller
have executed this Subcontract on the Dates shown.
Seller:
COMBINATORX, INCORPORATED SCIENCE APPLICATIONS INTERNATIONAL CORPORATION
---------------------------------------
(Company Name)
x /s/ Xxxxxx Xxxxxx x /s/ Xxxxxxxx X. Xxxxx
-------------------------------------------------------------------------
(Signature) (Signature)
NAME: XXXXXX XXXXXX NAME: XXXXXXXX X. XXXXX
-------------------------------------------------------------------------
(Type or Print) (Type or Print)
TITLE: PRESIDENT AND CEO TITLE: SUBCONTRACTS MANAGER
-------------------------------------------------------------------------
DATE: 7/19/05 DATE: 8/12/05
-------------------------------------------------------------------------
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PRIME CONTRACT NO.: N01-NS-3-2356
ATTACHMENT I
STATEMENT OF WORK
IN VITRO BIOLOGICAL ASSAY SUPPORT FOR SMA
MAY 15, 2005
Independently, and not as an agent of SAIC, the Contractor, CombinatoRx, shall
furnish services, qualified professional and technical personnel, material,
equipment, and facilities directly or through subcontractors to provide in vitro
biological assay support services for the SMA Project under the direction of
SAIC. Specifically, CombinatoRx shall provide the following essential services
in an efficient and timely manner:
1. PROGRAM MANAGEMENT SUPPORT
CombinatoRx shall ensure that all services are being conducted in an
efficient, high quality manner, that progress is routinely and effectively
communicated to SAIC, and that the receipt and distribution of SMA Project
materials and information by CombinatoRx is timely and accurate. As
requested, CombinatoRx will develop recommendations to address SMA Project
objectives.
2. COMPOUND SCREENING
CombinatoRx shall provide in vitro assay implementation and compound
screening to support iterative chemical optimization efforts to identify
compounds with improved bioactivity, safety, and pharmacokinetic (ADME)
characteristics for development of an SMA therapeutic.
3. INFORMATICS SUPPORT
CombinatoRx shall enter biological data generated by CombinatoRx and/or
other facilities into the SMA Project's centralized informatics system in
a format that is appropriate for this system. This informatics system will
be managed and maintained by a third party. CombinatoRx shall track and
store compounds received for use within CombinatoRx facilities to insure
that the compounds can be identified, retrieved and re-distributed as
necessary. CombinatoRx shall store and maintain SMA Project compounds with
methods that adhere to high standards of quality assurance to insure
compound integrity. Global compound management services for the SMA
Project will be the responsibility of a third party.
CombinatoRx may be requested to provide the following optional services,
upon request by SAIC. Price and level of effort will be negotiated at the
task order level.
4. IMPROVEMENTS TO EXISTING ASSAYS
CombinatoRx shall provide improvements to existing assays to increase the
efficiency and reliability of compound screening.
5. PREPARATION OF BIOLOGICAL SAMPLES
CombinatoRx shall provide preparation of biological samples, e.g., plated
cells, for assays to be performed at other SMA Project and/or collaborator
facilities.
Attachment I - Statement of Work Page 14
PRIME CONTRACT NO.: N01-NS-3-2356
6. DEVELOPMENT OF NEW ASSAYS
7. PROCESSING AND TESTING OF BIOLOGICAL SPECIMENS
CombinatoRx shall process and test biological specimen received from other
SMA Project facilities or collaborators.
8. OTHER SERVICES, WITHIN COMBINATORX CAPABILITIES, THAT ASSIST IN MEETING
SMA PROJECT OBJECTIVES
Prior to initiation of a new task under any of the aforementioned optional
services, CombinatoRx shall provide project plans, timelines, milestones, and a
schedule of deliverables for approval by SAIC. As part of this process, SAIC may
request that CombinatoRx submit a technical approach, cost estimate, and other
relevant material.
Attachment I - Statement of Work Page 15
PRIME CONTRACT NO.: N01-NS-3-2356
SCHEDULE B
U.S. GOVERNMENT TERMS AND CONDITIONS
Applicable to all U.S. Government subcontracts
PART I - FAR CLAUSES
1. DEFINITIONS
In all such clauses, unless the context of the clause requires otherwise, the
term "Contractor" shall mean Seller, the term "Contract" shall mean this Order,
and the terms "Government," "Contracting Officer" and equivalent phrases shall
mean Buyer and Buyer's Purchasing Representative, 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 Buyer, to insure
Seller's obligations to Buyer and to the United States Government, and to enable
Buyer to meet its obligations under its Prime Contract or Subcontract.
The following definitions apply unless otherwise specifically stated:
"Buyer" - the legal entity issuing this Order.
"Purchasing Representative" -Buyer's authorized representative.
"Seller" - the legal entity which contracts with the Buyer.
"This Order" - this contractual instrument, including changes.
"Prime Contract" - the Government contract under which this Order is
issued.
"FAR" - the Federal Acquisition Regulation.
2. IDENTIFICATION OF CONTRACT NUMBERS
Government contract numbers shown on this Order shall be included in
subcontracts and purchase orders issued by Seller hereunder.
3. DISPUTES
(a) Notwithstanding any provisions herein to the contrary:
(1) If a decision relating to the Prime Contract is made by the
Contracting Officer and such decision is also related to this Order,
said decision, if binding upon Buyer under the Prime Contract shall in
turn be binding upon Buyer and Seller with respect to such matter;
provided, however, that if Seller disagrees with any such decision
made by the Contracting Officer and Buyer elects not to appeal such
decision, Seller shall have the right reserved to Buyer under the
Prime Contract with the Government to prosecute a timely appeal in the
name of Buyer, as permitted by the contract or by law, Seller to bear
its own legal and other costs. If Buyer elects not to appeal any such
decision, Buyer agrees to notify Seller in a timely fashion after
receipt of such decision and to assist Seller in its prosecution of
any such appeal in every reasonable manner. If Buyer elects to appeal
any such decision of the Contracting Officer, Buyer agrees to furnish
Seller promptly with a copy of such appeal. Any decision upon appeal,
if binding upon Buyer, shall in turn be binding upon Seller. Pending
the making of any decision, either by the Contracting Officer or on
appeal, Seller shall proceed diligently with performance of this
Order.
Schedule B (Part I) - FAR Clauses Page 16
PRIME CONTRACT NO.: N01-NS-3-2356
(2) If, as a result of any decision or judgment which is binding upon
Seller and Buyer, as provided above, Buyer is unable to obtain payment
or reimbursement from the Government under the Prime Contract for, or
is required to refund or credit to the Government, any amount with
respect to any item or matter for which Buyer has reimbursed or paid
Seller, Seller shall, on demand, promptly repay such amount to Buyer.
Additionally, pending the final conclusion of any appeal hereunder,
Seller shall, on demand, promptly repay any such amount to Buyer.
Buyer's maximum liability for any matter connected with or related to
this Order which was properly the subject of a claim against the
Government under the Prime Contract shall not exceed the amount of
Buyer's recovery from the Government.
(3) If this Order is issued by Buyer under a Government Subcontract rather
than a Prime Contract, and If Buyer has the right under such
Subcontract to appeal a decision made by the Contracting Officer under
the Prime Contract in the name of the Prime Contractor (or if Buyer is
subject to any arbitrator's decision under the terms of its
subcontract), and said decision is also related to this Order, this
Disputes Clause shall also apply to Seller in a manner consistent with
its intent and similar to its application had this Order been issued
by Buyer under a Prime Contract with the Government.
(4) Seller agrees to provide certification that data supporting any claim
made by Seller hereunder is made in good faith and that the supporting
data is accurate and complete to the best of Seller's knowledge or
belief, all in accordance with the requirements of the Contract
Disputes Act of 1978 (41USC601-613) and implementing regulations. If
any claim of Seller is determined to be based upon fraud or
misrepresentation, Seller agrees to defend, indemnify and hold Buyer
harmless for any and all liability, loss, cost or expense resulting
therefrom.
(b) Any dispute not addressed In paragraph (a) above will be subject to the
disputes clause of Schedule A of this
subcontract agreement.
4. OTHER GOVERNMENT PROCUREMENT
Nothing contained herein shall be construed as precluding the Seller from
producing items for direct sale to the Government, utilizing therefore all
hardware and/or software, including designs, drawings, engineering data or other
technical or proprietary information furnished Seller by Buyer, provided the
Government has the unrestricted right to permit the use thereof for such
purpose.
5. INDEMNIFICATION - COST OR PRICING DATA - COST ACCOUNTING STANDARDS
Seller agrees to indemnify and hold Buyer harmless to the full extent of any
cost or price reduction effected by Buyer's customer, which may result from (i)
certified cost or pricing data submitted by Seller or its lower-tier
subcontractors which is not accurate, current or complete as certified by
Seller; (ii) the failure by Seller or its lower-tier subcontractors to disclose
and consistently follow applicable cost accounting practices and standards or
otherwise comply with pertinent parts of the FAR, applicable agency supplements
thereto, and regulations promulgated by the Cost Accounting Standards Board.
6. TERMINATION FOR CONVENIENCE
The Buyer may terminate performance of work under this subcontract in whole or
in part if the Purchasing Representative determines that a termination is in the
Buyer's interest. The Buyer shall terminate by delivering to the Seller a Notice
of Termination specifying the extent of
Schedule B (Part I) - FAR CLAUSES Page 17
PRIME CONTRACT NO.: N01-NS-3-2356
termination and the effective date. Termination will be in accordance with FAR
52.249-6 (Sep 1996).
7. GOVERNMENT PROPERTY
Seller shall comply with the Government Property requirements contained in FAR
clause 52.245-2 (Jun 2003) if this is a fixed priced contract and FAR clause
52.245-5 (Jun 2003) (substituting 52.245-2 subparagraph (g) for 52.245-5
subparagraphs (g) (1), (2), and (3) if this is a cost reimbursement contract.
8. CONTRACT COST PRINCIPLES AND PROCEDURES
Seller agrees that to the extent applicable, costs allocated to this contract
shall be in full compliance with Subpart 31.2 of FAR (Subpart 31.3 for
Educational Institutions) and the applicable agency supplements thereto, if any,
set forth in Part II hereof. In the event such compliance is not maintained,
Seller agrees to compensate Buyer to the full extent of any prices or costs,
including any penalties or interest, which are determined by Buyer's customer to
be unallowable or unreasonable or not allocable, under Buyer's contract with its
customer.
9. FAR CLAUSES APPLICABLE TO THIS ORDER
The clauses in FAR Subpart 52.2 referenced in subparagraph (a), the clauses
applicable at the dollar thresholds in subparagraph (b), and those clauses
referenced and checked in subparagraph (c) below, in effect on the date of this
Order, are incorporated herein and made a part of this Order. To the extent that
an earlier version of any such clause is included in the Prime Contract or
Subcontract under which this Order is issued, the date of the clause as it
appears in such Prime Contract or Subcontract shall be controlling and said
version shall be incorporated herein.
(a) The following clauses are applicable to this Order:
Clause/FAR
Reference Title of Clause
---------- ---------------
52.203-3 Gratuities (Apr 1984)
52.211-5 Material Requirements (Aug 2000)
52.214-34 Submission of Offers in the English Language (Apr 1991)
52.214-35 Submission of Offers in U.S. Currency (Apr 1991)
52.222-1 Notice to the Government of Labor Disputes (Feb 1997)
52.222-26 Equal Opportunity (Only Paragraphs (b)(1) through (b)(11) (Apr 2002)
52.223-3 Hazardous Material Identification and Material Safety Data (Jan 1997)
52.225-13 Restrictions on Certain Foreign Purchases (Jun 2003)
52.229-3 Federal, State, and Local Taxes (Apr 2003)
52.229-8 Taxes - Foreign Cost-Reimbursement Contracts (Mar 1990)
(b) The following clauses are applicable to this Order at the indicated dollar
values:
Clause/FAR
Reference Title of Clause
---------- ---------------
52.203-5 Covenant Against Contingent Fees (if order exceeds $50,000) (Apr 1984)
52.203-6 Restrictions on Subcontractor Sales to the Government (if order exceeds
$100,000) (Jul 1995)
52.203-7 Anti-Kickback Procedures (if order exceeds $100,000) (Jul 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Jan 1997)
Schedule B (Part I) - FAR Clauses Page 18
PRIME CONTRACT NO.: N01-NS-3-2356
52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (If order exceeds
$50,000) (Jan 1997)
52.203-11 Certification and Disclosure Regarding Payments to Influence
Certain Federal Transactions (if order exceeds or is expected
to exceed $100,000) (Apr 1991)
52.203-12 Limitation on Payments to Influence Certain Federal Transactions (If order
exceeds or is expected to exceed $100,000) (Jun 2003)
52.209-6 Protecting the Governments Interest when Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment (if Order exceeds $25,000)
(Jul 1995)
52.215-2 Audit and Records-Negotiation (if Order exceeds $50,000) (Jun 1999)
52.216-11 Cost Contract - No Fee (Applies to Non-profit and Educational Institutes)
(Apr 1984)
52.216-15 Predetermined Indirect Cost Rates (Applies to Non-profit and Educational
Institutes) (Aug 1984)
52.219-8 Utilization of Small Business Concerns (if Order exceeds $50,000} (Oct 2000)
52.219-9 Small Business Subcontracting Plan (if Subcontract exceeds or is expected to
exceed $500,000) (Jan 2002)
52.222-4 Contract Work Hours & Safety Standards Act - Overtime Compensation (if Order
exceeds $100,000) (Sep 2000)
52.222-35 Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era (if
Order exceeds $10,000) (Dec 2001)
52.222-36 Affirmative Action for Workers with Disabilities (if Order exceeds $2,500)
(Jun 1998)
52.222-37 Employment Reports on Special Disabled Veterans and Veterans of the Vietnam
Era (If Order exceeds $10,000) (Dec 2001)
52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (if Order
exceeds $50,000) (Aug 1996)
52.246-16 Responsibility for Supplies (if order exceeds $50,000) (Apr 1984)
52.247-63 Preference for U.S. Flag Air Carriers (if order exceeds $50,000) (Jun 2003)
52.247-64 Preference for Privately-Owned U.S. Flag Commercial Vessels (Apr 2003)
(c) The following clauses are applicable to this Order:
Clause/FAR
Reference Title of Clause
---------- ---------------
52.204-2 Security Requirements (Aug 1996)
52.204-4 Printing/Copying Double Sided on Recycled Paper (Aug 2000)
52.215-10 Price Reduction for Defective Cost or Pricing Data (Oct 1997)
52.215-12 Subcontractor Cost or Pricing Data (Oct 1997)
52.215-13 Subcontractor Cost or Pricing Data - Modifications (Oct 1997)
52.215-15 Termination of Defined Benefit Pension Plans (Dec 1998)
52.215-18 Reversion or Adjustment of Plans for Post-Retirement Benefits Other Than
Pensions (Oct 1997)
52.215-19 Notification of Ownership Changes (Oct 1997)
52.215-21 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data - Mods (Oct 1997)
52.216-7 Allowable Cost and Payment (Dec 2002)
52.216-8 Fixed Fee (Mar 1997)
52.219-16 Liquidated Damages-Subcontracting Plan (Over $500.000) (Jan 1999)
52.222-2 Payment for Overtime Premiums -Subparagraph (a) Add "0" (Jul 1990)
52.222-3 Convict Labor (Jun 2003)
52.223-6 Drug Free Workplace (May 2001)
Schedule B (Part I) - FAR Clauses Page 19
PRIME CONTRACT NO.: N01-NS-3-2356
52.223-14 Toxic Chemical Release Reporting (Aug 2003)
52.225-1 Buy American Act -Balance of Payments Program - Supplies (Jun 2003)
52.227-1 Authorization and Consent - Alternate I (Jul 1995)
52.227-11 Patent Rights - Retention by the Contractor (Short Form) (Jun 1997)
52.227-14 Rights in Data - General (Alternate I, II, III, IV, or V) (Jun 1987)
52.227-16 Additional Data Requirements (Jun 1987)
52.232-9 Limitation on Withholding of Payments (Apr 1984)
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 (Feb 2002)
52.239-1 Privacy or Security Safeguards (Aug 1996)
52.242-1 Notice of Intent to Disallow Costs (Apr 1 984)
52.242-3 Penalties for Unallowable Costs (May 2001)
52.242-4 Certification of Indirect Costs (Jan 1997)
52.242-13 Bankruptcy (Jul 1995)
52.242-15 Stop-Work Order (Aug 1989)
52.243-2 Changes - Cost-Reimbursement - Alternate V (Aug 1987)
52.244-2 Subcontracts (Aug 1998)
52.244-5 Competition in Subcontracting (Dec 1996)
52.246-23 Limitation of Liability (Feb 1997)
52.249-14 Excusable Delays (Apr 1984)
52.253-1 Computer Generated Forms (Jan 1991)
Schedule B (Part I) - FAR Clauses Page 20
PRIME CONTRACT NO.: N01-NS-3-2356
SCHEDULE B
CONTRACT CLAUSES
NATIONAL INSTITUTES OF HEALTH
PART II - SPECIAL REQUIREMENTS/CONTRACT CLAUSES
1. DEFINITIONS
In all such clauses, unless the context of the clause requires otherwise, the
term "Contractor" shall mean Seller, the term "Contract" shall mean this Order,
and the terms "Government," and "Contracting Officer," (and equivalent phrases)
shall mean Buyer and Buyer's Purchasing Representative, 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 Buyer, to
insure Seller's obligations to Buyer and to the United States Government, and to
enable Buyer to meet its obligations under its Prime Contract or Subcontract.
The following definitions apply unless otherwise specifically stated:
"Buyer" - the legal entity issuing this Order.
"Purchasing Representative" - Buyer's authorized representative.
"Seller" - the legal entity that contracts with the Buyer.
"This Order" - this contractual instrument, including changes.
"Prime Contract" - the Government contract under which this Order is Issued.
"FAR" - the Federal Acquisition Regulation.
2. HUMAN SUBJECTS AND HUMAN SPECIMENS(1)
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, will be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
Research involving tissues or other biological specimens derived from living or
deceased humans and cell lines derived from human tissues may only be conducted
if offerors have demonstrated their compliance with all appropriate guidelines
pertaining to the use of human specimens and have obtained approval of the
Contracting Officer. Please see the NIH brochure, RESEARCH ON HUMAN SPECIMENS:
ARE YOU CONDUCTING RESEARCH USING HUMAN SUBJECTS?, which is available on the Web
at xxxx://xxx.xxx.xxx.xxx.xxx.xxx/xxxxxxxx.xxxx and is based on REGULATIONS FOR
PROTECTION OF HUMAN SUBJECTS (45 CFR Part 46) and the conditions outlined in HHS
Acquisition Regulation 352,270-8.
----------
(1) Offerors must read, initial, and sign the Memorandum on Requirements Related
to Human Subjects, Specimens, and Recombinant DNA Research (Attachment 2), and
submit this document with the
Subcontract Agreement.
Schedule B (Part II) - Special Requirements/Contract Clauses Page 21
PRIME CONTRACT NO.: N01-NS-3-2356
3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH(1)
(a) Pursuant to Public Law(s) cited in paragraph (b), below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos
for research purposes; or (2) research in which a human embryo or embryos
are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45
CFR 46.204(b) 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.
The NIH has published final guidelines on stem cell research that relates
to this topic. The URL is xxxx://xxxxxxxxx.xxx.xxx/xxxxx.xxx.
(b) PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
-------------------------- ----------- --------------
108-199, Section 510 2004 10/01/2003 - 09/30/2004
4. RECOMBINANT DMA AND HUMAN GENE TRANSFER RESEARCH(1)
The NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT
DNA MOLECULES (NIH GUIDELINES) apply to NIH-funded and non-NIH-funded gene
transfer projects that are conducted at or sponsored by an institution that
receives NIH support for recombinant DNA research. As defined by the NIH
GUIDELINES, recombinant DNA molecules are either: (1) molecules that are
constructed outside living cells by joining natural or synthetic DNA segments to
DNA molecules that can replicate in a living cell; or (2) DNA molecules that
result from the replication of those described in (1). The NIH GUIDELINES set
forth principles and standards for safe and ethical conduct of recombinant DNA
research and apply to both basic and clinical research studies. Specific
guidance for the conduct of human gene transfer studies can be found at the
following link xxxx://xxx0.xx.xxx.xxx/xxx/xxx/xxxxxxxxxx/xxxxxxxxxx.xxxx. The
NIH GUIDELINES should be carefully reviewed to ensure compliance with all other
requirements.
5. 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 Contracting Officer and the Office of Laboratory
Animal Welfare (OLAW), Office of Extramural Research (OER), Office of the
Director, NIH, of an assurance to comply with the PHS Policy on Humane Care and
Use of Laboratory Animals (available on the Web at
xxxx://xxxxxx.xxx.xxx/xxxxxx/xxxx/xxxxxxxxxx/xxxxxx.xxx). This restriction
applies to all performance sites (e.g., collaborating institutions,
subcontractors, and subgrantees) without OLAW-approved assurances, whether
domestic or foreign.
----------
(1) Offerors must read, initial, and sign the Memorandum on Requirements Related
to Human Subjects, Specimens, and Recombinant DNA Research (Attachment 2), and
submit this document with the
Subcontract Agreement.
Schedule B (Part II) - Special Requirements/Contract Clauses Page 22
PRIME CONTRACT NO.: N01-NS-3-2356
6. ANIMAL WELFARE ASSURANCE (AWA)
In accordance with the PHS Policy on Humane Care and Use of Laboratory Animals
(available at xxxx://xxxxxx.xxx.xxx/xxxxxx/xxxx/xxxxxxxxxx/xxxxxx.xxx), prior to
the start of any work that involves the care or use of animals, the Contractor
shall obtain and submit copies of the following documentation:
(a) An approved AWA from the OLAW as required by Section IV-D-2 of the PHS
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 care and
use of animals shall also obtain and maintain an approved AWA. EVIDENCE OF
AWA APPROVAL MUST BE SUBMITTED WITH THE SUPPORTING DOCUMENTATION.
(b) Verification of approval (including the date of the most recent approval)
by the Institutional Animal Care and Use Committee (IACUC) of those
components related to the care and use of animals for work supported by
this agreement.
- The following information must accompany documentation of IACUC
approval:
- Identification of the species and approximate number of animals to
be used.
- Rationale for involving animals, and for the appropriateness of the
species and numbers used.
- A complete description of the proposed use of the animals.
- A description of the procedures designed to assure that discomfort
and injury to animals will be limited to that which is unavoidable
in the conduct of scientifically valuable research, and that
analgesic, anesthetic, and tranquilizing drugs will be used where
Indicated and appropriate to minimize discomfort and pain to
animals.
- A description of any euthanasia method to be used.
- Documentation for the aforementioned list can be in the form of a copy
of the application submitted to the offeror's IACUC.
7. SALARY RATE LIMITATION LEGISLATION PROVISIONS
(a) Pursuant to Public Law(s) cited in paragraph (b), below, no NlH Fiscal
Year funds may be used to pay the direct salary of an individual through
this contract at a rate in excess of the applicable amount shown for the
fiscal year covered. Direct salary is exclusive of fringe benefits,
overhead, and general and administrative expenses (also referred to as
"indirect cost" of "facilities and administrative (F&A) costs"). Direct
salary has the same meaning as the term "institutional base salary." An
individual's direct salary (or institutional base salary) Is the annual
compensation that the Contractor pays for an individual's direct salary
(or institutional base salary) is the annual compensation that the
Contractor pays for an individual's appointment whether that individual's
time is spent on research, teaching, patient Care or other activities.
Direct salary (or institutional base salary) excludes any income that an
individual may be permitted to earn outside of duties to the Contractor,
The per year salary rate limit also applies to individuals proposed under
subcontracts. It does not apply to fees paid to consultants. If this is a
multiple year contract, it may be subject to unilateral modifications by
the Government if an individual's salary rate exceeds any salary rate
ceiling established in future HHS appropriation acts.
Schedule B (Part II)- Special Requirements/Contract Clauses Page 23
PRIME CONTRACT NO.: N01-NS-3-2356
DOLLAR AMOUNT OF
(b) PUBLIC LAW NO. FISCAL YEAR SALARY LIMITATION*
-------------- ----------- ------------------
108-199, Division E, Title II- 2004 Executive Level I
General Provisions, Section 204
* For contract expenditures using FY04 funds, for the period 10/1/03
-12/31/03, the Executive Level I rate is $171,900. Effective 1/1/04, for
contract expenditures using FY04 funds, the Executive Level I rate is
increased to $174,500 (INCREASED BY EXECUTIVE ORDER ON 3/3/04 TO $175,700,
WHICH IS RETROACTIVE TO 1/1/04) and will remain at that level until such
time as it is determined to raise the Executive Schedule annual rates.
LINK to EXECUTIVE LEVEL SALARIES:
xxxx://xxx.xxx,gov/oca/04tables/html/ex.asp.
8. PUBLICATION AND PUBLICITY
The Contractor shall acknowledge the support of NIH whenever publicizing the
work under this contract in any media by including an acknowledgment
substantially as follows:
"This project has been funded in whole or in part with Federal funds from the
National Institute of Neurological Disorders and Stroke, National Institutes of
Health, under Contract No. N01-NS-3-2356."
9. PRESS RELEASES
(a) Pursuant to Public Law(s) cited in paragraph (b) below, the Contractor
shall clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations, and other documents describing projects or
programs funded in whole or in part with Federal money: (1) the percentage
of the total costs of the program or project that 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 non-governmental sources.
(b) PUBLIC LAW NO. AND SECTION NO FISCAL YEAR PERIOD COVERED
----------------------------- ----------- --------------
108-199, 2004 10/01/2003-09/30/2004
Section 507
10. 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 e-mail address is Xxxxx@xx.xxxx.xxx and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
XX XXX 00000
Xxxxxxxxxx, XX 00000
11. ANTI-LOBBYLNG
(a) Pursuant to Public Law(s) cited in paragraph c., below, contract funds
shall not be used, other than for normal and recognized
executive-legislative relationships, for publicity or
Schedule B (Part II) - Special Requirements/Contract Clauses Page 24
PRIME CONTRACT NO.: N01-NS-3-2356
propaganda purposes, for the preparation, distribution, or use of any kit,
pamphlet, booklet, publication, radio, television, or video presentation
designed to support or defeat legislation pending before the Congress or
any State legislature, except in presentation to the Congress or any State
legislature itself.
(b) Contract funds shall not be used to pay salary or expenses of the
Contractor or any agent acting for the Contractor, related to any activity
designed to influence legislation or appropriations pending before the
Congress or any State legislature.
(c) PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
-------------------------- ----------- --------------
108-199, Section 503 (a) 2004 10/01/2003-09/30/2004
Division G, Title V- General Provisions
108-199, Section 503 (b) 2004 10/01/2003-09/30/2004
Division G, Title V- General Provisions
12. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS
(COMMERCIALS ONLY)
The primary purpose of the PHS is to support and advance independent research
within the scientific community. This support is provided in the form of
contracts and grants totaling approximately 7 billion dollars annually. PHS has
established effective, time tested and well-recognized procedures for
stimulating and supporting this independent RESEARCH by selecting from
multitudes of applications those research projects most worthy of support within
the constraints of its appropriations. The reimbursement through the indirect
cost mechanism of Independent research and development costs not incidental to
product improvement would circumvent this competitive process.
To ensure that all research and development projects receive simitar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
13. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NlH-funded research are to be shared with
the scientific research community. NIH provides guidance entitled "Sharing
Biomedical Research Resources: Principles and Guidelines for Recipients of NIH
Research Grants and Contracts," (Federal Register Notice, December 23,1999 [64
FR 72090], concerning the appropriate terms for disseminating and acquiring
these research resources. This guidance, found at xxxx://xxx.xx.xxx.xxx/
NewPages/64FR72090.pdf is intended to help Contractors ensure that the
conditions they impose and accept on the transfer of research tools will
facilitate further biomedical research, consistent with the requirements of the
Xxxx-Xxxx Act and NIH funding policy.
14. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS
Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as
amended by Public Law 105-220 under Title IV (Rehabilitation Act Amendments of
1998), all Electronic and Information Technology (EIT) developed, procured,
maintained, and/or used under this contract shall be in compliance with the
"Electronic and Information Technology Accessibility Standards"
Schedule B (Part II) - Special Requirements/Contract Clauses Page 25
PRIME CONTRACT NO.: N01-NS-3-2356
set forth by the Architectural and Transportation Barriers Compliance Board
(also referred to as the "Access Board") in 36 CFR Part 1194. The complete text
of Section 508 Final Standards can be accessed at xxxx://xxx.xxxxxx-xxxxx-xxx/.
The standards applicable to this requirement are identified in the Statement of
Work.
15. SHARING RESEARCH DATA
The Buyer's data sharing plan, dated June 30, 2003 is hereby incorporated in
this contract; a complete copy of the document will be provided prior to award.
The subcontractor agrees to adhere to the plan and shall request prior approval
of the Contracting Officer for any changes made to its plan.
The NIH endorses the sharing of final research data to expedite the translation
of research results into knowledge, products, and procedures to improve human
health. This contract is expected to generate research data that must be shared
with the public and other researchers. NIH's data sharing policy may be found at
the following Web site:
xxxx://xxxxxx.xxx.xxx/xxxxxx/xxxxx/xxxxxx-xxxxx/XXX-XX-00-000.xxxx
NIH recognizes that data sharing may be complicated or limited, in some cases,
by institutional policies, local IRB rules, as well as local, state, and Federal
laws and regulations, including the Privacy Rule (see HHS-published
documentation on the Privacy Rule) at xxxx://xxx.xxx.xxx/xxx/. The rights and
privacy of people who participate in NIH-funded research must be protected at
all times; thus, data intended for broader use should be free of identifiers
that would permit linkages to individual research participants and variables
that could lead to deductive disclosure of the identity of Individual subjects.
16. INTELLECTUAL PROPERTY MANAGEMENT PLAN
Seller agrees to develop an Intellectual Property Plan (IPP) for each product
developed under this contract that can be utilized as a research resource or
tool by not-for-profit and for-profit organizations. The IPP must:
(a) Be in compliance with the provisions and spirit of the Xxxx-Xxxx Act (35
U.S.C. 200, et seq.),
(b) Be consistent with the Xxxx-Xxxx Act and provide for the Government
acquiring a non-exclusive license for the use of the product,
(c) Be in compliance with the provisions and spirit of the: Principles and
Guidelines for Recipients of NIH Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources (64 FR 72090, December, 1999;
available at xxxx://xxx.xx.xxx.xxx/XxxXxxxx/XXxxxxx_xxxxx.xxxx).
(d) Provide for the subject product being freely available for use within the
SMA Project, and
(e) Not impose inappropriate reach-through royalty terms on the sale of an end
item developed using the product.
An IPP for an (Note: name of corresponding proposal will be inserted here) that
is developed under this subcontract must be submitted to the Buyer and approved
prior to initial sale or transfer of the product other than as provided in (d)
above.
17. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (PL 101-391)
Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or
fund in whole or in part a meeting, convention, conference, or training
seminar that is conducted in, or that otherwise uses the rooms, facilities,
or services of a place of public accommodation that do not meet the
requirements of the fire prevention and control guidelines as described in
the Public
Schedule B (Part II) - Special Requirements/Contract Clauses Page 26
PRIME CONTRACT NO.: N01-NS-3-2356
Law. This restriction applies to public accommodations both foreign and
domestic.
Public accommodations that meet the requirements can be accessed at:
xxxx://xxx.xxxx.xxxx.xxx/xxxxx/xxxxx.xxx.
18. INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227-11, including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Office of
Extramural Inventions and Technology Resources Branch, Office of Policy for
Extramural Research Administration (OPERA), NIH, 0000 Xxxxxxxxx Xxxxx, Xxxx 0000
A, XXX 0000, Xxxxxxxx, XX 00000-0000 (Telephone: 301/000-0000). In addition, one
copy of the annual utilization report and a copy of the final invention
statement shall be submitted to the Contracting Officer at the address listed
below. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be
submitted within 60 days after contract expiration to the following address:
Science Applications International Corporation
Attn: Procurement
0000 Xxxxxxxx Xxxxx, Xxxxx X
Xxxxxxxxx, XX 00000-0000
To assist contractors in complying with invention reporting requirements of the
clause, the NIH has developed "Interagency Edison," an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (xxxx://xxx.xxxxxxx.xxx), or by
contacting the Office of Extramural Inventions and Technology Resources Branch,
OPERA, NIH.
19. PROVISIONS APPLICABLE TO DIRECT COSTS
(a) Items Unallowable Unless Otherwise Provided:
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, incorporated
in this contract, unless authorized elsewhere in the contract or in
writing by the Contracting Officer, 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 that are usable for purposes other than research,
such as office equipment and furnishings and pocket
calculators);
(4) Travel to attend general scientific meetings;
(5) Subcontracts;
(6) Patient Care Costs;
(7) Accountable Government property (defined as both real and
personal property with an acquisition cost of $1,000 or more
and a life expectancy of more than 2 years) and "sensitive
items" (defined and listed in the CONTRACTOR'S GUIDE FOR
CONTROL OF GOVERNMENT PROPERTY, 1990), regardless of
acquisition value; and
(8) Honoraria paid to outside meeting participants in excess of
$200/day.
Schedule B (Part II) - Special Requirements/Contract Clauses Page 27
PRIME CONTRACT NO.: N01-NS-3-2356
(b) TRAVEL COSTS
(1) DOMESTIC TRAVEL
(i) Total expenditures for domestic travel (including
transportation, lodging, subsistence, incidental
expenses, and honoraria) without the prior written
approval of the Contracting Officer.
(ii) The cost of travel by privately owned automobile
shall be reimbursed at the Government mileage rate
allowed Federal employees and in effect at the time
incurred in lieu of actual costs. However,
reimbursement for transportation by this means shall
not exceed the otherwise allowable comparative costs
of travel by common carrier.
(iii) The Contractor shall invoice and be reimbursed for
all travel costs in accordance with Federal
Acquisition Regulations (FAR) 31.205-46.
(2) FOREIGN TRAVEL
Request for foreign travel must be submitted at least six
weeks in advance and shall contain the following: (a)
meeting(s) and place(s) to be visited, with costs and dates;
(b) name(s) and title(s) of Contractor personnel to travel and
their functions in the contract project; (c) contract purposes
to be served by the travel; (d) how travel of Contractor
personnel will benefit and contribute to accomplishing the
contract project, or will otherwise justify the expenditure of
NIH contract funds; (e) how such advantages justify the costs
for travel and absence from the project of more than one
person if such are suggested; and (f) what additional
functions may be performed by the travelers to accomplish
other purposes of the contract and thus further benefit the
project.
20. PHS METRIC PROGRAM
Consistent with Government-wide implementing regulations, 15 CFR Part 19,
Subpart B and/or any other Government-wide requirements, PHS policy is to
support Federal transition to the metric system and to use the metric system of
measurement in all grants, cooperative agreements, and all other financial
assistance awards. Likewise, measurement values in reports, publications, and
other communications regarding grants will be in metric.
21. ACCESS TO RESEARCH DATA
By regulation (45 CFR 74.36), grantees that are institutions of higher
education, hospitals, or non-profit organizations are required to release
research data first produced in a project supported in whole or in part with
Federal funds that are cited publicly and officially by a Federal agency in
support of an action that has the force and effect of law (e.g., regulations and
administrative orders). "Research data" is defined as the recorded factual
material commonly accepted in the scientific community as necessary to validate
research findings. It does not include preliminary analyses; drafts of
scientific papers; plans for future research; peer reviews; communications with
colleagues; physical objects (e.g., laboratory samples, audio or video tapes);
trade secrets; commercial information; materials necessary to be held
confidential to a researcher until publication in a peer-reviewed journal;
information that is protected under the law (e.g. intellectual property);
personnel and medical files and similar files, the disclosure of which would
constitute an unwarranted invasion of personal privacy or information that could
be used to identify a particular person in a research study.
These requirements do not apply to commercial organizations or to research data
produced by
Schedule B (Part II) - Special Requirements/Contract Clauses Page 28
PRIME CONTRACT NO.: N01-NS-3-2356
State or local governments. However, if a state or local governmental grantee
contracts with an educational institution, hospital or non-profit organization,
and the contract results in covered research data, those data are subject to
these disclosure requirements.
22. RESEARCH MISCONDUCT
Each institution that receives or applies for a research, research training, or
research-related grant or cooperative agreement under the Public Health Service
Act must certify that the institution has established administrative policies as
required by (1) 42 CFR Part 50, Subpart A, "Responsibilities for PHS Awardee and
Applicant Institutions for Dealing with and Reporting Possible Misconduct in
Science" and (2) 42 CFR 94, "Public Health Service Standards for the Protection
of Research Misconduct Whistleblowers" (effective on the date set forth in the
final rule.)
The signature of the official signing for the applicant organization on the Face
Page of the application serves as certification that: 1. The institution will
comply with the requirements of the PHS regulations for dealing with reporting
possible scientific misconduct under 42 CFR Part 50, Subpart A, and for
protecting research misconduct whistleblowers under 42 CFR Part 94; 2. The
institution has established policies and procedures incorporating the provisions
set forth in 42 CFR Part 50, Subpart A, and 42 CFR Part 94; 3. The institution
will provide its policies and procedures to the Office of Research Integrity
upon request; and 4. The institution will submit an Annual Report on Possible
Research Misconduct (Form 6349). A copy of Form 6349, covering the previous
year, will be automatically sent to all awardees each January. "Misconduct in
Science" and "Research Misconduct" are defined by the Public Health Service as
"fabrication, falsification, plagiarism or other practices that seriously
deviate from those that are commonly accepted within the scientific community
for proposing, conducting or reporting research. It does not include honest
error or honest differences in interpretation or judgments of data."
23. NEEDLE EXCHANGE
(a) Pursuant to Public Law(s) cited in paragraph b., below, contract funds
shall not be used to carry out any program of distributing sterile
needles or syringes for the hypodermic injection of any illegal drug.
(b) PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
-------------------------- ----------- --------------
108-199, Section 505 2004 10/01/2003 - 09/30/2004
24. HHSAR 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(a) To help ensure the protection of the life and health of all persons,
and to help prevent damage to property, the Contractor shall comply
with all Federal, State and local laws and regulations applicable to
the work being performed under this contract. These laws are
implemented and/or enforced by the Environmental Protection Agency,
Occupational Safety and Health Administration and other agencies at the
Federal, State and local levels (Federal, State and local
regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional
safety measures as the Contracting Officer in conjunction with the
project or other appropriate officer, determines to be reasonably
necessary. If compliance with these additional safety measures results
in an increase or decrease in the cost or time required for performance
of any part of work under this contract, an equitable adjustment will
be made in accordance with the applicable "Changes" Clause set forth in
this contract.
Schedule B (Part II) - Special Requirements/Contract Clauses Page 29
PRIME CONTRACT NO.: N01-NS-3-2356
(c) The Contractor shall maintain an accurate record of, and promptly
report to the Contracting Officer, all accidents or incidents
resulting in the exposure of persons to toxic substances, hazardous
materials or hazardous operations; the injury or death of any person;
and/or damage to property incidental to work performed under the
contract and all violations for which the Contractor has been cited by
any Federal, State or local regulatory/enforcement agency. The report
shall include a copy of the notice of violation and the findings of
any inquiry or inspection, and an analysis addressing the impact these
violations may have on the work remaining to be performed. The report
shall also state the required action(s), if any, to be taken to
correct any violation(s) noted by the Federal, State or local
regulatory/enforcement agency and the time frame allowed by the agency
to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local regulatory/enforcement agency's directive(s) regarding
any violation(s) and prescribed corrective action(s), the Contracting
Officer may issue an order stopping all or part of the work until
satisfactory corrective action (as approved by the Federal, State or
local regulatory/enforcement agencies) has been taken and documented to
the Contracting Officer. No part of the time lost due to any stop work
order shall be subject to a claim for extension of time or costs or
damages by the Contractor.
(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.
(End of clause)
25. ADDITIONAL CONTRACT CLAUSES
The following Health and Human Services Acquisition Regulation, Public Health
Service Acquisition Regulation, and NIH clauses are applicable to this
subcontract in addition to the FAR clauses referenced elsewhere in this
subcontract.
(a) Health And Human Services Acquisition Regulation (HHSAR) (48 CFR
Chapter 3) Clauses:
CLAUSE/HHSAR
REFERENCE TITLE OF CLAUSE
352.202-1 Definitions-Alternate I (Jan 2001)
352.216-7 Additional Cost Principles (Oct 1990)
352.228-7 Insurance--Liability to Third Persons (Dec 1991)
352.232-9 Withholding of Contract Payments (Apr 1984)
352.233-70 Litigation and Claims (Apr 1984)
352.242-71 Final Decisions On Audit Findings (Apr 1984)
352.270-1 Accessibility of Meetings, Conferences, and
Seminars to Persons with Disabilities (Jan 2001).
352.270-5 Key Personnel (Apr 1984)
352.270-6 Publication and Publicity (Jul 1991)
352.270-7 Paperwork Reduction Act (Jan 2001)
352.270-9 Care of Live Vertebrate Animals (Jan 2001)
(b) National Institutes of Health (NIH) Research Contracting (RC) Clauses:
Schedule B (Part II) - Special Requirements/Contract Clauses Page 30
PRIME CONTRACT NO.: N01-NS-3-2356
CLAUSE/NIH(RC)
REFERENCE TITLE OF CLAUSE
NIH(RC)-7 Procurement of Certain Equipment (Apr 1984) (OMB Bulletin 81-16).
Schedule B (Part II) - Special Requirements/Contract Clauses Page 31
ATTACHMENT II
Memorandum
From: Xxxxxxxxx Xxxxxx Xxxx, Ph.D.
Project Manager, Science Applications International Corporation (SAIC)
To: Offerors Submitting Proposals to The Spinal Muscular Atrophy (SMA)
Project
Subject: Requirements Related to Human Subjects, Specimens, and Recombinant
DNA Research
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Offerors must be compliant with the requirements outlined in this Memorandum and
included in the
Subcontract Agreement. Offerors should demonstrate meeting these
requirements by reviewing the Memo, initialing sections 1, 3, and 4, as
appropriate, checking the relevant box in section 2 (and providing information
as necessary), and signing on page 2.
1. Human Subjects
Research involving human subjects shall not be conducted under this contract,
and no material developed, modified, or delivered by or to the Government under
this contract, or any subsequent modification of such material, will be used by
the Contractor or made available by the Contractor for use by anyone other than
the Government, for experimental or therapeutic use involving humans without the
prior written approval of the Contracting Officer.
_______ Human subjects will NOT be used in the proposed project.
2. Human Specimens
Research involving tissues or other biological specimens derived from living or
deceased humans and cell lines derived from human tissues may only be conducted
if Offerors have demonstrated their compliance with all appropriate guidelines
pertaining to the use of human specimens and have obtained approval of the
Contracting Officer.
|_| Human specimens will NOT be used in the proposed project.
|_| Human specimens will be used in the proposed project, and we are in
compliance with all NIH guidelines (XXXX://XXX.XXX.XXX.XXX.XXX.XXX/
BROCHURE.HTML). We propose using the following specimens that were derived
from human subjects. Please indicate all types of specimens and their source
(e.g., cell lines from ATCC, approved human embryonic cell lines, and blood).
Note, do not include information on animal specimens or cell lines.
SPECIMEN SOURCE
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Schedule B (Part I) - FAR Clauses Page 32
PRIME CONTRACT NO.: N01-NS-3-2356
3. Continued Ban on Funding of Human Embryo Research
Pursuant to Public Law, the NIH is prohibited from using appropriated funds to
support human embryo research.
_____ Contract funds will 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
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)).
4. Recombinant DNA and Human Gene Transfer Research
The NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT
DNA MOLECULES (NIH GUIDELINES) apply to subcontracts funded by the SMA Project.
The NIH GUIDELINES set forth principles and standards for safe and ethical
conduct of recombinant DNA research and apply to both basic and clinical
research studies.
_____ The Offer is in compliance with the NIH GUIDELINES for recombinant DNA
research and the conduct of human gene transfer studies
(XXXX://XXX0.XX.XXX.XXX/XXX/XXX/XXXXXXXXXX/XXXXXXXXXX.XXXX).
By submission of its offer, the Offeror certifies that its proposal is in
compliance with the above rules and guidelines as applicable. The Offeror shall
provide immediate written notice to SAIC if, at any time prior to contract
award, the Offeror learns that its certification was erroneous when submitted or
has become erroneous by reason of changed circumstances.
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Printed Name
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Signature Date
Attachment II - Memorandum Page 33
SCHEDULE B
CONTRACT CLAUSES
NATIONAL INSTITUTES OF HEALTH
PART III - REPORTING REQUIREMENTS
In addition to those reports required by the other terms of this contract, the
Subcontractor shall prepare and submit the following reports during the period
of performance of this contract:
1. MONTHLY PROGRESS REPORTS
By the FIFTH day of each month, after inception of the Subcontract, for the
entire Subcontract period, the Subcontractor shall describe the activities
during the reporting period, and the activities planned for the ensuing
reporting period. This report shall include the following: (1) a description of
overall progress within each current subcontract, how that progress corresponds
to planned milestones, and measures taken to correct any lack of milestone
achievement, (2) an indication of any current problems that may impede
performance, and proposed corrective action, (3) a discussion of the work to be
performed during the next reporting period and (5) any recommendations. Monthly
reports are not due in the final month of the quarter. These reports shall be
submitted electronically as a Microsoft Word document to both the Contracting
Officer and Project Officer
Monthly Progress Reports shall be delivered in accordance with the following
schedule for the entire Subcontract period:
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PERIOD COVERED DUE DATE
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01/01 - 01/31 02/05
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02/01 - 02/29 03/05
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04/01 - 04/30 05/05
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05/01 - 05/31 06/05
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07/01 - 07/31 08/05
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08/01 - 08/31 09/05
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10/01 - 10/31 11/05
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11/01 - 11/31 12/05
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2. QUARTERLY PROGRESS REPORTS
The Subcontractor shall deliver this report electronically as a Microsoft Word
document to both the Contracting Officer and the Project Officer. This report
shall include a summation of the monthly progress reports, including the final
month of the quarter, and a full report for the final month of the quarter in
the format of the monthly progress reports. This report shall be in sufficient
detail to comprehensively describe the results achieved.
Quarterly Progress Reports shall be delivered in accordance with the following
schedule for the entire Subcontract period:
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PERIOD COVERED DUE DATE
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01/01 - 03/31 04/05
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04/01 - 06/30 07/05
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07/01 - 09/30 10/05
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10/01 - 12/31 01/05
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Schedule B (Part I) - FAR Clauses Page 34
PRIME CONTRACT NO.: N01-NS-3-2356
3. OTHER REPORTS
(a) ANNUAL PROGRESS REPORTS
This report shall include a summation of the progress of the entire
Subcontract work for the period covered. The Subcontractor shall
deliver this report electronically as a Microsoft Word document to both
the Contracting Officer and the Project Officer.
(b) INDIVIDUAL SUBCONTRACT REPORTS
Upon the completion of each subcontract, a report of the results of
that project will be submitted. These reports shall be submitted within
1 week after completion of the subcontract. In addition to the complete
reporting of the data developed under the subcontract, this report
shall include the following: (1) the goal of the project and milestones
for achieving this goal, (2) planned schedule of achievement of project
milestones, and (3) actual schedule of achievement of project
milestones. These reports shall be submitted electronically to both the
Contracting Officer and Project Officer.
Other Reports shall be delivered in accordance with the following
schedule for the entire Subcontract period:
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OTHER REPORTS PERIOD COVERED DUE DATE
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a. Annual Report 01/01 - 12/31 01/20
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b. Individual Subcontract Reports To be determined Five days post completion
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4. FINAL REPORT
The final report shall include a summation of the work performed and results
obtained for the entire Subcontract period of performance. This report shall be
in sufficient detail to comprehensively describe the results achieved. An annual
progress report shall not be submitted for the period when the final report is
due. These reports shall be submitted electronically to both the Contracting
Officer and Project Officer.
The Subcontractor shall provide the Contracting Officer with copies of the final
report in DRAFT form 65 CALENDAR days prior to the delivery date for the final
version of the final report. The Project Officer shall review the draft report
and provide the Contracting Officer with comments within 45 CALENDAR days after
receipt. The final report shall be corrected by the Subcontractor, if necessary,
and the final version delivered in accordance with, DELIVERIES OR PERFORMANCE,
of the Subcontract.
The final report shall be delivered in accordance with the following schedule
for the entire Subcontract period:
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FINAL REPORT: PERIOD COVERED DUE DATE
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Draft Final Report Duration of Subcontract Sixty-five Days Before Last Day of Subcontract
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Final Report Duration of Subcontract Last Day of Subcontract
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5. PACKAGING, MARKING, AND SHIPPING
All deliverables required under this contract shall be packaged, marked, and
shipped in accordance with the contract. At a minimum, all deliverables shall be
marked with the contract number and Contractor name. The Subcontractor shall
guarantee that all required reports should be delivered in legible and
acceptable condition.
(a) Packaging
Schedule B (Part III) - Quarterly/Final Reporting Requirements Page 35
PRIME CONTRACT NO.: N01-NS-3-2356
For the purpose of reports, "immediately usable and acceptable
condition" includes securing the pages together in a suitable and
reasonable manner to be agreed upon by the Contractor and the NINDS
Project Officer.
Boxes and/or other types of outer packaging, i.e., containers, wraps,
etc., shall be suitable to the type of items being transmitted; and the
mode of transportation utilized shall assure that such materials be
received in an acceptable condition.
(b) Marking
All reports and/or other deliverable items under this contract shall be
marked on the cover and cover page with the following identifiers.
1. Project Title: "Collaborative Program to Accelerate
Therapeutics Development for Spinal Muscular Atrophy (SMA)"
2. Contract Number: N01-NS-3-2356
3. Name of Contractor: Science Applications International
Corporation
4. Name of Principal Investigator: Xx. Xxxxxxxxx X. Xxxx
(c) Shipping
Shipping shall be accomplished by reasonable and suitable means that
will ensure the integrity of the product delivered.
6. DELIVERIES
Satisfactory performance of the work under this subcontract shall be deemed to
occur upon performance of work described herein, and upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative, of
the following items in accordance with the stated delivery schedule:
(a) The items specified below as described in will be required to be
delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B.
DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance
with and by the date(s) specified below.
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ITEM DESCRIPTION REPORTING PERIOD DELIVERY SCHEDULE
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(1) Monthly Progress Report Monthly Fifth day of each month, after the
inception of the contract, for the entire
contract period.
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(2) Quarterly Progress Reports January 1 - March 31 April 5
April 1 - June 30 July 5
July 1 - September 30 October 5
October 1 - December 31 January 5
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(3) Other Reports:
a. Annual Progress Reports 01/01 - 12/31 01/20
b. Individual Subcontract Reports To be determined Five days post completion
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(4) Draft Final Report and Final Report Duration of contract and Sixty-five (65) days before last day of
Duration of contract contract.
Last day of contract.
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(b) Item numbers 1, 2, 3 and 4 shall be submitted electronically as
Microsoft Word documents or, when appropriate, as an Excel spreadsheet,
to both the Contracting Officer at xxxxxxxx.x.xxxxx@xxxx.xxx and the
Project Officer at xxxxxxxxx.x.xxxx@xxxx.xxx.
Schedule B (Part III) - Quarterly/Final Reporting Requirements Page 36