Exhibit 10.1

 

[award_image1.jpg] 

 

   

 

 

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Section B - Supplies or Services and Prices

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001   1 Lot
$1,975,047.00 $1,975,047.00              

RESEARCH

FFP

Research IAW the SOW (Contained in section C).

FOB: Destination

 

            NET AMT $1,975,047.00

 

           

PURCHASE REQUEST NUMBER: 1300211787

 

      000101 Funding Information     ACRN $938,583.00         AA  

 

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0002       NSP   CDRLs
       

 

 

 

 

 

   

 

 

 

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ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0003 1 Lot $835,124.00
$835,124.00 OPTION RESEARCH         FFP         Research IAW the SOW (Contained
in section C).     FOB: Destination                 NET AMT $835,124.00        
                           

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0004         NSP
OPTION CDRLs        

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0005           OPTION
  1 Lot $782,322.00 $782,322.00    

Human and Animal Use

FFP

Tasking in SOW section 2.3.2 will not be funded until the contractor obtains all

necessary IRB documentation and obtain both institutional and Government (SSC-

Pacific) approval in accordance with IRB documentation submission guidance

prior to conducting human or animal testing.

FOB: Destination

            NET AMT $782,322.00

 

 

 

   

 

 

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ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0006 1 Lot
$1,534,009.00 $1,534,099.00 OPTION RESEARCH         FFP         Research IAW the
SOW (Contained in section C).     FOB: Destination                 NET AMT
$1,534,099.00                                    

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0007     Lot   NSP
OPTION CDRLs        

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0008   1 Lot    
OPTION       $892,922.00 $892,922.00    

Research

FFP

Research IAW the SOW (Contained in section C).

FOB: Destination

            NET AMT $892,922.000

 

 

 

   

 

 

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ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0009         NSP
OPTION CDRLs        

 

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0010   1 Lot     
OPTION         NSP    

Hardware Deliverable

FFP

50 Prototype Optimized Cartridges

FOB: Destination

            NET AMT  

 

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0011   1 Lot    
OPTION RESEARCH     $774,875.00 $774,875.00   FFP
Research IAW the SOW (Contained in section C).

FOB: Destination

            NET AMT $774,875.000

 

 

   

 

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ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0012         NSP
OPTION CDRLs        

 

 

 

 

 

 

 

 

 

 

 

 

   

 

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Section C - Descriptions and Specifications

 

STATEMENT OF WORK (SOW)

Statement of Work

 

Aethlon Medical, Inc.

DATE: 23 September 2011

 

TITLE: Broad Spectrum Countermeasures for Viral and Bacterial Sepsis using
Dialysis-Like Devices

 

1. Scope

 

The scope of this effort is to use Aethlon’s ADAPT System as the core technology
within an extracorporeal blood purification device that would simultaneously
remove: viruses, virally-derived immunosuppressive glycoproteins, and multiple
classes of exosomes; complement activation, activation of virus growth (e.g.
cytomegalovirus) and TLR activation, all of which have implications to the
promotion of the well-being and recovery of wounded warfighters and the
prevention of sepsis.

 

1.1 Introduction

 

This effort will use the adaptable dialysis-like platform (ADAPT) technology
that allows for the selective removal of harmful agents from the entire
circulatory system. This revolutionary advance overcomes the limitation of
devices that indiscriminately adsorb or solely capture particles by molecule
size. The platform will provide an expansive therapeutic filtration mechanism to
immobilize multiple affinity agents directed toward precursors to sepsis,
bacterial toxins, viral pathogens, and disease enhancing particles transported
by exosomes. To insure benefit to wounded warfighters, this effort will advance
an innovative strategy that will allow therapy administration without systemic
anticoagulation.

 

The ADAPT platform has been previously used to create a broad-spectrum antiviral
device that immobilized one lectin affinity agent, resulting in the effective
capture of all tested Category A pathogens, as well as exosomes underlying
tuberculosis and cancer. In human studies, this same device, known as the
Hemopurifier, consistently provided greater than 50% average viral load
reductions during four-hour treatment periods in both hepatitis-C and HIV
infected individuals without antiviral drug therapy.

 

The resulting device would save thousands of military and civilian lives each
year. Each of these technology advancements will be integrated into a single
cartridge that will provide decision-free and life-saving medical care for the
wounded warfighter.

 

1.2 Background

 

The goal of the DLT program is to develop a portable device that removes “dirty”
blood from the body, separates harmful agents, and returns “clean” blood to the
body in a manner similar to dialysis treatment of kidney failure. While the
device could have an impact across multiple areas of medicine, the target
application for this device is sepsis. The envisioned device can also provide
early identification of the presence of a pathogen. Once the presence of
pathogens has been confirmed, the DLT device will provide continuous
"label-free" removal of pathogens, toxins and activated patient cells without
pathogen identification or use of pathogen-specific binding chemistries. As a
final step in the treatment process, the DLT device will enable closed-loop
therapy based on continuous, reduced dimensionality modeling of patient health.
Predictive modeling in this fashion will allow us to identify sepsis early,
learn what we need to remove, and direct the most effective intervention to
improve patient health. This cycle of sensing, adjustment, estimation,
computation, and manipulation will modulate key health parameters faster than
the underlying disease process and drive the patient towards a stable, healthy
state.

 

   

 

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2. Technical Requirements

 

2.1 Human and Animal use

 

Human use is anticipated in this effort, specifically related to the use of
human blood. The contractor shall obtain all necessary Institutional Review
Board (IRB) approvals, show proper assurance documentation, and obtain proper
approval from the Government officials prior to human use testing. Funds
associated with human subjected testing shall not be released until IRB
documentation has been provided to SSC’s HRPO and approval to release funds has
been obtained.

 

Animal use is anticipated in this effort. The contractor shall obtain all
necessary Institutional Animal Care and Utilization Committee (IACUC) approval
and demonstrate this approval to the Government (both ACURO and SSC-Pacific)
prior to beginning experimentation with animals. If animal use is no longer
anticipated, or changes significantly from the approved IACUC then the Principal
Investigator (PI) must submit a letter stating the discontinuation of animal use
for this effort and/or receive appropriate authorization for IACUC changes of
previously specified protocols. Unless prior approval by DARPA is given IACUC
documentation must be provided prior to contract award.

 

2.2 Base Effort (Year 1)

 

2.2.1 Subtask 1a: Anticoagulant-free Hemopurification Device

 

2.2.1.1Write requirements definition for the extracorporeal blood purification
system and acquire necessary equipment.

2.2.1.2Fabricate breadboard prototypes for anticoagulation-free anti-sepsis
extracorporeal system (ASEPSYS) device. Fabricate prototype blood tubing sets.
Acquire anti-thrombogenic surface-modified hollow fiber plasma separators.

2.2.1.3Assemble and test breadboard ASEPSYS devices ex vivo with bovine blood.
The test will most likely be conducted using a porcine model where the elapsed
time to reach a pre-defined degree of clotting in the blood treatment device
will be compared between the new device and two control groups; one using
standard anticoagulant therapy and one using none. Determine contribution of the
following techniques and approaches to eliminating anticoagulants:

(1) Backflushing at regular intervals, (2) Turbo loop, (3) Continuous
pre-dilution loop using re-captured hydration fluid, (4) Linear vs pulsatile
blood flow, (5) Elimination of air/blood interfaces in extracorporeal circuit,
(6) Anti-thrombogenic derivatized plasma separation membrane, and (7)
Ultra-short half-life anticoagulant nafamostat mesilate.

 

2.2.1.4IRB Documentation Generation: The contractor shall obtain all necessary
IRB documentation and obtain both institutional and Government (SSC-Pacific)
approval in accordance with IRB documentation submission guidance prior to
conducting human subject testing.

 

Milestones

M1:Demonstrate the effectiveness of the prototype device in preventing platelet
activation or clotting in at least a 2 hour blood pumping experiment at 100
mL/hr blood flow.

 

2.2.2 Subtask 2: Removal of Sepsis Precursors

2.2.2.1Begin to develop a device based on Aethlon’s ADAPT system to efficiently
capture sepsis precursors identified as potentially important in killing
patients undergoing sepsis. The strategy is takes advantage of the flexibility
and rapidity of modification of our ADAPT platform system to test any sepsis
precursor candidates that circulate in the blood. The sepsis precursors that
will be targeted are shown in Table I, in order of importance. No test for the
removal of bacterial toxins. No testing for removal of cytokines, since the
evidence to date does not support a role for them in death due to sepsis.
Additional factors may become known during the grant period and those will also
be tested as time and budget permit.

 

   

 

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2.2.2.2Screening Capture Agents: Perform initial screening of the different
proposed capture agents by measuring binding affinity and kinetics using surface
plasmon resonance (SPR) or biolayer surface interferometry (BLI).

2.2.2.3Perform quantitative real time PCR will also be used to measure viral
load, and specific DNA or RNA targets.

Milestones

 

M2:Target capture > 50% in 24 hours for at least 1 target in blood or blood
components

 

Table I Potential Target Sepsis Precursors and Broad Spectrum Binding Agents

 

Group Factor Proposed Binding Agents Sepsis related Exosomes     1.       iNOS
exosomes [1-3] Inducible NO synthase containing exosomes implicated in sepsis
GNA lectin or iNOS Specific antibody 2.       Platelet derived exosomes [4, 5]
Exosomes isolated from platelets associated with sepsis GNA lectin or antibodies
3.       Macrophage derived exosomes [6] Exosomes from cultured macrophages GNA
lectin Other Potential Sepsis Factors     4.       Complement Activation [7-9]
Humanized Cobra venom factor (CVF) from Incode, CVF is not a toxin CVF is a
stable analog of human complement that neutralizes C3a in animals 5.      
Bacterial DNA [13-15] CpG rich DNA activates macrophages via Toll Like Receptors
(TLR) Antisense nuclease resistant DNA analogs, TLRs or specific antibodies
6.       Common Sepsis associated Viruses including CMV Virus blooms in trauma
and burn patients [10] GNA Lectin 7.       Protease leakage through
          ischemic gut (e.g. trypsin) [11, 12] Ischemia in the gut leads to
protease leakage into the blood and the symptoms of sepsis (reperfusion injury)
Lima bean trypsin inhibitor, Soybean trypsin inhibitor

 

 

 

   

 

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2.3 Option 1 (Year 2)

 

2.3.2 Subtask 1a: Anticoagulant-free Hemopurification Device

 

2.3.2.1Demonstrate the effectiveness of the prototype device in vivo in animals
preventing platelet activation or clotting in at least a 2 hour blood pumping
experiment at 75 mL/min blood flow.

2.3.2.2Formulate initial design based on work from previous phase. Begin to
build and test selected instrument design and tubing sets.

2.3.2.3Write and test software. Conduct ergonomic research. Begin discussions
with System Integrator.

 

Milestone

 

M3:Demonstrate the effectiveness of the prototype device in preventing platelet
activation or clotting in at least a 8 hour blood pumping experiment at 500
mL/hr blood flow.

 

2.3.3 Subtask 2. Removal of Sepsis Precursors

 

2.3.3.1Build the ADAPT capture cartridges with the identified affinity agents.
Measure the rate of capture of the specific targets from in ex vivo
recirculation experiments from cell culture and blood.

2.3.3.2Cartridge construction with optimized affinity matrix design for each
potential target. Complete all capture agents screening. Initiate ex vivo
capture studies from blood using the optimized cartridges.

Milestones

 

M4:Target capture > 50% in 24 hours for at least 5 targets in blood or blood
components.

M5:Milestone 5: Target capture > 90% in 24 hours for at least 3 targets in blood
or blood components.

NOTE: TASK 2.3.2 SHALL NOT BE EXERCISED AND TASKING FUNDS RELEASED UNTIL IRB
DOCUMENTATION AND PROPER IRB APPROVAL HAS BEEN OBTAINED.

 

2.4 Option 2 (Year 3)

 

2.4.1 Subtask 1a: Anticoagulant-free Hemopurification Device

 

2.4.1.1Collaborate with System Integrator to build final prototypes for in vivo
pig testing.

2.4.1.2Perform animal tests to confirm the performance of the device in vivo.

2.4.1.3Document all adverse events and long term effects of treatment.

 

Milestones

 

M6:Demonstrate the effectiveness of the prototype device in preventing platelet
activation or clotting in at least a 24 hour blood pumping experiment at 1250
mL/hr blood flow in vivo in pigs.

 

2.4.2 Subtask 4: Target Capture in Combined Agent Cartridge

 

2.4.2.1Candidate cartridges that demonstrate >90% capture in 24 hours efficacy
in binding to individual sepsis precursor targets will move to the next stage.
These capture agents will be combined into a single cartridge and retested ex
vivo in pig blood or blood components.

2.4.2.2Optimize cartridge design in regard to fiber length, diameter and the use
of prototype ASEPSYS system. Demonstrate increased capture rates 2-7 fold from
the current system in blood or blood components. 2.4.2.3 Perform basic
biocompatibility studies to confirm that the combination cartridge does not
present any new patient risks that need to be addressed.

Milestones

 

M7:Target capture > 50% in 24 hours for at least 5 of the 7 targets ex vivo in
blood or blood components using the combination cartridge.

 

   

 

 

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M8:Optimize cartridge composition for target capture in a single cartridge
demonstrating increased capture rates 2-7 fold from the current system in blood
or blood components.

M9:Target capture > 90% in 24 hours (12 months) for at least 5 of the 7 targets
ex vivo in blood or blood components using the optimized cartridge

M10:Pass biocompatibility tests for the combination ADAPT device.

 

2.5 Option 3 (Year 4)

 

2.5.1 Subtask 1a: Anticoagulant-free Hemopurification Device

 

2.5.1.1System integrator implements design modifications emanating from pig
experiments.

2.5.1.2Collaborate with System Integrator in conducting verification and
validation testing and collecting all remaining data required for IDE submission
(e.g. biocompatibility, electromagnetic interference, electromagnetic
susceptibility, software V&V, etc.).

2.5.1.3Make additional cartridge or device modification as required by system
integrator.

 

Milestones

 

M11: Demonstrate the effectiveness of the newest device design in preventing
blood clotting in a 24 hour blood pumping experiment at 1275 mL/hr blood flow in
vivo.

 

2.5.2 Subtask 4: Target Capture in Combined Agent Cartridge

 

2.5.2.1Determine the in vivo efficiency of an optimized combined clearance
cartridge incorporating all the successful capture agents.

2.5.2.2Finish construction and delivery of 50 prototype cartridges for testing
by the system integrator. The

cartridgeswill need to be made available (packaged, labeled, sterilized and
qualified) to the system integrator.

2.5.2.3Perform basic biocompabability tests for the combination ADAPT device to
confirm the combination cartridge does not present any new patient risk.

 

Milestones

 

M12:Complete studies in septic pig models with optimized combination cartridge
for >90% clearance of at least 4 of the 7 sepsis marker targets in 24 hours (12
months)

M13:Construct and deliver of 50 prototype cartridges for testing by the system
integrator.

 

2.6 Option 4 (Year 5)

 

2.6.1 Subtask 5: Testing of final product by System Integrator

 

2.6.1.1System Integrator approval of ASEPSYS device for portable blood pump
without the need for systemic anticoagulation.

2.6.1.2System Integrator testing of the ADAPT treatment cartridge for reducing
sepsis related death by >20% in a septic animal pig model.

2.6.1.3Prepare and submit IDE proposal for sepsis treatment based on previously
approved IDE.

2.6.1.4Prepare and present Final report for DARPA.

 

Milestones

M13:System Integrator approval of a sepsis precursor ADAPT treatment cartridge
for reducing sepsis related death by >20% in a septic animal pig model.

M14:System integrator acceptance of the ASEPSYS anticoagulation device as the
blood pump that can avoid the need for systemic anticoagulation.

 

 

   

 

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3.0 Program Management and Reviews

 

3.1 Program Management Plan

 

The contractor shall develop a Program Management Plan. A graphical
representation of this plan (Gantt chart is one example) identifying major tasks
and their task leaders, milestones of the major task and their completion dates
shall be generated. In addition, a graphical representation of budget shall be
generated.

 

3.2 Kick-off Meeting

 

The contractor shall participate in a kick-off meeting within 60 days of
contract award. The purpose of this meeting is to introduce key program
personnel, discuss the proposed tasking, present the program schedule and
milestones and the initial Program Management Plan.

 

3.3 Quarterly Reviews

 

The contractor shall hold quarterly reviews for the duration of this effort. The
purpose of these reviews is to present a summary of work completed and
milestones met, discuss any problems encountered, update the program schedule,
present the program financial status, and discuss remaining work.

 

3.4 Final Contract Review

 

A final contract review held in place of the last quarterly review shall be
hosted by the principal contractor. The purpose of this review is to present a
summary of all work completed and milestones accomplished and to discuss any
relevant future efforts similar to the contract that may be pursued.

 

4.0 Deliverables

 

The reports and presentation materials are to be delivered in accordance with
the contract CDRLs.

 

CLAUSES INCORPORATED BY FULL TEXT

 

5252.227-9211 PROCEDURES FOR CONTROLLING TECHNICAL DOCUMENTS UNDER SPAWARSYSCEN
PACIFIC CONTRACTS (NOV 2008)

 

The Contractor shall comply with DOD Directive 5230.25 and the information
provided herein when the Government provides the Contractor with technical data.

 

(a) Location of distribution statement, export warning notice, and destruction
notice (classified and unclassified technical documents).

(1)  Standard written or printed material with covers and/or title pages:
Statement(s) to be printed, typed, or stamped on the front cover and title page.

(2)  Technical documents without covers or title pages: Statement(s) to be
typed, printed, or stamped on the first page of the document.

(3)  Deck of punched or aperture cards: Statement(s) to be typed, printed, or
stamped on face of first and last card and on top of deck.

(4)  Magnetic tape, cassette, or disk: Statement(s) to be typed, stamped, or
printed on a label applied to outside of material. The first page of the
resulting hard-copy report or computer printout is also marked with applicable
statement(s).

(5)  Microfilm: Statement(s) to be typed, stamped, or printed on outside of
jacket or canister housing the material. The first page of the resulting
hard-copy report or first frame is also marked with applicable statement(s). The
headers for microfiche must carry an abbreviated version of the statement(s).

(6)  Drawings: Applicable statement(s) to be typed, stamped, or printed near the
title block.

(b) Safeguarding of Unclassified, Limited-Access Documents (for classified
documents see NOSCINST 5500.1A).

(1)  Normal working hours: Limited-access documents and those that have not yet
been reviewed cannot be left unattended in work areas accessible to non-DoD
employees.

(2)  After normal working hours: Limited-access documents and those that have
not yet been reviewed should be placed in locked files, desks, or similar
containers. If this is not possible, locked offices or buildings are adequate.

 

 

   

 

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(3) Additional guidance for safeguarding limited-access media processed by an IT
system, activity, or network can be found in OPNAVINST 5239.1A.

 

(c) Destruction of Unclassified, Limited-Access Documents. Destroy by any method
that will prevent disclosure of contents or reconstruction of the material.
Examples of such destruction methods follow:

(1)  Printed document, deck of punched or aperture cards, computer printout, and
drawings: Destroy by tearing each copy into pieces to preclude reconstruction
and placing the pieces in regular trash containers or send to the Mail Room
Branch for destruction.

(2)  Magnetic tape, cassette, or disk: Destroy by erasing the magnetic storage
media.

(3)  Microfilm: Destroy by cutting into small pieces or send to the mailroom for
destruction.

 

(d) Safeguarding of Classified Documents: See NOSCINST 5500.1A.

 

(e) Destruction of Classified Documents: See NOSCINST 5500.1A.

 

(End of specification)

 

 

5252.237-9601 KEY PERSONNEL (DEC 1999)

 

(a)  The offeror agrees to assign to this contract those key personnel listed in
paragraph (d) below. No substitutions shall be made except in accordance with
this clause.

 

(b)  The offeror agrees that during the first 6 months of the contract
performance period no personnel substitutions will be permitted unless such
substitutions are necessitated by an individual's sudden illness, death or
termination of employment. In any of these events, the contractor shall promptly
notify the Contracting Officer and provide the information required by paragraph
(c) below. After the initial 6 month period, all proposed substitutions must be
submitted in writing, at least fifteen (15) days (thirty (30) days if a security
clearance is to be obtained) in advance of the proposed substitutions to the
contracting officer. These substitution requests shall provide the information
required by paragraph (c) below.

 

(c)  All requests for approval of substitutions under this contract must be in
writing and provide a detailed explanation of the circumstances necessitating
the proposed substitutions. They must contain a complete resume for the proposed
substitute or addition, and any other information requested by the Contracting
Officer or needed by him to approve or disapprove the proposed substitutions.
All substitutions proposed during the duration of this contract must have
qualifications of the person being replaced. The Contracting Officer or his
authorized representative will evaluate such requests and promptly notify the
contractor of his approval or disapproval thereof in writing.

 

(d)  List of Key Personnel

 

NAME CONTRACT LABOR CATEGORY Richard H. Tullis, PhD Chief Science Officer

 

(e)  If the Contracting Officer determines that suitable and timely replacement
of key personnel who have been reassigned, terminated or have otherwise become
unavailable for the contract work is not reasonably forthcoming or that the
resultant reduction of productive effort would be so substantial as to impair
the successful completion of the contract or the service order, the contract may
be terminated by the Contracting Officer for default or for the convenience of
the Government, as appropriate. In addition, if the Contractor is found at fault
for the condition, the Contracting Officer may elect to equitably decrease the
contract price or fixed fee to compensate the Government for any resultant
delay, loss or damage.

 

   

 

 

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(f) If the offeror wishes to add personnel to be used in a labor category he
shall employ the procedures outlined in paragraph (c) above. Adding personnel
will only be permitted in the event of an indefinite quantity contract, where
the Government has issued a delivery order for labor hours that would exceed a
normal forty hour week if performed only by the number of employees originally
proposed.

 

(End of clause)

 

 

 

 

 

 

 

 

 

 

 

   

 

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Section D - Packaging and Marking

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.235-7010 ACKNOWLEDGMENT OF SUPPORT AND DISCLAIMER (MAY 1995)

 

(a)  The Contractor shall include an acknowledgment of the Government’s support
in the publication of any material based on or developed under this contract,
stated in the following terms: This material is based upon work supported by the
(name of contracting agency(ies)) under Contract No. (Contracting agency(ies)
contract numbers(s).

 

(b)  All material, except scientific articles or papers published in scientific
journals, must, in addition to any notices or disclaimers by the Contractor,
also contain the following disclaimer: Any opinions, findings and conclusions or
recommendations expressed in this material are those of the author(s) and do not
necessarily reflect the views of the (name of contracting agency(ies).

 

(End of clause)

 

   

 

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Section E - Inspection and Acceptance

 

INSPECTION AND ACCEPTANCE TERMS

 

Supplies/services will be inspected/accepted at:

 

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY 0001 Destination Government
Destination Government 0002 Destination Government Destination Government 0003
Destination Government Destination Government 0004 Destination Government
Destination Government 0005 Destination Government Destination Government 0006
Destination Government Destination Government 0007 Destination Government
Destination Government 0008 Destination Government Destination Government 0009
Destination Government Destination Government 0010 Destination Government
Destination Government 0011 Destination Government Destination Government 0012
Destination Government Destination Government

 

CLAUSES INCORPORATED BY REFERENCE

 

52.246-7 Inspection Of Research And Development Fixed Price AUG 1996
252.246-7000 Material Inspection And Receiving Report MAR 2008

 

 

 

   

 

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Section F - Deliveries or Performance

 

DELIVERY INFORMATION

 

CLIN PERIOD OF   SHIP TO ADDRESS UIC   PERFORMANCE QUANTITY     0001 12 MONTHS
AFTER   SPAWAR SYSTEMS CENTER N66001   DATE OF CONTRACT   RECEIVING OFFICER    
AWARD N/A 4297 PACIFIC HIGHWAY, BLDG 7 SAN DIEGO CA 92110-5000        
619-553-1251         FOB: Destination             0002 12 MONTHS AFTER   (SAME
AS PREVIOUS LOCATION) N66001   DATE OF CONTRACT N/A FOB: Destination     AWARD  
              0003 12 MONTHS AFTER   (SAME AS PREVIOUS LOCATION) N66001   DATE
OF OPTION I N/A FOB: Destination     AWARD                 0004 12 MONTHS AFTER
  (SAME AS PREVIOUS LOCATION) N66001   DATE OF OPTION I N/A FOB: Destination    
AWARD                 0005 12 MONTHS AFTER   (SAME AS PREVIOUS LOCATION) N66001
  DATE OF OPTION I 1 FOB: Destination     AWARD                 0006 12 MONTHS
AFTER   (SAME AS PREVIOUS LOCATION) N66001   DATE OF OPTION II N/A FOB:
Destination     AWARD                 0007 12 MONTHS AFTER   (SAME AS PREVIOUS
LOCATION) N66001   DATE OF OPTION II N/A FOB: Destination     AWARD            
    0008 12 MONTHS AFTER   (SAME AS PREVIOUS LOCATION) N66001   DATE OF OPTION
III N/A FOB: Destination     AWARD                 0009 12 MONTHS AFTER   (SAME
AS PREVIOUS LOCATION) N66001   DATE OF OPTION III N/A FOB: Destination     AWARD
                0010 12 MONTHS AFTER   (SAME AS PREVIOUS LOCATION) N66001   DATE
OF OPTION III 1 FOB: Destination     AWARD      

 

   

 

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0011 12 MONTHS AFTER   (SAME AS PREVIOUS LOCATION) N66001   DATE OF OPTION IV
N/A FOB: Destination     AWARD                 0012 12 MONTHS AFTER   (SAME AS
PREVIOUS LOCATION) N66001   DATE OF OPTION IV N/A FOB: Destination     AWARD    
 

 

 

CLAUSES INCORPORATED BY REFERENCE

 

52.242-15 Stop-Work Order AUG 1989 52.242-15 Alt I Stop-Work Order (Aug 1989) -
Alternate I APR 1984 52.247-34 F.O.B. Destination NOV 1991

 

 

   

 

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Section G - Contract Administration Data

 

ACCOUNTING AND APPROPRIATION DATA

 

AA: 9710400 1320 595 0P1D1 0 2525DP AM 179166 1101E S12136

AMOUNT: $938,583.00

CIN 130021178700002: $938,583.00

 

CLAUSES INCORPORATED BY FULL TEXT

 

252.204-0007 CONTRACT-WIDE: SEQUENTIAL ACRN ORDER. (SEP 2009)

 

The payment office shall make payment in sequential ACRN order within the
contract or order, exhausting all funds in the previous ACRN before paying from
the next ACRN using the following sequential order: alpha/alpha; alpha/numeric;
numeric/alpha; and numeric/numeric.

 

(End of clause)

 

 

5252.201-9201 DESIGNATION OF CONTRACTING OFFICER'S REPRESENTATIVE (MAR 2006)

 

(a)  The Contracting Officer hereby appoints the following individual as
Contracting Officer’s Representative(s) (COR) for this contract/order:

 

CONTRACTING OFFICER REPRESENTATIVE

 

Name: John Rockway

Code: 52260

Address: 53560 Hull Street, San Diego, CA 92152-5001

 

Phone Number: 619-204-0988
E-mail: john.rockway@navy.mil

 

(b)  It is emphasized that only the Contracting Officer has the authority to
modify the terms of the contract, therefore, in no event will any understanding
agreement, modification, change order, or other matter deviating from the terms
of the basic contract between the Contractor and any other person be effective
or binding on the Government. When/If, in the opinion of the Contractor, an
effort outside the existing scope of the contract is requested, the Contractor
shall promptly notify the PCO in writing. No action shall be taken by the
Contractor unless the Procuring Contracting Officer (PCO) or the Administrative
Contracting Officer (ACO) has issued a contractual change.

 

   

 

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5252.216-9210 TYPE OF CONTRACT (DEC 1999)

 

This is a Firm-Fixed Price (FFP) Completion contract.

 

(End of clause)

 

 

5252.227-9213 PATENT MATTERS POINT OF CONTACT (OCT 2008)

 

The Point of Contact regarding Patent Matters for this contract is:

 

OFFICE OF PATENT COUNSEL / CODE 360012

SPAWARSYSCEN

53560 HULL STREET

SAN DIEGO, CA 92152-5001

(619) 553-3001

 

Do not submit interim and final invention reports to this address. See the
clause at 5252.227-9206 for the proper address.

 

(End of clause)

 

 

5252.232-9208 INVOICING INSTRUCTIONS FOR SERVICES USING WIDE AREA WORK FLOW
(WAWF) (APR 2009)

 

(a)  Invoices for services rendered under this contract shall be submitted
electronically through the Wide Area Work Flow-Receipt and Acceptance (WAWF).
The contractor shall submit invoices for payment per contract terms. The
Government shall process invoices for payment per contract terms.

 

(b)  The vendor shall have their Cage Code activated by calling 1-866-618-5988
and selecting option 2. Once activated, the vendor shall self-register at the
WAWF website at https://wawf.eb.mil. Vendor training is available on the
internet at https://wawftraining.eb.mil. WAWF Vendor “Quick Reference” Guides
are located at the following web site:
http://acquisition.navy.mil/rda/home/acquisitiononesource/ebusiness/donebusinesssolutions/wa
wfoverview/vendorinformation

 

(c)  Cost back-up documentation (such as delivery receipts, labor hours &
material/travel costs etc.) shall be included and attached to the invoice in
WAWF. Attachments created with any Microsoft Office product or Adobe (.pdf
files) are attachable to the invoice in WAWF. The total size limit for files per
invoice is 5 megabytes. A separate copy shall be sent to the COR/TOM.

 

(d)  Contractors approved by DCAA for direct billing will not process vouchers
through DCAA, but may submit directly to DFAS. Vendors MUST still provide a copy
of the invoice and any applicable cost back-up documentation supporting payment
to the Acceptor/Contracting Officer's Representative (COR) if applicable.
Additionally, a copy of the invoice(s) and attachment(s) at time of submission
in WAWF shall also be provided to each point of contact identified in section
(g) of this clause by email. If the invoice and/or receiving report are
delivered in the email as an attachment it must be provided as a .PDF, Microsoft
Office product or other mutually agreed upon form between the Contracting
Officer and vendor.

 

   

 

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(e)  A separate invoice will be prepared no more frequently than for every two
weeks. Do not combine the payment claims for services provided under this
contract.

 

(f)   The following information is provided for completion and routing of the
invoice in WAWF:

 

WAWF Invoice Type 2-n-1 (Services Only) Issuing Office DODAAC See Block 5 of the
SF26 Admin DODAAC See Block 6 of the SF26 Inspector DODAAC (if applicable)
N66001 Inspector Contact Information See Clause 5252.201-9201 Service Acceptor
DODAAC N66001 Acceptor Contact Information See Clause 5252.201-9201 COR Contact
Information See Clause 5252.201-9201 DCAA Auditor DoDAAC : N/A Service Approver
DoDAAC : See Block 6 of the SF26 PAY DODAAC See Block 12 of the SF26

 

(g)  After submitting the document(s) to WAWF, click on “Send More Email
Notifications” and add the acceptor/receiver email addresses noted below in the
email address blocks. The contractor shall, at a minimum, include the COR,
Receiver, and Acceptor. This additional notification to the government is
necessary to ensure that the acceptor/receiver is aware that the invoice
documents have been submitted into WAWF:

 

Send Additional Email Notification(s) to: Name Email Phone Role See Clause
5252.201-9201     COR

 

(End of clause)

 

 

5252.243-9600 AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER (JAN 1992)

 

(a)  Except as specified in paragraph (b) below, no order, statement, or conduct
of Government personnel who visit the Contractor’s facilities or in any other
manner communicates with Contractor personnel during the performance of this
contract shall constitute a change under the Changes clause of this contract.

 

(b)  The Contractor shall not comply with any order, direction or request of
Government personnel unless it is issued in writing and signed by the
Contracting Officer, or is pursuant to specific authority otherwise included as
a part of this contract.

 

(c)  The Contracting Officer is the only person authorized to approve changes in
any of the requirements of this contract and notwithstanding provisions
contained elsewhere in this contract, the said authority remains solely the
Contracting Officer’s. In the event the contractor effects any change at the
direction of any person other than the Contracting Officer, the change will be
considered to have been made without authority and no adjustment will be made in
the contract price to cover any increase in charges incurred as a result
thereof.

 

(End of clause)

 

   

 

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ADMINISTRATIVE INSTRUCTIONS

INCORPORATION OF REPRESENTATIONS AND CERTIFICATIONS

 

All representations and certifications and other written statements made by the
contractor in response to Section K of the solicitation or at the request of the
contracting officer which are incident to the award of the contract or
modification of this contract, are hereby incorporated by reference with the
same force and effect as if they were given in full text.

 

(End of Instruction)

 

MARKING OF SHIPMENT

 

Each shipment of material and/or data shall be clearly marked to show the
following information:

 

SHIP TO: MARK FOR: RECEIVING OFFICER Contract #: N66001-11-C-4188   Item #: ALL
  Receiving Officer Code: 56506

The receiving office is located at 4297 Pacific Highway, Bldg. 7, San Diego, CA
92110-5000 and is open for deliveries Monday through Thursday from 6:30 AM until
4:00 PM and Fridays 6:30 AM to 3:00 PM.

 

(End of Instruction)

 

AGREEMENT TO LICENSE--NO IMPLIED LICENSE

 

(a) Except as provided in paragraph (b) below:

 

(1)    Aethlon Medical, Inc. shall obtain a license from the U.S. Government
under the following U.S. patents, patent applications and all patents issuing
thereon, and under all patents that may issue and patent applications that may
be filed on the following invention disclosures, on reasonable terms and
conditions, consistent with law, regulation, and Navy policy prior to any
manufacture, use, sale, lease, license, or conveyance of any kind of any
process, machine, manufacture, or composition of matter that would, absent such
license, infringe any claim of such patent(s)/application(s):

 

NONE KNOWN AT THIS TIME

 

(2)    Nothing in this contract shall release Aethlon Medical, Inc. from any
obligation of or duty under any other Government contract; nor shall it grant to
or confer upon Aethlon Medical, Inc. any rights, express or implied,

 

(i) to any invention other than a Subject Invention,

(ii)  under any patent application or patent assigned to the U.S. Government
that is dominant over a patent protecting a Subject Invention,

(iii) under any patent application or patent assigned to the U.S. Government
protecting an invention other than a Subject Invention, or

(iv)  under the U.S. patent(s)/patent application(s) identified in paragraph
(a)(1) above.

 

(b) No license from the U.S. Government shall be required for research,
development, test and evaluation to be performed by Aethlon Medical, Inc. under
this contract.

 

(End of Instruction)

 

APPLICATION OF DFARS 252.227-7013 AND 252.227-7015 TECHNICAL DATA CLAUSES

 

The DFARS 252.227-7015, Technical Data--Commercial Items, clause applies to
technical data that pertains to a “commercial item” as defined in the DFARS
252.227-7015 clause. The DFARS 252.227-7013, Rights in Technical
Data--Noncommercial Items, clause applies to all other technical data.

 

(End of Instruction)

 

   

 

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DISSEMINATION NOTICES FOR TECHNICAL DOCUMENTS PREPARED UNDER SPAWARSYSCEN

PACIFIC CONTRACTS (NOV 2008)

 

(a) Unless otherwise specified, all classified and unclassified technical
documents generated under this contract must carry the following statements:

(1)          Do not distribute to DTIC or other data depositories.

(2)          Distribution authorized to DOD components only; premature
dissemination [Contractor to insert a date which will be determined by the
Program Manager and affixed by the Contractor]. Other requests shall be referred
to the Space and Naval Warfare Systems Center, Code 2015, San Diego, CA
92152-5001.

(b) The Contractor shall place the above statements on the original and all
copies before being delivered to the shipping address in Section F as follows:

(1)          Standard Written or Printed material with Covers and/or Title
Pages: Statement(s) to be printed, typed, or stamped on front cover and title
page.

(2)          Technical Documents Without Covers or Title Pages: Statement(s) to
be typed, printed, or stamped on first page of the document.

(3)          Drawing: Applicable statement(s) to be typed, printed, or stamped
near the title block.

(4)          Magnetic Tape, Cassette, or Disk: Statement(s) to be typed,
printed, or stamped on a label applied to outside of material. The first page of
the resulting hard-copy report or computer printout report is also marked with
applicable statement(s).

(5)          Microfilm: Statement(s) typed, printed, or stamped on outside of
jacket or canister housing the material. The first page of resulting hard-copy
report or first frame is also marked with applicable statement(s). The headers
for microfiche must carry an abbreviated version of the statement(s).

(6)          Deck of Punched or Aperture Cards: Statement(s) to be typed,
stamped, or printed on face of first and last card and on top of deck.

 

(End of Instruction)

 

EXPORT CONTROL (DARPA)

 

Should this project develop beyond fundamental research (basic and applied
research ordinarily published and shared broadly within the scientific
community) with military or dual-use applications the following apply:

 

(1)          The Contractor shall comply with all U.S. export control laws and
regulations, including the International Traffic in Arms Regulations (ITAR), 22
CFR Parts 120 through 130, and the Export Administration Regulations (EAR), 15
CFR Parts 730 through 799, in the performance of this contract. In the absence
of available license exemptions/exceptions the Contractor shall be responsible
for obtaining the appropriate licenses or other approvals, if required, for
exports of (including deemed exports) hardware, technical data, and software, or
for the provision of technical assistance.

(2)          The Contractor shall be responsible for obtaining export licenses,
if required, before utilizing foreign persons in the performance of this
contract, including instances where the work is to be performed on-site at any
Government installation (whether in or outside the United States), where the
foreign person will have access to export-controlled technologies, including
technical data or software.

(3)          The Contractor shall be responsible for all regulatory record
keeping requirements associated with the use of licenses and license
exemptions/exceptions.

(4)          The Contractor shall be responsible for ensuring that the
provisions of this clause apply to its subcontractors.

 

(End of instruction)

 

   

 

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Section H - Special Contract Requirements

 

CLAUSES INCORPORATED BY FULL TEXT

 

5252.209-9206 EMPLOYMENT OF NAVY PERSONNEL RESTRICTED (DEC 1999)

 

In performing this contract, the Contractor will not use as a consultant or
employ (on either a full or part-time basis) any active duty Navy personnel
(civilian or military) without the prior approval of the Contracting Officer.
Such approval may be given only in circumstances where it is clear that no law
and no DOD or Navy instructions, regulations, or policies might possibly be
contravened and no appearance of a conflict of interest will result.

 

(End of clause)

 

 

 

5252.227-9205 RIGHTS IN MASK WORKS (DEC 2002)

 

(a) Definitions.

 

As defined in 17 U.S.C. §901--

 

“Semiconductor chip product” is the final or intermediate form of any product--

 

(A)   having two or more layers of metallic, insulating, or semiconductor
material, deposited or otherwise placed on, or etched away or otherwise removed
from, a piece of semiconductor material in accordance with a predetermined
pattern; and

 

(B)   intended to perform electronic circuit functions.

 

“Mask work” is a series of related images, however fixed or encoded--

 

(A)   having, or representing the predetermined, three-dimensional pattern of
metallic, insulating, or semiconductor material present or removed from the
layers of a semiconductor chip product; and

 

(B)   in which series the relation of the images to one another is that each
image has the pattern of the surface of one form of the semiconductor chip
product.

 

 

(b) For any and every mask work generated in the performance of work under this
contract, the contractor grants to the Government a non-exclusive, irrevocable,
royalty free, worldwide license to:

 

(1)  reproduce or have reproduced the mask work by optical, electronic, or any
other means; and

 

(2)  import or distribute or have imported or distributed a semiconductor chip
product in which the mask work is embodied.

 

(c) The contractor shall include this clause, suitably modified to replace
“contractor” with “subcontractor” in all subcontracts, regardless of tier, in
which a mask work is likely to be created in the performance of the work under
the subcontract. The contractor shall not obtain rights in the subcontractor’s
mask works as any part of the consideration for awarding the subcontract.

 

(d) This license is specific to mask work rights and shall not be construed to
broaden any proprietary rights to technical data or computer software.

 

(End of clause)

 

   

 

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5252.227-9206 SUBMISSION OF INTERIM AND FINAL INVENTION REPORTS AND NOTIFICATION
OF ALL SUBCONTRACTS FOR EXPERIMENTAL, DEVELOPMENTAL, OR RESEARCH WORK (OCT 2008)

 

(a)  This contract contains either FAR 52.227-11 “Patent Rights--Ownership by
the Contractor” clause and DFARS 252.227-7039 “Patents--Reporting of Subject
Inventions” or DFARS 252.227-7038 “Patent Rights--Ownership by the Contractor
(Large Business)” clause, or FAR 52.227-13 “Patent Rights--Ownership by the
Government” clause.

 

(b)  Under these clauses, the Contractor is required to submit interim and final
invention reports and notification to the Government of all subcontracts for
experimental, developmental, or research work. The interim and final invention
reports and notification of all subcontracts for experimental, developmental, or
research work may be submitted on DD Form 882 “Report of Inventions and
Subcontracts.”

 

(c)  The Contractor shall submit interim and final invention reports and
notification of all subcontracts for experimental, developmental, or research
work, including negative reports, to:

 

CONTRACT CLOSEOUT / CODE 23100

SPAWARSYSCEN PACIFIC

53560 HULL STREET

SAN DIEGO, CA 92152-5001

 

(d)  The SPAWARSYSCEN Pacific Office of Patent Counsel, Code 360012, will
represent the Contracting Officer with regard to invention reporting matters
arising under the contract.

 

(End of clause)

 

 

5252.227-9207 LIMITED RELEASE OF CONTRACTOR CONFIDENTIAL BUSINESS INFORMATION
(APRIL 2010)

 

(a)  Definition.

 

“Confidential Business Information,” (Information) as used in this clause, is
defined as all forms and types of financial, business, economic or other types
of information other than technical data or computer software/computer software
documentation, whether tangible or intangible, and whether or how stored,
compiled, or memorialized physically, electronically, graphically,
photographically, or in writing if -- (1) the owner thereof has taken reasonable
measures to keep such Information secret, and (2) the Information derives
independent economic value, actual or potential from not being generally known
to, and not being readily ascertainable through proper means by, the public.
Information does not include technical data, as that term is defined in DFARS
252.227-7013(a)(14), 252.227-7015(a)(4), and 252.227-7018(a)(19). Similarly,
Information does not include computer software/computer software documentation,
as those terms are defined in DFARS 252.227-7014(a)(4) and 252.227-7018(a)(4).

 

(b)  The Space and Naval Warfare Systems Command (SPAWAR) may release to
individuals employed by SPAWAR support contractors and their subcontractors
Information submitted by the contractor or its subcontractors pursuant to the
provisions of this contract. Information that would ordinarily be entitled to
confidential treatment may be included in the Information released to these
individuals. Accordingly, by submission of a proposal or execution of this
contract, the offeror or contractor and its subcontractors consent to a limited
release of its Information, but only for purposes as described in paragraph (c)
of this clause.

 

(c)  Circumstances where SPAWAR may release the contractor’s or subcontractors’
Information include the following:

 

(1) To other SPAWAR contractors and subcontractors, and their employees tasked
with assisting SPAWAR in handling and processing Information and documents in
the administration of SPAWAR contracts, such as file room management and
contract closeout; and,

 

 

   

 

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(2) To SPAWAR contractors and subcontractors, and their employees tasked with
assisting SPAWAR in accounting support services, including access to
cost-reimbursement vouchers.

 

(d) SPAWAR recognizes its obligation to protect the contractor and its
subcontractors from competitive harm that could result from the release of such
Information. SPAWAR will permit the limited release of Information under
paragraphs (c)(1) and (c)(2) only under the following conditions:

(1)  SPAWAR determines that access is required by other SPAWAR contractors and
their subcontractors to perform the tasks described in paragraphs (c)(1) and
(c)(2);

(2)  Access to Information is restricted to individuals with a bona fide need to
possess;

(3)  Contractors and their subcontractors having access to Information have
agreed under their contract or a separate corporate non-disclosure agreement to
provide the same level of protection to the Information that would be provided
by SPAWAR employees. Such contract terms or separate corporate non-disclosure
agreement shall require the contractors and subcontractors to train their
employees on how to properly handle the Information to which they will have
access, and to have their employees sign company non disclosure agreements
certifying that they understand the sensitive nature of the Information and that
unauthorized use of the Information could expose their company to significant
liability. Copies of such employee non disclosure agreements shall be provided
to the Government;

(4)  SPAWAR contractors and their subcontractors performing the tasks described
in paragraphs (c)(1) or (c)(2) have agreed under their contract or a separate
non-disclosure agreement to not use the Information for any purpose other than
performing the tasks described in paragraphs (c)(1) and (c)(2); and,

(5)  Before releasing the Information to a non-Government person to perform the
tasks described in paragraphs (c)(1) and (c)(2), SPAWAR shall provide the
contractor a list of the company names to which access is being granted, along
with a Point of Contact for those entities.

 

(e) SPAWAR’s responsibilities under the Freedom of Information Act are not
affected by this clause.

 

(f) The contractor agrees to include, and require inclusion of, this clause in
all subcontracts at any tier that requires the furnishing of Information.

 

(End of clause)

 

 

5252.231-9200 REIMBURSEMENT OF TRAVEL COSTS (JAN 2006)

(a) Contractor Request and Government Approval of Travel

 

Any travel under this contract must be specifically requested in writing, by the
contractor prior to incurring any travel costs. If this contract is a definite
or indefinite delivery contract, then the written Government authorization will
be by task/delivery orders issued by the Ordering Officer or by a modification
to an issued task/delivery order. If this contract is not a definite or
indefinite delivery contract, then the written Government authorization will be
by written notice of approval from the Contracting Officer’s Representative
(COR). The request shall include as a minimum, the following:

 

(1)  Contract number

(2)  Date, time, and place of proposed travel

(3)  Purpose of travel and how it relates to the contract

(4)  Contractor’s estimated cost of travel

(5)  Name(s) of individual(s) traveling and;

(6)  A breakdown of estimated travel and per diem charges.

 

   

 

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The contractor shall submit the travel request in writing to the Contracting
Officer’s Representative (COR). The COR shall review and approve/disapprove (as
appropriate) all travel requests submitted giving written notice of such
approval or disapproval to the contractor.

 

(b) General

 

(1) The costs for travel, subsistence, and lodging shall be reimbursed to the
contractor only to the extent that it is necessary and authorized for
performance of the work under this contract. The costs for travel, subsistence,
and lodging shall be reimbursed to the contractor in accordance with the Federal
Acquisition Regulation (FAR) 31.205-46, which is incorporated by reference into
this contract. As specified in FAR 31.205-46(a) (2), reimbursement for the costs
incurred for lodging, meals and incidental expenses (as defined in the travel
regulations cited subparagraphs (b)(1)(i) through (b)(1)(iii) below) shall be
considered to be reasonable and allowable only to the extent that they do not
exceed on a daily basis the maximum per diem rates in effect at the time of
travel as set forth in the following:

 

(i) Federal Travel Regulation prescribed by the General Services Administration
for travel in the contiguous 48 United States;

 

(ii)         Joint Travel Regulation, Volume 2, DoD Civilian Personnel, Appendix
A, prescribed by the Department of Defense for travel in Alaska, Hawaii, The
Commonwealth of Puerto Rico, and the territories and possessions of the United
States; or

 

(iii)  Standardized Regulations, (Government Civilians, Foreign Areas), Section
925, “Maximum Travel Per Diem Allowances in Foreign Areas” prescribed by the
Department of State, for travel in areas not covered in the travel regulations
cited in subparagraphs (b)(1)(i) and (b)(1)(ii) above.

 

(2) Personnel in travel status from and to the contractor’s place of business
and designated work site or vice versa, shall be considered to be performing
work under the contract, and contractor shall bill such travel time at the
straight (regular) time rate; however, such billing shall not exceed eight hours
per person for any one person while in travel status during one calendar day.

 

(c) Per Diem

 

(1)  The contractor shall not be paid per diem for contractor personnel who
reside in the metropolitan area in which the tasks are being performed. Per diem
shall not be paid on services performed at contractor’s home facility and at any
facility required by the contract, or at any location within a radius of 50
miles from the contractor’s home facility and any facility required by this
contract.

 

(2)  Costs for subsistence and lodging shall be paid to the contractor only to
the extent that overnight stay is necessary and authorized in writing by the
Government for performance of the work under this contract per paragraph (a).
When authorized, per diem shall be paid by the contractor to its employees at a
rate not to exceed the rate specified in the travel regulations cited in FAR
31.205-46(a)(2) and authorized in writing by the Government. The authorized per
diem rate shall be the same as the prevailing locality per diem rate.

 

(3)  Reimbursement to the contractor for per diem shall be limited to payments
to employees not to exceed the authorized per diem and as authorized in writing
by the Government per paragraph (a). Fractional parts of a day shall be payable
on a prorated basis for purposes of billing for per diem charges attributed to
subsistence on days of travel. The departure day from the Permanent Duty Station
(PDS) and return day to the PDS shall be 75% of the applicable per diem rate.
The contractor shall retain supporting documentation for per diem paid to
employees as evidence of actual payments, as required by the FAR 52.216-7
“Allowable Cost and Payment” clause of the contract.

 

 

   

 

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(d) Transportation

 

(1)  The contractor shall be paid on the basis of actual amounts paid to the
extent that such transportation is necessary for the performance of work under
the contract and is authorized in writing by the Government per paragraph (a).

 

(2)  The contractor agrees, in the performance of necessary travel, to use the
lowest cost mode commensurate with the requirements of the mission and in
accordance with good traffic management principles. When it is necessary to use
air or rail travel, the contractor agrees to use coach, tourist class or similar
accommodations to the extent consistent with the successful and economical
accomplishment of the mission for which the travel is being performed.
Documentation must be provided to substantiate non-availability of coach or
tourist if business or first class is proposed to accomplish travel
requirements.

 

(3)  When transportation by privately owned conveyance (POC) is authorized, the
contractor shall be paid on a mileage basis not to exceed the applicable
Government transportation rate specified in the travel regulations cited in FAR
31.205-46(a)(2) and is authorized in writing by the Government per paragraph
(a).

 

(4)  When transportation by privately owned (motor) vehicle (POV) is authorized,
required travel of contractor personnel, that is not commuting travel, may be
paid to the extent that it exceeds the normal commuting mileage of such
employee. When an employee’s POV is used for travel between an employee’s
residence or the Permanent Duty Station and one or more alternate work sites
within the local area, the employee shall be paid mileage for the distance that
exceeds the employee’s commuting distance.

 

(5)  When transportation by a rental automobile, other special conveyance or
public conveyance is authorized, the contractor shall be paid the rental and/or
hiring charge and operating expenses incurred on official business (if not
included in the rental or hiring charge). When the operating expenses are
included in the rental or hiring charge, there should be a record of those
expenses available to submit with the receipt. Examples of such operating
expenses include: hiring charge (bus, streetcar or subway fares), gasoline and
oil, parking, and tunnel tolls.

 

(6)  Definitions:

 

(i) “Permanent Duty Station” (PDS) is the location of the employee’s permanent
work assignment (i.e., the building or other place where the employee regularly
reports for work.

(ii) “Privately Owned Conveyance” (POC) is any transportation mode used for the
movement of persons from place to place, other than a Government conveyance or
common carrier, including a conveyance loaned for a charge to, or rented at
personal expense by, an employee for transportation while on travel when such
rental conveyance has not been authorized/approved as a Special Conveyance.

(iii) “Privately Owned (Motor) Vehicle (POV)” is any motor vehicle (including an
automobile, light truck, van or pickup truck) owned by, or on a long-term lease
(12 or more months) to, an employee or that employee’s dependent for the primary
purpose of providing personal transportation, that:

(a)  is self-propelled and licensed to travel on the public highways;

(b)  is designed to carry passengers or goods; and

(c)  has four or more wheels or is a motorcycle or moped.

(iv) “Special Conveyance” is commercially rented or hired vehicles other than a
POC and other than those owned or under contract to an agency.

 

(v) “Public Conveyance” is local public transportation (e.g., bus, streetcar,
subway, etc) or taxicab.

 

(iv) “Residence” is the fixed or permanent domicile of a person that can be
reasonably justified as a bona fide residence.

 

   

 

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EXAMPLE 1: Employee’s one way commuting distance to regular place of work is 7
miles. Employee drives from residence to an alternate work site, a distance of
18 miles. Upon completion of work, employee returns to residence, a distance of
18 miles.

 

In this case, the employee is entitled to be reimbursed for the distance that
exceeds the normal round trip commuting distance (14 miles). The employee is
reimbursed for 22 miles (18 + 18 - 14 = 22).

 

EXAMPLE 2: Employee’s one way commuting distance to regular place of work is 15
miles. Employee drives from residence to an alternate work site, a distance of 5
miles. Upon completion of work, employee returns to residence, a distance of 5
miles.

 

In this case, the employee is not entitled to be reimbursed for the travel
performed (10 miles), since the distance traveled is less than the commuting
distance (30 miles) to the regular place of work.

EXAMPLE 3: Employee’s one way commuting distance to regular place of work is 15
miles. Employee drives to regular place of work. Employee is required to travel
to an alternate work site, a distance of 30 miles. Upon completion of work,
employee returns to residence, a distance of 15 miles.

 

In this case, the employee is entitled to be reimbursed for the distance that
exceeds the normal round trip commuting distance (30 miles). The employee is
reimbursed for 30 miles (15 + 30 + 15 - 30 = 30).

 

EXAMPLE 4: Employee’s one way commuting distance to regular place of work is 12
miles. In the morning the employee drives to an alternate work site (45 miles).
In the afternoon the employee returns to the regular place of work (67 miles).
After completion of work, employee returns to residence, a distance of 12 miles.

 

In this case, the employee is entitled to be reimbursed for the distance that
exceeds the normal round trip commuting distance (24 miles). The employee is
reimbursed for 100 miles (45 + 67 + 12 - 24 = 100).

 

EXAMPLE 5: Employee’s one way commuting distance to regular place of work is 35
miles. Employee drives to the regular place of work (35 miles). Later, the
employee drives to alternate work site #1 (50 miles) and then to alternate work
site #2 (25 miles). Employee then drives to residence (10 miles).

 

In this case, the employee is entitled to be reimbursed for the distance that
exceeds the normal commuting distance (70 miles). The employee is reimbursed for
50 miles (35 + 50 + 25 + 10 - 70 = 50).

 

EXAMPLE 6: Employee’s one way commuting distance to regular place of work is 20
miles. Employee drives to the regular place of work (20 miles). Later, the
employee drives to alternate work site #1 (10 miles) and then to alternate work
site #2 (5 miles). Employee then drives to residence (2 miles).

 

In this case, the employee is not entitled to be reimbursed for the travel
performed (37 miles), since the distance traveled is less than the commuting
distance (40 miles) to the regular place of work.

 

 

   

 

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Section I - Contract Clauses

 

CLAUSES INCORPORATED BY REFERENCE

 

52.202-1 Definitions JUL 2004 52.203-3 Gratuities APR 1984 52.203-5 Covenant
Against Contingent Fees APR 1984 52.203-6 Restrictions On Subcontractor Sales To
The Government SEP 2006 52.203-7 Anti-Kickback Procedures OCT 2010 52.203-8
Cancellation, Rescission, and Recovery of Funds for Illegal or
JAN 1997 Improper Activity   52.203-10 Price Or Fee Adjustment For Illegal Or
Improper Activity JAN 1997 52.203-12 Limitation On Payments To Influence Certain
Federal Transactions OCT 2010 52.204-4 Printed or Copied Double-Sided on
Postconsumer Fiber Content Paper MAY 2011 52.204-7 Central Contractor
Registration APR 2008 52.209-6 Protecting the Government's Interest When
Subcontracting DEC 2010   With Contractors Debarred, Suspended, or Proposed for
Debarment   52.215-2 Audit and Records--Negotiation OCT 2010 52.215-8 Order of
Precedence--Uniform Contract Format OCT 1997 52.215-15 Pension Adjustments and
Asset Reversions OCT 2010 52.215-17 Waiver of Facilities Capital Cost of Money
OCT 1997 52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits
JUL 2005 (PRB) Other than Pensions   52.215-19 Notification of Ownership Changes
OCT 1997 52.215-20 Alt II Requirements for Cost or Pricing Data or Information
Other OCT 1997
Than Cost or Pricing Data (Oct 2010) - Alternate II   52.219-28 Post-Award Small
Business Program Rerepresentation APR 2009 52.222-3 Convict Labor JUN 2003
52.222-21 Prohibition Of Segregated Facilities FEB 1999 52.222-26 Equal
Opportunity MAR 2007 52.222-35 Equal Opportunity for Veterans SEP 2010 52.222-36
Affirmative Action For Workers With Disabilities OCT 2010 52.222-37 Employment
Reports on Veterans SEP 2010 52.222-40 Notification of Employee Rights Under the
National Labor DEC 2010 Relations Act   52.222-50 Combating Trafficking in
Persons FEB 2009 52.222-54 Employment Eligibility Verification JAN 2009 52.223-6
Drug-Free Workplace MAY 2001 52.223-18 Encouraging Contractor Policies To Ban
Text Messaging While Driving AUG 2011 52.225-13 Restrictions on Certain Foreign
Purchases JUN 2008 52.227-1 Authorization and Consent DEC 2007 52.227-1 Alt I
Authorization And Consent (Dec 2007) - Alternate I APR 1984 52.227-2 Notice And
Assistance Regarding Patent And Copyright Infringement DEC 2007 52.227-3 Patent
Indemnity APR 1984 52.227-11 Patent Rights--Ownership By The Contractor DEC 2007
52.228-5 Insurance - Work On A Government Installation JAN 1997 52.228-7
Insurance--Liability To Third Persons MAR 1996 52.230-3 Disclosure And
Consistency Of Cost Accounting Practices OCT 2008

 

 

   

 

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52.232-2 Payments Under Fixed-Price Research And Development Contracts APR 1984
52.232-8 Discounts For Prompt Payment FEB 2002 52.232-9 Limitation On
Withholding Of Payments APR 1984 52.232-17 Interest OCT 2010 52.232-23
Assignment Of Claims JAN 1986 52.232-23 Alt I Assignment of Claims (Jan 1986) -
Alternate I APR 1984 52.232-25 Prompt Payment OCT 2008 52.232-25 Alt I Prompt
Payment (Oct 2008) Alternate I FEB 2002 52.232-33 Payment by Electronic Funds
Transfer--Central Contractor OCT 2003 Registration   52.233-1 Disputes JUL 2002
52.233-3 Protest After Award AUG 1996 52.233-3 Alt I Protest After Award (Aug
1996) - Alternate I JUN 1985 52.233-4 Applicable Law for Breach of Contract
Claim OCT 2004 52.237-2 Protection Of Government Buildings, Equipment, And
Vegetation APR 1984 52.242-13 Bankruptcy JUL 1995 52.243-1 Alt I Changes--Fixed
Price (Aug 1987) - Alternate I APR 1984 52.243-1 Alt V Changes--Fixed-Price (Aug
1987) - Alternate V APR 1984 52.244-6 Subcontracts for Commercial Items DEC 2010
52.245-1 Government Property AUG 2010 52.245-9 Use And Charges AUG 2010
52.246-25 Limitation Of Liability--Services FEB 1997 52.247-63 Preference For
U.S. Flag Air Carriers JUN 2003 52.249-2 Termination For Convenience Of The
Government (Fixed- MAY 2004 Price)   52.249-9 Default (Fixed-Priced Research And
Development) APR 1984 52.253-1 Computer Generated Forms JAN 1991 252.201-7000
Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating
to Compensation of Former DoD Officials JAN 2009 252.203-7001 Prohibition On
Persons Convicted of Fraud or Other Defense- DEC 2008 Contract-Related Felonies
  252.203-7002 Requirement to Inform Employees of Whistleblower Rights JAN 2009
  252.203-7002 Requirement to Inform Employees of Whistleblower Rights JAN 2009
  252.204-7003 Control Of Government Personnel Work Product APR 1992
252.204-7004 Alt A C entral Contractor Registration (52.204-7) Alternate A SEP
2007 252.204-7006 Billing Instructions OCT 2005 252.209-7004 Subcontracting With
Firms That Are Owned or Controlled By DEC 2006 The Government of a Terrorist
Country   252.223-7006 Prohibition On Storage And Disposal Of Toxic And
Hazardous Materials APR 1993 252.225-7012 Preference For Certain Domestic
Commodities JUN 2010 252.226-7001 Utilization of Indian Organizations and
Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns
SEP 2004 252.227-7012 Patent License And Release Contract SEP 1999 252.227-7013
Rights in Technical Data--Noncommercial Items MAR 2011 252.227-7014 Rights in
Noncommercial Computer Software and Noncommercial Computer Software
Documentation MAR 2011 252.227-7015 Technical Data--Commercial Items MAR 2011
252.227-7016 Rights in Bid or Proposal Information JAN 2011 252.227-7019
Validation of Asserted Restrictions--Computer Software JUN 1995 252.227-7027
Deferred Ordering Of Technical Data Or Computer Software APR 1988  

 

 

   

 

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      252.227-7030 Technical Data--Withholding Of Payment MAR 2000 252.227-7037
Validation of Restrictive Markings on Technical Data SEP 1999 252.231-7000
Supplemental Cost Principles DEC 1991 252.232-7010 Levies on Contract Payments
DEC 2006 252.235-7011 Final Scientific or Technical Report NOV 2004 252.242-7004
Material Management And Accounting System MAY 2011 252.243-7001 Pricing Of
Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment
MAR 1998 252.244-7000 Subcontracts for Commercial Items and Commercial NOV 2010
  Components (DoD Contracts)   252.246-7000 Material Inspection And Receiving
Report MAR 2008

 

CLAUSES INCORPORATED BY FULL TEXT

 

52.215-19 NOTIFICATION OF OWNERSHIP CHANGES (OCT 1997)

 

(a) The Contractor shall make the following notifications in writing:

(1) When the Contractor becomes aware that a change in its ownership has
occurred, or is certain to occur, that could result in changes in the valuation
of its capitalized assets in the accounting records, the Contractor shall notify
the Administrative Contracting Officer (ACO) within 30 days.

 

(2)  The Contractor shall also notify the ACO within 30 days whenever changes to
asset valuations or any other cost changes have occurred or are certain to occur
as a result of a change in ownership.

 

(b) The Contractor shall--

 

(1)  Maintain current, accurate, and complete inventory records of assets and
their costs;

 

(2)  Provide the ACO or designated representative ready access to the records
upon request;

 

(3)  Ensure that all individual and grouped assets, their capitalized values,
accumulated depreciation or amortization, and remaining useful lives are
identified accurately before and after each of the Contractor's ownership
changes; and

 

(4)  Retain and continue to maintain depreciation and amortization schedules
based on the asset records maintained before each Contractor ownership change.

 

The Contractor shall include the substance of this clause in all subcontracts
under this contract that meet the applicability requirement of FAR 15.408(k).

 

(End of clause)

 

 

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

 

(a)  The Government may extend the term of this contract by written notice to
the Contractor within the period of performance of this contract; provided that
the Government gives the Contractor a preliminary written notice of its intent
to extend at least 30 days before the contract expires. The preliminary notice
does not commit the Government to an extension.

 

(b)  If the Government exercises this option, the extended contract shall be
considered to include this option clause.

 

   

 

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(c) The total duration of this contract, including the exercise of any options
under this clause, shall not exceed five years.

 

(End of clause)

 

52.232-32 PERFORMANCE-BASED PAYMENTS (AUG 2010)

 

(a) Amount of payments and limitations on payments. Subject to such other
limitations and conditions as are specified in this contract and this clause,
the amount of payments and limitations on payments shall be specified in the
contract's description of the basis for payment.

 

(b) Contractor request for performance-based payment. The Contractor may submit
requests for payment of performance-based payments not more frequently than
monthly, in a form and manner acceptable to the Contracting Officer. Unless
otherwise authorized by the Contracting Officer, all performance-based payments
in any period for which payment is being requested shall be included in a single
request, appropriately itemized and totaled. The Contractor's request shall
contain the information and certification detailed in paragraphs (l) and (m) of
this clause.

 

(c) Approval and payment of requests.

 

(1)  The Contractor shall not be entitled to payment of a request for
performance-based payment prior to successful accomplishment of the event or
performance criterion for which payment is requested. The Contracting Officer
shall determine whether the event or performance criterion for which payment is
requested has been successfully accomplished in accordance with the terms of the
contract. The Contracting Officer may, at any time, require the Contractor to
substantiate the successful performance of any event or performance criterion
which has been or is represented as being payable.

 

(2)  A payment under this performance-based payment clause is a contract
financing payment under the Prompt Payment clause of this contract and not
subject to the interest penalty provisions of the Prompt Payment Act. The
designated payment office will pay approved requests on the 30th day after
receipt of the request for performance-based payment by the designated payment
office. However, the designated payment office is not required to provide
payment if the Contracting Officer requires substantiation as provided in
paragraph (c)(1) of this clause, or inquires into the status of an event or
performance criterion, or into any of the conditions listed in paragraph (e) of
this clause, or into the Contractor certification. The payment period will not
begin until the Contracting Officer approves the request.

 

(3)  The approval by the Contracting Officer of a request for performance-based
payment does not constitute an acceptance by the Government and does not excuse
the Contractor from performance of obligations under this contract.

 

(d) Liquidation of performance-based payments.

 

(1)  Performance-based finance amounts paid prior to payment for delivery of an
item shall be liquidated by deducting a percentage or a designated dollar amount
from the delivery payment. If the performance-based finance payments are on a
delivery item basis, the liquidation amount for each such line item shall be the
percent of that delivery item price that was previously paid under
performance-based finance payments or the designated dollar amount. If the
performance-based finance payments are on a whole contract basis, liquidation
shall be by either predesignated liquidation amounts or a liquidation
percentage.

 

(2)  If at any time the amount of payments under this contract exceeds any
limitation in this contract, the Contractor shall repay to the Government the
excess. Unless otherwise determined by the Contracting Officer, such excess
shall be credited as a reduction in the unliquidated performance-based payment
balance(s), after adjustment of invoice payments and balances for any
retroactive price adjustments.

 

   

 

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(e) Reduction or suspension of performance-based payments. The Contracting
Officer may reduce or suspend performance-based payments, liquidate
performance-based payments by deduction from any payment under the contract, or
take a combination of these actions after finding upon substantial evidence any
of the following conditions:

 

(1) The Contractor failed to comply with any material requirement of this
contract (which includes paragraphs (h) and (i) of this clause).

 

(2) Performance of this contract is endangered by the Contractor's --

 

(i)   Failure to make progress; or

 

(ii)  Unsatisfactory financial condition.

 

(3) The Contractor is delinquent in payment of any subcontractor or supplier
under this contract in the ordinary course of business.

 

(f) Title.

 

(1) Title to the property described in this paragraph (f) shall vest in the
Government. Vestiture shall be immediately upon the date of the first
performance-based payment under this contract, for property acquired or produced
before that date. Otherwise, vestiture shall occur when the property is or
should have been allocable or properly chargeable to this contract

 

(2) "Property," as used in this clause, includes all of the following described
items acquired or produced by the Contractor that are or should be allocable or
properly chargeable to this contract under sound and generally accepted
accounting principles and practices:

 

(i)   Parts, materials, inventories, and work in process;

 

(ii) Special tooling and special test equipment to which the Government is to
acquire title;

 

(iii)  Nondurable (i.e., noncapital) tools, jigs, dies, fixtures, molds,
patterns, taps, gauges, test equipment and other similar manufacturing aids,
title to which would not be obtained as special tooling under subparagraph
(f)(2)(ii) of this clause; and

 

(iv)  Drawings and technical data, to the extent the Contractor or
subcontractors are required to deliver them to the Government by other clauses
of this contract.

 

(3) Although title to property is in the Government under this clause, other
applicable clauses of this contract (e.g., the termination or clauses) shall
determine the handling and disposition of the property.

 

(4) The Contractor may sell any scrap resulting from production under this
contract, without requesting the Contracting Officer's approval, provided that
any significant reduction in the value of the property to which the Government
has title under this clause is reported in writing to the Contracting Officer.

 

(5) In order to acquire for its own use or dispose of property to which title is
vested in the Government under this clause, the Contractor shall obtain the
Contracting Officer's advance approval of the action and the terms. If approved,
the basis for payment (the events or performance criteria) to which the property
is related shall be deemed to be not in compliance with the terms of the
contract and not payable (if the property is part of or needed for performance),
and the Contractor shall refund the related performance-based payments in
accordance with paragraph (d) of this clause.

 

(6) When the Contractor completes all of the obligations under this contract,
including liquidation of all performance-based payments, title shall vest in the
Contractor for all property (or the proceeds thereof) not --

 

   

 

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(i)   Delivered to, and accepted by, the Government under this contract; or

 

(ii) Incorporated in supplies delivered to, and accepted by, the Government
under this contract and to which title is vested in the Government under this
clause.

 

(7) The terms of this contract concerning liability for Government-furnished
property shall not apply to property to which the Government acquired title
solely under this clause.

 

(g) Risk of loss. Before delivery to and acceptance by the Government, the
Contractor shall bear the risk of loss for property, the title to which vests in
the Government under this clause, except to the extent the Government expressly
assumes the risk. If any property is lost, stolen, damaged or destroyed, the
basis of payment (the events or performance criteria) to which the property is
related shall be deemed to be not in compliance with the terms of the contract
and not payable (if the property is part of or needed for performance), and the
Contractor shall refund the related performance-based payments in accordance
with paragraph (d) of this clause.

 

(h) Records and controls. The Contractor shall maintain records and controls
adequate for administration of this clause. The Contractor shall have no
entitlement to performance-based payments during any time the Contractor's
records or controls are determined by the Contracting Officer to be inadequate
for administration of this clause.

 

(i) Reports and Government access. The Contractor shall promptly furnish
reports, certificates, financial statements, and other pertinent information
requested by the Contracting Officer for the administration of this clause and
to determine that an event or other criterion prompting a financing payment has
been successfully accomplished. The Contractor shall give the Government
reasonable opportunity to examine and verify the Contractor's records and to
examine and verify the Contractor's performance of this contract for
administration of this clause.

 

(j) Special terms regarding default. If this contract is terminated under the
Default clause,

 

(1)  the Contractor shall, on demand, repay to the Government the amount of
unliquidated performance-based payments, and

 

(2)  title shall vest in the Contractor, on full liquidation of all
performance-based payments, for all property for which the Government elects not
to require delivery under the Default clause of this contract. The Government
shall be liable for no payment except as provided by the Default clause.

 

(k) Reservation of rights.

 

(1) No payment or vesting of title under this clause shall --

 

(i)   Excuse the Contractor from performance of obligations under this contract;
or

 

(ii) Constitute a waiver of any of the rights or remedies of the parties under
the contract.

 

(2) The Government's rights and remedies under this clause --

 

(i)   Shall not be exclusive, but rather shall be in addition to any other
rights and remedies provided by law or this contract; and

 

(ii) Shall not be affected by delayed, partial, or omitted exercise of any
right, remedy, power, or privilege, nor shall such exercise or any single
exercise preclude or impair any further exercise under this clause or the
exercise of any other right, power, or privilege of the Government.

 

(l) Content of Contractor's request for performance-based payment. The
Contractor's request for performance-based payment shall contain the following:

 

 

   

 

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(1) The name and address of the Contractor;

 

(2)  The date of the request for performance-based payment;

 

(3)  The contract number and/or other identifier of the contract or order under
which the request is made;

 

(4)  Such information and documentation as is required by the contract's
description of the basis for payment; and

 

(5)  A certification by a Contractor official authorized to bind the Contractor,
as specified in paragraph (m) of this clause.

 

(m) Content of Contractor's certification. As required in paragraph (l)(5) of
this clause, the Contractor shall make the following certification in each
request for performance-based payment:

 

I certify to the best of my knowledge and belief that --

 

 

(1)  This request for performance-based payment is true and correct; this
request (and attachments) has been prepared from the books and records of the
Contractor, in accordance with the contract and the instructions of the
Contracting Officer;

 

(2)  (Except as reported in writing on_________ ), all payments to
subcontractors and suppliers under this contract have been paid, or will be
paid, currently, when due in the ordinary course of business;

 

(3)  There are no encumbrances (except as reported in writing on_______ )
against the property acquired or produced for, and allocated or properly
chargeable to, the contract which would affect or impair the Government's title;

 

(4)  There has been no materially adverse change in the financial condition of
the Contractor since the submission by

the Contractor to the Government of the most recent written information
dated____________ ; and

 

(5)  After the making of this requested performance-based payment, the amount of
all payments for each deliverable item for which performance-based payments have
been requested will not exceed any limitation in the contract, and the amount of
all payments under the contract will not exceed any limitation in the contract.

 

(End of Clause)

 

 

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

 

This contract incorporates one or more clauses by reference, with the same force
and effect as if they were given in full text. Upon request, the Contracting
Officer will make their full text available. Also, the full text of a clause may
be accessed electronically at this/these address(es):

 

http://farsite.hill.af.mil
http://www.acquisition.gov

 

(End of clause)

 

 

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

 

(a) The use in this solicitation or contract of any Federal Acquisition
Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated
by the addition of "(DEVIATION)" after the date of the clause.

 

   

 

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(b) The use in this solicitation or contract of any Defense Federal Acquisition
Regulation Supplement (48 CFR Chapter 2) clause with an authorized deviation is
indicated by the addition of "(DEVIATION)" after the name of the regulation.

 

(End of clause)

 

 

252.204-7008 EXPORT-CONTROLLED ITEMS (APR 2010)

 

(a) Definition. Export-controlled items, as used in this clause, means items
subject to the Export Administration Regulations (EAR) (15 CFR parts 730-774) or
the International Traffic in Arms Regulations (ITAR) (22 CFR parts 120-130). The
term includes:

 

(1)  Defense items, defined in the Arms Export Control Act, 22 U.S.C.
2778(j)(4)(A), as defense articles, defense services, and related technical
data, and further defined in the ITAR, 22 CFR part 120.

 

(2)  Items, defined in the EAR as ̏commodities, software, and technology," terms
that are also defined in the EAR, 15 CFR 772.1.

 

(b) The Contractor shall comply with all applicable laws and regulations
regarding export-controlled items, including, but not limited to, the
requirement for Contractors to register with the Department of State in
accordance with the ITAR. The Contractor shall consult with the Department of
State regarding any questions relating to compliance with the ITAR and shall
consult with the Department of Commerce regarding any questions relating to
compliance with the EAR.

 

(c) The Contractor's responsibility to comply with all applicable laws and
regulations regarding export-controlled items exists independent of, and is not
established or limited by, the information provided by this clause.

 

(d) Nothing in the terms of this contract adds to, changes, supersedes, or
waives any of the requirements of applicable Federal laws, Executive orders, and
regulations, including but not limited to--

 

(1)  The Export Administration Act of 1979, as amended (50 U.S.C. App. 2401, et
seq.);

 

(2)  The Arms Export Control Act (22 U.S.C. 2751, et seq.);

 

(3)  The International Emergency Economic Powers Act (50 U.S.C. 1701, et seq.);

 

(4)  The Export Administration Regulations (15 CFR parts 730-774);

 

(5)  The International Traffic in Arms Regulations (22 CFR parts 120-130); and

 

(6)  Executive Order 13222, as extended.

 

(e) The Contractor shall include the substance of this clause, including this
paragraph (e), in all subcontracts. (End of clause)

 

 

 

   

 

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252.232-7003 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS
(MAR 2008)

 

(a) Definitions. As used in this clause--

 

(1)  Contract financing payment and invoice payment have the meanings given in
section 32.001 of the Federal Acquisition Regulation.

 

(2)  Electronic form means any automated system that transmits information
electronically from the initiating system to all affected systems. Facsimile,
e-mail, and scanned documents are not acceptable electronic forms for submission
of payment requests. However, scanned documents are acceptable when they are
part of a submission of a payment request made using Wide Area WorkFlow (WAWF)
or another electronic form authorized by the Contracting Officer.

 

(3)  Payment request means any request for contract financing payment or invoice
payment submitted by the Contractor under this contract.

 

(b) Except as provided in paragraph (c) of this clause, the Contractor shall
submit payment requests and receiving reports using WAWF, in one of the
following electronic formats that WAWF accepts: Electronic Data Interchange,
Secure File Transfer Protocol, or World Wide Web input. Information regarding
WAWF is available on the Internet at https://wawf.eb.mil/.

 

(c) The Contractor may submit a payment request and receiving report using other
than WAWF only when--

 

(1)  The Contracting Officer authorizes use of another electronic form. With
such an authorization, the Contractor and the Contracting Officer shall agree to
a plan, which shall include a timeline, specifying when the Contractor will
transfer to WAWF;

 

(2)  DoD is unable to receive a payment request or provide acceptance in
electronic form;

 

(3)  The Contracting Officer administering the contract for payment has
determined, in writing, that electronic submission would be unduly burdensome to
the Contractor. In such cases, the Contractor shall include a copy of the
Contracting Officer's determination with each request for payment; or

 

(4)  DoD makes payment for commercial transportation services provided under a
Government rate tender or a contract for transportation services using a
DoD-approved electronic third party payment system or other exempted vendor
payment/invoicing system (e.g., PowerTrack, Transportation Financial Management
System, and Cargo and Billing System).

 

(d) The Contractor shall submit any non-electronic payment requests using the
method or methods specified in Section G of the contract.

 

(e) In addition to the requirements of this clause, the Contractor shall meet
the requirements of the appropriate payment clauses in this contract when
submitting payments requests.

 

(End of clause)

 

 

252.247-7024 Notification of Transportation of Supplies by Sea (MAR 2000)

 

(a) The Contractor has indicated by the response to the solicitation provision,
Representation of Extent of Transportation by Sea, that it did not anticipate
transporting by sea any supplies. If, however, after the award of this contract,
the Contractor learns that supplies, as defined in the Transportation of
Supplies by Sea clause of this contract, will be transported by sea, the
Contractor --

 

(1) Shall notify the Contracting Officer of that fact; and

 

 

   

 

N66001-11-C-4188

Page 39 of 40

 

 

(2) Hereby agrees to comply with all the terms and conditions of the
Transportation of Supplies by Sea clause of this contract.

 

(b) The Contractor shall include this clause; including this paragraph (b),
revised as necessary to reflect the relationship of the contracting parties--

 

(1)    In all subcontracts under this contract, if this contract is a
construction contract; or

 

(2)    If this contract is not a construction contract, in all subcontracts
under this contract that are for--

 

(i)   Noncommercial items; or

 

(ii)  Commercial items that--

 

(A)   The Contractor is reselling or distributing to the Government without
adding value (generally, the Contractor does not add value to items that it
subcontracts for f.o.b. destination shipment);

 

(B)   Are shipped in direct support of U.S. military contingency operations,
exercises, or forces deployed in humanitarian or peacekeeping operations; or

 

(C)   Are commissary or exchange cargoes transported outside of the Defense
Transportation System in accordance with 10 U.S.C. 2643.

 

(End of clause)

 

 

 

 

 

 

 

 

 

 

 

   

 

N66001-11-C-4188

Page 40 of 40

Section J - List of Documents, Exhibits and Other Attachments

 

Exhibit/Attachment Table of Contents

 

DOCUMENT TYPE DESCRIPTION PAGES DATE Exhibit A Base Period CDRLs 4 26-SEP-2011
Exhibit B Option I CDRLs 4 26-SEP-2011 Exhibit C Option II CDRLs 4 26-SEP-2011
Exhibit D Option III CDRLs 4 26-SEP-2011 Exhibit E Option IV CDRLs 4 26-SEP-2011
Attachment 1 Performance Based 5 26-SEP-2011   Payments Schedule     Attachment
2 Clause 252.227-7017 2 28-SEP-2011

 

 

 

 

 

 

 

 

 

 

 

   

 

 

AMENDMENT OF SOLITICATION/MODIFICATION OF CONTRACT

 

 [image_001.jpg]

 

 1 

 

 

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

 

SUMMARY OF CHANGES

 

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

 

The following have been modified: STATEMENT OF WORK (SOW)

 

Aethlon Medical, Inc.

 

DATE: 11 December 2013, Revised: 12 March 2015

 

TITLE: Broad Spectrum Countermeasures for Viral and Bacterial Sepsis using
Dialysis-Like Devices

 

1.0Scope

The scope of this effort is to use Aethlon’s Hemopurifier as the core technology
within an extracorporeal blood purification device that would simultaneously
remove: viruses, virally-derived immunosuppressive glycoproteins, and multiple
classes of exosomes; complement activation, activation of virus growth (e.g.
cytomegalovirus) and TLR activation, all of which have implications to the
promotion of the well-being and recovery of wounded warfighters and the
prevention of sepsis.

 

1.1Introduction

This effort will create an adaptable dialysis-like platform (ADAPT) technology
that allows for the selective removal of harmful agents from the entire
circulatory system. This revolutionary advance overcomes the limitation of
devices that indiscriminately adsorb or solely capture particles by molecule
size. The platform will provide an expansive therapeutic filtration mechanism to
immobilize multiple affinity agents directed toward precursors to sepsis,
bacterial toxins, viral pathogens, and disease enhancing particles transported
by exosomes. To insure benefit to wounded warfighters, this effort will advance
an innovative strategy that will allow therapy administration without systemic
anticoagulation.

 

The ADAPT platform has been shown previously to create a broad-spectrum
antiviral device that immobilized one lectin affinity agent, resulting in the
effective capture of all tested Category A pathogens, as well as exosomes
underlying tuberculosis and cancer. In human studies, this same device, known as
the Hemopurifier, consistently provided greater than 50% average viral load
reductions during four-hour treatment periods in both hepatitis-C and HIV
infected individuals without antiviral drug therapy.

 

The resulting device would save thousands of military and civilian lives each
year. Each of these technology advancements will be integrated into a single
cartridge that will provide decision-free and life-saving medical care for the
wounded warfighter.

 

1.2Background

The goal of the DLT program is to develop a portable device that removes “dirty”
blood from the body, separates harmful agents, and returns “clean” blood to the
body in a manner similar to dialysis treatment of kidney failure. While the
device could have an impact across multiple areas of medicine, the target
application for this device is sepsis. The envisioned device will persistently
interrogate the entire blood volume, providing early identification of the
presence of a pathogen. Once the presence of pathogens has been confirmed, the
DLT device will provide continuous "label-free" removal of pathogens, toxins and
activated patient cells without pathogen identification or use of
pathogen-specific binding chemistries. As a final step in the treatment process,
the DLT device will enable closed-loop therapy based on continuous, reduced
dimensionality modeling of patient health. Predictive modeling in this fashion
will allow us to identify sepsis early, learn what we need to remove, and direct
the most effective intervention to improve patient health. This cycle of
sensing, adjustment, estimation, computation, and manipulation will modulate key
health parameters faster than the underlying disease process and drive the
patient towards a stable, healthy state.

 

 

 2 

 

 

2.0Technical Requirements

 

2.1Human and Animal use

 

Human use is anticipated in this effort, specifically related to the use of
human blood. The grantee shall obtain all necessary Institutional Review Board
(IRB) approvals, show proper assurance documentation, and obtain proper approval
from the Government officials prior to human use testing. Funds associated with
human subjected testing shall not be released until IRB documentation has been
provided to SSC’s HRPO and approval to release funds has been obtained.

 

Animal use is anticipated in this effort. The contractor shall obtain all
necessary Institutional Animal Care and Utilization Committee (IACUC) approval
and demonstrate this approval to the Government (both ACURO and SSC-Pacific)
prior to beginning experimentation with animals. If animal use is no longer
anticipated, or changes significantly from the approved IACUC then the Principal
Investigator (PI) must submit a letter stating the discontinuation of animal use
for this effort and/or receive appropriate authorization for IACUC changes of
previously specified protocols. Unless prior approval by DARPA is given IACUC
documentation must be provided prior to contract award.

 

2.2Base Effort (Year 1)

 

2.2.1Subtask 1a: Anticoagulant-free Hemopurification Device

 

2.2.1.1Write requirements definition for the extracorporeal blood purification
system and acquire necessary equipment.

2.2.1.2Fabricate breadboard prototypes for anticoagulation-free anti-sepsis
extracorporeal system (ASEPSYS) device. Fabricate prototype blood tubing sets.
Acquire anti-thrombogenic surface-modified hollow fiber plasma separators.

2.2.1.3Assemble and test breadboard ASEPSYS devices ex vivo with bovine blood.
The test will most likely be conducted using a porcine model where the elapsed
time to reach a pre-defined degree of clotting in the blood treatment device
will be compared between the new device and two control groups; one using
standard anticoagulant therapy and one using none. Determine contribution of the
following techniques and approaches to eliminating anticoagulants:

(1)   Backflushing at regular intervals, (2) Turbo loop, (3) Continuous
pre-dilution loop using re-captured hydration fluid, (4) Linear vs pulsatile
blood flow, (5) Elimination of air/blood interfaces in extracorporeal circuit,
(6) Anti-thrombogenic derivatized plasma separation membrane, and (7)
Ultra-short half-life anticoagulant nafamostat mesilate.

2.2.1.4IRB Documentation Generation: The contractor shall obtain all necessary
IRB documentation and obtain both institutional and Government (SSC-Pacific)
approval in accordance with IRB documentation submission guidance prior to
conducting human subject testing.

 

Milestones

M1: Demonstrate the effectiveness of the prototype device in preventing platelet
activation or clotting in at least a 2 hour blood pumping experiment at 100
mL/hr blood flow.

 

2.2.2Subtask 2: Removal of Sepsis Precursors

2.2.2.1Begin to develop a device based on Aethlon’s ADAPT system to efficiently
capture sepsis precursors identified as potentially important in killing
patients undergoing sepsis. The strategy is takes advantage of the flexibility
and rapidity of modification of our ADAPT platform system to test any sepsis
precursor candidates that circulate in the blood. The sepsis precursors that
will be targeted are shown in Table I, in order of importance. No test for the
removal of bacterial toxins. No testing for removal of cytokines, since the
evidence to date does not support a role for them in death due to sepsis.
Additional factors may become known during the grant period and those will also
be tested as time and budget permit.

 

 

 

 

 3 

 

 

 

2.2.2.2Screening Capture Agents: Perform initial screening of the different
proposed capture agents by measuring binding affinity and kinetics using surface
plasmon resonance (SPR) or biolayer surface interferometry (BLI).

2.2.2.3Perform quantitative real time PCR will also be used to measure viral
load, and specific DNA or RNA targets.

 

Milestones

M2: Target capture > 50% in 24 hours for at least 1 target in blood or blood
components

 

Table I Potential Target Sepsis Precursors and Broad Spectrum Binding Agents

Septic Exosomes Removal Agent INOS exosomes GNA Viruses Associated with Sepsis  
Dengue Fever virus GNA H1N1 Flu virus GNA Cytomegalovirus ** GNA Herpes viruses
– e.g. HSV 1 GNA Poxviruses - e.g. Vaccina (model for small pox) GNA Activation
of Innate Immunity   LPS endotoxins GNA LTA endotoxins GNA

 

2.3Option 1 (Year 2)

 

2.3.2Subtask 1a: Anticoagulant-free Hemopurification Device

2.3.2.1Demonstrate the effectiveness of the prototype device in vivo in animals
preventing platelet activation or clotting in at least a 2 hour blood pumping
experiment at 75 mL/min blood flow.

2.3.2.2Formulate initial design based on work from previous phase. Begin to
build and test selected instrument design and tubing sets.

2.3.2.3Write and test software. Conduct ergonomic research. Begin discussions
with System Integrator.

2.3.2.4Complete fabrication and testing of prototype instrument.

2.3.2.5Research literature and patent database for technical options for an
on-line/in-line sensor with the ability to quantify the clearance of citrate
and/or calcium in effluent dialysate.

2.3.2.6Collect feasibility data on at least one sensor option.

2.3.2.7Conduct a series of 21 experiments aimed at characterizing the
contribution of several alternate fluidic designs and methods of perfusing
plasma filters and affinity columns in the performance of affinity
plasmapheresis.

 

2,3.3 Subtask 2. Removal of Sepsis Precursors

2.3.3.1Build the ADAPT capture cartridges with the identified affinity agents.
Measure the rate of capture of the specific targets from in ex vivo
recirculation experiments from cell culture and blood.

2.3.3.2Cartridge construction with optimized affinity matrix design for each
potential target. Complete all capture agents screening. Initiate ex vivo
capture studies from blood using the optimized cartridges.

 

Milestones

M4: Target capture > 50% in 24 hours for at least 5 targets in blood or blood
components.

M5: Milestone 5: Target capture > 90% in 24 hours for at least 3 targets in
blood or blood components.

 

NOTE: TASK 2.3.2 SHALL NOT BE EXERCISED AND TASKING FUNDS RELEASED UNTIL IRB
DOCUMENTATION AND PROPER IRB APPROVAL HAS BEEN OBTAINED.

 

 

 

 

 4 

 

 

2.4Option 2 (Year 3)

 

2.4.1Subtask 1a: Anticoagulant-free Hemopurification Device

2.4.1.1Design and fabricate optimized configuration(s) of hemopurification
device(s) that contain(s) a combination of hemofilters, plasma filters, and
affinity columns.

 

Milestones

M6: Define Aethlon’s GMP manufacturing process and revise and upgrade Aethlon’s
quality procedures and policies to the current state of the art. Demonstrate the
safety of at least one prototype device within an optimized fluidic circuit
architecture preventing clotting in a 24 hour experiment in vivo at a blood flow
rate of 200 ml/min using either pigs or dogs.

 

2.4.2Subtask 4: Target Capture in Combined Agent Cartridge

2.4.2.1 Evaluate contribution of manufacturing process variables to binding
capacity of affinity resin.

2.4.2.2 Determine capacity requirements of affinity resin to multiple
simultaneous targets.

2.4.2.3 Perform basic biocompatibility tests for the combination ADAPT device to
confirm the combination cartridge does not present additional risk.

2.4.2.4 Finish construction and delivery of 25 experimental cartridges for
testing by the system integrator.

 

Milestones

M7: Target capture > 90% in 24 hours (12 months) for at least 3 targets ex vivo
in blood or blood components using the optimized cartridge.

M8: Pass biocompatibility tests for the combination ADAPT device.

M9: Construct and deliver of 25 prototype cartridges for testing by the system
integrator.

 

2.5Option 3 (Year 4)

 

2.5.1Subtask 1a: Anticoagulant-free Hemopurification Device

2.5.1.1Complete Aethlon’s GMP procedure and establish and maintain all GMP
documentation for the company. Revise and upgrade Aethlon’s quality procedures
and policies to the current state of the art and establish and maintain all GMP
documentation for the company.Develop additional optimized configuration(s) of
hemopurification device(s) that contain(s) a combination of hemofilters, plasma
filters, and affinity columns.

 

Milestones

M11: Develop a strategic plan for developing an alternate method of producing
GNA by cloning the gene into an alternate vector and identify potential partners
for such production. Demonstrate the safety of an additional prototype device
within an optimized fluidic circuit architecture preventing clotting in a 24
hour experiment in vivo at a blood flow rate of 200 ml/min using either pigs or
dogs.

 

2.5.2Subtask 4: Target Capture in Combined Agent Cartridge

2.5.2.2 Finish construction and delivery of 50 prototype cartridges for testing
by the system integrator. The cartridges will need to be made available
(packaged, labeled, sterilized and qualified) to the system integrator.

 

Milestones

M13: Construct and deliver of 50 prototype cartridges for testing by the system
integrator.

 

2.6 Option 4 (Year 5)

 

2.6.1 Subtask 5: Testing of final product by System Integrator

2.6.1.1 System integrator acceptance of the hemofilter device.

2.6.1.3Prepare and submit IDE proposal for sepsis treatment.

2.6.1.4Prepare and present Final report for DARPA.

 

 

 

 5 

 

 

Milestones

M12: System Integrator approval of a sepsis precursor ADAPT treatment cartridge

 

3.0Program Management and Reviews

 

3.1Program Management Plan

The contractor shall develop a Program Management Plan. A graphical
representation of this plan (Gantt chart is one example) identifying major tasks
and their task leaders, milestones of the major task and their completion dates
shall be generated. In addition, a graphical representation of budget shall be
generated.

 

3.2Kick-off Meeting

The contractor shall participate in a kick-off meeting within 60 days of
contract award. The purpose of this meeting is to introduce key program
personnel, discuss the proposed tasking, present the program schedule and
milestones and the initial Program Management Plan.

 

3.3Quarterly Reviews

The contractor shall hold quarterly reviews for the duration of this effort. The
purpose of these reviews is to present a summary of work completed and
milestones met, discuss any problems encountered, update the program schedule,
present the program financial status, and discuss remaining work.

 

3.4Final Contract Review

A final contract review held in place of the last quarterly review shall be
hosted by the principal contractor. The purpose of this review is to present a
summary of all work completed and milestones accomplished and to discuss any
relevant future efforts similar to the contract that may be pursued.

 

4.0 Deliverables

The reports and presentation materials are to be delivered in accordance with
the attached Data Delivery Matrix.

 

(End of SOW).

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

 

 

 

 

 6 

 

 

The following have been modified:

 

SCHEDULE OF PAYMENT MILESTONES

 

12 month duration base period (Year 1)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($908,384) 2.2.1.1 1 Write
requirements definition for the extracorporeal blood purification system and
acquire necessary equipment. ($358,284)

2.2.1.2

3

Fabricate breadboard prototypes for anticoagulation-free anti-sepsis
extracorporeal system (ASEPSYS) device.

Fabricate prototype blood tubing sets. Acquire anti- thrombogenic
surface-modified hollow fiber plasma separators.

($183,367)

2.2.1.3

6

Assemble and test breadboard ASEPSYS devices. Evaluate the use of different
techniques and approaches to eliminating anticoagulants.

($183,367)

2.2.1.4

12

Obtain all necessary IRB documentation and obtain both institutional and
Government (SSC-Pacific) approval in accordance with IRB documentation
submission guidance prior to conducting human or animal testing.

($183,367)

Subtask 2

& 4

  Removal of Sepsis Precursors ($1,066,663)

2.2.2.1

2

Begin to develop the Aethlon’s ADAPT device to efficiently capture sepsis
precursors and acquire important equipment and supplies

($416,424)

2.2.2.2

5

Perform initial screening of the different proposed capture agents by measuring
binding affinity and kinetics using surface plasmon resonance (SPR) or biolayer
surface interferometry (BLI).

($216,747)

2.2.2.3 8 Perform preliminary quantitative real time PCR to measure viral load,
and specific DNA or RNA targets. ($216,747) M2 12 Target capture > 50% in 24
hours for at least 1 target in blood or blood components ($216,747) Total
($1,975,047)

 

 

 

 7 

 

 

12 month duration option #1 period (Year2)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($782,322)

2.3.2.1

15

Demonstrate the effectiveness of the prototype device in vivo in animals
preventing platelet activation or clotting in at least a 2 hour blood pumping
experiment at 75 mL/min blood flow.

($195,581)

2.3.2.2

18

Formulate initial design based on work from previous phase. Begin to build and
test selected instrument design and tubing sets.

($195,581)

2.3.2.3

21

Write and test software. Conduct ergonomic research. Begin discussions with
System Integrator.

($195,581)

M3

24

Complete fabrication and testing of prototype instrument.

Research literature and patent database for technical.

($195,581)

Subtask 2   Removal of Sepsis Precursors ($835,124)

2.3.3.1

15

Build the ADAPT capture cartridges with the identified affinity agents. Measure
the rate of capture of the specific targets from in ex vivo recirculation
experiments from cell culture and blood.

($208,781)

M4 18 Target capture > 50% in 24 hours for at least 5 targets in blood or blood
components. ($208,781)

2.3.3.2

21

Cartridge construction with optimized affinity matrix design for each potential
target. Complete the capture agent screening.

($208,781)

M5 24 Target capture > 90% in 24 hours for at least 3 targets in blood or blood
components. ($208,781) Total ($1,617,446)

 

 

 

 

 

 

 

 8 

 

 

12 month duration option #2 period (Year 3)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($372,328)

2.4.1.1

27

Design and fabricate optimized configuration(s) of hemopurification device(s)
that contain(s) a combination of hemofilters, plasma filters, and affinity
columns.

($186,164)

M6

36

Define Aethlon’s GMP manufacturing process and revise and upgrade Aethlon’s
quality procedures and policies to the current state of the art.

($186,164)

Subtask 2+4   Target Capture in Combined Agent Cartridge ($720,726)

2.4.2.1

27

Evaluate contribution of manufacturing process variables to binding capacity of
affinity resin.

($197,362)

2.4.2.2

33

Determine capacity requirements of affinity resin to multiple simultaneous
targets.

($197,362)

2.4.2.3 30 Perform biocompatibility tests for the combination ADAPT device to
confirm the combination cartridge does not present additional risk. ($78,641)
2.4.2.4 36 Finish construction and delivery of 25 experimental cartridges for
testing by the system integrator. ($50,000)

M9

36

Target capture > 90% in 24 hours (12 months) for at least 3 targets ex vivo in
blood or blood components using the optimized cartridge.

($197,361)

Total ($1,093,054)

 

 

 

 

 

 

 

 9 

 

 

12 month duration option #3 period (Year 4)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($276,172)

2.5.1.1

45

Complete Aethlon’s GMP procedure and establish and maintain all GMP
documentation for the company. ($90,008)

M11

48

Develop a strategic plan for developing an alternate method of producing GNA by
cloning the gene into an alternate vector and identify potential partners for
such production.

($186,164)

Subtask 2+4   Target Capture in Combined Agent Cartridge ($296,964) 2.5.2.2 48
Finish construction and begin delivery of 50 prototype cartridges for testing by
the system integrator. ($296,964) Total ($573,136)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 10 

 

 

12 month duration option #4 period (Year 5)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 5   Testing of final
product by System Integrator ($581,157) 2.6.1.1 51 System integrator acceptance
of the hemofilter device. ($193,719) 2.6.1.3 57 Prepare and submit IDE proposal
for sepsis treatment. ($193,719) 2.6.1.4 60 Prepare and present Final Report for
DARPA. ($193,719) Total ($581,157)

 

 

(End of Milestone Schedule)

 

 

 

(End of Summary of Changes)

 

 

 

 

 11 

 

 

 

 

[image_002.jpg]

 

 1 

 

 

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

 

SUMMARY OF CHANGES

 

 

SECTION A - SOLICITATION/CONTRACT FORM

The standard size code 1,000 has been added.

The NAICS code 541711 has been added.

 

 

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

 

 

 

The following have been modified:

 

STATEMENT OF WORK (SOW)

Aethlon Medical, Inc.

 

DATE: 12 March 2015; Modified: 15 July 2016

 

TITLE: Broad Spectrum Countermeasures for Viral and Bacterial Sepsis using
Dialysis-Like Devices

 

1.0Scope

The scope of this effort is to use Aethlon’s Hemopurifier as the core technology
within an extracorporeal blood purification device that would simultaneously
remove: viruses, virally-derived immunosuppressive glycoproteins, and multiple
classes of exosomes; complement activation, activation of virus growth (e.g.
cytomegalovirus) and TLR activation, all of which have implications to the
promotion of the well-being and recovery of wounded warfighters and the
prevention of sepsis.

 

1.1Introduction

This effort will create an adaptable dialysis-like platform (ADAPT) technology
that allows for the selective removal of harmful agents from the entire
circulatory system. This revolutionary advance overcomes the limitation of
devices that indiscriminately adsorb or solely capture particles by molecule
size. The platform will provide an expansive therapeutic filtration mechanism to
immobilize multiple affinity agents directed toward precursors to sepsis,
bacterial toxins, viral pathogens, and disease enhancing particles transported
by exosomes. To insure benefit to wounded warfighters, this effort will advance
an innovative strategy that will allow therapy administration without systemic
anticoagulation.

The ADAPT platform has been shown previously to create a broad-spectrum
antiviral device that immobilized one lectin affinity agent, resulting in the
effective capture of all tested Category A pathogens, as well as exosomes
underlying tuberculosis and cancer. In human studies, this same device, known as
the Hemopurifier, consistently provided greater than 50% average viral load
reductions during four-hour treatment periods in both hepatitis-C and HIV
infected individuals without antiviral drug therapy.

 

The resulting device would save thousands of military and civilian lives each
year. Each of these technology advancements will be integrated into a single
cartridge that will provide decision-free and life-saving medical care for the
wounded warfighter.

 

 

 2 

 

 

1.2Background

The goal of the DLT program is to develop a portable device that removes “dirty”
blood from the body, separates harmful agents, and returns “clean” blood to the
body in a manner similar to dialysis treatment of kidney failure. While the
device could have an impact across multiple areas of medicine, the target
application for this device is sepsis. The envisioned device will persistently
interrogate the entire blood volume, providing early identification of the
presence of a pathogen. Once the presence of pathogens has been confirmed, the
DLT device will provide continuous "label-free" removal of pathogens, toxins and
activated patient cells without pathogen identification or use of
pathogen-specific binding chemistries. As a final step in the treatment process,
the DLT device will enable closed-loop therapy based on continuous, reduced
dimensionality modeling of patient health. Predictive modeling in this fashion
will allow us to identify sepsis early, learn what we need to remove, and direct
the most effective intervention to improve patient health. This cycle of
sensing, adjustment, estimation, computation, and manipulation will modulate key
health parameters faster than the underlying disease process and drive the
patient towards a stable, healthy state.

 

2.0Technical Requirements

 

2.1Human and Animal use

Human use is anticipated in this effort, specifically related to the use of
human blood. The grantee shall obtain all necessary Institutional Review Board
(IRB) approvals, show proper assurance documentation, and obtain proper approval
from the Government officials prior to human use testing. Funds associated with
human subjected testing shall not be released until IRB documentation has been
provided to SSC’s HRPO and approval to release funds has been obtained.

 

Animal use is anticipated in this effort. The contractor shall obtain all
necessary Institutional Animal Care and Utilization Committee (IACUC) approval
and demonstrate this approval to the Government (both ACURO and SSC-Pacific)
prior to beginning experimentation with animals. If animal use is no longer
anticipated, or changes significantly from the approved IACUC then the Principal
Investigator (PI) must submit a letter stating the discontinuation of animal use
for this effort and/or receive appropriate authorization for IACUC changes of
previously specified protocols. Unless prior approval by DARPA is given IACUC
documentation must be provided prior to contract award.

 

2.2Base Effort (Year 1)

 

2.2.1Subtask 1a: Anticoagulant-free Hemopurification Device

2.2.1.1Write requirements definition for the extracorporeal blood purification
system and acquire necessary equipment.

2.2.1.2Fabricate breadboard prototypes for anticoagulation-free anti-sepsis
extracorporeal system (ASEPSYS) device. Fabricate prototype blood tubing sets.
Acquire anti-thrombogenic surface-modified hollow fiber plasma separators.

2.2.1.3Assemble and test breadboard ASEPSYS devices ex vivo with bovine blood.
The test will most likely be conducted using a porcine model where the elapsed
time to reach a pre-defined degree of clotting in the blood treatment device
will be compared between the new device and two control groups; one using
standard anticoagulant therapy and one using none. Determine contribution of the
following techniques and approaches to eliminating anticoagulants:

(1)      Backflushing at regular intervals, (2) Turbo loop, (3) Continuous
pre-dilution loop using re-captured hydration fluid, (4) Linear vs pulsatile
blood flow, (5) Elimination of air/blood interfaces in extracorporeal circuit,
(6) Anti-thrombogenic derivatized plasma separation membrane, and (7)
Ultra-short half-life anticoagulant nafamostat mesilate.

 

2.2.1.4IRB Documentation Generation: The contractor shall obtain all necessary
IRB documentation and obtain both institutional and Government (SSC-Pacific)
approval in accordance with IRB documentation submission guidance prior to
conducting human subject testing.

 

Milestones

M1:Demonstrate the effectiveness of the prototype device in preventing platelet
activation or clotting in at least a 2 hour blood pumping experiment at 100
mL/hr blood flow.

 

2.2.2Subtask 2: Removal of Sepsis Precursors

2.2.2.1Begin to develop a device based on Aethlon’s ADAPT system to efficiently
capture sepsis precursors identified as potentially important in killing
patients undergoing sepsis. The strategy is takes advantage of the flexibility
and rapidity of modification of our ADAPT platform system to test any sepsis
precursor candidates that circulate in the blood. The sepsis precursors that
will be targeted are shown in Table I, in order of importance. No test for the
removal of bacterial toxins. No testing for removal of cytokines, since the
evidence to date does not support a role for them in death due to sepsis.
Additional factors may become known during the grant period and those will also
be tested as time and budget permit

 

 

 3 

 

 

.

2.2.2.2Screening Capture Agents: Perform initial screening of the different
proposed capture agents by measuring binding affinity and kinetics using surface
plasmon resonance (SPR) or biolayer surface interferometry (BLI).

2.2.2.3Perform quantitative real time PCR will also be used to measure viral
load, and specific DNA or RNA targets.

 

Milestones

 

M2:          Target capture > 50% in 24 hours for at least 1 target in blood or
blood components

 

Table I Potential Target Sepsis Precursors and Broad Spectrum Binding Agents

 

Septic Exosomes Removal Agent INOS exosomes GNA Viruses Associated with Sepsis  
Dengue Fever virus GNA H1N1 Flu virus GNA Cytomegalovirus ** GNA Herpes viruses
– e.g. HSV 1 GNA Poxviruses - e.g. Vaccina (model for small pox) GNA Activation
of Innate Immunity   LPS endotoxins GNA LTA endotoxins GNA

 

 

2.3Option 1 (Year 2)

 

2.3.2Subtask 1a: Anticoagulant-free Hemopurification Device

2.3.2.1Demonstrate the effectiveness of the prototype device in vivo in animals
preventing platelet activation or clotting in at least a 2 hour blood pumping
experiment at 75 mL/min blood flow.

2.3.2.2Formulate initial design based on work from previous phase. Begin to
build and test selected instrument design and tubing sets.

2.3.2.3Write and test software. Conduct ergonomic research. Begin discussions
with System Integrator.

2.3.2.4Complete fabrication and testing of prototype instrument.

2.3.2.5Research literature and patent database for technical options for an
on-line/in-line sensor with the ability to quantify the clearance of citrate
and/or calcium in effluent dialysate.

2.3.2.6Collect feasibility data on at least one sensor option.

2.3.2.7Conduct a series of 21 experiments aimed at characterizing the
contribution of several alternate fluidic designs and methods of perfusing
plasma filters and affinity columns in the performance of affinity
plasmapheresis.

 

 

2,3.3 Subtask 2. Removal of Sepsis Precursors

2.3.3.1Build the ADAPT capture cartridges with the identified affinity agents.
Measure the rate of capture of the specific targets from in ex vivo
recirculation experiments from cell culture and blood.

2.3.3.2Cartridge construction with optimized affinity matrix design for each
potential target. Complete all capture agents screening. Initiate ex vivo
capture studies from blood using the optimized cartridges.

 

Milestones

M4:     Target capture > 50% in 24 hours for at least 5 targets in blood or
blood components.

M5: Milestone 5: Target capture > 90% in 24 hours for at least 3 targets in
blood or blood components.

NOTE: TASK 2.3.2 SHALL NOT BE EXERCISED AND TASKING FUNDS RELEASED UNTIL IRB
DOCUMENTATION AND PROPER IRB APPROVAL HAS BEEN OBTAINED.

 

 

 4 

 

 

 

2.4Option 2 (Year 3)

 

2.4.1Subtask 1a: Anticoagulant-free Hemopurification Device

2.4.1.1Design and fabricate optimized configuration(s) of hemopurification
device(s) that contain(s) a combination of hemofilters, plasma filters, and
affinity columns.

 

Milestones

M6:Define Aethlon’s GMP manufacturing process and revise and upgrade Aethlon’s
quality procedures and policies to the current state of the art.

 

2.4.2Subtask 4: Target Capture in Combined Agent Cartridge

2.4.2.1Evaluate contribution of manufacturing process variables to binding
capacity of affinity resin.

2.4.2.2Determine capacity requirements of affinity resin to multiple
simultaneous targets.

2.4.2.3Perform basic biocompatibility tests for the combination ADAPT device to
confirm the combination cartridge does not present additional risk.

2.4.2.4Finish construction and delivery of 25 experimental cartridges for
testing by the system integrator.

 

Milestones

M7:Target capture > 90% in 24 hours (12 months) for at least 3 targets ex vivo
in blood or blood components using the optimized cartridge.

  M8: Pass biocompatibility tests for the combination ADAPT device.

  M9: Construct and deliver of 25 prototype cartridges for testing by the system
integrator.

 

 

2.5Option 3 (Year 4)

 

2.5.1Subtask 1a: Anticoagulant-free Hemopurification Device

2.5.1.1Complete Aethlon’s GMP procedure and establish and maintain all GMP
documentation for the company.

 

Milestones

M11:Develop a strategic plan for developing an alternate method of producing GNA
by cloning the gene into an alternate vector and identify potential partners for
such production.

 

2.5.2Subtask 4: Target Capture in Combined Agent Cartridge

2.5.2.2 Finish construction and delivery of 50 prototype cartridges for testing
by the system integrator. The cartridges will need to be made available
(packaged, labeled, sterilized and qualified) to the system integrator.

 

Milestones

M13:       Construct and deliver of 50 prototype cartridges for testing by the
system integrator.

 

 

2.6 Option 4 (Year 5)

 

2.6.1 Subtask 5: Testing of final product by System Integrator

2.6.1.1 System integrator acceptance of the hemofilter device.

2.6.1.3 Quantify the degree to which the MERS virus can be extracted from
circulation in vitro using miniature Hemopurifiers.

2.6.1.4 Prepare and present Final report for DARPA.

 

Milestones

M12: System Integrator approval of a sepsis precursor ADAPT treatment cartridge

 

 

 5 

 

 

3.0Program Management and Reviews

 

3.1Program Management Plan

The contractor shall develop a Program Management Plan. A graphical
representation of this plan (Gantt chart is one example) identifying major tasks
and their task leaders, milestones of the major task and their completion dates
shall be generated. In addition, a graphical representation of budget shall be
generated.

 

3.2Kick-off Meeting

The contractor shall participate in a kick-off meeting within 60 days of
contract award. The purpose of this meeting is to introduce key program
personnel, discuss the proposed tasking, present the program schedule and
milestones and the initial Program Management Plan.

 

3.3Quarterly Reviews

The contractor shall hold quarterly reviews for the duration of this effort. The
purpose of these reviews is to present a summary of work completed and
milestones met, discuss any problems encountered, update the program schedule,
present the program financial status, and discuss remaining work.

 

3.4Final Contract Review

A final contract review held in place of the last quarterly review shall be
hosted by the principal contractor. The purpose of this review is to present a
summary of all work completed and milestones accomplished and to discuss any
relevant future efforts similar to the contract that may be pursued.

 

4.0 Deliverables

The reports and presentation materials are to be delivered in accordance with
the attached Data Delivery Matrix.

 

(End of SOW).

 

 

 

 6 

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

 

The following have been modified:

 

 

SCHEDULE OF PAYMENT MILESTONES

 

12 month duration base period (Year 1)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($908,384) 2.2.1.1 1 Write
requirements definition for the extracorporeal blood purification system and
acquire necessary equipment. ($358,284)

 

 

2.2.1.2

 

 

3

Fabricate breadboard prototypes for anticoagulation-free anti-sepsis
extracorporeal system (ASEPSYS) device.

Fabricate prototype blood tubing sets. Acquire anti- thrombogenic
surface-modified hollow fiber plasma separators.

 

 

($183,367)

 

2.2.1.3

 

6

Assemble and test breadboard ASEPSYS devices. Evaluate the use of different
techniques and approaches to eliminating anticoagulants.

 

($183,367)

 

 

2.2.1.4

 

12

Obtain all necessary IRB documentation and obtain both institutional and
Government (SSC-Pacific) approval in accordance with IRB documentation
submission guidance prior to conducting human or animal testing.

 

($183,367)

Subtask 2

& 4

  Removal of Sepsis Precursors ($1,066,663)

 

2.2.2.1

 

2

Begin to develop the Aethlon’s ADAPT device to efficiently capture sepsis
precursors and acquire important equipment and supplies

 

($416,424)

 

2.2.2.2

 

5

Perform initial screening of the different proposed capture agents by measuring
binding affinity and kinetics using surface plasmon resonance (SPR) or biolayer
surface interferometry (BLI).

 

($216,747)

2.2.2.3 8 Perform preliminary quantitative real time PCR to measure viral load,
and specific DNA or RNA targets. ($216,747) M2 12 Target capture > 50% in 24
hours for at least 1 target in blood or blood components ($216,747) Total
($1,975,047)

 

 

 7 

 

 

12 month duration option #1 period (Year2)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($782,322)

 

 

2.3.2.1

 

 

15

 

Demonstrate the effectiveness of the prototype device in vivo in animals
preventing platelet activation or clotting in at least a 2 hour blood pumping
experiment at 75 mL/min blood flow.

 

 

($195,581)

 

2.3.2.2

 

18

 

Formulate initial design based on work from previous phase. Begin to build and
test selected instrument design and tubing sets.

 

($195,581)

 

2.3.2.3

 

21

 

Write and test software. Conduct ergonomic research. Begin discussions with
System Integrator.

 

($195,581)

 

M3

 

24

Complete fabrication and testing of prototype instrument.

Research literature and patent database for technical.

 

($195,581)

Subtask 2   Removal of Sepsis Precursors ($835,124)

 

2.3.3.1

 

15

Build the ADAPT capture cartridges with the identified affinity agents. Measure
the rate of capture of the specific targets from in ex vivo recirculation
experiments from cell culture and blood.

 

($208,781)

M4 18 Target capture > 50% in 24 hours for at least 5 targets in blood or blood
components. ($208,781)

 

2.3.3.2

 

21

Cartridge construction with optimized affinity matrix design for each potential
target. Complete the capture agent screening.

 

($208,781)

M5 24 Target capture > 90% in 24 hours for at least 3 targets in blood or blood
components. ($208,781) Total ($1,617,446)

 

 

 8 

 

 

12 month duration option #2 period (Year 3)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($372,328)

 

2.4.1.1

 

27

Design and fabricate optimized configuration(s) of hemopurification device(s)
that contain(s) a combination of hemofilters, plasma filters, and affinity
columns.

 

($186,164)

 

M6

 

36

 

Define Aethlon’s GMP manufacturing process and revise and upgrade Aethlon’s
quality procedures and policies to the current state of the art.

 

($187,164)

Subtask 2+4   Target Capture in Combined Agent Cartridge ($720,726)

 

 

2.4.2.1

 

 

27

 

 

Evaluate contribution of manufacturing process variables to binding capacity of
affinity resin.

 

 

($197,362)

 

2.4.2.2

 

33

 

Determine capacity requirements of affinity resin to multiple simultaneous
targets.

 

($197,362)

2.4.2.3 30 Perform biocompatibility tests for the combination ADAPT device to
confirm the combination cartridge does not present additional risk. ($78,641)
2.4.2.4 36 Finish construction and delivery of 25 experimental cartridges for
testing by the system integrator. ($50,000)

 

M9

 

36

Target capture > 90% in 24 hours (12 months) for at least 3 targets ex vivo in
blood or blood components using the optimized cartridge.

 

($197,361)

Total ($1,093,054)

 

12 month duration option #3 period (Year 4)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 1a  
Anticoagulant-free Hemopurification Device ($276,172)

 

2.5.1.1

 

45

Complete Aethlon’s GMP procedure and establish and maintain all GMP
documentation for the company. ($90,008)

 

M11

 

48

Develop a strategic plan for developing an alternate method of producing GNA by
cloning the gene into an alternate vector and identify potential partners for
such production.

 

($186,164)

Subtask 2+4   Target Capture in Combined Agent Cartridge ($296,964) 2.5.2.2 48
Finish construction and begin delivery of 50 prototype cartridges for testing by
the system integrator. ($296,964) Total ($759,300)

 

 

 9 

 

 

 

12 month duration option #4 period (Year 5)

Milestone Month Payable Milestone GOVT CONTRIBUTION Subtask 5   Testing of final
product by System Integrator ($581,157)

 

2.6.1.1

 

51

 

System integrator acceptance of the hemofilter device.

 

($193,719)

 

2.6.1.3

 

57

Quantify the degree to which the MERS virus can be extracted from circulation in
vitro using miniature Hemopurifiers.

 

($193,719)

2.6.1.4 60 Prepare and present Final Report for DARPA. ($193,719) Total
($581,157)

 

(End of Milestone Schedule)

 

 

(End of Summary of Changes)

 

 

 

 

 

 

 

 

 

 

 

 10