Exhibit 10.1


 


 


 






    	 	 	 



     


    

 





N66001-11-C-4188


Page 2 of 40


 


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	 	 	 	 


 


 


 


 


 






    	 	 	 



     


    

 




 


N66001-11-C-4188


Page 3  of 40


 


	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


 


 


 






    	 	 	 



     


    

 





N66001-11-C-4188


Page 4   of 40


 


	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


 


 


 






    	 	 	 



     


    

 


N66001-11-C-4188


Page 5    of 40



 





	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


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 6   of 40



 





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


 


 


 


 


 


 


 


 


 


 


 


 






    	 	 	 



     


    




N66001-11-C-4188


Page 7 of 40


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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 8  of 40



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 


 


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




	2.2.1.2		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.



	2.2.1.3		Assemble 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.






 


	2.2.1.4		IRB 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





	2.2.2.1		Begin 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.



 






    	 	 	 



     


    

N66001-11-C-4188


Page 9 of 40



 


 


	2.2.2.2		Screening 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).



	2.2.2.3		Perform 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


 


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 10 of 40


2.3 Option 1 (Year 2)


 


2.3.2 Subtask 1a: Anticoagulant-free Hemopurification
Device


 


	2.3.2.1		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.



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



	2.3.2.3		Write 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


 


	2.3.3.1		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.



	2.3.3.2		Cartridge 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


 





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



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



	2.4.1.3		Document 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


 





	2.4.2.1		Candidate 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.



	2.4.2.2		Optimize 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.



 






    	 	 	 



     


    

 


N66001-11-C-4188


Page 11  of 40



 




	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


 





	2.5.1.1		System integrator implements design modifications emanating from pig experiments.



	2.5.1.2		Collaborate 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.).



	2.5.1.3		Make 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


 





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



	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.



	2.5.2.3		Perform 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


 


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



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



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



	2.6.1.4		Prepare 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.





 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 12 of 40



 


 


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.


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 13 of 40



 


(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.


 






    	 	 	 



     


    

 


N66001-11-C-4188


Page 14 of 40


 



(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)


 


 


 


 


 


 


 


 


 


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 15 of 40



 


 


 


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)


 






    	 	 	 



     


    

N66001-11-C-4188


Page 16  of 40



 


 


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


 


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 17 of 40



 


 


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	 	 	 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 18 of 40



 


 


	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


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 19 of 40


 



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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 20 of 40


 



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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 21 of 40


 



(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)


 






    	 	 	 



     


    

N66001-11-C-4188


Page 22 of 40


 



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)


 






    	 	 	 



     


    

N66001-11-C-4188


Page 23 of 40


 



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)


 






    	 	 	 



     


    

N66001-11-C-4188


Page 24 of 40


 



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)


 






    	 	 	 



     


    

N66001-11-C-4188


Page 25 of 40


 



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,


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 26 of 40



 


(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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 27 of 40


 



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.


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 28 of 40


 



(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.


 







    	 	 	 



     


    

N66001-11-C-4188


Page 29 of 40


 



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.


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 30  of 40


 



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


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 31 of 40



 


	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	 


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 32 of 40


 



	 	 	 
	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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 33  of 40


 



(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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 34 of 40


 



(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 --


 






    	 	 	 



     


    

N66001-11-C-4188


Page 35 of 40



 


 


(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:


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 36  of 40



 


(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.


 






    	 	 	 



     


    

N66001-11-C-4188


Page 37 of 40


 



(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)


 


 


 






    	 	 	 



     


    

N66001-11-C-4188


Page 38 of 40


 



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


 


 


 






    	 	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


 


		1.0	Scope



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.


 


		1.1	Introduction



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.


 


		1.2	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 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	 



     

    

 


		2.0	Technical Requirements



 


		2.1	Human 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.


 


		2.2	Base Effort (Year 1)



 


		2.2.1	Subtask 1a: Anticoagulant-free Hemopurification Device



 


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



		2.2.1.2	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.



		2.2.1.3	Assemble 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.


		2.2.1.4	IRB 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 



		2.2.2.1	Begin 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	 



     

    

 


 


		2.2.2.2	Screening 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).



		2.2.2.3	Perform 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


 

		2.3	Option 1 (Year 2)



 


		2.3.2	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.3.2.1	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.



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



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



		2.3.2.4	Complete fabrication and testing of prototype instrument.



		2.3.2.5	Research 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.



		2.3.2.6	Collect feasibility data on at least one sensor option.



		2.3.2.7	Conduct 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 


		2.3.3.1	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.



		2.3.3.2	Cartridge 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	 



     

    

 


		2.4	Option 2 (Year 3)



 


		2.4.1	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.4.1.1	Design 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.


 


		2.4.2	Subtask 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.


 


		2.5	Option 3 (Year 4)



 


		2.5.1	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.5.1.1	Complete 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.


 


		2.5.2	Subtask 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	Prepare and submit IDE proposal for sepsis treatment.



		2.6.1.4	Prepare and present Final report for DARPA.



 


 


 






    	 	5	 



     

    

 


Milestones


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


 


		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 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	 



     


    

 







 


 





 



    	 	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


 


		1.0	Scope



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.


 


		1.1	Introduction



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	 



     


    

 


		1.2	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
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.


 


		2.0	Technical Requirements



 


		2.1	Human 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.


 


		2.2	Base Effort (Year 1)



 


		2.2.1	Subtask 1a: Anticoagulant-free Hemopurification Device



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



		2.2.1.2	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.



		2.2.1.3	Assemble 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.






 


		2.2.1.4	IRB 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



		2.2.2.1	Begin 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	 



     


    

 


.


		2.2.2.2	Screening 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).



		2.2.2.3	Perform 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


 


 


		2.3	Option 1 (Year 2)



 


		2.3.2	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.3.2.1	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.



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



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



		2.3.2.4	Complete fabrication and testing of prototype instrument.



		2.3.2.5	Research 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.



		2.3.2.6	Collect feasibility data on at least one sensor option.



		2.3.2.7	Conduct 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


		2.3.3.1	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.



		2.3.3.2	Cartridge 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	 



     


    

 


 


		2.4	Option 2 (Year 3)



 


		2.4.1	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.4.1.1	Design 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.



 


		2.4.2	Subtask 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.



 


 


		2.5	Option 3 (Year 4)



 


		2.5.1	Subtask 1a: Anticoagulant-free Hemopurification Device



		2.5.1.1	Complete 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.



 


		2.5.2	Subtask 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	 



     


    

 


		3.0	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 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