Document:

Exhibit
10.6

    

    SERVICE
AGREEMENT

    

    THIS
AGREEMENT (“Agreement”), effective January 30, 2008 (the "Effective Date"), is
by and between Sign Path
Pharmaceuticals, Inc., a company incorporated in the State of Delaware
and having its office at Office at 45 Broadway 2nd Floor New York, NY 10006, USA
(“CLIENT”) and BROOKWOOD PHARMACEUTICALS, INC having a principal place of
business at 756 Tom Martin Drive, Birmingham, Alabama 35211
("BROOKWOOD").

    

    WHEREAS,
BROOKWOOD is a corporation organized and operated for the purpose of developing
and manufacturing controlled release pharmaceutical formulations, biodegradable
polymers and biomaterials; and

    

    WHEREAS,
CLIENT desires to engage the services of BROOKWOOD for the purpose of performing
the services for CLIENT as described in Exhibit A; and

    

    WHEREAS,
BROOKWOOD represents that it has complied with all federal, state and local laws
regarding business permits and licenses of any kind that may be required to
carry out the said business and the tasks to be performed under this
Agreement.

    

    NOW THEREFORE, in
consideration of the premises and the mutual promises and undertakings herein
contained, the parties hereto agree as follows:

    

    Section 1 –
Services

    

    
      	
              1.1

            	
              CLIENT hereby retains
      BROOKWOOD to provide the services outlined in Exhibit A which is
      incorporated and made a part of this Agreement (the
      "Services").

            

    

    

    
      	
              1.2

            	
              BROOKWOOD
      represents that it shall have sufficient personnel, facilities, chemicals,
      and other supplies to perform the Services during the term of this
      Agreement.

            

    

    

    
      	
              1.3

            	
              BROOKWOOD
      hereby accepts the obligations contained in this Agreement and subject to
      terms and conditions hereinafter set forth agrees to provide the
      Services.

            

    

    

    
      
      

    

    
      	
              1.4

            	
              Any
      additional services not specifically set forth in this Agreement, shall be
      agreed to between the parties in writing prior to the performance of such
      services, and subsequently shall be incorporated into this Agreement. If
      CLIENT wishes to change the scope of the Services or wishes to obtain
      additional services not initially covered by this Agreement, CLIENT shall
      so advise BROOKWOOD and shall submit written specifications to BROOKWOOD.
      BROOKWOOD shall not conduct additional services nor change the scope of
      the Services without first submitting a list of such different or
      additional services and a quote therefore to CLIENT for written
      approval.  No purported amendment of this Agreement shall be
      valid unless made in writing and signed by both parties hereto. All
      Services shall be governed by the terms and conditions of this Agreement
      and by such supplementary written amendments of this Agreement as may be,
      from time to time, executed between the parties. In the event of a
      conflict between the terms of this Agreement and the Exhibit, the terms of
      this Agreement shall govern.

            

    

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

       

    

    Section 2 – Compensation and
Expenses

    

    
      	
              2.1

            	
              CLIENT’S
      liability for the payment of BROOKWOOD’s performance of the Services shall
      not exceed Eighty One Thousand U. S. Dollars ($81,000 US Dollars) without
      the written consent of CLIENT.  CLIENT shall pay to BROOKWOOD
      ten (10) percent of this amount within 30 days signing of this
      Agreement.  BROOKWOOD shall invoice CLIENT on a monthly basis
      for performance of the Services.  The monthly invoice will cover
      the actual amount of charges for the Services reduced by ten (10)
      percent.  CLIENT shall pay each invoice within forty five (45)
      days of the invoice date.  BROOKWOOD may terminate this
      Agreement if CLIENT fails to pay any invoice within ninety (90) days of
      the invoice date.

            

    

    

    
      	
              2.2

            	
              Within
      thirty (30) days of completion
      of the Services or termination of this Agreement, BROOKWOOD shall submit a
      final invoice to CLIENT for all monies due to BROOKWOOD under this
      Agreement.

            

    

    

    Section 3 –
Confidentiality

    

    
      	
              3.1

            	
              Each
      party is in possession of proprietary information, confidential technical
      information confidential business information concerning its business
      including, without limitation, drugs, drug formulations, formulation
      methods, pharmaceutical products, polymer technology, biodegradable
      polymer technology, drug-delivery technology and know-how, manufacturing
      know-how, business plans, financial projections, agreements with third
      parties, patents, patent applications, research results, product plans,
      inventions, customers and know how. All such information shall herein be
      designated as "Information", subject to this Section 3. With respect to
      any and all Information acquired by a receiving party from a disclosing
      party, as a result of this Agreement or from performance of the Services
      to be rendered hereunder, the receiving party agrees that it will not use
      such Information other than for the purposes of this Agreement, and it
      will not disclose any of said Information to any third party except to
      those of its employees, agents, subcontractors, affiliates, or consultants
      who need to know such Information and from whom the receiving party has
      secured an agreement to be bound by the confidentiality obligations
      hereof, for a period of seven (7) years from the Effective Date. The
      foregoing obligation shall not apply to the extent a given item of
      Information:

            

    

    

    
      	
               
      

            	
              (1)

            	
              can
      be shown to have been known to the receiving party prior to its receipt
      from the disclosing party;

            

    

    

    
      	
               
      

            	
              (2)

            	
              is
      or lawfully becomes generally known to the public without the fault of the
      receiving party;

            

    

    

    
      	
               
      

            	
              (3)

            	
              is
      lawfully acquired from third parties who have a right to disclose such
      Information;

            

    

    

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

       

    

    
      	
            	
              (4) 

            	
              is
      released from a confidential status by mutual written
      agreement;

            

    

    

    
      	
               
      

            	
              (5)

            	
              is
      subsequently and independently developed by employees of the receiving
      party, which it can show had no knowledge of the Information disclosed;
      and

            

    

    

    
      	
               
      

            	
              (6)

            	
              is
      required by law to be disclosed by the receiving party, provided that the
      disclosing party is given advance written notice of such requirement by
      the receiving party so that the disclosing party may contest or limit such
      release.

            

    

    

    
      	
              3.2

            	
              The
      terms of this Section 3, and the parties
      obligations hereunder, shall survive termination or expiration of this
      Agreement and the completion of BROOKWOOD's Services
      hereunder.

            

    

    

    Section 4 - Term and
Termination

    

    
      	
              4.1

            	
              This
      Agreement shall be effective for a period of six (6) months from the
      Effective Date; however, Sections 3, 8, 9 and 12 shall survive termination
      of this Agreement.

            

    

    

    
      	
              4.2

            	
              In
      the event that either party commits a breach or default in any of the
      terms or conditions of this Agreement and that party fails to remedy that
      default or breach within thirty (30) days after receipt
      of notice of that breach from the other party, the party giving notice
      may, at its option and without waiving any other remedy which may be
      available in law or equity, terminate this Agreement by sending written
      notice of termination to the other
party.

            

    

    

    
      	
              4.3

            	
              CLIENT
      shall have the right to terminate this Agreement at any time by giving
      appropriate written notice at thirty (30) days prior to the desired
      termination date. Upon receipt of CLIENT's written notice to terminate
      this Agreement, BROOKWOOD will promptly discontinue performance of the
      Services. BROOKWOOD will invoice CLIENT for the sum of any uninvoiced
      charges and any committed, non-cancelable costs incurred by BROOKWOOD
      prior to CLIENT's requested termination date. CLIENT shall pay to
      BROOKWOOD the sum of the charges listed on this invoice within thirty (30)
      days of the invoice date.

            

    

    

    
      	
              4.4

            	
              Upon
      the termination of this Agreement or the Services for any reason, except
      for breach by CLIENT, BROOKWOOD shall deliver to CLIENT, at CLIENT’S
      expense, copies of all data, results and other information in BROOKWOOD'S
      possession.

            

    

     

    Section 5 - Publicity
and Publication

    

    
      	
              5.1

            	
              BROOKWOOD
      may not disclose that CLIENT has retained BROOKWOOD for professional
      services unless CLIENT specifically agrees in writing that such disclosure
      may be made, and CLIENT may not disclose that BROOKWOOD has been retained
      by CLIENT for professional services unless BROOKWOOD agrees in writing
      that such disclosure may be made.

            

    

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    
      	
              5.2

            	
              No
      advertising or publicity matter having any reference to BROOKWOOD, express
      or implied, shall be made use of by CLIENT or anyone on behalf of CLIENT,
      unless and until such matter shall have first been submitted to and
      received the approval in writing of
BROOKWOOD.

            

    

    

    Section 6 - Independent
Contractor

    

    
      	
              6.1

            	
              BROOKWOOD
      shall perform the Services under this Agreement only as an independent
      contractor, and nothing contained herein shall be construed to be
      inconsistent with that relationship or status. BROOKWOOD, its employees,
      and agents shall not be considered employees or agents of CLIENT. This
      Agreement shall not constitute, create, or in any way be interpreted as, a
      joint venture, partnership, or business organization of any
      kind.

            

    

    

    Section 7 – Force
Majeure

    

    
      	
              7.1

            	
              The
      untimely performance of any obligation arising hereunder by either party
      will be excused, and such delay of performance shall not constitute a
      breach or grounds for termination or prejudice of any rights hereunder,
      provided that (a) the delay of performance is a result of circumstances or
      occurrences beyond the reasonable control of the party whose performance
      is excused hereunder (the "Delaying Event"), and (b) such party shall (i)
      immediately resume performance after the Delaying Event is removed and
      (ii) be reasonably diligent during such Delaying Event in avoiding further
      delay.  Without limiting the generality of circumstances or
      occurrences that shall constitute a Delaying Event, examples of Delaying
      Events include, but are not limited to, strikes, shortages of power or
      other utility services, materials or transportation, acts of government or
      of God, sabotage, insurrection and civil war.  A party whose
      performance may be affected by a Delaying Event promptly shall give notice
      to the other party of such Delaying Event and the fact that it intends to
      rely upon such Delaying Event to excuse its performance under this
      Agreement.

            

    

    

    Section 8 – Intellectual
Property

    

    
      	
              8.1

            	
              BROOKWOOD
      agrees to promptly notify CLIENT of any and all inventions, discoveries,
      or developments, whether or not patentable, directly resulting from
      BROOKWOOD's performance of the Services (each, an
      "INVENTION”).

            

    

    

    
      	
              8.2

            	
              Any
      INVENTION developed by BROOKWOOD during performance of the Services shall
      be owned by CLIENT and may be used by CLIENT without further accounting to
      BROOKWOOD provided that BROOKWOOD shall have a perpetual, royalty-free,
      paid-up right to use for internal and commercial purposes aspects of
      INVENTIONS which are procedures, formulation methods, or processes and do
      not involve CLIENT Information.

            

    

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    
      	
              8.3

            	
              BROOKWOOD
      represents and warrants that it has the right to enter into this Agreement
      and will not disclose to nor use for the benefit of CLIENT any trade
      secrets of another party in the performance of the
    Services.

            

    

    

    
      	
              8.4

            	
              BROOKWOOD's
      agreements with its officers, employees, representatives, consultants, and
      agents will contain appropriate terms to effectuate the provisions of
      Section 3 and Section 8 of this
      Agreement.

            

    

    

    
      	
              8.5

            	
              Notwithstanding
      the foregoing, BROOKWOOD shall retain ownership rights in and to all
      intellectual property, technical information, processes, know-how,
      specifications, data, characterization methods, formulation
      methods,  and other proprietary information owned or used by
      BROOKWOOD to perform the Services existing as of the Effective Date or
      developed by BROOKWOOD independently of the activities performed pursuant
      to this Agreement.

            

    

    

    
      	
              8.6

            	
              In
      the event that BROOKWOOD and CLIENT agree that BROOKWOOD will perform
      additional or different services than those described in Exhibit A, the
      parties agree that the ownership of INVENTIONS made in the performance of
      such services may be altered from that set forth in Section 8.2 and that
      compensation to BROOKWOOD also may include a royalty and other
      intellectual property payments.

            

    

    

    
      	
              8.7

            	
              All
      drawings, reports, designs, data, results of analysis, technical
      information resulting from the performance of the Services shall be
      reported to CLIENT and become the property of
  CLIENT.

            

    

    

    Section 9 – Representations,
Warrants, and Limitation of Liability

    

    
      	
              9.1

            	
              CLIENT
      and BROOKWOOD each represent, warrant, and covenant to the other
      that:

            

    

    

    
      	
              (i)

            	
              it
      has the right, power and authority to enter into this Agreement and to
      perform the transactions contemplated
hereby.

            

    

    

    
      	
              (ii)

            	
              this
      Agreement has been duly executed and delivered by such Party and
      constitutes the valid and binding obligation of such Party, enforceable
      against that Party in accordance with its terms, except as enforceability
      may be limited by bankruptcy, fraudulent conveyance, insolvency,
      reorganization, moratorium and other laws relating to or affecting
      creditors’ rights generally and by general equitable
      principles.  The execution, delivery and performance of this
      Agreement have been duly authorized by all necessary action on the part of
      such Party and its officers and directors.  The execution,
      delivery and performance of this Agreement does not breach, violate,
      contravene or constitute a default under any contracts, arrangements or
      commitments to which such Party is a party or by which it is bound nor
      does the execution, delivery and performance of this Agreement by such
      Party violate any order, law or regulation of any court, governmental body
      or administrative or other agency having authority over
  it.

            

    

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	
              (iii)

            	
              it
      will perform all of its obligations under this Agreement in accordance
      with the Agreement and all applicable laws and
  regulations.

            

    

    

    
      	
              9.2

            	
              Each
      party represents, warrants, and covenants that, to the best of its
      knowledge and belief it has sufficient and/or beneficial title under or
      rights to its intellectual property rights to enable the party to perform
      the Services and/or meet its obligations under this
      Agreement.  Sign Path represents and warrants to BROOKWOOD that
      to to the best of its knowledge that the performance of the Services by
      BROOKWOOD utilizing the Sign Path intellectual property rights will not
      constitute infringement or misappropriation of the intellectual property
      rights of any third party.

            

    

    

    
      	
              9.3

            	
              The
      sole remedy of CLIENT for any breach or default under this Agreement by
      BROOKWOOD which is not cured by BROOKWOOD within the requisite cure
      period, except for BROOKWOOD’s gross negligence or willful misconduct in
      performance of the Services shall be limited to termination of this
      Agreement as herein provided or a repeat of the Services, or portion
      thereof, which are the subject of the default or breach. Under no
      circumstances shall BROOKWOOD be liable for special or consequential
      damages.

            

    

    

    
      	
              9.4

            	
              Under
      this Agreement, BROOKWOOD is to perform certain Services and other work
      incidental thereto, and is to provide certain advice, conclusions and/or
      recommendations. BROOKWOOD will use its professional experience and
      diligent professional efforts in performing the Services. HOWEVER, THE
      COSTS AND TIMELINES SHOWN IN EXHIBIT A ARE ESTIMATES ONLY AND BROOKWOOD
      DOES NOT REPRESENT OR WARRANT THAT IT WILL BE ABLE TO COMPLETE THE
      SERVICES WITHIN THE SPECIFIED TIMELINES OR THAT THE PRODUCTS PRODUCED BY
      BROOKWOOD WILL MEET THE SPECIFICATIONS SET FORTH BY
      CLIENT.  FURTHER, BROOKWOOD DOES NOT REPRESENT, WARRANT, OR
      GUARANTEE THAT ITS RESULTS OR PRODUCTS PRODUCED THEREFROM ARE MERCHANTABLE
      OR SATISFACTORY FOR ANY PARTICULAR PURPOSE, AND THERE ARE NO WARRANTIES,
      EXPRESSED OR IMPLIED, TO SUCH EFFECT.  Any acceptance, reliance
      on, or use of such results or products shall be at the sole risk of
      CLIENT. CLIENT hereby agrees to release, waive, and forever discharge any
      demands, claims, suits, or actions of any character against BROOKWOOD
      arising out of or in connection with CLIENT's acceptance, reliance on, or
      use of such results or products. In connection with the work performed
      hereunder, BROOKWOOD shall in no event be responsible or liable in
      contract or in tort for any special, indirect, incidental, or
      consequential damages such as, but not limited to, loss of product,
      profits or revenues, damage or loss from operation or nonoperation of
      plant, or claims of customers of CLIENT. However, the representations made
      in this Section 9.4 shall not apply in
      the event that damage to CLIENT occurs as the result of BROOKWOOD's
      negligence or willful misconduct.

            

    

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      	
              9.5

            	
              CLIENT
      hereby agrees to indemnify, hold harmless, and defend BROOKWOOD and its
      officers, directors, representatives, agents and employees from and
      against any and all demands, claims or actions of any character presented
      or brought on account of any injuries, losses, or damages sustained by any
      person or property in consequence of any use by CLIENT of any results or
      materials produced hereunder.  The foregoing indemnity shall
      include but not be limited to court costs, and reasonable attorneys' fees,
      costs of investigation, and costs of defense associated with such demands,
      claims, suits, or actions. CLIENT'S obligations under this Section 9.5 are
      expressly conditioned on the following: a) that CLIENT is notified
      promptly in writing of any complaint, claim or injury relating to any
      injuries, losses, or damages subject to this indemnification; and (b) that
      CLIENT has the right to select defense counsel and to or direct the
      defense and settlement of any such complaint or claim(s); provided that
      CLIENT may not settle any such complaint or claim(s) in any manner
      affecting BROOKWOOD's rights without BROOKWOOD's prior written consent,
      which consent shall not be unreasonably withheld. BROOKWOOD, its employees
      and agents, shall reasonably cooperate with CLIENT and its legal
      representatives in the investigation and defense of any claim or suit
      covered under this Agreement. In the event a claim or action is or may be
      asserted, BROOKWOOD shall have the right to select and to obtain
      representation by separate legal counsel. If BROOKWOOD exercises such
      right, all fees, costs and expenses incurred by BROOKWOOD for such
      separate counsel shall be borne by BROOKWOOD, and CLIENT shall reasonably
      cooperate with BROOKWOOD and its legal representatives in the
      investigation and defense of any such claim or
  action.

            

    

    

    Section 10 – Quality Control
and Audits

    

    
      	
              10.1

            	
              BROOKWOOD
      shall, upon reasonable notice, allow CLIENT, its designated
      representatives, and/or regulatory agencies, access to its premises,
      records, processes, and Standard Operating Procedures for quality
      assurance purposes.

            

    

    

    Section 11 – Communications
and Payments

    

    
      	
              11.1

            	
              Payments
      for invoices shall be sent to Brookwood Pharmaceuticals, Inc., 756 Tom
      Martin Drive, Birmingham, Alabama 35211, Attention:  Accounts
      Receivable

            

    

    

    
      	
              11.2

            	
              BROOKWOOD
      shall send invoices for performance of the Services to Sign Path
      Pharmaceuticals, Inc., Attn: Dr. Larry Helson, 45 Broadway 2nd
      Floor New York, NY 10006.

            

    

    

    
      	
              11.3

            	
              Any
      notice required or permitted hereunder shall be in writing and shall be
      deemed given as of the date it is:

            

    

    

    (a)           delivered
by hand;

    

    (b)           received
by overnight courier, Registered or Certified Mail, postage prepaid, return
receipt requested; or

    

    (c)           received
by facsimile, as can be presumptively demonstrated by return fax or letter
demonstrating successful facsimile transmission; and addressed to the party to
receive such notice at the address(es) and/or facsimile telephone number(s) set
forth below, or such other address as is subsequently specified to the notifying
party by the receiving party in writing.

     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    

     

    If
to BROOKWOOD:

    

    Brookwood
Pharmaceuticals, Inc.

    756 Tom
Martin Drive

    Birmingham,
AL 35211

    Attention:  President

    Telephone:
(205) 917-2200

    Facsimile:
(205) 917-2205

    

    If
to CLIENT:

    

    Sign Path
Pharmaceuticals, Inc.

    Attn: Dr.
Larry Helson

    45
Broadway 2nd Floor

    New York,
NY 10006

    

    Section 12 -
Miscellaneous

    

    
      	
              12.1

            	
              Neither
      party shall have the right to assign this Agreement or any of the rights
      or obligations hereunder without the prior written consent of the other
      party, except that either party may unilaterally assign this Agreement to
      an affiliate or to a subsidiary or an acquirer of or successor to that
      area of its business to which this Agreement is related.  In the
      event of such an assignment, the assigning party will provide written
      notice to the other party within thirty (30) days of the
      assignment.

            

    

    

    
      	
              12.2

            	
              This
      Agreement constitutes the entire agreement between the parties on the
      subject matter and supersedes all prior contracts, agreements and
      understandings relating to the same subject matter between the parties.
      The parties intend this Agreement to be a complete statement of the terms
      of their agreement, and no change or modification of any of the provisions
      of this Agreement shall be effective unless it is in writing and signed by
      a duly authorized officer of BROOKWOOD and
  CLIENT.

            

    

    

    
      	
              12.3

            	
              This
      Agreement shall be governed by the laws of the State of Delaware, United
      States of America without regard to its conflict of laws
      rules.

            

    

    

    
      	
              12.3

            	
              This
      Agreement may be executed in multiple counterparts each of which shall be
      deemed an original but all of which taken together shall constitute one
      and the same instrument.

            

    

    

    
      	
              12.4

            	
              Subject
      to Section 1.4, this Agreement between the parties shall be considered a
      basic agreement, the terms and conditions of which shall apply to each
      Exhibit agreed upon by the parties. Exhibit A is hereby incorporated into
      this Agreement.

            

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              12.5

            	
              The
      failure of either party to insist upon the performance of any of the terms
      of this Agreement or to exercise any right hereunder or at law or in
      equity, or any delay by either party in the exercise of any such
      performance or right, and any effective waiver or relinquishment of any
      such right must be in writing and signed by a duly authorized officer of
      the party waiving or relinquishing the right or rights.  No
      waiver or relinquishment of any right granted by either party to the other
      shall be deemed to be a continuing waiver of such right in the future
      unless otherwise provided in the
waiver.

            

    

    

    
      	
              12.6

            	
              Each
      of the parties shall execute and deliver to, or cause to be executed and
      delivered to, the other party, such further instruments, or take such
      other action as may reasonably be requested of it to consummate more
      effectively the transactions contemplated
  hereby.

            

    

    

    
      	
              12.7

            	
              Descriptive
      headings used herein are for convenience only and shall not affect the
      meaning or construction of any provision
hereof.

            

    

    

    
      	
              12.8

            	
              If
      one or more provisions of this Agreement are held to be unenforceable
      under applicable law, such provisions shall be modified to the minimum
      extent necessary to comply with applicable law and the intent of the
      parties.

            

    

    

    IN
WITNESS WHEREOF, the following have caused this Agreement to be executed by
their respective duly authorized representatives effective as of this day and
year above written.

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              	
                                                      SIGNPATH
      PHARMA, INC.

                                                    	 
      	
                                                      BROOKWOOD
      PHARMACEUTICALS, INC.

                                                    
	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                                      By:

                                                    	
                                                      /s/ Lawrence Helson

                                                    	 
      	      
                                                      By:

                                                    	/s/ Arthur J. Tipton
	
                                                      Name:

                                                    	
                                                      Lawrence Helson

                                                    	 
      	
                                                      Name:

                                                    	
                                                      Arthur J. Tipton, PHD

                                                    
	
                                                      Title:

                                                    	
                                                      CEO

                                                    	 
      	
                                                      Title:

                                                    	
                                                      President

                                                    
	
                                                      Date:

                                                    	
                                                      1/30/2008

                                                    	 
      	
                                                      Date:

                                                    	
                                                      2/1/2008

                                                    

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    Exhibit
A

    

    BROOKWOOD
PROPOSAL P08.029

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    
      
        

      

    Proposal To:

    

    

    Signpath Pharma Inc.

    

    

    

    

    Synthesis of 60:20:20 NIPAAM/MMA/AA
Polymer Particles

    

    

    

    

    

    

    

                 Proposal P08.029

    

    18 December 2007

    

    

    

    

    

    

     

     

    
      
        

      

    

     

    This document is Lakeshore Biomaterials, a division of
Brookwood
Pharmaceuticals’,
Proposal
P08.029.  It contains proprietary information belonging to Brookwood
Pharmaceuticals.  Its contents should be handled

     according to the terms of the
Confidential Disclosure Agreement between

     Lakeshore Biomaterials, a division
of Brookwood Pharmaceuticals, and Signpath 20 September 2007.

     

    
      
        

      

      
 

      
        
          
             

          

          
             

            
              

            

          

          
             

          

        

      

      
         

        

        
          

        

      

       

      SUMMARY

    

    

    
      
        
          

        

      

      
        Goal

         

      

      Synthesize 100 grams of 

      NIPPAM/MMA/AA polymer particles 

      for pre-clinical studies.

       

      
        
 

    

    This is
Lakeshore Biomaterial’s proposal to Signpath Pharma to synthesize 60:20:20
N-isopropylacrylamide (NIPPAM)/methymethacrylate (MMA)/acrylic acid (AA) polymer
particles. The goal of the proposed program will be carried out with the
following specific aims:

     

    
      	
               
      

            	
              ·

            	
              Synthesis
      of the polymer particles of NIPAAM/MMA/AA (60:20:20) at the current scale
      using the protocol provided by
Signpath

            

    

    
      	
               
      

            	
              ·

            	
              Scale
      up the current batch size from 100 mL reaction to 10 L reaction.

            

    

    
      	
               
      

            	
              ·

            	
              Develop
      analytical methods to characterize the final
  product.

            

    

    

    The
proposed study will take place over a four months period.  Details of
the plan of work are described below. The estimated cost for this proposal is
$81,000 (USD). The
delivery of the final product is projected to be delivered in a four months time
period, which depends on the progress of the project.

    

    Technology and
Know-How:

    

    Lakeshore
Biomaterials, a division of Brookwood Pharmaceuticals is a global, commercial-scale supplier of cGMP compliant
bioabsorbable polymers for a wide variety of medical devices, and
implantable/injectable
sustained-release systems for new or existing drugs. With its cGMP
facilities and broad technical expertise, Lakeshore Biomaterials is well
equipped to synthesize, develop processes for scaling-up, characterize, and
manufacture new innovative biopolymers for preclinical, clinical, and commercial
programs. Our staff includes scientists with extensive experience in
research leading to the development of many commercial products.

     

      
        

      

    

    
      756 Tom
Martin Drive • Birmingham, AL 35211 • Phone: 205 917 2200 • Facsimile: 205 917
2205 • www.brookwoodpharma.com

       

    

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    

    
      

    

    PLAN OF WORK

    

    

           Tasks
1            Project Initiation and
Management

    

    Upon
initiation of the project, we will identify the personnel to review the
objectives of the project, time lines, and technical goals and coordinate the
Signpath/Lakeshore activities. This task would also include regular internal
project meetings, meetings with Signpath as needed.

    

    

    Task 2             Obtain All Necessary Equipment and
Materials

    

    The
protocol for the synthesis will be obtained from Signpath’s technical team. Upon
initiation of the project, all raw materials, equipment, chemicals, and other
laboratory supplies will be acquired.

    

    

    
      Task 3             Develop of Analytical
Methods to Characterize NIPAAM/MMA/AA Polymer
Particles

    

    

    Signpath
will provide a small amount of polymer particles from more than one batch,
preferably three batches, to Lakeshore to develop the analytical methods; such
as NMR and HPLC to characterize the polymer, and method to determine the
particle size. The specification of the final product will be decided based on
these results and upon discussion with Signpath’s technical team.

    

    

    Task 4             Perform Scout
Synthesis

    

    Once all
required chemicals and equipment arrive, we will perform the synthesis of
60:20:20 NIPAAM/MMA/AA at the current 100 mL scale following the protocol
provided by Signpath. The product from this batch will be characterized as per
the specification. The information from this scout synthesis will be used to
develop the protocol for scale-up batches.

    

    We
propose to have support from Signpath’s technical team to familiarize us with
the current synthetic process.

    

    
      Task 5             Scale-up the
Synthesis of 60:20:20
NIPAAM/MMA/AA

    

    

    Lakeshore
will scale-up the current batch size of 60:20:20 NIPAAM/MMA/AA from a 100 mL
reaction to at least a 10 L reaction.  A minimum of two batches will
be performed at the 10L scale. If the products from these batches do not meet
the specification, a third batch will be carried out.

     

    
      

    

    
      756 Tom
Martin Drive • Birmingham, AL 35211 • Phone: 205 917 2200 • Facsimile: 205 917
2205 • www.brookwoodpharma.com

      
        
           

        

        
          4

          
            

          

        

        
           

        

      

    

    
      
        

      

    Task 6             Product Shipment and Final
Report

    

    Lakeshore
Biomaterials will prepare an Analytical Report for the non-GMP produced 60:20:20
NIPAAM/MMA/AA. Once the product is released, it will be shipped to Signpath, or
to a location approved by Signpath.  A final report will be prepared
and submitted to Signpath.

     

    
      

    

    
      756 Tom
Martin Drive • Birmingham, AL 35211 • Phone: 205 917 2200 • Facsimile: 205 917
2205 • www.brookwoodpharma.com

      
        
           

        

        
          5

          
            

          

        

        
           

        

      

    

    
      
        

      

    BUSINESS SECTION

    

    A.           Time and Cost
Estimates

    

    This
proposal provides Signpath with a plan of work to synthesize, purify, and
characterize 60:20:20 NIPAAM/MMA/AA. We estimate that it will require
approximately four months to complete the proposed project.  The
estimated cost is $81,000 (USD).  These time and cost figures are
estimates only.  The actual charges will depend on the time required
to complete the tasks.  If the time and effort is less than we
anticipated, the cost will be less than the estimated figure.  On the
other hand, if we encounter unforeseen difficulties, we may not be able to
complete the tasks within the estimated time and/or cost.  We will not
exceed the approved budget without written approval from Signpath.

    

    The plan of work and scope of the
proposed feasibility assessment project may be changed by mutual consent of both
Lakeshore
Biomaterials and
Signpath.  Any changes may affect (increase or decrease) the
estimated cost.  Any changes will be undertaken in
accordance with the procedures described in the contract for this project. Signpath may also terminate the program at their
discretion at any point.

    

    B.           Agreements

    

    This proposal contains information that
is proprietary to Brookwood.  It should be handled according to the
terms of the Confidentiality Agreement between Lakeshore and
Signpath.

    

    C.           Proposal
Stipulations

    

    The offers expressed or implied in this
proposal will be valid until 31 January 2008. This document is for the purpose of
establishing a clear understanding of our potential relationship only. It does
not constitute a legal agreement.  Until the appropriate project
initiation document is executed, no terms or conditions within this document
should be construed as any firm offer or commitment, nor should this document be
construed as a constraint to preclude or limit concurrent discussions with other
parties regarding substantially identical, similar, or related subject matter.
If this proposal is
agreeable, please contact Mr. Paul Spencer, Vice President and
General Manager (205-917-2295), or Mr. Reese Frazer, Senior Director of
Licensing & Strategic Affairs (205-917-2270), to complete the necessary
contract to initiate the project.

    

    Brookwood Proposal P08.029

     

    
      

    

    
      756 Tom
Martin Drive • Birmingham, AL 35211 • Phone: 205 917 2200 • Facsimile: 205 917
2205 • www.brookwoodpharma.com

      
        
           

        

        
          6Exhibit
10.7

    

    SPONSORED
RESEARCH AGREEMENT

    

    This
agreement (the “Agreement”) is entered into as of this eighteenth day of
September, 2007 (the “Effective Date”), by and between The Johns Hopkins
University, having a School of Medicine located at 733 North Broadway, Suite 117
Baltimore, Maryland, 21205 (the “Institution”), employer of Dr. Anirban Maitra
(the “Investigator”), and Sign Path Pharma, Inc., a corporation organized under
the laws of the State of Delaware, located at 1375 California Road, Quakertown,
PA 18951, USA (the “Sponsor”).

    

    WHEREAS,
Sponsor wishes that Institution conduct pre-clinical research studies and such
studies are of mutual interest and benefit to the Institution and
Sponsor.

    WHEREAS,
Sponsor wishes to collaborate with University and is willing to sponsor
Institution’s research.

    WHEREAS,
Sponsor wishes to obtain certain rights to patents and technology resulting from
the research.

    WHEREAS,
Institution is willing to collaborate and to grant certain rights to patents and
technology that result from the research collaboration; and

    WHEREAS,
Institution and Sponsor will execute concurrently a License Agreement (JHU Ref:
5024).

    NOW,
THEREFORE, in consideration of the following mutual promises, covenants, and
conditions and any sums to be paid, the parties hereto agree as
follows:

    

    1.           STATEMENT
OF WORK

    

    The
Institution agrees to conduct research studies entitled Preclinical Evaluation
of Nanocurcumin in Pancreatic Cancer (Study), as described in the protocol for
this Study (attached as Exhibit A).  The Institution represents and
warrants that it has, or by the commencement of the Study will have, the
experience, capability, and resources, including, but not limited to, sufficient
personnel and equipment, to efficiently and expeditiously perform the Study in a
professional and competent manner, and in strict adherence to the
protocol.  In addition to the work outlined in Exhibit A, Sponsor may
present and pay for a separate Supplementary Study, budget and terms for
payment, upon agreement between the Investigator and Sponsor, for a second
indication.  Upon agreement between the Investigator and Sponsor for
the Supplementary Study, an Amendment to this Agreement will be
executed.

    

    2.           INVESTIGATOR

    

    This
Study will be conducted under the direction of the Investigator identified above
and at least one post-doctoral fellow who will be assigned full-time to the
Study for the term of this Agreement.  The Investigator shall be
responsible for performing this Study and for direct supervision of any
individual performing portions of this Study.  In the event the
Investigator becomes unwilling or unable to perform the duties required for the
Study conducted under this Agreement, the Institution and Sponsor shall attempt
to agree on a mutually agreeable replacement.  In the event a mutually
acceptable replacement is not available, then the Study may be terminated by
either party hereto in accordance with Section 9 of this
Agreement.

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

     

    3.           PAYMENT

    

    
      	
               
      

            	
              (a)

            	
              In
      consideration of conducting the Study hereunder, Sponsor shall pay
      Institution in accordance with the budget attached as Exhibit B of this
      Agreement.  Payments shall be made as
      follows:  Sponsor shall pay the sum of $100,000, in three equal
      installments, beginning 30 days after the final execution of this
      Agreement, and at two four (4) month intervals from the following
      activities: the development of an IND for
  nanocurcumin.

            

    

    

    
      	
               
      

            	
              (b)

            	
              In
      addition to these payments, Sponsor shall pay JHU indirect costs of
      $64,000, in three equal installments, at the time as the payments in
      Section 3(a).

            

    

    

    (c)          Payments
shall be made as follows:

     

                  
Payable to: The Johns Hopkins
University

                  
Tax I.D. Number: 52-0595110

     

    
      
        
          	
                  Sent
      to the Address:

                	
                  Johns
      Hopkins University Central Lockbox

                
	 
      	
                  Bank
      of America

                
	 
      	
                  12529
      Collections Center Drive

                
	 
      	
                  Chicago,
      IL 60693

                

        

      

    

    

    Checks
must also include the following:

    
      
        
          	
                  IPN:

                	
                  08031116

                
	
                  Investigator:

                	
                  Anirban
      Maitra, M.D.

                

        

      

    

     

    4.           RECORDKEEPING,
REPORTING, ACCESS

    

    Authorized
representatives of Sponsor or its designee shall have the right, upon reasonable
and advance notice, and during regular business hours, to examine and inspect
the Institution’s and applicable Investigator’s facilities and records
associated with this Study and inspect and copy all work products relating to
this Study.

    

    5.           PROPRIETARY
INFORMATION AND CONFIDENTIALITY

    

    Neither
party shall disclose to any third party or use for any purposes other than the
performance of this Study, any and all trade secrets, privileged records, or
other proprietary information disclosed to one party by the other party pursuant
to this Agreement (collectively, “Proprietary Information”),
without  the  prior written consent of the party whose
Proprietary Information is being disclosed, except as otherwise specified in
this Agreement.  The receiving  party shall treat the
Proprietary Information of the disclosing party as it would treat its own
proprietary information, but in no event shall it use less than a reasonable
degree of care.  The obligation of non-disclosure and non-use shall
not apply to the following.

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

    (a)           Information
that, at the time of disclosure hereunder, is generally available to the
public;

    (b)           Information
that, after disclosure hereunder, becomes generally available to the public,
except through breach of this Agreement;

    (c)           Information
that a party can demonstrate was in its possession at the time of disclosure by
the other party and that was not acquired from such other party;

    (d)           Information
that becomes available to a party from a third party that is not legally
prohibited from disclosing such information; or

    (e)           Information
required by any law, regulation, or order of court to be disclosed. Prior to
disclosing proprietary Information or confidential information of the other
party, the disclosing party shall first notify the providing party and provide
it an opportunity to prevent disclosure.

    

    In
addition, the terms of this Agreement supersede any previous non-disclosure
agreements or any other preliminary representations or understandings that have
been entered into by the parties to this Agreement with regard to the subject
Study.

    

    6.           CONFIDENTIAL
DATA AND CONFIDENTIALITY

    

    The
Institution and Sponsor shall respectively own study data that they generate by
performing this Study, including all Study results.  Sponsor shall
have the sole right to use study data for all commercial purposes, and
Institution’s use shall be limited to those instances dealing with patient care
and treatment, academic uses, and publication except for intellectual property
rights described in Article 8.  Notwithstanding anything to the
contrary herein, Institution’s use of study data to develop any invention or
other intellectual property shall not be considered a commercial
purpose.

    

    7.           PUBLICATION

    

    The
Institution and the Investigator are free to publish, present, or use any
results arising out of this Study for their own instructional, research, or
publication objectives, provided that such publication does not disclose any of
Sponsor’s Proprietary Information, as defined in this
Agreement.  Institution agrees to submit the draft of any proposed
publication to Sponsor at least thirty (30) days prior to submission for
publication, presentation, or use, and agrees, at the request of Sponsor, to
withhold any such submission for an additional period, not to exceed ninety (90)
days to allow Sponsor to work with Investigator to file patent applications or
IND submission or to take any other action designed to protect its patent
rights.

    

    8.           INTELLECTUAL
PROPERTY

    

    (a)           It
is expressly agreed that neither Sponsor nor Institution transfer by operation
of this Agreement to the other party hereto any patent right, copyright, or
other proprietary right that either party owns or controls as of the
commencement of this Study, except as specifically set forth
herein.

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    (b)          Inventions
developed under this Agreement which would be filed as continuation patent
applications that claim priority to the licensed IP in the License Agreement
(JHU Ref: 5024) signed concurrently herewith, of which this Sponsored Research
Agreement is an attachment, shall be the subject of and fall within the scope of
said License Agreement (JHU Ref: 5024).

     

    (c)         
All Other Inventions developed under this Agreement solely by Institution shall
be owned by Institution (“Institution Invention”).  All Other
Inventions developed solely by Sponsor shall be owned by Sponsor (“Sponsor
Invention”).  All Other Inventions developed by one or more employees
of both Sponsor and Institution under this Agreement shall be owned jointly by
Sponsor and Institution (“Joint Invention”).

    

    (e)         
Institution will provide to Sponsor a complete, written, confidential disclosure
of any Institution Invention or Joint Invention (“Disclosure”) after it is
received by the Johns Hopkins Technology Transfer office.  At that
time, Institution shall grant Sponsor a first option to negotiate an exclusive,
royalty bearing, worldwide license, including the right to sublicense, to make,
have made, use, and sell (in a designated field of use, where appropriate)
products incorporating Patent Rights.

    

    (f
)          Sponsor may exercise its
option at any time during a period of one hundred and eighty (180) days (“Option
Period”) after the receipt of each Disclosure by giving written notice to
Institution. During the Option Period, Sponsor shall reimburse Institution for
all out of pocket costs associated with filing and/or maintaining Patent Rights
(“Patent Expenses”).  Provided, however, if Sponsor decides that it is
not appropriate to apply for Patent Rights, Sponsor shall have no obligation to
reimburse Institution for Patent Expenses; and in such event, the option granted
in Article 9(d) shall lapse with respect to any Patent Rights for which Sponsor
declines to reimburse Institution.  If Sponsor decides to forgo the
option granted in Article 9(d), or if after one hundred and eighty (180) days of
good faith negotiations (“Negotiation Period”), the parties are unable to enter
into a license agreement, Institution shall be free to offer a commercial
license to any third party or to dispose of its interest in any Patent Rights in
any way it deems appropriate.

    

    (g)         
Institution agrees to grant to Sponsor a non-exclusive, non-commercial,
non-transferable, royalty-free license to Inventions for internal research
purposes.

    

    (h)         
Institution shall retain a perpetual, non-exclusive, non-transferable,
royalty-free license to use and make derivative works of all Inventions for
internal academic and research purposes.

     

    9.           TERM
AND TERMINATION

    

    (a)         
Unless earlier terminated in accordance with the provisions of this Agreement,
the term of this agreement shall commence on the Effective Date and shall
terminate twelve (12) months after the Effective Date.  This Agreement
may be terminated by Sponsor or Institution upon at least sixty (60) days prior
written notice to the other party that references a material breach of any of
the terms and conditions of this Agreement, which breach the other party fails
to cure within sixty (60) days from notice thereof.

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

     

    (b)         
In addition, the Agreement may be terminated by either party if the Investigator
conducting the Study is unwilling or unable to continue performing the Study and
a successor acceptable to both Sponsor and Institution is not
available.

    

    If this
Agreement is terminated prior to the original termination date and Sponsor has
not yet remitted the full estimated project total to Institution, Sponsor shall
still be responsible to pay for all non-cancelable Institution expenses and work
performed to the date of termination and shall remit such total within thirty
(30) days of Institution’s written request for final payment.

    

    10.         INDEMNIFICATION

    

    Sponsor
shall indemnify, defend and hold harmless The Johns Hopkins University, The
Johns Hopkins Hospital, The Johns Hopkins Bayview Medical Center, and/or other
affiliated and cooperating hospitals as well as the trustees, officers, agents,
employees, students, and others holding academic appointments within those
institutions (Institutions), from any liability, loss, or damage they may suffer
as a result of claims or judgments that arise from the Institutions'
participation in and/or performance of  the subject
Study.   Sponsor shall employ attorneys of its own selection and
will be responsible for all expenses that result from employing a vigorous,
diligent defense of Institutions, regardless of whether any claims are
rightfully or wrongfully brought or filed.  Institutions shall fully
cooperate with Sponsor in defending the claims and will make no compromise or
settlement without the prior written approval of
Sponsor.  Institutions also agree that any injury that results from
Institutions' gross negligence or intentional misconduct in carrying out Study
activities is excluded from Sponsor’s requirement to indemnify and hold
harmless.

    

    11.         NOTICES

    

    With the
exception of Study funds paid by Sponsor pursuant to Section 3 hereof, all
notices required or permitted to be given under this Agreement shall be in
writing and shall be sent as follows:

    

    If to
Sponsor:

    Lawrence
Helson MD, C.E.O.

    Sign Path
Pharma, Inc.

    1375
California Road

    Quakertown,
PA 18901

    Tel:
215-538-9996

    Fax:
215-538-1245

    

    If to Institution:

    

    original
to:            Michael
B. Amey

    Associate Dean, Research
Administration

    Johns
Hopkins University School of Medicine

    Office of Research
Administration

    733 North Broadway, Suite
117

    Baltimore, Maryland 21205

    

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    copy to:
Investigator

    

    Dr.
Anirban Maitra

    Associate
Professor of Pathology and Oncology

    Affiliate,
McKusick-Nathans Institute of Genetic Medicine

    The Sol
Goldman Pancreatic Cancer Research Center

    CRB-2,
Suite 345

    Johns
Hopkins University School of Medicine,

    1550
Orleans Street, Baltimore MD 21231

    Phone:
(410) 502-8191

    Fax:
(410) 614-0671

    

    12.         INDEPENDENT
CONTRACTORS

    

    The
relationship of Sponsor to Institution and its Investigator shall be that of an
Independent Contractor and none of the parties shall hold itself out to third
parties as purporting to act as, or on behalf of, the other party
hereto.

    

    13.         USE
OF OTHER PARTIES’ NAMES

    

    Neither
the Sponsor nor the Institution shall use directly or by implication the names
of the other party, nor any of the other party’s affiliates or contractors, nor
any abbreviations thereof, or of any staff member, faculty member, student, or
employee of the other party in connection with any products, publicity,
promotion, financing, advertising, or other public disclosure without the prior
written permission of the other party.

    

    14.         WAIVERS;
SEVERABILITY

    

    No waiver
of any term or provision of this Agreement whether by conduct or otherwise in
any one or more instances shall be deemed to be, or construed as, a further or
continuing waiver of any such term or provision, or of any other term or
provision, of this Agreement.

    

    15.         CONTINUING
OBLIGATION

    

    Except as
otherwise specifically provided herein, termination of this Agreement shall not
relieve either party hereto from any obligation under this Agreement that
accrued or arose from facts or circumstances in existence prior
thereto.

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    16.         GOVERNING
LAW

    This
Agreement shall be governed by and construed in accordance with the laws of the
State of Maryland (excepting any conflict of laws provisions which would serve
to defeat application of Maryland substantive law).  Each of the
Parties hereto agrees to venue in and submits to the exclusive jurisdiction of
the state and/or federal courts located within the State of Maryland for any
suit, hearing or other legal proceeding of every nature, kind and description
whatsoever in the event of any dispute or controversy arising hereunder or
relating hereto, or in the event any ruling, finding or other legal
determination is required or desired hereunder.

    

    17.         HEADINGS

    

    The
headings in this Agreement are for the convenience of reference only and are not
substantive parts of this Agreement nor shall they affect its
interpretation.

    

    18.         COUNTERPARTS

    

    This
Agreement and any amendments hereto may be executed in counterparts and all such
counterparts taken together shall be deemed to constitute one and the same
instrument.

     

    
      
         

      

      
        7

        
          

        

      

      
         

      

    

    In
Witness Whereof, the parties have caused this Agreement to be executed by their
duly authorized representatives as of the Effective Date.

     

    
      
        	
                THE
      JOHNS HOPKINS UNIVERSITY

              	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                By:

              	
                /s/ Michael B. Amey

              	 
      	
                By:

              	
                /s/ Dr. Lawrence Helson

              
	 
      	
                Michael
      B. Amey

              	 
      	 
      	
                Dr.
      Lawrence Helson

              
	 
      	
                Associate
      Dean for

              	 
      	 
      	
                CEO

              
	 
      	
                Research
      Administration

              	 
      	 
      	
                Sign
      Path Pharma, Inc.

              
	 
      	 
      	 
      	 
      	 
      
	
                Date:

              	
                9-21-07

              	 
      	
                Date:

              	
                10/02/07

              

      

    

     

    Read and
Agreed to abide by the terms contained herein, but not as a party
hereto:

    

    
      
        	
                /s/ Anirban Maitra

              
	
                Investigator

              
	
                Anirban
      Maitra

              

      

    

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

    EXHIBIT
A

    PROTOCOL
FOR STUDY

     

    Preclinical
Evaluation of Nanocurcumin in Pancreatic Cancer

     

    The goals
of this proposal are to perform in vivo preclinical
evaluation of nanocurcumin, a newly described nanoparticulate formulation of
curcumin, in small animal models.  The study shall focus on the
preclinical evaluation of nanocurcumin for cancer indications, with an emphasis
on cancers dependent on specific growth factors that signal through NF-κB, including pancreatic
cancer and multiple myeloma.  Specifically, the Study has the
following two aims:

     

    Specific Aim 1: To
perform in vivo studies
in mice for identifying an appropriate dosing schedule for nanocurcumin, using
oral and parenteral routes.

     

    Specific Aim 2: To perform
therapeutic efficacy studies using nanocurcumin in a xenograft model of
pancreatic cancer.

     

    Our
laboratory has synthesized the first nanoparticle formulation of curcumin
utilizing biodegradable polymeric components (Bisht et al, J Nanobiotechnology, 2007),
and this formulation, as well as modifications thereof that enable systemic and
oral delivery of curcumin, are embodied in the US Provisional Patent application
Serial No. 60,866/516, filed on November 20th, 2006, and entitled "Biocompatible
"smart" nanogels as carriers for hydrophobic drugs".  This technology
will be licensed to SignPath Pharma as defined under the appropriately reviewed
and executed licensing agreement.  We will conduct this sponsored
research agreement in the PI’s laboratory with the intent of further
characterizing nanocurcumin in
vivo.

     

    In
Specific Aim 1, we will test nanocurcumin administered by both oral and
parenteral routes in order to determine an appropriate dosing
schedule.  All studies will be conducted in wild type CD1
mice.  Curcumin bioavailability will be assessed by direct measurement
of plasma curcumin levels using an HPLC assay (Heath et al, J Chromatogr B 783: 287;
2003); in a subset of mice, urine levels will also be
measured.  Standard pharmacokinetic assays for area under the curve
(AUC) and maximal concentration (Cmax) will be performed in order to estimate
bioavailability.  In addition, pharmacodynamic assessment will be
performed by measuring serum IL-6 levels, which we have demonstrated is
reproducibly downregulated in peripheral blood lymphocytes upon curcumin
exposure (Bisht et al, J
Nanobiotechnology, 2007).  Dose escalation studies will be
performed in mice to evaluate potential toxicities, and identify a maximal
tolerated dose (MTD).  All studies will be performed with at least six
mice per arm in order to obtain statistically significant
differences.  Comprehensive necropsy will be performed and visceral
organs evaluated histologically for any evidence of toxicity from the
curcumin-nanoparticle formulation.

     

    In
Specific Aim 2, we will evaluate the therapeutic efficacy of nanocurcumin in a
pancreatic cancer xenograft model.  Briefly, we will generate
subcutaneous xenografts in athymic mice that will be randomized to receive
vehicle alone, nanocurcumin, gemcitabine (standard of care), and the
combination.  We postulate that the combination of nanocurcumin and
gemcitabine will demonstrate enhance efficacy to single agent
therapy.  Xenografts will be treated for a 4 week course, and
harvested at the end of the trial for histology and
immunohistochemistry.  Tumor growth inhibition (TGI) will be assessed
as tumor volume in treated xenografts over vehicle treated
controls.

     

    
      
         

      

      
        9

        
          

        

      

      
         

      

    

    EXHIBIT
B

    

    BUDGET
FOR STUDY

    

    SPONSORED
RESEARCH AGREEMENT :  SIGNPATH PHARMA

    PRECLINICAL
EVALUATION OF NANOCURCUMIN IN PANCREATIC CANCER

    

    
      
        
          
            
              
                
                  
                    	
                             

                          	
                            Role

                          	 	
                            Effort

                          	 	 	
                            Direct
      Costs

                          	 	 	
                            Fringes

                          	 	 	
                            Total
      Costs

                          	 
	      
                            Personnel 

                          	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            Anirban
      Maitra

                          	
                            PI

                          	 	 	10	%	 	 	14,944	 	 	 	5,081	 	 	 	20,025	 
	
                            Postdoctoral
      Fellow

                          	
                            Fellow

                          	 	 	100	%	 	 	38,976	 	 	 	3,118	 	 	 	42,094	 
	 
      	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            Supplies

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            Polymers

                          	 
      	 	 	 	 	 	 	5,000	 	 	 	 	 	 	 	 	 
	
                            Curcumin,
      miscellaneous chemicals

                          	 
      	 	 	 	 	 	 	5,000	 	 	 	 	 	 	 	 	 
	
                            PK
      studies, immunohistochemistry, histology

                          	 
      	 	 	 	 	 	 	9.116	 	 	 	 	 	 	 	 	 
	
                            Mouse
      costs, including animal housing

                          	 
      	 	 	 	 	 	 	7,500	 	 	 	 	 	 	 	 	 
	
                            Total
      Supplies

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	26,616	 
	 
      	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            Other
      Expenses

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            Life
      Insurance for Fellow

                          	 
      	 	 	 	 	 	 	857	 	 	 	 	 	 	 	 	 
	
                            Health
      and Dental Insurance

                          	 
      	 	 	 	 	 	 	2,801	 	 	 	 	 	 	 	 	 
	
                            Publication
      Costs

                          	 
      	 	 	 	 	 	 	1,500	 	 	 	 	 	 	 	 	 
	
                            Total

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	11,158	 
	 
      	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                            TOTAL
      DIRECT

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	99,893	 
	
                            INDIRECT
      COSTS

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	63,932	 
	
                            TOTAL
      COSTS

                          	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	163,825	 

                  

                

              

            

          

        

      

    

     

    
      
         

      

      
        10

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00160-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00160-of-00352.parquet"}]]