Document:

Unassociated Document

    Exhibit 10.1

     

    CONTRIBUTION
AGREEMENT

     

    BETWEEN

     

    SHIVA
BIOMEDICAL, LLC,

     

    PICTON
PHARMACEUTICALS, INC.,

     

    PICTON
HOLDING COMPANY, INC.,

     

    AND

     

    THE
STOCKHOLDERS OF PICTON PHARMACEUTICALS, INC.

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
 

      
        
           

        

        
           

          
            

          

        

        
           

        

      

    

     

    Table
of Contents

     

    
      
        
          	
                  Article
      1 Definitions

                	
                  2

                
	
                  1.1

                	
                  “Affiliate”

                	
                  2

                
	
                  1.2

                	
                  “Applicable
      Law(s)”

                	
                  2

                
	
                  1.3

                	
                  “Competent
      Authority(ies)”

                	
                  2

                
	
                  1.4

                	
                  “Compound”

                	
                  3

                
	
                  1.5

                	
                  “Contributed
      Product “

                	
                  3

                
	
                  1.6

                	
                  “Control”

                	
                  3

                
	
                  1.7

                	
                  “Development”

                	
                  3

                
	
                  1.8

                	
                  “DMF”

                	
                  3

                
	
                  1.9

                	
                  “FDA”

                	
                  3

                
	
                  1.10

                	
                  “Governmental
      Approval(s)”

                	
                  3

                
	
                  1.11

                	
                  “IND(s)”

                	
                  3

                
	
                  1.12

                	
                  “Improvements”

                	
                  3

                
	
                  1.13

                	
                  “Know-how”

                	
                  3

                
	
                  1.14

                	
                  “Licensed
      Product(s)”

                	
                  4

                
	
                  1.15

                	
                  “Marketing
      Authorization”

                	
                  4

                
	
                  1.16

                	
                  “NDA”

                	
                  4

                
	
                  1.17

                	
                  “Net
      Sales”

                	
                  4

                
	
                  1.18

                	
                  “Non-Royalty
      Sublicensing Income”

                	
                  5

                
	
                  1.19

                	
                  “Patent
      Rights”

                	
                  5

                
	
                  1.20

                	
                  “Royalty
      Term”

                	
                  6

                
	
                  1.21

                	
                  “Sublicense”

                	
                  6

                
	
                  1.22

                	
                  “Sublicensee”

                	
                  6

                
	
                  1.23

                	
                  “Technology”

                	
                  6

                
	
                  1.24

                	
                  “Term”

                	
                  6

                
	
                  1.25

                	
                  “Territory”

                	
                  6

                
	
                  1.26

                	
                  “Third
      Party”

                	
                  6

                
	
                  1.27

                	
                  “Valid
      Claim”

                	
                  6

                
	 
      	 
      
	
                  Article
      2 Grant

                	
                  7

                
	
                  2.1

                	
                  Grant
      of License

                	
                  7

                
	
                  2.2

                	
                  Sublicenses

                	
                  7

                
	 
      	 
      
	
                  Article
      3 Contributions of Technology, Rights and Picton Shares

                	
                  8

                
	
                  3.1

                	
                  Technology
      Transfer

                	
                  8

                
	
                  3.2

                	
                  Rights
      of Reference

                	
                  9

                
	
                  3.3

                	
                  Transfer
      of the IND

                	
                  9

                
	
                  3.4

                	
                  Costs
      of Transfer

                	
                  9

                
	
                  3.5

                	
                  Transfer
      of Compound Inventory

                	
                  10

                
	
                  3.6

                	
                  Contribution
      of Picton Shares

                	
                  10

                
	 
      	 
      
	
                  Article
      4 Regulatory Compliance

                	
                  10

                
	
                  4.1

                	
                  Ownership
      and Maintenance of Governmental Approvals

                	
                  10

                

        

      

    

     

    
      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions. 

       

      
        
          
             

          

          
            i

            
              

            

          

          
             

          

        

      

       

    

    
      
        
          
            	
                    4.2

                  	
                    Compliance

                  	
                    10

                  
	 
      	 
      
	
                    Article
      5 Development and Commercialization

                  	
                    11

                  
	
                    5.1

                  	
                    Development

                  	
                    11

                  
	 
      	 
      
	
                    Article
      6 Consideration for Contribution

                  	
                    11

                  
	
                    6.1

                  	
                    Equity
      and Other Consideration

                  	
                    11

                  
	
                    6.2

                  	
                    Equity
      to be Issued on Contribution

                  	
                    12

                  
	
                    6.3

                  	
                    Royalties

                  	
                    12

                  
	
                    6.4

                  	
                    Non-Royalty
      Sublicensing Income (NRSI)

                  	
                    13

                  
	
                    6.5

                  	
                    No
      Multiple Royalties

                  	
                    13

                  
	
                    6.6

                  	
                    Combination
      Products

                  	
                    13

                  
	
                    6.7

                  	
                    Place
      of Payment, Taxes and Conversions

                  	
                    13

                  
	
                    6.8

                  	
                    Time
      for Payment

                  	
                    14

                  
	
                    6.9

                  	
                    Interest

                  	
                    14

                  
	
                    6.10

                  	
                    Board
      of Directors; Consulting Agreement

                  	
                    14

                  
	
                    6.11

                  	
                    Consideration
      for Contribution of Picton Shares

                  	
                    14

                  
	 
      	 
      
	
                    Article
      7 Reports and Records

                  	
                    15

                  
	
                    7.1

                  	
                    Records
      and Audits

                  	
                    15

                  
	
                    7.2

                  	
                    Royalty
      Statements

                  	
                    15

                  
	
                    7.3

                  	
                    Confidential
      Treatment of Reports

                  	
                    15

                  
	 
      	
                     
      

                  
	
                    Article
      8 Patent Prosecution and Maintenance

                  	
                    16

                  
	
                    8.1

                  	
                    Prosecution
      and Maintenance

                  	
                    16

                  
	
                    8.2

                  	
                    Abandonment

                  	
                    16

                  
	 
      	 
      
	
                    Article
      9 Dispute Resolution

                  	
                    16

                  
	
                    9.1

                  	
                    Disputes

                  	
                    16

                  
	
                    9.2

                  	
                    Performance
      to Continue

                  	
                    18

                  
	
                    9.3

                  	
                    Determination
      of Patents and Other Intellectual Property

                  	
                    18

                  
	 
      	 
      
	
                    Article
      10 Term and Termination

                  	
                    18

                  
	
                    10.1

                  	
                    Term

                  	
                    18

                  
	
                    10.2

                  	
                    Termination
      for Insolvency

                  	
                    18

                  
	
                    10.3

                  	
                    Termination
      for Failure to make Payments

                  	
                    18

                  
	
                    10.4

                  	
                    Termination
      for Breach

                  	
                    19

                  
	
                    10.5

                  	
                    Expiry
      of Royalty Term on a Country by Country Basis

                  	
                    19

                  
	
                    10.6

                  	
                    Termination
      for Convenience

                  	
                    19

                  
	
                    10.7

                  	
                    Consequences
      of Termination

                  	
                    19

                  
	
                    10.8

                  	
                    Survival

                  	
                    20

                  
	
                    10.9

                  	
                    Failure
      to Satisfy Condition to Close

                  	
                    20

                  
	 
      	 
      
	
                    Article
      11 Infringement and Other Actions

                  	
                    20

                  
	
                    11.1

                  	
                    Notice
      of Infringement of Patent Rights

                  	
                    20

                  
	
                    11.2

                  	
                    Option
      to Prosecute or Defend Patent Rights

                  	
                    20

                  
	
                    11.3

                  	
                    Infringement
      by Licensed Product

                  	
                    21

                  

          

        

         

        [*] Certain information in this document has been omitted and filed
separately with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.

      

    
 

    
      
         

      

      
        ii

        
          

        

      

      
         

      

    

     

    
      
        
          
            	
                    11.4

                  	
                    Allocation
      of Damages Recovered

                  	
                    21

                  
	
                    11.5

                  	
                    Cooperation

                  	
                    21

                  
	 
      	 
      
	
                    Article
      12 Representations and Warranties

                  	
                    21

                  
	
                    12.1

                  	
                    Shiva
      Warranties

                  	
                    21

                  
	
                    12.2

                  	
                    Debarment

                  	
                    24

                  
	 
      	 
      
	
                    Article
      13 Limitation of Liability, Indemnity

                  	
                    24

                  
	
                    13.1

                  	
                    NO
      IMPLIED WARRANTIES

                  	
                    24

                  
	
                    13.2

                  	
                    Indemnity
      of Shiva

                  	
                    24

                  
	
                    13.3

                  	
                    Indemnity
      of Stockholders

                  	
                    25

                  
	 
      	 
      
	
                    Article
      14 Use of Names and Publication

                  	
                    25

                  
	
                    14.1

                  	
                    Use
      of Name; Labeling

                  	
                    25

                  
	
                    14.2

                  	
                    No
      Agency

                  	
                    25

                  
	
                    14.3

                  	
                    Publication

                  	
                    25

                  
	 
      	 
      
	
                    Article
      15 Confidentiality

                  	
                    26

                  
	
                    15.1

                  	
                    Confidentiality
      and Non-Use

                  	
                    26

                  
	 
      	 
      
	
                    Article
      16 Effective Date and Conditions to Close

                  	
                    26

                  
	
                    16.1

                  	
                      

                  	  26
      
	 
      	 
      
	
                    Article
      17 Miscellaneous Provisions

                  	
                    27

                  
	
                    17.1

                  	
                    Assignment

                  	
                    27

                  
	
                    17.2

                  	
                    Binding
      Nature and Enurement

                  	
                    27

                  
	
                    17.3

                  	
                    Compliance
      with Applicable Laws

                  	
                    27

                  
	
                    17.4

                  	
                    Counterparts;
      Facsimile

                  	
                    27

                  
	
                    17.5

                  	
                    Entire
      Agreement; Amendment

                  	
                    27

                  
	
                    17.6

                  	
                    Force
      Majeure

                  	
                    28

                  
	
                    17.7

                  	
                    Further
      Assurances

                  	
                    28

                  
	
                    17.8

                  	
                    Headings

                  	
                    28

                  
	
                    17.9

                  	
                    Law

                  	
                    28

                  
	
                    17.10

                  	
                    No
      Consequential Damages

                  	
                    28

                  
	
                    17.11

                  	
                    Payments,
      Notices and Other Communications

                  	
                    28

                  
	
                    17.12

                  	
                    Payment
      of Own Fees and Expenses

                  	
                    29

                  
	
                    17.13

                  	
                    Severability

                  	
                    29

                  
	
                    17.14   

                  	
                    Waiver

                  	
                    29

                  

          

        

      

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted
portions.

     

    
      
         

      

      
        iii

        
          

        

      

      
         

      

    

     

    CONTRIBUTION
AGREEMENT

    

    This
Contribution Agreement (hereinafter referred to as this “Agreement”), executed
as of July 28, 2006, is entered into by and between SHIVA BIOMEDICAL, LLC, a
limited liability company duly organized under the laws of New Jersey having a
place of business at 10810 Executive Center Drive, Danville Building, Suite 100,
Little Rock, AR 22211 (“Shiva”), PICTON PHARMACEUTICALS, INC.,
a corporation duly organized and existing under the laws of the State of
Delaware having a place of business at 787 Seventh Avenue, 48th Floor,
New York, NY 10019 (“Picton”), PICTON HOLDING COMPANY, INC.,
a corporation duly organized and existing under the laws of the State of
Delaware having a place of business at 787 Seventh Avenue, 48th Floor,
New York, NY 10019 (the “Company”), and the stockholders of Picton executing a
Joinder to this Contribution Agreement in the form attached hereto as Exhibit
16.1 (the “Stockholders”).

    

    WHEREAS, the Stockholders are
the owners of shares of Picton capital securities;

    

    WHEREAS, Shiva is engaged in
the development of novel products for the treatment and diagnosis of kidney
disease;

    

    WHEREAS, more specifically,
Shiva is the sole owner of all right, title and interest
in  deferiprone, otherwise known as Shiva 102 and a diagnostic test to
predict renal disease, referred to as Shiva 101 (collectively the “Technology”)
as claimed in the Patent Rights (as defined below) and Know How (as defined
below);

    

    WHEREAS, the Stockholders
desire to contribute their shares of Picton to the Company in exchange for an
equal number of shares of Company stock having the same rights and preferences
as their shares of Picton;

    

    WHEREAS, simultaneously with
the contribution by the Stockholders of their Picton shares to the Company,
Shiva desires to contribute its kidney products business to the Company in order
to create a new kidney products company and to effect this contribution by a
transfer (assignment) of non-intellectual property assets related to Shiva’s
kidney product business and by an exclusive license of intellectual property,
all as more fully provided in this Agreement;

    

    WHEREAS, the Company wishes to
provide for such contributions;

    

    WHEREAS, this Agreement will
become effective upon the execution of this Agreement by stockholders of Picton
owning shares of Picton capital stock representing at least 90% of the voting
power of Picton; and

    

    WHEREAS, the Parties intend
that the simultaneous contributions by Shiva and the Stockholders qualify as a
contribution transaction under Section 351 of the Internal Revenue
Code;

     

    NOW, THEREFORE, in
consideration of the foregoing Recitals, the premises and the mutual covenants
contained herein, the parties hereto, intending to be legally bound, agree as
follows:

      

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted
portions.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    Article
1 Definitions

     

    For the
purposes of this Agreement, the following words and phrases shall have the
following meanings:

     

    
      1.1         
“Affiliate” shall
mean, with respect to any Entity (as hereinafter defined), any Entity that
directly or indirectly controls, is controlled by, or is under common Control
with such Entity.

    

     

    
      	
               
      

            	
              1.1.1

            	
              “Control”
      shall mean, for this purpose, direct or indirect control of more than
      fifty percent (50%) of the voting securities of an Entity or, if such
      Entity does not have outstanding voting securities, more than 50% of the
      directorships or similar positions with respect to such
      Entity.

            

    

     

    
      	
               
      

            	
              1.1.2

            	
              “Entity”
      shall mean any corporation, association, joint venture, partnership,
      trust, university, business, individual, government or political
      subdivision thereof, including an agency, or any other organization that
      can exercise independent legal
standing.

            

    

     

    
      1.2       
  “Applicable
Law(s)” means the
Federal Food, Drug, & Cosmetic Act and all other applicable laws, rules,
regulations and guidelines within the Territory that apply to the import,
export, research and development, manufacture, marketing, distribution or sale
of any Licensed Product in the Territory or the performance of either party’s
obligations under this Agreement (including disclosure obligations as required
by the United States Securities and Exchange Commission or other comparable
exchange or securities commission having authority over a party) to the extent
applicable and relevant to  such party.

    

     

    
      1.3         
“Competent
Authority(ies)” means
collectively the entities in each country in the Territory responsible
for:

    

     

    
      	
               
      

            	
              (a)

            	
              the
      regulation of medicinal products intended for human use, including, but
      not limited to, the FDA, DEA, Health Canada (Canada), European Medicines
      Agency (EMEA), and the Ministry of Health and Welfare (Japan);
      or

            

    

     

    
      	
               
      

            	
              (b)

            	
              the
      establishment, maintenance and/or protection of rights related to the
      Patent Rights including the United States Patent and Trademark
      Office,

            

    

     

     and
any other comparable and applicable administrative agency in any other country
in the Territory and any successor entities thereto.

    
      

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

    

     

    
      1.4         
“Compound” means
Shiva 102 and any other chemical or molecule, the use of which is incorporated
in the Patent Rights.

    

     

    
      1.5          “Contributed
Product “ shall
mean any product (i) for the treatment or prevention of any kidney disease or
condition, including, without limitation, the treatment or prevention of renal
disease, diabetes, transplant dysfunction, contrast-induced nephropathy or
erythropoietin-resistant anemia through the use of deferiprone or any other iron
chelator, and/or (ii) for the diagnosis of any kidney disease or condition
through the use of any diagnostic test described in or covered by the Patent
Rights.

    

     

    
      1.6          “Control” means,  with
respect to any material, item of information, or intellectual property right,
the possession, whether by ownership or license, of the right to grant a license
or other right with respect thereto.

    

     

    
      1.7          “Development” means the
Company’s, Affiliate’s, or Sublicensee’s use of commercially reasonable
efforts:

    

     

    
      	
               
      

            	
              1.7.1

            	
              to
      secure the Marketing Authorizations for Licensed Products;
    and

            

    

     

    
      	
               
      

            	
              1.7.2

            	
              to
      manufacture or have manufactured the Licensed
  Products.

            

    

     

    
      1.8          “DMF” means a
Drug Master File, which is a submission to the FDA, as provided for in 21 CFR §
314.420,  that may be used to provide confidential detailed
information about facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more human
drugs.

    

     

    
      1.9          “FDA” means the
United States Food and Drug Administration and any successor entity
thereto.

    

     

    
      1.10        “Governmental
Approval(s)” means any
and all permits, licenses and authorizations required by any Competent Authority
as a prerequisite to the development, manufacturing, packaging, marketing and
selling of the Licensed Product in the Territory; excluding however import
permits.

    

     

    
      1.11        “IND(s)” means an
investigational new drug application as defined in 21 C.F.R. § 312 et seq
for the FDA in the United States or equivalent application to the Competent
Authorities of other countries in the Territory, to commence clinical testing of
a drug in humans, as defined by the FDA in the United States, or other
applicable Competent Authority, as the same may be amended, supplemented or
replaced from time to time.

    

     

    
      1.12        “Improvements” shall
mean any modification of the Technology or a Licensed Product or any inventions
(whether patentable or not), information and data, derived, conceived or reduced
to practice at any time after the Effective Date of the Agreement and during the
Term, which would be useful or necessary in the manufacture, use or sale of a
Licensed Product, or the practice of which would infringe an issued or pending
claim within the Patent Rights.

    

     

    
      1.13        “Know-how” shall
mean all non-public tangible or intangible information (other than
those contained in the Patent Rights) whether patentable or not (but which has
not been patented) related to the Technology or to the Licensed Product or to an
Improvement, including but not limited to: formulations, in vitro, preclinical
or clinical design, information or results, other proprietary materials,
processes, including but not limited to manufacturing processes, data, drawings
and sketches, designs, testing and test results, regulatory information of a
like nature, owned or controlled by Shiva which Shiva has the right to disclose
and license to the Company.

    

     

    
      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

       

    

    
      1.14        “Licensed
Product(s)” shall
mean (i) any product that cannot be manufactured, used or sold, in whole or
part, in the country in which the product is made, used, leased, imported,
exported, offered for sale or sold, without infringing one or more claims
included within an existing issued patent or pending patent application included
in the Patent Rights as of the date of execution of this Agreement or (ii) any
Contributed Product that cannot be manufactured, used or sold, in whole or part,
in the country in which the product is made, used, leased, imported, exported,
offered for sale or sold, without (x) infringing one or more claims otherwise
included at any time during the term of this Agreement within the Patent Rights
or (y) the use or incorporation of Know-How.

    

     

    
      1.15        “Marketing
Authorization” means all
necessary and appropriate regulatory approvals, including NDAs, where
applicable, to allow a Licensed Product to be marketed and sold in a particular
country in the Territory.

    

     

    
      1.16        “NDA” means a
New Drug Application, and all amendments and supplements thereto, for regulatory
approval by the FDA as defined in 21 CFR § 314.50 et seq.,
as such act or regulations may be amended, supplemented or replaced from time to
time, to commence commercial sale of the Licensed Product in the United States
and any other comparable term and act as applicable with regard to a new drug
application and all amendments, supplements or replacements to such act or
regulations in any other country in the Territory.

    

     

    
      1.17        “Net
Sales” shall
have the meaning set out below:

    

     

    
      	
               
      

            	
              1.17.1

            	
              “Net
      Sales” shall mean the total invoiced amount for sales of Licensed Products
      by or on behalf of the Company or any of its Affiliates or Sublicensees
      (as applicable), less only the sum of the following, in each case to the
      extent taken or allowed:

            

    

     

    
      	
               
      

            	
              (a)

            	
              usual
      trade discounts to customers;

            

    

     

    
      	
               
      

            	
              (b)

            	
              sales,
      tariff duties and/or use taxes directly imposed and with reference to
      particular sales;

            

    

     

    
      	
               
      

            	
              (c)

            	
              amounts
      allowed or credited on returns;

            

    

     

    
      	
               
      

            	
              (d)

            	
              bad
      debt deductions actually written off during the accounting
      period;

            

    

     

    
      	
               
      

            	
              (e)

            	
              outbound
      transportation prepaid or allowed and transportation insurance;
      and

            

    

     

    
      	
               
      

            	
              (f)

            	
              packaging
      and freight charges.

            

    

     

    
      	
               
      

            	
              1.17.2

            	
              Components
      of Net Sales shall be determined in accordance with
  GAAP.

            

    

     

    
      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

    

     

    
      	
               
      

            	
              1.17.3

            	
              Notwithstanding
      anything herein to the contrary, (i) the transfer of a Licensed Product to
      a third party without consideration to the Company in connection with the
      research, development or testing of a Licensed Product and (ii) the
      transfer of Licensed Product solely for indigent or similar public support
      or compassionate use programs shall not be considered a sale of Licensed
      Product under this Agreement and, accordingly, such sales shall not be
      used in the calculation of Net
Sales.

            

    

     

    
      	
               
      

            	
              1.17.4

            	
              Notwithstanding
      anything herein to the contrary, the transfer of Licensed Product between
      the Company, its Affiliate and/or its Sublicensee shall not be considered
      a sale of Licensed Product under this Agreement unless such Affiliate or
      Sublicensee are the end user of such Licensed
  Product.

            

    

     

    
      1.18        “Non-Royalty
Sublicensing Income” means any
and all consideration received from a Sublicensee in consideration for grant of
a Sublicense under the Patent Rights which shall include sublicense issue fees
and non-sales related sublicense milestone payments received by the Company
directly related to the sublicensing by the Company of rights to commercialize
Licensed Products, but shall exclude (a) sublicense maintenance fees; (b)
payments received from the sale, issuance or exchange of debt or equity
securities of the Company; (c) payments received by the Company that are
specifically designated in any agreement with a third party to be dedicated to
the research and development of the Technology or the establishment of a direct
sales force; (d) payments resulting from the sale of one or more Licensed
Products, including sales milestones and royalties (as such sales will be
subject to payment under 6.2); and (e) payments resulting from the achievement
of any of the milestones itemized in Article 6.3.2.

    

     

    
      1.19       
“Patent
Rights” means

    

     

    
      	
               
      

            	
              1.19.1

            	
              all
      U.S. and foreign patents and patent applications set forth in Exhibit
      1.19;

            

    

     

    
      	
               
      

            	
              1.19.2

            	
              any
      and all U.S. or foreign patents, patent applications, or other rights
      issuing from, or filed subsequent to the Effective Date, based on or
      claiming priority to or from the applications and rights listed on Exhibit
      1.19, including continuations, continuations in part, divisionals,
      reexaminations, extensions, renewals and reissues from such applications
      and rights, and any patents resulting from any application or right
      included in Articles 1.19.1 or
1.19.2;

            

    

     

    
      	
               
      

            	
              1.19.3

            	
              any
      other intellectual property rights owned or Controlled by Shiva relating
      to the Technology as of the Effective Date and any and all US or foreign
      patents, patent applications, or other rights, including continuations,
      continuations in part, divisionals, reexaminations, extensions, and
      reissues based on such rights;

            

    

     

    
      	
               
      

            	
              1.19.4

            	
              any
      other intellectual property rights owned or Controlled by Shiva at any
      time during the Term of this Agreement relating to an Improvement; and any
      and all US or foreign patents, patent applications, or other rights,
      including continuations, continuations in part, divisionals,
      reexaminations, extensions, renewals and reissues based on such rights;
      and

            

    

     

    
      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

       

    

    
      	
               
      

            	
              1.19.5

            	
              any
      foreign counterpart to any patent or patent application described in
      Articles 1.19.1 through 1.19.4.

            

    

     

    The
parties shall use commercially reasonable efforts to ensure that Exhibit 1.19
shall be amended in writing from time to time to reflect the foregoing, provided
that any failure to do so shall not limit the scope of the definition of Patent
Rights established above.

     

    
      1.20       
“Royalty
Term” means, in
respect of each country in the Territory, the later of (i) the period commencing
on the Effective Date and ending on the date of the last to expire Valid Claim
contained in the Patent Rights covering a Licensed Product, provided, however,
that any claim under the Patent Rights that has been pending for more than five
(5) years shall be deemed expired for the purposes of this Article 1.20 unless
and until the date on which such claim becomes a claim in an issued patent; and
(ii) ten (10) years from the first commercial sale of an applicable Licensed
Product in each country (as applicable).

    

     

    
      1.21       
“Sublicense” means any
license or other grant of rights (including, without limitation, any agreement
not to assert any right) to or under any right granted by Shiva to the Company
hereunder.   When used as a verb, Sublicense means to grant such
a license or other right.

    

     

    
      1.22       
“Sublicensee” means any
Third Party to whom any license or right has been granted under any Sublicense,
whether by the Company directly or by an existing
Sublicensee.

    

     

    
      1.23       
“Technology” means
deferiprone, otherwise known as Shiva 102 (the “Compound”), and a diagnostic
test to predict renal disease, otherwise known as Shiva 101, and any other
compound, device or technology, the use of which is covered by the Patent
Rights.

    

     

    
      1.24       
“Term” has the
meaning set out in Article 10.1.

    

     

    
      1.25        “Territory” means the
world.

    

     

    
      1.26       
“Third
Party” means any
Entity other than the Company, Picton or Shiva.

    

     

    
      1.27       
“Valid
Claim” means (i)
any issued claim of an unexpired patent within the Patent Rights that has not
been withdrawn, canceled, disclaimed, revoked or held unenforceable or invalid
by a court or other governmental agency of competent jurisdiction in a decision
that is no longer subject to appeal, and which has not been admitted to be
invalid or unenforceable through reissue or disclaimer or (ii) any pending claim
included in the Patent Rights.

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

    

     

    Article
2 Grant

     

    
      	
              2.1

            	
              Grant
      of License

            

    

     

    
      	
               
      

            	
              2.1.1

            	
              Shiva
      hereby grants to the Company and the Company accepts, subject to the terms
      and conditions of this Agreement, an exclusive license under the Patent
      Rights and the Know-How, and Shiva’s interest in any Improvements, to
      make, have made, use, have used, import, have imported, export, have
      exported, offer for sale, have sold, sell, produce, manufacture,
      distribute and market Licensed Products in the Territory, including the
      right to Sublicense in accordance with Article 2.2
  below.

            

    

     

    
      	
              2.2

            	
              Sublicenses

            

    

     

    
      	
               
      

            	
              2.2.1

            	
              The
      Company shall have the right to Sublicense rights granted in Article 2.1.1
      to its Affiliates in its sole discretion.  Affiliates shall have
      the right to grant further Sublicenses to such rights to their Affiliates
      in their sole discretion.

            

    

     

    
      	
               
      

            	
              2.2.2

            	
              The
      Company shall also have the right to sublicense rights granted in Article
      2.1.1 to Third Parties in its sole discretion.  The Company
      shall give Shiva prompt notice of the execution of any
      Sublicense.  Sublicensees of the Company shall have the right to
      grant further sublicenses only with the Company’s
      consent.  Company shall promptly notify Shiva of
      same.  In the event the Company grants Sublicenses to others to
      sell Licensed Products, such Sublicenses shall include an obligation for
      the Sublicensee to account for and report its Net Sales to Shiva on the
      same basis as if such sales were Net Sales by the Company and to afford to
      Shiva the same audit and other rights related to the determination of Net
      Sales and the amounts payable with respect thereto as are afforded to
      Shiva hereunder.

            

    

     

    
      	
               
      

            	
              2.2.3

            	
              The
      terms of this Article 2.2 shall apply to each subsequent Sublicensee
      (including sub-sublicensees), as if same were the Company’s original
      Sublicensee.

            

    

     

    
      	
               
      

            	
              2.2.4

            	
              Except
      as expressly agreed in writing by Shiva in its sole discretion, no
      Sublicense shall survive termination of this Agreement, provided, however,
      that in the event that Shiva terminates this Agreement pursuant to Section
      10.3 (non-payment) or Section 10.4 (Company breach) or this Agreement
      terminates pursuant to Section 10.2 (Company insolvency), Sublicensee
      shall have a direct grant from Shiva of the same rights Sublicensed to
      Sublicensee under the Sublicense, subject to Sublicensee assuming all
      obligations of the Company to Shiva under this Agreement and providing
      directly to Shiva, rather than to the Company, any additional
      consideration payable by Sublicensee to the Company under the
      Sublicense.  Upon request of the Company at the time it enters
      into any sublicense agreement, Shiva agrees to directly contract with each
      Sublicensee in writing in which Shiva agrees to the
    foregoing.

            

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

       

    

    
      	
               
      

            	
              2.2.5

            	
              Notwithstanding
      the foregoing, if the Company believes that Shiva has terminated this
      Agreement for the primary purpose of doing business directly with any
      Sublicensee, the termination may be disputed under the provisions of
      Article 9.

            

    

     

    
      	
               
      

            	
              2.2.6

            	
              Notwithstanding
      any other provision of this Agreement, the Company shall be responsible
      for the payment of any royalties or other amounts payable to Shiva by any
      Sublicensee.

            

    

     

    Article
3 Contributions of Technology, Rights and Picton Shares

     

    
      	
              3.1

            	
              Technology
      Transfer

            

    

     

    Unless
otherwise prohibited by law, Shiva shall assign to the Company the following
Shiva Know-how, to the extent Shiva has such access to such information, to
enable the Company to undertake the manufacture, development and
commercialization of the Licensed Product(s) under this Agreement. Such transfer
shall include:

     

    
      	
               
      

            	
              3.1.1

            	
              copies
      of all regulatory submissions;

            

    

     

    
      	
               
      

            	
              3.1.2

            	
              all
      data and reports from pre-clinical and clinical
  studies;

            

    

     

    
      	
               
      

            	
              3.1.3

            	
              any
      prototypes, designs or models of Shiva 101 and/or Shiva
    102;

            

    

     

    
      	
               
      

            	
              3.1.4

            	
              any
      communications with the FDA and the minutes of any meetings with the FDA
      relating to the Licensed Product;

            

    

     

    
      	
               
      

            	
              3.1.5

            	
              trial
      master files relating to the Licensed Product, including copies of all
      case report forms;

            

    

     

    
      	
               
      

            	
              3.1.6

            	
              copies
      of all listings and tables of results from the clinical trials relating to
      the Licensed Product;

            

    

     

    
      	
               
      

            	
              3.1.7

            	
              copies
      of all treatment-related serious adverse event reports from the clinical
      trials relating to the Licensed
Product;

            

    

     

    
      	
               
      

            	
              3.1.8

            	
              any
      retained samples of materials used in clinical trials relating to the
      Licensed Product;

            

    

     

    
      	
               
      

            	
              3.1.9

            	
              rights
      of access to CROs involved in the clinical trials relating to the Licensed
      Product;

            

    

     

    
      	
               
      

            	
              3.1.10

            	
              the
      data, files and results of any CMC related activities regarding the
      Licensed Product, and

            

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

    

     

    
      	
               
      

            	
              3.1.11

            	
              all
      other information that the Company may reasonably request regarding the
      manufacturing of Licensed Products, clinical trials with respect to each
      Licensed Product, and the commercial sale of Licensed
      Products.

            

    

     

    Shiva
shall use commercially reasonable efforts to arrange (i) for the assignment to
the Company of any supply or similar contract related to the Technology and
necessary or desirable for the continued conduct by the Company of the kidney
product development business now conducted by Shiva, which the Company wishes to
assume, subject to the assumption of such contract by the Company or (ii) for
any Third Party who is (as of the Effective Date) a party with Shiva to any such
contract to enter into a similar contract with the Company, on a basis
acceptable to the Company, provided that Shiva shall not be required to make any
payment or provide any other consideration in order to arrange for any such
assignment or similar contract. Notwithstanding the foregoing, contracts with
Shiva affiliates will only be assigned to the Company at Shiva’s option and at
fair market value.

     

    
      	
              3.2

            	
              Rights
      of Reference

            

    

     

    
      	
               
      

            	
              3.2.1

            	
              Shiva
      shall grant and hereby grants the Company a free-of-charge right to
      reference and use and have full access to all Governmental Approvals and
      all other regulatory documents relating to the Compound and products
      incorporating the Technology, including any IND, any NDA and any DMF
      (whether as an independent document or as part of any NDA, and all
      chemistry, manufacturing and controls information), and any supplements,
      amendments or updates to the foregoing, where such regulatory documents
      are owned or sufficiently Controlled by Shiva, directly or indirectly, to
      permit such grant (for the purposes of this Article, the “Right of
      Reference”). The Company may Sublicense the Right of Reference to
      Affiliates and to Third Parties, provided such Sublicense is consistent
      with Article 2.2.

            

    

     

    
      	
              3.3

            	
              Transfer
      of the IND

            

    

     

    
      	
               
      

            	
              3.3.1

            	
              The
      parties acknowledge that Shiva, as of the Effective Date, owns and holds
      certain Governmental Approvals in connection with the research and
      development of the Compound.  Upon the Company’s request, such
      request to be made as soon as reasonably possible, Shiva shall transfer to
      the Company, without any additional consideration except as provided in
      Article 3.4, such Government
Approvals.

            

    

     

    
      	
              3.4

            	
              Costs
      of Transfer

            

    

     

    
      	
               
      

            	
              3.4.1

            	
              The
      Company shall pay Shiva for any services performed by officers or
      employees of Shiva in effecting the technology transfer and other action
      to be taken by Shiva as provided for under this Article 3, at a rate of
      $[*] per day, per person (provided that there shall be no charge for the
      first five days of said service), and shall reimburse Shiva and such
      officers or employees for all reasonable, documented, actual travel and
      associated accommodation expenses of Shiva personnel who, at the Company’s
      request, travel to provide transition support under this
      Article.

            

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

    

     

    
      	
              3.5

            	
              Transfer
      of Compound Inventory

            

    

     

    Shiva
shall transfer to the Company at Company’s request all or any part of Shiva’s
inventory of GMP and non-GMP Compound, it being understood and agreed that if
Shiva has material amounts of such Compound, the Company shall compensate Shiva
at a mutually agreed price reflecting Shiva’s cost of goods.

     

    
      	
              3.6

            	
              Contribution
      of Picton Shares

            

    

     

    Simultaneously
with the other transactions contemplated by this Article 3, and upon the terms
and subject to the conditions set forth herein, the Stockholders hereby
irrevocably contribute, assign, transfer and deliver to the Company, and the
Company hereby accepts from the Stockholders, all shares of Picton equity
securities held by them.  The Company shall pay for all costs and
expenses incurred in connection with the contributions contemplated by this
Section 3.6, including all transfer, documentary, sales, use, stamp,
registration, recording, filing and other such taxes and fees.

     

    Article
4 Regulatory Compliance

     

    
      	
              4.1

            	
              Ownership
      and Maintenance of Governmental
Approvals

            

    

     

    
      	
               
      

            	
              4.1.1

            	
              The
      Company will own all Marketing Authorizations for each country in the
      Territory for Licensed Products. Without limiting the generality of the
      foregoing, the Company shall prepare and submit in its own name and at its
      expense NDAs with the FDA in the U.S. and any other equivalent application
      with the Competent Authorities in other countries in the
      Territory.

            

    

     

    
      	
               
      

            	
              4.1.2

            	
              The
      Company shall secure and maintain in good standing, at its sole cost and
      expense, any and all Governmental Approvals (including, Marketing
      Authorizations, licenses, permits and consents, facility licenses and
      permits required by Applicable Laws or by the applicable Competent
      Authorities) necessary and/or required for the Company to perform its
      obligations under this Agreement and use commercially reasonable efforts
      at its cost and expense to secure and maintain any variations and renewals
      thereof.

            

    

     

    
      	
              4.2

            	
              Compliance

            

    

     

    Subject
to the other terms and conditions of this Agreement, the parties agree to the
following general compliance provisions:

     

    
      	
               
      

            	
              4.2.1

            	
              As
      provided in this Agreement with regard to each party’s obligations
      hereunder, the Company and Shiva shall each comply in all material
      respects with all Applicable Laws within the Territory, including the
      provision of information by the Company and Shiva to each other necessary
      for Shiva and the Company, as the case may be, to comply with any
      applicable reporting requirements and Governmental Approvals required; and
      maintaining any and all licenses, permits and consents necessary and/or
      required for complying with such party’s obligations under this
      Agreement.

            

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

    

     

    
      	
               
      

            	
              4.2.2

            	
              Each
      party shall promptly notify the other party of any written or oral notices
      received from, or inspections by, the FDA, or other Competent Authority,
      relating to any Licensed Product, or to the Development and/or the
      Marketing Authorizations of or for any Licensed Product, and shall
      promptly inform the other party of any responses to such written notices
      or inspections and the resolution of any issue raised by the FDA or other
      Competent Authority.

            

    

     

    
      	
               
      

            	
              4.2.3

            	
              During
      the time that Shiva is the holder of the IND, the Company shall be
      entitled to attend any and all meetings and participate in telephone calls
      with the Competent Authorities, including without limitation any meeting
      preparation, meeting co-ordination, preparation of minutes and pre-NDA
      meeting with the FDA.

            

    

     

    Article
5 Development and Commercialization

     

    
      	
              5.1

            	
              Development

            

    

     

    
      	
               
      

            	
              5.1.1

            	
              The
      Company (or its Sublicensee) shall use, and shall cause its Affiliates and
      Sublicensees to use all reasonable commercial efforts to bring Licensed
      Products to market through a thorough, vigorous and diligent program for
      exploitation of the Technology as timely and efficiently as
      possible.  Such program shall include the preclinical and
      clinical development including research and development, manufacturing,
      laboratory and clinical testing and marketing of Licensed
      Products.  Without limiting the generality of the foregoing, the
      Company shall use all reasonable commercial efforts to carry out those
      activities provided for in the Development Plan attached hereto as Exhibit
      5.1, which Development Plan shall include a clinical trial and regulatory
      approval strategy and timeline for the anticipated Licensed
      Products.  The Development Plan shall cover a two year period,
      and may be modified at any time and from time to time as reasonably
      determined by the Company to be necessary or desirable in order to advance
      any Licensed Product toward Marketing
  Authorization.

            

    

     

    Article
6 Consideration for Contribution

     

    
      	
              6.1

            	
              Equity
      and Other Consideration

            

    

     

    As
consideration for the contribution by Shiva of its kidney products business to
the Company, Shiva shall receive the equity interests in the Company, the
royalty payments, and the additional consideration provided for in this Article
6.

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

    

     

    
      	
              6.2

            	
              Equity
      to be Issued on Contribution

            

    

     

    
      	
               
      

            	
              6.2.1

            	
              Upon
      the Effective Date, the Company shall issue to Shiva 800,000 shares of
      Series B Common Stock, 50,000 shares of Series C Common Stock, 50,000
      shares of Series D Common Stock, 50,000 shares of Series E Common Stock,
      and 50,000 shares of Series F Common Stock (as more particularly described
      in the Company’s Certificate of Incorporation attached hereto as Exhibit
      6.2, the “Common Stock”), which will represent twenty percent (20%) of the
      outstanding shares of equity securities of the Company on a fully
      converted and diluted basis immediately after taking into consideration
      the issuance of Common Stock to Shiva and the issuance of shares of equity
      securities to the Stockholders pursuant to Section 3.6 (using the number
      of shares of equity securities that would be issued if all of the Picton
      stockholders had participated in the contribution transaction contemplated
      by Section 3.6).  If all of the Picton stockholders do not
      participate in the contribution transaction contemplated by Section 3.6
      (such non-participating Picton stockholders shall be referred to as the
      “Remaining Stockholders”), then the Company will consummate a merger of
      Picton with either the Company or a newly-formed wholly-owned subsidiary
      of the Company pursuant to which the shares of Picton stock held by the
      Remaining Stockholders will be converted into the right to receive an
      equal number of shares of common stock of the Company that have the same
      rights and preferences as the Picton shares.  Such merger will
      be consummated as promptly as practicable after the Effective Date in a
      manner which allows the transactions contemplated hereby to continue to
      qualify as a contribution transaction under Section 351 of the Internal
      Revenue Code

            

    

     

    
      	
               
      

            	
              6.2.2

            	
              Neither
      the Company nor Picton shall take any action that would have the effect of
      denying to Shiva the intended benefits of the equity consideration
      provided for in this Section 6.2.

            

    

     

    
      	
              6.3

            	
              Royalties

            

    

     

    
      	
               
      

            	
              6.3.1

            	
              During
      the Royalty Term unless this Agreement shall be terminated as hereinafter
      provided, the Company shall pay Shiva royalties equal to [*] percent of
      Net Sales, provided, however, that if the Company sublicenses the right to
      sell or have sold Licensed Products granted to it under this Agreement by
      Shiva to a third party pursuant to Article 2.2 prior to the initiation of
      a Company sponsored clinical trial, the Company shall pay Shiva royalties
      equal to [*] percent of Net Sales.

            

    

     

    
      	
               
      

            	
              6.3.2

            	
              The
      Company shall also make the following one time payments to
      Shiva:

            

    

     

    
      	
               
      

            	
              (a)

            	
              Five
      Hundred Thousand Dollars ($500,000) upon the Effective Date (to be paid as
      provided in Section 6.8.2);

            

    

     

    
      	
               
      

            	
              (b)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (c)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (d)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (e)

            	
              [*];

            

    

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

    

     

    
      	
               
      

            	
              (f)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (g)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (h)

            	
              [*]

            

    

     

    
      	
               
      

            	
              (i)

            	
              [*];
      and

            

    

     

    
      	
               
      

            	
              (j)

            	
              [*].

            

    

     

    
      	
              6.4

            	
              Non-Royalty
      Sublicensing Income (NRSI)

            

    

     

    In the
event that the Company sublicenses the rights to sell or have sold a Licensed
Product prior to initiation of the first Company-sponsored clinical trial, then
the Company shall remit to Shiva the greater of (i) $[*] and (ii) [*] of all
Non-royalty Sublicense Income the Company receives from such sublicense
agreement.

     

    
      	
              6.5

            	
              No
      Multiple Royalties

            

    

     

    No
multiple royalties shall be payable because the use, lease or sale of any
Licensed Product is, or shall be, covered by more than one Valid
Claim.

     

    
      	
              6.6

            	
              Combination
      Products

            

    

     

    In the
event that a Licensed Product is sold in the form of a combination product
containing one or more products or technologies which are themselves not a
Licensed Product, the Net Sales for such combination product shall be calculated
by multiplying the Net Sales of such combination product by the fraction A/(A+B)
where A is the invoice price of the Licensed Product where the Licensed Product
is sold separately in the same country and B is the total invoice price of the
other products or technologies where such other product or technologies are sold
separately in such country.  If no such separate sales occur, the
fraction shall be such amount as is reasonably determined by the Company in good
faith.

     

    
      	
              6.7

            	
              Place
      of Payment, Taxes and Conversions

            

    

     

    Royalty
payments shall be paid in United States dollars at such place as Shiva may
reasonably designate consistent with applicable laws and regulations. Any taxes
which the Company, its Affiliate or any Sublicensee shall be required by law to
withhold on remittance of the royalty payments shall be deducted from such
royalty payment to Shiva. The Company shall furnish Shiva with the original
copies of all official receipts for such taxes. If any currency conversion shall
be required in connection with the payment of royalties hereunder, such
conversion shall be made by using the exchange rate prevailing at Citibank, N.A.
in New York, New York on the last business day of the calendar quarterly
reporting period to which such royalty payments relate.

    
       

      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

       

    

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

     

    
      	
              6.8

            	
              Time
      for Payment

            

    

     

    
      	
               
      

            	
              6.8.1

            	
              The
      Company shall pay to Shiva the royalties due and payable under this
      Agreement on a calendar quarterly basis.  Royalties with respect
      to any calendar quarter shall be paid within [*] of the end of such
      calendar quarter, at the same time as the Royalty Statement is delivered
      for such calendar quarter.

            

    

     

    
      	
               
      

            	
              6.8.2

            	
              The
      payments set forth in Section 6.3.2 shall be paid to Shiva within [*]
      after achievement of the indicated milestone, provided, however, that the
      payment provided for in Section 6.3.2 shall be paid no later than the
      earlier of 30 days after the Effective Date or August 31,
      2006.

            

    

     

    
      	
               
      

            	
              6.8.3

            	
              Payments
      owed to Shiva under Section 6.4 shall be paid within [*] of the event
      giving rise to the payment
obligation.

            

    

     

    
      	
               
      

            	
              6.8.4

            	
              If
      no royalties or other payments that may be due to Shiva under this
      Agreement shall be due, the Company shall not be required to make a report
      pursuant to Article 7.2.

            

    

     

    
      	
              6.9

            	
              Interest

            

    

     

    Amounts
which are not paid when due shall accrue interest from the due date until paid,
at a rate equal to the then prevailing prime rate of Citibank, N.A., plus
[*].

     

    
      	
              6.10

            	
              Board
      of Directors; Consulting Agreement

            

    

     

    Upon
execution of this Agreement and until the end of the Term, Shiva shall have the
right to appoint one (1) person to be a member of the board of directors of the
Company.  The Company and Picton shall reimburse this person for his
or her reasonable out-of-pocket travel or other expenses incurred in connection
with his or her service as director.  The Company shall enter into
consulting agreements with Dr. Sudhir Shah and with the University of Arkansas
for Medical Sciences substantially in the form of each such Agreement attached
as Exhibit 6.10.

     

    
      	
              6.11

            	
              Consideration
      for Contribution of Picton Shares

            

    

     

    As
consideration for the contribution by the Stockholders of their Picton shares to
the Company pursuant to Section 3.6, the Stockholders shall receive an equal
number of shares of common stock of the Company having the same rights and
preferences as their shares of Picton, such number of shares to equal 4,000,000
shares in the aggregate assuming contribution by all the
Stockholders.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        14

        
          

        

      

      
         

      

    

     

    Article
7 Reports and Records

     

    
      	
              7.1

            	
              Records
      and Audits

            

    

     

    The
Company shall keep full, true and accurate books of account containing all
particulars that may be necessary for the purpose of showing the amounts payable
to Shiva under this Agreement.  Said books of account shall be kept at
the Company’s principal place of business and the supporting data shall be
opened up to Shiva once per year upon reasonable notice to the Company for
inspection by Shiva’s internal audit division or by another designated auditor
selected by Shiva, except one to whom the Company has reasonable objection, for
the purpose of verifying the Company’s Royalty Statement or compliance in other
respects with this Agreement.  If an inspection shows an under
reporting or underpayment in excess of the greater of [*] of remuneration
payable, then the Company shall reimburse Shiva for the cost of the inspection
at the time the Company pays the unreported royalties, including any late
charges as required by Article 6.9 of this Agreement.  Said books of
account and the supporting data shall be made available to Shiva for [*
]following expiry of the Term.  All payments required under this
Article 7.1 shall be due within [*] of the date Shiva provides the Company
notice of the payment due.

     

    
      	
              7.2

            	
              Royalty
      Statements

            

    

     

    Within
[*] from the end of each calendar quarter of each calendar year, the Company
shall deliver to Shiva complete and accurate reports, giving such particulars of
the business conducted by the Company during the preceding quarter under this
Agreement as shall be pertinent to an accounting of royalties and other payments
that may be due to Shiva under this Agreement (the “Royalty Statement”). The
Royalty Statement shall include at least the following:

     

    
      	
               
      

            	
              7.2.1

            	
              an
      accounting of all Licensed Products used or
  sold;

            

    

     

    
      	
               
      

            	
              7.2.2

            	
              total
      amounts invoiced for Licensed
Products;

            

    

     

    
      	
               
      

            	
              7.2.3

            	
              Net
      Sales for each Licensed Product by each of the Company, each Affiliate and
      each Sublicensee;

            

    

     

    
      	
               
      

            	
              7.2.4

            	
              cumulative
      Net Sales for the current calendar
year;

            

    

     

    
      	
               
      

            	
              7.2.5

            	
              a
      breakdown of deductions applicable in computed Net Sales and taxes
      withheld, if any;

            

    

     

    
      	
               
      

            	
              7.2.6

            	
              a
      breakdown of royalties due based on Net Sales by or for the Company or its
      Affiliates;

            

    

     

    
      	
               
      

            	
              7.2.7

            	
              a
      breakdown of royalties due from any
Sublicensee;

            

    

     

    
      	
               
      

            	
              7.2.8

            	
              names
      and addresses of all Sublicensees and Affiliates of the Company;
      and

            

    

     

    
      	
               
      

            	
              7.2.9

            	
              a
      copy of each report from each Sublicensee as may be pertinent to an
      accounting of royalties and other payments that may be due to
      Shiva.

            

    

     

    
      	
              7.3

            	
              Confidential
      Treatment of Reports

            

    

     

    Shiva
agrees to hold in confidence each Royalty Statement delivered by the Company
pursuant to this Article 7 until the termination of this Agreement.
Notwithstanding the foregoing, Shiva may disclose any such information required
to be disclosed in its financial statements or as required by any stock exchange
or similar regulatory authority, or pursuant to any Applicable Laws or order or
subpoena from a court of law or government agency, provided that Shiva take
reasonable steps to provide the Company with the opportunity, where appropriate,
to contest such subpoena, requirement or order.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        15

        
          

        

      

      
         

      

    

     

    Article
8 Patent Prosecution and Maintenance

     

    
      	
              8.1

            	
              Prosecution
      and Maintenance

            

    

     

    Following
the Effective Date, the Company shall diligently prosecute and maintain the
Patent Rights as set forth in Exhibit A hereto (as the same may be amended or
supplemented in writing from time to time after the date hereof), including, but
not limited to, the filing of patent applications, extensions, continuations,
continuations in part, divisionals, re-examinations, renewals or re-issue
applications that the Company determines may be required to advance the purposes
of this Agreement or otherwise to protect the rights and licenses granted
hereunder.  The Company agrees to keep Shiva reasonably well informed
with respect to the status and progress of any such applications, prosecutions
and maintenance activities and to consult in good faith with Shiva and take into
account Shiva’s comments and requests with respect thereto.  Both
parties agree to provide reasonable cooperation to each other to facilitate the
application and prosecution of patents pursuant to this Agreement.

     

    
      	
              8.2

            	
              Abandonment

            

    

     

    The
Company may, in its discretion, elect to abandon any patent applications or
issued patent in the Patent Rights so long as such decision is consistent with
the Company’s obligations under Section 8.1.  Following such
abandonment, Shiva shall have the right, but not the obligation, to commence or
continue such prosecution and to maintain any such Patent Rights under its own
control and at its own expense.  At Shiva’s option, in its sole
discretion, Shiva may either (i) to continue to have any such Product Right
included in the Patent Rights or (ii) exclude such Patent Right from the Patent
Rights, in which event the Company shall (i) no longer have a right under this
Agreement to use, manufacture, or sell Licensed Products covered by such
abandoned Patent Rights and (ii) have no further royalty obligation to Shiva in
respect of any Licensed Product the manufacture, use or sale of which is covered
by an issued claim of such abandoned Patent Rights, provided, however, with
regard to both (i) and (ii), such manufacture, use or sale of such Licensed
Product not covered by other Valid Claims licensed to the Company under this
Agreement, in which case the Company shall have the right to use, manufacture
and sell Licensed Products and will be required to remit the applicable royalty
payments.  Prior to any such abandonment, the Company shall give Shiva
at least sixty (60) days notice and a reasonable opportunity to take over
prosecution of such Patent Rights.  The Company agrees to cooperate in
such activities including execution of any documents necessary to enable Shiva
to retain ownership and control of such Patent Rights.

     

    Article
9 Dispute Resolution

     

    
      	
              9.1

            	
              Disputes

            

    

     

    
      	
               
      

            	
              9.1.1

            	
              The
      parties recognize that disputes as to certain matters may from time to
      time arise during the Term which relate to either party’s rights and/or
      obligations hereunder or to the interpretation, performance, breach, or
      termination of this Agreement, (a “Dispute”). It is the objective of the
      parties to establish procedures to facilitate the resolution of a Dispute
      in an expedient manner by mutual cooperation and without resort to
      litigation. To accomplish this objective, the parties agree to follow the
      procedures set forth in this Article 9 if and when a Dispute arises under
      this Agreement.

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        16

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              9.1.2

            	
              A
      Dispute among the parties will be resolved as recited in this Article 9.
      Any Disputes relating to this Agreement shall be promptly presented to the
      Chief Executive Officers of Shiva and the Company for resolution. From the
      date of referral of a Dispute to the Chief Executive Officers of the
      parties and until such time as any matter has been resolved by the parties
      or has been finally settled by arbitration hereunder, the running of the
      cure periods (if any) as to which a party must cure a breach that is part
      of the subject matter of any Dispute shall be suspended. In the event that
      the Chief Executive Officers of Shiva and the Company, or their respective
      designees, cannot after good faith negotiations resolve the Dispute within
      thirty (30) days (or such other period of time as mutually agreed to by
      the parties in writing) of being requested by a party to resolve a
      Dispute, the parties agree that such Dispute shall be resolved by binding
      arbitration in accordance with this Article
9.1.

            

    

     

    
      	
               
      

            	
              9.1.3

            	
              If
      a party intends to begin arbitration to resolve such Dispute, such party
      shall provide written notice (the “Arbitration Notice”) to the other party
      informing such other party of such intention and the issues to be
      resolved. Any arbitration hereunder shall be conducted pursuant to the
      Commercial Arbitration Rules of the American Arbitration Association
      (“AAA”), including the Supplementary Procedures for Large Complex Disputes
      (the “AAA Rule”) except as modified herein. The arbitration shall be
      conducted by a panel of three (3) arbitrators (the “Panel”) to be mutually
      agreed upon by the parties and appointed by the AAA. The arbitrators shall
      be industry experts experienced in the issues comprising the Dispute and
      shall have no past, present or anticipated future affiliation with either
      party. If the parties are unable to agree upon all or any number of the
      three (3) mutually acceptable arbitrators within thirty (30) days after
      the filing of the Arbitration Notice, the AAA shall promptly appoint the
      arbitrator(s) to complete the Panel in accordance with the criteria set
      forth in this Article 9.1. The arbitration shall take place in New York,
      New York. The Panel shall apply the laws of the State of New York, without
      regard to its conflicts of laws provisions. The Panel shall issue
      appropriate protective orders to protect each party’s Confidential
      Information. If a party can demonstrate to the Panel that the complexity
      of the issue or other reasons warrant the extension of one or more
      timetables in the AAA Rules, the Panel may extend such timetables but in
      no event shall the proceeding extend more than six (6) months from the
      date of filing of the Arbitration Notice with the AAA. The Panel’s
      decision shall be in writing. The Panel shall have the authority to award
      any remedy allowed by law or in equity, including compensatory damages,
      pre-judgment interest and to grant final, complete, interim, or
      interlocutory relief, including specific performance, injunctions and
      other equitable relief, but not punitive or other damages and each party
      shall be deemed to have waived any right to such excluded damages. Each
      party shall bear its own costs, fees and expenses in the arbitration and
      shall share equally the Panel’s fees, unless the Panel determines that its
      fees are to be paid by the non-prevailing
party.

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        17

        
          

        

      

      
         

      

    

     

    
      	
              9.2

            	
              Performance
      to Continue

            

    

     

    Each
party shall continue to perform its obligations under this Agreement pending
final resolution of any Dispute arising out of or related to this Agreement;
provided, however, that a party may suspend performance of its obligations
during any period in which the other party fails or refuses to perform its
obligations.

     

    
      	
              9.3

            	
              Determination
      of Patents and Other Intellectual
Property

            

    

     

    Notwithstanding
Article 9.1 and any other Article in this Agreement, any dispute relating to the
determination of validity of claims, infringement or claim interpretation
relating to Shiva’s Patent Rights shall be submitted
exclusively to a federal court of appropriate jurisdiction.

     

    Article
10 Term and Termination

     

    
      	
              10.1

            	
              Term

            

    

     

    This
Agreement shall become effective on the Effective Date and shall expire on the
date of the expiration of the last to expire Royalty Term in any country in the
Territory (the “Term”), unless earlier terminated as provided in Articles 10.3,
10.4, or 10.6.

     

    
      	
              10.2

            	
              Termination for
      Insolvency  

            

    

     

    If the
Company shall become bankrupt, or shall file a petition in bankruptcy, or if the
business of the Company shall be placed in the hands of a receiver, assignee or
trustee for the benefit of creditors, whether by the voluntary act of the
Company or otherwise, this Agreement shall automatically terminate.

     

    
      	
              10.3

            	
              Termination
      for Failure to make Payments

            

    

     

    Should
the Company fail to make payment to Shiva of any royalty or other payment due in
accordance with the terms of this Agreement, Shiva shall have the right to
terminate this Agreement within forty-five (45) days after giving written notice
of termination unless the Company shall pay to Shiva, within the forty-five (45)
day period, all such royalties and other payments due and payable. In the event
of a bona fide dispute over royalties or other payments, the parties shall
resolve such dispute in accordance with Article 9. Subject to Article 9 and the
immediately preceding sentence of this Article 10.3, upon the expiration of the
forty-five (45) day period, if the Company shall not have paid all such
royalties and other payments due and payable, the rights, privileges and license
granted hereunder shall, at the option of Shiva, terminate upon written notice
of Shiva. If a dispute regarding termination is addressed according to Article
9, this Agreement shall remain in full force and effect until such dispute is
settled or determined in accordance with Article 9.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        18

        
          

        

      

      
         

      

    

     

    
      	
              10.4

            	
              Termination
      for Breach

            

    

     

    Upon any
material breach or default of this Agreement by the Company, other than as set
forth in Article 10.2 and 10.3 above, Shiva shall have the right to terminate
this Agreement and the rights, privileges and license granted hereunder by
giving ninety (90) days prior written notice to the Company. Subject to Article
9 and the immediately preceding sentence, upon the expiration of the ninety (90)
day period, if the Company shall have failed to cure such breach or default,
this Agreement shall, at the option of Shiva, terminate upon written notice of
Shiva.   Notwithstanding anything herein to the contrary, if the
nature of the breach is such that additional time is reasonably needed to cure
such breach, and Company has commenced with good faith efforts to cure such
breach, then Shiva shall provide Company with additional time (but in no event
more than a total of 180 days) in which to cure such breach.  If a
dispute regarding termination is addressed according to Article 9, this
Agreement shall remain in full force and effect until such dispute is settled or
determined in accordance with Article 9.

     

    
      	
              10.5

            	
              Expiry
      of Royalty Term on a Country by Country
Basis

            

    

     

    Upon
expiry of the Royalty Term in each country in the Territory, the Company will
have an irrevocable, paid up, royalty-free license under the Patent Rights to
make, have made, use, import, offer for sale and sell the Licensed Products in
such country.

     

    
      	
              10.6

            	
              Termination
      for Convenience

            

    

     

    The
Company shall have the right at any time to terminate this Agreement in its
entirety, for any reason or no reason, by giving thirty (30) days notice thereof
in writing to Shiva.

     

    
      	
              10.7

            	
              Consequences
      of Termination

            

    

     

    Upon the
early termination of this Agreement by either party prior to the end of each
Royalty Term, the following shall occur:

     

    
      	
               
      

            	
              10.7.1

            	
              the
      Company and any Sublicensee thereof may, after the effective date of such
      termination and continuing for a period not to exceed nine (9) months
      thereafter, sell all completed Licensed Products, and any Licensed
      Products in the process of manufacture at the time of such termination,
      and sell the same, provided that the
Company:

            

    

     

    
      	
               
      

            	
              (a)

            	
              notifies
      Shiva of its decision within thirty (30) days after the date it receives a
      notice of termination by Shiva or the date it provides a notice of
      termination to Shiva, as the case may
be;

            

    

     

    
      	
               
      

            	
              (b)

            	
              pays
      or cause to be paid to Shiva the royalties and other payments thereon as
      required by Article 6 of this Agreement;
and

            

    

     

    
      	
               
      

            	
              (c)

            	
              submits
      the reports required by Article 7
hereof.

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        19

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              10.7.2

            	
              In
      all other cases, unless Shiva, in its sole discretion elects to allow the
      Company or any Sublicensee  to sell-off or distribute, as
      applicable, any existing inventory of Licensed Product, the Company and
      any Sublicensee shall, at Shiva’s election,
  either:

            

    

     

    
      	
               
      

            	
              (a)

            	
              sell
      all existing inventory of Licensed Product to Shiva at fair market value
      (or at no charge, in the case of termination by Shiva for breach under
      Section 10.4); or

            

    

     

    
      	
               
      

            	
              (b)

            	
              destroy
      all remaining inventory of Licensed Product in accordance with Applicable
      Laws and provide Shiva with written proof of destruction sufficient to
      comply with Applicable Laws.

            

    

     

    
      	
              10.8

            	
              Survival

            

    

     

    Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination or obligations under Article 6, Article 7, and Article
11.  Except as set forth in Article 10.9, the following shall survive
termination for any reason, Article 9, Article 10.7, Article 13, Article 15 and
Article 17.7.

     

    
      	
              10.9

            	
              Failure
      to Satisfy Condition to Close

            

    

     

    If the
Effective Date, as described in Article 16.1, has not occurred on or before
August 17, 2006, then Shiva shall have the right, but not the obligation, to
terminate this Agreement upon written notice to the Company and
Picton.  In the event of the termination of this Agreement pursuant to
this Article 10.9, this Agreement shall be void and of no further force and
effect, with no liability on the party of any party hereto, except that the
provisions of Article 15 shall survive the termination of this
Agreement.

     

    Article
11 Infringement and Other Actions

     

    
      	
              11.1

            	
              Notice
      of Infringement of Patent Rights

            

    

     

    The
Company and Shiva shall promptly provide written notice, to the other party, of
any alleged infringement or any challenge or threatened challenge to the
validity, enforceability or priority of any of the Patent Rights, and provide
each other with any available evidence of such infringement, challenge or
threatened challenge by a third party of the Patent Rights and provide such
other party with any available evidence of such infringement.

     

    
      	
              11.2

            	
              Option
      to Prosecute or Defend Patent
Rights

            

    

     

    During
the term of this Agreement, the Company shall have the right, but not the
obligation, to prosecute and/or defend, at its own expense and utilizing counsel
of its choice, any infringement of the Patent Rights. In furtherance of such
right, Shiva hereby agrees that Shiva may join Company as a party in any such
suit (and will join at the Company’s request), provided that the Company pay all
of Shiva’s reasonable out-of-pocket expenses (including legal expenses). The
Company shall indemnify and hold Shiva harmless against any costs, expenses or
liability that may be found or assessed against Shiva in any such suit other
than resulting from Shiva’s negligence or willful misconduct. Any recovery of
damages pursuant to this Article 11.2 shall be allocated pursuant to Article
11.4 below.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        20

        
          

        

      

      
         

      

    

     

    
      	
              11.3

            	
              Infringement
      by Licensed Product

            

    

     

    In the
event that a claim or suit is asserted or brought against the Company alleging
that the manufacture or sale of any Licensed Product by the Company, an
Affiliate of the Company, or any Sublicensee, or the use of such Licensed
Product by any customer of any of the foregoing, infringes proprietary rights of
a third party, the Company shall give written notice thereof to Shiva. The
Company may, in its sole discretion, modify such Licensed Product to avoid such
infringement and/or may settle on terms that it deems advisable in its sole
discretion, provided that any final disposition of litigation that will restrict
the claims in or admit any invalidity of any Patent Rights(s) shall not be made
without full consultation with and approval by Shiva, such approval not to be
unreasonably withheld by Shiva. Otherwise, the Company shall have the right, but
not the obligation, to defend any such claim or suit. In the event the Company
elects not to defend such suit, Shiva shall have the right, but not the
obligation to do so, at its sole expense.

     

    
      	
              11.4

            	
              Allocation
      of Damages Recovered

            

    

     

    Any
recovery of damages by the Party bringing or defending any such suit under
Article 11.2 or 11.3, shall be applied first pro rata in satisfaction of any
unreimbursed expenses and legal fees of the Parties relating to the suit. The
balance remaining from any such recovery shall be allocated 99% to the party
bringing or defending such a suit and 1% to the other Party, provided, however,
if Shiva is required to bring the suit by law, but Company leads the enforcement
or defense action, as the case may be, the Company shall be deemed to have
brought the suit for purposes of this Article 11.4.

     

    
      	
              11.5

            	
              Cooperation

            

    

     

    In any
suit to enforce and/or defend the Patent Rights pursuant to this Agreement, the
party not in control of such suit shall, at the request and expense of the
controlling party, cooperate in all respects and, to the extent possible, have
its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.

     

    Article
12 Representations and Warranties

     

    
      	
              12.1

            	
              Shiva
      Warranties

            

    

     

    Shiva
represents and warrants that as of the date of this Agreement:

     

    
      	
               
      

            	
              12.1.1

            	
              Shiva
      has the exclusive right, title, and interest in and to all Patent Rights
      and Know-how, free and clear of all liens, charges, or
      encumbrances.

            

    

     

    
      	
               
      

            	
              12.1.2

            	
              To
      Shiva’s knowledge, the use of the Technology to manufacture, use, sell or
      import any Licensed Product will not infringe any claim of any issued
      patent Controlled by any Third Party.  To Shiva’s knowledge,
      there is no claim in any pending patent application Controlled by any
      Third Party which, if contained in an issued patent, would be infringed by
      such use of the Technology. Shiva has not granted any license, option,
      lien or any other right to a Third Party that limit Shiva’s rights in and
      to the Patent Rights or its obligation under this
    Agreement.

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        21

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              12.1.3

            	
              There
      is no claim, pending or to Shiva’s knowledge threatened, of infringement,
      interference, invalidity or unenforceability regarding any part or all of
      the Patent Rights or Know-how or their use. There is no judgment, order,
      injunction, decree, writ or award against Shiva that is not satisfied and
      remains outstanding with respect to any Licensed
  Product.

            

    

     

    
      	
               
      

            	
              12.1.4

            	
              The
      U.S. and foreign patent applications and patents itemized on Exhibit 1.19
      set forth all of the patents and patent applications necessary or useful
      for practicing the Technology to manufacture, use, sell or important any
      Licensed Product owned or Controlled by or licensed to Shiva on the
      Effective Date.

            

    

     

    
      	
               
      

            	
              12.1.5

            	
              The
      inventors listed on applications filed for such Patent Rights represent
      the true inventors and there are no inventors of Patent Rights other than
      those listed as inventors on applications filed for such Patent
      Rights.

            

    

     

    
      	
               
      

            	
              12.1.6

            	
              The
      Patent Rights and Know How were not supported in whole or party by funding
      or grants by any federal or state
agency.

            

    

     

    
      	
               
      

            	
              12.1.7

            	
              Shiva
      has provided Picton and the Company with copies of all documents
      reflecting support or funding for all or part of the research leading to
      Patent Rights and Know How, and has listed all such funding agencies on
      Exhibit 12.1.7.

            

    

     

    
      	
               
      

            	
              12.1.8

            	
              Shiva
      is a limited liability company duly organized, validly existing and in
      good standing under the laws of New Jersey.  Shiva has the
      requisite corporate power and authority to execute and deliver this
      Agreement and the other agreements contemplated hereby to which it is a
      party and to consummate the transactions contemplated hereby and
      thereby.  The execution and delivery of this Agreement and the
      other agreements contemplated hereby to which Shiva is a party and the
      performance and consummation of the transactions contemplated hereby and
      thereby by Shiva have been duly authorized by all necessary corporate
      action on the part of Shiva.  This Agreement and the other
      agreements contemplated hereby to which Shiva is a party have been duly
      executed and delivered by Shiva and, subject to the due authorization,
      execution and delivery of such agreements by the other parties thereto,
      this Agreement and such other agreements contemplated hereby constitute
      valid and binding obligations of Shiva, enforceable against Shiva in
      accordance with their respective terms, except as such enforcement may be
      affected by bankruptcy, reorganization, insolvency, moratorium or similar
      laws affecting creditor’s rights generally and except for general
      principles of equity.

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        22

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              12.1.9

            	
              The
      execution and delivery of this Agreement and the other agreements
      contemplated hereby do not, and the consummation of the transactions
      contemplated hereby and thereby will not, (i) conflict with, or
      result in any violation or breach of any provision of the certificate of
      incorporation or bylaws of Shiva, (ii) conflict with or violate any
      applicable foreign, Federal, state and local statutes, judgments, decrees,
      laws, ordinances, rules, regulations, injunctions and
      orders  (“Laws”) of any U.S. Federal, state, foreign or local
      government or any court, tribunal, administrative agency or commission or
      other governmental or regulatory authority, body or agency, including any
      self-regulatory organization (“Governmental Authorities”) applicable to
      Shiva or any of its assets or operations or any permit applicable to Shiva
      or (iii) result in (x) any violation or breach of, constitute (with
      or without notice or lapse of time or both) a default under or conflict
      with (or give rise to a right of termination, amendment, cancellation or
      acceleration of any material obligation or loss of any benefit under) the
      provisions of any material lease, contract or other agreement to which
      Shiva is a party or by which it or any of its properties or assets is
      otherwise bound or (y) the imposition of any lien, pledge,
      hypothecation, mortgage, security interest, claim, lease, charge, option,
      right of first refusal or first offer, easement, servitude, transfer
      restriction, voting requirement or any other encumbrance, restriction or
      limitation on any of the properties or assets of
  Shiva.

            

    

     

    
      	
               
      

            	
              12.1.10

            	
              No
      consent, approval or authorization of, or declaration or filing with, any
      Governmental Authority or Person (a “Consent”) is required on the part of
      Shiva in connection with its execution, delivery and performance of this
      Agreement or the consummation of the transactions contemplated hereby or
      in connection with the Licensed
Products.

            

    

     

    
      	
               
      

            	
              12.1.11

            	
              Shiva
      has not received from the Federal Drug Administration (“FDA”), the U.S.
      Drug Enforcement Administration (“DEA”) or any similar state, local or
      foreign Governmental Authority any written notice (i) regarding the
      approvability or approval of any of the Licensed Products, or
      (ii) alleging any violation by Shiva of any Law relating to any of
      the Licensed Products.  No Licensed Product has been withdrawn,
      suspended or discontinued by Shiva as a result of any action by the FDA,
      the DEA or any similar state, local or foreign Governmental Authority,
      either within or outside the U.S. (whether voluntarily or
      otherwise).  No officer, employee or agent of Shiva, on behalf
      of Shiva in regard to any Licensed Product, has made any untrue statement
      of a material fact or a fraudulent statement to the FDA, DEA or any
      similar state, local or foreign Governmental Authority, failed to disclose
      any material fact required to be disclosed to the FDA, the DEA or any
      similar state, local or foreign Governmental Authority, or committed an
      act, made a statement or failed to make a statement that, at the time such
      act, statement or omission was made, could reasonably be expected to
      provide a basis for the FDA, the DEA or any similar state, local or
      foreign Governmental Authority to invoke the FDA’s policy respecting
      “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
      Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991)
      or any similar policy, nor has any director, officer, employee or agent of
      Shiva on behalf of Shiva, has been convicted of any crime or engaged in
      any conduct for which debarment is mandated by 21 U.S.C. Article
      335a(a) (or any similar Law) or authorized by 21 U.S.C. Article
      335a(b) (or any similar Law).

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        23

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              12.1.12

            	
              Shiva
      has taken commercially reasonable efforts to preserve the confidentiality
      of all trade secrets, proprietary and other confidential information
      material to the business and operations of
  Shiva.

            

    

     

    
      	
              12.2

            	
              Debarment

            

    

     

    During
the Term, neither of the parties shall knowingly utilize any employee,
representative, agent, assistant or associate who has been debarred by the FDA
pursuant to 21 U.S.C. Article
335a (a) or (b)
of the FDA Act in connection with any of the activities to be carried out under
this Agreement.

     

    Article
13 Limitation of Liability, Indemnity

     

    
      	
              13.1

            	
              NO
      IMPLIED WARRANTIES

            

    

     

    EXCEPT AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT:

     

    
      	
               
      

            	
              13.1.1

            	
              SUBJECT
      TO ARTICLE 12, SHIVA DOES NOT MAKE AND EXPRESSLY DISCLAIMS ALL
      REPRESENTATIONS AND WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
      INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS FOR A
      PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR
      PENDING.

            

    

     

    
      	
               
      

            	
              13.1.2

            	
              SUBJECT
      TO ARTICLE 12, NOTHING HEREIN SHALL BE CONSTRUED AS A REPRESENTATION OR
      WARRANTY BY SHIVA TO THE COMPANY THAT THE PATENT RIGHTS AND KNOW-HOW ARE
      NOT INFRINGED BY ANY THIRD PARTY, OR THAT THE PRACTICE OF SUCH RIGHTS DOES
      NOT INFRINGE ANY INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD
      PARTY.

            

    

     

    
      	
              13.2

            	
              Indemnity
      of Shiva

            

    

     

    The
Company agrees to defend, indemnify and hold harmless Shiva, its Affiliates,
directors, employees and officers from and against all liability, demands,
damages, including without limitation reasonable legal fees and expenses and
losses including death, personal injury, illness or property damage arising
directly or indirectly:

     

    
      	
               
      

            	
              13.2.1

            	
              from
      the infringement by Licensed Products of the proprietary rights of a third
      party;

            

    

     

    
      	
               
      

            	
              13.2.2

            	
              out
      of the exploitation by the Company or its Affiliates or Sublicensees or
      their respective transferees of intellectual property rights licensed or
      information furnished under this Agreement;
or

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        24

        
          

        

      

      
         

      

    

     

    
      	
               
      

            	
              13.2.3

            	
              out
      of any testing, use, manufacture, sale or other disposition by the Company
      or its Affiliates or Sublicensees or their respective transferees of
      Patent Rights, Know-how or Licensed
Products,

            

    

     

    in each
case which are not the result of Shiva’s breach of warranty hereunder,
negligence or willful misconduct.

     

    
      	
              13.3

            	
              Indemnity
      of Stockholders

            

    

     

    The
Company agrees to defend, indemnify and hold harmless each Stockholder, each of
their Affiliates, directors, employees and officers from and against all
liability, demands, damages, including without limitation reasonable legal fees
and expenses and losses including death, personal injury, illness or property
damage arising directly or indirectly out of this Agreement or relating to the
development, testing, manufacture or commercialization of any Licensed Product,
except in each case relating to such Stockholder’s willful
misconduct.

     

    Article
14 Use of Names and Publication

     

    
      	
              14.1

            	
              Use
      of Name; Labeling

            

    

     

    Nothing
contained in this Agreement shall be construed as granting any right to the
Company or its Affiliates to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of Shiva or any
of its units (including contraction, abbreviation or simulation of any of the
foregoing) without the prior, written consent of Shiva; provided that Company
may use Shiva’s name in various documents used for capital raising and financing
without such prior written consent and where the use of such names may be
required by Applicable Law.

     

    
      	
              14.2

            	
              No
      Agency

            

    

     

    Nothing
herein shall be deemed to establish a relationship of principal and agent
between Shiva and the Company, nor any of their agents or employees for any
purpose whatsoever. This Agreement shall not be construed as creating a
partnership between Shiva and the Company, or as creating any other form of
legal association or arrangement, which would impose liability upon one party
for the act or failure to act of the other party.

     

    
      	
              14.3

            	
              Publication

            

    

     

    In the
event that Shiva desires to publish or disclose, by written, oral or other
presentation, Patent Rights, Know-how, or any material information related
thereto then Shiva shall notify the Company and in writing by facsimile where
confirmed by the receiving party, and/or by certified or registered mail (return
receipt requested) of their intention at least 30 days prior to any speech,
lecture or other oral presentation and at least 60 days before any written or
other publication or disclosure.  Shiva shall include with such notice
a description of any proposed oral presentation or, in any proposed written or
other disclosure, a current draft of such proposed disclosure or
abstract.  The Company may request that Shiva, no later than 15 days
following the receipt of such notice, delay such presentation, publication or
disclosure for up to an 60 days in order to enable the Company to file, or have
filed on their behalf, a patent application, copyright or other appropriate form
of intellectual property protection related to the information to be disclosed
or request that Shiva do so.  Upon receipt of such request to delay
such presentation, publication or disclosure, Shiva shall arrange for a delay of
such presentation, publication or disclosure for the lesser of 60 days or until
such time as the Company or Shiva has filed, or had filed on its behalf, such
patent application, copyright or other appropriate form of intellectual property
protection in form and in substance reasonably satisfactory to the Company and
Shiva.  If Shiva does not receive any timely request from the Company
to delay such presentation, publication or disclosure, Shiva may submit such
material for presentation, publication or other form of disclosure.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        25

        
          

        

      

      
         

      

    

     

    Article
15 Confidentiality

     

    
      	
              15.1

            	
              Confidentiality
      and Non-Use

            

    

     

    Any and
all information relating to the Patent Rights, Know-how (including but not
limited to patent prosecution documents relating to Patent Rights) and Reports
and Records under Article 7 collectively constitute the “Confidential
Information.”  Neither party will use the Confidential Information for
any purpose other than the development and commercialization of Licensed
Products under to this Agreement, and will hold it in confidence during the Term
and for a period of five (5) years after the termination or expiration date of
this Agreement. Each party shall exercise with respect to such the Confidential
Information the same degree of care as the party exercises with respect to its
own confidential or proprietary information of a similar nature, but in any
event no less than reasonable care, and shall not disclose it or permit its
disclosure to any third party (except to those of its employees, consultants, or
agents who are bound by the same obligation of confidentiality of this
Agreement). However, such undertaking of confidentiality shall not apply to any
information or data which:

     

    
      	
               
      

            	
              15.1.1

            	
              The
      receiving party receives at any time from a third-party lawfully in
      possession of same and having the right to disclose
  same;

            

    

     

    
      	
               
      

            	
              15.1.2

            	
              is,
      as of the date of this Agreement, in the public domain, or subsequently
      enters the public domain through no fault of the receiving
      party;

            

    

     

    
      	
               
      

            	
              15.1.3

            	
              is
      independently developed by the receiving party as demonstrated by written
      evidence without reference to information disclosed to the receiving party
      by the disclosing party;

            

    

     

    
      	
               
      

            	
              15.1.4

            	
              is
      disclosed pursuant to the prior written approval of the disclosing party;
      or

            

    

     

    
      	
               
      

            	
              15.1.5

            	
              is
      required to be disclosed pursuant to Applicable Law or legal process
      (including, without limitation, to a governmental authority) provided, in
      the case of disclosure pursuant to legal process, reasonable notice of the
      impending disclosure is provided to the non-disclosing
    party.

            

    

     

    Article
16 Effective Date and Conditions to Close

     

    The
closing of the transactions contemplated by this Agreement shall take place on
the second business day following the date that stockholders of Picton holding
at least ninety percent (90%) of the voting power of Picton execute the Joinder
to this Contribution Agreement in the form attached hereto as Exhibit 16.1 (such
date, the “Effective Date”).  All transactions contemplated to occur
on and as of the Effective Date shall be deemed to have occurred simultaneously
and to be effective as of the close of business on such date.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        26

        
          

        

      

      
         

      

    

     

    Article
17 Miscellaneous Provisions

     

    
      	
              17.1

            	
              Assignment

            

    

     

    This
Agreement and the rights and duties appertaining hereto may not be assigned by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld.  Any such purported
assignment, without the written consent of the other party, shall be null and of
no effect. Notwithstanding the foregoing, either Party may assign this Agreement
without the consent of the other Party to (i) a purchaser, merging or
consolidating corporation, or acquirer of substantially all of the assigning
party’s assets or business and/or pursuant to any reorganization qualifying
under section 368 of the Internal Revenue Code of 1986 as amended, or any
corresponding law in the jurisdiction of either party, as may be in effect at
such time; or (ii) to an Affiliate of the Company (including
Picton).

     

    
      	
              17.2

            	
              Binding
      Nature and Enurement

            

    

     

    This
Agreement will not be binding upon the parties until it has been signed below on
behalf of each party.  This Agreement is binding upon and inures to
the benefit of the parties and their respective permitted successors and
assigns.

     

    
      	
              17.3

            	
              Compliance
      with Applicable Laws

            

    

     

    The
Company shall observe all Applicable Laws with respect to the making,
manufacture, use, sale, offer for sale, export and/or import of Licensed
Products and related technical data to foreign countries, including, without
limitation, the regulations of Competent Authorities.

     

    
      	
              17.4

            	
              Counterparts;
      Facsimile

            

    

     

    This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument. This Agreement may be signed and delivered to the other party by
facsimile signature; such transmission will be deemed a valid
signature.

     

    
      	
              17.5

            	
              Entire
      Agreement; Amendment

            

    

     

    The
parties hereto acknowledge that this Agreement, including the Appendices and
documents incorporated by reference, sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and shall
not be subject to any change of modification except by the execution of a
written instrument subscribed to by the parties hereto and shall supersede all
previous communications, representations or understandings, either oral or
written, between the parties relating to the subject matter hereof. No
subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the parties hereto unless reduced to writing and signed by the
respective authorized officers of the parties.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        27

        
          

        

      

      
         

      

    

     

    
      	
              17.6

            	
              Force
      Majeure

            

    

     

    Neither
party is responsible for delays resulting from causes beyond its reasonable
control, including without limitation fire, explosion, flood, war, strike, or
riot, provided that the nonperforming party uses Commercially Reasonable Efforts
to avoid or remove those causes of nonperformance and continues performance
under this Agreement with reasonable dispatch whenever the causes are
removed.

     

    
      	
              17.7

            	
              Further
      Assurances

            

    

     

    From time
to time during the Term, at the request of either party, the other party shall
execute and deliver such documents and take such other action as the requesting
party may reasonably request to consummate more effectively the transactions
contemplated hereby.

     

    
      	
              17.8

            	
              Headings

            

    

     

    The
headings of the several articles are inserted for convenience of reference only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.

     

    
      	
              17.9

            	
              Law

            

    

     

    This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of New York, without regard to principles of
conflicts of laws.

     

    
      	
              17.10

            	
              No
      Consequential Damages

            

    

     

    EXCEPT
WITH REGARD TO DAMAGES ARISING FOR INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS
OR BREACH OF ARTICLE 15 AND ANY DUTY TO INDEMNIFY FOR INDIRECT, INCIDENTAL,
SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES RECOVERED BY A THIRD PARTY, IN NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, INCIDENTAL,
SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES INCURRED BY EITHER PARTY UNDER THIS
AGREEMENT OR OTHERWISE.

     

    
      	
              17.11

            	
              Payments,
      Notices and Other Communications

            

    

     

    Any
payment, notice or other communication required or permitted to be given
pursuant to this Agreement shall be in writing and sent by certified first class
mail, postage prepaid, by hand delivery or by facsimile if confirmed in writing,
in each case effective upon receipt, at the addresses below or as otherwise
designated by written notice given to the other party:

     

    In the
case of Shiva:

     

    Dr.
Sudhir V. Shah

    SHIVA
BIOMEDICAL LLC

    10810
Executive Center Drive

    Danville
Building, Suite 100

    Little
Rock, AR  22211

    Tel:  (501)
307-6434

    Fax:  (501)
257-5827

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        28

        
          

        

      

      
         

      

    

     

    With a
copy to:

     

    Geoffrey
B. Davis

    Ropes
& Gray LLP

    1
International Place

    Boston,
MA  02110

    Tel:  617-951-7742

    Fax:  617-951-7050

     

    In the
case of Picton or the Company:

    

    787
Seventh Avenue, 48th Floor

    New York,
NY 10019

    Attn:
President

    Tel:
212-554-4300

    Fax:
212-554-4355

     

    
      	
              17.12

            	
              Payment
      of Own Fees and Expenses

            

    

     

    Except as
otherwise set forth herein, each of the Company, Picton, the Stockholders and
Shiva shall be responsible for their own expenses relating to the preparation
and consummation of this Agreement and the agreements and transactions
contemplated hereby.

     

    
      	
              17.13

            	
              Severability

            

    

     

    The
provisions of this Agreement are severable, and in the event that any provision
of this Agreement shall be determined to be invalid or unenforceable under any
controlling body of law, such invalidity or unenforceability shall not in any
way affect the validity or enforceability of the remaining provisions
hereof.

     

    
      	
              17.14

            	
              Waiver

            

    

     

    The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver of
that right or excuse a similar subsequent failure to perform any such term or
condition by the other party. Any waiver of any rights or failure to act in a
specific instance relates only to that instance and is not an agreement to waive
any rights or fail to act in any other instance.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

    
      
         

      

      
        29

        
          

        

      

      
         

      

    

     

    IN WITNESS WHEREOF, the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.

    

    
      
        
          
            
              
                
                  	
                          PICTON
      PHARMACEUTICALS, INC.

                        	 
      	
                          SHIVA
      BIOMEDICAL, LLC

                        
	 
      	 
      	 
      
	
                          By:

                        	/s/
      J. Jay Lobell	 
      	
                          By:

                        	/s/
      Sudhir V. Shah,
M.D.
	 
      	 
      	 
      	 
      	 
      
	
                          Name:

                        	
                          J. Jay Lobell

                        	 
      	
                          Name:

                        	
                          Sudhir V. Shah, M.D.

                        
	 
      	 
      	 
      	 
      	 
      
	
                          Title:

                        	
                          President

                        	 
      	
                          Title:

                        	
                          President

                        
	 
      	 
      	 
      	 
      	 
      
	
                          Date:

                        	
                          7/28/06

                        	 
      	
                          Date:

                        	
                          7/27/06

                        
	 
      	 
      	 
      	 
      	 
      
	
                          PICTON
      HOLDING COMPANY, INC.

                        	 
      	 
      
	 
      	 
      	 
      
	
                          By:

                        	/s/ Stephen Rocamboli	 
      	 
      
	 
      	 
      	 
      	 
      
	
                          Name:

                        	
                          Stephen Rocamboli

                        	 
      	 
      
	 
      	 
      	 
      	 
      
	
                          Title:

                        	
                          President

                        	 
      	 
      
	 
      	 
      	 
      	 
      
	
                          Date:

                        	
                          7/28/06

                        	 
      	 
      

                

              

            

          

        

      

    

     

    [*] Certain information in
this document has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to
the omitted portions.Unassociated Document

    Exhibit 10.2

     

    AMENDMENT TO CONTRIBUTION
AGREEMENT

    

    This
Amendment (the “Amendment”), dated as of October 6, 2009, to that certain
Contribution Agreement (the “Agreement”) executed as of July 28, 2006 by the
parties hereto, is entered into by and between SHIVA BIOMEDICAL, LLC, a
limited liability company duly organized under the laws of New Jersey having a
place of business at 10810 Executive Center Drive, Danville Building, Suite 100,
Little Rock, AR 22211 (“Shiva”), and CORMEDIX, INC., formerly PICTON HOLDING COMPANY, INC.
and successor in interest to PICTON PHARMACEUTICALS, INC.,
a corporation duly organized and existing under the laws of the State of
Delaware having a place of business at 86 Summit Avenue, Suite 301, Summit,
NJ  07901 (the “Company”).

    

    WHEREAS, the parties hereto
desire to amend and restate certain provisions of the Agreement as set forth
herein;

     

    NOW, THEREFORE, in
consideration of the premises and the mutual covenants contained herein and
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto, intending to be legally bound, agree as
follows:

     

    

    
      	
               
      

            	
              1.

            	
              Capitalized
      terms used herein and not otherwise defined shall have the meanings given
      to them in the Agreement.  All references to an Article shall
      refer to an Article of the Agreement unless otherwise
      indicated.

            

    

     

    
      	
               
      

            	
              2.

            	
              Article
      1.14 is hereby amended and restated in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              “Licensed
      Product(s)” shall mean (i) any product that cannot be manufactured, used
      or sold, in whole or in part, in the country in which the product is made,
      used, leased, imported, exported, offered for sale or sold, without
      infringing one or more claims included within an existing issued patent or
      pending patent application included in the Patent Rights as of the date of
      the execution of this Agreement or (ii) any Contributed Product that
      cannot be manufactured, used or sold, in whole or in part, in the country
      in which the product is made, used, leased, imported, exported, offered
      for sale or sold, without (x) infringing one or more claims otherwise
      included at any time during the term of this Agreement within the Patent
      Rights or (y) the use or incorporation of
  Know-how.

            

    

     

    
      	
               
      

            	
              3.

            	
              Article
      1.18 is hereby amended and restated in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              “Non-Royalty
      Sublicensing Income” means any and all consideration received from a
      Sublicensee in connection with the grant of a Sublicense under the Patent
      Rights or Know-how, including without limitation sublicense issue fees,
      sublicense maintenance fees and sales and non-sales related milestone
      payments, but excluding (a) consideration received for the sale, issuance
      or exchange of debt or equity securities of the Company; (b) payments
      received by the Company as reimbursement or advance payment for expenses
      actually incurred by the Company in the research or development of the
      Technology or any Licensed Product; and (c) royalty payments based on the
      sales of Licensed Products (as such sales will be subject to payment under
      Article 6.3.1).

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

     

    
      	
            	
              4.

            	
              Article
      1.23 is hereby amended and restated in its entirety as
      follows:

            

    

     

    “Technology”
means deferiprone, otherwise known as Shiva 102, and a diagnostic test to
predict renal disease, otherwise known as Shiva 101, and any other compound,
device or technology, the use of which is covered by the Patent
Rights.

     

    
      	
               
      

            	
              5.

            	
              A
      new Article 1.28 shall be added, which shall read in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              “Company
      Technology Know-how” means all non-public tangible or intangible
      information whether patentable or not (but which has not been patented)
      related to the Technology, any Licensed Product or any Improvement,
      including but not limited to: formulations, in vitro, preclinical or
      clinical design, information or results, other proprietary materials,
      processes, including but not limited to manufacturing processes, data,
      drawings and sketches, designs, testing and test results, and regulatory
      information of a like nature.

            

    

     

    
      	
               
      

            	
              6.

            	
              A
      new Article 1.29 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Equity
Adjustment Shares” shall mean a number of shares of Series A Common Stock that,
when aggregated with the number of shares of Series A Common Stock held by Shiva
prior to an Equity Adjustment Event, results in Shiva owning at least the
Minimum Equity Percentage.

     

    
      	
               
      

            	
              7.

            	
              A
      new Article 1.30 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Equity
Adjustment Event” shall mean (i) the issuance of Equity Securities (other than
Exempted Securities), (ii) a Sale (as defined in the Restated Certificate) or
(iii) a Reverse Merger.

     

    
      	
               
      

            	
              8.

            	
              A
      new Article 1.31 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Equity
Securities” shall mean (i) any common stock, preferred stock or other security
of the Company, (ii) any security convertible into or exercisable or
exchangeable for, with or without consideration, any common stock, preferred
stock or other security (including any option to purchase such a convertible
security), (iii) any security carrying any warrant or right to subscribe to or
purchase any common stock, preferred stock or other security or (iv) any such
warrant or right.

     

    
      	
               
      

            	
              9.

            	
              A
      new Article 1.32 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Exempted Securities” shall
mean:

     

    
      	
               
      

            	
              (i)

            	
              all
      shares of Series A Common Stock and/or options, warrants or other Series A
      Common Stock purchase rights and the Series A Common Stock issued pursuant
      to such options, warrants or other rights (as adjusted for any stock
      dividends, combinations, splits, recapitalizations and the like after the
      date hereof) issued or to be issued after the date hereof to employees,
      officers or directors of, or consultants or advisors to the Company
      pursuant to stock purchase or stock option plans or other compensatory
      arrangements that are approved by the Board of Directors of the Company,
      not to exceed at any time, in the aggregate, more than fifteen percent
      (15%) of the outstanding shares of Series A Common Stock (after giving
      effect to (a) the assumed conversion of all then-outstanding securities
      convertible by their terms into shares of Series A Common Stock on the
      date of determination and (b) the assumed exercise of all then-outstanding
      securities exercisable by their terms for shares of Series A Common Stock
      on the date of determination);

            

    

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
        
           

        

        
          2

          
            

          

        

        
           

        

      

    

     

    
      	
               
      

            	
              (ii)

            	
              stock
      issued or issuable pursuant to those rights or agreements, options,
      warrants or convertible securities outstanding and determinable as of the
      date of this Amendment, all of which are fully and accurately described in
      Exhibit 1.32 attached hereto;

            

    

     

    
      	
               
      

            	
              (iii)

            	
              any
      Equity Securities issued pro rata in connection with any stock split,
      stock dividend or recapitalization by the
  Company;

            

    

     

    
      	
               
      

            	
              (iv)

            	
              any
      Equity Securities issued for consideration other than cash pursuant to a
      merger, consolidation, acquisition or similar business combination with an
      unaffiliated Third Party;

            

    

     

    
      	
               
      

            	
              (v)

            	
              any
      Equity Securities issued pursuant to any equipment loan or leasing
      arrangement, real property leasing arrangement, or debt financing from a
      bank or similar financial or lending
  institution;

            

    

     

    
      	
               
      

            	
              (vi)

            	
              any
      Equity Securities that are issued by the Company pursuant to a
      registration statement filed under the Securities Act of 1933, as
      amended;

            

    

     

    
      	
               
      

            	
              (vii)

            	
              any
      Equity Securities issued in connection with strategic transactions
      involving the Company and other entities, including, without limitation,
      (a) joint ventures, strategic alliances, or research and development
      collaborations and (b) technology transfer, licensing or development
      arrangements; provided, that such transaction is not primarily for equity
      financing purposes; and

            

    

     

    
      	
            	
              (viii)

            	
              any
      Equity Securities issued to Shiva.

            

    

     

    
      	
               
      

            	
              10.

            	
              A
      new Article 1.33 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Minimum
Equity Percentage” shall mean seven percent (7%) of the outstanding shares of
Series A Common Stock on the date of determination (after giving effect to (i)
the assumed conversion of all then-outstanding securities convertible by their
terms into shares of Series A Common Stock on the date of determination and (ii)
the assumed exercise of all then-outstanding securities exercisable by their
terms for shares of Series A Common Stock on the date of
determination).

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          3

          
            

          

        

        
           

        

      

    

    

    
      	
               
      

            	
              11.

            	
              A
      new Article 1.34 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Reverse
Merger” shall mean a merger, share exchange, or other transaction (or series of
related transactions), in which (i) the Company merges into or otherwise becomes
a wholly-owned subsidiary of a company subject to the public company reporting
requirements of the Securities Exchange Act of 1934, as amended, and (ii) the
aggregate consideration payable to the Company or its stockholders in such
transaction(s) is greater than or equal to $10,000,000.

     

    
      	
               
      

            	
              12.

            	
              A
      new Article 1.35 shall be added, which shall read in its entirety as
      follows:

            

    

     

    “Qualifying
Financing Amount” shall mean an aggregate of $25,000,000 in gross proceeds
received by the Company after the date of this Amendment from the issuance and
sale, to parties other than Shiva, of Equity Securities in one or a series of
transactions.

     

    
      	
               
      

            	
              13.

            	
              Article
      2.2.4 is hereby amended and restated in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              Except
      as expressly agreed in writing by Shiva in its sole discretion or as set
      forth in this Article 2.2.4, no Sublicense shall survive termination of
      this Agreement.  Notwithstanding the foregoing, with respect to
      any Sublicense granted after such time that the Company has raised ten
      million dollars ($10,000,000) in Additional Financing (as defined in
      Article 10.4.2(b)) (the “Financing Benchmark”), in the event that Shiva
      terminates this Agreement pursuant to Section 10.3 (non-payment) or
      Section 10.4 (termination for cause) or this Agreement terminates pursuant
      to Section 10.2 (Company bankruptcy), such Sublicense shall survive such
      termination of this Agreement and such Sublicensee shall have a direct
      grant from Shiva of the same rights Sublicensed to Sublicensee under the
      Sublicense, subject to Sublicensee assuming all obligations of the Company
      to Shiva under this Agreement and providing directly to Shiva, rather than
      to the Company, any additional consideration payable by Sublicensee to the
      Company under the Sublicense.  Upon request of the Company at
      the time it enters into any sublicense agreement after achievement of the
      Financing Benchmark, Shiva agrees to directly contract with each such
      Sublicensee in writing with respect to the foregoing
      conditions.

            

    

     

    
      	
               
      

            	
              14.

            	
              Article
      6.2 is hereby amended and restated in its entirety as
    follows:

            

    

     

    Equity to
be Issued

     

    
      	
               
      

            	
              6.2.1

            	
              On
      the date of this Amendment, the Company and Shiva shall enter into a
      common stock exchange agreement, in the form attached hereto as Exhibit
      6.2.1, pursuant to which Shiva shall exchange all shares of Series B
      Common Stock, Series C Common Stock, Series D Common Stock, Series E
      Common Stock and Series F Common Stock currently held by Shiva
      (collectively, the “Exchanged Shares”) for an aggregate of 773,717 shares
      of Series A Common Stock (as more particularly described in the Company’s
      Amended and Restated Certificate of Incorporation described in Article
      6.2.2 below) (the “New Shares”).  The New Shares shall represent
      no less than seven percent (7%) of the outstanding shares of Series A
      Common Stock on the date hereof (after giving effect to (i) the surrender
      of the Exchanged Shares and the issuance of the New Shares, (ii) the
      assumed conversion of all outstanding securities convertible by their
      terms into shares of Series A Common Stock on the date hereof and (iii)
      the assumed exercise of all outstanding securities exercisable by their
      terms for shares of Series A Common Stock on the date
    hereof).

            

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          4

          
            

          

        

        
           

        

      

    

     

    
      	
               
      

            	
              6.2.2

            	
              In
      conjunction with the execution of this Amendment, the Company shall file
      an Amended and Restated Certificate of Incorporation, in the form attached
      hereto as Exhibit 6.2.2 (the “Restated Certificate”), with the Secretary
      of State of the State of Delaware, which Restated Certificate shall set
      forth the rights, preferences and privileges of the Series A Common Stock
      representing the New Shares and shall remove all references to the several
      series of common stock that comprised the Exchanged
  Shares.

            

    

     

    
      	
               
      

            	
              6.2.3

            	
              In
      addition to the shares of Series A Common Stock to be issued pursuant to
      Article 6.2.1, upon any proposed Equity Adjustment Event, the Company
      shall, if necessary to achieve the Minimum Equity Percentage upon the
      consummation of such Equity Adjustment Event, cause to be issued to Shiva
      the applicable number of Equity Adjustment Shares as a condition to or
      concurrently with the consummation of the proposed Equity Adjustment
      Event.

            

    

     

    
      	
               
      

            	
              6.2.4

            	
              The
      Company’s obligations set forth in Article 6.2.3 shall terminate following
      the earlier of (i) the consummation of one or more equity financings
      following which the Qualifying Financing Amount has been received by the
      Company, provided that Shiva’s rights under Article 6.2.3 shall apply to
      the sale of Equity Securities up to and including the Qualifying Financing
      Amount; (ii) any Sale (as defined in the Restated Certificate), provided
      that Shiva’s rights under Article 6.2.3 shall apply up to and including
      such Sale; (iii) any Reverse Merger, provided that Shiva’s rights under
      Article 6.2.3 shall apply up to and including such Reverse Merger; or (iv)
      the Company’s first firm commitment underwritten public offering of its
      Series A Common Stock (or similar equity security for which the Series A
      Common Stock may be exchanged or recapitalized after the date hereof)
      registered under the Securities Act of 1933, as
  amended.

            

    

     

    
      	
               
      

            	
              6.2.5

            	
              The
      Company shall not take any action that would have the effect of denying to
      Shiva the intended benefits of the equity consideration provided for in
      this Article 6.2.

            

    

     

    
      	
               
      

            	
              15.

            	
              Article
      6.3.1 is hereby amended and restated in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              Unless
      this Agreement shall be terminated as hereinafter provided, during the
      applicable Royalty Term for each Licensed Product, the Company shall pay
      Shiva royalties on such Licensed Product on a country-by-country basis
      equal to [*] of Net Sales.

            

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              16.

            	
              Article
      6.3.2 is hereby amended and restated in its entirety as
      follows:

            

    

     

    The Company shall also make the
following one time payments to Shiva:

     

    
      	
               
      

            	
              (a)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (b)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (c)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (d)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (e)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (f)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (g)

            	
              [*];

            

    

     

    
      	
               
      

            	
              (h)

            	
              [*];
      and

            

    

     

    
      	
               
      

            	
              (i)

            	
              [*].

            

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      
        	
              	
                17.

              	
                Article
      6.4 is hereby amended and restated in its entirety as
    follows:

              

      

    

     

    The
Company shall remit to Shiva [*] of all Non-Royalty Sublicensing Income received
by the Company, within [*] of the Company’s receipt of any such Non-Royalty
Sublicensing Income; provided,
however, if the Company receives any Non-Royalty Sublicensing Income in
the form of a milestone payment upon achievement of an event requiring the
Company to pay Shiva a milestone payment pursuant to Article 6.3.2, then the
Company shall remit to Shiva [*] of the net amount of such Non-Royalty
Sublicensing Income after deducting the applicable cash payment to
Shiva.  By way of example, if the Company receives [*] from a
Sublicensee in the form of a milestone payment upon achievement of a certain
event, and the Company is obligated to pay Shiva a milestone payment of [*]
pursuant to Article 6.3.2 upon achievement of that same event, then the Company
shall remit to Shiva [*], which is equal to the [*] milestone payment plus [*]
of the [*] of such Non-Royalty Sublicensing Income that remains after
subtracting such milestone payment to Shiva.

     

    
      	
               
      

            	
              18.

            	
              A
      new Article 6.12 shall be added, which shall read in its entirety as
      follows:

            

    

     

    Restrictions
on Transfer of Shares

     

    
      	
               
      

            	
              6.12.1

            	
              Any
      shares issued to Shiva pursuant to Article 6.2 (collectively, the “Shiva
      Shares”) shall not be sold, pledged, or otherwise transferred, and the
      Company shall not recognize and shall issue stop-transfer instructions to
      its transfer agent with respect to any such sale, pledge, or transfer,
      except upon the conditions specified in this Agreement, which conditions
      are intended to ensure compliance with the provisions of the Securities
      Act of 1933, as amended (the “Securities Act”).  Shiva shall
      cause any proposed purchaser, pledgee, or transferee of the Shiva Shares
      to agree to take and hold such securities subject to the provisions and
      upon the conditions specified in this
Agreement.

            

    

     

    
      	
               
      

            	
              6.12.2

            	
              Each
      certificate or instrument representing the Shiva Shares and any other
      securities issued in respect of the Shiva Shares upon any stock split,
      stock dividend, recapitalization, merger, consolidation, or similar event,
      shall (unless otherwise permitted by the provisions of Article 6.12.3
      below) be stamped or otherwise imprinted with a legend substantially in
      the following form:

            

    

     

    THE
SECURITIES REPRESENTED HEREBY HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT
BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933.  SUCH SHARES MAY NOT
BE SOLD, PLEDGED, OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR A VALID
EXEMPTION FROM THE REGISTRATION AND PROSPECTUS DELIVERY REQUIREMENTS OF SAID
ACT.

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          7

          
            

          

        

        
           

        

      

    

    

    THE
SECURITIES REPRESENTED HEREBY MAY BE TRANSFERRED ONLY IN ACCORDANCE WITH THE
TERMS OF AN AGREEMENT BETWEEN THE COMPANY AND THE STOCKHOLDER, A COPY OF WHICH
IS ON FILE WITH THE SECRETARY OF THE COMPANY.

     

    Shiva
consents to the Company making a notation in its records and giving instructions
to any transfer agent of the Shiva Shares in order to implement the restrictions
on transfer set forth in this Article 6.12.

     

    
      
        
          	
                	
                  6.12.3

                	
                  Shiva,
      by its acceptance of the Shiva Shares, agrees to comply in all respects
      with the provisions of this Article 6.12.  Before any proposed
      sale, pledge, or transfer of any Shiva Shares, unless there is in effect a
      registration statement under the Securities Act covering the proposed
      transaction, Shiva shall give notice to the Company of its intention to
      effect such sale, pledge, or transfer.  Each such notice shall
      name the proposed transferee and state the number of Shiva Shares to be
      sold, pledged or transferred, the proposed consideration, and all other
      terms and conditions of the proposed sale, pledge or transfer in
      sufficient detail.  If reasonably requested by the Company, such
      notice shall be accompanied at Shiva’s expense by either (i) a written
      opinion of legal counsel who shall, and whose legal opinion shall, be
      reasonably satisfactory to the Company, addressed to the Company, to the
      effect that the proposed transaction may be effected without registration
      under the Securities Act; (ii) a “no action” letter from the SEC to the
      effect that the proposed sale, pledge, or transfer of such Shiva Shares
      without registration will not result in a recommendation by the staff of
      the SEC that action be taken with respect thereto; or (iii) any other
      evidence reasonably satisfactory to counsel to the Company to the effect
      that the proposed sale, pledge, or transfer of the Shiva Shares may be
      effected without registration under the Securities Act, whereupon Shiva
      shall be entitled to sell, pledge, or transfer such Shiva Shares in
      accordance with the terms of the notice given by Shiva to the Company,
      subject to the terms of Article 6.12.4 below.  The Company will
      not require such a legal opinion or “no action” letter (x) in any
      transaction in compliance with SEC Rule 144 or (y) in any transaction in
      which Shiva distributes Shiva Shares to an Affiliate of Shiva for no
      consideration; provided that each transferee agrees in writing to be
      subject to the terms of this Article 6.12.  Each certificate or
      instrument evidencing the Shiva Shares transferred as above provided shall
      bear, except if such transfer is made pursuant to SEC Rule 144, the
      appropriate restrictive legend set forth in Article 6.12.2, except that
      such certificate shall not bear such restrictive legend if, in the opinion
      of counsel for Shiva and the Company, such legend is not required in order
      to establish compliance with any provisions of the Securities
      Act.

                

        

      

       

    

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          8

          
            

          

        

        
           

        

      

    

     

    
      
        
          	
                	
                  6.12.4

                	
                  Shiva
      hereby agrees that it shall not sell, transfer, make any short sale of,
      grant any option for the purchase of, or enter into any hedging or similar
      transaction with the same economic effect as a sale, the Shiva Shares or
      any other securities of the Company held by Shiva (other than those
      included in the registration) (i) during the 180-day period following the
      effective date of the Company’s first firm commitment underwritten public
      offering of its common stock registered under the Securities Act (or such
      longer period as the underwriters or the Company shall request in order to
      facilitate compliance with FINRA Rule 2711 or NYSE Member Rule 472 or any
      successor or similar rule or regulation), and (ii) the 90-day period
      following the effective date of a subsequent registration statement of the
      Company filed under the Securities Act (or such longer period as the
      underwriters or the Company shall request in order to facilitate
      compliance with FINRA Rule 2711 or NYSE Member Rule 472 or any successor
      or similar rule or regulation); provided, that, with respect to (i) and
      (ii) above, all executive officers and directors of the Company and all
      holders of greater than three percent (3%) of the Company’s outstanding
      Series A Common Stock are bound by and have entered into similar
      agreements. The obligations described in this Article 6.12.4 shall not
      apply to a registration relating solely to employee benefit plans on Form
      S-1 or Form S-8 or similar forms that may be promulgated in the future, or
      a registration relating solely to a transaction on Form S-4 or similar
      forms that may be promulgated in the
future.

                

        

      

    

     

    
      	
               
      

            	
              19.

            	
              The
      heading for Article 10.2 is hereby amended to “Termination for Bankruptcy”
      and all references to Article 10.2 shall be amended to reflect “Company
      bankruptcy.”

            

    

     

    
      	
               
      

            	
              20.

            	
              The
      heading for Article 10.4 is hereby amended to “Termination for Cause”, and
      Article 10.4 is hereby amended and restated in its entirety as
      follows:

            

    

     

    
      
        	
              	
                10.4.1

              	
                Subject
      to Article 9 and the provisions of this Article 10.4.1, upon any material
      breach or default of this Agreement by the Company, other than as set
      forth in Article 10.2 and 10.3 above or as set forth in Article 10.4.2
      below, Shiva shall have the right to terminate this Agreement and the
      rights, privileges and license granted hereunder by giving ninety (90)
      days prior written notice to the Company.  Upon the expiration
      of the ninety (90) day period, if the Company shall have failed to cure
      such breach or default, this Agreement shall, at the option of Shiva,
      terminate upon written notice of Shiva.   Notwithstanding
      anything herein to the contrary, if the nature of the breach is such that
      additional time is reasonably needed to cure such breach, and Company has
      commenced with good faith efforts to cure such breach, then Shiva shall
      provide Company with additional time (but in no event more than a total of
      180 days) in which to cure such breach.  If a dispute regarding
      termination is addressed according to Article 9, this Agreement shall
      remain in full force and effect until such dispute is settled or
      determined in accordance with Article
9.

              

      

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          9

          
            

          

        

        
           

        

      

    

    

    
      	
               
      

            	
              10.4.2

            	
              Shiva
      shall have the right to terminate this Agreement within fifteen (15) days
      after giving written notice of termination to the Company if any of the
      following occurs:

            

    

     

    
      	
               
      

            	
              (a)

            	
              the
      Company has not raised at least one million five hundred thousand dollars
      ($1,500,000) on or before November 30,
2009;

            

    

     

    
      	
               
      

            	
              (b)

            	
              the
      Company has not, on or before March 31, 2010, either (i) obtained at least
      ten million dollars ($10,000,000) in financing that is additional to the
      capital raise described in Article 10.4.2(a) (“Additional Financing”) or
      (ii) filed a registration statement for an initial public offering with
      the United States Securities and Exchange
  Commission;

            

    

     

    
      	
               
      

            	
              (c)

            	
              the
      Company has not, on or before June 30, 2010, obtained at least ten million
      dollars ($10,000,000) in Additional
Financing;

            

    

     

    
      	
               
      

            	
              (d)

            	
              the
      Company has not initiated patient dosing in a “Proof of Concept Trial” for
      a Licensed Product on or before April 30, 2010, where a “Proof of Concept
      Trial” is a Phase II clinical study as and to the extent defined for the
      United States in 21 C.F.R. § 312.21(b), or its successor regulation, or
      the equivalent regulation in any other country;
  or

            

    

     

    
      	
               
      

            	
              (e)

            	
              the
      Company has not initiated patient dosing in a “Pivotal Trial” for a
      Licensed Product on or before September 30, 2011, where “Pivotal Trial”
      means (i) a Phase III clinical study (as such term is defined in 21
      C.F.R.§ 312.21(c) or its successor regulation or the equivalent regulation
      in any other country), or (ii) if it has been determined at the time of
      first dosing that the data generated in such study, if successful, will be
      sufficient, without data from further studies, to support the filing of an
      NDA, a Phase II clinical study (as described above) or a combination Phase
      II clinical study and Phase III clinical
study.

            

    

     

    
      	
               
      

            	
              21.

            	
              Article
      10.5 is hereby amended and restated in its entirety as
      follows:

            

    

     

    Upon
expiry of the Royalty Term in each country in the Territory, provided that this Agreement is still
in effect immediately prior to such expiration, the Company will have an
irrevocable, paid up, royalty-free license under the Patent Rights and Know-how
to make, have made, use, import, offer for sale and sell the Licensed Products
in such country.

     

    
      	
               
      

            	
              22.

            	
              The
      heading for Article 10.6 is hereby amended to “Termination by the
      Company”, and Article 10.6 is hereby amended and restated in its entirety
      as follows:

            

    

     

    
      	
               
      

            	
              10.6.1

            	
              The
      Company shall have the right at any time to terminate this Agreement in
      its entirety, for any reason or no reason, by giving thirty (30) days
      notice thereof in writing to Shiva.

            

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          10

          
            

          

        

        
           

        

      

    

    

    
      	
            	
              10.6.2

            	
              Without
      limiting the generality of the foregoing Article 10.6.1 or the right of
      the Company to terminate this Agreement at will as provided therein,
      subject to Article 9 and the provisions of this Article 10.6.2, the
      Company shall have the right to terminate this Agreement for cause as
      provided in this Article 10.6.2. Upon any material breach or default of
      this Agreement by Shiva, the Company shall have the right to terminate
      this Agreement by giving ninety (90) days prior written notice to Shiva.
      Upon the expiration of the ninety (90) day period, if Shiva shall have
      failed to cure such breach or default, this Agreement shall, at the option
      of the Company, terminate upon written notice of the Company.
      Notwithstanding anything herein to the contrary, if the nature of the
      breach is such that additional time is reasonably needed to cure such
      breach, and Shiva has commenced with good faith efforts to cure such
      breach, then the Company shall provide Shiva with additional time (but in
      no event more than a total of 180 days) in which to cure such breach. If a
      dispute regarding termination is addressed according to Article 9, this
      Agreement shall remain in full force and effect until such dispute is
      settled or determined in accordance with Article
  9.

            

    

     

    
      	
               
      

            	
              23.

            	
              A
      new Article 10.7.3 shall be added, which shall read in its entirety as
      follows:

            

    

     

    
      	
               
      

            	
              Without
      limiting the provisions of Article 10.7.1 and 10.7.2, upon early
      termination of this Agreement by either party for any reason other than
      termination by the Company for cause  pursuant to Article
      10.6.2, as of the effective date of such termination the following
      provisions shall apply:

            

    

     

    
      	
               
      

            	
              (a)

            	
              The
      Company shall reassign to Shiva all Know-how and other intellectual
      property that Shiva assigned to the Company pursuant to Article
      3.1.

            

    

     

    
      	
               
      

            	
              (b)

            	
              Unless
      otherwise prohibited by law, the Company shall transfer and assign to
      Shiva all Company Technology Know-how Controlled by the Company, including
      as applicable:  (i) copies of all regulatory submissions; (ii)
      all data and reports from pre-clinical and clinical studies; (iii) any
      prototypes, designs or models of Shiva 101 and/or Shiva 102; (iii) any
      communications with the FDA and the minutes of any meetings with the FDA
      relating to any Licensed Product; (iv) trial master files relating to any
      Licensed Product, including copies of all case report forms; (v) copies of
      all listings and tables of results from the clinical trials relating to
      any Licensed Product; (vi) copies of all treatment-related serious adverse
      event reports from the clinical trials relating to any Licensed Product;
      (vii) any retained samples of materials used in clinical trials relating
      to any Licensed Product; (viii) rights of access to CROs involved in the
      clinical trials relating to any Licensed Product; (ix) the data, files and
      results of any CMC related activities regarding any Licensed Product; and
      (x) all other information that Shiva may reasonably request regarding the
      manufacturing of any Licensed Product, clinical trials with respect to any
      Licensed Product, and the commercial sale of any Licensed
      Product.

            

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          11

          
            

          

        

        
           

        

      

    

    

    
      	
               
      

            	
              (c)

            	
              The
      Company shall use commercially reasonable efforts to arrange (i) for the
      assignment to Shiva of any manufacturing, supply, or similar commercial
      contract related to any Licensed Product or ingredient thereof and
      necessary or desirable for the manufacture, development, and
      commercialization of any Licensed Product or ingredient thereof by Shiva
      after the effective date of termination, subject to the assumption of such
      contract by Shiva or (ii) for any Third Party who is (as of the effective
      date of termination) a party with the Company to any such contract to
      enter into a similar contract with Shiva, on a basis acceptable to Shiva,
      provided that the Company shall not be required to make any payment or
      provide any other consideration in order to arrange for any such
      assignment or similar contract.

            

    

     

    
      	
               
      

            	
              (d)

            	
              The
      Company shall grant to Shiva a free-of-charge right to reference and use
      and have full access to all Governmental Approvals and all other
      regulatory documents relating to any Licensed Product, including any IND,
      any NDA and any DMF (whether as an independent document or as part of any
      NDA, and all chemistry, manufacturing and controls information), and any
      supplements, amendments or updates to the foregoing, where such regulatory
      documents are owned or sufficiently Controlled by the Company, directly or
      indirectly, to permit such grant (for the purposes of this Article, the
      “Right of Reference”). Shiva may sublicense the Right of Reference to
      Affiliates and to Third Parties, in Shiva’s sole
    discretion.

            

    

     

    
      	
               
      

            	
              (e)

            	
              Upon
      Shiva’s request, the Company shall transfer to Shiva any Governmental
      Approvals or other applicable regulatory filings related to Licensed
      Products, which are owned and held by the Company as of the effective date
      of termination.

            

    

     

    
      	
               
      

            	
              (f)

            	
              The
      Company shall transfer to Shiva at Shiva’s request all or any part of the
      Company’s inventory of (i) Licensed Products and (ii) GMP and non-GMP
      Compound.

            

    

     

    
      	
               
      

            	
              24.

            	
              Article
      10.8 is hereby amended and restated in its entirety as
      follows:

            

    

     

    Upon
termination or expiration of this Agreement for any reason, nothing herein shall
be construed to release either party from any obligation that matured prior to
the effective date of such termination or obligations under Article 6, Article
7, Article 9, Article 10.5, Article 10.7, this Article 10.8, Article 13, Article
15 and Article 17.

    

    
      	
               
      

            	
              25.

            	
              Article
      15.1 is hereby amended and restated in its entirety as
      follows:

            

    

     

    Any and
all information relating to the Patent Rights, Know-how (including but not
limited to patent prosecution documents relating to Patent Rights) and reports
and records under Article 7 collectively constitute the “Confidential
Information.”  Neither party will use the Confidential Information for
any purpose other than the development and commercialization of the Licensed
Products under this Agreement (or as otherwise permitted by this Article 15.1),
and will hold it in confidence during the Term and for a period of five (5)
years after the termination or expiration date of this Agreement (except for
permitted disclosures authorized by this Article 15.1).  Each party
shall exercise with respect to such Confidential Information the same degree of
care as the party exercises with respect to its own confidential or proprietary
information of a similar nature, but in any event no less than reasonable care,
and shall not disclose it or permit its disclosure to any Third Party (except to
those of its employees, consultants, or agents who are bound by substantially
similar obligations of confidentiality and non-use as set forth in this
Agreement).  However, such undertaking of confidentiality shall not
apply to any information or data which:

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

    
      	
               
      

            	
              15.1.1

            	
              the
      party using or disclosing such Confidential Information receives at any
      time from a Third Party lawfully in possession of such Confidential
      Information and having a right to disclose the
  same;

            

    

     

    
      	
               
      

            	
              15.1.2

            	
              is,
      as of the date of this Agreement, in the public domain, or subsequently
      enters the public domain through no fault of the party disclosing or using
      such Confidential Information; or

            

    

     

    
      	
               
      

            	
              15.1.3

            	
              is
      disclosed or used pursuant to the prior written consent of the other
      party.

            

    

     

    Notwithstanding
the obligations set forth in this Article 15.1, a party may disclose
Confidential Information and the terms of this Agreement to the
extent:

     

    
      
        	
              	
                i.

              	
                15.1.4
      such
      disclosure: (a) is reasonably necessary for filing, prosecuting,
      defending or asserting Patent Rights as contemplated by this Agreement;
      (b) is reasonably necessary in connection with any regulatory filings
      for any Licensed Product; or (c) is made to any Third Party bound by
      written obligations of confidentiality and non-use similar to those set
      forth under this Article 15.1, to the extent otherwise necessary or
      appropriate in connection with the exercise of its rights or the
      performance of its obligations
hereunder;

              

      

    

     

    
      
        
          
            	
                  	
                    ii.

                  	
                    15.1.5
      such disclosure is reasonably necessary: (a) to such party’s directors,
      attorneys, independent accountants or financial advisors for the sole
      purpose of enabling such directors, attorneys, independent accountants or
      financial advisors to provide advice to the party making such disclosure,
      provided that in each such case disclosure is on the condition that such
      directors, attorneys, independent accountants and financial advisors are
      bound by confidentiality and non-use obligations substantially similar
      with those contained in this Agreement; or (b) to actual or potential
      investors and/or acquirors solely for the purpose of evaluating an actual
      or potential investment or acquisition; provided that in each such case
      disclosure is on the condition that such actual or potential investors
      and/or acquirers are bound by confidentiality and non-use obligations
      substantially consistent with those contained in the Agreement;
      or

                  

          

        

      

    

     

    [*] Certain
information in this document has been omitted and filed separately with the
Securities and Exchange Commission.  Confidential treatment has been
requested with respect to the omitted portions.

     

    
      
        
           

        

        
          13

          
            

          

        

        
           

        

      

    

    

    
      
        	
              	
                iii.

              	
                15.1.6
      such
      disclosure is required by judicial or administrative process, provided
      that in such event such party shall promptly inform the other party of
      such required disclosure and provide the other party an opportunity to
      challenge or limit the disclosure obligations.  Confidential
      Information that is disclosed by judicial or administrative process shall
      remain otherwise subject to the confidentiality and non-use provisions of
      this Article 15.1, and the party disclosing Confidential Information
      pursuant to law or court order shall take all steps reasonably necessary,
      including seeking of confidential treatment or a protective order, to
      ensure the continued confidential treatment of such Confidential
      Information.

              

      

    

     

    
      
        
          
            
              	
                    	
                      26.

                    	
                      A
      new Exhibit 1.32 shall be added, which shall read in its entirety as
      provided in the Exhibit
      attached to this Amendment.

                    

            

          

           

        

      

    

    
      	
               
      

            	
              27.

            	
              This
      Amendment shall be in full force and effect from and after the date
      hereof.  Except as amended hereby, the Agreement shall remain in
      full force and effect.

            

    

     

    
      	
               
      

            	
              28.

            	
              This
      Amendment may be executed in two or more counterparts, each of which shall
      be deemed an original, but all of which together shall constitute one and
      the same instrument. This Amendment may be signed and delivered to the
      other parties by facsimile signature; such transmission will be deemed a
      valid signature.

            

    

     

    [SIGNATURE
PAGE FOLLOWS]

     

    [*] Certain information in
this document has been omitted and filed separately with the Securities and
Exchange Commission.  Confidential treatment has been requested with
respect to the omitted portions.

     

    
      
        
           

        

        
          14

          
            

          

        

        
           

        

      

    

     

    IN WITNESS WHEREOF, the
parties hereto have executed this Assignment, in triplicate by proper persons
thereunto duly authorized.

     

    
      
        
          
            
              
                
                  
                    
                      	
                              CORMEDIX,
      INC.

                            	 
      	
                              SHIVA
      BIOMEDICAL, LLC

                            
	 	 	 	 	 
	
                              By:

                            	
                              /s/ John C. Houghton

                            	 
      	
                              By:

                            	
                              /s/ Yashvant Patel

                            
	 	 	 	 	 
	
                              Name:

                            	
                              John C. Houghton

                            	 
      	
                              Name:

                            	
                              Yashvant Patel

                            
	 	 	 	 	 
	
                              Title:

                            	
                              President and CEO

                            	 
      	
                              Title:

                            	
                              Vice President

                            
	 	 	 	 	 
	
                              Date:

                            	
                              9/28/09

                            	 
      	
                              Date:

                            	
                              9/30/09

                            

                    

                  

                

              

            

          

        

      

    

     

    [*] Certain information in
this document has been omitted and filed separately with the Securities and
Exchange Commission.  Confidential treatment has been requested with
respect to the omitted portions.

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