Unassociated Document


    Exhibit
10.1

    


    AMENDMENT
NO. 2 TO THE AMENDED AND RESTATED LICENSE AGREEMENT

    


    This AMENDMENT NO. 2 TO THE AMENDED AND
RESTATED LICENSE AGREEMENT (this “Amendment No. 2”) is made
effective as of September 20, 2010 (the “Amendment No. 2 Effective
Date”) by and between TEKMIRA PHARMACEUTICALS CORPORATION (formerly INEX
PHARMACEUTICALS CORPORATION), a company duly incorporated under the laws of
British Columbia having an office at #100 – 8900 Glenlyon Parkway, Burnaby,
British Columbia, Canada V5J 5J8 (“Tekmira”) and HANA
BIOSCIENCES, INC., a company duly incorporated under the laws of Delaware having
an office at 7000 Shoreline Court, Suite 370, South San Francisco, CA 94080,
U.S.A. (“Hana”) (each of
HANA and TEKMIRA a “Party,” and collectively, the
“Parties”).

    


    BACKGROUND

    


    A.           Hana
and Tekmira have entered into (i) that certain Amended and Restated License
Agreement by and between the Parties effective as of April 30, 2007, as amended
by Amendment No. 1 to the Amended and Restated Agreement dated May 27, 2009
(collectively, the “Restated
License Agreement”) and (ii) that certain Sublicense Agreement dated May
6, 2006 (the “Sublicense
Agreement”).

    


    B.           Under
an agreement with Tekmira, certain third parties (the “Noteholders”) are entitled to
receive payments from Tekmira based on Hana’s payments to Tekmira under the
Restated License Agreement and the Sublicense Agreement.  Tekmira
anticipates executing a waiver and release (the “Waiver and Release”) with each
of the Noteholders under which Tekmira will make a payment to each Noteholder in
settlement of its obligations to make such payments, and each Noteholder will
waive and release Tekmira of all obligations to make such payments.

    


    C.           The
Parties wish to enter into an amendment to the Restated License Agreement and an
amendment and restatement of the Sublicense Agreement in order to amend and
restate, as applicable, certain rights and obligations in each of those
agreements, including, without limitation to modify certain milestone and
royalty payments.

    


    NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as follows:

     

    1.           Definitions.  All
capitalized terms not defined in this Amendment No. 2 shall have the meanings
given to them in the Restated License Agreement.

     

    2.           Defined
Terms.

     

    2.1           Section
1.1.4 of the Restated License Agreement is amended in its entirety to read as
follows:

     

    “1.1.4
“Agreement” means the
Restated License Agreement, all amendments and supplements to the Restated
License Agreement (including, without limitation, Amendment No. 1 to the Amended
and Restated Agreement and this Amendment No. 2) and all exhibits and schedules
to the foregoing.”

     

    3.           Sphingosomal
Vincristine.

     

    3.1           Section
3.1.1 of the Restated License Agreement is amended in its entirety (including
the deletion of the subsections) to read as follows:

     

    “3.1.1
Milestone Payments

    


    Hana
shall pay to Tekmira [***] Dollars ($[***]) by wire transfer of immediately
available funds via the Federal Reserve Wire Transfer System to an account
specified by Tekmira within sixty (60) days following the first to occur of (i)
Hana’s receipt of the approval of the FDA of the Sphingosomal Vincristine NDA or
(ii) Hana’s receipt of the approval in any of the Designated EU States of a
Regulatory Submission equivalent to a Sphingosomal Vincristine
NDA.”

    


    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.



    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    3.2           Section
3.1.2 of the Restated License Agreement is amended in its entirety to read as
follows:

     

    “3.1.2
Royalties

    


    Hana
shall pay to Tekmira royalty payments based on Net Sales of Sphingosomal
Vincristine as follows:

     

    
      	
               
      

            	
              (a)

            	
              With
      respect to Net Sales made by of Hana and/or its Affiliates only (the
      “Hana Net Sales”)
      of Sphingosomal Vincristine, a royalty no greater than [***] percent
      ([***]%) of Hana Net Sales comprised of the sum of one or more of the
      following percentages:  (i) [***] percent ([***]%) of Hana Net
      Sales in consideration of Patents if the Product sold is embraced within
      any Valid Claim under the Patents in the country where the Product was
      sold; (ii) [***] percent ([***]%) of Hana Net Sales in consideration of,
      and during any period of Product exclusivity provided by the laws of the
      country where the Product was sold, including but not limited to marketing
      exclusivity in the form of data exclusivity, pediatric exclusivity, and
      orphan drug designation exclusivity; and (iii) [***] percent ([***]%) of
      Hana Net Sales in consideration of Technology;
  and

            


    

     

    
      	
               
      

            	
              (b)

            	
              [Intentionally
      deleted]

            


    

     

    
      	
               
      

            	
              (c)

            	
              With
      respect to Net Sales made by Hana’s Licensees and Sublicensees only (the
      “Licensee/Sublicensee Net
      Sales”) of Sphingosomal Vincristine, a royalty equal to the lesser
      of (1) [***] percent ([***]%) of the royalty received by Hana on
      Licensee/Sublicensee Net Sales pursuant to a License Agreement and/or
      Sublicense, as applicable, and (2) the royalty rate set forth in Section
      3.1.2(a) above with respect to Hana Net Sales as applied to
      Licensee/Sublicensee Net Sales of Sphingosomal
  Vincristine.

            


    

     

    
      	
               
      

            	
              (d)

            	
              [Intentionally
      deleted]”

            


    

     

    4.           Sphingosomal
Vinorelbine.

     

    4.1           Section
3.2.2 of the Restated License Agreement is amended in its entirety to read as
follows:

     

    “3.2.2
Royalties

    


    Hana
shall pay to Tekmira royalty payments based on cumulative Net Sales of
Sphingosomal Vinorelbine as follows:

     

    
      	
               
      

            	
              (a)

            	
              With
      respect to Hana Net Sales of Sphingosomal Vinorelbine in the United
      States, a royalty no greater than [***] percent ([***]%) of Hana Net Sales
      comprised of the sum or one or more of the following
      percentages:  (i) [***] percent ([***]%) of Hana Net Sales in
      consideration of Patents if the Product sold is embraced within any Valid
      Claim under the Patents in the United States; (ii) [***] percent ([***]%)
      of Hana Net Sales in consideration of, and during any period of Product
      exclusivity provided by the laws of the United States of America,
      including but not limited to marketing exclusivity in the form of data
      exclusivity, pediatric exclusivity, and orphan drug designation
      exclusivity; and (iii) [***] percent ([***]%) of Hana Net Sales in
      consideration of Technology; provided, however, that the total royalty
      paid shall be limited to [***] percent ([***]%) on that portion of
      cumulative Hana Net Sales up to [***] Dollars ($[***]), and limited to
      [***] percent ([***]%) on that portion of cumulative Hana Net Sales in
      excess of [***] Dollars ($[***]);

            


    

     

    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.



    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    
      	
               
      

            	
              (b)

            	
              With
      respect to Hana Net Sales of Sphingosomal Vinorelbine in each country of
      the Territory other than the United States, a royalty of [***] percent
      ([***]%) of Hana Net Sales in consideration of Patents and Technology;
      provided, however, that the total royalty paid shall be limited to [***]
      percent ([***]%) on that portion of cumulative Hana Net Sales up to [***]
      Dollars ($[***]), and increased to [***] percent ([***]%) on that portion
      of cumulative Hana Net Sales in excess of [***] Dollars
      ($[***]);

            


    

     

    
      	
               
      

            	
              (c)

            	
              With
      respect to Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in
      the United States, a royalty equal to the lesser of (1) [***] percent
      ([***]%) of the royalty received by Hana on Licensee/Sublicensee Net Sales
      in the United States pursuant to a License Agreement and/or Sublicense, as
      applicable, and (2) the royalty rate set forth in Section 3.2.2(a) above
      with respect to Hana Net Sales in the United States as applied to
      Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in the United
      States; and

            


    

     

    
      	
               
      

            	
              (d)

            	
              With
      respect to Licensee/Sublicensee Net Sales of Sphingosomal Vinorelbine in
      each country of the Territory other than the United States, a royalty
      equal to the lesser of (1) [***] percent ([***]%) of the royalty received
      by Hana on Licensee/Sublicensee Net Sales pursuant to a License Agreement
      and/or Sublicense, as applicable, in each country of the Territory other
      than the United States, and (2) the royalty rate set forth in Section
      3.2.2(b) above with respect to Hana Net Sales in each country of the
      Territory other than the United States as applied to Licensee/Sublicensee
      Net Sales of Sphingosomal Vinorelbine in each country of the Territory
      other than the United States.”

            


    

     

    5.           Sphingosomal
Topotecan.

     

    5.1           Section
3.3.2 of the Restated License Agreement is amended in its entirety to read as
follows:

     

    “3.3.2
Royalties

    


    Hana
shall pay to Tekmira royalty payments based on cumulative Net Sales of
Sphingosomal Topotecan as follows:

     

    
      	
               
      

            	
              (a)

            	
              With
      respect to Hana Net Sales of Sphingosomal Topotecan in the United States,
      a royalty no greater than [***] percent ([***]%) of Hana Net Sales
      comprised of the sum or one or more of the following
      percentages:  (i) [***] percent ([***]%) of Hana Net Sales in
      consideration of Patents if the Product sold is embraced within any Valid
      Claim under the Patents in the United States; (ii) [***] percent ([***]%)
      of Hana Net Sales in consideration of, and during any period of Product
      exclusivity provided by the laws of the United States of America,
      including but not limited to marketing exclusivity in the form of data
      exclusivity, pediatric exclusivity, and orphan drug designation
      exclusivity; and (iii) [***] percent ([***]%) of Hana Net Sales in
      consideration of Technology; provided, however, that the total royalty
      paid shall be limited to [***] percent ([***]%) on that portion of
      cumulative Hana Net Sales up to [***] Dollars ($[***]), and limited to
      [***] percent ([***]%) on that portion of cumulative Hana Net Sales in
      excess of [***] Dollars ($[***]);

            


    

     

    
      	
               
      

            	
              (b)

            	
              With
      respect to Hana Net Sales of Sphingosomal Topotecan in each country of the
      Territory other than the United States, a royalty of [***] percent
      ([***]%) of Hana Net Sales in consideration of Patents and Technology;
      provided, however, that the total royalty paid shall be limited to [***]
      percent ([***]%) on that portion of cumulative Hana Net Sales up to [***]
      Dollars ($[***]), and increased to [***] percent ([***]%) on that portion
      of cumulative Hana Net Sales in excess of [***] Dollars
      ($[***]);

            


    

     

    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.



    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    
      	
               
      

            	
              (c)

            	
              With
      respect to Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in the
      United States, a royalty equal to the lesser of (1) [***] percent ([***]%)
      of the royalty received by Hana on Licensee/Sublicensee Net Sales in the
      United States pursuant to a License Agreement and/or Sublicense, as
      applicable, and (2) the royalty rate set forth in Section 3.3.2(a) above
      with respect to Hana Net Sales in the United States as applied to
      Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in the United
      States; and

            


    

     

    
      	
               
      

            	
              (d)

            	
              With
      respect to Licensee/Sublicensee Net Sales of Sphingosomal Topotecan in
      each country of the Territory other than the United States, a royalty
      equal to the lesser of (1) [***] percent ([***]%) of the royalty received
      by Hana on Licensee/Sublicensee Net Sales pursuant to a License Agreement
      and/or Sublicense, as applicable, in each country of the Territory other
      than the United States, and (2) the royalty rate set forth in Section
      3.3.2(b) above with respect to Hana Net Sales in each country of the
      Territory other than the United States as applied to Licensee/Sublicensee
      Net Sales of Sphingosomal Topotecan in each country of the Territory other
      than the United States.”

            


    

     

    6.           Consideration.  In
consideration for Tekmira amending the royalty and milestone payments above,
within fifteen (15) days of the execution of this Amendment No. 2, Hana will pay
Tekmira US $5,750,000 (the “Settlement Amount”) by wire
transfer of immediately available funds via the Federal Reserve Wire Transfer
System to an account specified by Tekmira.  Tekmira will use the
Settlement Amount only to pay the Noteholders amounts due under the Waiver and
Release.  Failure by Hana to pay any part or whole of the Settlement
Amount within this fifteen (15) day period shall render this Amendment No. 2
null and void.  Failure by Tekmira to pay any part or whole of the
Settlement Agreement to the Noteholders within a fifteen (15) day period after
receipt of the Settlement Amount from Hana shall give Hana the option to
terminate this Amendment No. 2 and, if Hana elects to terminate, Tekmira will
immediately refund to Hana all amounts previously paid to Tekmira under this
Amendment No. 2.

     

    7.           Further
Assurances.  The Parties will promptly execute and deliver such
further documents and take such action as may from time to time be required in
order to carry out the intent and purpose of this Amendment No. 2, including,
without limitation:

     

    7.1           in
the event that any Noteholder(s) do not execute the Waiver and Release, the
Parties will negotiate and execute an amendment to the terms and conditions of
this Amendment No. 2 to account for the non-participation of such Noteholder in
the settlement provided in the Waiver and Release; and

     

    7.2           within
ninety (90) days following the Amendment No. 2 Effective Date, the Parties
will:

     

    
      	
               
      

            	
              (i)

            	
              negotiate
      amendments to the Sublicense Agreement solely to incorporate the relevant
      terms of Amendment No. 1 and this Amendment No.
  2;

            


    

     

    
      	
               
      

            	
              (ii)

            	
              negotiate
      and execute a consent agreement with the University of British Columbia
      (the “UBC
      Consent”) in respect of such amendments;
  and

            


    

     

    
      	
               
      

            	
              (iii)

            	
              execute
      an Amended and Restated Sublicense Agreement embodying such amendments
      (the “Amended and
      Restated Sublicense
Agreement”).

            


    

     

    Neither
Party shall do any act or thing or cause any act or thing to be done, the effect
of which would be to compromise the intent and fulfillment of this Amendment No.
2.

     

    8.           Miscellaneous.  Except
as specifically modified or amended hereby, the Restated License Agreement shall
remain in full force and effect and, as modified or amended, is hereby ratified,
confirmed and approved.  Notwithstanding the foregoing, to the extent
any terms of this Amendment No. 2 conflict with the terms of the Restated
License Agreement, the terms of this Amendment No. 2 shall govern.  No
provision of this Amendment No. 2 may be modified or amended except expressly in
a writing signed by both Parties nor shall any terms be waived except expressly
in a writing signed by the Party charged therewith.

     

    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.


    
      
         


      

      
         


        
          

        

      

      
         


      

    

     

    9.           Execution in
Counterparts.  This Amendment No. 2 may be executed in
counterparts, including facsimile counterparts, each of which shall be deemed an
original and together which shall constitute one and the same
document.

     

    <Signature
page follows>

    


    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    IN WITNESS WHEREOF, the Parties have
executed this Amendment No. 2 in duplicate originals by their duly authorized
representatives as of the Amendment No. 2 Effective Date.

    


    
      
        	
                HANA
      BIOSCIENCES, INC.

              	 
      	
                TEKMIRA
      PHARMACEUTICALS

              
	 
      	 
      	 
      	
                CORPORATION

              
	 
      	 
      	 
      	 
      	 
      
	
                By:

              	
                /s/ Steven R. Deitcher

              	 
      	
                By:

              	
                /s/ Ian Mortimer

              
	 
      	 
      	 
      	 
      	 
      
	
                Name:

              	
                Steven R. Deitcher

              	 
      	
                Name:

              	
                Ian Mortimer

              
	 
      	 
      	 
      	 
      	 
      
	
                Title:

              	
                President and Chief Executive
      Officer

              	 
      	
                Title:

              	
                Chief Financial
  Officer

              


      

    

    


    INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION.