Document:

Fourth Amendment to Cellcept collaboration

 

    

 

    Exhibit: 10.39

 

    William M. Burns

    F. Hoffmann-La Roche Ltd

    Grenzacherstrasse 124

    CH-4070

    Basel, Switzerland

 

    August 17, 2007

 

		
	
    Re:  
	
    Fourth
    Amendment to the
    CellCept®
    Collaboration and Promotion Agreement by and between Aspreva
    Pharmaceuticals SA (“Aspreva”),
    F.Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.
    (collectively, “Roche”), dated as of July 18,
    2003, as amended (the “Agreement”)

 

    Dear Bill,

 

    Thank you for your letter of June 25, 2007. Since that
    time, as you know, Aspreva and Roche have been actively
    discussing the appropriate ways in which to update the Sales
    Tracking Methodology (as defined in the Agreement) used to
    determine payments to Aspreva by Roche as well as how to best
    implement those modifications. The purpose of this letter is to
    set out certain agreements that Aspreva and Roche (sometimes
    collectively referred to herein as “we” or
    “us”) have reached regarding such modifications to the
    Sales Tracking Methodology and their implementation. It is
    intended that such modifications, described below, would be
    formally approved by the JC, as provided under
    Section 8.5(b) of the Agreement.

 

    As we have come to appreciate from our work with [ * ],
    the inclusion of [ * ] in the Sales Tracking Methodology
    is not appropriate, and accordingly, we agree to eliminate this
    item from the Sales Tracking Methodology model. To do this, we
    agree to implement the following [ * ] steps: [ * ]

 

    In addition, there will be removal of [ * ] from the [
    * ] calculation effective [ * ] and from the [ * ]
    calculation from [ * ] with [ * ] of [ *
    ] added back to the [ * ].

 

    The above items are in addition to the following changes agreed
    by Aspreva and Roche in the [ * ] JC meeting: [ * ]

 

    Notwithstanding the second sentence of Section 8.5(b) of
    the Agreement, we also agree in this case to apply the
    elimination of [ * ] as provided above retrospectively,
    to the outset of the Sales Tracking Methodology, which results
    in a substantive increase in the historical value of the
    CellCept transplant business and an equally substantive decrease
    of approximately fifty percent (50%) in the Baseline Residual
    Sales (as defined in the Agreement). The following paragraph
    describes the
    agreed-upon
    decrease in Baseline Residual Sales in more detail.

 

    Further, given the elimination of the Switch Rates, we agree
    that the Baseline Residual Sales, set at one hundred thirty-four
    million (134,000,000) CHF on July 18, 2003, are now reset
    to be equal to sixty-two million, nine hundred twenty-seven
    thousand (62,927,000) CHF. All other aspects of the Baseline
    Residual Sales as used in our Agreement remain in effect,
    including without limitation all aspects of Section 8.7
    regarding adjustments to the Baseline Residual Sales and the
    like.

 

    Finally, notwithstanding our retrospective application of the
    elimination of the [ * ] and adjustment of Baseline
    Residual Sales, we are not recalculating or disturbing the
    royalties paid historically to Aspreva, nor will we revisit or
    alter any such amounts paid to date by Roche to Aspreva.

 

 

    [ * ] = Certain
    confidential information contained in this document, marked by
    brackets, has been omitted and filed separately with the
    Securities and Exchange Commission pursuant to
    Rule 24b-2
    of the Securities Exchange Act of 1934, as amended.
    

    

    1

 

    In the interest of preserving integrity within the Sales
    Tracking Methodology through this transition, we agree that the
    [ * ] is set to [ * ] effective [ * ].

 

    We also agree that the JC has a continuing obligation to review
    proposed new data which may serve to improve upon the Sales
    Tracking Methodology, in good faith. Each of us takes this duty
    quite seriously. Accordingly, we also agree that as new data
    becomes available, each of Roche and Aspreva will continue to
    have the right to propose that such new data be utilized in the
    Sales Tracking Methodology, and that the JC has a continuing
    obligation to review any such new data in the future, such as
    the full restatement of the [ * ]. For clarity, the
    foregoing paragraph is not intended to amend the Agreement, but
    merely to reiterate Roche’s and Aspreva’s commitment
    to those obligations that are already included in
    Section 8.5(b) of the Agreement.

 

    If the foregoing captures our agreements and understandings on
    the Sales Tracking Methodology modifications and their
    implementation, please indicate your agreement by signing and
    returning the duplicate original of this letter to Aspreva.

 

    Aspreva Pharmaceuticals SA

 

			
	 	    By: 
	
    /s/  John
    A. Parkinson 

    Name:     John Parkinson

			
	 	    Title: 
	
    VP Finance

 

    F. Hoffmann-La Roche Ltd

 

			
	 	    By: 
	
    /s/  Stefan
    Arnold 

    Name:     Stefan Arnold

			
	 	    Title: 
	
    Attorney at Law

 

    F. Hoffmann-La Roche Ltd

 

			
	 	    By: 
	
    /s/  W.
    M. Burns 

    Name:     W. M. Burns

			
	 	    Title: 
	
    CEO Pharma Division, Roche

 

    Hoffmann-La Roche Inc.

 

			
	 	    By: 
	
    /s/  
    Gary J. Zieziula

    Name:     Gary J. Zieziula

			
	 	    Title: 
	
    V. P. Commercial Operations

 

    8/28/07

 

 

    [ * ] = Certain
    confidential information contained in this document, marked by
    brackets, has been omitted and filed separately with the
    Securities and Exchange Commission pursuant to
    Rule 24b-2
    of the Securities Exchange Act of 1934, as amended.
    

    

    2Support Agreement dated August 28, 2007

 

    

 

    Exhibit 10.40

 

 

    William M. Burns

    F. Hoffmann-La Roche Ltd 

    Grenzacherstrasse  124

    CH-4070 

    Basel, Switzerland

 

    August 17, 2007

 

		
	
    Re:  
	
    Support
    of
    CellCept®
    activities outside the U.S. (the “ROW”) between
    Aspreva Pharmaceuticals SA (“Aspreva”), and F.
    Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.
    (collectively, “Roche”)

 

    Dear Mr. Burns,

 

    As a follow up to our recent discussions with you and your team
    regarding our
    CellCept®
    Collaboration and Promotion Agreement dated July 18, 2003,
    as amended (“Collaboration Agreement”), this letter
    (“Letter Agreement”) sets forth certain understandings
    and agreements reached by Aspreva and Roche with respect to
    activities undertaken by Roche to develop and commercialize
    CellCept for autoimmune indications (“ROW
    Activities”). The ROW Activities consist of the following:

 

    1. Clinical Development.  Through its
    local affiliate in China, Roche elected to perform several
    clinical trials for the treatment of lupus nephritis using
    CellCept (“Clinical Trials”). Activities performed by
    such affiliate included recruitment, study management, liaising
    with local CRO’s and investigators, and product
    distribution. Such activities are described in more detail in
    Exhibit A.

 

    2. ROW Commercialization.  In addition to
    Aspreva’s worldwide efforts to prepare for the
    commercialization of CellCept in autoimmune indications, Roche
    has undertaken certain activities to prepare for the
    commercialization of CellCept in autoimmune indications in
    territories outside the US, Canada and the major five EU
    countries. Activities performed by Roche included
    non-promotional pre-market preparation, educational programs,
    medical product related training, and market assessment. Such
    activities are described in more detail in Exhibit A.

 

    3. General.  Roche has provided Aspreva or
    Aspreva’s affiliates with guidance on clinical development,
    drug safety, product manufacturing and patent expiry strategies
    relating to CellCept.

 

    Aspreva agrees to reimburse Roche for certain expenses incurred
    by Roche in connection with the ROW Activities by making a
    one-time payment to Roche of twenty million dollars
    (US$20,000,000). Such payment shall be non-refundable and
    non-creditable. Such payment shall be made no later than thirty
    (30) days after the date of this letter by wire transfer to
    an account designated by Roche. Aspreva shall have no further
    obligations to Roche with respect to the ROW Activities, and
    nothing herein is intended to alter the allocation between Roche
    and Aspreva of costs incurred in connection with
    CellCept-related activities (other than the ROW Activities) that
    is set forth in the Collaboration Agreement.

 

	 	 	 
	
    Aspreva Pharmaceuticals SA
	
 
	
    Tel:+41 (0)32 720 0550

	
    Rue des Beaux-Arts 8
	
 
	
    Fax:+41 (0)32 720 0559

	
    Case postale 1611
	
 
	
 

	
    2001 Neuchâtel, Switzerland
	
 
	
    VAT Registration Nr. 622 567

	
    www.aspreva.com
	
 
	
 

 

 

    [ * ] = Certain
    confidential information contained in this document, marked by
    brackets, has been omitted and filed separately with the
    Securities and Exchange Commission pursuant to
    Rule 24b-2
    of the Securities Exchange Act of 1934, as amended.
    

    

    1

 

    In consideration for Aspreva’s agreement to make the
    payment specified above, Roche will provide Aspreva with access
    to, and copies of, all resulting data from the Clinical Trials
    for use by Aspreva (or its affiliates) in its permitted
    activities under the Agreement. Any such Clinical Trial
    information shall be deemed Roche Confidential Information under
    the Collaboration Agreement.

 

    This Letter Agreement sets forth the entire agreement and
    understanding of the parties relating to the subject matter
    hereof, and supersedes all prior oral and written, and all
    contemporaneous oral agreements, understandings and
    arrangements. For the avoidance of doubt, the Collaboration
    Agreement shall continue in full force and effect. No
    modification of or amendment to this Letter Agreement shall be
    effective unless signed by the parties. If any provision of this
    Letter Agreement is held to be invalid by a court of competent
    jurisdiction, then the remaining provisions shall remain in full
    force and effect. This Letter Agreement is to be interpreted and
    enforced in accordance with the laws of the State of New York,
    without regard for any conflicts of law principles that would
    provide for application of the laws of any jurisdiction outside
    New York.

 

    If the foregoing captures our agreements and understandings on
    these matters, please have this Letter Agreement signed below
    where indicated and return the duplicate original to Aspreva.

 

    Aspreva Pharmaceuticals SA

 

			
	 	    By: 
	
    /s/  John
    A. Parkinson

    Name:     John A. Parkinson

    Title: VP Finance

 

    F. Hoffmann-La Roche Ltd

 

			
	 	    By: 
	
    /s/  Stefan
    Arnold 

    Name:     Stefan Arnold

			
	 	    Title: 
	
    Attorney at Law

 

    F. Hoffmann-La Roche Ltd

 

			
	 	    By: 
	
    /s/  W.
    M. Burns 

    Name:     W. M. Burns

			
	 	    Title: 
	
    CEO Pharma Division, Roche

 

    Hoffmann-La Roche Inc.

 

			
	 	    By: 
	
    /s/  
    Gary J. Zieziula

    Name:     Gary J. Zieziula

			
	 	    Title: 
	
    V. P. Commercial Operations

 

    8/28/07

 

 

    [ * ] = Certain
    confidential information contained in this document, marked by
    brackets, has been omitted and filed separately with the
    Securities and Exchange Commission pursuant to
    Rule 24b-2
    of the Securities Exchange Act of 1934, as amended.
    

    

    2

 

    

 

    Exhibit A
    [ * ]

 

    [ * ] = Certain
    confidential information contained in this document, marked by
    brackets, has been omitted and filed separately with the
    Securities and Exchange Commission pursuant to
    Rule 24b-2
    of the Securities Exchange Act of 1934, as amended.
    

    

    3

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