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EXHIBIT 10.19

Amendment to Amended and Restated Agreement Between Genentech, Inc.
and F. Hoffmann-LaRoche Ltd Regarding Commercialization of Genentech's
Products Outside the United States

 

            This Amendment to Amended and Restated Agreement Between Genentech,
Inc. and F. Hoffmann-LaRoche Ltd Regarding Commercialization of Genentech's
Products Outside the United States (hereinafter, "Amendment") is made, effective
as of June 26, 2000 ("Amendment Effective Date"), by and among F.
Hoffmann-LaRoche Ltd, Grenzacherstrasse 124, CH 4070 Basel, Switzerland
("ROCHE"), Genentech, Inc., 1 DNA Way, South San Francisco, California USA
94080, Genentech Europe Limited, Reid House, 31 Church Street, Hamilton, Bermuda
HM FXV and Genentech Biopharmaceuticals Limited, Reid House, 31 Church Street,
Hamilton, Bermuda HM FXV ("GENENTECH").

WHEREAS, ROCHE and GENENTECH have entered into that certain Amended and Restated
Agreement Between Genentech, Inc. and F. Hoffmann-LaRoche Ltd Regarding
Commercialization of Genentech's Products Outside the United States
(hereinafter, the "Commercialization Agreement").

WHEREAS, ROCHE and GENENTECH now wish to have ROCHE commercialize and market in
Canada GENENTECH's tissue plasminogen activator Product, tenecteplase ("TNKase")
under certain terms and conditions, and to amend the Commercialization Agreement
with respect to such terms and conditions and related matters.

NOW, THEREFORE, THE PARTIES HERETO HEREBY AGREE AS FOLLOWS:

 1. All capitalized terms in this Amendment shall have the meanings given in the
    Commercialization Agreement unless otherwise expressly defined hereinbelow.
     
 2. The following sentence is hereby added at the end of Article 1, Section 5 of
    the Commercialization Agreement: "The term Canada Products shall also
    include TNKase tissue plasminogen activator, tenecteplase (hereinafter,
    "TNKase")."
     
 3. The following two sentences are hereby added at the end of Article II,
    Section 5(a):

    "The Parties acknowledge that GENENTECH has obtained a license to the
    trademark "TNK" with respect to its tissue plasminogen activator Product
    tenecteplase in the United States of America, but that GENENTECH has no
    license to the trademark "TNK" in any country other than the United States.
    The Parties acknowledge that ROCHE's Canadian affiliate has filed an
    application for registration of the trademark "TNKase" in Canada. ROCHE does
    not believe that a license under third party trademark rights is required
    for ROCHE's Canadian affiliate to register or to use the "TNKase" trademark
    in connection with tenecteplase in Canada. ROCHE shall defend, indemnify and
    hold harmless GENENTECH from and against all third party costs, claims,
    suits, expenses (including reasonable attorneys' fee) and damages arising
    out of or resulting from any claim of infringement or inducement to infringe
    any third party's trademark rights, or any contractual claim related
    thereto, that is based on any such registration or use of the "TNKase"
    trademark. "

     

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     The following new Section 4(c) shall be added to Article VI of the
    Commercialization Agreement:

"(c) Notwithstanding the royalty provisions of Article VI, Section 4(a) above,
with respect to the Canada Product TNKase only, ROCHE shall pay GENENTECH as
follows:

     i.   a non-refundable license fee of two million U.S. dollars ($2,000,000),
          which shall be paid within ten (10) days of signature of this
          Amendment by the Parties;
     ii.  a non-refundable milestone payment of four million U.S. dollars
          ($4,000,000), which shall be paid within thirty (30) days after the
          first regulatory approval for marketing of TNKase in Canada;
     iii. a royalty of twelve and one-half percent (12.5%) on Net Sales of
          TNKase in Canada. The payment of such royalties on TNKase shall
          continue until the latter to occur of: 1) the last expiration of a
          Valid Claim of a GENENTECH Patent which would be infringed by the sale
          of TNKase in Canada but for the license granted herein or 2) a period
          of 25 years from the Amendment Effective Date;
     iv.  an additional royalty of ten percent (10%) on Net Sales of TNKase in
          Canada. Such additional royalty payments shall cease when ROCHE has
          paid GENENTECH a combined total of $27 million U.S. dollars under this
          Section 4(c)(iv) and under Section 4(b) above.
           

 5. The Parties acknowledge and hereby agree that the payments under Section
    (c)(i) and (ii) above shall be made as ROCHE's share of GENENTECH's
    Development Costs related to development leading to the first regulatory
    approval of TNKase for acute myocardial infarction. For any other GENENTECH
    Development Costs incurred with respect to TNKase (for example, for
    Development Costs for any other indication, formulation, dosing regimen or
    regulatory approval), GENENTECH shall be reimbursed by ROCHE for ten percent
    (10%) of all such Development Costs, pursuant to Article IV, Section 3(a) of
    the Commercialization Agreement. GENENTECH will keep ROCHE's Canadian
    affiliate reasonably informed of GENENTECH's significant and material
    development activities for TNKase to aid ROCHE in its budget planning for
    its share of such Development Costs.
     
 6. This Amendment specifically cancels and supersedes that certain letter
    agreement between Hoffman-La Roche Limited and Genentech, Inc. dated June
    22, 1999 related to the subject matter hereof and signed by John Melville
    and William Young.
     
 7. Except as expressly amended herein, all of the terms and conditions of the
    Commercialization Agreement shall remain in full force and effect.
     
 8. This Agreement may be executed in any number of counterparts, each of which
    counterparts, when so executed and delivered, shall be deemed to be an
    original, and all of which counterparts, taken together, shall constitute
    one and the same instrument.

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by
their duly authorized representative as of the Amendment Effective Date.

 

GENENTECH, INC.

 

HOFFMANN-LA ROCHE LTD

         

By:

/s/ ART LEVINSON

 

By:

/s/ STEFAN ARNOLD

         

Name:

Art Levinson

 

Name:

Stefan Arnold

         

Title:

Chief Executive Officer

 

Title:

Vice Director

                         

By:

/s/ RON SCOTT

               

Name:

Ron Scott

               

Title:

Vice Director

                             

GENENTECH EUROPE LIMITED

             

By:

/s/ ART LEVINSON

     

         

Name:

Art Levinson

     

         

Title:

Chief Executive Officer

     

                   

GENENETECH BIOPHARMACEUTICALS LIMITED

             

By:

/s/ ART LEVINSON

     

         

Name:

Art Levinson

     

         

Title:

Chief Executive Officer

     

 

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