Exhibit 10.2


 


EXECUTION
COPY


 


***Text
Omitted and Filed Separately


with the
Securities and Exchange Commission.


Confidential
Treatment Requested


Under 17
C.F.R. Sections 200.80(b)(4)


and 240.24b-2.


 


AMENDMENT
AGREEMENT


 


This Amendment Agreement (the “Amendment
Agreement”)  is
effective as of the latest date of signature appearing below (the “Effective
Date”)  by and
between Valeant Pharmaceuticals North America, a Delaware corporation and
successor in interest to Valeant Research & Development, (“Valeant”), Metabasis Therapeutics, Inc., a Delaware
corporation (“Metabasis”), and Schering
Corporation, a New Jersey corporation (“Schering”).
(Valeant, Metabasis, and Schering are each from time to time referred to
individually as a “Party”  and
collectively as the “Parties”.)


 


Recitals


 


A.           Valeant,
Schering, and Metabasis entered into a Termination Agreement effective as of September 19,
2007 (the “Termination Agreement”).


 


B.           Valeant
and Schering entered into a Development and License Agreement dated as of December 12,
2006 and effective as of January 9, 2007, for the product known as
Pradefovir (the “Valeant/Schering Agreement”), which was terminated by the
Termination Agreement.


 


C.           Metabasis
and Schering entered into an Amended and Restated Development and License
Agreement, dated December 12, 2006 and effective as of January 9,
2007, for Pradefovir (the “Metabasis/Schering Agreement”), which was terminated by the
Termination Agreement.


 


D.           Valeant,
Metabasis, and Schering entered into an Assignment and Assumption Agreement,
having an effective date of January 9, 2007, in connection with the
Valeant/Schering Agreement and the Metabasis/Schering Agreement (the “Assignment”).


 


E.            Valeant,
Metabasis, and Schering desire to amend the Termination Agreement and the
Assignment on the terms and conditions set forth in this Amendment Agreement.


 


In consideration of the foregoing premises and the
mutual covenants set forth below, the Parties to this Agreement agree as
follows:


 


Article 1
- Definitions


 


1.1            Except
as otherwise expressly set forth in this Amendment Agreement, all capitalized
terms used in this Amendment Agreement (whether used in the plural or singular)
shall have the respective meanings set forth in, as applicable, the Termination
Agreement, Assignment, Valeant/Schering Agreement, and/or the
Metabasis/Schering Agreement.


 


“Amendment Date”  shall
mean July 1, 2008.


 


“Transaction Agreements”  shall mean, collectively, the Valeant/Schering Agreement, the
Metabasis/Schering Agreement, the Assignment, and the Termination Agreement.


 


1.2            For
clarity and avoidance of doubt, in the event of any conflict among the terms of
the Transaction Agreements, the terms of the Termination Agreement and the
Assignment, as amended by this Amendment Agreement, shall control.


 

















 


Article 2 - Amendment of
Assignment


 


The Parties hereby agree that the Assignment is
hereby amended effective as of the Amendment Date as set forth herein.


 


2.1            Section 11
of the Assignment is amended in its entirety to read in its entirety as set
forth below:


 


“11.   Valeant, Schering and Metabasis acknowledge
that the Amended Metabasis Agreement was terminated pursuant to a Termination
Agreement entered into by Valeant, Schering, and Metabasis effective as of September 19,
2007 (the “Termination Agreement”) and all of the rights to develop and
commercialize compounds and products in the Territory have reverted to
Metabasis.  The Parties further
acknowledge and agree that, effective as of the Termination Date (as defined in
the Termination Agreement) and subject to the terms of Section 12,
Metabasis has assumed all of Schering’s rights and obligations under the
Valeant/Schering Agreement in Territory and all references to “LICENSEE” in the
Valeant/Schering Agreement shall mean Metabasis.


 


2.2           Section 12 of
the Assignment is amended in its entirety to read in its entirety as set forth
below:


 


“12.   Valeant and Metabasis agree that:


 


(a)             if Metabasis advances the development or commercializes
a Product in the Territory on its own or sublicenses a Third Party to do so,
then Metabasis will pay Valeant in any calendar year during the Royalty
Obligation Period, royalties in the aggregate amounts as follows on a
Product-by-Product and country-by-country basis (for purposes of clarity, the
amounts set forth below constitute the full amount of the royalties due Valeant
under the Amendment Agreement, the Transaction Agreements, or otherwise):


 


(1)             (i)      
in any country where there is a Valid Claim of a Licensed Patent, a
royalty on Net Sales (as defined in the Valeant/Schering Agreement) in such
country as provided below:


 


(A)          on Net Sales of Products where annual worldwide  aggregate Net Sales of all Products are less
than or equal to [***], a royalty
of [***] on Net Sales;


 


(B)          on Net Sales of Products where annual
worldwide  aggregate Net
Sales of all Products are greater than [***] a royalty
of (i) [***] on the first [***] of annual worldwide aggregate Net Sales and (ii) [***] on the annual worldwide aggregate of Net Sales in
excess of [***].


 


(ii)       on Net Sales of each Product in any
country in which there is no Valid Claim of a Licensed Patent, [***] of the amounts set forth in Section 12(a)(l)(i) above.


 


(2)           Metabasis may obtain a license under any
issued patent from one or more Third Parties which patent, but for such
license, would be infringed by the manufacture or sale of the Products.  For any such Third Party licenses, Metabasis
may reduce 


 






***Confidential Treatment Requested


 


2

















 


the royalties otherwise due to Valeant
hereunder by an amount equal to [***] of the
total cumulative consideration paid by Metabasis to such Third Party or Third
Parties to the extent attributable to such license, including any upfront
payments, milestone payments and royalties; provided, however,
that the total such reduction for all such Third Party licenses shall not cause
the royalties due to Valeant in any calendar year to fall below [***] of the royalties which would otherwise be due (i.e.
without reference to the reduction due to Third Party license royalties) to
Valeant in such year.  Any portion of
such reduction which is unused in any year because of the foregoing proviso may
be applied to Metabasis in one or more subsequent years; and further provided
that no reduction in royalties will result from a license to a Third Party
patent that  claims a
formulation, method of treatment (or Swiss-type equivalent), method of
manufacturing, method of packaging, or packaging system that are not necessary
in order to develop, manufacture or commercialize the Licensed Compound, unless
entering into such license was expressly approved in advance in writing by
Valeant in its sole discretion; and further provided that no reduction
in royalties will result from a license to a Third Party patent where such
license covers a Combined Product and where no actual or alleged infringement
by the claims of such patent would result from activities relating to a Product
whose only active pharmaceutical ingredient is a Licensed Compound, unless
entering into such license was expressly approved by Valeant in its sole
discretion.


 


(3)      If a Third Party sells a product which is a Generic Equivalent
to a Product in any country in which Metabasis, an Affiliate or Sublicensee is
selling such Product,  the royalty payable
by Metabasis to Valeant under this Agreement with respect to such Product in
each such country will be reduced to [***] of the
royalty set forth in Section 12(a)(l) for the time period during
which such Generic Equivalent is sold by or on behalf of such Third Party in
such country.


 


(4)      Royalties on Net Sales will be calculated every Accounting
Period. Within forty-five (45) days after the last day of each such Accounting
Period during the term of this Agreement following the First Commercial Sale of
a Product, Metabasis will provide to Valeant the Sales & Royalty
Report and pay the royalties due to Valeant as set forth above within thirty
(30) days after providing the Sales & Royalty Report to Valeant.


 


(b)            The remaining schedule of milestone payments
due to Valeant by Metabasis upon achievement by Metabasis of certain events
under the assumed Valeant Schering Agreement shall be modified as set forth
herein:


 


(1)      Upon the first to occur of (A) Regulatory Approval by the
EMEA in respect of the EU Major Market, (B) Regulatory Approval in the US,
or (C) Regulatory Approval in Japan, Metabasis will make a one-time
payment (“Milestone Payment”) to Valeant in the amount of [***].


 


(2)      This Milestone Payment will be due only once regardless of the
number of Products or indications that may receive Regulatory Approval and will
be paid within ten (10) Business Days of the occurrence of the Milestone.
For purposes of clarity, except as set forth above, no milestone or other
payments are due to Valeant pursuant to the Transaction Agreements or
otherwise.”


 


2.3           Except as expressly
set forth in Sections 2.1 and 2.2 and subject to the terms of the Termination
Agreement (as amended below), all of the remaining terms of the Assignment
shall continue in full force and effect.


 






***Confidential Treatment Requested


 


3

















 


Article 3
- Amendment of Termination Agreement


 


3.1        Transfer of Responsibility for Patient Registries.  The Parties acknowledge that the
responsibility for Patient Registries as set forth in Section 4.3 of the
Termination Agreement is being transferred from Valeant to Metabasis, effective
as of the Amendment Date.  The Parties
therefore agree that Section 4.3 of the Termination Agreement is hereby
amended to provide that, effective as of the Amendment Date, Valeant shall not
be responsible for, and, if required by the FDA or other relevant Approval
Authority or under applicable law, Metabasis shall be solely responsible for,
the following: (i) obtaining approval from the FDA and all other relevant
Approval Authorities of the final protocol for the Patient Registries (and any
amendments thereto); (ii) the implementation and conduct of the Patient
Registries in accordance with such approved protocol, including without
limitation the timely preparation of any annual reports  required to be submitted to the FDA and/or
other Approval Authorities with respect to such Patient Registries; and (iii) identifying
and contracting with a suitable third party for the implementation and conduct
of the Patient Registries in accordance with the approved protocol and the
preparation of the clinical summary to be included in the annual reports.  The Parties further agree that Valeant and
Metabasis shall be solely responsible for any and all costs and expenses
arising in connection with the Patient Registries (including without limitation
the costs of any third party contractor engaged to conduct the Patient
Registries and prepare the clinical summaries); provided that such
responsibility shall be allocated between Valeant and Metabasis as follows: (i) Valeant
shall be responsible for and pay up to [***] of the
aggregate total costs and expenses arising in connection with the Patient
Registries, and (ii) Metabasis shall be solely responsible for and pay all
such costs and expenses in excess of such amount.  For clarity, under no circumstances will
Schering have any liability (1) with respect to any costs and expenses
arising in connection with the Patient Registries, and/or (2) arising in connection
with any failure or delay by Metabasis or Valeant in complying with any
requirements by the FDA or any other relevant Approval Authority or under
applicable law with respect to the implementation or conduct of the Patient
Registries.


 


3.2        Except
as expressly set forth in Section 3.1, all of the terms of the Termination
Agreement shall continue in full force and effect.


 


Article 4
- Miscellaneous


 


4.1.        Governing Law.  This
Amendment Agreement shall be governed, interpreted and construed in accordance
with the laws of the State of New York, without giving effect to conflict of
law principles.


 


4.2.        Waiver.  No
delay or failure by a Party to enforce any of its rights and obligations
hereunder shall be construed as a waiver of such rights and obligations, unless
such waiver is expressly set forth in writing by such Party.   Any written waiver by a Party of its rights
to enforce any provision of this Agreement shall not be construed as a
continuing waiver of such Party’s rights to enforce the same or other
provisions of this Agreement.


 


4.3.        Relationship of the Parties.  For purposes of this Amendment
Agreement, the relationship among the Parties is that of an independent
contractor.  Nothing herein contained
shall be deemed to create any agency, employment, joint venture or partnership
relationship between any of the Parties hereto. Except as otherwise expressly
set forth herein, no Party shall have any power to bind or obligate any other
Party in any manner whatsoever


 










***Confidential Treatment Requested


 


4

















 


4.4.        Notice.  Any
notice, consent, request or waiver required or permitted to be given or sent
under this Agreement shall be in writing and sent by personal delivery,
facsimile transmission (with confirmation copy by first-class mail), certified
or registered mail (postage prepaid), or internationally recognized overnight
courier, to the Parties at the addresses and facsimile numbers indicated below:


 


If to Valeant:


 


Valeant Pharmaceuticals North America One Enterprise

Aliso Viejo, California 92656

Attention: General Counsel

Facsimile: 949-461-6641


 


with a copy to:


 


Skadden, Arps, Slate, Meagher & Flom LLP


Four Times Square


New York, New York 10036


Attention: Bruce J. Goldner, Esq.


Facsimile: 917-777-2972


 


If to Metabasis:


 


Metabasis Therapeutics, Inc. 

11119 North Torrey Pines Road

La Jolla, CA 92037

Attention: Chief Executive Officer Facsimile: 858-458-3504


 


with a copy to:


 


Wilson Sonsini Goodrich & Rosati P.C. 650 Page

Mill Road

Palo Alto, California 94304-1050 Attention:

Michael J. O’Donnell Facsimile: 650-493-6811


 


If to Schering:


 


Schering Corporation


2000 Galloping Hill Road


Kenilworth, NJ 07033


Attn: Senior Vice President, Global Licensing & Strategic
Alliances


Facsimile: 908-298-7366


 


with a copy to:


 


Attn: Senior Legal Director, Licensing Facsimile:

908-298-2739


 


5

















 


4.5.         Entire Agreement.  This Amendment Agreement together
with the surviving provisions of the Transaction Agreements, embodies the entire
understanding between the Parties relating to the subject matter hereof, and as
of the Effective Date supersedes all prior understandings or agreements between
the Parties (whether written or oral) with respect thereto.


 


4.6.         Severability.  If any provision of this Amendment
Agreement is finally determined to be invalid, unlawful or incapable of being
enforced in a jurisdiction, (i) it will be deemed to be severed from this
Amendment Agreement in such jurisdiction, (ii) every other provision of
this Amendment Agreement will remain in full force and effect in such
jurisdiction, (iii) the Parties will negotiate in good faith to modify
this Amendment Agreement so as to achieve the original intent of the Parties as
closely as possible in an acceptable manner with respect to such jurisdiction and (iv) such
invalidity, unlawfulness or unenforceability will not affect the interpretation
or enforcement of this Amendment Agreement in any other jurisdiction.


 


4.7.         Amendments.  This Amendment Agreement may not
be altered or otherwise amended except by an instrument in writing signed by
authorized representatives of Metabasis and Valeant but in so far as such
amendment affects only the rights and obligations of Metabasis and Valeant, it
shall not require execution by Sobering.


 


4.8.         Counterparts.  This Amendment Agreement may be
executed in any number of counterparts and by facsimile, each of which shall be
deemed to be an original and all of which taken together will constitute one
and the same instrument.


 


4.9.         Further Assurances.  Each Party will duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further actions as any other Party may
reasonably request in connection with this Amendment Agreement in order to give
effect to the terms and conditions of this Amendment Agreement.


 


4.10.       Assignment.  Neither this Amendment Agreement
nor any interest under this Amendment Agreement may be assigned by any Party
without the prior written consent of all of the other Parties hereto, except
that any Party may assign this Amendment Agreement, in whole or in part, and/or
transfer rights or delegate obligations under this Amendment Agreement, to an
Affiliate or to any third party who acquires all or substantially all of the
business of the assigning Party and/or substantially all of the business to
which this Amendment Agreement relates (whether by merger, sale of assets or
otherwise); provided that such Affiliate or other third party successor
in interest promptly agrees in writing to be bound by the terms of this
Amendment Agreement. Any assignment that does not comply with this Section 4.10
shall be null and void.


 


[Remainder
of this page intentionally left blank.]


 


6

















 


IN WITNESS WHEREOF, the Parties intending that this
Amendment Agreement be binding on each of the Parties and their respective
successors and assigns have caused this Amendment Agreement to be executed by
their respective duly authorized representatives as of the dates set forth
below.


 


 


SCHERING
CORPORATION


 


 


	
  By:

  	
       /s/
  DAVID A. PIACQUAD

  	
   

  
	
   

  	
   

  
	
  Name:

  	
      David
  A. Piacquad

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Senior Vice President, Business Development

  	
   

  
	
   

  	
   

  
	
  Date:

  	
      9/17/08

  	
   

  
						



 


 


VALEANT PHARMACEUTICALS NORTH AMERICA


 


 


	
  By:

  	
       /s/
  RICH MASTERSON

  	
   

  
	
   

  	
   

  
	
  Name:

  	
      Rich
  Masterson

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   Executive Vice President, Commercial
  Development

  	
   

  
	
   

  	
   

  
	
  Date:

  	
      9/23/08

  	
   

  
						



 


 


METABASIS THERAPEUTICS, INC


 


	
  By:

  	
       /s/
  PAUL LAIKIND, PH.D.

  	
   

  
	
   

  	
   

  
	
  Name:

  	
      Paul
  Laikind, Ph.D.

  	
   

  
	
   

  	
   

  
	
  Title:

  	
      President and CEO

  	
   

  
	
   

  	
   

  
	
  Date:

  	
      9-24-08

  	
   

  
						



 


7