Document:

Exhibit
10.8

 

Biovail
Laboratories International SRL

Welches, Christ Church

Barbados, West Indies BB17154

 

May 14, 2009

 

SmithKline Beecham
Corporation

5 Moore Drive

Research Triangle Park, NC
27709

 

Re:  Fifth Amendment to the Distribution Rights
Agreement

 

Dear Sir/Madam:

 

This letter (the “Fifth
Amendment”), to be effective as of the date set forth above, is in
reference to that certain Amended and Restated Distribution Rights Agreement,
effective as of October 26, 2001, as amended by the First Amendment to the
Amended and Restated Distribution Rights Agreement, effective as of May 1,
2005, the Second Amendment to the Amended and Restated Distribution Rights
Agreement, effective as of October 12, 2005, the Third Amendment to the
Amended and Restated Distribution Rights Agreement, effective as of December 18,
2006, and the Fourth Amendment to the Amended and Restated Distribution Rights
Agreement, effective as of November 21, 2008 (collectively, the “Zovirax
Agreement”), between Biovail Laboratories International SRL (“Biovail”)
and SmithKline Beecham Corporation (“GSK”). Capitalized terms used herein but
not otherwise defined shall have the meanings set forth in the Zovirax
Agreement.

 

WHEREAS, Biovail and
GSK have entered into that certain Asset Purchase Agreement (“Asset Purchase
Agreement”), dated May 5, 2009, whereby Biovail purchased certain
assets of GSK related to Wellbutrin XL® in the United States.

 

NOW, THEREFORE, in
consideration of Biovail entering into the Asset Purchase Agreement and other
good and valuable consideration, the receipt and legal sufficiency of which are
mutually acknowledged, Biovail and GSK hereby agree to amend the Zovirax
Agreement as follows:

 

1.                                       Amendments to the
Zovirax Agreement.

 

(a)                                  Sections 5.01(c),
5.01(d), 5.01(f), 5.02(c) and 5.02(d) of the Zovirax Agreement are
hereby deleted in their entirety and shall have no further force or effect.

 

(b)                                 Section 5.02(b) of
the Zovirax Agreement is hereby amended and restated in its entirety as
follows:

 

“(b) Minimum
Purchase Requirements — There will be no minimum purchase requirements under
this Agreement.”

 

(c)                                  The following
definitions of the Zovirax Agreement are hereby deleted in their entirety:

 

 

“Additional Rights
Lump Sum Payment”

“Additional Rights
Payment”

“Annual Minimum
Purchase Requirements”

“Fixed Annual Minimum
Purchase Requirement”

“Variable Additional
Rights Payment”

“Variable Annual
Minimum Purchase Requirement”

 

2.                                       Miscellaneous.

 

(a)                                  Amendment.  This Fifth Amendment may not be amended,
terminated, waived or altered except by written instrument executed by Biovail
and GSK, nor shall any waiver be effective against any party unless in writing
and executed by such party.

 

(b)                                 Full Force and
Effect.  Except as expressly amended by
this Fifth Amendment, all terms and conditions of the Zovirax Agreement shall
remain in full force and effect except that each reference to the “Agreement”
or words of like import in the Agreement will mean and be a reference to the
Agreement as amended by this Fifth Amendment.

 

(c)                                  Governing Law.  This Fifth Amendment shall be governed by and
construed in accordance with the laws of the State of New York, without regard
to its conflicts of laws principles.

 

(d)                                 Conflict.  In all events, the terms and provisions of
this Fifth Amendment shall be enforceable notwithstanding any conflicting term
or provision set forth in the Zovirax Agreement. In the event of any conflict
between any term or provision of this Fifth Amendment and any term or provision
set forth in the Zovirax Agreement, such term or provision of this Fifth
Amendment shall prevail over such term or provision set forth in the Zovirax
Agreement.

 

(e)                                  Counterparts.  This Fifth Amendment may be executed in
counterparts and by facsimile, each of which shall be deemed an original, but
all of which together shall constitute one and the same instrument.

 

(f)                                    No Agency.  Nothing contained in this Fifth Amendment
shall be deemed to imply or constitute either party as the agent or
representative of the other party, or both parties as joint venturers or
partners for any purpose.

 

(g)                                 Validity.  If a court of competent jurisdiction holds
any provision hereof invalid or unenforceable, such invalidity shall not affect
the validity or operation of any other provision and such invalid provision
shall be deemed to be severed from this Fifth Amendment.

 

[NO
FURTHER TEXT ON THIS PAGE]

 

2

 

Please indicate your
acceptance of the terms of this Fifth Amendment to the Amended and Restated
Distribution Rights Agreement by returning a signed copy to the undersigned.

 

 

	
   

  	
  BIOVAIL LABORATORIES INTERNATIONAL SRL

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Michel Chouinard

  
	
   

  	
  Name: Michel Chouinard

  
	
   

  	
  Title: Chief Operating Officer

  

 

 

ACCEPTED AND AGREED BY:

 

	
  SMITHKLINE BEECHAM CORPORATION

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ William J. Mosher

  	
   

  
	
   

  	
  Name: William J. Mosher

  	
   

  
	
   

  	
  Title: Vice President & Secretary

  	
   

  
	
   

  	
  Date:

  	
   

  

 

Signature
Page to Fifth Amendment to the Distribution Rights Agreement

 

3Exhibit
10.9

 

SIXTH
AMENDMENT

TO THE

AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT

 

THIS
SIXTH AMENDMENT TO THE AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT (the “Sixth
Amendment”) is made effective as of this 16th day of September, 2009 by and between Biovail
Laboratories International SRL, a Barbados International Society with
Restricted Liability and having a principal place of business at Welches,
Christ Church, BB17154, Barbados, West Indies (“Biovail”) and SmithKline
Beecham Corporation, a GlaxoSmithKline company, a corporation duly organized
and existing under the applicable laws of the Commonwealth of Pennsylvania
having a principal place of business at One Franklin Plaza, Philadelphia, PA
19102 (“GSK”). GSK and Biovail are collectively referred to in this Sixth
Amendment as “Parties” and individually as a “Party”.

 

WHEREAS,
GSK and Biovail are parties to an Amended and Restated Distribution Rights
Agreement, effective as of October 26, 2001, as amended on May 1,
2005, October 12, 2005, December 18, 2006, November 21, 2008 and
May 14, 2009 (collectively, the “Agreement”);

 

WHEREAS,
the Parties desire to amend the Agreement to allow for Biovail or its Affiliate
to market, promote, advertise, detail, sell and distribute a 30 gram tube size
of Zoviraxe Ointment in the Territory in accordance with the terms of the
Agreement.

 

NOW
THEREFORE, in consideration of the promises, representations, warranties,
covenants and agreements contained herein, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereto, intending to be legally bound
hereby, agree to amend the Agreement as follows:

 

1.                                       The following
shall be added as the last entry under the list of “Trade Product (tubes)” set
forth in Exhibit 1.01A:

 

“Zovirax Ointment 30G     [NDC # to be
provided]     I tube”

 

2.                                       The reference to “30
gram Tube” shall be added as the last entry under the heading “Zovirax Ointment”
set forth in Exhibit 5.05 and the corresponding order quantity amount of “15,250”
shall be added as the last entry under the corresponding heading “Minimum Order
Quantity” in Exhibit 5.05.”

 

3.                                       For clarity, the
purchase price to be paid by Biovail for the 30 gram tube of Zovirax Ointment
will be as set forth in Sections 5.06(a)(ii) and 5.06(a)(iii) of the
Agreement, as applicable.

 

4.                                       All capitalized
terms not otherwise defined in this Sixth Amendment will have meanings ascribed
to them in the Agreement.

 

5.                                       Except as
otherwise amended by the terms of this Sixth Amendment, the provisions of the
Agreement are unchanged, remain in full force and effect and

 

 

are hereby ratified and
confirmed except that each reference to “Agreement” or words of like import in
the Agreement will mean and be a reference to the Agreement as amended by this
Sixth Amendment.

 

6.                                       In all events,
the terms and provisions of this Sixth Amendment shall be enforceable
notwithstanding any conflicting term or provision set forth in the Agreement.
In the event of any conflict between any term or provision of this Sixth
Amendment and any term or provision set forth in the Agreement, such term or
provision of this Sixth Amendment shall prevail over such term or provision set
forth in the Agreement.

 

7.                                       This Sixth
Amendment will be construed, and the respective rights of the Parties
determined, according to the substantive law of New York notwithstanding the
provisions governing conflict of laws under such New York law to the contrary.

 

8.                                       This Sixth
Amendment may be executed in any number of counterparts, each of which will be
deemed an original but all of which together will constitute one and the same
document.

 

9.                                       Nothing contained
in this Sixth Amendment shall be deemed to imply or constitute either party as
the agent or representative of the other party, or both parties as joint
venturers or partners for any purpose.

 

10.                                 If a court of
competent jurisdiction holds any provision hereof invalid or unenforceable,
such invalidity shall not affect the validity or operation of any other
provision and such invalid provision shall be deemed to be severed from this
Sixth Amendment.

 

[signatures
follow]

 

2

 

IN WITNESS WHEREOF,
the Parties have executed this Sixth Amendment to the Amended and Restated
Distribution Agreement on the day and year first above written.

 

 

	
  SMITHKLINE BEECHAM CORPORATION

  d/b/a GLAXOSMITHKLINE

  	
   

  	
  BIOVAIL LABORATORIES

  INTERNATIONAL SRL

  
	
   

  	
   

  	
   

  
	
  By: 

  	
  /s/ Justin T. Huang

  	
   

  	
  By: 

  	
  /s/ Jean-Luc Martre

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  Justin t. Huang

  	
   

  	
  Name: 

  	
  Jean-Luc Martre

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
  Assistant Secretary

  	
   

  	
  Title:  

  	
  VP Commercial Operations

  

 

3

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