Document:

Exhibit 10.4

 

AMENDMENT
TO AGREEMENT

 

This AMENDMENT TO
AGREEMENT is made effective as of this  1st day
of May, 2005, by and between Biovail Laboratories International SRL, a Barbados
International Society with Restricted Liability having a principal place of
business at Chelston Park, Building 2, Collymore Rock, St. Michael, BH1,
Barbados, W.I. (“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 19101 (“GSK”).

 

WHEREAS, the parties
are parties to an Amended and Restated Distribution Rights Agreement (the “Agreement”)
effective as of October 26, 2001; and

 

WHEREAS, the parties
now desire to amend the Agreement,

 

NOW, THEREFORE, in
consideration of the mutual covenants and agreements hereinafter set forth and
other good and valuable consideration, the receipt and sufficiency of which are
mutually acknowledged, GSK and Biovail agree as follows:

 

1.             Effective
as of the date set forth above, the definition of “Territory” set forth in Article 1
of the Agreement is hereby amended to add the United States Virgin Islands.

 

2.             All
other terms of the Agreement shall remain in full force and effect.

 

IN
WITNESS WHEREOF, the parties have executed
this Amendment to Agreement the day and year first above written.

 

 

	
  SMITHKLINE BEECHAM
  CORPORATION

  	
   

  	
  BIOVAIL LABORATORIES INTERNATIONAL SRL

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Donald F. Parman

  	
   

  	
  By:

  	
  /s/ John A.R. McCleery

  
	
  Title:

  	
  Vice President & Secretary

  	
   

  	
  Title:

  	
  Vice President, General ManagerExhibit
10.5

 

CONFIDENTIAL TREATMENT REQUESTED:

 

Portions of this Exhibit have been redacted
pursuant to a request for confidential treatment under Rule 24b-2 of the
General Rules and Regulations under the Securities Exchange Act of 1934,
as amended.  Such redacted portions have been replaced with “{***}” in this Exhibit.  An unredacted version of this document has
been filed separately with the Securities and Exchange Commission along with
the request for confidential treatment.

 

SECOND
AMENDMENT

 

TO
THE

 

AMENDED
AND RESTATED DISTRIBUTION RIGHTS AGREEMENT

 

This SECOND AMENDMENT
TO AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT (the “Second Amendment”)
is made effective as of this 12 day of October, 2005, by and between Biovail
Laboratories International SRL, a Barbados International Society with
Restricted Liability and having a principal place of business at Chelston Park,
Building 2, Collymore Rock, St. Michael, BH1, Barbados, WI (“Biovail”), and
SmithKline Beecham Corporation, a GlaxoSrnithKline company, a corporation duly
organized and existing under the applicable laws of the Commonwealth of
Pennsylvania and having a principal place of business at One Franklin Plaza,
Philadelphia, PA 19101 (“GSK”). Biovail and GSK are collectively referred to in
this Second Amendment as the “Parties” and individually as a “Party.”

 

WHEREAS, Biovail and
GSK are parties to an Amended and Restated Distribution Rights Agreement,
effective as of October 26, 2001, as amended (the “Agreement”); and

 

WHEREAS, pursuant to Section 2.01(c) Biovail
has contracted with its Affiliate, Biovail Pharmaceuticals, Inc., (“BPI”)
to be responsible for promotion, marketing and selling of the Products in the
Territory; and

 

WHEREAS, the pursuant
to Section 2.03 of the Agreement, neither Biovail nor BPI may, without GSK’s
prior written consent, engage any Third Party to market, promote, advertise, or
distribute the Product; and

 

WHEREAS, BPI desires
to engage MedPointe Healthcare, Inc., a corporation duly organized and
existing under the applicable laws of the State of Delaware and having a
principal place of business at 265 Davidson Avenue, Somerset, NJ 08873 (“MedPointe”),
to co-promote the Product as set forth in this Second Amendment; and

 

WHEREAS, Biovail and
GSK mutually desire to amend the terms of the Agreement to allow BPI to engage
MedPointe as provided in this Second Amendment.

 

NOW, THEREFORE, in
consideration of the mutual covenants and agreements hereinafter set forth and
other good and valuable consideration, the receipt and sufficiency of which are
mutually acknowledged, GSK and Biovail agree as follows:

 

 

1.             Section 2.04 of the
Agreement is hereby deleted in its entirety and replaced with the following:

 

“2.04 Approval of MedPointe.

 

(a)           Notwithstanding the provisions
of Section 2.03 and subject to the terms and conditions of this Section 2.04,
GSK hereby consents to the engagement by BPI of MedPointe Healthcare, Inc.
to perform certain promotional activities with respect to the Products.

 

(b)           The consent granted by GSK as
provided in Section 2.04(a) above is limited to MedPointe only and
only for the co-promotion activities set forth in Section 2.04(c).
Further, the consent granted by GSK to Biovail as provided in Section 2.04(a) will
become effective upon October 1, 2005, and will remain in effect for the
immediately succeeding consecutive three (3) year period (the “MedPointe
Term”), which MedPointe Term may be extended for additional consecutive twelve
(12) month periods by mutual written agreement of the Parties.

 

(c)           Biovail acknowledges and
agrees that BPI will enter into a written agreement with MedPointe to engage
MedPointe to perform promotional services with respect to the Products (the “MedPointe
Detailing Services Agreement”). The term of the MedPointe Detailing Services
Agreement will not exceed the duration of the MedPointe Term and the MedPointe
Detailing Services Agreement will immediately terminate upon termination of
this Agreement. The MedPointe Detailing Services Agreement will provide that
MedPointe’s activities will consist of providing annually approximately {***}† details of the Products
and distributing Sample Product. Biovail represents and warrants that (i) the
MedPointe Detailing Services Agreement will obligate MedPointe to comply with
all obligations of Biovail under this Agreement (including without limitation,
Biovail’s obligations under Article 3 and Biovail’s confidentiality
obligations) in the performance of MedPointe’s obligations under the MedPointe
Detailing Services Agreement; (ii) the terms and conditions of the
MedPointe Detailing Services Agreement will be consistent with, and no less
restrictive than, the terms and conditions of this Agreement, and (iii) Biovail
will provide to GSK a copy of the MedPointe Detailing Services Agreement within
ten (10) Business Days after execution thereof.

 

(d)           Biovail represents and
warrants that MedPointe is not an Ineligible Person. Biovail agrees that the
MedPointe Detailing Services Agreement will immediately terminate in the event
that MedPointe should become an Ineligible Person at any time during the
MedPointe Term. Biovail represents and warrants that the MedPointe Detailing
Services Agreement will obligate MedPointe not to hire or otherwise engage any
Ineligible Person to co-promote the Product and/or distribute the Sample
Product as provided in the MedPointe Detailing Services Agreement. For the
purposes of this Section 2.04(d), the term “Ineligible Person” means any
Person who is currently 

 

† Represents material which has been
redacted and filed separately with the Securities and Exchange Commission
pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934, as amended.

 

2

 

excluded, debarred, suspended or otherwise ineligible to participate in
the Federal health care programs or in Federal procurement or nonprocurement
programs, or has been convicted of a criminal offense that falls within the
ambit of 42 U.S.C. 1320a-7(a), but has not yet been excluded, debarred,
suspended or otherwise declared ineligible.

 

(e)           Biovail acknowledges and
agrees that despite GSK’s consent granted in Section 2.04 above to the
engagement of MedPointe as provided herein, Biovail remains obligated to
perform all terms, obligations, covenants and agreement ascribed to it in this
Agreement.

 

(f)            Biovail acknowledges and
agrees that for the purposes of this Agreement, MedPointe will be deemed to be
an agent of BPI and will also be regarded as a CSO. Biovail acknowledges and
agrees that its indemnification obligations provided in Section 9.02 of
this Agreement will also include any GSK Claim that arises out of, or is the
result of, any act or omission by MedPointe (as a CSO).

 

(g)           Biovail will indemnify and
hold harmless each GSK Party (as defined in Section 9.02) from and against
any and all losses, liabilities, damages (exclusive of consequential or special
losses or damages), fees (including, attorneys fees and costs of litigation),
and expenses paid or payable by a GSK Party that result from or arise in
connection with a claim, suit or other proceeding made or brought against a GSK
Party (i) based on, resulting from, or arising in connection with any act
or omission of any party under the MedPointe Detailing Services Agreement;
and/or (ii) arising by or on behalf of MedPointe and/or any of MedPointe’s
affiliates, employees, agents, officers, and directors.”

 

2.             The term “Designated Biovail
Affiliate” will be deleted throughout the Agreement and replaced in all
instances with “a CSO”, including, without limitation, in Section 9.02.

 

3.             The term “CSO” will be added
as a new definition in Section 1.01 between the definitions of “Confidentiality
Agreement” and “DDMAC.” The definition of “CSO” will be as follows:

 

“CSO” means a Third
Party contract sales organization which is engaged in the business of promoting
prescription drug products and which may only be engaged by Biovail or BPI as
provided in Section 2.04.

 

4.             Section 12.06(b) of
the Agreement will be deleted in its entirety and replaced with the following:

 

“(b)         All of the Parties’ rights and obligations under Articles 9 and 11 and
Sections 2.04(f), 2.04(g), 5.01(a), and 12.05 shall survive expiration or
termination of this Agreement.”

 

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

 

3

 

6.             Except as otherwise amended by
the terms of this Second 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 the “Agreement” or words of like import in the Agreement
will mean and be a reference to the Agreement as amended by this Second
Amendment.

 

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

 

8.             This Second 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.

 

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

 

	
  SMITHKLINE BEECHAM CORPORATION  D/B/A GLAXOSMITHKLINE

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Donald F. Parman

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Donald F. Parman

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Vice President & Secretary

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  BIOVAIL LABORATORIES INTERNATIONAL SRL

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Arlene Fong

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Arlene Fong

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Manager &
  Secretary

  	
   

  

 

4

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