Document:

Exhibit
10.6

 

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.

 

THIRD
AMENDMENT

TO THE

AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT

 

This THIRD AMENDMENT
TO AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT (the “Third Amendment”)
is made effective as of this 18th day of December, 2006, 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, 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 and having a principal place of business at One Franklin Plaza,
Philadelphia, PA 19101 (“GSK”). Biovail and GSK are collectively referred to in
this Third 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 by the First Amendment to the
Amended and Restated Distribution Rights Agreement effective as of May 1,
2005 and the Second Amendment to the Amended and Restated Distribution Rights
Agreement effective as of October 12, 2005 (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, grant to any Third Party any rights to market, promote,
advertise, or distribute the Product; and

 

WHEREAS, BPI desires
to retain to Sciele Pharma, Inc., a corporation duly organized and
existing under the applicable laws of the State of Delaware and having a
principal place of business at Suite 1800, Five Concourse Parkway,
Atlanta, Georgia 30328 and its wholly owned subsidiaries listed on Schedule “A”
attached hereto (collectively, “Sciele”), to provide to co-promotion and other
services in respect of the Products as set forth in this Third Amendment; and

 

WHEREAS, Biovail and
GSK mutually desire to amend the terms of the Agreement relating to Biovail’s
engagement of Sciele as provided in this Third 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 Sciele.

 

(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 Sciele to perform certain promotional activities with
respect to the Products.

 

(b)           The consent granted by GSK to BPI as provided in Section 2.04(a) above
is limited to Sciele only and only for the co-promotion activities set forth in
Section 2.04(c). For clarity, the consent granted by GSK as provided
herein will not apply to any successor (whether by merger, consolidation,
reorganization or other similar event) of Sciele’s business or to a purchaser
of all or substantially all of Sciele’s business assets (a “Change of Control”)
unless such successor has been approved by GSK. Further, the consent granted by
GSK to Biovail as provided in Section 2.04(a) will become effective
on January 1, 2007, and will extend until the earlier of (i) the
expiration or earlier termination of this Agreement, (ii) the expiration
or earlier termination of the Sciele Promotional Services Agreement, or (iii) the
effective date of a Change of Control if GSK has not approved such Change of
Control (the “Sciele Term”).

 

(c)           Biovail acknowledges and agrees that BPI will enter into a written
agreement with Sciele to engage Sciele to perform promotional services with
respect to the Products (the “Sciele Promotional Services Agreement”). The term
of the Sciele Promotional Services Agreement will not extend beyond the Term of
this Agreement. Further, the Sciele Promotional Services Agreement will
immediately terminate upon the expiration or earlier termination of this
Agreement. The Sciele Promotional Services Agreement will provide that Sciele’s
activities will consist of marketing, promoting, advertising and detailing
Products in the Territory as directed by BPI. Further, BPI and Sciele will
jointly develop and approve marketing plans and pricing for Products in the
Territory. Biovail represents and warrants that (i) the Sciele Promotional
Services Agreement will obligate Sciele to comply with those obligations of
Biovail under this Agreement (including without limitation, Biovail’s
obligations under Article 3, Biovail’s obligation to comply with the
Pre-Clearance Process, which was initiated by GSK in a letter to Biovail dated October 26,
2006 and further clarified by GSK in a letter to Robert W. Ashworth, Ph.D.
dated November 27, 2006, and Biovail’s confidentiality obligations)
related to the provision of advertising, marketing and promotional services and
detailing the Products in the Territory in the performance of Sciele’s
obligations under the Sciele Promotional Services Agreement, (provided that
Biovail shall continue to file any required Form 2253 filings with DDMAC
in respect of promotional materials for the Products); and (ii) the terms
and conditions of the Sciele Promotional Services Agreement will be in
compliance with Applicable Law and will be consistent with, and no less
restrictive than, the terms and conditions of this Agreement. In accordance
with 

 

2

 

the confidentiality
provisions of this Agreement, GSK hereby consents to Biovail providing Sciele
with a copy of the Agreement, subject to Sciele’s commitment to maintain such
confidentiality in accordance with Article 11 of this Agreement.

 

(d)           Biovail represents and warrants that Sciele is not an Ineligible Person.
Biovail agrees that the Sciele Promotional Services Agreement will immediately
terminate in the event that Sciele should become an Ineligible Person at any
time during the Sciele Term. Biovail represents and warrants that the Sciele
Promotional Services Agreement will obligate Sciele not to hire or otherwise
engage any Ineligible Person to co-promote the Product and/or distribute the
Sample Product as provided in the Sciele Promotional Services Agreement. For
the purposes of this Section 2.04(d), the term “Ineligible Person” means
any Person who is currently 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 BPI’s engagement of Sciele as provided herein, Biovail remains
obligated to perform all terms, obligations, covenants and agreements ascribed
to it in this Agreement.

 

(f)            Biovail acknowledges and agrees that for the purposes of this Agreement,
Sciele 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 Sciele (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 Sciele Promotional
Services Agreement; and/or (ii) arising by or on behalf of Sciele and/or
any of Sciele’s affiliates, employees, agents, officers, and directors.”

 

2.             Section 3.14 of the
Agreement is hereby deleted in its entirety and replaced with the following:

 

“3.14      Promotional Spend Requirement. In
each Calendar Year during the Term of this Agreement, Biovail shall, commit,
allocate and spend, at a minimum funds in the amounts set forth below for
Promotional Support of the Products as specified below (each a “Promotional
Spend Requirement”, collectively the “Promotional Spend Requirements”):

 

3

 

(i)            Calendar Years {***}† — {***}† of
Gross Sales of each Product during the immediately preceding Calendar Year;

 

(ii)           Calendar Years {***}†  — {***}† of Gross Sales of each Product during the
immediately preceding Calendar Year;

 

(iii)          Calendar Years {***}†— {***}† of
Gross Sales of each Product during the immediately preceding Calendar Year; and

 

(iv)          Calendar Years {***}†— {***}† of
Gross Sales of Zovirax® Cream during the immediately preceding Calendar Year.

 

For clarity, and
without limiting the foregoing, Biovail shall have no obligation to commit
promotional spending in respect of the Zovirax® Ointment Product after the end
of {***}†, and the Promotional Spend Requirement set forth in item (iv) above
shall be in respect of the Zovirax® Cream only.

 

In the event of
Generic Entry with respect to a Product, the Promotional Spend Requirement for
that Product for the period of {***}†
calendar months following the date of Generic Entry shall be {***}† of
the then applicable percentage rates set forth immediately above, and upon
expiration of said {***}† month period, shall
thereafter be zero.

 

In each Calendar
Year, Biovail shall allocate not less than {***}† of
the applicable Promotional Spend Requirement to personal field selling
activities for the relevant Products in the Territory.

 

3.             Section 5.06(a)(iii) of
the Agreement is hereby deleted in its entirety and replaced with the
following:

 

“(iii) Calendar
Years 2010-2021— For each of the Calendar Years 2010 through 2021, the purchase
price to be paid by Biovail for Zovirax® Ointment shall be {***}† of
the Net Wholesale Price charged for the Product by Biovail as of the issue date
of GSK’s invoice to Biovail therefor.”

 

4.             Section 5.06(b)(iii) of
the Agreement is hereby deleted in its entirety and replaced with the
following:

 

“(iii) Calendar
Years 2010-2021— For each of the Calendar Years 2010 through 2021, the purchase
price to be paid by Biovail for Zovirax® Cream shall be {***}†  of the Net Wholesale Price charged by Biovail
for the Product as of the issue date of GSK’s invoice to Biovail for the
Product.”

 

† 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.

 

4

 

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

 

6.             Except as otherwise amended by
the terms of this Third 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
Third Amendment.

 

7.             This Third 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 Third 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.

 

[The
remainder of this page is intentionally left blank]

 

5

 

Schedule “A”

 

Sciele Pharma Sales, Inc.

 

6

 

IN WITNESS WHEREOF,
the Parties have executed this Third 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 and
  Secretary

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  BIOVAIL LABORATORIES: 

  INTERNATIONAL SRL

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Michel Chouinard

  	
   

  
	
  Name: Michel Chouinard

  	
   

  
	
  Title: Chief Operating
  Officer

  	
   

  

 

7Exhibit 10.7

 

FOURTH
AMENDMENT

TO THE

AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT

 

This FOURTH AMENDMENT
TO AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT (the “Fourth Amendment”)
is made effective as of this 21st day of November, 2008, 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, 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 and
having a principal place of business at One Franklin Plaza, Philadelphia, PA
19101 (“GSK”).  Biovail and GSK are
collectively referred to in this Fourth 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 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 and the Third Amendment to the
Amended and Restated Distribution Rights Agreement effective as of December 18,
2006 (the “Third Amendment”) (collectively, the “Agreement”); and

 

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

 

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

 

WHEREAS, pursuant to
the Third Amendment, GSK consented to the engagement by Biovail Pharmaceuticals, Inc.
of Sciele Pharma, Inc. (“Sciele”) to perform certain promotional
activities with respect to the Products;

 

WHEREAS BTA recently
terminated the engagement of Sciele;

 

WHEREAS, BTA desires
to retain to Publicis Selling Solutions, Inc., a contract sales
organization duly organized and existing under the applicable laws of the State
of New Jersey and having a principal place of business at 2000 Lenox
Drive, Suite 100, Lawrenceville, New Jersey 08648 (“PSS”), to provide
promotion and other services in respect of the Products as set forth in this
Fourth Amendment; and

 

WHEREAS, Biovail and
GSK mutually desire to amend the terms of the Agreement relating to Biovail’s
engagement of PSS as provided in this Fourth 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
PSS.

 

(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 BTA of PSS to perform certain promotional
activities with respect to the Products.

 

(b)           The consent granted by GSK to BTA as provided in Section 2.04(a) above
is limited to PSS only and only for the promotion activities set forth in Section 2.04(c).  For clarity, the consent granted by GSK as
provided herein will not apply to any successor (whether by merger,
consolidation, reorganization or other similar event) of PSS’s business or to a
purchaser of all or substantially all of PSS’s business assets (a “Change of
Control”) unless such successor has been approved by GSK.  Further, the consent granted by GSK to
Biovail as provided in Section 2.04(a) will become effective on November 21,
2008, and will extend until the earlier of (i) the expiration or earlier
termination of this Agreement, (ii) the expiration or earlier termination
of the PSS Professional Detailing Services Agreement (as defined below), or (iii) the
effective date of a Change of Control if GSK has not approved such Change of
Control (the “PSS Term”).

 

(c)           Biovail acknowledges and agrees that BTA will enter into a
written agreement with PSS to engage PSS to perform promotional services with
respect to the Products (the “PSS Professional Detailing Services Agreement”).  The term of the PSS Professional Detailing
Services Agreement will not extend beyond the Term of this Agreement.  Further, the PSS Professional Detailing Services
Agreement will immediately terminate upon the expiration or earlier termination
of this Agreement.  The PSS Professional
Detailing Services Agreement will provide that PSS’s activities will consist of
promoting and detailing Products in the Territory as directed by BTA.  Biovail represents and warrants that (i) the
PSS Professional Detailing Services Agreement will obligate PSS to comply with
those obligations of Biovail under this Agreement (including without
limitation, Biovail’s obligations under Article 3, Biovail’s obligation to
comply with the Pre-Clearance Process, which was initiated by GSK in a letter
to Biovail dated October 26, 2006 and further clarified by GSK in a letter
to Robert W. Ashworth, Ph.D. dated November 27, 2006, and Biovail’s
confidentiality obligations) related to the provision promotional services and
detailing the Products in the Territory in the performance of PSS’s obligations
under the PSS Professional Detailing Services Agreement, (provided that Biovail
shall continue to file any required Form 2253 filings with DDMAC in
respect of promotional materials for the Products); and (ii) the terms and
conditions of the PSS Professional Detailing Services Agreement will be in
compliance with Applicable Law and will be consistent with, and no less
restrictive than, the terms and conditions of this Agreement.  In accordance with the confidentiality
provisions of this Agreement, GSK hereby consents to Biovail providing PSS with
a copy of the Agreement, subject to PSS’s commitment to maintain such
confidentiality in accordance with Article 11 of this Agreement.

 

2

 

(d)           Biovail represents and warrants that PSS is not an
Ineligible Person.  Biovail agrees that
the PSS Professional Detailing Services Agreement will immediately terminate in
the event that PSS should become an Ineligible Person at any time during the
PSS Term.  Biovail represents and
warrants that the PSS Professional Detailing Services Agreement will obligate
PSS not to hire or otherwise engage any Ineligible Person to co-promote the
Product and/or distribute the Sample Product as provided in the PSS
Professional Detailing Services Agreement. 
For the purposes of this Section 2.04(d), the term “Ineligible
Person” means any Person who is currently 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 BTA’s engagement of PSS as provided
herein, Biovail remains obligated to perform all terms, obligations, covenants
and agreements ascribed to it in this Agreement.

 

(f)            Biovail acknowledges and agrees that for the purposes of
this Agreement, PSS will be deemed to be an agent of BTA and will also be
regarded as a contract sale organization (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 PSS (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 PSS Professional Detailing Services Agreement; and/or (ii) arising
by or on behalf of PSS and/or any of PSS’s affiliates, employees, agents,
officers, and directors.”

 

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

 

3.                                       Except as
otherwise amended by the terms of this Fourth 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 Fourth Amendment.

 

4.                                       This Fourth
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.

 

3

 

5.                                       This Fourth
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.

 

[The remainder of this page is
intentionally left blank]

 

4

 

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

 

 

	
  SMITHKLINE
  BEECHAM CORPORATION

  	
   

  
	
  D/B/A
  GLAXOSMITHKLINE

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Carol G. Ashe

  	
   

  
	
  Name:

  	
  Carol G. Ashe

  	
   

  
	
  Title:

  	
  Company Secretary

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  BIOVAIL
  LABORATORIES

  	
   

  
	
  INTERNATIONAL SRL

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Jean-Luc Martre

  	
   

  
	
  Name:

  	
  Jean-Luc Martre

  	
   

  
	
  Title:

  	
  VP Commercial Operations

  	
   

  
	
   

  	
   

  	
   

  

 

 

5

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