Exhibit
10.10


 


SEVENTH
AMENDMENT


TO THE


AMENDED AND RESTATED DISTRIBUTION RIGHTS AGREEMENT


 


THIS
SEVENTH AMENDMENT  TO AMENDED AND
RESTATED DISTRIBUTION RIGHTS AGREEMENT (the “Seventh Amendment”) is made
effective as of this          day of
November, 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, Barbados, BB17154, 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 Seventh 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 March 1,
2005, October 12, 2005, December 18, 2006, November 21, 2008, May 14,
2009 and September 16, 2009 (collectively, the “Agreement”);


 


WHEREAS,
Exhibit 6.09 to the Agreement sets forth the procedures pursuant to which
the Parties will exchange adverse event information;


 


WHEREAS,
the Parties desire to amend Exhibit 6.09 to the Agreement as set forth in
this Seventh Amendment.


 


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.             Exhibit 6.09 to the Agreement
is hereby deleted in its entirety and replaced by Attachment 1 to this Seventh
Amendment in its place.


 


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


 


3.             Except as expressly amended by the
terms of this Seventh 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 Seventh
Amendment.


 


4.             In all events, the terms and
provisions of this Seventh 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 Seventh Amendment and any term or provision set forth in
the Agreement, such term or provision of this Seventh Amendment shall prevail
over such term or provision set forth in the Agreement.


 


5.             This Seventh 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.


 


6.             This Seventh 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.


 

















 


7.             Nothing contained in this Seventh
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.


 


8.             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 Seventh
Amendment.


 


[signatures follow]


 


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IN
WITNESS WHEREOF, the Parties have executed this Seventh Amendment to the
Agreement on the date first above written.


 




	
  SMITHKLINE BEECHAM CORPORATION
  d/b/a GLAXOSMITHKLINE

  	
   

  	
  BIOVAIL LABORATORIES

  INTERNATIONAL SRL

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Ed Pattishall

  	
   

  	
  By:

  	
  /s/ Jean-Luc Martre

  
	
  Name:
  Ed Pattishall

  	
   

  	
  Name: Jean-Luc Martre

  
	
  Title:   VP Clinical Safety

  	
   

  	
  Title:   VP Commercial Operations

  
					






 


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EXHIBIT 6.09


 


Safety Data Exchange Schedule

Between

Biovail Laboratories International SRL (Biovail)

and

SmithKline Beecham Corporation (GSK)

for

the following products:


 


Zovirax® (Acyclovir) Cream, 0.05%

Zovirax® (Acyclovir) Ointment, 0.05%


 


1.1                                 Definitions:  Except as otherwise set forth in this Section 1.1,
all capitalized terms used herein will have the meanings given to them in
Amended and Restated Distribution Rights Agreement, as amended.


 


1.1.1                        Confidential Information


 


Any non-public information furnished by one Party (the
“Disclosing Party”) to the other Party (the “Receiving Party”) in connection
with these terms or generated pursuant to these terms that is, or which the
Disclosing Party designates or would reasonably regard as being confidential.


 


1.1.2                        Day


 


A calendar day.


 


1.1.3                        Marketing Authorisation


 


Such authorisation(s) granted by the relevant
regulatory authorities which are necessary to market the Medicinal Product in
the Territory.


 


1.1.4                        Medicinal Product


 


Those medicinal products listed below with their
respective generic names or compound numbers:


 


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Zovirax® Ointment or Zovirax® Cream; each in the
presentations and formulations in finished product form, as described below, or
as developed by GSK under the terms of the Agreement.


 


	
  Trade
  Product

  	
   

  	
  GSK NDC

  	
   

  	
  Pkg Size

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Zovirax Ointment 3G

  	
   

  	
  0173099341

  	
   

  	
  1 tube

  
	
  Zovirax Ointment 15G

  	
   

  	
  0173099394

  	
   

  	
  1 tube

  
	
  Zovirax Cream 2G

  	
   

  	
  TBA*

  	
   

  	
  1 tube

  



 






*  To be
assigned upon approval of the Zovirax Cream NDA


 


1.1.5                        Pregnancy Report


 


A report of pregnancy in a patient to whom a Medicinal
Product has been administered or a report of a pregnancy where the father is a
patient or trial subject to whom a Medicinal Product has been administered.


 


1.1.6                        Receipt


 


The point at which Biovail (including any member of
the personnel of Biovail becomes aware of a report of an Adverse Event or a
Pregnancy Report.  For the purposes of
this definition, “personnel” includes those persons employed by Biovail or
persons engaged by Biovail for the provision of services.


 


2.                                      Responsibilities and
Exchange of Adverse Events and Pregnancy Reports


 


2.1                                 Biovail shall provide GSK with all
information regarding Adverse Events and Pregnancy Reports which it receives
arising from any source, in the form in which it is received, within two (2) Days
(or four (4) Days in the event the time period would expire during a
weekend or public holiday) of Receipt via secure mail (as outlined in Section 3).


 


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2.1.1                        Procedure During Working Hours:  During Biovail working hours (defined as 9:00
AM until 5:00 PM Eastern Time), Biovail will transfer all Medicinal
Product-related calls to a central phone number within Biovail, staffed by a
trained medically-qualified Biovail employee.


 


2.1.2                        Procedure After Working Hours:  After the Biovail telephone switchboard
closes (5:00 PM Eastern Time on Monday-Friday and all day Saturday and Sunday),
instructions on the main number will ask that callers leave a message regarding
adverse events and the call will be returned the following business day.


 


2.2                                 GSK will scan scientific/medical literature
for Adverse Events with the Medicinal Products. 
However, if Biovail becomes aware of any publication from the scientific
literature in which any of the Medicinal Products is a suspect drug, Biovail
will forward that publication to GSK by fax within the timeframes specified in Section 2.1.


 


2.3                                 Biovail will forward a copy of any written
correspondence describing an Adverse Event or Pregnancy Report to GSK
(including the envelope in which the correspondence was received) within the
timeframes specified in Section 2.1. 
Biovail will retain the original written correspondence in accord with
existing Biovail retention policies.


 


2.4                                 Biovail will train their staff who will be
managing reports regarding Medicinal Product calls, to ensure they have basic
knowledge of Adverse Events and Pregnancy Reports and Adverse Event-related
procedures.


 


2.5                                 Biovail will employ sales representatives
or other field staff who may learn of Adverse Events or pregnancies during the
course of their interactions with practicing health care professionals.  These Adverse Events and pregnancies must be
reported by telephone to Biovail immediately in order to ensure the reporting
obligation outlined in this Section is met.  Biovail will ensure that all field staff are
aware and are trained on this policy.


 


3.                                      Secure email exchange


 


3.1                                 Biovail shall ensure that to the extent any
Confidential Information is provided by email, that those emails and any
attachments sent to GSK are encrypted.


 


3.2                                 The Parties have agreed that email
encryption will be used to secure the exchange of electronic information.


 


4.                                      Tracking Adverse Events and
Pregnancy Reports


 


4.1                                 Biovail will ensure that each Adverse Event
and Pregnancy Report from any source that is provided by Biovail (including
follow up data) to GSK in accordance with these terms shall bear:


 


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4.1.1                        the date of its Receipt by Biovail,


 


4.1.2                        a unique reference number assigned by Biovail, and


 


4.1.3                        a description of the original source of the Adverse
Event or Pregnancy Report (whether healthcare professional, consumer,
regulatory authority, literature or otherwise).


 


4.2                                 Biovail shall conduct appropriate routine
checks to confirm that the Adverse Events and Pregnancy Reports that it sends
to GSK have been received.


 


4.3                                 If the confirmation envisaged in Section 2
cannot be obtained Biovail shall immediately re-send the Adverse Event or
Pregnancy Report and take reasonable steps to ensure the same does not occur
again.


 


4.4                                 GSK shall hold and maintain a database of
Adverse Events and Pregnancy Reports relating to the Medicinal Products.


 


4.5                                 GSK shall compile and maintain the Periodic
Reports (or Periodic Safety Update Reports (PSURs) when applicable) for the
Medicinal Products and will provide Biovail with data comparable to a Periodic
Report at the time of regulatory submission.


 


5.                                      Follow up of Adverse
Events and Pregnancy Reports


 


Biovail shall notify GSK of any follow up information about Adverse
Events and Pregnancy Reports exchanged under Section 2 which it receives
and/or of which it becomes aware in respect of the Medicinal Products to which
it has rights in the Territory.  Such
notification shall be made in the same timelines set out in Section 2
above.  GSK is responsible for
appropriate follow-up of Adverse Events and Pregnancy Reports it receives.


 


6.                                      Regulatory Authority and
other Enquiries


 


6.1                                 Biovail shall notify GSK forthwith of the
receipt of an enquiry from, or the notification of an issue by, a regulatory
authority, a healthcare professional or a consumer relating to the Medicinal
Products that is directed to it concerning any safety issue.  In each case, Biovail shall provide GSK with
all available information it has regarding the enquiry/issue.


 


6.2                                 Responses to any such queries received by
Biovail will be prepared by GSK and provided by GSK to the enquiring regulatory
authority within any actual or implied timeframe set by the enquiring
regulatory authority for the receipt of a response, and to any healthcare
professional or consumer as soon as is reasonably practicable.


 


7.                                      Audits/Adverse findings by
Regulatory Authorities


 


Provided such audits are requested at reasonable and objectively
justifiable times/intervals and that the scope of such audits is reasonable
having regard to their intended purpose, GSK 


 


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(“Auditor”) shall be entitled to conduct audits to assess Biovail’s (“Auditee”)
compliance with the terms of this Agreement. 
Provided the Auditor has given Auditee no less than fourteen (14) Days’
prior written notice of its intent to audit, Auditee shall ensure that Auditor
may enter onto the premises at which relevant functions are conducted by it or
on its behalf in order that the Auditor may conduct a full and proper audit
through the inspection of relevant documentation, compliance metrics, systems
and personnel interviews.


 


Auditee shall afford Auditor all reasonable co-operation in the conduct
of audits under Section 7.1.


 


8.                                      Obligations Surviving
Termination of this Agreement


 


8.1                                 Provided the requesting Party shall cover
the assisting Party’s reasonable costs of cooperating, the assisting Party
shall not unreasonably withhold, refuse or delay a request for assistance in
respect of litigation, arbitration or other means of dispute resolution, or in
respect of a request for information from a regulatory authority or to secure
compliance with a law or regulation.


 


8.2                                 Each Party shall provide the other with
appropriate follow-up data in respect of information provided under this Exhibit 6.09.


 


9.                                      Key Contacts


 


Notices required under this Exhibit 6.09 shall be
provided to the personnel listed in Appendix A to this Exhibit 6.09.


 


10.                               Reviews and Revisions


 


This Exhibit 6.09 will be reviewed every two years and revised as
necessary by agreement between the Parties.


 


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Appendix A


 


Key Contacts


 


For GlaxoSmithKline


 


	
  Receiving
  Adverse Event and Pregnancy Reports and notification of regulatory authority
  or other inquiries regarding any safety issues

  	
   

  	
  U.S.
  Case Management Group

  	
   

  	
  e-mail:
  US-SDE-reports@gsk.com

  AND cc: us.naps@gsk.com

  Fax: 919-483-5404

  Global Clinical Safety and

  Pharmacovigilance

  GlaxoSmithKline R&D

  Five Moore Drive

  Mail Code: 5.4376.4C

  Research Triangle Park, NC27709-3398

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  General
  pharmacovigilance agreement questions

  	
   

  	
  Desma
  Altobelli

  	
   

  	
  Global
  Clinical Safety and

  Pharmacovigilance

  GlaxoSmithKline R&D

  Five Moore Drive

  Mail Code: 5.4384B

  Research Triangle Park, NC27709-3398

  Tel: 919-483-6373

  Fax: 919-483-5404

  



 


For Biovail


 


	
  Forwarding
  Adverse Event and Pregnancy Reports

  	
   

  	
  Name

  	
   

  	
  Address
  and tel/fax numbers:

  E-mail address

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Primary:

  Christopher Chin, PharmD

  Associate Director,

  Medical Affairs

  	
   

  	
  Biovail
  Technologies, LTD

  700 Route 202/206 North

  Bridgewater, NJ 08807

  Tel: (908) 927-1869

  Fax: (908) 927-1469

  christopher.chin@biovail.com

  Biovail Technologies, LTD

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Secondary:

  Susan Wnorowski,

  PharmD

  Manager, Medical Affairs

  	
   

  	
  700
  Route 202/206 North

  Bridgewater, NJ 08807

  Tel: (908) 927-1867

  Fax: (908) 927-1467

  susan.wnorowski@biovail.com

  



 


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