Exhibit 10.19


 


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.


 


AMENDMENT
TO LICENSE AGREEMENT

(Diltiazem Formulations)


 


THIS
AGREEMENT IS EFFECTIVE THE 29th DAY OF DECEMBER, 2000


 


BETWEEN


 


BIOVAIL LABORATORIES
INCORPORATED,


a Barbados corporation
incorporated under the


International Business
Companies Act, 1991-24,


whose head office is


Chelston Park


Building 2, Collymore Rock


St Michael BH1


Barbados, West Indies


 


hereafter “BLI”


 


AND


 


ETHYPHARM S.A.


a French corporation having
offices at


21 rue Saint Mathieu


78550 Houdan


France


 


Hereafter “Ethypharm”


 


WHEREAS
Ethypharm has developed certain technology relating to diltiazem formulations
for the North American market, which are bioequivalent to Cardizem CD.


 


WHEREAS
Ethypharm and Aventis Pharmaceuticals Inc. (“API”) have entered into a
non-exclusive license agreement effective the 5th day of December, 1996, and
certain amendments to that agreement made the 5th day of December, 1996, the
4th of January, 1999, and the 21st day of July, 2000, (all collectively
referred to as the “License Agreement”) under which API was granted the
non-exclusive right and license under Ethypharm’s Technology in the Territory,
all as defined in the License Agreement.


 


WHEREAS BLI
has acquired the License Agreement by assignment from API;


 


WHEREAS BLI
and Ethypharm have agreed to effect certain changes to the License Agreement,
effective upon any assignment of the License Agreement from API to BLI;


 

















 


IN
CONSIDERATION OF the mutual covenants and
agreements contained in this Agreement and other good and valuable
consideration (the receipt and sufficiency of which are acknowledged by each of
the Parties), it is agreed by and between the Parties as follows:


 


1.                                    DEFINITIONS


 


Where used in
this Amendment any capitalized terms defined below shall have the meanings
given to them in this Agreement, and those not defined below shall have the
meanings given to them to them in the License Agreement, respectively:


 


1.1                               Conversion
Date
means the date upon which Biovail delivers to Ethypharm the notice contemplated
by paragraphs 4.1 or 4.2.


 


1.2                               Diltiazem
Products
means all controlled release formulations of any medicine containing diltiazem.


 


1.3                               Effective
Date
means the date set out on page 1 of this Agreement.


 


1.4                               Ethypharm
Patents
means any patents or patent applications disclosing or claiming the Ethypharm
Technology or any aspect of it, and includes without limitation US Patent
Application Number 09/091,646, filed June 22, 1998, and Canadian Patent
Application Number 2,242,224, filed June 22, 1998, and any patents to
issue from those applications.


 


1.5                               Parties means BLI and Ethypharm, and
Party means any one of them.


 


1.6                               Payment means the amount to be paid
to Ethypharm pursuant to the provisions of Article 3 of this Agreement.


 


1.7                               Sub-Licensed
Products
means any extended release oral formulation of diltiazem, containing less than
360 mg of diltiazem,


 


(a)                                  for which Regulatory Approval
will be sought or granted on the basis of a New Drug Application filed with the
FDA that does not assert that the Sub-Licensed Product is bioequivalent to any
product which has already received Regulatory Approval from the FDA; or


 


(b)                                 for which Regulatory Approval
will be sought or granted on the basis that such formulation is AB-rated
bioequivalent to a formulation described in New Drug Application #20-062,
approved by the FDA with respect to a once a day dosage form of diltiazem
hydrochloride; or


 


(c)                                  and which also contains at
least one other active ingredient; (ie is a combination product); or


 


(d)                                 is a formulation for which
Regulatory Approval will be sought or granted on the basis that it is, and which
will be Marketed as, a twice-daily formulation.


 


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but does not
include any extended release oral formulation of diltiazem for which Regulatory
Approval is sought or granted on the basis that such product or formulation is
AB-rated bioequivalent to any formulation described in Biovail’s New Drug
Application #20-401, approved by the FDA with respect to a once a day dosage
form of diltiazem hydrochloride, or in any supplements or amendments to that
New Drug Application.


 


1.8                               Term of
the Agreement means the time period starting on the Effective Date and continuing
until the expiry or termination of the License Agreement.


 


1.9                               Territory means the United States of
America, its territories and possessions, and Canada, including Quebec.


 


2.                                    ASSIGNMENT OF THE LICENSE
AGREEMENT


 


2.1                                 Ethypharm acknowledges that BLI has
acquired by assignment from API to BLI all of the right, title and interest of
API in, including all rights and obligations of API under, the License
Agreement for the Territory only, except for API’s obligations to Ethypharm
under Article VIII, of said License Agreement, and acknowledges that from
and after the Effective Date, all of the rights and obligations of API under
the License Agreement as limited here in and for the Territory shall have been
transferred and assigned to BLI.


 


3.                                    PAYMENT OF ROYALTIES


 


3.1                               On the Effective Date, BLI
shall pay by wire Transfer to Ethypharm the sum of {***}† in consideration
of all of the royalty payments owing to Ethypharm from the Effective Date to
the end of the Term of the License Agreement.


 


3.2                               Notwithstanding the provisions
of sections 4.02 and 4.03 of the Non-Exclusive License Agreement effective the
5th day of December, 1996, as amended, and
notwithstanding the provisions of sections 2 and 3 of the Amending Agreement of
July 21, 2000, BLI shall have no further obligation to pay to Ethypharm
any royalty payments, including any minimum royalty payments, in respect of the
use of the Ethypharm Technology or the Ethypharm Patents to make, use, sell,
offer for sale, or import Diltiazem Products in the Territory.


 


4.                                    BLI EXCLUSIVITY


 


4.1                               If at any time prior to February 20,
2001, BLI is satisfied that US patent application no. 09/091,646 will issue
with claims enforceable against competing controlled release diltiazem-based
products, BLI shall convert the rights granted by the License Agreement from
non-exclusive to exclusive by paying to Ethypharm the sum of {***}† within five
(5) business days after the date of issue of the patent.


 






† 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.


 


3

















 


4.2                               If at any time prior to March 15,
2001, BLI is satisfied that US patent application no. 09/091,646 will issue
with claims enforceable against competing controlled release diltiazem-based
products, BLI may convert the rights granted by the License Agreement from
non-exclusive to exclusive by notice in writing to Ethypharm. Upon delivery of
that notice, BLI shall pay to Ethypharm the sum of {***}† within five (5) business
days after the date of issue of the patent.


 


4.3                               Notwithstanding the provisions
of the License Agreement, Ethypharm acknowledges that, subject only to the
provisions of this Agreement, the rights granted to BLI from and after the
Conversion Date shall be exclusive, and that after the Conversion Date BLI
shall have the exclusive right to use the Ethypharm Technology and the
Ethypharm Patents to make, use, sell, offer for sale, or import Diltiazem
Products in the Territory.


 


4.4                               Upon the Conversion Date, BLI
shall grant to Ethypharm a royalty free, non-exclusive license to Manufacture
and Market, directly or indirectly, the Sub-Licensed Products in the Territory.


 


No other changes to the License Agreement


 


4.5                               Except as specifically amended
by this Agreement, all terms of the License Agreement shall remain in full
force and effect.


 


5.                                    OWNERSHIP OF ETHYPHARM
TECHNOLOGY


 


5.1                               In addition to the
representations and warranties contained in the License Agreement, Ethypharm
represents and warrants to BLI that:


 


(a)                                  it owns the Ethypharm Technology
and the Ethypharm Patents and has the right to grant to BLI the rights granted
by this Agreement.


 


(b)                                 it has not granted to any
other person any rights inconsistent with the rights granted to API by the
License Agreement or to BLI by this Agreement.


 


(c)                                  its performance of this
Agreement, and the grant to BLI of the exclusive rights granted by this
agreement, does not conflict with, or result in breach of, any other agreement
to which it or any of its Affiliates is a party, or by which its rights to
intellectual property are bound.


 


(d)                                 Ethypharm is not aware of any
breach by API of; and does not intend to make any claim for, any of the terms
of the License Agreement prior to the Effective Date.


 






† 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.


 


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6.                                    PROSECUTION OF PATENT
APPLICATION


 


6.1                               Ethypharm shall cause all
applications for the Ethypharm Patents in the Territory to be prosecuted
diligently and shall take all steps reasonably available to Ethypharm to ensure
that any patents issue as soon as possible.


 


6.2                               Ethypharm shall provide to BLI
or to a patent attorney or patent agent designated by BLI copies of all
communications from the US and Canadian patent offices, and all responses to
those communications. If at any time after the Effective Date BLI is not satisfied
with the prosecution of any applications for the Ethypharm Patents in the
Territory, BLI may on notice in writing to Ethypharm assume responsibility for
the prosecution of those applications. Ethypharm shall provide all assistance
that BLI may reasonably require for that purpose.


 


7.                                    INFRINGMENT PROCEEDINGS


 


7.1                               Effective from and after the
Conversion Date, each of BLI and Ethypharm shall immediately report to the
other any infringement of, challenge to the validity or ownership of, or use of
the Ethypharm Technology or of the Ethypharm Patents that may come to their
attention. BLI shall have the sole and exclusive right to commence and
prosecute any action or proceeding in respect of any such infringement or
misappropriation, and if necessary may do so in the name of Ethypharm.
Ethypharm shall fully co-operate with BLI at the expense of BLI and execute
such documents and do such acts and things as, in the opinion of BLI, may be
necessary or desirable. If BLI shall fail within a reasonable time to take appropriate
steps against that infringement or misappropriation, Ethypharm shall be
entitled to take such reasonable steps against such infringement or
misappropriation for the protection of BLI’s and/or Ethypharm’s rights, and if
necessary may do so in the name of and on behalf of BLI.


 


8.                                    TERM AND TERMINATION


 


8.1                               The Term of this Agreement
shall terminate upon any termination or expiry of the License Agreement, and
shall be extended upon any extension of the License Agreement.


 


8.2                               This Agreement shall not be
subject to termination for any breach or default of either party, except after
all other remedies as provided for in this Agreement have been exhausted, and
the Party found to be in default has failed to comply with an order or judgment
of a court of competent jurisdiction.


 


9.                                      FORCE MAJEURE


 


9.1                               In the event that either party
hereto shall be rendered unable to carry out its obligations under this
Agreement, other than obligations to render statements and make payments
pursuant to the provisions of this Agreement, by reason or causes beyond its
control, including but not restricted to acts of God, acts, omissions, or
regulations of any government or subdivision thereof, judicial action, fire,
storm, accident, war, riot, labor disputes, or transportation failure, then the
performance of the obligations of such party insofar as it is affected by such
cause, shall be excused during the continuance of any 


 


5

















 


inability so caused provided that the party affected advises
the other party of its inability within thirty (30) days after such cause comes
into existence.


 


10.                             GOVERNING LAW


 


10.1                         This Agreement shall be
construed, interpreted and enforced in accordance with the laws of New York
without giving effect to principles of conflicts of law, unless otherwise
provided for in this Agreement.


 


11.                               MISCELLANEOUS


 


11.1                         Nothing herein contained shall
be deemed to constitute or be construed as constituting either Party the agent
or partner of the other. The relationship of the Parties shall be that of
independent contractors. Neither party shall have any right, title or authority
to enter into any contract, agreement or commitment on behalf of the other or
to bind the other in any manner whatsoever.


 


11.2                         This Agreement, together with
the Licensing Agreement, constitutes the entire agreement between the Parties
with respect to the subject matter hereof and supersedes all prior agreements,
undertakings, negotiations and discussions, whether oral or written, with
respect to the subject matter hereof. There are no other agreements between the
Parties, collateral or otherwise, written or oral, relating to the subject
matter hereof. Unless expressly stated otherwise herein, this Agreement shall
not be amended, modified or supplemented except by a writing signed by the
Parties.


 


11.3                         If any one or more provisions
of this Agreement are found or held prohibited, invalid, illegal or
unenforceable in any respect in any jurisdiction in relation to any Party, such
prohibition, invalidity, illegality or unenforceability shall not affect,
impair or invalidate the remaining provisions hereof or of the Agreement
itself, or affect or impair the validity, legality or enforceability of such
provision in any other jurisdiction or in relation to any other Party, and any
such prohibited, invalid, illegal or unenforceable provision shall be deemed to
be severable.


 


11.4                         Ethypharm confirms that it has
received its own independent legal advice with respect to this Agreement and is
satisfied that the terms of this Agreement comply with all applicable laws and
regulations in the Territory.


 


11.5                         Any notices required or
permitted to be given hereunder may be effectively given if delivered
personally or sent by facsimile and addressed in the case of BLI to:


 


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In the case of Biovail to:


 


Biovail Laboratories Incorporated


Chelston Park


Building 2, Collymore Rock


St Michael


Barbados, West Indies


 


Attention:            Eugene
Melnyk, President


Facsimile:            (246)
437-7085


 


with a copy to:


 


Biovail Corporation International


2488 Dunwin Drive


Mississauga, Ontario L5L 1J9


 


Attention: The President


Facsimile (416) 285-6499


 


or in the case of Ethypharm to:


 


Ethypharm S.A.


21 rue Saint Mathieu


78550 Houdan, France


 


Attention:            
Patrice Debregeas


President, Directeur General


Facsimile:            33-1-41122989


 


11.6                         Any such notice shall be
deemed to have been given and received when actually received, unless the day
of receipt is not a Business Day in which event it shall be deemed to have been
given and received on the next following Business Day. Any Party may change its
address for notice from time to time by notice given in accordance with the
foregoing.


 


11.7                         This Agreement may be signed
in any number of counterparts which when taken together will constitute one and
the same Agreement, and may be delivered by facsimile transmission of an executed
counterpart of the Agreement.


 


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IN
WITNESS WHEREOF the Parties to this
Agreement have caused this Agreement to be executed by their duly authorized
representatives effective as of the date first written above.


 


 


	
  BIOVAIL LABORATORIES INCORPORATED

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Per:

  	
  /s/ Eugene Melnyk

  	
   

  	
   

  
	
   

  	
  Eugene Melnyk, President

  	
   

  	
   

  



 


 


	
  ETHYPHARM S.A.

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Patrice Debregeas

  	
   

  	
   

  
	
   

  	
  Patrice Debregeas, President Directeur General