Exhibit 10.12


 


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 NO. 1 TO THE SUPPLY
AGREEMENT


 


This Amendment No. 1,
is entered into as of the 30th day of December 2005 (the “Effective Date”),
by and between:


 


PLANTEX USA, INC.


 


a corporation organized under the laws of the State
of New Jersey with offices at Two University Plaza, Suite 305, Hackensack
NJ 07601


 


(“Plantex”)


 


- and -


 


BIOVAIL LABORATORIES INTERNATIONAL SRL


 


a Barbados society with restricted liability, whose
head office is Chelston Park, Building 2, Collymore Rock, St. Micheal BH1,
Barbados, West Indies


 


(“Biovail”)


 


WHEREAS on or about September 30,
2004, Biovail Laboratories Incorporated (“BLI”) and Plantex entered into a
Supply Agreement (the “Agreement”) for the purchase and supply of the active
pharmaceutical ingredient, diltiazem hydrochloride, under the terms and
conditions set forth in the Agreement;


 


WHEREAS effective as of January 27,
2005, BLI merged into its parent and was subsequently wound up into its
affiliate Biovail;


 


WHEREAS Biovail and Plantex
have agreed to amend the Agreement as provided herein;


 


NOW, THEREFORE, for and in
consideration of the premises and mutual promises and benefits contained
herein, the parties hereby agree as follows:


 


1.             Unless otherwise specifically defined
herein, each term used herein which is defined in the Agreement, shall have the
same meaning ascribed to such term in the Agreement.


 


2.             As of the Effective Date of this Amendment
No.1, the Agreement is amended and modified as follows:


 

















 


a.             Section 1.4.21 is added:


 


“Stored API”
- means the API which has been purchased by Biovail or its Affiliates from
Plantex and has been sold and stored by Plantex on behalf of Biovail or its
Affiliates pursuant to Section 2.1.”


 


b.             Section 2.1 is deleted in its entirety
and is replaced with the following:


 


“From the Effective Date
through December 31, 2005, Biovail shall purchase, or cause its Affiliates
to purchase, from Plantex, and Plantex shall sell to Biovail or such
Affiliates, a minimum quantity of {***}†  of API. Plantex acknowledges that, as of November 22, 2005,
Biovail has purchased and taken delivery of {***}† of
API. By December 31, 2005, Biovail shall purchase, or cause its Affiliates
to purchase, from Plantex, and Plantex shall sell to Biovail or such
Affiliates, an additional {***}† of
API (“Additional API”).


 


For the calendar year 2006,
Biovail shall purchase, or cause its Affiliates to purchase, from Plantex, and
Plantex shall sell to Biovail or such Affiliates {***}† of
API (“2006 API”).


 


Plantex shall store the 2006
API and the Additional API on Biovail’s behalf or such Affiliates’ behalf under
cGMP conditions in Israel, for delivery to Biovail or such Affiliates in
accordance with Biovail’s or such Affiliates’ directions and Section 4
(Ownership; Delivery; Risk of Loss) herein below.


 


Thereafter, for the period
commencing on January 1, 2007 through to the end of the Term, Biovail
hereby agrees that at least {***}† of
the API used in all Finished Products manufactured and/or marketed by Biovail
or its Affiliates for sale in the Territory shall be comprised of API sold by
Plantex to Biovail or its Affiliates hereunder, and Biovail and its Affiliates
shall purchase such API directly from Plantex and Plantex shall sell such API
to Biovail or its Affiliates in accordance with the terms of this Agreement to
accomplish the foregoing. In addition to the 2006 API and the Additional API,
Plantex shall store all API purchased by Biovail or its Affiliates (to the
extent Biovail and Plantex subsequently expressly agree in writing that Plantex
store such API) under cGMP conditions in Israel, for delivery to Biovail in
accordance with Biovail’s or such Affiliates’ directions and Section 4
(Ownership; Delivery; Risk of Loss) herein below.”


 


c.             The fourth (4th) sentence in Section 2.2 (“Plantex will...of API”)
is replaced with the following sentences:


 


“Plantex will issue invoices
upon departure of API from the API manufacturing facility.” Plantex will
provide Biovail or its Affiliates, with such invoices, the lot 


 






†  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

















 


numbers and the quantities
of API in each such lot and the expiration dates of each such lot, which are
held by Plantex as Stored API in accordance with Section 2.1”


 


d.             Section 4 is deleted in its entirety
and is replaced with the following:


 


“Ownership; Delivery; Risk
of Loss


 


Title to and ownership of
Stored API shall pass from Plantex to Biovail or its Affiliates only after the
Stored API ordered by Biovail or its Affiliates is manufactured by Plantex,
invoiced to Biovail or its Affiliates and stored by Plantex on Biovail’s or its
Affiliates’ behalf in accordance with Section 2.1. Notwithstanding
transfer of ownership, risk of loss of Stored API shall pass from Plantex to
Biovail or its Affiliates when the Stored API is delivered CIP (per Incoterms
2000) San Juan, Puerto Rico or such other port as may be directed from time to
time by Biovail or its Affiliate.


 


Other than Stored API, title
to, ownership of and risk of loss of API ordered by Biovail or its Affiliates
in accordance with this Agreement shall pass from Plantex to Biovail or its
Affiliates when API is delivered CIP (per Incoterms 2000) San Juan, Puerto Rico
or such other port as may be directed from time to time by Biovail or its
Affiliate.


 


All deliveries from Plantex
will be made on or before the delivery date specified on each Firm Purchase
Order or the additional purchase orders accepted and confirmed in writing by
Plantex.”


 


e.             Section 14.3 is amended as follows:


 


“BIOVAIL LABORATORIES
INCORPORATED” is deleted and replaced with “BIOVAIL LABORATORIES INTERNATIONAL
SRL”.


 


3.             It is agreed that the Parties are currently
developing “new” specifications for the API which may be different from those
specifications attached as “Schedule I” to the Agreement. Once the Parties
agree in writing to “new” specifications that are appropriate for the
manufacture of the Finished Products and that Plantex or its Affiliate can meet
such “new” specifications, then these “new” specifications shall be deemed “Specifications”
for all purposes of the Agreement and deemed added to the Agreement as Schedule
I, replacing the existing Schedule I. Plantex shall bear all the
costs associated with ensuring API (including Stored API) conforms to “Specifications”
at the time of delivery to Biovail or its Affiliates.


 


4.             Except as amended hereby, the Agreement
shall continue in full force and effect in accordance with its terms. This
Amendment No. 1 shall be deemed incorporated into, and a part of, the
Agreement for any and all purposes as of its Effective Date.


 


5.             This Amendment No. 1 and the
Agreement, as amended by this Amendment No. 1, constitute the entire
agreement and understanding between the parties hereto and 


 


3

















 


supersede all prior negotiations, representations or
agreements, whether written or oral, relating to the subject matter hereof.


 


6.             This Amendment No. 1 may be executed
in multiple counterparts, each of which shall be deemed an original but all of
which, taken together, shall constitute one and the same instrument.


 


7.             The validity, performance and construction
of this Amendment No. 1 shall be governed by, and construed in accordance
with the laws of the State of New Jersey, without regard to its choice of law
or conflict of law rules.


 


4

















 


IN WITNESS THEREOF, the
parties hereto have caused this Amendment No. 1 to be executed by their
duly authorized representatives as of the latest date set forth below.


 


	
  Plantex USA, Inc.

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Georve Svokos

  	
   

  	
  By:

  	
  /s/ Cheryl Bohnel

  
	
  Name:

  	
  George Svokos

  	
   

  	
  Name:

  	
  Cheryl Bohnel

  
	
  Title:

  	
  President

  	
   

  	
  Title:

  	
  Director of Accounting /
  Corporate Secretary

  
	
  Date:

  	
  December 30, 2005

  	
   

  	
  Date:

  	
  December 30, 2005

  



 


 


	
  Biovail Laboratories International SRL

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ John A.R. McCleery

  	
   

  	
  By:

  	
   

  
	
  Name:

  	
  John A.R. McCleery

  	
   

  	
  Name:

  	
   

  
	
  Title:

  	
  Vice President, General
  Manager

  	
   

  	
  Title:

  	
   

  
	
  Date:

  	
  December 30, 2005

  	
   

  	
  Date:

  	
   

  



 


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