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:

 

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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

 

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† 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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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

 

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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.

 

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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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