EXHIBIT 10.5
Amendment Number One
To That Certain Agreement by and between Xxxxxxxxxx Laboratories, Inc.,
and
Xxxxxxxxxx Laboratories Belgium, N.V. and CSC Pharmaceuticals, LTD.,
Dublin
This attachment amends and revises that certain Sales
Distribution Agreement dated April 17, 1998, by and between Xxxxxxxxxx
Laboratories, Inc., and Xxxxxxxxxx Laboratories Belgium N.V. (together
hereinafter referred to as "Xxxxxxxxxx") and CSC Pharmaceuticals, LTD,
Dublin, a Swiss Corporation ("CSC").
Article 3. Certain Performance Requirements
3.13 CSC shall have the ability to access all technical files
relevant to all products covered under this agreement for a
period up to five (5) years after termination of the
Agreement.
3.14 CSC is granted authorization to all Xxxxxxxxxx post-
marketing data obtained in any market area covered by this
Agreement and CSC is authorized to use Xxxxxxxxxx'x current
contractors or select a contractor of its choice to gather
market data in the territory covered by this Agreement. This
shall include production and post-marketing surveillance
data.
Article 4. Registration of Products
4.10 The DiaB[TM] and RadiaCare[TM] Products are authorized to be
marketed in the U.S., European Union and Pacific Rim by the
relevant regulatory body. Xxxxxxxxxx authorizes CSC to
market the Products under the DiaB[TM] or RadiaCare[TM]
names or a name that CSC selects for the Products in the
territory covered by this Agreement.
This Amendment shall become effective upon its execution by both
parties.
All other terms and conditions of the Agreement remain unchanged.
AGREED AND ACCEPTED BY:
XXXXXXXXXX LABORATORIES, INC.
_________________________________
Name: Xxxxxxx X. Xxxxxx, Ph.D., X.Xx.
Title: President & CEO
XXXXXXXXXX LABORATORIES BELGIUM N.V.
_________________________________
Name: Xxxxxxx X. Xxxxxx, Ph.D., X.Xx.
Title: President & CEO
CSC PHARMACEUTICALS, LTD DUBLIN
_________________________________
Name: Xx. Xxxxxxx Xxxxxxxxx
Title: CEO
