CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE
CONFIDENTIAL PORTIONS HAVE BEEN REDACTED AND ARE DENOTED BY A
TRIPLE ASTERISK (***). THE CONFIDENTIAL PORTIONS HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION.
THIS FIRST
AMENDMENT TO DISTRIBUTION AGREEMENT (the “First Amendment”) is entered
into as of this 15 th day of August, 2008 (the “Amendment
Date”) by and between Amphastar Pharmaceuticals, Inc., a
Delaware Corporation, (“Amphastar”) and Andrx
Pharmaceuticals, Inc. a Florida Corporation, d/b/a Watson
Laboratories — Florida (“Watson”).
WHEREAS,
Amphastar and Watson have previously entered into that certain
Distribution Agreement dated May 2, 2005 (the
“Agreement”) related to, among other things,
Watson’s distribution of Product (as defined in the
Agreement); and
WHEREAS, the
parties wish to amend the Agreement as set forth below;
NOW THEREFORE,
in consideration of the mutual covenants and promises contained
herein, and for other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties
hereby agree as follows:
1. Amendment
of Section 3.1 and 3.2.2 of the Agreement.
(a) Section 3.1 of the Agreement is
hereby deleted in its entirety and replaced with the
following:
“ 3.1
Milestones and Payments. In consideration of Seller’s
grant of the exclusive distribution rights hereunder to Purchaser,
Purchaser shall pay Seller the sum of $4,500,000 upon the Effective
Date of this Agreement.”
(b) The
fourth line of Section 3.2.2 of the Agreement is hereby
amended by replacing “Section 3.1(a)” with
“Section 3.1.”
2. Amendment
of Sections 4.1.1 and 4.1.2 of the Agreement.
(a) The
fourth line of Section 4.1.1 of the Agreement is hereby
amended by replacing [***] with [***] The fifth line of
Section 4.1.1 of the Agreement is hereby amended by replacing
[***] with [***].
(b) The
first line of Section 4.1.2 is hereby amended by replacing
“third anniversary” with “first
anniversary.”
3. Amendment
of Section 4.2.1(a) of the Agreement.
Section 4.2.1(a) of the Agreement is hereby
amended by replacing “60%” with [***]
*** Certain
confidential information contained in this document, marked with
three asterisks, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.
4. Amendment
of Section 5.1 of the Agreement.
Section 5.1 of the Agreement is hereby
deleted in its entirety and replaced with the following section
5.1:
“ 5.1
Initial Purchase Order; Launch Quantities. Within ten
(10) days of the Amendment Date, Purchaser shall deliver to
Seller an initial binding order (the “Initial Purchase
Order”) for [***] units of Product (the “Launch
Quantities”) required for Purchaser’s commercial launch
of the Product consistent with Purchaser’s then current
Forecast. Subject to the terms of this Agreement , Seller shall
supply the Launch Quantities to Purchaser within [***] days of
Seller’s receipt of final FDA approval of the Product ANDA.
Seller shall thereafter use Commercially Reasonable Efforts to
supply Purchaser such additional quantities of the Product as
ordered by Purchaser hereunder pursuant to Section 5.3. All Launch
Quantities shall have at least [***] of expiry dating remaining on
such Products at the time of delivery to Purchaser. In order to
ensure adequate inventory to timely deliver Purchaser’s
anticipated needs for Launch Quantities, upon receipt of the
Initial Purchase Order Seller shall promptly commence manufacture
of [***]
