Exhibit 10.22
AMENDMENT NO. 1 TO AAD DEVICE
SUPPLY AGREEMENT
December 2, 2005 (effective October 1,
2005)
This Amendment No. 1 to AAD
Device Supply Agreement (“ Amendment ”) is made
this second day of December, 2005, effective as of October 1,
2005, by and between Respironics Respiratory Drug Delivery (UK)
Ltd., formerly known as Profile Drug Delivery Ltd., with its
principal place of business at Heath Place, Bognor Regis, West
Sussex, PO22 9SL, United Kingdom (“ Respironics RDD UK
”), and CoTherix, Inc. with its principal place of business
at 5000 Shoreline Court, Suite 101, South San Francisco, California
94080 (“ CoTherix ”).
WHEREAS, Respironics RDD UK
and CoTherix are parties to that certain AAD Device Supply
Agreement dated December 29, 2004 (the “ Original
Agreement ” and together with this Amendment, the “
Agreement ”); and
WHEREAS, the parties wish to amend
the Original Agreement as set forth below.
NOW, THEREFORE, the parties hereto,
intending to be legally bound, hereby agree as follows:
1. Article 7 of the Original
Agreement is hereby amended to read in its entirety as
follows:
ARTICLE 7 - RIGHTS TO DISTRIBUTE;
EXCLUSIVITY
7.1 Exclusivity with Respect to
Ventavis and Iloprost . Except for any third party licensed by
Schering (or any successor or assign of Schering) to distribute
Ventavis or any other formulation of Iloprost in the Territory
during the Term (“ Schering Iloprost Licensee
”), CoTherix shall have the exclusive right, during the Term,
to distribute in the Territory, with Ventavis and any formulation
of Iloprost (or any product containing Iloprost (in any form) as
its active pharmaceutical ingredient), the AAD Devices and
Successor AAD Devices (as hereinafter defined in this
Section 7.1), and Consumables and Successor Consumables (as
hereinafter defined in this Section 7.1).
CoTherix shall not have any right to
distribute AAD Devices and Successor AAD Devices, or Consumables
and Successor Consumables, (a) outside the Territory,
(b) with any pharmaceuticals other than Ventavis or
formulations of Iloprost (or any product containing Iloprost (in
any form) as its active pharmaceutical ingredient), or
(c) after the end of the Term.
Respironics RDD UK shall retain the
right to distribute AAD Devices and Successor AAD Devices and
Consumables and Successor Consumables, both inside and outside the
Territory, provided that during the Term, neither Respironics RDD
UK nor any of its affiliates shall, nor shall any of them grant to
any third party other than a Schering Iloprost Licensee, the right
to distribute or offer for sale in the Territory AAD Devices and
Successor AAD Devices and/or Consumables and Successor Consumables
with, or otherwise use, exercise or exploit in the Territory, any
AAD Device Medication Volume Work, Device IP or AAD Device
Medication Volume IP (all as defined in Article 11) in connection
with Ventavis or Iloprost in any formulation (or any product
containing Iloprost (in any form) as its active pharmaceutical
ingredient), except on behalf of CoTherix under this Agreement and
on behalf of any other Schering Iloprost Licensee.
In the event of an early termination
of this Agreement due to an uncured Material Breach by Respironics
RDD UK or a Bankruptcy of Respironics RDD UK, the exclusive rights
granted to CoTherix (and corresponding restrictions on Respironics
RDD UK) in this Section shall survive such termination for a period
of time equal to the remainder of the Initial Term had this
Agreement not been terminated.
1
As used in this Agreement, the
following terms shall have the meanings set forth below:
“ AAD Devices ”
means the Prodose Device and the I-Neb.
“ Successor AAD Devices
” means (a) any future aerosol drug delivery device
developed or marketed by or for Respironics RDD UK that is an
improvement, derivative or new version of, or replacement or
substitute for, the Prodose Device or the I-Neb, provided that such
future aerosol drug delivery device combines AAD Technology (as
hereinafter defined) with vibrating mesh technology, and
(b) if the Prodose Device is discontinued at a time when the
I-Neb is not available, or the I-Neb is discontinued at a time when
Respironics RDD UK no longer offers for sale any aerosol drug
delivery device that combines AAD Technology with a vibrating mesh
technology, the aerosol drug delivery device that Respironics RDD
UK is marketing as the replacement for the Prodose Device, or the
I-Neb, as applicable, even if such new aerosol drug delivery device
does not combine AAD Technology with a vibrating mesh
technology.
“ AAD Technology
” means proprietary technology of Respironics RDD UK that
uses electronics and sensors contained within the aerosol drug
delivery device to do all of the following during the course of
each treatment: (a) deliver aerosolized drug during the first
part of an inspiratory breath, (b) analyze and monitor a
patient’s preceding breaths, and (c) based on the
analysis of the preceding breaths, adapt the delivery of the
aerosolized drug.
“ Successor Consumables
” means any improvement, derivative or new version of, or
replacement or substitute for, a Consumable, which is marketed,
sold or otherwise disposed of, or licensed by or for Respironics
RDD UK for use with AAD Devices and/or any Successor AAD
Devices.
7.2 Exclusivity in Pulmonary
Hypertension Market . CoTherix has elected for the period
beginning on October 1, 2005 and ending on December 31,
2005 (the “ Initial Exclusivity Period ”), to
receive, and Respironics RDD UK hereby grants CoTherix, the
exclusive right, in the Territory, to distribute (itself or through
one or more distribution layers), offer for sale or otherwise
dispose of AAD Devices and Successor AAD Devices and Consumables
and Successor Consumables, with any and all compounds belonging to
the prostacyclin class of compounds or that are synthetic or
naturally occurring analogues of prostacyclin capable of binding to
the prostaglandin I2 (PG I2) re
