Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
April 30, 2007
Xxx Xxxxxxx
Vice President, Sales
Ortho Biotech Inc.
000 Xxxxx 00 Xxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
RE: First Amendment to the Co-Promotion Agreement between Millennium
Pharmaceuticals, Inc. ("Millennium") and Ortho Biotech Inc. ("OBI") dated
October 25, 2006 (the "Co-Promotion Agreement")
Dear Xxx:
The purpose of this letter ("Letter Amendment") is to amend the responsibilities
and obligations of OBI regarding attainment of reach and frequency minimums
under the Co-Promotion Agreement. Capitalized terms used herein but not defined
will have the same meaning given to them in the Co-Promotion Agreement.
This Letter Amendment shall be in effect upon the FDA's issuance of a notice of
approval of OBI's or its Affiliate's license to market and sell Doxil(R) for use
in combination with the Product for treatment of multiple myeloma ("Doxil
Approval") and shall continue in full force and effect until December 31, 2007
(the "Term").
The Parties agree as follows:
1. OBI shall submit to the CPMC for review and approval, any advertising,
promotional, (training and communication) materials of Doxil, including
without limitation the core visual sales aid for the launch of the
Doxil Approval, which are intended for use by Sales Representatives to
Co-Promote the Product in combination with Doxil within the
Co-Promotion Territory. During the Term, OBI shall use its best efforts
to incorporate Millennium's comments on these materials in accordance
with the review and approval provisions for Core Promotional Materials
as set forth in Section 2.4.1 of the Co-Promotion Agreement.
2. The Co-Promotion Agreement shall be amended by replacing the defined
terms Call, First Position Call and Second Position Call with the
definitions set forth below. These revised definitions will be in
effect during the Term, and thereafter,
the terms Call, First Position Call and Second Position Call will be
defined as set forth under the Co-Promotion Agreement as of its
effective date.
a. "CALL" means an in-person presentation of the Product made by
a Sales Representative or the Product in combination with
Doxil made by a Sales Representative using the materials
approved by the CPMC in paragraph 1 above, to a MLNM Target
during which the Sales Representative describes the Product in
a fair and balanced manner consistent with the requirements of
the Agreement and Applicable Law and in a manner that is
customary in the industry for the purpose of promoting a
prescription pharmaceutical product. "Calls" shall be deemed
to include only full sales presentations and shall not be
deemed to include "reminder" details or e-details, in each
case as such terms are generally understood in the
pharmaceutical industry, or any presentations made at
conventions, consulting programs or similar gatherings.
b. "FIRST POSITION CALL" shall mean a Call in which at least [**]
percent ([**]%) of the presentation is dedicated solely to the
Product or the Product in combination with Doxil, each in
accordance with the Co-Promotion Plan and in which the Product
or the Product in combination with Doxil is the first product
presented to the First Position Target.
c. "SECOND POSITION CALL" shall mean (a) a Call in which at least
[**] percent ([**]%) of the presentation is dedicated solely
to the Product or the Product in combination with Doxil, each
in accordance with the Co-Promotion Plan and in which the
Product or the Product in combination with Doxil is at least
the second product presented to the Second Position Target; or
(b) a Call in which at least [**] percent ([**]%) of the
presentation is dedicated solely to the Product or the Product
in combination with Doxil, each in accordance with the
Co-Promotion Plan and in which the Product or the Product in
combination with Doxil is the first product presented to the
Second Position Target.
Except as otherwise expressly modified by this Letter Amendment, the
Co-Promotion Agreement shall remain in full force and effect in accordance with
its terms.
Please acknowledge your acceptance of the terms set forth above by
countersigning this Letter Amendment where indicated below and returning a
signed copy to my attention.
Sincerely,
Millennium Pharmaceuticals, Inc.
By: /s/ XXXXX X. XXXXX
Title: SVP - Sales and Marketing
Date: 4/30/07
AGREED TO AND ACCEPTED:
Ortho Biotech Products, L.P.
By: /s/ XXXXXXX XXXXX
Title: VP ONCOLOGY
Date: 5-2-07
cc:
Xxxxxxx Xxxxx
President
Ortho Biotech Products, L.P.
