EXHIBIT 10.3
*Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Corixa Corporation
0000 Xxxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000, X.X.X.
Attention: Chairman
Re: Amendment of Collaboration Agreement between
Xxxxxxx Pharmaceutical, Inc. and SmithKline Xxxxxxx Corporation
Dear Sir:
This Amendment Agreement sets forth our agreement that, as to the
matters set forth herein in connection with the Collaboration Agreement (the
"Agreement"), executed as of October 23, 1998 by and between Xxxxxxx
Pharmaceutical, Inc., a company incorporated under the laws of the State of
Delaware, with its principal place of business at 000 Xxxxxxx Xxxxxxxxx, Xxxxx
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000, U.S.A. which has been acquired by Corixa
Corporation, a company incorporated under the laws of the State of Delaware,
with its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxx, Xxxxxxxxxx 00000, X.X.X. ("Xxxxxxx"), and SmithKline Xxxxxxx
Corporation (a GlaxoSmithKline Company), a company incorporated under the laws
of the Commonwealth of Pennsylvania, with its principal place of business at Xxx
Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X. ("SB"), as amended to
date, the parties hereto agree as follows.
All terms not defined herein shall have the meanings ascribed to them in the
Agreement.
- Section 3.2.4(a) - The following sentence shall be added to the
end of the paragraph:
" Notwithstanding Sections 3.2.1, 3.2.2, 3.2.3 or the above,
lead party responsibility for phase IV clinical programs will be determined by
the JDC and JCC. Such determination will take into consideration size, cost and
data required by a proposed clinical trial."
- Section 6.7 - This Section shall be deleted in its entirety.
- Sections 7.1.6(a) and 7.1.6(b)(i) - These Sections shall be
deleted in their entirety and replaced with the following:.
"7.1.6(a) SALES EFFORTS. Xxxxxxx and SB shall each use
COMMERCIALLY REASONABLE EFFORTS to CO-PROMOTE the PRODUCT in TERRITORY A
pursuant to the terms and conditions hereof. The JCC will agree upon and monitor
each Party's SALES EFFORT (as defined below) for each Co-Promotion Year during
the TERM OF CO-PROMOTION. "Co-Promotion Year" shall mean, for the calendar year
in which the Parties are first engaged in CO-PROMOTION, the portion of the
calendar year remaining beginning upon the date of the FIRST COMMERCIAL SALE of
the PRODUCT in TERRITORY A, and shall mean the relevant January 1 through
December 31 calendar year, or pro rata portion thereof, for all subsequent
calendar years during the TERM OF CO-PROMOTION. "SALES EFFORT" shall mean only
those FTEs who receive a percentage of their
Redacted
performance bonus for their activities directly related to actual face-to-face
interactions with members of the target audience in TERRITORY A, in accordance
with the then current JOINT MARKETING PLAN, provided such interactions take
place in an environment conducive to selling and are made by a Xxxxxxx or SB
pharmaceutical sales representative, including SB's Oncology Account Managers
including, but not limited to, SB's Oncology/Acute Care Account Managers and
SB's Clinical Educators. For the avoidance of doubt, it is understood that each
Party's district, regional, and national sales managers shall not be considered
as part of any SALES EFFORT and, thus, shall be excluded from the calculation of
the JOINT P&L outlined in Section 7.1.14.
(i) Launch through and including December 31,
2004 - Notwithstanding the foregoing, the Parties agree that, as of the
Effective Date, SB shall provide all of the SALES EFFORT for the promotion of
PRODUCT from the date of the commercial launch of PRODUCT in the TERRITORY up
through and including December 31, 2004. Such SALES EFFORT shall consist of SB
providing [*] FTEs of SALES EFFORT in support of the promotion of PRODUCT. The
SB personnel in support of such SALES EFFORT shall be responsible for detailing
hospital-based decision-makers (e.g., the nuclear medicine department, hospital
pharmacists, the oncology department and logistical teams at hospitals)
radiopharmacies, office-based oncologists, nuclear medicine physicians,
radiation oncologists at free standing clinics, and managed care
decision-makers. Xxxxxxx may, at its sole discretion and expense, provide FTEs
in the form of pharmaceutical sales representatives to support SALES EFFORT
between launch and December 31, 2004, but such FTEs shall be excluded from the
calculation of the JOINT P&L outlined in Section 7.1.14.
(ii) January 1, 2005 and beyond - Commencing
January 1, 2005, each of SB and Xxxxxxx shall provide [*] FTEs; provided, that
employees of Corixa shall qualify as Xxxxxxx FTEs for purposes of this
Agreement, of SALES EFFORT for the Co-Promotion of PRODUCT. These FTEs will be
included in the calculation of the JOINT P&L outlined in Section 7.1.14
effective January 1, 2005. The Xxxxxxx FTEs shall take the lead on detailing
hospital-based decision-makers (e.g., the nuclear medicine department, hospital
pharmacists, the oncology department and logistical teams at hospitals) and
radiopharmacies, and the SB FTEs shall take the lead on detailing office-based
oncologists, managed care decision-makers and hospital-based decision-makers in
those hospitals not detailed by Xxxxxxx. It is further understood that the fact
that the JCC decides that one Party's Sales Effort personnel takes the lead with
respect to a particular target audience does not preclude the other Party's
Sales Effort personnel from detailing such target audience or from otherwise
providing input with respect to the lead Party's activities, provided that such
is in accordance with the then current JOINT MARKETING PLAN.
(iii) Changes to the date for the reduction in the
number of FTEs of SALES EFFORT to be provided by SB and initiation by Xxxxxxx of
the provision of FTEs of SALES EFFORT that can be included in the calculation of
the JOINT P&L outlined in Section 7.1.14, as well as the level of change in each
such number, may be altered by approval of the JCC.
(iv) Beginning upon the date of the FIRST
COMMERCIAL SALE of the PRODUCT in TERRITORY A:
(a) Non-sales field based resources
shall be provided by SB including SB's Payor Relations Managers and Regional
Medical Scientists. Such personnel are not FTEs which support SALES EFFORT and
shall not be charged to the JOINT P&L,
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[*] Confidential treatment requested.
Redacted
(b) Non-sales field based support shall
be provided by Xxxxxxx in the form of the Xxxxxxx Medical Science Liaisons. Such
personnel are not FTEs which support SALES EFFORT and shall not be charged to
the JOINT P&L. The Xxxxxxx Medical Science Liaisons shall be responsible for
providing support for site initiations and assisting SB field representatives
with issues related to the radioactive components of PRODUCT. Such support shall
include, but not be limited to, working with nuclear medicine department
personnel, radiation safety officers, radiopharmacists, and state radiation
regulatory personnel. Xxxxxxx Medical Science Liaisons shall work closely with
SB field personnel to coordinate the prioritization of the foregoing Xxxxxxx
promotional efforts.
(c) During any Co-Promotion Year, each
Party shall use its good faith efforts to deliver at least [*] of the number of
FTEs of SALES EFFORT to be provided by such Party during each Co-Promotion Year
as determined by the JCC ("Minimum Sales Effort"). During any Co-Promotion Year
in which a Party fails to deliver its Minimum Sales Effort, such Party shall pay
the other Party [*] for each FTE (or the pro rata portion thereof for each part
FTE) for which it falls short of the Minimum Sales Effort. By way of
illustration, if the number of FTEs of SALES EFFORT to be provided by a Party
during a Co-Promotion Year as determined by the JCC was [*] and the number of
FTEs of SALES EFFORT actually provided was [*], such Party would owe the other
Party a payment of [*], such payment determined according to the following:
(i) the Minimum Sales Effort
to be delivered by the Party during such Co-Promotion Year would be [*] FTEs,
(i.e., [*] multiplied by [*] equals [*]); and
(ii) Minimum Sales Effort ([*]
FTEs) minus actual SALES EFFORT ([*] FTEs) equals [*] FTE. [*] FTE multiplied by
[*] equals U.S. [*]."
- Section 7.1.12 - This Section shall be deleted in its entirety
and replaced with the following:
"7.1.12 CO-PROMOTION EXPENSES.
(a) PRE-LAUNCH. Prior to commercial launch of
PRODUCT in TERRITORY A, each Party will be allowed to allocate to the JOINT P&L
calculated under Section 7.1.14 only OUT-OF-POCKET COSTS which are SALES COSTS,
MARKETING COSTS, PATENT COSTS, TRADEMARK COSTS or OTHER OPERATING
INCOME/EXPENSE, all subject to the prior approval of the JCC or in accordance
with the then current JOINT MARKETING PLAN. In no event shall Xxxxxxx be
permitted to allocate to the JOINT P&L any SALES EFFORT expenses for any
personnel employed on a full-time or part-time basis by Xxxxxxx during the
period preceding the commercial launch of PRODUCT in TERRITORY A."
(b) POST-LAUNCH. After the commercial launch of
PRODUCT in TERRITORY A, those expenses outlined in Exhibit B-1 shall be
allocated to the JOINT P&L calculated under Section 7.1.14, except as may
otherwise be provided in Section 7.1.6(a) or Section 7.1.12(a)"
- Section 7.1.16(a) - The following sentence shall be added to the
end of this Section:
" The travel and subsistence expenses incurred
by the Parties' attendees at such sales training sessions shall be borne
directly by the Parties and are excluded from the calculation of the JOINT P&L
outlined in Section 7.1.14."
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[*] Confidential treatment requested.
Redacted
- Section 7.1.16(b) - The following sentence shall be added to the
end of this Section:
" The travel and subsistence expenses incurred
by the Parties' attendees during the development and/or delivery of
PRODUCT-specific training program shall be borne directly by the Parties and are
excluded from the calculation of the JOINT P&L outlined in Section 7.1.14."
- All other terms and conditions of the Agreement shall remain in
full force and effect.
If Xxxxxxx and Corixa agree with the terms and conditions of this
Letter, please have an appropriate representative of each of Xxxxxxx and Corixa
sign and date the enclosed duplicate of this Letter as indicated below and
return it to GSK.
Very truly yours,
SMITHKLINE XXXXXXX CORPORATION
(a GlaxoSmithKline Company)
By: /s/ Xxxxxx X. Xxxxxx
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Title: Vice President and Secretary
Date: May 19, 2003
AGREED TO AND ACCEPTED:
CORIXA CORPORATION
By: /s/ Xxxxx Xxxxxx
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Title: Chairman and CEO
Date: May 22, 2003
XXXXXXX PHARMACEUTICAL, INC.
By: /s/ Xxxxx Xxxxxx
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Title: President
Date: May 22, 2003
Redacted
