EXHIBIT 10.4
RESTATED CO-MARKETING
AGREEMENT
This Restated Co-Marketing Agreement
(the “ Agreement ”) is entered into on
July 8, 2008 and effective as of May 5, 2008 (the “
Effective Date ”), between Cambridge Heart, Inc.
(“ Cambridge ”), a Delaware corporation, and St.
Jude Medical, Inc. (“ SJM ”), a Minnesota
corporation.
RECITALS
A. The parties previously entered
into a certain Co-Marketing Agreement on March 21, 2007 (as
amended from time to time, the “ Original Agreement
”).
B. Cambridge has the right to
terminate the Original Agreement in the event that certain minimum
sales targets set forth in the Original Agreement are not achieved;
and the sales targets for the period from the effective date in the
Original Agreement through April 30, 2008 were not achieved.
Cambridge has recently introduced an alternative financing model
for the HearTwave System under which customers may obtain the
HearTwave System for no initial, upfront charge but rather pay for
the unit entirely through quarterly installments which begin after
deliver of the unit. As a result of the foregoing, the parties have
determined that the exclusive co-marketing arrangement, agent fee
compensation structure and other provisions described in and
mandated by the Original Agreement should be replaced by the
present Agreement to be entered into by the parties.
C. SJM desires to continue to
collaborate with Cambridge in promoting and marketing MTWA
technology, including the HearTwave System, as a tool to increase
market awareness of sudden cardiac death and the role of risk
stratification in improving the delivery of appropriate therapy;
and Cambridge desires to continue to leverage SJM’s marketing
capabilities in an effort to increase placement of HearTwave
Systems in the marketplace. Accordingly, the parties desire to
restate the Original Agreement on the terms and conditions set
forth herein.
D. The parties previously entered
into that certain Securities Purchase Agreement on March 21,
2007 (the “ Purchase Agreement ”), and the
parties desire to amend the Purchase Agreement as set forth
herein.
E. Section 15(d) of the
Original Agreement and Section 5.5 of the Purchase Agreement
(which the parties also entered into on March 21, 2007) permit
the parties to amend or modify the Original Agreement and the
Purchase Agreement, as the case may be, in a writing signed by
authorized representatives of SJM and Cambridge.
Accordingly, for good and valuable
consideration the receipt and sufficiency of which is hereby
acknowledged by each of Cambridge and SJM, each of Cambridge and
SJM, intending to be legally bound, agree that all rights and
obligations under the Original Agreement are hereby terminated and
the Original Agreement is hereby restated in its entirety as
follows:
1. Definitions As used in
this Agreement:
A. “ Act ” means
the United States Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, as amended from time to time.
B. “ Business Day
” means any day other than a Saturday, Sunday, or other day
on which most or all commercial banks are closed in New York, New
York.
C. “ Cardiology
Practices ” means any physician practices that include
one or more practicing cardiologists specializing in the diagnosis
and/or treatment of cardiac conditions, including, without
limitation, electrophysiology, cardiac rhythm management,
cardiovascular and cardiac surgery (but excluding any general
practitioners and internal medicine physicians who are not part of
a Cardiology Practice).
D. “ HearTwave System
” means the non-implantable diagnostic systems for the
surface recording of ECG for measurement of Microvolt T-Wave
Alternans, which Cambridge markets under the tradenames HearTwave I
and HearTwave II, any improvements and upgrades thereto, and any
later generations of such products and all product accessories
required for the use thereof.
E. “ Intellectual
Property ” means any U.S. or foreign patents and patent
applications (including any substitutions, extensions, reissues,
renewals, divisionals, or continuations); trademarks, service marks
and registrations thereof and applications therefore; copyrights
and copyright registrations and applications; mask works and
registrations thereof; all discoveries, innovations, ideas,
inventions, technology, techniques, methods, know-how, trade
secrets, processes, formulas, specifications, drawings and designs,
computer programs or software, including all amendments,
modifications, and improvements to any of the foregoing, and any
other proprietary information.
F. “ Products ”
means all non-implantable diagnostic systems for the surface
recording of ECG for measurement of Microvolt T-Wave Alternans
(including, without limitation, the following components:
(i) the HearTwave System, (ii) Disposables, and
(iii) other components associated with the Products, including
warranties and service contracts) developed, manufactured or made
commercially available by Cambridge.
G. “ SJM Direct
Competitor ” means Abbott Laboratories, Biotronik, Boston
Scientific, Edwards Lifesciences, Johnson & Johnson,
Medtronic and Sorin, or any entities that are affiliates of any of
the foregoing and any entities or persons, including, without
limitation, direct sales representatives, or independent sales
representatives, acting as an agents for, or independent
contractors on behalf of, the foregoing.
H. “ Target Accounts
” mean all physician practices, including without limitation,
any general practitioners and any internal medicine physicians
(whether or not such general practitioners or internal medicine
physicians offer testing, diagnosis or treatment with respect to
cardiac conditions) and all Cardiology Practices.
I. “ Territory ”
means the continent of North America, including the 50 states of
the United States of America and the District of Columbia, Canada
and Mexico.
2. Non-Exclusive Co-Marketing
Arrangement
Appointment
. Subject to the terms and
conditions of this Agreement, effective as of the Effective Date,
Cambridge hereby appoints SJM, and SJM accepts such appointment, as
a non-exclusive marketing representative for the Products in the
Territory; provided, however, that SJM shall act solely as a
referral source and marketing partner to Cambridge and SJM shall
have no responsibility to provide sales service or support, and
will not be entitled to agent or other marketing representative
fees for any Product sales. For the avoidance of doubt, the parties
agree that Cambridge retains full sales responsibility for the
Products and may approach and deal directly with any account.
Cambridge also retains full responsibility for installation,
training and service with respect to the Products.
B. Co-Marketing . SJM and
Cambridge agree to develop and implement co-marketing programs with
respect to the marketing of the Products. The allocation of costs
may be shared between the parties with respect to such marketing
programs that may involve co-branding marketing materials,
co-sponsorship of educational events and joint presence at industry
conventions and trade shows (the “ Co-Marketing
Program ”). It is understood that any program development
or shared costs are at the sole discretion of SJM and Cambridge
Heart, respectively, and costs incurred by either SJM or Cambridge
Heart must be agreed to by authorized personnel of the party
incurring the cost.
C. Notification of Leads and
Placements . Cambridge agrees to notify SJM, on a weekly basis,
of the names and locations of Target Accounts where HearTwave
Systems have been placed following the Effective Date. SJM agrees
to notify Cambridge, on a weekly basis, of the names and locations
of leads identified by the SJM sales force for the placement or
sale of HearTwave Systems.
D. Independent Contractors .
SJM and Cambridge are independent contractors and are engaged in
the operation of their own businesses. Except as expressly set
forth herein, neither party is to be considered the agent of the
other party for any purpose whatsoever, and neither party has any
authority to enter into any contracts or assume any obligations for
the other party or make any warranties or representations on behalf
of the other party unless agreed to in writing by the other
party.
E. Non-Implantable Similar
Products . During the Term (the “ Restricted
Period ”), SJM shall not distribute, sell, market or
promote, directly or indirectly, any non-implantable diagnostic
systems (systems that do not have any implanted components, it
being understood that this Section 2(E) shall not apply to any
systems consisting of a pacemaker, defibrillator or other implanted
pulse generator communicating with an external programmer) for the
surface recording of ECG for the measurement of Microvolt T-Wave
Alternans (“ Covered Product ”), provided,
however, that the Restricted Period shall be extended following the
expiration or termination of the Term of this Agreement for a
period equal to the Term of this Agreement with respect to any
Covered Product that is solely developed by SJM or any of its
affiliates (as opposed to a third party Covered
Product).
F. Third Party Implantable
Diagnostic Systems . Prior to developing or commercializing
with a third party any implantable diagnostic systems for the
recording of intracardiac electrograms for the measurement of
Microvolt T-Wave Alternans or entering into any agreement,
arrangement or understanding, oral or written, with any third party
concerning
such development or commercialization (in either
case, an “ IDS Development Effort ”), SJM must
first give advance written notice to Cambridge indicating the
general subject matter of such proposed IDS Development Effort. If
Cambridge delivers a written request to SJM within 10 Business Days
after receipt of written notice from SJM, SJM shall not commence
any IDS Development Effort for 30 days from the receipt of
Cambridge’s written request, and SJM shall negotiate,
exclusively, in good faith with Cambridge with respect to the terms
and conditions of an IDS Development Effort involving Cambridge or
the Intellectual Property of Cambridge. If Cambridge and SJM do not
enter into a letter of intent with respect to the IDS Development
Effort within the 30-day period, SJM may commence the IDS
Development Effort either alone or in collaboration with a third
party.
G. Cambridge Restrictions .
During the Term (as defined below), Cambridge agrees that it will
not be a party to or enter into any agreement, arrangement or
understanding, oral or written, with any SJM Direct Competitor with
respect to the co-branding of the Products or co-sponsorship of
events related to the Products in the Territory.
3. Marketing
Materials
A. Marketing Materials . To
the extent that SJM prepares any sales or marketing materials with
respect to the Products, Cambridge shall have a reasonable
opportunity to review, and provide SJM with input concerning, such
sales and marketing materials, and, except with respect to sales
and marketing materials that are consistent with materials
previously used or approved by the parties which remain accurate
and meet regulatory requirements, the final form and content of any
such sales and marketing materials shall be approved in advance by
Cambridge, which approval shall not be unreasonably
withheld.
B. Study Links. SJM may, in
its sole discretion, promote and link any clinical or post-market
studies that are sponsored by SJM to the Products; provided
that prior to linking the Products to such clinical or post-market
studies, SJM shall provide Cambridge
