Exhibit 99.6
CLINICAL AND MARKETING SUPPORT
SERVICES AGREEMENT
CONFIDENTIAL
This Clinical and Marketing Support Services
Agreement (this “ Agreement ”) is made and
entered into as of this 11th day of December, 2007 (the “
Effective Date ”) among ABIOMED, Inc., a Delaware
corporation (“ Abiomed ”), World Heart
Corporation, an Ontario corporation (“ WHC ”)
and World Heart Inc., a Delaware corporation (“ WHI
”). Abiomed, WHC and WHI shall each, at times, be
referenced herein individually as a “ Party ”
and together as the “ Parties ”.
WITNESSETH:
WHEREAS,
simultaneously with the execution and delivery of this Agreement,
WHC, WHI and Abiomed are entering into a Note Purchase Agreement
(the “ Purchase Agreement ”) through which
Abiomed is purchasing an 8% secured convertible promissory note
issued by WHC and WHI (the “ Note ”) and a
warrant to purchase shares of the common stock of WHC (the “
Warrant ”); and
WHEREAS, in partial
consideration for the Warrant, Abiomed wishes to make available and
WHC wishes to have available, certain clinical and marketing
support services to be provided by Abiomed to WHC and WHI;
NOW, THEREFORE, in
consideration of the premises and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as follows:
1.
DEFINITIONS.
1.1.
Definitions . In addition to other terms specifically
defined elsewhere in this Agreement, (a) capitalized terms
that are not otherwise defined herein have the meanings given to
such terms in the Purchase Agreement and (b) the following
terms shall have the meanings indicated in this
Section 1.1:
“
Abiomed ” has the meaning set forth in the
preamble.
“
Abiomed Default ” has the meaning set forth in
Section 7.1(a).
“
Abiomed Services ” means the Marketing Support
Services and Clinical Support Services provided under this
Agreement.
“
Affiliate ” means any Person who, directly or
indirectly controls, is under common control with, or is controlled
by, another Person, whether directly or indirectly through one or
more intermediaries. For the purposes of this definition,
“control” and its derivatives mean, with respect to any
Person, the possession, directly or indirectly, of the
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power to
direct or cause the direction of the management and policies of
such Person, whether through the ownership of voting securities or
otherwise.
“
Agreement ” has the meaning set forth in the
preamble.
“
Assign ” and “ Assignment ” have
the meanings set forth in Section 9.2.
“
Clinical Statement of Work ” has the meaning set forth
in Section 3.2.
“ Clinical Support Services
” has the meaning set forth in Section
3.2 .
“
Confidential Information ” shall mean all trade
secrets and confidential or proprietary information owned,
possessed or used by a Disclosing Party hereunder (whether in
written, oral, graphical, machine-readable or other form) that is
disclosed to a Receiving Party hereunder or to which the Receiving
Party has access, including, without limitation, all such
information concerning the Disclosing Party’s applications,
concepts, developments, devices, designs, disclosures, discoveries,
formulae, ideas, improvements, inventions, know-how, materials
formulations, methods, processes, products, research results,
specifications, systems, technical data, any and all clinical or
non-clinical documentation, memoranda, notebooks, photos, sketches,
prints, drawings, research materials, charts, graphs, machinery,
prototypes, tools, written material and plans, as well as a
Disclosing Party’s present or future business plans and
strategies, financial models, cost estimates and analyses,
operations, commercial activities, customers, suppliers and
business partners, and all information of third parties that the
Disclosing Party has an obligation to keep confidential. To
the extent reasonably practicable, the Disclosing Party will
prominently mark “Confidential” on the cover
page of all written materials to be provided to Receiving
Party hereunder.
“
Disclosing Party ” shall mean the Party disclosing
Confidential Information hereunder.
“
Governmental Authority ” has the meaning set forth in
the Purchase Agreement.
“
Marketing Statement of Work ” has the meaning set
forth in Section 3.3.
“
Marketing Support Services ” has the meaning set forth
in Section 3.3.
“
Note ” has the meaning set forth in the
preamble.
“
Persons ” means any individual, corporation,
partnership, company, joint venture, association, trust,
unincorporated organization or Governmental Authority.
“
Receiving Party ” shall mean the Party receiving
Confidential Information hereunder.
“
Term ” has the meaning set forth in
Section 2.1.
“
Warrant ” has the meaning set forth in the
preamble.
“
WHC ” has the meaning set forth in the preamble
hereof.
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“
WHI ” has the meaning set forth in the preamble
hereof.
“ WHC
Default ” has the meaning set forth in
Section 7.2(a).
2.
TERM AND TERMINATION.
2.1.
Term . The term of this Agreement shall commence on the
Effective Date hereof, and continue until the second anniversary
thereof (the “ Term ”), unless terminated
earlier pursuant to Section 7, or extended by mutual written
agreement of all the Parties.
3.
DESCRIPTION OF ABIOMED SERVICES.
3.1.
Abiomed Services . During the Term, Abiomed, WHC and
WHI shall use good faith efforts to explore opportunities where
they can work efficiently together for the mutual benefit of the
Parties, including areas where Abiomed can provide the Abiomed
Services described below in a cost-effective manner by leveraging
economies of scale and existing infrastructure.
3.2.
Clinical Support Services . During the Term, WHC and WHI
may, from time to time, request that Abiomed perform certain
clinical support services for WHC or WHI (the “ Clinical
Support Services ”); provided, however, that WHC and WHI
are under no obligation to request any Clinical Support Services,
or to request any minimum amount of Clinical Support Services
during the Term. If Abiomed agrees to perform such Clinical
Support Services, the parties shall mutually agree on a written
statement of work in the form of Exhibit B hereto
(“ Clinical Statement of Work ”), provided,
however, the Parties may mutually agree on variations to such form
as required, on a case-by-case basis. Examples of the types
of Clinical Support Services that may be provided, upon mutual
agreement, include the following:
Clinical Support
(Clinical Field Specialist level):
(a)
On-site start-up and ongoing training of a clinical center’s
clinical staff responsible for the care and management of LVAS
recipients or LVAS hardware.
(b)
On-site clinical support to clinical centers, including but not
limited to direct support at implants. This would include
from time-to-time, providing urgent clinical or technical on-site
support.
(c)
Participation in a rotating schedule to provide 24-hour on-call
clinical and technical support to clinical centers.
(d)
Documenting clinical experiences per WHC/WHI’s internal
business and regulatory processes.
Clinical Trial Support (CRA I
level):
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(e)
Conducting study site initiations and close-out visits in
compliance with WHC/WHI Clinical Affairs operating procedures and
policies. Ensuring collection of required essential documents
for study start-up and throughout conduct of study.
(f)
Conducting study site monitoring visits to ensure that conduct of a
Clinical Trial is in compliance with the then-currently approved
protocol/amendment(s), with GCP, and with applicable regulatory
requirements. Conducting source data/document
verification.
3.3.
Marketing Support Services . During the Term, WHC and WHI
may, from time to time, request that Abiomed perform certain
marketing support services for WHC and WHI (the “
Marketing Support Services ”); provided, however, that
WHC and WHI are under no obligation to request any Marketing
Support Services, or to request any minimum amount of Marketing
Support Services during the Term. If Abiomed agrees to
perform such Marketing Support Services, the parties shall mutually
agree on a written statement of work in the form of
Exhibit B hereto (“ Marketing Statement of
Work ”), provided, however, the Parties may mutually
agree on variations to such form as required, on a case-by-case
basis. Examples of the types of Marketing Support Services
that may be provided, upon mutual agreement, include the
following:
(a)
Strategic marketing and or consulting services related to WHC, WHI
or their products; and
(b)
Abiomed providing WHC access to floor space and other resources
purchased by Abiomed at trade-shows in which Abiomed, in its sole
discretion, has agreed to participate, in order to provide WHC and
WHI the opportunity to market and promote their
products.
3.4.
Integration . All executed Clinical Statements of Work
and Marketing Statements of Work shall be attached as consecutively
numbered exhibits to this Agreement, and each shall constitute an
integral part of this Agreement.
4.
CONSIDERATION FOR ABIOMED SERVICES.
4.1.
Warrant . In consideration for the Abiomed Services,
WHC shall issue the Warrant to Abiomed on the Effective Date of
this Agreement.
4.2.
Abiomed Fees . In addition to the consideration
provided in Section 4.1, WHI, WHC and Abiomed shall
agree in any Clinical Statement of Work or Marketing Statement of
Work on additional reasonable compensation paid by WHC and WHI to
Abiomed for any Abiomed Services, which compensation shall be at a
negotiated price that is for the benefit of all of the Parties
(“ Abiomed Fees ”). The Parties agree to
negotiate in goo
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