EXHIBIT 10.9
CONFIDENTIALITY TREATMENT
REQUESTED
CONFIDENTIAL TREATMENT REQUESTED
UNDER RULE 24(b)(2) OF THE SECURITIES AND EXCHANGE ACT OF 1934.
CONFIDENTIAL TREATMENT IS REQUESTED AND IS NOTED WITH
“[CONFIDENTIAL TREATMENT REQUESTED].” AN UNREDACTED
VERSION OF THIS DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION.
R ESEARCH C OLLABORATION
AND L ICENSE
A GREEMENT
BY AND AMONG
A DVANCED C ARDIOVASCULAR D EVICES ,
I NC .
AND
S OMANTA L IMITED
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CONFIDENTIAL TREATMENT
REQUESTED
RESEARCH COLLABORATION AND
LICENCE AGREEMENT
This agreement dated August 1,
2004 is between:
(1) ADVANCED CARDIOVASCULAR
DEVICES, INC. (“ACD”); a California corporation
with principal address at 26261 Glen Canyon, Laguna Hills, CA
92653.
(2) SOMANTIS LIMITED
(“Somantis”) a company incorporated in England and
Wales, (with company number 4201851) whose registered office is at
117 Alexandra Park Road, London N10 2DP.
RECITALS:
A. Somantis is the owner of the
Somantis Intellectual Property (as defined below).
B. Somantis is willing to grant to
ACD and ACD is willing to accept, a license of the Somantis
Intellectual Property (as defined below), solely for use in the
Field (as defined below).
C. ACD is willing to use the
Somantis Intellectual Property to carry out ACD’s Project
Responsibilities (as defined below) and for commercialization of
the resulting products.
NOW THEREFORE, for good and valuable
consideration, included the premises and mutual promises herein, IT
IS AGREED as follows:
In this agreement the following
words shall have the following meanings:
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1.1 “ACD’s
Project Responsibilities”
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The work to be
carried out by ACD in connection with the Research Project,
including the creation of a drug coated cardiovascular device,
carrying out
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CONFIDENTIAL TREATMENT
REQUESTED
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preclinical and
clinical research with the intent to obtain regulatory approval for
the drug coated cardiovascular device, and if successful in
clinical research, the commercialization thereof.
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1.2 “Background
Information”
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any information
and/or know-how made available by either party to the other party
pursuant to Clause 4.1.
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1.3 “Commencement
Date”
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The
Commencement Date shall be the date of signing of this
agreement.
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1.4 “Field”
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The treatment
of vascular disorders or proliferation using stents and
devices.
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1.5 “Intellectual
Property”
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Trade marks,
service marks, trade names, logos, Know-How, patents, inventions,
rights in designs, trade or business names, copyrights and
topography rights (whether or not any of these is registered and
including applications for registration of any such thing) and
rights under licences and consents in relation to any such thing
and all rights or forms of protection of a similar nature or having
equivalent or similar effect
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CONFIDENTIAL TREATMENT
REQUESTED
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of these which
may subsist anywhere in the world, and all improvements
thereto.
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1.6 “Know-how”
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Technical and
other information which is not in the public domain including
information comprising or relating to concepts, discoveries, data,
designs, formulae, ideas, inventions, methods, models, assays,
research plans, procedures, designs for experiments and tests and
results of experimentation and testing (including results of
research or development), processes, laboratory records, chemical,
toxicological, clinical, analytical and quality control data, trial
data, case report forms, data analyses, reports or summaries and
information contained in submissions to and information from
regulatory authorities.
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1.7 “Net Sales
Value”
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The
[CONFIDENTIAL TREATMENT REQUESTED] of Royalty-bearing
Products sold or in any way transferred of like kind by ACD or
sub-licensees or its Affiliates to independent third parties in
arm’s length transaction, or, where the
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CONFIDENTIAL TREATMENT
REQUESTED
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Royalty-bearing
Products are sold in a commercial transaction, and this sale is not
at arm’s length, the price that would have been so
[CONFIDENTIAL TREATMENT REQUESTED ] if it had been at
arm’s length, after deduction of normal trade discounts
actually granted and any credits actually given and, provided the
amounts are separately charged on the relevant [CONFIDENTIAL
TREATMENT REQUESTED] , any costs of packaging, insurance,
carriage and freight, any value added tax or other sales tax, and
any import duties or similar applicable government
levies.
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1.8 “Project
Intellectual Property”
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All
Intellectual Property arising out of the Research Project
including, without limitation, the Project Information.
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1.9 “Project
Information”
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All
discoveries, inventions, results, data, analyses, designs,
formulae, processes, specifications, reports, methods, know-how,
drawings or other information arising out of the Research
Project.
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CONFIDENTIAL TREATMENT
REQUESTED
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1.10 “Project Plan”
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The plan for
the Research Project attached hereto as Schedule I.
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“Research Project”
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The research
project described in Clause 2.
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1.11 “Research
Team”
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The persons
engaged in the Research Project.
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1.12 “Somantis Intellectual
Property”
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All
Intellectual Property in the Field owned by Somantis and created
during research carried out by Somantis (including without
limitation the Somantis Patents and the Somantis
Know-How).
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1.13 “Somantis
Know-How”
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All Know-How in
the Field owned by Somantis and created during research carried out
by Somantis.
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1.14 “Somantis
Patents”
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All patents and
patent applications throughout the world, including, but not
limited to U.S. Patent application number [CONFIDENTIAL
TREATMENT REQUESTED] , known as the Alchemix patent, relating
to a series of substituted anthraquinones including any
continuations, continuations in part, extensions, reissues,
divisions, and any patents, supplementary protection certificates
and similar rights that
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CONFIDENTIAL TREATMENT
REQUESTED
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are based on or
derive priority from the foregoing, and all improvements on
inventions in such patents and patent applications.
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1.15 “Somantis’ Project
Responsibilities”
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The work to be
carried out by Somantis in connection with the Research Project
including the production and provision of small amounts of Alchemix
to ACD at no cost through phase two completion and thereafter at
cost for research and development purposes
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2.1 ACD and Somantis shall use
reasonable commercial efforts to carry out their respective Project
Responsibilities with reasonable skill and care, and in accordance
with the timetable set out in the Project Plan.
2.2 At the end of each six month
period commencing as of the Commencement Date, ACD shall supply
Somantis with a progress report on the Research Project setting out
following:
2.2.1 the work which ACD has carried
out on the Research Project during the previous 6 months
.
2.2.2 any data and/or results
obtained during the previous 6 months; and
2.2.3 the work that ACD intends to
carry out during the next 6 months .
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CONFIDENTIAL TREATMENT
REQUESTED
2.3 Within 14 days of the end of
each calendar quarter the parties shall meet or have a conference
call to discuss progress on the Research Project in general and in
particular ACD’s latest progress report submitted under
Clause 2.2.
3.1 All sums due under this
Agreement shall be paid in U.S. Dollars.
3.2 Sums specified in this Agreement
are exclusive of Value Added Tax or any similar tax which shall be
the responsibility of Somantis.
3.3 Funds will be raised within one
year of signing this agreement and within 30 days of raising the
funds , ACD shall pay Somantis the non-refundable, non-deductible
sum of $10,000.
3.4 If ACD fails to meet the
milestone dates as set forth in clause 3.5.1 and 3.5.2, Somantis
will have the right but not the obligation to terminate this
agreement (including the license granted hereunder), provided, that
ACD can eliminate this termination right by paying a missed
milestone fees as set forth below:
3.4.1 [CONFIDENTIAL TREATMENT
REQUESTED] after the completion of Phase I clinical study (as
defined in Schedule I) but prior to ACD initiating Phase II
clinical trials.
3.4.2 [CONFIDENTIAL TREATMENT
REQUESTED] after completion of Phase II clinical
trials.
3.4.3 [CONFIDENTIAL TREATMENT
REQUESTED] after completion of Phase III clinical
trials.
3.4.4 $500,000 after FDA approval
and prior to launch
3.5 ACD will pay Somantis a royalty
of [CONFIDENTIAL TREATMENT REQUESTED] of Net Sales Value of
ACD products covered by one or more claims of the Somantis Patents
and also by Project Intellectual Property, for sales in the region
covered only, marketed by ACD or by a third party on behalf of ACD.
In the event that ACD pays other
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CONFIDENTIAL TREATMENT
REQUESTED
royalties for other third party intellectual
property in relation to the Somantis Patents for such ACD products,
ACD may reduce the royalties payable to Somantis under this section
in an amount equal to the royalties payable to such third party, to
a maximum reduction of [CONFIDENTIAL TREATMENT REQUESTED]
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4.
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OWNERSHIP
AND USE OF BACKGROUND INFORMATION AND THE PROJECT INTELLECTUAL
PROPERTY
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4.1 Each party shall make available
to the other party such background information as may assist the
parties in carrying out their responsibilities under the Research
Project, provided that nothing in this Clause 4.1 shall oblige
either party to act in breach of a confidentiality ob
