CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.9
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE SECURITIES AND
EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED 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.
RESEARCH COLLABORATION
AND LICENSE
AGREEMENT
BY AND AMONG
ADVANCED CARDIOVASCULAR DEVICES, INC.
AND
SOMANTA LIMITED
[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:
1. DEFINITIONS
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In this agreement the following words shall have the following
meanings:
1.1 "ACD's Project Responsibilities" 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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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.
1.2 "Background Information" any information and/or
know-how made available
by either party to the
other party pursuant to
Clause 4.1.
1.3 "Commencement Date" The Commencement Date
shall be the date of
signing of this
agreement.
1.4 "Field" The treatment of
vascular disorders or
proliferation using
stents and devices.
1.5 "Intellectual Property" 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
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effect of these which
may subsist anywhere in
the world, and all
improvements thereto.
1.6 "Know-how" 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.
1.7 "Net Sales Value" 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
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the 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.
1.8 "Project Intellectual Property" All Intellectual
Property arising out of
the Research Project
including, without
limitation, the Project
Information.
1.9 "Project Information" 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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1.10 "Project Plan" The plan for the
Research Project
attached hereto as
Schedule I.
"Research Project" The research project
described in Clause 2.
1.11 "Research Team" The persons engaged in
the Research Project.
1.12 "Somantis Intellectual Property" 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).
1.13 "Somantis Know-How" All Know-How in the
Field owned by Somantis
and created during
research carried out by
Somantis.
1.14 "Somantis Patents" 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
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and similar rights that
are based on or derive
priority from the
foregoing, and all
improvements on
inventions in such
patents and patent
applications.
1.15 "Somantis' Project Responsibilities" 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
2. THE RESEARCH PROJECT
--------------------
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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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. PAYMENT
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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 [CONFIDENTIAL TREATMENT REQUESTED].
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 [CONFIDENTIAL TREATMENT REQUESTED] after FDA approval
and prior to launch
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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 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].
4. OWNERSHIP AND USE OF BACKGROUND INFORMATION AND THE PROJECT
-----------------------------------------------------------
INTELLECTUAL PROPERTY
---------------------
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
obligation owed to any third party.
4.2 Somantis will provide to ACD at no charge, reasonable
quantities of Alchemix, and any improvements thereto, as reasonably required by
ACD to complete the Research Project.
4.3 If either party makes or acquires any Project Intellectual
Property it shall forthwith disclose the same in confidence to the other party.
Project Intellectual Property made or acquired by ACD shall remain the property
of ACD and Project Intellectual Property made or acquired by Somantis shall
remain the property of Somantis. Project Intellectual Property made or acquired
arising from work carried out jointly shall belong to the parties equally unless
they shall otherwise agree.
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4.4 Somantis grants to ACD a non-exclusive, royalty-free license
to make use of the Somantis Intellectual Property solely for the purposes of
carrying out ACD's Project Responsibilities under the Research Project.
4.5 Somantis grants to ACD an exclusive, world-wide license of the
Somantis Intellectual Property, with rights to sublicense, to make, have made,
use, offer to sell, sell, import and export products for use in the Field.
4.6 Without prejudice to the generality of Clauses 4.4 and 4.5,
Somantis shall have the exclusive right to apply for patents in respect of
inventions made by Somantis in the course of the Research Project, and ACD shall
provide Somantis with such assistance as Somantis shall from time to time
request in connection with the filing and prosecution of such patent
applications.
4.7 ACD will have the exclusive right, but not the obligation, to
apply for patents in respect to inventions made by ACD, including inventions on
drug coated and coating devices, and Somantis will provide ACD with such
assistance ACD shall from time to time request in connection with the filing and
prosecution of such patent applications.
4.8 Somantis represents and warrants that it has the right to
grant the rights granted herein to ACD, and that no other agreements or
commitment conflict with this Agreement.
5. CONFIDENTIAL INFORMATION AND PUBLICATIONS
-----------------------------------------
5.1 In this Agreement, subject to Clause 5.2:
5.1.1 "Confidential Information" belonging to Somantis
shall include Somantis's Background Information, the Somantis Know-How
and any other information disclosed to ACD by Somantis relating to
Somantis's business, technical and/or research plans;
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5.1.2 "Confidential Information" belonging to ACD shall
mean all Project Information and ACD's Background Information, and any
other information disclosed to Somantis by ACD relating to ACD's
business, technical and/or research plans.
5.2 "Confidential Information" shall not include any information
which:
5.2.1 is or becomes public knowledge through no improper
conduct on the part of the party receiving the Confidential Information; and/or
5.2.2 is already lawfully possessed by the party receiving
Confidential Information prior to receiving it; and/or
5.2.3 is obtained subsequently from a third party without any
obligations of confidentiality and such third party is in lawful possession of
such material and is not in violation of any contractual or legal obligation to
maintain the confidentiality of such material.
5.3 The onus shall be on the party asserting that any of the
exceptions set out in Clause 5.2 apply to prove that such exceptions apply.
5.4 Each party shall, and shall procure that its respective
employees and members of the Research Team shall, keep confidential all
Confidential Information belonging to the other party and shall not use any
Confidential Information belonging to the other party other than for the
purposes of carrying out the Research Project and/or exercising its rights
hereunder.
5.5 Each party shall take all reasonable steps to:
5.5.1 minimize the disclosure of Confidential Information
belonging to the other party;
5.5.2 ensure that only the Research Team shall have access
to Confidential Information belonging to the other party; and
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5.5.3 ensure that its Research Team members use
Confidential Information belonging to the other party for the sole
purpose of carrying out the Research Project or exercising its rights
hereunder.
5.6 Each party shall procure that each of its employees and
members of the Research Team are bound by appropriate confidentiality and
non-use obligations in respect of Confidential Information belonging to the
other party.
5.7 ACD shall be entitled to publish the results of work carried
out by ACD under the Research Project provided that:
5.7.1 ACD has first submitted to Somantis a complete copy
of the proposed text of the publication (or an abstract which includes
the results to be published) at least 30 days prior to prior to its
disclosure to any third party; and
5.7.2 the proposed publication does not contain any
Confidential Information belonging to Somantis.
5.8 Any publication of the results of the Research Project shall
acknowledge the assistance of Somantis, to the extent such assistance was
rendered.
5.9 The obligations of confidentiality and non-use set out in this
Clause 5 shall remain in force and shall be binding upon the parties for so long
as any party has knowledge or possession of any Confidential Information
belonging to the other party and for the avoidance of doubt shall survive any
termination or cancellation of this Agreement.
6. DURATION AND TERMINATION
------------------------
6.1 This Agreement shall commence on the Commencement Date and
shall expire on the last to expire of the Somantis Patents covering the ACD
Products unless sooner terminated in accordance with the provisions of this
Clause 6.
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6.2 Either party may terminate this Agreement forthwith if:
6.2.1 the other party breaches any provision of this
Agreement and, having been notified of such breach, fails to remedy it
within 30 days of notification; or
6.2.2 any of the following events occur:
6.2.2.1 an order is made or a resolution passed for
the winding up of the other party (other than for the purpose
of a solvent scheme of reconstruction or amalgamation);
6.2.2.2 an administration, administrative receiver
or receiver is appointed in respect of a material part of the
other party's assets or business; or
6.2.2.3 as a consequence of financial difficulties
the other party makes any voluntary arrangement with its
creditors; or
6.2.2.4 the other party ceases to continue its
business; or
6.2.2.5 the other party becomes unable to pay its
debts as and when they fall due;
6.2.2.6 as a consequence of debt and/or
maladministration, the other party takes or suffers any
similar or analogous action to those listed in Clauses 6.2.2.1
to 6.2.2.3 above.
6.3 ACD may terminate this Agreement forthwith, without further
obligations to Somantis, if the technology licensed from Somantis does not
perform to the reasonable satisfaction of ACD, or cannot reasonably be
commercialized because of safety or efficacy reasons, or because ACD is unable
to raise appropriate funds.
7. CONSEQUENCES OF EXPIRE AND TERMINATION
--------------------------------------
7.1 On expiry or termination of this Agreement for any reason:
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7.1.1 Subject to Clause 7.1.2, each party shall return all
materials containing any Background Information in its possession or
control to the party which made such Background Information available;
and
7.1.2 Subject to Clause 7.2, the provisions of Clauses 1,
4.2, 4.4 to 4.7 inclusive, 5, 7 and 8 shall continue in full force and
effect.
7.2 Within 30 days of the date of expiry or termination of this
Agreement, ACD shall notify Somantis with a final project report setting out a
full description of the methods used to carry out the Research Project, the raw
results arising out of the Research Project, analysis of the raw results of the
Research Project and a description of any inventions made in the course of
carrying out the Research Project.
7.3 Expiry and termination of this Agreement shall be without
prejudice to any other right or remedy for breach of this Agreement which either
party may have which accrued on or prior to the date of expiry or termination
(including, without limitation. Somantis' rights to receive the payments
specified in Clause 3).
7.4 In the event that Somantis discontinues pursuing the
technology licensed to ACD under this Agreement, Somantis agrees to continue to
support ACD under the terms and conditions of this Agreement.
8. GENERAL
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8.1 Notices
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8.1.1 Any notice or other communication given under this
Agreement shall be in writing and shall be sent by pre-paid first class
mail or by fax (confirmed by pre-paid first class mail placed in the
post on or on the day after the date of transmission) to the other
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party at the address set out at the beginning of this Agreement or to
such other address or fax number as may from time to time be notified
to the other party in writing.
8.1.2 Any notice so sent by pre-paid first class mail shall
be deemed to have been given on the third business day from and
including the date of posting. Any notice so sent by fax (and confirmed
by first class mail as aforesaid) shall be deemed to have been given
the next business day following the day of transmission.
8.2 Severability
------------
If any provision of this Agreement is declared by any judicial or other
competent authority to be void, voidable, illegal or otherwise unenforceable
then the remaining provisions of this Agreement shall continue in full force and
effect. The judicial or other competent authority making such determination
shall have the power to limit, construe or reduce the duration, scope, activity
and/or area of such provision, and/or delete specific words or phrases as
necessary to render, such provision enforceable.
8.3 Waiver
------
Failure or delay by any party to exercise any right or remedy under
this Agreement shall not be deemed to be a waiver of that right or remedy, or
prevent it from exercising that or any other right or remedy on that occasion or
on any other occasion.
8.4 Entire Agreement and Amendments
-------------------------------
8.4.1 This Agreement constitutes the entire agreement and
understanding of the parties relating to the subject matter of this
Agreement and supersedes all prior oral or written agreements,
representations, understandings or arrangements between the parties.
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8.4.2 The parties acknowledge that they are not relying on
any agreement, understanding, arrangement, warranty, representation or
term which is not set out in this Agreement.
8.4.3 Nothing in this Clause 8.4 shall operate to:
8.4.3.1 exclude any provision implied into this Agreement by
law and which may not be excluded by law; or
8.4.3.2 limit or exclude any liability, right or remedy to a
greater extent than is permissible under law.
8.4.4 No change may be made to this Agreement except in
writing signed by the duly authorized representatives of each of the
parties.
8.5 Relationship of the Parties
---------------------------
8.5.1 Nothing in this Agreement shall create evidence or
imply any agency, partnership or joint venture between the parties.
8.5.2 No party shall act or describe itself as the agent of
any of the other parties nor shall a party represent that it has any
authority to make commitments on behalf of the other parties.
8.6 Assignment and Sub-contracting
------------------------------
This Agreement is personal to the parties and neither party shall
assign, transfer, charge, or otherwise deal in its rights or obligations under
this Agreement except as expressly provided in this Agreement; provided,
however, that either party may assign this agreement without consent in
connection with a sale or other transfer or change in control of all or
substantially all of the assets of such party to which this Agreement relates.
This Agreement will be binding on successors and assigns.
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8.7 Publicity
---------
Except as required by law or regulation, no shall make any
announcement, or comment upon, or originate any publicity, or otherwise provide
any information to any third party (other than its legal advisors) concerning
this Agreement (including without limitation the existence of this Agreement,
the performance of this Agreement and/or any dispute, arbitration or
disagreement relating to this Agreement) without the prior written consent of
the other parties.
8.8 Further Assurances
------------------
As and when requested by another party, each party shall, and shall
procure that their respective employees shall, do all acts and execute all
documents as may be reasonably necessary to give effect to the provisions of
this Agreement.
8.9 Headings
--------
The headings used in this Agreement are for convenience only and shall
not affect the interpretation of this Agreement.
8.10 Law and Jurisdiction
--------------------
The validity, construction and performance of this Agreement shall be
governed by the laws of New York, and the parties accept the exclusive
jurisdiction of the Courts in New York in respect thereof. Both parties will
abide by standard arbitration prior to any legal procedures.
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For and on behalf of For and on behalf of
ACD SOMANTIS LIMITED
/s/ BALBIR S. BRAR /s/ AGAMEMNON A. EPENETOS
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Signed signed
Balbir S. Brar Agamemnon A. Epenetos
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print name print name
illegible Chairman and CEO
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title title
31/8/04 31/8/04
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date date
ACD Research PROJECT PLAN SCHEDULE I
[CONFIDENTIAL TREATMENT REQUESTED]
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