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Exhibit 10.8
PATENT AND KNOW-HOW LICENSE AGREEMENT
Made and entered into on February 18, 2003, by and between
OMRIX BIOPHARMACEUTICALS LTD.
MDA
Building,
Tel-Hashomer
Israel
(hereinafter - "OMRIX")
on the one part
AND
AMERSHAM BIOSCIENCES AB
Bjorkgatan 30
751 84 Uppsala, Sweden
(hereinafter - "AMERSHAM")
on the other hand
WHEREAS OMRIX possesses certain proprietary know-how, as to the
technology and
methodology required to manufacture Plasminogen Removal Gel-TA
Resin (as more
fully defined below as "PLASMINOGEN RESIN"): and
WHEREAS AMERSHAM has conducted certain development work in
collaboration with
OMRIX relating to the Plasminogen Resin, without such work
derogating in any way
from OMRIX's intellectual property rights with respect to the
Plasminogen Resin
and/or the Patent(s): and
WHEREAS OMRIX and AMERSHAM wish to enter into agreements for the
manufacture of
the Plasminogen Resin by AMERSHAM, and for the distribution and
sale of the
Plasminogen Resin by AMERSHAM: and
WHEREAS AMERSHAM wishes to receive from OMRIX the Know-How and the
License
necessary to manufacture the Plasminogen Resin in accordance with
the Know-How
and to market and sell the Plasminogen Resin worldwide, and OMRIX
is willing to
give AMERSHAM the Know-How AND grant AMERSHAM the License, subject
to the terms
and conditions of this Agreement
NOW THEREFORE, in consideration of the covenants and obligations
hereinafter set
forth, the parties hereto agree as follows:
PORTIONS
OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED PURSUANT
TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
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1.
DEFINITIONS
In
this Agreement, unless context otherwise requires, the following
terms
shall have the respective meanings assigned to them below:
1.1.
"AFFILIATES" shall mean any person, corporation, firm, partnership
or
other entity which directly or indirectly controls, owns, is owned
by
or is under common ownership with a party to this Agreement to
the
extent of at least fifty percent (50%) of the equity and having
the
power to vote on or direct the affairs of the entity.
1.2.
"AMERSHAM" shall mean AMERSHAM BIOSCIENCES AB, a Swedish
corporation
and including any entity controlling, owned or controlled by
AMERSHAM.
1.3.
"CUSTOMERS" shall mean purchasers of Plasminogen Resin from
AMERSHAM
with the exclusion of OMRIX.
1.4.
"EFFECTIVE DATE" shall mean the date on which the last of the
Agreements is executed.
1.5.
"IMPROVEMENTS" shall mean any additions, innovations or updates to
the
existing Know-How developed, reached or obtained by OMRIX or by
AMERSHAM, which did not exist prior to the date of this Agreement
and
which update, simplify or in any way improve the Know-How so as
to
make it simpler, less costly or more efficient or so as to result
in a
superior Plasminogen Resin.
1.6.
"KNOW-HOW" shall mean and include all the information included in
the
Patent(s) and all know-how, knowledge, expertise, technology,
methodology and technical information regarding Plasminogen Resin
and
any use thereof, including, without limitation, advice,
guidance,
directions, instructions and training, necessary to manufacture
Plasminogen Resin, that is owned, possessed or controlled by OMRIX
or
licensed to OMRIX by a third party, and including Improvements.
1.7.
"NET SALES" shall mean, in the case of Plasminogen Resin that is
sold,
the cumulative invoice price of Plasminogen Resin in a form
suitable
for sale to the Customers (regardless of non-collectible
accounts)
less any (i) outbound transportation costs paid, (ii) insurance
fees,
(iii) bad debts, (iv) discounts, (v) allowed allowances and
credits
because of returns, or (vi) sales taxes. Such items not to be
included
in the Net Sales shall be considered to amount to four percent (4%)
of
the invoice price, unless AMERSHAM presents proof that the
actual
amount is higher.
1.8.
"OMRIX" shall mean OMRIX BIOPHARMACEUTICALS S.A., a company
organized
under the laws of Belgium and including its Affiliates.
1.9.
"PATENT(S)" shall mean patent application WO 02/095019designated
as
"Removal of Plasminogen From protein solutions" (and any
patents
granted in respect thereof) together with all foreign
equivalents,
divisionals, continuations, continuations-in-part, extensions,
re-examinations and revisions (including any extensions
thereof).
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1.10. "PLASMINOGEN RESIN" shall mean Plasminogen Removal Gel-TA
Resin and
such other products which, by utilizing the Know-How, can be
developed, severally or collectively, as more fully described in
the
Patent Application.
2. LICENSE
2.1.
Subject to the terms and conditions set forth in this Agreement,
OMRIX
hereby grants AMERSHAM and its Affiliates an exclusive,
worldwide
license under the Patents and the Know-how to manufacture, sell,
have
sold and market Plasminogen Resin (the "LICENSE"). OMRIX reserves
a
right to freely use the Plasminogen Resin in its own production
processes and to grant non-exclusive licenses to Customers for
the
commercial use of Plasminogel Resin as described in Section
2.3.
2.2.
As long as AMERSHAM manufacture Plasminogen Resin it will sell
OMRIX,
at a fair market price and in accordance with Amersham standard
supply
conditions as regards lead times and delivery conditions
(Conditions
of Sale, as attached). Amersham undertakes to sell up to ***
litre
with *** days lead time. The parties intend to enter into a
separate
supply agreement when the annual volumes exceeds *** litres. In
the
event Amersham decides to stop manufacture the Plasminogen Resin
it
shall give OMRIX six (6) months written notice in advance. In
the
event that AMERSHAM stops supplying Plasminogen Resin for a period
of
over 5 months, OMRIX will have right to terminate this
Agreement
forthwith upon thirty (30) days written notice, provided
AMERSHAM
fails to supply the quantity of Plasminogen Resin ordered by
Omrix
within such notice period, and in addition to the provisions of
Section 14 hereto, AMERSHAM will upon written request transfer
to
OMRIX all the know how specific to the manufacturing of the
Plasminogen Resin, provided OMRIX agrees to reimburse AMERSHAM for
its
reasonable and verified costs in connection with such transfer
(as
opposed to consideration for the know how itself). AMERSHAM
shall
under no circumstances be obliged to disclose any secret
manufacturing
know-how relating to other products or AMERSHAMS general
manufacturing
methods.
2.3.
Without prejudice to the provisions of Sections 2.1-2.2 above,
AMERSHAM undertakes to inform Customers that OMRIX owns the Patent
and
all other intellectual property rights related to the
Plasminogen
Resin, and that any Customer wishing to use Plasminogen Resin for
any
purpose falling under any valid claims of the Patent other then
for
research purposes, needs prior to such use, and as condition
precedent
thereto, to (a) contact OMRIX directly, (b) sign a license
agreement
with OMRIX (the "RESTRICTION NOTICE"). The Restriction Notice will
be
included by AMERSHAM in its product catalogue and on its website.
In
addition, an insert with the Restriction Notice shall be supplied
with
all packages of Plasminogen Resin. Notwithstanding the above,
Amersham
shall in no event be responsible for the Customer's use of the
Plasminogen Resin, provided that AMERSHAM is not in breach of
this
Section 2.3. However, Amersham has no intention to act in breach
of
applicable patent law or any court orders prohibiting any supplies
to
a certain customer.
2.4.
Subject to Section 2.3, AMERSHAM shall not use the name of OMRIX
nor
of any of OMRIX's shareholders, directors, employees, agents,
or
Affiliates, nor the name of any inventor of Plasminogen Resin, nor
any
adaptation of
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such names, in any sales promotion, advertising, or any other form
of
publicity without the prior written approval of OMRIX in each
case.
3. APPLICATION
AND OWNERSHIP OF PATENT(S)
3.1.
OMRIX shall be responsible and will bear all past, present and
future
costs relating to the Patent(s) and Patent(s) applications.
3.2.
The parties shall in good faith mutually decide in which countries
to
file Patent application(s) in the name of OMRIX, and obtain the
best
possible Patent protection.
3.3
Should OMRIX decide
not to file Patent(s) application in any certain
country/ies), it shall promptly notify AMERSHAM of such decision.
In
such event, AMERSHAM, in addition to any other right it has, may
take
all necessary measures in order to obtain the best possible
Patent
protection in such country/ies and OMRIX undertakes to sign all
documents necessary to effectuate such protection.
3.4
AMERSHAM shall
reimburse OMRIX for 50% of its fees and expenses
relating to all agreed activities for the prosecution and
maintenance
of the Patents, provided however that AMERSHAM has been provided
with
a list of elected countries for the purpose of national phase
and/or a
draft of the filing so as to allow for review and approval at
least
thirty (30) days in advance. AMERSHAM's obligation to reimburse
OMRIX
shall not exceed 5 % of the Net Sales of the Plasminogen Resin
per
calendar year.
4. DELIVERY OF
KNOW-HOW
Subject to applicable laws, rules, regulations and the provisions
of this
Agreement, and for the purpose of enabling AMERSHAM to more fully
implement
the
License, OMRIX shall deliver to AMERSHAM all its documentary
materials
with
respect to the Know-How, and provide AMERSHAM with reasonable
assistance in the implementation of the Know-How in its plant in
Uppsala.
Nothing in this section shall require OMRIX to disclose to
AMERSHAM, or
grant AMERSHAM access to, any technological information received by
OMRIX
from
a third party and subject to restrictions on use or disclosure.
5. RESERVATION
OF RIGHTS
5.1.
AMERSHAM agrees and acknowledges that the Know-How is the sole
property of OMRIX, and nothing in this Agreement shall be construed
as
giving AMERSHAM any right or title to the Know-How, except for
the
License as specifically detailed in this Agreement.
5.2.
Except as described in Section 15.8 AMERSHAM shall not have the
right
to assign and/or to transfer and/or sublicense any of its rights
and
obligations under this Agreement to another or others without
the
prior written consent of OMRIX.
5.3.
Upon termination of this Agreement, all rights granted to
AMERSHAM,
under the License, shall revert back to OMRIX, and AMERSHAM shall
have
no further rights with respect to the rights ensuing from the
License.
However, upon expiration of the Patents or the Agreement (not as
a
result of
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early termination), AMERSHAM shall have a fully-paid up
non-exclusive
license to freely use the Know-how.
6. OMRIX'
WARRANTIES, REPRESENTATIONS AND DISCLAIMERS
6.1.
OMRIX represents and warrants that:
6.1.1. that it has full authority to enter into this Agreement,
6.1.2. that it has no knowledge of any third party rights that
would
affect its ability to grant the license hereunder,
6.1.3. that to the best of its knowledge, all information and data
to
be provided to AMERSHAM is accurate and complete,
6.1.4. that the Patents to the best of its knowledge are not
infringed
or attacked by any third party,
6.1.5. that the Patents are not licensed to any third party, except
as
provided for in Section 2.1, and
6.1.6. it is not aware of any third party patent rights that would
be
infringed by anything made, use or sold under the License.
6.2.
Save for the warranties set forth in Section 6.1 nothing In
this
Agreement shall be construed as:
6.2.1. a warranty or representation by OMRIX as to the validity
or
scope of any right related to the Plasminogen Resin;
6.2.2. a warranty or representation that anything made, used, sold
or
otherwise disposed of under the license granted in this
Agreement
will or will not infringe patents of third parties;
6.2.3. an obligation to bring or prosecute actions or suits
against
third parties for infringement of OMRlX's intellectual property
rights related to the Plasminogen Resin;
6.2.4. an obligation to furnish any know-how or any services
other
than those specified in this Agreement.
6.3.
Except as otherwise expressly set forth in this Agreement, OMRIX
makes
no representation and extends no warranties of any kind, either
express or implied, including but not limited to warranties of
merchantability, fitness for a particular purpose, and validity
of
patent rights claims, issued or pending. OMRIX assumes no
responsibilities whatsoever with respect to use, sale, or other
disposition by AMERSHAM or its Customers or other transferees
of
products incorporating or made by use of the Kno
