LICENSE AGREEMENT
THIS AGREEMENT (the "Agreement") dated as of April ___, 1999 by and between
HAEMACURE CORPORATION, a corporation organized and existing under the laws of
Quebec, Canada having its main office at _____________________ Quebec, Canada
_______, (hereinafter referred to as "HAE" or the "Licensor") and ZLB CENTRAL
LABORATORY BLOOD TRANSFUSION SERVICE SRC, a foundation organized and existing
under the laws of Switzerland, having its main office and place of business at
Wankdorfstrasse 10, of 3000 Bern 22, (hereinafter referred to as "ZLB" or the
"Licensee"), (HAE and ZLB are hereinafter jointly referred to as "the Parties").
RECITALS:
A. WHEREAS, ZLB develops, manufactures and sells blood products and
derivatives and has the respective expertise;
B. WHEREAS, HAE has developed certain technology and know-how relating to
a fibrin sealant product. HAE is the owner of certain Patent Rights (as
hereinafter defined) having claims covering inventions and improvements relating
to HAE's technology relating to this fibrin sealant product;
C. WHEREAS, HAE and ZLB entered into a Cooperation and License Agreement
dated March 29, 1996 in order to (i) further develop and scale-up the
manufacturing process in respect of the Initial Product (as hereinafter defined)
incorporating the HAE Technology (as hereinafter defined) and Patent Rights and
(ii) conduct clinical testing of the Initial Product;
D. WHEREAS, HAE and ZLB both contributed technology regarding the scale-up
and commercial manufacturing of the Initial Product;
E. WHEREAS, ZLB desires to obtain, and HAE is willing to grant, a
non-exclusive right and license to manufacture, use and market on a worldwide
basis the Products (as hereinafter defined) for the financial consideration and
royalties described herein, as well as HAE desires to obtain, and ZLB is willing
to grant, a non-exclusive cross-license to HAE to use, market and promote
Products on a world-wide basis.
AGREEMENT:
NOW, THEREFORE, in consideration of premises and covenants hereinafter set
forth, the parties hereto agree as follows:
<PAGE>
1. DEFINITIONS
As used in this Agreement, the following terms have the following meanings
respectively;
1.1 "Affiliate" means, with respect to any Person, any other Person that
directly, or indirectly through one or more intermediaries, controls
or is controlled by or is under common control with such Person. For
purposes hereof, the term "control" (including, with its correlative
meanings, the terms "controlled by": and "under common control with"),
with respect to any Person, means the possession, directly or
indirectly, of the power or direct or cause the direction of the
management and policies of such Person (whether through the ownership
of voting securities, by contract or otherwise); provided, that in
each event in which any Person owns directly or indirectly more than
30% of the securities having ordinary voting power forth election of
directors or other governing body of a corporation or more than 30% of
the ownership interest of any other Person, such Person shall be
deemed to control such corporation or other Person.
1.2 "Bio-Material Projects" shall mean the projects regarding fibrin
sealant products as described on Exhibit A hereto with Nycomed
Amersham and Quadrant Healthcare (UK) limited, or any Affiliate
thereof.
1.3 "Device" means any accessory, applicator, device or other means for
application of Products.
1.4 "Field of Use" means any application of Products other than the
specific Bio-Material Projects.
1.5 "HAE Technology" shall mean all technical information, technical
knowledge, know-how, experience, trade secrets, clinical data and
information, product specifications, formulations, designs, dossiers,
uses, processes and toxicological, pharmacological clinical and
medical data, health registration data, relating to the manufacture,
use, registration and sale developed, owned or controlled by HAE
relating to the Initial Product or Patent Rights.
1.6 "Improvements" shall mean any improvement, development or invention
derived from or relating to Patent Rights or HAE Technology
identified, developed or made at any time during the term of this
Agreement.
2
<PAGE>
1.7 "Initial Products" shall mean the fibrin sealant product known under
the trade name Hemaseel HMN and the specifications which are those set
forth in Exhibit B attached hereto.
1.8 "Net Sales" means the gross amount invoiced or otherwise charged by
Licensee and its Affiliates for the sale or other disposition of
Products, less the following deductions (to the extent not recovered
or recoverable from any Person): (a) trade and/or quantity discounts
actually allowed and taken in amounts as are customary in the trade,
(b) sales and other excise taxes and customs duties paid, absorbed or
allowed, (c) transportation, postage and insurance costs, (d) amounts
repaid, credited or allowed by reason of rejection, defects or
returns; and (e) amounts allocated for any Device sold with the
Product; provided, that in no event shall the aggregate of all such
deductions with respect to the Net Sales of any Products in a
particular country exceed ___% of the amount invoiced or otherwise
charged by Licensee or such Affiliate (as the case may be) for such
Products in such country unless Licensee provides to Licensor
appropriate documentation reasonably satisfactory to Licensor
indicating for such particular country that the aggregate of all such
deductions exceed ___% and Licensor approves the deduction thereof in
writing (which approval shall not be unreasonably withheld by
Licensor) (collectively "Permitted Deductions"). In the event of any
sale or other disposition of any Products by Licensee to any Affiliate
thereof for resale to its customers, "Net Sales" shall be based on the
greater of the gross amount invoiced or otherwise charged by Licensee
to such Affiliate or the gross amount invoiced or otherwise charged by
such Affiliate to its customers for such Products, less (in either
such case) the Permitted Deductions. In the event of any Products
which are not sold but are otherwise disposed of by Licensee or any
Affiliate thereof, "Net Sales" for purposes of computing the royalties
payable hereunder shall be the then current selling price charged by
Licensee or such Affiliate for such Products or, if none, the selling
price at which products of a similar nature sold in similar quantities
are then currently being offered for sale by Licensee or such
Affiliate less (in either such case) the Permitted Deductions;
provided, that "Net Sales" shall not include any amount for any
Products which are not sold but are otherwise disposed of by Licensee
or any Affiliate thereof in the ordinary course of its business (and
consistent with past practices) solely for purposes of research and
development activities, obtaining governmental approvals or providing
free samples or other similar marketing efforts relating to the
Products.
3
<PAGE>
1.9 "Patent Rights" means the patents and patent applications as specified
in Exhibit C, and all patent applications that may hereafter be filed
by or on behalf of HAE for the Initial Product, and, all patents which
may be granted pursuant to any of such patent applications, including
any and all reissues, extensions, substitutions, confirmations,
registrations, revalidations, additions, continuations in part and
divisions/thereof and any supplemental protection certificates related
thereto.
1.10 "Persons" means any individual, estate, trust, partnership, joint
venture, association, firm, corporation, limited liability company or
company, or any governmental body, agency or official, or any other
entity.
1.11 "Products" means a fibrin sealant consisting of combining fibrinogen
and thrombin, in any form, made, used, developed or sold by Licensee
using any of the HAE Technology or which is covered by any claim
included within the Patent Rights, including any Improvements.
1.12 "ZLB Technology" shall mean all patents, patent applications,
technical information, know-how, experience, trade secrets, clinical
data and information, including but not limited to product
specifications, formulations, designs, dossiers, uses, processes and
toxicological, pharmacological, clinical and medical data, health
registration data, related to the manufacture, use registration and
sale developed, owned or controlled by ZLB relating to the Products.
2. GRANT OF LICENSE
2.1 Exclusive Manufacturing License for Initial Product: HAE hereby grants
ZLB a sole and exclusive worldwide license to manufacture the Initial
Product under the Patent Rights and HAE Technology. HAE hereby
confirms and undertakes that during the term of this Agreement, HAE
shall not make, use or grant to any third party whatsoever any right,
title or interest in the Patents and HAE Technology for the sole
purpose of manufacturing the Initial Product.
2.2 Non-exclusive License. Licensor hereby grants to ZLB a non-exclusive
worldwide license to the HAE Technology and Patent Rights to make,
use, sell, offer for sale, research and develop Products in the Field
of Use.
4
<PAGE>
2.3 Sublicense. ZLB shall be entitled to sublicense the rights granted in
Sections 2.2-2.3 to a third party in the event that ZLB has difficulty
in production capacity or otherwise and for purposes of appointing a
marketing partner to sell such Products.
2.4 Cross License. ZLB hereby grants HAE a non-exclusive world-wide
license to use, sell, offer for sale and import any and all Products,
including any and all rights in ZLB Technology necessary to use, sell,
offer for sale and import the Products. Notwithstanding the forgoing
or the fact HAE Technology or Patent Rights has been incorporated into
a developed product other than the Initial Product, Haemacure shall
have no rights to Products developed under this License Agreement
(other than the Initial Product or liquid formulation of the Product)
if such product was developed with a third-party that provided
substantial technology or development efforts to develop the product
and such third party fails to consent to Haemacure's co-marketing the
product after ZLB extends commercially reasonable efforts to obtain
HAE such rights.
2.5 Title and Ownership. Title to and ownership of the HAE Technology and
the Patent Rights shall remain with HAE, and ZLB shall not acquire (by
implication, by estoppel or otherwise) any rights thereto or license
thereunder, except as expressly provided herein. Nothing in this
Agreement shall be construed to provide either party with any rights
to assets of the other party or its Affiliates other than as
specifically provided in this Agreement. HAE specifically retains the
right to do itself all things it is licensing hereunder, except for
the manufacture of the Initial Product described in Section 2.1.
2.6 Disclosure. HC shall disclose to ZLB the complete patent applications
filed or to be filed relating to Products as well as all information
received concerning the institution or possible institution of any
interference, opposition, re-examination, reissue, revocation,
nullification or any official proceeding involving a patent anywhere.
ZLB shall have the right to review all such pending and proposed
applications and other proceedings.
2.7 Notification of Improvement. ZLB undertakes to notify and furnish HAE
information relating to any Improvements made by or which may come
within the possession or control of ZLB relating to the Products.
5
<PAGE>
3. RESPONSIBILITIES OF LICENSEE
3.1 Facility. Licensee shall (at its sole cost and expense) use reasonable
diligence relating to the development, manufacture and sale of the
Initial Product, including continuing construction of a dedicated
facility for the manufacture of the Initial Product in accordance with
the project schedule attached as Exhibit D; provided, however, that
Licensee shall be entitled to exercise customary and prudent business
judgment in performing its obligations hereunder.
3.2 Clinical Trials. Licensee shall (at its sole cost and expense) use
reasonable diligence in conducting clinical trials for registration of
the Initial Product in the United States and European countries. HAE
shall provide ZLB such assistance as is reasonably requested by ZLB.
ZLB shall consult with HAE regarding indications of use, provided
however, the strategy and implementation of the clinical trials shall
be in the sole discretion of ZLB.
3.3 Registrations. Licensee shall in each country or jurisdiction in which
Licensee desires to import, manufacture, market, distribute, sell or
use any Products, obtain all necessary licenses, declarations, filings
and registrations and pay or otherwise satisfy all applicable taxes,
fees, fines and penalties to, any governmental or regulatory (domestic
or foreign) or any other Person (either governmental or private)
relating thereto. All development, including but not limited to
registration, shall be made in the name of ZLB.
3.4 Good Faith. Licensee shall take no action the purpose of which is to
avoid its obligations under this Agreement, including designing around
the Patent Rights or entering into third-party development agreements
to foreclose HAE's co-marketing rights in the Products.
4. PAYMENT
4.1 General Consideration: In consideration of the license granted under
Section 2, ZLB agrees to the following payments and grant of rights:
(i) Up-front Payment: ZLB agrees to pay HAE an initial
non-refundable, one-time payment of USD __ Mio payment, payable
contemporaneous with the execution of this Agreement.
6
<PAGE>
(ii) Royalty: Further, ZLB shall pay to HAE a royalty amount of 5%
percent of Net Sales of the Products.
(iii) Co-marketing Right: Further, ZLB's license hereunder is
conditioned upon the grant to HAE of co-marketing rights as
described in Section 2.4 and the execution by ZLB of the Supply
Agreement attached hereto as Exhibit D.
4.2 No Offsets; Late Payments. All amounts payable under this Agreement
are payable in [U.S. Dollars], without any deduction, offset, defense
or counterclaim for any reason whatsoever. Interest on late payments
shall be assessed by Licensor and payable by Licensee at the rate of
1-1/2% per month of part thereof that any such payment remains unpaid,
or the maximum amount permitted by law, whichever is less. Licensee
shall pay or reimburse Licensor for all costs of collection,
including, without limitation, reasonable attorneys' fees and
expenses.
4.3 Payment. Royalties shall be payable by Licensee within 30 days after
the end of each calendar quarter based on the Net Sales of the
Products during the preceding calendar quarter. Such payments shall be
accompanied by a statement setting forth the Net Sales of the Products
by Licensee and its Affiliates, which statement shall indicate (i) the
gross amount invoiced or otherwise charged by Licensee and its
Affiliates for the sale or other disposition of the charged by
Licensee and its Affiliates for the sale or other disposition of the
Products, (ii) the Net Sales of the Products, and (iii) the Permitted
Deductions taken by Licensee with respect to sales or other
dispositions of the Products in any country where the amount thereof
exceeds 20% of the gross amount invoiced or otherwise charged therefor
and Licensor has approved the deduction thereof as provided in Section
1.8 hereof.
4.4 Accounting; Blocked Currency. The aggregate amount of the Net sales of
the Products used for computing the royalties payable by Licensee
pursuant to Section 5.1(i) hereof shall be computed in the U.S.
Dollars, and all payments of such royalties shall be made in U.S.
Dollars. For purposes of determining the amount of royalties due with
respect to any period, the amount of the Net Sales of the Products
during such period in any foreign currency ("Other Currency") shall be
computed generally by converting such amount into U.S. Dollars in
accordance with generally accepted accounting principles and pursuant
to Licensee's formal established accounting procedures for the
calculation of Licensee's foreign earnings for financial reporting
purposes with
7
<PAGE>
respect to such period. Licensee shall pay to Licensor the amount of
accrued royalties in respect of any such Net Sales within 30 business
days after the date on which the relevant Other Currency shall become
convertible into U.S. Dollars and transferable to _________. Licensee
shall provide to Licensor such documentation with respect to any of
the above situations as Licensor shall reasonably request.
4.5 Records. Licensee shall keep complete and accurate records of the Net
Sales of the Products in sufficient detail to allow the royalties
payable hereunder to be accurately determined. Licensor shall have the
right for a period of two years after receiving any report or
statement with respect to royalties due and payable hereunder to
appoint an independent accounting firm reasonably acceptable to
Licensee to inspect and audit the relevant records of Licensee and its
Affiliates to verify such report or statement. Licensee and its
Affiliates shall make their records available for inspection and audit
by such independent accounting firm of Licensor during regular
business hours at such place r places where such records are
customarily kept, upon reasonable notice to Licensee, to the extent
reasonably necessary to verify the accuracy of the reports and
payments required hereunder; provided, that such inspection and audit
right shall not be exercised more than once in any calendar year with
respect to Licensee or any Affiliate thereof. Licensor shall be
responsible for the cost of any such inspection and audit by an
independent accounting firm, unless such inspection and audit
discloses for any calendar quarter examined that there shall have been
a discrepancy of greater than 5% between the royalties payable by
Licensee hereunder and the royalties actually paid to Licensor with
respect to such calendar quarter, in which case Licensee shall be
responsible for the payment of the entire cost of such inspection and
audit. Licensor agrees to hold confidential all information concerning
royalty payments and reports, and all information obtained from
Licensee or any Affiliate thereof in the course of any inspection or
audit hereunder, except to the extent that it is necessary for
Licensor to disclose such information in order to enforce its rights
under this Agreement or if required by law or any governmental
authority (including, without limitation, any s tock exchange upon
which Licensor's shares or other securities may be traded); provided,
however, if any party shall be required by law to disclose any such
Confidential Information to any other Person, such party shall give
prompt written notice thereof to the other party and impose upon any
Person entitled to obtain such Confidential Information such
obligations of confidentiality as may be lawfully available.
8
<PAGE>
5. REPRESENTATIONS AND WARRANTIES
5.1 By Licensor. Licensor hereby represents and warrants to Licensee that
(a) Licensor has full legal right, power and authority to execute,
deliver and perform its obligations under this Agreement, (b) the
execution, delivery and performance by Licensor of this Agreement do
not contravene or constitute a default under any provision of
applicable law or of any agreement, judgment, injunction, order,
decree or other instrument binding upon Licensor, (c) to the best
knowledge of Licensor, the use of the HAE Technology and practice of
the Patent Rights by Licensee as provided herein do not infringe or
violate any patent or other right of any Person, and (d) this
Agreement constitutes a valid and binding agreement of Licensor,
enforceable against Licensor in accordance with its terms except as
such enforceability may be (i) limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting creditors' rights
generally and (ii) subject to general principles of equity (regardless
of whether such enforceability is considered in a proceeding in equity
or at law).
5.2 By Licensee. Licensee hereby represents and warrants to Licensor that
(a) Licensee has full legal right, power and authority to execute,
deliver and perform its obligations under this Agreement, (b) the
execution, delivery and performance by Licensee of this Agreement do
not contravene or constitute a default under any provision of
applicable law or of any agreement, judgment, injunction, order,
decree or other instrument binding upon Licensee, and (c) this
Agreement constitutes a valid and binding agreement of Licensee,
enforceable against Licensee in accordance with its terms except as
such enforceability may be (i) limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting creditors' rights
generally and (ii) subject to general principles of equity (regardless
of whether such enforceability is considered in a proceeding in equity
or at law).
5.3 Negation of Representations and Warranties. Nothing in this Agreement
shall be construed as:
(i) an obligation of either party to bring, prosecute or defend
actions or suits, or to assist the other party in bringing,
prosecuting or defending actions or suits, against third parties
for infringement, except as provided in Section 8.2; or
9
<PAGE>
(ii) conferring the right to use in advertising, publicity or
otherwise any trademark, trade name, or names, or any
contraction, abbreviation, simulation or adaptation thereof, of
either party or any contraction thereof or the name of any of
its employees, inventors, officers, and trustees in any
advertising, promotional, or sales literature without the prior
written consent of such party, including the express
understanding that the trade name Hemaseel HMN shall remain the
sole property of HAE; or
(iii) conferring by implication, estoppel or otherwise any license or
rights under any patents of Licensor other than the Patent
Rights, regardless of whether such patents are dominant or
subordinate to the Patent Rights; or
(iv) granting any rights to Licensor in any patents or trade secrets
of Licensee developed independently of any technology licensed
hereunder and without use of any trade secrets, patents or other
intellectual property of Licensor.
5.4 Survival of Representations and Warranties. The representations and
warranties contained herein shall survive the execution, delivery and
performance of this Agreement by the parties, notwithstanding any
investigation at any time made by or on behalf of any party or
parties.
6. LIMITATIONS ON LIABILITY
6.1 No Warranties. Except as expressly set forth in Section 5 of this
Agreement, neither party makes any representations or warranties as to
any matter whatsoever. LICENSOR DISCLAIMS ANY EXPRESS OR IMPLIED
WARRANTY (a) THAT THE LICENSOR DISCLAIMS ANY EXPRESS OR IMPLIED
WARRANTY (a) THAT HAE TECHNOLOGY OR THE USE THEREOF, THE PATENT RIGHTS
OR THE PRACTICE THEREOF OR THE PRODUCTS WILL BE FREE FROM CLAIMS OF
PATENT INFRINGEMENT, INTERFERENCE OR UNLAWFUL USE OF PROPRIETARY
INFORMATION OF ANY PERSON AND (b) OF THE ACCURACY, RELIABILITY,
TECHNOLOGICAL OR COMMERCIAL VALUE OR MERCHANTABILITY OF THE HAE
TECHNOLOGY, THE PATENT RIGHTS OR THE PRODUCTS, OR THEIR SUITABILITY OR
THE FITNESS THEREOF FOR ANY PARTICULAR PURPOSE, INCLUDING, WITHOUT
LIMITATION, THE DESIGN,
10
<PAGE>
DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY PRODUCTS, AND LICENSOR
DISCLAIMS ALL OTHER WARRANTIES OF WHATEVER NATURE, EXPRESS OR IMPLIED.
6.2 Limitation of Liability. The liability of Licensor under this
Agreement for any cause whatsoever, regardless of the form of action
(whether in contract, in tort, including negligence, or otherwise),
shall be limited to general money damages (and no other relief) in an
amount not to exceed the aggregate amounts actually paid by Licensee
or Licensor hereunder. UNDER NO CIRCUMSTANCES SHALL LICENSOR BE LIABLE
TO LICENSEE OR ANY OTHER PERSON FOR ANY LOSS OF PROFITS OR SPECIAL,
CONSEQUENTIAL OR INDIRECT DAMAGES OF ANY KIND WHATSOEVER.
6.3 Force Majeure. No party shall be liable for failure or delay in
performing any of its obligations hereunder if such failure or delay
is occasioned by compliance with any governmental regulation, request
or order, or by circumstances beyond the reasonable control of the
party so failing or delaying, including, without limitation, Acts of
God, war, insurrection, fire, flood, accident, labor strikes, work
stoppage or slowdown (whether or not such labor event is within the
reasonable control of the parties), or inability to obtain raw
materials, supplies, power or equipment necessary to enable such party
to perform it obligations hereunder. Each party shall (a) promptly
notify the other party in writing of any such event of force majeure,
the expected duration thereof and its anticipated effect on the
ability of such party to perform its obligations hereunder, and (b)
make reasonable efforts to remedy any such event of force majeure.
7. PATENT MAINTENANCE AND RENEWAL
7.1 Patent prosecution. HAE and ZLB undertake to keep each other promptly
and fully informed of the course of patent prosecution or other
proceedings. ZLB shall provide such patent consultation to HAE at no
cost to HAE.
7.2 Patent Maintenance; Extension. Licensor shall pay any maintenance fee
or take any other steps to maintain any of its Patent Rights relating
to the Product in force; provided, however, Licensor shall not be
required to do any of the foregoing if Licensor believes any such
action would be contrary to its reasonable business judgment, in which
event Licensor shall notify Licensee in writing at least 30 days prior
to taking or not
11
<PAGE>
taking any action which would result in the loss of rights hereunder
and if Licensee chooses; Licensor shall permit Licensee to take such
actions at its own expense.
7.3 Grant regarding future patent. HAE shall independently, or at ZLB's
request, but at its own cost diligently prosecute to grant all future
patent applications within the Patent Rights so as to secure the
broadest claims reasonably obtainable.
7.4 Timely notification. HAE shall notify ZLB in a timely manner before
taking any decision to abandon a pending patent application or an
issued patent included in Patent Rights. Thereafter, ZLB shall have
the option, at its own expense, of continuing to prosecute any such
pending patent application or of keeping the issued patent in force.
7.5 Reimbursements of costs. Within 30 days of receipt of invoices from
HAE, ZLB shall reimburse HAE for 50% of all the costs of filing,
prosecuting, extending, responding to opposition and maintaining
patent applications and patents in countries where filings have been
made as of the execution date of this Agreement.
7.6 Improvements. In the event of any Improvements by ZLB, ZLB shall
decide on its own discretion as to whether or not patent applications
shall be filed. And any such application shall be in ZLB's name only.
8. PATENT PROTECTION AND LITIGATION
8.1 Notification of infringement: Each of the parties shall promptly
notify the other in the event of any potential infringement by any
third party or any claims relating to the Patent Rights or Products.
The Parties shall keep one another informed of the status of and of
their respective activities regarding any litigation or settlement
thereof concerning the Patent Rights and HAE Technology, or the
Initial Products.
8.2 Infringement Claims. If infringement occurs, Licensor may, at its
option, and at its own expense, take steps to prevent further
infringement by third parties of Patent Rights or other rights
licensed hereunder. In connection with any action taken by Licensor to
prevent infringement of or defend challenges to any Patent Rights or
other rights licensed hereunder, the Licensee shall cooperate fully
and, if requested, make available to Licensor any and all relevant
information, data, documents, consultants, expert witnesses, and any
other materials or
12
<PAGE>
assistance reasonably required, provided that the costs of any such
materials or assistance shall be paid for by the Licensor. In the
event Licensor fails to take reasonable steps to prevent further
infringement of Patient Rights or other rights licensed hereunder by
third parties within 30 days following notice of an infringement,
Licensee shall have the right to take such action as it deems
appropriate to halt such infringement, at its own expense, provided
that the infringement is on fibrin sealant products, and materially
affects Licensee's exercise of the rights licensed hereunder. Licensee
recognizes Licensor's substantial interest in the outcome of such
proceedings and shall diligently pursuant such proceedings with
competent counsel. Licensee shall permit Licensor, at its own expense,
to engage counsel and participate fully in such proceedings. Licensor
agrees to cooperate fully with Licensee and execute any documents
determined by Licensee to be necessary, at Licensee's expense.
8.3 Product Liability Claims. Licensee agrees to indemnify, defend and
hold harmless Licensor and its Affiliates, and their respective
directors, officers, employees and agents, from and against any and
all claims, demands, losses, liabilities, damages, costs and expenses
(including the cost of settlement, legal and accounting fees and any
other expenses for investigating or defending any actions or
threatened actions) arising out of, relating to, resulting from or in
connection with the manufacture, packaging, labeling, marketing,
distribution, sale and/or use by Licensee or any Affiliate thereof of
any Product or the negligence, misconduct or fraud of Licensee or any
affiliate thereof, or their respective directors, officers, employees
or agents, except to the extent that the same relates only to the
Patent Rights, the Licensed Test Technology or the use thereof by
Licensee as provided herein. In the event such claim is made or such
an action is commenced, Licensor agrees to promptly notify Licensee of
such claim or action and Licensee may, at its option, elect to assume
control of the defense of such claim or action; provided, however,
that (a) Licensor shall be entitled to participate therein (through
counsel of its own choosing) at Licensor's sole cost and expense, and
(b) Licensee shall not settle or compromise any such claim or action
without the prior written consent of Licensor, unless such settlement
or compromise includes a general release of Licensor and its
Affiliates, and their respective directors, officers, employees and
agents, from any and all liability with respect thereto.
8.4 Litigation: The party taking enforcement action shall not settle any
alleged infringement of the Patent Rights or rights licensed
13
<PAGE>
hereunder that would adversely affect the other party without such
other party" prior written consent, which will not be unreasonably
withheld.
8.5 Allocation of Recovery: The award or settlement in any such litigation
shall be used first to reimburse the party taking such action for its
fees and expenses, with any balance divided between the parties in
proportion to the injury caused to each by the infringement.
9. DURATION AND TERMINATION
9.1 Duration. This Agreement shall commence on the date of signing and
shall continue in full force until the expiry of the last patent
included in the Patent Rights unless earlier terminated in accordance
with Section 9.2 below. After the end of this period, the Agreement
shall expire without notice. The parties may agree to extend the term
of this Agreement.
9.2 Circumstances of Termination. The Parties hereto anticipate this
Agreement may be terminated by the respective Party upon the
occurrence of one of the following events:
(i) Either party may terminate this Agreement in the event that the
other party files or has filed against it (and such filing is
not dismissed or stayed within 60 days) a petition in bankruptcy
or enters into any similar arrangement for the benefit of its
creditors.
(ii) In the event that any of the Patent Rights shall be invalidated
or denied by a final court decision, ZLB shall be entitled to
terminate this Agreement upon 30 days written notice.
(iii) In the event that the Initial Product becomes incapable of
obtaining approval or registration with the appropriate
agencies, both Parties shall be entitled to terminate this
Agreement upon 60 days written notice.
(iv) Either party may terminate this Agreement if the other party
commits a material breach of its obligations hereunder and such
breach is not cured within 30 days after receipt of notice
specifying such breach.
(v) In the event that ZLB materially violates the Supply Agreement
between the parties and such violation is not
14
<PAGE>
cured within 30 days, HAE shall be entitled to terminate this
Agreement upon 30 days written notice.
9.3 Consequences of Termination. The termination of this Agreement for any
reason shall be without prejudice to(i) the right of Licensor to
receive all amounts accrued under Section 4 hereof prior to the
effective date of such termination, (ii) the confidentiality and
nondisclosure obligations of the parties pursuant to Section 10
hereof, and (iii) any other remedies as may now or hereafter be
available to any party, whether under this agreement of otherwise. If
this Agreement is terminated by the Licensor pursuant to this Section
9, Licensee and its Affiliates shall (a) discontinue the manufacture,
use and sale of the Products, if (i) any patents shall have issued and
be included within the Patent Rights which cover such Products, and
(ii) the effective date of such termination is before the expiration
of the last to expire of such patents, and (b) immediately cease the
use of all Confidential Information and all HAE Technology obtained
from Licensor.
10. CONFIDENTIALITY
10.1 Confidentiality. During the term of this Agreement and for a period of
10 years thereafter, each party shall keep strictly confidential and
shall not disclose to any third party any proprietary or confidential
information disclosed to it by the other Party hereunder or pursuant
to the Cooperation and License Agreement in writing, or orally
disclosed hereunder and confirmed in writing as being confidential
promptly after its oral disclosure, except to the extent such
disclosed information
(i) is or becomes generally available to the public through no fault
on the part of the receiving party, or
(ii) was known to the receiving party prior to receipt thereof as
evidenced by prior written documents in the possession of the
receiving party, or
(iii) is subsequently disclosed to the receiving party in good faith
by a third party who is not under an obligation of secrecy as to
the information disclosed.
10.2 Inter-Party Disclosures. It is agreed that, for the purpose of this
Agreement, specific disclosures of information disclosed to each other
shall not be deemed to be within the foregoing exceptions merely
because they are embraced by general disclosures in the receiving
party's possession or in the public domain.
15
<PAGE>
10.3 Third parties. Each party hereby undertakes to impose the same
obligation of secrecy on its employees, licensees or sub-licensees,
contractors or agents, as the case may be.
11. GOVERNING LAW AND ARBITRATION
11.1 Governing Law: The validity, construction, interpretation and
performance of this Agreement shall be governed by the substantive
Laws of Switzerland expressly excluding the conflict of law rules.
11.2 Arbitration: Any or all disputes arising between the parties hereto
from or in connection with this Agreement or in respect of the
conclusion interpretation, breach or enforcement thereof shall, where
not capable of being settled amicably, be settled to the exclusion of
recourse to the ordinary courts of law finally and with binding effect
by arbitration under the Rules of the International Chamber of
Commerce by an arbitration tribunal consisting of three arbitrators
appointed in accordance with the said Rules, save that each party is
entitled as a provisional and protective measure to seek injunctive
relief from an ordinary court of law as may be possible under
[Canadian or US] or Swiss law. The foregoing shall also apply to the
decision respecting the jurisdiction of the arbitration tribunal and
the validity of this arbitration clause. Any such arbitration shall be
held in Paris and be conducted in the English language.
12. MODIFICATIONS AND NOTICES
12.1 Modifications. No modification hereof shall be of any force or effect
unless reduced to writing and signed by the parties claimed to be
bound thereby and no modification shall be effected by the
acknowledgement or acceptance of any order containing different
conditions.
12.2 Notice. All communication notices or the like between the parties
shall be valid when made by telegraph or telex communication
subsequently to be confirmed in writing and addressed to the following
addresses:
To Licensee: CEO
ZLB CENTRAL LABORATORY,
BLOOD TRANSFUSION SERVICE SRC,
Wankdorfstrasse 10,
3000 Bern 22, Switzerland
Attention: Chief Executive Officer
16
<PAGE>
with a copy to: Naegeli & Streichenberg
Stockerstrasse 38
CH-8002 Zurich, Switzerland
Attention: Peter J. Schmid
To Licensor: HAEMACURE CORPORATION
One Sarasota Tower
Two North Tamiami Trail, Suite 802,
Sarasota FL 34236, USA
Attention: Chief Executive Officer
with a copy to: Foley & Lardner
777 East Wisconsin Avenue
Milwaukee, Wisconsin 53202-5367
Attention: James F. Stern
13. SEVERABILITY
13.1 In the event any provision of this Agreement is declared illegal or
unenforceable, it is the intent of both parties that the remaining
provisions shall continue in full force and effect and that the
illegal or unenforceable provision shall be substituted by a provision
having a similar commercial effect.
14. NO WAIVER
14.1 No waiver: No waiver of any breach of any part of the terms or
conditions herein contained to be performed by the other party shall
not be construed as a waiver of any subsequent breach whether for the
same or any other term or condition hereof
15. MISCELLANEOUS
15.1 Assignment by ZLB. This Agreement and all rights, liabilities and
obligations hereunder shall be binding upon and inure to the benefit
of ZLB or its successor ZLB AG or any of its subsidiaries or licensees
under this Agreement. HC expressly agrees that all rights and duties
contained in this Agreement may be transferred and assigned to the new
ZLB AG after its incorporation.
17
<PAGE>
15.2 Assignment by HAE. This Agreement and all rights, liabilities and
obligations hereunder shall be binding upon and inure to the benefit
of HAE or its successor, assigns, subsidiaries or licenses under this
Agreement, provided, however, the cross license under Section 2.4 and
Supply Agreement may only be assigned in whole and not in part.
15.3 Entire Agreement: Along with the Supply Agreement, this Agreement
constitutes the legal, valid, binding and enforceable obligation and
sets forth the entire understanding of the parties and supersedes and
cancels any prior communications, understandings and agreements
between the parties relating to the subject matter hereof and may not
be amended or modified except in writing executed by each of the
parties.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.
For and on behalf of Haemacure For and on behalf of ZLB
By: By:
--------------------------- ------------------------------
Typed name: Typed name:
------------------- ----------------------
Position: Position:
--------------------- ------------------------
18
<PAGE>
EXHIBIT A
DESCRIPTION OF
BIO-MATERIAL PROJECTS
19
<PAGE>
EXHIBIT B
SPECIFICATIONS:
INITIAL PRODUCT
20
<PAGE>
EXHIBIT C
PATENTS AND
PATENT APPLICATIONS
21
<PAGE>
EXHIBIT D
FACILITY PROJECT SCHEDULE
22
